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.

Angiographic quantification of aortic regurgitation following myval octacor implantation; independent core lab adjudication.

BACKGROUND: The balloon expandable Myval transcatheter heart valve (THV) showed encouraging results regarding residual aortic regurgitation (AR) from multiple observational studies. The newly designed Myval Octacor has been introduced recently, aiming for a reduction in AR and improved performance. OBJECTIVES: The focus of this study is to report the incidence of AR using the validated quantitative Videodensitometry angiography technology (qLVOT-AR%) in the first in human use of the Myval Octacor THV system. METHODOLOGY: We report on the first in human use of the Myval Octacor THV system in 125 patients in 18 Indian centres. Independent retrospective analysis of the final aortograms following implantation of the Myval Octacor was performed using the CAAS-A-Valve software. AR is reported as a regurgitation fraction. The previously validated cutoff values have been used to identify ≥moderate AR (RF% >17%), mild (6% < RF% ≤17%), and none or trace AR (RF% ≤ 6%). RESULTS: Final aortogram was analysable for 103 patients (84.4%) among the 122 available aortograms. 64 (62%) patients, had tricuspid aortic valve (TAV), 38 (37%) with bicuspid AV (BAV), and one with unicuspid AV. The median absolute RF% was 2% [1, 6], moderate or more AR incidence was 1.9%, mild AR in 20.4%, and none or trace AR in 77.7%. The two cases with RF% >17% were in the BAV group. CONCLUSION: The initial results of Myval Octacor using quantitative angiography-derived regurgitation fraction demonstrated a favourable outcome regarding residual AR, possibly due to improved device design. Results must be confirmed in a larger randomised study, including other imaging modalities.

Three dimensional transesophageal echocardiography guided transcatheter closure of mitral paraprosthesis regurgitation - a case report.

The last two decades have witnessed vast advances in the field of cardiac intervention, particularly with regard to nonsurgical closure of structural heart diseases including para prosthetic valvular leaks. The use of imaging techniques to guide even well-established procedures enhances the efficiency and safety of these procedures. The present case report aims to highlight the role of three dimensional transesophageal echocardiography in pre, intra and post operative management of patients with mitral para prosthetic valvular regurgitation.

Hyponatremic-hypertensive syndrome: think of unilateral renal artery stenosis.

Hyponatremic hypertensive syndrome (HHS) is an uncommon disorder, in which hypertension is associated with profound hyponatremia. It is mostly encountered in adults with unilateral renal artery stenosis. Although renovascular hypertension is one of the commonest causes for severe hypertension in children, HHS is rarely reported in childhood. The authors report a 9-y old boy with hypertensive emergency and severe hyponatremia due to unilateral renal artery stenosis who was successfully managed by vascular stenting of the affected vessel. Prompt recognition of this disorder can be life-saving and can subsequently lead to appropriate referral and treatment as in the present case.

Cobalt chromium stent with antiproliferative for restenosis trial in India (COSTAR I).

BACKGROUND: The CoStar stent is a novel cobalt chromium stent designed specifically for drug delivery. The COSTAR I trial represents the first-in-man study of the CoStar Paclitaxel-Eluting Coronary Stent System evaluating three dose release formulations of paclitaxel in a bioresorbable polymer matrix in the treatment of de novo coronary lesions. METHODS: The COSTAR I Trial was a prospective, multi-center registry enrolling 87 patients in four Indian centers for treatment of up to two de novo lesions = 25 mm in length in a reference vessel 2.5-3.5 mm in diameter. Three dose release formulations were studied: 30 microg eluted over 10 days bidirectionally (Group 1, n =10), 10 microg eluted over 30 days abluminally (Group 2, n=40) and 3 microg eluted over 30 days abluminally (Group 3, n = 37). RESULTS: Demographics and lesion characteristics were similar between the groups and treatment in all three groups included small caliber vessels (RVD 2.45 +/- 0.30 - 2.57 +/- 0.36 mm). The primary endpoint of in-stent late loss at four months was lowest in Group 2 (0.43 +/- 0.43 mm) compared to Group 1 and Group 3 (0.51 +/- 7 mn; 0.74 mm and 1.07 +/- 0.65 mm respectively). In-segment late loss followed similar trends, being lowest in Group 2 (0.24 +/- 0.39 mm) compared to Groups 1 and 3 (0.52 +/- 0.66 mm and 0.76 +/- 0.57 mm respectively). Group 2 demonstrated better angiographic out-comes at 12 months with in-stent late loss of 0.55 +/- 0.38 mm when compared to Groups 1 and 3 (0.90 +/- 0.76 mm and 0.74 +/- 0.55 mm respectively). Cumulative binary restenosis rates at twelve months were 1.9%, 35.7% and 39.1% in Groups 2, 1 and 3 respectively. Clinical outcomes trended similarly with cumulative MACE rates at twelve months being lowest at 7.5% in Group 2 as compared to 20% in Group 1 and 21.6% in Group 3 respectively. CONCLUSIONS: In this first-in-man feasibility trial, angiographic and clinical results seen with the extended release formulation at a higher dose (10 microg/30 days) demonstrate the feasibility of the CoStar stent platform in the treatment of native coronary lesions. It also demonstrates the importance of drug dose and release kinetics.

EMPIRE (Escorts Multiple ProNova Implantation Registry) Study: Evaluating the ProNova SES in De Novo Coronary Artery Lesions.

BACKGROUND: The main limitation of percutaneous coronary intervention (PCI) with bare metal stents was the increased incidence of instant restenosis. The introduction of drug-eluting stents has decreased the rate of restenosis. Various DESs, using different drugs and stent designs, are now being used in interventional cardiology worldwide. The EMPIRE study was conducted to evaluate the safety and efficacy of the slow-release sirolimus-eluting ProNova stent in de novo coronary artery lesions in patients with single- or multi-vessel disease. METHODS AND RESULTS- A total of 300 patients, enrolled in a single-centre registry, were successfully implanted with ProNova, a sirolimus-eluting stent (SES). They were followed up clinically, first at 30 days and then six months after the procedure for parameters like death, target vessel failure, documented myocardial infarction (MI) and restenosis. Assessment of binary restenosis was done angiographically at six months. The primary success rate of stent implantation was 100%, the percentage of acute major adverse cardiac events (MACE) being 0% and 2% at 30 days and six months, respectively. Angiographic restenosis was documented in 12.6% of the patients enrolled in the study. CONCLUSION: The ProNova stent was found to be safe and effective in this trial.

Protein C deficiency leading to pulmonary thromboembolism in a patient with hereditary spherocytosis.

Hereditary protein C deficiency results in a hypercoagulable state that can manifest itself as venous thrombosis and pulmonary embolism. The prevalence of this condition, even among patients with familial thrombosis, is quite low. We report a case of protein C deficiency presenting as massive pulmonary thromboembolism in a patient with hereditary spherocytosis, an uncommon hemolytic disorder not usually associated with increased thrombotic risk. A review of the literature revealed only a few cases of thrombosis associated with hereditary spherocytosis, and none of them had protein C deficiency. This makes the present case the first of its kind to be reported.

Covered stents deployed for coarctation of aorta with aneurysm.

Three patients presented to us with upper extremity hypertension and aortic coarctation. Aortic angiograms and spiral computerized tomography delineated the anatomy at the site of coarctation and the associated small aneurysmal dilation. They were taken up for percutaneous stenting of the coarctation segment with cheathum-platinum covered stents. Post-deployment, there was a significant fall in pullback gradients and exclusion of the aneurysms.