Oversized versus Non-oversized Prosthesis: Midterm Outcomes after Transcatheter Aortic Valve Replacement Using SAPIEN 3 Valve.
Aged
Aged, 80 and over
Aortic Valve
/ diagnostic imaging
Aortic Valve Stenosis
/ diagnostic imaging
Female
Heart Valve Prosthesis
Humans
Male
Postoperative Complications
/ etiology
Prosthesis Design
Prosthesis Failure
Recovery of Function
Retrospective Studies
Risk Assessment
Risk Factors
Time Factors
Tomography, X-Ray Computed
Transcatheter Aortic Valve Replacement
/ adverse effects
Treatment Outcome
Journal
The Thoracic and cardiovascular surgeon
ISSN: 1439-1902
Titre abrégé: Thorac Cardiovasc Surg
Pays: Germany
ID NLM: 7903387
Informations de publication
Date de publication:
Aug 2021
Aug 2021
Historique:
pubmed:
21
7
2020
medline:
24
11
2021
entrez:
21
7
2020
Statut:
ppublish
Résumé
A certain degree of prosthesis oversizing is recommended for the SAPIEN 3 (S3; Edwards Lifesciences Corp., Irvine, California, United States) to ensure device success. We aimed to investigate midterm outcomes in patients who received oversized (OS) S3 valve after transapical-transcatheter aortic valve replacement (TA-TAVR). Out of 122 patients with aortic stenosis who underwent TA-TAVR using S3 at our institution, 42 received OS prosthesis. We used computed tomography (CT) derived effective diameter to assess oversizing. We defined oversizing if the labeled diameter of the selected valve for implantation was ≥2 mm bigger than the effective annulus diameter calculated by the annulus area. We conducted a midterm follow-up and compared the OS cohort with the non-OS (nOS) cohort. The study groups showed similar risk score and age (STS [Society of Thoracic Surgery] score: 5.4 ± 3; mean age: 80.7 ± 5.7). The 30-day mortality was 7.1% in OS versus 2.4% in nOS. The 30-day all-stroke was 2.4% in OS versus 0% in nOS. The 1- and 3-year all-cause mortality were 28.5 and 42.8% in OS versus 21.9 and 26.8% in nOS, respectively. Midterm freedom from death and from cardiocerebral events was similar in both groups. Moderate/severe paravalvular leakage occurred in 0% in OS versus 5.4% in nOS. The postdilation rate was 7.1% in OS versus 15.3% in nOS. The rate of new permanent pacemaker implantation (PPI) was 15.7% in OS versus 9.3% in nOS. The STS score was detected as an independent predictor of mortality. Oversizing reduces the risk of device failure and intraprocedural postdilation but increases the risk of PPI. Early and midterm morbidity and mortality after OS and nOS with S3 are comparable.
Sections du résumé
BACKGROUND
BACKGROUND
A certain degree of prosthesis oversizing is recommended for the SAPIEN 3 (S3; Edwards Lifesciences Corp., Irvine, California, United States) to ensure device success. We aimed to investigate midterm outcomes in patients who received oversized (OS) S3 valve after transapical-transcatheter aortic valve replacement (TA-TAVR).
METHODS
METHODS
Out of 122 patients with aortic stenosis who underwent TA-TAVR using S3 at our institution, 42 received OS prosthesis. We used computed tomography (CT) derived effective diameter to assess oversizing. We defined oversizing if the labeled diameter of the selected valve for implantation was ≥2 mm bigger than the effective annulus diameter calculated by the annulus area. We conducted a midterm follow-up and compared the OS cohort with the non-OS (nOS) cohort.
RESULTS
RESULTS
The study groups showed similar risk score and age (STS [Society of Thoracic Surgery] score: 5.4 ± 3; mean age: 80.7 ± 5.7). The 30-day mortality was 7.1% in OS versus 2.4% in nOS. The 30-day all-stroke was 2.4% in OS versus 0% in nOS. The 1- and 3-year all-cause mortality were 28.5 and 42.8% in OS versus 21.9 and 26.8% in nOS, respectively. Midterm freedom from death and from cardiocerebral events was similar in both groups. Moderate/severe paravalvular leakage occurred in 0% in OS versus 5.4% in nOS. The postdilation rate was 7.1% in OS versus 15.3% in nOS. The rate of new permanent pacemaker implantation (PPI) was 15.7% in OS versus 9.3% in nOS. The STS score was detected as an independent predictor of mortality.
CONCLUSION
CONCLUSIONS
Oversizing reduces the risk of device failure and intraprocedural postdilation but increases the risk of PPI. Early and midterm morbidity and mortality after OS and nOS with S3 are comparable.
Identifiants
pubmed: 32688405
doi: 10.1055/s-0040-1713168
doi:
Types de publication
Comparative Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
445-454Informations de copyright
Thieme. All rights reserved.
Déclaration de conflit d'intérêts
J. S. received lecture fees from Edwards Lifesciences in regard to the surgical sutureless aortic prosthetic valve Edwards Intuity. M. B. received lecture fees from Edwards Lifesciences in regard to the surgical sutureless aortic prosthetic valve Edwards Intuity. M. S. received lecture fees from Edwards Lifesciences in regard to the surgical sutureless aortic prosthetic valve Edwards Intuity. These three authors have nothing else to disclose. All other authors declare no potential conflict of interest.