1. Heart Failure Surgery The Last Frontier
Gerardo S. Manzo, MD, FPCS, FPCC
Bringing Global Trends in Cardiology Closer to Home
PHA Convention 26 May 2012

2.    Figure 1. Stages in the development of heart failure/recommended therapy by stage. FHx CM indicates family history of cardiomyopathy; ACEI, angiotensin converting enzyme inhibitor; and ARB, angiotensin receptor blocker.
et al. Circulation 2006;113:e684-e685
Copyright © American Heart Association

3. STAGES OF HEART FAILURE
(Divinagracia,RA Novel Therapy HF)

4. (Divinagracia,RA Novel Therapy HF)

5. STAGES OF HEART FAILURE
(Divinagracia,RA Novel Therapy HF)

6. (Divinagracia,RA Novel Therapy HF)

7. Therapy Stage D : Refractory HF All Stage A, B and C
Mechanical assist devices
Heart transplantation
Continuous IV inotropic infusion for palliation
Hospice care

8. Surgical Options for the Failing Ventricle
Transmyocardial Revascularization (laser)
End-to-End Mitral Repair (Everest Clip/ Alfieri)
Cardiomyoplasty
CorCap Cardiac Support Device (mesh)
Coapsys LV Support Device (intracavitary rod)
Partial Left Ventriculectomy (Batista)
Stem Cell Therapy ???
Mechanical Circulatory Support Devices
Heart Transplantation
PHA Annual 2005
GSManzo

9. Percutaneous Implantation
Transcatheter joining of mitral valve leaflets
Co-joined leaflets result in dual orifice
Transeptal delivery in cath lab
Edge-to-Edge Repair EVEREST (Endovascular Valve Edge-to-Edge REpair Study)
5th Annual Heart Failure Convention March 08 GSM

10. CorCap™ Cardiac Support Device
The CorCap is designed to:
Provide end-diastolic ventricular support to reduce wall stress and myocardial stretch
Negate the stimuli for ventricular remodeling and promote myocardial reverse remodeling
Reverse progressive dilation and improve cardiac function and patient functional status

11. Annuloplasty : Transventricular / Transatrial / Epicardial Approach
Intracavitary shortening
rod connecting two
external pads to shorten
septolateral dimension
of LV and mitral annulus
Myocor Surgical Coapsys System
5th Annual Heart Failure Convention March 08 GSM

12. Surgical Approaches to Heart Failure
HFSA 2010 Recommendations

13. HFSA 2010 Practice Guideline Surgery
Recommendation 10.1
It is recommended that the decision to undertake surgical intervention for severe HF be made in light of the following:
Functional status
Prognosis based on
severity of underlying HF
co-morbid conditions.
Procedures should be done at centers with the following:
Demonstrable expertise
Multidisciplinary medical and surgical teams experienced in the selection, care, and perioperative and long-term management of high risk patients with severe HF
Strength of Evidence = C

14. HFSA 2010 Practice Guideline Heart Transplantation
Recommendation 10.2
Evaluation for heart transplantation is recommended in selected patients with the following:
severe HF
debilitating refractory angina
or ventricular arrhythmia that cannot be controlled despite drug, device or alternative surgical therapy Strength of Evidence = B

15. HFSA 2010 Practice Guideline Mitral Valve Repair or Replacement
Recommendation 10.3
Isolated mitral valve repair or replacement for severe mitral regurgitation secondary to ventricular dilatation in the presence of severe LV systolic dysfunction is not generally recommended Strength of Evidence = C

16. HFSA 2010 Practice Guideline Surgery
Recommendation 10.4
“Batista Procedure”
Partial left ventricular resection is not recommended in nonischemic cardiomyopathy.
Strength of Evidence = B

17. HFSA 2010 Practice Guideline Mechanical Support
Recommendation 10.5
Patients awaiting heart transplantation who have become refractory to all means of medical circulatory support should be considered for a mechanical support device as a bridge to transplant.
Strength of Evidence = B

18. HFSA 2010 Practice Guideline Permanent Mechanical Assistance
Recommendation 10.6
Permanent mechanical assistance using an implantable assist device may be considered in highly selected patients with severe HF refractory to conventional therapy who are not candidates for heart transplantation, particularly those who cannot be weaned from IV inotropic support at an experienced HF center Strength of Evidence = B

19. HFSA 2010 Practice Guideline “Bridge to Decision”
Recommendation 10.7 (NEW in 2010)
The following patients should be considered for urgent mechanical circulatory support as a “bridge to decision”:
Patients with refractory HF and hemodynamic instability
and/or compromised end-organ function
with relative contraindications to cardiac transplantation or permanent mechanical circulatory assistance, who are expected to improve with time or restoration of an improved hemodynamic profile
These patients should be referred to a center with expertise in the management of patients with advanced HF
Strength of Evidence = C

21. The Role Of INTERMACS in Patient Selection for Longer Term Mechanical Circulatory Support
For Extended Use / Durable
Lynne Warner Stevenson
Investigational indications will be discussed
No conflicts related to MCS

22. INTERMACS: Patient Selection
Patient Profile/ Status: INTERMACS Levels
1. Critical cardiogenic shock
Progressive decline
Stable but inotrope dependent
Recurrent advanced HF
Exertion intolerant
Exertion limited
Advanced NYHA III

23. General time frame for support
PROFILE
NTERMACS LEVEL
# Pts
Yr 1
Official Shorthand
General time frame for support
LEVEL 1 Cardiogenic Shock 82
“Crash and burn”
Hours
LEVEL 2 Progressive Decline 81
“Sliding fast”
Days to week
LEVEL Stable On Inotropes 18
Stable but Dependent
Weeks
LEVEL 4 Recurrent Advanced HF 9
“Frequent flyer”
Weeks to few months, if baseline restored
Level 5
Exertion Tolerant 4
“Housebound”
Weeks to months
LEVEL Exercise Limited 3
“Walking wounded”
Months, if nutrition and activity maintained
INTERMACS
Advance NYHA III
Advanced Class III

24. The Fourth INTERMACS Annual Report: 4,000 implants and counting
James K. Kirklin, MD, David C. Naftel, PhD, Robert L. Kormos, MD, Lynne W. Stevenson, MD, Francis D. Pagani, MD, PhD, Marissa A. Miller, DVM, MPH, J. Timothy Baldwin, PhD and James B. Young, MD
The Journal of Heart and Lung Transplantation
Volume 31, Issue 2, Pages (February 2012)
DOI: /j.healun
Copyright © Terms and Conditions

25. Figure 4
Primary left ventricular assist device (LVAD) or total artificial heart (TAH) patient enrollment in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database from June 23, 2006, to June 30, 2011, stratified by univentricular or biventricular support and year of implant. Bi-VAD, biventricular assist device.
Source: The Journal of Heart and Lung Transplantation 2012; 31: (DOI: /j.healun )
Copyright © Terms and Conditions

26. Figure 10
Actuarial survival for 3,405 primary continuous-flow implants, stratified by device strategy. *Note: An additional 53 patients had initial device strategy of rescue therapy (n = 11), recovery (n = 21), and other (n = 21); these patients are not included in the Figure. LVAD, left ventricular assist device; INTERMACS, Interagency Registry for Mechanically Assisted Circulatory Support; RVAD, right ventricular assist device.
Source: The Journal of Heart and Lung Transplantation 2012; 31: (DOI: /j.healun )
Copyright © Terms and Conditions

27. Device Strategy
Bridge to Recovery (BTR)
Bridge to “Decision”
Bridge to a Bridge
Bridge to Transplant (BTT)
Destination Therapy
Rescue Therapy

28. The CentriMag & PediVas:
Magnetically Levitated Pumps
for ECMO & VAD’s;
Neonates to Adults
Stephen Harwood, CCP, CPC, BA

29. CentriMag & PediVas

30. CentriMag® System Components
The CentriMag is the first disposable, extracorporeal short-term magnetically levitated blood pump. The components are a polycarbonate pump which sits in the motor and is driven by a console.
Each of these components will be further described on following slides.
Pump Motor Console

31. Indications Longest duration : 304 days followed by HeartMate II
The CentriMag and PediVas pumps are classified as short term devices (30 days)
Are often used as a ‘bridge’ from one point in treatment to another
They are well suited in the critical setting because they are extremely easy to institute
They have been widely used as ventricular support devices, but also are popular in ECMO /ECLS circuits as well
Longest duration : 304 days
followed by HeartMate II

32. Contemporary Outcomes With the HeartMate II® LVAS
David J. Farrar, PhD
Vice President, Research and Scientific Affairs
Thoratec Corporation J

33. HeartMate II® LVAS
A surgically implanted, rotary continuous-flow device in parallel with the native left ventricle
Left ventricle to ascending aorta
Percutaneous driveline
Electrically powered
Batteries and line power
Fixed-speed operating mode
Home discharge with ability to return to activities of daily life (work, school, exercise, hobbies, etc.)
Implantable
Pump
Controller
Percutaneous
Lead
Batteries

34. HeartMate II—Indications for Use
HeartMate II is the first and only FDA-approved continuous-flow device for both Bridge-to-Transplantation (BTT) and Destination Therapy (DT).
Bridge-to-Transplantation
Risk of imminent death from nonreversible left ventricular failure
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

35. Clinical Outcomes Based on INTERMACS Profile
Length of Stay Post-VAD
Actuarial Survival Post-VAD
Less acutely ill, ambulatory patients in INTERMACS profiles 4–7 had better survival and reduced length of stay compared to patients who were more accurately ill in profiles 1–3.
Group 1: INTERMACS 1
Group 2: INTERMACS 2–3
Group 3: INTERMACS 4–7
Boyle, Ascheim, Russo, et al. JHLT. 2011;30:4.

36. Contemporary Destination Therapy Results
Park SJ. AHA Scientific Sessions, November 2010.

37. In Summary
Over 7,000 patients implanted with HeartMate II—long-term durability
Improvements in Bridge-to-Transplant and Destination Therapy survival and adverse event rates
Adverse-event differences in LVAD patients may lead to targeted approaches for men and women
Driveline infections can possibly be reduced by new tunneling techniques
New HeartMate II risk model along with INTERMACS profiles may help guide future patient selection

38. Is Device Therapy unaffordable for Filipino patients?
Stage D : Refractory HF
Therapy
All Stage A, B and C
Mechanical assist devices
Heart transplantation
Continuous IV inotropic infusion for palliation
Hospice care
Is Device Therapy unaffordable for Filipino patients?

40. About 250,000 Americans each year have an ICD implanted at the cost of about $100,000 each.
Weisfeldt, Myron L., and Susan L. Zeiman. "Advances in the Prevention and Treatment of Cardiovascular Disease: One of the most important contributors to improved human survival is the treatment of cardiovascular disease". Health Affairs. Vol. 26, No. 1, pp January 2007

41. ICD CRT in the Philippines
Total ICD CRT
DESCRIPTION
Unit Price
ICD (Single)
600,000
ICD (Dual)
750,000
CRTD
1,000,000

42. First procedure by Alain Cribier in France 2002
Over 40,000 TAVI as of Nov 2011
First procedure by Alain Cribier in France 2002

43. Transcatheter Aortic Valve Implantation TAVI Devices
$ 25,000 ~ P1M for device only
Transfemoral TAVI
Transapical TAVI

45. EVAR
TEVAR
$12,000 ~ P 500,000
For Device

46. CentriMag® System Components
The CentriMag is the first disposable, extracorporeal short-term magnetically levitated blood pump. The components are a polycarbonate pump which sits in the motor and is driven by a console.
Each of these components will be further described on following slides.
Pump Motor Console
$10,500 ~ P 590,000
For Patient Device
$70,000 ~ P 3.9M
For Hospital

47. HEART TRANSPLANTATION
Overall
ISHLT
J Heart Lung Transplant Oct; 30 (10):
ISHLT
2011

48. NUMBER OF HEART TRANSPLANTS REPORTED BY YEAR
This figure includes only the heart transplants that are reported to the ISHLT Transplant Registry. As such, the presented data may not mirror the changes in the number of heart transplants performed worldwide.
NOTE: This figure includes only the heart transplants that are reported to the ISHLT Transplant Registry.  As such, the presented data may not mirror the changes in the number of heart transplants performed worldwide
ISHLT
J Heart Lung Transplant Oct; 30 (10):
ISHLT
2011

49. ADULT HEART TRANSPLANTATION Kaplan-Meier Survival by Era (Transplants: 1/1982 – 6/2009)
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 known 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. No adjustments were made for multiple comparisons.
ISHLT
J Heart Lung Transplant Oct; 30 (10):
ISHLT
2011

50. ADULT HEART RECIPIENTS Cross-Sectional Analysis Functional Status of Surviving Recipients (Follow-ups: June 2010)
This figure shows the functional status reported on the 1-year, 3-year and 5-year annual follow-ups. Because all follow-ups between 1995 and June 2010 were included, the bars do not include the same patients.
ISHLT
J Heart Lung Transplant Oct; 30 (10):
ISHLT
2011

51. ADULT HEART RECIPIENTS Employment Status of Surviving Recipients Age at Follow-up: Years (Follow-ups: June 2010)
This figure shows the employment status reported on annual follow-ups. Because all follow-ups between 1995 and June 2010 were included, the bars do not include the same patients.
ISHLT
J Heart Lung Transplant Oct; 30 (10):
ISHLT
2011

52. ADULT HEART RECIPIENTS Rehospitalization Post-transplant of Surviving Recipients (Follow-ups: June 2010)
This figure shows the hospitalizations reported on the annual follow-ups, representing the hospitalizations between discharge and 1 year, between the 2-year and 3-year follow-up, and between the 4-year and 5-year follow-ups, respectively. Because all follow-ups between 1995 and June 2010 were included, the bars do not include the same patients.
ISHLT
J Heart Lung Transplant Oct; 30 (10):
ISHLT
2011

53. Global Burden of Heart Disease

54. Global Burden of Heart Disease
Focused on Prevention & Risk Modification
genetic susceptibility
marked environmental changes usually secondary to
urbanization
increasing affluence
influences from early childhood to adulthood.

55. Individual Burden of Heart Failure
Direct Costs of Care
Inpatient : Frequent Re-hospitalization
Rehabilitation
Follow-up care
Cost of Devices
Indirect Costs
Loss of employment
“Medicare” benefits
Family expenses

56. Heart Failure Surgery in the Philippines
Create Multidisciplinary medical and surgical teams experienced in the selection, care, and perioperative and long-term management of high risk patients with severe HF
Implement evidence based HF therapies
Develop expertise on appropriate surgical procedures for HF
Increase patient awareness on available treatment options

57. We need to stop condemning our Stage D Heart Failure patients… …and conquer the last frontiers of Philippine cardiology...
THANK YOU