introduction to crt - abbott · michael r. gold, ulrika birgersdotter-green, jagmeet p. singh,...

Introduction to CRT for Allied Health Professionals

IMPLANTABLE CARDIAC MONITORS

Monitors Heartbeat

CRM Devices at a Glance

33668-SJM-CRM-0819-0243 | Item approved for global use.

PACEMAKERS

Heartbeat Is Too Slow

CARDIAC RESYNCHRONIZATION

THERAPY

Heartbeat Is Out of Sync

DEFIBRILLATORS

Heartbeat Is Too Fast

Agenda

Recent Advancements Improving CRT Response

1

2

5

4

Stepwise Approach to CRT Optimization6

What is Cardiac Resynchronization Therapy?

Addressing Non-Response

The Clinical & Economic Burden of Heart Failure in the U.S.

Patient Selection and Indications 3

CRT Case Study733668-SJM-CRM-0819-0243 | Item approved for global use.

The Clinical & Economic Burden of Heart Failure in the U.S.


Heart Failure (HF) Is a Growing Clinical Burden

1. AHA 2016 Statistics at a Glance, 2016.2. Krumholz HM, et al. Patterns of hospital performance in acute myocardial infarction and heart failure 30-day mortality and readmission. Circ Cardiovasc Qual Outcomes. 2009; 2:407-13. 3. Heidenreich PA, et al. Forecasting the impact of heart failure in the United States. A policy statement from the American Heart Association. Circ Heart Fail. 2013; 6: 606-619.

HIGH INCIDENCE, HIGH PREVALENCE AND POOR PROGNOSISdespite advances in the treatment of HF over the past few decades

PREVALENCE 2.2%prevalence1

5.7MHF patients1

Projected to increase to > 8M people ≥ 18 years of age with HF by 20301

INCIDENCE915,000

people ≥ 45 years of age are newly diagnosed each year with HF1

MORBIDITY AND MORTALITY

For AHA/ACC Stage C/D patients diagnosed with HF:

50% readmitted within

six months2

50% will die within

five years3

ACC = American College of CardiologyAHA = American Heart Association

UNITED STATES


1. American Cancer Society. Cancer Facts and Figures 2013. Atlanta, GA: American Cancer Society; 2013.2. National Cancer Institute. Surveillance, epidemiology, and end results program. Cancer stat fact sheets.

http://seer.cancer.gov/statfacts. Accessed July 30, 2014.

3. Roger VL, Weston SA, Redfield MM, et al. Trends in heart failure incidence and survival in a community-based population. JAMA. 2004;292(3):344-350.

Five-year Death Rates Approximate Many Forms of Malignant Neoplastic Diseases1

11%215%2

31%235%2

43%248%3

0

10

20

30

40

50

Breast Cancer Hodgkin's Lymphoma Non-Hodgkin'sLymphoma

Colon and Rectal Cancer Leukemia Heart Failure

PERC

ENT

(%)


Acute Exacerbations Contribute to Disease Progression

NORMAL HEART CHRONIC HF DEATH

ADHF = acute decompensated heart failureLV = left ventricular

ACUTE EVENT

TIME

MYO

CARD

IAL

FUN

CTIO

NFU

NCT

ION

AL A

BILI

TY

First ADHF episode:Pulmonary edema ACUTE EVENT

ACUTE EVENT

1. Gheorghiade MD, et al. (graph adapted from) Pathophysiologic targets in the early phase of acute heart failure syndromes. Am J Cardiol. 2005; 96[suppl]: 11G-17G.

WITH EACH EVENT,myocardial injury may contribute to progressive LV dysfunction


STROKE VOLUME

PRELOADAFTERLOAD

CONTRACTILITY

CARDIAC OUTPUT

HEART RATE

VENTRICULAR DYSSYNCHRONYCRT

MITRAL REGURGITATION

Therapeutic Approaches To Heart Failure

Diuretics

Digitalis

ACE-InhibitorARB‘sRenin Inhibitor

ß-BlockersAldosterone Antagonist

Mitra-Clip(TM) therapy


What is Cardiac Resychronization Therapy?


Early History of Cardiac Resynchronization Therapy

Delayed conduction between atrium and ventricle RESULTS IN REDUCED CARDIAC OUTPUT• Diastolic mitral regurgitation• Limited diastolic filling time• Decreased contribution of the atrial kick

1980’s – Interest in MANIPULATION OF AV INTERVALS in heart failure patients

ATRIAL KICK is typically 5 - 20% of cardiac output which can be significant for heart failure patients


1987 - Mower devised and was granted a patent for the concept of “BIVENTRICULAR PACING,” explicitly aimed at HF treatment

By the 1990s, a link emerged between ELECTRICAL DYSSYNCHRONY

and LV FUNCTION resulting in REDUCED CARDIAC OUTPUT

Early History of CRT


Lack Of AV And V-to-V Synchrony Result In Poor Cardiac Function

• Mitral regurgitation• Improper LV filling• Sub-optimal atrial filling• Delayed LV contraction• Abnormal septal motion

ENLARGED HEART



Cardiac Resynchronization Therapy is the placement of an

ADDITIONAL PACING LEAD on the LEFT SIDE of the heart



INDEPENDENT PACING allows pacing of the slower

ventricle first to create SIMULTANEOUS CONTRACTION

while maintaining atrial - ventricular synchrony

SEPARATE LEADS allow independent pacing

of the right atrium, right

ventricle and left ventricle



COMPARED TO OPTIMAL PHARMACOLOGICAL THERAPY, CRT:• Improves EF, NYHA Class and 6 MWT results1

• Reduces rates of all-cause, cardiac, and HF hospitalization2

COMPARED TO TRADITIONAL ICD THERAPY, CRT:• Decreases hospitalizations3

• Reduces the risk of death4

Benefits of Cardiac Resynchronization Therapy

1. Abraham WT, et al. Cardiac resynchronization in chronic heart failure. N Engl J Med. 2002 Jun;346(24):1845-53.2. Anand IS, et al. Cardiac resynchronization therapy reduces the risk of hospitalizations in patients with advanced heart failure:

results from the Comparison of Medical Therapy, Pacing and Defibrillation In Heart Failure (COMPANION) trial. Circulation. 2009Feb 24;119(7):969-77.

3. Tang AS, Resynchronization-Defibrillation for Ambulatory Heart Failure Trial Investigators, et al.Cardiac-resynchronization therapy for mild-to-moderate heart failure. N Engl J Med. 2010 Dec 16;363(25): 2385-95. Epub 2010 Nov 14.

4. Cleland JG, Daubert ,Cardiac Resynchronization- Heart Failure (CARE-HF) Study Investigators, et al. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. 2005 Apr 14;352(15):1539-49.

CRT BENEFITS HF PATIENTS WITH A WIDE QRS AND LOW LVEF

Who Can Benefit From CRT?

HEALTHY HEART ENLARGED HEART

Approximate 40% HEART FAILURE PATIENTS, specifically those with inter- or intra-ventricular conduction delays (IVCDs)


Device Goals of Cardiac Resynchronization Therapy

Overall goal is to IMPROVE CARDIAC OUTPUT

CRT provides options:• Restore appropriate AV Synchrony• Electrically Restore Mechanical Ventricular

Synchrony• Improve symptoms and quality of life• Decrease likelihood of disease progression;

possibly reverse remodel• Complement drug therapy


What’s Most Important?


I WANT THE LOWEST!(Threshold)

CRTPACEMAKERIn CRT devices, optimal lead placement is aGOOD LOCATION with an ACCEPTABLE THRESHOLD.

I WANT THE SLOWEST!(Latest site of activation)

2012 EHRA/HRS expert consensus statement on cardiac resynchronization therapy in heart failure: implant and follow-up recommendations and management

What’s Most Important?


The device is programmed to maximize the chance of a

POSITIVE RESPONSE TO CRT device therapy.

CRT

Compared to programming pacemaker outputs, the ideal left ventricular pacing location does

not always have the lowest capture threshold.

2012 EHRA/HRS expert consensus statement on cardiac resynchronization therapy in heart failure: implant and follow-up recommendations and management Asbach S, Hartmann M, Wengenmayer T, Graf E, Bode C, Biermann J. Vector selection of a quadripolar left ventricular pacing lead affects acute hemodynamic response to cardiac resynchronization therapy: a randomized cross-over trial. PLoS One. 2013;8(6):e67235. Published 2013 Jun 24. doi:10.1371/journal.pone.0067235

Which Vectors or Lead Positions Optimize CRT?

Biventricular Pacing at a SITE OF LATE ELECTRICAL ACTIVATION Has Been Shown To Improve CRT Outcomes1,2,3

1.Gold MR et al. The relationship between ventricular electrical delay and left ventricular remodeling with cardiac resynchronization therapy. Euro Heart J 2011; 32, 2516-25242.Polasek R et al. Local electrogram delay recorded from left ventricular lead at implant predicts response to cardiac resynchronizaiton therapy; retrospective study with 1 year follow up. BMC Cardiovascular Disorders 2012; 12:343.Pappone C, et al. Left ventricular pacing from a site of late electrical activation improves acute hemodynamic response to cardiac resynchronization therapy. (Abstract) APHRS 2012


“VECTOR” refers to the two electrodes you are

pacing between

The QLV Interval (Site of Late Electrical Activation)

The best outcomes were observed with a QLV > 95 ms, so this target should be considered when selecting LV lead position at the time of CRT implantation2

1. Michael R. Gold, Ulrika Birgersdotter-Green, Jagmeet P. Singh, Kenneth A. Ellenbogen, Yinghong Yu, Timothy E. Meyer, Milan Seth, and Patrick J. Tchou. The relationship between ventricular electrical delay and left ventricular remodeling with cardiac resynchronization therapy. Eur Heart J. 2011 Oct;32(20):2516-24. doi: 10.1093/eurheartj/ehr329. Epub 2011 Aug 29.2. Francesco Zanon, MD, FESC, FHRS; Enrico Baracca, MD; Gianni Pastore, MD; Chiara Fraccaro, MD, PhD; Loris Roncon, MD; Silvio Aggio, MD; Franco Noventa, MD; Alberto Mazza, MD, PhD; Frits Prinzen, PhD. Determination of the Longest Intrapatient Left Ventricular Electrical Delay May Predict Acute Hemodynamic Improvement in Patients After Cardiac Resynchronization Therapy. Circ Arrhythm Electrophysiol. 2014 Jun;7(3):377-83. doi: 10.1161/CIRCEP.113.000850. Epub 2014 Mar 25.

HELPS IDENTIFY GOOD LV PACING SITES; STRONGLY ASSOCIATED WITH RESPONSE1


Traditional QLV

MEASURED WITH A SURFACE EKG from the onset of the QRS to the first large positive or negative peak of the LV EGM during a cardiac cycle1

Q

LV

Surface ECG

LV EGM

1. Michael R. Gold, Ulrika Birgersdotter-Green, Jagmeet P. Singh, Kenneth A. Ellenbogen, Yinghong Yu, Timothy E. Meyer, Milan Seth, and Patrick J. Tchou. The relationship between ventricular electrical delay and left ventricular remodeling with cardiac resynchronization therapy. Eur Heart J. 2011 Oct;32(20):2516-24. doi: 10.1093/eurheartj/ehr329. Epub 2011 Aug 29.


The RV-LV Conduction Test Can Help

CONVENIENT, AUTOMATIC, PROGRAMMER BASED TEST • Measures a surrogate to QLV to help identify the vectors that might be

able to pace the slowest conducting LV location


Patient Selection and Indications


CARDIAC RESYNCHRONIZATION THERAPY

Indications: Who Needs a Device?

The American Heart Association (AHA) Classification System is based on the CLASSES (STRENGTH) OF RECOMMENDATION (COR) shown here as well as LEVEL (QUALITY) OF EVIDENCE (LOE) on the next slide.

CLASS I (STRONG)

CLASS IIa (MODERATE)

CLASS IIb (WEAK)

CLASS III (NO BENEFIT)

CLASS III (HARM)

BENEFIT >>> RISK BENEFIT >> RISK BENEFIT ≥ RISK BENEFIT = RISK RISK > BENEFIT

PROCEDURE/ TREATMENT





Should be performed/ administered

Is reasonable to perform/ administer

May/might be reasonable

Is not recommended

Potentially harmful

Epstein AE, DiMarco JP, Ellenbogen KA, et al. 2012 ACCF/AHA/HRS focused update incorporated into the ACCF/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol 2013; 61:e6. 33668-SJM-CRM-0819-0243 | Item approved for global use.

Indications: Who Needs a Device?

LEVEL (QUALITY) OF EVIDENCE (LOE)

LEVEL A High quality evidence from more than 1 RCT Randomized Controlled Trial

LEVEL B-R Moderate quality evidence from 1 or more RCTs Randomized

LEVEL B-NR Moderate quality evidence from 1 or more well-designed, well-executed nonrandomized studies Non-randomized

LEVEL C-LDRandomized or nonrandomized observational or registry studies with limitations of design or execution

Limited Data

LEVEL C-EO Consensus of expert opinion based on clinical experience Expert Opinion

Epstein AE, DiMarco JP, Ellenbogen KA, et al. 2012 ACCF/AHA/HRS focused update incorporated into the ACCF/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol 2013; 61:e6. 33668-SJM-CRM-0819-0243 | Item approved for global use.

CRT Trials Started In 2001MUSTIC, PATH-HF: First to address safety & efficacy of CRT

COMPANION: First large study to show clear advantage of CRT pacing. Both cardiac resynchronization therapy pacemaker (CRT-P) and CRT defibrillator (CRT-D) showed reduction in all-cause mortality or first hospitalization1

CARE-HF: First study powered to prove CRT alone reduces mortality. CRT is more beneficial than drugs alone2

MADIT-CRT: CRT-D therapy is effective for reducing the risk of HF events in patients with Class I and II HF, especially those with QRS > 150 ms3

REVERSE: CRT therapy is effective for delaying the progression of HF in patients with Class I and II HF4

RAFT: CRT therapy is effective for Class II and III patients, especially those with QRS > 150 ms5

1.Cazeau S, Leclercq C, Lavergne T, et al., for the Multisite Stimulation in Cardiomyopathies (MUSTIC) Study Investigators. Effects of multisite biventricular pacing in patients with heart failure and intraventricular conduction delay.N Engl J Med 2001;344:873–80.2.Auricchio A, Stellbrink C, Sack S, et al., for the Pacing Therapies in Congestive Heart Failure (PATH-CHF) Study Group. Long-term clinical effect of hemodynamically optimized cardiac resynchronization therapy in patients with heart failure and ventricular conduction delay. J Am CollCardiol 2002;39:2026–33. 3.Bristow, MR et al. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004;350:2140-50. 4.Cleland, JGF, et al. The Effect of Cardiac Resynchronization on Morbidity and Mortality in Heart Failure. N Engl J Med. 2005;352:1539-49.5.Moss AJ, et al. Cardiac Resynchronization Therapy for the Prevention of Heart Failure Events. N Engl J Med. 2009;361:1329-1338. doi: 10.1056/NEJMoa09064316.Linde C, et al. Randomized Trial of Cardiac Resynchronization in Mildly Symptomatic Heart Failure Patients and in Asymptomatic Patients with Left Ventricular Dysfunction and Previous Heart Failure Symptoms Free. J Am Coll Cardiol. 2008;52(23):1834-1843. doi:10.1016/j.jacc.2008.08.027 7.Tang ASL, et al. Cardiac Resynchronization Therapy for Mild to Moderate Heart Failure. N Engl J Med. 2010;363:25.


CRT-Pacemaker (CRT-P) Trials

PAVEStatistically improved functional performance and exercise capacity in patients with chronic, refractory AF undergoing atrioventricular (AV) nodal ablation and pacemaker implantation1

1.Doshi RN, Daoud EG, Fellows C, Turk K, Duran A, Hamdan MH, Pires LA; PAVE Study Group. Left ventricular-based cardiac stimulation post AV nodal ablation evaluation (the PAVE study). J Cardiovasc Electrophysiol. 2005 Nov;16(11):1160-5. 2.Curtis AB, Adamson PB, Chung E, et al. Biventricular Versus Right Ventricular Pacing in Patients With AV Block (BLOCK HF): Clinical Study Design and Rationale.

PATIENTS WITH HEART FAILURE BUT NO ICD INDICATION CAN BENEFIT FROM CRT-P• Bi-V pacing maintains synchrony in AV node ablated patients with mild CHF • Evidence showing better outcomes for BiV pacing vs. RV only

BLOCK-HFBiventricular pacing has better outcomes for patients with EF < 50%, NYHA Class I, II or III who are expected to pace the majority of the time2


CRT-P vs. CRT-D

RECENT STUDIES HAVE SHOWN THAT THOSE WITH EF < 50% AND WITH A NEED FOR PACING WILL BENEFIT FROM CRT• PAVE — post AV node ablation• BLOCK — HF heart block patients

• Patients with HF but no ICD indication can benefit from CRT-P

• BiV pacing maintains synchrony in AV node ablated patients with mild CHF

• Evidence shows better outcomes for BiV pacing versus right ventricular (RV) only

UNTIL RECENTLY IN THE U.S., the decision between CRT-P and CRT-D was in most part made by the patients’ wishes or the referring/implanting physician (those with EF < 35%).

1.Doshi RN, Daoud EG, Fellows C, Turk K, Duran A, Hamdan MH, Pires LA; PAVE Study Group. Left ventricular-based cardiac stimulation post AV nodal ablation evaluation (the PAVE study). J Cardiovasc Electrophysiol. 2005 Nov;16(11):1160-5. 2.Curtis AB, Adamson PB, Chung E, et al. Biventricular Versus Right Ventricular Pacing in Patients With AV Block (BLOCK HF): Clinical Study Design and Rationale. 33668-SJM-CRM-0819-0243 | Item approved for global use.

Kusumoto FM, Schoenfeld MH, Barrett C, Lee R, Edgerton JR, Marine JE,Ellenbogen KA, McLeod CJ, Gold MR, Oken KR, Goldschlager NF, Patton KK, Hamilton RM, PellegriniCN, Joglar JA, Selzman KA, Kim RJ, Thompson A, Varosy PD, 2018 ACC/AHA/HRS Guideline on theEvaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay, Heart Rhythm(2018), doi: https://doi.org/10.1016/j.hrthm.2018.10.037.Epstein AE, DiMarco JP, Ellenbogen KA, et al. 2012 ACCF/AHA/HRS focused update incorporated into the ACCF/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol 2013; 61:e6.

CRT Indications

Class 1 (Should be performed)• LVEF <= 35%• Sinus rhythm, LBBB, QRS >= 150 ms• NYHA class II, III, or ambulatory IV

• Level of Evidence: A for NYHA class III/IV• Level of Evidence: B for NYHA class II

• Symptoms on GDMT (Guideline-Directed Medical Therapy)

*Access the latest guidelines through ACC/AHA/HRS online

Based on the 2012 ACCF/AHA/HRS Focused Update of the 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities*


IMPORTANT NOTE: CLASS OF INDICATION IS NOT THE SAME AS NYHA CLASS

CRT-Pacemaker (CRT-P) Indications

*Access the latest guidelines through ACC/AHA/HRS online

CRT-P CLASS 1 INDICATIONS ARE THE SAME AS THOSE FOR CRT-D• HF patients (that meet CRT-D requirements) who are not, or who choose not

to be, candidates for CRT-D therapy

Kusumoto FM, Schoenfeld MH, Barrett C, Lee R, Edgerton JR, Marine JE,Ellenbogen KA, McLeod CJ, Gold MR, Oken KR, Goldschlager NF, Patton KK, Hamilton RM, Pellegrini CN, Joglar JA, Selzman KA, Kim RJ, Thompson A, Varosy PD, 2018 ACC/AHA/HRS Guideline on theEvaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay, Heart Rhythm(2018), doi: https://doi.org/10.1016/j.hrthm.2018.10.037.Epstein AE, DiMarco JP, Ellenbogen KA, et al. 2012 ACCF/AHA/HRS focused update incorporated into the ACCF/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol 2013; 61:e6.

Class IIa (Reasonable to perform) • AV Block with an indication for permanent pacing• LVEF 35 – 50% and:

• Ventricular pacing ≥ 40 - Level of Evidence B-RSR

(SR = Systematic Review S6.4.4.1-19)

NEW CLASS IIA INDICATION based on the 2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay:


QRS DurationA Wide QRS Is An Electrical Abnormality On An EKG

• A normal heart conducts almost simultaneously, resulting in narrow QRS• Electrical conduction affects mechanical contraction• Causes dyssynchrony• Lowers cardiac output

WIDE QRSNORMAL QRS(NARROW)

THE RIGHT AND LEFT SIDES OF THE HEART CONDUCT ELECTRICITY AT DIFFERENT SPEEDS

Normal QRS = 80-100 ms


EF = Blood pumped out of Left VentricleBlood available to be pumped out

Ejection Fraction (EF)

Normal EF > 50%Heart Failure EF ≤ 35%

MECHANICAL ABNORMALITY ON AN ECHO (expressed as a percentage)


Echo Comparisons

CHF HEARTHEALTHY HEART


CLASS DESCRIPTION

CLASS I (MILD)

CLASS II (MILD)

CLASS III (MODERATE)

CLASS IV (SEVERE)

New York Heart Association (NYHA) Classes

HFSA website.

No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea.

Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.

Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.

Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased.

DESCRIPTION

No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).

Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).

Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.

Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.


12%

24%

64%

NYHA IIn = 103

Modes of Death in Congestive Heart Failure (CHF)1

1. MERIT-HF Study Group. Effect of Metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL randomized intervention trial in congestive heart failure (MERIT-HF). Lancet. 1999;353:2001-07.

CHFOtherSudden Death

26%

15%59%

NYHA IIIn = 103

56%

11%

33%

NYHA IVn = 27


Addressing Non-ResponseCARDIAC RESYNCHRONIZATION THERAPY


Causes of CRT Non-response1

1. Mullens W, Grimm RA, Verga T, et al. Clinical Research: Insights from a Cardiac Resynchronization Optimization Clinic as Part of a Heart Failure DiseaseManagement Program. Journal of the American College of Cardiology. 2009;53:765-773.

SUBOPTIMAL AV TIMING

SUBOPTIMAL LV LEAD POSITION< 90% BIV PACING


Which Patients Will Benefit The Most?CLINICAL FACTORS INFLUENCING RESPONSE TO CRT

ESC Guidelines 2013 European Heart Journal (2013) 34, 2281–2329 doi:10.1093/eurheartj/eht15033668-SJM-CRM-0819-0243 | Item approved for global use.

Primary Challenges Managing CRT Patients

LEAD PLACEMENT

TIMING(AV, V-to-V)

NON-RESPONSE


LEAD PLACEMENT

LEAD PLACEMENT

LACK OF DATA

AV SYNCHRONY

V to V TIMING

Lead Placement

ack of Data

1. DIFFICULT TO ACCESS2. UNPREDICTABLE PATIENT ANATOMY

• Small/Medium/Large Vessels• Apical/Mid/Basal Terminations • Scar Tissue

3. LESS STABLE• Traditionally passive fixation

4. HIGHER THRESHOLDS• Epicardial (pacing from outside the LV)

5. CONDUCTION TIME• Epicardial vs. Endocardial

6. PHRENIC NERVE STIMULATION• Desired pacing location may be too close to phrenic nerve

CRT Challenge1,2,3,4

LEAD PLACEMENT TIMING (AV, V-to-V) NON-RESPONSE


1. Duray et al. Coronary sinus side branches for cardiac resynchronization therapy: prospective evaluation of availability, implant success, and procedural determinants. J Cardiovasc Electrophysiol. 2008 May;19(5):489-94.

2. Gurevitz, O. et al. Programmable multiple pacing configurations help to overcome high left ventricular pacing thresholds and avoid phrenic nerve stimulation. Pacing Clin Electrophysiol. 2005 Dec;28(12):1255-9.

3. Biffi, M. et al. Phrenic stimulation: a challenge for cardiac resynchronization therapy. Circ Arrhythm Electrophysiol. 2009 Aug;2(4):402-10.

4. Leon, A.R. et al. Safety of transvenous cardiac resynchronization system implantation in patients with chronic heart failure: combined results of over 2,000 patients from a multicenter study program. J Am Coll Cardiol. 2005 Dec 20;46(12):2348-56.

2004 2011 2018

QUICKFLEX™ µ LV Lead Quartet™ LV Lead Family of Quartet™ of LV Leads

CRT Solution

PROGRESSION OF LV LEAD TECHNOLOGY



LEAD PLACEMENT

LACK OF DATA

V to V TIMING

Lead Placement

ack of Data

CRT Solution

Quartet™ Lead 1456Q Quartet™ Lead 1458Q Quartet™ Lead 1458QL Quartet™ Lead 1457Q

Small S-shape Traditional S-shape

Traditional S-shape(wide spacing)

Double Bend shape

IMPORTANCE OF QUADRIPOLAR LEADS• Size

• Shape

• Spacing between electrodes



LEAD PLACEMENT

LEAD PLACEMENT

LACK OF DATA

AV SYNCHRONY

V to V TIMING

Lead Placement

ack of Data

CRT Challenge

20% of patients with heart failure develop AF within 4 years

CO-MORBIDITIES: AF1

Framingham Study: Unadjusted Cumulative Incidence Of First AF After Heart Failure

DEVELOPMENT OF AF WAS ASSOCIATED WITH INCREASED MORTALITY: Hazard ratio of 1.6 in men (95% CI, 1.2 to 2.1)

Hazard ratio 2.7 in women (95% CI, 2.0 to 3.6)

LEAD PLACEMENT TIMING (AV SYNCHRONY) NON-RESPONSE

1. Wang, T. J. et al. Circulation 2003;107:2920-2925 33668-SJM-CRM-0819-0243 | Item approved for global use.

LEAD PLACEMENT

LACK OF DATA

AV SYNCHRONY

Lead Placement

ack of Data

CRT Challenge

CRT Optimization (AV and V-to-V synchrony) improves cardiac output1, acute hemodynamics and early clinical response to CRT.2

• May play key role in converting non-responders to responders

Challenges with echocardiography optimization (echo opt) include:• Time consuming (30 min -1.5 hours)• Heavily dependent on technician for accuracy and consistency• Costly procedure and requires coordination of several clinical services• Optimization may not be performed frequently enough• Lack of standard protocol


33668-SJM-CRM-0819-0243 | Item approved for global use.1. Sawhney. Heart Rhythm 2004; 1:562–567; Kerlan. Heart Rhythm 2006; 3:148–154.2. Auricchio, et al. Effect of pacing chamber and atrioventricular delay on acute systolic function of paced patients with congestive heart failure. Circulation 1999;99:2993–3001.

LEAD PLACEMENT

LACK OF DATA

AV SYNCHRONY

Lead Placement

ack of Data

CRT Solution

QUICKOPT™ Timing Cycle Optimization is a reliable and simple alternative to standard optimization techniques

• CLINICALLY PROVEN to correlate with more time-consuming echo-based methods1

• Measures AV and V-to-V timing and provides suggested settings for the device

• Can be used routinely in all CRT recipients, at the time of device follow-up1


1. Porciani MC, A real-time three-dimensional echocardiographic validation of intracardiac electrogram based method for optimizing cardiac resynchronization, PACE 2008; 31: 56-632.Porterfield, et al. “Device based intracardiac delay optimization vs.echo in ICD patients (Acute IEGM AV and PV Study)” Europace Vol 8 Supp 1 July 2006 [abstract #6178].


Lead Placement

ack of Data

CRT ChallengeNON-RESPONSE

1. Daubert, J.C., Saxon, L., Adamson, P.B., Auricchio, A., Berger, … Torp-Pedersen, C.T. (2012). 2012 EHRA/HRS expert consensus statement on cardiac resynchronization therapy in heart failure: implant and follow-up recommendations and management. Europace, 14(9):1236-86.

KEY FACTThe definition of response VARIES GREATLY among physicians

RESPONSE TO CRT IS INADEQUATE AND UNPREDICTABLE

TIMING (AV, V-to-V) NON-RESPONSELEAD PLACEMENT



43% of CRT patients are classified as NON-RESPONDERS or NEGATIVE-RESPONDERS by LVESV after 6 months (n = 303)

REPRESENTATIVE EXPERIENCE1

43%

35%

22%

SUPER-RESPONDERSLVESV ≥ 30%

NEGATIVE-RESPONDERSLVESV

RESPONDERSLVESV 15-29%

NON-RESPONDERSLVESV 0-14%

Successful CRT: Does Patient’s Outcome Meet Expectations?

KEY FACT Historically response rates, regardless of metric used, are ~30-40%

1. Pappone, C., et al Improving Cardiac Resynchronization Therapy Response with Multipoint Left Ventricular Pacing: 12-month Follow-up Study (2015). Heart Rhythm, 12, 1250-1258.

Lead Placement

ack of Data

CRT Solutions

APICAL PLACEMENT may enhance lead stability, but is associated with WORSE CRT OUTCOMES1

• MADIT-CRT data showed LV pacing in basal/mid-ventricular location reduced propensity for HF or death by 42% (P < 0.02) compared to apical pacing1


1. Singh, J.P. et al. Left ventricular lead position and clinical outcome in the Multicenter Automatic Defibrillator Implantation Trial Cardiac Resynchronization Therapy (MADIT-CRT) Trial. Circulation 2011 Mar 22;123(11):1159-66. 33668-SJM-CRM-0819-0243 | Item approved for global use.

Unipolar Bipolar Quadripolar

1 Electrode 2 Electrodes 4 Electrodes

PROVIDES ACCESS TO BASAL PACING LOCATIONS, MORE OPTIONS

CRT Solutions: Progression of LV Lead Technology


Preferred LV-Lead Location1,2

MADIT-CRT

1. Singh, J.P. et al. Left ventricular lead position and clinical outcome in the Multicenter Automatic Defibrillator Implantation Trial Cardiac Resynchronization Therapy (MADIT-CRT) Trial. Circulation 2011 Mar 22;123(11):1159-66.

2. Merchant, F.M. et al. Impact of segmental left ventricle lead position on cardiac resynchronization therapy outcomes. Heart Rhythm 2010;7:639 – 644


Quartet™ Leads: Designed for MPP

1456Q

1458Q

1458QL

1457Q

203040D1M2M3P4

203047

D1M2M3P4

203047D1M2M3P4

2060 47D1M2M3P4

020304060 mmmm

COMPARISON OF ELECTRODE SPACING ON QUARTET™ LV LEADS


DO MORE FOR MORE CRT PATIENTSSpacing Matters

1. Sperzel J, Dänschel W, Gutleben KJ, Kranig W, et al. First prospective, multi-centre clinical experience with a novel left ventricular quadripolar lead. Europace. 2012;14(3):365-3.

Prospective, Multi-Center Study Shows CRT Efficacy with Use of Quadripolar Pacing System

THE QUADRIPOLAR PACING SYSTEM ALLOWS FOR:

• Pacing in non-apical positions while securing placement of the lead near the apex:

– LV pacing using the Quartet™ LV lead’s two proximal electrodes improved hemodynamics in more than 40% of patients at one month compared to pacing with traditional vectors1

• Significant improvement in LV reverse remodeling:

– 71.4% and 44.4% of patients in quadripolar versus bipolar groups, respectively1

0

10

20

30

40

50

60

70

80

PERC

ENT O

F PA

TIEN

TS

% OF PATIENTS WITH LV REVERSE MODELING

QuadripolarGroup

Bipolar Group


Diagnostics and Remote Monitoring

CARDIAC RESYNCHRONIZATION THERAPY


Progression of Heart Failure DecompensationTHERE ARE MANY SIGNS AND SYMPTOMS OF HF DECOMPENSATION

EARLY WARNING WITH CLINICAL DATA CAN LEAD TO EARLIER INTERVENTION

Pressure ChangesImpedance

Changes

Weight Changes, BP, HF

Symptoms Hospitalization

Time

Stable DECOMPENSATION

* Graph adapted from Adamson PB, et al. Curr Heart Fail Reports, 2009.

• Exercise Intolerance• Increased Heart Rate• Pulmonary Edema

• Atrial Fibrillation• Dyspnea• Orthopnea


CorVue™ Thoracic Impedance Monitoring*

*Not available in all countries

UTILIZES MULTIPLE VECTORS, allowing the device to assess more changes in impedance

ASSESSES IMPEDANCE CHANGES THROUGHOUT THE DAY to increase confidence that changes are clinically relevant PROVIDES THE FLEXIBILITY TO CUSTOMIZE REPORTING for each patient through programmable thresholds and remote monitoring via Merlin.net™ Patient Care Network (PCN)

VECTORS: RV Coil to Can RV Ring to Can

Wireless MonitoringREMOTE MONITORING IS AN HRS CLASS 1A RECOMMENDATION

– 2015 HRS Expert Consensus Statement

RemoteInterrogation

Remote Monitoring

Requires patient interaction to transmit data.

Can be programmed to automatically transmit select clinical events even

when asymptomatic.


WEB-BASED PLATFORM THAT COMBINES PA PRESSURES WITH HF-RELATED DEVICE DIAGNOSTICS:• AT/AF Burden

• Percent Ventricular Pacing

• Patient Activity

• Day and Night Heart Rate

• VT/VF events with ATP and Shock therapies

Merlin.net™ Patient Care Network


CARDIOMEMS™ HF SYSTEMMERLIN.NET™ PCN

Merlin.net™ HF PortalFor CRT devices with remote diagnostic reporting, reporting can be integrated with the CardioMEMS™ HF System, via Merlin.net HF Portal.

Daily Remote Monitoring of AlertsATRIAL FIBRILLATION (AF) IS A COMMON HEART FAILURE COMORBIDITY

1.Khand AU, et al. Clinical events leading to the progression of heart failure: insights from a national database of hospital discharges. Eur Heart J 2001;22:153–1642.Pozzoli M, et al. Predictors of primary atrial fibrillation and concomitant clinical and hemodynamic changes in patients with chronic heart failure: a prospective study in 344 patients with baseline sinus rhythm. J Am Coll Cardiol 1998;32:197–204. 3.Healey, Jeff MD et al, Subclinical Atrial Fibrillation and the Risk of Stroke (The Assert Trial,) N. Engl J Med 366;2 January 12, 2012

• AF is a frequent reason for hospitalization in HF patients1

• New onset AF deteriorates NYHA class in HF patients2

• Device detected atrial arrhythmias have a 2.5 fold increased risk of ischemic stroke or systemic embolism3


Recent Advancements Improving CRT Response


Next Level CRT Technologies

Advancing a patient to the next level of response is associated with decreased mortality rates, reduced heart failure events and a decrease in healthcare expenditures 1,2

1. Rickard J, Cheng A, Spragg D, et al. Durability of the survival effect of cardiac resynchronization therapy by level of left ventricular functional improvement: fate of “nonresponders.” Heart Rhythm. 2014;11(3):412-416. https://doi.org/10.1016/j.hrthm.2013.11.025. Accessed July 31, 2018.

2. Varma N, et al. The cost of non-response to CRT: analysis from the ADVANCE-CRT registry. Poster presented at Heart Rhythm Society. 2018.

&

70

MULTIPOINT™ PACING provides pacing from multiple sites of the Left Ventricle

SYNCAV™ CRT TECHNOLOGY automatically adjusts AV delays based on the patient’s intrinsic conduction


www.NextLevelCRT.com

http://www.nextlevelcrt.com/

DELIVERS TWO LV PULSES FROM THE QUARTET™ LEAD PER PACING CYCLE• Allows LV first or RV first

• Delays between pulses are programmable

Delay1 Delay2

LV1 LV2 RV

RV LV1 LV2

MultiPoint™ Pacing (MPP)

5 - 80 ms 5 - 50 ms


1. Zannon F, Baracca E, Pastore G, Marcantoni C, et al. Multipoint pacing by a left ventricular quadripolar lead improves the acute hemodynamic response to CRT compared with conventional biventricular pacing at any site. Heart Rhythm. 2015;12(5):975-981.

MultiPoint™ Pacing (MPP)1

Pacing from TWO LV SITES is designed to CAPTURE MORE TISSUE and potentially improve:• Pattern of depolarization• Engage areas around scar tissue• Hemodynamics• Resynchronization RV

LV1

LV2

MultiPoint™ Pacing allows pacing from two LV sites through just one CRT lead.


Dynamic timing feature for quadripolar CRT devices, it can complement MultiPoint™ Pacing

Individualize and dynamically adjust timing (AV Delays) based on intrinsic patient rhythm

Drive fusion with intrinsic rhythm for improved electrical synchrony and narrower QRS¹

Intrinsic Conduction

LV/RV Pacing1. Wisnoskey BJ, Cranke G, Cantillon DJ, and Varma N. “Feasibility of Device-Based Electrical Optimization via Application of the Negative AV Hysteresis Algorithm during Cardiac Resynchronization Therapy (CRT).” Heart Rhythm. 2016; 13 (5S): S443.

AV Node LV

RV

SyncAVTM CRT TECHNOLOGYDYNAMICALLY TAILORED TO THE PATIENT’S BEAT


What Is Triple Wavefront Fusion?BIVENTRICULAR PACING FUSED WITH INTRINSIC CONDUCTION (BiVp-fusion, Triple Wavefront Fusion)

Ter Horst IAH, Bogaard MD, Tuinenburg AE, et al. The concept of triple wavefront fusion during biventricular pacing: using the EGM to produce the best acutehemodynamic improvement in CRT. Pacing Clin Electrophysiol 2017;40:873–82.

Recent work has shown that selecting device settings that allow fusion with intrinsic

conduction was associated with the BEST HEMODYNAMIC IMPROVEMENT BY CRT in

the majority of patients.


Using SyncAV™ CRT Technology AND MultiPoint™ Pacing

Patient presented with significant symptoms-NYHA CLASS III, EF 30%, LBBB

Physician was worried about a short PR interval and AV delays, so MultiPoint™ Pacing was selected with a plan to use SyncAV™ CRT Technology.

The lead was placed in a posterior branch as all others were inaccessible. The Quartet™ Lead 1458QL (large electrode spacing) was selected.

Case Study courtesy Randy Jones, M.D. in Portland, Oregon 33668-SJM-CRM-0819-0243 | Item approved for global use.

Single-Site CRT with SyncAV™Intrinsic MultiPoint™ Pacing & SyncAv™

MPP Programmed D1 M2 & M3 Can

SyncAV™ ON, Delta -30ms

Using SyncAV™ CRT Technology AND MultiPoint™ Pacing

33668-SJM-CRM-0819-0243 | Item approved for global use.Case Study courtesy Randy Jones, M.D. in Portland, Oregon

Is CRT Response Improving? Yes.1. BETTER PATIENT SELECTION

– LBBB, no lateral scar

2. ATTENTION TO OPTIMAL LEAD PLACEMENT – Basal to mid-LV region

3. QUADRIPOLAR LEAD TECHNOLOGY– Better management of PNS, stability

– More therapeutic options, e.g. QLVs, Basal LV positioning, MultiPoint™ Pacing 87% response rate*

4. OPTIMAL DEVICE PROGRAMMING– Maximize BiV pacing

5. OPTIMIZATION ALGORITHMS– QuickOpt™ timing cycle

optimization

– SyncAV™ CRT technology

– Surrogate Q-LV Measurement (RV-LV Conduction Time)

*Was shown in investigational device exemption (IDE) study subgroup with anatomically programmed separation using MultiPoint™ Pacing.Niazi I, et al. Safety and efficacy of multipoint pacing in cardiac resynchronization therapy—the multipoint pacing trial. JACC. 2017;3(11):1519-1522. http://dx.doi.org/10.1016/j.jacep.2017.06.022. Accessed July 31, 2018.*Behar quad publication 33668-SJM-CRM-0819-0243 | Item approved for global use.

Troubleshooting Non-responders1

1. ARE MEDICATIONS OPTIMIZED?

2. IS THE LV LEAD IN THE OPTIMAL POSITION?• Latest site of activation?

3. ARE THERE ANY OTHER COMORBIDITIES?• Anemia, Renal Failure, AF

4. IS THE PATIENT BIV PACING (> 98%)?• Is the LV lead capturing?• Is LV2 capturing (if using MultiPoint™ Pacing)?

5. DOES THE PATIENT NEED OPTIMIZATION OF AV, V-TO-V TIMING?• QuickOpt™ Timing Cycle Optimization, MultiPoint™ Pacing

1. Willcoff B L, Fauchier L, Stiles M K, et al. 2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement on optimal implantable cardioverter-defibrillator programming and testing. Heart Rhythm. 2016;13:e50–e86. 33668-SJM-CRM-0819-0243 | Item approved for global use.

Abbott Leadership in CRTFirst to market with

QUADRIPOLAR LEAD, MULTIPONT™ PACING and RV-LV CONDUCTION TIME

Exclusively providingQuickOpt™ Timing Cycle Optimization and SyncAV™ CRT Technology


www.NextLevelCRT.com

http://www.nextlevelcrt.com/

Stepwise Approach to CRT Optimization

PROGRAMMING SYNCAV CRT™ TECHNOLOGY AND MULTIPOINT™ PACING



Programming guidance is based on the latest clinical evidence, key opinion leader presentations and best practices from the field.

• Programming can occur at implant for new patients and follow-up for existing patients.

• The goal is to improve CRT response and narrow the QRS in applicable patients with the unique tools offered by Abbott CRT systems, including:

1. MULTIPLE LV LEAD OPTIONS WITH ≥ 30 MM ELECTRODE SPACING

2. SYNCAV™ CRT TECHNOLOGY

3. MULTIPOINT™ PACING

• The ideal programming for any patient may include both SyncAV™ CRT technology and MultiPoint™ Pacing, or just one or neither, and this programming guidance will help you tailor the therapies accordingly.


Start HereTESTS CRT TOOLKIT TAB

Each test in the Stepwise Approach to CRT can be accessed from this screen• The RV-LV CONDUCTION TEST will run immediately after pushing any of the

buttons highlighted below (if it hasn’t been run yet)



STEP 1 Measure RV-LV Conduction Time to find the latest site of activation

STEP 2 Check LV Thresholds to find the viable vectors

STEP 3 (Optional) Perform QuickOpt™ Timing Cycle Optimization to find the recommended

AV and V-to-V delays

STEP 4 Perform SyncAV™ CRT for patients with intrinsic conduction*

STEP 5 Program MultiPoint™ Pacing to capture more LV tissue


Stepwise Approach to CRT OptimizationSTEP 1: Measure RV-LV Conduction Time and take note of the longest measured time.

• This automatic test measures the delay between sensing* an RV signal to each LV electrode

*Nominally RV Sense, but can be programmed to RV Pace under Additional Parameters

Helps identify the LV electrode with THE LONGEST

ELECTRICAL DELAY from the RV lead



NOTICE THE VECTORS WITH THE LONGER CONDUCTION TIMES ARE PRE-SELECTED

STEP 2: Check LV Thresholds. The Auto VectSelect Quartet ™ algorithm recommends vectors based on electrodes with the LONGEST RV-LV CONDUCTION TIME


Stepwise Approach to CRT OptimizationSTEP 3: (Optional) Perform QuickOpt™ Timing Cycle Optimization to get recommendations for Paced and Sensed AV delays and V-to-V timing.



STEP 4: Perform SyncAV™ CRT Technology (for patients with in-tact conduction*)

Choose AV delays to ALLOW INTRINSIC CONDUCTION

*In-tact conduction, PR< 300ms, LBBB, Minimal PVCs, Low AT/AF Burden

1

IMPORTANT NOTE: Patients with SyncAV enabled will have AV DELAYS PROGRAMMED LONGER THAN THEIR INTRINSIC CONDUCTION. While this might appear abnormally long for a CRT device, these are only the AV delays used every 32 or 256 cycles to assess conduction.


Stepwise Approach to CRT OptimizationSTEP 4: Perform SyncAV™ CRT Technology (for patients with in-tact conduction*)

Measure QRS width on surface EKG (measured with electronic calipers on the programmer)

2

QRSd: 180ms


QRS Measurement MethodBASELINE: UNDERLYING/ INTRINSIC QRS DURATION

100 MM/SEC SWEEP SPEED for accuracy

MEASUREMENT TECHNIQUE(1)

• QRS onset measured from start of first deflection on Surface EKG

5-LEAD SURFACE ECG*• Choose a clear lead• This example used the

chest lead as it displayed the best morphology for measurements

• Consistency is key (measure from that same lead for the rest of measurements)

Surface ECG moved to 3rd position to help measure since the electronic calipers somewhat block the visualization of the first position

*12 Lead is best, but a 5-Lead surface ECG connected to the programmer was used for this example.33668-SJM-CRM-0819-0243 | Item approved for global use.


STEP 4: Perform SyncAV™ CRT Technology (for patients with in-tact conduction*)

Run SyncAV™ at various deltas (measuring each QRS width) USING THE PREVIEW BUTTON

3

3

Start temporary, wait 8-10 beats, screenshot and then cancel temporary


Stepwise Approach to CRT OptimizationEXAMPLE: Delta -50 ms: PREVIEW BUTTON Screen Shot Calipers Measure QRS

Repeat for Delta -40 ms and -60ms Measure QRSFollow directionality toward shorter QRS duration until the narrowest QRSd is reachedCheck V-to-V offsets: LV-30 / 0 ms / RV-30

Program the DELTA that results in the NARROWEST QRS WIDTH


Stepwise Approach to CRT OptimizationSTEP 5: Program MultiPoint™ Pacing

Choose two vectors that give you the WIDEST POSSIBLE SPACING. Include the LATEST SITE OF ACTIVATION if possible.

1

1

1

3

2 Measure QRS Width (Surface EKG)

3 Program V-V offsets using:• Shortest timing • Narrowest QRS• QuickOpt™ Timing Cycle

Optimization recommendations as a guideline


CRT Case StudyCOURTESY OF JOHN ROGERS, M.D. Associate Chief, Division of Cardiovascular DiseasesScripps HealthSan Diego, CA


CASE BACKGROUND: 52-year-old Oil Worker with Nonischemic Cardiomyopathy of Two Years’ Duration

• Admitted for acute on chronic CHF; transferred to our HF service

• He has been hospitalized for HF nine times in the last 18 months

• On maximal medical therapy• NYHA Class III–IV CHF• Echo revealed EF has decreased from 30% to

12% (previous echo six months earlier), MR now moderate to severe (was mild)

• Chronic LBBB33668-SJM-CRM-0819-0243 | Item approved for global use.

CASE STUDY


Post-op Course

THE PATIENT TOLERATED THE PROCEDURE WELLAFTER CLOSING THE INCISION, QuickOpt™ timing cycle optimization was run, which resulted in an immediate increase of EF from 12% to 28% (Prox 4 to RV coil best)

CASE STUDY


10 Days Post-op

• Patient seen in clinic• Continued Class 2 CHF (from Class 4 pre-op)• Walking daily• Three weeks post op, echo EF 35%• Distal tip electrode was eliminated due to PNS

(now three of 10 vectors)

CASE STUDY


Two Months Post-op

ECHO EF APPROXIMATELY 35%

MULTIPOINT™ PACING turned on using D1–P4 and P4–RV coil

CASE STUDY


Five Months Post-op

ECHO — EF 44%, MR MILDPATIENT CLASS 1 HF• No hospitalizations for HF after discharge

from implantation of CRT-D

CASE STUDY


DisclaimerThis document and the information contained herein is for general information purposes only and is not intended, and does not constitute legal, reimbursement, business, or other advice. Furthermore, it does not constitute a representation or guarantee of reimbursement, and it is not intended to increase or maximize payment by any payer. Nothing in this document should be construed as a guarantee by Abbott regarding reimbursement, payment amounts, or expenditure reduction, or that reimbursement or other payment will be received. The ultimate responsibility for obtaining payment/reimbursement remains with the customer. This includes the responsibility for accuracy and veracity of all claims submitted to third-party payers. Also note that actual costs for products and services and any related expenditures vary, and that the information presented herein represents only one of many potential scenarios, based on the assumptions, variables, and data presented. In addition, the customer should note that laws, regulations, and coverage policies are complex and are updated frequently, and, therefore, the customer should check with its local Medicare Administrative Contractor often and should consult with legal counsel or a financial or reimbursement specialist for any questions related expenditure reduction, billing, reimbursement or any related issue. This information does not guarantee coverage or payment at any specific level, and Abbott does not advocate or warrant the appropriateness of the use of any particular code. This update reproduces information for reference purposes only. It is not provided or authorized for marketing use. All content provided by Dr. John Rogers, M.D. unless otherwise noted.


Fluoro Projections of Coronary Vein Branches

APPENDIX


Anterior Posterior (AP) Projection


Right Anterior Oblique (RAO) Projection


Left Anterior Oblique View (LAO)


GlossaryACC = American College of CardiologyAHA = American Heart Association ADHF = Acute Decompensated Heart FailureARB = Angiotensin II Receptor Blocker BiV = Biventricular CRT = Cardiac Resynchronization Therapy CRT-D = Cardiac Resynchronization Therapy DefibrillatorCRT-P = Cardiac Resynchronization Therapy PacemakerEcho = EchocardiogramEF = Ejection FractionEKG = ElectrocardiogramHF = Heart Failure

ICD = Implantable Cardioverter-DefibrillatorICM = Implantable Cardiac Monitor LV = Left VentricleLVAD = Left Ventricular Assist DeviceLVEF = Left Ventricular Ejection FractionMWT = Minute Walk Test (6 MWT = 6 minute)NYHA = New York Heart Association


Photos on file at Abbott.

Quartet™ LV leadIndications and Usage: The Quartet lead has application as part of an Abbott Biventricular system.

Contraindications: The use of the Quartet lead is contraindicated in patients who are expected to be hypersensitive to a single dose of 1.0 mg of dexamethasone sodium phosphate; are unable to undergo an emergency thoracotomy procedure; have coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.

MultiPoint™ Pacing and SyncAV™ CRT TechnologyIndications: Abbott ICDs and CRT-Ds are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. AF Suppression™ pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indication and sinus node dysfunction. In patients indicated for an ICD, CRT-Ds are also intended to provide a reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy (as defined in the clinical trials section included in the Merlin™ PCS on-screen help) and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration to maintain synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III heart failure.

Contraindications: Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance or acute myocardial infarction.

Adverse Events: Implantation of the pulse generator system, like that of any other device, involves risks, some possibly life-threatening. These include but are not limited to the following: acute hemorrhage/bleeding, air emboli, arrhythmia acceleration, cardiac or venous perforation, cardiogenic shock, cyst formation, erosion, exacerbation of heart failure, extrusion, fibrotic tissue growth, fluid accumulation, hematoma formation, histotoxic reactions, infection, keloid formation, myocardial irritability, nerve damage, pneumothorax, thromboembolism, venous occlusion. Other possible adverse effects include mortality due to component failure, device programmer communication failure, lead abrasion, lead dislodgment or poor lead placement, lead fracture, inability to defibrillate, inhibited therapy for a ventricular tachycardia, interruption of function due to electrical or magnetic interference, shunting of energy from defibrillation paddles, system failure due to ionizing radiation. Other possible adverse effects include mortality due to inappropriate delivery of therapy caused by multiple counting of cardiac events, including T waves, P waves or supplemental pacemaker stimuli. Among the psychological effects of device implantation are imagined pulsing, dependency, fear of inappropriate pulsing and fear of losing pulse capability.

AbbottOne St. Jude Medical Dr., St. Paul, MN 55117 USA, Tel: 1 651 756 2000Abbott.com

Rx OnlyBrief Summary: Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

™ Indicates a trademark of the Abbott group of companies.‡ Indicates a third party trademark, which is property of its respective owner.© 2019 Abbott. All Rights Reserved.SJM-CRM-0819-0243 | Item approved for global use.


introduction to crt - abbott · michael r. gold, ulrika birgersdotter-green, jagmeet p. singh,...

Documents