[CRT-FORUM] 48E Non-responders. Dr. Levine

[CRT-INFO]

Dear Dr. Sham’a,

You are asking a question that is on the minds of Heart Failure and 
Implanting physicians around the world.  In that every procedure may be 
associated with complications and implantation of a CRT system is 
complicated, often challenging, definitely expensive even in the United 
States but more so in parts of the world where the patient/family must 
pay for the implanted devices and the patients and family pin all their 
hopes on this being the answer to their inexorable downward spiral, we 
would certainly like to implant these devices in patients who we know 
will respond and not waste the resources (financial, medical as well as 
emotional) for those patients who we can prove will not respond.  We are 
still waiting for the crystal ball.  The best we can do is use clinical 
judgment based on the multiple studies that are being published even 
though there may be some conflicts between the different studies.

Our non-invasive colleagues have been trying to develop a single 
technique to accomplish this pre-op assessment but as one follows the 
literature, no "gold standard" has emerged.  The tests used as both a 
screening tool and monitoring tool for system effectiveness vary from 
study to study.  Some use the Velocity Time Integral in the LV outflow 
tract or aortic root, others use temporal delay between RV and LV 
outflow, others use mitral inflow, others use tissue-Doppler imaging 
while other clinicians use echo-strain and there are still other 
techniques. A few years ago, I was intrigued and excited by the studies 
of Pitzallis and colleagues from Italy looking a Septal Posterior Wall 
Motion Delay (SPWMD) and they reported superb results in identifying 
dyssynchrony with a standard 2D transthoracic echo system that is 
commonly available.  Unfortunately, other investigators have not been 
able to reproduce those results and even in the authors’ papers, some of 
the patients who should not have responded based on the SPWMD 
measurement had a good response while others who had a marked 
discrepancy between the contractions of the two walls had a poor 
response. I have attached my review of the two articles published by Dr. 
Pitzallis and colleagues, the first in 2002 with a follow-up article in 
2005.

The February 24, 2009 issue of Circulation has both an article and an 
accompanying editorial on an updated analysis of the COMPANION data with 
respect to hospitalizations.  COMPANION was a study sponsored by Boston 
Scientific comparing optimal pharmacologic therapy to CRT-P and to 
CRT-D.   The patients who were randomized to the device groups also had 
optimal pharmacologic therapy.  The editorial is by Dr. Clyde Yancy, one 
of the leaders in heart failure management in the United States and 
President-elect of the American Heart Association.   Dr. Yancy concludes 
that for all the negatives (the cost of the device, a surgical procedure 
to implant it…) “it appears evident that greater use of device-based 
therapy for heart failure is warranted.”  He points out that the AHA/ACC 
guidelines for both heart failure (2005) and device implantation (2008) 
now list CRT as a Class I indication with level of evidence A 
(well-designed randomized prospective trials).  He goes on to conclude 
that “even in the absence of a more refined patient selection 
(acknowledging the incidence of non-responders) algorithm, further 
hesitancy in the update of this therapy appears unwarranted. 
Evidence-based, guideline-indicated therapies for heart failure that 
offer the potential to positively impact the natural history of this 
disease should be used, used avidly and used equitably.”  (the last 
comment referring to an apparent bias in that women and minorities do 
not receive these devices in the same proportion as caucasian males).

The specific references are:
Yancy CW, Filardo G, Cardiac Resynchronization Therapy for Heart 
Failure: Has the Time Come?  Circulation 2009; 119: 916-918 
[10.1161/CIRCULATIONAHA.108.834390 ISSN: 0009-7322]

·          Anand IS, Carson P, Galle E, et al, Cardiac Resynchronization 
Therapy reduces the risk of hospitalization in patients with advanced 
heart failure, Results from the Comparison of Medical Therapy, Pacing 
and Defibrillation in Heart Failure (COMPANION) trial, Circulation 2009; 
119: 969-977.  [DOI: 10.1161/CIRCULATIONAHA.108.793273 ISSN: 0009-7322]

For everything we have learned and cardiac resynchronization therapy 
moving up from a Class III (non-indication) in the 1988 Guidelines to 
Class II and more recently, a Class I indication with level of evidence 
A, we still do not have a fool-proof means for identifying who will and 
who will not respond.

Paul A. Levine MD, FHRS, FACC, CCDS
Vice President, Medical Services
St. Jude Medical CRMD
Tel: 1-818-493-2900 Fax: 1-818-362-2242
plevine at sjm.com
Clinical Professor of Medicine, Loma Linda University
Clinical Associate Professor of Medicine, UCLA

> Dear Colleagues and teachers
>
> Dearest Prof Pérez Riera and Prof Levine
>
> Greetings
>
> CRT represent a state-of-art therapy for patients with advanced heart
> failure maintained on optimal medical therapy and have 
> electrocardiographic
> evidence of dyssynchrony. This therapy sometimes complicated by rapid
> clinical deterioration which may lead to SCD, frequent hospitalization,
> decreased in NYHA functional class or worsening of quality of life score.
> These patients are considered as non-responders, but the reality that 
> these patient are "worse than non-responders" as they deteriorated.
> Do we have any predictors for this group of patients which may help in
> avoiding implantation of such patients? This may help in decreasing the
> percentage of non-responders.
>
> Warm Regards
>
> Raed Abu Sham'a, MD
> Palestine
>
>


-- 
Dr. Sergio Dubner
President of Scientific Committee

Dr. Edgardo Schapachnik
President of Steering Committee