CRT Vs RV Pacing Benefits

Transcription

1 CRT-P & CRT-D Indications According to Guidelines are Guidelines Fully Adopted? Salama H. Omar M.D. Prof. Critical Care Medicine, Cairo University CRT Vs RV Pacing Benefits 1

2 Benefit of Upgrade CTR-P & CRT-D Benefits 2

3 Eligible Patients Treated 10/27/2013 Relative Cost of CRT Cost per patient Total Annual Expenditures Dialysis CABG PTCA Hip/knee replace CRT CRT+ICD $60 $40 $20 $ thousands $0 $0 $5 $10 $15 $20 $ Billions Doug Smith: Results: Improvement in Quality Measures at 24 Months (Patient Level Analysis) 100% 80% 60% 40% Significant Improvement in 6 of 7 Quality Measures at 12 and 24 Months Pre-specified Primary Objective Met: Relative Improvement 20% in 3 Quality Measures * * 87% 84% 80% 86% * * 93% 94% 34% * 51% * 62% 69% 69% 69% 69% 38% * 58% * 49% * 71% * 79% 62% * * 71% 69% 20% 0% ACEI/ARB ß-blocker Aldosterone Antagonist Anticoagulant for AF Baseline 12 months 24 months CRT ICD HF Education * P<0.001 vs. baseline P-values are for relative change Fonarow GC, et al. Circulation. 2010;122:

4 Guidelines 4

5 Indications for cardiac resynchronization therapy in patients in sinus rhythm 5

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7 Upgrade..?? PM Indication..?? 7

8 Atrial Fibrillation..?? 8

9 A. Fib. 9

10 CRT-P Vs CRT-D 10

11 Recommendations for CRT in Patients with Systolic Heart Failure (AHA) Changes in the recommendations: All recommendations for the 2008 Guidelines and 2012 Update are predicated on the expectation that appropriate medical therapy guideline-directed medical therapy (GDMT) already is being provided. the discussion below assumes that GDMT is being provided Update provides both expansion and limitation of the indications for CRT. Previously, the only Class I recommendation for CRT was in patients with relatively severe symptoms (NYHA Functional Class III or IV heart failure) accompanied by sinus rhythm, left ventricular ejection fraction (LVEF) 35%, a QRS duration 0.12 second. 11

12 Changes in the recommendations: Since publication of the 2008 Guideline, REVERSE, MADIT-CRT, and RAFT have allowed for the refinements, (based on their inclusion criteria) that provide data for CRT use in patients with less severe symptoms. Class I 1. CRT is indicated for patients who have LVEF less than or equal to 35%, sinus rhythm, LBBB with a QRS duration greater than or equal to 150 ms, and NYHA class II, III, or ambulatory IV symptoms on GDMT. (Level of Evidence: A for NYHA class III/IV; Level of Evidence: B for NYHA class II) Modified recommendation (specifying CRT in patients with LBBB of 150 ms; expanded to include those with NYHA class II symptoms). 12

13 Rationale for the changes These large randomized studies, along with meta-analyses, have also tempered enthusiasm for CRT in patients with QRS less than 150 msec based on failure to respond to CRT for all functional NYHA classes. Furthermore, studies published in 2009 and 2010, and a meta-analysis from 2011, demonstrated that non-lbbb conduction abnormalities are associated with failure to benefit from CRT. The jury may still be out on this issue, since there are some data to suggest that patients with non-lbbb can benefit from CRT when the QRS is markedly prolonged; as such, these patients still are included in recommendation Class II Class IIa 1. CRT can be useful for patients who have LVEF less than or equal to 35%, sinus rhythm, LBBB with a QRS duration 120 to 149 ms, and NYHA class II, III, or ambulatory IV symptoms on GDMT. (Level of Evidence: B) New recommendation 2. CRT can be useful for patients who have LVEF less than or equal to 35%, sinus rhythm, a non-lbbb pattern with a QRS duration greater than or equal to 150 ms, and NYHA class III/ambulatory class IV symptoms on GDMT. (Level of Evidence: A) New recommendation 13

14 Class IIa 3. CRT can be useful in patients with atrial fibrillation and LVEF less than or equal to 35% on GDMT if a) the patient requires ventricular pacing or otherwise meets CRT criteria and b) AV nodal ablation or pharmacologic rate control will allow near 100% ventricular pacing with CRT. (Level of Evidence: B) Modified recommendation (wording changed to indicate benefit based on ejection fraction rather than NYHA class; level of evidence changed from C to B). 4. CRT can be useful for patients on GDMT who have LVEF less than or equal to 35% and are undergoing new or replacement device placement with anticipated requirement for significant (40%) ventricular pacing. (Level of Evidence: C) Modified recommendation (wording changed to indicate benefit based on ejection fraction and need for pacing rather than NYHA class); class changed from IIb to IIa. Class IIb 1. CRT may be considered for patients who have LVEF less than or equal to 30%, ischemic etiology of heart failure, sinus rhythm, LBBB with a QRS duration of greater than or equal to 150 ms, and NYHA class I symptoms on GDMT. (Level of Evidence: C) New recommendation 2. CRT may be considered for patients who have LVEF less than or equal to 35%, sinus rhythm, a non-lbbb pattern with QRS duration 120 to 149 ms, and NYHA class III/ambulatory class IV on GDMT. (Level of Evidence: B) New recommendation 3. CRT may be considered for patients who have LVEF less than or equal to 35%, sinus rhythm, a non-lbbb pattern with a QRS duration greater than or equal to 150 ms, and NYHA class II symptoms on GDMT. (Level of Evidence: B) New recommendation 14

15 Class III: No Benefit 1. CRT is not recommended for patients with NYHA class I or II symptoms and non-lbbb pattern with QRS duration less than 150 ms. (Level of Evidence: B) New recommendation 2. CRT is not indicated for patients whose comorbidities and/or frailty limit survival with good functional capacity to less than 1 year. (Level of Evidence: C) Modified recommendation (wording changed to include cardiac as well as noncardiac comorbidities). The new 2013 ACCF/AHA Guideline AICD (ICD) guidelines have not changed in the 2013 guidelines and include Class I recommendations for primary prevention of sudden cardiac death in selected patients with LVEF 35% and NYHA Class II or III symptoms, who have reasonable expectation of meaningful survival for more than 1 year. 15

16 Real World 16

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19 How to standardize? Clinical Experience.? Guidelines? There will always be groups of patients for whom guidelines are not strictly applicable AUC..? Give a range of decisions Appropriate Use Criteria for ICD/CRT 19

20 AUC The 369 Clinical Scenario (Indications) in this document were developed by a multidisciplinary writing group and scored by a separate independent technical panel A Score of1 to 9 is used to designate care: Appropriate (median 7 to 9), May Be Appropriate (median 4 to 6), and Rarely Appropriate (median 1 to 3). 20

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23 Appropriate Use Criteria for ICD/CRT 23

24 Appropriate Use Criteria for ICD/CRT Algorithms 24

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30 Conclusion 30

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32 CRT.Who Responds Better..? Conclusion The Appropriate Use Criteria for ICD/CRT have the potential to enhance physician decision making, healthcare delivery, and reimbursement policy. Furthermore, recognition of clinical scenarios rated as May Be Appropriate facilitates the identification of areas that would benefit from future research. 32

33 Parachutes Appear to Reduce the Risk of Injury & mortality, Is This Supported by Randomized Controlled Trials (RCT) Conclusion Exactly as they are named guidelines. These documents synthesize the data that are available and provide recommendations to the clinician for consideration in each individual patient. There will always be groups of patients for whom guidelines are not strictly applicable. Unfortunately, at times placement of CIEDs in situations not covered by the document or contrary to the guidelines, but appropriate for the individual patient, may risk failure of reimbursement or even litigation. 33

34 Conclusion In situations where the guidelines do not apply to real world patients, it is hoped that appropriate use criteria (AUC) methodology will further guide therapy. This methodology, currently being applied to ICD and CRT therapy will examine a large number of indications or scenarios where the guidelines might not strictly apply, and provide the practitioner with levels of appropriateness based on the scale of 1 through 9. The AUC document, in combination with this current focused update, will provide the best guidance to date for application of CIED therapy. MADIT-CRT LIFR Early intervention with CRT-D in patients with mild HF symptoms is associated with sustained clinical abnsd Echocardiographic benefits during an extended perind of follow up of at least 6 years The long term benefit of CRT in this population appears to be restricted to patients with LBBB 34

35 Changes in the recommendations: Since publication of the 2008 Guideline, REVERSE, MADIT-CRT, and RAFT have allowed for the refinements, (based on their inclusion criteria) that provide data for CRT use in patients with less severe symptoms. So, 2012 update, this Class I indication is expanded to patients with NYHA Class II, extending the clear message that CRT is indicated for a population with milder symptoms. It limits, or refines, this single Class I recommendation by confining it only to patients with left bundle branch block (LBBB) and QRS 150 msec. Class IIa: The patients with LBBB, but QRS duration only msec and those with non-lbbb pattern and QRS 150 msec now receive a Class IIa recommendation. 35

36 Class IIa: In Patients with atrial fibrillation with a pacing indication and LVEF 35% if rate control allows near 100% ventricular pacing; this recommendation no longer specifies functional symptom class. In addition, there is now a IIa recommendation (as opposed to IIb) for patients with LVEF 35% who are anticipated to require ventricular pacing greater than 40% of the time. Class IIb: There are also Three other new IIb recommendations: A) for patients with LVEF 35%, a non-lbbb pattern with QRS duration msec and NYHA Class III/ functional Class IV; and, B) for patients with LVEF 35%, in sinus rhythm with non- LBBB pattern but QRS 150 msec and NYHA Class II symptoms (again expanding the option of guideline-based CRT in patients with relatively modest symptoms). A further major expansion of the indication for CRT, for the first time ever in patients with NYHA Class I symptoms, This is limited to patients with relatively severe cardiomyopathy (LVEF 30%) due to ischemia, LBBB, and QRS duration 150 msec, but expands the option of CRT to patients who previously would not have been considered candidates. 36

37 Class III The Class III recommendations, where CRT is not recommended, are reserved for patients with: 1) NYHA Class I or II symptoms, non-lbbb pattern and QRS <150 msec; in addition, 2) patients in whom cardiac or non-cardiac comorbidity and/or frailty limit survival with good functional capacity to less than 1 year. Where Do We Go From Here? With the publication of the 2012 focused update, CRT has truly come of age. Even though CRT is generally appreciated to increase the risk of complications, prolong procedural time and increase cost, in comparison to single or dual chamber ICD therapy, wellconducted randomized trials irrefutably demonstrate benefit in well-defined patient groups. The cardiovascular and clinical cardiac electrophysiology community should be congratulated for the generation of important data that provide for evidence-based recommendations for CRT. Of course, as soon as this Focused Update is published, new data will be available, and future Updates or full Guidelines will follow along with further refinement. 37

38 The new 2013 ACCF/AHA Guideline for the Management of Heart Failure Of note, for patients with non-lbbb and QRS msec, the indication is not expanded beyond patients with NYHA Class III/ ambulatory Class IV; and, to the contrary, CRT for patients in this group with NYHA Class II symptoms is not recommended. Changes in the recommendations: The patients with LBBB but QRS duration only 120 to 149 msec and those with non-lbbb pattern and QRS 150 msec, included in Class I in 2008, now receive a Class IIa recommendation. Of note, the former group (LBBB with QRS 120 to 149 msec) is now extended to patients with NHYA Class II (in addition to Class III/ambulatory Class IV). 38