Evidence map›Paper›PMID 40063122›Full record

ArticleClinical research in cardiology : official journal of the German Cardiac Society2025

Cardiac implantable electronic device carriers undergoing transcatheter tricuspid valve annuloplasty: real-world insights.

Jan M Wrobel, Johannes Kirchner, Kai Friedrichs, Thorsten Gietzen, Jan Althoff, Caroline Hasse, Philipp von Stein, Jonas Wörmann, Jennifer von Stein, Jonathan Curio and 9 more

Abstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical research in cardiology : official journal of the German Cardiac Society, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

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

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Review
4 · The record

Corrections and comments

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

19 authors.

Jan M WrobelHeart Center, Department III of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Kerpener Straße 62, 50937, Cologne, Germany.ORCID http://orcid.org/0000-0002-1637-3413
Johannes KirchnerClinic for General and Interventional Cardiology/Angiology, Herz- Und Diabeteszentrum NRW, Ruhr-Universität Bochum, Med. Fakultät OWL (Universität Bielefeld), Bad Oeynhausen, Germany.
Kai FriedrichsClinic for General and Interventional Cardiology/Angiology, Herz- Und Diabeteszentrum NRW, Ruhr-Universität Bochum, Med. Fakultät OWL (Universität Bielefeld), Bad Oeynhausen, Germany.
Thorsten GietzenHeart Center, Department III of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Kerpener Straße 62, 50937, Cologne, Germany.
Jan AlthoffHeart Center, Department III of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Kerpener Straße 62, 50937, Cologne, Germany.
Caroline HasseHeart Center, Department III of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Kerpener Straße 62, 50937, Cologne, Germany.
Philipp von SteinHeart Center, Department III of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Kerpener Straße 62, 50937, Cologne, Germany.
Jonas WörmannHeart Center, Department III of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Kerpener Straße 62, 50937, Cologne, Germany.
Jennifer von SteinHeart Center, Department III of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Kerpener Straße 62, 50937, Cologne, Germany.
Jonathan CurioHeart Center, Department III of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Kerpener Straße 62, 50937, Cologne, Germany.
Felix RudolphClinic for General and Interventional Cardiology/Angiology, Herz- Und Diabeteszentrum NRW, Ruhr-Universität Bochum, Med. Fakultät OWL (Universität Bielefeld), Bad Oeynhausen, Germany.
Maria IvannikovaClinic for General and Interventional Cardiology/Angiology, Herz- Und Diabeteszentrum NRW, Ruhr-Universität Bochum, Med. Fakultät OWL (Universität Bielefeld), Bad Oeynhausen, Germany.
Christos IliadisHeart Center, Department III of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Kerpener Straße 62, 50937, Cologne, Germany.
Daniel StevenHeart Center, Department III of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Kerpener Straße 62, 50937, Cologne, Germany.
Stephan BaldusHeart Center, Department III of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Kerpener Straße 62, 50937, Cologne, Germany.
Volker RudolphClinic for General and Interventional Cardiology/Angiology, Herz- Und Diabeteszentrum NRW, Ruhr-Universität Bochum, Med. Fakultät OWL (Universität Bielefeld), Bad Oeynhausen, Germany.
Roman PfisterHeart Center, Department III of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Kerpener Straße 62, 50937, Cologne, Germany.
Muhammed GerçekClinic for General and Interventional Cardiology/Angiology, Herz- Und Diabeteszentrum NRW, Ruhr-Universität Bochum, Med. Fakultät OWL (Universität Bielefeld), Bad Oeynhausen, Germany.
Maria I KoerberHeart Center, Department III of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, Kerpener Straße 62, 50937, Cologne, Germany. maria.koerber@uk-koeln.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTranstricuspid cardiac implantable electronic devices (CIEDs) complicate the management of tricuspid regurgitation (TR). Transcatheter tricuspid valve annuloplasty (TTVA) offers a promising approach due to minimal interaction with leaflets and transvalvular CIEDs, though real-world evidence is limited.

methodsThis bi-center, retrospective study includes 204 consecutive patients who underwent TTVA with the Cardioband (Edwards Lifesciences) for severe symptomatic TR. Patients were divided into CIED carriers and non-CIED carriers. CIED carriers were further classified into those with lead-associated TR (LTR-A) and those with TR unrelated to CIED leads (LTR-B).

resultsAmong the 204 patients, 41 (20%) were CIED carriers. Of these, 24% had mixed TR etiology (functional and LTR-A), while 76% had predominantly functional TR (LTR-B). Compared to non-CIED-carriers, CIED carriers were more symptomatic (NYHA-FC > II; 93% vs. 89%; p = 0.026) with comparable TR severity at baseline. Intraprocedural success according to the Tricuspid Valve Academic Research Consortium was 68% in CIED carriers and 70% in non-CIED carriers (p = 0.851). LTR-A was associated with poorer TR reduction immediately after TTVA (p = 0.022). Overall safety was comparable, with right ventricular lead dislodgement occurring in one patient. Beyond that, CIED function remained unimpaired. At 30 days, echocardiographic follow-up showed comparable TR reduction (TR ≤ II: 56% vs. 68%; p = 0.219) and NYHA-FU ≤ II (63% vs. 70%; p = 0.524) in CIED-and non-CIED carriers, respectively.

conclusionsTTVA achieves significant TR reduction, providing a safe and effective therapeutic option for TR treatment in CIED carriers. WHAT IS KNOWN?: TTVA using the Cardioband has been approved for severe, symptomatic TR patients, however data on the safety and efficacy in CIED carriers is lacking. WHAT THE STUDY ADDS?: Intraprocedural success and safety were comparable in CIED and non-CIED carriers treated with TTVA. Subgroup analyses showed a trend towards worse outcome and efficiency of TTVA in patients with LTR-A. Postinterventional CIED interrogations did not show critical technical issues.

Indexed as

Cardiac CatheterizationCardiac Valve AnnuloplastyDefibrillators, ImplantablePacemaker, ArtificialTricuspid ValveTricuspid Valve InsufficiencyAgedAged, 80 and overFemaleFollow-Up StudiesHumansMaleMiddle AgedRetrospective StudiesTreatment OutcomeCardiac implantable electronic devicesEfficacySafetyTranscatheter tricuspid valve annuloplastyTricuspid regurgitationTVARC

Identifiers

PMID40063122
PMCPMC12202581

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.