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Background Vascular complications during transcatheter aortic valve replacement (TAVR) still pose a significant concern regarding procedural safety. Designated closure devices for large-bore vascular access are needed. Methods Patients undergoing TAVR were prospectively enrolled into the study. The InSeal vascular closure device (VCD) achieves hemostasis by utilizing a crescent-shaped nitinol scaffold covered by a biodegradable membrane, which is delivered at the arterial puncture site. The coprimary endpoints were predefined as hemostasis within 15 min following vessel access site closure and after activated clotting time falls below 200 s and the rate of related major vascular adverse events in first month. Results A total of 50 patients were prospectively enrolled into the study, with an average age of 80.8 ± 7.4 years and 62% males. Hemostasis with the Inseal VCD was achieved in 94% of the patients with average time-to-hemostasis of 51 ± 97 s. The rates of in-hospital vascular complications were 12% mostly driven by minor vascular complications (10%). Femoral artery stents were used in three patients due to failed hemostasis. Conclusions Initial clinical experience indicates that a novel, nitinol-based, large-bore vascular closure device is safe and effective in achieving hemostasis after TAVR.

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.

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

OBJECTIVE To evaluate the efficacy and safety of periprocedural beta-blocker (BB) discontinuation among patients undergoing transcatheter aortic valve replacement (TAVR) and high degree atrioventricular block (HD-AVB) and/or atrial fibrillation (AF). METHODS The study population comprised 743 consecutive patients who underwent TAVR between 2009 and 2017 in two high-volume tertiary centers. All patients received chronic BB therapy, and were divided into two groups: (1) BB continuation and (2) BB discontinued 24 hr prior to the procedure. The primary endpoint was the development of composite brady and tachy-arrhytmic events (including HD-AVB and/or NOAF) following the procedure. RESULTS Among 743 study patients, 366 (49%) continued BB prior to the procedure and in 377 (51%) chronic BB therapy was discontinued. The rate of the composite periprocedural arrhythmic event was significantly higher among patients who stopped BB (20% vs. 13%, respectively, P = 0.018). Consistently, multivariate analysis showed that discontinuation of BB was associated with two-fold (P = 0.003) increase in the risk for periprocedural arrhythmic events (OR = 2.0; 95% CI 1.24-3.23; P = 0.004). The association between BB discontinuation and periprocedural arrhythmic events was consistent for the separate endpoints for HDAV and NOAF. Furthermore, the need for permanent pacemaker was significantly higher among patients who discontinued BB (20% vs. 13%; P = 0.018, respectively). CONCLUSIONS Among patients undergoing TAVR who receive chronic BB therapy, BB discontinuation prior to the procedure is independently associated with a significant increase in the rate of adverse arrhythmic events, including HDAVB, NOAF, and the need for pacemaker implantation.

Objectives The ability of the Society of Thoracic Surgeons (STS) and European System for Cardiac Operative Risk Evaluation (EuroSCORE)-2 scores to predict outcomes after transcatheter aortic valve replacement (TAVR) is insufficient. Frailty and serum albumin as a frailty marker were shown to correlate with prognosis after TAVR. We sought to evaluate the additive value of serum albumin to STS and EuroSCORE-2 scores to predict mortality in individuals undergoing TAVR. Design Retrospective analysis. Setting Tertiary-care hospital prospective registry. Participants Individuals who underwent TAVR (N = 426). Measurements We compared survival rates according to median baseline albumin levels (4 g/dL), STS score (4.5%), and EuroSCORE-2 (3.45%). Participants were divided into four groups according to median serum albumin and median STS and EuroSCORE-2 scores (high vs low), and 1-year survival rates were compared. A category-free net reclassification index (NRI) was calculated to compare the ability of a model of STS or EuroSCORE-2 alone to classify mortality risk with and without the addition of baseline serum albumin. Results Participants with low albumin levels had higher mortality (hazard ratio (HR) = 3.03, 95% confidence interval (CI) = 1.66–5.26, P < .001). Participants with low serum albumin and a high STS (HR = 4.55, 95% CI = 2.21–9.38, P < .001) or EuroSCORE-2 (HR = 2.72, 95% CI = 1.48–5.06, P = .001) score had higher mortality. Using NRI analysis, a model that included albumin in addition to STS correctly reclassified 42% of events (NRI = 0.58) and a model that included albumin in addition to EuroSCORE-2 correctly reclassified 44% of events (NRI = 0.64). Conclusion Serum albumin, as a marker of frailty, can significantly improve the ability of STS and EuroSCORE-2 scores to predict TAVR-related mortality.

To evaluate the effect of baseline aortic valve gradient (AVG) both as a continuous and a categorical variable on mortality in patients undergoing transcatheter aortic valve replacement (TAVR), focusing on the high-gradient severe aortic stenosis (AS) patients.Identifying new predictors of mortality in the TAVR population can help refine risk stratification and improve the patient selection process for this procedure. So far, AVG has mainly been studied as a categorical variable and there is a paucity of data on its prognostic value as a continuous variable, especially in patients with high AVG AS, who constitute the majority of patients referred for TAVR.We analyzed data on 1,224 consecutive symptomatic severe AS patients, who underwent TAVR at 3 centers. The relation between pre-TAVR AVG and mortality was evaluated among all patients and in patients with high AVGs (mean AVG ≥40 mm Hg) using the Cox proportional hazard model adjusting for multiple variables.During a mean follow-up of 1.8 years, baseline AVG was inversely associated with mortality in the entire cohort and in patients with high AVG AS. By multivariable analysis, patients with mean AVG 40-60 mm Hg and60 mm Hg had a respective 38% (P = 0.010) and 61% (P 0.001) reduction in mortality compared to patients with mean AVG40 mm Hg. Every 10 mm Hg increase in mean AVG was associated with 20% reduction in mortality (P 0.001). Analyses among patients with high (mean AVG40 mm Hg) and very high AVG AS (mean AVG60 mm Hg) yielded similar results (HR = 0.88, P = 0.031, and HR = 0.80, P = 0.019, per 10 mm Hg increase in AVG, respectively). Using peak AVGs and an analysis restricted to patients without reduced ejection fraction yielded consistent results.Baseline AVGs show an inverse association with mortality post-TAVR. These results were consistent also in patients with high-gradient AS, suggesting that AVG can be used to identify patients most likely to benefit from TAVR.

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

Background About a decade past the first transcatheter aortic valve implantation (TAVI), data are limited regarding temporal trends accompanying its evolution from novel technology to mainstream therapy. We evaluated these trends in a large multicenter TAVI registry. Hypothesis TAVI is changing and improving with time. Methods Patients who underwent TAVI between January 2008 and December 2014 at 3 high-volume Israeli centers were divided into 5 time quintiles according to procedure date. Outcomes were analyzed and reported according to Valve Academic Research Consortium-2. Results A total of 1285 patients were studied (43% male; mean age, 83 ± 3 years; mean Society of Thoracic Surgeons [STS] score, 5.5 ± 3.6). Over time, there was a shift toward treating patients at lower STS score, increased use of conscious sedation and transfemoral approach, and decreased use of balloon predilatation. The balloon-expandable to self-expandable valve utilization ratio decreased, the valve-in-valve experience increased from 4% to 17% of all TAVI volume, and length of hospital stay was halved (P = 0.006). Kaplan-Meier survival curves showed gradual decrease in mortality risk (P = 0.031), but there was no significant 1-year mortality decrease by multivariable analysis. Each year increment was associated with an adjusted 20%, 15%, and 12% decrease in new pacemaker obligation (P = 0.004), new pacemaker obligation or left bundle branch block (P = 0.008), and in-hospital infections (P = 0.082), respectively. Conclusions Temporal trends accompanying TAVI evolution include its utilization in lower-risk patients, procedural simplification, improved overall survival, decreased pacemaker obligation, and shorter hospital stay.

Background Acute kidney injury (AKI) was demonstrated to adversely affect outcome in patients undergoing transcatheter aortic valve implantation (TAVI). We compared predictors for AKI and associated outcomes according to various definitions among patients undergoing TAVI in a tertiary medical center. Methods Two-hundred and seventeen TAVI patients were evaluated for the occurrence of AKI according to Kidney Disease Improving Global Outcomes (KDIGO)/Valve Academic Research Consortium (VARC-2) and Risk Injury Failure Loss End-Stage (RIFLE) definitions. Multivariate analysis was conducted to assess predictors of AKI. Cox hazard ratio was used to evaluate long-term mortality in this patient population. Results AKI occurred in 23 and 21% of patients (n = 49, n = 46) according to KDIGO/VARC-2 and RIFLE definitions, respectively, with an approximate 10% of disagreement between both systems. Predictors of AKI according to KDIGO/VARC-2 were chronic obstructive pulmonary disease (COPD; OR = 2.66, P = 0.01), PVD (OR = 3.45, P = 0.02) and a lower baseline eGFR (OR = 1.03 per 1 mL/min/1.73 m2 decrease, P = 0.02). While BMI (OR = 1.12, P = 0.01), prior ischemic heart disease (OR = 2.35, P = 0.04) and COPD (OR = 2.18, P = 0.04) were associated with AKI as defined by the RIFLE definition. AKI defined by either classification was independently associated with long-term mortality (HR = 1.63, for the KDIGO/VARC-2 definition and HR = 1.60 for RIFLE definition, P = 0.04 for both models), with borderline superiority of the KDIGO/VARC-2 classification. Conclusions Different clinical characteristics predict the occurrence of AKI after TAVI when RIFLE and KDIGO/VARC-2 classifications are used. Both classification systems of AKI identify patients with increased risk for long-term mortality, with superiority of the KDIGO/VARC-2 definition, which should be used for AKI grading. © 2015 Wiley Periodicals, Inc.

Objective To assess the rate of Vascular complications in steroid treated patients undergoing transfemoral aortic valve implantation (TAVI). Background Steroid therapy has been associated with increased post-surgical bleeding. Vascular complications are a major concern in patients undergoing TAVI. However, the effect of corticosteroids on vascular complications has not been assessed in these patients. Methods We conducted a retrospective analysis of 220 consecutive patients undergoing transfemoral TAVI at our institute between 2009 and 2013. Patients who were on steroids at the time of the procedure (n = 25) were compared with those who were not (n = 195). Results Baseline characteristics between groups were similar except for greater incidence of chronic renal failure (52 vs. 25%, P = 0.05) and lower left ventricular ejection fraction (50.3 vs. 55.8%, P = 0.037) in the steroid group. The rate of procedural success and nonvascular complication were similar in both groups with the exception of more temporary AV block in the steroid group (24 vs. 8%, P = 0.016). Patients treated with steroids had significantly more minor vascular complication (44 vs. 23%, P = 0.024), and significantly more femoral artery stenosis (16 vs. 5%, P = 0.036), occlusion (8 vs. 1%, P = 0.014), need for femoral artery percutaneous transluminal angioplasty (PTA) (32 vs. 12%, P = 0.009), and femoral artery PTA or stenting (32% vs. 15%, P = 0.031). On multivariate analysis steroid treatment was the only predictor of minor vascular complications (RR=2.65, 95% CI 1.04-6.8, P = 0.042). Conclusions Concurrent corticosteroid treatment is associated with a higher rate of minor vascular complication following transfemoral TAVI. Operators should be aware of this risk when assessing patients for the procedure. © 2015 Wiley Periodicals, Inc.

Aims Heart failure with preserved ejection fraction can lead to pulmonary hypertension. The aim of the present study was to evaluate the role of exercise during right heart catheterization in the unmasking of diastolic dysfunction. Methods and results Between 2004 and 2012, 200 symptomatic patients with exertional dyspnoea, preserved left ventricular systolic function and suspected pulmonary hypertension, underwent right heart catheterization. Included in the study were 63 patients with resting pulmonary arterial wedge pressure (PAWP) ≤15 mmHg. Patients were divided to three tertiles based on their peak exercise PAWP. Mean age was 60 ± 20 years and 29% were males. Mean pulmonary arterial pressure was 31 ± 14 mmHg at rest and 42 ± 18 mmHg upon exercise. Mean change in PAWP between rest and exercise was 0.0 ± 4.3, 4.6 ± 2.4, and 16.6 ± 7.1 mmHg in the lower, middle, and upper tertiles, respectively (P

Background: Current risk assessment of patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) may fail to identify some patients with severe coronary artery disease (CAD). We aimed to identify predictors of the angiographic extent and severity of CAD in patients with NSTE-ACS undergoing early angiography and to evaluate its impact on prognosis. Methods: We evaluated 923 patients with NSTE-ACS who underwent coronary angiography. High-risk coronary anatomy (HRCA) was defined as left main disease >50%, proximal LAD lesion >70%, or 2- to 3-vessel disease involving the LAD. Clinical characteristics, in-hospital, and 30-day outcome and 1-year mortality were compared between the high-risk (N 5370) and the low-risk groups (N 5553). Results: Proportion of patients with elevated cardiac biomarkers was similar in both groups. The presence of peripheral vascular disease (OR 51.88, 95% confidence interval [CI] 51.62–5.80, P 140 (OR 51.88, 95% CI 51.29–2.75, P 140 (OR 56.86, 95% CI 51.68–27.9, P 50.007; OR 54.84, 95% CI 51.74–13.5, P 50.002) were significant predictors of 30-day and 1-year mortality

Objectives: To assess whether visible angiographic complication is related to outcome in patients with elevated creatine phosphokinase (CK-MB) following percutaneous coronary intervention (PCI). Background: Elevated biomarkers following PCI are associated with increased incidence of adverse events but the absolute risk of such events is low. A more specific marker of risk is needed. Methods: Consecutive patients with elevated post-PCI CK-MB were divided into two groups according to presence (n = 115, 43%) or absence (n = 150, 57%) of an angiographic complication. A control group (n = 250) was randomly chosen from 2,403 patients undergoing PCI during the same period without CK-MB elevation. Major adverse cardiac events (MACE) were assessed at 30 days and 1 year. Results: Patients with an identifiable angiographic complication and elevated postprocedural CK-MB had significantly worse outcomes at 30 days and 1 year compared with biomarker positive patients without an identifiable complication and control patients (30 day MACE rate: 8% vs 0% vs 0.4%, respectively, p < 0.001; 1 year MACE rate: 26% vs 11% vs 11%, respectively, p = 0.002, all p-values for angiographic complication vs no angiographic complication and for angiographic complication vs control). Biomarker positive patients without identifiable angiographic complication had an excellent short and long term outcome, which was no different from biomarker negative patients (1 year MACE rate: 11% vs 11%, p = 0.53). Conclusion: Post-PCI patients without visible angiographic complications have an excellent short and long term outcome. These findings call into question the need for routine CK-MB monitoring after PCI in the absence of clinical symptoms or angiographic complication. © 2010 Wiley-Liss, Inc.

Despite major advancements in the technology used for the percutaneous treatment of coronary artery disease, chronic total occlusions (CTOs) persist as a major challenge to the interventional cardiologist with relatively low success rates. CTOs are evident in 20% of patients undergoing cardiac catheterization and are responsible for the majority of cases that are referred to bypass surgery. There is growing evidence that patients may benefit from recanalization of a CTO by alleviation of angina, improving left ventricular function, and potentially long-term survival. The major obstacle to percutaneous recanalization of CTOs is the inability to cross the occlusion with coronary guidewires. Even when crossed, the operator has to deal with the exact location of the distal wire (e.g., dissection or true lumen) and the existence of relatively long lesion requiring multiple stents with high restenosis rates. New technologies for CTO revascularization have been focused mainly on a mechanical approach including specialized guidewires and more recently, specific devices using highly sophisticated technology such as laser guidewire, optical coherence reflectometry, and a blunt microdissection catheter. An alternate biological approach involves the local administration of enzymes such as plasminogen activators (urokinase) or collagenase, which can act locally to specifically degrade the collagen content of the CTO, thereby "softening" the occlusion and allowing easier guidewire crossing. In conclusion, CTOs emerge as a great technical challenge and are the focus of novel series of mechanical and biological approaches.

Patients with intractable angina pectoris due to end-stage coronary artery disease who are not amenable to conventional revascularization provide a therapeutic challenge. We describe the first published case of a young patient with intractable coronary artery disease that was successfully treated by endocardial cryotherapy.

Hepatitis A is a common self-limited liver disease. However, 15% of patients may have some complications. Autoimmune hepatitis that is triggered by viral hepatitis has been reported. We hereby describe an unrecognized association of hepatitis A with a full blown lupus-like syndrome manifested by the appearance of arthralgia, exudative pleural effusion with the presence of lupus erythematosus cells and autoantibodies. All these findings disappeared after a short course of steroid treatment. The case is presented and the literature is reviewed.