{
  "abstract": "Objective\n\nNew 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\n\nA 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\n\nThe 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\n\nThis 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.",
  "abstract_shown": true,
  "affiliations": [
    "Department of Cardiovascular and Thoracic Surgery, University of Louisville, Louisville, Ky.",
    "Department of Cardiac Surgery, Johns Hopkins University, Baltimore, Md.",
    "Department of Cardiac Surgery, Ascension Saint Thomas, Nashville, Tenn."
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 9,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Mark S Slaughter"
    },
    {
      "affs": [
        0
      ],
      "name": "Joshua G Crane"
    },
    {
      "affs": [
        0
      ],
      "name": "Toyokazu Endo"
    },
    {
      "affs": [
        0
      ],
      "name": "Michele Gallo"
    },
    {
      "affs": [
        0
      ],
      "name": "Yash Vaidya"
    },
    {
      "affs": [
        0
      ],
      "name": "Siddharth V Pahwa"
    },
    {
      "affs": [
        1
      ],
      "name": "Niv Ad"
    },
    {
      "affs": [
        2
      ],
      "name": "Clayton A Kaiser"
    },
    {
      "affs": [
        0
      ],
      "name": "Jaimin R Trivedi"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/388rsk0s6j1bp.bib",
  "cited_by": 0,
  "doi": "10.1016/j.xjon.2026.102076",
  "fulltext_url": "https://europepmc.org/articles/PMC13711286",
  "id": "388rsk0s6j1bp",
  "issns": [
    "2666-2736"
  ],
  "landing_url": "https://europepmc.org/article/MED/42948487",
  "language": "eng",
  "licence": "CC-BY-NC-ND",
  "licence_label": "CC BY-NC-ND",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc-nd/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "Adult: Arrhythmias: Clinical Trial"
    ],
    [
      "openalex",
      "2705|Atrial Fibrillation Management and Outcomes"
    ]
  ],
  "openalex": "W7203973127",
  "pdf_url": "https://europepmc.org/articles/PMC13711286?pdf=render",
  "pmcid": "PMC13711286",
  "pmid": "42948487",
  "published": "2026-08-22",
  "publisher": "Elsevier",
  "ris": "https://research.draconitic.com/paper/388rsk0s6j1bp.ris",
  "sources": [
    {
      "first_seen": "2026-10-31T00:20:35Z",
      "native_id": "MED:42948487",
      "source": "europepmc",
      "url": "https://europepmc.org/article/MED/42948487"
    },
    {
      "first_seen": "2026-10-31T12:22:05Z",
      "native_id": "PMC13711286",
      "source": "pmc",
      "url": "https://doi.org/10.1016/j.xjon.2026.102076"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2705|Atrial Fibrillation Management and Outcomes",
      "subfield": "cardiovascular"
    }
  ],
  "title": "Pilot safety and efficacy trial of amiodarone-infused biologic acellular biatrial patches to prevent new-onset postoperative atrial fibrillation.",
  "title_text": "Pilot safety and efficacy trial of amiodarone-infused biologic acellular biatrial patches to prevent new-onset postoperative atrial fibrillation.",
  "type": "peer-reviewed",
  "updated_at": "2026-10-31T12:22:05Z",
  "url": "https://research.draconitic.com/paper/388rsk0s6j1bp",
  "venue": "JTCVS open",
  "versions": []
}