Pilot safety and efficacy trial of amiodarone-infused biologic acellular biatrial patches to prevent new-onset postoperative atrial fibrillation.
- 1Department of Cardiovascular and Thoracic Surgery, University of Louisville, Louisville, Ky.
- 2Department of Cardiac Surgery, Johns Hopkins University, Baltimore, Md.
- 3Department of Cardiac Surgery, Ascension Saint Thomas, Nashville, Tenn.
Abstract
Objective
New onset postoperative atrial fibrillation (POAF) occurs in approximately 25% to 40% of patients undergoing heart surgery and is associated with increased perioperative morbidity and mortality. We evaluated the safety and exploratory efficacy of amiodarone-infused CardiaMend (Helios Cardio) biatrial patches for POAF prevention.Methods
A single-center pilot clinical trial enrolled 40 patients after applying inclusions and exclusion criteria, randomized in 1:1 fashion. Patients in the treatment group received the CardiaMend patch, a porous acellular matrix derived from fetal bovine dermis, infused with 70 mg amiodarone, placed on both atria, whereas the control group received standard care. The primary end point was safety, defined as major adverse cardiovascular and cerebrovascular events. Secondary end points included POAF, length of hospital stay, 30-day readmission, and POAF duration.Results
The 2 randomized groups had similar baseline characteristics. There were 2 major adverse cardiovascular and cerebrovascular events: 1 patient in the control group experienced an embolic stroke with full recovery before discharge, and 1 patient in the treatment group died from an acute abdominal event following intra-aortic balloon pump removal, deemed unrelated to the study device. The incidence of POAF (4 patients [20%] vs 8 patients [40%]; P = .30) and mean atrial fibrillation duration (2.5 ± 2.4 days vs 3.8 ± 4.1 days) were lower in the treatment group. Mean length of hospital stay was shorter in the treatment group (5.8 ± 1.2 days vs 9.3 ± 7.5 days; P = .07). At 30-day follow-up, Holter monitoring revealed no atrial fibrillation in the treatment group and 3 (15%) patients in the control group (P = .23), and readmission rates were also lower in the treatment group (5% vs 15%; P = .6).Conclusions
This pilot randomized clinical trial showed that amiodarone-infused CardiaMend biatrial patches were safe, with no evidence of systemic amiodarone toxicity. Treatment with amiodarone-infused CardiaMend patches was associated with a clinically noticeable reduction in POAF, length of stay, and postdischarge atrial fibrillation.
Related
- Efficacy of Stellate Ganglion Block for Preventing Postoperative Atrial Fibrillation After Cardiac Surgery: A Randomized, Double‐Blind, Placebo‐Controlled Trial
- Low-dose colchicine for the prevention of postoperative atrial fibrillation after bypass surgery: Results from the COLPOAF study
- Association of the triglyceride-glucose index and triglyceride-glucose-body mass index with postoperative atrial fibrillation in patients undergoing off-pump coronary artery bypass grafting: a retrospective cohort study
- Thromboembolic and Mortality Risk in Patients with Postoperative Atrial Fibrillation After Coronary Artery Bypass Graft—The TRIP-AF Study
- Efficacy and Predictors of Response to Biologic Therapy and Endoscopic Sinus Surgery in Patients With Nasal Polyps: A Systematic Review
BibTeX
@article{slaughter2026pilot,
title = {{Pilot safety and efficacy trial of amiodarone-infused biologic acellular biatrial patches to prevent new-onset postoperative atrial fibrillation.}},
author = {Mark S Slaughter and Joshua G Crane and Toyokazu Endo and Michele Gallo and Yash Vaidya and Siddharth V Pahwa and Niv Ad and Clayton A Kaiser and Jaimin R Trivedi},
journal = {JTCVS open},
year = {2026},
month = aug,
doi = {10.1016/j.xjon.2026.102076},
url = {https://europepmc.org/article/MED/42948487},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Pilot safety and efficacy trial of amiodarone-infused biologic acellular biatrial patches to prevent new-onset postoperative atrial fibrillation.
AU - Mark S Slaughter
AU - Joshua G Crane
AU - Toyokazu Endo
AU - Michele Gallo
AU - Yash Vaidya
AU - Siddharth V Pahwa
AU - Niv Ad
AU - Clayton A Kaiser
AU - Jaimin R Trivedi
PY - 2026
DA - 2026/08/22
JO - JTCVS open
DO - 10.1016/j.xjon.2026.102076
UR - https://europepmc.org/article/MED/42948487
AB - Objective New onset postoperative atrial fibrillation (POAF) occurs in approximately 25% to 40% of patients undergoing heart surgery and is associated with increased perioperative morbidity and mortality. We evaluated the safety and exploratory efficacy of amiodarone-infused CardiaMend (Helios Cardio) biatrial patches for POAF prevention.Methods A single-center pilot clinical trial enrolled 40 patients after applying inclusions and exclusion criteria, randomized in 1:1 fashion. Patients in the treatment group received the CardiaMend patch, a porous acellular matrix derived from fetal bovine dermis, infused with 70 mg amiodarone, placed on both atria, whereas the control group received standard care. The primary end point was safety, defined as major adverse cardiovascular and cerebrovascular events. Secondary end points included POAF, length of hospital stay, 30-day readmission, and POAF duration.Results The 2 randomized groups had similar baseline characteristics. There were 2 major adverse cardiovascular and cerebrovascular events: 1 patient in the control group experienced an embolic stroke with full recovery before discharge, and 1 patient in the treatment group died from an acute abdominal event following intra-aortic balloon pump removal, deemed unrelated to the study device. The incidence of POAF (4 patients [20%] vs 8 patients [40%]; P = .30) and mean atrial fibrillation duration (2.5 ± 2.4 days vs 3.8 ± 4.1 days) were lower in the treatment group. Mean length of hospital stay was shorter in the treatment group (5.8 ± 1.2 days vs 9.3 ± 7.5 days; P = .07). At 30-day follow-up, Holter monitoring revealed no atrial fibrillation in the treatment group and 3 (15%) patients in the control group (P = .23), and readmission rates were also lower in the treatment group (5% vs 15%; P = .6).Conclusions This pilot randomized clinical trial showed that amiodarone-infused CardiaMend biatrial patches were safe, with no evidence of systemic amiodarone toxicity. Treatment with amiodarone-infused CardiaMend patches was associated with a clinically noticeable reduction in POAF, length of stay, and postdischarge atrial fibrillation.
SN - 2666-2736
ER -