innovazione nel settore dei dispositivi medici€¦ · innovazione ? the isdb is a forum for over...
TRANSCRIPT
Innovazione nel settore dei dispositivi medici
GF Gensini
Roma 20 dicembre 2016
INNOVAZIONE
The ISDB is a forum for over 80 therapeutic journals
which are all independent of the pharmaceutical industry
the distinction between
bull genuine therapeutic advance and
bull mere innovation
were the driving force behind this ISDB Declaration
The term lsquoinnovationrsquo covers three concepts
bullThe commercial concept any newly marketed me-
too product new substances new indications
new formulations and new treatment methods
bullThe technology concept any industrial innovation
such as use of biotechnology or the introduction of
a new substance delivery system (patch spray
etc) selection of an isomer or a metabolite
bullThe concept of therapeutic advance a new
treatment that benefits the patient when compared to
previously existing options
ISDB Declaration on therapeutic advance - November 2001
Disponibile per iOS e Android
APP ndash Dispositivo medico certificato
wwwlaborsadelmedicoit
reg
La app laquoLa borsa del medicoraquo permette il
calcolo di score relativi a vari aspetti clinici
Il calcolo degli score egrave in alcuni casi legato ad
informazioni sulle possibili prescrizioni
terapeutiche secondo linee guida ufficiali
Impiego delle app come strumento di
supporto alle attivitagrave cliniche dei
sanitari
Vantaggi
Abbiamo chiesto a 6 medici volontari di effettuare un test di confronto tra il metodo
classico manuale e quello della APP laquoLa borsa del medicoraquo
Questi i risultati ottenuti
How to manage
Errors in blood transfusion
bullHydratation
bullEarly Ultrafiltration
bullEculizumab ()
1995
Lrsquoinnovazione dirompentedistruttiva
hellip angioplasty was disruptive to open heart surgery just as drugs that lower cholesterol are
disruptive to angioplasty telemedicine to usual medicinehellip
Lrsquoinnovazione dirompentedistruttiva
hellip angioplasty was disruptive to open heart surgery just as drugs that lower cholesterol are
disruptive to angioplasty telemedicine to usual medicinehellip
This person does not exist
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
This person does not exist
This person does not exist HeShe is the average person of
EBM Evidence
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
EBM Groups and Individuals
bull Evidence comes from groups of patients Decisions are made by for individuals
bull Whatrsquos best on average must be best for each individual
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
KaplanndashMeier Curves for Total Revascularizations
De Bruyne B et al N Engl J Med 20143711208-1217
Conclusions
bull In patients with stable coronary artery disease FFR-guided PCI as compared with medical therapy alone improved the outcome
bull Patients without ischemia had a favorable outcome with medical therapy alone
Public Health Regional Resolution
Personalized Medicine
Stratified medicine
Systems Medicine
P4 Medicine
Narrative Medicine
Knowledge Based Medicine Translational Medicine
Patient Centered Care
Precision medicine
Heart Failure Facts bull The primary economical and social burden of HF syndrome is
hospitalization rate whose costs represent the highest ones ($40B per year in USA) within the entire health care management [1]
bull Approximately 80 of HF hospital admissions are driven by pulmonary congestion symptoms [23]
bull Almost 90 of acute decompensated HF patients after the admittance to the emergency department receive iv loop diuretic as the treatment of choice [4]
bull Despite therapy more than 50 of hospitalized patients for acute decompensated HF have little or no dyspnea improvement and weight loss after hospital discharge [235]
1 2014 American Heart Association Heart and Stroke Statistics 2 OConnor CM J Cardiac Fail 2005 11 200-205 3 Tavazzi L et al Eur Heart J 2006271207-1215 4 Wong YW he (ADHERE-EM) Am Heart J 2013 Aug166(2)349-56 doi 101016 5 Fonarow GC Rev Cardiovasc Med 20034 Suppl 7S21-30
Physiological Premise of IHM Guided Care
-21 -14 - 7 Days
Reactive Proactive
0
Symptoms
Pressure Changes
Heart Failure Event
CHAMPION Trial By Targeting Pressure Ranges and Titrating Medications Overall PAPs Can Be Reduced
Compared to the control group patients managed with PAP had persistently lower mean PA pressures over the treatment period
CHAMPION Trial PAP Mean Change from Baseline
Abraham WT et al Lancet 2011
PA
Me
an
Pre
as
ure
AU
C (
mm
Hg
-Da
ys
)
-220
-200
-180
-160
-140
-120
-100
-80
-60
-40
-20
0
20
40
60
80
100
Days from Implant
0 30 60 90 120 150 180
p = 00077
Treatment (-1557 mmHg-Days)Control (331 mmHg-Days)
cardioMEMS-CHAMPION trial
In 68 of cases Loop diuretic dose change
The Evolution of Pressure-Guided Therapy
Congestion is the limiting symptom
Symptoms and weights do not provide a reliable early warning system
Seeing is relieving
Events are associated with increased pulmonary pressures
HF preserved EF is more the same than different
Treating the peaks is not enough to prevent events
Reduce not just peaks but also the plateau
Does CHAMPION duplicate what can be seen by measuring electrical Intra-thoracic Impedance (ITI)
bull Remote of assessment of ITI is now currently provided by innovative technology embedded in implantable defibrillators (ICD and CRT D devices)
bull The OPTIVOL ITI detection system has been developed by MEDTRONIC and has been widely tested to prove efficacy of intra-thoracic impedance decline to manage pending acute decompensated HF
Intrathoracic impedance measurement by implantable system
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
Algorithm performance on validation data set
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
For validation data set nominal threshold of 60 Ωd resulted in
sensitivity of 769 and false-positive rate of 15 false-
positives per patient-year of monitoring as highlighted by
circle
15
The OPTIVOL fluid index pivotal trials van Veldhuisen D et al Circulation 2011 DOT HF
The OPTIVOL fluid index pivotal trials Bohm M et al et al EHJ 2015 OPTILINK
Patients with potentially higher risk of cardiac decompensationdeterioration presenting at least 1 out of 4 criteria
bull HF-related Hospitalization within the last 12 months bull IV-Oral Diuretic Treatment within last 30 days bull Increased BNP within last 30 daysgt 400pgml bull Increased NT-pro-BNP within last 30 days [gt 400 pgml (lt 50 yrs) gt 900 pgml (50-75 yrs) gt 1800 pgml (gt 75 yrs)]
Intra-thoracic Impedance Limitations
bull The OptiVol find can be insensitive in chronically volume overloaded patients or when volume accumulation occurs very slowly
bull In the case the reference impedance also changes it prevent separation to occur between reference and measured impedance and than it prevent the calculated cumulative sum to rise
Zile M et al Circulation Heart Failure 2016
1924hellipTelemedicine (radiomedicine)
come in
INNOVAZIONE
The ISDB is a forum for over 80 therapeutic journals
which are all independent of the pharmaceutical industry
the distinction between
bull genuine therapeutic advance and
bull mere innovation
were the driving force behind this ISDB Declaration
The term lsquoinnovationrsquo covers three concepts
bullThe commercial concept any newly marketed me-
too product new substances new indications
new formulations and new treatment methods
bullThe technology concept any industrial innovation
such as use of biotechnology or the introduction of
a new substance delivery system (patch spray
etc) selection of an isomer or a metabolite
bullThe concept of therapeutic advance a new
treatment that benefits the patient when compared to
previously existing options
ISDB Declaration on therapeutic advance - November 2001
Disponibile per iOS e Android
APP ndash Dispositivo medico certificato
wwwlaborsadelmedicoit
reg
La app laquoLa borsa del medicoraquo permette il
calcolo di score relativi a vari aspetti clinici
Il calcolo degli score egrave in alcuni casi legato ad
informazioni sulle possibili prescrizioni
terapeutiche secondo linee guida ufficiali
Impiego delle app come strumento di
supporto alle attivitagrave cliniche dei
sanitari
Vantaggi
Abbiamo chiesto a 6 medici volontari di effettuare un test di confronto tra il metodo
classico manuale e quello della APP laquoLa borsa del medicoraquo
Questi i risultati ottenuti
How to manage
Errors in blood transfusion
bullHydratation
bullEarly Ultrafiltration
bullEculizumab ()
1995
Lrsquoinnovazione dirompentedistruttiva
hellip angioplasty was disruptive to open heart surgery just as drugs that lower cholesterol are
disruptive to angioplasty telemedicine to usual medicinehellip
Lrsquoinnovazione dirompentedistruttiva
hellip angioplasty was disruptive to open heart surgery just as drugs that lower cholesterol are
disruptive to angioplasty telemedicine to usual medicinehellip
This person does not exist
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
This person does not exist
This person does not exist HeShe is the average person of
EBM Evidence
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
EBM Groups and Individuals
bull Evidence comes from groups of patients Decisions are made by for individuals
bull Whatrsquos best on average must be best for each individual
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
KaplanndashMeier Curves for Total Revascularizations
De Bruyne B et al N Engl J Med 20143711208-1217
Conclusions
bull In patients with stable coronary artery disease FFR-guided PCI as compared with medical therapy alone improved the outcome
bull Patients without ischemia had a favorable outcome with medical therapy alone
Public Health Regional Resolution
Personalized Medicine
Stratified medicine
Systems Medicine
P4 Medicine
Narrative Medicine
Knowledge Based Medicine Translational Medicine
Patient Centered Care
Precision medicine
Heart Failure Facts bull The primary economical and social burden of HF syndrome is
hospitalization rate whose costs represent the highest ones ($40B per year in USA) within the entire health care management [1]
bull Approximately 80 of HF hospital admissions are driven by pulmonary congestion symptoms [23]
bull Almost 90 of acute decompensated HF patients after the admittance to the emergency department receive iv loop diuretic as the treatment of choice [4]
bull Despite therapy more than 50 of hospitalized patients for acute decompensated HF have little or no dyspnea improvement and weight loss after hospital discharge [235]
1 2014 American Heart Association Heart and Stroke Statistics 2 OConnor CM J Cardiac Fail 2005 11 200-205 3 Tavazzi L et al Eur Heart J 2006271207-1215 4 Wong YW he (ADHERE-EM) Am Heart J 2013 Aug166(2)349-56 doi 101016 5 Fonarow GC Rev Cardiovasc Med 20034 Suppl 7S21-30
Physiological Premise of IHM Guided Care
-21 -14 - 7 Days
Reactive Proactive
0
Symptoms
Pressure Changes
Heart Failure Event
CHAMPION Trial By Targeting Pressure Ranges and Titrating Medications Overall PAPs Can Be Reduced
Compared to the control group patients managed with PAP had persistently lower mean PA pressures over the treatment period
CHAMPION Trial PAP Mean Change from Baseline
Abraham WT et al Lancet 2011
PA
Me
an
Pre
as
ure
AU
C (
mm
Hg
-Da
ys
)
-220
-200
-180
-160
-140
-120
-100
-80
-60
-40
-20
0
20
40
60
80
100
Days from Implant
0 30 60 90 120 150 180
p = 00077
Treatment (-1557 mmHg-Days)Control (331 mmHg-Days)
cardioMEMS-CHAMPION trial
In 68 of cases Loop diuretic dose change
The Evolution of Pressure-Guided Therapy
Congestion is the limiting symptom
Symptoms and weights do not provide a reliable early warning system
Seeing is relieving
Events are associated with increased pulmonary pressures
HF preserved EF is more the same than different
Treating the peaks is not enough to prevent events
Reduce not just peaks but also the plateau
Does CHAMPION duplicate what can be seen by measuring electrical Intra-thoracic Impedance (ITI)
bull Remote of assessment of ITI is now currently provided by innovative technology embedded in implantable defibrillators (ICD and CRT D devices)
bull The OPTIVOL ITI detection system has been developed by MEDTRONIC and has been widely tested to prove efficacy of intra-thoracic impedance decline to manage pending acute decompensated HF
Intrathoracic impedance measurement by implantable system
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
Algorithm performance on validation data set
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
For validation data set nominal threshold of 60 Ωd resulted in
sensitivity of 769 and false-positive rate of 15 false-
positives per patient-year of monitoring as highlighted by
circle
15
The OPTIVOL fluid index pivotal trials van Veldhuisen D et al Circulation 2011 DOT HF
The OPTIVOL fluid index pivotal trials Bohm M et al et al EHJ 2015 OPTILINK
Patients with potentially higher risk of cardiac decompensationdeterioration presenting at least 1 out of 4 criteria
bull HF-related Hospitalization within the last 12 months bull IV-Oral Diuretic Treatment within last 30 days bull Increased BNP within last 30 daysgt 400pgml bull Increased NT-pro-BNP within last 30 days [gt 400 pgml (lt 50 yrs) gt 900 pgml (50-75 yrs) gt 1800 pgml (gt 75 yrs)]
Intra-thoracic Impedance Limitations
bull The OptiVol find can be insensitive in chronically volume overloaded patients or when volume accumulation occurs very slowly
bull In the case the reference impedance also changes it prevent separation to occur between reference and measured impedance and than it prevent the calculated cumulative sum to rise
Zile M et al Circulation Heart Failure 2016
1924hellipTelemedicine (radiomedicine)
come in
The term lsquoinnovationrsquo covers three concepts
bullThe commercial concept any newly marketed me-
too product new substances new indications
new formulations and new treatment methods
bullThe technology concept any industrial innovation
such as use of biotechnology or the introduction of
a new substance delivery system (patch spray
etc) selection of an isomer or a metabolite
bullThe concept of therapeutic advance a new
treatment that benefits the patient when compared to
previously existing options
ISDB Declaration on therapeutic advance - November 2001
Disponibile per iOS e Android
APP ndash Dispositivo medico certificato
wwwlaborsadelmedicoit
reg
La app laquoLa borsa del medicoraquo permette il
calcolo di score relativi a vari aspetti clinici
Il calcolo degli score egrave in alcuni casi legato ad
informazioni sulle possibili prescrizioni
terapeutiche secondo linee guida ufficiali
Impiego delle app come strumento di
supporto alle attivitagrave cliniche dei
sanitari
Vantaggi
Abbiamo chiesto a 6 medici volontari di effettuare un test di confronto tra il metodo
classico manuale e quello della APP laquoLa borsa del medicoraquo
Questi i risultati ottenuti
How to manage
Errors in blood transfusion
bullHydratation
bullEarly Ultrafiltration
bullEculizumab ()
1995
Lrsquoinnovazione dirompentedistruttiva
hellip angioplasty was disruptive to open heart surgery just as drugs that lower cholesterol are
disruptive to angioplasty telemedicine to usual medicinehellip
Lrsquoinnovazione dirompentedistruttiva
hellip angioplasty was disruptive to open heart surgery just as drugs that lower cholesterol are
disruptive to angioplasty telemedicine to usual medicinehellip
This person does not exist
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
This person does not exist
This person does not exist HeShe is the average person of
EBM Evidence
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
EBM Groups and Individuals
bull Evidence comes from groups of patients Decisions are made by for individuals
bull Whatrsquos best on average must be best for each individual
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
KaplanndashMeier Curves for Total Revascularizations
De Bruyne B et al N Engl J Med 20143711208-1217
Conclusions
bull In patients with stable coronary artery disease FFR-guided PCI as compared with medical therapy alone improved the outcome
bull Patients without ischemia had a favorable outcome with medical therapy alone
Public Health Regional Resolution
Personalized Medicine
Stratified medicine
Systems Medicine
P4 Medicine
Narrative Medicine
Knowledge Based Medicine Translational Medicine
Patient Centered Care
Precision medicine
Heart Failure Facts bull The primary economical and social burden of HF syndrome is
hospitalization rate whose costs represent the highest ones ($40B per year in USA) within the entire health care management [1]
bull Approximately 80 of HF hospital admissions are driven by pulmonary congestion symptoms [23]
bull Almost 90 of acute decompensated HF patients after the admittance to the emergency department receive iv loop diuretic as the treatment of choice [4]
bull Despite therapy more than 50 of hospitalized patients for acute decompensated HF have little or no dyspnea improvement and weight loss after hospital discharge [235]
1 2014 American Heart Association Heart and Stroke Statistics 2 OConnor CM J Cardiac Fail 2005 11 200-205 3 Tavazzi L et al Eur Heart J 2006271207-1215 4 Wong YW he (ADHERE-EM) Am Heart J 2013 Aug166(2)349-56 doi 101016 5 Fonarow GC Rev Cardiovasc Med 20034 Suppl 7S21-30
Physiological Premise of IHM Guided Care
-21 -14 - 7 Days
Reactive Proactive
0
Symptoms
Pressure Changes
Heart Failure Event
CHAMPION Trial By Targeting Pressure Ranges and Titrating Medications Overall PAPs Can Be Reduced
Compared to the control group patients managed with PAP had persistently lower mean PA pressures over the treatment period
CHAMPION Trial PAP Mean Change from Baseline
Abraham WT et al Lancet 2011
PA
Me
an
Pre
as
ure
AU
C (
mm
Hg
-Da
ys
)
-220
-200
-180
-160
-140
-120
-100
-80
-60
-40
-20
0
20
40
60
80
100
Days from Implant
0 30 60 90 120 150 180
p = 00077
Treatment (-1557 mmHg-Days)Control (331 mmHg-Days)
cardioMEMS-CHAMPION trial
In 68 of cases Loop diuretic dose change
The Evolution of Pressure-Guided Therapy
Congestion is the limiting symptom
Symptoms and weights do not provide a reliable early warning system
Seeing is relieving
Events are associated with increased pulmonary pressures
HF preserved EF is more the same than different
Treating the peaks is not enough to prevent events
Reduce not just peaks but also the plateau
Does CHAMPION duplicate what can be seen by measuring electrical Intra-thoracic Impedance (ITI)
bull Remote of assessment of ITI is now currently provided by innovative technology embedded in implantable defibrillators (ICD and CRT D devices)
bull The OPTIVOL ITI detection system has been developed by MEDTRONIC and has been widely tested to prove efficacy of intra-thoracic impedance decline to manage pending acute decompensated HF
Intrathoracic impedance measurement by implantable system
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
Algorithm performance on validation data set
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
For validation data set nominal threshold of 60 Ωd resulted in
sensitivity of 769 and false-positive rate of 15 false-
positives per patient-year of monitoring as highlighted by
circle
15
The OPTIVOL fluid index pivotal trials van Veldhuisen D et al Circulation 2011 DOT HF
The OPTIVOL fluid index pivotal trials Bohm M et al et al EHJ 2015 OPTILINK
Patients with potentially higher risk of cardiac decompensationdeterioration presenting at least 1 out of 4 criteria
bull HF-related Hospitalization within the last 12 months bull IV-Oral Diuretic Treatment within last 30 days bull Increased BNP within last 30 daysgt 400pgml bull Increased NT-pro-BNP within last 30 days [gt 400 pgml (lt 50 yrs) gt 900 pgml (50-75 yrs) gt 1800 pgml (gt 75 yrs)]
Intra-thoracic Impedance Limitations
bull The OptiVol find can be insensitive in chronically volume overloaded patients or when volume accumulation occurs very slowly
bull In the case the reference impedance also changes it prevent separation to occur between reference and measured impedance and than it prevent the calculated cumulative sum to rise
Zile M et al Circulation Heart Failure 2016
1924hellipTelemedicine (radiomedicine)
come in
Disponibile per iOS e Android
APP ndash Dispositivo medico certificato
wwwlaborsadelmedicoit
reg
La app laquoLa borsa del medicoraquo permette il
calcolo di score relativi a vari aspetti clinici
Il calcolo degli score egrave in alcuni casi legato ad
informazioni sulle possibili prescrizioni
terapeutiche secondo linee guida ufficiali
Impiego delle app come strumento di
supporto alle attivitagrave cliniche dei
sanitari
Vantaggi
Abbiamo chiesto a 6 medici volontari di effettuare un test di confronto tra il metodo
classico manuale e quello della APP laquoLa borsa del medicoraquo
Questi i risultati ottenuti
How to manage
Errors in blood transfusion
bullHydratation
bullEarly Ultrafiltration
bullEculizumab ()
1995
Lrsquoinnovazione dirompentedistruttiva
hellip angioplasty was disruptive to open heart surgery just as drugs that lower cholesterol are
disruptive to angioplasty telemedicine to usual medicinehellip
Lrsquoinnovazione dirompentedistruttiva
hellip angioplasty was disruptive to open heart surgery just as drugs that lower cholesterol are
disruptive to angioplasty telemedicine to usual medicinehellip
This person does not exist
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
This person does not exist
This person does not exist HeShe is the average person of
EBM Evidence
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
EBM Groups and Individuals
bull Evidence comes from groups of patients Decisions are made by for individuals
bull Whatrsquos best on average must be best for each individual
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
KaplanndashMeier Curves for Total Revascularizations
De Bruyne B et al N Engl J Med 20143711208-1217
Conclusions
bull In patients with stable coronary artery disease FFR-guided PCI as compared with medical therapy alone improved the outcome
bull Patients without ischemia had a favorable outcome with medical therapy alone
Public Health Regional Resolution
Personalized Medicine
Stratified medicine
Systems Medicine
P4 Medicine
Narrative Medicine
Knowledge Based Medicine Translational Medicine
Patient Centered Care
Precision medicine
Heart Failure Facts bull The primary economical and social burden of HF syndrome is
hospitalization rate whose costs represent the highest ones ($40B per year in USA) within the entire health care management [1]
bull Approximately 80 of HF hospital admissions are driven by pulmonary congestion symptoms [23]
bull Almost 90 of acute decompensated HF patients after the admittance to the emergency department receive iv loop diuretic as the treatment of choice [4]
bull Despite therapy more than 50 of hospitalized patients for acute decompensated HF have little or no dyspnea improvement and weight loss after hospital discharge [235]
1 2014 American Heart Association Heart and Stroke Statistics 2 OConnor CM J Cardiac Fail 2005 11 200-205 3 Tavazzi L et al Eur Heart J 2006271207-1215 4 Wong YW he (ADHERE-EM) Am Heart J 2013 Aug166(2)349-56 doi 101016 5 Fonarow GC Rev Cardiovasc Med 20034 Suppl 7S21-30
Physiological Premise of IHM Guided Care
-21 -14 - 7 Days
Reactive Proactive
0
Symptoms
Pressure Changes
Heart Failure Event
CHAMPION Trial By Targeting Pressure Ranges and Titrating Medications Overall PAPs Can Be Reduced
Compared to the control group patients managed with PAP had persistently lower mean PA pressures over the treatment period
CHAMPION Trial PAP Mean Change from Baseline
Abraham WT et al Lancet 2011
PA
Me
an
Pre
as
ure
AU
C (
mm
Hg
-Da
ys
)
-220
-200
-180
-160
-140
-120
-100
-80
-60
-40
-20
0
20
40
60
80
100
Days from Implant
0 30 60 90 120 150 180
p = 00077
Treatment (-1557 mmHg-Days)Control (331 mmHg-Days)
cardioMEMS-CHAMPION trial
In 68 of cases Loop diuretic dose change
The Evolution of Pressure-Guided Therapy
Congestion is the limiting symptom
Symptoms and weights do not provide a reliable early warning system
Seeing is relieving
Events are associated with increased pulmonary pressures
HF preserved EF is more the same than different
Treating the peaks is not enough to prevent events
Reduce not just peaks but also the plateau
Does CHAMPION duplicate what can be seen by measuring electrical Intra-thoracic Impedance (ITI)
bull Remote of assessment of ITI is now currently provided by innovative technology embedded in implantable defibrillators (ICD and CRT D devices)
bull The OPTIVOL ITI detection system has been developed by MEDTRONIC and has been widely tested to prove efficacy of intra-thoracic impedance decline to manage pending acute decompensated HF
Intrathoracic impedance measurement by implantable system
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
Algorithm performance on validation data set
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
For validation data set nominal threshold of 60 Ωd resulted in
sensitivity of 769 and false-positive rate of 15 false-
positives per patient-year of monitoring as highlighted by
circle
15
The OPTIVOL fluid index pivotal trials van Veldhuisen D et al Circulation 2011 DOT HF
The OPTIVOL fluid index pivotal trials Bohm M et al et al EHJ 2015 OPTILINK
Patients with potentially higher risk of cardiac decompensationdeterioration presenting at least 1 out of 4 criteria
bull HF-related Hospitalization within the last 12 months bull IV-Oral Diuretic Treatment within last 30 days bull Increased BNP within last 30 daysgt 400pgml bull Increased NT-pro-BNP within last 30 days [gt 400 pgml (lt 50 yrs) gt 900 pgml (50-75 yrs) gt 1800 pgml (gt 75 yrs)]
Intra-thoracic Impedance Limitations
bull The OptiVol find can be insensitive in chronically volume overloaded patients or when volume accumulation occurs very slowly
bull In the case the reference impedance also changes it prevent separation to occur between reference and measured impedance and than it prevent the calculated cumulative sum to rise
Zile M et al Circulation Heart Failure 2016
1924hellipTelemedicine (radiomedicine)
come in
La app laquoLa borsa del medicoraquo permette il
calcolo di score relativi a vari aspetti clinici
Il calcolo degli score egrave in alcuni casi legato ad
informazioni sulle possibili prescrizioni
terapeutiche secondo linee guida ufficiali
Impiego delle app come strumento di
supporto alle attivitagrave cliniche dei
sanitari
Vantaggi
Abbiamo chiesto a 6 medici volontari di effettuare un test di confronto tra il metodo
classico manuale e quello della APP laquoLa borsa del medicoraquo
Questi i risultati ottenuti
How to manage
Errors in blood transfusion
bullHydratation
bullEarly Ultrafiltration
bullEculizumab ()
1995
Lrsquoinnovazione dirompentedistruttiva
hellip angioplasty was disruptive to open heart surgery just as drugs that lower cholesterol are
disruptive to angioplasty telemedicine to usual medicinehellip
Lrsquoinnovazione dirompentedistruttiva
hellip angioplasty was disruptive to open heart surgery just as drugs that lower cholesterol are
disruptive to angioplasty telemedicine to usual medicinehellip
This person does not exist
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
This person does not exist
This person does not exist HeShe is the average person of
EBM Evidence
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
EBM Groups and Individuals
bull Evidence comes from groups of patients Decisions are made by for individuals
bull Whatrsquos best on average must be best for each individual
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
KaplanndashMeier Curves for Total Revascularizations
De Bruyne B et al N Engl J Med 20143711208-1217
Conclusions
bull In patients with stable coronary artery disease FFR-guided PCI as compared with medical therapy alone improved the outcome
bull Patients without ischemia had a favorable outcome with medical therapy alone
Public Health Regional Resolution
Personalized Medicine
Stratified medicine
Systems Medicine
P4 Medicine
Narrative Medicine
Knowledge Based Medicine Translational Medicine
Patient Centered Care
Precision medicine
Heart Failure Facts bull The primary economical and social burden of HF syndrome is
hospitalization rate whose costs represent the highest ones ($40B per year in USA) within the entire health care management [1]
bull Approximately 80 of HF hospital admissions are driven by pulmonary congestion symptoms [23]
bull Almost 90 of acute decompensated HF patients after the admittance to the emergency department receive iv loop diuretic as the treatment of choice [4]
bull Despite therapy more than 50 of hospitalized patients for acute decompensated HF have little or no dyspnea improvement and weight loss after hospital discharge [235]
1 2014 American Heart Association Heart and Stroke Statistics 2 OConnor CM J Cardiac Fail 2005 11 200-205 3 Tavazzi L et al Eur Heart J 2006271207-1215 4 Wong YW he (ADHERE-EM) Am Heart J 2013 Aug166(2)349-56 doi 101016 5 Fonarow GC Rev Cardiovasc Med 20034 Suppl 7S21-30
Physiological Premise of IHM Guided Care
-21 -14 - 7 Days
Reactive Proactive
0
Symptoms
Pressure Changes
Heart Failure Event
CHAMPION Trial By Targeting Pressure Ranges and Titrating Medications Overall PAPs Can Be Reduced
Compared to the control group patients managed with PAP had persistently lower mean PA pressures over the treatment period
CHAMPION Trial PAP Mean Change from Baseline
Abraham WT et al Lancet 2011
PA
Me
an
Pre
as
ure
AU
C (
mm
Hg
-Da
ys
)
-220
-200
-180
-160
-140
-120
-100
-80
-60
-40
-20
0
20
40
60
80
100
Days from Implant
0 30 60 90 120 150 180
p = 00077
Treatment (-1557 mmHg-Days)Control (331 mmHg-Days)
cardioMEMS-CHAMPION trial
In 68 of cases Loop diuretic dose change
The Evolution of Pressure-Guided Therapy
Congestion is the limiting symptom
Symptoms and weights do not provide a reliable early warning system
Seeing is relieving
Events are associated with increased pulmonary pressures
HF preserved EF is more the same than different
Treating the peaks is not enough to prevent events
Reduce not just peaks but also the plateau
Does CHAMPION duplicate what can be seen by measuring electrical Intra-thoracic Impedance (ITI)
bull Remote of assessment of ITI is now currently provided by innovative technology embedded in implantable defibrillators (ICD and CRT D devices)
bull The OPTIVOL ITI detection system has been developed by MEDTRONIC and has been widely tested to prove efficacy of intra-thoracic impedance decline to manage pending acute decompensated HF
Intrathoracic impedance measurement by implantable system
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
Algorithm performance on validation data set
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
For validation data set nominal threshold of 60 Ωd resulted in
sensitivity of 769 and false-positive rate of 15 false-
positives per patient-year of monitoring as highlighted by
circle
15
The OPTIVOL fluid index pivotal trials van Veldhuisen D et al Circulation 2011 DOT HF
The OPTIVOL fluid index pivotal trials Bohm M et al et al EHJ 2015 OPTILINK
Patients with potentially higher risk of cardiac decompensationdeterioration presenting at least 1 out of 4 criteria
bull HF-related Hospitalization within the last 12 months bull IV-Oral Diuretic Treatment within last 30 days bull Increased BNP within last 30 daysgt 400pgml bull Increased NT-pro-BNP within last 30 days [gt 400 pgml (lt 50 yrs) gt 900 pgml (50-75 yrs) gt 1800 pgml (gt 75 yrs)]
Intra-thoracic Impedance Limitations
bull The OptiVol find can be insensitive in chronically volume overloaded patients or when volume accumulation occurs very slowly
bull In the case the reference impedance also changes it prevent separation to occur between reference and measured impedance and than it prevent the calculated cumulative sum to rise
Zile M et al Circulation Heart Failure 2016
1924hellipTelemedicine (radiomedicine)
come in
Vantaggi
Abbiamo chiesto a 6 medici volontari di effettuare un test di confronto tra il metodo
classico manuale e quello della APP laquoLa borsa del medicoraquo
Questi i risultati ottenuti
How to manage
Errors in blood transfusion
bullHydratation
bullEarly Ultrafiltration
bullEculizumab ()
1995
Lrsquoinnovazione dirompentedistruttiva
hellip angioplasty was disruptive to open heart surgery just as drugs that lower cholesterol are
disruptive to angioplasty telemedicine to usual medicinehellip
Lrsquoinnovazione dirompentedistruttiva
hellip angioplasty was disruptive to open heart surgery just as drugs that lower cholesterol are
disruptive to angioplasty telemedicine to usual medicinehellip
This person does not exist
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
This person does not exist
This person does not exist HeShe is the average person of
EBM Evidence
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
EBM Groups and Individuals
bull Evidence comes from groups of patients Decisions are made by for individuals
bull Whatrsquos best on average must be best for each individual
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
KaplanndashMeier Curves for Total Revascularizations
De Bruyne B et al N Engl J Med 20143711208-1217
Conclusions
bull In patients with stable coronary artery disease FFR-guided PCI as compared with medical therapy alone improved the outcome
bull Patients without ischemia had a favorable outcome with medical therapy alone
Public Health Regional Resolution
Personalized Medicine
Stratified medicine
Systems Medicine
P4 Medicine
Narrative Medicine
Knowledge Based Medicine Translational Medicine
Patient Centered Care
Precision medicine
Heart Failure Facts bull The primary economical and social burden of HF syndrome is
hospitalization rate whose costs represent the highest ones ($40B per year in USA) within the entire health care management [1]
bull Approximately 80 of HF hospital admissions are driven by pulmonary congestion symptoms [23]
bull Almost 90 of acute decompensated HF patients after the admittance to the emergency department receive iv loop diuretic as the treatment of choice [4]
bull Despite therapy more than 50 of hospitalized patients for acute decompensated HF have little or no dyspnea improvement and weight loss after hospital discharge [235]
1 2014 American Heart Association Heart and Stroke Statistics 2 OConnor CM J Cardiac Fail 2005 11 200-205 3 Tavazzi L et al Eur Heart J 2006271207-1215 4 Wong YW he (ADHERE-EM) Am Heart J 2013 Aug166(2)349-56 doi 101016 5 Fonarow GC Rev Cardiovasc Med 20034 Suppl 7S21-30
Physiological Premise of IHM Guided Care
-21 -14 - 7 Days
Reactive Proactive
0
Symptoms
Pressure Changes
Heart Failure Event
CHAMPION Trial By Targeting Pressure Ranges and Titrating Medications Overall PAPs Can Be Reduced
Compared to the control group patients managed with PAP had persistently lower mean PA pressures over the treatment period
CHAMPION Trial PAP Mean Change from Baseline
Abraham WT et al Lancet 2011
PA
Me
an
Pre
as
ure
AU
C (
mm
Hg
-Da
ys
)
-220
-200
-180
-160
-140
-120
-100
-80
-60
-40
-20
0
20
40
60
80
100
Days from Implant
0 30 60 90 120 150 180
p = 00077
Treatment (-1557 mmHg-Days)Control (331 mmHg-Days)
cardioMEMS-CHAMPION trial
In 68 of cases Loop diuretic dose change
The Evolution of Pressure-Guided Therapy
Congestion is the limiting symptom
Symptoms and weights do not provide a reliable early warning system
Seeing is relieving
Events are associated with increased pulmonary pressures
HF preserved EF is more the same than different
Treating the peaks is not enough to prevent events
Reduce not just peaks but also the plateau
Does CHAMPION duplicate what can be seen by measuring electrical Intra-thoracic Impedance (ITI)
bull Remote of assessment of ITI is now currently provided by innovative technology embedded in implantable defibrillators (ICD and CRT D devices)
bull The OPTIVOL ITI detection system has been developed by MEDTRONIC and has been widely tested to prove efficacy of intra-thoracic impedance decline to manage pending acute decompensated HF
Intrathoracic impedance measurement by implantable system
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
Algorithm performance on validation data set
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
For validation data set nominal threshold of 60 Ωd resulted in
sensitivity of 769 and false-positive rate of 15 false-
positives per patient-year of monitoring as highlighted by
circle
15
The OPTIVOL fluid index pivotal trials van Veldhuisen D et al Circulation 2011 DOT HF
The OPTIVOL fluid index pivotal trials Bohm M et al et al EHJ 2015 OPTILINK
Patients with potentially higher risk of cardiac decompensationdeterioration presenting at least 1 out of 4 criteria
bull HF-related Hospitalization within the last 12 months bull IV-Oral Diuretic Treatment within last 30 days bull Increased BNP within last 30 daysgt 400pgml bull Increased NT-pro-BNP within last 30 days [gt 400 pgml (lt 50 yrs) gt 900 pgml (50-75 yrs) gt 1800 pgml (gt 75 yrs)]
Intra-thoracic Impedance Limitations
bull The OptiVol find can be insensitive in chronically volume overloaded patients or when volume accumulation occurs very slowly
bull In the case the reference impedance also changes it prevent separation to occur between reference and measured impedance and than it prevent the calculated cumulative sum to rise
Zile M et al Circulation Heart Failure 2016
1924hellipTelemedicine (radiomedicine)
come in
How to manage
Errors in blood transfusion
bullHydratation
bullEarly Ultrafiltration
bullEculizumab ()
1995
Lrsquoinnovazione dirompentedistruttiva
hellip angioplasty was disruptive to open heart surgery just as drugs that lower cholesterol are
disruptive to angioplasty telemedicine to usual medicinehellip
Lrsquoinnovazione dirompentedistruttiva
hellip angioplasty was disruptive to open heart surgery just as drugs that lower cholesterol are
disruptive to angioplasty telemedicine to usual medicinehellip
This person does not exist
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
This person does not exist
This person does not exist HeShe is the average person of
EBM Evidence
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
EBM Groups and Individuals
bull Evidence comes from groups of patients Decisions are made by for individuals
bull Whatrsquos best on average must be best for each individual
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
KaplanndashMeier Curves for Total Revascularizations
De Bruyne B et al N Engl J Med 20143711208-1217
Conclusions
bull In patients with stable coronary artery disease FFR-guided PCI as compared with medical therapy alone improved the outcome
bull Patients without ischemia had a favorable outcome with medical therapy alone
Public Health Regional Resolution
Personalized Medicine
Stratified medicine
Systems Medicine
P4 Medicine
Narrative Medicine
Knowledge Based Medicine Translational Medicine
Patient Centered Care
Precision medicine
Heart Failure Facts bull The primary economical and social burden of HF syndrome is
hospitalization rate whose costs represent the highest ones ($40B per year in USA) within the entire health care management [1]
bull Approximately 80 of HF hospital admissions are driven by pulmonary congestion symptoms [23]
bull Almost 90 of acute decompensated HF patients after the admittance to the emergency department receive iv loop diuretic as the treatment of choice [4]
bull Despite therapy more than 50 of hospitalized patients for acute decompensated HF have little or no dyspnea improvement and weight loss after hospital discharge [235]
1 2014 American Heart Association Heart and Stroke Statistics 2 OConnor CM J Cardiac Fail 2005 11 200-205 3 Tavazzi L et al Eur Heart J 2006271207-1215 4 Wong YW he (ADHERE-EM) Am Heart J 2013 Aug166(2)349-56 doi 101016 5 Fonarow GC Rev Cardiovasc Med 20034 Suppl 7S21-30
Physiological Premise of IHM Guided Care
-21 -14 - 7 Days
Reactive Proactive
0
Symptoms
Pressure Changes
Heart Failure Event
CHAMPION Trial By Targeting Pressure Ranges and Titrating Medications Overall PAPs Can Be Reduced
Compared to the control group patients managed with PAP had persistently lower mean PA pressures over the treatment period
CHAMPION Trial PAP Mean Change from Baseline
Abraham WT et al Lancet 2011
PA
Me
an
Pre
as
ure
AU
C (
mm
Hg
-Da
ys
)
-220
-200
-180
-160
-140
-120
-100
-80
-60
-40
-20
0
20
40
60
80
100
Days from Implant
0 30 60 90 120 150 180
p = 00077
Treatment (-1557 mmHg-Days)Control (331 mmHg-Days)
cardioMEMS-CHAMPION trial
In 68 of cases Loop diuretic dose change
The Evolution of Pressure-Guided Therapy
Congestion is the limiting symptom
Symptoms and weights do not provide a reliable early warning system
Seeing is relieving
Events are associated with increased pulmonary pressures
HF preserved EF is more the same than different
Treating the peaks is not enough to prevent events
Reduce not just peaks but also the plateau
Does CHAMPION duplicate what can be seen by measuring electrical Intra-thoracic Impedance (ITI)
bull Remote of assessment of ITI is now currently provided by innovative technology embedded in implantable defibrillators (ICD and CRT D devices)
bull The OPTIVOL ITI detection system has been developed by MEDTRONIC and has been widely tested to prove efficacy of intra-thoracic impedance decline to manage pending acute decompensated HF
Intrathoracic impedance measurement by implantable system
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
Algorithm performance on validation data set
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
For validation data set nominal threshold of 60 Ωd resulted in
sensitivity of 769 and false-positive rate of 15 false-
positives per patient-year of monitoring as highlighted by
circle
15
The OPTIVOL fluid index pivotal trials van Veldhuisen D et al Circulation 2011 DOT HF
The OPTIVOL fluid index pivotal trials Bohm M et al et al EHJ 2015 OPTILINK
Patients with potentially higher risk of cardiac decompensationdeterioration presenting at least 1 out of 4 criteria
bull HF-related Hospitalization within the last 12 months bull IV-Oral Diuretic Treatment within last 30 days bull Increased BNP within last 30 daysgt 400pgml bull Increased NT-pro-BNP within last 30 days [gt 400 pgml (lt 50 yrs) gt 900 pgml (50-75 yrs) gt 1800 pgml (gt 75 yrs)]
Intra-thoracic Impedance Limitations
bull The OptiVol find can be insensitive in chronically volume overloaded patients or when volume accumulation occurs very slowly
bull In the case the reference impedance also changes it prevent separation to occur between reference and measured impedance and than it prevent the calculated cumulative sum to rise
Zile M et al Circulation Heart Failure 2016
1924hellipTelemedicine (radiomedicine)
come in
1995
Lrsquoinnovazione dirompentedistruttiva
hellip angioplasty was disruptive to open heart surgery just as drugs that lower cholesterol are
disruptive to angioplasty telemedicine to usual medicinehellip
Lrsquoinnovazione dirompentedistruttiva
hellip angioplasty was disruptive to open heart surgery just as drugs that lower cholesterol are
disruptive to angioplasty telemedicine to usual medicinehellip
This person does not exist
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
This person does not exist
This person does not exist HeShe is the average person of
EBM Evidence
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
EBM Groups and Individuals
bull Evidence comes from groups of patients Decisions are made by for individuals
bull Whatrsquos best on average must be best for each individual
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
KaplanndashMeier Curves for Total Revascularizations
De Bruyne B et al N Engl J Med 20143711208-1217
Conclusions
bull In patients with stable coronary artery disease FFR-guided PCI as compared with medical therapy alone improved the outcome
bull Patients without ischemia had a favorable outcome with medical therapy alone
Public Health Regional Resolution
Personalized Medicine
Stratified medicine
Systems Medicine
P4 Medicine
Narrative Medicine
Knowledge Based Medicine Translational Medicine
Patient Centered Care
Precision medicine
Heart Failure Facts bull The primary economical and social burden of HF syndrome is
hospitalization rate whose costs represent the highest ones ($40B per year in USA) within the entire health care management [1]
bull Approximately 80 of HF hospital admissions are driven by pulmonary congestion symptoms [23]
bull Almost 90 of acute decompensated HF patients after the admittance to the emergency department receive iv loop diuretic as the treatment of choice [4]
bull Despite therapy more than 50 of hospitalized patients for acute decompensated HF have little or no dyspnea improvement and weight loss after hospital discharge [235]
1 2014 American Heart Association Heart and Stroke Statistics 2 OConnor CM J Cardiac Fail 2005 11 200-205 3 Tavazzi L et al Eur Heart J 2006271207-1215 4 Wong YW he (ADHERE-EM) Am Heart J 2013 Aug166(2)349-56 doi 101016 5 Fonarow GC Rev Cardiovasc Med 20034 Suppl 7S21-30
Physiological Premise of IHM Guided Care
-21 -14 - 7 Days
Reactive Proactive
0
Symptoms
Pressure Changes
Heart Failure Event
CHAMPION Trial By Targeting Pressure Ranges and Titrating Medications Overall PAPs Can Be Reduced
Compared to the control group patients managed with PAP had persistently lower mean PA pressures over the treatment period
CHAMPION Trial PAP Mean Change from Baseline
Abraham WT et al Lancet 2011
PA
Me
an
Pre
as
ure
AU
C (
mm
Hg
-Da
ys
)
-220
-200
-180
-160
-140
-120
-100
-80
-60
-40
-20
0
20
40
60
80
100
Days from Implant
0 30 60 90 120 150 180
p = 00077
Treatment (-1557 mmHg-Days)Control (331 mmHg-Days)
cardioMEMS-CHAMPION trial
In 68 of cases Loop diuretic dose change
The Evolution of Pressure-Guided Therapy
Congestion is the limiting symptom
Symptoms and weights do not provide a reliable early warning system
Seeing is relieving
Events are associated with increased pulmonary pressures
HF preserved EF is more the same than different
Treating the peaks is not enough to prevent events
Reduce not just peaks but also the plateau
Does CHAMPION duplicate what can be seen by measuring electrical Intra-thoracic Impedance (ITI)
bull Remote of assessment of ITI is now currently provided by innovative technology embedded in implantable defibrillators (ICD and CRT D devices)
bull The OPTIVOL ITI detection system has been developed by MEDTRONIC and has been widely tested to prove efficacy of intra-thoracic impedance decline to manage pending acute decompensated HF
Intrathoracic impedance measurement by implantable system
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
Algorithm performance on validation data set
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
For validation data set nominal threshold of 60 Ωd resulted in
sensitivity of 769 and false-positive rate of 15 false-
positives per patient-year of monitoring as highlighted by
circle
15
The OPTIVOL fluid index pivotal trials van Veldhuisen D et al Circulation 2011 DOT HF
The OPTIVOL fluid index pivotal trials Bohm M et al et al EHJ 2015 OPTILINK
Patients with potentially higher risk of cardiac decompensationdeterioration presenting at least 1 out of 4 criteria
bull HF-related Hospitalization within the last 12 months bull IV-Oral Diuretic Treatment within last 30 days bull Increased BNP within last 30 daysgt 400pgml bull Increased NT-pro-BNP within last 30 days [gt 400 pgml (lt 50 yrs) gt 900 pgml (50-75 yrs) gt 1800 pgml (gt 75 yrs)]
Intra-thoracic Impedance Limitations
bull The OptiVol find can be insensitive in chronically volume overloaded patients or when volume accumulation occurs very slowly
bull In the case the reference impedance also changes it prevent separation to occur between reference and measured impedance and than it prevent the calculated cumulative sum to rise
Zile M et al Circulation Heart Failure 2016
1924hellipTelemedicine (radiomedicine)
come in
Lrsquoinnovazione dirompentedistruttiva
hellip angioplasty was disruptive to open heart surgery just as drugs that lower cholesterol are
disruptive to angioplasty telemedicine to usual medicinehellip
Lrsquoinnovazione dirompentedistruttiva
hellip angioplasty was disruptive to open heart surgery just as drugs that lower cholesterol are
disruptive to angioplasty telemedicine to usual medicinehellip
This person does not exist
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
This person does not exist
This person does not exist HeShe is the average person of
EBM Evidence
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
EBM Groups and Individuals
bull Evidence comes from groups of patients Decisions are made by for individuals
bull Whatrsquos best on average must be best for each individual
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
KaplanndashMeier Curves for Total Revascularizations
De Bruyne B et al N Engl J Med 20143711208-1217
Conclusions
bull In patients with stable coronary artery disease FFR-guided PCI as compared with medical therapy alone improved the outcome
bull Patients without ischemia had a favorable outcome with medical therapy alone
Public Health Regional Resolution
Personalized Medicine
Stratified medicine
Systems Medicine
P4 Medicine
Narrative Medicine
Knowledge Based Medicine Translational Medicine
Patient Centered Care
Precision medicine
Heart Failure Facts bull The primary economical and social burden of HF syndrome is
hospitalization rate whose costs represent the highest ones ($40B per year in USA) within the entire health care management [1]
bull Approximately 80 of HF hospital admissions are driven by pulmonary congestion symptoms [23]
bull Almost 90 of acute decompensated HF patients after the admittance to the emergency department receive iv loop diuretic as the treatment of choice [4]
bull Despite therapy more than 50 of hospitalized patients for acute decompensated HF have little or no dyspnea improvement and weight loss after hospital discharge [235]
1 2014 American Heart Association Heart and Stroke Statistics 2 OConnor CM J Cardiac Fail 2005 11 200-205 3 Tavazzi L et al Eur Heart J 2006271207-1215 4 Wong YW he (ADHERE-EM) Am Heart J 2013 Aug166(2)349-56 doi 101016 5 Fonarow GC Rev Cardiovasc Med 20034 Suppl 7S21-30
Physiological Premise of IHM Guided Care
-21 -14 - 7 Days
Reactive Proactive
0
Symptoms
Pressure Changes
Heart Failure Event
CHAMPION Trial By Targeting Pressure Ranges and Titrating Medications Overall PAPs Can Be Reduced
Compared to the control group patients managed with PAP had persistently lower mean PA pressures over the treatment period
CHAMPION Trial PAP Mean Change from Baseline
Abraham WT et al Lancet 2011
PA
Me
an
Pre
as
ure
AU
C (
mm
Hg
-Da
ys
)
-220
-200
-180
-160
-140
-120
-100
-80
-60
-40
-20
0
20
40
60
80
100
Days from Implant
0 30 60 90 120 150 180
p = 00077
Treatment (-1557 mmHg-Days)Control (331 mmHg-Days)
cardioMEMS-CHAMPION trial
In 68 of cases Loop diuretic dose change
The Evolution of Pressure-Guided Therapy
Congestion is the limiting symptom
Symptoms and weights do not provide a reliable early warning system
Seeing is relieving
Events are associated with increased pulmonary pressures
HF preserved EF is more the same than different
Treating the peaks is not enough to prevent events
Reduce not just peaks but also the plateau
Does CHAMPION duplicate what can be seen by measuring electrical Intra-thoracic Impedance (ITI)
bull Remote of assessment of ITI is now currently provided by innovative technology embedded in implantable defibrillators (ICD and CRT D devices)
bull The OPTIVOL ITI detection system has been developed by MEDTRONIC and has been widely tested to prove efficacy of intra-thoracic impedance decline to manage pending acute decompensated HF
Intrathoracic impedance measurement by implantable system
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
Algorithm performance on validation data set
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
For validation data set nominal threshold of 60 Ωd resulted in
sensitivity of 769 and false-positive rate of 15 false-
positives per patient-year of monitoring as highlighted by
circle
15
The OPTIVOL fluid index pivotal trials van Veldhuisen D et al Circulation 2011 DOT HF
The OPTIVOL fluid index pivotal trials Bohm M et al et al EHJ 2015 OPTILINK
Patients with potentially higher risk of cardiac decompensationdeterioration presenting at least 1 out of 4 criteria
bull HF-related Hospitalization within the last 12 months bull IV-Oral Diuretic Treatment within last 30 days bull Increased BNP within last 30 daysgt 400pgml bull Increased NT-pro-BNP within last 30 days [gt 400 pgml (lt 50 yrs) gt 900 pgml (50-75 yrs) gt 1800 pgml (gt 75 yrs)]
Intra-thoracic Impedance Limitations
bull The OptiVol find can be insensitive in chronically volume overloaded patients or when volume accumulation occurs very slowly
bull In the case the reference impedance also changes it prevent separation to occur between reference and measured impedance and than it prevent the calculated cumulative sum to rise
Zile M et al Circulation Heart Failure 2016
1924hellipTelemedicine (radiomedicine)
come in
Lrsquoinnovazione dirompentedistruttiva
hellip angioplasty was disruptive to open heart surgery just as drugs that lower cholesterol are
disruptive to angioplasty telemedicine to usual medicinehellip
This person does not exist
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
This person does not exist
This person does not exist HeShe is the average person of
EBM Evidence
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
EBM Groups and Individuals
bull Evidence comes from groups of patients Decisions are made by for individuals
bull Whatrsquos best on average must be best for each individual
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
KaplanndashMeier Curves for Total Revascularizations
De Bruyne B et al N Engl J Med 20143711208-1217
Conclusions
bull In patients with stable coronary artery disease FFR-guided PCI as compared with medical therapy alone improved the outcome
bull Patients without ischemia had a favorable outcome with medical therapy alone
Public Health Regional Resolution
Personalized Medicine
Stratified medicine
Systems Medicine
P4 Medicine
Narrative Medicine
Knowledge Based Medicine Translational Medicine
Patient Centered Care
Precision medicine
Heart Failure Facts bull The primary economical and social burden of HF syndrome is
hospitalization rate whose costs represent the highest ones ($40B per year in USA) within the entire health care management [1]
bull Approximately 80 of HF hospital admissions are driven by pulmonary congestion symptoms [23]
bull Almost 90 of acute decompensated HF patients after the admittance to the emergency department receive iv loop diuretic as the treatment of choice [4]
bull Despite therapy more than 50 of hospitalized patients for acute decompensated HF have little or no dyspnea improvement and weight loss after hospital discharge [235]
1 2014 American Heart Association Heart and Stroke Statistics 2 OConnor CM J Cardiac Fail 2005 11 200-205 3 Tavazzi L et al Eur Heart J 2006271207-1215 4 Wong YW he (ADHERE-EM) Am Heart J 2013 Aug166(2)349-56 doi 101016 5 Fonarow GC Rev Cardiovasc Med 20034 Suppl 7S21-30
Physiological Premise of IHM Guided Care
-21 -14 - 7 Days
Reactive Proactive
0
Symptoms
Pressure Changes
Heart Failure Event
CHAMPION Trial By Targeting Pressure Ranges and Titrating Medications Overall PAPs Can Be Reduced
Compared to the control group patients managed with PAP had persistently lower mean PA pressures over the treatment period
CHAMPION Trial PAP Mean Change from Baseline
Abraham WT et al Lancet 2011
PA
Me
an
Pre
as
ure
AU
C (
mm
Hg
-Da
ys
)
-220
-200
-180
-160
-140
-120
-100
-80
-60
-40
-20
0
20
40
60
80
100
Days from Implant
0 30 60 90 120 150 180
p = 00077
Treatment (-1557 mmHg-Days)Control (331 mmHg-Days)
cardioMEMS-CHAMPION trial
In 68 of cases Loop diuretic dose change
The Evolution of Pressure-Guided Therapy
Congestion is the limiting symptom
Symptoms and weights do not provide a reliable early warning system
Seeing is relieving
Events are associated with increased pulmonary pressures
HF preserved EF is more the same than different
Treating the peaks is not enough to prevent events
Reduce not just peaks but also the plateau
Does CHAMPION duplicate what can be seen by measuring electrical Intra-thoracic Impedance (ITI)
bull Remote of assessment of ITI is now currently provided by innovative technology embedded in implantable defibrillators (ICD and CRT D devices)
bull The OPTIVOL ITI detection system has been developed by MEDTRONIC and has been widely tested to prove efficacy of intra-thoracic impedance decline to manage pending acute decompensated HF
Intrathoracic impedance measurement by implantable system
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
Algorithm performance on validation data set
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
For validation data set nominal threshold of 60 Ωd resulted in
sensitivity of 769 and false-positive rate of 15 false-
positives per patient-year of monitoring as highlighted by
circle
15
The OPTIVOL fluid index pivotal trials van Veldhuisen D et al Circulation 2011 DOT HF
The OPTIVOL fluid index pivotal trials Bohm M et al et al EHJ 2015 OPTILINK
Patients with potentially higher risk of cardiac decompensationdeterioration presenting at least 1 out of 4 criteria
bull HF-related Hospitalization within the last 12 months bull IV-Oral Diuretic Treatment within last 30 days bull Increased BNP within last 30 daysgt 400pgml bull Increased NT-pro-BNP within last 30 days [gt 400 pgml (lt 50 yrs) gt 900 pgml (50-75 yrs) gt 1800 pgml (gt 75 yrs)]
Intra-thoracic Impedance Limitations
bull The OptiVol find can be insensitive in chronically volume overloaded patients or when volume accumulation occurs very slowly
bull In the case the reference impedance also changes it prevent separation to occur between reference and measured impedance and than it prevent the calculated cumulative sum to rise
Zile M et al Circulation Heart Failure 2016
1924hellipTelemedicine (radiomedicine)
come in
This person does not exist
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
This person does not exist
This person does not exist HeShe is the average person of
EBM Evidence
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
EBM Groups and Individuals
bull Evidence comes from groups of patients Decisions are made by for individuals
bull Whatrsquos best on average must be best for each individual
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
KaplanndashMeier Curves for Total Revascularizations
De Bruyne B et al N Engl J Med 20143711208-1217
Conclusions
bull In patients with stable coronary artery disease FFR-guided PCI as compared with medical therapy alone improved the outcome
bull Patients without ischemia had a favorable outcome with medical therapy alone
Public Health Regional Resolution
Personalized Medicine
Stratified medicine
Systems Medicine
P4 Medicine
Narrative Medicine
Knowledge Based Medicine Translational Medicine
Patient Centered Care
Precision medicine
Heart Failure Facts bull The primary economical and social burden of HF syndrome is
hospitalization rate whose costs represent the highest ones ($40B per year in USA) within the entire health care management [1]
bull Approximately 80 of HF hospital admissions are driven by pulmonary congestion symptoms [23]
bull Almost 90 of acute decompensated HF patients after the admittance to the emergency department receive iv loop diuretic as the treatment of choice [4]
bull Despite therapy more than 50 of hospitalized patients for acute decompensated HF have little or no dyspnea improvement and weight loss after hospital discharge [235]
1 2014 American Heart Association Heart and Stroke Statistics 2 OConnor CM J Cardiac Fail 2005 11 200-205 3 Tavazzi L et al Eur Heart J 2006271207-1215 4 Wong YW he (ADHERE-EM) Am Heart J 2013 Aug166(2)349-56 doi 101016 5 Fonarow GC Rev Cardiovasc Med 20034 Suppl 7S21-30
Physiological Premise of IHM Guided Care
-21 -14 - 7 Days
Reactive Proactive
0
Symptoms
Pressure Changes
Heart Failure Event
CHAMPION Trial By Targeting Pressure Ranges and Titrating Medications Overall PAPs Can Be Reduced
Compared to the control group patients managed with PAP had persistently lower mean PA pressures over the treatment period
CHAMPION Trial PAP Mean Change from Baseline
Abraham WT et al Lancet 2011
PA
Me
an
Pre
as
ure
AU
C (
mm
Hg
-Da
ys
)
-220
-200
-180
-160
-140
-120
-100
-80
-60
-40
-20
0
20
40
60
80
100
Days from Implant
0 30 60 90 120 150 180
p = 00077
Treatment (-1557 mmHg-Days)Control (331 mmHg-Days)
cardioMEMS-CHAMPION trial
In 68 of cases Loop diuretic dose change
The Evolution of Pressure-Guided Therapy
Congestion is the limiting symptom
Symptoms and weights do not provide a reliable early warning system
Seeing is relieving
Events are associated with increased pulmonary pressures
HF preserved EF is more the same than different
Treating the peaks is not enough to prevent events
Reduce not just peaks but also the plateau
Does CHAMPION duplicate what can be seen by measuring electrical Intra-thoracic Impedance (ITI)
bull Remote of assessment of ITI is now currently provided by innovative technology embedded in implantable defibrillators (ICD and CRT D devices)
bull The OPTIVOL ITI detection system has been developed by MEDTRONIC and has been widely tested to prove efficacy of intra-thoracic impedance decline to manage pending acute decompensated HF
Intrathoracic impedance measurement by implantable system
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
Algorithm performance on validation data set
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
For validation data set nominal threshold of 60 Ωd resulted in
sensitivity of 769 and false-positive rate of 15 false-
positives per patient-year of monitoring as highlighted by
circle
15
The OPTIVOL fluid index pivotal trials van Veldhuisen D et al Circulation 2011 DOT HF
The OPTIVOL fluid index pivotal trials Bohm M et al et al EHJ 2015 OPTILINK
Patients with potentially higher risk of cardiac decompensationdeterioration presenting at least 1 out of 4 criteria
bull HF-related Hospitalization within the last 12 months bull IV-Oral Diuretic Treatment within last 30 days bull Increased BNP within last 30 daysgt 400pgml bull Increased NT-pro-BNP within last 30 days [gt 400 pgml (lt 50 yrs) gt 900 pgml (50-75 yrs) gt 1800 pgml (gt 75 yrs)]
Intra-thoracic Impedance Limitations
bull The OptiVol find can be insensitive in chronically volume overloaded patients or when volume accumulation occurs very slowly
bull In the case the reference impedance also changes it prevent separation to occur between reference and measured impedance and than it prevent the calculated cumulative sum to rise
Zile M et al Circulation Heart Failure 2016
1924hellipTelemedicine (radiomedicine)
come in
This person does not exist
This person does not exist HeShe is the average person of
EBM Evidence
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
EBM Groups and Individuals
bull Evidence comes from groups of patients Decisions are made by for individuals
bull Whatrsquos best on average must be best for each individual
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
KaplanndashMeier Curves for Total Revascularizations
De Bruyne B et al N Engl J Med 20143711208-1217
Conclusions
bull In patients with stable coronary artery disease FFR-guided PCI as compared with medical therapy alone improved the outcome
bull Patients without ischemia had a favorable outcome with medical therapy alone
Public Health Regional Resolution
Personalized Medicine
Stratified medicine
Systems Medicine
P4 Medicine
Narrative Medicine
Knowledge Based Medicine Translational Medicine
Patient Centered Care
Precision medicine
Heart Failure Facts bull The primary economical and social burden of HF syndrome is
hospitalization rate whose costs represent the highest ones ($40B per year in USA) within the entire health care management [1]
bull Approximately 80 of HF hospital admissions are driven by pulmonary congestion symptoms [23]
bull Almost 90 of acute decompensated HF patients after the admittance to the emergency department receive iv loop diuretic as the treatment of choice [4]
bull Despite therapy more than 50 of hospitalized patients for acute decompensated HF have little or no dyspnea improvement and weight loss after hospital discharge [235]
1 2014 American Heart Association Heart and Stroke Statistics 2 OConnor CM J Cardiac Fail 2005 11 200-205 3 Tavazzi L et al Eur Heart J 2006271207-1215 4 Wong YW he (ADHERE-EM) Am Heart J 2013 Aug166(2)349-56 doi 101016 5 Fonarow GC Rev Cardiovasc Med 20034 Suppl 7S21-30
Physiological Premise of IHM Guided Care
-21 -14 - 7 Days
Reactive Proactive
0
Symptoms
Pressure Changes
Heart Failure Event
CHAMPION Trial By Targeting Pressure Ranges and Titrating Medications Overall PAPs Can Be Reduced
Compared to the control group patients managed with PAP had persistently lower mean PA pressures over the treatment period
CHAMPION Trial PAP Mean Change from Baseline
Abraham WT et al Lancet 2011
PA
Me
an
Pre
as
ure
AU
C (
mm
Hg
-Da
ys
)
-220
-200
-180
-160
-140
-120
-100
-80
-60
-40
-20
0
20
40
60
80
100
Days from Implant
0 30 60 90 120 150 180
p = 00077
Treatment (-1557 mmHg-Days)Control (331 mmHg-Days)
cardioMEMS-CHAMPION trial
In 68 of cases Loop diuretic dose change
The Evolution of Pressure-Guided Therapy
Congestion is the limiting symptom
Symptoms and weights do not provide a reliable early warning system
Seeing is relieving
Events are associated with increased pulmonary pressures
HF preserved EF is more the same than different
Treating the peaks is not enough to prevent events
Reduce not just peaks but also the plateau
Does CHAMPION duplicate what can be seen by measuring electrical Intra-thoracic Impedance (ITI)
bull Remote of assessment of ITI is now currently provided by innovative technology embedded in implantable defibrillators (ICD and CRT D devices)
bull The OPTIVOL ITI detection system has been developed by MEDTRONIC and has been widely tested to prove efficacy of intra-thoracic impedance decline to manage pending acute decompensated HF
Intrathoracic impedance measurement by implantable system
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
Algorithm performance on validation data set
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
For validation data set nominal threshold of 60 Ωd resulted in
sensitivity of 769 and false-positive rate of 15 false-
positives per patient-year of monitoring as highlighted by
circle
15
The OPTIVOL fluid index pivotal trials van Veldhuisen D et al Circulation 2011 DOT HF
The OPTIVOL fluid index pivotal trials Bohm M et al et al EHJ 2015 OPTILINK
Patients with potentially higher risk of cardiac decompensationdeterioration presenting at least 1 out of 4 criteria
bull HF-related Hospitalization within the last 12 months bull IV-Oral Diuretic Treatment within last 30 days bull Increased BNP within last 30 daysgt 400pgml bull Increased NT-pro-BNP within last 30 days [gt 400 pgml (lt 50 yrs) gt 900 pgml (50-75 yrs) gt 1800 pgml (gt 75 yrs)]
Intra-thoracic Impedance Limitations
bull The OptiVol find can be insensitive in chronically volume overloaded patients or when volume accumulation occurs very slowly
bull In the case the reference impedance also changes it prevent separation to occur between reference and measured impedance and than it prevent the calculated cumulative sum to rise
Zile M et al Circulation Heart Failure 2016
1924hellipTelemedicine (radiomedicine)
come in
EBM Groups and Individuals
bull Evidence comes from groups of patients Decisions are made by for individuals
bull Whatrsquos best on average must be best for each individual
D Kent Institute for Clinical Research and Health Policy Studies Tufts Medical Center
KaplanndashMeier Curves for Total Revascularizations
De Bruyne B et al N Engl J Med 20143711208-1217
Conclusions
bull In patients with stable coronary artery disease FFR-guided PCI as compared with medical therapy alone improved the outcome
bull Patients without ischemia had a favorable outcome with medical therapy alone
Public Health Regional Resolution
Personalized Medicine
Stratified medicine
Systems Medicine
P4 Medicine
Narrative Medicine
Knowledge Based Medicine Translational Medicine
Patient Centered Care
Precision medicine
Heart Failure Facts bull The primary economical and social burden of HF syndrome is
hospitalization rate whose costs represent the highest ones ($40B per year in USA) within the entire health care management [1]
bull Approximately 80 of HF hospital admissions are driven by pulmonary congestion symptoms [23]
bull Almost 90 of acute decompensated HF patients after the admittance to the emergency department receive iv loop diuretic as the treatment of choice [4]
bull Despite therapy more than 50 of hospitalized patients for acute decompensated HF have little or no dyspnea improvement and weight loss after hospital discharge [235]
1 2014 American Heart Association Heart and Stroke Statistics 2 OConnor CM J Cardiac Fail 2005 11 200-205 3 Tavazzi L et al Eur Heart J 2006271207-1215 4 Wong YW he (ADHERE-EM) Am Heart J 2013 Aug166(2)349-56 doi 101016 5 Fonarow GC Rev Cardiovasc Med 20034 Suppl 7S21-30
Physiological Premise of IHM Guided Care
-21 -14 - 7 Days
Reactive Proactive
0
Symptoms
Pressure Changes
Heart Failure Event
CHAMPION Trial By Targeting Pressure Ranges and Titrating Medications Overall PAPs Can Be Reduced
Compared to the control group patients managed with PAP had persistently lower mean PA pressures over the treatment period
CHAMPION Trial PAP Mean Change from Baseline
Abraham WT et al Lancet 2011
PA
Me
an
Pre
as
ure
AU
C (
mm
Hg
-Da
ys
)
-220
-200
-180
-160
-140
-120
-100
-80
-60
-40
-20
0
20
40
60
80
100
Days from Implant
0 30 60 90 120 150 180
p = 00077
Treatment (-1557 mmHg-Days)Control (331 mmHg-Days)
cardioMEMS-CHAMPION trial
In 68 of cases Loop diuretic dose change
The Evolution of Pressure-Guided Therapy
Congestion is the limiting symptom
Symptoms and weights do not provide a reliable early warning system
Seeing is relieving
Events are associated with increased pulmonary pressures
HF preserved EF is more the same than different
Treating the peaks is not enough to prevent events
Reduce not just peaks but also the plateau
Does CHAMPION duplicate what can be seen by measuring electrical Intra-thoracic Impedance (ITI)
bull Remote of assessment of ITI is now currently provided by innovative technology embedded in implantable defibrillators (ICD and CRT D devices)
bull The OPTIVOL ITI detection system has been developed by MEDTRONIC and has been widely tested to prove efficacy of intra-thoracic impedance decline to manage pending acute decompensated HF
Intrathoracic impedance measurement by implantable system
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
Algorithm performance on validation data set
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
For validation data set nominal threshold of 60 Ωd resulted in
sensitivity of 769 and false-positive rate of 15 false-
positives per patient-year of monitoring as highlighted by
circle
15
The OPTIVOL fluid index pivotal trials van Veldhuisen D et al Circulation 2011 DOT HF
The OPTIVOL fluid index pivotal trials Bohm M et al et al EHJ 2015 OPTILINK
Patients with potentially higher risk of cardiac decompensationdeterioration presenting at least 1 out of 4 criteria
bull HF-related Hospitalization within the last 12 months bull IV-Oral Diuretic Treatment within last 30 days bull Increased BNP within last 30 daysgt 400pgml bull Increased NT-pro-BNP within last 30 days [gt 400 pgml (lt 50 yrs) gt 900 pgml (50-75 yrs) gt 1800 pgml (gt 75 yrs)]
Intra-thoracic Impedance Limitations
bull The OptiVol find can be insensitive in chronically volume overloaded patients or when volume accumulation occurs very slowly
bull In the case the reference impedance also changes it prevent separation to occur between reference and measured impedance and than it prevent the calculated cumulative sum to rise
Zile M et al Circulation Heart Failure 2016
1924hellipTelemedicine (radiomedicine)
come in
KaplanndashMeier Curves for Total Revascularizations
De Bruyne B et al N Engl J Med 20143711208-1217
Conclusions
bull In patients with stable coronary artery disease FFR-guided PCI as compared with medical therapy alone improved the outcome
bull Patients without ischemia had a favorable outcome with medical therapy alone
Public Health Regional Resolution
Personalized Medicine
Stratified medicine
Systems Medicine
P4 Medicine
Narrative Medicine
Knowledge Based Medicine Translational Medicine
Patient Centered Care
Precision medicine
Heart Failure Facts bull The primary economical and social burden of HF syndrome is
hospitalization rate whose costs represent the highest ones ($40B per year in USA) within the entire health care management [1]
bull Approximately 80 of HF hospital admissions are driven by pulmonary congestion symptoms [23]
bull Almost 90 of acute decompensated HF patients after the admittance to the emergency department receive iv loop diuretic as the treatment of choice [4]
bull Despite therapy more than 50 of hospitalized patients for acute decompensated HF have little or no dyspnea improvement and weight loss after hospital discharge [235]
1 2014 American Heart Association Heart and Stroke Statistics 2 OConnor CM J Cardiac Fail 2005 11 200-205 3 Tavazzi L et al Eur Heart J 2006271207-1215 4 Wong YW he (ADHERE-EM) Am Heart J 2013 Aug166(2)349-56 doi 101016 5 Fonarow GC Rev Cardiovasc Med 20034 Suppl 7S21-30
Physiological Premise of IHM Guided Care
-21 -14 - 7 Days
Reactive Proactive
0
Symptoms
Pressure Changes
Heart Failure Event
CHAMPION Trial By Targeting Pressure Ranges and Titrating Medications Overall PAPs Can Be Reduced
Compared to the control group patients managed with PAP had persistently lower mean PA pressures over the treatment period
CHAMPION Trial PAP Mean Change from Baseline
Abraham WT et al Lancet 2011
PA
Me
an
Pre
as
ure
AU
C (
mm
Hg
-Da
ys
)
-220
-200
-180
-160
-140
-120
-100
-80
-60
-40
-20
0
20
40
60
80
100
Days from Implant
0 30 60 90 120 150 180
p = 00077
Treatment (-1557 mmHg-Days)Control (331 mmHg-Days)
cardioMEMS-CHAMPION trial
In 68 of cases Loop diuretic dose change
The Evolution of Pressure-Guided Therapy
Congestion is the limiting symptom
Symptoms and weights do not provide a reliable early warning system
Seeing is relieving
Events are associated with increased pulmonary pressures
HF preserved EF is more the same than different
Treating the peaks is not enough to prevent events
Reduce not just peaks but also the plateau
Does CHAMPION duplicate what can be seen by measuring electrical Intra-thoracic Impedance (ITI)
bull Remote of assessment of ITI is now currently provided by innovative technology embedded in implantable defibrillators (ICD and CRT D devices)
bull The OPTIVOL ITI detection system has been developed by MEDTRONIC and has been widely tested to prove efficacy of intra-thoracic impedance decline to manage pending acute decompensated HF
Intrathoracic impedance measurement by implantable system
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
Algorithm performance on validation data set
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
For validation data set nominal threshold of 60 Ωd resulted in
sensitivity of 769 and false-positive rate of 15 false-
positives per patient-year of monitoring as highlighted by
circle
15
The OPTIVOL fluid index pivotal trials van Veldhuisen D et al Circulation 2011 DOT HF
The OPTIVOL fluid index pivotal trials Bohm M et al et al EHJ 2015 OPTILINK
Patients with potentially higher risk of cardiac decompensationdeterioration presenting at least 1 out of 4 criteria
bull HF-related Hospitalization within the last 12 months bull IV-Oral Diuretic Treatment within last 30 days bull Increased BNP within last 30 daysgt 400pgml bull Increased NT-pro-BNP within last 30 days [gt 400 pgml (lt 50 yrs) gt 900 pgml (50-75 yrs) gt 1800 pgml (gt 75 yrs)]
Intra-thoracic Impedance Limitations
bull The OptiVol find can be insensitive in chronically volume overloaded patients or when volume accumulation occurs very slowly
bull In the case the reference impedance also changes it prevent separation to occur between reference and measured impedance and than it prevent the calculated cumulative sum to rise
Zile M et al Circulation Heart Failure 2016
1924hellipTelemedicine (radiomedicine)
come in
Conclusions
bull In patients with stable coronary artery disease FFR-guided PCI as compared with medical therapy alone improved the outcome
bull Patients without ischemia had a favorable outcome with medical therapy alone
Public Health Regional Resolution
Personalized Medicine
Stratified medicine
Systems Medicine
P4 Medicine
Narrative Medicine
Knowledge Based Medicine Translational Medicine
Patient Centered Care
Precision medicine
Heart Failure Facts bull The primary economical and social burden of HF syndrome is
hospitalization rate whose costs represent the highest ones ($40B per year in USA) within the entire health care management [1]
bull Approximately 80 of HF hospital admissions are driven by pulmonary congestion symptoms [23]
bull Almost 90 of acute decompensated HF patients after the admittance to the emergency department receive iv loop diuretic as the treatment of choice [4]
bull Despite therapy more than 50 of hospitalized patients for acute decompensated HF have little or no dyspnea improvement and weight loss after hospital discharge [235]
1 2014 American Heart Association Heart and Stroke Statistics 2 OConnor CM J Cardiac Fail 2005 11 200-205 3 Tavazzi L et al Eur Heart J 2006271207-1215 4 Wong YW he (ADHERE-EM) Am Heart J 2013 Aug166(2)349-56 doi 101016 5 Fonarow GC Rev Cardiovasc Med 20034 Suppl 7S21-30
Physiological Premise of IHM Guided Care
-21 -14 - 7 Days
Reactive Proactive
0
Symptoms
Pressure Changes
Heart Failure Event
CHAMPION Trial By Targeting Pressure Ranges and Titrating Medications Overall PAPs Can Be Reduced
Compared to the control group patients managed with PAP had persistently lower mean PA pressures over the treatment period
CHAMPION Trial PAP Mean Change from Baseline
Abraham WT et al Lancet 2011
PA
Me
an
Pre
as
ure
AU
C (
mm
Hg
-Da
ys
)
-220
-200
-180
-160
-140
-120
-100
-80
-60
-40
-20
0
20
40
60
80
100
Days from Implant
0 30 60 90 120 150 180
p = 00077
Treatment (-1557 mmHg-Days)Control (331 mmHg-Days)
cardioMEMS-CHAMPION trial
In 68 of cases Loop diuretic dose change
The Evolution of Pressure-Guided Therapy
Congestion is the limiting symptom
Symptoms and weights do not provide a reliable early warning system
Seeing is relieving
Events are associated with increased pulmonary pressures
HF preserved EF is more the same than different
Treating the peaks is not enough to prevent events
Reduce not just peaks but also the plateau
Does CHAMPION duplicate what can be seen by measuring electrical Intra-thoracic Impedance (ITI)
bull Remote of assessment of ITI is now currently provided by innovative technology embedded in implantable defibrillators (ICD and CRT D devices)
bull The OPTIVOL ITI detection system has been developed by MEDTRONIC and has been widely tested to prove efficacy of intra-thoracic impedance decline to manage pending acute decompensated HF
Intrathoracic impedance measurement by implantable system
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
Algorithm performance on validation data set
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
For validation data set nominal threshold of 60 Ωd resulted in
sensitivity of 769 and false-positive rate of 15 false-
positives per patient-year of monitoring as highlighted by
circle
15
The OPTIVOL fluid index pivotal trials van Veldhuisen D et al Circulation 2011 DOT HF
The OPTIVOL fluid index pivotal trials Bohm M et al et al EHJ 2015 OPTILINK
Patients with potentially higher risk of cardiac decompensationdeterioration presenting at least 1 out of 4 criteria
bull HF-related Hospitalization within the last 12 months bull IV-Oral Diuretic Treatment within last 30 days bull Increased BNP within last 30 daysgt 400pgml bull Increased NT-pro-BNP within last 30 days [gt 400 pgml (lt 50 yrs) gt 900 pgml (50-75 yrs) gt 1800 pgml (gt 75 yrs)]
Intra-thoracic Impedance Limitations
bull The OptiVol find can be insensitive in chronically volume overloaded patients or when volume accumulation occurs very slowly
bull In the case the reference impedance also changes it prevent separation to occur between reference and measured impedance and than it prevent the calculated cumulative sum to rise
Zile M et al Circulation Heart Failure 2016
1924hellipTelemedicine (radiomedicine)
come in
Public Health Regional Resolution
Personalized Medicine
Stratified medicine
Systems Medicine
P4 Medicine
Narrative Medicine
Knowledge Based Medicine Translational Medicine
Patient Centered Care
Precision medicine
Heart Failure Facts bull The primary economical and social burden of HF syndrome is
hospitalization rate whose costs represent the highest ones ($40B per year in USA) within the entire health care management [1]
bull Approximately 80 of HF hospital admissions are driven by pulmonary congestion symptoms [23]
bull Almost 90 of acute decompensated HF patients after the admittance to the emergency department receive iv loop diuretic as the treatment of choice [4]
bull Despite therapy more than 50 of hospitalized patients for acute decompensated HF have little or no dyspnea improvement and weight loss after hospital discharge [235]
1 2014 American Heart Association Heart and Stroke Statistics 2 OConnor CM J Cardiac Fail 2005 11 200-205 3 Tavazzi L et al Eur Heart J 2006271207-1215 4 Wong YW he (ADHERE-EM) Am Heart J 2013 Aug166(2)349-56 doi 101016 5 Fonarow GC Rev Cardiovasc Med 20034 Suppl 7S21-30
Physiological Premise of IHM Guided Care
-21 -14 - 7 Days
Reactive Proactive
0
Symptoms
Pressure Changes
Heart Failure Event
CHAMPION Trial By Targeting Pressure Ranges and Titrating Medications Overall PAPs Can Be Reduced
Compared to the control group patients managed with PAP had persistently lower mean PA pressures over the treatment period
CHAMPION Trial PAP Mean Change from Baseline
Abraham WT et al Lancet 2011
PA
Me
an
Pre
as
ure
AU
C (
mm
Hg
-Da
ys
)
-220
-200
-180
-160
-140
-120
-100
-80
-60
-40
-20
0
20
40
60
80
100
Days from Implant
0 30 60 90 120 150 180
p = 00077
Treatment (-1557 mmHg-Days)Control (331 mmHg-Days)
cardioMEMS-CHAMPION trial
In 68 of cases Loop diuretic dose change
The Evolution of Pressure-Guided Therapy
Congestion is the limiting symptom
Symptoms and weights do not provide a reliable early warning system
Seeing is relieving
Events are associated with increased pulmonary pressures
HF preserved EF is more the same than different
Treating the peaks is not enough to prevent events
Reduce not just peaks but also the plateau
Does CHAMPION duplicate what can be seen by measuring electrical Intra-thoracic Impedance (ITI)
bull Remote of assessment of ITI is now currently provided by innovative technology embedded in implantable defibrillators (ICD and CRT D devices)
bull The OPTIVOL ITI detection system has been developed by MEDTRONIC and has been widely tested to prove efficacy of intra-thoracic impedance decline to manage pending acute decompensated HF
Intrathoracic impedance measurement by implantable system
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
Algorithm performance on validation data set
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
For validation data set nominal threshold of 60 Ωd resulted in
sensitivity of 769 and false-positive rate of 15 false-
positives per patient-year of monitoring as highlighted by
circle
15
The OPTIVOL fluid index pivotal trials van Veldhuisen D et al Circulation 2011 DOT HF
The OPTIVOL fluid index pivotal trials Bohm M et al et al EHJ 2015 OPTILINK
Patients with potentially higher risk of cardiac decompensationdeterioration presenting at least 1 out of 4 criteria
bull HF-related Hospitalization within the last 12 months bull IV-Oral Diuretic Treatment within last 30 days bull Increased BNP within last 30 daysgt 400pgml bull Increased NT-pro-BNP within last 30 days [gt 400 pgml (lt 50 yrs) gt 900 pgml (50-75 yrs) gt 1800 pgml (gt 75 yrs)]
Intra-thoracic Impedance Limitations
bull The OptiVol find can be insensitive in chronically volume overloaded patients or when volume accumulation occurs very slowly
bull In the case the reference impedance also changes it prevent separation to occur between reference and measured impedance and than it prevent the calculated cumulative sum to rise
Zile M et al Circulation Heart Failure 2016
1924hellipTelemedicine (radiomedicine)
come in
Personalized Medicine
Stratified medicine
Systems Medicine
P4 Medicine
Narrative Medicine
Knowledge Based Medicine Translational Medicine
Patient Centered Care
Precision medicine
Heart Failure Facts bull The primary economical and social burden of HF syndrome is
hospitalization rate whose costs represent the highest ones ($40B per year in USA) within the entire health care management [1]
bull Approximately 80 of HF hospital admissions are driven by pulmonary congestion symptoms [23]
bull Almost 90 of acute decompensated HF patients after the admittance to the emergency department receive iv loop diuretic as the treatment of choice [4]
bull Despite therapy more than 50 of hospitalized patients for acute decompensated HF have little or no dyspnea improvement and weight loss after hospital discharge [235]
1 2014 American Heart Association Heart and Stroke Statistics 2 OConnor CM J Cardiac Fail 2005 11 200-205 3 Tavazzi L et al Eur Heart J 2006271207-1215 4 Wong YW he (ADHERE-EM) Am Heart J 2013 Aug166(2)349-56 doi 101016 5 Fonarow GC Rev Cardiovasc Med 20034 Suppl 7S21-30
Physiological Premise of IHM Guided Care
-21 -14 - 7 Days
Reactive Proactive
0
Symptoms
Pressure Changes
Heart Failure Event
CHAMPION Trial By Targeting Pressure Ranges and Titrating Medications Overall PAPs Can Be Reduced
Compared to the control group patients managed with PAP had persistently lower mean PA pressures over the treatment period
CHAMPION Trial PAP Mean Change from Baseline
Abraham WT et al Lancet 2011
PA
Me
an
Pre
as
ure
AU
C (
mm
Hg
-Da
ys
)
-220
-200
-180
-160
-140
-120
-100
-80
-60
-40
-20
0
20
40
60
80
100
Days from Implant
0 30 60 90 120 150 180
p = 00077
Treatment (-1557 mmHg-Days)Control (331 mmHg-Days)
cardioMEMS-CHAMPION trial
In 68 of cases Loop diuretic dose change
The Evolution of Pressure-Guided Therapy
Congestion is the limiting symptom
Symptoms and weights do not provide a reliable early warning system
Seeing is relieving
Events are associated with increased pulmonary pressures
HF preserved EF is more the same than different
Treating the peaks is not enough to prevent events
Reduce not just peaks but also the plateau
Does CHAMPION duplicate what can be seen by measuring electrical Intra-thoracic Impedance (ITI)
bull Remote of assessment of ITI is now currently provided by innovative technology embedded in implantable defibrillators (ICD and CRT D devices)
bull The OPTIVOL ITI detection system has been developed by MEDTRONIC and has been widely tested to prove efficacy of intra-thoracic impedance decline to manage pending acute decompensated HF
Intrathoracic impedance measurement by implantable system
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
Algorithm performance on validation data set
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
For validation data set nominal threshold of 60 Ωd resulted in
sensitivity of 769 and false-positive rate of 15 false-
positives per patient-year of monitoring as highlighted by
circle
15
The OPTIVOL fluid index pivotal trials van Veldhuisen D et al Circulation 2011 DOT HF
The OPTIVOL fluid index pivotal trials Bohm M et al et al EHJ 2015 OPTILINK
Patients with potentially higher risk of cardiac decompensationdeterioration presenting at least 1 out of 4 criteria
bull HF-related Hospitalization within the last 12 months bull IV-Oral Diuretic Treatment within last 30 days bull Increased BNP within last 30 daysgt 400pgml bull Increased NT-pro-BNP within last 30 days [gt 400 pgml (lt 50 yrs) gt 900 pgml (50-75 yrs) gt 1800 pgml (gt 75 yrs)]
Intra-thoracic Impedance Limitations
bull The OptiVol find can be insensitive in chronically volume overloaded patients or when volume accumulation occurs very slowly
bull In the case the reference impedance also changes it prevent separation to occur between reference and measured impedance and than it prevent the calculated cumulative sum to rise
Zile M et al Circulation Heart Failure 2016
1924hellipTelemedicine (radiomedicine)
come in
Heart Failure Facts bull The primary economical and social burden of HF syndrome is
hospitalization rate whose costs represent the highest ones ($40B per year in USA) within the entire health care management [1]
bull Approximately 80 of HF hospital admissions are driven by pulmonary congestion symptoms [23]
bull Almost 90 of acute decompensated HF patients after the admittance to the emergency department receive iv loop diuretic as the treatment of choice [4]
bull Despite therapy more than 50 of hospitalized patients for acute decompensated HF have little or no dyspnea improvement and weight loss after hospital discharge [235]
1 2014 American Heart Association Heart and Stroke Statistics 2 OConnor CM J Cardiac Fail 2005 11 200-205 3 Tavazzi L et al Eur Heart J 2006271207-1215 4 Wong YW he (ADHERE-EM) Am Heart J 2013 Aug166(2)349-56 doi 101016 5 Fonarow GC Rev Cardiovasc Med 20034 Suppl 7S21-30
Physiological Premise of IHM Guided Care
-21 -14 - 7 Days
Reactive Proactive
0
Symptoms
Pressure Changes
Heart Failure Event
CHAMPION Trial By Targeting Pressure Ranges and Titrating Medications Overall PAPs Can Be Reduced
Compared to the control group patients managed with PAP had persistently lower mean PA pressures over the treatment period
CHAMPION Trial PAP Mean Change from Baseline
Abraham WT et al Lancet 2011
PA
Me
an
Pre
as
ure
AU
C (
mm
Hg
-Da
ys
)
-220
-200
-180
-160
-140
-120
-100
-80
-60
-40
-20
0
20
40
60
80
100
Days from Implant
0 30 60 90 120 150 180
p = 00077
Treatment (-1557 mmHg-Days)Control (331 mmHg-Days)
cardioMEMS-CHAMPION trial
In 68 of cases Loop diuretic dose change
The Evolution of Pressure-Guided Therapy
Congestion is the limiting symptom
Symptoms and weights do not provide a reliable early warning system
Seeing is relieving
Events are associated with increased pulmonary pressures
HF preserved EF is more the same than different
Treating the peaks is not enough to prevent events
Reduce not just peaks but also the plateau
Does CHAMPION duplicate what can be seen by measuring electrical Intra-thoracic Impedance (ITI)
bull Remote of assessment of ITI is now currently provided by innovative technology embedded in implantable defibrillators (ICD and CRT D devices)
bull The OPTIVOL ITI detection system has been developed by MEDTRONIC and has been widely tested to prove efficacy of intra-thoracic impedance decline to manage pending acute decompensated HF
Intrathoracic impedance measurement by implantable system
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
Algorithm performance on validation data set
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
For validation data set nominal threshold of 60 Ωd resulted in
sensitivity of 769 and false-positive rate of 15 false-
positives per patient-year of monitoring as highlighted by
circle
15
The OPTIVOL fluid index pivotal trials van Veldhuisen D et al Circulation 2011 DOT HF
The OPTIVOL fluid index pivotal trials Bohm M et al et al EHJ 2015 OPTILINK
Patients with potentially higher risk of cardiac decompensationdeterioration presenting at least 1 out of 4 criteria
bull HF-related Hospitalization within the last 12 months bull IV-Oral Diuretic Treatment within last 30 days bull Increased BNP within last 30 daysgt 400pgml bull Increased NT-pro-BNP within last 30 days [gt 400 pgml (lt 50 yrs) gt 900 pgml (50-75 yrs) gt 1800 pgml (gt 75 yrs)]
Intra-thoracic Impedance Limitations
bull The OptiVol find can be insensitive in chronically volume overloaded patients or when volume accumulation occurs very slowly
bull In the case the reference impedance also changes it prevent separation to occur between reference and measured impedance and than it prevent the calculated cumulative sum to rise
Zile M et al Circulation Heart Failure 2016
1924hellipTelemedicine (radiomedicine)
come in
Physiological Premise of IHM Guided Care
-21 -14 - 7 Days
Reactive Proactive
0
Symptoms
Pressure Changes
Heart Failure Event
CHAMPION Trial By Targeting Pressure Ranges and Titrating Medications Overall PAPs Can Be Reduced
Compared to the control group patients managed with PAP had persistently lower mean PA pressures over the treatment period
CHAMPION Trial PAP Mean Change from Baseline
Abraham WT et al Lancet 2011
PA
Me
an
Pre
as
ure
AU
C (
mm
Hg
-Da
ys
)
-220
-200
-180
-160
-140
-120
-100
-80
-60
-40
-20
0
20
40
60
80
100
Days from Implant
0 30 60 90 120 150 180
p = 00077
Treatment (-1557 mmHg-Days)Control (331 mmHg-Days)
cardioMEMS-CHAMPION trial
In 68 of cases Loop diuretic dose change
The Evolution of Pressure-Guided Therapy
Congestion is the limiting symptom
Symptoms and weights do not provide a reliable early warning system
Seeing is relieving
Events are associated with increased pulmonary pressures
HF preserved EF is more the same than different
Treating the peaks is not enough to prevent events
Reduce not just peaks but also the plateau
Does CHAMPION duplicate what can be seen by measuring electrical Intra-thoracic Impedance (ITI)
bull Remote of assessment of ITI is now currently provided by innovative technology embedded in implantable defibrillators (ICD and CRT D devices)
bull The OPTIVOL ITI detection system has been developed by MEDTRONIC and has been widely tested to prove efficacy of intra-thoracic impedance decline to manage pending acute decompensated HF
Intrathoracic impedance measurement by implantable system
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
Algorithm performance on validation data set
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
For validation data set nominal threshold of 60 Ωd resulted in
sensitivity of 769 and false-positive rate of 15 false-
positives per patient-year of monitoring as highlighted by
circle
15
The OPTIVOL fluid index pivotal trials van Veldhuisen D et al Circulation 2011 DOT HF
The OPTIVOL fluid index pivotal trials Bohm M et al et al EHJ 2015 OPTILINK
Patients with potentially higher risk of cardiac decompensationdeterioration presenting at least 1 out of 4 criteria
bull HF-related Hospitalization within the last 12 months bull IV-Oral Diuretic Treatment within last 30 days bull Increased BNP within last 30 daysgt 400pgml bull Increased NT-pro-BNP within last 30 days [gt 400 pgml (lt 50 yrs) gt 900 pgml (50-75 yrs) gt 1800 pgml (gt 75 yrs)]
Intra-thoracic Impedance Limitations
bull The OptiVol find can be insensitive in chronically volume overloaded patients or when volume accumulation occurs very slowly
bull In the case the reference impedance also changes it prevent separation to occur between reference and measured impedance and than it prevent the calculated cumulative sum to rise
Zile M et al Circulation Heart Failure 2016
1924hellipTelemedicine (radiomedicine)
come in
CHAMPION Trial By Targeting Pressure Ranges and Titrating Medications Overall PAPs Can Be Reduced
Compared to the control group patients managed with PAP had persistently lower mean PA pressures over the treatment period
CHAMPION Trial PAP Mean Change from Baseline
Abraham WT et al Lancet 2011
PA
Me
an
Pre
as
ure
AU
C (
mm
Hg
-Da
ys
)
-220
-200
-180
-160
-140
-120
-100
-80
-60
-40
-20
0
20
40
60
80
100
Days from Implant
0 30 60 90 120 150 180
p = 00077
Treatment (-1557 mmHg-Days)Control (331 mmHg-Days)
cardioMEMS-CHAMPION trial
In 68 of cases Loop diuretic dose change
The Evolution of Pressure-Guided Therapy
Congestion is the limiting symptom
Symptoms and weights do not provide a reliable early warning system
Seeing is relieving
Events are associated with increased pulmonary pressures
HF preserved EF is more the same than different
Treating the peaks is not enough to prevent events
Reduce not just peaks but also the plateau
Does CHAMPION duplicate what can be seen by measuring electrical Intra-thoracic Impedance (ITI)
bull Remote of assessment of ITI is now currently provided by innovative technology embedded in implantable defibrillators (ICD and CRT D devices)
bull The OPTIVOL ITI detection system has been developed by MEDTRONIC and has been widely tested to prove efficacy of intra-thoracic impedance decline to manage pending acute decompensated HF
Intrathoracic impedance measurement by implantable system
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
Algorithm performance on validation data set
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
For validation data set nominal threshold of 60 Ωd resulted in
sensitivity of 769 and false-positive rate of 15 false-
positives per patient-year of monitoring as highlighted by
circle
15
The OPTIVOL fluid index pivotal trials van Veldhuisen D et al Circulation 2011 DOT HF
The OPTIVOL fluid index pivotal trials Bohm M et al et al EHJ 2015 OPTILINK
Patients with potentially higher risk of cardiac decompensationdeterioration presenting at least 1 out of 4 criteria
bull HF-related Hospitalization within the last 12 months bull IV-Oral Diuretic Treatment within last 30 days bull Increased BNP within last 30 daysgt 400pgml bull Increased NT-pro-BNP within last 30 days [gt 400 pgml (lt 50 yrs) gt 900 pgml (50-75 yrs) gt 1800 pgml (gt 75 yrs)]
Intra-thoracic Impedance Limitations
bull The OptiVol find can be insensitive in chronically volume overloaded patients or when volume accumulation occurs very slowly
bull In the case the reference impedance also changes it prevent separation to occur between reference and measured impedance and than it prevent the calculated cumulative sum to rise
Zile M et al Circulation Heart Failure 2016
1924hellipTelemedicine (radiomedicine)
come in
cardioMEMS-CHAMPION trial
In 68 of cases Loop diuretic dose change
The Evolution of Pressure-Guided Therapy
Congestion is the limiting symptom
Symptoms and weights do not provide a reliable early warning system
Seeing is relieving
Events are associated with increased pulmonary pressures
HF preserved EF is more the same than different
Treating the peaks is not enough to prevent events
Reduce not just peaks but also the plateau
Does CHAMPION duplicate what can be seen by measuring electrical Intra-thoracic Impedance (ITI)
bull Remote of assessment of ITI is now currently provided by innovative technology embedded in implantable defibrillators (ICD and CRT D devices)
bull The OPTIVOL ITI detection system has been developed by MEDTRONIC and has been widely tested to prove efficacy of intra-thoracic impedance decline to manage pending acute decompensated HF
Intrathoracic impedance measurement by implantable system
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
Algorithm performance on validation data set
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
For validation data set nominal threshold of 60 Ωd resulted in
sensitivity of 769 and false-positive rate of 15 false-
positives per patient-year of monitoring as highlighted by
circle
15
The OPTIVOL fluid index pivotal trials van Veldhuisen D et al Circulation 2011 DOT HF
The OPTIVOL fluid index pivotal trials Bohm M et al et al EHJ 2015 OPTILINK
Patients with potentially higher risk of cardiac decompensationdeterioration presenting at least 1 out of 4 criteria
bull HF-related Hospitalization within the last 12 months bull IV-Oral Diuretic Treatment within last 30 days bull Increased BNP within last 30 daysgt 400pgml bull Increased NT-pro-BNP within last 30 days [gt 400 pgml (lt 50 yrs) gt 900 pgml (50-75 yrs) gt 1800 pgml (gt 75 yrs)]
Intra-thoracic Impedance Limitations
bull The OptiVol find can be insensitive in chronically volume overloaded patients or when volume accumulation occurs very slowly
bull In the case the reference impedance also changes it prevent separation to occur between reference and measured impedance and than it prevent the calculated cumulative sum to rise
Zile M et al Circulation Heart Failure 2016
1924hellipTelemedicine (radiomedicine)
come in
The Evolution of Pressure-Guided Therapy
Congestion is the limiting symptom
Symptoms and weights do not provide a reliable early warning system
Seeing is relieving
Events are associated with increased pulmonary pressures
HF preserved EF is more the same than different
Treating the peaks is not enough to prevent events
Reduce not just peaks but also the plateau
Does CHAMPION duplicate what can be seen by measuring electrical Intra-thoracic Impedance (ITI)
bull Remote of assessment of ITI is now currently provided by innovative technology embedded in implantable defibrillators (ICD and CRT D devices)
bull The OPTIVOL ITI detection system has been developed by MEDTRONIC and has been widely tested to prove efficacy of intra-thoracic impedance decline to manage pending acute decompensated HF
Intrathoracic impedance measurement by implantable system
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
Algorithm performance on validation data set
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
For validation data set nominal threshold of 60 Ωd resulted in
sensitivity of 769 and false-positive rate of 15 false-
positives per patient-year of monitoring as highlighted by
circle
15
The OPTIVOL fluid index pivotal trials van Veldhuisen D et al Circulation 2011 DOT HF
The OPTIVOL fluid index pivotal trials Bohm M et al et al EHJ 2015 OPTILINK
Patients with potentially higher risk of cardiac decompensationdeterioration presenting at least 1 out of 4 criteria
bull HF-related Hospitalization within the last 12 months bull IV-Oral Diuretic Treatment within last 30 days bull Increased BNP within last 30 daysgt 400pgml bull Increased NT-pro-BNP within last 30 days [gt 400 pgml (lt 50 yrs) gt 900 pgml (50-75 yrs) gt 1800 pgml (gt 75 yrs)]
Intra-thoracic Impedance Limitations
bull The OptiVol find can be insensitive in chronically volume overloaded patients or when volume accumulation occurs very slowly
bull In the case the reference impedance also changes it prevent separation to occur between reference and measured impedance and than it prevent the calculated cumulative sum to rise
Zile M et al Circulation Heart Failure 2016
1924hellipTelemedicine (radiomedicine)
come in
Does CHAMPION duplicate what can be seen by measuring electrical Intra-thoracic Impedance (ITI)
bull Remote of assessment of ITI is now currently provided by innovative technology embedded in implantable defibrillators (ICD and CRT D devices)
bull The OPTIVOL ITI detection system has been developed by MEDTRONIC and has been widely tested to prove efficacy of intra-thoracic impedance decline to manage pending acute decompensated HF
Intrathoracic impedance measurement by implantable system
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
Algorithm performance on validation data set
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
For validation data set nominal threshold of 60 Ωd resulted in
sensitivity of 769 and false-positive rate of 15 false-
positives per patient-year of monitoring as highlighted by
circle
15
The OPTIVOL fluid index pivotal trials van Veldhuisen D et al Circulation 2011 DOT HF
The OPTIVOL fluid index pivotal trials Bohm M et al et al EHJ 2015 OPTILINK
Patients with potentially higher risk of cardiac decompensationdeterioration presenting at least 1 out of 4 criteria
bull HF-related Hospitalization within the last 12 months bull IV-Oral Diuretic Treatment within last 30 days bull Increased BNP within last 30 daysgt 400pgml bull Increased NT-pro-BNP within last 30 days [gt 400 pgml (lt 50 yrs) gt 900 pgml (50-75 yrs) gt 1800 pgml (gt 75 yrs)]
Intra-thoracic Impedance Limitations
bull The OptiVol find can be insensitive in chronically volume overloaded patients or when volume accumulation occurs very slowly
bull In the case the reference impedance also changes it prevent separation to occur between reference and measured impedance and than it prevent the calculated cumulative sum to rise
Zile M et al Circulation Heart Failure 2016
1924hellipTelemedicine (radiomedicine)
come in
Intrathoracic impedance measurement by implantable system
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
Algorithm performance on validation data set
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
For validation data set nominal threshold of 60 Ωd resulted in
sensitivity of 769 and false-positive rate of 15 false-
positives per patient-year of monitoring as highlighted by
circle
15
The OPTIVOL fluid index pivotal trials van Veldhuisen D et al Circulation 2011 DOT HF
The OPTIVOL fluid index pivotal trials Bohm M et al et al EHJ 2015 OPTILINK
Patients with potentially higher risk of cardiac decompensationdeterioration presenting at least 1 out of 4 criteria
bull HF-related Hospitalization within the last 12 months bull IV-Oral Diuretic Treatment within last 30 days bull Increased BNP within last 30 daysgt 400pgml bull Increased NT-pro-BNP within last 30 days [gt 400 pgml (lt 50 yrs) gt 900 pgml (50-75 yrs) gt 1800 pgml (gt 75 yrs)]
Intra-thoracic Impedance Limitations
bull The OptiVol find can be insensitive in chronically volume overloaded patients or when volume accumulation occurs very slowly
bull In the case the reference impedance also changes it prevent separation to occur between reference and measured impedance and than it prevent the calculated cumulative sum to rise
Zile M et al Circulation Heart Failure 2016
1924hellipTelemedicine (radiomedicine)
come in
Algorithm performance on validation data set
Cheuk-Man Yu et al Circulation 2005112841-848
Copyright copy American Heart Association Inc All rights reserved
For validation data set nominal threshold of 60 Ωd resulted in
sensitivity of 769 and false-positive rate of 15 false-
positives per patient-year of monitoring as highlighted by
circle
15
The OPTIVOL fluid index pivotal trials van Veldhuisen D et al Circulation 2011 DOT HF
The OPTIVOL fluid index pivotal trials Bohm M et al et al EHJ 2015 OPTILINK
Patients with potentially higher risk of cardiac decompensationdeterioration presenting at least 1 out of 4 criteria
bull HF-related Hospitalization within the last 12 months bull IV-Oral Diuretic Treatment within last 30 days bull Increased BNP within last 30 daysgt 400pgml bull Increased NT-pro-BNP within last 30 days [gt 400 pgml (lt 50 yrs) gt 900 pgml (50-75 yrs) gt 1800 pgml (gt 75 yrs)]
Intra-thoracic Impedance Limitations
bull The OptiVol find can be insensitive in chronically volume overloaded patients or when volume accumulation occurs very slowly
bull In the case the reference impedance also changes it prevent separation to occur between reference and measured impedance and than it prevent the calculated cumulative sum to rise
Zile M et al Circulation Heart Failure 2016
1924hellipTelemedicine (radiomedicine)
come in
The OPTIVOL fluid index pivotal trials van Veldhuisen D et al Circulation 2011 DOT HF
The OPTIVOL fluid index pivotal trials Bohm M et al et al EHJ 2015 OPTILINK
Patients with potentially higher risk of cardiac decompensationdeterioration presenting at least 1 out of 4 criteria
bull HF-related Hospitalization within the last 12 months bull IV-Oral Diuretic Treatment within last 30 days bull Increased BNP within last 30 daysgt 400pgml bull Increased NT-pro-BNP within last 30 days [gt 400 pgml (lt 50 yrs) gt 900 pgml (50-75 yrs) gt 1800 pgml (gt 75 yrs)]
Intra-thoracic Impedance Limitations
bull The OptiVol find can be insensitive in chronically volume overloaded patients or when volume accumulation occurs very slowly
bull In the case the reference impedance also changes it prevent separation to occur between reference and measured impedance and than it prevent the calculated cumulative sum to rise
Zile M et al Circulation Heart Failure 2016
1924hellipTelemedicine (radiomedicine)
come in
The OPTIVOL fluid index pivotal trials Bohm M et al et al EHJ 2015 OPTILINK
Patients with potentially higher risk of cardiac decompensationdeterioration presenting at least 1 out of 4 criteria
bull HF-related Hospitalization within the last 12 months bull IV-Oral Diuretic Treatment within last 30 days bull Increased BNP within last 30 daysgt 400pgml bull Increased NT-pro-BNP within last 30 days [gt 400 pgml (lt 50 yrs) gt 900 pgml (50-75 yrs) gt 1800 pgml (gt 75 yrs)]
Intra-thoracic Impedance Limitations
bull The OptiVol find can be insensitive in chronically volume overloaded patients or when volume accumulation occurs very slowly
bull In the case the reference impedance also changes it prevent separation to occur between reference and measured impedance and than it prevent the calculated cumulative sum to rise
Zile M et al Circulation Heart Failure 2016
1924hellipTelemedicine (radiomedicine)
come in
Intra-thoracic Impedance Limitations
bull The OptiVol find can be insensitive in chronically volume overloaded patients or when volume accumulation occurs very slowly
bull In the case the reference impedance also changes it prevent separation to occur between reference and measured impedance and than it prevent the calculated cumulative sum to rise
Zile M et al Circulation Heart Failure 2016
1924hellipTelemedicine (radiomedicine)
come in
1924hellipTelemedicine (radiomedicine)
come in