Future research prioritization in cardiac resynchronization therapy - 06/05/20

Doi : 10.1016/j.ahj.2020.02.011

Marat Fudim, MD, MHS ^a,^b, Frederik Dalgaard, MD ^a,^c, Sana M. Al-Khatib, MD, MHS ^a,^b,^d, Daniel J. Friedman, MD ^a,^b, Kathryn Lallinger, MSLS ^a,^e,^f, William T. Abraham, MD ^g, John G.F. Cleland, MD, PhD ^h, Anne B. Curtis, MD ⁱ, Michael R. Gold, MD ^j, Valentina Kutyifa, MD ^k, Cecilia Linde, MD ^l, Daniel E. Schaber, PharmD ^m, Anthony Tang, MD ⁿ, Fatima Ali-Ahmed, MD ^a, Sarah A. Goldstein, MD ^a, Brystana Kaufman, PhD ^e, Robyn Fortman, BA ^a,^e,^f, J. Kelly Davis, BA ^e, Lurdes Y.T. Inoue, PhD ^o, Gillian D. Sanders, PhD ^a,^d,^e,^f,^p,^{^⁎}
^a Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC
^b Division of Cardiology, Duke University School of Medicine, Durham, NC
^c Department of Cardiology, Herlev and Gentofte hospital, Copenhagen, Denmark
^d Department of Medicine, Duke University School of Medicine, Durham, NC
^e Duke-Margolis Center for Health Policy, Duke University, Durham, NC
^f Evidence Synthesis Group, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC
^g Division of Cardiovascular Medicine, The Ohio State University, Columbus, OH
^h National Heart and Lung Institute, Royal Brompton & Harefield Hospitals, Imperial College, London, United Kingdom
ⁱ Department of Medicine, University at Buffalo, Buffalo, NY
^j Medical University of South Carolina, Charleston, SC
^k Division of Cardiology, Department of Medicine, University of Rochester Medical Center, Rochester, NY
^l Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden
^m Medtronic, Inc, Minneapolis, MN
ⁿ Department of Medicine, Western University, London, Ontario, Canada
^o Department of Biostatistics, University of Washington, Seattle, WA
^p Department of Population Health Sciences, Duke University School of Medicine, Durham, NC

^⁎Reprint requests: Gillian D. Sanders PhD, Duke Clinical Research Institute, 200 Morris St, Durham, NC 27701.Duke Clinical Research Institute200 Morris StDurhamNC27701

Abstract

Background

Although cardiac resynchronization therapy (CRT) is effective for some patients with heart failure and a reduced left ventricular ejection fraction (HFrEF), evidence gaps remain for key clinical and policy areas. The objective of the study was to review the data on the effects of CRT for patients with HFrEF receiving pharmacological therapy alone or pharmacological therapy and an implantable cardioverter-defibrillator (ICD) and then, informed by a diverse group of stakeholders, to identify evidence gaps, prioritize them, and develop a research plan.

Methods

Relevant studies were identified using PubMed and EMBASE and ongoing trials using clinicaltrials.gov. Forced-ranking prioritization method was applied by stakeholders to reach a consensus on the most important questions. Twenty-six stakeholders contributed to the expanded list of evidence gaps, including key investigators from existing randomized controlled trials and others representing different perspectives, including patients, the public, device manufacturers, and policymakers.

Results

Of the 18 top-tier evidence gaps, 8 were related to specific populations or subgroups of interest. Seven were related to the comparative effectiveness and safety of CRT interventions or comparators, and 3 were related to the association of CRT treatment with specific outcomes. The association of comorbidities with CRT effectiveness ranked highest, followed by questions about the effectiveness of CRT among patients with atrial fibrillation and the relationship between gender, QRS morphology and duration, and outcomes for patients either with CRT plus ICD or with ICD.

Conclusions

Evidence gaps presented in this article highlight numerous, important clinical and policy questions for which there is inconclusive evidence on the role of CRT and provide a framework for future collaborative research.

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Methods

Prioritization approach

Identification of evidence gaps

Selection and engagement of stakeholders

Prioritization of future research

Horizon scan of studies potentially relevant to top-tier evidence gaps

Results

Ranked future research

Horizon scan of potential studies relevant to top-tier evidence gaps

Competency in medical knowledge

Translational outlook

Disclosures:

•	Marat Fudim, MD, MHS: Marat Fudim consults for Axontherapies, and Daxor.
•	Frederik Dalgaard, MD: nothing to disclose
•	Sana M. Al-Khatib, MD, MHS: nothing to disclose
•	Daniel J. Friedman, MD: educational grants from Boston Scientific, Medtronic, and Abbott; research grants from the National Cardiovascular Data Registry, Boston Scientific, Abbott, Medtronic, and Biosense Webster; consulting fees from Abbott; salary support via the National Institutes of Health T 32 training grantHL069749; and has filed a provisional patent application pertaining to the use of electrogram analysis for CRT optimization.
•	Kathryn Lallinger, MSLS: nothing to disclose
•	William T. Abraham, MD: nothing to disclose
•	John G. F. Cleland, MD, PhD: honoraria for advisory boards and speaking for Medtronic and Abbott; support for meta-analysis of Medtronic trials of CRT.
•	Anne B. Curtis, MD: Medtronic, Inc: honoraria for speaking, data monitoring board for clinical trial; Abbott: medical advisory board, honoraria for speaking, data monitoring board for clinical trial; Novartis: medical advisory board, honoraria for speaking; Janssen Pharmaceuticals: medical advisory board; Biotronik: honoraria for speaking; Milestone Pharmaceuticals: medical advisory board
•	Michael R. Gold, MD: consulting fees from Boston Scientific, EBR, and Medtronic
•	Valentina Kutyifa, MD: research grants from Boston Scientific, Biotronik, and ZOLL and consultant fees from Biotronik and ZOLL.
•	Cecilia Linde, MD: nothing to disclose
•	Daniel E. Schaber, PharmD: employee of Medtronic
•	Anthony Tang, MD: research support from Medtronic and Abbott
•	Fatima Ali-Ahmed, MD: nothing to disclose
•	Sarah A. Goldstein, MD: nothing to disclose
•	Brystana Kaufman, PhD: nothing to disclose
•	Robyn Fortman, BA: nothing to disclose
•	J. Kelly Davis, BA: nothing to disclose
•	Lurdes Y.T. Inoue, PhD: nothing to disclose
•	Gillian D. Sanders, PhD: nothing to disclose

Funding: Primary funding was provided by the National Heart, Lung, and Blood Institute (1R01HL131754). The National Heart, Lung, and Blood Institute did not participate in the literature search, determination of study eligibility criteria, data analysis or interpretation, or preparation or approval of the manuscript for publication.

Esportazione

Vol 223

P. 48-58 - maggio 2020 Ritorno al numero

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Future research prioritization in cardiac resynchronization therapy - 06/05/20

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