GR2012-04 Surgical Strategies for Advanced Heart Failures - Dr Ergie

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Are LVADs Ready To Be Mainstream?:

Are LVADs Ready To Be Mainstream? Glenn Egrie CPMC 2012 J105-0311 (Please advance slide manually. Thank you.)



Mainstream Therapies:

Address a large patient population Established safety and efficacy Have a proven track record of clinical success Have an acceptable risk / reward tradeoff Mainstream Therapies

Addressing An Unmet Need:

Addressing An Unmet Need The VAD patient population is approaching 100,000 in the United States alone. US population 1 Target population (35-74 age cohort) 1 Diagnosed CHF population 2 All ages 35-74 NYHA Class IIIB and IV 3 in 35-74 age cohort Comorbidities estimated in this cohort Target VAD patient population (35-74 years) 301,000,000 139,100,000 5,520,000 3,744,000 374,400 (280,800) 93,600 1 US Census Bureau Statistics (2007) 2 Heart and Stroke Statistics, American Heart Association 3 Cardiovascular Round Table research and analysis, The Advisory Board company (2009)

What is a VAD?:

What is a VAD? A single system device that is surgically attached to the left ventricle of the heart and to the aorta for left ventricular support For Right Ventricular support, the device is attached to the right atrium and to the pulmonary artery

Ventricular Assist Device (VAD):

Ventricular Assist Device (VAD) A mechanical pump that is surgically attached to one of the heart’s ventricles to augment or replace native ventricular function Can be used for the left (L VAD), right (R VAD), or both ventricles (Bi VAD) Are powered by external power sources that connect to the implanted pump via a percutaneous lead (driveline) that exits the body on the right abdomen Pump output flow can be pulsatile or nonpulsatile

System Overview:

System Overview Left Ventricular Assist Device (LVAD) Mechanical device that helps pump blood from the heart to the rest of the body. Implanted in patients with heart diseases or poor heart function.

PowerPoint Presentation:

Thoratec VAD (pVAD/iVAD) Pneumatic, external(pVAD) or internal (iVAD), pulsatile pump(s) right-, left-, or bi-ventricular support (RVAD/LVAD/BiVAD) up to ~7.2 lpm flow Short- to medium-term use (up to ~1-2 years) bridge to recovery bridge to transplant hospital discharge possible iVAD pVAD

PowerPoint Presentation:

Thoratec pVAD

Heart Failure Has A High Mortality Rate Similar To Aggressive Malignancies:

Medical therapy alone can be a poor long-term treatment option for many in the more advanced stages of heart failure. Four major publications show the mortality risk associated with NYHA Class IV heart failure is high, with a 1-year mortality between 60 and 94 percent. 1-4 Heart Failure Has A High Mortality Rate Similar To Aggressive Malignancies Class IV heart failure patients treated with medical therapy alone have mortality rates similar to or greater than aggressive forms of cancer. 5 1 Rose, Gelijns, Moskowitz, et al. NEJM . 345:1435-43, 2001. 2 Rogers, Butler, Lansman, et al. J Am Coll Cardiol . 50:741-47, 2007. 3 Hershberger, Nauman, Walker, et al . J Card Fail . 22:616-24, 2003. 4 Gorodeski, Chu, Reese, et al . Circ Heart Fail . 2:320-24, 2009.

PowerPoint Presentation:

HeartMate II is the first and only FDA-approved continuous flow device for both Bridge-to-Transplantation (BTT) and Destination Therapy (DT). HeartMate II — A Proven Adjuvant Therapy For Advanced-Stage Heart Failure Bridge-to-Transplantation Non-reversible left heart failure Imminent risk of death Candidate for cardiac transplantation Destination Therapy NYHA Class IIIB or IV heart failure Optimal medical therapy 45 of last 60 days Not a candidate for cardiac transplantation For inpatient and outpatient use

Return to Life:

Return to Life

PowerPoint Presentation:

Redundant circuitry of the percutaneous lead and system controller provides backup if there is a problem with the primary source Lithium-ion batteries provide a full work day of support (10–14 hours) on a single charge and are designed to last up to 3 years before replacement Reliability of percutaneous lead design continuously refined through extensive clinical trial data and feedback over thousands of implants HeartMate II—Designed For Extended Reliability

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HeartMate II—Design Features - Optimized blood flow Low thrombosis risk Low anticoagulation requirements Reliability

HeartMate II—Designed For Highly Washed Flow Path And Low Rates Of Stroke & Pump Thrombosis :

HeartMate II—Designed For Highly Washed Flow Path And Low Rates Of Stroke & Pump Thrombosis Rotor speed typically set between 8,000 and 10,000 RPM and capable of pumping up to 10 liters of blood per minute. A single moving part combined with open flow paths help to optimize the blood flow. Flow dynamics designed to maximize washing and minimize the risk of thrombus stasis formation and stroke. Flow design maintains integrity of blood cells.

HeartMate II—Widespread Approval And Adoption:

Received European CE Mark in November 2005 Received FDA approval for BTT in April 2008 (CPMC in Trial) Received Health Canada approval in May 2009 Received FDA approval for DT in January 2010 (CPMC in Trial) JACHO Certification - CPMC HeartMate II—Widespread Approval And Adoption 2010 2005 2008 2007 2006 2009 FDA approval for BTT April 2008 European CE Mark November 2005 FDA approval for DT January 2010

PowerPoint Presentation:

More than 6,000 patients, spanning over 6,000 patient years across 254 centers worldwide, have now been implanted with the HeartMate II LVAD* Patients supported  2 years: 700 Over 60 patients supported 4 or more years Longest support duration: 6 years Smallest patient: 1.1 BSA Largest patient: 3.2 BSA Age range: 11 – 87 HeartMate II— Widely Used, Efficacious, and Durable in Broad Patient Population *As of January 2011

Improvements With BTT Results Over Time:

Improvements With BTT Results Over Time Miller, Pagani, Russell, et al . NEJM . 357:885-96, 2007. Pagani, Miller, Russell, et al . JACC . 54:312-21, 2009. Starling, Naka, Boyle, et al. JACC , in press 2010. n = 133 n = 281 n = 169

Contemporary BTT Outcomes:

Contemporary BTT Outcomes The HeartMate II BTT post-approval study was initiated to assess outcomes in a broader patient care environment outside of a clinical setting, representing real life situations. HeartMate II Group First 169 consecutive HeartMate II patients enrolled in INTERMACS listed, or likely to be listed, for transplant 77 centers enrolled patients from April to August 2008, and were followed for at least 1 year post-implant Endpoints The primary endpoint was survival, and secondary endpoints included adverse events reported upon occurrence and functional status using the 6-minute walk test and EuroQoL scale—determined at baseline and 3, 6, and 12 months post-implant Kirklin JK, Naftel DC, Kormos RL, et al. Second INTERMACS annual report: more than 1,000 primary left ventricular assist device implants . J Heart Lung Transplant . 2010;29:1-10.

PowerPoint Presentation:

The majority of enrolled patients were noted to be INTERMACS 1 or 2. HeartMate II Post-Approval Study Patient Demographics

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Operative 30-day survival was 96% and patients achieved 90% successful outcomes at 6 months and 85% at 1 year. HeartMate II Post-Approval Study Actuarial Survival Starling, Naka, Boyle, et al. JACC; May 10, 2011

PowerPoint Presentation:

As demonstrated by the EuroQoL instrument, HeartMate II patients experienced early and sustained improvement in quality of life over the course of follow-up, with scores doubling at 12 months post-implant. HeartMate II Post-Approval Study Quality Of Life Starling, Naka, Boyle, et al. JACC; May 10, 2011

HeartMate II Adverse Event Rates From The BTT Post-Approval Study:

HeartMate II Adverse Event Rates From The BTT Post-Approval Study Events per patient year. Pagani FD, Miller LW, Russell SD. Extended mechanical circulatory support with a continuous-flow rotary left ventricular assist device . J Am Coll Cardiol . 2009;54:312-21. Starling, Naka, Boyle, et al. JACC; May 10, 2011 . The HeartMate II post-approval study demonstrated low adverse event rates for stroke and RV failure. Stroke and RV failure rates have improved from the HeartMate II pivotal clinical trial.

PowerPoint Presentation:

Destination Therapy Pivotal Trial Slaughter MS, Rogers JG, Milano CA, et al. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med . 2009;361(23):2241-51.

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The pivotal HeartMate II Destination Therapy trial demonstrated significant improvements in outcomes compared to randomized patients with pulsatile LVADs 68% survival at 1 year 58% survival at 2 years Survival In The Destination Therapy Pivotal Trial Slaughter MS, Rogers JG, Milano CA, et al. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med . 2009;361(23):2241-51. Fang JC. Rise of the machines–left ventricular assist devices as permanent therapy for advanced heart failure. N Engl J Med . 2009;361(23):2282-84.

PowerPoint Presentation:

Destination Therapy Trial CAP: Overview And Baseline Park SJ. AHA Scientific Sessions, November 2010. More than 500 additional DT patients have been enrolled under a continued access protocol (CAP). Mid-trial patients did not vary in baseline characteristics Trial Overview and Baseline Characteristics DT Trial Experience Early Trial Mid-Trial Cohort description: Primary data cohort Portion of DT CAP HeartMate II patients: N = 133 N = 281 Enrollment period: March 2005 – May 2007 May 2007 – March 2009

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Improvements In DT Survival Patients enrolled in the mid-trial experienced better survival. * P value adjusted for body surface area Park SJ. AHA Scientific Sessions, November 2010.

ADULT HEART TRANSPLANTATION Kaplan-Meier Survival by Era Transplants: 1/1982 – 6/2008:

ADULT HEART TRANSPLANTATION Kaplan-Meier Survival by Era Transplants: 1/1982 – 6/2008 J Heart Lung Transplant. 2010 Oct; 29 (10): 1083-1141

DT CAP Trial Shows Significant Reductions In Adverse Events:

Park SJ. AHA Scientific Sessions, November 2010. Hemorrhagic stroke > 50% reduction 0.03 events per patient year Device-related infections > 35% reduction 0.27 events per patient year Sepsis > 25% reduction 0.27 events per patient year DT CAP Trial Shows Significant Reductions In Adverse Events * p < 0.05 ** p < 0.01

PowerPoint Presentation:

HeartMate II therapy stroke rates are similar to other commonly accepted cardiac surgical procedures such as CABG and valve procedures. Stroke Rates Similar To Other Cardiac Surgical Procedures McKhann GM, Grega MA, Borowicz LM, et al. Stroke and encephalopathy after cardiac surgery - an update. Stroke . 2006;37:562-71. Boyle AJ, Russell SD, Teuteberg JJ, et al. Low thromboembolism and pump thrombosis with the HeartMate II left ventricular assist device: analysis of outpatient anti-coagulation. J Heart Lung Transplant . 2009;28:881-87.

PowerPoint Presentation:

DT CAP Trial Functional Class Improvements Park SJ. AHA Scientific Sessions, November 2010. n = 266 n = 191 n = 158 n = 125 n = 67 All patients were Class IIIB or IV at baseline.

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DT CAP Trial Quality Of Life Improvements 74 30 225 m 343 m Park SJ. AHA Scientific Sessions, November 2010.

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LVAD Survival Compared To OMM Therapy Park SJ. AHA Scientific Sessions, November 2010.

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A range of referral criteria assessments and scoring systems can be utilized to define the right moment to screen a patient for a LVAD implant. 1 Appropriate timing for referral is when a patient presents in Class IIIB or IV heart failure and has more than one of the functional or laboratory risk factors. Improved Timing Of Patient Referral For Evaluation Functional Assessment Inability to walk one block without shortness of breath Intolerant or refractory to ACE inhibitor, angiotensin receptor blockers, or beta-blockers One heart failure-related hospital admission in the past 6 months 2 CRT nonresponder High diuretic dose (e.g., 120 mg/d Furosemide) Lab Assessment Serum sodium < 136 mmol/L BUN > 40 mg/dL or Serum Creatinine > 1.8 mg/dL Hemotocrit < 35% 1 Russell SD, Miller LW, Pagani FD. Advanced heart failure: a call to action. Congest Heart Fail. 2008;14:316-21. 2 Teuteberg J, Lewis E, Nohria A, et al. Characteristics of patients who die with heart failure and low ejection fraction in the new millennium. J Card Fail. 2006;12(1):47-53.

Volume of VAD Implants:

Volume of VAD Implants YTD* *Through 11/30/11


CPMC (n=17) INTERMACS (n=483) Age (mean) 56.5 36.0 Age (range) 17-77 N/A Age < 60 yrs 35% 71.2% Gender (male) 88% 79% Demographics


Interagency Registry of Mechanically Assisted Circulatory Support - INTERMACS Mandatory U.S. registry for VADs 18 adverse events defined and monitored Largest published series to date Group composition (n=483) Bridge to transplant = 80% Destination therapy = 15% Bridge to recovery = 5% Benchmarking Holman WL, et al. J Am Coll Surg 2009;208:755-762

Length of Stay:

Length of Stay 19.2 61.8 479 . . . Target Total LOS 47 days

Adverse Event Comparison:

CPMC (n=17) INTERMACS (n=483) Bleeding* 100% (17) 35.6% (172) Respiratory failure 41.1% (7) 23.6% (114) Infection 35.3% (6) 40% (193) Right heart failure 29.5% (5) 7.2% (35) Renal failure 23.5% (4) 17% (83) Arrhythmias 23.5% (4) 15.1% (73) Neuro event 17.6% (3) 18% (87) Pericardial drainage 5.9% (1) 8.5% (41) Embolic event (non-neuro) 0 8.3% (40) Acute MI 0 0.4% (2) Adverse Event Comparison * All CPMC patients transfused > 5 units within 30 days, need verification of timing


Mortality Percent (%) 4/15 3/17 3/15 Holman WL, et al. J Am Coll Surg 2009;208:755-762


Timing of Patient Referrals High number of status 1 patients “Current analysis suggests that earlier referral for circulatory support before the onset of cardiogenic shock and clinically evident right heart failure is a key strategy to improve outcomes” Opportunities Holman WL, et al. J Am Coll Surg2009;208:759.

Recommendations for Selection :

Comprehensive, multidisciplinary evaluation that includes: Severity of heart failure Anatomic considerations Non-cardiac considerations Co-existing life-limiting illnesses Psychosocial & age-related LVAD operative risk Mandatory participation by team Mandatory use of Lietz scores Curtail VAD use in high-risk (>16) DT patients Recommendations for Selection

PowerPoint Presentation:

In Summary HeartMate II: Compelling data from large clinical trials demonstrates efficacy Achieved very high survival rates BTT – 90% 6 months, 85% 1 year DT – 74% 1 year, 64% 2 years Superior to what is anticipated with optimal medical management Substantial and sustained quality of life improvements Acceptable adverse event profile

PowerPoint Presentation:

67 y/o referred for advanced heart failure therapy Ischemic cardiomyopathy EF < 20% with LVEDD = 7.3 cm Cath 1 month prior: 20% pLM, 100% pLAD, stent in pLCX, 50% stenosis pOM1, 60% pRCA with diffuse 50% stenosis throughout. Patent LIMA to LAD, patent SVG to PDA with 50% proximal stenosis Thallium: anterior infarct, no ischemia ICD Co-morbidities: HTN, DM, hyperlipidemia Case Study

PowerPoint Presentation:

Hospitalized once in past 6 months Progressive exertional dyspnea and fatigue (e.g., unable to climb 1 flight of stairs without dyspnea or unhappy with current level of functionality) Occasional nocturnal dyspnea No edema Appetite adequate and no weight change No ICD shocks Meds: ASA 81 mg daily, Clopidogrel 75 mg daily, Furosemide 40 mg daily, Lisinopril 10 mg daily, Metoprolol Tartrate 25 mg twice daily, Simvastatin 20 mg daily, Spironolactone 25 mg daily Case Study

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Examination HR=92, BP=96/78 Clear lungs Depressed carotid upstrokes, JVP=12, RRR, No S3 or murmur Trace LE edema Labs: Sodium=134mmol/L, BUN=12 mg/dl, Cr=0.8 mg/dl, BNP=436pg/ml, Albumin=3.5 g/dl Case Study

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Case Study

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Level 1 CPX Results 2 minutes and 37 seconds, Ekelund protocol Peak HR=148, Peak BP=102/71 RER=1.16 Peak VO2=11.6 ml/kg/min (49% predicted) VE-VCO2 Slope=49.8 Case Study

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Questions: Should this patient receive an ICD upgrade to BiV-ICD? Are there opportunities for revascularization? Are the medications optimized? Is this patient an appropriate VAD patient? Case Study

Is Transplant the Future?:

Is Transplant the Future?

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