Search

Background: Transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BAV) stenosis is technically challenging and is burdened by an increased risk of paravalvular regurgitation (PVR)., Objectives: The aim of this study was to identify the incidence, predictors, and clinical outcomes of PVR after TAVR in Sievers type 1 BAV stenosis., Methods: Consecutive patients with Sievers type 1 BAV stenosis undergoing TAVR with current-generation transcatheter heart valves (THVs) in 24 international centers were enrolled. PVR was graded as none/trace, mild, moderate, and severe according to echocardiographic criteria. The endpoint of major adverse events (MAEs), defined as a composite of all-cause death, stroke, or hospitalization for heart failure, was assessed at the last available follow-up., Results: A total of 946 patients were enrolled. PVR occurred in 423 patients (44.7%)-mild, moderate, and severe in 387 (40.9%), 32 (3.4%), and 4 (0.4%) patients, respectively. Independent predictors of moderate or severe PVR were a larger virtual raphe ring perimeter (adjusted OR: 1.07; 95% CI: 1.02-1.13), severe annular or left ventricular outflow tract calcification (adjusted OR: 5.21; 95% CI: 1.45-18.77), a self-expanding valve (adjusted OR: 9.01; 95% CI: 2.09-38.86), and intentional supra-annular THV positioning (adjusted OR: 3.31; 95% CI: 1.04-10.54). At a median follow-up of 1.3 years (Q1-Q3: 0.5-2.4 years), moderate or severe PVR was associated with an increased risk of MAEs (adjusted HR: 2.52; 95% CI: 1.24-5.09)., Conclusions: After TAVR with current-generation THVs in Sievers type 1 BAV stenosis, moderate or severe PVR occurred in about 4% of cases and was associated with an increased risk of MAEs during follow-up., Competing Interests: Funding Support and Author Disclosures Dr Aurigemma has reported speaker fees from Abbott, Medtronic, Abiomed, and Terumo. Dr Trani has been involved in advisory board meetings or received speaker fees from Medtronic, Abbott, Terumo, Daiichi-Sankyo, and Abiomed. Dr Adamo has reported speaker honoraria from Abbott Vascular and Edwards Lifesciences. Dr Burzotta has been involved in advisory board meetings or has received speaker fees from Medtronic, Abbott, Terumo, Daiichi-Sankyo, and Abiomed. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Transcatheter aortic valve replacement (TAVR) has become more common than surgical aortic valve replacement since 2016, with over 200,000 procedures globally each year. As patients increasingly outlive their TAVR devices, managing these cases is a growing concern. Treatment options include surgical removal of the old TAVR device (transcatheter aortic valve [TAV] explant) or implantation of a new transcatheter aortic valve (redo TAV). Redo TAV is complex because of the unique designs of TAV devices; compatibility issues; and the need for individualized planning based on factors such as implant depth, shape, and coronary artery relationships. This review serves as a comprehensive guide for redo TAV, detailing the design characteristics of TAV devices, device compatibility, standardized terminology, and a structured approach for computed tomography analysis. It aims to facilitate decision making, risk identification, and achieving optimal outcomes in redo TAV procedures., Competing Interests: Funding Support and Author Disclosures Dr Bapat has served as a consultant for Medtronic, Edwards Lifesciences, Abbott, Anteris, Meril Lifesciences, and Boston Scientific. Dr Jilaihawi has received institutional research grants and consulting fees from Abbott Vascular, Edwards Lifesciences, and Medtronic Inc; and has received institutional research grants from Boston Scientific and Pi-Cardia. Dr Rogers is a consultant for Edwards Lifesciences, Medtronic, Boston Scientific, and Transmural Systems; serves on advisory boards for Medtronic and Boston Scientific; holds an equity interest in Transmural Systems; and is a coinventor on patents, assigned to National Institutes of Health, for transcatheter electrosurgery devices. Dr Khalique is a consultant for Edwards Lifesciences, Restore Medical, Croivalve, Heartflow, and Vdyne; and holds equity in Triflo. Dr Cavalcante is a consultant for 3Mensio, 4C Medical, Abbott Structural, Anteris, Boston Scientific, Edwards Lifesciences, JenaValve, Medtronic, and Siemens Healthineers. Dr Landes has received consulting fees from Edwards Lifesciences. Dr Sathananthan has received speaker fees from Edwards Lifesciences, Medtronic, NVT Medical, and Boston Scientific; is a consultant for Edwards Lifesciences, Boston Scientific, Medtronic, and Anteris; and serves as chief medical officer for structural division of Boston Scientific. Dr Tarantini has received lecture fees from Medtronic, Edwards Lifesciences, Abbott, and Boston Scientifics. Dr Tang has received speaker honoraria and has served as a physician proctor, consultant, advisory board member, TAVR publications committee member, APOLLO trial screening committee member, and IMPACT MR steering committee member for Medtronic; has received speaker honoraria and has served as a physician proctor, consultant, advisory board member, and TRILUMINATE trial anatomic eligibility and publications committee member for Abbott Structural Heart; has served as an advisory board member for Boston Scientific and JenaValve, a consultant and physician screening committee member for Shockwave Medical, a consultant for NeoChord, Peija Medical, and Shenqi Medical Technology; and has received speaker honoraria from Siemens Healthineers. Dr Blackman is a consultant, proctor, and advisory board member for Medtronic and Abbott Vascular; and has received institutional research grants from Medtronic. Dr De Backer has received institutional research grants and consulting fees from Abbott and Boston Scientific. Dr Mack served as co–primary investigator for the PARTNER trial for Edwards Lifesciences and the COAPT trial for Abbott; and has served as study chair for the APOLLO trial for Medtronic. Dr Leon has received institutional grants for clinical research from Abbott, Boston Scientific, Edwards Lifesciences, JenaValve, and Medtronic; and has received stock options (equity) for advisory board participation in Valve Medical, Picardia, and Venus MedTech. 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: The SAPIEN 3 (S3) addresses several limitations of the SAPIEN XT (SXT) for the performance of transfemoral (TF-) balloon expandable transcatheter aortic valve implantation (TAVI)., Objectives: We aimed to determine whether their altered features translate into improved outcomes in a real-world TF-TAVI patient population., Methods: Data for 3,314 patients were extracted from the European registries SOURCE-XT and SOURCE-3. Patients were propensity-score (PS) matched (n = 1,169/group)., Results: In the PS matched comparison, device success was higher in the S3 (99.2%) compared to the SXT group (98.2%; p = .04). S3 patients experienced a lower rate of procedural death (0.7 vs. 2.6%; p = .0004), moderate/severe paravalvular leakage (PVL; 1.4 vs. 5.5%; p < .0001), and procedure-related stroke (1.2 vs. 2.4%; p = .04) while higher rates of mean aortic valve gradients ≥20 mmHg, and new permanent pacemaker implantations were seen. At 30 days a lower rate of all-cause mortality was seen (2.1% vs. 4.3%; p = .003), which was preserved after 1 year (10.7% vs. 14.9%; p = .002). A Cox regression predicting 1-year mortality resulted in a hazard ratio of 0.684 in favor of S3 (p = .0026). The same was true of stroke (2.8% vs. 5.7%; p = .0007), and moderate/severe PVL (2.7 vs. 7.3%; p = .0002) at 1 year. The rate of new pacemaker implantations (13.6% vs. 9.5%; p = .001) and NYHA III/IV (12.8 vs. 8.6%; p = .004) was higher with the S3., Conclusions: The improved features of the S3 appear to translate into improved survival and reduced rates of adverse complications, with the exception of a higher rate of new pacemaker implantations., (© 2019 Wiley Periodicals LLC.)

Background Transcatheter aortic valve replacement (TAVR)-in-TAVR is a possible treatment for transcatheter heart valve (THV) degeneration. However, the displaced leaflets of the first THV will create a risk plane (RP) under which the passage of a coronary catheter will be impossible. The aim of our study was to evaluate the potential risk of impaired coronary access (CA) after TAVR-in-TAVR. Methods and Results We prospectively performed coronary angiography after TAVR with different THVs in 137 consecutive patients, looking where the catheter crossed the valve frame. If coronary cannulation was achieved from below the RP, the distance between valve frame and aortic wall was measured by aortic angiography. CA after TAVR-in-TAVR was defined as feasible if the catheter passed above the RP, as theoretically feasible if passed under the RP with valve-to-aorta distance >2 mm, and as unfeasible if passed under the RP with valve-to-aorta distance ≤2 mm. Seventy-two patients (53%) received a Sapien 3 THV, 26 (19%) received an Evolut Pro/R THV, and 39 (28%) received an Acurate Neo THV. CA after TAVR-in-TAVR was considered feasible in 40.9% (68.1%, 19.2%, and 5.1%, respectively; P <0.001), theoretically feasible in 27.7% (8.3%, 42.3%, and 53.8%, respectively; P <0.001), and unfeasible in 31.4% (23.6%, 38.5%, and 41.1%, respectively; P =0.116). Independent predictors of impaired CA after TAVR-in-TAVR were female sex (odds ratio [OR], 3.99; 95% CI, 1.07-14.86; P =0.040), sinotubular junction diameter (OR, 0.62; 95% CI, 0.48-0.80; P <0.001), and implantation of a supra-annular THV (OR, 6.61; 95% CI, 1.98-22.03; P =0.002). Conclusions CA after TAVR-in-TAVR might be unfeasible in >30% of patients currently treated with TAVR. Patients with a small sinotubular junction and those who received a supra-annular THV are at highest risk of potential CA impairment with TAVR-in-TAVR.

Background: Large data comparing the performance of new-generation self-expandable versus balloon-expandable transcatheter heart valves in bicuspid aortic stenosis are lacking. We aim to compare the safety and performance of balloon-expandable and self-expandable transcatheter heart valves in the treatment of bicuspid aortic stenosis., Methods: The BEAT (balloon versus self-expandable valve for the treatment of bicuspid aortic valve stenosis) registry included 353 consecutive patients who underwent transcatheter aortic valve implantation using new-generation Evolut R/PRO or Sapien 3 valves in bicuspid aortic valve., Results: A total of 353 patients (n=242 [68.6%] treated with Sapien 3 and n=111 [68.6%] treated with Evolut R (n=70)/PRO [n=41]) were included. Mean age was 77.8±8.3 years and mean Society of Thoracic Surgeons Predicted Risk of Mortality was 4.4±3.3%. Valve Academic Research Consortium-2 device success was similar between Sapien 3 and Evolut R/PRO (85.6% versus 87.2%; P =0.68). In the Sapien 3 group, 4 patients experienced annular rupture whereas this complication did not occur in the Evolut R/PRO group. After propensity score matching, Valve Academic Research Consortium-2 device success was similar between both groups (Sapien 3=85.7% versus Evolut R/Pro=84.4%; P =0.821). Both in the overall and in the matched population, no differences in the rate of permanent pacemaker implant were observed. At 1-year follow-up, the rate of overall death and cardiovascular death were similar between the 2 groups. In the unmatched population, the 1-year echocardiographic follow-up demonstrated similar rate of moderate-to-severe paravalvular aortic regurgitation (Evolut R/PRO 10.5% versus Sapien 3 4.2%, P =0.077); however, after propensity matching, the rate of moderate-to-severe paravalvular leak became significantly higher among patients treated with self-expandable valves (9.3% versus 0%; P =0.043)., Conclusions: Our study confirms the feasibility of both Sapien 3 and Evolut R/PRO implantation in bicuspid aortic valve anatomy; a higher rate of moderate-severe paravalvular aortic regurgitation was observed in the Evolut R/PRO group at 1-year follow-up in the matched cohort, although patients treated with balloon-expandable valve had a higher rate of annular rupture.

Background: Coronary artery disease and aortic stenosis often coexist. Transcatheter aortic valve implantation (TAVI) has emerged as a valid therapeutic option for younger, lower-risk patients who may eventually require coronary artery disease treatment. Thus, post-TAVI coronary access (CA) and percutaneous coronary intervention are expected to increase. The purpose of this study was to retrospectively evaluate patients who were enrolled in the SOURCE 3 (SAPIEN 3 Aortic Bioprosthesis European Outcome) European registry for treatment with the balloon-expandable SAPIEN 3 transcatheter heart valve and underwent CA with or without percutaneous coronary intervention after TAVI., Methods: Baseline characteristics and clinical outcomes of patients with or without CA up to 3 years after TAVI were compared. A Kaplan-Meier estimate with a univariate model determined the impact of CA on cardiac mortality., Results: Of 1936 TAVI patients (mean age 81.6 years, 52% male), 68 (3.5%) had CA within 3 years (mean 441±332 days) after TAVI. At baseline, the logistic EuroSCORE was similar (20.2% versus 18.3%, P =0.2, CA and non-CA groups, respectively). Higher rates of coronary artery disease (76.5% versus 50.6%, P <0.001), myocardial infarction (20.6% versus 11.5%, P =0.03) and previous coronary artery bypass graft (22.1% versus 11.0%, P =0.01) were present in the CA group. In 100% of patients, CA was successfully achieved. The clinical success of percutaneous coronary intervention was 97.9%. Cardiovascular mortality was numerically higher in patients with CA than in those without CA., Conclusions: In the large SOURCE 3 European registry, CA was needed at 3-year follow-up after TAVI with a balloon-expandable valve in 3.5% of patients and was successful in all patients. The clinical success of percutaneous coronary intervention was 97.9%. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02698956.

Objectives: We aimed to analyze the baseline features and clinical outcomes of patients younger than 80 years undergoing transfemoral transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) enrolled in the OBservational Study of Effectiveness of SAVR-TAVR procedures for severe Aortic steNosis Treatment (OBSERVANT) real-world study, focusing on variables guiding Heart Team decision toward TAVI., Background: Patients treated with TAVI, independently of surgical risk score, are mostly older than 80 years., Methods: OBSERVANT is a multicenter, observational, prospective cohort study that enrolled patients with symptomatic severe aortic stenosis (AS) who underwent SAVR or TAVI from December 2010 to June 2012 in 93 Italian participating hospitals. For this analysis, baseline characteristics, therapeutic approach and outcomes up to 5 years of follow-up of 4,801 patients under 80 years of age were collected. Patients were stratified by age classes (<65, 65-74, and 75-79 years)., Results: Patients <80 years of age with severe symptomatic AS undergoing TAVI (n = 483) had significantly higher Logistic EuroSCORE (10.84% vs. 5.22%, p < .001) and prevalence of comorbidities compared to subjects undergoing SAVR (n = 4,318). The decision to perform TAVI over SAVR was driven by anatomical factors, mainly previous cardiac surgery (odds ratio [OR] 24.73, confidence interval [CI] 12.71-48.10, p < .001) and the presence of porcelain aorta (OR 17.44, CI 6.67-45.55, p < .001), and clinical factors, mainly moderate-severe frailty score (OR 5.49, CI 3.33-9.07, p < .001), oxygen dependency (OR 7.42, CI 2.75-20.04, p < .001) and need for dialytic treatment (OR 5.24, CI 1.54-17.80, p < .008). Among patients undergoing TAVI, those under 65 years had the highest baseline risk profile (despite a low Logistic EuroSCORE) and the highest 5-year mortality compared to those 65-74 and 75-79-year-old (65.22% vs. 48.54% vs. 55.24%, log-rank p = .061)., Conclusion: Among patients under 80 years of age with symptomatic severe AS, only 10% underwent TAVI. These patients were at higher baseline risk compared to those undergoing SAVR. The decision to perform TAVI was driven by the presence of both anatomical and clinical factors beyond surgical risk scores. Patients under 65 years of age, despite the low Logistic EuroSCORE, had the highest preoperative risk profile and carried the worse outcome., (© 2019 Wiley Periodicals, Inc.)

Background: Peripheral arterial disease (PAD) plays a decisive role in the preinterventional selection process of the optimal vascular access site in patients undergoing transcatheter aortic valve implantation (TAVI). However, the impact of PAD on mortality and vascular complications (VCs) in TAVI-treated patients remains unclear. Accordingly, we aimed to assess the outcomes of patients with and without PAD undergoing TAVI, by performing a meta-regression analysis., Methods: Studies published between January 2002 and March 2018 and reporting outcomes according to the presence of PAD in TAVI patients were identified. Outcome measures analyzed were short-, mid- and long-term mortality, and peri-procedural VC. The interaction between sheath size and PAD on outcomes was also assessed., Results: A total of 26 studies (68,581 TAVI patients, of whom 17,326 with preprocedural PAD) were included in the analysis. Patients with PAD had higher risk of mortality at short- (HR 1.36, 95% confidence interval [CI] 1.13-1.63, p = .0009), mid- (HR 1.18, 95% CI 1.08-1.30, p = .0005), and long-term (HR 1.36, 95% CI 1.24-1.48, p < .0001) follow-up, and higher risk of VC (RR 1.55, 95% CI 1.27; 1.89, p < .0001). Moreover, the adoption of smaller sheaths during TAVI procedures was associated with fewer VC both in PAD and non-PAD patients, but the latter group had a more pronounced benefit., Conclusions: Patients with pre-existent PAD are at increased risk of all-cause mortality and VC after TAVI. The adoption of smaller sheaths during the procedure seems to be associated with fewer peri-procedural VC both in PAD and non-PAD patients., (© 2019 Wiley Periodicals, Inc.)

Objectives: The aim of this study was to investigate the safety and efficacy of coronary protection by preventive coronary wiring and stenting across the coronary ostia in patients at high risk for coronary obstruction after transcatheter aortic valve replacement (TAVR)., Background: Coronary obstruction following TAVR is a life-threatening complication with high procedural and short-term mortality., Methods: Data were collected retrospectively from a multicenter international registry between April 2011 and February 2019., Results: Among 236 patients undergoing coronary protection with preventive coronary wiring, 143 had eventually stents implanted across the coronary ostia after valve deployment. At 3-year follow-up, rates of cardiac death were 7.8% in patients receiving stents and 15.7% in those not receiving stents (adjusted hazard ratio: 0.42; 95% confidence interval: 0.14 to 1.28; p = 0.13). There were 2 definite stent thromboses (0.9%) in patients receiving stents, both occurring after TAVR in "valve-in-valve" procedures. In patients not receiving stents, there were 4 delayed coronary occlusions (DCOs) (4.3%), occurring from 5 min to 6 h after wire removal. Three cases occurred in valve-in-valve procedures and 1 in a native aortic valve procedure. Distance between the virtual transcatheter valve and the protected coronary ostia <4 mm was present in 75.0% of patients with DCO compared with 30.4% of patients without DCO (p = 0.19)., Conclusions: In patients undergoing TAVR at high risk for coronary obstruction, preventive stent implantation across the coronary ostia is associated with good mid-term survival rates and low rates of stent thrombosis. Patients undergoing coronary protection with wire only have a considerable risk for DCO., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: The aim of this study was to evaluate 30-day safety and efficacy outcomes of transcatheter aortic valve implantation (TAVI) performed with the SAPIEN 3 Ultra system., Methods and Results: The S3U registry is a physician-led, post-approval, multicentre, observational registry of transfemoral TAVI with the SAPIEN 3 Ultra. New features include an improved sealing skirt, a 14 Fr expandable sheath and a new delivery catheter. Overall, 139 consecutive patients at nine participating centres were enrolled. Mean age was 81.4±8.3 years, average STS score 3.8±2.4%. The vast majority (97.2%) underwent TAVI with local anaesthesia (28.8%) or conscious sedation (68.3%). Balloon predilatation was performed in 30 patients (21.6%), post-dilatation in three (2.2%). In-hospital, there were no cases of death, stroke, or conversion to open heart surgery. Major vascular complications occurred in three patients (2.2%), as well as major or life-threatening bleedings in three patients (2.2%). There were two moderate (1.4%) and no moderate/severe paravalvular leaks. Median length of stay after TAVI was three days (IQR 3-5 days). At 30 days, there were no deaths, MI, or strokes, and the incidence of new permanent pacemaker implantation was 4.4%., Conclusions: This first multicentre international experience of transfemoral TAVI with the SAPIEN 3 Ultra transcatheter heart valve shows good in-hospital and 30-day clinical outcomes.

Background: Early hypo-attenuated leaflet thickening after transcatheter aortic valve implantation (TAVI) has been recently described presumably reflecting thrombus apposition. Although its clinical relevance is still unknown, oral anticoagulant therapy (OAT) led to almost complete resolution., Methods: The retrospecitve Italian Transcatheter balloon-Expandable valve registry that included all patients undergoing balloon-expandable TAVI in 33 Italian centers. Patients discharged after TAVI with aspirin alone were compared with those assuming aspirin and OAT before and after propensity score with matching. Prosthetic heart valve dysfunction at follow-up was the primary end point. All-cause death, cardiovascular death, bleeding, vascular complications and cerebrovascular accidents at 30 days and at follow-up were the secondary ones., Results: Among the 1904 patients enrolled in the Italian Transcatheter balloon-Expandable valve registry, 716 patients on OAT and aspirin or aspirin alone were identified and analyzed: 555 were on aspirin alone and 161 on OAT and aspirin. The median follow-up was 44.0 ± 12 months. After matching, risk of prosthetic valve dysfunction at follow-up did not differ between the two groups: 3.1% in patients treated with aspirin alone vs. 1.9% in those treated with OAT and aspirin, (P = 0.72). Nevertheless patients treated with aspirin alone at follow-up had a significantly lower risk of death (21 vs. 33%, P = 0.03) and major bleeding (4 vs. 14%, P = 0.04) with a similar rate of stroke/transient ischemic attack (TIA) (1.2 vs. 3.1%, P = 0.45). At 30 days rates of Valve Academic Research Consortium death were similar in both groups (0.6 vs. 3.7%, P = 0.12) with higher risk of life threatening bleeding and minor vascular complications in patients on OAT and aspirin., Conclusion: After TAVI with Edwards Sapien valve OAT did not reduce the incidence of valve dysfunction and stroke but was responsible for mortality and bleeding increases.

Background: Subjects with bicuspid aortic valve (BAV) have been excluded from transcatheter aortic valve replacement (TAVR) randomized trials., Methods: With this meta-analysis of observational studies we first compared TAVR outcomes of BAV vs. tricuspid aortic valve (TAV) patients, stratifying the results by device generation. Then, we looked for differences between balloon-expandable (BE) and self-expandable (SE) bioprostheses in BAV patients. Primary outcome was 30-day mortality. Secondary outcomes were 30-day stroke, moderate-severe paravalvular leakage, new pacemaker implantation, vascular complications and 1-year mortality., Results: Thirteen studies (11,032 patients, 7291 TAV and 3741 BAV) and seven studies (706 patients, 367 treated with BE, 339 with SE valve) met inclusion criteria. Thirty-day (OR = 1.13; 95% CI 0.88-1.46, p = 0.33) and 1-year mortality (OR = 1.02; 95% CI 0.77-1.37, p = 0.87) were similar between patients receiving TAVR for BAV or TAV. Subjects treated for BAV were at higher risk of conversion to conventional surgery (OR = 2.35; 95% CI 1.30-4.23, p = 0.005), implantation of a second valve (OR = 2.06; 95% CI 1.31-3.25; p = 0.002), moderate/severe paravalvular leakage (PVL) (OR = 1.67; 95% CI 1.29-2.17; p = 0.0001) and device failure (OR = 1.26; 95% CI 1.02-1.56; p = 0.04). Rates of adverse events decreased significantly with the use of new-generation devices, but outcome differences remained consistent. BAV patients treated with BE vs. SE valves had similar 30-day and 1-year mortality, stroke and moderate-severe PVL. Balloon-expandable valves were associated with lower rates of a second valve and new pacemaker implantation but carried higher risk of annular rupture., Conclusions: BAV patients treated with TAVR had similar 30-day and 1-year mortality as well as stroke and new pacemaker implantation rates compared to TAV subjects, but carried higher risk of moderate/severe PVL, conversion to surgery and device failure. Event rates significantly decreased with the use of new-generation devices, but TAVR still showed better procedural results in TAV compared to BAV., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Background: Transfemoral aortic valve replacement (TAVR) is a guideline-recommended treatment option for patients with severe aortic valve stenosis. Women and men present with different baseline characteristics, which may influence procedural outcomes., Objectives: This study sought to evaluate differences between women and men undergoing transfemoral TAVR across the globe during the last decade., Methods: The CENTER (Cerebrovascular EveNts in patients undergoing TranscathetER aortic valve implantation with balloon-expandable valves versus self-expandable valves)-collaboration was a global patient level dataset of patients undergoing transfemoral TAVR (N = 12,381) from 2007 to 2018. In this retrospective analysis, the study examined differences in baseline patient characteristics, 30-day stroke and mortality, and in-hospital outcomes between female and male patients. The study also assessed for temporal changes in outcomes and predictors for mortality per sex., Results: We included 58% (n = 7,120) female and 42% (n = 5,261) male patients. Women had higher prevalence of hypertension and glomerular filtration rate <30 ml/min/1.73 m 2 but lower prevalence of all other traditional cardiovascular comorbidities. Both sexes had similar rates of 30-day stroke (2.3% vs. 2.5%; p = 0.53) and mortality (5.9% vs. 5.5%; p = 0.17). In contrast, women had a 50% higher risk of life-threatening or major bleeding (6.7% vs. 4.4%; p < 0.01). Over the study period, mortality rates decreased to a greater extent in men than in women (60% vs. 50% reduction; both p < 0.001), with no reductions in stroke rates over time., Conclusions: In this global collaboration, women and men had similar rates of 30-day mortality and stroke. However, women had higher rates of procedural life-threatening or major bleeding after TAVR. Between 2007 and 2018, mortality rates decreased to a greater extent in men than in women., (Copyright © 2019. Published by Elsevier Inc.)

Objectives: The aim of this study was to explore the time course of survival advantage of TAVR over SAVR as function of the patients' risk and sex., Background: Women have been reported to have better survival than men undergoing transcatheter aortic valve replacement (TAVR). However, scant data on the sex-based survival benefit of TAVR over surgical aortic valve replacement (SAVR) are available., Methods: A systematic review of studies reporting clinical outcomes of men and women undergoing TAVR or SAVR was performed. Studies were divided into two groups according to average patient's risk score and the interplay of surgical risk and sex on outcomes were analyzed., Results: Eight studies involving 6,596 women and 7,204 men patients were extracted. Unlike mens, women patients had survival advantage from TAVR over SAVR that became substantial at 1 year from index procedure and persisted at 2-year of follow-up. Moreover, this sex-based TAVR survival advantage was mainly observed in higher surgical risk patients. Men showed a significantly lower rate of residual paravalvular leak after SAVR., Conclusions: Women patients had a selective mortality benefit from TAVR compared to SAVR. This sex-based TAVR benefit was mainly observed in high surgical risk patients beyond 1 year from procedure., (© 2019 Wiley Periodicals, Inc.)

Acute aortic root thrombosis extended to coronary ostia is a rare but potentially life-threatening complication of aortic valve replacement with bioprosthetic substitutes. We aimed to present the case of a 72-year-old woman with symptomatic rheumatic valve disease and associated atrial fibrillation who underwent conventional mitroaortic valve replacement with two stented bioprostheses (pericardial and porcine, respectively). Eight days after surgery, she had cardiac arrest due to ventricular fibrillation, requiring immediate cardiopulmonary resuscitation. Left ventricle akinesia by echocardiography and troponin levels up to 35,000 ng/L pointed to coronary ischemia. Emergent coronary angiography showed a subocclusion of the left main trunk, with the suspicion of aortic root thrombosis. The patient was immediately reoperated, fresh thrombi were removed from the aortic root, and the aortic Magna Ease 21-mm bioprosthesis was replaced with a stentless Solo Smart 21-mm bioprosthesis. The patient died of septic complications., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Transcatheter aortic valve replacement (TAVR) has been recognized as a well-established alternative to surgical aortic valve replacement (SAVR) for symptomatic aortic stenosis with high surgical risk. With this updated systematic review and meta-analysis, we evaluated TAVR vs. SAVR in low- and intermediate-risk subjects. Studies comparing TAVR and SAVR in low-risk patients (defined as STS ≤ 8% or EuroSCORE ≤ 20%) were identified with electronic searches. The principal endpoint was all-cause mortality at short term (< 3 months), 1, and 2 years. Other outcomes of interest were cardiac mortality, neurological events, paravalvular leakage (PVL), myocardial infarction (MI), major bleeding, acute kidney injury (AKI), vascular complications, and new pacemaker (PM) implantation. Seventeen articles including 9805 (4956 TAVR and 4849 SAVR) patients were eligible. There was no significant difference in all-cause mortality at short term [odds ratio (OR) 0.83, 95% confidence interval (CI) 0.63-1.09], 1 year (OR 1.01, 95% CI 0.86-1.20) and 2 years (OR 0.86, 95% CI 0.64-1.16) between treatment groups. Subgroup analyses stratified by surgical risk score (low-risk subgroup: STS < 4% or EuroSCORE < 10%, intermediate-risk subgroup: the others) did not show interaction on primary endpoints. Compared to SAVR, TAVR had similar rates of neurological events, significantly lower risk of MI and AKI, but higher risk of vascular complications, new PM implantation and moderate/severe PVL. In low- and intermediate-risk patients, TAVR and SAVR have similar short- and mid-term all-cause mortality. Compared to SAVR, TAVR carries higher rates of vascular complications, PM implantation and moderate/severe PVL, but lower risk of MI and AKI.

Objectives: This study aimed to compare differences in patient characteristics and clinical outcomes of nonagenarians undergoing transcatheter aortic valve replacement (TAVR) versus patients younger than 90 years of age and to test the predictive accuracy of the logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation), the EuroSCORE II, and the STS-PROM (Society of Thoracic Surgeons Predicted Risk of Mortality) for mortality after TAVR in nonagenarians., Background: The prevalence of severe aortic valve stenosis is increasing due to the rising life expectancy. However, there are limited data evaluating outcomes in patients older than 90 years of age. Moreover, the predictive accuracy of risk scores for mortality has not been evaluated in nonagenarian patients undergoing transfemoral TAVR., Methods: The CENTER (Cerebrovascular EveNts in Patients Undergoing TranscathetER Aortic Valve Implantation) collaboration (N = 12,381) is an international collaboration consisting of 3 national registries, 6 local or multicenter registries, and 1 prospective clinical study, selected through a systematic online search. The primary endpoint of this study was the difference in 30-day all-cause mortality and stroke after TAVR in nonagenarians versus patients younger than 90 years of age. Secondary endpoints included differences in baseline characteristics, in-hospital outcomes, and the differences in predictive accuracy of the logistic EuroSCORE, the EuroSCORE II, and STS-PROM., Results: A total of 882 nonagenarians and 11,499 patients younger than 90 years of age undergoing transfemoral TAVR between 2007 and 2018 were included. Nonagenarians had considerably fewer comorbidities than their counterparts. Nevertheless, rates of 30-day mortality (9.9% vs. 5.4%; relative risk [RR]: 1.8; 95% confidence interval [CI]: 1.4 to 2.3; p = 0.001), in-hospital stroke (3.0% vs. 1.9%; RR: 1.5; 95% CI: 1.0 to 2.3; p = 0.04), major or life-threatening bleeding (8.1% vs. 5.5%; RR: 1.6; 95% CI: 1.1 to 2.2; p = 0.004), and new-onset atrial fibrillation (7.9% vs. 5.2%; RR: 1.6; 95% CI: 1.1 to 2.2; p = 0.01) were higher in nonagenarians. The STS-PROM adequately estimated mortality in nonagenarians, with an observed-expected mortality ratio of 1.0., Conclusions: In this large, global, patient-level analysis, mortality after transfemoral TAVR was 2-fold higher in nonagenarians compared with patients younger than 90 years of age, despite the lower prevalence of baseline comorbidities. Moreover, nonagenarians had a higher risk of in-hospital stroke, major or life-threatening bleeding, and new-onset atrial fibrillation. The STS-PROM was the only surgical risk score that accurately predicted the risk of mortality in nonagenarians., (Copyright © 2019 American College of Cardiology Foundation. All rights reserved.)

Background: Stroke remains one of the most devastating complications of transcatheter aortic valve implantation (TAVI). The aim of this study was to identify the incidence, timing, temporal trends, and predictors of stroke after TAVI and evaluate the outcomes of patients with stroke., Methods and Results: The CENTER-Collaboration is an international collaboration consisting of 3 national registries and 7 local registries or prospective clinical trials, selected through a systematic review. Accordingly, a total of 10 982 patients undergoing transfemoral TAVI between 2007 and 2018 were included in the current patient-level pooled analyses. A total of 261 patients (2.4%) experienced stroke during the first month after TAVI. The median time between TAVI and stroke was 1 day (interquartile range, 0-6 days). The stroke rate was comparable in procedures performed in the early years of TAVI (2007-2012) to those in the more recent years of TAVI (2013-2018; both 2.4%; P=1.0). Independent predictors of stroke at 30 days were a history of cerebrovascular events (odds ratio, 2.2; 95% CI, 1.4-3.6; P=0.0012) and a glomerular filtration rate of <30 mL/min per 1.73 m 2 (odds ratio, 1.7; 95% CI, 1.0-2.8; P=0.05). Stroke occurring within the first 30 days after TAVI was associated with a 6-fold increase of 30-day mortality (odds ratio, 6.0; 95% CI, 4.4-8.1; P<0.001). Moreover, patients with stroke more frequently had documented new-onset atrial fibrillation (16% versus 3%; P<0.001) and major or life-threatening bleedings (12% versus 7%; P=0.002) at 30-day follow-up., Conclusions: In this large, global, patient-level analysis, the incidence of stroke after transfemoral TAVI was 2.4%. Prior cerebrovascular events and a low glomerular filtration rate independently predicted the occurrence of stroke after TAVI. The occurrence of stroke after TAVI was associated with a strikingly 6-fold increase of 30-day mortality; additionally, there was a 5-fold higher rate of new-onset atrial fibrillation in patients with stroke., Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03588247.

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: New-generation transcatheter heart valves have been developed to reduce complications of transcatheter aortic valve implantation (TAVI). With this study we sought to compare procedural and 30-day outcomes of the new-generation repositionable Boston Scientific Lotus (Lotus) and the balloon-expandable Edwards Sapien 3 (ES3) transcatheter heart valves., Methods: A total of 315 patients with severe symptomatic aortic stenosis undergoing transfemoral TAVI with Lotus or ES3 included in two large Italian registries were considered for this analysis. After propensity matching, 93 matched pairs of patients were included. Outcomes were evaluated according to Valve Academic Research Consortium-2 definition at discharge and 30 days., Results: There were no differences in baseline characteristics, except for lower mean aortic gradient and larger mean aortic annulus in the ES3-treated patients. Valve Academic Research Consortium-2 defined device success was high and comparable between groups (97.8 for Lotus vs. 98.9% for ES3, P = 0.09). The frequency of moderate/severe paravalvular leak was low and similar for both devices (2.2 vs. 1.1%, P = 0.10). At 30 days, both groups showed low all-cause mortality (5.4 vs. 1.1%, P = 0.10) and rates of disabling stroke (3.2 vs. 1.1%, P = 0.31). New pacemaker implantation was more common after Lotus deployment (31.7 vs. 10.5%, P < 0.001)., Conclusion: Transfemoral TAVI with both Lotus and ES3 resulted in favorable clinical and hemodynamic procedural and 30-day outcomes. Rates of significant paravalvular leak were low with both devices. The Lotus valve was associated with higher risk of pacemaker implantation.

Background: Previous implantation of a permanent pacemaker (PPM) is common among patients undergoing transcatheter aortic valve implantation (TAVI). Moreover, onset of conduction disturbances needing new PPM implantation after TAVI is frequent. The interplay of pre-existing and new-PPM on mortality after TAVI remains controversial., Methods: We performed a systematic review and study-level meta-analysis on the influence of PPM on mortality after TAVI. Patients were divided into 3 groups: pre-existing PPM, new-PPM (implantation within 30 days after TAVI) and no-PPM (without PPM up to 30 days after TAVI). Outcomes were compared using pairwise and network meta-analysis., Results: A total of 28 studies including 40,016 subjects were eligible. Patients of the no-PPM group had a lower mortality outcome compared to the rest of the study population (relative risk [RR] 0.76, 95% confidence interval [CI] 0.68-0.85, P < 0.0001) at median follow up of 16.3 months. In particular, patients with a pre-existing PPM (RR 1.43, 95% CI 1.26-1.62, P < 0.0001), but not those with a newly implanted PPM (RR 1.08, 95% CI 0.99-1.18, P = 0.10), had a significantly higher mortality compared to patients of the no-PPM group. Moreover, meta-regression analysis showed that the transapical approach rate had a detrimental interaction with pre-existing PPM on mortality (P = 0.03)., Conclusion: Compared to patients without PPM, those with a pre-existing PPM before TAVI had higher mortality, in particular if treated by the transapical approach. New-PPM implantation did not have a negative relation on mid-term outcome., (© 2018 Wiley Periodicals, Inc.)

We aimed to investigate whether the expression of the OPG/RANK/RANKL triad in peripheral blood mononuclear cells (PBMC) and circulating levels of markers of ectopic mineralization (OPG, FGF-23, PPi) are modified in patients with calcific aortic valve disease (CAVD). We found that patients affected by CAVD (n = 50) had significantly higher circulating levels of OPG as compared to control individuals (p = 0.003). No differences between the two groups were found in FGF-23 and PPi levels. RANKL expression was higher in the PBMC from CAVD patients (p = 0.018) and was directly correlated with the amount of valve calcification (p = 0.032). In vitro studies showed that treatment of valve interstitial cells (VIC) with RANKL plus phosphate was followed by increase in matrix mineralization (p = 0.001). In conclusion, RANKL expression is increased in PBMC of patients with CAVD, is directly correlated with the degree of valve calcification, and promotes pro-calcific differentiation of VIC.

: The introduction of percutaneous treatment of severe aortic stenosis with transcatheter aortic valve implantation (TAVI) remains one of the greatest achievements of interventional cardiology. In fact, TAVI emerged as a better option than either medical therapy or balloon aortic valvuloplasty for patients who cannot undergo surgical aortic valve replacement (SAVR) or are at high surgical risk. Recently, increased operator experience and improved device systems have led to a worldwide trend toward the extension of TAVI to low-risk or intermediate-risk patients. In this expert opinion paper, we first discuss the basic pathophysiology of aortic stenosis in different settings then the key results of recent clinical investigations on TAVI in intermediate-risk aortic stenosis patients are summarized. Particular emphasis is placed on the results of the nordic aortic valve intervention, placement of aortic transcatheter valves (PARTNER) 2 and Surgical Replacement and Transcatheter Aortic Valve Implantation Randomized trials. The PARTNER 2 was the first large randomized trial that evaluated the outcome of TAVI in patients at intermediate risk. The PARTNER 2 data demonstrated that TAVI is a feasible and reasonable alternative to surgery in intermediate-risk patients (Society of Thoracic Surgeons 4-8%), especially if they are elderly or frail. There was a significant interaction between TAVI approach and mortality, with transfemoral TAVI showing superiority over SAVR. Moreover, we examine the complementary results of the recently concluded Surgical Replacement and Transcatheter Aortic Valve Implantation trial. This prospective randomized trial demonstrated that TAVI is comparable with surgery (primary end point 12.6% in the TAVI group vs. 14.0% in the SAVR group) in severe aortic stenosis patients deemed to be at intermediate risk. We review the most relevant clinical evidence deriving from nonrandomized studies and meta-analyses. Altogether, clinical outcome available data suggest that TAVI with a newer generation device might be the preferred treatment option in this patient subgroup. Finally, the differences between the latest European and American Guidelines on TAVI were reported and discussed. The conclusion of this expert opinion article is that TAVI, if feasible, is the treatment of choice in patients with prohibitive or high surgical risk and may lead to similar or lower early and midterm mortality rates compared with SAVR in intermediate-risk patients with severe aortic stenosis.

Background: Limited data exist about safety and efficacy of transcatheter aortic valve replacement (TAVR) in patients with pure native aortic regurgitation (AR)., Objectives: This study sought to compare the outcomes of TAVR with early- and new-generation devices in symptomatic patients with pure native AR., Methods: From the pure native AR TAVR multicenter registry, procedural and clinical outcomes were assessed according to VARC-2 criteria and compared between early- and new-generation devices., Results: A total of 331 patients with a mean STS score of 6.7 ± 6.7 underwent TAVR. The early- and new-generation devices were used in 119 patients (36.0%) and 212 patients (64.0%), respectively. STS score tended to be lower in the new-generation device group (6.2 ± 6.7 vs. 7.6 ± 6.7; p = 0.08), but transfemoral access was more frequently used in the early-generation device group (87.4% vs. 60.8%; p < 0.001). Compared with the early-generation devices, the new-generation devices were associated with a significantly higher device success rate (81.1% vs. 61.3%; p < 0.001) due to lower rates of second valve implantation (12.7% vs. 24.4%; p = 0.007) and post-procedural AR ≥ moderate (4.2% vs. 18.8%; p < 0.001). There were no significant differences in major 30-day endpoints between the 2 groups. The cumulative rates of all-cause and cardiovascular death at 1-year follow-up were 24.1% and 15.6%, respectively. The 1-year all-cause mortality rate was significantly higher in the patients with post-procedural AR ≥ moderate compared with those with post-procedural AR ≤ mild (46.1% vs. 21.8%; log-rank p = 0.001). On multivariable analysis, post-procedural AR ≥ moderate was independently associated with 1-year all-cause mortality (hazard ratio: 2.85; 95% confidence interval: 1.52 to 5.35; p = 0.001)., Conclusions: Compared with the early-generation devices, TAVR using the new-generation devices was associated with improved procedural outcomes in treating patients with pure native AR. In patients with pure native AR, significant post-procedural AR was independently associated with increased mortality., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: We report procedural and 30-day clinical outcomes following transcatheter aortic valve replacement (TAVR) with Lotus Valve system in a high-risk population., Background: Lotus valve is a second-generation TAVR fully repositionable and retrievable device. RELEVANT (REgistry of Lotus valvE for treatment of aortic VAlve steNosis with Tavr) study is an Italian prospective multicentre registry., Methods: Five major centers performing TAVR using Lotus participated. All high-risk symptomatic patients with severe aortic stenosis were evaluated by a heart team and screened for eligibility for TAVR. Primary end-points were procedural and 30-day mortality. Secondary endpoints included procedural and 30-day safety/effectiveness metrics according to Valve Academic Research Consortium (VARC)-2 criteria., Results: Two hundred and twenty-five patients undergoing TAVR with Lotus were enrolled. Mean age was 82.6 ± 6.3 years, 51.6% females. Mean STS score for mortality was 8.3 ± 5.6. Procedural success was achieved in 98.7% of patients. All-cause mortality was 2.2% at discharge and 2.7% at 30-day. Stroke rate was 2.2% at discharge and 3.1% at 30-day. Patients requiring a new permanent pacemaker implantation were 30.7% at discharge and 31.8% at 30-day. Paravalvular regurgitation (PVR) was trace/mild in 99.1% of patients at discharge. Only two patients (0.9%) had moderate PVR at discharge and at 30-day, whereas none had severe PVR., Conclusions: RELEVANT study showed that TAVR using Lotus, in a real-world population of patients with severe aortic stenosis at high surgical risk, was associated with excellent device success implantation and early safety according to VARC-2 definition. The pacemaker implantation rate was about a third of patients. © 2017 Wiley Periodicals, Inc., (© 2017 Wiley Periodicals, Inc.)

Objectives: The most commonly used accesses for transcatheter aortic valve implantation (TAVI) are the transfemoral (TF-TAVI) and the transapical (TA-TAVI) ones. There are concerns about TA-TAVI use in patients with reduced left ventricular ejection fraction (LVEF). The aim of this retrospective multicentre study was to compare the outcomes of TA-TAVI and TF-TAVI in patients with poor LVEF., Methods: Patients with LVEF ≤35% were included in the analysis. Data were obtained from the Italian Transcatheter Balloon-Expandable Registry (ITER), which enrolled patients undergoing TAVI with the Sapien bioprosthesis in 33 national centres. Patients were divided into 2 groups according to the access: TA or TF. A multivariable logistic regression analysis was performed in order to evaluate whether the type of approach (TA and TF) has an impact on outcomes., Results: Between 2007 and 2012, 1882 patients were enrolled in the Registry. LVEF ≤35% was found in 208 (11.1%) patients. TA-TAVI and TF-TAVI were performed in 69 (33.2%) and 139 (66.8%) patients, respectively. Overall 30-day mortality was 11.6% and 7.9% in TA and TF patients, respectively (P = 0.45). Overall Kaplan-Meier survival was significantly higher in the TF-TAVI group (log rank: P = 0.003). Age [odds ratio (OR) 1.066, P = 0.016], creatinine (OR: 2.301, P < 0.001), preoperative permanent pacemaker (OR: 4.662, P = 0.035) and TA approach (OR: 2.577, P = 0.006) were identified as independent predictors of overall mortality at follow-up. However, the TA approach resulted an independent variable of mortality only 3 years after TAVI., Conclusions: TAVI yields good results in patients with depressed LVEF. Age, preoperative creatinine and preoperative pacemaker are independently associated with mortality. The TA access is associated with mortality only after 3 years of follow-up, thus probably reflecting a worse general clinical status of these patients., (© The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: The fully retrievable and repositionable Lotus Valve System uses a unique mechanical expansion mechanism. Balloon aortic valvuloplasty (BAV) is recommended before valve deployment. There are no studies focusing on feasibility and efficacy of Lotus Valve implantation without previous BAV., Methods and Results: Thirty consecutive patients (63.3% female; mean age, 80±6.2years) underwent transcatheter aortic valve replacement (TAVR) with the Lotus Valve without preparatory BAV. Mean baseline aortic valve area was 0.41±0.14cm 2 /m 2 ; mean transvalvular gradient was 50.2±16.2mmHg. All patients were successfully implanted, with 96.6% device success (VARC-2 definition) and 0% intra-procedural mortality. Partial and full valve repositioning were performed in 11 (36.7%) and 2 (6.7%) cases, respectively. Mean 30-day transprosthetic gradient was 11.3±3.6mmHg, with an effective aortic orifice area of 1.0±0.2cm 2 /m 2 , and more than mild paravalvular leakage (PVL) in only one patient. At 30days, cardiac mortality was 3.3%, and 96.3% of subjects were NYHA Class I or II. The rate of life-threatening bleeding was 10%; one patient experienced disabling stroke. Ten patients underwent new pacemaker implantation (38%)., Conclusions: TAVR with the mechanically expandable Lotus Valve seems feasible without performing preparatory BAV. Valve hemodynamics at 30-days were favorable, and clinical outcomes were similar to studies employing routine preparatory BAV., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Objective: The aim of this study was to investigate interactions among pre-procedural aortic regurgitation (AR), post-procedural paravalvular leak (PVL) and long-term clinical outcomes., Methods and Results: We analyzed data prospectively collected in the Italian Transcatheter balloon-Expandable Registry (ITER) on aortic stenosis (AS) patients. The degree of pre-procedural AR and post-procedural PVL was stratified as: absent/trivial, mild, and moderate/severe. VARC definitions were applied to outcomes. Of 1708 patients, preoperatively, AR was absent/trivial in 40% of the patients, mild in 42%, and moderate in 18%. Postoperatively, PVL was moderate-severe in 5%, mild in 32% of patients, and absent/trivial in 63%. Clinical follow-up, median 821days (IQR 585.75), was performed in 99.7% of patients. PVL, but not preoperative AR, was a major predictor of adverse outcome (HR 1.33, CI 95% 0.9-2.05, p=0.012 for mild PVL, HR 1.36, CI 95% 0.9-2.05, p<0.001 for PVL≥moderate and OR 1.04, p=0.97 respectively). Patients with moderate-severe PVL and preoperative left ventricle (LV) dilatation (LVEDVi>75ml/m 2 ) showed better survival than those without dilatation (HR 8.63, p=0.001)., Conclusions: In patients with severe AS treated with balloon-expandable TAVI, the presence of PVL, but not pre-procedural AR, was a major predictor of adverse outcome. Preoperative LV dilatation seemed to offer some clinical advantages., (Copyright © 2017 Elsevier B.V. All rights reserved.)

This article underscores the importance of the haemodynamic principles of the methods of measurement, as well as inherited limitations of each method, to adequately manage differing data between invasive and non-invasive tests.

Objectives: This study sought to evaluate transcatheter aortic valve replacement (TAVR) in bicuspid aortic valve (BAV) aortic stenosis (AS), with a particular emphasis on TAVR-directed bicuspid aortic valve imaging (BAVi) of morphological classification., Background: TAVR has been used to treat BAV-AS but with heterogeneous outcomes and uncertainty regarding the relevance of morphology., Methods: In 14 centers in the United States, Canada, Europe, and Asia, 130 BAV-AS patients underwent TAVR. Baseline cardiac computed tomography (CT) was analyzed by a dedicated Corelab. Outcomes were assessed in line with Valve Academic Research Consortium criteria., Results: Bicommissural BAV (vs. tricommissural) accounted for 68.9% of those treated in North America, 88.9% in Europe, and 95.5% in Asia (p = 0.003). For bicommissural bicuspids, non-raphe type (vs. raphe type) BAV accounted for 11.9% of those treated in North America, 9.4% in Europe, and 61.9% in Asia (p < 0.001). Overall rates of 30-day mortality (3.8%) and cerebrovascular events (3.2%) were favorable and similar among anatomical subsets. The rate of new permanent pacemaker insertion was high (26.2%) and similar between balloon-expandable (BE) and self-expanding (SE) designs (BE: 25.5% vs. SE: 26.9%; p = 0.83); there was a trend to greater permanent pacemaker insertion in BE TAVR in the presence of coronary cusp fusion BAV morphology. Paravalvular aortic regurgitation (PAR) ≥ moderate was 18.1% overall but lower at 11.5% in those with pre-procedural CT. In the absence of pre-procedural CT, there was an excess of PAR in BE TAVR that was not the case in those with a pre-procedural CT; SE TAVR required more post-dilation. Predictors of PAR included intercommissural distance for bicommissural bicuspids (odd ratio [OR]: 1.37; 95% confidence interval [CI]: 1.02 to 1.84; p = 0.036) and lack of a baseline CT for annular measurement (OR: 3.03; 95% CI: 1.20 to 7.69; p = 0.018)., Conclusions: In this multicenter study, TAVR achieved favorable outcomes in patients with pre-procedural CT, with the exception of high permanent pacemaker rates for all devices and shapes., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: To compare the outcomes of trans-subclavian (TS) and transapical (TA) access for transcatheter aortic valve implantation (TAVI)., Background: A considerable proportion of patients undergoing TAVI are not eligible for transfemoral approach. To date, there are few data to guide the choice between alternative vascular access routes., Methods: Among 874 consecutive patients who underwent TAVI, 202 procedures were performed through TA (n = 142, 70.3%) or TS (n = 60, 29.7%) access. Medtronic Corevalve (CV, Medtronic, Minneapolis, MN) was implanted in 17.3% of the patients, the Edwards-Sapien (ES, Edwards Lifesciences Inc., Irvine, CA) in 81.2% and other prostheses in 0.1%. In-hospital and long-term outcome were assessed using the Valve Academic Research Consortium (VARC)-2 definitions., Results: Mean age was 82 ± 6 years, STS score 9.3 ± 7.9%. The 2 groups showed a relevant imbalance in baseline characteristics. In hospital mortality was 6.4% (1.7% TS vs. 8.4% TA, P = 0.06), stroke 2.0%, acute myocardial infarction 1.0%, acute kidney injury 39.4%, sepsis 4.0% with no significant differences between groups, while bleeding was more frequent in TA patients (53.5% vs. 11.7% TS, P < 0.001). One- and 2-year survival was 85.2% and 73.2% in TS patients, and 83.9% and 74.9% in TA patients (P = ns for both). Access site was not an independent predictor of mortality at multivariable analysis., Conclusion: Transapical compared with trans-subclavian access for TAVI was associated with a nonsignificant trend to increased periprocedural events. However, 1- and 2-year survival appears similar., (© 2015 Wiley Periodicals, Inc.)

Background: A detailed assessment of calcium within the aortic root may provide important additional information regarding the risk of aortic root injury during transcatheter heart valve replacement (TAVR)., Objective: We sought to delineate the effect of calcium volume and distribution on aortic root injury during TAVR., Methods: Thirty-three patients experiencing aortic root injury during TAVR with a balloon-expandable valve were compared with a control group of 153 consecutive TAVR patients without aortic root injury (as assessed by post-TAVR multidetector CT). Using commercial software to analyze contrast-enhanced pre-TAVR CT scans, calcium volume was determined in 3 regions: (1) the overall left ventricular outflow tract (LVOT), extending 10 mm down from the aortic annulus plane; (2) the upper LVOT, extending 2 mm down from the annulus plane; and (3) the aortic valve region., Results: Calcium volumes in the upper LVOT (median, 29 vs 0 mm(3); P < .0001) and overall LVOT (median, 74 vs 3 mm(3); P = .0001) were higher in patients who experienced aortic root injury compared with the control group. Calcium in the aortic valve region did not differ between groups. Upper LVOT calcium volume was more predictive of aortic root injury than overall LVOT calcium volume (area under receiver operating curve [AUC], 0.78; 95% confidence interval, 0.69-0.86 vs AUC, 0.71; 95% confidence interval, 0.62-0.82; P = .010). Upper LVOT calcium below the noncoronary cusp was significantly more predictive of aortic root injury compared to calcium underneath the right coronary cusp or the left coronary cusp (AUC, 0.81 vs 0.68 vs 0.64). Prosthesis oversizing >20% (likelihood ratio test, P = .028) and redilatation (likelihood ratio test, P = .015) improved prediction of aortic root injury by upper LVOT calcium volume., Conclusion: Calcification of the LVOT, especially in the upper LVOT, located below the noncoronary cusp and extending from the annular region, is predictive of aortic root injury during TAVR with a balloon-expandable valve., (Copyright © 2015 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.)

Two different devices, 1 self-expanding and 1 balloon-expandable, have been developed for patients who underwent transcatheter aortic valve implantation with contrasting data about efficacy and safety. Pubmed, Medline, and Google Scholar were systematically searched for studies of these different devices, with data derived from randomized controlled trial or registries with multivariate analysis. All-cause death at 30 days and at follow-up were the primary end points, whereas postprocedural moderate or severe aortic regurgitation (AR), stroke, major vascular complications, bleedings, and pacemaker implantation the secondary ones. Six studies with 957 self-expanding and 947 balloon-expandable valves were included: 1 randomized controlled trial and 5 observational studies. At 30 days follow-up, rates of death did not differ between self-expanding and balloon-expandable valves (odds ratio [OR] 0.74, 95% confidence interval [CI] 0.47 to 1.17), whereas balloon expandable reduced rates of moderate or severe AR (OR 0.51, 95% CI 0.27 to 0.99) and of pacemaker implantation (OR 0.28, 95% CI 0.17 to 0.47). After a follow-up of 360 days (300 to 390), rates of all-cause death did not differ between the 2 groups. In conclusion, risks of moderate or severe AR and pacemaker implantation were lower with the balloon-expandable devices without an impact on 30 days and midterm mortality., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: Little is known of the prognostic significance of mitral regurgitation (MR) on transcatheter aortic valve replacement (TAVR), the impact of TAVR on MR severity, and the variables associated with possible post-TAVR improvement in MR. We evaluated these issues in a multicenter registry of patients undergoing CoreValve Revalving System-TAVR., Methods and Results: Among 1007 consecutive patients, 670 (66.5%), 243 (24.1%), and 94 (9.3%) presented with no/mild, moderate, and severe MR, respectively. At 1 month after TAVR, patients with severe or moderate MR showed comparable mortality rates (odds ratio, 1.1; 95% confidence interval [95% CI], 0.7-1.55; P=0.2), but both were significantly higher compared with patients with mild/no MR (odds ratio, 2.2; 95% CI, 1.78-3.28; P<0.001; and odds ratio, 1.9; 95% CI, 1.1-3.3; P=0.02, respectively). One-year mortality was also similar between patients with severe and those with moderate MR (hazard ratio, 1.4; 95% CI, 0.94-2.4; P=0.06) and still significantly higher compared with patients with mild/no MR (hazard ratio, 1.7; 95% CI, 1.2-3.41; P<0.001; and hazard ratio, 1.4; 95% CI, 1.2-2.2; P=0.03, respectively). Severe pulmonary hypertension, atrial fibrillation, and MR more than mild, but not an improvement of ≥1 grade in MR severity, were independent predictors of mortality at 1 year. At 1 year, an improved MR was observed in 47% and 35% of patients with severe and moderate MR, respectively. The rate of low implantation was consistent across groups with improved, unchanged, or worsened MR. A functional type of MR and the absence of severe pulmonary hypertension and atrial fibrillation independently predicted the improvement in MR severity., Conclusions: Baseline MR greater than mild is associated with higher mortality after CoreValve Revalving System-TAVR. A significant improvement in MR was more likely in patients with functional MR and without severe pulmonary hypertension or atrial fibrillation. The improvement in MR did not independently predict mortality.

Objectives: This study was designed to establish the incidence, impact, and predictors of post-transcatheter aortic valve replacement (TAVR) aortic regurgitation (AR)., Background: AR is an important limitation of TAVR with ill-defined predictors and unclear long-term impact on outcomes., Methods: Studies published between 2002 and 2012 with regard to TAVR were identified using an electronic search and reviewed using the random-effects model of DerSimonian and Laird. From 3,871 initial citations, 45 studies reporting on 12,926 patients (CoreValve [Medtronic CV Luxembourg S.a.r.l., Tolochenaz, Switzerland] n = 5,261 and Edwards valve [Edwards Lifesciences, Santa Ana, California] n = 7,279) were included in the analysis of incidence and outcomes of post-TAVR AR., Results: The pooled estimate for moderate or severe AR post-TAVR was 11.7% (95% confidence interval [CI]: 9.6 to 14.1). Moderate or severe AR was more common with use of the CoreValve (16.0% vs. 9.1%, p = 0.005). The presence of moderate or severe AR post-TAVR increased mortality at 30 days (odds ratio: 2.95; 95% CI: 1.73 to 5.02) and 1 year (hazard ratio: 2.27; 95% CI: -1.84 to 2.81). Mild AR was also associated with an increased hazard ratio for mortality, 1.829 (95% CI: 1.005 to 3.329) that was overturned by sensitivity analysis. Twenty-five studies reported on predictors of post-TAVR AR. Implantation depth, valve undersizing, and Agatston calcium score (r = 0.47, p = 0.001) were identified as important predictors., Conclusions: Moderate or severe aortic regurgitation is common after TAVR and an adverse prognostic indicator of short- and long-term survival. Incidence of moderate or severe AR is higher with use of the CoreValve. Mild AR may be associated with increased long-term mortality. Therefore, every effort should be made to minimize AR by a comprehensive pre-procedural planning and meticulous procedural execution., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

An 88-year-old man with severe aortic stenosis and normal left ventricular ejection fraction underwent transcatheter aortic valve implantation via a transapical approach, without periprocedural complications. Some 16 months later the patient was readmitted because of worsening dyspnea, when left ventricular dysfunction due to apical akinesia was identified. A gated, rest-only myocardial single-photon emission computed tomography (G-SPECT) demonstrated apical hypoperfusion that persisted after attenuation correction. Necrosis involved the apical and mid-inferior wall, the apical lateral wall, and the apical segment.

Although transcatheter aortic valve implantation (TAVI) for severe aortic stenosis is becoming an established technique, the effect of gender-related differences is poorly described. We performed a gender-based comparison of high-risk patients undergoing TAVI with the self-expandable CoreValve Revalving System for severe aortic stenosis to evaluate early and mid-term clinical outcomes. From the Italian prospective CoreValve registry, 659 consecutive patients (55.8% women) who underwent TAVI were included in the present study. We analyzed the gender-based differences in terms of clinical, angiographic, and procedural features and the differences in the rate of early and mid-term major adverse cardiac and cerebrovascular events. The men were younger, presented more often with severe left ventricular dysfunction, and had a greater rate of previous myocardial infarction, coronary revascularization, peripheral artery disease, renal failure, and heart conduction disorders than the women. The logistic European System for Cardiac Operative Risk Evaluation score did not differ between the 2 groups. The overall unadjusted and adjusted analyses failed to show significant differences between genders in terms of major adverse cardiac and cerebrovascular events at a median follow-up of 13 months (range 8 to 18). At late follow-up (landmark analysis >12 months), a survival benefit was observed in women (hazard ratio 0.27, 95% confidence interval 0.09 to 0.84, p = 0.02). In conclusion, in this multicenter registry, the gender-based comparison of TAVI patients showed that men, despite the younger age, had more extensive atherosclerotic burden compared to women. Overall, the early and mid-term outcomes were similar between genders, although women might have a survival benefit with longer follow-up., (Copyright © 2013 Elsevier Inc. All rights reserved.)

We present the case of an 83-year-old man who was admitted with New York Heart Association class III dyspnea and paroxysmal nocturnal dyspnea. Because of high surgical risk, a percutaneous treatment of both mitral and aortic valvulopathies was planned. This case reports the feasibility of a totally percutaneous approach in combined rheumatic mitral and aortic valve disease for patients with prohibitive surgical risk.

Background: Severe aortic stenosis with a low transvalvular gradient and preserved left ventricular ejection fraction (LVEF) is often misdiagnosed, leading to undertreatment of such patients with no clear indication for surgical intervention. This study investigated the outcome of aortic valve replacement (AVR) in patients with severe aortic stenosis and a low transvalvular gradient despite normal LVEF., Methods: Between 1985 and 2008, we evaluated 73 patients who underwent AVR compared with 29 patients who did not. Overall, aortic valve area was 1.0 cm2 or smaller, LVEF was 0.50 or higher, and transvalvular gradient was 30 mm Hg or less. Multivariate and Cox analyses were used to compare these two groups according to AVR., Results: Compared with controls, AVR patients were younger and with higher body mass index. Coronary artery bypass grafting was performed simultaneously in 38 AVR patients (52%). At follow-up (median, 42 months; interquartile range, 23 to 75 months), survival was longer in AVR patients. By Cox analysis, AVR remained a major predictor of lower mortality (hazard ratio, 0.237; 95% confidence interval, 0.119 to 0.470; p<0.0001)., Conclusions: In patients with severe aortic stenosis and low transvalvular gradient despite a normal LVEF, AVR was associated with significant improvement in long-term survival and functional status and with a low operative mortality., (Copyright © 2011 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

The purpose of this study was to analyze the relation of aortic valve weight to transvalvular gradient and area, with special regard to valve anatomy, size of calcific deposits, gender, and body size. Two hundred forty-two surgically excised stenotic aortic valves of patients (139 men, mean age 72 ± 9 years) who had undergone preoperative cardiac catheterization and echocardiography were weighed and examined with respect to number of cusps (tricuspid vs bicuspid), size of calcium deposits (microaggregates vs nodular macroaggregates), and presence of cholesterol clefts. The relation among valve weight, gradient, and area was studied. Transvalvular gradient was independent of gender or valve anatomy and was linearly correlated with valve weight absolutely (r = 0.33, p <0.01) or normalized by body surface area (r = 0.40, p <0.01). No correlation was evident between valve area and weight. Calcium macroaggregates were mainly present in men (51%) and in bicuspid valves (67%) and were seen to be strong determinants of valve weight (2.84 ± 1.03 g with macroaggregates vs 1.63 ± 0.56 g with microaggregates, p <0.001) but not of transvalvular gradient. Calcium microaggregates characterized tricuspid valves (62%), where transvalvular gradient was determined by valve weight (p = 0.0026). In conclusion, the heavier the valve, the less frequent were hypercholesterolemia, valve cholesterol clefts, hypertension, and diabetes mellitus., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Objective: The influence of left ventricular (LV) dysfunction on survival of patients with severe aortic stenosis is poorly characterized. Few data are available about preoperative predictors of cardiac mortality and LV function recovery after aortic valve replacement of such patients. The aim of our study was to examine the outcome and the preoperative predictors of postoperative cardiac death and of LV function recovery in these patients., Methods: We evaluated 85 consecutive patients with severe aortic stenosis (aortic valve area <1 cm(2)) and severe depression of LV ejection fraction (EF) <35% at cardiac catheterization. Among them, 52 underwent aortic valve replacement and they were compared to patients who were not operated on. All patients had a mean clinical follow-up of 53 months and 94% of them had a mean echocardiographic follow-up of 14 months after aortic valve replacement., Results: The mean baseline characteristics included: LVEF 28+/-6%, peak-to-peak transvalvular gradient 51+/-29 mmHg, aortic valve area 0.63+/-0.25 cm(2). Thirty-three patients did not undergo aortic valve replacement: 32 of them died within 3 years. Fifty-two patients underwent aortic valve replacement and 16 had a concomitant coronary bypass surgery. In-hospital mortality was 8%. Postoperative NYHA functional class changed from 2.84+/-0.67 to 1.43+/-0.44 (P<0.001) and LVEF from 29+/-6% to 43+/-10% (P<0.001). At follow-up 10 patients died of heart disease. By multivariate analysis, preoperative LV end-systolic volume index (ESVI) was the only covariate of cardiac death (LVESVI/10 ml/m(2), OR 1.3, CI 1.1-1.8, P<0.028). By using a receiver operating characteristic curve, LVESVI< or =90 ml/m(2) was the best cut-off value (sensitivity and specificity 78%) to fit with a better survival (93% vs. 63%, P<0.01) and with LVEF recovery after aortic valve replacement (EF improved by 15+/-10% vs. 8+/-5%, P<0.001)., Conclusions: Despite LV dysfunction, aortic valve replacement appears to change drastically the natural history of severe aortic stenosis. Preoperative LV levels predict different postoperative survival rate and LVEF recovery.