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Background: Chronic coronary syndrome (CCS) is common among elderly patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI). Current guidelines recommend performance of percutaneous coronary intervention (PCI) of any > 70% proximal coronary lesions prior to TAVI., Aims: To evaluate the outcomes of two diagnostic approaches for CCS clearance pre-TAVI and to determine the reduction in the need of invasive angiography (IA)., Methods: We investigated 2219 patients undergoing TAVI for severe aortic stenosis at two large centers with different pre-procedural strategies for CCS assessment: pre-TAVI computed tomography angiography (CTA) with selective invasive angiography according to CTA results or mandatory IA. We preformed propensity score matching analysis using a 1:1 ratio. The final study cohort included 870 matched patients. Peri-procedural complications were documented according to the VARC-2 criteria. Mortality rates were prospectively documented., Results: Mean age of the study population was 82 ± 7, of whom 55% were female. Patients in the IA group had significantly higher rates of pre-TAVI PCI compared to the CTA group (39% vs. 22%, p < 0.001). Following TAVI, peri-procedural myocardial infarction (MI) rates were similar between the two groups (0.3% vs. 0.7%, p value = 0.41), but spontaneous MI were significantly lower among the IA group (0% vs. 1.3%, p value = 0.03). Kaplan-Meier's survival analysis found that the cumulative probability of 1-year morality was similar between the two groups (p value log rank = 0.65). Cox regression analysis did not find association between CCS clearance strategy and outcome., Conclusions: In elderly patients, CTA-driven approach for CCS evaluation pre-TAVI is a valid strategy with similar outcome as compared to invasive approach. CTA strategy significantly reduces invasive procedures rates without compromising patient's outcome., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.)

Background: There are conflicting data regarding the efficacy and safety of suture vs plug-based vascular closure devices (VCDs) for large-bore catheter management in patients undergoing transcatheter aortic valve replacement (TAVR). We compared the rates of vascular complications (VCs) associated with 2 commonly used VCDs in a large cohort of patients undergoing TAVR., Methods: We conducted a single-centre, all-comer, prospective registry study, enrolling patients undergoing TAVR for symptomatic severe aortic stenosis (AS) between the years 2009 and 2022. Clinical outcomes were compared between patients undergoing closure of the femoral access point using the MANTA VCD (M-VCD) (Teleflex, Wayne, PA) vs the ProGlide VCD (P-VCD) (Abbott Vascular, Abbott Park, IL). The main outcome measures were researcher adjudicated events of VARC-2 defined major and minor VCs., Results: Overall, 2368 patients were enrolled in the registry; 1315 (51.0% male, 81.0 ± 7.0 years) patients were included in the current analysis. P-VCD was used in 813 patients, whereas M-VCD was used in 502 patients. In-hospital VCs were more frequent in the M-VCD vs the P-VCD group (17.3% vs 9.8%; P < 0.001). This outcome was mainly driven by elevated rates of minor VCs in the M-VCD group, whereas no significant difference was observed for major VCs (15.1% vs 8.4%; P < 0.001 and 2.2% vs 1.5%; P = 0.33, respectively)., Conclusions: In patients undergoing TAVR for severe AS, M-VCD was associated with higher rates of VCs. This outcome was mainly driven by minor VCs. The rate of major VCs was low in both groups., (Copyright © 2023 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Background: Neutrophil-to-lymphocyte ratio (NLR) is a simple and cost-effective marker of inflammation. This marker has been shown to predict cardiac arrhythmias, progression of valvular heart disease, congestive heart failure decompensation, acute kidney injury, and mortality in cardiovascular patients. The pathologic process of aortic stenosis includes chronic inflammation of the valve and therefore biomarkers of inflammation might offer additive prognostic value., Objectives: To evaluate NLR and its association with long term mortality in transcatheter aortic valve implantation (TAVI) patients., Methods: We evaluated data of 1152 consecutive patient from the Tel Aviv Medical Center TAVI registry who underwent TAVI. Data included baseline clinical, demographic, and echocardiographic findings; procedural complications; and post-procedure mortality. Patients were compared by using the median NLR value (4.1) and evaluated for long-term mortality., Results: Patients with NLR above the median had higher mortality rates (26.4% vs. 16.3%, P < 0.001) at 3 years post-procedure. A multivariable analysis found NLR to be an independent risk factor for mortality (hazard ratio = 1.47, 95% confidence interval 1.09-1.99, P = 0.013). In addition, high NLR was linked to complicationsduring and after the procedure., Conclusions: NLR is an independent prognostic marker among TAVI patients. This marker may represent an increased inflammatory response and should be added to previous known prognostic factors.

Background: The Medtronic Evolut Pro valve (EPV) is a new-generation self-expanding valve (SEV), particularly designed to reduce paravalvular leak (PVL) rates in transcatheter aortic valve replacement (TAVR). We aimed to compare the safety and efficacy of EPV with older-generation SEVs, in particular, postprocedural PVL and permanent pacemaker (PPM) implantation rates., Methods: We performed a retrospective, multicenter, propensity-matched analysis of the Israeli TAVR registry between September 2008 and June 2019. Two independent propensity score-matched comparisons were performed comparing EPV with the first-generation CoreValve (CV), and comparing EPV with the second-generation Evolut R valve (ERV)., Results: The registry included 2591 patients who were propensity-matched into 3 cohorts: EPV (n = 222), CV (n = 212), and ERV (n = 213). Moderate and above PVL rates were lower for EPV (angiographic PVL [aPVL], 0.6%; echocardiographic PVL [ePVL], 3.0%) as compared with CV (aPVL, 7.8% [P<.001] and ePVL, 11.6% [P<.01]), but not as compared with ERV (aPVL, 6.4% [P<.01] and ePVL, 4.4% [P=.57]). Lower rates of PPM were noted for EPV (16.3%) as compared with both CV (33.5%; P<.001) and ERV (24.4%; hazard ratio, 0.61; 95% confidence interval, 0.37-0.995; P=.046). Other safety and efficacy outcome rates were excellent, with significant improvements as compared with older-generation SEVs., Conclusions: The EPV demonstrates excellent procedural safety and efficacy outcomes. Moderate and above PVL rates were significantly reduced in comparison with CV; however, not significantly reduced as compared with ERV. The need for PPM implantation was lower as compared with both older-generation valves.

Objectives: This study aimed to compare permanent pacemaker implantation (PPMI) rates among patients undergoing Trans-catheter Aortic Valve Implantation (TAVI) with first generation (G1) versus second generation (G2) valves and the impact of PPMI on long-term mortality., Background: PPMI is a known adverse event after TAVI. Recently, two novel iterations of valve designs of both the balloon expandable valves (BEV) and self-expanding valves (SEV) were introduced as a second generation valves., Methods: All patients included in the Israeli multicenter TAVI registry were grouped according to valve type (BEV vs. SEV) and generation (G1 vs. G2). A comparison was made for clinical and outcome indices of patients undergoing TAVI with G1 and G2 in each of the valve systems., Results: A total of 1377 patients were included. The incidence of PPMI did not differ between G1-BEV versus G2-BEV (15.3% vs. 17.4%; p = 0.598) nor between G1-SEV versus G2-SEV (23.4% vs. 20.3%; p = 0.302). Depth of implantation and complete right bundle branch block were independently associated with PPMI post-TAVI in both valve systems. PPMI was not associated with an increased risk for 2-year mortality., Conclusions: The incidence of PPMI remains a relevant adverse event post-TAVI even when the newer generation valves are used. Since the predictors for PPMI are well established, a standardized approach for the management of conduction disorders is much needed., (© 2021 Wiley Periodicals LLC.)

Objectives: Right ventricular (RV) dysfunction and tricuspid regurgitation (TR) are associated with adverse outcomes in severe aortic stenosis (AS) patients. Our aim was to evaluate the association between ≥moderate TR and RV dysfunction on long-term mortality following transcatheter aortic valve replacement (TAVR)., Methods: A retrospective analysis of the Israeli multicenter TAVR registry among 4,344 consecutive patients, with all-cause mortality as the main outcome measure., Results: Echocardiographic assessment of TR grade and RV dysfunction was available for 3,733 and 1,850 patients, of whom ≥moderate TR and RV dysfunction was noted for 478(13%) and 78(4%), respectively. The mean follow-up time was 2.9 ± 2.3 years. In univariate models, ≥Moderate TR and ≥moderate RV dysfunction were associated with increased long-term mortality (HR 1.45, 95% CI 1.24-1.69, p < .001 and HR 1.73, 95% CI 1.21-2.47, p = 0.003, respectively). These finding did not remained significant after adjusting to echocardiographic parameters. A subset of patients with no improvement in RV function had the highest long-term mortality risk (HR 3.3, 95% CI 1.95-5.7, p < .001)., Conclusion: When adjusted to multiple echocardiographic characteristics baseline ≥Moderate TR and ≥moderate RV dysfunction were not associated with long-term mortality following TAVR. Persistent RV dysfunction following TAVR was associated with the highest risk for mortality., (© 2021 Wiley Periodicals LLC.)

Background: Transcatheter aortic valve replacement (TAVR) has become quite common. Atrioventricular conduction defects remain a frequent complication resulting with permanent pacemaker (PPM) implantation. Past studies showed conflicting results regarding PPM effect on mortality., Objective: The purpose of this study was to assess the influence of PPM implantation on mid- and long-term mortality in a large cohort of patients who underwent TAVR., Methods: Patients undergoing TAVR between 2009 and 2019 were categorized into groups: no PPM implanted (no-PPM), PPM implanted before the procedure (pre-PPM), and PPM implanted postprocedure (post-PPM). All-cause mortality up to 6 years was compared. Subanalyses were performed according to pacing burden. Proportion of patients who had decreased left ventricular ejection fraction within 1 year of the procedure after TAVR was also recorded., Results: A total of 1489 patients were followed. Unadjusted mortality was similar for patients regardless of PPM status within 12 months (P > .187), yet within 72 months, mortality was similar for the post-PPM (P = .257) and higher for pre-PPM (hazard ratio 1.53; P = .002) groups. Analysis adjusted by clinical characteristics did not show any independent long- or mid-term survival effects of PPM (P > .563). Analysis according to pacing burden showed no significant mortality difference (P > .8). Analysis of post-PPM patients with "high" or "near constant" (>40%) pacing burden vs no-PPM patients showed similar mortality for both mid- and long-term mortality (P = .055 and P = .513). Left ventricular ejection fraction decrease within 1 year was more common in both PPM groups, with a higher proportion with higher pacing burden (P < .001)., Conclusion: This cohort of consecutive patients undergoing TAVR showed that postprocedure PPM was not associated with increased long-term mortality. This conclusion was not altered by ventricular pacing burden., (Copyright © 2020 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to assess coronary accessibility after transcatheter aortic valve replacement (TAVR)-in-TAVR using multidetector computed tomography., Background: Expanding TAVR to patients with longer life expectancy may involve more frequent bioprosthetic valve failure and need for redo TAVR. Coronary access after TAVR-in-TAVR may be challenging, particularly as the leaflets from the initial transcatheter heart valve (THV) will form a neo-skirt following TAVR-in-TAVR., Methods: In 45 patients treated with different combinations of CoreValve and Evolut (CV/EV) THVs with supra-annular leaflet position and SAPIEN THVs with intra-annular leaflet position, post-TAVR-in-TAVR multidetector computed tomographic scans were analyzed to examine coronary accessibility., Results: After TAVR-in-TAVR, the coronary arteries originated below the top of the neo-skirt in 90% of CV/EV-first cases compared with 67% of SAPIEN-first cases (p = 0.009). For these coronary arteries originating below the top of the neo-skirt, the distance between the THV and the aortic wall was <3 mm in 56% and 25% of CV/EV-first and SAPIEN-first cases, respectively (p = 0.035). Coronary access may be further complicated by THV-THV stent frame strut misalignment in 53% of CV/EV-in-CV/EV cases. The risk for technically impossible coronary access was 27% and 10% in CV/EV-first and SAPIEN-first cases, respectively (p = 0.121). Absence of THV interference with coronary accessibility can be expected in 8% and 33% of CV/EV-first and SAPIEN-first cases, respectively (p = 0.005)., Conclusions: Coronary access after TAVR-in-TAVR may be challenging in a significant proportion of patients. THVs with intra-annular leaflet position or low commissural height and large open cells may be preferable in terms of coronary access after TAVR-in-TAVR., Competing Interests: Author Relationship With Industry Dr. De Backer has received institutional research grants and consulting fees from Abbott and Boston Scientific. Dr. Kim has been a proctor for and has received speaking fees from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Thomas Pilgrim has received institutional research grants and speaking fees from Biotronik and Boston Scientific; and is a consultant for HighLife SAS. Dr. Barbanti has received consulting fees from Edwards Lifesciences. Dr. Nombela-Franco has received consulting fees from Abbott, Boston Scientific, and Edwards Lifesciences. Dr. Kofoed has received institutional grants from AP Møller og Hustru Chastine McKinney Møllers Fond, the John and Birthe Meyer Foundation, The Research Council of Rigshopitalet, the University of Copenhagen, the Danish Heart Foundation, the Danish Agency for Science, Technology and Innovation by The Danish Council for Strategic Research, and Canon Medical Corporation. Dr. Windecker has received research and educational grants to the institution from Abbott, Amgen, Bristol Myers Squibb, Bayer, Boston Scientific, Biotronik, Cardinal Health, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Johnson & Johnson, Medtronic, Querbet, Polares, Sanofi, Terumo, and Sinomed. Dr. Sinning has received speaking honoraria and research grants from Abbott, Abiomed, Medtronic, Boston Scientific, and Edwards Lifesciences. Dr. Webb has received institutional research grants and consulting fees from Abbott, Boston Scientific, and Edwards Lifesciences. Prof. Dr. Søndergaard has received institutional research grants and consulting fees from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Symetis. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: The aim of this study was to assess the prognostic implications of increased right ventricle volume index (RVVI) using cardiac-gated computed tomography angiography (CCTA) data among patients undergoing transcatheter valve replacement (TAVR)., Methods and Results: CCTA of 323 patients who underwent TAVR at Stanford University Medical Center (CA, USA) and Tel Aviv Medical Center (Israel) between 2013 and 2016 was analysed by an automatic four-chamber volumetric software and grouped into quartiles according to RVVI. Higher one-year mortality rates were noted for the upper quartiles - 5%, 4.9%, 8.6%, and 16% (p=0.039), in Q1 <59 ml/m2, Q2 59-69 ml/m2, Q3 69-86 ml/m2, and Q4 >86 ml/m2, respectively. However, the differences were not significant after propensity score adjustments. Sub-analyses of Q1 demonstrated an escalating risk for one-year mortality in concordance to RVVI: HR 2.28, HR 2.76, and HR 4.7, for the upper 25th, 15th, and 5th percentiles, respectively (p<0.05 for all comparisons). After propensity score adjustments for clinical and echocardiographic characteristics, only the upper 5th percentiles (RVVI >120 ml/m2) retained statistical significance (HR 2.82, 95% CI: 1.02-7.78, p=0.045). Notably, 68.7% of patients from this group were considered low-intermediate risk for surgery., Conclusions: Cardiac volumetric data by CCTA performed for procedural planning may help to predict outcome in patients undergoing TAVR.

We evaluated the safety and efficacy of transcatheter aortic valve implantation (TAVI) in aortic stenosis patients with mid-range ejection fraction (ASmrEF) and compared it to aortic stenosis patients with reduced ejection fraction (ASrEF) and preserved ejection fraction (ASpEF). TAVI cases were stratified by baseline ejection fraction (ASrEF, ASmrEF, ASpEF) and compared for characteristics, procedural outcomes, and change in echocardiographic parameters at 1 year and mortality over a 5-year follow-up. The final study population included 708 patients who underwent TAVI. ASmrEF patients presented with improved EF at 1-year after procedure (49.0 ± 9.8 at 1 year vs 43.0 ± 2.5 at baseline, p <0.001) and showed improvements in left ventricular (LV) diameters (LV end-diastolic diameter: 50.4 ± 6.0 at 1 year vs 53.0 ± 5.5 at baseline and LV end-systolic diameter 34.7 ± 7.8 at 1 year vs 39.5 ± 5.9 at baseline, p <0.001 for both). LVEF improved for patients with ASrEF but not in ASpEF patients. LV diameters did not improve for patients in either group. Procedural safety and success rates were similar between all heart failure groups. Survival rates over a 5-year follow-up post-TAVI were not different between patients with ASmrEF, ASrEF, and ASpEF (ASrEF 78.4%, ASmrEF 81.9%, ASpEF 78.3%, p = 0.327). TAVI for patients with ASmrEF is safe and effective and results in marked improvement of LV function and structure., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: In contrast to surgical aortic valve replacement, left ventricle (LV) hypertrophy (LVH) had not been clearly associated with mortality following transcatheter aortic valve replacement (TAVR)., Methods: We performed a retrospective analysis of patients enrolled in the Israeli multicenter TAVR registry for whom preprocedural LV mass index (LVMI) data were available. Patients were divided into categories according to LVMI: normal LVMI and mild, moderate, and severe LVH. Mild LVH was regarded as the reference group. Additionally, LV geometry patterns were examined (concentric and eccentric LVH, and concentric remodeling)., Results: The cohort consisted of 1,559 patients, 46.5% male, with a mean age of 82.2 (±6.8) years and mean LVMI of 121 (±29) g/m 2 . Rates of normal LVMI and mild, moderate, and severe LVH were 31% (n = 485), 21% (n = 322), 18% (n = 279), and 30% (n = 475), respectively. Three-year mortality rates for normal LVMI and mild, moderate, and severe LVH were 19.8%, 18.3%, 23.7%, and 24.4%, respectively. Compared to mild LVH, moderate LVH and severe LVH were independently associated with an increased risk for all-cause mortality (hazard ratio [HR] 1.58, 95% CI 1.15-2.18, P = .005; HR 1.46, 95% CI 1.1-1.95, P = .009; respectively). Concentric LVH was independently associated with a decreased risk for mortality compared to normal LV geometry (HR 0.75, 95% CI 0.63-0.89, P = .001). Compared to concentric LVH, eccentric LVH was independently associated with a 33% increased risk for mortality (HR 1.33, 95% CI 1.11-1.60, P = .002)., Conclusions: Mild concentric LVH confers a protective effect among patients with severe aortic stenosis undergoing TAVR. However, hypertrophy becomes maladaptive, and an increased baseline LVMI, eccentric pattern particularly, may be associated with all-cause mortality in this population., Competing Interests: Disclosures Dr Ariel Finkelstein receives proctor fees from Medtronic and Edwards Lifesciences. None of the other authors have disclosures to declare., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Patients with right bundle branch block (RBBB) prior to transcatheter aortic valve implantation (TAVI) are at high risk for immediate post-procedural heart block and long-term mortality when discharged without a pacemaker., Objectives: To test whether prophylactic permanent pacemaker implantation (PPI) is beneficial., Methods: Of 795 consecutive patients who underwent TAVI, 90 patients had baseline RBBB. We compared characteristics and outcomes of the prophylactic PPI with post-TAVI PPI. Need for pacing was defined as  greater than 1% ventricular pacing., Results: Forty patients with RBBB received a prophylactic PPI (group 1), and in 50 the decision was based on standard post-procedural indications (group 2). There were no significant differences in clinical baseline characteristics. One patient developed a tamponade after a PPI post-TAVI. A trend toward shorter hospitalization duration in group 1 patients was observed (P = 0.06). On long-term follow-up of 848 ± 56 days, no differences were found in overall survival (P = 0.77), the composite event-free survival of both mortality and hospitalizations (P = 0.66), or mortality and syncope (P = 0.65). On multivariate analysis, independent predictors of the need for pacing included baseline PR interval increase of 10ms (odds ratio [OR] 1.21 per 10 ms increment 95% confidence interval [95%CI] 1.02-1.44, P = 0.028), and the use of new generation valves (OR 3.92, 95%CI 1.23-12.46, P = 0.023)., Conclusions: In patients with baseline pre-TAVI RBBB, no outcome differences were found with prophylactic PPI. On multivariate analysis, predictors of the need for pacing included baseline long PR interval, and the use of newer generation valves.

Objective: To compare procedural outcomes of transcatheter aortic valve implantation (TAVI) patients who were implanted with older versus newer generation valves., Background: The current evidence base for improved safety of the newer commercially available TAVI valves is limited., Methods: A retrospective analysis of the Israeli multicenter TAVI registry was performed. Patients were stratified by valve generation of four commercially available devices: Edwards Sapien (ESX) Edwards Sapien S3 (ES3), Medtronic CoreValve (MCV), and Medtronic Evolut R (MER)., Results: The cohort consisted of 737 patients with new generation valves (NGVs; ES3 n = 223; MER n = 514) and 1,869 with old generation valves (OGVs; MCV n = 1,181; ESX n = 688). Device success rates were significantly higher in NGV (97.5 versus 95.4%), with less post-procedural paravalvular leak (3 versus 5.8%), and valve mal-positioning (1.2 versus 3.4%); all P-values<0.05. There were no differences in rates of permanent pacemaker implantation, stroke or acute kidney injury (AKI) of any stage between the groups, although stage ≥2 AKI was more prevalent in NGV. After adjustment to significant differences in baseline patient and procedural characteristics, device success was higher (OR 1.86, 95% confidence interval (CI) 1.09-3.18, P = 0.023) and the 1-month safety outcome was significantly lower (OR 0.72, 95% CI 0.55-0.96, P = 0.025) for NGV. Device success was driven mainly by improved rates of PVL of ES3, while the safety outcome was mainly driven by improved rates of life-threatening bleeding and valve mal-positioning of MER., Conclusion: As compared to OGV, use of NGV for TAVI was associated with higher rates of device success and lower rates of adverse events., (© 2018 Wiley Periodicals, Inc.)

Increased inflammatory response after aortic valve replacement is linked to higher postprocedural mortality. The aim of the present analysis was to assess the impact of baseline statin therapy on procedural outcomes and mortality after transcatheter aortic valve implantation (TAVI). We performed a retrospective analysis on patients who underwent TAVI stratified to 3 statin therapy groups: high-intensity statin (HIS), low-medium intensity statins, and no statin. Included were 1,238 patients. Patients treated with HIS were significantly younger, had higher body mass index, lower Society of Thoracic Surgeons score, and higher prevalence of dyslipidemia, hypertension, past stroke, and ischemic heart disease. Procedural outcomes were similar between groups. There were no statistically significant short-term mortality differences at 1 month (2.2% vs 2.1% vs 3.5%, p = 0.50) and 1 year (6.9% vs 9.3% vs 14.2%, p = 0.15), albeit the observed numerical trend. As for long-term mortality (median follow time of 2.5 years, interquartile range 1.3 to 4.2), lower mortality rates were observed in the HIS group (14.5% vs 25.2% vs 36.6%, p = 0.001). Compared with no statin, the HIS group was significantly associated with reduced risk of long-term mortality in multivariate analysis (hazard ratio = 0.59, 95% CI 0.37 to 0.96, p = 0.03). Baseline HIS therapy is associated with reduced rates of long-term morality after TAVI., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Elevated pulmonary vascular resistance (PVR) determined using right heart catheterization portends an adverse prognosis following transcatheter aortic valve replacement (TAVR). The prognostic role of preprocedural PVR determined noninvasively using transthoracic echocardiography has not been studied in the TAVR setting., Methods: Baseline clinical and echocardiographic variables from a prospective TAVR registry were analyzed to determine preprocedural PVR and its impact on late outcomes (all-cause mortality, stroke, readmission for heart failure, new-onset atrial fibrillation). Echocardiographic PVR was estimated by the ratio of peak tricuspid regurgitation velocity to the time-velocity integral of the right ventricular outflow tract., Results: Ninety-seven patients were included in the study, with complete 3-year follow-up data available for all survivors. Mean PVR was 2.1 ± 0.) WU in the entire cohort and 2.7 ± 0.9 WU among patients with pulmonary hypertension. In the entire cohort, 29 patients (29.9%) died during the study period. Three-year all-cause mortality and composite adverse event rates were higher with increased versus normal PVR (55.6% vs 24.1% [P = .008] and 66.7% vs 41.8% [P = .06], respectively). By multivariate analysis, PVR as either a continuous (hazard ratio, 1.75; 95% CI, 1.1-2.81; P = .02) or a categorical (≥2.5 vs >2.5 WU; hazard ratio, 2.49; 95% CI, 1.09-5.71; P = .03) variable was independently associated with all-cause mortality. Although systolic pulmonary artery pressure was associated with all-cause mortality on univariate analysis, this association was not statistically significant on multivariate analysis accounting for PVR., Conclusions: PVR estimated using transthoracic echocardiography is an independent predictor of mortality at long-term follow-up after TAVR. Systolic pulmonary artery pressure was associated with increased late mortality, although this relation was not significant after adjustment for baseline variables and PVR., (Copyright © 2019 American Society of Echocardiography. Published by Elsevier Inc. All rights reserved.)

Aim: To compare procedural outcomes of transcatheter aortic valve replacement (TAVR) patients treated with new-generation valves., Methods: We performed a retrospective analysis on an Israeli multicenter registry comprised of four tertiary centers, comparing patient outcomes implanted with the Edwards SAPIEN S3 (ES3) vs. the Medtronic Evolut R (MER) valves., Results: The study population included 735 patients (ES3 n = 223; MER n = 512). The use of MER was significantly associated (p < 0.05) with higher rates of post-dilatation (35% vs. 10%), and the need for a second valve (2.7% vs. 0.5%). Procedural device success was comparable between groups (97% vs. 98%, p = 0.76); however, moderate angiographic paravalvular leak was higher (3.3% vs. 0.5%, p = 0.027) for MER vs. ES3, respectively. As compared to MER, 1 month echocardiography revealed higher peak and mean aortic valve gradients for ES3 (12/6 vs. 17/10 mmHg, p < 0.001, respectively). While the safety outcome at 1 month was lower for MER (8.8% vs. 13.9%, p = 0.035), similar 1-month, 1-year, and 3-year all-cause mortality were observed (1.9% vs. 1.3%; 8% vs. 8.5%, and 9.7 vs. 10.3%, for MER vs. ES3, respectively). In a propensity score matching analysis, there was no difference in major outcomes between the groups, including device success and the 1 month safety outcome., Conclusion: Although favorable efficacy and safety clinical outcomes were observed in this large contemporary registry for both new-generation devices used, some procedural and post-procedural outcomes differ significantly between the two valves.

Although the natural history of aortic stenosis (AS) depends on the severity of symptoms, the prognostic significance of AS clinical progression in patients who underwent aortic valve replacement is less clear. Here, we studied the correlation between the severity of AS presenting symptoms and survival after transcatheter aortic valve implantation (TAVI). We evaluated long-term survival of a consecutive cohort of severe AS patients (n = 862, mean Society of Thoracic Surgeons score 4.16 ± 2.9) who underwent transfemoral TAVI from 2009 to 2016. Patients were classified as having severe symptoms (i.e., angina, syncope, or heart failure, n = 424) or mild symptoms (i.e., dizziness, fatigue, effort dyspnea, chest discomfort, n = 438). No differences in device success nor in-hospital complications were found between groups. During a median follow-up of 2.84 (1.9 to 4.5) years, survival at 1, 3, and 5 years in the entire cohort, was 89% ± 1.1%, 75% ± 1.6%, and 59% ± 2.1%, respectively. Severe symptoms were associated with higher mortality (hazard ratio 1.54, 95% confidence intervals 1.230 to 1.939, p <0.001). The 1-, 3-, and 5-year survival was 94% ± 1.9%, 81% ± 3.3%, and 71% ± 4.3% in patients with angina, 92% ± 3.3%, 75% ± 5.6%, and 56% ± 8.2% in patients with syncope and 77% ± 3%, 54% ± 3.7%, and 41% ± 4.1% in patients with heart failure, respectively, (p <0.001). Heart failure symptoms emerged as independent predictor of mortality (hazard ratio 1.66, 1.28 to 2.17, p <0.001), regardless of left ventricular ejection fraction. The severity of AS symptoms affects survival after TAVI and overt heart failure independently predicts early mortality. Early intervention after diagnosis of severe AS is crucial to reduce the unfavorable effects of clinical progression on survival after TAVI., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to determine the prognostic value of contractile reserve (CR) at baseline in patients with low-flow, low-gradient severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR)., Background: Patients with severe AS, left ventricular dysfunction, and low transaortic gradient are at high risk for mortality during surgical aortic valve replacement (SAVR). Furthermore, patients without CR have been shown to have perioperative mortality comparable to that of patients treated medically for severe AS., Methods: We retrospectively analyzed patients who underwent TAVR with a diagnosis of low-gradient severe AS (mean transvalvular aortic gradient < 40 mmHg, LVEF < 50%, and AVA ≤ 1.0 cm 2 or AVAi ≤ 0.6 cm 2 ) and who had a pre-TAVR dobutamine stress echocardiogram (DSE). Patients were stratified by the presence or absence of CR, defined as an increase in stroke volume ≥ 20% during DSE., Results: From 2008 to 2016, 61 patients with low-gradient severe AS underwent TAVR and had pre-TAVR DSE. CR was present in 31 patients (51%) and absent in 30 (49%). There was no significant difference between the two groups in baseline demographics, medical history, access site, or types of valves. All-cause mortality was similar in both groups at 30 days (13% with CR vs 10% without CR, P = 1.00) and 1 year (29% with CR vs 33% without CR, HR 1.20, 95% CI 0.49-2.96, P = 0.69)., Conclusion: In patients with low-flow, low-gradient severe AS undergoing TAVR, the presence or absence of CR does not predict all-cause mortality at 30 days or 1 year., (© 2018 Wiley Periodicals, Inc.)

Referral of low surgical risk (LSR) patients for transcatheter aortic valve implantation (TAVI) becomes common in multiple tertiary centers, and clinical trial data for this population are not available to date. We performed a retrospective analysis on an Israeli multicenter registry. LSR and intermediate-high surgical risk (I-HSR) were defined by a Society of Thoracic Surgery score of <4% and ≥4%, respectively. The cohort included 2336 patients (LSR n = 1198, I-HLR n = 1138). As compared with LSR, patients with I-HSR were older and had significantly higher rates of baseline comorbidities. Although devices success rates (94% vs 96%), paravalvular leak (3.5% vs 5.2%), and permanent pacemaker implantation (17.2 vs 18%) were comparable (p >0.05 for all comparisons), the safety outcome at 1 month (12.7% vs 9.8%), procedural mortality (1.9% vs 0.6%), and mortality at 3 years (30.1% vs 16.1%) were higher in patients with I-HSR (p <0.05 for all comparisons). In a subanalysis of patients with very LSR, comparable rates of device success and safety outcomes were observed, whereas mortality at 1 to 3 years was lower. In conclusion, although procedural outcomes were comparable between LSR and I-HSR TAVI patients, the rates of short- and long-term mortality, as well as the safety outcome, were lower in LSR patients., (Copyright © 2018. Published by Elsevier Inc.)

Background: Severe aortic stenosis (AS) and severe tricuspid regurgitation (TR) may coexist. The aim of this study was to determine the change in right ventricular (RV) function and TR after surgical aortic valve replacement combined with tricuspid valve repair (SAVR+TVr), transcatheter aortic valve replacement (TAVR), or conservative management and compare outcomes dependent on RV functional parameters and treatment allocation., Methods: A retrospective analysis was conducted in 147 consecutive patients with severe AS and TR of baseline and 6-month clinical and echocardiographic parameters, including quantitative estimation of RV size and function (end-diastolic and end-systolic areas, tricuspid annular plane systolic excursion, fractional area change, and Tei index)., Results: SAVR+TVr and TAVR were associated with superior reduction in TR jet area after 6 months (P = .01 for time × group interaction) compared with conservative therapy. However, RV function (tricuspid annular plane systolic excursion and stroke volume) improved after TAVR but not after SAVR+TVr (P = .007 and P = .02 for time × group interaction, respectively). Conservative therapy for combined AS and TR was associated with >80% mortality in <4 years. TAVR and SAVR+TVr were associated with improved survival compared with conservative therapy (P < .0001), without significant difference between each other. Quantitative RV functional parameters were associated with poor outcomes, including tricuspid annular plane systolic excursion (P = .002), Tei index (P = .02), and RV fractional area change (P = .03)., Conclusions: In this nonrandomized, retrospective, observational study, SAVR+TVr and TAVR were associated with reductions in TR in patients with severe AS combined with severe TR. Importantly, RV function improved after TAVR but not after SAVR+TVr. Patients with severe AS and TR have a very poor prognosis with conservative therapy. When contemplating invasive procedures, assessment should include quantitative functional RV parameters., (Copyright © 2018 American Society of Echocardiography. Published by Elsevier Inc. All rights reserved.)

Background: Multi-detector computed tomography (MDCT) predicted orthogonal projection angles have been introduced to guide valve deployment during transcatheter aortic valve replacement (TAVR). Our aim was to investigate the accuracy of MDCT prediction methods versus actual angiographic deployment angles., Methods: Retrospective analysis of 2 currently used MDCT methods: manual multiplanar reformations (MR) and the semiautomatic optimal angle graph (OAG). Paired analysis was used to compare the 2-dimensional distributions and means., Results: We included 101 patients with a mean (±SD) age of 81 ± 9 years. The MR and OAG methods were used in 46 and 55 patients, respectively. A ≥5% change from the predicted MDCT range in left anterior oblique/right anterior oblique (LAO/RAO) and the cranial/caudal (CRA/CAU) angle occurred in 42% and 58% of patients, respectively. The mean predicted versus actual deployment angles were significantly different (CRA/CAU: -2.6 ± 11.5 vs. -7.6 ± 10.7, p < 0.001; RAO/LAO 8.1 ± 10.9 vs. 9.5 ± 10.6, p = 0.048; respectively). The MR method resulted in a more accurate CRA/CAU angle (CRA/CAU: -4.6 ± 11.1 vs. -6.5 ± 11.8, p = 0.139; RAO/LAO 7.4 ± 11.2 vs. 10.4 ± 11.2, p = 0.008; respectively), whereas the use of the OAG resulted in a more accurate RAO/LAO angle (CRA/CAU: -0.9 ± 10.8 vs. -9±11.2, p < 0.001; RAO/LAO 9.05 ± 10.6 vs. 8.5 ± 9.9, p = 0.458; respectively). For the entire cohort, the 2-dimensional distributions and means of the predicted versus the actual angles were significantly different from each other (p < 0.001). We repeated our analysis using both MDCT methods and demonstrated similar results with each method., Conclusions: Currently used MDCT methods for TAVR implantation angles are significantly modified before actual valve deployment. Thus, further refinement of these prediction methods is required., (Copyright © 2018 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.)

Permanent pacemaker (PPM) implantation remains common after transcatheter aortic valve implantation (TAVI). Invasive electrophysiology studies (EPSs) may reduce PPM implantation rates by identifying patients who do not require long-term pacing. At our institution, a new strategy in which patients with equivocal indications for pacing underwent EPSs to determine the need for PPM implantation was adopted. We compared baseline demographics, TAVI procedural details, and outcomes in patients without any conduction disturbance after TAVI, patients with new PPM implantation, and patients with EPS ± new PPM implantation. After exclusion for preexisting PPMs, of a total of 614 consecutive TAVI patients, 117 (19.1%) required new PPM implantation for unequivocal pacing indications, and 95 (15.5%) underwent EPSs. Of those patients who underwent EPSs, 28 (29.5%) required PPM implantation and 67 (70.5%) did not. The overall rate of new PPM implantation was higher for self-expanding versus balloon-expandable valves (34.0% vs 19.9%, p = 0.0011). PPM implantation increased intensive care and hospital length of stay compared with patients without any conduction disturbance (10.7 ± 8.3 vs 8.5 ± 6.4 days, p = 0.003). A negative EPS did not prolong length of stay. There were no significant differences in 30-day and 1-year mortality between groups. In conclusion, among TAVI patients with new-onset conduction disturbance, EPS is a safe strategy to identify those who require PPM implantation and those in whom PPMs can be avoided., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: The impact of frailty assessment on outcomes in patients undergoing transcatheter aortic valve replacement (TAVR) remains unclear. Our aim was to evaluate the individual effect of each frailty test and the utility of an additive frailty index score on short- and long-term survival following TAVR., Methods: Retrospective analysis of consecutive TAVR patients for whom a complete set of frailty tests was obtained: algorithm defined grip strength and 5-m walking tests, body mass index <20 kg/m 2 , Katz activities of daily living ≤4/6, serum albumin <3.5 g/dL. Frailty status was defined as having 3 or more positive frailty tests. Included were 498 patients with a mean age of 82±8 years., Results: Frailty status, observed in 266 (53%) patients, was associated with both 30-day and 1-year mortality (6% vs. 2%, P=.016; 20% vs. 9%, P<.001; within the respective frailty groups). As compared to 0-2 frailty criteria, a higher frailty index score was associated with increased risk of death at 1 year (OR 2.23; 95% CI 1.14-4.34; P=.019 and OR 3.30; 95% CI 1.36-8.00; P=.008 for 3 and 4-5 frailty criteria met, respectively). In Cox regression analysis, frailty status was correlated with 1-year mortality (HR=2.2; 95%CI 1.25-3.96; P=.007), and a higher frailty index was associated with increased mortality risk (HR=2.0; 95% CI 1.08-3.7; P=.027; and HR=3.07; 95% CI 1.4-6.7; P=.005; for any 3, and 4-5 frailty criteria, respectively)., Conclusions: Frailty status and a higher frailty index score were associated with increased 1-year mortality risk following TAVR., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Society of Thoracic Surgeons (STS) score and frailty index are calculated routinely as part of transcatheter aortic valve implantation (TAVI) assessment to determine procedure risk. We aim to evaluate the incremental improvement of STS risk score using frailty status in predicting short- and long-term outcome after TAVI. Study population included 544 consecutive TAVI patients who completed full frailty assessment and STS score calculation before the procedure. Frailty is defined by the presence of any 3 of the following 5 criteria: algorithm-defined grip strength and 15-foot walking tests, body mass index < 20 kg/m 2 , Katz activity of daily living ≤ 4/6, serum albumin < 3.5 g/dl. Multivariable logistic analysis of 30-day and 1-year mortality was performed using a logistic regression model that comprised the STS risk score model as a single variable. Based on frailty definition, 242 patients were frail and 302 patients were not. STS score was higher in the frail group than in the nonfrail group. Compared with STS risk score alone, frailty status was a significant predictor of 1-year mortality after TAVI procedure (odds ratio 1.0, 95% confidence interval [CI] 1.0 to 1.1, p = 0.029 vs 2.75, 95% CI 1.55 to 4.87, p <0.001, respectively). Although the c-statistic of the 1-year STS risk prediction model only changed from 0.62 to 0.66 (p = 0.08), the net reclassification improvement increased significantly to 52.8% after adding frailty to the prediction model (95% CI 0.28 to 0.77, p <0.0001). Frailty status is associated with higher mortality in TAVI cohort and incrementally improves the well-validated STS risk prediction model. Frailty assessment should continue to be part of the preprocedural assessment to further improve patient outcomes after TAVI., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objective: Evaluation of invasive hemodynamic parameters as prognostic markers of mortality in patients undergoing TAVR., Background: The value of invasive intraprocedural hemodynamic evaluation of patients undergoing transcatheter aortic valve replacement is unclear., Methods: Consecutive patients who underwent transfemoral TAVR and had complete prospectively collected intraprocedural invasive hemodynamic parameters were retrospectively analyzed. Patients with alternative access, planned general anesthesia, or baseline ≥moderate Tricuspid Regurgitation were excluded. Pre- and post-valve implant parameters included heart rate, systolic and diastolic blood pressures, cardiac output and index, pulmonary arterial systolic and diastolic pressures, transaortic pressure gradient and right atrial pressure. The primary end points were the association of the intraprocedural hemodynamic changes with all-cause mortality at 30days and 1year. Extensive Receiver Operating Characteristic analyses yielded dichotomized threshold of hemodynamic values in association with the binary outcome of mortality., Results: A total of 312 patients (52% male, mean age 83years) were evaluated. A significant association with 30-day and 1-year mortality was found between intraprocedural post-valve implant cardiac index <1.9 vs. ≥1.9L/min/m 2 (Log-ranked p=0.0286 and p=0.0432, respectively). Four subgroups with pre- and post-valve implant CI changes (L/min/m 2 ) were compared: [1] pre<1.9, stable&#95;post<1.9; [2] pre<1.9, improved&#95;post≥1.9; [3] pre≥1.9, stable&#95;post≥1.9; and [4] pre≥1.9, worsened&#95;post<1.9. Group 1 (lower CI with no post-valve improvement) had the worst survival, and Group 3 (higher CI and stable post-valve) had the best survival at 1-year follow-up (Log-ranked p=0.0089)., Conclusions: In patients with severe aortic stenosis undergoing TAVR, invasive monitoring can assess for hemodynamic prognostic markers of survival., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Clinical indications for transcatheter aortic valve replacement (TAVR) and elements of the implantation procedure, including delivery system miniaturization and novel access options, have evolved over time. The reasons patients are excluded from TAVR also have changed. The impact of these changes on patient referral for and exclusion from TAVR is unknown., Methods: We retrospectively analyzed patients referred to our center for TAVR from January 2010 to August 2016 to evaluate reasons for patient exclusion. Patients were divided into three groups based on initial screening date for trends in demographics and exclusion: Group 1, 2010-2012; Group 2, 2012-2014; Group 3, 2014 to August 1, 2016. Annual trends for patient exclusion from TAVR were assessed., Results: One thousand nine hundred fifty-three patients were referred and underwent screening for TAVR. The rates at which patients were referred for TAVR were 23.8, 25.9, and 24.5 per month in groups 1, 2, and 3, respectively. Rate of patient exclusion from TAVR decreased from 68% in Group 1 to 38% in Group 3 (P < .001). The largest percentage of patients (29.4%) were initially excluded from TAVR for cardiac reasons, but this trend has decreased over time. Twenty-five percent are excluded for lack of procedural indication. Exclusion from TAVR for vascular access reasons decreased from 7.9% in 2010 to 1.0% in 2016 (P = .017)., Conclusions: Referral numbers have been robust since TAVR became available. The percentage of patients excluded from TAVR has decreased over time. Patients are most commonly excluded from TAVR for concomitant coronary artery disease (CAD), asymptomatic severe AS, moderate AS, or non-cardiac critical illness. Patients with CAD and those with asymptomatic severe AS or moderate AS should be a focus for continued research in TAVR., (Copyright © 2017 Elsevier Inc. All rights reserved.)

The Valve Academic Research Consortium-2 recommends cutoff levels of cardiac troponin of >15 and of creatine kinase MB (CKMB) of >5 of the upper limit of normal (ULN) as markers of periprocedural myocardial infarction. We aimed to evaluate the correlation of these cutoffs with the survival rate in patients who underwent transcatheter aortic valve implantation (TAVI) through the femoral access. Patients who underwent TAVI were classified according to the postprocedural peak marker level of >15 and >5 ULN for troponin and CKMB, respectively. Baseline characteristics were compared, and the impact of these markers on a 1-year survival rate was assessed. Of 474 patients who underwent TAVI, 77% had a peak troponin level of >15 ULN, whereas only 8% had a CKMB level of >5 ULN. Factors associated with troponin and CKMB elevations differed except for the preserved ejection fraction, which was associated with the elevation of both markers. Patients with troponin elevations had higher rates of postprocedure conduction defects (p = 0.001), whereas patients with CKMB had higher rates of bleeding (p <0.001) and stroke (p = 0.03). A troponin elevation of >15 ULN had no impact on the 1-year survival rate (p = 0.52); however, patients with a CKMB level of >5 ULN had increased mortality (p = 0.008), which remained significant in the multivariate analysis (hazard ratio = 2.02, p = 0.035). Troponin level and CKMB had a good correlation (r = 0.7), and a troponin level of 75 ULN was linked with a CKMB level of >5 ULN. In conclusion, cardiac markers differ in their peak levels above the ULN after TAVI. Careful attention should be taken for patients who underwent TAVI with a CKMB level of >5 ULN, as this is the only biomarker independently associated with survival rate., (Copyright © 2017 Elsevier Inc. All rights reserved.)

We aimed to evaluate the success rates of balloon valvuloplasty post-dilation (BVPD) and a second-valve deployment in reducing residual aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) and its impact on outcome. Residual AR immediately post-TAVI in patients with aortic stenosis is a common condition that adversely affects outcome. Patients who underwent TAVI who had more-than-mild residual AR were managed either with medical therapy, re-intervention with BVPD, or a second valve. The clinical impact of these strategies was evaluated, and the anatomical features of patients with successful and unsuccessful intervention were compared. Among 572 patients with TAVI, 110 (19%) had significant residual AR after initial device deployment. Sixty patients were treated by BVPD (n = 49) or second-device deployment (n = 11), whereas 50 patients were treated medically. Successful reduction in residual AR to mild and below was achieved in 56% of the intervention group. Eccentric and calcified annuli were present in patients in whom residual AR remained despite re-intervention (p = 0.004). Interventions to reduce residual AR were independently associated with improved survival compared with conservative medical therapy (hazard ratio 0.45, 95% confidence interval 0.94 to 0.21, p = 0.03). BVPD or a second valve were safe and were not associated with increased rate of periprocedural complications. In conclusion, both BVPD and a second-valve deployment to reduce residual AR post-TAVI are effective and safe. The success rates are inversely correlated with the annulus eccentricity and calcification. These measures should be encouraged to reduce acute residual AR as they are associated with improved long-term survival., (Copyright © 2017. Published by Elsevier Inc.)

Objectives: To evaluate balloon-expandable and self-expanding third-generation transcatheter aortic valve replacement (TAVR) devices according to patient selection criteria and outcomes., Background: Two competing third-generation TAVR technologies are currently commercially available in the US. There are no published head-to-head comparisons of the relative performance of these two devices., Methods: 257 consecutive patients undergoing TAVR with a third-generation balloon-expandable (Edwards Sapien 3) or self-expanding device (Medtronic CoreValve Evolut R) at a single US medical center were included. Choice of TAVR device was at the discretion of the multidisciplinary Heart Team. Baseline clinical characteristics, echocardiographic and CT imaging, procedural and 30-day outcomes were prospectively collected., Results: 74 patients received a self-expanding valve (SEV) and 183 received a balloon-expandable valve (BEV). Patients selected for SEV were more frequently women, with lower body surface area and smaller calcified iliofemoral arteries. Three SEV patients required implantation of a second valve to successfully treat paravalvular leak. Only one BEV patient had moderate paravalvular regurgitation. There was no difference in the rate of stroke, major vascular complication or bleeding. Permanent pacemaker implantation rate was significantly higher with SEV (12.7% vs 4.7%, P = 0.49) and hospital length of stay was longer (8.3% vs 6.5%, P = 0.043), but 30-day mortality was comparable (1.4% vs 1.6%, P = 1.00)., Conclusions: Short-term outcomes were equivalent between the two technologies. Clinically significant paravalvular regurgitation was rare. SEV were more frequently selected in women and patients with challenging transfemoral access, but were associated with higher permanent pacemaker implantation rate and longer hospital length of stay., (© 2017, Wiley Periodicals, Inc.)

Aims: Conduction abnormalities following transcatheter aortic valve replacement (TAVR) are caused by damage of the aortoventricular conduction tissue during positioning of the valve. Therefore, our aim was to assess whether a higher difference between the long and short diameters of the elliptic aortoventricular annulus will possess higher forces on the annulus, and thus will be a predictor of pacemaker need following TAVR., Methods: We retrospectively analyzed 123 patients who had the aortoventricular annulus measured by computed tomography angiography. The difference between maximal (Dmax) and minimal (Dmin) diameters of the annulus was considered the elliptic factor (ELFA), which was analyzed using t test to evaluate whether it differs between the group who received a pacemaker and the group without the need for a pacemaker. Then, using univariate and multivariate models adjusted for other confounders predicting the need for a pacemaker, we sought to evaluate whether a higher ELFA is a predictor of pacemaker implantation., Results: Mean age was 82.2 ± 6.4 years, and 62.6% were women. Average Dmax, Dmin and ELFA were 25.8, 20.8 and 5 mm, respectively. Fourteen patients (11.4%) underwent pacemaker implantation. Those patients had an ELFA of 5.9 mm compared with 4.9 mm in those who did not receive a pacemaker (P < 0.01). In multivariate analysis, a higher ELFA remained a statistically significant and independent predictor for the need of a pacemaker (P = 0.046)., Conclusion: A high ELFA is an independent and significant predictor of the need for pacemaker implantation after TAVR and suggests further investigation whether it should be considered as a factor in managing TAVR patients.

We sought to determine whether balloon-expandable valve (BEV) and self-expanding valve (SEV) affect valve hemodynamics differently according to native aortic annulus size. Transcatheter aortic valve replacement can achieve superior prosthetic valve hemodynamics compared with surgical aortic valve replacement, particularly in patients with small aortic annulus. One hundred ninety-three consecutive transcatheter aortic valve replacement patients were grouped into tertiles defined by computed tomography derived aortic annulus systolic perimeter. The predischarge echocardiogram was analyzed for prosthetic valve hemodynamics. Tertile perimeter cutoffs were 73 and 80 mm. STS score decreased as annulus size increased (7.8% vs 7.6% vs 6.0%, p ≤0.05 for small, medium, and large annulus, respectively). In patients with small aortic annulus, SEV was associated with significantly higher dimensionless index (0.64 vs 0.53, p = 0.02) and lower peak velocity (1.8 vs 2.4 m/sec, p <0.001) and a trend toward lower mean gradient (7.5 vs 10.0 mm Hg, p = 0.07) compared with BEV. These differences were attenuated and absent in patients with medium and large annulus, respectively. Few patients had moderate/severe paravalvular leak, with no association with valve type or annulus size. There was no difference in mortality between tertiles or valve type at 30 days or 1 year. There was no association between aortic annulus perimeter and 1-year mortality by univariate analysis (hazard ratio 1.00, 95% CI 0.95 to 1.05, p = 0.86) or multivariate analysis (hazard ratio 1.02, 95% CI 0.95 to 1.09, p = 0.60). In conclusion, SEV hemodynamics was superior to BEV in patients with small aortic annulus. This difference was diminished in patients with larger aortic annulus. This study highlights the importance of valve selection in patients with small aortic annulus., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Aim: To assess the impact of left ventricular (LV) filling parameters on outcomes following trans-catheter aortic valve replacement (TAVR)., Methods and Results: A total of 526 TAVR patients were compared with 300 patients with severe aortic stenosis (AS) treated conservatively. Clinical variables were collected along with echocardiographic data at baseline, 1 month, and 6 months after study entry. End points included all-cause mortality and the combination of death and heart failure admission. LV filling parameters associated with mortality included reduced A wave velocity (P = 0.005) and shorter deceleration time (DT) (P = 0.0005). DT was superior to all other parameters (P = 0.05) apart from patients with atrial fibrillation in whom E/e' was better. Short DT (<160 ms) was associated with lower survival than long DT (≥220 ms; P = 0.002) or intermediate DT (P = 0.05), even after adjustment for age, gender, stroke volume index (SVI), and co-morbidities. However, patients with short baseline DT exhibited greater improvement in DT, E/A, and systolic pulmonary pressure at follow-up than patients with baseline DT ≥160 ms (P < 0.05 for all time x group interactions). Most importantly, among patients with short DT, TAVR was associated with better survival than conservative treatment (46 ± 7 vs. 28 ± 12% at 3 years, P = 0.05), even after adjustment for age, gender, and SVI (P = 0.05)., Conclusion: Short DT is an independent predictor of adverse outcome following TAVR. Nevertheless, LV filling parameters improve in most patients post TAVR, and TAVR is associated with improved survival compared with conservative therapy, even in patients with evidence of elevated LV filling. Thus, evidence of elevated LV filling should not be viewed as a contraindication for TAVR., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.)

Objectives: Our aim was to describe our experience with the use of an ePTFE-covered nitinol self-expanding stent graft (GORE® VIABAHN® Endoprosthesis, Gore Medical, USA) placed in the common femoral artery for the treatment of suture-mediated pre-closure device failure following transcatheter aortic valve replacement (TAVR)., Background: Access site-related vascular complications (VC) following sheath removal related to pre-closure device failure during TAVR are common and treatment options may vary., Methods: We performed an observational study on a series of consecutive patients who underwent TAVR between 2013 and 2015., Results: Included were 25 patients at a mean (±SD) age of 82±9. Failure of the closure device resulted in overt bleeding in 19 patients, dissection or no flow in 5 patients, and angiographic pseudoaneurysm in 1. Overall 29 stents were deployed with diameters ranging from 8 to 11mm and a length of 50mm (26, 90%). All stent-graft deployments achieved complete hemostasis of the arteriotomy site and resulted in normal flow to the distal vessels. None of the patients required open surgical repair. The mean hemoglobin drop was 2.6±1.3g/dl. Blood transfusions were used in 15 (60%) patients. Acute kidney injury occurred in 4 (16%) patients, none of whom was treated with dialysis. Length of hospital stay was 9±5days. All patients survived during a 30-day follow-up period, and none had VC related to the stented site., Conclusions: The use of an ePTFE-covered Nitinol self-expanding stent graft is a feasible, safe, and effective treatment modality for access site-related VC following TAVR., Summary: The use of an ePTFE-covered nitinol self-expanding stent graft placed in the common femoral artery for the treatment of suture-mediated pre-closure device failure following transcatheter aortic valve replacement (TAVR) is described in 25 patients. Its use was found to be feasible, safe, and an effective treatment modality for access site-related vascular complications following TAVR., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valve replacement (TAVR) is an alternative to open cardiac surgery in selected patients with severe aortic stenosis (AS). Carotid artery stenosis (CAS) has been associated with an increased risk of stroke following cardiac surgery, although the association between CAS and outcomes following TAVR is unclear. We therefore sought to study the prognostic impact of CAS on outcomes of patients undergoing TAVR., Methods: Consecutive patients (n=312) with severe symptomatic AS who underwent a carotid Doppler study immediately prior to TAVR were followed prospectively. Major adverse cardiovascular event (MACE) rates were stratified by the presence of CAS, defined in accordance with current practice guidelines., Results: Carotid atherosclerosis (CA, defined as any carotid plaque) was present in 301 (96.5%) of patients and CAS (peak systolic velocity [PSV]≥125cm/s; ≥50% diameter stenosis) in 97 (31.1%) patients. Severe CAS (PSV≥230cm/s; ≥70% stenosis, or near occlusion) was found in 20 (6.4%) patients. At long-term follow-up (248±205days), composite (20.9% vs. 19.6%, p=0.50) and individual (all-cause mortality, stroke, myocardial infarction, readmission for heart failure [19.5%% vs. 14.4%%, p=0.24; 3.3% vs. 2.1%, p=0.47; 1.4% vs. 0%, p=0.22; and 7.9% vs. 8.2%, p=0.84 respectively]) MACE rates did not differ significantly between patients without versus those with CAS. By multivariate analysis, CAS was not independently predictive of late MACE rates (HR=0.85, [95%CI 0.50-1.78], p=0.85)., Conclusions: CAS was not associated with worse outcomes following TAVR. The relative prognostic significance of CAS in patients considered for either surgical or transcatheter valve replacement merits further research., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

New generation of the most widely used devices for transcatheter aortic valve implantation have been recently introduced into practice. We compare the short-term outcomes of transcatheter aortic valve implantation with the Edwards SAPIEN S3 and the Medtronic Evolut-R. We performed a retrospective analysis from a single high-volume tertiary center. Valve Academic Research Consortium-2 criteria were used to define composite end points of device success and safety at 30 days. Study population included 232 patients implanted with the SAPIEN S3 (n = 124) and Evolut-R (n = 108). Device success reached 91.9% and 95.4% in the SAPIEN S3 and Evolut-R groups, respectively (p = 0.289). Postprocedural echocardiography showed greater aortic valve gradients (22.8 ± 7 vs 16 ± 9 mm Hg, p <0.001) among SAPIEN S3 group. Paravalvular leak of ≥ moderate severity was observed in 2.4% and 0% in the SAPIEN S3 and Evolut-R groups, respectively (p = 0.251). Similar rates of in-hospital complications, including major bleedings, vascular complications, and pacemaker implantations were recorded in both groups. At 30-day follow-up, the combined safety end point was reached in 5.6% and in 6.5% of patients in the SAPIEN S3 and Evolut-R groups, respectively (p = 0.790). During follow-up of 237 ± 138 days, all-cause mortality was higher in patients implanted with Evolut-R compared with SAPIEN S3 (7 vs 1 cases, respectively, p = 0.006), however, cardiovascular mortality was not significantly different between groups. In conclusions, in a single-center comparative analysis, comparable rate of device success as well as safety profile and long-term cardiovascular mortality were observed with the SAPIEN S3 and Evolut-R valves., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valve replacement (TAVR) exposes the systemic vasculature to increased mechanical forces. Endothelial adaptation to mechanical stimuli is associated with angiogenic activation through various growth factors. We studied the potential angiogenic shift evoked by TAVR., Methods: From a cohort of 69 consecutive patients undergoing TAVR, we excluded patients with conditions known to affect angiogenic factors, and serum vascular endothelial growth factor (VEGF) and angiopoietin (Ang)-1 and Ang-2 were assessed by ELISA. We assessed in vitro the properties of endothelial cells after exposure to serum collected from patients undergoing TAVR using adhesion, migration, and Matrigel angiogenesis assays. The correlation between changes in angiogenic factors and cardiac functions was evaluated on 30- day echocardiograms., Results: The study population consisted of 46 patients (82 ± 5 years). Two days after TAVR the post/pre TAVR ratio of VEGF, Ang-1, and Ang-2 was 5.38 ± 4 (P < 0.001), 1.05 ± 0.49 (P = 0.27), and 4.65 ± 2.01 (P < 0.001), respectively. The increase in VEGF and Ang-2 showed a significant correlation (r = 0.609; P < 0.001), but no correlation was found with hemolysis or tissue injury markers. Patients with relatively low levels of VEGF or an Ang-2 rise had more severe aortic stenosis and coronary disease at baseline. Exposure of endothelial cells to post-TAVR serum induced adhesion, migration, and tube formation compared with pre-TAVR serum. An increase in VEGF levels correlated with improvement in pulmonary systolic pressure and a right ventricular fractional area change at 30 days, (r = 0.54 and r = 0.48, respectively; P < 0.01)., Conclusions: Sustained elevation of VEGF and Ang-2 levels occur after TAVR, reflecting a systemic angiogenic shift. A rise in VEGF levels is associated with a decrease in pulmonary blood pressure in patients undergoing TAVR., (Copyright © 2016 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Background: Accurate risk stratification is pivotal for appropriate selection of patients with severe symptomatic aortic stenosis for either surgical or transcatheter aortic valve replacement (TAVR). We sought to determine whether recent risk prediction models developed specifically in TAVR patients enhance prognostication in comparison with previous surgical scores used in clinical practice (EuroScore I, EuroScore II, STS)., Methods: The Israeli TAVR Registry Risk Model Accuracy Assessment (IRRMA) study utilized a multicenter prospective TAVR database (n=1327) to perform a quantitative comparison between previous risk scores developed in either surgical or TAVR populations, with the present registry serving as an independent external validation set., Results: In the IRRMA population, 4 variables (NYHA functional class IV, chronic obstructive pulmonary disease, systolic pulmonary artery pressure ≥60mmHg, vascular access other than by the femoral route) identified by cross-validation and leave-one-out analyses provided the most discriminative model (C-statistic=0.63) for predicting 30-day mortality. Previous scores developed in surgical (EuroScores I and II, STS), TAVR (FRANCE-2, OBSERVANT), or mixed (German AV score) populations were applied to the IRRMA cohort. Resultant C-statistics ranged between 0.52-0.71 (for the German AV and FRANCE-2 scores, respectively) and did not differ significantly (p=0.07 for the comparison between the lowest and highest C-statistics). The observed C-statistic for 5 of these 6 scores was lower than originally reported when applied to the IRRMA population., Conclusion: Available TAVR risk scores showed limited accuracy when applied to an independent validation set and did not enhance prognostication in comparison to previous surgical scores., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Background: The Norton scale is traditionally used to assess the risk of pressure ulcers. However, recent studies have shown its prognostic utilization in elderly patients with diverse medical conditions. The association between low admission Norton scale scores (ANSS), complications, and mortality in elderly patients following trans-catheter aortic valve implantation (TAVI) has never been studied. We aimed to determine if low ANSS (≤16) is associated with complications and 30-day and 1-year mortality in elderly patients undergoing TAVI., Methods: The medical charts of elderly (≥70 years) TAVI patients at the Tel-Aviv Medical Center, a tertiary medical center, were studied for the following measurements: ANSS, demographics, co-morbidities, complications during hospitalization, and 30-day and 1-year mortality. Complications included: an atrio-ventricular block, stroke, and vascular complications., Results: The cohort included 302 elderly patients: 179 (59.3%) were women; the mean age was 83.3±5.1 years. Following TAVI, 112 (37.1%) patients had complications other than pressure ulcers, 10 (3.3%) patients died within 30 days, and 42 (13.9%) patients died within one year. Overall, 36 (11.9%) patients had low ANSS. 1-year mortality rates were almost three times higher in patients with low ANSS relative to patients with high ANSS (27.8% vs. 12.0%; the relative risk 1.1; p=0.018). A stepwise logistic regression analysis showed that ANSS was independently inversely associated with 1-year mortality (p=0.018). Complications and 30-day mortality rates were similar in both groups., Conclusions: Low ANSS are associated with 1-year mortality after TAVI. The Norton scale may therefore be used as an additional tool for elderly patient selection before TAVI., (Copyright © 2016 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.)

Objectives: To investigate the impact of preprocedural left ventricular (LV) diastolic function on outcomes of patients with postprocedural aortic regurgitation (ARpost ) following transcatheter aortic valve replacement (TAVR)., Background: The predictors and mechanisms of the increased mortality in patients with ARpost are inadequately defined., Methods: Baseline clinical and echocardiographic variables from a prospective TAVR registry were analyzed. Preprocedural correlates of late outcomes (all-cause mortality and the composite of mortality, stroke, heart failure, and new-onset atrial fibrillation) were examined according to the presence and severity of ARpost ., Results: Of the 418 patients undergoing TAVR, ARpost was present in 212 (51%): mild 36%, moderate-severe 15%. Mean follow-up was 909 ± 489 days. All-cause mortality and composite endpoint rates were significantly increased in patients with moderate-severe ARpost compared with patients with either none or only mild ARpost (38, 22, 21%, P = 0.02; and, 56, 35, 40%, P = 0.01; respectively). Moderate-severe (though not mild) ARpost was independently associated with mortality and the composite endpoint (HR = 1.93 [95%CI 1.15-3.14], P = 0.01; HR = 1.85 [95%CI 1.22-2.77], P = 0.004], respectively). By multivariate analysis, preprocedural LV deceleration time (DT) < 160 ms was independently associated with the risk of all-cause mortality and the composite endpoint among patients with mild AR (HR = 1.74 [95%CI 1.14-2.60], P = 0.01; and, HR = 1.73 [95%CI 1.23-2.41], P = 0.002, respectively) and moderate-severe ARpost (HR = 1.81 [95%CI 1.28-2.51], P < 0.001; HR = 1.86 [95%CI 0.22-2.80], P = 0.004, respectively)., Conclusions: Preprocedural impairment of LV filling, reflected by short DT, portends an adverse prognosis in TAVR patients who develop ARpost independently of other clinical and echocardiocardigraphic measures including AS severity and systolic LV function. © 2015 Wiley Periodicals, Inc., (© 2015 Wiley Periodicals, Inc.)

Intermediate- or low-risk patients with severe aortic stenosis were excluded from earlier transcatheter aortic valve implantation (TAVI) clinical trials; however, they are already being treated by TAVI despite a lack of data regarding the safety and efficacy in these patients. We aimed to assess the safety and efficacy of TAVI in patients at intermediate or low risk. Patients undergoing TAVI during 2008 to 2014 were included into a shared database (n = 1,327). Procedural outcomes were adjudicated according to Valve Academic Research Consortium 2 definitions. Patients were stratified according to their Society of Thoracic Surgeons (STS) score into 3 groups: high (STS ≥8, n = 223, 17%), intermediate (STS 4 to 8; n = 496, 38%), or low risk (STS <4; n = 576, 45%). Low-risk patients were significantly younger and more likely to be men compared to intermediate- and high-risk patients. Baseline characteristics differed significantly between the groups with a gradual increase in the rates of previous bypass surgery, stroke, peripheral vascular disease, renal failure, lung disease, and frailty scores, from low to high risk groups. Compared with intermediate- and high-risk patients, low-risk patients were more likely to undergo TAVI through the transfemoral route (81% vs 88% vs 95%, p <0.001) and under conscious sedation (69% vs 72% vs 81%, <0.001). There were no significant differences in the rates of procedural complications apart from acute kidney injury (19% vs 17% vs 13%, p = 0.03) and stroke rates (4.5% vs 2% vs 2.3%, p = 0.1). Short- and long-term mortality rates were significantly higher for intermediate- (hazard ratio [HR] 1.9, 95% confidence interval [CI] 1.2 to 2.9) and high-risk patients (HR 4.1, 95% CI 2.7 to 6.4) than low-risk patients also after multivariate adjustment (HR 1.6, 95% CI 1 to 2.6 and HR 2.7, 95% CI 1.7 to 4.5, respectively; all p <0.05). In conclusion, TAVI for intermediate- and low-risk patients is safe and associated with improved outcome compared with high-risk patients., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Surgical aortic valve replacement (SAVR) is associated with an increased mortality risk in elderly or high-risk patients. Transcatheter aortic valve implantation (TAVI) is an alternative to surgery in patients with symptomatic severe aortic stenosis who are inoperable or at high operative risk. The impact of diabetes mellitus (DM) on patients referred to TAVI merits further investigation. The aim of our study was to evaluate the clinical characteristics and the impact of DM status on the updated Valve Academic Research Consortium 2-defined outcomes of TAVI and to stratify patient outcomes according to their initial glycated hemoglobin (HbA1c) levels. We enrolled and stratified patients who underwent TAVI at our institution according to DM status. A total of 586 patients were enrolled: 348 (59%) without DM and 238 (41%) with DM. There were no significant differences in 30-day mortality patients with diabetes compared to patients without diabetes (3.3% vs 2.9%, p = 0.974). Insulin-treated DM was not associated with adverse outcome in comparison to orally treated DM. To delineate the prognostic power of HbA1C in these patients, the cohort was divided into 3 groups according to HbA1C levels (<5.7%, 5.7% to 6.49%, and ≥6.5%). Patients with HbA1C ≥6.5% were at increased risk for mortality during follow-up (hazard ratio 2.571, 95% confidence interval 1.077 to 6.136, p = 0.033) compared to patients with HbA1C <5.7%. In conclusion, unlike SAVR, DM is not associated with an increased mortality risk after TAVI, nor is it associated with increased complications rates. A more poorly controlled disease, as manifested by elevated HbA1c levels, may be associated with increased mortality during long-term follow-up., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Patients with previous coronary artery bypass grafting (CABG) are considered to be at increased perioperative risk for a redo cardiac operation. In the era of transcatheter aortic valve implantation (TAVI), these patients constitute a considerable portion of those with severe aortic stenosis referred for TAVI. We evaluated the impact of previous CABG on transfemoral TAVI outcomes. Patients with severe symptomatic aortic stenosis (n = 515) who underwent transfemoral TAVI were divided according to the presence of history of CABG. Patients with previous valvular surgery were excluded (n = 12). TAVI clinical end points and adverse events were considered according to the Valve Academic Research Consortium 2 definitions. Survival was estimated using Cox regression models at the enter mode with the dependent variable defined as all-cause mortality. Of the total 503 patients who underwent TAVI, 91 (18.1%) had previous CABG. At baseline, patients with previous CABG were younger (80.8 vs 83.1 years, p <0.001), mostly men (85% vs 35%, p <0.001), had more cardiac and vascular co-morbidities, higher mean logistic EuroSCORE (32.8 vs 22; p <0.001), lower ejection fraction (53% vs 56%, p <0.001), and lower AV gradients and larger valve area. At a mean follow-up of 636 days, the overall Valve Academic Research Consortium 2-adjudicated end points did not differ. No differences in mortality were observed at 30 days, 6 months, and 1 year after TAVI (hazard ratio 1.34, p = 0.55, Cox regression). We conclude that patients with previous CABG who underwent TAVI do not have increased risk of periprocedural complications or mortality, although having distinct clinical features compared with the total TAVI population., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Vascular complications (VC) after transcatheter aortic valve implantation (TAVI) are reported using various criteria and several access site approaches. We aimed to describe them in a solely percutaneous transfemoral TAVI approach and their association with survival using both the updated Valve Academic Research Consortium (VARC)-2 criteria and the former VARC-1 criteria. From March 2009 to September 2013, 403 consecutive patients at a mean age (±SD) of 83 ± 6 years underwent percutaneous transfemoral TAVI. VC were defined by both VARC-1 and VARC-2 criteria and analyzed separately. Cox proportional hazard ratio models for all-cause mortality were adjusted separately as defined by each criteria. VARC-1-defined and VARC-2-defined VC occurred in 71 (18%) and 78 (19%) patients, respectively, with 15 (4%) and 33 (8%) defined as major VC. The difference in frequency of major and minor VC was mainly driven by VARC-2 implementation of major bleeding events. With either VARC definition, patients with minor VC had similar mortality and complications rates as those patients without VC. In multivariate analyses, referenced to patients with minor or no VC, only VARC-1-defined major VC were significantly associated with increased mortality (hazard ratio 3.52; confidence interval 1.5 to 8.4; p = 0.005), whereas VARC-2-defined major VC were found to be only marginally significant (hazard ratio 1.9; confidence interval 0.9 to 3.9; p = 0.08). In conclusion, the implementation of the VARC-2 criteria resulted in a higher rate of reported major VC after TAVI compared with VARC-1 criteria, mainly by the inclusion of major bleeding events and a reduced association with patient mortality., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) is frequent and is associated with adverse outcomes. Past studies have attributed AKI to impaired kidney function at baseline, amount of contrast medium used, major bleeding, and hemodynamic instability during the procedure. Because major bleeding might play a role in the development of AKI, we analyzed the relationship between periprocedural bleeding and the development of AKI and assessed the impact of these 2 important procedure-related complications on outcome., Methods: Consecutive patients undergoing transfemoral TAVI for severe aortic stenosis were prospectively recruited. AKI and bleeding events during hospitalization were recorded, defined, and classified according to the Valve Academic Research Consortium 2 definitions. Logistic and Cox regression was used for predictor and survival analyses., Results: We recruited 422 consecutive patients who underwent TAVI; the mean follow-up duration was 576 ± 400 days. AKI occurred in 66 (15.6%) patients. No patient required dialysis. Fifty patients (12%) had major or life-threatening bleeding. Periprocedural major or life-threatening bleeding was a strong predictor of the development of AKI (odds ratio, 3.19; 95% confidence interval [CI], 1.38-7.1; P = 0.006). Major bleeding was a strong independent predictor for both 30-day and long-term mortality (hazard ratio [HR], 6.67; 95% CI, 2.2-19.8; P = 0.001 and HR, 3.3, 95% CI, 1.2-9.0; P = 0.02, respectively), whereas AKI was not independently associated with increased mortality after TAVI., Conclusions: In patients undergoing transfemoral TAVI, periprocedural bleeding is a strong risk factor for the development of AKI and a major determinant of short- and long-term mortality., (Copyright © 2015 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Transcatheter aortic valve implantation (TAVI) is considered a suitable treatment for patients with severe symptomatic aortic stenosis and high operative risk. Our aim was to evaluate the effect of preprocedural and new-onset atrial fibrillation (NOAF) on mortality and stroke in patients who underwent TAVI. We performed a single-center study of 380 consecutive patients enrolled to a TAVI registry. NOAF was defined as postprocedural atrial fibrillation (AF) occurring within 30 days after the procedure. Patients were followed up for a mean of 528 ± 364 days. During follow-up, 19 (5%) new episodes of stroke occurred, of whom 6 and 18 cases occurred within 30 days and 1 year, respectively. Overall mortality during the follow-up was 68 (20%), of those 12 and 58 patients died within 30 days and 1 year, respectively. NOAF occurred in 31 (8.2%) patients and was not associated with higher stroke or mortality rates at 30 days or 1 year of follow-up. Notably, compared with patients without previous AF, patients with previous AF at baseline had increased rates of stroke and mortality at 1-year follow-up (2.1% vs 9.6%, p = 0.01, and 8.2% vs 34.9%, p <0.01; respectively). In multivariate analysis, AF at baseline but not NOAF was a significant predictor of mortality throughout the follow-up period (HR 2.2, 95% confidence interval 1.3 to 3.8, p = 0.003, and HR 1.5, 95% confidence interval 0.5 to 4.1, p = 0.390, respectively). In conclusion, previous AF at baseline but not NOAF significantly increases stroke and mortality rates after TAVI. The inclusion of AF into future TAVI risk stratification scores should be strongly considered., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: Data to support the routine use of embolic protection devices for stroke prevention during transcatheter aortic valve replacement (TAVR) are controversial. Identifying patients at high risk for peri-procedural cerebrovascular events may facilitate effective patient selection for embolic protection devices during TAVR. Aim: To generate a risk score model for stratifying TAVR patients according to peri-procedural cerebrovascular events risk. Methods and results: A total of 8779 TAVR patients from 12 centers worldwide were included. Peri-procedural cerebrovascular events were defined as an ischemic stroke or a transient ischemic attack occurring ≤24 h from TAVR. The peri-procedural cerebrovascular events rate was 1.4% (n = 127), which was independently associated with 1-year mortality (hazards ratio (HR) 1.78, 95% confidence interval (CI) 1.06–2.98, p < 0.028). The TASK risk score parameters were history of stroke, use of a non-balloon expandable valve, chronic kidney disease, and peripheral vascular disease, and each parameter was assigned one point. Each one-point increment was associated with a significant increase in peri-procedural cerebrovascular events risk (OR 1.96, 95% CI 1.56–2.45, p < 0.001). The TASK score was dichotomized into very-low, low, intermediate, and high (0, 1, 2, 3–4 points, respectively). The high-risk TASK score group (OR 5.4, 95% CI 2.06–14.16, p = 0.001) was associated with a significantly higher risk of peri-procedural cerebrovascular events compared with the low TASK score group. Conclusions: The proposed novel TASK risk score may assist in the pre-procedural risk stratification of TAVR patients for peri-procedural cerebrovascular events. [ABSTRACT FROM AUTHOR]

The initially reported periprocedural neurological events rates associated with transcatheter aortic valve replacement raised concerns that ultimately led to the development and to the clinical research of novel embolic protection devices. Although the reduction of clinical stroke is a desired goal, the current research design of embolic protection devices focuses on surrogate markers of the clinical disease, primarily on silent central nervous system lesions observed in postprocedural diffuse-weighted magnetic resonance imaging and cognitive function testing. As the mere presence of particulate debris in brain matter may not correlate with the extent of brain injury, cognitive function, or quality of life, the clinical significance of embolic protection devices has yet to be determined, and interpretation of study results with regard to real-life clinical use should be viewed accordingly. The purpose of this article is to provide an overview of the updated ongoing clinical research on embolic protection devices and present its major caveats. [ABSTRACT FROM AUTHOR]

The late breaking trials released at the American Heart Association scientific sessions conference in November in New Orleans, LA covered a wide range of topics, including new devices within the field of heart failure, new registry data on transcatheter aortic valve replacement (TAVR) in intermediate risk patients, and medical management of peripheral arterial disease, coronary artery disease, and hypercholesterolemia. The following review highlights the late breaking trials presented at the conference that will have significant impact on clinical practice. [ABSTRACT FROM AUTHOR]