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.

Less invasive treatments for pure aortic insufficiency: Are we there yet?

The gold standard for the treatment of pure aortic insufficiency (PAI) is surgical valve repair or replacement.1 With the newest transcatheter heart valve technologies and the accumulating years of experience of heart teams with the current transcatheter aortic valve replacement (TAVR) prostheses, implanters have push the envelope with off-label use of those valves designed and approved for aortic stenosis, in patients with pure aortic insufficiency especially those at higher risks or for compassionate use.3 However, new prostheses are currently under investigation in clinical use and evidences are provided on the safety and efficacy of those latter. It will be discussed in this commentary, the actual clinical evidences and the use of transcatheter heart valves, in and off label, for the treatment of pure aortic insufficiency.

The Wattson temporary pacing guidewire for transcatheter heart 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.

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

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.

778 Acute clinical valve thrombosis after transcatheter mitral valve-in-valve replacement

Aims Transcatheter heart valve (THV) thrombosis is a frequent and potentially life-threatening complication of transcatheter mitral valve replacement (TMVR), occurring in approximately 12% of patients (mainly within the first 3 months after the procedure). The majority of THV thromboses is non-obstructive and subclinical, and remains undetected until a routine echocardiogram is performed. Methods A 65 years old male was suffering from post-ischaemic dilated cardiomyopathy and severe left ventricle systolic dysfunction (LVEF 28%), secondary to a previous STEMI in 2010 treated with primary PCI on proximal LAD; after the STEMI he developed a left ventricle aneurysm and a subsequent severe secondary mitral regurgitation. In late 2020 he underwent a surgical valve replacement with a biologic valve (Perimount Magna Mitral Ease n. 27), alongside a left ventricle reshaping (Dor procedure). After a few months, the patient developed worsening dyspnoea and severe exercise intolerance; a transesophageal echocardiogram (TEE) showed an extensive valve degeneration with diffuse leaflet thickening determining severe valve stenosis and regurgitation. The patient was then admitted to the Cardiology department. A coronary angiography was performed, showing good result of previous PCI and excluding other critical stenoses. The patient then underwent a transcatheter valve-in-valve replacement with a Sapien S3 n. 29 in mitral position. The patient was already in chronic therapy with acetilsalicilic acid (ASA), and after the procedure anticoagulant therapy with Warfarin was started. In the post-procedural period the patient developed an acute worsening of the LVEF with severe hypotension, likely due to after-load mismatch; hence, supportive inotropic therapy with Adrenalin and Enoximone was required. A TEE performed 7 days after the procedure showed absence of diastolic excursion of posterior and lateral cusps and leaflet thickening with a 4 mm thrombotic apposition on the ventricular side, determining severe valve stenosis with markedly increased transvalvular gradients (peak gradient 20 mmHg, mean gradient 11 mmHg). A CT scan of the heart confirmed the valve thrombosis on the inferior and lateral leaflets. Results Unfractioned heparin (UFH) was then added to ASA and Warfarin (INR target of 3.0). After 11 days of aggressive antithrombotic therapy a new TEE was performed, showing marked reduction in transvalvular gradients (peak gradient 10 mmHg, mean gradient 5 mmHg) due to partial dissolution of the thrombotic formation. Warfarin was then stopped, and after switching from UFH to Enoxaparin the patient was discharged asymptomatic and in good general conditions, with indication of follow-up with TEE at 1 month. Conclusions Valve-in-valve TMVR is a relatively new and still infrequent procedure, therefore few evidences about its complications are currently available. Thrombosis on these valves is not rare (12%), but usually develops on the atrial side of the leaflets; interestingly, in this patient the thrombosis was on the ventricular side, likely due to an acute reduction in flow velocity caused by the after-load mismatch and the subsequent cardiogenic shock.