(274) Methods of Evaluating the Safety and Effectiveness of Cardiac Ablation Catheters Using Real-World Data: A Test-Case of The National Evaluation System for Health Technology Coordinating Center (NESTcc)

Saturday, August 27, 2022

8:00 AM – 6:00 PM CEST

Location: Hall C

Publication Number: 948

Presenting Author(s)

Shumin Zhang, MD, DSc
– J&J, New Brunswick, New Jersey, United States

Co-Author(s)

Sanket Dhruva, MD, MHS
– Section of Cardiology, Department of Medicine, University of California San Francisco School of Medicine, San Francisco, California, USA, San Francisco, CA, United States
Jiajing Chen, PhD
– Mercy Research, Mercy, Chesterfield, Missouri, USA, St. Louis, MO, United States
Yue Yu, PhD
– Department of Artificial Intelligence and Informatics, Mayo Clinic, Rochester, Minnesota, USA, United States
Guy Cafri
– Johnson & Johnson, San Diego, California, United States
Peter A. Noseworthy, MD
– Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA, United States
Amit Doshi, MD
– Mercy Clinic, St. Louis, Missouri, USA, United States
Guoqian Jiang, MD, PhD
– Department of Artificial Intelligence and Informatics, Mayo Clinic, Rochester, Minnesota, USA, United States
Kolade M. Agboola, MD
– Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA, United States
Jeph Herrin, PhD
– Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA, United States
Kimberly Collison Farr
– Mercy Research, Mercy, Chesterfield, Missouri, USA, United States
Meijia Zhou, PhD, MHS
– Manager, Johnson & Johnson, New Brunswick, New Jersey, United States
Eric Brandt, MBA
– Mercy Research, Mercy, Chesterfield, Missouri, USA, United States
Thomas Forsyth
– Mercy Research, Mercy, Chesterfield, Missouri, USA, United States
Keondae Ervin, MS
– National Evaluation System for health Technology Coordinating Center (NESTcc), Medical Device Innovation Consortium, Arlington, Virginia, USA, United States
Joseph Ross, MD, MHS
– Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA, United States
Joseph Drozda, Jr., MD
– Mercy Research, Mercy, Chesterfield, Missouri, USA, United States
Paul M. Coplan, MBA, ScD, FISPE
– Vice President and head of Medical Device Epidemiology and Real-World Data Sciences , University of Pennsylvania School of Medicine, Fort Washington, Pennsylvania, United States

Background: Recent changes in healthcare policy have placed increasing emphasis on using real-world evidence (RWE) for regulatory decision-making. One potential use of RWE is to support label extension.

Objectives: To discuss the development and implementation of methods for evaluating device safety and effectiveness using electronic health record (EHR) and supply chain data for label extensions using a National Evaluation System for health Technology Coordinating Center’s ablation catheter test-case as an exemplar.

Methods: A retrospective cohort study was conducted at Mercy and Mayo Clinic, 2 large multicenter US healthcare systems, in patients treated for persistent atrial fibrillation (AF) or ventricular tachycardia (VT) with one of two variants of an ablation catheter: ThermoCool SmartTouch (ST) or ThermoCool SmartTouch Surround Flow (STSF). Code-based algorithms were developed for efficient identification of cohorts and effectiveness outcomes, with accuracy assessed by comparing to clinician chart review and measured by positive predictive values (PPVs). Physician chart review was used to ascertain primary composite safety outcomes that comprised numerous individual components. Three criteria (hospitalization/readmission or emergency department visit within 7 days post ablation, index hospital stay ≥48 hours, or codes for events that may not have been captured by the other 2 criteria) were used for flagging charts for physician review. Propensity scores were used for balancing baseline covariates. A federated model was used in which each healthcare system maintained its own data, and a combined treatment effect was estimated.

Results: PPVs of code-based algorithms to identify cohorts and effectiveness outcomes ranged from 89%-95% and 87.5%-100%, respectively. A two-phase analytic approach was implemented by using different statisticians, first balancing covariates using propensity scores blinded to outcomes and subsequently conducting outcome analyses of covariate-balanced data. Treatment effects across healthcare systems were averaged using a fixed-effects model for evaluating ThermoCool ST vs STSF to treat persistent AF. When covariate balance could not be achieved, study cohorts from both healthcare systems were combined and compared to an externally derived performance goal, an approach used for evaluating ThermoCool STSF to treat ischemic VT.

Conclusions: Feasible methods were developed for conducting comparative analyses for label extensions of ablation catheters using healthcare system EHR and supply chain data.