Treatment of Severe Aortic Stenosis with a Transcatheter or Surgical Bioprosthesis: Results from the FinnValve Registry

Marko Virtanen

Research output: Book/ReportDoctoral thesisCollection of Articles

Abstract

Symptomatic severe aortic valve stenosis is associated with high mortality rate, even up to 50% at 1 to 2 years, unless treated operatively. Transcatheter aortic valve implantation (TAVI) has emerged as a valid alternative to surgical aortic valve replacement (SAVR) in patients with high surgical risk. However, there are insufficient data comparing TAVI and SAVR in patients with low surgical risk.

This thesis is based on three original publications that are referred to by the Roman numerals I, II and III. The aim of this study was to compare operative mortality, estimated 3- to 4-year mortality and procedural safety in patients with severe aortic stenosis who underwent TAVI or SAVR with a bioprosthesis and who were I at low risk for surgery, II at low risk for surgery without having concomitant coronary artery disease, or III treated with a transcatheter balloon-expandable or surgical bioprosthesis made of bovine pericardial leaflets.

Data of patients included in the retrospective FinnValve registry were used (n=6463). A total of 2841 patients in study I, 1006 patients in study II, and 2000 patients in study III fulfilled the inclusion criteria. Propensity score matching was performed to balance the baseline variables and provided 304 (I), 140 (II) and 308 (III) matched pairs. Primary endpoints: Operative mortality between matched pairs was 1.3% vs. 3.6% (p=0.12) (I), 2.1% vs. 2.1% (p=1.000) (II), and 1.3% vs. 3.6% (p=0.092) (III) for TAVI vs. SAVR. The estimated mortality at 3 years after TAVI vs. SAVR was 14.3% vs. 12.3% (p=0.45) in study I and 17.0% vs. 14.6% (p=0.805) in study II. The estimated mortality at 4 years was 20.6% after TAVI vs. 25.9% after SAVR (p=0.910) in study III. Secondary endpoints: No significant differences were observed in the postoperative rate of stroke or acute kidney injury in study I or II. In study III, TAVI was associated with lower rates of stroke (1.3% vs. 3.6%, p=0.006) and acute kidney injury (0.3% vs. 7.8% p< 0.0001) than SAVR. In all studies, TAVI was associated with a higher incidence of major vascular complications (e.g., II 7.9% vs. 0.7%, p=0.006), lower rates of atrial fibrillation (e.g., III 33.1% vs. 64.9%, p<0.0001) and severe bleeding (e.g., II 2.3% vs. 16.9% p<0.001), and a four-day-shorter hospital stay (p<0.001 in all) than SAVR. Paravalvular regurgitation was more common after TAVI, but the incidence of moderate/severe paravalvular regurgitation was similar (1.9% vs. 1.3%, p=0.754 III). Permanent pacemaker implantation was more often needed after TAVI (9.5%) than after SAVR (4.6%) (p=0.03) in study I, but this was not observed in study II or III. The rates of late coronary revascularization, prosthetic valve endocarditis and aortic valve reintervention at 3 to 4 years were low and were similar between TAVI and SAVR. TAVI was associated with increased risk of permanent pacemaker implantation at 4 years (HR 2.16; 95% CI 1.27–3.68) compared to SAVR in study III, but not in study II.

Conclusions: TAVI is associated with similar mid-term survival at 3 to 4 years compared to SAVR in low-risk patients with aortic stenosis who undergo valve intervention with bioprosthesis. Postoperative complications are typical for both treatments. Its lower frequencies of bleeding, acute kidney injury, atrial fibrillation, stroke, and shorter hospital stay favour TAVI, while the lower incidences of major vascular complications, permanent pacemaker implantations and paravalvular regurgitation favour SAVR. TAVI can be offered as an alternative to SAVR in low- risk patients, but longer-term follow-up studies are essential to assess the durability of TAVI prostheses.
Original languageEnglish
Place of PublicationTampere
PublisherTampere University
ISBN (Electronic)978-952-03-1942-7
ISBN (Print)978-952-03-1941-0
Publication statusPublished - 2021
Publication typeG5 Doctoral dissertation (article)

Publication series

NameTampere University Dissertations - Tampereen yliopiston väitöskirjat
Volume411
ISSN (Print)2489-9860
ISSN (Electronic)2490-0028

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