Predictors and Trends of New Permanent Pacemaker Implantation: A Subanalysis of the International Navitor IDE Study.

Sultan, Ibrahim; Reardon, Michael J; Søndergaard, Lars; Chehab, Bassem; Smith, Dave; Walton, Antony S; Worthley, Stephen G; Manoharan, Ganesh; Yong, Gerald; Jilaihawi, Hasan; Asch, Federico; Bates, Nicholas; Fontana, Gregory P

Sultan, Ibrahim; Reardon, Michael J; Søndergaard, Lars; Chehab, Bassem; Smith, Dave; Walton, Antony S; Worthley, Stephen G; Manoharan, Ganesh; Yong, Gerald; Jilaihawi, Hasan; Asch, Federico; Bates, Nicholas; Fontana, Gregory P.

Afiliação

Sultan I; Division of Cardiac Surgery, Department of Cardiothoracic Surgery, Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
Reardon MJ; Department of Cardiovascular Surgery, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas, USA.
Søndergaard L; Structural Heart Medical Affairs, Abbott Medical, Santa Clara, California, USA.
Chehab B; Department of Cardiology, Ascension Via Christi Hospital, University of Kansas, Wichita, Kansas, USA.
Smith D; Morriston Hospital, Swansea Bay University Health Board, Swansea, UK.
Walton AS; Department of Interventional Cardiology, Alfred Hospital, Melbourne, Victoria, Australia.
Worthley SG; Monash University, Melbourne, Victoria, Australia.
Manoharan G; Department of Cardiology, Macquarie University Hospital, Macquarie Park, New South Wales, Australia.
Yong G; Regional Cardiology Centre, Royal Victoria Hospital, Belfast, UK.
Jilaihawi H; Department of Cardiology, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.
Asch F; Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Bates N; Cardiovascular Core Labs, MedStar Health Research Institute and Georgetown University, Washington, District of Columbia, USA.
Fontana GP; Structural Heart Clinical Affairs, Abbott Medical, St. Paul, Minnesota, USA.

Struct Heart ; 8(4): 100293, 2024 Jul.

Article em En | MEDLINE | ID: mdl-39100579

ABSTRACT

ABSTRACT

Background:

The Navitor Investigational Device Exemption (IDE) study is a prospective, multicenter, global study assessing the safety and effectiveness of the Navitor valve in a population with severe, symptomatic aortic stenosis who are at high and extreme surgical risk. The impact of pre-existing conduction abnormalities and implantation technique on new permanent pacemaker implantation (PPI) for the Navitor platform is not fully understood. Therefore, the goal of this analysis was to investigate the associations between patient and procedural factors and the 30-day new PPI rate.

Methods:

A total of 260 patients who underwent implantation of a Navitor valve in the Navitor IDE study were reviewed. Patients with preprocedural permanent pacemakers (n = 28) were excluded. Baseline risk factors were assessed for statistical significance. Multivariable logistic regression analyses were performed to identify independent predictors of new PPI.

Results:

Mean age of the pacemaker-naïve population was 83.3 ± 5.2 years, 58.6% were female, average Society of Thoracic Surgeons score was 3.8% ± 1.9%, median frailty score was 1 (interquartile range 1, 2), and 17.7% were deemed at extreme surgical risk. Pre-existing first-degree atrioventricular block and right bundle branch block significantly increased the risk of new PPI postimplantation, whereas left bundle branch block did not. Membranous septum length in relation to noncoronary cusp implant depth was a significant predictor of new PPI, with higher rates of new PPI observed when noncoronary cusp implant depth exceeded membranous septum length. Analysis of implant depth alone revealed deeper implants were associated with a higher rate of new PPI, regardless of patient baseline conduction abnormality.