Objective: T-Flex registry was designed to investigate the safety and clinical performance of the ultrathin (60 µm) strut biodegradable polymercoated sirolimus-eluting stent (SES) with a unique long dual Z (LDZ) link design on a cobalt-chromium stent platform (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) in a real-world all-comer population including high-risk subgroups. Methods: This was an observational, multicenter, single-arm, and investigator-initiated retrospective registry. A total of 1,203 patients treated with an ultrathin biodegradable polymer-coated SES, irrespective of lesion complexity, comorbidities, and acute presentation were analyzed from May 2016 to January 2017. The primary endpoint was the one-year incidence of target lesion failure (TLF), a composite of cardiac death, target-vessel myocardial infarction (TV-MI), and clinically-indicated target lesion revascularization (CI-TLR). Stent thrombosis was assessed as an additional safety endpoint.Results: At the one-year follow-up, TLF was observed in 3.8% [95% confidence interval (CI) 2.9-5.1] patients, composed of 0.6% (95% CI: 0.3-1.3) cardiac death, 1.3% (95% CI: 0.8-2.2) TV-MI, and 1.9% (95% CI: 1.3-2.9) CI-TLR. In the high-risk subgroups, TLF at one-year was 6.8% (95% CI: 4.6-9.8) in patients with diabetes, 5.2% (95% CI: 3.4-8) in patients with small-vessel disease, 6.1% (95% CI: 3.9-9.6) in patients with ST-elevation myocardial infarction, and 4.5% (95% CI: 2.4-8.3) in patients with total occlusion. During follow-up, stent thrombosis was reported in 0.8% (95% CI: 0.4-1.5) patients in the overall population. Conclusion: Low event rates of TLF and stent thrombosis at one-year follow-up indicate that this ultrathin biodegradable polymer-coated SES has encouraging safety and clinical performance in real-world all-comer populations as well as in high-risk subgroups.
BackgroundAlthough a number of drug-eluting stents have been developed with different design, composition, and polymers, the search for an ideal drug-eluting stent is ongoing. The Tetriflex (Sahajanand Medical Technology, Surat, India) is a newer-generation, ultrathin (60 µm) biodegradable polymer–coated sirolimus-eluting stent (SES) designed with a unique long dual Z-link on a cobalt–chromium alloy. The present registry aimed to evaluate the safety and clinical outcomes of the Tetriflex SES at 6-month post-implantation.MethodsThis was an investigator-initiated, retrospective, multicenter, single-arm, observational registry conducted at five tertiary-care centers in India. A total of 1,269 consecutive patients with coronary artery disease who underwent implantation of at least one Tetriflex SES between March 2017 and March 2018 were included. The primary outcome was considered a composite of cardiac death, myocardial infarction and target-lesion revascularization (TLR) at 6-month follow-up. Stent thrombosis was evaluated as a safety outcome at 6-month follow-up.ResultsThe mean age of patients was 54.99±10.80 years. Among 1,515 lesions treated with 1,682 Tetriflex SES, 58.3% were type C lesions. Six-month follow-up was done for 1,245 of 1,269 (98.1%) patients. At 6 months, composite events had occurred in 31 (2.5%) patients, consisting of ten (0.8%) cardiac deaths, 16 (1.3%) myocardial infarctions, and five (0.4%) TLRs. Stent thrombosis was observed in seven (0.56%) cases at 6 months. A subgroup analysis between diabetic and nondiabetic patients did not reveal any statistically significant difference for clinical outcomes at 6-month follow-up.ConclusionThe results of the current registry outline the safety and effectiveness of the Tetriflex SES in real-world patients, as it displayed favorable clinical outcomes at 6-month follow-up, with low incidence of TLR and stent thrombosis.
Congenitally corrected transposition of the great arteries (CCTGA) is rare form of congenital heart diseases. It may be present with or without associated anomalies. Patients with CCTGA are usually diagnosed at early stages of life due to associated anomalies, but they may even remain asymptomatic till later decades of their life. We report a case of a 42-year-old man who presented at neurosurgery department with dizziness, seizures, and loss of consciousness, in whom isolated CCTGA was discovered incidentally. Further investigation depicted right ventricular hypertrophy, mild valvular regurgitation, mildly dilated pulmonary artery, low heart rate with AV dissociation, and third-degree heart block. These indicated for implantation of permanent pacemaker into the patient. The implantation of VVI mode pacemaker was uneventful and the patient is being followed up in the past eight months in favorable condition.
Background: Long-term damage and malfunction of various organ systems can be linked to diabetes and its related complications. The objective is to evaluate the microvascular and macrovascular complications of Type 2 Diabetes Mellitus. Subjects and Methods: Patients with confirmed diabetes attending OPD were included. A detailed history is recorded for each individual case with diabetes mellitus, obesity, symptoms and family history with individuals suffering from diabetes mellitus. The physical examination was done for sensory and motor signs. Prevalence rates were typically calculated and standardized for age and sex for microvascular and macrovascular complications at baseline. Results: The overall number of patients examined was 100, of which 54% were male and 46% were female. The mean age of the patients in the sample was 53 years. The prevalence of diabetes increased with age. The prevalence of diabetes in elderly patients was maximum for 61 to 70 years of age. 29 percent of patients have a positive history of diabetes in the family. 13% of patients were smokers and all of them were males. The risk factor – Hypertension –19%, Obesity – 25% and hypercholesterolemia – 43% were present at the time of diagnosis. Conclusion: The general risk of microvascular and macrovascular problems is severe in patients with type 2 diabetes that are relatively early in the disease phase. Such findings indicate that the early risk factor may be actively changed, especially in regions with a high prevalence of complications. There are important correlations between predominant diabetes and the rising circumference and body mass index. Coronary artery disease, nephropathy and retinopathy have become particularly prevalent.
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