ACD Heart failure - biventricular pacing (cardiac resynchronisation)

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1 Mr Christopher Feinmann Project Manager NICE Mid-City Place 71 High Holborn London WC1V 6NA 18 December 2006 Dear Mr Feinmann Re: NICE Appraisal Consultation Document: Cardiac resynchronisation therapy for the treatment of heart failure We would like to thank you for giving the opportunity to review and comment on the above Appraisal Consultation Document (ACD), issued in November Having reviewed the ACD we are concerned with the interpretation of the clinical evidence as we believe this may lead to inappropriate recommendations particularly relating to the use of CRT-D and the impact this is likely to have on the guidance relating to the mix between CRT-D and CRT-P., as an active member of the ABHI CRM SIS group, has contributed to and fully endorses the industry submission dated 18 December We would, however, like to highlight and reinforce the following points, which cause us particular concern. The Appraisal Committee states that this guidance should be read in conjunction with the guidance on the use of implantable cardioverter defibrillators (ICDs) for the treatment of arrhythmias (NICE technology appraisal guidance 95). It is therefore assumed that patients fulfilling the criteria for ICD therapy and CRT should receive a CRT-D. This assumption is in line with the European Society of Cardiology (ESC) guidelines for HF patient selection for device therapy.

2 However it appears that the guidance in this ACD is not consistent with this assumption and could therefore lead to a situation in which a patient qualifies for a CRT-P and an ICD but does not qualify for a CRT-D. Clearly such a situation is not acceptable as it would be unethical or not cost-effective to pursue such a strategy. It is assumed the Appraisal Committee will want to rectify the guidance to eliminate this anomaly. The table below highlights those aspects of the guidance where this contradiction appears to exist: History of MI (more than 4 weeks) with NYHA III and LVEF <35% and Non sustained VT on Holter, inducible on EP testing History of MI (more than 4 weeks) with NYHA III and LVEF <30% and QRS >120ms CRT ACD CRT-D NO NO NICE TA95 ICDs YES YES The appraisal committee agrees that CRT-D provides an incremental mortality benefit over CRT-P. The MERIT HF study has shown that SCD is the mode of death for HF patients in NYHA III in 59% of cases.

3 The results of COMPANION taken together with those of CARE-HF demonstrate unequivocal benefit for CRT in NYHA class III and IV HF patients with QRS >150 ms or QRS >120 ms plus dyssynchrony. It is also worth pointing out that in COMPANION, 36% of the deaths in the CRT- P arm were sudden, very similar to the 35% in the CARE-HF study. In the absence of ICD back-up, both studies showed that despite the evident benefits of CRT-P therapy, one-third of the fatalities were attributable to sudden cardiac death. The CRT-D arm of the COMPANION trial reduced the SCD incidence to 16%, a 55% relative risk reduction. According to COMPANION, CARE-HF and CARE-HF extended, CRT-P reduces both the overall mortality and SCD. However, more than one-third of the deaths were still due to SCD. Evidence from COMPANION and the ICD studies: MADIT II and SCD-HeFT, indicates that CRT- D reduces both overall mortality and SCD. With CRT-D providing an additional gain compared to CRT-P. Salukhe et al. (2004) analysed 8 published ICD trials to estimate the cumulative benefits in life-years. They found that the number of life years gained from an ICD increased non-linearly with the length of follow-up. The authors concluded that benefit rises with the square of time. Thus, the benefits from CRT-D in terms of life-years gained may be underestimated.

4 It is stated in the ACD that the Committee heard that a CRT-P device would be appropriate for 90% of heart failure patients with electrical dyssynchrony who do not have additional risk factors for SCD. With the remaining 10% of patients with heart failure and electrical dyssynchrony who present with additional risk factors for SCD, the addition of a defibrillator function (CRT-D) would be beneficial. This statement is potentially very misleading as it can be interpreted in a number of ways. If a heart failure patient with electrical dyssynchrony presents with no SCD risk factors then such a patient should receive a CRT-P. However if the suggestion is that of all HF patients with electrical dyssynchrony (and who qualify for device therapy) only 10% of these patients would present with SCD risk factors. There is currently no evidence to support this supposition. On the contrary, adoption of CRT-D based primarily on clinical evidence already accounts for the majority of CRT implants in England and Wales. As previously mentioned, the MERIT HF trial shows that the mode of death in HF patients due to SCD is greater than 60%. Data reported in this ACD from the England and Wales indicates that in 2004 the actual split between CRT-P and CRT-D was 42% to 58%. The estimate for CRT-D usage in Europe was 66% of total CRT implants. It should be noted that CRT-D adoption in some European countries is already at 80% of the total CRT mix. Such an underestimation based purely on opinion would clearly have a dramatic impact on the budget impact analysis and we strongly urge the Committee to reconsider the guidance in this respect. Finally, we would like to thank you in advance for your consideration of our position and for allowing the opportunity to comment on the ACD report.

5 Yours sincerely Mark McIntyre Public Affairs Director UK & Ireland Mobile: