scholarly journals Transcatheter aortic valve replacement for bicuspid aortic valve stenosis with first- and new-generation bioprostheses: a systematic review and meta-analysis

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
D Ueshima ◽  
L.N.F Nai Fovino ◽  
S.J.B Brener ◽  
A.P Pavei ◽  
C.F Fraccaro ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Bicuspid Aortic Valve ◽  
Meta Analysis ◽  
Pacemaker Implantation ◽  
Vascular Complications ◽  
Device Failure ◽  
Paravalvular Leakage ◽  
Transcatheter Aortic Valve ◽  
Outcome Differences ◽  
New Generation

Abstract Background Subjects with bicuspid aortic valve (BAV) have been excluded from transcatheter aortic valve re- placement (TAVR) randomized trials. Methods With this meta-analysis of observational studies we first compared TAVR outcomes of BAV vs. tricuspid aortic valve (TAV) patients, stratifying the results by device generation. Then, we looked for differences between balloon-expandable (BE) and self-expandable (SE) bioprostheses in BAV patients. Primary outcome was 30-day mortality. Secondary outcomes were 30-day stroke, moderate-severe paravalvular leakage, new pacemaker im- plantation, vascular complications and 1-year mortality. Results Thirteen studies (11,032 patients, 7291 TAV and 3741 BAV) and seven studies (706 patients, 367 treated with BE, 339 with SE valve) met inclusion criteria. Thirty-day (OR=1.13; 95% CI: 0.88–1.46, p=0.33) and 1-year mortality (OR=1.02; 95% CI: 0.77–1.37, p=0.87) were similar between patients receiving TAVR for BAV or TAV. Subjects treated for BAV were at higher risk of conversion to conventional surgery (OR=2.35; 95% CI: 1.30–4.23, p=0.005), implantation of a second valve (OR=2.06; 95% CI: 1.31–3.25; p=0.002), moderate/severe paravalvular leakage (PVL) (OR=1.67; 95% CI: 1.29–2.17; p=0.0001) and device failure (OR=1.26; 95% CI: 1.02–1.56; p=0.04). Rates of adverse events decreased significantly with the use of new-generation devices, but outcome differences remained consistent. BAV patients treated with BE vs. SE valves had similar 30-day and 1-year mortality, stroke and moderate-severe PVL. Balloon-expandable valves were associated with lower rates of a second valve and new pacemaker implantation but carried higher risk of annular rupture. Conclusions BAV patients treated with TAVR had similar 30-day and 1-year mortality as well as stroke and new pacemaker implantation rates compared to TAV subjects, but carried higher risk of moderate/severe PVL, conver- sion to surgery and device failure. Event rates significantly decreased with the use of new-generation devices, but TAVR still showed better procedural results in TAV compared to BAV. Funding Acknowledgement Type of funding source: None

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

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Arturo Giordano ◽  
◽  
Nicola Corcione ◽  
Paolo Ferraro ◽  
Alberto Morello ◽  
...  
Keyword(s):  
Renal Failure ◽  
Aortic Valve ◽  
Pacemaker Implantation ◽  
Vascular Complications ◽  
Permanent Pacemaker ◽  
Transcatheter Aortic Valve ◽  
Aortic Valve Implantation ◽  
Valve Implantation ◽  
New Generation ◽  
Unadjusted Analysis

AbstractTranscatheter 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 were found for procedural features. Despite these differences, device and procedural success were similarly high (ranging from 98.0% to 99.4%, p > 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 < 0.001), major vascular complications (favoring Lotus, p < 0.001), renal failure (favoring Portico, p = 0.035), and permanent pacemaker implantation (favoring Acurate, p < 0.001). Propensity score-adjusted analyses showed lower rates of major adverse events with Evolut and Portico (p < 0.05), major vascular complications with Lotus and Portico (p < 0.05), renal failure with Sapien3 (p < 0.05) and permanent pacemaker implantation with Acurate (p < 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.

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

2020 ◽  
Vol 32 (1) ◽  
pp. 20-28
Author(s):  
Riccardo Gorla ◽  
Matteo Casenghi ◽  
Alice Finotello ◽  
Federico De Marco ◽  
Simone Morganti ◽  
...  
Keyword(s):  
Aortic Valve ◽  
Stress Distribution ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Bicuspid Aortic Valve ◽  
Transcatheter Aortic Valve Replacement ◽  
Paravalvular Leak ◽  
Orifice Area ◽  
Transcatheter Aortic Valve ◽  
New Generation

Abstract 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.

Abstract 3047: Management Of Procedural Complications Associated With Transcatheter Aortic Valve Implantation

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Ruediger Lange ◽  
Sabine Bleiziffer ◽  
Hendrik Ruge ◽  
Domenico Mazzitelli ◽  
Christian Schreiber ◽  
...  
Keyword(s):  
Cardiopulmonary Bypass ◽  
Aortic Valve ◽  
Transcatheter Aortic Valve Implantation ◽  
Pacemaker Implantation ◽  
Vascular Complications ◽  
Lv Function ◽  
Transcatheter Aortic Valve ◽  
Surgical Suture ◽  
Aortic Valve Implantation ◽  
Valve Implantation

Objective The transcatheter aortic valve implantation (TAVI) technology is rapidly evolving. The complications related to these procedures are different from those seen after conventional aortic valve replacement. Herein, we report our experience on the incidence and management of procedure-related complications in the first series of TAVI. Methods Between 6/2007 and 6/2008, 112 patients (n=62 female, mean age 81.3±7y, mean logistic EuroScore 25.0±15.6%) underwent TAVI through either a retrograde (n=92 transfemoral, n=3 via subclavian artery, n=1 ascending aorta) or antegrade (n=16 transapical) approach at our institution. 95 CoreValve and 17 Edwards Sapien (n=17) prostheses were implanted. Results 30-day mortality was 8.9% (n=10). Major vascular complications occurred in 19 patients (16,9%). 2 patients with iliac or femoral rupture were treated with covered stent. 14 patients with bleeding from vascular site were treated with surgical suture or prosthesis implantation. Three patients had lethal aortic root (n=2) or abdominal (n=1) aortic rupture. Cardiac tamponade occurred in 8 patients (7.1%); among these 3 were treated conservatively, 4 underwent subxyphoid puncture and one patient had thoracotomy. Valve displacement could be treated interventionally in 5 out of 6 patients, 1 patient underwent conventional surgery. In 2 patients, with extremely poor LV function, emergent institution of cardiopulmonary bypass was required during the procedure. 5 patients underwent interventional re-valving (n=2) or surgical re-replacement (n=3) due to high-grade regurgitation (n=5) or valve displacement (n=1). Pacemaker implantation due to postprocedural AV block was required in 23 patients (20.7%). Despite these complications, the overall initial procedural success was 98 % (n= 110/112). Conclusions A significant number of complications after TAVI requires surgical treatment. Therefore, TAVI procedures should be performed in a hybrid operating room which allows for immediate surgical intervention and the rapid institution of cardiopulmonary bypass if necessary.

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