Comparing the safety and effectiveness of five leading new-generation devices for transcatheter aortic valve implantation: Twelve-month results from the RISPEVA study

Objectives. The management of severe aortic stenosis has been revolutionized by the introduction of transcatheter aortic valve implantation (TAVI), especially in patients at intermediate, high, or prohibitive surgical risk. There is uncertainty, however, regarding the comparative effectiveness and safety of contemporary TAVI devices. Methods. We queried detailed data from the ongoing national Italian TAVI registry and compared baseline features, procedural details, and 12-month outcomes of Acurate Neo (Boston Scientific), Evolut Pro/R (Medtronic), Lotus (Boston Scientific), Portico (Abbott Vascular), and Sapien/ Sapien S3 Ultra (Edward Lifesciences) transcatheter aortic valves. Several endpoints were collected and appraised, including the composite of death, stroke, myocardial infarction (MI), major bleeding, major vascular complication, surgical aortic valve replacement and transcatheter aortic valve reimplantation, which were deemed major adverse events (MAEs). Results. A total of 1976 patients were included, with 234 treated with Acurate, 703 with Evolut, 151 with Lotus, 347 with Portico, and 541 with Sapien. Twelve-month events were not significantly different among the 5 devices, including death (P=.29) and MAE (P=.21), with the notable exception of major vascular complications, which were more common with Acurate and Sapien (P<.001) and permanent pacemaker implantation, which was more frequent with Lotus and Evolut (P<.001). Differences in MAE were more pronounced in women and subjects with prior cardiac surgery, with the lowest event rates in the Evolut group. Propensity-score adjusted analysis suggested that Acurate, Evolut, Portico, and Sapien were all associated with similarly favorable results, whereas adverse events were more evident with Lotus (P<.05). Conclusion. Leading current-generation TAVI devices offer similarly favorable results at mid-term follow-up

Comparative one-month safety and effectiveness of five leading new-generation devices for transcatheter aortic valve implantation

Transcatheter aortic valve implantation (TAVI) for aortic stenosis is becoming an appealing alternative to surgical aortic valve replacement in high-risk patients and to medical therapy for inoperable ones. Several new-generation TAVI devices have been recently introduced, but comparative analyses are lacking. We aimed to compare 1-month outcomes associated with such five leading new-generation TAVI devices exploiting data collected in the prospective observational RISPEVA (Registro Italiano GISE sull’impianto di Valvola Aortica Percutanea) Study. We queried the dataset of the ongoing RISPEVA study to retrieve baseline, procedural and 1-month outcome details of patients undergoing TAVI with Acurate, Evolut, Portico, Lotus, and Sapien3. Analysis was based on unadjusted and propensity score-adjusted methods. We included 1976 patients, 234 (11.8%) treated with Acurate, 703 (35.6%) with Evolut, 151 (7.6%) with Lotus, 347 (17.6%) with Portico, and 541 (27.4%) with Sapien3. Unadjusted analysis for baseline features highlighted several significant differences, and other discrepancies&nbsp;were found for procedural features. Despite these differences, device and procedural success were similarly high (ranging from 98.0% to 99.4%, p &gt; 0.05). However, procedural valve migration appeared more common with Acurate (p = 0.007), and major bleeding with Sapien3 (p = 0.002). Unadjusted analysis for 1-month outcomes also highlighted significant differences in the composite of death, stroke, myocardial infarction, major vascular complication, major bleeding, or renal failure (favoring Portico, p &lt; 0.001), major vascular complications (favoring Lotus, p &lt; 0.001), renal failure (favoring Portico, p = 0.035), and permanent pacemaker implantation (favoring Acurate, p &lt; 0.001). Propensity score-adjusted analyses showed lower rates of major adverse events with Evolut and Portico (p &lt; 0.05), major vascular complications with Lotus and Portico (p &lt; 0.05), renal failure with Sapien3 (p &lt; 0.05) and permanent pacemaker implantation with Acurate (p &lt; 0.05). In conclusion, new-generation TAVI devices have different profiles of early comparative safety and efficacy. These findings should be taken into account for individualized decision making and patient management

Distal Versus Conventional Radial Access for Coronary Angiography and Intervention: The DISCO RADIAL Trial.

BACKGROUND: Currently, transradial access (TRA) is the recommended access for coronary procedures because of increased safety, with radial artery occlusion (RAO) being its most frequent complication, which will increasingly affect patients undergoing multiple procedures during their lifetimes. Recently, distal radial access (DRA) has emerged as a promising alternative access to minimize RAO risk. A large-scale, international, randomized trial comparing RAO with TRA and DRA is lacking. OBJECTIVES: The aim of this study was to assess the superiority of DRA compared with conventional TRA with respect to forearm RAO. METHODS: DISCO RADIAL (Distal vs Conventional Radial Access) was an international, multicenter, randomized controlled trial in which patients with indications for percutaneous coronary procedure using a 6-F Slender sheath were randomized to DRA or TRA with systematic implementation of best practices to reduce RAO. The primary endpoint was the incidence of forearm RAO assessed by vascular ultrasound at discharge. Secondary endpoints include crossover, hemostasis time, and access site-related complications. RESULTS: Overall, 657 patients underwent TRA, and 650 patients underwent DRA. Forearm RAO did not differ between groups (0.91% vs 0.31%; P = 0.29). Patent hemostasis was achieved in 94.4% of TRA patients. Crossover rates were higher with DRA (3.5% vs 7.4%; P = 0.002), and median hemostasis time was shorter (180 vs 153 minutes; P < 0.001). Radial artery spasm occurred more with DRA (2.7% vs 5.4%; P = 0.015). Overall bleeding events and vascular complications did not differ between groups. CONCLUSIONS: With the implementation of a rigorous hemostasis protocol, DRA and TRA have equally low RAO rates. DRA is associated with a higher crossover rate but a shorter hemostasis time

Experimental characterisation on the behaviour of PLLA for stretch blowing moulding of bioresorbable vascular scaffolds

Processing tubes from poly (l-lactic acid) (PLLA) by stretch blow moulding (SBM) is used in the manufacture of bioresorbable vascular scaffolds (BVS) to improve their mechanical performance. To better understand this processing technique, a novel experimental setup by free stretch blow inside a water bath was developed to visualise the tube forming process and analyse the deformation behaviour. PLLA tubes were heated, stretched and blown with no mould present inside a temperature-controlled water bath whilst recording the processing parameters (axial force, inflation pressure). The onset of pressure activation relative to the axial stretch was controlled deliberately to produce a simultaneous (SIM) or sequential (SEQ) mode of deformation. Real-time images of the tube during forming were captured using high speed cameras and the surface strain of the patterned tube was extracted using digital image correlation (DIC). The deformation characteristics of PLLA tubes in SBM was quantified by analysis of shape evolution, strain history and stress-strain relationship

MitraClip after failed surgical mitral valve repair: an international multicenter study

BackgroundRecurrence of mitral regurgitation (MR) after surgical mitral valve repair (SMVR) varies and may require reoperation. Redo mitral valve surgery can be technically challenging and is associated with increased risk of mortality and morbidity. We aimed to assess the feasibility and safety of MitraClip as a treatment strategy after failed SMVR and identify procedure modifications to overcome technical challenges.Methods and ResultsThis international multicenter observational retrospective study collected information for all patients from 16 high-volume hospitals who were treated with MitraClip after failed SMVR from October 29, 2009, until August 1, 2017. Data were anonymously collected. Technical and device success were recorded per modified Mitral Valve Academic Research Consortium criteria. Overall, 104 consecutive patients were included. Median Society of Thoracic Surgeons score was 4.5% and median age was 73 years. At baseline, the majority of patients (82%) were in New York Heart Association class >= III and MR was moderate or higher in 86% of patients. The cause of MR pre-SMVR was degenerative in 50%, functional in 35%, mixed in 8%, and missing/unknown in 8% of patients. The median time between SMVR and MitraClip was 5.3 (1.9-9.7) years. Technical and device success were 90% and 89%, respectively. Additional/modified imaging was applied in 21% of cases. An MR reduction of >= 1 grade was achieved in 94% of patients and residual MR was moderate or less in 90% of patients. In-hospital all-cause mortality was 2%, and 86% of patients were in New York Heart Association class <= II.ConclusionsMitraClip is a safe and less invasive treatment option for patients with recurrent MR after failed SMVR. Additional/modified imaging may help overcome technical challenges during leaflet grasping.Cardiolog

Baseline, procedural and outcome features of patients undergoing transcatheter aortic valve implantation according to different body mass index categories

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has become first-line treatment for severe aortic valve stenosis in patients with moderate, high or prohibitive surgical risk. However, access site complications may occur more frequently in extreme body mass index (BMI) categories. The aim of this study was to describe the features and outcomes of patients undergoing TAVI in a comprehensive Italian prospective clinical registry, focusing on BMI classes. METHODS: A national prospective database was queried for baseline, procedural, and outcome details of patients undergoing TAVI according to established BMI categories: underweight (BMI &lt;18.5 kg/m2), normal weight (BMI 18.5-24.9 kg/m2), overweight (BMI 25.0-29.9 kg/m2), and obese (BMI≥30 kg/m2). Short- and long-term outcomes, including major adverse events (MAE), i.e. the composite of death, stroke, myocardial infarction, major vascular complication, major bleeding, or renal failure, were appraised with bivariate and multivariable analyses. RESULTS: A total of 3075 subjects were included, 64 (2.1%) were underweight, 1319 (42.9%) were normal weight, 1152 (37.4%) were overweight, and 540 (17.6%) were obese. Several baseline differences were evident, including gender, diabetes mellitus, renal function, chronic obstructive pulmonary disease, surgical scores, and left ventricular ejection fraction (LVEF) (all P&lt;0.05). Several procedural differences were also evident, including percutaneous approach, predilation, prosthesis type and size (all P&lt;0.05), with postprocedural aortic regurgitation &gt;2+ significantly more common in underweight patients (P&lt;0.05). Nonetheless, unadjusted analysis for one-month outcomes showed similar rates for fatal and non-fatal outcomes, including MAE (all P&gt;0.05), with the notable exception of permanent pacemaker implantation, which was more common in higher BMI classes (P=0.010) Unadjusted analysis for long-term events showed an increased rate of death in underweight patients (P=0.024). Multivariable adjusted analysis confirmed the increased risk of permanent pacemaker implantation in obese patients (P=0.015 when comparing obese vs. normal weight subjects), but disproved differences in long-term mortality and other outcomes (P&gt;0.05 for all comparisons). CONCLUSIONS: Irrespective of BMI class, TAVI is associated with favorable outcomes in surgical high-risk risk patients, with the notable exclusion of permanent pacemaker implantation, which is significantly more common in obese subjects

Outcome of transcatheter aortic valve replacement in bicuspid aortic valve stenosis with new-generation devices

OBJECTIVES: To compare device success and paravalvular leak rates of 3 new-generation transcatheter aortic valve replacement devices in patients with bicuspid aortic valve stenosis and to test their biomechanical performance in a computer-based simulation model of aortic root with increasing ellipticity. METHODS: This retrospective multicentre study included 56 bicuspid aortic valve patients undergoing transcatheter aortic valve replacement with new-generation devices: Lotus/Lotus Edge (N = 15; 27%), Evolut-R (N = 20; 36%) and ACURATE neo (N = 21; 37%). Three virtual simulation models of aortic root with increasing index of eccentricity (0-0.25-0.5) were implemented. Stress distribution, stent-root contact area and paravalvular orifice area were computed. RESULTS: Device success was achieved in 43/56 patients (77%) with comparable rates among Lotus (87%), Evolut-R (60%) and ACURATE neo (86%; P = 0.085). Moderate paravalvular leak rate was significantly lower in the Lotus group as compared to Evolut-R group (0% vs 30%; P = 0.027) and comparable to the ACURATE neo group (0% vs 10%; P = 0.33). By index of eccentricity = 0.5, Lotus showed a uniform and symmetric pattern of stress distribution with absent paravalvular orifice area, ACURATE neo showed a mild asymmetry with small paravalvular orifice area (1.1 mm2), whereas a severely asymmetric pattern was evident with Evolut-R, resulting in a large paravalvular orifice area (12.0 mm2). CONCLUSIONS: Transcatheter aortic valve replacement in bicuspid aortic valve patients with new-generation devices showed comparable device success rates. Lotus showed moderate paravalvular leak rate comparable to that of ACURATE neo and significantly lower than Evolut-R. On simulation, Lotus and ACURATE neo showed optimal adaptability to elliptic anatomies as compared to Evolut-R

Coronary access following ACURATE neo implantation for ViV-TAVI: ex vivo analysis in patient-specific anatomies

Background Coronary access after transcatheter aortic valve implantation (TAVI) with supra-annular self-expandable valves may be challenging or un-feasible. There is little data concerning coronary access following transcatheter aortic valve-in-valve implantation (ViV-TAVI) for degenerated surgical bioprosthesis Aims To evaluate the feasibility and challenge of coronary access after ViV-TAVI with the supra-annular self-expandable ACURATE neo valve. Methods Sixteen patients underwent ViV-TAVI with the ACURATE neo valve. Post-procedural computed tomography (CT) was used to create 3D-printed life-sized patient-specific models for bench-testing of coronary cannulation. Primary endpoint was feasibility of diagnostic angiography and PCI. Secondary endpoints included incidence of challenging cannulation for both diagnostic catheters (DC) and guiding catheters (GC). The association between challenging cannulations with aortic and transcatheter/surgical valve geometry was evaluated using pre and post-procedural CT scans. Results Diagnostic angiography and PCI were feasible for 97% and 95% of models respectively. All non-feasible procedures occurred in ostia that underwent prophylactic ‘chimney’ stenting. DC cannulation was challenging in 17% of models and was associated with a narrower SoV width (30mm vs. 35mm, p<0.01), STJ width (28mm vs. 32mm, p<0.05) and shorter STJ height (15mm vs. 17mm, p<0.05). GC cannulation was challenging in 23% of models and was associated with narrower STJ width (28mm vs. 32mm, p<0.05), smaller transcatheter-to-coronary distance (5mm vs. 9.2mm, p<0.05) and a worse coronary-commissural overlap angle (14.3° vs. 25.6o, p<0.01). Advanced techniques to achieve GC cannulation were required in 22/64 (34%) of cases. Conclusion In this exploratory bench analysis, diagnostic angiography and PCI was feasible in almost all cases following ViV-TAVI with the ACURATE neo valve. Prophylactic coronary stenting, higher implantation, narrower aortic sinus dimensions and commissural misalignment were associated with an increased challenge of coronary cannulation