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BACKGROUND: Controversy exists over whether sex has significant interaction with revascularization strategy for unprotected left main coronary artery disease. Higher mortality has been reported among women treated with percutaneous coronary intervention compared with coronary artery bypass grafting. METHODS AND RESULTS: The DELTA (Drug-Eluting Stents for Left Main Coronary Artery Disease) and DELTA-2 registries are in-ternational, multicentric registries evaluating the outcomes of subjects undergoing coronary revascularization for unprotected left main coronary artery disease. The primary outcome was a composite of death, myocardial infarction, or cerebrovascular accidents. The population consisted of 6253 patients, including 1689 (27%) women. Women were older and more likely to have diabetes and chronic kidney disease than men (P<0.05). At a median follow-up of 29 months (interquartile range 12–49), a significant interaction between sex and revascularization strategy was observed for the primary end point (p int =0.012) and all-cause death (p int =0.037). Among women, compared with percutaneous coronary intervention, coronary artery bypass grafting was associated with lower risk of the primary end point (event rate 9.5% versus 15.3%; adjusted hazard ratio [AHR], 0.53; 95% CI, 0.35–0.79, P<0.001) and all-cause death (event rate 5.6% versus 11.7% AHR, 0.50; 95% CI, 0.30–0.82) and no significant differences were observed in men. CONCLUSIONS: In women undergoing coronary revascularization for unprotected left main coronary artery disease, coronary artery bypass grafting was associated with lower risk of death, myocardial infarction, or cerebrovascular accidents whereas no significant differences between coronary artery bypass grafting and percutaneous coronary intervention were observed in men. Further dedicated studies are needed to determine the optimal revascularization strategy in women with unprotected left main coronary artery disea

Background: Transcatheter aortic valve replacement (TAVR) has determined a paradigm shift in the treatment of patients with severe aortic stenosis. However, the durability of bioprostheses is still a matter of concern, and little is known about the management of degenerated TAV. We sought to evaluate the outcomes of patients with a degenerated TAV treated by means of a second TAVR. Methods: The TRANSIT is an international registry that included cases of degenerated TAVR from 28 centers. Among around 40 000 patients treated with TAVR in the participating centers, 172 underwent a second TAVR: 57 (33%) for a mainly stenotic degenerated TAV, 97 (56%) for a mainly regurgitant TAV, and 18 (11%) for a combined degeneration. Overall, the rate of New York Heart Association class III/IV at presentation was 73.5%. Results: Valve Academic Research Consortium 2 device success rate was 79%, as a consequence of residual gradient (14%) or regurgitation (7%). At 1 month, the overall mortality rate was 2.9%, while rates of new hospitalization and New York Heart Association class III/IV were 3.6% and 7%, respectively, without significant difference across the groups. At 1 year, the overall mortality rate was 10%, while rates of new hospitalization and New York Heart Association class III/IV were 7.6% and 5.8%, respectively, without significant difference across the groups. No cases of valve thrombosis were recorded. Conclusions: Selected patients with a degenerated TAV may be safely and successfully treated by means of a second TAVR. This finding is of crucial importance for the adoption of the TAVR technology in a lower risk and younger population.

Objective: To evaluate the incidence, predictors and outcomes of female patients with patient-prosthesis mismatch (PPM) following transcatheter aortic valve intervention (TAVI) for severe aortic stenosis (AS). Background: Female AS TAVI recipients have a significantly lower mortality than surgical aortic valve replacement (SAVR) recipients, which could be attributed to the potentially lower PPM rates. TAVI has been associated with lower rates of PPM compared to SAVR. PPM in females post TAVI has not been investigated to date. Methods: The WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) registry is

Background: The Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial was a non-inferiority trial that compared percutaneous coronary intervention (PCI) using first-generation paclitaxel-eluting stents with coronary artery bypass grafting (CABG) in patients with de-novo three-vessel and left main coronary artery disease, and reported results up to 5 years. We now report 10-year all-cause death results. Methods: The SYNTAX Extended Survival (SYNTAXES) study is an investigator-driven extension of follow-up of a multicentre, randomised controlled trial done in 85 hospitals across 18 North American and European countries. Patients with de-novo three-vessel and left main coronary artery disease were randomly assigned (1:1) to the PCI group or CABG group. Patients with a history of PCI or CABG, acute myocardial infarction, or an indication for concomitant cardiac surgery were excluded. The primary endpoint of the SYNTAXES study was 10-year all-cause death, which was assessed according to the intention-to-treat principle. Prespecified subgroup analyses were performed according to the presence or absence of left main coronary artery disease and diabetes, and according to coronary complexity defined by core laboratory SYNTAX score tertiles. This study is registered with ClinicalTrials.gov, NCT03417050. Findings: From March, 2005, to April, 2007, 1800 patients were randomly assigned to the PCI (n=903) or CABG (n=897) group. Vital status information at 10 years was complete for 841 (93%) patients in the PCI group and 848 (95%) patients in the CABG group. At 10 years, 244 (27%) patients had died after PCI and 211 (24%) after CABG (hazard ratio 1·17 [95% CI 0·97–1·41], p=0·092). Among patients with three-vessel disease, 151 (28%) of 546 had died after PCI versus 113 (21%) of 549 after CABG (hazard ratio 1·41 [95% CI 1·10–1·80]), and among patients with left main coronary artery disease, 93 (26%) of 357 had died after PCI versus 98 (28%) of 348 after CABG (0·90 [0·68–

Item does not contain fulltext, OBJECTIVES: This study sought to examine the safety and performance of contemporary transcatheter aortic valve replacement (TAVR) in an exclusive all-women TAVR population, and to further investigate the potential impact of female sex-specific characteristics on composite 1-year clinical outcomes. BACKGROUND: Women comprise >/=50% patients undergoing TAVR. Several data have shown the noninferiority of TAVR compared with surgical aortic valve replacement for symptomatic significant aortic stenosis, but no study so far has been specifically powered to detect differences by sex. METHODS: The WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) registry is a multinational, prospective, observational registry of women undergoing TAVR for significant aortic stenosis, across 18 sites in Europe and 1 site in the United States, between January 2013 and December 2015. The primary Valve Academic Research Consortium (VARC)-2 efficacy endpoint was a composite of mortality, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure or valve-related dysfunction beyond 30 days. Secondary endpoints included composite 1-year death or stroke. Predictors of 1-year outcomes were determined using Cox regression methods. RESULTS: A total of 1,019 intermediate to high-risk women, with mean age 82.5 +/- 6.3 years, mean European System for Cardiac Operative Risk Evaluation (EuroSCORE) I 17.8 +/- 11.7% and mean Society of Thoracic Surgeons score 8.3 +/- 7.4% were enrolled. TAVR was performed via transfemoral access in 90.6% and new-generation devices were used in 42.1%. The primary VARC-2 efficacy composite endpoint occurred in 111 (10.9%) patients beyond 30 days and in 167 (16.5%) patients at 1 year. The incidence of 1-year death or stroke was 13.9% (n = 141). Death occurred in 127 (12.5%) patients and stroke in 22 (2.2%) patients. Prior coronary revascularization (hazard ratio [HR]: 1.72; 95% confidence interval [CI]: 1.17 to 2.52; p = 0.0

Aims: This analysis aimed to evaluate the incidence and predictors of the need for permanent pacemaker (PPM) implantation following implantation of the repositionable and fully retrievable LOTUS Aortic Valve Replacement System. Methods and Results: The prospective, single-arm, multicentre REPRISE II study with extended cohort enrolled 250 symptomatic, high surgical risk patients with severe aortic stenosis for transfemoral transcatheter aortic valve implantation (TAVI) with a 23 mm or 27 mm LOTUS valve. Echocardiography, computed tomography, and electrocardiography data were evaluated by independent core labs. Post TAVI, 32.0% (72/225) of pacemaker-naive patients underwent new PPM implantation at 30 days. Most (59/72, 82%) patients were implanted for third-degree atrioventricular block, and >10% overstretch of the LVOT by area was observed in 59.7% (43/72) of PPM patients. Significant independent predictors of PPM at 30 days included baseline RBBB (odds ratio [OR] 12.7, 95% CI: 4.5, 36.2; p<0.001) and LVOT overstretch >10% (OR 3.4, 95% CI: 1.7, 6.7; p<0.001). There was a trend towards a lower 30-day PPM rate in patients with a shallower (<=5 mm) implant depth (23.9% <=5 mm vs. 36.9% >5 mm depth from LCS; p=0.06). Conclusion(s): Careful attention to valve sizing and implant depth may help to reduce the rate of PPM with the LOTUS valve.Copyright © Europa Digital & Publishing 2017. All rights reserved.

BACKGROUND The repositionable and fully retrievable LotusTM Valve (Boston Scientific, Marlborough, MA, USA) was designed to provide precise positioning and minimize paravalvular leak (PVL) in patients with severe aortic stenosis. This analysis will present the first report of 3-year outcomes from the REPRISE II CE-Mark study. METHODS The REPRISE II study is a prospective, single-arm trial that enrolled patients with symptomatic severe calcific aortic stenosis who are at high or extreme surgical risk (based on STS Score or Heart Team assessment) at 14 centers in Europe and Australia. Follow-up is continuing through 5 years. RESULTS Among 120 enrolled patients, the mean age was 84.4+/-5.3 years, 57% (68/120) were female, and mean STS Score was 7.1+/-4.6. All patients were successfully implanted with a Lotus Valve. The primary performance endpoint of 30-day mean aortic valve pressure gradient was 11.5+/-5.2mmHg, and was significantly less than the performance goal of 18mmHg (P<0.001). The primary safety endpoint of 30-day allcause mortality was 4.2%. Two-year clinical follow-up data or death was available for all patients. At 2 years, the Kaplan-Meier rate of allcause mortality was 16.9% (n=20) and disabling stroke was 3.5% (n=4). There were no repeat procedures for valve-related dysfunction, valve migration, embolization, or TAV-in-TAV. Two additional patients received a new permanent pacemaker (PPM) between 1 and 2 years (complete heart block on day 432 and symptomatic bradycardia on day 673) for a total 2-year PPM rate of 34.2% (n=40). By independent core lab adjudication, the 2-year mean aortic valve gradient was 12.3+/-6.2mmHg and mean aortic valve area was 1.7+/-0.5cm2. A total of 90.5% patients had no or trivial PVL at 2 years and 9.5% had mild paravalvular regurgitation; no patient had moderate or severe PVL. CONCLUSION The Lotus Valve has demonstrated negligible PVL, good sustained hemodynamics, and low rates of death and stroke at 2 years. The 3-year results

Aims: The REPRISE IIE trial aimed to evaluate outcomes following transcatheter aortic valve implantation of the fully repositionable and retrievable LOTUS valve with a unique seal designed to minimise paravalvular leak (PVL). Methods and Results: This prospective, multicentre study enrolled 250 patients with severe aortic stenosis considered high-risk for surgery by a multidisciplinary Heart Team. An independent clinical events committee adjudicated events per Valve Academic Research Consortium criteria. Mean age was 84 years; 77% were in NYHA Class III/IV. LOTUS valve implantation produced significant haemodynamic improvements at one year without valve embolisation, ectopic valve deployment, or additional valve implantation. Primary endpoints were met as the 30-day mortality rate in the extended cohort (4.4%, N=250), and mean valve gradient in the main cohort (11.5+/-5.2 mmHg, N=120) were below (p<0.001) their predefined performance objectives. At 30 days, disabling stroke was 2.8% and new pacemaker implantation was 28.9% in all patients and 32.0% in pacemaker-naive patients. By one year, all-cause mortality was 11.6%, disabling stroke was 3.6%, 95% of patients alive were in NYHA Class I/II, and there was no core laboratory-adjudicated moderate/severe PVL. Conclusion(s): LOTUS valve implantation produced good valve haemodynamics, minimal PVL, sustained significant improvement in functional status, and good clinical outcomes one year post implant.Copyright © Europa Digital & Publishing 2017. All rights reserved.

Paravalvular leak (PVL) after transcatheter aortic valve replacement is associated with worse long-term outcomes. The Lotus Valve incorporates an innovative Adaptive Seal designed to minimize PVL. This analysis evaluated the incidence and predictors of PVL after implantation of the Lotus transcatheter aortic valve. The REPRISE II (REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus Valve System - Evaluation of Safety and Performance) Study With Extended Cohort enrolled 250 high-surgical risk patients with severe symptomatic aortic stenosis. Aortic regurgitation was assessed by echocardiography pre-procedure, at discharge and 30 days, by an independent core laboratory. Baseline and procedural predictors of mild or greater PVL at 30 days (or at discharge if 30-day data were not available) were determined using a multivariate regression model (n = 229). Of the 229 patients, 197 (86%) had no/trace PVL, 30 had mild, and 2 had moderate PVL; no patient had severe PVL. Significant predictors of mild/moderate PVL included device:annulus area ratio (odds ratio [OR] 0.87; 95% CI 0.83 to 0.92; p <0.001), left ventricular outflow tract calcium volume (OR 2.85; 95% CI 1.44 to 5.63; p = 0.003), and annulus area (OR 0.89; 95% CI 0.82 to 0.96; p = 0.002). When the device:annulus area ratio was <1, the rate of mild/moderate PVL was 53.1% (17 of 32). The rates of mild/moderate PVL with 0% to 5%, 5% to 10%, and >10% annular oversizing by area were 17.5% (11 of 63), 2.9% (2 of 70), and 3.2% (2 of 63), respectively. Significant independent predictors of PVL included device:annulus area ratio and left ventricular outflow tract calcium volume. When the prosthetic valve was oversized by >=5%, the rate of mild or greater PVL was only 3%. In conclusion, the overall rates of PVL with the Lotus Valve are low and predominantly related to device/annulus areas and calcium; these findings have implications for optimal device sizing.Copyright © 2017 Elsevie

Aims: First-generation transcatheter aortic valve implantation (TAVI) devices may be associated with an increased risk for stroke, vascular complications, and paravalvular leak, which can be associated with higher early and late mortality. The second-generation, fully repositionable and retrievable LotusTM Valve (Boston Scientific, Marlborough, MA, USA) was designed to allow precise positioning of the valve during implantation, provide early valve function for haemodynamic stability, and with an Adaptive Seal to mitigate paravalvular leak. Methods and Results: The prospective, single-arm, multi-centre REPRISE II study with extended cohort enrolled 250 patients at 20 sites in Europe and Australia. Patients at high surgical risk, defined as Society of Thoracic Surgeons risk score >8% and/or documented Heart Team agreement of high risk due to frailty or other comorbidities, who had symptomatic, calcific native aortic valve stenosis (annulus size 1927 mm) received a 23 mm or 27 mm transfemoral Lotus Valve. Patients were 52.4% female, mean age was 84.0 years, mean STS Score (v2.73) was 6.5%, and 77.2% (193/25) were New York Heart Association functional class III or IV. The primary device performance endpoint of 30 day mean pressure gradient, as assessed by an independent echocardiographic core laboratory, was 11.5 mmHg, which was significantly (P<0.001) below the pre-specified performance goal of 18.0 mmHg. Similarly, the primary safety endpoint of 30 day all-cause mortality was 4.4%, which was also significantly (P<0.001) less than the performance goal of 16%. The rate of disabling stroke at 30 days was 3.2% and 28.9% (72/249) patients required a newly implanted pacemaker. By independent core lab adjudication, at 30 days, 80.2% of patients had no paravalvular regurgitation, 5.6% had trace, 13.6% had mild, and 1 (0.6%) patient had moderate; no patients had severe paravalvular regurgitation. Conclusion(s): In the REPRISE II extended cohort, the Lotus Valve met the primary

Objectives This analysis presents the first report of 1-year outcomes of the 120 patients enrolled in the REPRISE II (Repositionable Percutaneous Placement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Evaluation of Safety and Performance) study. Background The fully repositionable and retrievable Lotus Valve (Boston Scientific, Marlborough, Massachusetts) was designed to facilitate accurate positioning, early valve function, and hemodynamic stability during deployment and to minimize paravalvular regurgitation in patients undergoing transcatheter aortic valve replacement. Methods The study enrolled 120 symptomatic patients 70 years of age or older at 14 centers in Australia and Europe. Patients had severe calcific aortic stenosis and were deemed to be at high or extreme risk of surgery based on assessment by the heart team. Results The mean age was 84.4 +/- 5.3 years, 57% (68 of 120) of patients were women, and the mean Society of Thoracic Surgeons score was 7.1 +/- 4.6. The mean baseline aortic valve area was 0.7 +/- 0.2 cm2, and the mean transvalvular pressure gradient was 46.4 +/- 15.0 mm Hg. All patients were successfully implanted with a Lotus Valve, and 1-year clinical follow-up was available for 99.2% (119 of 120 of patients). The mean 1-year transvalvular aortic pressure gradient was 12.6 +/- 5.7 mm Hg, and the mean valve area was 1.7 +/- 0.5 cm2. A total of 88.6% patients had no or trivial paravalvular aortic regurgitation at 1 year by independent core lab adjudication, and 97.1% of patients were New York Heart Association functional class I or II. At 1 year, the all-cause mortality rate was 10.9% (13 of 119 patients), disabling stroke rate was 3.4% (4 of 119 patients), disabling bleeding rate was 5.9% (7 of 119 patients), with no repeat procedures for valve-related dysfunction. A total of 31.9% (38 of 119 patients) underwent new permanent pacemaker implantation at 1 year. Conclusions At 1 year of follow-up, the Lotus Valve demonstrat

Background Transcatheter aortic valve replacement (TAVR) has revolutionized management of high-risk patients with severe aortic stenosis. However, survival and the incidence of severe complications have been assessed in relatively small populations and/or with limited follow-up. Objectives This report details late clinical outcome and its determinants in the FRANCE-2 (FRench Aortic National CoreValve and Edwards) registry. Methods The FRANCE-2 registry prospectively included all TAVRs performed in France. Follow-up was scheduled at 30 days, at 6 months, and annually from 1 to 5 years. Standardized VARC (Valve Academic Research Consortium) outcome definitions were used. Results A total of 4,201 patients were enrolled between January 2010 and January 2012 in 34 centers. Approaches were transarterial (transfemoral 73%, transapical 18%, subclavian 6%, and transaortic or transcarotid 3%) or, in 18% of patients, transapical. Median follow-up was 3.8 years. Vital status was available for 97.2% of patients at 3 years. The 3-year all-cause mortality was 42.0% and cardiovascular mortality was 17.5%. In a multivariate model, predictors of 3-year all-cause mortality were male sex (p < 0.001), low body mass index, (p < 0.001), atrial fibrillation (p < 0.001), dialysis (p < 0.001), New York Heart Association functional class III or IV (p < 0.001), higher logistic EuroSCORE (p < 0.001), transapical or subclavian approach (p < 0.001 for both vs. transfemoral approach), need for permanent pacemaker implantation (p = 0.02), and post-implant periprosthetic aortic regurgitation grade ≥2 of 4 (p < 0.001). Severe events according to VARC criteria occurred mainly during the first month and subsequently in <2% of patients/year. Mean gradient, valve area, and residual aortic regurgitation were stable during follow-up. Conclusions The FRANCE-2 registry represents the largest database available on late results of TAVR. Late mortality is largely related to noncardiac

Aims: This analysis evaluated the incidence and predictors of paravalvular regurgitation at 30 days following implantation of the Lotus Valve in the extended REPRISE II cohort of 250 patients. Methods and Results: The prospective, single arm, multicentre REPRISE II and REPRISE II Extension studies enrolled 250 symptomatic, high-surgical-risk patients with calcific aortic stenosis and an annulus of 19-27 mm. Two valve sizes of 23 mm or 27 mm were available in these studies. Paravalvular regurgitation was assessed by echocardiography at discharge and 30 days according to VARC-2 criteria, and aortic valve dimensions and calcification by CT in end-systole; both were analysed and reported by an independent corelab. At 30 days, 80.2% (142/177) of patients had no paravalvular regurgitation, 5.6% (10/177) had trace/trivial regurgitation, 13.6% (24/177) had mild regurgitation, 0.6% (1/177) had moderate regurgitation, and no patients had severe paravalvular regurgitation. Baseline and procedural predictors of mild or moderate paravalvular regurgitation at 30 days (or at discharge if 30-day data were not available) were determined by using a multivariate regression model (n=229). Significant independent predictors of mild/moderate paravalvular regurgitation included the ratio of device area to annulus area (odds ratio 0.87; 95% CI: 0.83, 0.92; p<0.001), calcium volume in the left ventricular outflow tract (odds ratio: 2.85 per 100 mm increase; 95% CI: 1.44, 5.63; p=0.003), and annulus area (odds ratio per 10 mm increase: 0.89; 95% CI: 0.82, 0.96; p=0.002). Calcium volume in the leaflet and annulus was a borderline-significant predictor (odds ratio: 1.07 per 100 mm increase; 95% CI: 1.00, 1.16; p=0.06). When the nominal valve area was smaller than the annulus, i.e., device:annulus area ratio <1, the rate of mild or moderate paravalvular regurgitation was 53.1% (17/32). The rates of mild/moderate paravalvular regurgitation with 0-5%, 5-10%, and >10% annular oversizing by area we

Background The majority of transcatheter aortic valve implantation (TAVI) procedures are currently performed by percutaneous transfemoral approach. The potential contribution of the type of vascular closure device to the incidence of vascular complications is not clear. Aim To compare the efficacy of a Prostar XL-vs. Perclose ProGlide-based vascular closure strategy. Methods The ClOsure device iN TRansfemoral aOrtic vaLve implantation (CONTROL) multi-center study included 3138 consecutive percutaneous transfemoral TAVI patients, categorized according to vascular closure strategy: Prostar XL-(Prostar group) vs. Perclose ProGlide-based vascular closure strategy (ProGlide group). Propensity-score matching was used to assemble a cohort of patients with similar baseline characteristics. Results Propensity matching identified 944 well-matched patients (472 patient pairs). Composite primary end point of major vascular complications or in-hospital mortality occurred more frequently in Prostar group when compared with ProGlide group (9.5 vs. 5.1%, P = 0.016), and was driven by higher rates of major vascular complication (7.4 vs. 1.9%, P < 0.001) in the Prostar group. However, in-hospital mortality was similar between groups (4.9 vs. 3.5%, P = 0.2). Femoral artery stenosis occurred less frequently in the Prostar group (3.4 vs. 0.5%, P = 0.004), but overall, Prostar use was associated with higher rates of major bleeding (16.7 vs. 3.2%, P < 0.001), acute kidney injury (17.6 vs. 4.4%, P < 0.001) and with longer hospital stay (median 6 vs. 5 days, P = 0.007). Conclusions Prostar XL-based vascular closure in transfemoral TAVI procedures is associated with higher major vascular complication rates when compared with ProGlide; however, in-hospital mortality is similar with both devices.

Results Mean age was 84.4 years, 57% of the patients were female, and 76% were New York Heart Association functional class III/IV. Mean aortic valve area was 0.7 +/- 0.2 cm2. The valve was successfully implanted in all patients, with no cases of valve embolization, ectopic valve deployment, or additional valve implantation. All repositioning (n = 26) and retrieval (n = 6) attempts were successful; 34 patients (28.6%) received a permanent pacemaker. The primary device performance endpoint was met, because the mean gradient improved from 46.4 +/- 15.0 mm Hg to 11.5 +/- 5.2 mm Hg. At 30 days, the mortality rate was 4.2%, and the rate of disabling stroke was 1.7%; 1 (1.0%) patient had moderate PVR, whereas none had severe PVR. Conclusions REPRISE II demonstrates the safety and effectiveness of the Lotus valve in patients with severe aortic stenosis who are at high surgical risk. The valve could be positioned successfully with minimal PVR. (REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of LotusTM Valve System - Evaluation of Safety and Performance; NCT01627691). Background Transcatheter aortic valve replacement provides results comparable to those of surgery in patients at high surgical risk, but complications can impact long-term outcomes. The Lotus valve, designed to improve upon earlier devices, is fully repositionable and retrievable, with a unique seal to minimize paravalvular regurgitation (PVR). Objectives The prospective, single-arm, multicenter REPRISE II study (REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System: Evaluation of Safety and Performance) evaluated the transcatheter valve system for treatment of severe symptomatic calcific aortic valve stenosis. Methods Patients (n = 120; aortic annulus 19 to 27 mm) considered by a multidisciplinary heart team to be at high surgical risk received the valve transfemorally. The primary device performance endpoin

Aims: Early transcatheter aortic valve implantation (TAVI) devices have established the feasibility of TAVI in patients who are unsuitable for surgical valve replacement, but these devices may face challenges with precise valve positioning, paravalvular leakage, and undesirable rates of stroke, bleeding, or vascular complications. The repositionable and fully retrievable LotusTM Valve was designed to facilitate accurate positioning and minimise paravalvular leakage in patients with severe aortic stenosis who are at high or extreme risk for surgery. The device demonstrated favourable efficacy and safety primary outcomes at 30 days in the REPRISE II CE-Mark trial. This analysis will present the first report of 6-month outcomes in the full cohort of patients in REPRISE II. Methods and Results: The prospective, single-arm, multicentre REPRISE II study was designed to assess the safety and performance of the Lotus Valve System in symptomatic patients aged >=70 years with severe calcific aortic stenosis who are at high or extreme surgical risk. The primary device performance endpoint was the mean aortic valve pressure gradient at 30 days post-procedure, as assessed by an independent core laboratory. The primary safety endpoint was 30-day all-cause mortality. Among 120 enrolled patients, the mean age of 84.4+/-5.3 years, 57% (68/120) were female, mean STS Score was 7.1+/-4.6, mean euroSCORE II was 6.9+/-5.8, and 26% had medically treated diabetes. The mean baseline aortic valve area was 0.7+/-0.2 cm, and the mean aortic valve pressure gradient was 46.4+/-15.0 mmHg. All patients (100%) were successfully implanted with a Lotus valve. A total of 28.6% (34/119) patients had a permanent pacemaker implanted within 30 days post-procedure. The primary device performance endpoint of 30-day mean aortic valve pressure gradient was 11.5+/-5.2 mmHg, which was significantly less than the performance goal of 18 mmHg (P<0.001). All-cause mortality at 30 days was 4.2% and disabling stroke