Innovative%20Surgical%20Techniques%20for%20Heart%20Failure

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Innovative Surgical Techniques for Heart Failure

• Walter E. Pae, Jr., M.D. FACC, FACS
• Professor of Surgery
• Milton S. Hershey Medical Center
• Hershey, Pa.

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Surgical Options

• Starving Heart Feed it.hibernating
  myocardium.CABG
• Intrinsic Bad Valves (Congenital, rheumatic,
  degenerative) Repair or Replace it
• Aneurysmal Heart Fix itthe bulging
  nonfunctioning muscle increases wall stress
  and decreases heart function, adversely affects
  remote areas.remodel
• Dilated Heart Remodel itdevices, mitral
  annular reduction
• The Dead Heart Sometimes transplant it

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Coronary Artery Bypass Grafting

• STICH Trial. observational data 70s
  and early 80s suggest a survival advantage with
  bypass surgery in low ejection fraction and
  congestive heart failure, biases favoring
  referral of fittest patients confounds
  comparisons. Medical therapy for CHF has improved
  dramatically. Choice of medical therapy vs CABG
  for CHF and obstructive coronary disease is
  usually decided by guesswork. This study is
  designed to provide a solid answer.

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Nonischemic Valvular Heart Disease

• Stenotic or leaking aortic valve.places a
  working burden on the heart..no matter how bad
  the pump this can almost always be fixed? Long
  term outcome

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Ventricular Aneurysm and Remodeling Procedures

• Reconstructive Endoventricular Surgery returning
  Torsion Original Radius Elliptical (RESTORE)
• Basis for STICH overall design and trial arm of
  CABG /- SVR

Athanasuleas, et al JACC 200444143945
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RESTORE

• SVR in 1,198 post-infarction patients
  between 1998 and 2003. Early and late examined,
  risk factors identified. Concomitant procedures
  included CABG in 95, MVR in 22, and MV
  replacement in 1. 30-day mortality after SVR was
  5.3 (8.7 with MVR vs. 4.0 without MVR p lt
  0.001). Perioperative mechanical support was
  uncommon (lt9). EF increased from 29.6 11.0
  preop to 39.5 12.3 postop (p lt 0.001). LVESVI
  decreased from 80.4 51.4 ml/m2 preop to 56.6
  34.3 ml/m2 postop (p lt 0.001). 5 yr survival was
  68.6 2.8. Logistic regression analysis
  identified EF 30, LVESVI 80 ml/m2, advanced
  NYHA functional class, and age 75 years as risk
  factors for death. Five-year freedom from
  hospital readmission for CHF was 78. Preop, 67
  of patients were NYHA III or IV and postop, 85
  were class I or II.

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Ventricular Aneurysm and Remodeling Procedures
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Ventricular Aneurysm and Remodeling Procedures
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Ventricular Aneurysm and Remodeling Procedures
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Cardiac Support Devices (CSD)Implantable devices
for Dilated Cardiomyopathy

• The CSD is intended to
• Provide end-diastolic ventricular support to
  reduce wall stress and myocardial stretch
• Negate the stimuli for ventricular remodeling and
  promote myocardial reverse remodeling
• Halt progressive dilation and improve cardiac
  function and patient functional status

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Theory of OperationCardiac Support Device
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The Dilated Heart..Passive Cardiac Restraint

Paracor
Myosplint
ACORN
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ACORN TRIAL

• RESULTS Primary endpoint composite with patients
  classified as improved, same or worsened based on
  death, a major cardiac procedure and change in
  NYHA class. Compared to the control, CSD had more
  patients improved (38 percent vs. 27 percent)
  and fewer pa worsened (37 percent vs. 45
  percent), yielding an odds ratio of 1.73 (1.07,
  2.79 p 0.02). The CSD group had fewer major
  cardiac procedures (e.g. transplant, LVAD)
  compared to controls (19 vs. 33 p 0.01), a
  greater reduction in LV end diastolic (p 0.009)
  and systolic volumes (p 0.026) and a greater
  improvement in sphericity index (p 0.026).
  Quality of life (Minnesota Living with HF and SF
  36) was significantly improved in the CSD group
  (p 0.05 and p 0.015 respectively). Repeat
  hospitalizations and adverse events were not
  different between the two groups.

• Presented at the American Heart Association
  Scientific Sessions Nov. 7, 2004

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The Dilated Heart..Mitral Valve
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The Dilated Heart..Mitral Valve
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The Dilated Heart..Mitral Valve
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MVR in CHF A Failed Concept?

• Patients have improved functional NYHA class
• Low operative mortality 5
• Impact on survival not clear
• Randomized trial in order
• New techniques, pt. selection (LVEDDi 30-40
  mm/m2) combined with CSD may improve results

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New Techniques

• Geoform ring
• CSD.Acorn
• 193 patients were enrolled in the MVR stratum of
  the Acorn Clinical Trial. 102 patients were
  randomized to the MV surgery alone group
  (control) and 91 patients were randomized to MV
  surgery with implantation of the CorCap CSD.
  Patients were followed for a median duration of
  22.9 months. For the entire MV surgery group, the
  30 day operative mortality rate was only 1.6 at
  30 days. Mitral surgery was associated with
  progressive reductions in LV end diastolic
  volume, LV end systolic volume and left
  ventricular mass, and increases in LV ejection
  fraction and sphericity index, all consistent
  with reverse remodeling. Recurrence of clinically
  significant MR was uncommon. Quality of life,
  exercise performance and NYHA functional class
  were all improved. Finally, the addition of the
  CorCap CSD led to greater decreases in LVEDV and
  LVESV, a more elliptical shape and a trend for a
  reduction in major cardiac procedures and
  improvement in quality of life compared to mitral
  surgery alone.

Acker, et al presented AATS 2005
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Patients with End-Stage Heart Disease

• Have a poor quality of life
• Are treated with multiple medications
• Have multiple hospitalizations
• Cost the health care system - 100,000 -
  150,000/pt.
• Generally die within 12 to 18 months in spite of
  treatment

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The Heart That Cant Be Fixed

• Conventional Therapy Heart Transplant
• Emerging Therapies Heart Assist or Replacement
• The Future cell transplants?

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NUMBER OF HEART TRANSPLANTS REPORTED BY YEAR
(worldwide)
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HEART TRANSPLANTATION Kaplan-Meier Survival
N followed at longest time point 25,908
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Number of Available Donor Hearts is Inadequate
For The Need
US Heart transplants (2005)
2,127 Patients on waiting list
3,005 Patient who need
40,000-100,000 heart assistance but are not
eligible for a transplant
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Potential Contraindications To Cardiac
Transplantation

• Advancing Age (generally 65)
• Pulmonary Hypertension
• Renal or hepatic dysfunction
• Peripheral/Cerebrovascular Disease
• Other systemic disease limiting rehab or
  prolonged survival
• IDDM
• PUD/Diverticular Disease
• ETC.

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• Total Transplants Performed 352
• Average Transplants per year 17
• 1mo, 1yr and 3yr survival .no different from
  national/regional averages

Cardiac Transplant
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The Heart That Cant Be Fixed

• Conventional Therapy Heart Transplant
• Emerging Therapies Heart Assist or Replacement
• The Future cell transplants?

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Bridging

• Bridge to recovery.cardiomyopathy,
  myocarditis, post-cardiotomy, AMI, high risk PCI
• Bridge to bridge.temporary to long term or
  permanent support
• Bridge to transplant.

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Spectrum of Devices
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Circulatory Support

• Total Number of Implants 291 (18/yr)
• Thoratec (P-D Design) 127
• Abiomed BVS 5000 37
• Abiomed AB5000 3
• HeartMate IP 43
• HeartMate VE 48
• LionHeart 5
• TandemHeart 7
• Subclavian IABP 18
• IMPELLA 2

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TandemHeart PTVA System

• Indicated for Post Cardiotomy and Cardiogenic
  Shock and high risk PCIs
• Percutaneously Placed Can be done in the Cath
  Lab.
• Centrifugal Pump
• Allows up to 4 lpm support.
• Short Term use.
• Recovery or Bridge to bridge.

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Impella

• Investigational miniature rotary pump.
• Cardiogenic shock
• Percutaneous retrograde aortic insertion 2-3 l
  /min

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Impella
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Intra-Aortic Balloon Pump
Gore-Tex Graft
IABP Exit Site
Balloon Tip
Subclavian Approach
Traditional Approach
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Subclavian IABP

• Total Implanted at HMC 18
• Transplanted 13 (72)
• Switched to Long Term Device 2 (11)
• Elective Explants 1 (5)
• Death on Device 2 (11)

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Subclavian IABP

• HMC Implants 18
• Transplanted 13 (72)
• Switched to Long Term Device 2 (11)
• Elective Explants 1 (5)
• Death on Device 2 (11)

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Bridge to Transplant
Study Device Survival Tx
PSU All 82
Frazier (2001) HeartMate VE 71
Farrar (1997) Thoratec BiVAD 58
DiBella (2000) Novacor 70
Minami (2000) Thoratec 61
Novacor 54
HeartMate 51
El-Banayosy (2000) Novacor HeartMate 65 60
SynCardia TAH 79
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CardioWest TAH System
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Survival from Transplantation
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Randomized Evaluation of Mechanical Assistance
for the Treatment of Congestive Heart failure
(REMATCH)

• Medical therapy... 25 one year and 8 two year
  survivals
• Device therapy52 one year and 23 two year
  survivals
• Serious adverse events predominately infection,
  bleeding, device malfunction were 6.45/pt-yr.
• QOL significantly improved at one year in device
  group

NEJM, 20013451435-43
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Survival
100
90
80
70
5225
60
50
238
Survival
40
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Medical Mgmt
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REMATCH
10
0
30
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18
12
6
0
Months
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Kaplan-Meier Survival
Transplant
TX gt 65
After REMATCH
REMATCH
OMM
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Small Pumps of the Future
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