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.

Percutaneous Coronary Intervention in Anomalously arising Coronary Arteries.

OBJECTIVE: Anomalous origin of coronary arteries (ACA) is rare. The objective of this communication is to describe the difficulties in angiographic recognition and challenges in percutaneous management. METHODS: The material for this retrospective study was provided by contributing interventional cardiologists practicing in tertiary care centers. RESULTS: From 2010 to 2019, 27 patients underwent percutaneous coronary intervention (PCI) for ACA. Four groups were encountered including anomalous origin from opposite sinus [left anomalous coronary artery from opposite sinus (L-ACAOS, n = 5), right anomalous coronary artery from opposite sinus (R-ACAOS n = 4)], origin of left circumflex from right sinus (n = 12), and origin of right coronary artery from posterior sinus (n = 6). The selection of a guiding catheter is the crucial step and a wide range of accessories was required to achieve an excellent outcome. Radial access may have an advantage in R-ACAOS, although the majority had a successful procedure from the femoral approach. CONCLUSION: Percutaneous management of patients with anomalous coronary arteries is challenging but can be accomplished with an excellent immediate outcome.

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.

Radiation doses during cardiac catheterisation procedures in India: a multicentre study: Radiation dose study.

AIMS: Established, evidence-based measures of radiation are required to minimise its hazards, while maintaining adequate image quality. The aim of this study is to evaluate radiation data and generate reference radiation levels for commonly performed coronary catheterisation procedures in India. METHODS AND RESULTS: In this prospective, observational study, all procedures were performed in accordance with the established standards using Innova IGS 520/2100-IQ catheterisation laboratories. Demographic, procedural and radiation data were collected. Dose reference limits (DRL) were established as the 75th percentile of the total distribution. There were 2,906 coronary angiograms (CAG), 750 percutaneous coronary interventions (PCI) and 715 CAG+PCI. DRLs for dose area product were: 19.6 Gy·cm2 for CAG, 49.8 Gy·cm2 for PCI and 72.0 Gy·cm2 for CAG+PCI, respectively. Median cumulative air kerma levels were: 185 mGy for CAG, 533mGy for PCI, and 891 mGy for CAG+PCI. Male gender, higher BMI, combining CAG+PCI, fluoroscopy time, number of cine frames, and image acquisition settings were significant contributors to increased radiation dose. CONCLUSIONS: This study established reference radiation dose levels for diagnostic and interventional coronary procedures in India, which were comparable to and in the lower range of international standards.

Cardiac Amyloidosis: A Case Series from India.

OBJECTIVE: Cardiac amyloidosis (CA) is not well recognized in Indian literature. The aim of this communication is to highlight the difficulties in diagnosis. METHODS: A retrospective analysis of data of six patients of CA diagnosed during 2008 to 2015 was done. Clinical, investigative, management and follow-up data is analyzed. RESULTS: The mean age was 51 years with male preponderance. Heart failure was the commonest manifestation. Atrial arrhythmias were seen in 33%. Syncope, peripheral neuropathy and macroglossia were striking features. A speckled inter-ventricular septum (66%) or thickened inter-atrial septum (16%) on echocardiography strongly favoured CA. Other echocardiography features include thickened ventricular wall, enlarged atria and pericardial effusion (PE). Late gadolinium enhancement (LGE) on cardiac magnetic resonance (CMR) was characteristic of CA. Plasma cell dyscrasia confirmed light chain amyloidosis. Abdominal fat pad and rectal biopsy confirmed the diagnosis. Chemotherapy for plasma cell dyscrasia was administered in 50% of patients. CONCLUSION: Echocardiography and CMR imaging enable the diagnosis of CA in background of strong clinical suspicion. Abdominal fat pad biopsy is a simple and reliable method for confirming the diagnosis. IMPLICATIONS AND PRACTICE: The awareness of this entity can enable an early diagnosis and improve the survival with timely novel chemotherapy.

Tricuspid valve endocarditis in non-drug abusers: A case series from India.

OBJECTIVE: The etiology of tricuspid valve endocarditis (TVE) seems to be different in our country as intravenous (IV) drug abuse is not known to be a major health hazard. The objective of this communication is to study the risk factors, clinical profile, follow-up data of TVE patients and focus on the difficulties in diagnosis and variations encountered. METHODS: A retrospective analysis of data of 10 patients of TVE managed in a tertiary care center during January 1992 to June 2015 was done. RESULTS: TVE was encountered in a diverse subset of patients with cardiac implantable electronic device (CIED) (group I; 3 patients), immunocompromised state with indwelling central venous catheter (CVC) (group II; 2 patients), congenital heart disease (CHD) (group III; 3 patients) and in apparently healthy individuals (group IV; 2 patients). Blood cultures were negative in half the patients. In group I early surgical extraction of leads, device and vegetation provided excellent results. Prognosis was poor with 100% mortality in immunocompromised patients. Patients in group III did well on medical management. The overall mortality was high (30% in hospital and additional 20% within one year). CONCLUSIONS: TVE is rare and can occur in different clinical scenarios. Indiscriminate use of antibiotics modifies the clinical picture causing delay in diagnosis and referral to speciality care. Echocardiography remains the main modality and should be used serially to facilitate early diagnosis. The prognosis is guarded. Early surgery is recommended in pacemaker lead, fungal endocarditis, persistent sepsis or hemodynamic instability for favorable prognosis.

Triple vessel percutaneous coronary intervention in a patient with situs inversus dextrocardia using a transradial approach.

Situs inversus dextrocardia is a challenging situation for an interventional cardiologist. This report presents a rare case where multivessel percutaneous coronary intervention was performed in a single sitting using transradial approach. The challenges encountered in the procedure and clues to successful outcome are discussed.

Aorto - Left atrial fistula after mitral valve replacement.

Acquired aorto-left atrial fistula is uncommon. A rare case of aorto-left atrial fistula following mitral valve replacement is reported with echocardiographic, computed tomograpic and angiographic images.

Spontaneous coronary artery dissection: Case series and review of literature.

AIM: Spontaneous coronary artery dissection (SCAD) is a less recognized cause of ST elevation myocardial infarction (STEMI) in clinical practice. The aim of this communication is to describe a case series in South Asian population and highlight on the long-term clinical outcomes on conservative management. METHODS: A retrospective analysis of data of five patients (6 instances) of SCAD managed in a tertiary care center during January 1994 to June 2015 was done. Clinical, angiographic, therapeutic, and follow-up data till end of June 2015 are analyzed. RESULTS: All patients were young (mean - 33 years) and predominantly male. Etiology of SCAD was diverse and included peripartum state, vigorous activity and atherosclerosis. Left anterior descending (LAD) coronary artery was predominantly involved and the majority had angiographic type 1 SCAD. Medical treatment provides excellent long-term benefits. Coronary stenting provided symptomatic benefit in a patient with favorable anatomy. CONCLUSIONS: Clinical recognition of SCAD is difficult. It should be suspected in peripartum state, young females and in presence of other precipitating factors. Coronary angiography is essential for establishing the diagnosis. Medical treatment provides favorable long-term survival. IMPLICATIONS AND PRACTICE: The awareness of SCAD is important for all clinicians involved in STEMI care. A prompt suspicion can avoid administration of thrombolytic therapy. Early coronary angiography will provide an accurate diagnosis and help in deciding appropriate therapy. Percutaneous intervention can be challenging.

The 'MAP strategy' (Maximum aspiration of atherothrombus and adjunctive glycoprotein IIb/IIIa inhibitor utilization combined with prolonged inflation of balloon/stent) for preventing no-reflow in patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention: A retrospective analysis of seventy-one cases.

'No-reflow' phenomenon is a common occurrence in percutaneous coronary intervention (PCI). A three-component 'MAP strategy' was designed to prevent no-reflow by addressing both intralesional and intraluminal thrombus in patients with ST-segment elevation myocardial infarction (STEMI). In this analysis, we observed Thrombolysis In Myocardial Infarction (TIMI) flow grade 3 or 2 in all patients, with no incidence of no-reflow. Myocardial blush grade (MBG) 3 or 2 was observed in most (87.32%) patients. Left ventricular ejection fraction (LVEF) was improved, without any incidence of death up to 9-month follow-up. All patients safely tolerated the strategy-driven prolonged, 35-s inflation of the balloon/stent.

Percutaneous transluminal renal stenting for transplant renal artery stenosis.

OBJECTIVES: Renal transplantation is a well-accepted therapeutic option for patients with end stage renal disease. Renal artery stenosis occurring in a transplanted kidney is a potentially serious condition and adversely affects graft survival and prognosis. The objective of this study is to document the immediate and intermediate term clinical results of renal stenting in this rare subset of renal artery stenosis. BACKGROUND: There is limited data about the effectiveness of renal stenting in transplant renal artery stenosis. METHODS: Eight patients, aged between 22 and 51 (42.5 ± 9.25) years, were referred to our tertiary care interventional cardiology services for renal intervention. The diagnosis of transplant renal artery stenosis was based on clinical presentation (uncontrolled hypertension (n = 4, 50%), worsening renal function (n = 3, 37.5%) or flash pulmonary oedema (n = 1, 12.5%)] and Doppler ultrasound. RESULTS: All patients had live donor renal transplant using end to end anastomosis 2 to 11 (6.25 ± 3.24) months prior to intervention. Angiography revealed discrete stenosis at the anastomotic site. Intrarenal stenting performed from femoral access using 6 F accessories produced excellent angiographic results. There were no access site or procedure related complications. The intervention produced excellent immediate and intermediate term clinical results. In three patients, there was stabilization of renal function during 62 ± 9.16 months of follow-up with decrease in serum creatinine by 38.86 ± 6.62 %; P = 0.0476. In four patients with refractory hypertension, excellent blood pressure control was achieved with a reduction in mean blood pressure by 25.95 ± 5.48 mm Hg (from 122.4 ± 5.7 to 96.45 ± 2.45 mm Hg; P = 0.0002) during 65.25 ± 23.79 months follow-up. There was decrease in antihypertensive drug requirement from 3.75 ± 0.5 to 1.75 ± 0.5. During follow-up, Doppler ultrasound documented a high peak systolic velocity in one asymptomatic patient with well controlled blood pressure and preserved renal function. Sustained benefits of percutaneous revascularization were supported by normal Doppler parameters in the remaining patients. CONCLUSIONS: Percutaneous renal stenting provides excellent angiographic and clinical results sustained at intermediate term follow-up in patients with symptomatic transplant renal artery stenosis.