Latest-iteration balloon- and self-expandable transcatheter valves for severe bicuspid aortic stenosis: the TRITON study.

INTRODUCTION AND OBJECTIVES: No comparisons have been published yet regarding the newest iteration of balloon- and self-expandable transcatheter heart valves for the treatment of bicuspid aortic valve (BAV) stenosis. METHODS: Multicenter registry of consecutive patients with severe BAV stenosis treated with balloon-expandable transcatheter heart valves (Myval and SAPIEN 3 Ultra, S3U) or self-expanding Evolut PRO+(EP+). TriMatch analysis was carried out to minimize the impact of baseline differences. The primary endpoint of the study was 30-day device success, and the secondary endpoints were the composite and individual components of early safety at 30 days. RESULTS: A total of 360 patients (age 76.6±7.6 years, 71.9% males) were included: 122 Myval (33.9%), 129 S3U (35.8%), and 109 EP+(30.3%). The mean STS score was 3.6±1.9%. There were no cases of coronary artery occlusion, annulus rupture, aortic dissection, or procedural death. The primary endpoint of device success at 30 days was significantly higher in the Myval group (Myval: 100%; S3U: 87.5%; and EP+: 81.3%), mainly due to higher residual aortic gradients with S3U and greater≥moderate aortic regurgitation (AR) with EP+. No significant differences were found in the unadjusted rate of pacemaker implantation. CONCLUSIONS: In patients with BAV stenosis deemed unsuitable for surgery, Myval, S3U and EP+showed similar safety but balloon-expandable Myval had better gradients than S3U, and both balloon-expandable devices had lower residual AR than EP+, suggesting that, taking into consideration the patient-specific risks, any of these devices can be selected with optimal outcomes.

Transcatheter Mitral Valve-in-Valve Implantation with the Balloon-Expandable Myval Device.

Background: The vast majority of transcatheter valve-in-valve (ViV) mitral procedures have been reported with the SAPIEN family. We aimed to report the preliminary experience with the Myval balloon-expandable device in this setting. Methods: Multicenter retrospective study of high-risk surgical patients with mitral bioprosthesis degeneration undergoing transcatheter ViV implantation with Myval device. Results: A total of 11 patients from five institutions were gathered between 2019 and 2022 (age 68 ± 7.8, 63% women). The peak and mean transvalvular gradients were 27 ± 5 mmHg and 14.7 ± 2.3 mmHg, respectively, and the predicted neo-left ventricular outflow tract (neo-LVOT) area was 183.4 ± 56 mm2 (range: 171 to 221 mm2). The procedures were performed via transfemoral access in all cases (through echocardiography-guided transeptal puncture (81.8% transesophageal, 11.2% intracardiac)). Technical success was achieved in all cases, with no significant residual mitral stenosis in any of them (peak 7.2 ± 2.7 and mean gradient 3.4 ± 1.7 mmHg) and no complications during the procedure. There were no data of LVOT obstruction, migration, or paravalvular leak in any case. Mean hospital stay was 3 days, with one major vascular complication and no stroke. At 6-month follow-up, there was one case with suboptimal anticoagulation presenting an increase in the transmitral gradients (mean 15 mmHg) that normalized after optimization of the anticoagulation, but no other relevant events. Conclusions: Transseptal ViV mitral implantation with the balloon-expandable Myval device was feasible and safe avoiding redo surgery in high-risk patients with bioprosthesis degeneration.

Case report of a rare purine synthesis disorder due to 5-aminoimidazole-4-carboxamide ribonucleotide formyltransferase (AICAR) deficiency.

BACKGROUND: AICA (5-aminoimidazole-4-carboxamide) ribosiduria is an inborn error in purine biosynthesis caused due to biallelic pathogenic variants in the 5-aminoimidazole-4-carboxamide ribonucleotide-formyltransferase/imp cyclohydrolase (ATIC) gene located on chromosome 2q35. ATIC codes for a bifunctional enzyme, AICAR transformylase and inosine monophosphate (IMP) cyclohydrolase, which catalyse the last two steps of de novo purine synthesis. This disorder has been previously reported in only 4 cases worldwide, and herein, we report the first from India. CASE REPORT: The proband presented with global developmental delay, developmental hip dysplasia (DDH), acyanotic heart disease and nystagmoid eye movements. Whole exome sequencing (WES) identified compound heterozygous pathogenic variants in the ATIC. A novel splice site variant; c.1321-2A > G and a previously reported missense variant; c.1277A > G (p.Lys426Arg) were identified. Segregation analysis of parents showed the father to be a heterozygous carrier for the splice site variant and the mother, a heterozygous carrier for the missense variant. CONCLUSION: This case of a rare genetic disorder of purine biosynthesis of ATIC deficiency is the first case reported from India. Early diagnosis lead to early interventional therapy and genetic counselling.

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.

Myval transcatheter heart valve system in the treatment of severe symptomatic aortic stenosis.

The transcatheter aortic valve replacement (TAVR) is an established treatment for patients with severe symptomatic aortic stenosis (AS) at prohibitive risk for surgery. It is an alternative treatment to surgical aortic valve replacement in patients with AS at intermediate- and high-surgical risk. Although regulatory authorities extend the indications of TAVR to treat patients at low-surgical risk, the limitations of earlier-generation transcatheter heart valve (THV) systems accelerate the development of improved newer generation of THV systems. Myval™ THV (Meril Life Sciences Pvt. Ltd., Vapi, Gujarat, India) is a newer-generation, balloon-expandable TAVR system with features that facilitate accurate positioning of the bioprosthetic valve and favorable procedural and clinical outcomes. This review summarizes existing preclinical and clinical data on Myval THV for the intervention of symptomatic native AS and lays out the plan for future research program.

Radiation dose from percutaneous transluminal coronary angioplasty procedure performed using a flat detector for different clinical angiographic projections.

The radiation dose from complex cardiac procedures is of concern due to the lengthy fluoroscopic screening time and vessel complexities. This study intends to assess radiation dose based on angiographic projection and vessel complexities for clinical protocols used in the performance of percutaneous transluminal coronary angioplasty (PTCA). Dose-area product (DAP), reference air kerma (K a,r) and real-time monitoring of tube potentials and tube current for each angiographic projection and dose setting were evaluated for 66 patients who underwent PTCA using a flat detector system. The mean DAP and cumulative K a,r were 32.71 Gy cm2 (0.57 Gy), 51.24 Gy cm2 (0.9 Gy) and 102.03 Gy cm2 (1.77 Gy) for single-, double- and triple-vessel PTCA, respectively. Among commonly used angiographic projections, left anterior oblique 45°-caudal 35° reached 2 Gy in 55 min using a low-dose fluoroscopy setting and 21 min for a medium-dose setting. Use of a low-dose setting for fluoroscopic screening showed a radiation dose reduction of 39% compared with a medium-dose setting.

Follicular thyroid carcinoma with tumour thrombus extending into superior vena cava and right atrium - A case report.

Intra-cardiac extension of tumour thrombus of follicular carcinoma of thyroid is uncommon. We report a case of advanced thyroid carcinoma where tumour thrombus was well profiled with CT scan and transesophageal echo images and extension was noted from SVC into right atrium, with clinical features of superior vena cava syndrome. The clinical significance of the "ring sign" is discussed.

Redo TAVI: initial experience at two German centres.

AIMS: The aim of this study was to assess the feasibility and early outcomes of transcatheter aortic valve implantation (TAVI) in dysfunctional TAVI prostheses (redo TAVI). METHODS AND RESULTS: Nineteen redo TAVI procedures were performed between October 2011 and November 2015 at two German centres. Mean age was 78 years, 13 (68%) were male, and the mean logistic EuroSCORE was 32%. Median time elapsed since index TAVI was 644 days (interquartile range 191-1,831). Failure mode of the index TAVI prosthesis was regurgitation (AR) in 16 patients (n=12 paravalvular AR, n=3 combined paravalvular/valvular AR, n=1 valvular AR) and stenosis in three patients. Device success was achieved in 89% (17/19). Median invasive post-interventional transprosthetic gradient was 3.0 mmHg. No severe prosthesis-patient mismatch (PPM) was observed. At one year, mean pressure gradient was 9±1.2 mmHg and no relevant PPM was documented in 90% of the cases. All-cause mortality at 30 days and one year was 11% and 33% (6/18, five non-cardiac deaths), respectively. Mean follow-up time was 404 days. CONCLUSIONS: Redo TAVI appears to be feasible. Paravalvular regurgitation was the most common indication for a redo procedure. Rates of device success were high with low post-interventional gradients and no severe PPM. Good functional status of the prosthesis was maintained after 12 months, but mortality rates were high in this small comorbid patient population.