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Dr. Maurizio Gasparini UO Elettrofisiologia ed Elettrostimolazione

ADVANCES IN CRT What Is The Patient Profile Who Can Benefit from CRT-P only?. Progressi nella CRT Quale è il profilo del paziente che può beneficiare della sola CRT ?. Dr. Maurizio Gasparini UO Elettrofisiologia ed Elettrostimolazione Istituto Clinico Humanitas , IRCCS, Rozzano-Milano.

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Dr. Maurizio Gasparini UO Elettrofisiologia ed Elettrostimolazione

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  1. ADVANCES IN CRT What Is The Patient Profile Who Can Benefit from CRT-P only? Progressi nella CRT Quale è il profilo del paziente che può beneficiare della sola CRT ? • Dr. Maurizio Gasparini • UO Elettrofisiologia ed Elettrostimolazione • Istituto Clinico Humanitas, IRCCS, Rozzano-Milano

  2. Eur Heart J 2007; 28: 2256-95 Cardiac resynchronization therapy guidelines published for the first time in 2007 …

  3. Few months later , American GL published…

  4. NYHA III-IV pts on OPT LV EF < 35% Sinus rhythm QRS ≥ 120 msec Thank you for your attention  So very simple and clear indications for CRT-P in HF patients !

  5. However reading carefully….

  6. The ESC and AHA/ACC/HRS Guidelines on indications for device therapy do not clearly indicate which patients are candidates toCRT-P only • Solved dilemma by recent HF Guidelines ??!!

  7. …Once again

  8. On the other hand,following GL in the clinical practice, it is mandatory to control if in the same field (i.e. ICD therapy) some other guidelines exist: ICD therapy has been demonstrated to be particularly effective in preventing sudden cardiac death (SD) and thus reducing total mortality : in primary as well as in secondary prevention  in patients withseverely compromised left ventricular function  regardless of underlyingetiology… as clearly demonstrated by several studies

  9. MADIT II Post-MI, FE ≤ 30%, any NYHA ICD  mortality by31% DEFINITE Non isch DCM; NYHA I/III; EF ≤ 36%;ICD  mortality by35% NEJM 2002; 346 (12); 877-83 NEJM 2004;350:2151-8 NEJM 2004;350:2140-50 NEJM 2005;352:225-37 COMPANION Isch/non EF ≤ 35%; NYHA III- IV; CRT-D mortality by36% SCD-HeFT Isch/non isch;EF ≤ 35%; NYHAII-III ICD  mortality by23% ICD decreases total mortality in pts with systolic dysfunction of any etiology regardless NYHA functional class

  10. How to combine both these 2 statements?

  11. 85% of CRT candidates are in NYHA III !!

  12. Long-term follow up after cardiac resynchronization therapy: poor clinical outcome in patients enrolled in advanced NYHA class IV Maurizio Gasparini Istituto Clinico Humanitas - Rozzano, Milano (Italy) Presented at AHA Congress 2003 Published on theHeart.org

  13. 268 consecutive CRT pts • October 1999 / July 2003 NYHA II: 34 pts (13%) NYHA III: 194 pts (72%) NYHA IV: 40 pts (15%)

  14. .04 .01 .001 Total mortality rate according to NYHA class at baseline m.r. 0% m.r. 5.7% m.r. 16.6% H.R. 3-4 = 1.7 H.R. 2-4 = 4.5 Log rank p= .002

  15. NYHA IV pt into details : NYHA IV: 40 pts 7 pts IV advanced 33 pts IV No ev amine No mechanical ventilation 4 ev amine + mech. vent 3 ev amine no mech. vent deaths :3/33 deaths :5/7

  16. .02 ns ns All p= .00001 Cardiac mortality rate according to NYHA class at baseline m.r. 0% m.r. 4.7% m.r. 7.8% Log rank p= .00001 m.r. 80.8% • Non advancedNYHA IV survival rate:similar to NYHA III !!

  17.  So ambulatory NYHA IV behaviour is like NYHA III patients Which pts are candidates to CRT-P only ??

  18. Which data in the literature? Care HF CRT-P  37% mortality with respect to OPT Clealand NEJM 2005 COMPANION: Risk of secondary endpoint death from any cause  24 % CRT (p=0.059) vs OPT  36 % CRT-D (p=0.003) vs OPT Bristow NEJM2004

  19. 120primaryprevention 71 secondary prevention Inclusion criteria : NYHA III-IV, EF< 35%, QRS > 120 191 pts CRT-D • Results ( fu:2 yrs): • at least 1 appropriate therapy 21% primary prevention 35% secondary prevention • No predictors

  20. MILOS STUDY 4 European Centers 1303 pts All cause mortality reduction  by 17% Sudden death reduction  by 96%

  21. Data from metanalisis Further 9% of mortality reduction with CRT-D!!! CRT-D with respect to OPT  mortality by 43% CRT-P with respect to OPT  mortality by 34% ICD with respect to OPT  mortality by 31%

  22. IB IA IA even in the upcoming European GL

  23. Progressive dramatic increase in % of CRT-D in Europe !! CRT-D allows all cause mortality reduction  by 17% Which is the behaviour in real world ? 1303 pts

  24. CRT-P Similar behaviour in USA (small rate of CRT-P implant with respect to CRT-D)

  25. If ICD back up seems reasonable… we should consider the possibility of…. • No major technical differences between CRT and CRT D implantation disadvantages of CRT-D systems in CRT candidates • Aside from costs considerations 1) No significant increased risk of complications (implant - related) 2) No significant increased complications during follow up

  26. 1 aComplications(COMPANION trial, Bristow et al., NEJM 2004) Absolutely no differences in severe implant-related adverse events between device type adverse events are mainly associated to LV lead positioning...

  27. 2) DFT can be safely delayed • 1 b Complications related to defibrillation testing (DT) 1) DFT can be avoided

  28. The CARE-HF & CARE-HF extension phase data So…at this point … which arguments for not associate ICD function to CRT-P? It has been postulated that CRT-P per se  mortality due to sudden death……especially in the “long term” f.u.

  29. Scissors CRT-P / OPT at 240 days Scissors CRT-D /CRT at 120-240 days • Does CRT-P really  sudden death ? Companion COMPANION - Bristow NEJM 2004;350:2140-50

  30. Care HF Mean f.u. = 29,4 months CRT-P diverges from OPT only at 240 days !! NEJM 2005;352:1539-49

  31. COMPANION: same behaviour of CRT-P of CARE-HF !!!! COMPANION - Bristow NEJM2004 Between day 120 and 240 gg CRT-D begins to saves lifes…… Clealend NEJM 2005

  32. The identical behaviour is based on the typical temporal pattern of the“reverse remodeling”process conferred by CRT… SR AF + AVJ Ablation AF no AVJ Ablation Baseline 6 12 24 36 48 mos Baseline 6 12 24 36 48 mos (Gasparini et al., JACC 2006)

  33. 2 different studies with SAME CRT-P curve behaviour 1/3 pts die for SD in CRT-P -with SAME SD % in CRT-P SD in HF patients treated with CRT-P Mode of death in CRT-P COMPANION Other 32% CHF Sudden 47% death 21% OPT CRT-P Other 22% CHF Sudden 45% death 32% CARE-HF

  34. COMPANION Would you take the CRT leap… 6 mos With a parachute (ICD) or without a parachute… SCD in HF patients treated with CRT • What about the earlier phases of CRT when reverse remodeling has still to take place? • Would it be worthwhile to stratify arrhythmic risk? • (“ethical” issue this day and age) 2) Simply implant a CRT-D system !! • Benefits from ICD back up to protect from SD between 120 and 240 days after CRT clearly demonstrated by Care HF and Companion

  35. CARE HF John G.F. Cleland N Engl J Med 2005;352:1539-49 • Does really CRT-P  sudden death in the long term follow up ?! CARE HF extension phase John G.F. Cleland EHJ (2006) 27, 1928–1932 Mean f.u. = 37,4 months Mean f.u = 29,4 months

  36. CAREfully looking inside CARE HF extended At the end of the study: n of deaths: 200 pts Due to the demonstrated benefit of CRT-P CRT-P strongly recommanded at the end of CARE HF for pts randomized in OPT group Mean f.u = 29,4 months

  37. However….. Recommendation letter • CRT-P strongly recommended at the end of CARE HF for pts randomized in OPT group !!!!

  38. statistically significant and statistically correct… Optimal drug therapy 404 pts / 154 deaths: CRT 409 pts / 101 deaths: 35% 32% • Risk reduction of death from HF by 45% ( HR = 0,55) • Risk reduction of death from SCD by 46% ( HR = 0,54) but clinically uncorrect…

  39. Doesreally CRT-P  sudden death in the long term f.u.? • Why such a big spaceball ?!

  40. Mean f.u. =37,4months 8 months longer than CARE HF… BUT CONSIDER that n of pts is LOWER due to the 200 deaths.. CARE HF extended  Considering pts still alive… for them LONGER f.u (~ 10 months)  WITHOUT protection of CRT: ETHICAL ???

  41. CAREfully looking inside CARE HF extended 2.5%/y SD: 32% in CRT CRT:32/409 (7.8%) OPT: 54/404 (13.4%) 4.3% / y 2.5% 2.5% 2.5% 2.5% 2.5% 2.5% 8 % 8% 2 yr 3 yr 4 yr 1 yr 2 yr 3 yr 1 yr 4 yr SD

  42. CAREfully looking inside CARE HF extended 82 † (29.4 months) 20% mortality 154 † (37.4 months) 102 † (37.4 months) 38% mortality 25% mortality 120 † (29.4 months) 29.7% mortality DESPERATE OPT 95 OPT CONVERTED to CRT:22 † 23.2% mortality BUT… 404pts 309 pts: 132 † (DESPERATE OPT!!) 42.7% mortality CRTarm 409pts OPTarm 404pts

  43. CARE HF investigators postulated that CRT-P SCD during long term f.u I honestly think that it is not true Pts left on OPT (despite recommendations!) continues to dramatically die like flies… that the only reason for the supposed reduction of SD with CRT !!! If CRT-P would protect from SD this would be the pattern of the survival curve but SD rate in CRT-P REMAIN THE SAMEover time !!

  44. In conclusions…. 1) CRT-Dundeniably reduce mortality with respect to OPT 2) All studies comparing CRT-P and CRT-D, CRT-Darm has shown greater benefit with respect to CRT-P in terms of SD reduction 3) Metanalisys data undeniably shown that CRT-D saves more lives than CRT-P (9% more!!) 4) We should offer to any HF pt the best possible therapy, i.e complete therapy CRT-D 5) Last but not least, more than 85% of CRT candidates satisfy a class IA indication for ICD !!!

  45. Is there still place for CRT-P ?

  46.  consider CRT-P FOR WHOM? 1) LIFE EXPECTANCY if life expectancy < 1 yr  very advanced anagraphic age (at least > 80 years) very advanced biological age due to severe comorbidities cachexia neurological diseases severe COPD / severe renal/epatic insufficiency complicated insulin dependent diabetes peripheral vascular disease Reasonable NOT to provide an ICD back-up Aim of the intervention:  QOL for the remaining life

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