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OBJECTIVES To evaluate the safety and performance of the Hydra transcatheter aortic valve (THV) in the treatment of symptomatic severe aortic stenosis in patients at high or extreme surgical risk. BACKGROUND The Hydra THV (Vascular Innovations Co. Ltd., Nonthaburi, Thailand) is a novel flexible repositionable self-expanding system with supra-annular bovine pericardial leaflets, available in three sizes, covering aortic annuli between 17 and 27 mm. METHODS The GENESIS trial was a prospective, multi-center, single-arm, 6 month follow-up study conducted in India. The primary performance endpoint was device success defined as per VARC-II criteria at 30 days. The primary safety endpoint was all-cause mortality at 30 days. All endpoints were adjudicated by an independent clinical events committee. RESULTS Forty high-risk patients (74.5 ± 6.7 years, 60% men; STS Score:5.6 ± 4.2%) were enrolled in 11 centres. Device success was achieved in 92.5%. The effective orifice area improved from 0.7 ± 0.2 to 2.3 ± 0.6 cm2 at 30 days and to 2.2 ± 0.7 cm2 at 6 months (p

Aims: Although the proof of concept of the bioresorbable vascular scaffold (BRS) is well documented, device-related adverse outcomes with first-generation BRS indicate longer-term surveillance. The current study provides insights into the safety and performance of the MeRes100, a novel second-generation sirolimus-eluting BRS, beyond one-year up to three-year follow-up (FU). Methods and results: A total of 108 enrolled patients with de novo coronary artery lesions who underwent implantation of MeRes100 as part of the first-in-human MeRes-1 trial were followed up clinically beyond one year at two and three years and with multiple modality imaging at six months and two years. At three-year FU, the cumulative major adverse cardiac events rate was 1.87%, in the form of two ischaemia-driven target lesion revascularisations. No scaffold thrombosis was reported. Between six months and two years at quantitative coronary angiography, in-segment late lumen loss (LLL) (0.15±0.22 mm vs 0.23±0.32 mm; p=0.18) and in-scaffold LLL (0.13±0.22 mm vs 0.24±0.34 mm; p=0.10) changed insignificantly. IVUS subset analysis revealed a non-significant reduction in mean lumen area (6.17±1.28 mm2 vs 5.47±1.50 mm2 ; p=0.21) and minimum lumen area (5.14±1.19 mm2 vs 4.05±1.42 mm2 ; p=0.10) at two years compared to post-procedural measurements. OCT subset analysis demonstrated 99.24±2.27% neointimal strut coverage. Conclusions: The extended outcomes of the MeRes-1 trial demonstrated sustained efficacy and safety of the MeRes100 BRS with maintained lumen patency up to two years by multimodality imaging and no very late scaffold thrombosis up to three-year clinical FU. The MeRes-1 trial is registered at the Clinical Trials Registry-India. CTRI Number: CTRI/2015/04/005706

Background: MeRes 100™ (Meril Life Sciences Pvt. Ltd., Vapi, India) is a novel sirolimus-eluting bioresorbable vascular scaffold (BRS). The purpose of this sub-study of MeRes-1 trial is to evaluate the systemic release of sirolimus from MeRes100 BRS implanted for the treatment of de novo native coronary artery lesions. Methods: The MeRes-1 is a prospective, multicenter, first-in-human trial of sirolimus-eluting MeRes100 BRS. The pharmacokinetic sub-study was conducted at two Indian sites in 10 patients who were implanted with the MeRes100 BRS loaded with sirolimus at a dose of 1.25 µg/mm 2 . Venous blood samples were collected at pre-dose and 12-time points after implantation of the scaffold. Sirolimus concentration was successively analyzed using ultra-performance liquid chromatography-electrospray ionization tandem mass spectrometry method. Results: A total of 12 scaffolds were implanted in 10 patients. Non-compartmental analysis demonstrated time to reach peak concentration of sirolimus between 0.5 h to 3 h after scaffold implantation. The peak concentration (C max ) was deduced to be 7.47 ± 2.61 ng/mL, AUC was 436.45 ± 171.24 h·ng/mL, and the t ½ was observed at 98.59 ± 33.58 h. The clearance was 0.66 ± 0.16 L/h and lower limit of quantification was detectable at 14.1 days. Conclusions: The MeRes-1 pharmacokinetic sub-study confirmed that MeRes100 BRS is safe and tolerable at limited systemic exposure of sirolimus. Cardiol Res. 2018;9(6):364-369 doi: https://doi.org/10.14740/cr799 Â

Aims The MeRes-1 trial sought to study the safety and effectiveness of a novel sirolimus-eluting bioresorbable vascular scaffold (MeRes100 BRS) in treating de novo native coronary artery lesions by clinical evaluation and using multiple imaging modalities. Methods and results The MeRes-1 first-in-human trial was a single-arm, prospective, multicentre study, which enrolled 108 patients with de novo coronary artery lesions (116 scaffolds were deployed to treat 116 lesions in 108 patients). At six months, quantitative coronary angiography revealed in-scaffold late lumen loss of 0.15±0.23 mm with 0% binary restenosis. Optical coherence tomography demonstrated minimum scaffold area (6.86±1.73 mm2) and percentage neointimal strut coverage (99.30%). Quantitative intravascular ultrasound analysis confirmed a 0.14±0.16 mm2 neointimal hyperplasia area. At one year, major adverse cardiac events, a composite of cardiac death, any myocardial infarction and ischaemia-driven target lesion revascularisation, occurred in only one patient (0.93%) and there was no scaffold thrombosis reported. At one year, computed tomography angiography demonstrated that all scaffolds were patent and in-scaffold mean percentage area stenosis was 11.33±26.57%. Conclusions The MeRes-1 trial demonstrated the safety and effectiveness of MeRes100 BRS. The favourable clinical outcomes and effective vascular responses have provided the basis for further studies in a larger patient population. The MeRes-1 trial is registered at the Clinical Trials Registry-India.

Patient Initials or Identifier Number P.K. ### Relevant Clinical History and Physical Exam A 16-year-old girl, who was 1st diagnosed at 7 years of age with CCF during routine School Health screening program, Became symptomatic for 1st time ay 10 years of age with mild effort intolerance. She

The development of fully bioresorbable vascular scaffolds (BRS) offers a new intervention strategy for coronary artery lesion by replacement of “full-metal jacket” into “full-plastic jacket”. The aim of the present study was to assess the long-term safety and performance of thin strut

MeRes100 (Meril Life Science, Gujarat, India) is a novel Sirolimus-eluting BioResorbable Vascular Scaffold System (BRS). This sub study of MeRes-1 trial evaluated the systemic release of sirolimus from the MeRes100 BRS applied for the treatment of de novo native coronary artery lesions. The MeRes-1

The life-long presence of the metallic prosthesis interferes with the restoration of vasomotion and restricts quality lesion imaging during repeat surgical or percutaneous treatment. As a solution to this, we assessed safety and efficacy of a novel Poly-L-Lactide based Sirolimus-eluting