[CRT-FORUM] 50E Non-responders. Dr. Schapachnik

[CRT-INFO]

Dear colleagues,
The last message by Dr. Levine was accompanied by an attached file that
illustrated his text. For some technical reason, the file were not 
distributed.
Those of you that wish to receive it, may pick them up over the next five
days at the following address:

http://www.grupoakros.com.ar/upload/files/90941103138/Dr._Levine.pdf

Best regards,

Edgardo

> 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