In a randomized trial involving 664 patients who had had a cryptogenic stroke, closure of a PFO combined with antiplatelet therapy resulted in significantly lower rates of subsequent stroke than ...antiplatelet therapy alone over a median follow-up of 3.2 years.
Abstract
Aims
Owing to new evidence from randomized controlled trials (RCTs) in low-risk patients with severe aortic stenosis, we compared the collective safety and efficacy of transcatheter aortic ...valve implantation (TAVI) vs. surgical aortic valve replacement (SAVR) across the entire spectrum of surgical risk patients.
Methods and results
The meta-analysis is registered with PROSPERO (CRD42016037273). We identified RCTs comparing TAVI with SAVR in patients with severe aortic stenosis reporting at different follow-up periods. We extracted trial, patient, intervention, and outcome characteristics following predefined criteria. The primary outcome was all-cause mortality up to 2 years for the main analysis. Seven trials that randomly assigned 8020 participants to TAVI (4014 patients) and SAVR (4006 patients) were included. The combined mean STS score in the TAVI arm was 9.4%, 5.1%, and 2.0% for high-, intermediate-, and low surgical risk trials, respectively. Transcatheter aortic valve implantation was associated with a significant reduction of all-cause mortality compared to SAVR {hazard ratio HR 0.88 95% confidence interval (CI) 0.78–0.99, P = 0.030}; an effect that was consistent across the entire spectrum of surgical risk (P-for-interaction = 0.410) and irrespective of type of transcatheter heart valve (THV) system (P-for-interaction = 0.674). Transcatheter aortic valve implantation resulted in lower risk of strokes HR 0.81 (95% CI 0.68–0.98), P = 0.028. Surgical aortic valve replacement was associated with a lower risk of major vascular complications HR 1.99 (95% CI 1.34–2.93), P = 0.001 and permanent pacemaker implantations HR 2.27 (95% CI 1.47–3.64), P < 0.001 compared to TAVI.
Conclusion
Compared with SAVR, TAVI is associated with reduction in all-cause mortality and stroke up to 2 years irrespective of baseline surgical risk and type of THV system.
Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis and intermediate or high surgical risk.
The aim of ...this study was to compare the durability of transcatheter and surgical bioprosthetic aortic valves using standardized criteria.
In the NOTION (Nordic Aortic Valve Intervention) trial, all-comer patients with severe aortic stenosis and lower surgical risk for mortality were randomized 1:1 to TAVR (n = 139) or SAVR (n = 135). Moderate/severe structural valve deterioration (SVD) was defined as a mean gradient ≥20 mm Hg, an increase in mean gradient ≥10 mm Hg from 3 months post-procedure, or more than mild intraprosthetic aortic regurgitation (AR) either new or worsening from 3 months post-procedure. Nonstructural valve deterioration (NSVD) was defined as moderate/severe patient-prosthesis mismatch at 3 months or moderate/severe paravalvular leakage. Bioprosthetic valve failure (BVF) was defined as: valve-related death, aortic valve reintervention, or severe hemodynamic SVD.
At 6 years, the rates of all-cause mortality were similar for TAVR (42.5%) and SAVR (37.7%) patients (p = 0.58). The rate of SVD was higher for SAVR than TAVR (24.0% vs. 4.8%; p < 0.001), whereas there were no differences in NSVD (57.8% vs. 54.0%; p = 0.52) or endocarditis (5.9% vs. 5.8%; p = 0.95). BVF rates were similar after SAVR and TAVR through 6 years (6.7% vs. 7.5%; p = 0.89).
In the NOTION trial through 6 years, SVD was significantly greater for SAVR than TAVR, whereas BVF was low and similar for both groups. Longer-term follow-up of randomized clinical trials will be necessary to confirm these findings. (Nordic Aortic Valve Intervention Trial; NCT01057173)
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Subclinical leaflet thrombosis - a concern, but also an issue? Søndergaard, Lars
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,
02/2018, Letnik:
13, Številka:
15
Journal Article
BACKGROUND:The NOTION trial (Nordic Aortic Valve Intervention) was designed to compare transcatheter aortic valve replacement (TAVR) with surgical aortic valve replacement (SAVR) in patients ≥70 ...years old with isolated severe aortic valve stenosis. Clinical and echocardiographic outcomes are presented after 5 years.
METHODS:Patients were enrolled at 3 Nordic centers and randomized 1:1 to TAVR using the self-expanding CoreValve prosthesis (n=145) or SAVR using any stented bioprostheses (n=135). The primary composite outcome was the rate of all-cause mortality, stroke, or myocardial infarction at 1 year defined according to Valve Academic Research Consortium-2 criteria.
RESULTS:Baseline characteristics were similar. The mean age was 79.1±4.8 years and mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 3.0%±1.7%. After 5 years, there were no differences between TAVR and SAVR in the composite outcome (Kaplan-Meier estimates 38.0% versus 36.3%, log-rank test P=0.86) or any of its components. TAVR patients had larger prosthetic valve area (1.7 cm versus 1.2 cm, P<0.001) with a lower mean transprosthetic gradient (8.2 mm Hg versus 13.7 mm Hg, P<0.001), both unchanged over time. More TAVR patients had moderate/severe total aortic regurgitation (8.2% versus 0.0%, P<0.001) and a new pacemaker (43.7% versus 8.7%, P<0.001). Four patients had prosthetic reintervention and no difference was found for functional outcomes.
CONCLUSIONS:These are currently the longest follow-up data comparing TAVR and SAVR in lower risk patients, demonstrating no statistical difference for major clinical outcomes 5 years after TAVR with a self-expanding prosthesis compared to SAVR. Higher rates of prosthetic regurgitation and pacemaker implantation were seen after TAVR.
CLINICAL TRIAL REGISTRATION:URLhttps://clinicaltrials.gov. Unique identifierNCT01057173.
The authors sought to investigate whether a patient-specific implantation technique during transcatheter aortic valve replacement (TAVR) can result in a safe and reproducible neo-commissural ...alignment of self-expanding transcatheter heart valves (THVs).
To date, little attention has been paid to neo-commissural alignment during TAVR.
A fluoroscopy-based, patient- and valve-specific TAVR implantation technique was applied in 60 patients treated with 3 different self-expanding THV platforms (Evolut R/PRO, Medtronic; ACURATE neo2, Boston Scientific; and Portico, Abbott—20 patients in each group). Post-TAVR cardiac computed tomography was used to assess THV neo-commissural alignment.
Considering all 60 patients, ≤mild commissural misalignment (CMA <30°) was obtained in 53 patients (88%) using this modified TAVR implantation technique—in 36 patients (60%), optimal commissural alignment (<15°) was obtained. In 2 patients, cardiac computed tomography revealed severe CMA (>45°) with overlap between the coronary ostia and THV commissures. Using the ACURATE neo2 platform, operators succeeded in avoiding ≥moderate CMA in all 20 cases. When analyzing those cases in which the optimal amount of THV rotation could be assessed and applied before THV expansion (n = 52; 87%), the success rate of TAVR with ≤mild CMA was 98%. No procedure- or valve-related complications occurred in this study cohort.
A patient-specific TAVR implantation technique aiming to obtain neo-commissural alignment is feasible and safe, and aides to prevent THV implantations with overlap between the coronary ostia and THV commissures. Optimized TAVR devices and design may further improve the success rate of TAVR with neo-commissural alignment.
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