TAVI PACER: A two-step risk score for prediction of permanent pacemaker implantation after TAVI.

Abstract

Background 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.

Methods Between January 2019 and December 2020, 1039 patients underwent TAVI at our institution. We retrospectively evaluated clinical, electrocardiographic, echocardiographic, computed tomographic, and periprocedural data. Patients with prior PPMI were excluded. We developed a prediction model for the occurrence of PPMI, initially using 55 patient and procedural characteristics.

Results We included 836 patients (mean age 80.2 ± 9.1 years, 50.5% female), among whom 140 patients (16.6%) needed PPMI within 30 days after TAVI. In the first step, the TAVI PACER score calculates an individual risk for PPMI, including 14 preprocedural risk factors such as preexisting right bundle branch block, atrioventricular block, left bundle branch block, bradycardia, interventricular septum thickness in diastole, NYHA class, and aortic annulus perimeter. In the second step, intraprocedural variables are included to demonstrate how PPMI risk can vary based on the chosen valve type and implantation depth. The TAVI PACER score can predict PPMI with a sensitivity of 76% and specificity of 72% (AUC = 0.8).

Conclusions The TAVI PACER score provides a novel tool for daily clinical practice, which predicts the individual risk for PPMI after TAVI based on various patient and two procedural characteristics.

What Is Known High-grade conduction disturbances are among the most common and clinically significant complications following TAVI. While recent research has extensively explored the factors leading to an increased risk of pacemaker implantation after TAVI, an established scoring system that considers individual patient risk profiles and predicts the likelihood of requiring a pacemaker before the procedure is still lacking.

What the Study Adds We developed a new two-step risk score called the TAVI PACER Score, which aims to close the gap in existing data on current prosthesis generations. In the first step, it considers various patient characteristics, and in the second step, it evaluates the impact of different procedural options on the necessity for pacemaker implantation. By calculating the individual pacemaker risk before the procedure and integrating it into treatment planning, our risk score aims to improve transparency in patient care, facilitate shared decision-making, and ultimately enhance the treatment outcomes of TAVI.

Competing Interest Statement

H.D. received research support from Abbott, advisory board, and speaker?s fees from Abbott and Edwards. V. T. received research support from Abbott and Zoll, as well as speaker fees from Novartis, Biotronik, Medtronic, and Astra Zeneca.

Funding Statement

In order to conduct this study, there was no funding received.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The Ethics Committee at the Charite Mitte Campus of the Charite Ethics Committee (management: Katja Orzechowski, Chariteplatz 1, 10117 Berlin) gave ethical approval for this work on 22nd december 2021 (EA1/341/21).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data utilized in this study can be requested and viewed by the authors.

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