Evidence map›Paper›PMID 42158035›Full record

ArticleTransplantation direct2026

Leadless Helix-fixation Pacemakers in Solid Organ Transplant Recipients: A Multisite Experience.

Amal Youssef, Julie L Rosenthal, Bashar A Aqel, Andrew Rosenbaum, Parag C Patel, Hicham El-Masry, Mayank Sardana

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Article in Transplantation direct, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

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PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Amal YoussefDepartment of Cardiovascular Medicine, Mayo Clinic, Phoenix, AZ.
Julie L RosenthalDepartment of Cardiovascular Medicine, Mayo Clinic, Phoenix, AZ.
Bashar A AqelDepartment of Gastroenterology and Hepatology, Mayo Clinic, Phoenix, AZ.
Andrew RosenbaumDepartment of Cardiovascular Medicine, Mayo Clinic, Rochester, MN.
Parag C PatelDepartment of Cardiovascular Medicine, Mayo Clinic, Jacksonville, FL.
Hicham El-MasryDepartment of Cardiovascular Medicine, Mayo Clinic, Phoenix, AZ.
Mayank SardanaDepartment of Cardiovascular Medicine, Mayo Clinic, Phoenix, AZ.ORCID https://orcid.org/0000-0001-9465-1047

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Solid organ transplant recipients (SOTRs) are at heightened risk for cardiovascular implantable electronic device-related complications, particularly infection, because of chronic immunosuppression and comorbidities. Although leadless pacemakers (LPs) reduce infection risk by eliminating transvenous leads and generator pockets, adoption in SOTRs has remained limited, largely because earlier systems were restricted to single-chamber ventricular pacing and lacked physiologic atrioventricular synchrony. The helix-fixation Aveir LP platform enables atrial, ventricular, and dual-chamber leadless pacing, but clinical experience in transplant recipients remains limited. Methods: We conducted a retrospective, multisite analysis across an integrated health system, identifying all adult SOTRs who underwent Aveir LP implantation between January 2022 and October 2025. Clinical characteristics, transplant details, pacing indications, device configuration, procedural outcomes, and follow-up data were collected. Primary outcomes included procedural success, complications, and device-related infection. Secondary outcomes included pacing performance, need for system revision or upgrade, and early device durability. Results: Thirteen SOTRs (mean age 64 ± 15 y; 15% female) underwent Aveir LP implantation, including atrial (n = 4), ventricular (n = 5), and dual-chamber (n = 4) systems. Transplanted organs included heart (46%), lung (31%), kidney (38%), and liver (15%), with 31% having multiple organ transplants. Over half of patients were critically ill at implantation, and 46% were dialysis-dependent, representing a high-risk cohort. All procedures were acutely successful with no intraprocedural complications. During a median follow-up of 258 d (interquartile range, 216-641 d), no device-related infections occurred. Electrical performance remained stable, with 1 atrial device replacement at 2.5 y for elevated capture thresholds. Conclusions: In a high-risk population of SOTRs, atrial and atrioventricular synchronous leadless pacing using the Aveir platform was feasible, achieved high acute procedural success, and demonstrated favorable early safety signals, including absence of device-related infection over available follow-up. Larger studies with longer-term follow-up are needed to define durability and long-term outcomes.

Identifiers

PMID42158035
PMCPMC13183142

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