BioVentrix (United States)

The evidence supporting surgical aneurysmectomy in ischemic heart failure is inconsistent. The aim of the study was to describe long-term effect of minimally invasive hybrid transcatheter and minithoracotomy left ventricular (LV) reconstruction in patients with ischemic cardiomyopathy. Twenty-three subjects with transmural anterior wall scarring, LV ejection fraction 15–45%, and New York Heart Association class ≥ II were intervened using Revivent TC anchoring system. LV end-systolic volume index was reduced from 73.2 ± 27 ml at baseline to 51.5 ± 22 ml after 6 months (p < 0.001), 49.9 ± 20 ml after 2 years (p < 0.001), and 56.1 ± 16 ml after 5 years (p = 0.047). NYHA class improved significantly at 5 years compared to baseline. Six-min walk test distance increased at 2 years compared to the 6-month visit. Hybrid LV reconstruction using the anchoring system provides significant and durable LV volume reduction during 5-year follow-up in preselected patients with ischemic heart failure.Graphical abstractLegend: Hybrid left ventricular reconstruction using the anchoring system provides significant and durable LV volume reduction throughout 5-year follow-up in preselected patients with ischemic heart failure.

Coronary flow reserve is impaired in asymptomatic patients with aortic stenosis and has a prognostic value. We investigated whether the type II diabetes mellitus additionally impairs microvascular circulation assessed by coronary flow reserve in patients with asymptomatic severe aortic stenosis, normal left ventricular ejection fraction and nonobstructed coronary arteries. A total of 128 patients, mean age of 66.35 ± 10.51 (58.6% males), with severe aortic stenosis and normal left ventricular ejection fraction were enrolled in this study. Patients with diabetes mellitus, those who were treated for diabetes mellitus or had documentation confirming the diagnosis of diabetes mellitus, were considered. All patients underwent coronary angiography and had no obstructive coronary disease (defined as having no stenosis >50% in diameter), standard transthoracic Doppler-echocardiographic study and adenosine stress transthoracic echocardiography for coronary flow reserve measurement. Diabetes mellitus was present in 26 patients (20.31%). There was no significant difference in aortic stenosis severity between diabetic and non-diabetic patients [aortic valve area (0.81 ± 0.18 vs 0.85 ± 0.15 cm(2)) and Vmax (4.20 ± 0.57 vs 4.21 ± 0.48 m/s)]. Mean coronary flow reserve in diabetic patients was 1.98 ± 0.48, while mean coronary flow reserve in non-diabetic patients was 2.64 ± 0.54 (p < 0.01). Diabetes mellitus was independent predictor of coronary flow reserve [B = -0.636, 95% confidence interval (-0.916 to -0.368), p < 0.001]. Diabetes mellitus additionally impairs coronary microvascular function in asymptomatic patients with severe aortic stenosis and nonobstructed coronary arteries.

We previously presented early results employing a technique designed for beating heart, ventricular volume reduction (surgical ventricular restoration, SVR) without ventriculotomy for patients with antero-septal scar and dilated ischaemic cardiomyopathy. Significant volume reduction and clinical improvement were achieved. We now report durability in the first 11 patients available for assessment at 6 and 12 months after operation. After the Ethics Committee approval, 31 symptomatic patients with left ventricular (LV) dilatation and antero-septal scars underwent operation. The scarred lateral LV wall was apposed to the septal scar with serial paired anchors placed through epicardial transmural catheters, excluding non-viable portions of the chamber. Patients were followed at 1, 3, 6 and 12 months postoperatively with echocardiograms. Data are presented for the first 11 patients for whom core lab echocardiographic data were available at 12 months of follow-up. LV end-systolic index (LVESVI), percent decreases from baseline at 6 and 12 months were 36.2 ± 18.3 (P < 0.001) and 39.6 ± 14.8 (P < 0.001). LV end-diastolic volume index (LVEDVI) percent decreases from baseline at 6 and 12 months were 28.6 ± 18.8 (P < 0.001) at 6 months and 32.2 ± 14.9 (P < 0.005) at 12 months. All comparisons were by one-tailed t-tests using paired data. These results demonstrate the persistence of volume reduction employing a technique designed to be used on beating hearts without ventriculotomy or cardiopulmonary bypass. The extent of volume reduction was consistent with results of conventional SVR in experienced centres. These early data validate the further development of technical iterations leading to a clinical study employing a closed chest endovascular platform.