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Real-World Evidence Demonstrates an Appropriate Atrial Fibrillation Population for Hybrid Convergent Approach versus Stand-Alone Cryoballoon Ablation: A Long-Term Safety and Efficacy Study
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  • Christian Lorenzo,
  • Yahaira Ortiz-Gonzalez,
  • Dustin Hill,
  • Jennifer Kinaga,
  • Lauren Filart,
  • David Bello,
  • Aurelio Duran,
  • Jeffery Bott,
  • Roland Filart
Christian Lorenzo
Orlando Regional Medical Center

Corresponding Author:[email protected]

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Yahaira Ortiz-Gonzalez
Orlando Regional Medical Center
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Dustin Hill
Orlando Regional Medical Center
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Jennifer Kinaga
Orlando Regional Medical Center
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Lauren Filart
Orlando Regional Medical Center
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David Bello
Orlando Regional Medical Center
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Aurelio Duran
Orlando Regional Medical Center
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Jeffery Bott
Orlando Regional Medical Center
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Roland Filart
Orlando Regional Medical Center
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Abstract

Introduction: A hybrid convergent approach (endocardial and epicardial ablation) demonstrated superior effectiveness in a recent randomized study for long-standing persistent atrial fibrillation (LSPAF). Yet, there is a lack of real-world, long-term evidence as to which patients are best candidates for a hybrid convergent approach compared to standard endocardial cryoballoon pulmonary vein isolation (CB PVI). Methods and Results: This single-center, retrospective analysis spanning from 2010 to 2015 compared two distinctly different atrial fibrillation (AF) cohorts; one treated with stand-alone cryoablation and one treated with a hybrid convergent approach. Baseline characteristics described candidates for each approach. The following criteria were utilized to determine CB PVI candidacy: 1) paroxysmal AF (PAF) with failed class I/III antiarrhythmic drug (AAD) or 2) persistent/LSPAF with failed class I/III AAD unwilling to undergo hybrid procedure. Selection criteria for the hybrid procedure included: 1) PAF refractory to both class I/III AAD and prior CB PVI or 2) persistent/LSPAF with failed class I/III AAD agreeable to hybrid procedure. Prior sternotomy was excluded. Serial electrocardiograms and continuous monitoring evaluated primary efficacy outcome of time-to-first recurrence of atrial arrhythmia after a 90-day blanking period. Secondary outcomes were procedure-related complications and AAD use (at discharge, 12, and 36 months). Kaplan-Meier methods evaluated arrhythmia recurrence. Of 276 patients, 197 (64.2 ± 10.6 years old; 66.5% male; 74.1% PAF; 18.3% persistent AF; 1.0% LSPAF; 6.6% undetermined) underwent CB PVI and 79 (61.4 ± 8.1 years old; 83.5% male; 41.8% PAF; 45.5% persistent AF; 12.7% LSPAF) underwent hybrid procedure. Arrhythmia freedom through 36 months was 55.2% for CB PVI and 50.4% for hybrid (p =0.32). Class I AAD utilization at discharge occurred in 38 (19.3%) patients in the CB PVI group and 5 (6.3%) patients in the hybrid group (p=0.01). CB PVI class I AAD utilization at 12 months occurred in 14 (9.0) patients versus 0 patients for hybrid convergent (p=0.004). Patients with one or more adverse event were as follows: two (1.0%) in the CB PVI group (both transient phrenic nerve palsy) and three (3.7%) in the hybrid group (two with significant bleeding and one with wound infection) (p=0.14). Conclusion: This study demonstrated that patients with more complex forms of AF (PAF refractory to both AAD and index endocardial ablation or persistent/LSPAF) could be well managed with a convergent approach. Moreover, outcomes match safety and efficacy thresholds achieved by patients with an early, less complex AF etiology treated by CB PVI alone.
15 Jun 2023Submitted to Journal of Cardiovascular Electrophysiology
15 Jun 2023Review(s) Completed, Editorial Evaluation Pending
15 Jun 2023Submission Checks Completed
15 Jun 2023Assigned to Editor
19 Jun 2023Reviewer(s) Assigned
07 Aug 2023Editorial Decision: Revise Minor
06 Oct 20231st Revision Received
25 Jan 20242nd Revision Received
25 Jan 2024Submission Checks Completed
25 Jan 2024Assigned to Editor
25 Jan 2024Review(s) Completed, Editorial Evaluation Pending
27 Jan 2024Reviewer(s) Assigned
12 May 2024Review(s) Completed, Editorial Evaluation Pending