Introdução à Medicina IIClass 6

24th May 2011

Aged, hypertensive and obese population [1]

GREATER INCIDENCE OF

CARDIOVASCULAR DISEASES

[1] Thibault B, Guerra PG. 2010.

Not wasting time with stable patients, without complications, so that the

doctors can pay more attention to more urgent and serious patients [2]

[2] Jung W, Rillig A, Birkemeyer R, Miljak T, Meyerfeldt U. 2008.

So, we should pay more attention to cardiovascular diseases’ PREVENTION

and to its TREATMENT, to optimize the treatment conditions, not only for the

doctor but also for the patient [2].

Better quality of life [2]

• Pacemakers • ICDs (implantable cardioverter defibrillators)

• CRTs (cardiac resynchronization devices)

• Loop recorders• Implantable hemodynamic monitors

IECD have the ability to [4]:

1. restore normal cardiac activation sequence

2. detect and treat a malignant arrhythmia, by means of electrical therapy

3. maintain rhythm

4. provide cardiac resynchronization therapy

5. prevent sudden cardiac death

[4] Costa PD, Rodrigues PP, Reis AH, Costa-Pereira A. 2010.

Some of cardiovascular diseases require IECD [4]

This way, doctors could follow patients more carefully [4]

Since the 70s

[4] Costa PD, Rodrigues PP, Reis AH, Costa-Pereira A. 2010.[5] Guevara, Valdivia ME. 2009.

• It consists on the use of electronic information and communication technologies to provide health care at distance and allow remote decisions, in order of maintaining or improving patients’ health [8]

REMOTE MONITORING• Has been used in the follow-up of patients with IECD in alternative to monitoring on a presential consultation [4, 5, 7, 8]

[7] Burri H, Senouf D. 2009.[8] Angaran DM. 1999.

IS REMOTE MONITORING REALLY IMPROVING PATIENT CARE? [9]

[9] Guédon-Moreau L, Chevalier P, Marquié C, Kouakam C, Klug D, Lacroix D, Brigadeau F, Kacet S; ECOST trial Investigators. 2010.

IS REMOTE MONITORING IN THE FOLLOW-UP OF PATIENTS WITH IECD

REDUCING THE MORTALITY RATE, THE NUMBER OF HOSPITAL ADMISSIONS

AND IMPROVING PATIENTS’ QUALITY OF LIFE, IN COMPARISON WITH

MONITORING AT PRESENTIAL CONSULTATION?

Aim

To collect evidence regarding whether

remote monitoring of IECD IMPROVES PATIENT CAREIMPROVES PATIENT CARE

Does remote monitoring:

• Reduce the mortality rate and the number of hospital visits and admissions? [5,7]

• Provide real time information regarding device operation and patient diagnosis/therapies

between appointments? [2,3,4]

• Reduce costs, not only for the patient, but also for the hospital? [2,6]

• Improve patients’ quality of life? [3,6]

[2] Jung W, Rillig A, Birkemeyer R, Miljak T, Meyerfeldt U. 2008.[3] Sticherling C, Kühne M, Schaer B, Altmann D, Osswald S. 2009.[4] Costa PD, Rodrigues PP, Reis AH, Costa-Pereira A. 2010.[5] Guevara, Valdivia ME. 2009.

[6] Al-Khatib SM, Piccini JP, Knight D, Stewart M, Clapp-Channing N, Sanders GD. 2010.[7] Burri H, Senouf D. 2009.

To perform a SYSTEMATIC REVIEW to determine whether remote monitoring is better than monitoring on a presential consultation for patients with IECD

• Construct a QueryPubMed

ISI Web of Knowledge

• Eliminate duplicated articles

• Assign each article to 2 reviewers for REVISION BY TITLE AND ABSTRACT

- If the articles met all inclusion criteria and didn’t meet the exclusion criterion- If both reviewers agree

INCLUDED

• Extract study variables from the included articles on a REVISION BY FULL TEXT

• Import articles’ information to EndNote

- If the 2 reviewers don’t agree – third revision will decide articles’ inclusion

POPULATION-IECD OR ICD OR…

INTERVENTION-remote monitoring OR telemedicine OR…

OUTCOMES- mortality rate OR number of hospital admissions OR quality of life OR…

TYPE OF STUDY- randomized controlled trial

QUERY4 elements

ANDAND

ANDAND

ANDAND

((("cardiovascular system"[MeSH Terms] OR ("cardiovascular"[All Fields] AND "system"[All Fields]) OR "cardiovascular system"[All Fields] OR "cardiovascular"[All Fields]) AND ("electronics"[MeSH Terms] OR "electronics"[All Fields] OR "electronic"[All Fields]) AND ("instrumentation"[Subheading] OR "instrumentation"[All Fields] OR "devices"[All Fields] OR "equipment and supplies"[MeSH Terms] OR ("equipment"[All Fields] AND "supplies"[All Fields]) OR "equipment and supplies"[All Fields])) OR "CIED"[All Fields] OR (implantable[All Fields] AND ("cardiovascular system"[MeSH Terms] OR ("cardiovascular"[All Fields] AND "system"[All Fields]) OR "cardiovascular system"[All Fields] OR "cardiovascular"[All Fields]) AND ("defibrillators"[MeSH Terms] OR "defibrillators"[All Fields])) OR "ICD"[All Fields] OR "defibrillators"[MeSH Terms] OR "defibrillators"[All Fields] OR "cardiac resynchronization"[All Fields] OR "CRT devices"[All Fields] OR "pacemakers"[All Fields] OR "IECD"[All Fields]) AND (("remote"[All Fields] OR "distant"[All Fields] OR "far"[All Fields] OR "faraway"[All Fields]) AND ("monitoring"[All Fields] OR "supervising"[All Fields] OR "observing"[All Fields] OR "overseeing"[All Fields] OR "managing"[All Fields] OR "following"[All Fields] OR "consultation"[All Fields])) OR "telemedicine"[MeSH Terms] OR "telemedicine"[All Fields] OR "tele-medicine"[All Fields] OR "tele-health"[All Fields] OR "telehealth"[All Fields] OR "telecare"[All Fields] OR "tele-care"[All Fields] OR "telemonitoring"[All Fields] OR "tele-monitoring"[All Fields] OR "e-health"[All Fields] OR "eHealth"[All Fields] OR "e-healthcare"[All Fields] OR "mHealth"[All Fields] OR "m-health"[All Fields] OR "telecardiology"[All Fields] OR "tele-cardiology"[All Fields] OR "Remote Consultation"[Mesh] OR "Telemedicine"[Mesh]) AND ("mortality"[All Fields] OR "mortality rate"[All Fields] OR "arrhythmia"[All Fields] OR "heart failure"[All Fields] OR (("hospitalar"[All Fields] OR "institution"[All Fields]) AND "admission"[All Fields]) OR "patient admission"[Mesh] OR "life quality"[All Fields] OR "quality of life"[All Fields] OR "efficiency"[All Fields] OR "patient acceptance"[All Fields] OR "patient satisfaction"[All Fields] OR "patient satisfaction"[Mesh] OR "patient acceptance of health care"[Mesh]) AND "trial"[All Fields]

(("electronic"[All Fields] OR "instrumentation"[All Fields]) OR "devices"[All Fields] OR ("equipment"[All Fields] AND "supplies"[All Fields]) OR "CIED"[All Fields] OR (implantable[All Fields] AND ("cardiovascular"[All Fields] AND "system"[All Fields])) OR "defibrillators"[All Fields] OR "ICD"[All Fields] OR "cardiac resynchronization"[All Fields] OR "CRT devices"[All Fields] OR "pacemakers"[All Fields] OR "IECD"[All Fields]) AND ((("remote"[All Fields] OR "distant"[All Fields] OR "far"[All Fields]) AND ("monitoring"[All Fields] OR "supervising"[All Fields] OR "overseeing"[All Fields] OR "following"[All Fields] OR "consultation"[All Fields])) OR "telemedicine"[All Fields] OR "tele-health"[All Fields] OR "telecare"[All Fields] OR "tele-care"[All Fields] OR "telemonitoring"[All Fields] OR "tele-monitoring"[All Fields] OR "e-health"[All Fields] OR "eHealth"[All Fields] OR "e-healthcare"[All Fields] OR "mHealth"[All Fields] OR "m-health"[All Fields] OR "telecardiology"[All Fields] OR "tele-cardiology"[All Fields]) AND ("mortality"[All Fields] OR "mortality rate"[All Fields] OR "arrhythmia"[All Fields] OR "heart failure"[All Fields] OR (("hospitalar"[All Fields] OR "institution"[All Fields]) AND "admission"[All Fields]) OR "life quality"[All Fields] OR "quality of life"[All Fields] OR "efficiency"[All Fields] OR "patient acceptance"[All Fields] OR "patient satisfaction"[All Fields]) AND ("trial"[All Fields])

• We adapted the previous query, in order to be able to search articles in ISI Web of Knowledge (e.g. we eliminated Mesh Terms)

Inclusion criteria Exclusion criteriaType of study: randomized controlled trial Language (other than english)

Reference to population: information on

people with IECD

IF too many articles are included we will

consider only the last 10 years

Reference to intervention: information on

remote monitoring of IECD

Reference to outcomes, like mortality, number

of hospital admissions, the patient satisfaction,

and others

IF not enough randomized controlled trials are

found, we may consider observational studies

Citations identified from electronic search on PubMed

(498)Citations identified from electronic search on ISI Web of Knowledge

(411)

Articles selected for review by title and abstract

(893)

Duplicated data excluded

(16)

Excluded articles on peer’s review

(819)Selected articles on peer’s review

(23)

Articles submited to a 3rd review by title and abstract

(51)

Articles excluded because:

- Language is not english…..(11)- Don’t mention IECD……..(774)- Mention IECD, but not remote monitoring of IECD................................

(19)- Mention IECD, remote monitoring of IECD, but aren’t RCT……..............

(14)- Mention IECD, remote monitoring of IECD, are RCT but don’t mention

outomes………………….…...(1)

Excluded articles on third peer’s review

(47)

Selected articles on 3rd peer’s review

(4)

Articles selected for full text review

(28)

Articles excluded because:

- Language is not english……………………....

(1)- Don’t mention IECD……………………..…..

(40)- Mention IECD, but not remote monitoring of IECD………………………………………….

(3)- Mention IECD, remote monitoring of IECD,

but aren’t RCT……………………….………...(3)

Articles included by reference

(1)

Articles selected for full text review

(28)

Selected articles included on full text review

(4)

Articles excluded because:

- Don’t mention IECD................................

(12)- Mention IECD, but not remote monitoring of IECD......................................................

(3)- Mention IECD, remote monitoring of IECD, but aren’t RCT...........................................

(5)- Mention IECD, remote monitoring of IECD, are RCT but don’t mention outomes......................................................

(4)

Selected articles excluded on full text review

(24)

New full text review of articles that were excluded on review by title and abstract because

they met all criteria but RCT and outcomes

(17)

Articles excluded

(17)

Articles excluded because:

- Don’t mention IECD.....................................

(11)- Mention IECD, but not remote monitoring of IECD...........................................................

(3)- Don’t mention IECD nor remote monitoring of IECD...........................................................

(5)

New full text review of articlesthat were excluded on full text review

(24)

Observational studies included

(5)

Articles included

(0)

Selected articles included on full text review

(4)

Observational studies included(5)

Articles includedfor systematic review

(9)INCLUDED

So, we’ve already extracted all variables from these articles...

• Next step: Statistical Analysis

Article 41 Article 80 Article 147 Article 894

Type of study Experimental Experimental Experimental Experimental

Place where study was conducted

102 US centers Duke Clinical Research Institute and Duke University Medical Center, Durham, North Carolina, USA

136 US clinical sites 102 US centers

Study duration (months) 15 12 18 15

Patient’s age (mean)

I63.3±12.8 65.2 ±12.4

std deviation63.3±12.8

C64.0±12.1 64.9 ± 11.9

std deviation64.0±12.1

Total63 65± 12,1

std deviation

Sample size

I 908 76 1014 908

C 431 75 983 431

Total 1339 (2:1) 151 1997 (1:1) 1339 (2:1)

Male patients

I 254 72 254

C 315 73 315

Total 569 145 1442 569

Female patients

I 654 4 654

C 116 2 116

Total 770 6 555 770

Article 127 Article 150 Article 154 Article 160 Article 415

Type of study Observational Observational Observational Observational Observational

Place where study was conducted

Department of Cardiology, Erasmus MC, Rotterdam, The Netherlands

Department of Cardiology, San Filippo Neri Hospital, Rome, Italy

Department of Cardiology, San Filippo Neri Hospital, Rome, Italy

German Pediatric Heart Centre, Sankt Augustin, Germany

Study duration (months) 22 ±16 73±10 3 13 3

Patient’s age (mean) Total58±14 64±9 15,5 (SD= 10,4

years)70,2±10,4

Sample size

single-chamber devices

117

dual-chamber devices

21

cardiac resynchronization therapy systems

8

Pacemaker 121 4

ICD 22 4

ICD+RCT-D 23

Total 146 166 67 8 93

Male patients Total66 112 58 62

Female patients Total 36 44 9 31

Article 41

Type of study Experimental

Sample size 1339

Mortality rate (%)I 3.4%

C 4.9%

Reduction of total in-office visits in remote monitoring at 12 months (%) 45%

Median time to evaluation for all arrhythmic events (days)I <2

C 36

Article 80

Type of study Experimental

Sample size 151

Mortality rate (%)I 5,33 %

C 4.00 %

Measure of health outcome by standardized instruments – 6 months(%)

IEuroQoL: 75 (50,85)General Satisfaction: 75(75,88)

CEuroQoL: 83 (70,90)General Satisfaction: 88(75,100)

Measure of health outcome by standardized instruments – 12 months(%)

IEuroQoL: 80 (65,92)General Satisfaction: 75(75,88)

CEuroQoL: 80 (70,90)General Satisfaction: 88(75,100

Time spent on consultation (min)I

C 67

Costs for the patientI 374,73 dollars

C 265,44 dollars

Article 147Type of study Experimental

Sample size 1997

Mortality rate (%)

No statistical difference was found between arms.

Costs for health servicesI 8114 dollars

C 9822 dollars

Median time between clinical event and clinical decision per patient (days)

I 4,6

C 22

Rate of total clinical visits (pacient/year)I 3.9

C 6.3

Mean LOS per hospitalization visit (days)I 3,3

C 4

Article 894Type of study Experimental

Sample size 1339

Device related complications (number of patients)I 40

C 6

Device related complications requiring surgical revision occurred duringthe course of the study 20

Device problems requiring surgical revisionI 15

C 5

Lead problem notificationsI 21

C 5

Time until evaluation of device related complications (days)I 4.4±9.2

C 23.6±40.2

Article 127

Type of study Observational

Sample size 146

Median number of events/patient/month 0,14

Article 150

Type of study Observational

Sample size 166

Time from the last in-hospital follow-up visit to the detection and the first intervention for atrial fibrillation (median; days) 50

Value of reaction time to event in advance to the scheduled follow-up (median; days) 148

Article 154

Type of study Observational

Sample size 67

Mortality rate (%) 1,49%

Changes in therapy due to early data transmission (by remote monitoring) (%) 3,78%

Reduction of total in-office visits in remote monitoring at 12 months (%) 5,30%

Article 160

Type of study Observational

Sample size 8

Changes in therapy due to early data transmission (by remote monitoring) 87%

Article 415

Type of study Observational

Sample size 93

Number of events transmitted 5311

Event reports triggered by the patients (%) 64,8%

Transmission interrupts that lasted 1 day (%) 63%

Transmission interrupts that lasted longer than 4 days (%) 4%

Mortality rate• Article 41 shows a decrease on remote monitoring, but it’s not significant.• Article 80 shows an increase on remote monitoring, but it’s not significant.• Article 147 shows a non-singificant diference between remote monitoring and presential monitoring.

In-clinic and hospital visits• Article 41 shows a significant decrease on remote monitoring.• Article 80 shows a decrease on remote monitoring, but it’s not significant.

Lenght of stay per hospitalization• Article 147 showed a significant reduction on remote monitoring.

Reduction of scheduled hospital visits• Articles 41, 80 and 154 showed a reduction on remote monitoring.

Unscheduled in-clinic hospital visits• Article 41 showed a significant increase on remote monitoring.

Preliminary conclusions

Costs for health services• Article 147 shows a decrease on remote monitoring.

Costs for the patient• Article 80 shows an increase on remote monitoring.

Health related quality of life• Article 80 shows a decrease on remote monitoring, but it’s not significant.

Time between event and clinical decision• Article 147 shows a significant decrease on remote monitoring.• Article 894 shows a significant decrease on remote monitoring.

Device related complications• Article 894 shows a significant increase on remote monitoring.

Preliminary conclusions

Time until evaluation of device related complications- Article 894 shows a reduction on remote monitoring , but it is not significant.

It was very difficult to find articles that measured our outcomes.

We’ve extracted variables that we didn’t intend to analyse in the first place.

• The obtained data was very heterogeneous.

• It may be difficult for us to conclude anything from statistically analysing these variables.

• Some of our expectations were not confirmed by the studied articles.

• Remote monitoring seems to bring some advantages at other levels.

• More clinical trials need to be conducted in this area.

[1] Thibault B, Guerra PG. Implanted cardiac devices with remote monitoring capacity: “it’s like having a physician follow me on a daily basis”. Expert Review of Cardiovascular Therapy. 2010; 8 (5): 617-9.

[2] Jung W, Rillig A, Birkemeyer R, Miljak T, Meyerfeldt U. Advances in remote monitoring of implantable pacemakers, cardioverter defibrillators and cardiac resynchronization therapy systems. J Interv Card Electrophysiol. 2008; 23(1): 73-85.

[3] Sticherling C, Kühne M, Schaer B, Altmann D, Osswald S. Remote monitoring of cardiovascular implantable electronic devices: Prerequisite or luxury?. Swiss Med Wkly. 2009; 139 (41-42): 596-601.

[4] Costa PD, Rodrigues PP, Reis AH, Costa-Pereira A. A Review on Monitoring Technology Applied to Implantable Electronic Cardiovascular Devices, Telemedicine and e-Health. 2010; 16(10): 1042-50.

[5] Guevara, Valdivia ME. Remote monitoring of automatic implantable cardiovascular devices (pacemakers, implantable cardioverter defibrillator and cardiac resynchronization. Arch Cardiol Mex. 2009; 79(3): 221-5.

[6] Al-Khatib SM, Piccini JP, Knight D, Stewart M, Clapp-Channing N, Sanders GD. Remote Monitoring of Implantable Cardioverter Defibrillators versus Quarterly Device Interrogations in Clinic: Results from a Randomized Pilot Clinical Trial. J Cardiovasc Electrophysiol. 2010; 21: 545-50.

[7] Burri H, Senouf D. Remote monitoring and follow-up of pacemakers and implantable cardioverter defibrillators. Europace. 2009; 11(6): 701-9.

[8] Angaran DM. Telemedicine and telepharmacy: current status and future implications. American Journal of Health System Pharmacy. 1999; 56(14): 1405-26.

[9] Guédon-Moreau L, Chevalier P, Marquié C, Kouakam C, Klug D, Lacroix D, Brigadeau F, Kacet S; ECOST trial Investigators. Contributions of remote monitoring to the follow-up of implantable cardioverter–defibrillator leads under advisoryl. Eur Heart J. 2010; 31(18):2246-52.

[10] Ricci RP, Morichelli L, Quarta L, Sassi A, Porfili A, Laudadio MT, Gargaro A, Santini M. Long-term acceptance of and satisfaction with implantable device remote monitoring. Europance. 2010; 12(5): 647-9.

[11] Ricci RP, Morichelli L, Gargaro A, Laudadio MT, Santini M. Home monitoring with implantaple cardiac devices: is there a potential reduction of stroke risk? Results from a computer model testes through monte carlo simulatons. J Cardiovasc Electrophysiol. 2009; 20(11): 1244-51.