scholarly journals 464 Implantation of contemporary transcatheter aortic valves in small aortic annuli: the international multicentre TAVI-SMALL 2 registry

2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Pier Pasquale Leone ◽  
Damiano Regazzoli ◽  
Francesco Cannata ◽  
Matteo Pagnesi ◽  
Mauro Chiarito ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Stenosis ◽  
Severe Aortic Stenosis ◽  
Pacemaker Implantation ◽  
High Volume ◽  
Paravalvular Leak ◽  
Surgical Aortic Valve Replacement ◽  
Transcatheter Aortic Valve ◽  
All Cause Mortality ◽  
Sapien 3

Abstract Aims In patients with severe aortic stenosis, trans-prosthetic haemodynamics after transcatheter aortic valve implantation (TAVI) tend to be more favourable than after surgical aortic valve replacement, especially after self-expandable valve (SEV) implantation. The relative performance of TAVI according to leaflet position, that is supra-annular and intra-annular valves (SAV and IAV, respectively), has not been investigated thoroughly. Moreover, prosthesis-patient mismatch (PPM) is more common in patients with small aortic annuli, even though its clinical impact after TAVI is debated. Compare haemodynamics and clinical outcomes of transcatheter SAV and IAV in patients with small annuli. Methods TAVI SMALL 2 is an international retrospective registry of 1378 patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm2 on computed tomography) treated with transfemoral transcatheter SEV (Evolut R/Pro, n = 750, Acurate Neo, n = 170 and Portico n = 172) and balloon-expandable valves (BEV, Sapien 3, n = 286) in 16 high-volume centres. Analyses were performed according to mechanism of valve release, that is SEV (n = 1092) vs. BEV (n = 286), and according to leaflet position, that is SAV (Evolut R/Pro and Acurate Neo, n = 920) vs. IAV (Sapien 3 and Portico, n = 458). Primary endpoints were pre-discharge mean aortic gradient and incidence of severe PPM. Secondary endpoint was incidence of all-cause mortality. Results Pre-discharge mean aortic gradient was lower both after SAV vs. IAV (7.8 ± 3.9 vs. 12.0 ± 5.1, P <0.001) and SEV vs. BEV implantation (8.0 ± 4.1 vs. 13.6 ± 4.7, P<0.001). IAV implantation was more often complicated by severe PPM when compared to SAV implantation (8.8% vs. 3.6%, P = 0.007), and severe PPM was more common after BEV than after SEV implantation (8.7% vs. 4.6%, P = 0.041). At a median follow-up of 377 days (interquartile range 168–700 days), all-cause mortality occurred in 11.9% of patients after IAV and 9.4% after SAV implantation (P = 0.172), and in 12.3% and 9.8% of BEV and SEV groups, respectively (P = 0.218). Results were confirmed at Kaplan-Meier analysis (log-rank P = 0.748 and 0.687 for SAV vs. IAV and SEV vs. BEV, respectively, Figure 1). Pre-discharge more than mild paravalvular leak (PVL) was more common with SEV than BEV (11.6% vs. 2.6%, P <0.001), while incidence of more than moderate PVL was higher both after SAV vs. IAV (1.5% vs. 0.2%, P = 0.043) and SEV vs. BEV implantation (1.4% vs. 0%, P = 0.052). New permanent pacemaker implantation was higher after SEV than BEV (13.5% vs. 8.1%, P = 0.013). Conclusions In this high-numerosity registry of patients with small aortic annuli, TAVI with SAV and SEV yielded a more favourable forward haemodynamic profile than after IAV and BEV implantation, respectively. All-cause mortality did not differ between groups.

scholarly journals Transcatheter aortic valve implantation vs. surgical aortic valve replacement for treatment of symptomatic severe aortic stenosis: an updated meta-analysis

2019 ◽  
Vol 40 (38) ◽  
pp. 3143-3153 ◽  
Author(s):  
George C M Siontis ◽  
Pavel Overtchouk ◽  
Thomas J Cahill ◽  
Thomas Modine ◽  
Bernard Prendergast ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Stenosis ◽  
Transcatheter Aortic Valve Implantation ◽  
Severe Aortic Stenosis ◽  
Surgical Aortic Valve Replacement ◽  
Surgical Risk ◽  
Transcatheter Aortic Valve ◽  
All Cause Mortality ◽  
Aortic Valve Implantation ◽  
Valve Implantation

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.

scholarly journals Aortic valve function post-replacement of severe aortic stenosis by transcatheter procedure versus surgery: A systematic review and metanalysis

2020 ◽  
Author(s):  
Charbel Abi Khalil ◽  
Barbara Ignatiuk ◽  
Guliz Erdem ◽  
Hiam Chemaitelly ◽  
Fabio Barilli ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Stenosis ◽  
Randomized Clinical Trials ◽  
Severe Aortic Stenosis ◽  
Meta Analysis ◽  
Paravalvular Leak ◽  
Effective Orifice Area ◽  
Surgical Aortic Valve Replacement ◽  
Transcatheter Aortic Valve ◽  
Transcatheter Heart Valve

Abstract Transcatheter aortic valve implantation (TAVI) has shown to reduce mortality compared to surgical aortic valve replacement (sAVR). However, it is known which procedure is associated with better post-procedural valvular function. We conducted a meta-analysis of randomized clinical trials that compared TAVI to sAVR for at least 2 years. The primary outcome was post-procedural patient-prosthesis-mismatch (PPM). Secondary outcomes were post-procedural and 2-year: effective orifice area (EOA), paravalvular gradient (PVG) and moderate/severe paravalvular leak (PVL). We identified 6 trials with a total of 7022 participants with severe aortic stenosis. TAVI was associated with 37% (95% CI [0.51-0.78) mean RR reduction of post-procedural PPM, a decrease that was not affected by the surgical risk at inclusion, neither by the transcatheter heart valve system. Postprocedural changes in gradient and EOA were also in favor of TAVI as there was a pooled mean difference decrease of 0.56 (95% CI [0.73-0.38]) in gradient and an increase of 0.47 (95% CI [0.38-0.56]) in EOA. Additionally, self-expandable valves were associated with a higher decrease in gradient than balloon ones (beta= 0.38; 95% CI [0.12-0.64]). However, TAVI was associated with a higher risk of moderate/severe PVL (pooled RR: 9.54, 95% CI [5.53-16.46]). All results were sustainable at 2 years.

scholarly journals The ACURATE neo2 valve system for transcatheter aortic valve implantation: 30-day and 1-year outcomes

2021 ◽  
Author(s):  
Helge Möllmann ◽  
David M. Holzhey ◽  
Michael Hilker ◽  
Stefan Toggweiler ◽  
Ulrich Schäfer ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Transcatheter Aortic Valve Implantation ◽  
Pacemaker Implantation ◽  
Paravalvular Leak ◽  
Transcatheter Aortic Valve ◽  
All Cause Mortality ◽  
Valve Thrombosis ◽  
Aortic Valve Implantation ◽  
And Performance ◽  
Valve Implantation

Abstract Background Transcatheter aortic valve implantation (TAVI) has become standard treatment for elderly patients with symptomatic severe aortic valve stenosis. The ACURATE neo AS study evaluates 30-day and 1-year clinical and hemodynamic outcomes in patients treated with the ACURATE neo2 valve. Methods The primary endpoint of this single-arm multicenter study is 30-day all-cause mortality. Other key endpoints include device performance, echocardiographic measures assessed by an independent core laboratory, and VARC-2 clinical efficacy and safety endpoints through 12 months. Results The study enrolled 120 patients (mean age 82.1 ± 4.0 years; 67.5% female, mean baseline STS score 4.8 ± 3.8%). The VARC-2 composite safety endpoint at 30 days occurred in 13.3% of patients. All-cause mortality was 3.3% at 30 days and 11.9% at 1 year. The 30-day stroke rate was 2.5% (disabling stroke 1.7%); there were no new strokes between 30 days and 12 months. The rate of permanent pacemaker implantation was 15.0% (18/120) at 30 days and 17.8% (21/120) at 1 year. No patients required re-intervention for valve-related dysfunction and there were no cases of valve thrombosis or endocarditis. Patients demonstrated significant improvement in mean aortic valve gradient (baseline 38.9 ± 13.1 mmHg, 1 year 7.8 ± 3.5 mmHg; P < 0.001 in a paired analysis). In the overall population, paravalvular leak was evaluated at 1 year as none/trace in 60.5%, mild in 37.0%, and moderate in 2.5%; no patients had severe PVL. Conclusions One-year outcomes from the ACURATE neo AS study support the safety and performance of TAVI with the ACURATE neo2 valve. Graphic Abstract

scholarly journals Aortic valve function post-replacement of severe aortic stenosis by transcatheter procedure versus surgery: a systematic review and metanalysis

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Charbel Abi Khalil ◽  
Barbara Ignatiuk ◽  
Guliz Erdem ◽  
Hiam Chemaitelly ◽  
Fabio Barilli ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Stenosis ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Randomized Clinical Trials ◽  
Severe Aortic Stenosis ◽  
Paravalvular Leak ◽  
Effective Orifice Area ◽  
Surgical Aortic Valve Replacement ◽  
Transcatheter Heart Valve

AbstractTranscatheter aortic valve replacement (TAVR) has shown to reduce mortality compared to surgical aortic valve replacement (sAVR). However, it is unknown which procedure is associated with better post-procedural valvular function. We conducted a meta-analysis of randomized clinical trials that compared TAVR to sAVR for at least 2 years. The primary outcome was post-procedural patient-prosthesis-mismatch (PPM). Secondary outcomes were post-procedural and 2-year: effective orifice area (EOA), paravalvular gradient (PVG) and moderate/severe paravalvular leak (PVL). We identified 6 trials with a total of 7022 participants with severe aortic stenosis. TAVR was associated with 37% (95% CI [0.51–0.78) mean RR reduction of post-procedural PPM, a decrease that was not affected by the surgical risk at inclusion, neither by the transcatheter heart valve system. Postprocedural changes in gradient and EOA were also in favor of TAVR as there was a pooled mean difference decrease of 0.56 (95% CI [0.73–0.38]) in gradient and an increase of 0.47 (95% CI [0.38–0.56]) in EOA. Additionally, self-expandable valves were associated with a higher decrease in gradient than balloon ones (beta = 0.38; 95% CI [0.12–0.64]). However, TAVR was associated with a higher risk of moderate/severe PVL (pooled RR: 9.54, 95% CI [5.53–16.46]). All results were sustainable at 2 years.

scholarly journals IMPULSE: the impact of gender on the presentation and management of aortic stenosis across Europe

Open Heart ◽  
2021 ◽  
Vol 8 (1) ◽  
pp. e001443
Author(s):  
Richard Paul Steeds ◽  
David Messika-Zeitoun ◽  
Jeetendra Thambyrajah ◽  
Antonio Serra ◽  
Eberhard Schulz ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Stenosis ◽  
Severe Aortic Stenosis ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Surgical Aortic Valve Replacement ◽  
Ventricular Ejection Fraction ◽  
Patient Profile ◽  
Transcatheter Aortic Valve ◽  
The Impact

AimsThere is an increasing awareness of gender-related differences in patients with severe aortic stenosis and their outcomes after surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI).MethodsData from the IMPULSE registry were analysed. Patients with severe aortic stenosis (AS) were enrolled between March 2015 and April 2017 and stratified by gender. A subgroup analysis was performed to assess the impact of age.ResultsOverall, 2171 patients were enrolled, and 48.0% were female. Women were characterised by a higher rate of renal impairment (31.7 vs 23.3%; p<0.001), were at higher surgical risk (EuroSCORE II: 4.5 vs 3.6%; p=0.001) and more often in a critical preoperative state (7.0vs 4.2%; p=0.003). Men had an increased rate of previous cardiac surgery (9.4 vs 4.7%; p<0.001) and a reduced left ventricular ejection fraction (4.9 vs 1.3%; p<0.001). Concomitant mitral and tricuspid valve disease was substantially more common among women. Symptoms were highly prevalent in both women and men (83.6 vs 77.3%; p<0.001). AVR was planned in 1379 cases. Women were more frequently scheduled to undergo TAVI (49.3 vs 41.0%; p<0.001) and less frequently for SAVR (20.3 vs 27.5%; p<0.001).ConclusionsThe present data show that female patients with severe AS have a distinct patient profile and are managed in a different way to males. Gender-based differences in the management of patients with severe AS need to be taken into account more systematically to improve outcomes, especially for women.

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