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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: 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.)

There is limited organized "real life" data regarding the long-term structural and functional durability of transcatheter aortic valve implants, a topic of major importance. We assessed the 5-year structural and functional integrity outcomes following trans-catheter aortic valve implantation (TAVI) with both self-expandable and balloon-expandable prosthetic valve devices. This study included 450 consecutive patients who underwent TAVI for severe symptomatic aortic stenosis (AS) between September 2008 and December 2011. Data were acquired from a multicenter Israeli registry and the median follow up time was 5.6 years. In 184 patients (40.9%) who survived 5 years, prostheses displayed sustained hemodynamic performance, with average peak and mean aortic valve gradients of 16.2 ± 8.9 and 9.2 ± 6.6 mm Hg, respectively. Late structural valve deterioration was found in 22 (12.3%) patients. Of these, 16 (8.9%) experienced valve deterioration and 6 (3.3%) experienced valve failure. Among the 6 patients with bioprosthetic valve failure, only 3 underwent re-interventions. Bioprosthetic valve dysfunction occurred more frequently in patients with small valves (23 mm) and high peak and mean transvalvular gradients at baseline. In conclusion, a relatively low rate of valve deterioration or failure was noted in our long-term follow-up study after TAVI procedures with both the catheter-based self-expandable and balloon-expandable prosthetic valves., (Copyright © 2019 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.)

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.)

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.

We evaluated temporal trends in gender-related differences in patients who underwent transcatheter aortic valve implantation (TAVI) for severe symptomatic aortic stenosis from a multicenter TAVI registry during the years 2008 to 2016. Our final cohort included 1,159 males and 1,370 females, with a median follow-up of 2.3 (IQR 1.2, 4.4) years. For temporal trends analysis, the entire population was divided according to period of procedure: 2008 to 2012 and 2013 to 2016. During the 2008 to 2012 period, the rates of in-hospital aortic paravalvular leak, myocardial infarction, pacemaker implantation, and stroke were higher among men than women, but became comparable between the gender during the 2013 to 2016 period. Multivariate analysis demonstrated that female patients who underwent TAVI between the years 2008 and 2012 had a 26% lower risk of death compared with male patients (p = 0.004), but there were no gender-related differences in mortality risk between the years 2013 and 2016 (hazard ratio 1.07, p = 0.6; gender-by-year of procedure, p = 0.027 for interaction). In conclusion, the favorable long-term prognosis described in female patients during the earlier TAVI period seemed to diminish with contemporary TAVI. This might be attributed to current technological advances and improved valve sizing, with a more significant benefit in favor of male patients., (Copyright © 2018. Published by Elsevier Inc.)

Background: Rapid ventricular pacing (RVP) is used commonly during transcatheter aortic valve replacement (TAVR). Little is known about the safety and clinical consequences of this step. The aim of this study was to assess the impact of RVP on immediate and long-term clinical outcomes in a large cohort of non-selected TAVR patients., Method and Results: The study included 412 consecutive patients undergoing TAVR with a mean age of 82±7 years, of which 47% were male. Patients were divided according to the number of RVPs during the TAVR procedure comparing patients undergoing no pacing (0), 1 to 2, and ≥3 pacing episodes (3+). Patients undergoing 3+ pacing episodes were significantly more likely to develop new atrial fibrillation (5.6% versus 7.3% versus 15%, respectively, for 0, 1-2, and 3+ groups, P =0.047), acute kidney injury (AKI) (18% versus 18% versus 28%, respectively, P <0.001), prolonged procedural hypotension (0%, 16%, and 25%, respectively; P <0.001), and suffered greater in-hospital mortality (1.7%, 1.7%, and 6.5%, respectively, P =0.045), and 1-year mortality (11.1%, 7.7%, and 18%, respectively, P =0.015). Multivariate Cox regression analysis indicated that acute kidney injury (OR 3.27 [1.763-6.09], P <0.001), euroSCORE II (OR 1.06 per unit [1.01-1.12], P =0.03), and 3+ pacing episodes (OR 2.35 [1.18-4.7], P =0.02) were the only independent predictors for 1-year mortality., Conclusions: In patients undergoing TAVR, multiple RVP episodes and prolonged RVP duration are associated with adverse outcomes including short- and long-term mortality. Thus, operators should attempt to minimize the use of RVP, especially in patients who are at risk for post-procedural acute kidney injury., (© 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)

Background: Transcatheter aortic valve replacement (TAVR) is now the treatment of choice for high-surgical risk patients with symptomatic aortic stenosis. Little is known regarding the outcome of TAVR in patients with previous malignancy., Methods: We investigated 477 patients who underwent TAVR in a tertiary medical center. Subjects were divided into two groups according to malignancy status: no history of malignancy (n = 386) and positive history of malignancy (n = 91)., Results: Mean age of the study population was 81 ± 7 years, and 52% were men. No major differences in baseline characteristics were found between groups. All-cause mortality was 24% for both malignancy and non-malignancy groups at a mean follow-up of 851 ± 629 days. Kaplan-Meier survival analysis demonstrated no difference in all-cause mortality between groups. Multivariate Cox regression analysis showed that malignancy status did not affect prognosis regarding overall mortality (hazard ratio [HR], 0.83; 95% confidence interval [CI], 0.5-1.4; P=.46). However, cancer therapy administered within 12-months of TAVR was significantly associated with increased total mortality among patients undergoing TAVR (HR, 4.38; 95% CI, 1.14-16.77; P=.03)., Conclusions: Malignancy is a common comorbidity among TAVR candidates. Mere history of malignancy among elderly patients does not adversely affect short-term or long-term outcomes after TAVR; however, history of recent (<1 year) cancer-related treatment increases the risk for long-term mortality after TAVR. Decisions regarding TAVR among oncological patients should be individualized according to their malignancy status and anticipated life expectancy.

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.)

Background: The Syntax score (SS) is a helpful tool for determining the optimal revascularization strategy regarding coronary artery bypass surgery (CABG) vs. percutaneous coronary intervention (PCI) in patients with complex coronary disease. While an association between higher SS and mortality was found for PCI patients, no such association was found for CABG patients., Objectives: To assess whether the SS predicts late mortality in patients undergoing CABG in a real-world setting., Methods: The study included 406 consecutive patients referred for CABG over a 2 year period. Baseline and clinical characteristics were collected. Angiographic data SS were interpreted by an experienced angiographer. Patients were divided into three groups based on SS tertiles: low ≤ 21 (n = 205), intermediate 22-31 (n = 138), and high ≥ 32 (n = 63). Five year mortality was derived from the National Mortality Database., Results: Compared with low SS, patients with intermediate and high scores were significantly older (P = 0.02), had lower left ventricular ejection fraction (64% vs. 52% and 48%, P < 0.001) and greater incidence of acute coronary syndrome, left main disease, presence of chronic total occlusion of the left anterior descending and/or right coronary artery, and a higher EuroSCORE (5% vs. 5% and 8%, P < 0.01). Patients with intermediate and high SS had higher 5 year mortality rates (18.1% and 19%, respectively) compared to patients with low score (9.8%, P = 0.04). On multivariate analysis, SS was not an independent predictor of late mortality., Conclusion: Patients with lower SS had lower mortality after CABG, which is attributable to lower baseline risk. SS is not independently predictive of late mortality in patients with multi-vessel coronary artery disease undergoing CABG.

Objectives: The presence of a coronary chronic total occlusion (CTO) is a common consideration in favour of surgical revascularization. However, studies have shown that not all patients undergoing coronary artery bypass grafting (CABG) have a bypass graft placed on the CTO vessel. The aim of this study was to determine the prevalence of CTO among patients referred for CABG and the significance of incomplete CTO revascularization in these patients., Methods: The study included 405 consecutive patients undergoing CABG during a 2-year period. Clinical, echocardiographic and angiographic data were collected. Determination of whether or not a CTO was bypassed was made by correlating data from the surgical reports and preprocedural angiograms. The primary end point of this study was 5-year all-cause mortality., Results: Two hundred and twenty-one CTOs were found in 174 patients: 132 patients (76) had 1 CTO; 37 (21) had 2 CTOs and 5 (3) had 3 CTOs. Of the 221 CTOs, 191 (86%) were bypassed. All left anterior descending (LAD) CTOs were grafted; however, 12 of left circumflex and 22% of right coronary artery CTOs did not receive bypass grafts. Incomplete CTO revascularization was associated with older age, more comorbidities, including stroke, renal impairment and lower ejection fraction. However, incomplete CTO revascularization was not associated with increased 5-year mortality., Conclusions: Coronary CTOs are a common finding in patients referred for bypass surgery. The presence of a CTO is not independently associated with an adverse long-term outcome. While most CTOs are successfully bypassed, failure to revascularize a non-LAD CTO is not associated with adverse long-term outcome., (© The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: Percutaneous edge-to-edge mitral valve repair using the MitraClip system has evolved as a new tool in the treatment of mitral regurgitation (MR)., Objectives: To present our initial experience with MitraClip implantation in 20 high risk patients at Sheba Medical Center., Methods: Twenty high surgical risk patients with symptomatic significant MR underwent MitraClip implantation. Clinical and echocardiographic parameters were recorded at baseline and at follow-up., Results: The patients' mean age was 76 years and 65% were male. Coronary artery disease was present in 85% and 45% ent in had previous bypass surgery. Renal failure was present in 65%, atrial fibrillation in 60%, and 30% had an implantable cardioverter defibrillator/cardiac resynchronization therapy device. Mean left ventricular ejection fraction was 36%. Grade III-IV MR was present in all patients with the vast majority suffering from functional MR secondary to ventricular remodeling. New York Heart Association (NYHA) class was III-IV in 90%. Patients were followed for a mean of 231 days. Acute reduction of MR grade to < or = 2 was accomplished in 19 of the 20 patients (95%) with a 30 day mortality of 5%. At follow-up MR was reduced to < or = 2 in 64% of patients, and NYHA class improved in 70% of patients. An additional 2 patients (11%) died during follow-up., Conclusions: MitraClip implantation is feasible and safe in high risk highly symptomatic patients with significant MR. Acute and mid-term results are comparable to similar high risk patient cohorts in the literature. Continued surveillance and longer follow-up are needed to elucidate which patients are most likely to benefit from the procedure.

Objectives: We aimed to evaluate the management and outcomes of patients of the octogenarian age group with non-ST elevation myocardial infarction (NSTEMI) in a real-world setting., Methods: The risk of 30-day and 1-year mortality by age and the time of coronary angiography [categorized as early (≤48 h of admission) and late (>48 h of admission)] was assessed among 2021 NSTEMI patients enrolled in the Acute Coronary Syndrome Israeli Survey (ACSIS) between 2004 and 2008., Results: Elderly patients (≥80 years) comprised almost 20% of the study population, and experienced a significantly higher rate of in-hospital complications. The risk of 1-year mortality was 3.4-fold (P<0.001) higher among octogenarian patients compared with younger patients. Multivariate analysis showed that among patients aged at least 80 years, utilization of revascularization was associated with a lower risk of death at 1 year [hazard ratio (HR)=0.50, P=0.004], but not at 30 days, compared with no angiography. However, referral for early coronary angiography was associated with a lower risk of death both at 30 days and at 1 year (HR=0.4, P=0.04 and HR=0.38, P=0.02, respectively)., Conclusion: Our findings indicate that patients of the octogenarian age group comprise a high-risk subset of the NSTEMI population, in whom early referral for coronary angiography is independently associated with a lower risk of mortality at 30 days and 1 year.

Background: The prevalence of aortic stenosis increases with advancing age. Once symptoms occur the prognosis in patients with severe aortic stenosis is poor. The current and recommended treatment of choice for these patients is surgical aortic valve replacement. However, many patients, mainly the very elderly and those with major comorbidities, are considered to be at high surgical risk and are therefore denied treatment. Recently, a transcatheter alternative to surgical AVR has emerged., Objectives: To describe the first year experience and 30 day outcome of transcatheter aortic self-expandable CoreValve implantation in Israel., Methods: Transcatheter aortic valve implantation using the CoreValve system has been performed in Israel since September 2008. In the following year 55 patients underwent CoreValve TAVI in four Israeli centers., Results: Patients' mean age was 81.7 +/- 7.1 years; there were 35 females and 20 males. The mean valve area by echocardiogram was 0.63 +/- 0.16 cm2. The calculated mean logistic Euroscore was 19.3 +/- 8%. Following TAVI, mean transvalvular gradient decreased from baseline levels of 51 +/- 13 to 9 +/- 3 mmHg. The rate of procedural success was 98%. One patient died on the first day post-procedure (1.8%) and all-cause 30 day mortality was 5.5% (3 of 55 patients). One patient had a significant post-procedural aortic regurgitation of > grade 2. Symptomatic improvement was evident in most patients, with reduction in functional capacity grade from 3.2 +/- 0.6 at baseline to 1.4 +/- 0.7. The most common post-procedural complication was complete heart block, which necessitated permanent pacemaker implantation in 37% of patients., Conclusions: The Israeli first year experience of transcatheter aortic valve implantation using the CoreValve self-expandable system demonstrates an effective and safe procedure for the treatment of severe aortic stenosis in patients at high surgical risk.

The aim of this study was to evaluate long-term (3.4 years) outcomes and predictors of clinical events in patients treated with sirolimus-eluting stents in the Israeli arm of the e-Cypher registry. From July 2002 to October 2003, 488 patients from 8 medical centers in Israel were enrolled in the e-Cypher registry. Nineteen patients with interventions in venous grafts were excluded from the final analysis. Long-term follow-up was completed for 98% of the remaining patients. There were 29 cases (6.3%) of death (3.9% cardiac and 2.4% noncardiac deaths). According to the broad academic research consortium definition of stent thrombosis, there were 19 cases (4%) of stent thrombosis (incidence density 0.9 cases/100 patient-years). There were 46 cases (9.9%) of target lesion revascularization and 76 cases (16.3%) of major adverse cardiac events (combination of death, myocardial infarction, and target lesion revascularization). Independent predictors of stent thrombosis were renal failure (hazard ratio 9.6, 95% confidence interval 1.9 to 47), stent length (hazard ratio 1.1, 95% confidence interval 1 to 1.2), and the off-label use of sirolimus-eluting stents (hazard ratio 5.3, 95% confidence interval 1.2 to 24). In conclusion, during >3 years of follow-up, stent thrombosis, major adverse cardiac events, and target lesion revascularization continued at constant rates over time. Clinical parameters such as renal failure and procedural parameters such as off-label use and stent length were independent predictors of stent thrombosis.

Background: Left ventricular apical ballooning, a new syndrome recently described in Japan, is characterized by chest pain, electrocardiographic changes mimicking acute myocardial infarction, and transient apical dyskinesia with normal coronary arteries. Although several studies have defined the clinical characteristics, the prevalence of this syndrome remains unclear., Hypothesis: This study sought to determine the prevalence of left ventricular apical ballooning syndrome., Methods: From January 2002 to September 2004, clinical, echocardiographic, and angiographic data of hospitalization and follow-up were collected from 638 consecutive patients referred to our Heart Institute for primary percutaneous intervention., Results: Thirteen patients (2%) were diagnosed with transient left ventricular apical ballooning. All but one patient were women, representing a 6% incidence for the female patients with acute myocardial infarction. A triggering factor was identified in eight. One patient died of cardiogenic shock. Left ventricular systolic function recovered completely within 4-5 weeks in the remaining 12 survivors., Conclusion: This syndrome is not uncommon and should be considered particularly in female patients presenting with acute myocardial infarction.

Background: Five to 15% of the population have allergy to nickel, chromium, or molybdenum, which is a potential cause for in-stent restenosis. The Titan stent is made of stainless steel and is coated with titanium-nitride oxide (TiNOX), which completely prevents the discharge of metal elements. We performed a real-life multicenter registry to assess the short- and long-term characteristics of the Titan stent., Methods and Results: A total of 103 Titan stents was implanted in 100 patients. Patients were 61.4+/-12.6 years old (81 men). Risk factors included hypercholesterolemia (63%), hypertension (53%), diabetes mellitus (DM; 35%), and current smoking (23%). Indications for PCI (percutaneous coronary intervention) were acute coronary syndromes (ACS) in 68% [acute ST elevation myocardial infarction (MI) in 8%], stable AP (angina pectoris) in 25%, and silent ischemia in 7% of the patients. Fifty-two percent of the treated lesions were of Type B2 or C. Lesion length was 14.3+/-2.9 mm and stent diameter was 3.06+/-0.36 mm. Indications for stenting were prevention of restenosis in 66%, residual stenosis in 33%, dissection in 13%, acute MI in 13%, and in-stent restenosis in 7% of the patients. Procedural success was 100%, with no complications. At 30 days, there were no major adverse cardiac events (MACE), including death, MI, and revascularization. At 180 days, only three patients had TVR (target vessel revascularization); two had TLR (target lesion revascularization) (one PCI and one CABG [coronary artery bypass grafting]), and one patient had a new narrowing proximal to the stent and underwent CABG due to multivessel disease., Conclusions: The Titan stent has a remarkable safety profile in high-risk patients and complex coronary lesions and excellent short- and long-term outcome with a very low clinical TLR rate.

Background: Prior studies have yielded conflicting data on the advantage of primary angioplasty compared with thrombolysis in elderly patients with acute myocardial infarction (AMI). These studies, however, were performed before the contemporary widespread use of intracoronary stents and glycoprotien IIb/IIIa antagonists., Methods: We prospectively compared the outcome of 130 consecutive elderly patients (aged > or =70 years) with ST-elevation AMI who were admitted to 2 similar neighboring medical centers. Patients were assigned to receive either thrombolytic therapy with accelerated tissue-type plasminogen activator (center I) or primary angioplasty with routine stenting (center II)., Results: Of the patients assigned to receive primary angioplasty, 91% underwent stenting. At 6 months, patients treated with primary angioplasty, compared with those treated with thrombolytic therapy, had a lower incidence of reinfarction (2% vs 14%, P =.053) and revascularization for recurrent ischemia (9% vs 61%, P <.001) and a significant reduction in the prespecified combined end point of death, reinfarction, or revascularization for recurrent ischemia (29% vs 93%, P <.01). Primary angioplasty remained an independent predictor of the triple combined end point after controlling for potential covariables (relative risk 0.63, 95% CI 0.38-0.84). Major bleeding complications were also significantly reduced in the primary angioplasty group (0% vs 17%, P =.03)., Conclusions: Compared with thrombolysis, primary angioplasty with routine stenting in elderly patients with AMI is associated with better clinical outcomes and a lower risk of bleeding complications.