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Background: Data about the long-term performance of new-generation ultrathin-strut drug-eluting stents (DES) in challenging coronary lesions, such as left main (LM), bifurcation, and chronic total occlusion (CTO) lesions are scant., Methods: The international multicenter retrospective observational ULTRA study included consecutive patients treated from September 2016 to August 2021 with ultrathin-strut (<70 µm) DES in challenging de novo lesions. Primary endpoint was target lesion failure (TLF): composite of cardiac death, target-lesion revascularization (TLR), target-vessel myocardial infarction (TVMI), or definite stent thrombosis (ST). Secondary endpoints included all-cause death, acute myocardial infarction (AMI), target vessel revascularization, and TLF components. TLF predictors were assessed with Cox multivariable analysis., Results: Of 1801 patients (age: 66.6 ± 11.2 years; male: 1410 [78.3%]), 170 (9.4%) experienced TLF during follow-up of 3.1 ± 1.4 years. In patients with LM, CTO, and bifurcation lesions, TLF rates were 13.5%, 9.9%, and 8.9%, respectively. Overall, 160 (8.9%) patients died (74 [4.1%] from cardiac causes). AMI and TVMI rates were 6.0% and 3.2%, respectively. ST occurred in 11 (1.1%) patients while 77 (4.3%) underwent TLR. Multivariable analysis identified the following predictors of TLF: age, STEMI with cardiogenic shock, impaired left ventricular ejection fraction, diabetes, and renal dysfunction. Among the procedural variables, total stent length increased TLF risk (HR: 1.01, 95% CI: 1-1.02 per mm increase), while intracoronary imaging reduced the risk substantially (HR: 0.35, 95% CI: 0.12-0.82)., Conclusions: Ultrathin-strut DES showed high efficacy and satisfactory safety, even in patients with challenging coronary lesions. Yet, despite using contemporary gold-standard DES, the association persisted between established patient- and procedure-related features of risk and impaired 3-year clinical outcome., (© 2023 Wiley Periodicals LLC.)

Objective: Patients with rapidly deteriorating clinical status due to severe aortic stenosis are often referred for expedited transcatheter aortic valve replacement (TAVR). Data regarding the outcome of such interventions is limited. We aimed to evaluate the outcome of patients undergoing expedited TAVR., Design and Setting: Data were derived from the Israeli Multicenter Registry., Subjects: Subjects were divided into two groups based on procedure urgency: patients who were electively hospitalized for the procedure (N = 3140) and those who had an expedited TAVR (N = 142). Procedural and periprocedural complication rates were significantly higher among patients with an expedited indication for TAVR compared to those having an elective procedure: valve malposition 4.6% versus 0.6% (p &lt; 0.001), procedural cardiopulmonary resuscitation 4.3% versus 1.0% (p = 0.007), postprocedure myocardial infarction 2.0% versus 0.4% (p = 0.002), and stage 3 acute kidney injury 3.0% versus 1.1%, (p &lt; 0.001). Patients with expedited indication for TAVR had significantly higher in hospital mortality (5.6% vs. 1.4%, p = 0.003). Kaplan-Meier's survival analysis showed that patients undergoing expedited TAVR had higher 3-year mortality rates compared to patients undergoing an elective TAVR procedure (p &lt; 0.001). Multivariate analysis found that patients with expedited indication had fourfolds increased risk of in-hospital mortality (odds ratio: 4.07, p = 0.001), and nearly twofolds increased risk of mortality at 3-year (hazard ratio: 1.69, p = 0.001) compared to those having an elective procedure., Conclusion: Patients with expedited indications for TAVR suffer from poor short- and long-term outcomes. It is important to characterize and identify these patients before the deterioration to perform TAVR in a fast-track pathway to minimize their procedural risk., (© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

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: To evaluate the use and outcomes of percutaneous mechanical circulatory support (pMCS) utilized during transcatheter aortic valve implantation (TAVI) from high-volume centers., Methods and Results: Our international multicenter registry including 13 high-volume TAVI centers with 87 patients (76.5 ± 11.8 years, 63.2% men) who underwent TAVI for severe aortic stenosis and required pMCS (75.9% VA-ECMO, 19.5% Impella CP, 4.6% TandemHeart) during the procedure (prior to TAVI 39.1%, emergent rescue 50.6%, following TAVI 10.3%). The procedures were considered high-risk, with 50.6% having severe left ventricular dysfunction, 24.1% biventricular dysfunction, and 32.2% severe pulmonary hypertension. In-hospital and 1-year mortality were 27.5% and 49.4%, respectively. Patients with prophylactic hemodynamic support had lower periprocedural mortality compared to patients with rescue insertion of pMCS (log rank = 0.013) and patients who did not undergo cardiopulmonary resuscitation during the TAVI procedure had better short and long term survival (log rank <0.001 and 0.015, respectively)., Conclusions: Given the overall survival rate and low frequency of pMCS-related complications, our study results support the use of pMCS prophylactically or during the course of TAVI (bailout) in order to improve clinical outcomes in high-risk procedures or in case of acute life-threatening hemodynamic collapse., (© 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.)

Objectives: We sought to document aortic cusps fluoroscopic projections and their distributions using leaflet alignment which is a novel concept to optimize visualization of leaflets and for guiding BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent coronary artery obstruction) and determine whether these projections were feasible in catheter laboratory., Background: Optimal fluoroscopic projections of aortic valve cusps have not been well described., Methods: A total of 128 pre-transcatheter aortic valve replacement (pre-TAVR) computed tomographies (CT) (72 native valves and 56 bioprosthetic surgical valves) were analyzed. Using CT software (3Mensio, Pie medical imaging, the Netherlands), leaflet alignment was performed and the feasibility of these angles, which were defined as rate of obtainable with efforts (within LAO/RAO of 85° and CRA/CAU of 50°) were evaluated., Results: High feasibility was seen in right coronary cusp (RCC) front view (100%) and left coronary cusp (LCC) side view (99.2%), followed by noncoronary cusp side view (95.3%). In contrast, low feasibility of RCC side view (7.8%) and LCC front view (47.6%) was observed. No statistical differences were seen between the distribution of native valves and bioprosthetic surgical valves. With patient/table tilt of 20°LAO and 10°CRA, the feasibility of RCC side view and LCC front view increased to 43.7 and 85.2%, respectively., Conclusion: Distributions of each cusp's leaflet alignment follows "sigmoid curve" which can provide better understanding of aortic valve cusp orientation in TAVR and BASILICA. RCC side view used in right cusp BASILICA is commonly unachievable in catheter laboratory and may improve with patient/table tilt., (© 2020 Wiley Periodicals LLC.)

Background: Transcatheter aortic valve implantation (TAVI) for aortic stenosis (AS) risk assessment is still developing and mostly concerned with mortality in the periprocedural period. We therefore sought to develop and then validate a score to predict 1-year adverse outcome., Methods: Patients that underwent TAVI for severe AS in the Israeli registry. Patients with unsuccessful/suboptimal implantation were excluded. The cohort was split to derivation/validation cohorts by a ratio of 70:30. The outcome was defined as 1-year composite of mortality, stroke, and no improvement in NYHA class (vs. baseline). Logistic regression was used to fit the prediction model., Results: Out of 2,440 patients meeting inclusion criteria, 276 were excluded, leaving 2,160 patients for both cohorts. At 1 year, 299 (14%) patients experienced the adverse ("futile") outcome. The derived prediction model included mean aortic valve (AV) gradient, previous pacemaker, previous oncological disease, need for diuretics, baseline NYHA class, hemoglobin and creatinine levels, and nonfemoral access site. The model's area under the curve (AUC) was 0.69 in the derivation and 0.70 in the validation cohort. Performance of other scores in the validation cohort were lower (0.60 for STS, 0.55 for Euroscore2, 0.56 for TVT score, and 0.53 for TAVI2-score, p = .03). Based on three risk tiers, patients had a low risk (20/306, 7% futility), a medium risk (50/304, 17%), and high risk (18/37, 49%) for futility., Conclusions: The TAVI futility risk model can be used to provide further insight regarding prediction measures and/or patients' outcomes outside of the periprocedural period (NCT02023060)., (© 2020 Wiley Periodicals, Inc.)

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., (© 2020 Wiley Periodicals, Inc.)

Background: Patients treated with primary percutaneous coronary intervention (pPCI) for ST elevation myocardial infarction (STEMI) who have a history of coronary artery bypass grafting (CABG) are at high risk of adverse cardiovascular outcomes. Data on the risk of a saphenous vein graft (SVG)-infarct-related artery (IRA) compared to other culprit vessels are sparse., Methods: The study was based on a prospectively collected registry of 2,405 consecutive patients with STEMI attending a tertiary medical center in 2001-2017. Patients with an SVG-IRA (n = 172) were compared with patients with native vessel disease (n = 2,333) for mortality and major adverse cardiac events (MACE), which included death, myocardial infarction (MI), target vessel revascularization (TVR), and coronary artery bypass surgery (CABG) at 1 month and 3 years., Results: The SVG-IRA group was significantly older than the native vessel group (p = .05), with no between-group differences in rates of male patients (76 vs. 82%, p = .59), diabetes (24.2 vs. 26.2%, p = .73), and renal failure (18.8 vs. 9.2%, p = .25). Mortality was higher in the SVG-IRA group at 1 month (13.9 vs. 2.5%, p < .01) and 3 years (23.9 vs. 7.4%, p < .01). At 3 years, SVG-IRA was associated with the highest rates of MACE (55.6%), compared with native vessel disease. After correction for confounders, SVG-IRA remained an independent risk factor for MACE both at 1 month (HR-2.08, 95%CI 1.72-3.11, p < .01) and 3 years (HR-2.01, 95%CI 1.28-3.09, p < .01)., Conclusion: Among patients treated with pPCI for STEMI, outcomes are worse when the culprit is an SVG., (© 2019 Wiley Periodicals, Inc.)

Objectives: To assess the long-term safety and efficacy of a sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster), in comparison to a benchmark everolimus-eluting, permanent polymer stent (PP-EES; Xience), in a prespecified subgroup of patients with multivessel coronary artery disease (MVD) enrolled in the CENTURY II trial., Background: The use of coronary stenting in high-risk subgroups, like MVD patients, is rising. The clinical evidence, including long-term comparative analysis of the efficacy and safety benefits of different new-generation drug eluting stents, however, remains insufficient., Methods: Among 1,119 patients (intention-to-treat) enrolled in the CENTURY II prospective, randomized, single-blind, multicenter trial, a prespecified subgroup of 456 MVD patients were allocated by stratified randomization to treatment with BP-SES (n = 225) or PP-EES (n = 231). The previously reported primary endpoint of this study was freedom from target lesion failure (TLF: a composite of cardiac death, target vessel-related myocardial infarction [MI] and clinically-indicated target lesion revascularization) at 9 months., Results: In this MVD substudy, baseline patient, lesion and procedure characteristics were similar between the treatment arms. At 1 and 5 years, both BP-SES and PP-EES displayed low and comparable rates of TLF (5.3 vs. 7.8%; p = .29 and 10.2 vs. 13.4%; p = .29), and definite or probable stent thrombosis (0.4 vs. 1.3%; p = .33 and 0.9 vs. 1.7%; p = .43), respectively. Composite endpoint of cardiac death and MI, and patient-oriented composite endpoint of any death, MI, and coronary revascularizations were also similar., Conclusions: These results confirm good long-term safety and efficacy of the studied bioresorbable polymer stent in this high-risk patient population., (© 2019 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals, Inc.)

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.)

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., (© 2018 Wiley Periodicals, Inc.)

Background: The last decade, regarded as the DES era in PCI, has witnessed significant advances in the management of coronary disease. We aimed to assess temporal trends in the practice and outcome of percutaneous coronary intervention (PCI) during the drug eluting stent (DES) era., Methods: We analyzed 18,641 consecutive PCI's performed between January 2004 and December 2016, distinguished by procedural date (Q 1 : 2004-2006, n = 4,865; Q 2 : 2007-2009, n = 4,977; Q 3 : 2010-2012, n = 4,230; Q 4 : 2013-2016, n = 4,569)., Results: At presentation, mean patients age was 65 (±11) years and 22.8% were females. Over time, there was a rise in the relative number of octogenarians (Q 1 : 10.7% vs Q 4 : 15.5%, P < 0.001) and an increase in the burden of most comorbidities (e.g., left ventricular dysfunction ≥ moderate and chronic kidney disease, P < 0.001 for both). Despite a 2-fold increase in the rate of complex interventions, and a 3-fold increase in the rate of unprotected left-main angioplasty (P < 0.001 for both), the radial approach was increasingly adopted (Q 1 : 2% to Q 4 : 63.5%, P < 0.001). DES implantation increased from 43% to 83% at the expense of bare metal stent (BMS) application, and accompanied by drug coated balloon sprout to 1.8%, P < 0.001. Kaplan-Meier survival curves revealed a time-based enhanced outcome, with a decreased rate of death, MI, target vessel revascularization and CABG over the years., Conclusions: In the last decade, PCI has evolved to offer better outcome to more elderly, sicker patient population, with more complex coronary disease interventions. The shift to second generation DES and to enhanced PCI techniques may explain part of this progress., (© 2017 Wiley Periodicals, Inc.)

Background: Although transcatheter aortic valve replacement (TAVR) is officially indicated for high risk aortic stenosis (AS) patients, the procedure is increasingly being performed in patients who are not at high surgical risk, including a substantial number of low risk patients. However, data on the benefit of TAVR in this patient population is limited., Methods: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) and observational studies with propensity score matching (PSM) of TAVR versus surgical aortic valve replacement (SAVR) in patients who are at low surgical risk. The primary outcome was all-cause mortality. The secondary outcomes included stroke, myocardial infarction, bleeding, and various procedural complications., Results: Six studies (2 RCTs and 4 PSM studies) totaling 3,484 patients were included. Follow-up ranged from 3 months to 3 years (median 2 years). The short-term mortality was similar with either TAVR or SAVR (2.2% for TAVR and 2.6% for SAVR, RR 0.89, 95% CI 0.56-1.41, P = 0.62), however, TAVR was associated with increased risk for intermediate-term mortality (17.2% for TAVR and 12.7% for SAVR, RR 1.45, 95% CI 1.11-1.89, P = 0.006). In terms of periprocedural complications, TAVR was associated with reduced risk for bleeding and renal failure and an increase in vascular complications and Pacemaker implantation., Conclusions: In patients who are at low surgical risk, TAVR seems to be associated with increased mortality risk. Until more data in this population is available, SAVR should remain the treatment of choice for these patients., (© 2018 Wiley Periodicals, Inc.)

Objective: 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., Background: 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., Methods: 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., Results: 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 and >60 mm Hg had a respective 38% (P = 0.010) and 61% (P < 0.001) reduction in mortality compared to patients with mean AVG <40 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 AVG >40 mm Hg) and very high AVG AS (mean AVG >60 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., Conclusions: 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., (© 2017 Wiley Periodicals, Inc.)

Objective: To broaden the data supporting the use of the residual SYNTAX score (rSS) to define "reasonable" incomplete coronary revascularization (ICR) in order to improve the allocation of patients with severe coronary artery disease (CAD) to surgical/percutaneous revascularization and long-term clinical outcomes., Introduction: ICR is associated with a worse prognosis in patients with severe CAD, yet no consensus exists regarding its definition., Methods: We studied 148 consecutive patients with triple vessel/left main (3VD/LM) CVD treated by percutaneous coronary interventions (PCI). Clinical outcomes at 3 years were collected; the SS and rSS were calculated. We used various definitions of "reasonable" ICR:no post-PCI total occlusion, single vs. mutivessel residual post-PCI disease, and the rSS at a cutoff value determined according to ROC curve fitted for 3 years major adverse cardiovascular and cerebrovascular adverse events (MACCE) in order to determine which definition has the strongest correlation with long-term outcomes., Results: rSS ≤ 8 was associated with significant reductions in 3 year MACCE (19.4 vs. 51.1%, HR = 3.62, P = 0.014) Death/MI/CVA (13.7 vs. 28.8%, HR = 6.01, P = 0.030) and repeat revascularization (8.6 vs. 28.9%, HR = 3.44, P = 0.033) using a Cox proportional hazard ratio model adjusted to baseline characteristics, whereas single vessel residual disease and absence of total occlusion were not., Conclusions: "Reasonable" ICR as determined by rSS carries better long-term prognosis in terms of clinical outcomes vs. more extensive residual coronary disease in patients with 3VD/LM coronary artery disease treated by PCI. The rSS may improve the allocation of coronary patients to the optimal mode of revascularization., (© 2014 Wiley Periodicals, Inc.)

We describe a Bedouin family with a novel autosomal recessive syndrome characterized by dilated cardiomyopathy and septo-optic dysplasia. Genetic analysis revealed a homozygous missense mutation in TAX1BP3, which encodes a small PDZ domain containing protein implicated in regulation of the Wnt/β-catenin signaling pathway, as the causative mutation. The mutation affects a conserved residue located at the core of TAX1BP3 binding pocket and is predicted to impair the nature of a crucial hydrophobic patch, thereby interrupting the structure and stability of the protein, and its ability to interact with other proteins. TAX1BP3 is highly expressed in heart and brain and consistent with the clinical findings observed in our patients; a knockdown of TAX1BP3 causes elongation defects, enlarged pericard, and enlarged head structures in zebrafish embryos. Thus, we describe a new genetic disorder that expands the monogenic cardiomyopathy disease spectrum and suggests that TAX1BP3 is essential for heart and brain development., (© 2015 WILEY PERIODICALS, INC.)

Background: Studies have shown sex-based disparities in ST-segment elevation myocardial infarction (STEMI) management and prognosis. We sought to compare women and men undergoing primary percutaneous coronary intervention (PCI) for STEMI in a large, prospective, contemporary context., Methods: The Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial randomized 3,602 patients (23.4% women and 76.6% men) with STEMI presenting within 12 hr of onset of symptoms to bivalirudin or heparin plus glycoprotein IIb/IIIa inhibitors and to PCI with drug-eluting or bare metal stents., Results: Compared with men, women presented later after symptom onset and were more often treated with medical management alone (6.9% vs. 4.7%; P = 0.01). Women had significantly higher rates of 3-year major adverse cardiac events (MACE) and major bleeding. After adjusting for baseline differences, female sex remained an independent predictor of major bleeding (hazard ratio [HR] 1.81, 95% confidence interval [CI] 1.41-2.33; P < 0.0001) but not of MACE (HR 1.09; 95% CI 0.91-1.32; P = 0.35)., Conclusions: This study found that women with STEMI are at increased risk of bleeding as compared to men. While female sex may not directly contribute to increased risk of MACE, it is, however, associated with the presence of comorbidities that increase the risk of ischemic events long-term. Further dedicated studies are needed to confirm these findings and to assess strategies to optimize both the initial emergent treatment and long-term management in this high-risk subset. © 2014 Wiley Periodicals, Inc., (© 2014 Wiley Periodicals, Inc.)

Objective: To assess the relationship of femoral vascular closure device (VCD) use to bleeding and ischemic events in patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) via different anticoagulation strategies., Background: It is unknown whether femoral VCD reduce major bleeding after primary PCI for STEMI using bivalirudin anticoagulation., Methods: We compared VCD-treated patients with propensity-matched controls in the HORIZONS-AMI trial with respect to net adverse clinical events (NACE), defined as the composite of major bleeding unrelated to coronary artery bypass graft surgery (CABG) and major adverse cardiac events (comprised of death, reinfarction, ischemia-driven target vessel revascularization, and stroke), at 30 days and 1 year., Results: Among 3,602 patients enrolled in HORIZONS-AMI, 2,948 underwent primary PCI via femoral arterial access and 896 (30%) received VCDs, of whom 642 were included in our model along with 642 propensity-matched controls. At 30 days, VCD-treated patients had significantly less NACE (6.7% vs. 10.8%, HR: 0.61, 95% CI: 0.42-0.89, P = 0.009), driven by a lower rate of non-CABG related major bleeding (5.0% vs. 8.1%, HR: 0.61, 95% CI: 0.39-0.94, P = 0.02). Bleeding reduction was maintained at one year and consistent in magnitude regardless of randomization to bivalirudin or unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor (P for interaction = 0.84)., Conclusion: In patients undergoing transfemoral primary PCI for STEMI, VCD use was associated with significantly lower non-CABG major bleeding irrespective of anticoagulation strategy., (© 2014 Wiley Periodicals, Inc.)

Background: Accurate positioning of the valve device during transcutaneous aortic valve implantation (TAVI) is of crucial importance. The Paieon C-THV navigation system has been designed to correctly guide device deployment during TAVI., Objectives: Using this navigation system we aimed to determine the correlation between the anatomic measures of the native aortic valve and the deployed self-expandable valve positioning and to explore the impact upon procedural outcomes., Methods: We analyzed data of 68 patients with severe symptomatic aortic stenosis undergoing TAVI, using the catheter-based Medtronic-CoreValve self-expandable system. Patients were subdivided into two groups according to whether the C-THV system was used (50) or not (18) during the implantation process. Analysis of geometrical outcomes vs. clinical outcomes including postprocedural electrical conduction defect and/or para-valvular leaks was performed., Results: Taking the target implantation line as a reference; relatively lower vs. higher implantations correlated with a higher frequency of any new onset electrical conduction defect (ECD). The mean corresponding distance from valve inferior edge below the virtual aortic annulus line was 3.0 ± 1.6 mm vs. 1.2 ± 1.3 mm in patients with (38.5%) vs. without any new onset ECD, respectively (P = 0.05). The use of C-THV navigation seemed to correlate with higher valve implants but it had no impact on the occurrence of postprocedural paravalvular leaks., Conclusions: Self-expandable valve implants guided by C-THV navigation seems to be associated with more precise implants and lower risk for postprocedural electrical conduction defects, due to higher location in relation to the target line., (© 2014 Wiley Periodicals, Inc.)

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 = 370) and the low-risk groups (N = 553)., Results: Proportion of patients with elevated cardiac biomarkers was similar in both groups. The presence of peripheral vascular disease (OR = 1.88, 95% confidence interval [CI] = 1.62-5.80, P < 0.001) and a GRACE score of >140 (OR = 1.88, 95% CI = 1.29-2.75, P < 0.001) were the strongest predictors of HRCA. Patients with HRCA were prone to more complications during hospitalization and at 30 days (11.9% vs. 6%, P < 0.01) and increased 1-year mortality (6.7% vs. 0.9%, P < 0.001). HRCA was the strongest predictor for 30-day MACCE (OR = 2.32, 95% CI = 1.42-3.79, P < 0.001). HRCA (OR = 8.36, 95% CI = 1.01-69.4, P = 0.049; OR = 3.64, 95% CI = 1.2-11.07, P = 0.02) and GRACE score of >140 (OR = 6.86, 95% CI = 1.68-27.9, P = 0.007; OR = 4.84, 95% CI = 1.74-13.5, P = 0.002) were significant predictors of 30-day and 1-year mortality, respectively., Conclusions: HRCA is predicted by clinical parameters and was not associated with elevated cardiac biomarkers. These patients fared worse when compared with those with low-risk anatomy. We suggest that HRCA predictors should be included in the risk stratification of patients with NSTE-ACS., (Copyright © 2013 Wiley Periodicals, Inc.)

Objectives: To assess the impact of age on safety and efficacy of paclitaxel-eluting stent (PES) implantation during primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI)., Background: The benefits of paclitaxel-eluting stent (PES) implantation during primary PCI were confirmed by the long-term results of the HORIZONS-AMI trial. Whether the effects of PES are independent of age has not been reported., Methods: Data on 3,006 patients from the HORIZONS-AMI study randomized in a 3:1 ratio to PES or bare-metal stent (BMS) in whom at least one stent was implanted were assessed. There were 2,302 (76.6%) patients <70, and 704 patients ≥70 years of age., Results: At 3 years, among older patients a trend toward lower risk of major adverse cardiac events (MACE; death from any cause, stroke, reinfarction and unplanned revascularization for ischemia) related to PES use was observed (PES vs. BMS: 18.0% vs. 21.3%; P = 0.07). There was also a trend for reduction of MACE related to PES in older patients (26.4% vs. 33.1%; P = 0.09). Both, patients <70 and ≥70 years of age treated with PES were at lower risk for ischemic target vessel revascularization. However, a higher risk of major bleeding in elderly patients treated with PES was observed (P = 0.02 for interaction between age group and PES effects). No interaction between age and stent type in terms of the risk of other clinical end points, including all-cause death, was confirmed., Conclusions: For STEMI patients undergoing primary PCI, the implantation of PES as compared with BMS reduced ischemic TVR, and this effect was independent of age., (Copyright © 2013 Wiley Periodicals, Inc.)

Background: The study sought to assess the clinical profile, outcome, and predictors for mortality of "real-world" high-risk severe aortic stenosis patients according to the mode of treatment assigned., Methods: Patients were referred to a dedicated clinic for meticulous screening and multidisciplinary team assessment and 343 were finally assigned treatment (age 81.3 ± 7.2 years, 42.3% men): transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN or CoreValve device, 100 (29.2%); surgical aortic valve replacement (SAVR), 61 (17.8%); balloon valvuloplasty (as definitive therapy), 27 (7.9%); medication only, 155 (45.2%). No patient was lost to follow-up., Results: The balloon valvuloplasty group had a significantly higher 1-month mortality rate (18.5%) than the TAVR group (3%, P = 0.006) and medical therapy group (3.9%; P = 0.004), without significant difference from the SAVR group (11.5%, P = 0.5). One-year cumulative survival was significantly higher in the TAVR group (92%) than in the other groups (SAVR 71%, balloon valvuloplasty 61.5%, medication 65%; all P < 0.001). Among survivors, 1-year rates of high functional class (NYHA I/II) were as follows: TAVR, 84.6%; SAVR, 63.3%; balloon valvuloplasty, 18.2%; medication, 21.4% (TAVR vs. SAVR, P = 0.04; SAVR vs. balloon valvuloplasty or medical therapy, P = 0.01). On multivariate regression analysis, renal failure (hazard ratio [HR] = 5.3, P < 0.001), not performing TAVR (HR = 4.9, P < 0.001), and pulmonary pressure (10 mm Hg, HR = 1.2, P = 0.02) were independent predictors of 1-year mortality., Conclusions: TAVR, performed in carefully selected high-risk patients, is associated with an excellent survival rate and high functional class. Patients treated with another of the available modalities, including SAVR, had a worse outcome, regardless of which alternative treatment they receive., (Copyright © 2012 Wiley Periodicals, Inc.)

Objectives: To explore the long-term results following implantation of drug-eluting stents (DES) in bifurcation lesions according to contemporary "real world" practice., Background: Limited information is available on the long-term outcomes of patients with bifurcation lesions who are treated using DES. A systematic approach for bifurcation lesion management was applied, using either a "provisional" single stent technique or a dedicated two stents strategy according to the side-branch diameter and severity of its ostial stenosis., Methods: Four hundred one consecutive patients underwent bifurcation percutaneous coronary intervention (PCI) using DES and were included in our prospective registry. All adverse events were recorded up to 2 years and distinguished according to the planned PCI strategy (e.g., one versus two stents technique)., Results: A planned two stents strategy was used in 141 patients (35% of patients). In 260 patients (65%), the planned treatment involved stenting of the main branch only with "provisional" stenting of the side-branch according to procedural course. Thus, 24 patients (9.2%) needed additional stenting at the side-branch to complete the PCI. Cumulative major adverse cardiac event rate at 1 and 2 years was similar for both groups (11.4% vs. 14.8% at 1 year and 19.4% vs. 25.7% at 2 years for the single vs. two stents groups, accordingly, P = NS for both). Likewise, there was no difference in mortality, cardiac mortality, myocardial infarction, need for target lesions or target vessel revascularization, or definite stent thrombosis rate between the two groups at 6, 12, and 2 years follow-up. The rate of angiographically confirmed (i.e., definite) stent thrombosis did not differ between the two groups during follow-up., Conclusions: Our study revealed favorable long-term clinical results following DES implantation using a systematic, rather simplified approach towards bifurcation stenting and using either a single or double stenting technique., (Copyright © 2011 Wiley Periodicals, Inc.)

We describe a patient with severe aortic stenosis who underwent CoreValve (Medtronic) implantation and presented several days later with a tachyarrhythmic episode. The electrocardiographic features of the arrhythmia were compatible with left-ventricular outflow tract ventricular-tachycardia. The life-threatening event was not associated with ischemia or an electrolyte disorder and was not drug-induced. A probable cause was the irritation of the myocardium by the prosthetic valve. Clinicians should be aware that the presence of anatomical parameters that increases the risk for myocardial injury and the need for pacemaker implantation might indicate an increased risk of a tachyarrhythmic episode., (Copyright © 2011 Wiley Periodicals, Inc.)

Objectives: We aim to explore the clinical outcome of drug-eluting stents (DES) versus bare-metal stents (BMS) implantation in diabetics versus nondiabetic patients., Background: Diabetic patients sustain worse long-term clinical outcomes after percutaneous coronary interventions (PCI) when compared with nondiabetics. The use of DES decreases the rate of repeat revascularization in this population but data concerning long-term clinical benefits, such as myocardial infarction (MI) or mortality is scant., Methods: We analyzed data from a comprehensive registry of 6,583 consecutive patients undergoing PCI at our center. A propensity score was used for analysis of outcomes and for matching (DES vs. BMS). Outcome parameters were total mortality, MI, repeat target vessel revascularization (TVR) rates, and risk-adjusted event-free survival. Within this cohort, we identified 2,571 nondiabetic patients and these were compared with 1,826 diabetic coronary patients., Results: Mean and median follow up time was 3 and 3.25 years, respectively. Overall, diabetics had higher rates of major-adverse cardiovascular events (MACE) at 4 years compared with nondiabetics (23.03 vs. 31.96 P > 0.001). DES use was associated with lower rates of TVR in both groups [diabetics hazard ratio (HR) = 0.56, 95% confidence interval (CI): 0.42-0.76, P < 0.001, nondiabetics HR = 0.73, 95% CI: 0.55-0.97, P = 0.03] while sustained decreased rates of both mortality and MI were evident solely among diabetics (HR = 0.71, 95% CI: 0.56-0.89, P = 0.004 in diabetic vs. HR = 0.88, 95% CI: 0.69-1.13, P = 0.3)., Conclusions: In a "real-world," unselected population and extended clinical use, DES in diabetics was associated with sustained decreased rates of MI, death, TVR, and MACE while this benefit was attenuated in the nondiabetic population., (Copyright © 2011 Wiley-Liss, Inc.)

Objective: To assess the value of the ratio between contrast medium volume and glomerular filtration rate (CMGFRr) for prediction of development of contrast-induced nephropathy (CIN) and mortality in patients with ST-segment elevation acute myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI)., Background: Renal function is a strong predictor of outcome in patients with STEMI. CIN may complicate the course of primary PCI in these patients., Methods: The study population included all 871 consecutive patients with STEMI without cardiogenic shock who underwent primary PCI at our center from January 1, 2001, to October 30, 2006. CIN was defined as an absolute increase in serum creatinine > 0.5 mg/dL or a relative increase >25% within 48 hr after PCI., Results: In-hospital CIN developed in 72 (8.3%) patients. On linear regression analysis, the following variables were independently associated with CIN: male sex (odds ratio [OR] = 0.42, 95% confidence interval [CI], 0.18-0.97, P = 0.04), GFR < 60 (OR = 3.6, 95% CI, 2.79-4.78, P < 0.0001), multivessel coronary artery disease (OR = 1.67, 95% CI, 1.08-2.58, P = 0.02), CMGFRr (OR = 1.53, 95% CI, 1.01-2.31, P = 0.04, for upper tertile vs. lower two tertiles), and Killip class > 1 (OR = 1.35, 95% CI, 1.03-1.76, P = 0.03). CMGFRr > 3.7 was a strong independent predictor of CIN (OR = 3.87, 95% CI, 1.72-8.68, P = 0.001). Twenty-six (2.9%) patients died at 1 month after PCI. The following variables were independently predictive of 1-month mortality: CMGFRr > 3.7 (OR = 3.3, 95% CI, 1.22-9.04, P = 0.018) and multivessel coronary artery disease (OR = 2.3, 95% CI, 1.28-4.07, P = 0.005)., Conclusion: The contrast medium-to-GFR ratio is a strong predictor of CIN and of 1-month mortality in patients undergoing primary PCI for STEMI., (Copyright © 2010 Wiley-Liss, Inc.)

Thorough imaging of the aortic valve and related structures is highly important before and during percutaneous valve implantation. However, imaging modalities currently used in the catheterization room, namely, conventional aortography and transesophageal echocardiography are limited in guiding the precise valve placement during the implantation procedure. A novel real-time imaging modality capable of three-dimensional reconstruction of the ascending aorta has recently been introduced (CardioOp-THV, C-THV, Paieon Inc., Park Afek, Israel). We applied this system during a complex procedure of percutaneous aortic valve implantation in a patient with severe aortic tortuosity, large aortic-valve angulation, and asymmetric septal hypertrophy. We found the guidance system very helpful not only for accurate positioning of the valve but also for selecting the optimal projection for valve implantation, selecting the prosthetic valve size, and evaluating the results after deployment.

Objectives: To ascertain the long-term safety, efficacy, and pattern of use of drug-eluting stents (DES) in routine clinical practice., Methods: We analyzed a registry of 6,583 consecutive patients undergoing percutaneous coronary intervention (PCI), of whom 2,633 were treated using DES (DES group) and 3,950 were treated using bare-metal stents (BMS group). Propensity score was used for stratified analysis of outcomes and for matching. Outcomes were total mortality, myocardial infarction (MI), repeat target vessel revascularization (TVR) rates, and risk-adjusted event-free survival., Results: Follow-up time was 6 months to 5.18 years (mean: 3 years). Patients in the DES group were more likely to be diabetic and had use of longer or more stents, treatment of more lesions and of more proximal main vessels. After propensity score matching, the cumulative mortality was 12.85% in the DES group versus 14.14% in the BMS group (P = 0.001). Use of DES reduced the occurrence of MI (5.17% vs.5.83%, P = 0.046), of clinically driven TVR (9.76% vs. 12.28%, P < 0.001) and of the composite endpoint of death/MI/TVR (23.38% vs. 26.07%; P < 0.001)., Conclusions: Our risk-adjusted event-free survival analysis indicates a prognostic benefit for DES utilization that sustains up to 5 years following PCI.