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September 25, 2018 Circulation. 2018;138:e272–e391. DOI: 10.1161/CIR.0000000000000549 e354

CLINICAL STATEMENTS AND GUIDELINES 18 EVIDENCE GAPS AND FUTURE

RESEARCH NEEDS

Despite the numerous advances in risk stratification for SCD and prevention and treatment of SCD and VA, many gaps in knowledge remain. These gaps include:

•	 Identification of patients who are most likely to benefit from an ICD among all ICD-eligible patients. The role of novel markers (including genetic and imaging markers) and combinations of markers should be studied. •	 Characterizing the role of the ICD in patient subgroups not well-represented in the pivotal ICD trials. Such subgroups include patients ≥80 years of age and those with kidney disease, especially patients with ESRD on dialysis, or multiple comorbidities. •	 Methods to identify and treat patients at high individual risk for SCD who are not identified by current ICD eligibility criteria, including those who are within 40 days of an MI. •	 Defining the role of the ICD in patients with HCM, arrhythmogenic right ventricular cardiomyopathy, cardiac sarcoidosis, and inherited cardiac channelopathies in prospective studies (preferably RCT). •	 Determining the best approach to patients due for elective ICD generator replacement due to battery depletion, but who may now be at low risk for SCA, such as if significant LVEF improvement has occurred. •	 Obtaining more data on the efficacy and effectiveness of the subcutaneous implantable cardioverter-defibrillator, compared with transvenous ICDs and on the extent of testing required, and its use with other novel technologies, including leadless pacemakers. •	 Conducting RCTs on catheter ablation of VT in ischemic heart disease and cardiomyopathies that evaluates procedural end points, mortality, arrhythmia suppression, QoL, and costs. •	 Improving identification of individuals without significant ventricular dysfunction who are at risk of SCD. •	 Identifying mechanisms and risk factors for SCD in patients with HFpEF. •	 Improving emergency response to out-of-hospital cardiac arrest. •	 Developing better methods for identifying and ablating  the arrhythmia substrate in structural heart disease. •	 Developing better risk stratification of diseases and syndromes associated with sudden death, including ischemic heart disease, NICM, adult congenital heart disease, and Brugada syndrome. •	 Identifying what causes different types of long QT syndrome, catecholaminergic polymorphic ventricular tachycardia, Brugada syndrome, HCM, and arrhythmogenic right ventricular cardiomyopathy and advancing the genotype-phenotype relationships, genotype-dependent risk, and genotypebased tailoring of therapies for patients with inherited cardiomyopathies and inherited channelopathies. •	 Defining the most appropriate and beneficial use of wearable cardioverter-defibrillators. •	 Developing methods to identify and treat patients at high personal risk for SCD who are not identified by current ICD eligibility criteria. •	 Defining the role of CMR in enhancing risk stratification for SCD. Increasing research funding in this area, through existing and new mechanisms is critically important. Some have proposed research funding strategies that would offer business incentives to the insurance industries, while providing support for unresolved research goals. Such approaches should be tested.

ACC/AHA TASK FORCE MEMBERS

Glenn N. Levine, MD, FACC, FAHA, Chair; Patrick T. O’Gara, MD, MACC, FAHA, Chair-Elect; Jonathan L. Halperin, MD, FACC, FAHA, Immediate Past Chair*; Sana M. Al-Khatib, MD, MHS, FACC, FAHA; Joshua A. Beckman, MD, MS, FAHA; Kim K. Birtcher, MS, PharmD, AACC; Biykem Bozkurt, MD, PhD, FACC, FAHA*; Ralph G. Brindis, MD, MPH, MACC*; Joaquin E. Cigarroa, MD, FACC; Anita Deswal, MD, MPH, FACC, FAHA; Lesley H. Curtis, PhD, FAHA*; Lee A. Fleisher, MD, FACC, FAHA; Federico Gentile, MD, FACC; Samuel Gidding, MD, FAHA*; Zachary D. Goldberger, MD, MS, FACC, FAHA; Mark A. Hlatky, MD, FACC, FAHA; John Ikonomidis, MD, PhD, FAHA; José A. Joglar, MD, FACC, FAHA; Laura Mauri, MD, MSc, FAHA; Barbara Riegel, PhD, RN, FAHA; Susan J. Pressler, PhD, RN, FAHA*; Duminda N. Wijeysundera, MD, PhD

PRESIDENTS AND STAFF American College of Cardiology

Mary Norine Walsh, MD, FACC, President Shalom Jacobovitz, Chief Executive Officer William J. Oetgen, MD, MBA, FACC, Executive Vice President, Science, Education, Quality, and Publishing Amelia Scholtz, PhD, Publications Manager, Science,

Education, Quality, and Publishing

American College of Cardiology/ American Heart Association

Katherine A. Sheehan, PhD, Director, Guideline

Strategy and Operations

*Former Task Force member; current member during the writing effort.

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