Sur gical Ventricular Remodeling for Congestive Heart Failure “When BB and ACEI are not Enough” May 18th 2006 Jeffrey Marogil Malek Massad

Heart Failure Introduction Major Health Concern in US Affects 4.8 million people in U.S. 400,000 new cases each year. Anticipated increase in incidence & prevalence as population ages.

INTRODUCTION Significant progress has been made in the medical management of patients with heart failure However the surgical management of patients with end-stage heart failure has evolved in a less structured fashion

INTRODUCTION Heart transplantation remains the ultimate treatment for heart failure

INTRODUCTION Cardiac transplantation is currently the only established surgical approach (excluding AVR and CABG) for the treatment of refractory HF as listed in the 2005 ACC/AHA heart failure guidelines

INTRODUCTION Cardiac transplantation is currently the only established surgical approach (excluding AVR and CABG) for the treatment of refractory HF as listed in the 2005 ACC/AHA heart failure guidelines Small number of available donor hearts Inapplicable in older pts or those with comorbid conditions

NUMBER OF HEART TRANSPLANTS REPORTED BY YEAR AND LOCATION This figure includes only the heart transplants that are reported to the ISHLT Transplant Registry. As such, this should not be construed as evidence that the number of hearts transplanted worldwide has declined in recent years.

Need for Heart Transplant # of Potential Recipients that can Benefit from OHT

HEART TRANSPLANTATION ACTUARIAL SURVIVAL (1982-2000) Half-life =9.1 years Conditional Half-life = 11.6 years N=52,195

ADULT HEART TRANSPLANTATION Actuarial Survival by Diagnosis (Transplants: 1/1982-6/2001) Survival was calculated using the Kaplan-Meier method, which incorporates information from all transplants for whom any follow-up has been provided. Since many patients are still alive and some patients have been lost to follow-up, the survival rates are estimates rather than exact rates because the time of death is not know for all patients. The half-life is the estimated time point at which 50% of all of the recipients have died. Survival rates were compared using the log-rank test statistic.

Who Should Not Be Offered a Heart Transplant? Irreversible PHTN or pulmonary parenchymal disease Irreversible renal or hepatic dysfunction Severe peripheral or cerebrovascular disease IDDM with end-organ damage Coexisting cancer Non-compliance, addiction Elderly patients (aprox > 70yo)

Surgical Ventricular Remodeling Other Surgical Treatment Options are needed since transplants limited by Available donors Suitable recipients

Surgical Treatment of heart failure Coronary revascularization in ischemic cardiomyopathy Mitral valve repair in patients with dilated cardiomyopathy. Left ventricular assist devices (LVADs) Resynchronization therapy Total Artificial Heart Reconstructive cardiac surgery

2005 ACC/AHA Guidelines Alternate surgical and mechanical approaches for the treatment of end-stage HF are under development. Chronic Heart Failure in the Adult: ACC/AHA 2005 Guideline Update for the Diagnosis and Management August 16, 2005

Surgical remodeling for heart Failure Theory behind treatment History of procedures Ischemic Batista Left ventricular aneurysmectomy Nonischemic Cardiomyoplasty Current and Future LV Reconstructive procedures Dor procedure Non-ischemic Acorn & myosplint Conclusions

Theory Systolic HF leads to an enlarged LV volume to maintain stroke volume This leads to increase in wall stress due to Laplace's law stress = pressure x radius ÷ 2 x wall thickness The ventricular geometry becomes less ellipsoid and more spherical leading to progression of left ventricular dysfunction and worsening heart failure.

Theory Removing or excluding portions of the dysfunctional myocardium returns the left ventricular cavity to a smaller chamber with more normal geometry This should improve cardiac work efficiency and theoretically should improve heart failure symptoms. Ideally it would also translate into prolonged survival

Theory In the 1990’s studies showed a relationship between LV size and Mortality

Theory 382 patients with NYHA III and IV LV size measured by EDV/BSA LV size was a predictor of sudden cardiac death LV’s > 4 cm/m2 had a 2 year survial of 49% compared to 75% if < 4 cm/m2 Independent of disease and %EF Lee th et al Am J Cardiology 1993;72:672-676

Surgical remodeling for heart Failure Theory behind treatment History of procedures Ischemic Batista Left ventricular aneurysmectomy Nonischemic Cardiomyoplathy Current and Future LV Reconstructive procedures Dor procedure Non-ischemic Acorn & myosplint Conclusions

Batista procedure Batista procedure also called the partial left ventriculectomy (PLV) Developed by Dr. Randas Batista (Brazil) in 1996

Partial Left Ventriculectomy (Batista Operation) Removal of a section of the left ventricular free wall, between both papillary muscles and extending from the apex to the mitral annulus Remaining free edges were re- -approximated and stitched together Mitral valve and subvalvular apparatus were either preserved, repaired, or replaced,

Partial Left Ventriculectomy (Batista Operation) UIC

Partial Left Ventriculectomy (Batista Operation) Initial experience with the Batista procedure demonstrated an initial increase in LVEF, reduction in heart size, and improvement in clinical functional status However, of 120 patients Batista reported a 22% operative mortality and 2 year survival of 55%.

Partial Left Ventriculectomy (Batista Operation) Late fatal arrhythmias plagued this procedure, forcing the use of concomitant implantable defibrillators Therefore the Batista procedure has fallen out of favor and is no longer considered to be an appropriate option

Surgical remodeling for heart Failure Theory behind treatment History of procedures Ischemic Batista Left ventricular aneurysmectomy Nonischemic Cardiomyoplathy Current and Future LV Reconstructive procedures Dor procedure Non-ischemic Acorn & myosplint Conclusions

Left ventricular aneurysmectomy The first successful surgical correction of an LV aneurysm occurred in 1957 by Dr. Bailey Done without off cardiac bypass by placing a clamp on the base of an aneurysm and passing suture beneath allowing excision of the aneurysm.

Left ventricular aneurysmectomy Dr. Denton Cooley performed a resection of an LV aneurysm one year later on bypass which remained the standard for nearly 30 years.

Left ventricular aneurysmectomy A 2004 ACC/AHA task force concluded that it is reasonable (class IIa recommendation) to consider aneurysmectomy, accompanied by coronary artery bypass grafting (CABG), in patients with a left ventricular aneurysm in the setting of an acute MI who have intractable ventricular arrhythmias and/or heart failure unresponsive to medical and catheter-based therapy

Surgical remodeling for heart Failure Theory behind treatment History of procedures Ischemic Batista Left ventricular aneurysmectomy Nonischemic Cardiomyoplathy Current and Future LV Reconstructive procedures Dor procedure Non-ischemic Acorn & myosplint Conclusions

Cardiomyoplasty Cardiomyoplasty, also referred to as "dynamic cardiomyoplasty," Surgical therapy for dilated cardiomyopathy in which the latissimus dorsi muscle is wrapped around the heart and paced during ventricular systole.

Cardiomyoplasty Carpentier and Chachques peformed the first successful surgery on a humen in 1985

Cardiomyoplasty Symptomatic improvement occured after cardiomyoplasty Mechanism for improvement is unclear Pacemaker synchronization was critical for obtaining optimal improvement.

Cardiomyoplasty 600 patients undergoing this procedure found that, over time, the operative mortality decreased from 31 to 3 percent Improvement in NYHA classification occurred in 80 to 85 percent of hospital survivors However, long-term outcome data with cardiomyoplasty are limited.

Cardiomyoplasty A large, randomized clinical trial of cardiomyoplasty was initiated for NYHA class III heart failure patients Plagued by lagging randomization and marginal overall clinical improvement culminated in the premature termination of the study.

Cardiomyoplasty “It appears that those who can survive the operation do not need it and those who need it, cannot survive it” Leier, CV. Cardiomyoplasty: is it time to wrap it up?. J Am Coll Cardiol 1996; 28:1181.

2005 ACC/AHA Guidelines Although both cardiomyoplasty and left ventriculectomy (Batista procedure) at one time generated considerable excitement as potential surgical approaches to the treatment of refractory HF these procedures failed to result in clinical improvement and were associated with a high risk of death Chronic Heart Failure in the Adult: ACC/AHA 2005 Guideline Update for the Diagnosis and Management August 16, 2005

2005 ACC/AHA Guidelines A variant of the aneurysmectomy procedure is now being developed for the management of patients with ischemic cardiomyopathy, but its role in the management of HF remains to be defined. Chronic Heart Failure in the Adult: ACC/AHA 2005 Guideline Update for the Diagnosis and Management August 16, 2005

Surgical remodeling for heart Failure Theory behind treatment History of procedures Ischemic Batista Left ventricular aneurysmectomy Nonischemic Cardiomyoplathy Current and Future LV Reconstructive procedures Dor procedure Non-ischemic Acorn & myosplint Conclusions

LV Reconstruction for Ischemic Cardiomyopathy Dor procedure also called endoventricular circular patch plasty (EVCPP), is an approach to surgical reconstruction in the setting of postinfarction aneurysm formation first reported in 1985 Advantage to aneurysmectomy is in an attempt to restore left ventricular geometry

Dor procedure for Ischemic Cardiomyopathy May be considered in patients with symptomatic aneurysms as defined by heart failure, angina pectoris, systemic embolization, and/or malignant ventricular tachyarrhythmias.

Dor procedure for Ischemic Cardiomyopathy Purse string stitch around a nonviable scarred aneurysm to minimize the excluded area. The residual defect is sometimes covered by a patch made from Dacron, pericardium, or an autologous tissue flap

Dor procedure for Ischemic Cardiomyopathy The remaining aneurysmal scar is closed over the outside of the patch to give additional stability to the repair. The result is a more normal left ventricular chamber geometry and overall function

Dor procedure for Ischemic Cardiomyopathy The operation shortens the long axis, but leaves the short axis length unchanged, producing an increase in ventricular diastolic sphericity while the systolic shape becomes more elliptical

Dor procedure for Ischemic Cardiomyopathy The first 661 patients Overall operative mortality was 8 percent; (urgently 16.3 versus 6.2 percent when planned) LVEF less than 20 percent (17 versus 1.4 percent for LVEF greater than 40 percent) Jpn J Thorac Cardiovasc Surg 1998 May;46(5):389-98

Dor procedure for Ischemic Cardiomyopathy 495 patients available for follow-up, there was dramatic improvements Overall LVEF improved from 33% versus 50% at one week postoperatively) maintained at one year. The end-diastolic volume index decreased and symptomatic heart failure status, (212 pt) at one year, improved in 92 percent; In addition, 91 percent of patients with spontaneous ventricular tachycardia were free of arrhythmia at one year.

LV Reconstruction for Ischemic Cardiomyopathy At present there are four variations of LV reconstruction are used excluding the septum Linear closure by Jatene Modified liner closure by Mickleborough Circular closure with a path by Dor Circular closure without a patch by McCarthy

LV Reconstruction for Ischemic Cardiomyopathy First randomized trial of surgical ventricular restoration + CABG vs CABG alone for ischemic cardiomyopathy was published April 2006 isure of Journal of Cardiac Failure Journal of Cardiac Failure Vol 12 No 3 2006

LV Reconstruction for Ischemic Cardiomyopathy 74 Consecutive patients with ischemic cardiomyopathy and EF < 35% with LESV > 80ml/m2

LV Reconstruction for Ischemic Cardiomyopathy Limitations Non-Blinded Excluded > 2+ MR or other significant valvular heart disease Dyskinetic ant wall Non-viable Ant wall on Thallium testing

LV Reconstruction for Ischemic Cardiomyopathy

LV Reconstruction for Ischemic Cardiomyopathy

LV Reconstruction for Ischemic Cardiomyopathy STICH Trial NIH sponsored trial to compare medical therapy vs CABG for patients with CHF and EF < 35% including SVR + CABG as a treatment arm in patients with LVESVI > 60ml/m 600 patient scheduled to enroll

Considered Criteria for Surgical Repair Anteroseptal MI, with dilated left ventricle (end-diastolic volume index >100 mL/m2) Depressed LVEF Left ventricular regional dyskinesis or akinesis >30 percent of the ventricular perimeter, and Either symptoms of angina, heart failure, or arrhythmias

The following are considered to be relative contraindications Systolic pulmonary artery pressure >60 mmHg Severe right ventricular dysfunction Regional dyskinesis or akinesis without dilation of the ventricle

Surgical remodeling for heart Failure Theory behind treatment History of procedures Ischemic Batista Left ventricular aneurysmectomy Nonischemic Cardiomyoplathy Current and Future LV Reconstructive procedures Dor procedure Non-ischemic Acorn & myosplint Conclusions

LV Reconstruction for Non-ischemic Cardiomyopathy Cardiomyoplasty experience has led to other novel approaches to heart failure. Observations suggested that some patients benefited from the diastolic "girdling" effect of the muscle wrap This observation led to the development of the Acorn device and Myosplint

LV Reconstruction for Non-ischemic Cardiomyopathy Acorn device knitted polyester sock that is drawn up and anchored over the ventricles in order to limit left ventricular dilation Preliminary data suggest that the device produces an improvement in heart failure symptoms, LVEF, left ventricular end-diastolic dimension, and quality of life

LV Reconstruction for Non-ischemic Cardiomyopathy Study of 27 pt NYHA class went from mean 2.5 to 1.7 After one year, there is no evidence of constriction and coronary blood flow reserve remained normal Larger clinical trials of this device in the United States and Europe are ongoing

LV Reconstruction for Non-ischemic Cardiomyopathy Myosplint Two epicardial pads and a tension wire Two pads on the surface of the heart Wire passes through the ventricle Placed under tension to to create a bilobular shape

LV Reconstruction for Non-ischemic Cardiomyopathy 21 consecutive patients, 9 patients received a Myosplint device alone while 12 patients underwent a mitral valve repair as well NYHA functional class went from 3.0 +/- 0.3 at baseline to 2.1 +/- 0.7 at 6 months (p = 0.001). The LV ejection fraction significantly increased in the Myosplint alone group (from 17.1 +/- 4.0% at baseline to 23.1 +/- 7.2% at 6 months No serious device-related adverse events or device failures were observed J Card Surg. 2005 Nov-Dec;20(6):S43-7.

Surgical remodeling for heart Failure Theory behind treatment History of procedures Ischemic Batista Left ventricular aneurysmectomy Nonischemic Cardiomyoplathy Current and Future LV Reconstructive procedures Dor procedure Non-ischemic Acorn & myosplint Conclusions

Conclusion Ventricular resonstruction attempts to restore the geometry of the diseased heart Several promising surgical therapies for ischemic and non-ischemic cardiomyopathy are being developed In Ischemic CM select patient may already be able to benefit from therapy Results of the STICH Trial will help and define the role or SVR in ischemic heart failure

Conclusion The Role surgical therapy in Non-ischemic is not clearly defined but promising studies are underway