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A severely stenosed and calcified prosthetic aortic valve may be difficult to cross, on occasion even with only a wire. In the majority of cases eventually the valve will be crossed, but at a cost of prolonged fluoroscopy time, resulting in excessive exposure to radiation. It is therefore important to consider alternative techniques. The apical-femoral rail technique has been previously described. However, this technique involved establishing apical access, either surgically or percutaneously with a sheath. In the current case we describe a modified apical-femoral rail technique, performed sheathless with removal of the apical wire, allowing for spontaneous sealing., Competing Interests: Declaration of competing interest Dr. Gnall receives advisory fees from Livanova, ABIOMED, and Maquet. Dr. Rozenbaum has no disclosures to declare., (Copyright © 2022 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.

Background: Chronic kidney disease (CKD) has a negative impact on outcomes after transcatheter aortic valve replacement (TAVR). Data on outcomes in renal transplant recipients (RTRs) undergoing TAVR are scarce. We compared the outcomes in RTRs undergoing TAVR with matched patients who have native kidneys and similar kidney function., Methods: This retrospective cohort study used data from 16 TAVR centres (13,941 patients). The study cohort included 216 patients (72 RTRs and 144 matched controls)., Results: The mean estimated glomerular filtration rate (eGFR) was 39.2 ± 23.6 vs 44.5 ± 23.6 mL/min for RTRs and control patients (P = 0.149), with a similar CKD stage distribution. After TAVR, the eGFR declined among RTRs but remained stable for up to 1 year in controls (P = 0.021). Long-term hemodialysis was required in 19 (26.4%) RTRs and 20 (13.8%) controls (hazard ratio [HR] = 2.09 95% confidence interval [CI], 1.03-3.86; P = 0.039) and was most often initiated during the periprocedural period (14 RTRs vs 16 controls; P = 0.039). After a median follow-up of 2.3 years, risk of death (29.2% vs 31.9%) and death/hemodialysis (40.3% vs 36.8%) was similar between the groups. The contrast volume/eGFR ratio was the strongest predictor of hemodialysis initiation (odds ratio [OR] = 1.64; 95% CI, 1.36-1.97 per 1 unit increase; P < 0.001), with a greater effect among RTRs than controls (P for interaction = 0.022)., Conclusion: s: TAVR appears safe in RTRs with mortality rates similar to matched patients with native kidneys. However, RTRs carry an increased risk of progressive renal impairment and need for hemodialysis initiation after TAVR. Our data highlight the importance of minimizing contrast load during TAVR, particularly in RTRs., (Copyright © 2019 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

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.

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: Balloon pre-dilatation before transcatheter aortic valve replacement (TAVR) is performed at the discretion of the treating physician. Clinical data assessing the implications of this step on procedural outcomes are limited., Methods: We conducted a retrospective analysis of 1164 consecutive TAVR patients in the Israeli multicenter TAVR registry (Sheba, Rabin, and Tel Aviv Medical Centers) between the years 2008 and 2014. Patients were divided to those who underwent balloon pre-dilation (n=1026) versus those who did not (n=138)., Results: Rates of balloon pre-dilation decreased from 95% in 2008-2011 to 59% in 2014 (p for trend=0.002). Baseline characteristics between groups were similar except for more smoking (22% vs. 8%, p=0.008), less past CABG (18% vs. 26%, p=0.016), less diabetes mellitus (35% vs. 45%, p=0.01), and lower STS mortality scores (5.2±3.7 vs. 6.1±3.5, p=0.006) in the pre-dilatation group. The pre-dilation group included less patients with moderate to severely depressed LVEF (7% vs. 16%, p<0.001) and higher aortic peak gradients (76.9±22.7mmHg vs. 71.4±24.3mmHg, p=0.01). Stroke rates were comparable in both groups (2.5% vs. 3%, p=0.8), but pre-dilation was associated with lower rates of balloon post-dilatation (9% vs. 26%, p<0.001). On multivariate analysis, balloon pre-dilatation was not a predictor of device success or any post-procedural complications (p=0.07)., Conclusions: Balloon pre-dilatation was not associated with procedural adverse events and may decrease the need for balloon post-dilatation. The results of the present study support the current practice to perform liberally balloon pre-dilatation prior to valve implantation., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Background: Right ventricular (RV) dysfunction and tricuspid regurgitation (TR) may coexist with aortic stenosis. The aim of this study was to assess the association between RV dysfunction, TR, associated comorbidities, and outcomes following transcatheter aortic valve replacement (TAVR)., Methods: A retrospective analysis was conducted of baseline and 6-month clinical and echocardiographic parameters, including TR grade, RV size (grade, end-diastolic and end-systolic areas, annular diameter), and function (grade, tricuspid annular plane systolic excursion [TAPSE], fractional area change, Tei index), in 519 consecutive TAVR patients., Results: The prevalence of moderate or greater TR was 11% (n = 59). Although TR was associated with increased mortality (P = .02) in unadjusted analysis, it did not demonstrate an independent association with outcome when adjusted for RV dysfunction (TAPSE; P = .30) or multiple clinical parameters (P ≥ .20). RV parameters associated with poor outcomes included TAPSE (P = .006) and Tei index (P = .005). TAPSE was associated with lower survival even when adjusted for TR (P = .009) and all clinical parameters (P = .01). Persistence of moderate or greater TR 6 months after TAVR seemed to be associated with lower survival (P = .02), even when adjusted for clinical and RV parameters (P = .07)., Conclusions: TR in association with aortic stenosis is frequently progressive despite TAVR but is not independently associated with outcomes. RV function is a stronger driver of adverse outcomes compared with TR itself, and RV quantitative rather than qualitative evaluation is the key to stratify these patients., (Copyright © 2016 American Society of Echocardiography. Published by Elsevier Inc. All rights reserved.)