TAVI PACER: A Two-step Risk Score for Prediction of Permanent Pacemaker Implantation After TAVI.

German Heart Institute1,000 enrolled

Overview

The need for permanent pacemaker implantation (PPMI) remains one of the most frequent complications after transcatheter aortic valve implantation (TAVI). This study aimed to develop a novel, two-step risk score to predict PPMI probability after TAVI and to implement it into a user-friendly website. Our risk score addresses the gap in existing data on current prosthesis generations and provides a new and clinically motivated approach to calculating the risk for PPMI.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Pacemaker TAVI Risk Score

Interventions

TAVI, pacemakerDEVICE

Retrospective analysis of need for pacemaker implantation after TAVI

Eligibility

Sex: ALLMin age: 51 YearsMax age: 95 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients undergoing TAVI at Deutsches Herzzentrum der Charité between January 2019 and December 2020 Exclusion Criteria: * previous device implantation * valve-in-valve procedure * patients who had received an ALLEGRATM valve (NVT AG, Morges, Switzerland), a LOTUS EdgeTM valve (Boston, Scientific, Natick, Massachusetts), or a CENTERATM valve (Edwards Lifesciences, Irvine, California)

Locations (1)

Deutsches Herzzentrum der Charité

Mitte, State of Berlin, Germany

Outcomes

Primary Outcomes

Pacemaker Implantation

Rate of pacemaker implantation up to 30 days after TAVI according to current guidelines

Time frame: 30 days after TAVI

Data from ClinicalTrials.gov

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