Valvular Intervention: Aortic
Early Results of Myval Transcatheter Aortic Valve in Severe Bicuspid Aortic Stenosis (Procedural and 30-Day Outcome)
Ahmed Elkoumy1, Osama Soliman2, Mahmoud Abdelshafy2, Ashok Seth3, Francesco Bedogni4, Hesham Elzomor2, Sreenivas Arramraju Kumar5, Maurizio Tespili6, Keyur Parikh7, Patrick W. Serruys2
Galway University Hospital, Ireland1, National University of Ireland, Galway, Ireland2, Fortis Escorts Heart Institute, India3, IRCCS Policlinico San Donato, Italy4, Care Hospitals, India5, Bolognini Hospital, Italy6, CIMS Hospital, India7
TAVR is still challenging in bicuspid aortic valve (BAV) anatomy. There are various anatomical constraints and heterogenicity associated with BAV, like asymmetric valve opening, the fusedraphe, extensive calcifications and associated aortopathy, all making the outcomes are non-predictable. In absence of RCTs comparing TAVR and SAVR , or various devices technologies and designs, surgical intervention is still the recommended treatment modality in stenotic BAV.
This retrospective study includes 68 patients with severe aortic stenosis and BAV anatomy, treated with the Myval balloon-expandable TAVRvalve (Meril Life Sciences Pvt. Ltd, India), at 7 Indian and 5 European centers. To assess the safety and efficacy of the Myval. The technical success, in addition to the 30-day clinical and echocardiographic assessment were analyzed according to the VARC-3 recommendations.
The mean age was 72 ± 9.4 years, 72% were male. STSsurgical risk score was 3.54 ± 2.1%. Sixty-seven patients (98.5%) were treated through a transfemoral access. Balloon pre-dilatation was performed in forty-nine(72%), and eight patients (12 %) underwent balloon post-dilatation. Eight different Myval sizes were used; conventional sizes with 3 mm increment in size were used in fifty-four (79%) patients, whereas the novel extra-large 32 mm and intermediate sizes (1.5 mm increment in size device) were used in two (3%) and twelve (18%) patients , respectively. Technical success was achieved in 97%of cases; there was no procedural death,no conversion to surgery, or need for second valve implantation. Major vascularcomplication related to the access site and major vascular bleeding were seenin 2 patients. Device success at 30-day was achieved in 93% of cases, echocardiographic assessment documented a transvalvular maximum velocity of 1.9±0.5 m/sec, a mean pressure gradient of 9.8 ± 4.5 mmHg, an effective orifice area of1.9 ± 0.6 cm2
, and a dimensionless velocity index of 0.58 ± 0.16.Severe patient prosthesis mismatch was reported in three patients (5.6%). Noneor trace AR was seen in 76.5 %, mild AR in 20.5% and moderate AR in 3%. All-cause mortality at 30-day was 3%, permanent pacemaker was required in six (8.5%) of patients. No stroke,no acute kidney injury or need for valve related re-intervention was reported, with 91% early safety was achieved among the included population.
Transfemoral TAVR using Myval in BAV has demonstrated good clinical and hemodynamic outcomes up to30 days. The results need to be confirmed in prospective and adequately powered study.