Transcript Surgical Therapy for Heart Failure

Surgical 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
4500
4000
North America
3500
Europe
Australia/Oceania
3000
Asia
Africa
2500
2000
1500
1000
500
2001
2000
1999
1998
1997
1996
1995
1994
1993
1992
1991
1990
1989
1988
1987
1986
1985
1984
1983
0
1982
Number of Transplants
South America
Need for Heart Transplant
# of Potential Recipients that can Benefit from
OHT
45000
40000
35000
30000
25000
20000
15000
Potential Donors
Potential Recipients
Column 3
10000
5000
0
< 55 YRS
< 65 YRS
HEART TRANSPLANTATION
ACTUARIAL SURVIVAL (1982-2000)
100
Half-life =9.1 years
Conditional Half-life = 11.6 years
Survival (%)
80
60
N=52,195
40
20
0
0
1
2
3
4
5
6
7
8
9
10 11 12 13 14 15 16 17
Years Post-Transplantation
ADULT HEART TRANSPLANTATION
Actuarial Survival by Diagnosis
100
(Transplants: 1/1982-6/2001)
Coronary Artery Disease (N=23,682)
Congenital Diagnosis (N=2,933)
Valvular (N=1,917)
Cardiomyopathy (N=25,543)
Retransplant (N=1,227)
Other (N=962)
Survival (%)
80
60
40
20
0
0
1
2
3
4
5
Years
6
7
8
9
10
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
– Ischemic
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
– Ischemic
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
– Ischemic
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
– Ischemic
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”
1.
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
– Ischemic
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
– Ischemic
Dor procedure
– Non-ischemic
Acorn & myosplint
Conclusions
LV Reconstruction for Nonischemic 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 Nonischemic 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 enddiastolic dimension, and
quality of life
LV Reconstruction for Nonischemic 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 Nonischemic 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 Nonischemic 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
– Ischemic
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