Transcatheter Aortic Valve Implantation With the Third Generation Balloon-Expandable Bioprosthesis in Patients With Severe Landing Zone Calcium

Mohammad Abdelghani; Nader Mankerious; Martin Landt; Ralph Toelg; Mohamed Abdel-Wahab; Gert Richardt

doi:10.1016/j.amjcard.2019.12.022

Transcatheter Aortic Valve Implantation With the Third Generation Balloon-Expandable Bioprosthesis in Patients With Severe Landing Zone Calcium

Am J Cardiol. 2020 Mar 15;125(6):931-940. doi: 10.1016/j.amjcard.2019.12.022. Epub 2019 Dec 27.

Authors

Mohammad Abdelghani¹, Nader Mankerious², Martin Landt², Ralph Toelg², Mohamed Abdel-Wahab³, Gert Richardt²

Affiliations

¹ Heart Center, Segeberger Kliniken, Bad Segeberg, Germany; Cardiology Department, the Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Cardiology Department, Al-Azhar University, Cairo, Egypt. Electronic address: m.abdelghani.nl@gmail.com.
² Heart Center, Segeberger Kliniken, Bad Segeberg, Germany.
³ Cardiology Department, Heart Center Leipzig - University Hospital, Leipzig, Germany.

PMID: 31959428
DOI: 10.1016/j.amjcard.2019.12.022

Abstract

Device success of earlier generation balloon-expandable transcatheter heart valves (BE-THV) is lower in patients with severe landing zone calcium (LZC). We sought to explore the impact of LZC on the outcome of transcatheter aortic valve implantation (TAVI) with the next generation Edwards Sapien 3 BE-THV. In the present study, severe LZC was defined as severe aortic valve cusp calcium (AVC) and/or left ventricular outflow tract calcium (LVOTC) on computed tomography. Patients who underwent TAVI for pure/predominant aortic regurgitation, bicuspid aortic valve disease, or failed bioprosthetic valve were excluded. Out of 350 patients who underwent TAVI with the Edwards Sapien 3 (age 80.7 ± 6.1, female: 45.1%, Society of Thoracic Surgeons score: 4.9 ± 3.8, transfemoral: 97.4%), 106 (30.3%) had severe LZC; 78 severe AVC (22.3%) and 49 severe LVOTC (14.0%). Severe LZC was associated with lower device success (96.2% vs 100%, p = 0.008) driven by more prosthetic valve regurgitation (PVR, p = 0.008). On multivariable analysis, PVR was associated with severe LVOTC (odds ratio [95% confidence interval] 2.130 [1.092 to 4.158]) but not with severe AVC (1.529 [0.835 to 2.800]). Balloon predilatation (BPreD) was performed in 42.5% of patients with severe LZC (vs 19.3% in nonsevere LZC; p <0.001) and was associated with prolonged procedural time (p = 0.001) and higher irradiation exposure (p = 0.027). Device success (p = 0.311), major procedural complications (p = 0.132), 30-day safety end point (p = 0.815), and PVR (p = 0.684) were not significantly different between patients with severe LZC who underwent BPreD versus direct TAVI. In conclusion, device success of the third generation BE-THV is lower in severe LZC driven by more PVR, especially in patients with severe LVOTC. In those patients, BPreD prolonged the procedure without improving THV performance.

Trial registration: ClinicalTrials.gov NCT03192774.

Publication types

Clinical Trial

MeSH terms

Aged
Aged, 80 and over
Aortic Valve / pathology*
Aortic Valve Stenosis / complications*
Aortic Valve Stenosis / therapy
Bioprosthesis*
Calcinosis / complications*
Calcinosis / therapy
Female
Humans
Male
Middle Aged
Multivariate Analysis
Prosthesis Design*
Transcatheter Aortic Valve Replacement / instrumentation*
Transcatheter Aortic Valve Replacement / methods
Treatment Outcome

Supplementary concepts

Aortic Valve, Calcification of

Associated data

ClinicalTrials.gov/NCT03192774