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Background The presence of severe calcific atherosclerotic disease at iliac artery level is a contraindication to transfemoral (TF) TAVI procedures, challenging TF delivery in 15–20% of cases. Many case reports described the efficacy of Intravascular lithotripsy (IVL) to facilitate TF access but only one prospective registry has been reported in literature and dates back 2018. For this reason a new multicenter prospective registry was ideated to confirm the role of IVL technology in facilitating TF TAVR. Aims The aims of this study were 1)to analyze the trend of TF TAVR compared to alternative approaches in the last 5 years and 2)to evaluate the prevalence of IVLassistedTAVR since it was introduced in this specific setting in 2018 3) to evaluate the success rate in terms of valve performance and procedural success of TF-TAVR system delivery after IVL lesion preparation. Materials and methods We prospectively collected data from all consecutive TAVRprocedures performed between Jan2016 andDec2020 at 4Italian and 1 Denmark centres. All patients underwent CT angiography of lower extremity before the procedure in order to assess the severity of aorto-iliac-femoral calcification and to select those patients who required specific lesion preparation to preserve TF access. For each target calcified lesion we measured length, diameter and %of stenosis, circumferential extension and minimal cross-sectional area. Angiographic IVL-related and access site complications (dissection, perforation, major bleeding) were examined. Results Between 2016 and 2020, a total of 3710 TAVR were performed, 3428 (92%) via TF route while the remaining 240 (8%) included alternative approaches mainly represented by subclavian and transapical access. IVL-assisted TAVR were 0 in 2016 and 2017, 13 (2%) in 2018 when the first IVL-assisted aortic valve implantation was performed and doubled in 2019, reaching a total of 112 in the whole 5-year period considered. The number of IVL-facilitated TAVR has been increased in the 5-year period, achieving 7% of the TF procedures while non-TF TAVR decreased considerably from 10% to 6%. Common and external iliac axis was the target lesion in the majority of cases (54%) followed by common iliac artery alone. lesion minimum diameter 4.7mm, with average stenosis of 50%. The maximum calcium angle was 332°. The majority of IVL was performed with a 7-mm catheter (78.6%). 1 balloon per lesion was employed. 1 perforation and 2 severe dissections occurred, that required stent placement. In 55% of cases the aortic regurgitation was absent or minimal. Conclusions TF approach remained the first choice for TAVR procedure in the majority of cases compared to non-TF thanks to the progressive increase of IVLassistedTAVR that allowed operators to preserve TF route. Peripheral IVL appeared feasible, safe and effective in patients with severe peripheral artery disease, with high success rate in terms of valve performance and low rate of complications. Funding Acknowledgement Type of funding sources: None.

OBJECTIVES The aim of this study was to evaluate the short-term safety and efficacy of transcatheter aortic valve replacement (TAVR) with the LOTUS Edge system. BACKGROUND The LOTUS Edge system was commercially re-released in April 2019. The authors report the first European experience with this device. METHODS A multicenter, single-arm, retrospective registry was initiated to evaluate short-term clinical outcomes. Included cases are the first experience with this device and new implantation technique in Europe. Clinical, echocardiographic, and computed tomographic data were analyzed. Endpoints were defined according to Valve Academic Research Consortium-2 and were site reported. RESULTS Between April and November 2019, 286 consecutive patients undergoing TAVR with the LOTUS Edge system at 18 European centers were included. The mean age and Society of Thoracic Surgeons score were 81.2 �� 6.9 years and 5.2 �� 5.4%, respectively. Nearly one-half of all patients (47.9%) were considered to have complex anatomy. Thirty-day major adverse events included death (2.4% [n��=��7]) and stroke (3.5% [n��=��10]). After TAVR, the mean aortic valve area was 1.9 �� 0.9��cm2, and the mean transvalvular gradient was 11.9 �� 5.7��mm��Hg. None or trace paravalvular leak (PVL) occurred in 84.4% and moderate PVL in 2.0%. There were no cases of severe PVL. New permanent pacemaker (PPM) implantation was required in 25.9% among all patients and 30.8% among PPM-naive patients. CONCLUSIONS Early experience with the LOTUS Edge system demonstrated satisfactory short-term safety and efficacy, favorable hemodynamic data, and very low rates of PVL in an anatomically complex cohort. New PPM implantation remained high. Further study will evaluate if increasing operator experience with the device and new implantation technique can reduce the incidence of PPM implantation.

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Background: Bicuspid aortic stenosis accounts for almost 50% of patients undergoing surgical aortic valve replacement in the younger patients. Expanding the indication of transcatheter aortic valve replacement (TAVR) toward lower-risk and younger populations will lead to increased use of TAVR for patients with bicuspid aortic valve (BAV) stenosis despite the exclusion of bicuspid anatomy in all pivotal clinical trials. Objectives: This study sought to evaluate the association of BAV morphology and outcomes of TAVR with the new-generation devices. Methods: Patients with BAV confirmed by central core laboratory computed tomography (CT) analysis were included from the international multicenter BAV TAVR registry. BAV morphology including the number of raphe, calcification grade in raphe, and leaflet calcium volume were assessed with CT analysis in a masked fashion. Primary outcomes were all-cause mortality at 1 and 2 years, and secondary outcomes included 30-day major endpoints and procedural complications. Results: A total of 1,034 CT-confirmed BAV patients with a mean age of 74.7 years and Society of Thoracic Surgeons score of 3.7% underwent TAVR with contemporary devices (n = 740 with Sapien 3; n = 188 with Evolut R/Pro; n = 106 with others). All-cause 30-day, 1-year, and 2-year mortality was 2.0%, 6.7%, and 12.5%, respectively. Multivariable analysis identified calcified raphe and excess leaflet calcification (defined as more than median calcium volume) as independent predictors of 2-year all-cause mortality. Both calcified raphe plus excess leaflet calcification were found in 269 patients (26.0%), and they had significantly higher 2-year all-cause mortality than those with 1 or none of these morphological features (25.7% vs. 9.5% vs. 5.9%; log-rank p < 0.001). Patients with both morphological features had higher rates of aortic root injury (p < 0.001), moderate-to-severe paravalvular regurgitation (p = 0.002), and 30-day mortality (p = 0.016). Conclusions: Outcomes of TAVR in bicuspid aortic stenosis depend on valve morphology. Calcified raphe and excess leaflet calcification were associated with increased risk of procedural complications and midterm mortality. (Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry; NCT03836521)

Transcatheter aortic valve replacement (TAVR) is an established therapy for patients with symptomatic severe aortic stenosis. Technological advances and the learning curve have resulted in better procedural results in terms of hemodynamic valve performance and intermediate-term clinical outcomes. The integration of anatomical and functional information provided by multimodality imaging has improved size selection of TAVR prostheses, permitted better patient selection, and provided new insights in the performance of the TAVR prostheses at follow-up. Furthermore, the field of TAVR continues to develop and expand the technique to younger patients with lower risk on the one hand, and more complex clinical scenarios, on the other hand, such as degenerated aortic bioprostheses, bicuspid aortic valves, or pure native aortic regurgitation. The present review article summarizes how multimodality imaging can be integrated in TAVR in clinical (sometimes complex) scenarios that have not been included in the landmark randomized clinical trials. (C) 2020 by the American College of Cardiology Foundation.

OBJECTIVES The aim of this study was to describe baseline characteristics, and periprocedural and mid-term outcomes of patients undergoing transcatheter mitral valve interventions post-transcatheter aortic valve replacement (TAVR) and examine their clinical benefit. BACKGROUND The optimal management of residual mitral regurgitation (MR) post-TAVR is challenging. METHODS This was an international registry of 23 TAVR centers. RESULTS In total, 106 of 24,178 patients (0.43%) underwent mitral interventions post-TAVR (100 staged, 6 concomitant), most commonly percutaneous edge-to-edge mitral valve repair (PMVR). The median interval post-TAVR was 164 days. Mean age was 79.5 +/- 7.2 years, MR was >moderate in 97.2%, technical success was 99.1%, and 30-day device success rate was 88.7%. There were 18 periprocedural complications (16.9%) including 4 deaths. During a median follow-up of 464 days, the cumulative risk for 3-year mortality was 29.0%. MR grade and New York Heart Association (NYHA) functional class improved dramatically; at 1 year, MR was moderate or less in 90.9% of patients (mild or less in 69.1%), and 85.9% of patients were in NYHA functional class I/II. Staged PMVR was associated with lower mortality versus medical treatment (57.5% vs. 30.8%) in a propensity-matched cohort (n = 156), but this was not statistically significant (hazard ratio: 1.75; p = 0.05). CONCLUSIONS For patients who continue to have significant MR, remain symptomatic post-TAVR, and are anatomically suitable for transcatheter interventions, these interventions are feasible, safe, and associated with significant improvement in MR grade and NYHA functional class. These results apply mainly to PMVR. A staged PMVR strategy was associated with markedly lower mortality, but this was not statistically significant. (Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter Valve Registry [AMTRAC]; NCT04031274) (C) 2020 by the American College of Cardiology Foundation.

BACKGROUND The new self-expanding, repositionable transcatheter heart valve (THV) system was designed for treatment of severe, symptomatic aortic stenosis in patients with high surgical risk. OBJECTIVES The purpose of this study was to report 1-year outcomes of transcatheter aortic valve replacement with the new THV system. METHODS This ongoing, international, multicenter study evaluated patients with severe, symptomatic aortic stenosis implanted with the THV via transfemoral access and follow-up at 30 days, 1 year, and annually through 5 years. The primary endpoint is all-cause mortality at 1 year; secondary endpoints include clinical outcomes and echocardiographic measurements, both adjudicated. RESULTS A total of 941 patients (82.4 +/- 5.9 years; 65.7% female; Society of Thoracic Surgeons Predicted Risk of Operative Mortality score: 5.8%) were enrolled and underwent an implant at 61 sites in Europe, Australia, and Canada. At 1 year, Kaplan-Meier estimates for all-cause mortality, cardiovascular mortality, disabling stroke rates, and myocardial infarction were 12.1%, 6.6%, 2.2%, and 2.5%, respectively. Mean aortic transvalvular gradient and aortic valve area were 8.66 mm Hg and 1.75 cm(2), respectively. Paravalvular leakage was moderate or higher in 2.6% of patients with no severe leakage. New pacemaker rates were 18.7% and 21.3% for pacemaker naive patients at 30 days and 1 year, respectively. Functional class, exercise capacity, and quality of life improved significantly from baseline to 1 year. CONCLUSIONS Transcatheter aortic valve replacement with the new THV in patients who are at increased surgical risk is associated with low 1-year mortality and stroke rates. Favorable hemodynamic results at 1 year are observed with low transvalvular pressure gradient and incidence of significant paravalvular leakage. (5 Year Observation of Patients With PORTICO Valves [PORTICO-I]; NCT01802788) (c) 2018 the American College of Cardiology Foundation. Published by Elsevier. All rights reserved.

Transcatheter mitral valve implantation for mitral valve regurgitation is in the very early phase of development because of challenging anatomy and device dimensions. We describe the procedure of a transfemoral-transseptal implantation of the second-generation CardiAQ mitral valve bioprosthesis and 30-day follow-up.The procedure was performed percutaneously, without any left extracorporeal circulatory support. The patient had severe mitral regurgitation with severely depressed ventricular function and other comorbidities. The patient was deemed extreme high risk for conventional cardiac surgery by a multidisciplinary team. The main procedural steps were the creation of an arteriovenous loop with an exchange nitinol wire, and the use of a customised "steerable snare system" to facilitate the catheter delivery system into the mitral annulus. Transoesophageal echocardiography and fluoroscopy were utilised for device positioning and deployment. The mitral valve prosthesis was implanted with mild mitral regurgitation. The postoperative course was uneventful and at 30-day follow-up the patient is in NYHA Class I, with good function of the mitral valve bioprosthesis.This procedure shows that percutaneous transfemoral transcatheter mitral valve implantation is feasible, safe and successful. Further experience is needed to render this procedure clinically available.