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.

Early exercise after coronary stenting is safe.

OBJECTIVES: In this study, we sought to assess safety of symptom-limited exercise stress tests the day after coronary stenting. BACKGROUND: Isolated cases of coronary stent thrombosis have been linked to early exercise stress testing, thereby questioning the safety of unrestricted physical activity after the coronary procedure. METHODS: At a single center, 1,000 patients were randomized to a symptom-limited stress test the day after coronary stenting or no stress test. The antiplatelet regimen consisted of acetylsalicylic acid and postprocedural ticlopidine or clopidogrel. The primary end point of the study was the incidence of clinical stent thrombosis at 14 days. The secondary end point was the occurrence of access site complications. RESULTS: Clinical stent thrombosis occurred in five patients (1%) undergoing stress test and in five patients (1%) randomized to no stress test (p = 1.0). Access site complications were detected in 4% and 5.2% of cases, respectively (p = 0.37). CONCLUSIONS: Symptom-limited exercise stress testing the day after coronary stenting does not increase the risk of clinical stent thrombosis or access site complications. Further investigations on safety of early vigorous exercise after coronary stenting in a non-supervised setting are warranted.

Influence of frequency of stenting on acute and one-year follow-up results.

BACKGROUND: There has been a continuous increase in the frequency of stenting, with recent reports suggesting performing stenting in all coronary angioplasty interventions. The aim of this retrospective investigation was to study the in-hospital and 1-year event rates of the most and the least avid stent user (both highly experienced) at our institution. METHODS: A total of 322 consecutive patients undergoing coronary angioplasty at our institution were retrospectively studied. Post-intervention CK, CK-MB and troponin T values and information of major in-hospital cardiac events were obtained from the charts. Events during a 1-year follow-up were collected. Comparisons were made between patients treated by the most generous (operator 1: 71% stenting) and the most frugal (operator 2: 49% stenting) stent user. RESULTS: The 2 groups were comparable. Post-intervention CK max (418+/- 744 versus 427+/- 1250; p = 0.33), CK-MB (105+/- 159 versus 239+/-263; p = 0.07) and troponin T (149+/-326 versus 282+/- 380; p = 0.3) values were similar in both groups. In-hospital (2% versus 1.8%; p = 1) and 1-year follow-up cardiac events (21% versus 18%; p = 0.58) between both groups were also comparable. CONCLUSIONS: Stenting is a useful tool for selected patients. However, a higher frequency of stenting does not beneficially influence in-hospital or 1-year cardiac events. These findings recommend provisional stenting rather then elective stenting.

Exercise-induced human coronary collateral function: quantitative assessment during acute coronary occlusions.

In 50 patients undergoing percutaneous transluminal coronary angioplasty because of chronic angina pectoris, a collateral flow index (CFI) was determined at the start and the end of two 1-min coronary occlusions, randomly accompanied by a resting state or a 3-min dynamic handgrip exercise (DHE). CFI expressing collateral flow relative to normal antegrade flow was determined by simultaneous coronary occlusive pressure, mean aortic pressure and central venous pressure measurements. When comparing CFI without and with DHE at the start as well as at the end of balloon occlusions, a significant increase was observed with DHE (overall p < 0.0001); start: 0.18 +/- 0.12 vs. 0.22 +/- 0.13, respectively (p = 0.01); end of occlusion: 0.21 +/- 0.14 vs. 0.25 +/- 0.14, respectively (p = 0.007).

Four French catheters for diagnostic coronary angiography.

A randomized study was conducted to assess the feasibility of 4 Fr catheters for diagnostic coronary angiograms. A total of 1,114 consecutive patients were randomized to 4 or 5 Fr catheters. Ease of use of catheters was subjectively assessed by the primary operator and the picture quality was assessed by two independent observers with a good interobserver variability (r = 0.94; P < 0.001). Predischarge local complications were recorded by the attending physician. No statistically significant difference was observed in the picture quality for the left coronary artery, right coronary artery, aorta, left ventricle, venous grafts, or renal arteries between the two groups. Fluoroscopy time (7.1 +/- 5.6 for 4 Fr vs. 6.7 +/- 5.7 min for 5 Fr) and contrast quantity (140 +/- 58 vs. 144 +/- 57 ml) were comparable between the two groups. There was a statistically significant difference in favor of the 5 Fr group as regards maneuverability of catheters (93% vs. 79%; P < 0.001), and 5 Fr pigtail catheters crossed the aortic valve easier than the 4 Fr pigtail catheters (91% vs. 81%; P < 0.001). Crossover to the other catheter size or a larger sheath was more frequent with 4 Fr catheters (33/522 vs. 3/592; P < 0.001). Median time to hemostasis was 9 min for 4 Fr and 14 min for 5 Fr (P < 0.001). Of the 4 Fr patients, 84% could be mobilized at 1 hr and 86% of 5 Fr patients at 2 hr. Significant hematomas were observed in 2% with 4 Fr or 5 Fr and small hematomas in 10% and 16%, respectively (P = NS). Time to discharge was comparable in both groups (4.0 +/- 3.2 with 4 Fr vs. 4.3 +/- 3.7 hr with 5 Fr). The 4 Fr catheters are a good alternative for diagnostic coronary angiograms. The increased difficulty in maneuverability and a need for catheter changes in 70% are compensated for in part by easier hemostasis. With increasing use and finesse of these catheters, the difficulty in maneuverability are likely to be overcome.

Novel femoral artery puncture closure device in patients undergoing interventional and diagnostic cardiac procedures.

BACKGROUND: The wide range of closure devices for arterial access sites still leaves room for improvement. METHODS AND RESULTS: We report our initial experience with a novel, cost-effective, suture-mediated device (6 French X-PRESS device, X-SITE Medical, Blue Bell, Pennsylvania) for closure of the arterial access site after both diagnostic and therapeutic interventions. A total of 51 consecutive patients are reported. The closure was performed immediately after the procedure. No patient had more than 5,000 U heparin administered during the procedure. The closure device was used in 36 patients (73%) after diagnostic angiography and in 15 patients (27%) after therapeutic intervention. The device could be successfully deployed in 48 patients (94%). In the remaining 3 cases (6%), hemostasis was achieved with standard manual compression without any further event. Immediate total hemostasis was achieved with the device in 44 of 48 patients (92%). Four devices (8%) could not be deployed correctly due to technical problems and the patients needed additional manual compression. The average time to achieve complete hemostasis was 5.5 +/- 3.5 minutes (range, 3-26 minutes). The patients were ambulated after a period of 1.3 +/- 0.4 hours of bedrest (range, 0.8-3.5 hours). Time to possible discharge was 4.2 +/- 3.4 hours (range, 0.9-12.5 hours). One patient experienced a minor complication (hematoma < 6 cm) and was treated with manual compression without clinical sequelae. Telephone follow-up was carried out 2 weeks after deployment and revealed no sequelae. CONCLUSION: The 6 French X-PRESS device is safe and effective in providing rapid hemostasis following interventional or diagnostic catheterization procedures. Use of the device is associated with a low rate of complications and facilitates quick hemostasis, mobilization and discharge.

Thrombin activatable fibrinolysis inhibitor (TAFI) levels in patients with coronary artery disease investigated by angiography.

Due to its role in the balance between coagulation and fibrinolysis, thrombin activatable fibrinolysis inhibitor (TAFI) may be involved in the development of cardiovascular diseases. We studied 362 patients with coronary artery disease (CAD) and 134 control subjects free of CAD, both groups investigated by angiography. TAFI antigen levels were determined in venous and intracoronary plasma samples and were related to metabolic and hemostatic risk factors and extent of coronary atherosclerosis. Venous TAFI levels tended to be higher in CAD patients compared to controls, whereas this difference was significant in intracoronary samples. A subgroup of patients who had not experienced acute myocardial infarction or undergone previous cardiac interventions showed significantly higher TAFI levels in both venous and intracoronary plasma samples. TAFI levels correlated with acute phase reactants indicating a role for TAFI in inflammation. However, TAFI levels did not correlate with extent of coronary atherosclerosis and among the classical cardiovascular risk factors TAFI levels only correlated with total cholesterol and fibrinogen concentration. Our results suggest that TAFI might be a risk factor for the development of CAD.