PhD Scientific Days 2023

Clinical Medicine - Posters A

Intracardiac Leadless Pacemaker: Long Term Safety Over Traditional Pacemakers. A Systematic Review and Meta-analysis

Előadó neve

Dr. Ghare, Sara

Neptun code

RS34DR

Előadó munkahelye

Semmelweis Egyetem Doktori Iskola

Előadó telefonszáma

+36705860624

Előadó e-mail címe

saraghrh@gmail.com

Az előadás címe

Intracardiac Leadless Pacemaker: Long Term Safety Over Traditional Pacemakers. A Systematic Review and Meta-analysis

Szerző(k) neve és munkahelye

Sara Ghare1,2, Marie Anne Engh1, Nikolett Vigh4, Peter Fehervari1, Boglarka Veres 1,3, Endre Zima1,3, Peter Hegyi1,5,6, Gabor Duray1,4

1. Centre for Translational Medicine, Semmelweis University, Budapest, Hungary
2. Gottsegen György National Cardiovascular Institute, Budapest, Hungary
3. Heart and Vascular Center, Semmelweis University, Budapest, Hungary
4. Central Hospital of Northern Pest - Military Hospital, Budapest, Hungary
5. Institute of Pancreatic Diseases, Semmelweis University, Budapest, Hungary
6. Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary

Bemutatás módja

Poszter

Szekció

Clinical Medicine - Posters A

Language of the presentation

English

Preferred session

Clinical Medicine

Összefoglaló szövege

Introduction: Leadless pacemaker (LP) is a novel technology designed to reduce lead-related complications that can be used in patients with high-degree AV block, sinus node dysfunction, and bradycardia with syncope. The advantage of a leadless pacemaker is the elimination of several complications associated with traditional pacemakers and leads, including pocket infections. We performed a systematic review and meta-analysis to examine the long-term safety of intra-cardiac leadless pacemakers over traditional pacemakers.

Methods: Our protocol was registered in advance on PROSPERO (CRD42021287570). Studies were eligible if they compared complications, revision, cardiac perforation, infections, and all-cause mortality between patients who received leadless pacemakers versus traditional pacemakers. The systematic search was conducted in four databases (MEDLINE, EMBASE, CENTRAL, Web of Science) without restriction. The random-effect model was implemented to calculate pooled odds ratio (OR) with a 95% confidence interval (CI). Also, the Mantel-Haenszel method, Paule-Mandel estimator for tau^2, Q-Profile method for the confidence interval of tau^2 and tau, and Hartung-Knapp adjustment for random effects model methods were used for the prediction of data extracted directly from the curves. ROBINS-I tool was used for the risk of bias assessment, and the certainty of the evidence was evaluated with the GRADE approach.

Results: Of 6450 studies screened, we identified 21 observational studies of Nanostim and Micra leadless pacemakers. The pooled incidence of complications of leadless versus traditional pacemakers at 1, 6, 12-24 months show the odds are clinically and statistically different (OR=0.66, random effect model CI: 0.46–1.02, prediction interval CI: 0.24-1.78; OR=0.44, random effect model CI: 0.22–0.86, prediction interval CI: 0.07-2.54; OR=0.41, random effect model CI: 0.32–0.53, prediction interval CI: 0.29-0.59 respectively). The pooled incidence of infection rate at 6, 12-24 months show clinically and statistically significant results at these outcomes (OR=0.37, random effect model CI: 0.31–0.44, prediction interval CI: 0.10-1.44; OR=0.44, random effect model CI: 0.00–4281.65). The studies comparing all-cause mortality during 6, 12-24 months in leadless versus conventional pacemakers did not show statistically significant differences in these outcomes (OR=1.26, random effect model CI: 0.88–1.81, prediction interval CI: 0.31-5.12; OR=0.86, random effect model CI: 0.25–2.92, prediction interval CI: 0.00-654.10, respectively)

Conclusion: Our results show that complications and infections occur less often in patients with leadless pacemakers than in conventional pacemakers. However, the need for high-quality randomized clinical trials and propensity score-matched studies focusing on this clinically relevant question is crucial.

Funding: The project was supported by the ÚNKP-22-3-I, a New National Excellence Program of the Ministry for Innovation and Technology from the source of the National Research, Development, and Innovation Fund (ÚNKP-22-3-I-SE-1).

University and Doctoral School

Semmelweis University, Doctoral School of Theoretical and Translational Medicine

Supervisor

Dr. Duray Gabor

Publication of my abstract

I do not give consent to the publication of my abstract on the website of the congress.

Kind

Szabad

Status

elfogadva

Accepted presentation method

poszter

Előadás fájl jóváhagyás

nem rendelkezett róla

Előadó

7525

Start

12:00

End

12:05

Authors (legacy)

Sara Ghare1,2, Marie Anne Engh1, Nikolett Vigh4, Peter Fehervari1, Boglarka Veres 1,3, Endre Zima1,3, Peter Hegyi1,5,6, Gabor Duray1,4

1. Centre for Translational Medicine, Semmelweis University, Budapest, Hungary
2. Gottsegen György National Cardiovascular Institute, Budapest, Hungary
3. Heart and Vascular Center, Semmelweis University, Budapest, Hungary
4. Central Hospital of Northern Pest - Military Hospital, Budapest, Hungary
5. Institute of Pancreatic Diseases, Semmelweis University, Budapest, Hungary
6. Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary