Pacing/CRT Current Guidelines. Panos E. Vardas Professor of Cardiology Heraklion University Hospital Crete, Greece

Transcription

1 Pacing/CRT Current Guidelines Panos E. Vardas Professor of Cardiology Heraklion University Hospital Crete, Greece

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3 ESC/EHRA Guidelines The ESC guidelines cover two main areas: the first includes permanent pacing in bradyarrhythmias, syncope and other specific conditions, while the second refers to ventricular resynchronization as an adjunct therapy in patients with HF.

4 ESC/EHRA pacing guidelines Appendices The guidelines have been enriched with two appendices that refer not only to conventional pacemaker follow-up but also to technical considerations and requirements for implanting and followup of CRT devices.

5 ESC/EHRA Guidelines Main topics Conventional indications for pacing Pacing for specific conditions Cardiac resynchronization therapy

6 Conventional indications for pacing The ESC/EHRA 2007 Guidelines present detailed definitions follow an up-to-date approach to the evaluation of patients with syncope. take into consideration the results of recent trials (MOST, CTOPP, PASE, DAVID etc) and the technological advances, providing level of evidence in mode selection. recommendations for the use of new algorithms (MPV, ANTITACHY)

7 Sinus node disease Recommendations for cardiac pacing in SND

8 Conventional indications for pacing ESC/EHRA 2007 vs ACC/AHA/HRS 2008 Guidelines Differences in terminology: e.g. ACC/AHA/HRS GLs use the term advanced second degree AV block while in the ESC 2007 GLs we use the terms second degree AV block Mobitz I or II Differences in classification and ranking: e.g. For asymptomatic patients with 3 rd degree AVB pacing is considered to be class IIa, LoE C in ESC/EHRA 2007 GLs, while it is classified as I, LoE B in the presence of SHD, or if the site of block is below AVN and IIa, LoE C if there is no SHD in the ACC/ AHA/HRS GLs

10 Recommendations for cardiac pacing in carotid sinus syndrome

11 Recommendations for cardiac pacing in VVS (ESC/EHRA 2007 GLs)

12 Recommendations for cardiac pacing in VVS (ACC/AHA/HRS 2008 GLs) Significantly symptomatic neurocardio-genic syncope associated with bradycardia documented spontaneously or at the time of tilttable testing is class IIb LoE B.

14 Pacemaker mode selection in sinus node disease

15 Pacing for specific conditions New chapters: Sleep-apnoea syndrome Adenosine- sensitive syndrome

16 Sleep-apnoea syndrome Atrial overdrive pacing at a rate of 15 b.p.m. higher than the mean nocturnal heart rate had a positive effect on sleep apnoea, reducing both obstructive and central apnoeic episodes in patients who were already paced for conventional indications. Garrigue S, et al. N Engl J Med 2002 These positive results, were not confirmed by other studies that included patients with pure obstructive sleep apnoea. Simantirakis EN e al. N Engl J Med 2005 Krahn AD, J Am Coll Cardiol 2006 More studies are needed to clarify the possible effect of atrial pacing on sleep apnoea and to determine in which subgroups of patients this approach might be beneficial.

17 Adenosine- sensitive syndrome There has been no well-designed randomized study able to determine the utility of pacing in patients with a positive ATP test, thus no definitive recom-mendations can be made.

18 Cardiac Resynchronization Therapy The ESC/EHRA 2007 GLs From a theoretical point of view it may be more appropriate to target mechanical dyssynchrony, rather than electrical conduction delay. However, the existence of mechanical dyssynchrony in HF has not yet been established as a patient selection criterion for CRT.

19 Cardiac Resynchronization Therapy Criteria for patient selection Echocardiographic criteria for CRT Ten years of research in the field of dyssynchrony in echocardiography have resulted in two negative studies which have, to some extent, discredited the method: PROSPECT RETHINQ

20 ESC / EHRA Guidelines for Cardiac Pacing and Cardiac Resynchronization Therapy ESC Guidelines for Cardiac Pacing and Resynchronization Therapy 2007 (EHJ 2007) Recommendation for the use of cardiac resynchronization therapy by CRT-P and CRT-D in HF patients Heart failure patients, who remain symptomatic in NYHA classes III IV, despite optimal medical therapy, with: LVEF < 35 % LV dilatation QRS complex > 120 ms Normal sinus rhythm Class I, level of evidence and mortality. A for CRT-P to reduce morbidity CRT-D is an acceptable option for patients who have expectancy of survival > 1 year

21 ESC / EHRA Guidelines for Cardiac pacing and Cardiac Resynchronization Therapy ESC Guidelines for Cardiac Pacing and Resynchronization Therapy 2007 (EHJ 2007) Recommendations for the use of an ICD combined with biventricular pacemaker (CRT-D) in heart failure patients with an indication for an ICD Heart failure patients with a Class I Indication for an ICD with: Symptoms in NYHA classes III IV despite OPT LVEF < 35 % LV dilatation QRS complex > 120 ms In Sinus Rhythm Class I, Level of evidence B

22 ESC / EHRA Guidelines for Cardiac pacing and Cardiac Resynchronization Therapy ESC Guidelines for Cardiac Pacing and Resynchronization Therapy 2007 (EHJ 2007) Recommendations for the use of biventricular pacing in heart failure patients with permanent AF Heart failure patients who remain symptomatic in NYHA classes III IV despite OPT, with: Low LVEF < 35 % LV dilatation Permanent AF Indication for AV junction ablation Class IIa, Level of evidence C

23 CRT for specific issues ESC/EHRA 2007 Guidelines Patients with mild HF or asymptomatic LV systolic dysfunction Class III LoE C Patients with permanent AF and indication of AVJ ablation IIa C Patients with bradycardic indications for pacemaker implantation IIa C Patients who already have a pacemaker implanted IIa C Should all CRT patients have an ICD back-up? I B

24 Cardiac Resynchronization Therapy ESC/EHRA 2007 vs ACC/AHA/HRS 2008 Guidelines There are many similarities in classification, ranking and patient selection criteria However In the ACC/AHA/HRS 2008 GLs, LV dilatation is not included in the selection criteria In the ACC/AHA/HRS 2008 GLs, AF is a class IIa LoE B indication while in ESC/EHRA 2007 GLs only patients with AF who are candidates for AVJ ablation have a class IIa LoE C indication

25 Recommendations for CRT in Patients With Severe Systolic Heart Failure For patients who have LVEF less than or equal to 35%, a QRS duration greater than or equal to 0.12 seconds, and sinus rhythm, CRT with or without an ICD is indicated for the treatment of NYHA functional Class III or ambulatory Class IV heart failure symptoms with optimal recommended medical therapy. Class I, Level of Evidence A

26 Recommendations for CRT in Patients With Severe Systolic Heart Failure For patients who have LVEF less than or equal to 35%, a QRS duration greater than or equal to 0.12 seconds, and AF, CRT with or without an ICD is reasonable for the treatment of NYHA functional Class III or ambulatory Class IV heart failure symptoms on optimal recommended medical therapy. Class IIa,Level of Evidence B

27 Open Issues for CRT implantation Patient selection criteria Electrical or mechanical asynchrony Mild heart failure No heart failure Pacemaker dependent patients Patients with dyssynchrony

28 Open Issues for CRT implantation Special group of patients CRT in patients with mild heart failure Can an early intervention with CRT slow the progression of heart failure? REVERSE (Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction) study has shown that implanting these devices in class I and II patients, shows a comparable benefit to what we saw in class III and IV patients. There was about a 50% reduction in hospitalizations for HF and overall patients did very well with that therapy. Linde, C. J Am Coll Cardiol 2008; 52:

29 Open Issues for CRT implantation Special group of patients CRT in patients with mild heart failure MADIT-CRT In high risk, asymptomatic or mildly symptomatic, NYHA Class I and II patients, LVEF 0.30, and QRS duration 130 ms, CRT-Ds associated with a significant 29% reduction (p=0.003) in death or heart failure interventions when compared to traditional ICDs. Early use of CRT in milder heart failure patients might be beneficial in improving LV function, leading to a reduction in symptoms, hospitalizations, and mortality. Moss AJ, N Engl J Med 2009; 361:

30 Open Issues for CRT implantation Special group of patients CRT in paced patients RV LV BiV Acutely, LV-based pacing is superior to RV apical pacing in terms of contractile function and LV filling following AVJ ablation for drug-refractory AF.

31 BiV pacing following chronic RV pacing may improve LV function reverse LV remodeling Upgrade to BiV pacing might be considered in chronically RV paced patients with mild cardiomyopathy. van Geldorp IE et al, Europace 2010; 12,

32 BiV pacing to prevent iatrogenic LV remodeling in patients with normal hearts RV-pacing resulted in LV remodeling and reduction in LVEF BiV-pacing prevented these adverse effects Yu et al, N Engl J Med ;22

33 Open Issues for CRT implantation Updated Guidelines Has the time come for an update of the existing guidelines? It is clear that the findings of the REVERSE study and of some sub-studies (eg the Wide QRS arm) as well as the MADIT- CRT trial indicate the need to alter sections of the existing Guidelines. Especially for patients with mild heart failure, it is very probable that recommendations will be changed in the update of the Guidelines.

34 Conclusions The published Guidelines from both sides of the Atlantic, based on the latest scientific evidence, contribute to the improved management of pacemaker candidates. Undoubtedly, the rapid advances in our scientific field require the frequent updating of such GLs to include all the facts that are important for contemporary evidencebased medicine. An important target is the implementation of ESC/EHRA Guidelines.