Comparing Obtura Vascular Closure Device to Manual Compression for Achieving Hemostasis After Percutaneous Transfemoral Procedures: A Randomized Study.

PURPOSE: This trial was designed and aimed to compare safety and efficacy of Obtura™ vascular closure device (VCD) to manual compression (MC) among patients undergoing transfemoral catheterization. MATERIAL AND METHODS: This prospective, randomized, controlled, multicenter trial of Obtura VCD against MC randomized patients in 1:1 (n=268; 134:134) ratio. Safety and efficacy were measured by primary endpoints (time to hemostasis [TTH] and deployment success) and secondary endpoints which included technical success, device-related adverse events, and time to ambulation (TTA). RESULTS: The procedural access using right femoral artery was performed in 95.52% of patients in Obtura VCD versus 96.27% in standard MC method, whereas 2.99% of patients in each group underwent left femoral access. Bilateral access was performed in 1.49% (n=2) versus 0.75% (n=1) in Obtura VCD versus MC, respectively. Both the technical success and deployment success were 100%. Patients in Obtura VCD group had shorter TTH (3.26±3.39 vs 23.95±8.24 minutes; p<0.0001) and TTA (155.44±125.32 vs 723.84±197.98 minutes; p<0.0001) than MC group. No access site complications (re-bleeding, infection, arteriovenous fistula, and transient access site nerve injury) were noted at 2-week, 1-month, and 3-month follow-ups. There were 4 (3%) and 6 (4.5%) cases of hematoma, respectively, in Obtura VCD versus MC and 1 case (0.7%) of post-procedural arterial pseudoaneurysm each in both the groups which were successfully resolved and patients were discharged with no further complications. Further follow-up was without any adverse events. CONCLUSIONS: The study demonstrated favorable safety and efficacy of Obtura™ VCD with a significantly short TTH and TTA compared to MC. CLINICAL IMPACT: In patients undergoing cardiac catheterization, vascular closure devices (VCDs) can achieve hemostasis faster after successful implantation of the device with fewer complications such as bleeding and ambulation can be achieved faster. In terms of effectiveness, Obtura VCD was found to be better than manual compression in achieving early hemostasis and higher technical and deployment success was accomplished. Obtura VCD does not require enlargement of the route through the tissues, uses the same existing arterial sheath as its conduit, and does not cause patients' access sites to feel uncomfortable while it is being deployed.

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.

Tenecteplase in the treatment of acute pulmonary thrombo-embolism.

This is a retrospective study documenting the use of tenecteplase in 41 cases of suspected or confirmed pulmonary embolism receiving in-hospital tenecteplase as per weight-adjusted dosing in addition to standard heparin and oral anticoagulant therapy. The presenting symptoms of dyspnoea, chest pain, hemoptysis and syncope were found in 40 (97.56%), 19 (46.34%), 6 (14.63%) and 9 (21.95%) patients, respectively. There was one case of mortality who was a 26 yrs old female of postpartum pulmonary thrombo-embolism with severe hypotension, cyanosis, bilateral crepitations in lungs and pulmonary hypertension. In the 40 survived patients, there was alleviation of dyspnoea and hemoptysis in all patients. Significant reduction in tachycardia (P < 0.0001) and increase in the oxygen saturation (SaO2) (P < 0.0001) were seen at discharge as compared to at the time of presentation. Eighteen patients had hypotension which recovered in all patients till the time of discharge (P < 0.0001). There was a significant reduction in right ventricular systolic pressure in all 18 patients who underwent 2-D echocardiography both before and after the tenecteplase therapy. Resolution of pulmonary embolism on CT pulmonary angiography was documented in only two patients. No bleeding events or any other adverse events were reported during this study. The present study suggests favourable efficacy of tenecteplase in patients with suspected or confirmed acute pulmonary embolism. Although no major adverse events were noted, a large prospective study on the use of tenecteplase in pulmonary embolism is suggested.

A Report of Successful Procedural, Clinical, and Angiographic Outcomes with a Tapered Stent of a Patient in Naturally Tapered Coronary Vessel.

In cases involving stenosis or occlusions in major parts of a long vessel, natural tapering of coronary vessels may create dilemma in deciding the optimal stent size during percutaneous coronary intervention. In this regard, tapered stents have been developed recently. Herein, we present a case of 67-year-old male patient with triple vessel disease including two tandem lesions in naturally tapered Left Anterior Descending (LAD) artery. The patient received a 3.0-2.5x60 mm Sirolimus-eluting BioMime Morph stent (Meril life Sciences, Gujarat, India) in the mid-distal LAD lesion along with conventional stent implantations in other two lesions. The procedure was successful and good coronary flow was obtained after revascularization. The patient remained asymptomatic thereafter. At one year, angiographic follow-up revealed good flow and no restenosis in the LAD vessel. We are of opinion that using tapered stents with decremented diameter may offer the advantages of excellent adaptation to vessel size, vessel tapering, and good apposition in patients with long coronary lesions in tapered vessels.

Percutaneous closure of post-myocardial infarction ventricular septal rupture - A single centre experience.

BACKGROUND: Post-infarction ventricular septal rupture (VSR) is a rare but lethal mechanical complication of an acute myocardial infarction (AMI). Survival to 1 month without intervention is 6%. Given high surgical mortality, transcatheter closure has emerged as a potential strategy in selected cases. Indian data on percutaneous device closure of post AMI-VSR is scarce hence we report our single-centre experience with ASD occluder device (Amplatzer and lifetech) for closure of post-AMI VSR. METHODS AND RESULTS: In this single-centre, retrospective, cohort study, patients who underwent transcatheter closure of post-MI VSR between 2005 and 2015 at KIMS Hospital were included. Primary outcome was mortality rate at 30 days. Seven patients were included in the study (mean age, 58.29±9.8 years). 5 patients had anterior wall myocardial infarction (AWMI) & 2 had inferior wall myocardial infarction (IWMI). None of the patients received thrombolytic therapy. Device was successfully placed in 5 patients (71.4%) with minimal residual shunt in 2 patients (40%). Out of 7 cases 2 patients survived (29% survival rate) and are doing well on follow up at 1 and 5 years respectively. Cardiogenic shock, IWMI and serpigenious form of VSR were associated with poor outcomes. Delayed revascularization (PCI) was associated with better outcomes. CONCLUSION: Percutaneous closure is a potential technique in a selected group of patients. The presence of cardiogenic shock, IWMI and serpigeneous form of VSR constitutes important risk factors for mortality. Device implantation is in general successful with few procedure-related complications and should be applied on a case-by-case basis.

A rare case of acquired aortopulmonary fistula with bicuspid aortic valve: report of successful surgical repair.

An acquired aortopulmonary fistula is a rare and usually fatal phenomenon. Rarer still are reports of successful surgical repair of aortopulmonary fistulae. We present the case of a 48-year-old hypertensive man who presented with congestive cardiac failure. Examination revealed a bicuspid aortic valve and a large aneurysm of the arch of the aorta, which was communicating with the main pulmonary artery. The diagnosis of acquired aortopulmonary fistula was made using transthoracic echocardiography findings and confirmed by CT. The patient was successfully managed by surgery, with an uneventful postoperative recovery, with control of congestive cardiac failure. At 1-year follow-up, the patient had Class I symptoms.