Transcript Cardiac Resynchronization Therapy for HF - 2002

Congestive Heart Failure: Update 2002
Bruce D. Hettleman, MD
DHMC
December 2, 2002
CASE PRESENTATION
• 71 yo retired submarine captain is admitted with
pulmonary edema and an elevated troponin. His
PMH is notable for advanced CAD and previous MI.
He had CABGX3 in 1990.
• Echo demonstrated a severely dilated LV with an EF
of 20% and 3+/4 mitral regurgitation.
• EKG showed sinus rhythm at 52 with first degree AV
block and LBBB.
• Cardiac Cath revealed a patent IMA to the LAD,
patent SVG to the RCA and a severely diseased
SVG to the circumflex.
What should be done once the patient is
initially stabilized?
• 1. Perform urgent repeat bypass surgery and mitral
valve replacement.
• 2.Perform percutaneous intervention (stent) on the
SVG to the circumflex.
• 3. Put in a dual chamber pacemaker
• 4.Maximize medical therapy because he is too high
a risk for revascularization.
Case Presentation--Continued
• After stenting the SVG to the circumflex his
pulmonary edema subsequently responded to
medical therapy and he was able to ambulate but
remained Class III CHF.
• Discharge medications consisted of a
diuretic,digoxin, beta blocker, ace inhibitor, aspirin,
plavix and spironolactone.
• He was given dietary and weight-based diuretic
adjustment guidelines.
• Follow-up in CHF Clinic was scheduled for 1 month.
What is the most likely adverse event after
adding aldactone in the treatment of CHF?
• 1. Hypotension
• 2. Breast enlargement
• 3. Yellow vision
• 4. Hyperkalemia
• 5. Worsening CHF
After starting aldactone in Class IV CHF,
when should electrolytes be rechecked?
• 1. No worries, mate
• 2. One week ( big worries, mate)
• 3. Four weeks
• 4. Three months
Potassium Level
8
7
6
5
4
Potassium
3
2
1
0
JNRY 15
JNRY 25
20-Feb
1-Apr
Drugs that have shown to prolong life in CHF
are:
• 1. ACE inhibitors
• 2. Beta Blockers
• 3. Digoxin
• 4. Aldactone
• 5. 1,2 and 4
DIG Trial: Effect of Digoxin on Survival in CHF
• NHLBI sponsored study of 7,788 patients with
class II and III CHF and LVEFs
< 45% or >
45%
• Randomized, controlled, double-blinded
• 93% of patients on ACEIs
• Superimposable survival curves
• 25% reduction with Dig on first CHF
hospitalization
Weight of Evidence: ACE Inhibitors
Approximately 7000 patients evaluated in long-term
placebo-controlled clinical trials
Improvement in cardiac function, symptoms, and
clinical status; equivocal effects on exercise tolerance
Decrease in all-cause mortality by 20%-25% (P<.001) and
decrease in combined risk of death and hospitalization
by 30%-35% (P<.001)
- Effect shown in SOLVD Treatment, CONSENSUS, and
V-HeFT II trials
Garg and Yusuf, 1995.
Weight of Evidence: -Blockade
Traditionally contraindicated in heart failure, due
to impaired inotropy, early lack of tolerability, and
worsening heart failure
Over 10,000 patients have now been evaluated in
long-term placebo-controlled clinical trials;
Improvement in cardiac function and NYHA class;
and decrease in mortality and morbidity shown in
multiple clinical trials
Effects shown in patients already receiving ACE
inhibitors
Improved survival with aldactone in advanced
CHF--Rales Trial
Will a permanent pacemaker help this man?
• 1. No, he has no indication for a pacemaker and if
you put one in medicare will send you the bill.
• 2. Yes, he should have a VVI back up pacemaker
prior to discharge because he has LBBB and may
unpredictably develop complete heart block and die.
• 3. Yes, the placement of a routine DDD pacemaker
will reliably improve his hemodynamics
• 4.Yes, he ought to have a brand-spankin new
biventricular resynchronization device because he
has LBBB.
Cardiac Resynchronization
Therapy for Heart Failure
Mechanisms, Clinical Outcomes,
Patient Selection, and Implant
Ventricular Dysynchrony and Cardiac
Resynchronization
• Ventricular Dysynchrony1
– Electrical: Inter- or
Intraventricular conduction delays typically manifested as left bundle
branch block
– Structural: disruption of myocardial collagen matrix impairing electrical
conduction and mechanical efficiency
– Mechanical: Regional wall motion abnormalities with increased workload
and stress—compromising ventricular mechanics
• Cardiac Resynchronization
– Therapeutic intent of atrial synchronized biventricular pacing
• Modification of interventricular, intraventricular, and atrial-ventricular
activation sequences in patients with ventricular dysynchrony
• Complement to optimal medical therapy
1
Tavazzi L. Eur Heart J 2000;21:1211-1214
Animation – Ventricular Dysynchrony
Click to Start/Stop
Cardiac Resynchronization
Click to Start/Stop
Clinical Consequences of
Ventricular Dysynchrony
• Abnormal
interventricular
septal wall motion1
• Reduced dP/dt3,4
• Reduced pulse
pressure4
• Reduced EF and
CO4
• Reduced diastolic
filling time1,2,4
• Prolonged MR
duration1,2,4
1
Grines CL, Bashore TM, Boudoulas H, et al. Circulation 1989;79:845-853.
HB, Lee CH, Gibson DG. Br Heart J 1991;66:443-447.
3 Xiao HB, Brecker SJD, Gibson DG. Br Heart J 1992;68:403-407.
4 Yu C-M, Chau E, Sanderson JE, et al. Circulation. 2002;105:438-445.
2 Xiao,
Proposed Mechanisms: Improved
Intraventricular Synchrony
Improved Intraventricular
Synchrony1,2
 dP/dt 1,3,4 EF1,5
 Pulse Pressure 3,4  SV&CO1, 2
 LVESV1
1 Yu
 MR1
 LA
Pressure1
C-M, Chau E, Sanderson J, et al. Circulation 2002;105:438-445
P, Kim W, Jensen H, et al. Cardiology 2001;95:173-182
3 Kass D Chen-Huan C, Curry C, et al. Circulation 1999;99:1567-73
4 Auricchio A, Ding J, Spinelli J, et al. J Am Coll Cardiol 2002;39:1163-1169
5 Stellbrink C, Breithardt O, Franke A, et al. J Am Coll Cardiol 2001;38:1957- 65
2 Søgaard
Prevalence of Inter- or Intraventricular
Conduction Delay
General HF Population1,2
Moderate to Severe
HF Population3,4,5
IVCD >30%
IVCD 15%
1
2
3
4
5
Havranek E, Masoudi F, Westfall K, et al. Am Heart J 2002;143:412-417
Shenkman H, McKinnon J, Khandelwal A, et al. Circulation 2000;102(18 Suppl II): abstract 2293
Schoeller R, Andresen D, Buttner P, et al. Am J Cardiol. 1993;71:720-726
Aaronson K, Schwartz J, Chen T, et al. Circulation 1997;95:2660-2667
Farwell D, Patel N, Hall A, et al. Eur Heart J 2000;21:1246-1250
Increased Mortality Rate with LBBB
• Risk remains significant
even after adjusting for
age, underlying cardiac
disease, indicators of
HF severity, and HF
medications
* HR = Hazard Ratio
All patients N=5517
20
HR* 1.70
(1.41-2.05)
1-Year Mortality (%)
• Increased 1-year
mortality with presence
of complete LBBB
(QRS > 140 ms)
LBBB N=1391
16.1
15
11.9
HR * 1.58
(1.21-2.06)
10
7.3
5
5.5
0
All Cause
Sudden Cardiac
Cause of Death
Baldasseroni S, Opasich C, Gorini M, et al. Am Heart J 2002;143:398-405
Proposed Mechanisms of
Cardiac Resynchronization
Cardiac Resynchronization
Improved Intraventricular
Synchrony
Improved Atrioventricular
Synchrony
Yu C-M, Chau E, Sanderson J, et al. Circulation 2002;105:438-445
Improved Interventricular
Synchrony
Summary of Proposed Mechanisms
Cardiac Resynchronization
Intraventricular
Synchrony
 dP/dt,  EF,  CO
( Pulse Pressure)
 LVESV
Atrioventricular
Synchrony
 MR
 LA
Pressure
 LV Diastolic
Filling
 LVEDV
Reverse Remodeling
Yu C-M, Chau E, Sanderson J, et al. Circulation 2002;105:438-445
Interventricular
Synchrony
 RV Stroke
Volume
Achieving Cardiac Resynchronization
Mechanical Goal: Atrial-synchronized bi-ventricular pacing
• Transvenous Approach
– Standard pacing lead in RA
– Standard pacing or defibrillation lead in RV
– Specially designed left heart lead placed in a left ventricular
cardiac vein via the coronary sinus
Right Atrial
Lead
Right Ventricular
Lead
Left Ventricular
Lead
CRT Improves Quality of Life Score and
NYHA Functional Class
QoL
NYHA
PATH-CHF1 (n=41)
+
+
InSync (Europe)2 (n=103)
+
+
InSync ICD (Europe)3 (n=84)
+
+
MUSTIC4 (n=67)
+
MIRACLE5 (n=453)
+
+
MIRACLE ICD6 (n=364)
+
+
+

Blank
1 Auricchio
Statistically significant improvement with CRT (p  0.05)
Not statistically significant or No statistical analysis performed on data
Indicates test neither performed nor reported
A. Stellbrink C, Sack S., et al. J Am Coll Cardiol 2002;39:2026-
2033
Gras D, Leclercq C, Tang A, et al. Eur J Heart Failure 2002;4:311-320
3 Kuhlkamp V. JACC 2002;39:790-797
4 Linde C, Leclercq C, Rex S, et al. J Am Coll Cardiol 2002;40:111-118
2
5 Abraham
W, Fisher W, Smith A, et al.
N Engl J Med. 2002;346:1845-1853
6 Leon A. NASPE Scientific Sessions – Late Breaking
Clinical Trials. May 2002; Medtronic Inc. data on file
CRT Improves Exercise Capacity
6 Min Walk
Peak VO2
PATH-CHF1 (n=41)
+
+
InSync (Europe)2 (n=103)
+
InSync ICD (Europe)3 (n=84)
+
MUSTIC4 (n=67)
+

MIRACLE5 (n=453)
+
+
+

+
+
MIRACLE ICD6 (n=364)
+

Blank
1 Auricchio
Statistically significant improvement with CRT (p  0.05)
Not statistically significant or No statistical analysis performed on data
Indicates test neither performed nor reported
A. Stellbrink C, Sack S., et al. J Am Coll Cardiol 2002;39:2026-
2033
Gras D, Leclercq C, Tang A, et al. Eur J Heart Failure 2002;4:311-320
3 Kuhlkamp V. JACC 2002;39:790-797
4 Linde C, Leclercq C, Rex S, et al. J Am Coll Cardiol 2002;40:111-118
2
Exercise
Time
5 Abraham
W, Fisher W, Smith A, et al.
N Engl J Med. 2002;346:1845-1853
6 Leon A. NASPE Scientific Sessions – Late Breaking
Clinical Trials. May 2002; Medtronic Inc., data on file
CRT Improves Cardiac Function/Structure
LVEF
MR
PATH-CHF1 (n=41)
+ LVEDP
+ LV dP/dtmax
InSync (Europe)2 (n=103)
+
InSync ICD (Europe)3 (n=84)
MUSTIC4 (n=67)
+


 LVEDD,LVESD
 Filling Time
MIRACLE5 (n=453)
+
+
+ LVEDD,
+ LVEDV, LVESV
MIRACLE ICD6 (n=362)

+
+ LVESV,
+ LVEDV
+

Blank
1 Auricchio
+ Filling Time
+ Filling Time
Statistically significant improvement with CRT (p  0.05)
Not statistically significant or No statistical analysis performed on data
Indicates test neither performed nor reported
A. Stellbrink C, Sack S., et al. J Am Coll Cardiol 2002;39:2026-
2033
Gras D, Leclercq C, Tang A, et al. Eur J Heart Failure 2002;4:311-320
3 Kuhlkamp V. JACC 2002;39:790-797
4 Linde C, Leclercq C, Rex S, et al. J Am Coll Cardiol 2002;40:111-118
2
Other
5 Abraham
W, Fisher W, Smith A, et al.
N Engl J Med. 2002;346:1845-1853
6 Young J. ACC Scientific Sessions – Late Breaking
Clinical Trials III. March 2002; Medtronic Inc.,
data on file
Cardiac Resynchronization Outcomes
Sustained for at least 12 months
NYHA
QoL
6 Minute
Peak VO2
Walk
InSync European
and Canadian Study1
+
(n=67, followed to 12 months)
+
+
PATH-CHF Study2
+
(n=29, followed to 12 months)
+
+
+
+
+
+
MUSTIC Study3
(n=42 in sinus rhythm group,
n=33 in atrial fibrillation group
followed to 12 months)
+

Blank
1
Statistically significant improvement with CRT (p  0.05)
No statistically significant improvement with CRT
Indicates test neither performed nor reported
Gras D, Leclercq C, Tang A, et al. Eur J Heart Fail 2002;4:311-320
A. Stellbrink C, Sack S., et al. J Am Coll Cardiol 2002;39:2026-2033
3 Linde C, Leclercq C, Rex S, et al. J Am Coll Cardiol 2002;40:111-118
2 Auricchio

Step 1: Cannulate CS
Attain LDS Model 6216A
• Use extreme care when passing the
guide catheter through vessels
• Due to the relative stiffness of the
catheter, damage to the walls of the
vessels may include dissections or
perforations
Step 2: Perform Venograms
Varying Patient Anatomy 1,2,3
1. Potkin et al. Am J Cardiol 1987;60:1418-1421
2. Neri et al. Europace 2000;I :D95 Abstract 88/2
3. Hill et al. Europace 2000;I:D238 Abstract 167/2
Photos Courtesy of Dr. Daniel Gras
Step 2: Perform Venograms
Great
CS Os
Middle
Posterior
Postero-lateral
Anterolateral
Lateral
Anterior
Cardiac Venous Anatomy
Step 2: Perform Venograms
Lead in Lateral Cardiac Vein
Step 4: Place Lead
Attain OTW Model 4193
Click to Start/Stop
Step 4: Place Lead
Attain OTW Model 4193
Courtesy of
Dr. Daniel Gras
Click to Start/Stop
LAO View:
Tracking Over the Wire
Courtesy of
Dr. Daniel Gras
Click to Start/Stop
Step 4: Place Leads
Attain LV Model 2187
Video compliments of
Dr. Vince Paul
Click to Start/Stop
Biventricular Pacing is indicated for the
reduction of CHF symptoms in patients with:
• 1. Stable Class III-IV CHF
• 2. QRS> 130 ms
• 3.EF <35%
• 4. Optimal medical therapy