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Waiting Period Before Implantable Cardioverter-Defibrillator Implantation in Newly Diagnosed Heart Failure With Reduced Ejection Fraction

2017; Lippincott Williams & Wilkins; Volume: 10; Issue: 11 Linguagem: Inglês

10.1161/circheartfailure.117.004478

1941-3297

Ersilia M. DeFilippis, Javed Butler, Muthiah Vaduganathan,

Cardiac Valve Diseases and Treatments

HomeCirculation: Heart FailureVol. 10, No. 11Waiting Period Before Implantable Cardioverter-Defibrillator Implantation in Newly Diagnosed Heart Failure With Reduced Ejection Fraction Free AccessArticle CommentaryPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessArticle CommentaryPDF/EPUBWaiting Period Before Implantable Cardioverter-Defibrillator Implantation in Newly Diagnosed Heart Failure With Reduced Ejection FractionA Window of Opportunity Ersilia M. DeFilippis, MD, Javed Butler, MD, MPH, MBA and Muthiah Vaduganathan, MD, MPH Ersilia M. DeFilippisErsilia M. DeFilippis From the Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA (E.M.D., M.V.); and Division of Cardiology, Stony Brook University, NY (J.B.). , Javed ButlerJaved Butler From the Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA (E.M.D., M.V.); and Division of Cardiology, Stony Brook University, NY (J.B.). and Muthiah VaduganathanMuthiah Vaduganathan From the Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA (E.M.D., M.V.); and Division of Cardiology, Stony Brook University, NY (J.B.). Originally published14 Nov 2017https://doi.org/10.1161/CIRCHEARTFAILURE.117.004478Circulation: Heart Failure. 2017;10:e004478A critical waiting period of ≈3 months is generally accepted in patients with newly diagnosed heart failure with reduced ejection fraction (HFrEF) outside the context of an acute myocardial infarction before reassessing left ventricular (LV) ejection fraction and considering implantable cardioverter-defibrillator (ICD) therapy. This time window is offered to allow optimization of guideline-directed medical therapy (GDMT) to promote LV reverse remodeling, which if above a certain threshold, would render the need for an ICD unnecessary. Consideration for an ICD after this time-frame is endorsed by major professional groups,1 serves as a key quality and performance measure, and is deemed appropriate by the Appropriate Use Criteria for ICD therapy.2 This duration also guides reimbursement schema, for example, the Centers for Medicare & Medicaid Services limit coverage for ICDs in nonischemic dilated cardiomyopathy to after this 3-month waiting period.Perhaps it is time to lengthen this time-frame before ICD decision making in newly diagnosed patients with HFrEF. In many cases, 3 months are not sufficient to truly optimize GDMT and allow adequate chance for LV recovery. Evolving risks of sudden cardiac death (SCD), recent expansion of the heart failure (HF) therapeutic armamentarium, and greater focus on shared decision making all support extension of this time window. We summarize these converging lines of evidence and critically appraise the merits of extending this traditional waiting period. We contend that consideration for ICD implantation should only occur once GDMT has been achieved at target doses and may be deferred up to 1 year after diagnosis in appropriately selected patients. As the Centers for Medicare & Medicaid Services plan to update the national coverage determination regarding ICD implantation over the next year, we believe this issue is timely and topical to address.Landscape of Sudden Cardiac DeathEpidemiological studies3 and clinical trials4 during the past several decades have demonstrated that overall rates of SCD have declined, potentially reflecting greater uptake of GDMT, more complete coronary revascularization, and improved overall processes of care, including for comorbidities. After hospital discharge, patients face low-to-modest risks of SCD. Based on trials enrolling patients hospitalized for HFrEF with infrequent baseline use of ICDs (<15%), the estimated risks of SCD at 30 days is 30 000 patients enrolled in contemporary chronic HF trials.4 Although the absolute risks of SCD increase with the duration of HF diagnosis, patients recently diagnosed with HF face low absolute rates of SCD.4 Real-world experiences show that patients who receive wearable cardioverter-defibrillators experience rates of sustained ventricular tachyarrhythmias in 1% and 3% in nonischemic and ischemic cardiomyopathies, respectively, at 3 months.7Competing Risks of DeathThe HF population in general is elderly with multimorbidity burden. Although SCD is an important consideration and is the most common mode of death in patients with chronic, stable HFrEF, progressive pump failure death, and noncardiovascular deaths predominate and account for twice the SCD event rate at each follow-up time-point after hospital discharge (Figure 1). This highlights the need for an individualized approach to determine the optimal timeline before ICD consideration based on age, functional status, hospitalization burden, and comorbidities.Time to Optimize GDMTNeurohormonal modulation significantly reduces both HF-related death and SCD. However, there remain many missed opportunities to modify the risk of SCD in patients with HFrEF. At the time of hospitalization for de novo HFrEF, prescription of GDMT is relatively low, even in clinical trial populations.8 With progress in GDMT, clinicians will require more time to optimize multidrug regimens (Figure 2). The step-wise initiation of ≥3 agents safely with simultaneous ambulatory monitoring of laboratory parameters, hemodynamics, and symptoms requires frequent medical contact. As suggested by recent guidelines,9 most therapies require 1 to 3 dosing changes before achieving target doses, with titration intervals between 2 and 8 weeks. Even structured programs using a nurse facilitator to guide aggressive titration to target doses of GDMT require ≈6 months.10 Merged data from the National Cardiovascular Data Registry ICD Registry and Medicare administrative data show that only ≈60% of patients filled any neurohormonal antagonist prescription before primary prevention ICD implant.11 The variable interpretation of the timeline (as time from initial diagnosis of HFrEF or time on optimal GDMT) may contribute to this observed poor use of GDMT. There are dose-dependent effects of HF therapies on improvements in LV ejection fraction that may occur beyond the 3-month time window. Thus, taking time to achieve recommended doses is important and may take up to 1 year to not only optimize therapy but also to see the effect of optimal therapy after it has been achieved.Download figureDownload PowerPointFigure 2. How long does it take to optimize guideline-directed medical therapy in newlydiagnosed heart failure with reduced ejection fraction? We have developed a theoretical timeline for the step-wise initiation and uptitration of 3 to 4 drugs in contemporary regimens for newly diagnosed heart failure with reduced ejection fraction. Starting doses, target doses, titration schedule, and necessary laboratory monitoring were based on suggestions from the 2016 European Society of Cardiology Guidelines.9 This generic timeline does not account for pre-existing therapies, specific order of initiation of therapies, or simultaneous drug uptitration. ACEi indicates angiotensin-converting enzyme inhibitor; ARB, angiotensin II receptor blocker; ARNi, angiotensin receptor neprilysin inhibitor; EF, ejection fraction; GDMT, guideline-directed medical therapy; and MRA, mineralocorticoid receptor antagonist.Reappraisal of Benefits With ICD TherapyThe recent DANISH (Danish Study to Assess the Efficacy of ICDs in Patients with Non-ischemic Systolic Heart Failure on Mortality) trial in patients with nonischemic cardiomyopathy and LV ejection fraction ≤35% reaffirm the uncertainty of ICD benefit in certain cohorts,12 especially those with high uptake of GDMT or who face greater competing risks of mortality. Indeed, ICD therapy is of uncertain value in patients who experience recurrent hospitalizations or have severe comorbidities (Class IIb; Level of Evidence B). Device implantation is met with procedural risks, costs, require routine follow-up, and may malfunction. As such, decisions to pursue ICD therapy should be well-informed, calculated, guided by individualized risk estimates of SCD versus non-SCD death, and only occur after an adequate trial of GDMT.A Path ForwardThe course after HF diagnosis is riddled with hurdles and opportunities that may modify risks of SCD and non-SCD death (Figure 1). Advances in GDMT have introduced further uncertainty about the benefit of ICD implantation after initial HFrEF diagnosis. Few SCD events occur during the currently acceptable 3-month timeline, and GDMT remains poorly optimized before many device implantations. In this context, a longer waiting period up to 1 year would facilitate several important goals:– Initiation, uptitration, and optimization of multidrug regimens and assess their attendant effects on LV recovery– Improve implementation and ensure adherence, especially in under-represented or low-income populations– Allow time for assessing and managing competing risks (HF-related death or other non-SCD modes of death) and comorbidities– Permit greater opportunity for risk stratification for SCD, including application of wearable cardioverter-defibrillators in select patients– Provide sufficient time for patients to understand the HF syndrome, risks of SCD, and harms and benefits of ICD implantationThere will be a small, but significant and accruing, risk of SCD that will be incurred if the proposed extended timeline is routinely undertaken. Younger patients without significant comorbidities should continue to be evaluated for ICD therapy within the traditional timeframe.13 Precision medicine techniques (risk scores, deep phenotyping with biomarkers, and imaging, etc.) may be used to identify other subgroups of patients who may benefit from shorter timelines to ICD consideration. The uncertain benefits of early ICD implantation in select patients reinforces the critical role of shared decision making in guiding timing for individual patents. Cause-specific prognostic risk scores and better valuation of patients' goals and expectations are needed in clinical practice. Considering the modest early risks of SCD, high cost and other unintended consequences of ICD therapy, and the potential to obviate its need with GDMT, serious consideration should be afforded to extending the time period before proceeding with ICD implantation for primary prevention in appropriately selected patients with newly diagnosed HFrEF.DisclosuresDr Butler has received research support from the National Institutes of Health and European Union and has been a consultant for Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, CVRx, Janssen, Luitpold Pharmaceuticals, Medtronic, Merck, Novartis, Relypsa, Vifor Pharma, and ZS Pharma. Dr Vaduganathan is supported by the National Heart, Lung, and Blood Institute T32 postdoctoral training grant (T32HL007604). The other author reports no conflicts.FootnotesThe opinions expressed in this article are not necessarily those of the editors or the American Heart AssociationCirc Heart Fail is available at http://circheartfailure.ahajournals.org.Correspondence to: Muthiah Vaduganathan, MD, MPH, Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, 75 Francis St, Boston MA 02115. E-mail [email protected]References1. 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November 2017Vol 10, Issue 11 Advertisement Article InformationMetrics © 2017 American Heart Association, Inc.https://doi.org/10.1161/CIRCHEARTFAILURE.117.004478PMID: 29138249 Originally publishedNovember 14, 2017 Keywordsdeath, sudden, cardiaccardiomyopathiesheart failuredefibrillators, implantablePDF download Advertisement SubjectsCardiomyopathyCatheter Ablation and Implantable Cardioverter-DefibrillatorHeart FailureSudden Cardiac Death