Denise Todaro

Early discharge after transfemoral transcatheter aortic valve implantation

Background The aim of this study was to assess the feasibility and the safety of early discharge (within 72 h) after transfemoral transcatheter aortic valve implantation (TAVI) and to identify baseline features and/or peri-procedural variables, which may affect post-TAVI length-of-stay (LoS) duration. Methods and results Patients discharged within 72 h of TAVI (early discharge group) were compared with consecutive patients discharged after 3 days (late discharge group). Propensity-matched cohorts of patients with a 2:1 ratio were created to better control confounding bias. Among 465 patients, 107 (23.0%) were discharged within 3 days of the procedure. Multivariable regression analysis of unmatched patients demonstrated that baseline New York Heart Association (NYHA) class IV (OR: 0.22, 95% CI 0.05 to 0.96; p=0.045) and any bleeding (OR: 0.31, 95% CI 0.74 to 0.92; p=0.031) were less likely to be associated with early discharge after TAVI. Conversely, the year of procedure (OR: 1.66, 95% CI 1.25 to 2.20; p<0.001) and the presence of a permanent pacemaker (PPM) before TAVI (OR: 2.80, 95% CI 1.36 to 5.75; p=0.005) were associated with a higher probability of early discharge. In matched populations, patients in the early discharge group reported lower incidence of in-hospital bleeding (7.9% vs 19.4%, p=0.014), major vascular complications (2.3% vs 9.1%, p=0.038) and PPM implantation (7.9% vs18.5%, p=0.021), whereas after discharge, at 30-day, no significant differences were reported between groups in terms of death (2.2% vs 1.7%, p=0.540), bleeding (0.0% vs 1.1%, p=0.444), PPM implantation (1.1% vs 0.0%, p=0.333) and re-hospitalisation (1.1% vs 1.1%, p=1.000). Conclusions Early discharge (within 72 h) after transfemoral TAVI is feasible and does not seem to jeopardise the early safety of the procedure, when performed in a subset of patients selected by clinical judgement. Patients undergoing TAVI in unstable haemodynamic compensation and patients experiencing bleeding after the procedure demonstrated to be poorly suitable to this approach, whereas increasing experience in post-TAVI management was associated with a reduction of LoS.

Outcomes of Redo Transcatheter Aortic Valve Replacement for the Treatment of Postprocedural and Late Occurrence of Paravalvular Regurgitation and Transcatheter Valve Failure

Background—Transcatheter aortic valves can degenerate in a manner similar to surgical bioprostheses. Methods and Results—Clinical and echocardiographic outcomes of patients who underwent redo transcatheter aortic valve replacement (TAVR) procedures >2 weeks post procedure were collected from 14 centers. Among 13 876 patients, 50 (0.4%) underwent redo TAVR procedure at participating centers. Indications for redo TAVR were moderate–severe prosthetic aortic valve stenosis (n=10, 21.7%), moderate–severe central prosthetic aortic valve regurgitation (n=13, 28.3%), and moderate–severe paraprosthetic aortic valve regurgitation (n=25, 50.0%). The index TAVR was most commonly a Medtronic CoreValve (N=38, 76.0%), followed by Edwards SAPIEN-type valves (n=12, 24.0%) and Portico (n=1, 2.0%). The redo TAVR device was most commonly a CoreValve/Evolut R (n=29, 58.0%), followed by a SAPIEN-type valve (n=20,40.0%) or a Boston Lotus valve (n=1, 2.0%). In 40 patients (80.0%), redo TAVR was performed using the identical device type or that of the succeeding generation. Valve performance was uniformly good after redo TAVR (mean transvalvular gradient post redo TAVR: 12.5±6.1 mm Hg). At hospital discharge, all patients remained alive, with 1 nondisabling stroke (2.0%) and 1 life-threatening bleed (2.0%). Permanent pacemaker implantation was required in 3 out of 35 patients without a prior pacemaker (8.6%). Late survival was 85.1% at a median follow-up of 1589 days (range: 31–3775) after index TAVR and 635 days (range: 8–2460) after redo TAVR. Conclusions—Redo TAVR for the treatment of postprocedural and late occurrence of paravalvular regurgitation and transcatheter aortic valve prosthesis failure seems to be safe, and it is associated with favorable acute and midterm clinical and echocardiographic outcomes.

Optimized Screening of Coronary Artery Disease With Invasive Coronary Angiography and Ad Hoc Percutaneous Coronary Intervention During Transcatheter Aortic Valve Replacement

Background— We sought to describe an optimized approach to coronary artery disease (CAD) screening and management in patients undergoing transcatheter aortic valve replacement (TAVR). Methods and Results— When invasive coronary angiography showed CAD, the treatment strategy and completeness of revascularization was determined based on coronary anatomy. TAVR was performed in the same setting if percutaneous coronary intervention (PCI) was uncomplicated; otherwise TAVR was postponed. A total of 604 patients undergoing CAD screening at the time of TAVR procedure were prospectively included in this study. Severe CAD was found in 136 patients (22.5%). Among patients with severe CAD, 53 patients (8.8%) underwent uncomplicated PCI. After PCI, TAVR was postponed in 2 patients (0.3%). In 83 patients (13.8%), coronary angiography showed severe CAD that was left untreated. After TAVR, all-cause and cardiovascular 30-day mortality rates were 2.4% and 1.4%, respectively. Disabling stroke, myocardial infarction, and life-threatening bleeding occurred in 0.5%, 0.8%, and 4.0% of patients, respectively. Acute kidney injury II or III rate was 3.3%. At 2 years, all-cause mortality rate was 14.1%. Disabling stroke and myocardial infarction occurred in 2.5% and 1.8% of patients, respectively. Patients undergoing TAVR and PCI in the same session had similar rate of the composite of death, disabling stroke, and myocardial infarction when compared with patients without CAD, and patients with severe CAD left untreated (TAVR+PCI: 10.4%; severe CAD left untreated: 15.4%; no-CAD: 14.8%; P=0.765). Conclusions— In patients undergoing TAVR, screening of CAD with invasive coronary angiography and ad hoc PCI during TAVR is feasible and was not associated with increased periprocedural risks. PCI followed by TAVR in the same session had similar outcomes than TAVR in which PCI was not performed.

Acute and long-term (2-years) clinical outcomes of the CoreValve 31 mm in large aortic annuli: A multicenter study

INTRODUCTION Little is known about the early and late performance of the 31mm CoreValve Revalving System (CRS, Medtronic Inc., Galway, Ireland). Our aim was to compare acute and long-term results of the 31mm CRS with other valve sizes. METHODS Consecutive patients undergoing transcatheter aortic valve implantation (TAVI) with CRS in nine Italian centers were prospectively included and dichotomized according to prosthesis size in two different groups, as follows: 31mm and other valve sizes (i.e., 23, 26, and 29mm combined). End points were defined according to Valve Academic Research Consortium definitions. Propensity score matching was performed. RESULTS In total, 2069 patients (n=169 [8%] in the 31mm group and n=1900 [92%] in the other valve sizes group) were included. After propensity matching, the implantation of the 31mm valve was associated with lower rates of procedural- (91.3% vs. 98.1%, p=0.030) and device-success (88.5% vs. 97.1%, p=0.016), longer procedural time (120 [80-180] min. vs. 90 [60-120] min., p<0.001), and higher rates of implantation of a second valve (10.6% vs. 2.9%, respectively, p=0.027). The rates of permanent pacemaker implantation in the 31mm group were higher but not statistically different from other valve sizes (41.7% vs. 30.9%, respectively, p=0.149). Significant improvement, without between-group differences, was observed in NYHA functional class. Cardiovascular death was lower in the 31mm valve group through 2-years (3.8% vs. 13.5%, respectively, p=0.014). CONCLUSIONS The acute performance of the 31mm CRS was worse than other valve sizes but no negative impact was observed in long-term outcomes.

Non-Contrast Three-Dimensional Magnetic Resonance Imaging for Pre-Procedural Assessment of Aortic Annulus Dimensions in Patients Undergoing Transcatheter Aortic Valve Implantation

ABSTRACT Background: We sought to appraise the accuracy of non-contrast three-dimensional (3D) magnetic resonance imaging (MRI) in comparison with computed tomography (CT). Methods: This is a single-center prospective study enrolling 48 consecutive patients with severe aortic stenosis screened for transcatheter aortic valve implantation (TAVI), who underwent non-contrast 3D MRI and standard cardiac CT for pre-TAVI aortic annulus assessment. Systolic MRI dimensions were modelled, by adding a corrective factor (+7.5% of the area). Tests of correlation and agreement were performed. Results: The mean subjective MRI image quality was 3.2±0.8. According to CT, 20 patients (43.5%) had severe or massive annular calcifications. Bland–Altman plots and Passing and Bablock regression analysis showed no relevant differences of cross-sectional area measurements for corrected systolic MRI vs. systolic CT measurements (mean bias 0.09 cm2; 95% limits of agreement: -0.48 to 0.67). Higher bias was seen in patients with severe or massive annular calcifications. Disagreement between CT and MRI in terms of transcatheter valve size was reported in 3 patients (6.5%). All of them had severe or massive annular calcifications. Conclusion: In patients referred for TAVI, aortic annulus measurements using corrected systolic MRI compare favorably with those made at CT. Caution should be applied when choosing transcatheter valve size in the presence of severe or massive annular calcification as they reduce the accuracy of MRI measurements.

Early and Mid-Term Outcomes of Transcatheter Aortic Valve Replacement Using the New Generation Self-Expanding Corevalve Evolut R Device

ABSTRACT Background: To assess early and mid-term efficacy of transcatheter aortic valve replacement (TAVR) using the new-generation CoreValve Evolut R (Medtronic Inc., Galway, Ireland). Methods: This is a prospective, single-center study. All consecutive patients undergoing TAVR with 23-, 26-, 29-, 34-mm Evolut R valve were included. In a secondary analysis, patients undergoing Evolut R implantation were compared using the propensity score method with a historical cohort of patients who underwent CoreValve implantation in our institution. Results: From March 2015 to September 2017, a total of 320 patients with a median age of 81.1 years (IQR 77–84) and mean STS score of 4.9 ± 3.1% were treated. Device success was obtained in 300 patients (93.8%). Effective recapture and repositioning of the valve due to initial suboptimal deployment was accomplished in 40 patients (12.5%). Post-TAVR transthoracic echocardiogram showed a reduction in mean gradient from 49.1 ± 18.2 mmHg to 7.6 ± 0.4 mmHg (p < 0.001). Moderate paravalvular regurgitation (PVR) was observed in 4.2% patients. No patient had severe PVR. At 30-day, all-cause and cardiovascular mortality rates were 2.2% and 1.9%, respectively; disabling stroke occurred in 5 patients (1.6%). Life-threatening and major bleeding occurred in 16 (5.0%) and 42 (13.1%) patients, respectively. Pacemaker implantation rate was 12.6%. Compared with the CoreValve, Evolut R use was associated with higher device success (92.8% vs. 79.7%, p < 0.001) and lower rates of moderate or severe PVR (2.1% vs. 14.4%, p < 0.001), minor vascular complications (4.9% vs. 14.5%, p < 0.001), and pacemaker implantation (13.5% vs. 21.0%, p = 0.026). Conclusion: In this prospective, single-center study, TAVR using the new-generation self-expanding Evolut R system, was associated with high device success rate, excellent hemodynamics, and low early complications rates.

Transcatheter Aortic Valve Implantation: Medtronic CoreValve Evolut R

The Evolut® R valve (Medtronic, Inc., Minneapolis, Minnesota, USA) represents the latest generation of Medtronic self-expanding aortic valve devices. It consists of a trileaflet valve made of porcine pericardial tissue and sutured in a supra-annular position on a compressible and self-expandable nitinol frame. The high radial force of the stent allows the self-expansion and the exclusion of native-calcified valve leaflets, which are pressed against the wall of the aortic root, while preventing the device from collapsing on itself.

Echocardiographic Imaging for Transcatheter Aortic Valve Replacement

Echocardiography plays an important role in the percutaneous procedure of transcatheter aortic valve replacement (TAVR), starting with pre-implant screening, choosing the correct size of the valve device, in the case of complications during implantation, and in post-implant and follow-up assessment.

Clinical Outcomes and Prognosis Markers of Patients With Liver Disease Undergoing Transcatheter Aortic Valve Replacement : A Propensity Score-Matched Analysis

Background— Chronic liver disease is a known risk factor for perioperative morbidity and mortality in patients undergoing cardiac surgery. Very little data exist about such patients treated with transcatheter aortic valve replacement (TAVR). Our objective was to evaluate early and late clinical outcomes in a large cohort of patients with liver disease undergoing TAVR and to determine predictive factors of mortality among these patients. Methods and Results— This multicenter study collected data from 114 patients with chronic liver disease who underwent TAVR in 12 institutions. Perioperative and long-term outcomes were compared with a cohort of 1118 patients without liver disease after a propensity score–matching analysis (114 matched pairs). In-hospital mortality and vascular and bleeding complications were similar between matched groups. Acute kidney injury was more common in liver disease group (30.8% versus 13.5%; P=0.010). Although cardiovascular mortality was similar between groups (9.4% versus 6.5%; P=0.433) at 2-year follow-up, noncardiac mortality was higher in the liver group (26.4% versus 14.8%; P=0.034). Lower glomerular filtration rate (hazard ratio, 1.10, for each decrease of 5 mL/min in estimated glomerular filtration rate; 95% confidence interval, 1.03–1.17; P=0.005) and Child-Pugh class B or C (hazard ratio, 3.11; 95% confidence interval, 1.47–6.56; P=0.003) were the predictors of mortality in patients with chronic liver disease, with a mortality rate of 83.2% at 2-year follow-up in patients with both factors (estimated glomerular filtration rate <60 mL/min and Child-Pugh B or C). Conclusions— These findings suggested that TAVR is a feasible treatment for severe aortic stenosis in patients with early-stage liver disease or as bridge therapy before a curative treatment of the hepatic condition. Patients with Child-Pugh class B-C, especially in combination with renal impairment, had a very low survival rate, and TAVR should be carefully considered to avoid a futile treatment. These results may contribute to improve the clinical decision-making process and management in patients with liver disease.