Safety and effectiveness of the novel Myval Octacor transcatheter heart valve in severe, symptomatic aortic valve stenosis - A real-world Indian experience (The OCTACOR India Study).

PURPOSE: To evaluate the safety and effectiveness of the novel, next-generation Myval Octacor - Transcatheter Heart Valve (THV) in patients with severe, symptomatic, native aortic stenosis (AS). METHODS: This multicenter, real-world observational registry included 123 patients with severe symptomatic AS, across 16 Indian centers who underwent treatment with the novel Myval Octacor THV. Study endpoints included all-cause mortality, all stroke, acute kidney injury (AKI), major vascular complications, moderate or severe paravalvular leakage (PVL) and new permanent pacemaker implantation (PPI) until 30 days follow-up. RESULTS: Of the 123 patients (average age 70.07 ± 8.33 years), 37.4 % (n = 46) were female and 39.84 % presented with bicuspid valves. The technical success rate of the procedure was 100 % and the device success rate at 30 days was 98.4 %. At 30 days (n = 123) after the procedure, the overall mortality was 1.6 %. AKI occurred in 1.6 % of patients and there was no incidence of stroke, bleeding (types 3 and 4), and major vascular complications. In an analysis of 31 patients whose echocardiographic parameters were available across all timepoints, there were significant improvements in the mean pressure gradient (54.31 ± 18.19 mmHg vs. 10.42 ± 4.24 mmHg; p < 0.0001) and effective orifice area (0.66 ± 0.21 cm2 vs. 1.80 ± 0.44 cm2; p < 0.0001) from baseline to the 30-day follow-up. None of the patients experienced severe PVL, while moderate PVL was observed in two patients (1.6 %). CONCLUSIONS: Early outcomes of the next-generation, novel Myval Octacor THV proved its safety and effectiveness in the treatment of severe AS.

Clinical Outcomes Following Transcatheter Mitral Valve-in-Valve Replacement Using a Meril Myval Transcatheter Heart Valve.

AIM: Transcatheter mitral valve-in-valve (TMViV) replacement for degenerated surgically implanted bioprosthetic valves has been described by both transseptal and transapical approaches. The balloon-expandable Myval transcatheter valve (Meril Life Sciences, Vapi, India) is commonly used for transcatheter valve-in-valve procedures in India. This study aimed to report in-hospital, 30-day, and 1-year outcomes of Myval patients who underwent TMViV in a single tertiary care centre in India. METHODS: Symptomatic patients with surgical bioprosthetic mitral valve failure with New York Heart Association (NYHA) class III-IV symptoms, despite optimal medical therapy and high or very high risk for redo surgery, were assigned to TMViV following heart team discussions. Data were retrospectively collected and outcomes assessed. RESULTS: Twenty patients were treated, with mean age 64.4 years, 60% were female, and mean Society of Thoracic Surgeons (STS) predicted risk of operative mortality score was 8.1. The failure mechanism was combined stenosis and regurgitation in 60% of patients. Technical success was achieved in 100% of patients. The mean postprocedure and 30-day gradients were 4.6±2.7 and 6.3±2.1, respectively. None of them had significant valvular or paravalvular leaks or left ventricular outflow tract obstruction. All-cause mortality at 1 year was 10%, and all survivors were in New York Heart Association (NYHA) class I or II. CONCLUSION: TMViV replacement with a Meril Myval can be safely performed with high technical success, and low 30-day and 1-year mortality.

Impact of real-time optical coherence tomography and angiographic coregistration on the percutaneous coronary intervention strategy.

Background: The use of optical coherence tomography (OCT) with angiographic coregistration (ACR) during percutaneous coronary intervention (PCI) for procedural decision-making is evolving; however, large-scale data in real-world practice are lacking. Aims: Our study aims to evaluate the real-time impact of OCT-ACR on clinician decision-making during PCI. Methods: Patients with angiographic diameter stenosis >70% in at least one native coronary artery were enrolled in the study. The pre- and post-PCI procedural strategies were prospectively assessed after angiography, OCT, and ACR. Results: A total of 500 patients were enrolled in the study between November 2018 and March 2020. Among these, data related to 472 patients with 483 lesions were considered for analysis. Preprocedural OCT resulted in a change in PCI strategy in 80% of lesions: lesion preparation (25%), stent length (53%), stent diameter (36%), and device landing zone (61%). ACR additionally impacted the treatment strategy in 34% of lesions. Postprocedural OCT demonstrated underexpansion (15%), malapposition (14%), and tissue/thrombus prolapse (7%), thereby requiring further interventions in 30% of lesions. No further change in strategy was observed with subsequent postprocedural ACR. Angiographic and procedural success was achieved in 100% of patients, and the overall incidence of major adverse cardiovascular events at 1 year was 0.85%. Conclusions: The outcomes reflect the real-time impact of OCT-ACR on the overall procedural strategy in patients undergoing PCI. ACR had a significant impact on the treatment strategy and was associated with better clinical outcomes at 1 year after index PCI. OCT-ACR has become a practical tool for improving outcomes in patients with complex lesions.

Effectiveness and safety of optical coherence tomography-guided PCI in Indian patients with complex lesions: A multicenter, prospective registry.

BACKGROUND: Optical coherence tomography (OCT) is reported to be a feasible and safe imaging modality for the guidance of percutaneous coronary intervention (PCI) of complex lesions. METHODS: This multicenter, prospective registry assessed the minimum stent area (MSA) achieved under OCT guidance. A performance goal of 24% improvement in MSA over and above the recommendation set by the European Association of Percutaneous Cardiovascular Interventions Consensus 2018 (4.5 mm2 MSA for non-left main and 3.5 mm2 for small vessels). The incidence of contrast-induced nephropathy was also assessed. Core lab analysis was conducted. RESULTS: Five hundred patients (average age: 59.4 ± 10.1 years; 83% males) with unstable angina (36.8%), NSTEMI (26.4%), and STEMI (22%) were enrolled. The primary endpoint was achieved in 93% of lesions with stent diameter ≥2.75 mm (average MSA: 6.44 mm2) and 87% of lesions with stent diameter ≤2.5 mm (average MSA: 4.56 mm2). The average MSA (with expansion ≥80% cutoff) was 6.63 mm2 and 4.74 mm2 with a stent diameter ≥2.75 mm and ≤2.5 mm, respectively. According to the core lab analysis, the average MSA achieved with a stent diameter ≥2.75 mm and ≤2.5 mm was 6.23 mm2 and 3.95 mm2, respectively (with expansion ≥80% cutoff). Clinically significant serum creatinine was noted in two patients (0.45%). Major adverse cardiac events at 1 year were noted in 1.2% (n = 6) of the patients; all were cardiac deaths. CONCLUSION: PCI under OCT guidance improves procedural and long-term clinical outcomes in patients with complex lesions not just in a controlled trial environment but also in routine clinical practice.

AngioNet: a convolutional neural network for vessel segmentation in X-ray angiography.

Coronary Artery Disease (CAD) is commonly diagnosed using X-ray angiography, in which images are taken as radio-opaque dye is flushed through the coronary vessels to visualize the severity of vessel narrowing, or stenosis. Cardiologists typically use visual estimation to approximate the percent diameter reduction of the stenosis, and this directs therapies like stent placement. A fully automatic method to segment the vessels would eliminate potential subjectivity and provide a quantitative and systematic measurement of diameter reduction. Here, we have designed a convolutional neural network, AngioNet, for vessel segmentation in X-ray angiography images. The main innovation in this network is the introduction of an Angiographic Processing Network (APN) which significantly improves segmentation performance on multiple network backbones, with the best performance using Deeplabv3+ (Dice score 0.864, pixel accuracy 0.983, sensitivity 0.918, specificity 0.987). The purpose of the APN is to create an end-to-end pipeline for image pre-processing and segmentation, learning the best possible pre-processing filters to improve segmentation. We have also demonstrated the interchangeability of our network in measuring vessel diameter with Quantitative Coronary Angiography. Our results indicate that AngioNet is a powerful tool for automatic angiographic vessel segmentation that could facilitate systematic anatomical assessment of coronary stenosis in the clinical workflow.

Percutaneous edge-to-edge mitral valve repair for symptomatic high surgical risk patients with significant mitral regurgitation - Short term and one year follow up results from a single center in India.

This series reports the safety and feasibility of MitraClip (Abbott Vascular) in 7 high surgical risk Indian patients with symptomatic mitral regurgitation (MR). The clip was deployed successfully in all patients, and more than one clip was required in 5. All had reduction in MR to ≤2+. Mean mitral valve gradient was 3.0 ± 0.8 mmHg. At 12 months follow up, all were alive, and the MR grade was 1+ in 6 patients and 2+ in one. Mean MV gradient was 3.4 ± 1.0 mmHg. The modified Kansas City Quality of life (KCQ) analysis revealed significant improvement in their quality of life (p < 0.0001).

Acute ST-Elevation Myocardial Infarction in the Young Compared With Older Patients in the Tamil Nadu STEMI Program.

OBJECTIVE: To compare the clinical presentation, risk factors and outcomes of young patients (≤45 years) presenting with ST segment-elevation myocardial infarction (STEMI) with older STEMI patients in the Tamil Nadu STEMI program (TN-STEMI). METHODS: A total of 2,420 patients were enrolled in the TN-STEMI program, which is a pre-implementation and post-implementation quality of care study. The cohort of patients was divided into young STEMI patients (≤45 years) and compared with those aged >45 years. RESULTS: A total of 591(24.4%) patients in this cohort were aged ≤45 years; 92.5% of the young STEMI were males. Smoking was the most common risk factor and its use was significantly more in younger myocardial infarction (MI) patients than in older patients (57% vs 31%; p<0.001). Compared with their older counterparts, younger patients had a lower prevalence of hypertension (14.2% vs 28.3%; p<0.001) and diabetes mellitus (13.2% vs 29.7%; p<0.001). Total ischaemic time was shorter for younger patients (235 vs 255 mins; p=0.03). Young STEMI patients more frequently presented with single vessel disease and the left anterior descending coronary artery was the most common infarct-related artery; they also had a higher thrombus load. Young MI patients had reduced mortality, both in-hospital (3.4% vs 6.4%; p=0.005) and at one year (7.6% vs 17.6%; p<0.001). Younger male STEMI patients also showed lower mortality than younger female patients. CONCLUSIONS: Young STEMI patients compared with older STEMI patients had lower prevalence of traditional risk factors, shorter ischaemic time and reduced mortality. Young female STEMI patients had higher mortality than young male STEMI patients.

Optical coherence tomography: fundamentals and clinical utility.

Although coronary angiography is the standard method employed to assess the severity of coronary artery disease and to guide treatment strategies, it provides only 2D image of the intravascular lesions. In contrast, intravascular imaging modalities such as optical coherence tomography (OCT) produce cross-sectional images of the coronary arteries at a far greater spatial resolution, capable of accurately determining vessel size as well as plaque morphology, eliminating many of the disadvantages inherent to angiography. This review will discuss the role of OCT in the catherization laboratory for the assessment and management of coronary disease.

Percutaneous coronary intervention for coronary allograft vasculopathy with drug-eluting stent in Indian subcontinent: Issues in diagnosis and management.

Coronary allograft vasculopathy fails to give a warning anginal pain due to denervation and often presents with acute coronary syndrome, ventricular dysfunction, or sudden cardiac death. Early diagnosis in a pediatric patient is difficult as it involves invasive coronary angiography or advanced imaging such as intravascular ultrasound or optical coherence tomography. A 12-year-old boy developed acute coronary syndrome, elevated troponins, and right bundle branch block, 5 years after cardiac transplantation and was treated with culprit-vessel angioplasty with a drug-eluting stent. Advanced imaging showed the involvement of nonculprit vessels too. In a detailed literature search, we failed to identify a similar clinical presentation and management in the subcontinent, hence our interest in publishing this report for educational value. Issues in diagnosis, management, prognosis, and prevention are discussed.

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.

Comparison of resting and adenosine-free pressure indices with adenosine-induced hyperemic fractional flow reserve in intermediate coronary lesions.

OBJECTIVE: Fractional flow reserve (FFR) using adenosine has been the gold standard in the functional assessment of intermediate coronary stenoses in the catheterization laboratory. We aim to study the correlation of adenosine-free indices such as whole cycle Pd/Pa [the ratio of mean distal coronary pressure (Pd) to the mean pressure observed in the aorta (Pa)], instantaneous wave-free ratio (iFR), and contrast-induced submaximal hyperemia (cFFR) with FFR. METHODS: This multicenter, prospective, observational study included patients with stable angina or acute coronary syndrome (>48 h since onset) with discrete intermediate coronary lesions (40-70% diameter stenosis). All patients underwent assessment of whole cycle Pd/Pa, iFR, cFFR, and FFR. We then evaluated the correlation of these indices with FFR and assessed the diagnostic efficiencies of them against FFR ≤0.80. RESULTS: Of the 103 patients from three different centers, 83 lesions were included for analysis. The correlation coefficient (r value) of whole cycle Pd/Pa, iFR, and cFFR in relation to FFR were +0.84, +0.77, and +0.70 (all p values < 0.001), respectively, and the c-statistic against FFR ≤0.80 were 0.92 (0.86-0.98), 0.89(0.81-0.97), and 0.91 (0.85-0.97) (all p values < 0.001), respectively. The best cut-off values identified by receiver-operator characteristic curve for whole cycle Pd/Pa, iFR, and cFFR were 0.94, 0.90, and 0.88, respectively, for an FFR ≤0.80. By the concept of "adenosine-free zone" (iFR = 0.86-0.93), 59% lesions in this study would not require adenosine. CONCLUSION: All the three adenosine-free indices had good correlation with FFR. There is no difference in the diagnostic accuracies among the indices in functional evaluation of discrete intermediate coronary stenoses. However, further validation is needed before adoption of adenosine-free pressure parameters into clinical practice.

Predictors of short-term outcomes in patients undergoing percutaneous coronary intervention in cardiogenic shock complicating STEMI-A tertiary care center experience.

BACKGROUND: Studying the outcomes in patients presenting with cardiogenic shock with ST-segment elevation myocardial infarction (CS-STEMI) and undergoing primary or rescue percutaneous coronary intervention (PCI) may give an insight to the unmet needs in STEMI-care in our region and may help in future recommendations in improving survival. MATERIALS AND METHODOLGY: During the period from January 2001- June 2017, there were 114 patients included in the study. The demographic, clinical and angiographic characteristics were compared between the survivors and non-survivors. All these variables were also compared between two-time frames (Phase 1- January 2001 to June 2007; Phase 2- July 2007 to June 2017). RESULTS: Among patients undergoing PCI for STEMI, 7.5% were in cardiogenic shock. In-hospital mortality for the patients included in the study was 53.5%. Total ischemic time (OR=0.99, 0.99-1; p=0.02), left ventricular ejection fraction (LVEF) (OR=0.90, 0.82-0.98; p=0.02), need for cardio-pulmonary resuscitation (OR=0.12, 0.24-0.66; p=0.01), and post PCI TIMI flows (OR=0.08, 0.02-0.29; p<0.001) were the significant determinants of in-hospital mortality in the regression analysis. There was no significant change in mortality between the two phases of the study, though there was a reduction in total ischemic and door-to-balloon times, transfer admissions, use of thrombolytics, glycoprotein IIb/IIIa inhibitors, intra-aortic balloon pump, and mechanical ventilation in phase 2. CONCLUSION: Patients presenting in CS-STEMI and undergoing PCI continue to experience high mortality rates, despite improvements in total ischemic times. Further improvement in the systems-of-care are required to bring about reduction in mortality in this high-risk subset.

Epidermal bulla: A dermatology complication of radial artery compression band.

Patent hemostasis technique is used with the trans radial (TR) band to prevent radial artery occlusion following diagnostic coronary angiogram or percutaneous coronary intervention using radial artery access. We report epidermal bulla as a complication of TR band usage and a modified patent hemostasis technique using barbeau test to prevent this complication.

Zero contrast optical coherence tomography-guided percutaneous coronary intervention for in-stent restenosis of the saphenous vein graft using a non-contrast flush medium.

Percutaneous coronary intervention (PCI) is often denied for individuals with coronary artery disease who are prone to develop contrast-induced acute kidney injury. We report a 73-year-old, stage 3 chronic kidney disease patient (CKD), who underwent coronary artery bypass surgery and saphenous vein graft (SVG) stenting in the past, presented with in-stent restenosis (ISR) of SVG stent. Zero contrast optical coherence tomography (OCT) guided-PCI was successfully performed using low molecular weight dextran-40 (LMWD-40) as the flush medium. Our report suggests the safety and feasibility of LMWD-40-based OCT-guided zero contrast PCI in ISR of SVG in a CKD patient, although further prospective studies are needed to evaluate this technique.

The impact of systems-of-care on pharmacoinvasive management with streptokinase: The subgroup analysis of the TN-STEMI programme.

OBJECTIVES: We evaluated the impact of implementation of the TN-STEMI programme on various characteristics of the pharmacoinvasive group by comparing clinical as well as angiographic outcomes between the pre- and post-implementation groups. METHODS: The TN-STEMI programme involved 2420 patients of which 423 patients had undergone a pharmacoinvasive strategy of reperfusion. Of these, 407 patients had a comprehensive blinded core-lab evaluation of their angiograms post-lysis and clinical evaluation of various parameters including time-delays and adverse cardio- and cerebro-vascular events at 1year. Streptokinase was used as the thrombolytic agent in 94.6% of the patients. RESULTS: In the post-implementation phase, there was a significant improvement in 'First medical contact (FMC)-to-ECG' (11 vs. 5min, p<0.001) and 'Lysis-to-angiogram' (98.3 vs. 18.2h, p<0.001) times. There was also a significant improvement in the number of coronary angiograms performed within 24h (20.7% vs. 69.3%, p<0.001). The 'Time-to-FMC' (160 vs. 135min, p=0.07) and 'Total ischemic time' (210 vs. 176min, p=0.22) also showed a decreasing trend. IRA patency rate (70.2% vs. 86%, p<0.001) and thrombus burden (TIMI grade 0: 49.1% vs. 73.4%, p<0.001) were superior in this group. The MACCE rates were similar except for fewer readmissions (29.8% vs. 12.6%, p=0.0002) and target revascularizations at 1year (4.8% vs. none, p=0.002) in the post-implementation group. CONCLUSION: The implementation of a system-of-care (hub-and-spoke model) in the pharmacoinvasive group of the TN-STEMI programme demonstrated shorter lysis-to-angiogram times, better TIMI flow patterns and lower thrombus burden in the post-implementation phase.

A System of Care for Patients With ST-Segment Elevation Myocardial Infarction in India: The Tamil Nadu-ST-Segment Elevation Myocardial Infarction Program.

Importance: Challenges to improving ST-segment elevation myocardial infarction (STEMI) care are formidable in low- to middle-income countries because of several system-level factors. Objective: To examine access to reperfusion and percutaneous coronary intervention (PCI) during STEMI using a hub-and-spoke model. Design, Setting, and Participants: This multicenter, prospective, observational study of a quality improvement program studied 2420 patients 20 years or older with symptoms or signs consistent with STEMI at primary care clinics, small hospitals, and PCI hospitals in the southern state of Tamil Nadu in India. Data were collected from the 4 clusters before implementation of the program (preimplementation data). We required a minimum of 12 weeks for the preimplementation data with the period extending from August 7, 2012, through January 5, 2013. The program was then implemented in a sequential manner across the 4 clusters, and data were collected in the same manner (postimplementation data) from June 12, 2013, through June 24, 2014, for a mean 32-week period. Exposures: Creation of an integrated, regional quality improvement program that linked the 35 spoke health care centers to the 4 large PCI hub hospitals and leveraged recent developments in public health insurance schemes, emergency medical services, and health information technology. Main Outcomes and Measures: Primary outcomes focused on the proportion of patients undergoing reperfusion, timely reperfusion, and postfibrinolysis angiography and PCI. Secondary outcomes were in-hospital and 1-year mortality. Results: A total of 2420 patients with STEMI (2034 men [84.0%] and 386 women [16.0%]; mean [SD] age, 54.7 [12.2] years) (898 in the preimplementation phase and 1522 in the postimplementation phase) were enrolled, with 1053 patients (43.5%) from the spoke health care centers. Missing data were common for systolic blood pressure (213 [8.8%]), heart rate (223 [9.2%]), and anterior MI location (279 [11.5%]). Overall reperfusion use and times to reperfusion were similar (795 [88.5%] vs 1372 [90.1%]; P = .21). Coronary angiography (314 [35.0%] vs 925 [60.8%]; P < .001) and PCI (265 [29.5%] vs 707 [46.5%]; P < .001) were more commonly performed during the postimplementation phase. In-hospital mortality was not different (52 [5.8%] vs 85 [5.6%]; P = .83), but 1-year mortality was lower in the postimplementation phase (134 [17.6%] vs 179 [14.2%]; P = .04), and this difference remained consistent after multivariable adjustment (adjusted odds ratio, 0.76; 95% CI, 0.58-0.98; P = .04). Conclusions and Relevance: A hub-and-spoke model in South India improved STEMI care through greater use of PCI and may improve 1-year mortality. This model may serve as an example for developing STEMI systems of care in other low- to middle-income countries.

A case of recurrent unstable angina - Insight from optical coherence tomography imaging.

Intimal tear is a rare cause of ACS and is angiographically indistinguishable. OCT provides unprecendented insight to the mechanism of ACS with its near tissue level definition. This is a case of unstable angina with non-significant RCA lesion. OCT showed intimal tear/flaps with evidence of thrombi, thus clinching the diagnosis.

Prevalence of parameters of suboptimal scaffold deployment following angiographic guided bioresorbable vascular scaffold implantation in real world practice - an optical coherence tomography analysis.

AIM: To assess the prevalence of suboptimal bioresorbable vascular scaffold (BVS, Abbott Vascular, Santa Clara, California) deployment in real world practice with intracoronary optical coherence tomography (OCT) imaging. METHODS: Consecutive patients who underwent percutaneous coronary intervention using BVS and the final optimization assessed with OCT imaging in two tertiary care centers between December 2012 and February 2015 were evaluated for parameters of suboptimal scaffold deployment by OCT. RESULTS: Overall, 36 scaffolds were implanted in 27 patients during this period. Mean age of the population was 54.7±8.2years and 19 (70.4%) were type B2/C lesions. The prevalence of parameters of suboptimal scaffold deployment were: underexpansion-22(61.1%), geographic miss-3(8.3%), tissue prolapse-7(25.9%), scaffold pattern irregularity-1(2.8%), longitudinal elongation-7(38.8%). Of the 7 overlaps imaged: excessive overlap was observed in 3 and scaffold gap in one. The median duration of follow up was 679days (range 193-963days). There were four events during this period. None were associated with suboptimal scaffold deployment. CONCLUSION: OCT based parameters of suboptimal scaffold deployment are common in real world scenario and were not associated with adverse outcomes on long term follow up. These findings need to be confirmed in larger studies.