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Background: Patients with mitral regurgitation (MR) and morphologic presence of relevant mitral annular calcification (MAC) represent a challenging phenotypic subset with limited treatment options., Objectives: The aim of this study was to assess the feasibility of transcatheter mitral valve replacement (TMVR) using dedicated devices for the treatment of MAC patients., Methods: Consecutive patients with symptomatic MR receiving TMVR and with available computed tomography data from the CHOICE-MI (Choice of Optimal Transcatheter Treatment for Mitral Insufficiency) multicenter registry were stratified by the presence of none or mild mitral annular calcification (MAC none/mild ) vs moderate or severe mitral annular calcification (MAC mod/sev )., Results: Among 279 eligible patients (median age = 76.0 years [Q1-Q3: 71.0-81.0 years], EuroSCORE II = 6.2% [Q1-Q3: 3.9%-12.1%]), 222 (79.6%) presented with MAC none/mild and 57 (20.4%) with MAC mod/sev . Patients with MAC mod/sev  had a higher prevalence of extracardiac arteriopathy (P = 0.011) and primary MR (P < 0.001). Although the technical success rate and the extent of MR elimination did not differ, TMVR treatment in MAC mod/sev patients was associated with higher rates of postprocedural bleeding complications (P = 0.02) and renal failure (P < 0.001). Functional improvement at the 1- and 2-year follow-up did not differ between groups. At the 2-year follow-up, there were no differences between patients with MAC mod/sev and MAC none/mild regarding all-cause mortality (38.5% vs 37.7%; P = 0.76), cardiovascular mortality (21.3% vs 24.9%; P = 0.97), and all-cause mortality or heart failure hospitalization (52.4% vs 46.7%; P = 0.28) CONCLUSIONS: TMVR in patients with MAC mod/sev is associated with higher rates of postprocedural complications but similar rates of survival, MR resolution, and functional improvement compared to MAC none/mild . Further studies are necessary to define the role of dedicated TMVR devices in this population. (Choice of Optimal Transcatheter Treatment for Mitral Insufficiency Registry [CHOICE-MI]; NCT04688190)., Competing Interests: Funding Support and Author Disclosures This study was supported by a grant from the German Heart Foundation. Dr Coisne is a proctor for Abbott Vascular; and has received speaker fees for Abbot Vascular, Edwards Lifesciences, GE Healthcare, Merck Sharp & Dohme, and Pfizer. Dr Ludwig has received travel compensation from Edwards Lifesciences; has received honoraria from Bayer and Abbott; is a consultant for NVT; and was supported by a research grant from the German Heart Foundation. Dr Ali has received research grants from Medtronic and Edwards Lifesciences. Dr Duncan is a consultant for and has received honoraria from Abbott Laboratories, Edward Lifesciences, and Medtronic. Dr Kalbacher has received personal fees from Abbott, Edwards Lifesciences, Pi-Cardia Ltd, and Medtronic. Dr Rudolph has received speaker honoraria from Abbott Vascular. Dr Hausleiter has received consulting fees, speaker honoraria, and support of research projects paid to the institution from Abbott Vascular and Edwards Lifesciences. Dr Ruge serves as a physician proctor for Abbott and Edwards Lifesciences; is a consultant for Medtronic, Abbott, and Edwards Lifesciences; and is a member of the Abbott Advisory Board. Dr Schmidt has received consultant fees and travel support from Cardiovalve. Dr Taramasso is consultant or has received consultancy fees from Abbott, Edwards Lifesciences, Medtronic, Boston Scientific, Shenqi Medical, MEDIRA, PiCardia, CoreMedic, Cardiovalve, Simulands, CoreQuest, HiD Imaging, and OneCrea Medical. Dr Denti has received speaker honoraria from Abbott and Edwards Lifesciences; and has received consultant fees from Approxima, HVR, InnovHeart, and Pi-Cardia Ltd. Dr Andreas is a proctor, consultant, and speaker for Edwards Lifesciences, Abbott, Medtronic, Boston, and Zoll; and has received institutional research grants from Edwards Lifesciences, Abbott, Medtronic, and LSI. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: In the SCOPE I trial (Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis), transcatheter aortic valve implantation with the self-expanding ACURATE neo (NEO) did not meet noninferiority compared with the balloon-expandable SAPIEN 3 (S3) device regarding a composite end point at 30 days due to higher rates of prosthetic valve regurgitation and acute kidney injury. Data on long-term durability of NEO are scarce. Here, we report whether early differences between NEO and S3 translate into differences in clinical outcomes or bioprosthetic valve failure 3 years after transcatheter aortic valve implantation., Methods: Patients with severe aortic stenosis were randomized to transfemoral transcatheter aortic valve implantation with NEO or S3 at 20 European centers. Clinical outcomes at 3 years are compared using Cox proportional or Fine-Gray subdistribution hazard models by intention-to-treat. Bioprosthetic valve failure is reported for the valve-implant cohort., Results: Among 739 patients, 84 of 372 patients (24.3%) had died in the NEO and 85 of 367 (25%) in the S3 group at 3 years. Comparing NEO with S3, the 3-year rates of all-cause death (hazard ratio, 0.98 [95% CI, 0.73-1.33]), stroke (subhazard ratio, 1.04 [95% CI, 0.56-1.92]), and hospitalization for congestive heart failure (subhazard ratio, 0.74 [95% CI, 0.51-1.07]) were similar between the groups. Aortic valve reinterventions were required in 4 NEO and 3 S3 patients (subhazard ratio, 1.32 [95% CI, 0.30-5.85]). New York Heart Association functional class ≤II was observed in 84% (NEO) and 85% (S3), respectively. Mean gradients remained lower after NEO at 3 years (8 versus 12 mm Hg; P <0.001)., Conclusions: Early differences between NEO and S3 did not translate into significant differences in clinical outcomes or bioprosthetic valve failure throughout 3 years., Registration: URL: https://clinicaltrials.gov, Unique identifier: NCT03011346., Competing Interests: Disclosures Dr Lanz has received speaker fees from Edwards Lifesciences. Dr Möllmann has received speaker fees or is a proctor from Abbott, Biotronik, Boston Scientific, and Edwards Lifesciences. Dr Kim is a proctor for Boston Scientific and Abbott, and has received speaker fees from Boston Scientific, Abbott, and Edwards Lifesciences. Dr Linke is a consultant to Medtronic, Edwards, Boston Scientific, Abbott, Transverse Medical Inc, Astra Zeneca, and Claret Medical. He owns stock options from Emboline and Transverse Medical Inc, and has received speaker honoraria from Edwards, Boston Scientific, Medtronic, Abbott, Astra Zeneca, Bayer, and Novartis. Dr Prendergast has received unrestricted research grants and speaker fees from Edwards Lifesciences. Dr Conzelmann reports personal fees from Boston Scientific, Medtronic, and Edwards Lifesciences. Dr Conradi is advisory board member for Abbott, Medtronic, JenaValve, and Neovasc, and has received personal honoraria from Boston Scientific, Edwards Lifesciences, NVT, and Microinterventions. Dr Stortecky reports grants from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; and personal fees from BTG, Teleflex, and Boston Scientific. Dr Windecker reports research and educational grants to the institution from Abbott, Amgen, BMS, Bayer, Boston Scientific, Biotronik, Cardinal Health, CardioValve, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Johnson&Johnson, Medtronic, Querbet, Polares, Sanofi, Terumo, and Sinomed. Dr Windecker serves as unpaid member of the steering/excecutive group of trials funded by Abbott, Abiomed, Amgen, BMS, Boston Scientific, Biotronik, Cardiovalve, Edwards Lifesciences, MedAlliance, Medtronic, Polares, Sinomed, V-Wave and Xeltis, but has not received personal payments by any pharmaceutical company or device manufacturer. Dr Windecker is also member of the steering/excecutive committee group of several investigated-initiated trials that receive funding by industry without impact on his personal remuneration. Dr Pilgrim has received institutional research grants from Biotronik, Boston Scientific, and Edwards Lifesciences; speaker/consultancy fees from Biotronik, Boston Scientific, Abbott, Medtronic, and HighLife SAS. The other authors report no conflicts.

Background: Transcatheter therapies are a recognized alternative intervention in patients with severe mitral regurgitation who are at high surgical risk. The purpose of this study was to characterize patients screened for transcatheter mitral valve replacement (TMVR), establish the clinical and anatomic reasons for unsuitability, and determine clinical course and early outcomes., Methods: International multicentre registry was conducted of consecutive patients screened for TMVR at 12 centres in Europe, the United States, and Canada between April 2015 and September 2018. Patient-level retrospective data were collected for all patients screened., Results: From a total of 294 patients, 87 (30%) patients were suitable for and underwent TMVR, whereas 207 (70%) patients were unsuitable for TMVR. There was no difference in Society of Thoracic Surgeons predicted risk of mortality (6.3% ± 4.3% vs 6.7 ± 6.1%, P = 0.52) for mitral valve replacement between the groups. The most common reasons for TMVR unsuitability were mitral annular size outside therapeutic range (28%) and small predicted neo-LVOT (25%). Preprocedural multidetector computed tomographic demonstrated that patients unsuitable for TMVR had smaller predicted neo-left ventricular outflow tract (LVOT) area (318 ±192 mm 2 vs 495 ± 202 mm 2 , P = 0.04). At 30 days, there was no difference in rates of rehospitalization (8% vs 8%, P = 0.21), stroke (1% vs 2%, P = 0.42), or mortality (4% vs 10%, P = 0.10), unadjusted for procedural risk, between unsuitable for TMVR and TMVR groups, respectively., Conclusions: Two-thirds of patients failed screening as anatomically unsuitable for TMVR. The findings of this study have important clinical implications, highlighting an unmet clinical need and provide a target for design innovation in future iterations of TMVR devices., (Copyright © 2023 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Subclinical leaflet thrombosis (LT) may occur following surgical and transcatheter aortic valve replacement. Computed tomography (CT) has become an established imaging modality to diagnose subclinical LT following bioprosthetic aortic valve replacement. Even so, there is a limited (but growing) experience in utilizing CT imaging for this indication. This review emphasizes a systematic approach to acquiring and analysing CT imaging for subclinical LT, highlighting evidence surrounding clinical sequelae of subclinical LT and anti-thrombotic implications following diagnosis., Competing Interests: Declaration of Competing Interest JL has received institutional core laboratory contracts with Edwards Lifesciences, Medtronic, Abbott, Boston Scientific, PI Cardia, and Conformal. PMH is a shareholder of Neumann Medical Ltd. RPG has received personal fees from Boston Scientific, Medtronic, and Abbott Vascular. The remaining authors have nothing to disclose in relation to this article., (Copyright © 2022 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.)

Objectives: We describe the first experience using calcification of anatomical landmarks to obviate the need for transcatheter aortic valve implantation (TAVI) alignment aortography and secondary TAVI access., Background: TAVI alignment conventionally involves secondary femoral access for contrast aortography using a second catheter. Secondary femoral access accounts for up to 25% of all vascular complications. Heavily calcified aortic leaflets are often visible fluoroscopically and can act as markers for TAVI alignment., Methods: We considered 100 consecutive patients for transfemoral TAVI. The first group was considered for a conventional dual access technique and the subsequent group was considered for a single access technique. Relevant baseline, and procedural and outcome measures were recorded., Results: Baseline characteristics were comparable between groups. Balloon-expandable transcatheter heart valves (THV) were used in all cases. THV implantation was successful in 100% of cases with no procedural or in-hospital mortality. Procedural time and contrast use were lower in the single access group. There were no Valve Academic Research Consortium (VARC)-2 major vascular complications with the single access technique., Conclusions: This is the first study describing the use of calcification of anatomical landmarks to obviate the need for secondary TAVI access. Notable observations included successful device implantation in all cases, no VARC-2 major vascular complications, comparable rates of paravalvular leak and permanent pacemaker requirement, shorter procedural times, and lower contrast use. Single access TAVI is a viable alternative technique to minimize vascular access, contrast use, and procedural duration in experienced centers and with selected patients, allowing successful device implantation and low complication rates while further streamlining TAVI workflow., (© 2022 Wiley Periodicals LLC.)

Objectives: To determine whether a permanent pacemaker (PPM) in situ can enhance survival after transcatheter aortic valve implantation (TAVI), in a predominantly inoperable or high risk cohort., Background: New conduction disturbances are the most frequent complication of TAVI, often necessitating PPM implantation before hospital discharge., Methods: We performed an observational cohort analysis of the UK TAVI registry (2007-2015). Primary and secondary endpoints were 30-day post-discharge all-cause mortality and long-term survival, respectively., Results: Of 8,651 procedures, 6,815 complete datasets were analyzed. A PPM at hospital discharge, irrespective of when implantation occurred (PPM 1.68% [22/1309] vs. no PPM 1.47% [81/5506], odds ratio [OR] 1.14, 95% confidence interval [CI] 0.71-1.84; p = .58), or a PPM implanted peri- or post-TAVI only (PPM 1.44% [11/763] vs. no PPM 1.47% [81/5506], OR 0.98 [0.51-1.85]; p = .95) did not significantly reduce the primary endpoint. Patients with a PPM at discharge were older, male, had right bundle branch block at baseline, were more likely to have received a first-generation self-expandable prosthesis and had experienced more peri- and post-procedural complications including bailout valve-in-valve rescue, bleeding and acute kidney injury. A Cox proportional hazards model demonstrated significantly reduced long-term survival in all those with a PPM, irrespective of implantation timing (hazard ratio [HR] 1.14 [1.02-1.26]; p = .019) and those receiving a PPM only at the time of TAVI (HR 1.15 [1.02-1.31]; p = .032). The reasons underlying this observation warrant further investigation., Conclusions: A PPM did not confer a survival advantage in the first 30 days after hospital discharge following TAVI., (© 2021 Wiley Periodicals LLC.)

A plethora of catheter-based strategies have been developed to treat mitral valve disease. Evolving 3-dimensional (3D) multidetector computed tomography (MDCT) technology can accurately reconstruct the mitral valve by means of 3-dimensional computational modeling (3DCM) to allow virtual implantation of catheter-based devices. 3D printing complements computational modeling and offers implanting physician teams the opportunity to evaluate devices in life-size replicas of patient-specific cardiac anatomy. MDCT-derived 3D computational and 3D-printed modeling provides unprecedented insights to facilitate hands-on procedural planning, device training, and retrospective procedural evaluation. This overview summarizes current concepts and provides insight into the application of MDCT-derived 3DCM and 3D printing for the planning of transcatheter mitral valve replacement and closure of paravalvular leaks. Additionally, future directions in the development of 3DCM will be discussed., Competing Interests: Funding Support and Author Disclosures Dr. Wang has served as a consultant for Edwards Lifesciences, Boston Scientific, and Materialise. Dr. Redwood has served as a proctor and consultant for Edwards Lifesciences. Dr. Popma has received institutional grants from Medtronic, Boston Scientific, Edwards Lifesciences, and Abbott; and is a member of the Medical Advisory Board of Edwards Lifesciences. Dr. Little has served as a consultant for Abbot Cardiovascular and Medtronic; and has received a research grant from Siemens Health. Dr. Pfeiffer has served as a consultant for LivaNova Inc.; and has served as a speaker and proctor for Edwards Lifesciences and Abbott Cardiovascular. Dr. Dahle has served as a proctor for Abbot Cardiovascular. Mrs. Minet is a former employee of Materialise NV. Dr. O’Neill has served as a consultant for Boston Scientific. Dr. Van Mieghem has received research grant support from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; and has served as a consultant for Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, Pie Medical, and Materialise NV. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: We sought to identify baseline demographics and procedural factors that might independently predict in-hospital stroke following transcatheter aortic valve implantation (TAVI)., Background: Stroke is a recognized, albeit infrequent, complication of TAVI. Established predictors of procedure-related in-hospital stroke; however, remain poorly defined., Methods: We conducted an observational cohort analysis of the multicenter UK TAVI registry. The primary outcome measure was the incidence of in-hospital stroke., Results: A total of 8,652 TAVI procedures were performed from 2007 to 2015. There were 205 in-hospital strokes reported by participating centers equivalent to an overall stroke incidence of 2.4%. Univariate analysis showed that the implantation of balloon-expandable valves caused significantly fewer strokes (balloon-expandable 96/4,613 [2.08%] vs. self-expandable 95/3,272 [2.90%]; p = .020). After multivariable analysis, prior cerebrovascular disease (CVD) (odds ratio [OR] 1.51, 95% confidence interval [CI 1.05-2.17]; p = .03), advanced age at time of operation (OR 1.02 [0.10-1.04]; p = .05), bailout coronary stenting (OR 5.94 [2.03-17.39]; p = .008), and earlier year of procedure (OR 0.93 [0.87-1.00]; p = .04) were associated with an increased in-hospital stroke risk. There was a reduced stroke risk in those who had prior cardiac surgery (OR 0.62 [0.41-0.93]; p = .01) and a first-generation balloon-expandable valve implanted (OR 0.72 [0.53-0.97]; p = .03). In-hospital stroke significantly increased 30-day (OR 5.22 [3.49-7.81]; p < .001) and 1-year mortality (OR 3.21 [2.15-4.78]; p < .001)., Conclusions: In-hospital stroke after TAVI is associated with substantially increased early and late mortality. Factors independently associated with in-hospital stroke were previous CVD, advanced age, no prior cardiac surgery, and deployment of a predominantly first-generation self-expandable transcatheter heart valve., (© 2020 Wiley Periodicals LLC.)

Aims: We sought to evaluate the outcomes of transcatheter mitral valve replacement (TMVR) for patients with degenerated bioprostheses [valve-in-valve (ViV)], failed annuloplasty rings [valve-in-ring (ViR)], and severe mitral annular calcification [valve-in-mitral annular calcification (ViMAC)]., Methods and Results: From the TMVR multicentre registry, procedural and clinical outcomes of ViV, ViR, and ViMAC were compared according to Mitral Valve Academic Research Consortium (MVARC) criteria. A total of 521 patients with mean Society of Thoracic Surgeons score of 9.0 ± 7.0% underwent TMVR (322 patients with ViV, 141 with ViR, and 58 with ViMAC). Trans-septal access and the Sapien valves were used in 39.5% and 90.0%, respectively. Overall technical success was excellent at 87.1%. However, left ventricular outflow tract obstruction occurred more frequently after ViMAC compared with ViR and ViV (39.7% vs. 5.0% vs. 2.2%; P < 0.001), whereas second valve implantation was more frequent in ViR compared with ViMAC and ViV (12.1% vs. 5.2% vs. 2.5%; P < 0.001). Accordingly, technical success rate was higher after ViV compared with ViR and ViMAC (94.4% vs. 80.9% vs. 62.1%; P < 0.001). Compared with ViMAC and ViV groups, ViR group had more frequent post-procedural mitral regurgitation ≥moderate (18.4% vs. 13.8% vs. 5.6%; P < 0.001) and subsequent paravalvular leak closure (7.8% vs. 0.0% vs. 2.2%; P = 0.006). All-cause mortality was higher after ViMAC compared with ViR and ViV at 30 days (34.5% vs. 9.9% vs. 6.2%; log-rank P < 0.001) and 1 year (62.8% vs. 30.6% vs. 14.0%; log-rank P < 0.001). On multivariable analysis, patients with failed annuloplasty rings and severe MAC were at increased risk of mortality after TMVR [ViR vs. ViV, hazard ratio (HR) 1.99, 95% confidence interval (CI) 1.27-3.12; P = 0.003; ViMAC vs. ViV, HR 5.29, 95% CI 3.29-8.51; P < 0.001]., Conclusion: The TMVR provided excellent outcomes for patients with degenerated bioprostheses despite high surgical risk. However, ViR and ViMAC were associated with higher rates of adverse events and mid-term mortality compared with ViV.

Background: Transcatheter aortic valve implantation is increasingly being used in patients at lower risk for surgery. We aimed to assess the distribution of surgical risk score categories in current clinical practice and their relationship with clinical outcomes and the calibration and discrimination power of both the logistic EuroSCORE (logES) and EuroSCORE II. The SOURCE 3 study is a European prospective registry of patients with severe aortic stenosis treated with the commercially available SAPIEN 3 transcatheter heart valve., Methods and Results: Out of 1785 patients, 518 patients (low-surgical risk) had a baseline logES <10%, 691 (intermediate-surgical risk) had a logES 10% to 20%, and only 576 patients (high-surgical risk) had a logES ≥20%. Even if low-risk patients were younger compared with the other groups, the mean age was about 80 years old in each risk category. At 1 year, all-cause mortality was 10.3%, 11.4%, and 17.1% in low-, intermediate-, or high-surgical risk patients, respectively, while cardiac mortality was 5.3%, 7.7%, and 11.4%, respectively. Observed mortality rates were substantially lower than that predicted with logES. The observed/predicted mortality ratio was 0.26 in low-surgical risk patients, 0.08 in intermediate-surgical risk patients, and 0.12 in high-surgical risk patients. Similar observations were obtained with EuroSCORE II., Conclusions: In this real-world setting, two-thirds of SAPIEN 3 transcatheter heart valve treated transcatheter aortic valve implantation patients had a logES <20 but were still considered appropriate transcatheter aortic valve implantation candidates by the heart team, mainly because of older age and less frequently because of conditions not captured by risk scores. logES and EuroSCORE II had poor discrimination and calibration power in this transcatheter aortic valve implantation cohort., Clinical Trial Registration: URL: https://clinicaltrials.gov . Unique identifier: NCT02698956.

Background: The aim of the Portico TAVI (transcatheter aortic valve implantation) system study was to evaluate outcomes ≤1 year after implantation of a novel resheathable, self-expanding TAVI system in a multicenter patient population with severe aortic stenosis (AS)., Methods and Results: High-risk patients (n=222) with symptomatic severe AS (mean age, 83.0±4.6 years; 74.3% women) were enrolled across 12 centers in Europe and Australia. The study's primary end point was all-cause mortality at 30 days. A total of 209 patients who received the Portico TAVI system were available for follow-up after the 30-day visit. Data collection included hemodynamic assessment by echocardiography with core laboratory evaluation and assessment of functional status. Valve Academic Research Consortium-defined adverse events were adjudicated by an independent Clinical Events Committee. TAVI using the Portico valve led to a significant and persistent improvement in aortic valve function at 1 year. More than mild paravalvular leak was present in 5.7% and 7.5% of patients at 30 days and 1 year, respectively. Kaplan-Meier estimates at 30 days and 1 year were 3.6% and 13.8% for all-cause mortality, 3.6% and 9.6% for cardiovascular mortality, and 3.2% and 5.8% for major (disabling) stroke. After 30 days and ≤1 year of follow-up, adverse events included stage 3 acute kidney injury (n=3), major vascular complications (n=5), and life-threatening/disabling bleeding (n=3). Overall permanent pacemaker rate was 14.7%. At 1 year, 74.8% improved ≥1 New York Heart Association class compared with baseline ( P <0.0001)., Conclusions: The Portico TAVI system is safe and effective at 1 year, yielding low mortality and stroke rates in high-risk patients with severe AS., Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01493284., (© 2018 American Heart Association, Inc.)

In the United Kingdom, a clinical data set is completed for every patient undergoing coronary intervention and certain structural interventions, and sent to central servers in the National Institute for Cardiovascular Outcomes Research (NICOR) on behalf of the British Cardiovascular Intervention Society (BCIS). These data are linked to the national mortality register. In addition, data are obtained about the structure of healthcare provision using an annual survey. Analyses of these data are provided for different audiences in several formats. Public reports of individual consultant operator activity and risk-adjusted outcomes from percutaneous coronary intervention (PCI) have also been produced annually since 2012. Transcatheter aortic valve implantation (TAVI) has been performed since 2007. Over 2,000 cases were performed in 2015, giving a rate of 30 per million population. Complications to discharge have fallen as case mix has changed and technologies improved. While the mean age has remained about 81 years, the logistic EuroSCORE of patients treated by TAVI has fallen from about 22 in 2010 to 18 in 2015. Tracked 30-day mortality was 3.7% in 2014. Left atrial appendage occlusion and patent foramen ovale (PFO) closure for stroke, and the use of the MitraClip® system (Abbott Vascular, Santa Clara, CA, USA) for mitral regurgitation have been funded through a process called "commissioning through evaluation".

Background: While transcatheter aortic valve implantation (TAVI) is established for treating high-operative risk surgical aortic valve replacement candidates, until recently the smallest transcatheter heart valve (THV) measured 23 mm, posing greater risk for annular rupture and THV failure in patients with aortic stenosis (AS) with small aortic annuli (≤20 mm)., Objectives: In the setting of a multicentre registry, we report on the safety, efficacy and early clinical outcomes of the SAPIEN XT 20 mm balloon-expanding THV., Results: Among TAVI 55 recipients (n=30 for native AS, n=25 for a valve-in-valve procedure (V-in-V)), median age and Society of Thoracic Surgeons score were 85 (81 to 87) years and 7.8 (4.7 to 12.4)%, respectively. Mean and minimum annular diameters were 19±1 and 17±2 mm, respectively, in native patients with AS, and 17±1 mm (internal diameter) in V-in-V recipients. Successful device implantation rate was 96%, with no procedural-related death. Overall in-hospital-30-day death, stroke and major bleeding rates were 5%, 2% and 9%, respectively. In native AS TAVI recipients, mean transaortic gradient decreased from 54±20 to 12±5 mm Hg (p<0.001), and from 45±17 to 24±8 mm Hg (p<0.001) in V-in-V recipients. Severe prosthesis-patient mismatch (PPM) rates were 10% and 48% in native AS and V-in-V TAVI recipients, respectively (p=0.03). Post-TAVI, the rate of moderate aortic regurgitation was 7% and 0% in native AS and V-in-V TAVI recipients, respectively., Conclusions: TAVI with the 20 mm SAPIEN XT THV appears safe and technically feasible, with acceptable short-term clinical outcomes and low rates of severe PPM in those with native AS., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Aims: This study sought to investigate outcomes of transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 transcatheter heart valve (THV) in patients at intermediate risk for surgery. The 30-day results of the transfemoral cohort are reported., Methods and Results: The SAPIEN 3 European approval trial intermediate-risk cohort included a total of 101 patients with severe, symptomatic aortic stenosis, at intermediate risk for surgery suitable for TAVI via the transfemoral route (TF). Outcomes were adjudicated by a clinical events committee. Echocardiography, computed tomography and electrocardiography exams were analysed in core laboratories. The mean STS-PROM score and logistic EuroSCORE of the study population were 5.2±1.7 and 13.2±3.8, respectively. A completely percutaneous procedure was performed in 90.1% of patients and conscious sedation and/or local anaesthesia was utilised in 54.5%. Technical success was achieved in 98.0% of patients. At 30 days, mortality was 1.0%, with stroke in 3.0% and a new permanent pacemaker in 4.0% (4.3% of patients without pre-procedural permanent pacemaker). No patients had severe aortic regurgitation after the procedure, only one patient had moderate aortic regurgitation, and 70.8% of patients had no or trace aortic regurgitation., Conclusions: TF-TAVI using the SAPIEN 3 THV in patients at intermediate risk for surgery is associated with a very low risk of death and complications, including new pacemakers and paravalvular leaks. Although compelling, these initial results are being confirmed in larger global studies before expanding the indications for TAVI in severe aortic stenosis.

Objectives: This study sought to present the U.K. experience to date with the second-generation LOTUS bioprosthesis (Boston Scientific, Natick, Massachusetts)., Background: First-generation transcatheter aortic valves have limitations. Second-generation repositionable valves may improve on some of those limitations., Methods: Prospectively collected data relating to procedural and in-hospital outcome was analyzed from 10 implantation centers in the United Kingdom., Results: Implants in 228 patients age 81.4 ± 7.6 years were studied; 53.5% were male. Mean logistic EuroScore was 17.5 ± 12.4. One hundred eighty-seven (82.0%) were undertaken for aortic stenosis, 7 (3.1%) for aortic regurgitation, and 34 (14.9%) for mixed aortic valve disease. A total of 67.1% of cases were done under local anesthetic and/or sedation with transfemoral access in 94.7% and transaortic in 5.3%. Three device sizes were used: 23 mm (n = 66, 28.9%), 25 mm (n = 39, 17.1%), and 27 mm (n = 123, 53.9%). The valve was successfully deployed in 99.1% of procedures. After implantation, the mean aortic gradient was 11.4 ± 5.4 mm Hg and aortic valve area 1.6 ± 0.5 cm(2). In-hospital mortality was 1.8% (n = 4). Complications included cardiac tamponade (1.8%), conversion to sternotomy (1.3%), stroke (3.9%), vascular access-related (7.0%), and acute kidney injury (7.9%). The incidence of moderate/severe aortic regurgitation was 0.8% (n = 2). A total of 31.8% of patients required new permanent pacemaker implantation., Conclusions: This analysis represents the largest published series on use of the LOTUS valve. Outcomes using this valve are excellent. In-hospital mortality is very low. Complication rates are low, and the LOTUS valve improves on first-generation valves, particularly with regard to residual aortic regurgitation., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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 cm(2), 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 cm(2). 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 demonstrated excellent valve hemodynamics, no moderate or severe paravalvular regurgitation, and significant and sustained improvement in New York Heart Association functional class status, with good clinical outcomes. (Repositionable Percutaneous Placement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Evaluation of Safety and Performance [REPRISE II]; NCT01627691)., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to assess the 1-year outcome after transcatheter aortic valve replacement (TAVR) of the Direct Flow Medical (DFM) valve in patients with severe symptomatic aortic stenosis who were contraindicated or high risk for surgery., Background: The DFM transcatheter heart valve is a new-generation, nonmetallic aortic valve with a pressurized support structure and conformable double-ring annular sealing delivered through an 18-F sheath. The device allows repositioning, retrieval, and assessment of valve performance before permanent implantation., Methods: A prospective multicenter European registry was set up to determine the safety and performance of the valve in 100 consecutive patients (10 centers). Echocardiographic and angiographic data were evaluated by an independent core laboratory, and adverse events were adjudicated by a clinical events committee using Valve Academic Research Consortium criteria., Results: Patients were 83.1 ± 5.9 years of age and had a logistic EuroSCORE of 22.5 ± 11.3% and a Society of Thoracic Surgeons score of 9.7 ± 8.7%. Correct valve positioning was obtained in 99% of cases with a combined 30-day safety endpoint at 10%, including major stroke in 5.0%, major vascular complications in 2.0%, and death in 1%. At 12 months, 95% of patients were in New York Heart Association functional class I or II. Freedom from any death was 90%, and freedom from any death or major stroke was 85%. Echocardiography demonstrated none/trace to mild aortic regurgitation in 100% of patients and an unchanged mean aortic gradient of 12.2 ± 6.6 mm Hg and effective orifice area of 1.6 ± 0.4 cm(2)., Conclusions: At 1 year, the DFM transcatheter heart valve had durable hemodynamics. This study demonstrates that the low rate of early complications and the low risk of significant aortic regurgitation translated into midterm clinical benefit., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: We sought to evaluate the effects of significant coronary artery disease (CAD) upon outcome after transcatheter aortic valve implantation (TAVI)., Methods and Results: We performed a retrospective study of 271 consecutive patients undergoing TAVI using either the Edwards SAPIEN or Edwards SAPIEN XT valve. Pre-procedural coronary angiograms were analysed by quantitative coronary angiography (defining significant CAD as a stenosis of ≥70% or ≥50% if in the left main stem or a vein graft). Ninety-three out of 271 patients had significant CAD. There was no difference in mortality at 30 days or 12 months between the two groups (6.7% vs. 7.5% and 21.5% vs. 23.7%; log-rank p=0.805). A secondary analysis using the SYNTAX algorithm of coronary anatomy complexity was performed on 189 patients. Those in the high SYNTAX score (>33) group had higher mortality at 30 days and 12 months (14.3% and 57.1%) than the low (5.2% and 23.3%) and intermediate-risk groups (11.1% and 22.2%; log-rank p=0.007). ROC analysis identified a SYNTAX score of >9 at the time of TAVI as the optimal cut-off, with an independent association with mortality (HR 1.95 [95% CI: 1.21-3.13]; p=0.006). Patients with a SYNTAX score >9 had greater 30-day, 12-month and overall mortalities than those with a SYNTAX score <9 (3.7% vs. 11.3% and 20.7% vs. 34.3%; log-rank p=0.005)., Conclusions: Significant CAD, as defined using "real-world" QCA margins, did not have a significant effect upon mortality after TAVI for severe aortic stenosis. However, higher-risk SYNTAX groups, including those with a score >9, had increased mortality.

Aims: To evaluate the effects of access route upon clinical results and quality of life (QoL) in patients undergoing either transfemoral (TF-TAVI) or transapical balloon-expandable transcatheter aortic valve implantation (TA-TAVI) in the real world., Methods and Results: A prospective analysis was performed upon 264 consecutive patients receiving TF-TAVI or TA-TAVI. QoL was assessed using the EQ-5D questionnaire. At baseline, TA-TAVI patients reported significantly more problems in mobility, self-care, usual activities and lower overall health status domains (p<0.01 for all). At 30 days, the TF-TAVI group reported fewer problems with usual activity (p=0.01) and pain/discomfort (p<0.01), and higher EQ-5D index and visual analogue scale (VAS) (p=0.01 and p<0.01, respectively) than the TA-TAVI group. Nevertheless, the absolute improvements (ΔEQ-5D index and ΔEQ-5D VAS) were larger in the TA-TAVI group, with most dramatically marked QoL absolute improvements (p<0.01 and p=0.02, respectively). By one year, notwithstanding higher all-cause mortality in the sicker TA-TAVI group, there were no differences between groups in any EQ-5D domain. Indeed, surviving TA-TAVI group's greater absolute improvements remained (p<0.01)., Conclusions: QoL is greater at the earlier time point of 30 days in the TF-TAVI cohort but equatable by one year. However, the magnitude of improvement in QoL is greater in the TA-TAVI patients at both 30 days and one year.

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 endpoint, 30-day mean pressure gradient, was assessed by an independent echocardiographic core laboratory and compared with a pre-specified performance goal. The primary safety endpoint was 30-day mortality. Secondary endpoints included safety/effectiveness metrics per Valve Academic Research Consortium criteria., 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 cm(2). 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 Lotus™ Valve System - Evaluation of Safety and Performance; NCT01627691)., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: Transcatheter valve-in-valve is an accepted treatment in high-risk patients with degenerative stented bioprostheses in the aortic position. Experience in treating stentless valves is, however, limited. Our aim was to determine the feasibility and single-center outcome of balloon expandable SAPIEN valve placement in degenerated stentless aortic valve bioprostheses., Methods: From February 2010 to January 2014, 10 patients with failing stentless bioprostheses underwent transcatheter aortic valve implantation using the Edwards SAPIEN transcatheter heart valve (SAPIEN, SAPIEN XT, and SAPIEN 3) at our institution. Seven patients had valve failure due to regurgitation and three to stenosis. The mean age was 73.3 ± 15.0 years. The mean logistic EuroSCORE was 31.8 ± 20.3, and the Society of Thoracic Surgeons score was 7.6 ± 5.4., Results: Technical success was achieved in 9 of 10 patients. One patient required immediate placement of a second valve owing to low placement of the first. Two intraoperative complications developed that needed additional procedures. One patient underwent immediate repair of a right ventricular perforation from a pacing lead, the other, reexploration for epicardial bleeding. No deaths occurred. The median length of stay was 8.5 days (range, 3-44). The mean follow-up was 8.1 months (range, 1-21). No late reoperations or reinterventions were required., Conclusions: Transcatheter aortic valve implantation after previous stentless aortic valve replacement is technically demanding but a safe and feasible approach. The early results were excellent, with consistent improvement in hemodynamics. Prospective long-term follow-up in larger series is needed to evaluate this technique further., (Copyright © 2014 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Transcatheter aortic valve implantation (TAVI) has demonstrated the feasibility of treating valvular heart disease with transcatheter therapy. On the back of this success, various transcatheter concepts are being evaluated to treat other valvular disease, especially mitral regurgitation (MR). The concepts currently approved to treat MR replicate surgical mitral valve repair. However, most of them cannot eliminate MR completely. Similar to TAVI, a transcatheter mitral valve implantation may provide a valuable alternative. The FORTIS transcatheter mitral valve (Edwards Lifesciences, Irvine, CA, USA) is a self-expanding device implanted via a transapical approach. We describe our experience and early results in the first five patients treated on compassionate grounds. We also describe the details of the device, selection criteria and technical details of implantation.

Objectives: The study sought a prospective multicenter nonrandomized evaluation of the Direct Flow Medical (DFM) system for the treatment of severe aortic stenosis., Background: The DFM transcatheter aortic valve system is a nonmetallic design with a pressurized support structure that allows precise positioning, retrieval, and assessment of valve performance prior to permanent implantation., Methods: One hundred high surgical risk patients with severe aortic stenosis were evaluated for the primary endpoint. There were 75 patients in the group evaluable for the secondary endpoints and 25 in the pre-specified roll-in training phase. Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events adjudicated by clinical event committee and classified according to Valve Academic Research Consortium (VARC) criteria., Results: There was 99% freedom from all cause mortality at 30 days (primary endpoint). VARC criteria defined 30 day combined freedom from patient safety event rate was 91% and overall device success was 93%. The post-implantation echocardiography results demonstrated mild or no aortic regurgitation in 99% (73 of 74) with a mean gradient of 12.6 ± 7.1 mm Hg (n = 72) and effective orifice area of 1.50 ± 0.56 cm(2) and New York Heart Association functional class was I or II in 92% of cases., Conclusions: The present study demonstrates the safety and efficacy of the DFM system in surgical high risk patients with severe aortic stenosis and complex anatomy aortic regurgitation was less than moderate in 99% of patients., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objective: Transcatheter aortic valve implantation has been used to treat high-risk patients with bioprosthetic valve degeneration (valve-in-valve). We report our experience with transcatheter aortic valve implantation in the treatment of degenerated biologic aortic valve prostheses and discuss factors that can influence the outcome., Methods: From February 2009 to October 2011, 278 patients underwent transcatheter aortic valve implantation, of whom 23 underwent a valve-in-valve procedure with the Edwards Sapien valve to treat a failing bioprostheses in the aortic position. Eight of these valves were stentless bioprostheses. Thirteen patients had valve failure resulting predominantly from stenosis, and the remaining resulting from regurgitation., Results: Mean age was 76.9 ± 14.4 years. The mean logistic EuroSCORE was 31.8% ± 20.3% and the Society of Thoracic Surgeons score was 7.6% ± 5.4%. All patients were New York Heart Association class III or IV. The majority of the operations (21/23) were performed via the transapical route. Procedural success was 100%, although 1 patient with a degenerated homograft needed immediate placement of a second valve because of low placement of the first. The reduction in the mean gradient was 31.2 ± 17.06 mm Hg to 9.13 ± 4.9 mm Hg. In those patients with predominant aortic regurgitation (9/23), reduction in aortic regurgitation was achieved in all. The median length of stay was 11.7 days (range, 3-44 days). In-hospital and/or 30-day mortality was 0%., Conclusions: Valve-in-valve is a safe and feasible alternative to treat high-risk patients with failing aortic bioprostheses. The early results are excellent, with improvement seen in hemodynamics., (Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Objectives: To evaluate feasibility and outcome of Transoartic Transcatheter Sapien valve implantation., Background: Transcatheter Aortic valve implantation (TAVI) using the Edwards SAPIEN device (Edwards LifeScience, Irvine, CA) is usually performed via the transfemoral (TF) or transapical (TA) routes. Some patients are not suitable for these approaches. We report our experience with the novel transaortic (TAo) approach via a partial upper sternotomy and discuss the advantages and future applications., Methods: Between January 2008 to March 2011 193 patients with severe aortic stenosis underwent TAVI with the Edwards SAPIEN bioprosthesis at the St. Thomas' Hospital, London. 108 patients were unable to undergo a TF-TAVI and of those 17 were accepted for a TAo-TAVI on the basis of anatomy, risk, LV function, and significant respiratory disease., Results: The TAo-TAVI group (n = 17) had more prevalent respiratory disease than the TA-TAVI group (47.0% vs. 18.7%, P = 0.011). Otherwise the groups were similar in demographics and history. Despite this the 30 day mortalities were not significantly different between the groups (TAo-TAVI 4.3% at 30 days versus TA-TAVI 7.7%, P = 0.670). There were no significant differences in procedural complications., Conclusions: The TA-TAVI approach may not be desirable in patients with severe chest deformity, poor lung function or poor left ventricular function. TAo-TAVI via a partial sternotomy is safe and feasible in these patients., (Copyright © 2011 Wiley Periodicals, Inc.)