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

SurSurgical Ventricular Remodeling gical Ventricular Remodeling for Congestive Heart Failurefor Congestive Heart Failure

““When BB and ACEI are not Enough”When BB and ACEI are not Enough”

May 18May 18thth 2006 2006

Jeffrey MarogilJeffrey Marogil

Malek MassadMalek Massad

Major Health Concern in USMajor Health Concern in US– Affects 4.8 million people in U.S.Affects 4.8 million people in U.S.– 400,000 new cases each year.400,000 new cases each year.– Anticipated increase in incidence & Anticipated increase in incidence &

prevalence as population ages.prevalence as population ages.

Heart FailureHeart FailureIntroductionIntroduction

INTRODUCTIONINTRODUCTION

Significant progress has been made in the Significant progress has been made in the medical management of patients with medical management of patients with heart failure heart failure

However the surgical management of However the surgical management of patients with end-stage heart failure has patients with end-stage heart failure has evolved in a less structured fashionevolved in a less structured fashion


Heart transplantation remains the ultimate Heart transplantation remains the ultimate treatment for heart failuretreatment for heart failure

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


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 heartsSmall number of available donor hearts– Inapplicable in older pts or those with comorbid Inapplicable in older pts or those with comorbid

conditionsconditions


NUMBER OF HEART TRANSPLANTS NUMBER OF HEART TRANSPLANTS REPORTED BY YEAR AND LOCATIONREPORTED BY YEAR AND LOCATION

0

500

1000

1500

2000

2500

3000

3500

4000

45001

98

2

19

83

19

84

19

85

19

86

19

87

19

88

19

89

19

90

19

91

19

92

19

93

19

94

19

95

19

96

19

97

19

98

19

99

20

00

20

01

Nu

mb

er o

f T

ran

spla

nts

South America

North America

Europe

Australia/Oceania

Asia

Africa

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

OHTOHT

0

5000

10000

15000

20000

25000

30000

35000

40000

45000

< 55 YRS < 65 YRS

Potential DonorsPotential RecipientsColumn 3

HEART TRANSPLANTATIONHEART TRANSPLANTATIONACTUARIAL SURVIVAL (1982-2000)

0

20

40

60

80

100

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17

Years Post-Transplantation

Sur

viva

l (%

)

N=52,195

Half-life =9.1 yearsConditional Half-life = 11.6 years

ADULT HEART TRANSPLANTATION ADULT HEART TRANSPLANTATION Actuarial Survival by Diagnosis Actuarial Survival by Diagnosis (Transplants: 1/1982-6/2001)(Transplants: 1/1982-6/2001)

0

20

40

60

80

100

0 1 2 3 4 5 6 7 8 9 10

Years

Su

rviv

al

(%)

Coronary Artery Disease (N=23,682) Cardiomyopathy (N=25,543)Congenital Diagnosis (N=2,933) Retransplant (N=1,227)Valvular (N=1,917) Other (N=962)

Who Should Not Be OfferedWho Should Not Be Offereda Heart Transplant?a Heart Transplant?

Irreversible PHTN or pulmonary Irreversible PHTN or pulmonary parenchymal diseaseparenchymal diseaseIrreversible renal or hepatic dysfunctionIrreversible renal or hepatic dysfunctionSevere peripheral or cerebrovascular Severe peripheral or cerebrovascular diseasediseaseIDDM with end-organ damageIDDM with end-organ damageCoexisting cancerCoexisting cancerNon-compliance, addictionNon-compliance, addictionElderly patients (aprox > 70yo)Elderly patients (aprox > 70yo)

Surgical Ventricular RemodelingSurgical Ventricular Remodeling

Other Surgical Treatment Options are Other Surgical Treatment Options are needed since transplants limited by needed since transplants limited by – Available donors Available donors – Suitable recipientsSuitable recipients

Surgical Treatment of heart failureSurgical Treatment of heart failure

Coronary revascularization in ischemic Coronary revascularization in ischemic cardiomyopathycardiomyopathy

Mitral valve repair in patients with dilated Mitral valve repair in patients with dilated cardiomyopathy. cardiomyopathy.

Left ventricular assist devices (LVADs)Left ventricular assist devices (LVADs)

Resynchronization therapyResynchronization therapy

Total Artificial HeartTotal Artificial Heart

Reconstructive cardiac surgeryReconstructive cardiac surgery

2005 ACC/AHA Guidelines2005 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 Chronic Heart Failure in the Adult: ACC/AHA 2005 Guideline Update for the Diagnosis and Management August 16, 2005Diagnosis and Management August 16, 2005

Surgical remodeling for heart Surgical remodeling for heart FailureFailure

Theory behind treatment Theory behind treatment History of proceduresHistory of procedures– IschemicIschemic

BatistaBatistaLeft ventricular aneurysmectomy Left ventricular aneurysmectomy

– Nonischemic Nonischemic CardiomyoplastyCardiomyoplasty

Current and Future LV Reconstructive proceduresCurrent and Future LV Reconstructive procedures– Ischemic Ischemic

Dor procedureDor procedure– Non-ischemicNon-ischemic

Acorn & myosplintAcorn & myosplintConclusionsConclusions

TheoryTheory

Systolic HF leads to an enlarged LV Systolic HF leads to an enlarged LV volume to maintain stroke volume volume to maintain stroke volume This leads to increase in wall stress due to This leads to increase in wall stress due to Laplace's law Laplace's law stress = pressure x radius ÷ 2 x wall thicknessstress = pressure x radius ÷ 2 x wall thickness

The ventricular geometry becomes less The ventricular geometry becomes less ellipsoid and more spherical leading to ellipsoid and more spherical leading to progression of left ventricular dysfunction progression of left ventricular dysfunction and worsening heart failure.and worsening heart failure.

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

TheoryTheory

TheoryTheory

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

382 patients with NYHA III and IV 382 patients with NYHA III and IV

LV size measured by EDV/BSA LV size measured by EDV/BSA

LV size was a predictor of sudden cardiac LV size was a predictor of sudden cardiac deathdeath

LV’s > 4 cm/mLV’s > 4 cm/m22 had a 2 year survial of had a 2 year survial of 49% compared to 75% if < 4 cm/m49% compared to 75% if < 4 cm/m22

Independent of disease and %EFIndependent of disease and %EF

Lee th et al Am J Cardiology 1993;72:672-676

TheoryTheory




– Nonischemic Nonischemic CardiomyoplathyCardiomyoplathy




Batista procedureBatista procedure

Batista procedure also called the partial Batista procedure also called the partial left ventriculectomy (PLV) left ventriculectomy (PLV)

Developed by Dr. Randas Batista (Brazil) Developed by Dr. Randas Batista (Brazil) in 1996in 1996

Partial Left VentriculectomyPartial Left Ventriculectomy(Batista Operation)(Batista Operation)

Removal of a section of the left Removal of a section of the left ventricular free wall, between ventricular free wall, between both papillary muscles and both papillary muscles and extending from the apex to the extending from the apex to the mitral annulusmitral annulus

Remaining free edges were re- Remaining free edges were re- -approximated and stitched -approximated and stitched togethertogether

Mitral valve and subvalvular Mitral valve and subvalvular apparatus were either apparatus were either preserved, repaired, or preserved, repaired, or replaced, replaced,


UICUIC

Initial experience with the Batista Initial experience with the Batista procedure demonstrated an initial increase procedure demonstrated an initial increase in LVEF, reduction in heart size, and in LVEF, reduction in heart size, and improvement in clinical functional status improvement in clinical functional status

However, of 120 patients Batista reported However, of 120 patients Batista reported a 22% operative mortality and 2 year a 22% operative mortality and 2 year survival of 55%.survival of 55%.


Late fatal arrhythmias plagued this Late fatal arrhythmias plagued this procedure, forcing the use of concomitant procedure, forcing the use of concomitant implantable defibrillatorsimplantable defibrillators

Therefore the Batista procedure has fallen Therefore the Batista procedure has fallen out of favor and is no longer considered to out of favor and is no longer considered to be an appropriate optionbe an appropriate option









Left ventricular aneurysmectomyLeft ventricular aneurysmectomy

The first successful The first successful surgical correction of an surgical correction of an LV aneurysm occurred LV aneurysm occurred in 1957 by Dr. Baileyin 1957 by Dr. Bailey

Done without off cardiac Done without off cardiac bypass by placing a bypass by placing a clamp on the base of an clamp on the base of an aneurysm and passing aneurysm and passing suture beneath allowing suture beneath allowing excision of the excision of the aneurysm.aneurysm.

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

Left ventricular aneurysmectomyLeft ventricular aneurysmectomy

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

Left ventricular Left ventricular aneurysmectomyaneurysmectomy








CardiomyoplastyCardiomyoplasty

Cardiomyoplasty, also referred to as Cardiomyoplasty, also referred to as "dynamic cardiomyoplasty," "dynamic cardiomyoplasty,"

Surgical therapy for dilated Surgical therapy for dilated cardiomyopathy in which the latissimus cardiomyopathy in which the latissimus dorsi muscle is wrapped around the heart dorsi muscle is wrapped around the heart and paced during ventricular systole. and paced during ventricular systole.

Carpentier and Chachques peformed the Carpentier and Chachques peformed the first successful surgery on a humen in first successful surgery on a humen in 19851985


Symptomatic improvement occured after Symptomatic improvement occured after cardiomyoplastycardiomyoplasty

Mechanism for improvement is unclearMechanism for improvement is unclear

Pacemaker synchronization was critical for Pacemaker synchronization was critical for obtaining optimal improvement.obtaining optimal improvement.


600 patients undergoing this procedure 600 patients undergoing this procedure found that, over time, the operative found that, over time, the operative mortality decreased from 31 to 3 percentmortality decreased from 31 to 3 percent

Improvement in NYHA classification Improvement in NYHA classification occurred in 80 to 85 percent of hospital occurred in 80 to 85 percent of hospital survivors survivors

However, long-term outcome data with However, long-term outcome data with cardiomyoplasty are limited. cardiomyoplasty are limited.


A large, randomized clinical trial of A large, randomized clinical trial of cardiomyoplasty was initiated for NYHA cardiomyoplasty was initiated for NYHA class III heart failure patientsclass III heart failure patients

Plagued by lagging randomization and Plagued by lagging randomization and marginal overall clinical improvement marginal overall clinical improvement culminated in the premature termination of culminated in the premature termination of the study.the study.


““It appears that those who can survive It appears that those who can survive the operation do not need it and those the operation do not need it and those who need it, cannot survive it”who need it, cannot survive it”

1.1. Leier, CV. Cardiomyoplasty: is it time to wrap it up?. J Am Coll Cardiol Leier, CV. Cardiomyoplasty: is it time to wrap it up?. J Am Coll Cardiol 1996; 28:1181. 1996; 28:1181.



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



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.









LV Reconstruction for Ischemic LV Reconstruction for Ischemic CardiomyopathyCardiomyopathy

Dor procedure also called endoventricular Dor procedure also called endoventricular circular patch plasty (EVCPP), is an circular patch plasty (EVCPP), is an approach to surgical reconstruction in the approach to surgical reconstruction in the setting of postinfarction aneurysm setting of postinfarction aneurysm formation first reported in 1985formation first reported in 1985

Advantage to aneurysmectomy is in an Advantage to aneurysmectomy is in an attempt to restore left ventricular geometryattempt to restore left ventricular geometry

Dor procedure for Ischemic Dor procedure for Ischemic CardiomyopathyCardiomyopathy

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


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


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


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

The first 661 patients The first 661 patients

Overall operative mortality was 8 percent; Overall operative mortality was 8 percent; (urgently 16.3 versus 6.2 percent when (urgently 16.3 versus 6.2 percent when planned) planned)

LVEF less than 20 percent (17 versus 1.4 LVEF less than 20 percent (17 versus 1.4 percent for LVEF greater than 40 percent)percent for LVEF greater than 40 percent)

Jpn J Thorac Cardiovasc Surg 1998 May;46(5):389-98 Jpn J Thorac Cardiovasc Surg 1998 May;46(5):389-98


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



At present there are four variations of LV At present there are four variations of LV reconstruction are used excluding the reconstruction are used excluding the septumseptum– Linear closure by JateneLinear closure by Jatene– Modified liner closure by MickleboroughModified liner closure by Mickleborough– Circular closure with a path by DorCircular closure with a path by Dor– Circular closure without a patch by McCarthyCircular closure without a patch by McCarthy

First randomized trial of surgical First randomized trial of surgical ventricular restoration + CABG vs CABG ventricular restoration + CABG vs CABG alone for ischemic cardiomyopathy was alone for ischemic cardiomyopathy was published April 2006 isure of Journal of published April 2006 isure of Journal of Cardiac FailureCardiac Failure


Journal of Cardiac Failure Vol 12 No 3 2006


74 Consecutive patients with ischemic 74 Consecutive patients with ischemic cardiomyopathy and EF < 35% with LESV cardiomyopathy and EF < 35% with LESV > 80ml/m> 80ml/m22

LimitationsLimitations– Non-BlindedNon-Blinded– Excluded > 2+ MR or other significant valvular Excluded > 2+ MR or other significant valvular

heart disease heart disease – Dyskinetic ant wallDyskinetic ant wall– Non-viable Ant wall on Thallium testingNon-viable Ant wall on Thallium testing





STICH Trial STICH Trial – NIH sponsored trial to compare medical NIH sponsored trial to compare medical

therapy vs CABG for patients with CHF and therapy vs CABG for patients with CHF and EF < 35% including SVR + CABG as a EF < 35% including SVR + CABG as a treatment arm in patients with LVESVI > treatment arm in patients with LVESVI > 60ml/m60ml/m

– 600 patient scheduled to enroll600 patient scheduled to enroll

Considered Criteria for Surgical Considered Criteria for Surgical RepairRepair

Anteroseptal MI, with dilated left ventricle Anteroseptal MI, with dilated left ventricle (end-diastolic volume index >100 mL/m2)(end-diastolic volume index >100 mL/m2)

Depressed LVEF Depressed LVEF

Left ventricular regional dyskinesis or Left ventricular regional dyskinesis or akinesis >30 percent of the ventricular akinesis >30 percent of the ventricular perimeter, and perimeter, and

Either symptoms of angina, heart failure, Either symptoms of angina, heart failure, or arrhythmias or arrhythmias

The following are considered to be relative The following are considered to be relative contraindicationscontraindications

Systolic pulmonary artery pressure >60 Systolic pulmonary artery pressure >60 mmHg mmHg

Severe right ventricular dysfunction Severe right ventricular dysfunction

Regional dyskinesis or akinesis without Regional dyskinesis or akinesis without dilation of the ventricle dilation of the ventricle








LV Reconstruction for Non-LV Reconstruction for Non-ischemic Cardiomyopathyischemic Cardiomyopathy

Cardiomyoplasty experience has led to Cardiomyoplasty experience has led to other novel approaches to heart failure. other novel approaches to heart failure.

Observations suggested that some Observations suggested that some patients benefited from the diastolic patients benefited from the diastolic "girdling" effect of the muscle wrap "girdling" effect of the muscle wrap

This observation led to the development of This observation led to the development of the Acorn device and Myosplintthe Acorn device and Myosplint


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

Study of 27 pt NYHA class went from Study of 27 pt NYHA class went from mean 2.5 to 1.7mean 2.5 to 1.7

After one year, there is no evidence of After one year, there is no evidence of constriction and coronary blood flow constriction and coronary blood flow reserve remained normalreserve remained normal

Larger clinical trials of this device in the Larger clinical trials of this device in the United States and Europe are ongoingUnited States and Europe are ongoing



MyosplintMyosplint– Two epicardial pads and a tension wireTwo epicardial pads and a tension wire– Two pads on the surface of the heartTwo pads on the surface of the heart– Wire passes throughWire passes through

the ventriclethe ventricle– Placed under tension toPlaced under tension to

to create a bilobularto create a bilobular

shapeshape


21 consecutive patients, 9 patients received a 21 consecutive patients, 9 patients received a Myosplint device alone while 12 patients Myosplint device alone while 12 patients underwent a mitral valve repair as well underwent a mitral valve repair as well NYHA functional class went from 3.0 +/- 0.3 at NYHA functional class went from 3.0 +/- 0.3 at baseline to 2.1 +/- 0.7 at 6 months (p = 0.001). baseline to 2.1 +/- 0.7 at 6 months (p = 0.001). The LV ejection fraction significantly increased in The LV ejection fraction significantly increased in the Myosplint alone group (from 17.1 +/- 4.0% at the Myosplint alone group (from 17.1 +/- 4.0% at baseline to 23.1 +/- 7.2% at 6 months baseline to 23.1 +/- 7.2% at 6 months No serious device-related adverse events or No serious device-related adverse events or device failures were observeddevice failures were observed

J Card Surg. 2005 Nov-Dec;20(6):S43-7.








ConclusionConclusion

Ventricular resonstruction attempts to restore the Ventricular resonstruction attempts to restore the geometry of the diseased heartgeometry of the diseased heart

Several promising surgical therapies for Several promising surgical therapies for ischemic and non-ischemic cardiomyopathy are ischemic and non-ischemic cardiomyopathy are being developedbeing developed

In Ischemic CM select patient may already be In Ischemic CM select patient may already be able to benefit from therapyable to benefit from therapy

Results of the STICH Trial will help and define Results of the STICH Trial will help and define the role or SVR in ischemic heart failure the role or SVR in ischemic heart failure

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

ConclusionConclusion

Documents

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