Safety and Efficacy of Myval Implantation in Patients with Severe Bicuspid Aortic Valve Stenosis—A Multicenter Real-World Experience

Bicuspid aortic valve (BAV) is the most common valvular congenital anomaly and is apparent in nearly 50% of candidates for AV replacement. While transcatheter aortic valve implantation (TAVI) is a recommended treatment for patients with symptomatic severe aortic stenosis (AS) at all surgical risk levels, experience with TAVI in severe bicuspid AS is limited. TAVI in BAV is still a challenge due to its association with multiple and complex anatomical considerations. A retrospective study has been conducted to investigate TAVI’s procedural and 30-day outcomes using the Myval transcatheter heart valve (THV) (Meril Life Sciences Pvt. Ltd. Vapi, Gujarat, India) in patients with severe bicuspid AS. Data were collected on 68 patients with severe bicuspid AS who underwent TAVI with the Myval THV. Baseline characteristics, procedural, 30-day echocardiographic and clinical outcomes were collected. The mean age and STS PROM score were 72.6 ± 9.4 and 3.54 ± 2.1. Procedures were performed via the transfemoral route in 98.5%. Major vascular complications (1.5%) and life-threatening bleeding (1.5%) occurred infrequently. No patient had coronary obstruction, second valve implantation or conversion to surgery. On 30-day echocardiography, the mean transvalvular gradient and effective orifice area were 9.8 ± 4.5 mmHg and 1.8 ± 0.4 cm2, respectively. None/trace aortic regurgitation occurred in 76.5%, mild AR in 20.5% and moderate AR in 3%. The permanent pacemaker implantation rate was 8.5% and 30-day all-cause death occurred in 3.0% of cases. TAVI with the Myval THV in selected BAV anatomy is associated with favorable short-term hemodynamic and clinical outcomes.

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Impact of Mitral Regurgitation on Clinical Outcomes After Transcatheter Aortic Valve Implantation

Interventional Cardiology Review ◽

10.15420/icr.2016.11.01.54 ◽

2016 ◽

Vol 11 (1) ◽

pp. 54

Author(s):

Crochan J O’Sullivan ◽

◽

...

Keyword(s):

Aortic Valve ◽

Mitral Regurgitation ◽

Clinical Outcomes ◽

Transcatheter Aortic Valve Implantation ◽

Severe Aortic Stenosis ◽

Surgical Aortic Valve Replacement ◽

Transcatheter Aortic Valve ◽

Transcatheter Heart Valve ◽

Aortic Valve Implantation ◽

Valve Implantation

Severe aortic stenosis (AS) and mitral regurgitation (MR) are the two most common valvular lesions referred for surgical intervention in Europe and frequently co-exist. In patients with both severe AS and significant MR referred for surgical aortic valve replacement (SAVR), a concomitant mitral valve intervention is typically performed if the MR is severe, despite the higher associated perioperative risk. The management of moderate MR among SAVR patients is controversial and depends on a number of factors including MR aetiology (i.e., organic versus functional MR), feasibility of repair and patient risk profile. Moderate or severe MR is present in up to one-third of patients undergoing transcatheter aortic valve implantation (TAVI), is mainly of functional aetiology and is typically left untreated. Although data are conflicting, a growing body of evidence suggests that significant MR exerts an adverse effect on both short- and long-term clinical outcomes after TAVI. Moderate or severe MR improves in just over half of patients following TAVI and recent data suggest MR is more likely to improve among patients receiving a balloon-expandable as compared with a self-expandable transcatheter heart valve.

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

Interventional Cardiology Review ◽

10.15420/icr.2021.09 ◽

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.

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

10.21203/rs.3.rs-770281/v1 ◽

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.

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Impact of Mitral Regurgitation on Clinical Outcomes After Transcatheter Aortic Valve Implantation

Interventional Cardiology Review ◽

10.15420/icr.2016:11:1 ◽

2016 ◽

Vol 11 (1) ◽

pp. 54 ◽

Cited By ~ 4

Author(s):

Crochan J O’Sullivan ◽

◽

...

Keyword(s):

Aortic Valve ◽

Mitral Regurgitation ◽

Clinical Outcomes ◽

Transcatheter Aortic Valve Implantation ◽

Severe Aortic Stenosis ◽

Surgical Aortic Valve Replacement ◽

Transcatheter Aortic Valve ◽

Transcatheter Heart Valve ◽

Aortic Valve Implantation ◽

Valve Implantation

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Clinical Outcomes of Transcatheter Aortic Valve Replacement in Nonagenarians: A Systematic Review and Meta-Analysis

Journal of Interventional Cardiology ◽

10.1155/2019/5819232 ◽

2019 ◽

Vol 2019 ◽

pp. 1-10 ◽

Cited By ~ 2

Author(s):

Yan Liu ◽

Yu Du ◽

Mingjie Fu ◽

Yue Ma ◽

Deguang Wang ◽

...

Keyword(s):

Aortic Valve ◽

Aortic Valve Replacement ◽

Clinical Outcomes ◽

Valve Replacement ◽

Severe Aortic Stenosis ◽

Meta Analysis ◽

Pacemaker Implantation ◽

Vascular Complications ◽

Surgical Aortic Valve Replacement ◽

Younger Patients

Objectives. To compare the incidence of mortality and complications between nonagenarians and younger patients undergoing transcatheter aortic valve replacement (TAVR). Background. TAVR has become an alternative treatment for nonagenarian patients with severe aortic stenosis. Previous studies have reported conflicting results regarding the clinical outcomes between nonagenarians and younger patients who underwent TAVR. Methods. We searched PubMed, EMBASE, and Cochrane Library databases with predefined criteria from the inception dates to July 8, 2018. The primary clinical endpoint was 30-day and 1-year all-cause mortalities. Secondary outcomes were considered the rates of stroke, myocardial infarction, any bleeding, any acute kidney injury, any vascular complications, new pacemaker implantation, and conversion to surgical aortic valve replacement. Results. A total of 5 eligible studies with 25,371 patients were included in this meta-analysis. Compared with younger patients who underwent TAVR, nonagenarians had a significantly higher mean Society of Thoracic Surgeons score (STS score) (MD, 2.80; 95%CI: 2.58, 3.30; P<0.00001) and logistic European System for Cardiac Operative Risk Evaluation (logistic EuroSCORE) (MD, 2.72; 95%CI: 1.01, 4.43; P=0.002). Nonagenarians were associated with significantly higher 30-day mortality (6.2% vs. 3.7%; OR, 1.73; 95%CI: 1.49, 2.00) and 1-year mortality (15.5% vs. 11.8%; OR, 1.39; 95%CI: 1.26, 1.53), without significant statistical heterogeneity. Nonagenarians were associated with significantly increased rates of major or life-threatening bleeding, vascular complications and stroke of 20%, 35%, and 32%, respectively. There were no significant differences in the rate of myocardial infarction, stage 2 or 3 acute kidney injury, new pacemaker implantation, or conversion to surgical aortic valve replacement. Conclusions. Nonagenarians showed worse clinical outcomes than younger patients after TAVR, while the incidence of mortality was acceptable. TAVR remains an option for nonagenarian patients with severe aortic stenosis and should be comprehensively evaluated by the heart valve team.

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Management and Prevention of Vascular Complications Related to Transcatheter Aortic Valve Implantation and Aortic Aneurysm Repair Procedures – A Technical Note

Interventional Cardiology Review ◽

10.15420/icr.2010.5.1.81 ◽

2010 ◽

Vol 5 (1) ◽

pp. 81

Author(s):

Andrea Pacchioni ◽

Dimitris Nikas ◽

Carlo Penzo ◽

Salvatore Saccà ◽

Luca Favero ◽

...

Keyword(s):

Aortic Valve ◽

Aortic Aneurysm ◽

Transcatheter Aortic Valve Implantation ◽

Severe Aortic Stenosis ◽

Vascular Complications ◽

Technical Note ◽

Closure Device ◽

Transcatheter Aortic Valve ◽

Aortic Valve Implantation ◽

Valve Implantation

Transcatheter aortic valve implantation (TAVI) and endovascular aortic repair (EVAR) are increasingly being used as therapeutic options for patients with severe aortic stenosis who are ineligible for surgery and who have aortic aneurysm with suitable anatomical features. These procedures can be associated with severe complications, especially related to vascular access and the use of a large introducer sheath (from 18 to 24 French [Fr]). In this article we describe possible vascular complications emerging during TAVI and EVAR and their appropriate management, beginning with patient selection, the correct way to perform vessel puncture and the use of a vascular closure device, up to the recently proposed cross-over technique, which is thought to minimise the risk of dangerous consequences of vascular damage.

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Real-time observation of a high-echoic mass in the left ventricle during transcatheter aortic valve implantation: a case report

European Heart Journal - Case Reports ◽

10.1093/ehjcr/ytaa392 ◽

2020 ◽

Author(s):

Akiko Masumoto ◽

Takeshi Kitai ◽

Mitsuhiko Ota ◽

Kitae Kim ◽

Natsuhiko Ehara ◽

...

Keyword(s):

Aortic Valve ◽

Aortic Stenosis ◽

Transcatheter Aortic Valve Implantation ◽

Severe Aortic Stenosis ◽

Cerebral Arteries ◽

Transoesophageal Echocardiography ◽

Transcatheter Aortic Valve ◽

Transcatheter Heart Valve ◽

Aortic Valve Implantation ◽

Valve Implantation

Abstract Background Increasing number of symptomatic patients with severe aortic stenosis is treated with transcatheter aortic valve implantation (TAVI). Stroke is one of the most serious complications of TAVI, and the majority of cerebral events in patients undergoing TAVI have an embolic origin. Case summary A 90-year-old female underwent trans-femoral TAVI for symptomatic severe aortic stenosis. Just before the implantation of the transcatheter heart valve (THV), transoesophageal echocardiography (TOE) showed a mobile, high-echoic mass attached to the THV, which gradually enlarged to 26 mm, then spontaneously detached from the THV and flowed up the ascending aorta, disappearing from the TOE field of. After the procedure, the patient presented with ischaemic stroke. The patient’s stroke was thought to have resulted from the embolism migrating to the distal cerebral arteries. Discussion The detailed images acquired with TOE during TAVI enabled the prompt identification of the unusual intracardiac mass.

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

Scientific Reports ◽

10.1038/s41598-021-91548-x ◽

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.

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Transcatheter aortic valve replacement for bicuspid aortic valve stenosis with first- and new-generation bioprostheses: a systematic review and meta-analysis

European Heart Journal ◽

10.1093/ehjci/ehaa946.1927 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

D Ueshima ◽

L.N.F Nai Fovino ◽

S.J.B Brener ◽

A.P Pavei ◽

C.F Fraccaro ◽

...

Keyword(s):

Aortic Valve ◽

Bicuspid Aortic Valve ◽

Meta Analysis ◽

Pacemaker Implantation ◽

Vascular Complications ◽

Device Failure ◽

Paravalvular Leakage ◽

Transcatheter Aortic Valve ◽

Outcome Differences ◽

New Generation

Abstract Background Subjects with bicuspid aortic valve (BAV) have been excluded from transcatheter aortic valve re- placement (TAVR) randomized trials. Methods With this meta-analysis of observational studies we first compared TAVR outcomes of BAV vs. tricuspid aortic valve (TAV) patients, stratifying the results by device generation. Then, we looked for differences between balloon-expandable (BE) and self-expandable (SE) bioprostheses in BAV patients. Primary outcome was 30-day mortality. Secondary outcomes were 30-day stroke, moderate-severe paravalvular leakage, new pacemaker im- plantation, vascular complications and 1-year mortality. Results Thirteen studies (11,032 patients, 7291 TAV and 3741 BAV) and seven studies (706 patients, 367 treated with BE, 339 with SE valve) met inclusion criteria. Thirty-day (OR=1.13; 95% CI: 0.88–1.46, p=0.33) and 1-year mortality (OR=1.02; 95% CI: 0.77–1.37, p=0.87) were similar between patients receiving TAVR for BAV or TAV. Subjects treated for BAV were at higher risk of conversion to conventional surgery (OR=2.35; 95% CI: 1.30–4.23, p=0.005), implantation of a second valve (OR=2.06; 95% CI: 1.31–3.25; p=0.002), moderate/severe paravalvular leakage (PVL) (OR=1.67; 95% CI: 1.29–2.17; p=0.0001) and device failure (OR=1.26; 95% CI: 1.02–1.56; p=0.04). Rates of adverse events decreased significantly with the use of new-generation devices, but outcome differences remained consistent. BAV patients treated with BE vs. SE valves had similar 30-day and 1-year mortality, stroke and moderate-severe PVL. Balloon-expandable valves were associated with lower rates of a second valve and new pacemaker implantation but carried higher risk of annular rupture. Conclusions BAV patients treated with TAVR had similar 30-day and 1-year mortality as well as stroke and new pacemaker implantation rates compared to TAV subjects, but carried higher risk of moderate/severe PVL, conver- sion to surgery and device failure. Event rates significantly decreased with the use of new-generation devices, but TAVR still showed better procedural results in TAV compared to BAV. Funding Acknowledgement Type of funding source: None

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The Wattson temporary pacing guidewire for transcatheter heart valve implantation

Future Cardiology ◽

10.2217/fca-2021-0105 ◽

2021 ◽

Author(s):

James Carey ◽

Anthony Buckley ◽

Stephen O'Connor ◽

Mark Hensey

Keyword(s):

Aortic Valve ◽

Heart Valve ◽

Transcatheter Aortic Valve Implantation ◽

Pacemaker Implantation ◽

Left Ventricular ◽

Temporary Pacing ◽

Transcatheter Aortic Valve ◽

Transcatheter Heart Valve ◽

Aortic Valve Implantation ◽

Valve Implantation

Transcatheter aortic valve implantation and implantation of other transcatheter heart valves, generally requires insertion of a temporary venous pacemaker. Implantation of a temporary venous pacemaker adds complexity, time and risk to the procedure. Guidewire modification to allow pacing is increasingly popular, however it requires technical expertise and provides unipolar pacing resulting in high thresholds and potential capture loss. The Wattson temporary pacing guidewire is a novel device which offers guidewire support for valve delivery and concomitant bipolar pacing. It may offer a safe and effective solution to guidewire pacing for transcatheter aortic valve implantation and other transcatheter heart valve implantations. Herein, we review the literature surrounding left ventricular guidewire pacing along with the features and clinical data of the Wattson wire.

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