scholarly journals 467 Update on supra-annular sizing of transcatheter aortic valve prostheses in raphe-type bicuspid aortic valve disease according to the LIRA method

2021 ◽  
Vol 23 (Supplement_G) ◽  
Author(s):  
Gianmarco Iannopollo ◽  
Vittorio Romano ◽  
Nicola Buzzatti ◽  
Marco Ancona ◽  
Luca Ferri ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Ct Scan ◽  
Bicuspid Aortic Valve ◽  
Paravalvular Leak ◽  
Plane Method ◽  
Transcatheter Aortic Valve ◽  
Transcatheter Heart Valve ◽  
Balloon Size ◽  
Study Population

Abstract Aims Transcatheter Aortic Valve Replacement (TAVR) in patients with bicuspid aortic valve (BAV) still represents a challenge due to the peculiar anatomy and the lack of consensus for the optimal CT scan sizing method for prosthesis selection. Recent evidences have shown that transcatheter heart valve (THV) anchoring in BAV patients might occur at the raphe-level, known as the LIRA (Level of Implantation at the RAphe) plane. Furthermore, a novel supra-annular sizing method based on the measurement of the perimeter at the raphe-level (LIRA-method) was shown to be safe and effective in 20 consecutive BAV patients with severe aortic stenosis. The purpose of this study was to confirm the safety and the efficacy of the LIRA method in a larger study population. Methods and results the LIRA plane method was applied to all consecutive patients with raphe-type BAV disease between November 2018 to September 2021 in our centre. We prospectively sized TAVI prosthesis according to the manufacture recommendations on the basis of baseline CT scan perimeters at the LIRA plane. Post-procedural device success, defined according to Valve Academic Research Consortium-2 (VARC-2) criteria, was evaluated in the overall cohort. Forty-four patients were identified as having a raphe-type BAV disease at pre-TAVI CT scans. Mean patient age was 80 ± 6.2 years and 74% were males; median Society of Thoracic Surgeons (STS) predicted risk of mortality score was 4.3 (3.0–6.5). Three different BAV anatomies (36 patients with BAV type 1 with calcific raphe, 5 patients with BAV type 1 with fibrotic raphe, and 3 patients with BAV type 2) were implanted with different types of TAVI prostheses (6 Acurate Neo 2,16 Acurate Neo, 21 Core Valve Evolut R/Pro , 1 Lotus) sized prospectively according to the LIRA plane method. In all patients, there was a significant discrepancy between LIRA and virtual basal ring (VBR) measurements with LIRA plane perimeter smaller than VBR perimeter (mean perimeter LIRA 73.1 ± 8.3 mm vs. mean perimeter VBR 81.5 ± 6.6 mm; P < 0.001). The prostheses were sized according to the manufacture recommendations on the basis of the LIRA plane perimeter (diameter prosthesis implanted/diameter prosthesis according to LIRA plane = 1) (DPI/DP LIRA = 1) and significantly downsized according to the VBR perimeter (DPI/DP VBR 0.89; P < 0.001). The median prosthesis size was 25 mm (23–27). Pre-dilatation was frequently performed (86%) with a median balloon size of 20 mm (18–22), whereas post-dilatation was applied in 27% of the cases with a median balloon size of 23 mm (20–26). The LIRA plane method appeared to be highly successful (100% VARC-2 device success) with no procedural mortality, no valve migration, residual trivial/mild paravalvular leak with no cases of moderate-severe regurgitation and low transprosthetic gradient (residual mean gradient of 8.3 ± 3.5 mmHg) with no cases of mean gradient >20 mmHg pre-discharge. The rate of new pacemaker implantation was 9%. Conclusions Supra-annular sizing according to the LIRA plane method confirmed to be safe with a high device success in a larger study population. The application of the LIRA plane method might optimize TAVI prosthesis sizing in patients with raphe-type BAV disease.

scholarly journals Transcatheter Aortic Valve Implantation in Sievers Type 0 vs. Type 1 Bicuspid Aortic Valve Morphology: Systematic Review and Meta-Analysis

2021 ◽  
Vol 8 ◽  
Author(s):  
Yu Du ◽  
Zhijian Wang ◽  
Wei Liu ◽  
Yonghe Guo ◽  
Wei Han ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Bicuspid Aortic Valve ◽  
Transcatheter Aortic Valve Implantation ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Paravalvular Leak ◽  
Transcatheter Aortic Valve ◽  
Aortic Valve Implantation ◽  
Valve Implantation

Background: Transcatheter aortic valve implantation (TAVI) has achieved satisfactory outcomes in the selected patients with bicuspid aortic valve (BAV), predominately type 1 BAV (~90%). However, there are few reports about the safety and efficacy of TAVI in type 0 BAV. Therefore, in the current study, we aimed to compare procedural and 30-day outcomes after TAVI between type 0 and type 1 BAV.Methods: Studies comparing the outcomes of TAVI in Sievers type 0 vs. type 1 BAV were retrieved from PubMed, EMBASE, Cochrane Library, and Web of Science from inception to May 2021. The data were extracted regarding the study characteristics and outcomes. The odds ratios (ORs) with 95% CIs were pooled for procedural and 30-day outcomes.Results: Six observational studies were included with determined type 0 BAV in 226 patients and type 1 BAV in 902 patients. The patients with type 0 BAV were slightly younger, had larger supra-annular structure, and more frequently implanted self-expanding prosthesis compared with type 1 BAV. In the pooled analyses, the patients with type 0 BAV had a similar incidence of procedural death (OR = 2.6, 95% CI 0.7–10.3), device success (OR = 0.6; 95% CI 0.3–1.3), and ≥ mild (OR = 0.8; 95% CI 0.4–1.6) or moderate (OR = 0.9, 95% CI 0.4–1.8) paravalvular leak, whereas significantly higher mean aortic gradient (mean difference = 1.4 mmHg, 95% CI 0.03–2.7) and increased coronary compromise risk (OR = 7.2; 95% CI 1.5–34.9), compared with type 1 BAV. Meanwhile, the incidence of death (OR = 1.2; 95% CI 0.5–3.1), stroke (OR = 0.5; 95% CI 0.1–2.4), and new pacemaker (OR = 0.6; 95% CI 0.2–2.2) at 30 days were not significantly different between the BAV morphologies (p > 0.05). The treatment effect heterogeneity across the studies for the above outcomes were low.Conclusions: The patients with type 0 BAV appear to have similar short-term outcomes after TAVI compared with type 1 BAV. Whereas, TAVI for type 0 BAV aortic stenosis might lead to an elevated coronary obstruction risk and suboptimal aortic valvular hemodynamics.

scholarly journals Outcome of transcatheter aortic valve replacement in bicuspid aortic valve stenosis with new-generation devices

2020 ◽  
Vol 32 (1) ◽  
pp. 20-28
Author(s):  
Riccardo Gorla ◽  
Matteo Casenghi ◽  
Alice Finotello ◽  
Federico De Marco ◽  
Simone Morganti ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Stress Distribution ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Bicuspid Aortic Valve ◽  
Transcatheter Aortic Valve Replacement ◽  
Paravalvular Leak ◽  
Orifice Area ◽  
Transcatheter Aortic Valve ◽  
New Generation

Abstract OBJECTIVES To compare device success and paravalvular leak rates of 3 new-generation transcatheter aortic valve replacement devices in patients with bicuspid aortic valve stenosis and to test their biomechanical performance in a computer-based simulation model of aortic root with increasing ellipticity. METHODS This retrospective multicentre study included 56 bicuspid aortic valve patients undergoing transcatheter aortic valve replacement with new-generation devices: Lotus/Lotus Edge (N = 15; 27%), Evolut-R (N = 20; 36%) and ACURATE neo (N = 21; 37%). Three virtual simulation models of aortic root with increasing index of eccentricity (0–0.25–0.5) were implemented. Stress distribution, stent–root contact area and paravalvular orifice area were computed. RESULTS Device success was achieved in 43/56 patients (77%) with comparable rates among Lotus (87%), Evolut-R (60%) and ACURATE neo (86%; P = 0.085). Moderate paravalvular leak rate was significantly lower in the Lotus group as compared to Evolut-R group (0% vs 30%; P = 0.027) and comparable to the ACURATE neo group (0% vs 10%; P = 0.33). By index of eccentricity = 0.5, Lotus showed a uniform and symmetric pattern of stress distribution with absent paravalvular orifice area, ACURATE neo showed a mild asymmetry with small paravalvular orifice area (1.1 mm2), whereas a severely asymmetric pattern was evident with Evolut-R, resulting in a large paravalvular orifice area (12.0 mm2). CONCLUSIONS Transcatheter aortic valve replacement in bicuspid aortic valve patients with new-generation devices showed comparable device success rates. Lotus showed moderate paravalvular leak rate comparable to that of ACURATE neo and significantly lower than Evolut-R. On simulation, Lotus and ACURATE neo showed optimal adaptability to elliptic anatomies as compared to Evolut-R.

scholarly journals Transcatheter and surgical aortic valve replacement in patients with bicuspid aortic valve

2020 ◽  
Author(s):  
Annastiina Husso ◽  
Juhani Airaksinen ◽  
Tatu Juvonen ◽  
Mika Laine ◽  
Sebastian Dahlbacka ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Bicuspid Aortic Valve ◽  
Surgical Aortic Valve Replacement ◽  
Clinical Trial Registration ◽  
Term Outcome ◽  
Transcatheter Aortic Valve

Abstract Objectives To compare the outcomes after surgical (SAVR) and transcatheter aortic valve replacement (TAVR) for severe stenosis of bicuspid aortic valve (BAV). Methods We evaluated the early and mid-term outcome of patients with stenotic BAV who underwent SAVR or TAVR for aortic stenosis from the nationwide FinnValve registry. Results The FinnValve registry included 6463 AS patients and 1023 (15.8%) of them had BAV. SAVR was performed in 920 patients and TAVR in 103 patients with BAV. In the overall series, device success after TAVR was comparable to SAVR (94.2% vs. 97.1%, p = 0.115). TAVR was associated with increased rate of mild-to-severe paravalvular regurgitation (PVR) (19.4% vs. 7.9%, p < 0.0001) and of moderate-to-severe PVR (2.9% vs. 0.7%, p = 0.053). When newer-generation TAVR devices were evaluated, mild-to-severe PVR (11.9% vs. 7.9%, p = 0.223) and moderate-to-severe PVR (0% vs. 0.7%, p = 1.000) were comparable to SAVR. Type 1 N-L and type 2 L-R/R-N were the BAV morphologies with higher incidence of mild-to-severe PVR (37.5% and 100%, adjusted for new-generation prostheses p = 0.025) compared to other types of BAVs. Among 75 propensity score-matched cohorts, 30-day mortality was 1.3% after TAVR and 5.3% after SAVR (p = 0.375), and 2-year mortality was 9.7% after TAVR and 18.7% after SAVR (p = 0.268) Conclusions In patients with stenotic BAV, TAVR seems to achieve early and mid-term results comparable to SAVR. Type 1 N-L and type 2 L-R/R-N BAV morphologies had higher incidence of PVR. Larger studies evaluating different phenotypes of BAV are needed to confirm these findings. Clinical trial registration ClinicalTrials.gov Identifier: NCT03385915. Graphic abstract

scholarly journals Patient-specific Computer Simulation: An Emerging Technology for Guiding the Transcatheter Treatment of Patients with Bicuspid Aortic Valve

2021 ◽  
Vol 16 ◽  
Author(s):  
Cameron Dowling ◽  
Robert Gooley ◽  
Liam McCormick ◽  
Sami Firoozi ◽  
Stephen J Brecker
Keyword(s):  
Computer Simulation ◽  
Aortic Valve ◽  
Clinical Outcomes ◽  
Bicuspid Aortic Valve ◽  
Patient Specific ◽  
Transcatheter Aortic Valve ◽  
Anatomical Basis ◽  
Transcatheter Heart Valve ◽  
Risk Patients ◽  
Valve Implantation

Transcatheter aortic valve implantation (TAVI) is increasingly being used to treat younger, lower-risk patients, many of whom have bicuspid aortic valve (BAV). As TAVI begins to enter these younger patient cohorts, it is critical that clinical outcomes from TAVI in BAV are matched to those achieved by surgery. Therefore, the identification of patients who, on an anatomical basis, may not be suitable for TAVI, would be desirable. Furthermore, clinical outcomes of TAVI in BAV might be improved through improved transcatheter heart valve sizing and positioning. One potential solution to these challenges is patient-specific computer simulation. This review presents the methodology and clinical evidence surrounding patient-specific computer simulation of TAVI in BAV.

scholarly journals Device Selection in Patients with Borderline Size Aortic Valve Annulus Undergoing Transcatheter Aortic Valve Implantation

2021 ◽  
Author(s):  
Yeela Talmor-Barkan ◽  
Ran Kornowski ◽  
Noam Bar ◽  
Jeremy Ben-Shoshan ◽  
Hanna Vaknin-Assa ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Transcatheter Aortic Valve Implantation ◽  
Severe Aortic Stenosis ◽  
Pacemaker Implantation ◽  
Paravalvular Leak ◽  
Transcatheter Aortic Valve ◽  
Transcatheter Heart Valve ◽  
Device Selection ◽  
Aortic Valve Implantation ◽  
Valve Implantation

Abstract Transcatheter heart valve (THV) selection for transcatheter aortic valve implantation (TAVI) is crucial to achieve procedural success. Borderline aortic annulus size (BAAS), which allows a choice between two consecutive valve sizes, is a common challenge during device selection. In the present study, we evaluated TAVI outcomes in patients with BAAS according to THV size selection. We performed a retrospective study including patients with severe aortic stenosis (AS) and BAAS, measured by multidetector computed tomography (MDCT), undergoing TAVI with self-expandable (SE) or balloon-expandable (BE) THV from the Israeli multicenter TAVI registry. TAVI outcomes were assessed according to the Valve Academic Research Consortium-2 (VARC-2). Out of 2,352 patients with MDCT measurements, 598 patients with BAAS as defined for at least one THV type were included in the study. In BAAS patients treated with SE-THV, larger THV selection was associated with lower rate of paravalvular leak (PVL), compared to smaller THV (45.3% vs. 64.5%; pv = 0.0038). Regarding BE-THV, larger valve selection was associated with lower post-procedural transvalvular gradients compared to smaller THV (mean gradient: 9.9 ± 3.7mmHg vs. 12.5 ± 7.2mmHg; p = 0.019). Of note, rates of mortality, left bundle branch block, permanent pacemaker implantation, stroke, annular rupture and/or coronary occlusion did not differ between groups. BAAS is common among patients undergoing TAVI. Selection of a larger THV in these patients is associated with lower rates of PVL and better hemodynamic profile in patients implanted with SE and BE-THV, respectively, with no effect on procedural complications.

scholarly journals Transcatheter aortic valve implantation for bicuspid aortic valve stenosis: Acute and intermediate-term outcomes in a high volume institution

2017 ◽  
Vol 86 (1-2) ◽  
Author(s):  
Anže Djordjević ◽  
Giuseppe D'Ancona ◽  
Axel Unbehaun ◽  
Stephan Kische ◽  
Hüseyin Ince ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Bicuspid Aortic Valve ◽  
Transcatheter Aortic Valve Implantation ◽  
Academic Research ◽  
High Volume ◽  
Paravalvular Leak ◽  
Conventional Surgery ◽  
Transcatheter Aortic Valve ◽  
Aortic Valve Implantation ◽  
Valve Implantation

Background: We report our experience with transcatheter aortic valve implantation (TAVI) in patients with bicuspid aortic valve (BAV) stenosis.Methods: Perioperative and intermediate-term follow-up data were retrospectively analysed. All procedures were performed within the premises of an experienced high-volume TAVI centre.Results: Tirty-three consecutive BAV patients (age 55 to 87 years) underwent TAVI. Mean logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) was 23,2 ± 19,3. Transapical Edwards Sapien® valve was implanted in the majority of patients (87.9 %). Nine patients (27.3 %) required post-ballooning of the implanted valve for moderate to severe paravalvular leak, 3 patients (9 %) required a second valve implantation for persistent severe paravalvular leak, and 2 (6 %) required conversion to conventional surgery. Post-operative mild aortic regurgitation (AR) was presented in 12 patients (36.4%) and AR = 2 in 3 %. No AR > 2 was observed. Te device success rate according to the valve academic research consortium (VARC) criteria was 82 %. Similar BAV anatomy, calcium distribution, type and size of implanted valve were noticed in patients with and without residual AR. Tere was no thirty-day mortality. Two-year estimated survival was 70 % (CI: 52.7–93.1) and was similar in patients with and without post-procedural residual paravalvular leak.Conclusions: TAVI in BAV stenosis is feasible but, even in experienced centres, is technically more challenging and is associated with a higher rate of post-dilatation, re-valving, and conversion to conventional surgery. Results should be re-tested in light of the recent introduction of second-generation TAVI prostheses.

Transcatheter Aortic Valve Replacement for Bicuspid Aortic Valve Stenosis: A Practical Operative Overview

2021 ◽  
Author(s):  
Giuseppe Tarantini ◽  
Tommaso Fabris
Keyword(s):  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Bicuspid Aortic Valve ◽  
Transcatheter Aortic Valve Replacement ◽  
Heart Valves ◽  
Imaging Techniques ◽  
Transcatheter Aortic Valve ◽  
Transcatheter Heart Valve ◽  
Implantation Techniques

The bicuspid aortic valve (BAV) represents a complex anatomic scenario for transcatheter aortic valve replacement (TAVR) because of its unique technical challenges. As TAVR is moving towards younger and lower-risk populations, the proportion of BAV patients undergoing TAVR is expected to rise. Initial experiences of TAVR with first-generation transcatheter heart valves in high surgical risk patients with BAV stenosis showed higher rates of device failure and periprocedural complications as compared to tricuspid anatomy. The subsequent advances in imaging techniques and understanding of BAV anatomy, new iterations of transcatheter heart valves, and growing operators’ experience yielded better outcomes. However, in the lack of randomized trials and rigorous evidence, the field of TAVR in BAV has been driven by empirical observations, with wide variability in transcatheter heart valve sizing and implantation techniques across different centers and operators. Thus, in this review article, we provide a fully illustrated overview of operative periprocedural steps for TAVR in BAV stenosis, though recognizing that it still remains anecdotal.

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

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