Gerlando Pilato

Transcatheter aortic valve replacement with new-generation devices: A systematic review and meta-analysis

OBJECTIVE The aim of this study was to conduct a weighted meta-analysis to determine the rates of acute (≤30days) major outcomes after (TAVR) with second-generation devices. METHODS A comprehensive search of multiple electronic databases from January 2011 to May 2017 was conducted using predefined criteria. New-generation TAVR devices were defined as any device which received CE mark approval or is still under evaluation for CE marking after CoreValve and SAPIEN XT prostheses. RESULTS A total of 37 studies including 10,822 patients met inclusion criteria and were included in the analysis. Devices investigated in the studies were the following: SAPIEN 3 (n=5423, 45.9%), Lotus Valve (n=3007, %), Portico (n=130, 1.1%), JenaValve (n=345, 2.9%), Symetis Acurate (n=1314, 11,1%), and Evolut R (n=1603, 13.6%). Thirty-day all-cause and cardiovascular 30-day death were 2.2% (95% CI: 1.6% to 2.8%) and 1.6% (95% CI: 0.9% to 2.3%), respectively; Any stroke and major/disabling stroke occurred at a pooled estimate rate of 2.6% (95% CI: 2.0% to 3.3%) and 0.9% (95% CI: 0.2% to 1.6%), respectively; life-threatening bleeding, 3.9% (95% CI: 2.9% to 5.0%); major vascular complications, 4.5% (95% CI: 3.7% to 5.4%); pacemaker implantation, 16.2% (95% CI: 12.7% to 19.6%); more than mild aortic regurgitation, 1.6% (95% CI: 0.9 to 2.3). CONCLUSIONS Second-generation TAVR devices are associated with very low mortality and major complications rates at 30-day, and improved prosthesis performance with <2% of patients having more than mild post-procedural aortic regurgitation. On the other hand, the need for pacemaker implantation seems to remain an unresolved issue, and warrants further investigation.

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.

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.

Vascular Access Management in Transcatheter Aortic Valve Implantation

Though transcatheter aortic valve implantation (TAVI) has given ample proof of being a safe procedure, it is not devoid of complications. Peripheral vascular complications and bleeding at the access site are still among the problems most frequently associated with transfemoral TAVI. The transfemoral route is the access of first choice, and the improvement of TAVI devices has made it possible to reduce the size of introducers and delivery systems from the initial 22–24 Fr of the early devices to 18 Fr, first, and now to the 14–16 Fr of many new-generation devices. This has made it possible to broaden the range of indications treated with the transfemoral approach to serve a larger number of patients.

Transcatheter Aortic Valve Implantation: Boston ACURATE and ACURATE-neo TF

The Symetis ACURATE platform is designed for all transcatheter aortic valve implantation (TAVI) access routes: transfemoral, transapical, and transaortic. These bioprostheses are based on a unique, self-seating, and self-sealing design that allows for optimal positioning of the valve.

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.

TCT-665 Safety and Efficacy of Second Generation Self Expanding Portico® Valve System for the Treatment of Failed Aortic Bioprosthesis: Results from an International Multicenter Valve-in-Valve Registry

Background: Portico valve is a second-generation self-expanding repositionable system with a nitinol stent frame and bovine pericardial leaflets, which is increasingly utilized for transcatheter ao...