Transcript Document

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
et al. Circulation 2006;113:e684-e685
Copyright © American Heart Association
STAGES OF HEART FAILURE
(Divinagracia,RA Novel Therapy HF)
(Divinagracia,RA Novel Therapy HF)
STAGES OF HEART FAILURE
(Divinagracia,RA Novel Therapy HF)
(Divinagracia,RA Novel Therapy HF)
Stage D : Refractory HF
Therapy
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All Stage A, B and C
Mechanical assist devices
Heart transplantation
Continuous IV inotropic
infusion for palliation
• Hospice care
Surgical Options for the
Failing Ventricle
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PHA Annual 2005
GSManzo
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
Percutaneous Implantation
 Transcatheter joining
of mitral valve
leaflets
 Co-joined leaflets
result in dual orifice
 Transeptal delivery
in cath lab
Edge-to-Edge Repair
5th Annual Heart Failure
Convention March 08 GSM
EVEREST (Endovascular Valve Edge-to-Edge REpair Study)
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
Annuloplasty : Transventricular /
Transatrial / Epicardial Approach
Intracavitary shortening
rod connecting two
external pads to shorten
septolateral dimension
of LV and mitral annulus
5th Annual Heart Failure
Convention March 08 GSM
Myocor Surgical Coapsys System
Surgical Approaches
to Heart Failure
HFSA 2010 Recommendations
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
Lindenfeld J, et al. HFSA 2010 Comprehensive
Heart Failure Guideline. J Card Fail 2010;16:e1-e194.
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
Lindenfeld J, et al. HFSA 2010 Comprehensive
Heart Failure Guideline. J Card Fail 2010;16:e1-e194.
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
Lindenfeld J, et al. HFSA 2010 Comprehensive
Heart Failure Guideline. J Card Fail 2010;16:e1-e194.
HFSA 2010 Practice Guideline
Surgery
Recommendation 10.4
“Batista Procedure”
Partial left ventricular resection
is not recommended in nonischemic
cardiomyopathy.
Strength of Evidence = B
Lindenfeld J, et al. HFSA 2010 Comprehensive
Heart Failure Guideline. J Card Fail 2010;16:e1-e194.
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
Lindenfeld J, et al. HFSA 2010 Comprehensive
Heart Failure Guideline. J Card Fail 2010;16:e1-e194.
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
Lindenfeld J, et al. HFSA 2010 Comprehensive
Heart Failure Guideline. J Card Fail 2010;16:e1-e194.
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
Lindenfeld J, et al. HFSA 2010 Comprehensive
Heart Failure Guideline. J Card Fail 2010;16:e1-e194.
The Role Of INTERMACS
in Patient Selection
LongerUse
Term
Forfor
Extended
/
DurableCirculatory Support
Mechanical
Lynne Warner Stevenson
Investigational indications will be
discussed
No conflicts related to MCS
INTERMACS: Patient Selection
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
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 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 5
Exertion Tolerant
4
“Housebound”
Weeks to months
LEVEL 6
Exercise Limited
3
“Walking wounded”
Months, if nutrition
and activity
maintained
INTERMACS
Advance 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 Transplantation
Volume 31, Issue 2, Pages 117-126 (February 2012)
DOI: 10.1016/j.healun.2011.12.001
Copyright © 2012 Terms and Conditions
Figure 4
Source: The Journal of Heart and Lung Transplantation 2012; 31:117-126 (DOI:10.1016/j.healun.2011.12.001 )
Copyright © 2012 Terms and Conditions
Figure 10
Source: The Journal of Heart and Lung Transplantation 2012; 31:117-126 (DOI:10.1016/j.healun.2011.12.001 )
Copyright © 2012 Terms and Conditions
Device Strategy
1. Bridge to Recovery (BTR)
2. Bridge to “Decision”
3. Bridge to a Bridge
4. Bridge to Transplant (BTT)
5. Destination Therapy
6. 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
Contemporary Outcomes With the HeartMate II® LVAS
David J. Farrar, PhD
Vice President, Research and Scientific Affairs
Thoratec Corporation
J138-0711
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
Percutaneous
Lead
Controller
Batteries
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
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.
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
Stage D : Refractory HF
Therapy
•
•
•
•
All Stage A, B and C
Mechanical assist devices
Heart transplantation
Continuous IV inotropic
infusion for palliation
Is Device
Therapy
• Hospice
care 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. 2537 January 2007
ICD CRT in the Philippines
54
60
50
38
40
32
Total
Series1 ICD
CRT
2007-2011
30
20
17
18
2007
1
2008
2
10
0
2009
3
2010
4
2011
5
DESCRIPTION
ICD (Single)
ICD (Dual)
CRTD
Unit Price
600,000
750,000
1,000,000
Over 40,000 TAVI as of Nov 2011
First procedure by Alain Cribier in
France 2002
Transcatheter Aortic Valve Implantation TAVI Devices
Transfemoral
TAVI
$ 25,000 ~ P1M
for device only
Transapical TAVI
EVAR
TEVAR
$12,000 ~ P 500,000
For Device
CentriMag®
System Components
Pump
$10,500 ~ P 590,000
For Patient Device
Motor
Console
$70,000 ~ P 3.9M
For Hospital
HEART TRANSPLANTATION
Overall
ISHLT
2011
J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
NUMBER OF HEART TRANSPLANTS
REPORTED BY YEAR
5000
4000
Other
Europe
North America
3500
3000
2500
2000
1500
1000
500
0
19
82
19
83
19
8
19 4
85
19
86
19
87
19
88
19
8
19 9
90
19
91
19
92
19
93
19
94
19
9
19 5
96
19
97
19
98
19
99
20
00
20
0
20 1
02
20
03
20
04
20
05
20
0
20 6
07
20
08
20
09
Number of Transplants
4500
ISHLT
2011
J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
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)
100
1982-1991 vs. 1992-2001: p = 0.8460
1982-1991 vs. 2002-6/2009: p < 0.0001
1992-2001 vs. 2002-6/2009: p < 0.0001
Survival (%)
80
60
1982-1991 (N=20,504)
40
1992-2001 (N=36,879)
2002-6/2009 (N=22,477)
20
HALF-LIFE 1982-1991: 10.2 years; 1992-2001: 10.7 years; 2002-6/2009: NA
0
0
1
2
ISHLT
3
4
5
6
7
8
Years
2011
J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
9
10
11
12
13
14
15
ADULT HEART RECIPIENTS
Cross-Sectional Analysis
Functional Status of Surviving Recipients
(Follow-ups: 1995 - June 2010)
100%
80%
60%
40%
20%
No Activity Limitations
Performs with Some Assistance
Requires Total Assistance
0%
1 Year (N = 16,087)
ISHLT
3 Years (N = 14,235)
2011
J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
5 Years (N = 12,181)
ADULT HEART RECIPIENTS
Employment Status of Surviving Recipients
Age at Follow-up: 25-55 Years
(Follow-ups: 1995 - June 2010)
100%
80%
Retired
Not Working
60%
Working Part Time
40%
Working Full Time
Working (FT/PT
status unknown)
20%
0%
1 Year (N = 9,115)
ISHLT
3 Year (N = 6,967)
5 Year (N = 5,163)
2011
J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
ADULT HEART RECIPIENTS
Rehospitalization Post-transplant of Surviving Recipients
(Follow-ups: 1995 - June 2010)
100%
80%
60%
40%
20%
No Hospitalization
Hospitalized: Rejection Only
Hospitalized: Rejection + Infection
Hospitalized: Not Rejection/Not Infection
Hospitalized: Infection Only
0%
Up to 1 Year
Between 2 and 3 Years
(N = 26,546)
(N = 22,651)
ISHLT
2011
J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132
Between 4 and 5 Years
(N = 19,481)
Global Burden of Heart Disease
Global Burden of Heart Disease
Focused on Prevention & Risk Modification
o genetic susceptibility
o marked environmental changes usually secondary to
• urbanization
• increasing affluence
• influences from early childhood to adulthood.
Individual Burden of Heart Failure
Direct Costs of Care
o
Inpatient : Frequent Re-hospitalization
o
Rehabilitation
o
Follow-up care
o
Cost of Devices
Indirect Costs
o
Loss of employment
o
“Medicare” benefits
o
Family expenses
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
We need to stop condemning our
Stage D Heart Failure patients…
…and conquer the last frontiers of
Philippine cardiology...
THANK YOU