Ultrathin, biodegradable polymer-coated everolimus-eluting stents for patients undergoing percutaneous coronary intervention: Final three-year results of the PERFORM-EVER registry.

The registry reports 3-year safety and clinical performance of the ultrathin strut (60 µm) biodegradable polymer-coated Tetrilimus, an everolimus-eluting stent (EES) (Sahajanand Medical Technologies Limited, India), in 'real-world' patients with coronary artery disease. A total of 815 Tetrilimus EES were implanted in 735 lesions in 594 patients. At 3-year follow-up, primary endpoint (target lesion failure, TLF) was reported in 8.6 % patients, including 2.6 % cardiac deaths, 3.5 % myocardial infarction and 2.6 % target lesion revascularization. At three-year, no cases of definite stent thrombosis were reported. The final three-year results of PERFORM-EVER registry endorse the continuous safety and effectiveness Tetrilimus EES.

Safety and Clinical Performance of Biodegradable Polymer-Coated Ultra-Thin Everolimus-Eluting Stents in "Real-World" Patients: A Multicenter Registry (PERFORM-EVER).

BACKGROUND: Tetrilimus (Sahajanand Medical Technologies Limited, Surat, India) is a biodegradable polymer-coated everolimus-eluting stent with cobalt-chromium stent platform and ultra-thin (60 µm) strut thickness. We aimed to report 1-year safety and clinical performance of Tetrilimus everolimus-eluting stent in patients with coronary artery disease in "real-world" clinical practice. METHODS: The PERFORMance of biodegradable polymer-coated ultra-thin EVERolimuseluting stents was an observational, multicenter, single-arm, and investigator-initiated retrospective registry. All "real-world" patients who had received Tetrilimus everolimuseluting stent between July-2015 and October-2016 at four study centers were analyzed. The data were collected retrospectively either by extraction from existing databases in consecutive fashion where index and follow-up data existed or the follow-up was obtained by telephonic contact. Primary endpoint was 1-year incidence of target lesion failure, which was defined as a composite endpoint of cardiac death, myocardial infarction, and target lesion revascularization by percutaneous or surgical methods. The Academic Research Consortium-defined stent thrombosis was assessed as additional safety endpoint. RESULTS: During the study period, 815 Tetrilimus everolimus-eluting stents (1.4 ± 0.5 stent/ patient) were implanted to treat 735 coronary lesions (1.1 ± 0.3 stent/lesion) in 594 patients (mean age: 55.6 ± 12.1 years). The cumulative incidence of target lesion failure at 1-year follow-up was 3.7%, which included 9 (1.5%) cardiac deaths, 8 (1.4%) myocardial infarctions, and 5 (0.8%) target lesion revascularizations. There were 5 (0.8%) cases of probable stent thrombosis and 4 (0.7%) cases of possible stent thrombosis at 1-year follow-up. CONCLUSION: Low incidences of target lesion failure and stent thrombosis at 1-year followup indicates that biodegradable polymer-coated ultra-thin Tetrilimus everolimus-eluting stents may have encouraging safety and efficacy in unselected real-world patients with coronary artery disease, including those with high-risk characteristics and complex lesions.

Immediate impact of successful percutaneous balloon mitral valvuloplasty on right and left ventricular functions: An echocardiographic study using load independent tissue velocity imaging indices.

BACKGROUND: The impact of successful percutaneous balloon mitral valvuloplasty (PBMV) on left ventricular (LV) function has been a controversial subject. This study aimed to determine the immediate impact of PBMV on biventricular function using recent Tissue Velocity Imaging (TVI) derived load-independent indices. METHODS AND RESULTS: A total of 30 patients with severe mitral stenosis (MS) who underwent PBMV at a tertiary center of India from August 2012 to December 2013 were included in the study. Thirty age-matched and gender-matched healthy controls were also enrolled. Out of 30 patients, 27(90%) were female. Mean mitral valve area (MVA) of patients before and after PBMV was 0.78 and 1.82cm2 (p<0.001), respectively. All TVI-derived LV and RV basal systolic (IVCV, Sm and the relatively load independent IVA) and diastolic velocities (Em, Em/Am) were significantly decreased in patients with MS compared to controls (p<0.001 for all) which improved significantly after PBMV (6.4±0.7 vs 11±1.6; 5.8±0.7 vs 9.9±1.6; 1.5±0.3 vs 4.2±0.6; 6.4±0.6 vs 13.1±2.1; 0.7±0.1 vs 1.7±0.2 for mitral annulus respectively, p<0.001 for all). Increment in MVA positively correlated with Tricuspid annular plane systolic excursion (TAPSE) and tricuspid annular Sm and isovolumic contraction velocity (IVCV) and inversely with left atrium (LA) size and Pulmonary arterial systolic pressure (PASP) (p=0.01 for LA size; p<0.001 for others) while no such correlation was found with mitral annulus isovolumic acceleration (IVA) (r=-0.078; p=0.679). CONCLUSION: The improved right ventricular (RV) function appears to be predominantly due to afterload reduction, while that of LV appears to be more due to the acute relief of mechanical restraint.