One-year Outcomes of Biodegradable Polymer-coated Sirolimus-eluting Coronary Stent in Acute Coronary Syndrome - A Patient-level Pooled Analysis from Two Indian Registries.

INTRODUCTION: This pooled analysis was conducted to assess the clinical safety and performance of the Supra family (Sahajanand Medical Technologies Ltd., Surat, India) of sirolimus-eluting stents (SES) in patients with acute coronary syndromes (ACS) including ST segment elevation myocardial infarction (STEMI) from two real-world all-comers Indian registries at one-year. METHODS: We evaluated 1824 patients with ACS who underwent percutaneous coronary intervention with the Supra family of SES from two real-world Indian registries (891 patients from T-Flex registry and 933 patients from Tetriflex real-world registry). The primary endpoint was the incidence of target lesion failure (TLF) defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI), and target lesion revascularization (TLR) at one-year follow-up. The safety endpoint was stent thrombosis at one-year follow-up. RESULTS: Among a total of 1824 patients with ACS, 689 (37.8%) patients presented with STEMI. In ACS and STEMI groups, 47.6% and 41.8% patients had multi-vessel disease, respectively. Of 2128 lesions in ACS group, 76.7% lesions were type B2/C and 16.2% lesions were totally occluded. In the STEMI group, out of 784 treated lesions, 76.7% were type B2/C lesions and 21.9% were totally occluded. At one-year follow-up, incidence of TLF was 5.3% (cardiac death: 0.9%, TV-MI: 2.5%, TLR: 1.9%) in patients with ACS and 6.2% (cardiac death: 1.4%, TV-MI: 2.1%, TLR: 2.7%) in patients with STEMI. The one-year rate of definite/probable stent thrombosis were 0.3% and 0.7% in patients with ACS and STEMI, respectively. CONCLUSION: This patient-level pooled analysis provides evidence for the safe and effective use of the Supra family of SES in complex patient populations such as ACS and even in STEMI with favourable rates of TLF and stent thrombosis at one-year follow-up.

Ultrathin Strut Biodegradable Polymer-Coated Sirolimus-Eluting Coronary Stents: Patient-Level Pooled Analysis From Two Indian Registries.

Background Despite significant evolution in stent technology, female gender, and patients with diabetes mellitus, multivessel disease, total occlusions, long lesions, and small vessels represent the "Achilles' heel" of contemporary percutaneous coronary intervention (PCI). We performed a pooled analysis of high-risk subgroup on patient-level data from the T-Flex registry (1,203 patients) and a real-world Indian registry (1,269 patients), with the aim of assessing one-year safety and clinical performance of ultrathin strut biodegradable polymer-coated Supra family of sirolimus-eluting stents (SES) (Sahajanand Medical Technologies Limited, Surat, India) in the real-world, all-comer population. Method We pooled the following high-risk subgroups data from two all-comer registries: female gender (n=678), diabetes mellitus (n=852), multivessel disease (n=406), total occlusions (n=420), long lesions (≥28 mm) (n=1241), and small vessels (≤2.5 mm) (n=726). Both the registries included patients with coronary artery disease who underwent implantation of at least one SES belonging to the Supra family of stents from May 2016 until March 2018, irrespective of lesion complexity and comorbidities. The primary endpoint was the inci-dence of target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revas-cularization by percutaneous or surgical methods up to one year. The safety endpoint was stent thrombosis.  Results According to prespecified high-risk subgroups, one-year rates of TLF and overall stent thrombosis, respectively, were as follows: female gender (4.9% and 0.6%), diabetes mellitus (6.9% and 1.0%), multivessel disease (6.4% and 0.8%), total occlusions (5.2% and 0.5%), long lesions (≥28 mm) (6.6% and 0.8%), and small vessels (≤2.5 mm) (6.1% and 1.3%). Conclusion This present pooled analysis demonstrated the one-year safety and clinical performance of ultrathin strut biodegradable polymer-coated Supra family of SES in a real-world, all-comer population, with considerably low rates of TLF and stent thrombosis.

Twelve months clinical outcomes of ultrathin strut sirolimus-eluting stent in real-world Indian patients with coronary artery disease.

PURPOSE: Although the field of interventional cardiology has witnessed extraordinary progression, the search of an ideal coronary drug-eluting stent is still going on. Tetriflex (Sahajanand Medical Technologies Limited, Surat, India) is a latest generation biodegradable polymer-coated ultrathin (60 µm) sirolimus-eluting stent (SES) with unique Long Dual Z-link (LDZ) design. The present registry reports the 12 months clinical follow-up results of Tetriflex SES in unselected, real-world patients with coronary artery disease (CAD). METHODS: This was an investigator-initiated, retrospective, multi-center, single-arm, observational registry conducted in India between March-2017 and March-2018. The registry included 1269 consecutive patients with CAD who underwent implantation of at least one Tetriflex SES. The primary outcome was considered as target lesion failure (TLF), which was a composite of cardiac death, target-vessel myocardial infarction (TV-MI) and clinically-driven target lesion revascularisation (CD-TLR) at 12 months follow-up. The safety outcome, at 12 months follow-up, was stent thrombosis. RESULTS: Mean age of patients was 54.99±10.80 years. Among all, 36.6% patients had diabetes and 51.7% patients had multi-vessel disease. A total of 1515 lesions were treated with 1682 Tetriflex SES of which 73.2% lesions were complex B2/C type and 14.7% were totally occluded. At 12 months, the cumulative incidence of TLF was 5.75% comprising 0.8% cardiac death, 3.20% TV-MI and 1.72% CD-TLR. All the incidences of definite/probable stent thrombosis (n = 4, 0.32%) were reported within 30 days of the index procedure. Twelve-month cumulative incidence of TLF in diabetic subgroup was 7.10%. CONCLUSION: Twelve months clinical follow-up results of an ultrathin (60 µm), biodegradable polymer-coated Tetriflex SES, with unique LDZ-link, further clarify its safety and effectiveness in real-world, unselected Indian patients.

Clinical outcomes of ultrathin biodegradable polymer-coated sirolimus-eluting stents in an all-comer population: One-year results from the T-FLEX registry including high-risk subgroups.

OBJECTIVE: T-Flex registry was designed to investigate the safety and clinical performance of the ultrathin (60 µm) strut biodegradable polymer-coated 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.

Real-World Use Of Ultrathin-Strut Biodegradable Polymer-Coated Sirolimus-Eluting Stents In Patients With Coronary Artery Disease: 6-Month Clinical Outcomes.

BACKGROUND: Although 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. METHODS: This 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. RESULTS: The 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. CONCLUSION: The 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.

Primary transcatheter closure of post-myocardial infarction ventricular septal rupture using amplatzer atrial septal occlusion device: A study from tertiary care in South India.

OBJECTIVE: The study investigated effectiveness of transcatheter closure of post-myocardial infarction (MI) ventricular septal rupture (VSR) using atrial septal device (ASD) occluder in a cohort of patients admitted at our institute. METHOD: This was a retrospective, observational and single center study, which included patients who were treated with transcatheter closure for post-MI VSR at our tertiary care center between May 2000 and August 2014 depending upon inclusion and exclusion criteria. Primary outcome was all-cause mortality at 30-days follow-up. The MELD-XI (Model for End Stage Liver Disease) score was used as a predictor for poor outcome in these patients. RESULTS: A total of 21 patients (mean age 66.4±5.9years) were included in the study. Study cohort predominantly included male patients (n=15; 71.4%) and patients with single vessel disease (n=15; 71.4%). Revascularization of the culprit lesion, before VSR closure, was attempted in 6 patients. Except one patient (treated with Cera® occluder), all patients were treated with Amplatzer® ASD occluders. Average diameter of VSR was 20.8±6.9mm. Diameter of the device used in the study ranged from 10mm to 30mm. Residual defect was detected in 13 patients (62%). All-cause mortality at 30-day follow-up was observed in 9 (42.9%) patients. Time to VSR closure, diameter of VSR, and serum creatinine levels were significantly related to the 30-day mortality. MELD-XI score was found to be strongly associated with increased risk of mortality. CONCLUSION: Primary transcatheter VSR closure using ASD occluders is a feasible approach which can provide reasonable survival outcomes along with equitable mortality rates.

A Case Series of Young Patients with Completely Reversed Severe Pulmonary Hypertension.

Pulmonary Arterial Hypertension (PAH) is a progressive symptomatic disorder, which may ultimately lead to death if left untreated. Although majority of PAH cases are idiopathic, pulmonary hypertension resulting due to certain underlying conditions are also observed frequently. In such cases, it becomes essential to identify any potentially treatable or reversible causes for PAH. There have been significant advances in the medical management of PAH and various medicines have been approved by US Food and Drug Administration (FDA) for various stages of PAH. With these therapies, there can be varying degrees of improvement in the pulmonary artery pressures and hemodynamic profile. Therefore, physiologic reversal can and does occur, sometimes to the point of normalization. We hereby present three such cases of severe PAH in patients below 50 years of age due to various aetiologies like left heart disease, isolated unilateral absence of right pulmonary artery with hypoplastic right lung and factor V Leiden mutation associated pulmonary thromboembolism, all of whose pulmonary artery pressures are completely normalised with adequate treatment of the underlying disease and with optimised medications for PAH, ultimately leading to tapering and stoppage of PAH medications.

Surviving All Odds: A Unique Case of Multiple Congenital Unruptured Sinus of Valsalva Aneurysms Involving Both Left and Right Coronary Sinuses with Biventricular Dysfunction and Heart Block.

Aneurysms of the sinus of Valsalva are very uncommon, with an incidence ranging from 0.1 to 3.5% of all congenital heart defects. Very few cases have been reported in the literature that presented with involvement of two or more sinuses. We report a case of 27-year-old male with a history of exertional breathlessness of one-month duration. After complete evaluation using transesophageal echocardiography (TEE) and multiple detector computed tomography (MDCT) scanning, the patient was diagnosed to have large congenital unruptured sinus of Valsalva aneurysms involving both left and right coronary sinuses with extension into the interventricular septum. The patient also displayed second-degree heart block (Mobitz type 2) and biventricular dysfunction. The patient was managed successfully. We present the case with an aim to highlight the management challenges including intraoperative and postoperative complications that are associated with unruptured sinus of Valsalva aneurysms of ≥2 sinuses.

A Rare Case of Fatal Endocarditis and Sepsis Caused by Pseudomonas aeruginosa in a Patient with Chronic Renal Failure.

Nosocomial catheter-related and Arteriovenous fistula (AV)-related infections are significant concern in patients undergoing haemodialysis. These infections are associated with multiple complications as well as mortality and demands immediate and appropriate management. While coagulase-negative staphylococci, S.aureus, and Escherichia coli are the most common causes of catheter-related infections in haemodialysis patients, such infections caused by Pseudomonas aeruginosa are relatively rare. Here, we present an unusual case of 36-year-old male patient with chronic renal failure, who developed endocarditis and sepsis from Pseudomonas aeruginosa infection of the left hand arteriovenous fistula. The bacteraemia in the present case caused multiple complications including dry gangrene of bilateral lower limbs, stroke, endophthalmitis, left brachial artery thrombosis and vegetations on the interventricular septum and aortic wall. Despite antibiotic treatment, the patient suffered a cardiac arrest and could not be revived.

Isolated rheumatic severe tricuspid regurgitation.

Severe isolated tricuspid regurgitation (TR) is very rare, with most cases of TR being functional and secondary to pulmonary hypertension from left heart pathologies. We report an unusual case of a young Nigerian male, who presented to us with dyspnea, repeated hospital admissions for heart failure, and a childhood history of rheumatic fever. Echocardiogram showed massively dilated right atrium and ventricle, noncoaptation of thickened tricuspid valve with torrential free tricuspid regurgitation. Other valves were normal. Cardiac MRI showed normal right ventricular function and viability. Patient underwent tricuspid valve replacement with 35-mm St. Jude valve.

An Unusual Case of Biatrial Myxoma in a Young Female.

Myxoma, a rare type of intracardiac tumor, forms a very small percentage of the cardiac cases. Reports of biatrial myxoma are rarer, with cases of single tumor reaching both atria being more common. Here, we present an unusual case of two independently growing atrial myxoma in a 29-year-old female. We emphasize that early recognition of symptoms, confirmation of diagnosis by transesophageal echocardiography, and prompt surgical excision remain vital in the management of such patients. The patient in the present case was managed successfully with no evidences of recurrence at the last follow-up.

Use of Lung Ultrasound For Diagnosing Acute Heart Failure in Emergency Department of Southern India.

INTRODUCTION: Diagnosing heart failure is often a challenge for the healthcare providers due to it's non-specific and usually subtle physical presentations. The outcomes for treatment are strongly related to the stage of the disease. Considering the importance of early and accurate diagnosis, it is important to have an easy, inexpensive, non-invasive, reliable and reproducible method for diagnosis of heart failure. Recent advancement in radiology and cardiology are supporting the emerging technique of lung ultrasound through B-line evaluation for identifying extravascular lung water. AIM: To establish lung ultrasound as an easy, inexpensive, non-invasive, reliable and reproducible method for diagnosing Acute Decompensated Heart Failure (ADHF) in emergency department. MATERIALS AND METHODS: The study was a cross-sectional, prospective, observational, diagnostic validation study of lung ultrasound for diagnosis of acute heart failure in an emergency department and was performed at Amrita Institute of Medical Science, Kochi, Kerala, India. A total of 42 patients presenting with symptoms suggestive of acute decompensated heart failure were evaluated by plasma B-type Natriuretic Peptide (BNP), Echocardiography (ECHO) and X-ray. Lung ultrasound was done to look for the presence of B-lines. STATISTICAL ANALYSIS: Sensitivity, specificity and predictive value of diagnostic modalities were calculated using Mc Nemar's Chi-square test for the presence and absence of heart failure. RESULTS: Lung ultrasound showed a sensitivity of 91.9% and a specificity of 100% in diagnosing acute heart failure comparable to plasma BNP which had a sensitivity of 100% and a specificity of 60%. It was also superior to other methods of diagnosing ADHF namely X-ray and ECHO and showed a good association. CONCLUSION: Lung ultrasound and its use to detect ultrasonographic B-lines is an early, sensitive and an equally accurate predictor of ADHF in the emergency setting as compared to BNP.