First-in-human evaluation of a novel balloon-expandable transcatheter heart valve in patients with severe symptomatic native aortic stenosis: the MyVal-1 study.

AIMS: The aim of this study was to demonstrate the safety and efficacy of the next-generation balloon-expandable Myval transcatheter heart valve (THV) in an intermediate- or high-risk patient population with severe symptomatic native aortic stenosis. METHODS AND RESULTS: MyVal-1 was a first-in-human, prospective, multicentre, single-arm, open-label study. Between June 2017 and February 2018, a total of 30 patients were enrolled at 14 sites across India. Mean age was 75.5±6.7 years; 43.3% had coronary artery disease. The mean Society of Thoracic Surgeons score was 6.4±1.8% and 100% of the patients were in New York Heart Association (NYHA) functional Class II/III/IV pre-procedure. The six-minute walk test and Kansas City Cardiomyopathy Questionnaire (KCCQ) scores were recorded. After successful implantation of the Myval THV, 96.6% and 100% were in NYHA functional Class I/II at 30-day and 12-month follow-up, respectively. Outcomes of the six-minute walk test (148.0±87.4 vs 336.0±202.9 m) and KCCQ score (36.6±11.0 vs 65.9±11.4) improved from baseline to 12-month follow-up. The effective orifice area (0.6±0.2 vs 1.8±0.3 cm2, p<0.0001), mean aortic valve gradient (47.4±8.8 vs 12.0±3.3 mmHg, p<0.0001), peak aortic valve gradient (71.7±13.0 vs 20.3±5.9 mmHg, p<0.0001) and transaortic velocity (4.5±0.4 vs 2.2±0.4 m/s, p<0.0001) improved substantially from baseline to 12 months post procedure. Four all-cause mortality cases were reported up to 12 months. Moreover, there was no other moderate/severe paravalvular leak, aortic regurgitation or need for new permanent pacemaker (PPM) up to 12-month follow-up. CONCLUSIONS: The MyVal-1 study demonstrated the primary safety and efficacy of the Myval THV with no new PPM requirement up to 12-month follow-up. However, future trials with a larger number of patients and long-term follow-up are warranted to establish the safety and efficacy of the device.

Three-year clinical and two-year multimodality imaging outcomes of a thin-strut sirolimus-eluting bioresorbable vascular scaffold: MeRes-1 trial.

AIMS: Although the proof of concept of the bioresorbable vascular scaffold (BRS) is well documented, device-related adverse outcomes with first-generation BRS indicate longer-term surveillance. The current study provides insights into the safety and performance of the MeRes100, a novel second-generation sirolimus-eluting BRS, beyond one-year up to three-year follow-up (FU). METHODS AND RESULTS: A total of 108 enrolled patients with de novo coronary artery lesions who underwent implantation of MeRes100 as part of the first-in-human MeRes-1 trial were followed up clinically beyond one year at two and three years and with multiple modality imaging at six months and two years. At three-year FU, the cumulative major adverse cardiac events rate was 1.87%, in the form of two ischaemia-driven target lesion revascularisations. No scaffold thrombosis was reported. Between six months and two years at quantitative coronary angiography, in-segment late lumen loss (LLL) (0.15±0.22 mm vs. 0.23±0.32 mm; p=0.18) and in-scaffold LLL (0.13±0.22 mm vs. 0.24±0.34 mm; p=0.10) changed insignificantly. IVUS subset analysis revealed a non-significant reduction in mean lumen area (6.17±1.28 mm2 vs. 5.47±1.50 mm2; p=0.21) and minimum lumen area (5.14±1.19 mm2 vs. 4.05±1.42 mm2; p=0.10) at two years compared to post-procedural measurements. OCT subset analysis demonstrated 99.24±2.27% neointimal strut coverage. CONCLUSIONS: The extended outcomes of the MeRes-1 trial demonstrated sustained efficacy and safety of the MeRes100 BRS with maintained lumen patency up to two years by multimodality imaging and no very late scaffold thrombosis up to three-year clinical FU.The MeRes-1 trial is registered at the Clinical Trials Registry-India. CTRI Number: CTRI/2015/04/005706.

Comparison of Morphologic Findings in Patients with Dextrocardia with Situs Solitus vs Situs Inversus: a Retrospective Study.

BACKGROUND: Studies on dextrocardia have been limited by low numbers. Hence, it is very difficult to find the most common diagnosis in patients with dextrocardia, who are seeking medical attention in tertiary care center. AIMS AND OBJECTIVE: To identify the most common diagnostic pattern in patients with dextrocardia with different situs. METHODS: It is a retrospective study with records dating back to up to last 21 years from a major tertiary care center in south India. All the patients with diagnosis of dextrocardia (defined as right-sided baso-apical axis of heart) will be included in the study. Segmental analysis will be done as defined previously. RESULTS: There were total of n = 378 patients with dextrocardia, 43.3% were females and median age was 1 year while mean age was 7 years. Situs solitus was present in 43.1%, Situs inversus in 38.1%, and Situs ambiguus in 18.8%. In patients with situs solitus and dextrocardia, the most common diagnosis was congenitally corrected TGA ± PS/PA followed by Double outlet Right ventricle ± PS/PA; whereas in patients with Situs inversus and dextrocardia, the most common diagnosis was Double outlet Right ventricle ± PS/PA followed by normal hearts and Left to right shunts. CONCLUSION: In patients with dextrocardia who are seeking medical advice in a tertiary care center, they are more likely to have situs solitus followed by situs inversus. In situs solitus atrio-ventricular discordance with right ventricular outflow obstruction is the most common lesion suggesting L-looping is the most predominant mechanism. In patients with situs inversus, DORV with RVOTO is the most common lesion.

Clinical Outcomes of patients with coronary artery disease who underwent FFR evaluation of intermediate coronary lesionS- COFFRS study.

BACKGROUND: We undertook this study to validate the impact of FFR-guided coronary interventions among Indian patients, which is not readily available as of date. Our patients differ from their western counterparts, both in terms of risk profile (younger, more metabolic syndrome, lipid rich diet) as well as their coronary size. METHODS: We retrospectively evaluated 282 patients with intermediate stenosis in their coronary arteries, who underwent FFR to assess the functional severity of the lesion. There were 3 groups: Group 1-FFR>0.8 and kept on medical follow-up; Group 2-FFR≤0.8 and underwent revascularisation; and Group 3-FFR≤0.8 and refused to undergo revascularization. 281(99.6%) patients had regular follow-up in our clinic. RESULTS: Median age-57 years (range=28-78). Males=230, 90 patients were in Group 1, 175 in group 2 (PCI in 144 & CABG in 31) and 17 in group 3. Median follow-up of patients was 17.9 months (2 to 56 months). Three patients(3.4%) in Group 1 had MACE (1 STEMI, 2 UA); 4 patients (2.3%) in Group 2 had Non-STE-ACS; 7 patients (41%) in Group 3 had MACE (3 deaths with acute LVF, 2 NSTEMI, 2 STEMI) CONCLUSION: In our experience, MACE events were not higher in patients with FFR>0.8 and kept under medical therapy and were similarly lower in patients with FFR ≤0.8 and underwent revascularisation (p=0.73). Also MACE events were higher in patients with FFR≤0.8 and did not undergo revascularisation compared to other two appropriately treated groups (p=0.03). FFR based revascularization decision appears to be a safe strategy in Indian patients.

Flecainide challenge test: Predictors of unmasking of type 1 Brugada ECG pattern among those with non-type 1 Brugada ECG pattern.

BACKGROUND: Many subjects in community have non-type 1 Brugada pattern ECG with atypical symptoms, relevance of which is not clear. Provocative tests to unmask type 1 Brugada pattern in these patients would help in diagnosing Brugada Syndrome. However sensitivity and specificity of provocating drugs are variable. METHODS: We studied 29 patients referred to our institute with clinical presentation suggestive but not diagnostic of Brugada or with non-Type 1 Brugada pattern ECG. Flecainide Challenge Test (FCT) was done in these patients (IV Flecainide test in 4 patients and Oral Flecainide in 25 patients). Resting 12-lead ECG with standard precordial leads and ECG with precordial leads placed 1 Intercostal space above were performed after flecainide administration every 5 min for first 30 min and every 30 min thereafter until ECG became normal or upto 6 h. The positivity was defined as inducible Type 1 Brugada pattern in atleast 2 right sided leads. RESULT: Median age was 35(range = 5-65) years. In 16 (55%) patients the Type 1 Brugada pattern was unmasked. There were no episodes of major AV block, atrial or ventricular tachyarrhythmia. Three groups were considered for analysis: Group 1(n = 9) - FCT Positive among patients with non-type 1 Brugada ECG pattern, Group 2(n = 4) - FCT Negative among the patients with non-type 1 Brugada ECG pattern, and Group 3(n = 7) - FCT Positive among patients with no spontaneous Brugada ECG pattern. Binary logistic regression analysis found that family h/o SCD was predictive of FCT positivity in Group 1 (Odd's ratio 21, 95% Confidence interval 1.04 to 698.83, p = 0.004). CONCLUSION: Oral flecainide is useful and safe for unmasking of Type I Brugada pattern. In our study, among the many variables studied, family history of sudden cardiac death was the only predictor of flecainide test positivity among those with non-Type 1 Brugada pattern.

Percutaneous valvuloplasty for mitral valve restenosis: postballoon valvotomy patients fare better than postsurgical closed valvotomy patients.

AIM: To compare the results of percutaneous mitral valvuloplasty (BMV) for mitral restenosis in post-BMV versus postclosed mitral valvotomy (CMV) patients. METHODS AND RESULTS: Ninety-two patients who underwent BMV for mitral restenosis were followed up prospectively. Of these, 28 patients had undergone previous percutaneous mitral valvuloplasty (PRIOR BMV) and 64 patients had undergone previous closed mitral valvotomy (PRIOR CMV). BMV for mitral restenosis was a success in 59% patients (57.1% PRIOR BMV, 59.3% PRIOR CMV, P = 1.0). Incidence of severe mitral regurgitation was 3.25%, all in the PRIOR CMV group. In univariate analysis, the major predictor of successful BMV for mitral restenosis was Wilkins score (P = 0.004). At a follow up of 3.47 + 2.07 years, mitral valve area was similar between groups (1.45 +/- 0.22, 1.46 +/- 0.26, P = 0.35). The combined end points of mitral valve replacement (MVR), need for re-repeat BMV for mitral restenosis or death was higher in the PRIOR CMV group (31.2% PRIOR CMV, 7.1% PRIOR BMV, P = 0.027). Event-free survival at follow up was lower in the PRIOR CMV group (69% PRIOR CMV, 92.8% PRIOR BMV) mainly due to the higher need for MVR (11 vs. 0 patients, P = 0.03). CONCLUSIONS: In conclusion, following BMV for mitral restenosis, patients with PRIOR BMV are found to have lesser event rates on follow-up compared to patients with PRIOR CMV, though procedural success rates are similar.

Left hemothorax: a presentation of a late ventricular perforation caused by an active fixation pacing lead.

Ventricular perforation, late after ventricular lead placement at the right ventricular apex is rare, and though, commonly presents with chest pain, loss of pacing and/or sensing, and hemodynamic instability caused by cardiac tamponade, it can rarely cause left sided hemothorax needing surgical exploration.

Efficacy and safety of combination of extended release niacin and atorvastatin in patients with low levels of high density lipoprotein cholesterol.

OBJECTIVE: We investigated the safety and efficacy of combination therapy of extended release (ER) niacin and atorvastatin in patients with low HDL-C and compared the results with atorvastatin monotherapy. METHODS: This open label study recruited consecutive men and women who had coronary artery disease with HDL-C levels <35 mg/dL. These patients were already on atorvastatin therapy targeted to lower low density lipoprotein cholesterol (LDL-C), for a minimum period of 6 months. Group 1, n = 104 (mean age 52.7 years) received ER niacin in addition to atorvastatin and group 2 (n = 106) continued on atorvastatin (mean age 52.3 years). ER niacin dose was built up to a maximum of 1.5 g and atorvastatin dose titrated according to LDL levels in both the groups. The lipoprotein levels at baseline were similar (p = NS). RESULTS: At 9 +/- 1.8 months of follow-up, the mean dose of ER niacin was 1.3 g and atorvastatin 13.2 mg in group 1. In comparison, group 2 patients had mean atorvastatin dose of 15.9 mg. Patients in group 1 had significant elevation in HDL-C cholesterol (39.5 +/- 5.5 vs 35.7 +/- 4.5 mg/dL), reduction in total cholesterol (156.4 +/- 31 vs 164.5 +/- 39.3 mg/dL) and also LDL-C (88.9 +/- 28.3 vs 99.8 +/- 35.4 mg/dL) compared to group 2 (all p < 0.05). The magnitude of reduction in triglyceride levels was not significant between the groups (140.1 +/- 40.4 vs 145.2 +/- 46.5 mg/dL) (p = NS). No major adverse events or clinical myopathy occurred in either groups. Four patients (4%) discontinued ER niacin (2 due to gastro-intestinal symptoms and 2 due to worsening of diabetes). Flushing occurred in 3% patients, but none felt it to be troublesome. CONCLUSION: Adding ER niacin to atorvastatin exhibited beneficial effects on lipid profile with significant elevation of HDL-C cholesterol and further lowering of LDL-C compared to monotherapy. This treatment offered better targeted therapy and was well tolerated with proper monitoring in Indian patients.