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

Heart Failure Surgery

The Last Frontier

Gerardo S. Manzo, MD, FPCS, FPCCBringing Global Trends in Cardiology Closer to Home

PHA Convention 26 May 2012

et al. Circulation 2006;113:e684-e685

Copyright © American Heart Association

STAGES OF HEART FAILURE

(Divinagracia,RA Novel Therapy HF)


STAGES OF HEART FAILURE



• All Stage A, B and C• Mechanical assist devices• Heart transplantation• Continuous IV inotropic

infusion for palliation• Hospice care

Stage D : Refractory HF

Therapy

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

5th Annual Heart Failure Convention March 08 GSM

Edge-to-Edge Repair EVEREST (Endovascular Valve Edge-to-

Edge REpair Study)

Percutaneous Implantation

Transcatheter joining of mitral valve leaflets

Co-joined leaflets result in dual orifice

Transeptal delivery in cath lab

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

CorCap™ Cardiac Support Device

5th Annual Heart Failure Convention March 08 GSM

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

Surgical Approaches to Heart Failure

HFSA 2010 Recommendations

Lindenfeld J, et al. HFSA 2010 Comprehensive Heart Failure Guideline. J Card Fail 2010;16:e1-e194.

HFSA 2010 Practice GuidelineSurgery

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


HFSA 2010 Practice GuidelineHeart 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


HFSA 2010 Practice GuidelineMitral 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.



HFSA 2010 Practice GuidelineSurgery

Recommendation 10.4

“Batista Procedure”

Partial left ventricular resection is not recommended in nonischemic cardiomyopathy.

Strength of Evidence = B


HFSA 2010 Practice GuidelineMechanical 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


HFSA 2010 Practice GuidelinePermanent 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


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


The Role Of INTERMACS in Patient Selection for Longer Term

Mechanical Circulatory Support

Lynne Warner Stevenson

Investigational indications will be discussed

No conflicts related to MCS

For Extended Use / Durable

Patient Profile/ Status: INTERMACS Levels

1. Critical cardiogenic shock

2. Progressive decline

3. Stable but inotrope dependent

4. Recurrent advanced HF

5. Exertion intolerant

6. Exertion limited

7. Advanced NYHA III

INTERMACS: Patient Selection

PROFILENTERMACS LEVEL

# PtsYr 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 3 Stable On Inotropes

18 Stable but Dependent

Weeks

LEVEL 4 Recurrent

Advanced HF

9 “Frequent flyer” Weeks to few months, if baseline restored

Level 5Exertion Tolerant

4 “Housebound” Weeks to months

LEVEL 6 Exercise Limited

3 “Walking wounded” Months, if nutrition and activity maintained

INTERMACSAdvance NYHA III

4 Advanced Class III

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 TransplantationVolume 31, Issue 2, Pages 117-126 (February 2012)

DOI: 10.1016/j.healun.2011.12.001

Copyright © 2012 Terms and Conditions

http://www.jhltonline.org/article/S1053-2498(11)01250-2/abstract

http://www.jhltonline.org/misc/terms

Figure 4

Source: The Journal of Heart and Lung Transplantation 2012; 31:117-126 (DOI:10.1016/j.healun.2011.12.001 )




Figure 10

Source: The Journal of Heart and Lung Transplantation 2012; 31:117-126 (DOI:10.1016/j.healun.2011.12.001 )




Device Strategy1.Bridge to Recovery (BTR)2.Bridge to “Decision”3.Bridge to a Bridge4.Bridge to Transplant (BTT)5.Destination Therapy6.Rescue Therapy

The CentriMag & PediVas:

Magnetically Levitated Pumps

for ECMO & VAD’s;

Neonates to Adults

Stephen Harwood, CCP, CPC, BA

CentriMag & PediVas

CentriMag®

System Components

Pump Motor Console

Indications

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

J138-0711

Contemporary Outcomes With the HeartMate II® LVAS

David J. Farrar, PhDVice President, Research and Scientific AffairsThoratec Corporation

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

PercutaneousLead

Batteries

HeartMate II® LVAS

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

HeartMate II—Indications for Use

Boyle, Ascheim, Russo, et al. JHLT. 2011;30:4.

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 1Group 2: INTERMACS 2–3Group 3: INTERMACS 4–7

Contemporary Destination Therapy Results

Park SJ. AHA Scientific Sessions, November 2010.

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

• All Stage A, B and C• Mechanical assist devices• Heart transplantation• Continuous IV inotropic

infusion for palliation• Hospice care

Stage D : Refractory HF

Therapy

Is Device Therapy unaffordable for Filipino patients?

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. 25-37 January 2007

DESCRIPTION Unit PriceICD (Single) 600,000ICD (Dual) 750,000

CRTD 1,000,000

Total ICD CRT

2007-2011

1 2 3 4 50

10

20

30

40

50

60

17 18

3238

54

Series1

2007 2008 2009 2010 2011

ICD CRT in the Philippines

Over 40,000 TAVI as of Nov 2011 First procedure by Alain Cribier in

France 2002

$ 25,000 ~ P1M for device only

Transcatheter Aortic Valve Implantation TAVI Devices

Transapical TAVI

Transfemoral TAVI

EVARTEVAR

$12,000 ~ P 500,000For Device

CentriMag®

System Components

Pump Motor Console$10,500 ~ P 590,000For Patient Device

$70,000 ~ P 3.9MFor Hospital

HEART TRANSPLANTATION

Overall

ISHLT 2011ISHLTJ Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132

NUMBER OF HEART TRANSPLANTS REPORTED BY YEAR

0

500

1000

1500

2000

2500

3000

3500

4000

4500

5000

1982

1983

1984

1985

1986

1987

1988

1989

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

Nu

mb

er

of

Tra

ns

pla

nts

Other

EuropeNorth America

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


ADULT HEART TRANSPLANTATION Kaplan-Meier Survival by Era

(Transplants: 1/1982 – 6/2009)

0

20

40

60

80

100

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

Years

1982-1991 (N=20,504)

1992-2001 (N=36,879)

2002-6/2009 (N=22,477)

1982-1991 vs. 1992-2001: p = 0.84601982-1991 vs. 2002-6/2009: p < 0.00011992-2001 vs. 2002-6/2009: p < 0.0001

HALF-LIFE 1982-1991: 10.2 years; 1992-2001: 10.7 years; 2002-6/2009: NA

Su

rviv

al (

%)


ADULT HEART RECIPIENTSCross-Sectional Analysis

Functional Status of Surviving Recipients (Follow-ups: 1995 - June 2010)

0%

20%

40%

60%

80%

100%

1 Year (N = 16,087) 3 Years (N = 14,235) 5 Years (N = 12,181)

No Activity Limitations Performs with Some Assistance Requires Total Assistance


ADULT HEART RECIPIENTSEmployment Status of Surviving Recipients

Age at Follow-up: 25-55 Years (Follow-ups: 1995 - June 2010)

0%

20%

40%

60%

80%

100%

1 Year (N = 9,115) 3 Year (N = 6,967) 5 Year (N = 5,163)

Retired

Not Working

Working Part Time

Working Full Time

Working (FT/PTstatus unknown)


ADULT HEART RECIPIENTSRehospitalization Post-transplant of Surviving Recipients

(Follow-ups: 1995 - June 2010)

0%

20%

40%

60%

80%

100%

Up to 1 Year Between 2 and 3 Years Between 4 and 5 Years

No Hospitalization Hospitalized: Not Rejection/Not Infection

Hospitalized: Rejection Only Hospitalized: Infection Only

Hospitalized: Rejection + Infection

(N = 22,651) (N = 26,546) (N = 19,481)


Global Burden of Heart Disease

Global Burden of Heart Disease

Focused on Prevention & Risk Modificationo genetic susceptibilityo marked environmental changes usually secondary to

• urbanization• increasing affluence• influences from early childhood to

adulthood.

Individual Burden of Heart Failure

Direct Costs of Careo Inpatient : Frequent Re-hospitalizationo Rehabilitationo Follow-up careo Cost of DevicesIndirect Costso Loss of employmento “Medicare” benefitso Family expenses

Heart Failure Surgeryin 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

We need to stop condemning our Stage D Heart Failure

patients…

…and conquer the last frontiers of Philippine cardiology...

THANK YOU

Documents

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