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Case report: Transcatheter aortic valve replacement in a large bicuspid anatomy using the XL-Myval 32 mm.

ABSTRACT: Transcatheter aortic valve replacement (TAVR) is a recommended intervention for selected population with severe aortic stenosis (AS). Bicuspid aortic valve (BAV) anatomy has been categorized as an unfavorable anatomy for TAVR due to multiple considerations as exclusion from randomized trials in addition to the challenging and unpredictable anatomy. The anatomical constraints of BAV include the large anatomy of the annulus, sinus of Valsalva, and aorta (aortopathy), in addition to significant calcifications of the device landing zone. Most commercial transcatheter heart valves (THV) have upper dimension limits of the annulus and area in which the device can be implanted safely without significant oversizing. Myval-XL THVs (Meril Life Sciences Pvt. Ltd., India) are balloon-expandable valves (BEV) that have been developed with two new sizes, 30.5 and 32 mm, aiming to treat patients with large annulus dimensions and that exceed the upper limit of an ordinary device's sizing matrix. This case series report describes TAVR using the XL-Myval 32 mm THV in three European patients with symptomatic severe bicuspid aortic stenosis with significant calcifications and large annular dimensions exceeding the limits of the other THVs.

SUBMITTER: Elkoumy A

PROVIDER: S-EPMC9727381 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Case report: Transcatheter aortic valve replacement in a large bicuspid anatomy using the XL-Myval 32 mm.

Elkoumy Ahmed A Terkelsen Christian J CJ Abdelshafy Mahmoud M Ellert-Gregersen Julia J Elzomor Hesham H Thim Troels T Serruys Patrick W PW Soliman Osama O Nissen Henrik H

Frontiers in cardiovascular medicine 20221123

Transcatheter aortic valve replacement (TAVR) is a recommended intervention for selected population with severe aortic stenosis (AS). Bicuspid aortic valve (BAV) anatomy has been categorized as an unfavorable anatomy for TAVR due to multiple considerations as exclusion from randomized trials in addition to the challenging and unpredictable anatomy. The anatomical constraints of BAV include the large anatomy of the annulus, sinus of Valsalva, and aorta (aortopathy), in addition to significant cal ...[more]

PMID: 36505358

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Project description:ImportanceThe outcomes of transcatheter aortic valve replacement (TAVR) in low-risk patients with bicuspid aortic valve stenosis have not been studied in a large scale, multicentered, prospective fashion.ObjectiveTo evaluate the procedural safety, efficacy, and 30-day outcomes of TAVR in patients with bicuspid aortic stenosis at low surgical risk.Design, setting, and participantsThe Low Risk Bicuspid Study is a prospective, single-arm trial study with inclusion/exclusion criteria developed from the Evolut Low Risk Randomized Trial. Follow-up is planned for 10 years. Patients underwent TAVR at 25 centers in the United States who were also participating in the Evolut Low Risk Randomized Trial from December 2018 to October 2019. Eligible patients had severe bicuspid aortic valve stenosis and met American Heart Association/American College of Cardiology guideline indications for aortic valve replacement.InterventionsPatients underwent attempted implant of an Evolut or Evolut PRO transcatheter aortic valve, with valve size based on annular measurements.Main outcomes and measuresThe prespecified primary end point was the incidence of all-cause mortality or disabling stroke at 30 days. The prespecified primary efficacy end point was device success defined as the absence of procedural mortality, the correct position of 1 bioprosthetic heart valve in the proper anatomical location, and the absence of more than mild aortic regurgitation postprocedure.ResultsA total of 150 patients underwent an attempted implant. Baseline characteristics include mean age of 70.3 (5.5) years, 48.0% female (n = 72), and a mean Society of Thoracic Surgeons score of 1.4 (0.6%). Most patients (136; 90.7%) had Sievers type I valve morphology. The incidence of all-cause mortality or disabling stroke was 1.3% (95% CI, 0.3%-5.3%) at 30 days. The device success rate was 95.3% (95% CI, 90.5%-98.1%). At 30 days, the mean (SD) AV gradient was 7.6 (3.7) mm Hg and effective orifice area was 2.3 (0.7) cm2. A new permanent pacemaker was implanted in 22 patients (15.1%). No patients had greater than mild paravalvular leak.Conclusions and relevanceTranscatheter aortic valve replacement in low-surgical risk patients with bicuspid aortic valve stenosis achieved favorable 30-day results, with low rates of death and stroke and high device success rate.Trial registrationClinicalTrials.gov Identifier: NCT03635424.

Project description:Aims: To report our single-center data regarding the initial 52 consecutive patients with a bicuspid aortic valve who underwent a Transcatheter Aortic Valve Implantation (TAVI) procedure using the new balloon-expandable MYVAL system. The focus is on reporting procedural details and outcomes over the 30-day postoperative period. Methods: From December 2019 to July 2023, 52 consecutive patients underwent a TAVI procedure with bicuspid anatomy. All patients had moderate to-high surgical risk or were unsuitable for surgical aortic valve replacement based on the Heart Team's decision. Outcomes were analyzed according to the VARC-2 criteria. The results of bicuspid patients were compared to patients with tricuspid anatomy in the overall study group, and further analysis involved a comparison between 52 pairs after propensity score matching. The device performance was evaluated using transthoracic echocardiography. Data collection was allowed by the Local Ethical Committee. Results: The mean age was 71 ± 7.1 years, and 65.4% were male. The mean Euroscore II and STS score were 3.3 ± 3.2 and 5.2 ± 3.3, respectively. Baseline characteristics and echocardiographic parameters were well balanced even in the unmatched comparison. Procedures were significantly longer in the bicuspid group and resulted in a significantly higher ARI index. All relevant anatomic dimensions based on the CT scans were significantly higher in bicuspid anatomy, including a higher implantation angulation, a higher rate of horizontal aorta and a higher proportion of patients with aortopathy. In the unmatched bicuspid vs. tricuspid comparison, postprocedural outcomes were as follows: in-hospital mortality 0% vs. 1.4% (p = 0.394), device success 100% vs. 99.1% (p = 0.487), TIA 1.9% vs. 0% (p = 0.041), stroke 1.9% vs. 0.9% (p = 0.537), major vascular complication 3.8% vs. 2.3% (p = 0.530), permanent pacemaker implantation 34% vs. 30.4% (p = 0.429), and cardiac tamponade 0% vs. 0.5% (p = 0.624). In the propensity-matched bicuspid vs. tricuspid comparison, postprocedural outcomes were as follows: in-hospital mortality 0% vs. 0%, device success 100% vs. 100%, TIA 1.9% vs. 0% (p = 0.315), stroke 1.9% vs. 0.9% (p = 0.315), major vascular complication 3.8% vs. 0% (p = 0.475), permanent pacemaker implantation 34% vs. 24% (p = 0.274), and cardiac tamponade 0% vs. 0%. There was no annular rupture nor need for second valve or severe aortic regurgitation in both the unmatched and matched comparison. The peak and mean aortic gradients did not differ at discharge and at 30-day follow-up between the two groups regardless of whether the comparison was unmatched or matched. There were no paravalvular leakages (moderate or above) in the bicuspid patients. Intermediate and extra sizes of the Myval THV system used a significantly higher proportion in bicuspid anatomy with a significantly higher oversize percentage in tricuspid anatomy. Conclusions: The TAVI procedure using the Myval THV system in patients with significant aortic stenosis and bicuspid aortic valve anatomy is safe and effective. Hemodynamic parameters do not differ between tricuspid and bicuspid patients. However, the permanent pacemaker implantation rate is higher than expected; its relevance on long-term survival is controversial.

Dataset Information

Case report: Transcatheter aortic valve replacement in a large bicuspid anatomy using the XL-Myval 32 mm.

Publications

Case report: Transcatheter aortic valve replacement in a large bicuspid anatomy using the XL-Myval 32 mm.

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