Partial Hepatectomy of a VA-ECMO Patient After Mechanical CPR by LUCAS Device Due to a Catastrophic Liver Laceration: A Case Report.

BACKGROUND Many patients experiencing acute coronary syndrome (ACS) present in cardiac arrest. Mechanical chest compressions are a common tool in cardiopulmonary resuscitation (CPR) and have their benefits as well as disadvantages and reported complications. In recent years, veno-arterial extracorporeal oxygenation membrane (VA-ECMO) has proven to be a promising tool in these circumstances and is now considered part of the treatment algorithm in emergent and refractory cases. The combination of mechanical compressions and the ECMO lead to "new" complicated situations in the patients. We discuss such a patient, who required emergent surgery due to complications from his resuscitation, while under ECMO. CASE REPORT A 56-year-old man, with medical history of cardiovascular risk factors, presented to our facility due to ST segment elevation myocardial infarction. During his catheterization, he went into cardiac arrest and needed cardiopulmonary resuscitation (CPR) using a LUCAS3™ device. Because no rhythm was restored, he was promptly placed on VA-ECMO support with immediate, albeit transient, stabilization. After transportation to our Intensive Care Unit (ICU), he quickly deteriorated again hemodynamically and after imaging workup it was discovered he had a major laceration to his liver and was rushed emergently to the operating room where he underwent partial hepatectomy, while on full anticoagulation due to the ECMO support. CONCLUSIONS Complications from mechanical CPR are common, including liver laceration. Patients who are placed on ECMO following such measures should be carefully evaluated for such complications as they might affect the treatment and prognosis.

Shifting from vitamin K antagonists to non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation: predictors, patterns and temporal trends.

BACKGROUND: Non-Vitamin K antagonist oral anticoagulants (NOACs) emerged as an alternative with comparable or superior efficacy and safety to vitamin K antagonists (VKAs) for stroke prevention in patients with non-valvular atrial fibrillation (AF). OBJECTIVES: The aim of the current study was to investigate the patterns, predictors, timelines and temporal trends of shifting from VKAs to NOACs. METHODS: In this retrospective observational study, the computerized database of a large healthcare provider in Israel, Maccabi Healthcare Services, was searched to identify patients with AF for whom either a VKA or NOAC was prescribed between 2012 and 2015. Time from diagnosis to therapy initiation and to shifting between therapies was evaluated. RESULTS: Out of 6987 eligible AF incident patients, 2338 (33.4%) initiated treatment with a VKA and 2221 (31.7%) with a NOAC. In addition, 5259 prevalent patients were analyzed. During the study period, NOAC prescriptions proportion among the newly diagnosed cases increased from 32 to 68.4% (p for trend <  0.001). The median time from diagnosis to first dispensing was greater in NOAC than VKA and decreased among patients treated with NOAC during the study period (2012: 1.9 and 0.3 months, 2015: 0.7 and 0.2 months, respectively). During follow-up, 3737 (49%) patients (54.3% and 47.1% of the incident and prevalent cases, respectively), shifted from a VKA to a NOAC, after a median of 22 months and 39 months in the incident and prevalent cases, respectively, decreasing throughout the study period. Female gender, younger age, southern district, higher CHADS2 and CHA2DS2-VASC score, non-smoking, and treatment with antiplatelets were associated with a greater likelihood for therapy shift. Shifting from a NOAC to a VKA decreased over time from 8 to 4.5% in 2012 to 0.5% and 0.7% in 2015 in the incident and prevalent groups, p <  0.001 respectively. CONCLUSIONS: Shifting from VKA to NOAC occurred in 50% of the cases, more frequently among incident cases, and younger patients with greater stroke risk. Shifting from a NOAC to a VKA was much less frequent, yet it occurred more often in incident cases and decreased over time. A socially and economically sensitive program to optimize the initiation of OAC therapy upon diagnosis is warranted.

Sex-specific contemporary trends in incidence, prevalence and survival of patients with non-valvular atrial fibrillation: A long-term real-world data analysis.

INTRODUCTION: Atrial fibrillation (AF) is a major increasing public health problem worldwide, with clinical and epidemiological differences between men and women. However, contemporary population-level data on incidence and survival are scarce. AIM: To evaluate sex-specific contemporary trends in the incidence, prevalence, and long-term survival of non-valvular AF in a real-world setting. METHODS: AF patients diagnosed between 2007-2015, insured by a large, state-mandated health organization in Israel (Maccabi Healthcare Services) were included. AF was diagnosed based on registered diagnoses. Patients with valvular disease, active malignancy, cardiac surgery ≤ 6 months, or recent pregnancy, were excluded. Annual incidence rate, period prevalence, and 5-year survival for each calendar year during the study period, were calculated. RESULTS: A total of 15,409 eligible patients (8,288 males, 7,121 females) were identified. Males were more likely to be younger, have higher rates of underlying diseases (ischemic heart disease, heart failure, and chronic obstructive pulmonary disease), but with lower rates of hypertension and chronic kidney diseases as compared to female patients. During the study period, age-adjusted incidence decreased both in men: (-0.020/1,000-person year, p-for trend = 0.033) and, women (-0.025/1,000 person-year p = 0.009). The five-year survival rate was significantly higher among men vs. women (77.1% vs. 71.5%, respectively, p<0.001). Age-adjusted prevalence increased significantly among men (+0.102 per year, p-for trend<0.001) yet decreased among women (-0.082 per year, p-for trend = 0.005). A significant trend toward improved long-term survival was observed in women and not in men. CONCLUSIONS: The current study shows significant sex-related disparities in the incidence, prevalence, and survival of AF patients between 2007-2015; while the adjusted incidence of both has decreased over-time, prevalence and mortality decreased significantly only in women.

ECG changes after non-cardiac surgery: a prospective observational study in intermediate-high risk patients.

BACKGROUND: Efforts to mitigate the risk for perioperative cardiac events focus on both patient's and operation's risk and often include a preprocedural electrocardiogram (ECG). The merits of postprocedural ECG for detection of occult cardiac events occurring during surgery are unknown. We aim to explore the incidence of pre, and new postprocedural ECG pathologies in an intermediate-high risk population undergoing non-cardiac surgery. METHODS: This single-center, prospective, observational study, included patients older than 18 years with at least two cardiovascular risk factors who were scheduled for non-cardiac surgery. All patients had pre, and postprocedural ECG. The ECG was analyzed and coded according to the Minnesota criteria. A multivariable logistic regression analysis was performed for indices associated with new postoperative ECG pathologies. RESULTS: A total of 217 patients were enrolled. Preoperative pathologic ECG changes were recorded in 62.2% of the patients. Postoperatively, new ECG pathologies were documented in 49.8% of patients, most commonly T-wave changes (36.4% of changes). Pathologic ECG changes at baseline (OR 3.15, 95% CI [1.61-6.17]; P<0.01), diabetes (OR 1.93, 95% CI [1.02-3.64]; P=0.04), history of ischemic heart disease (OR 2.14, 95% CI [1.03-4.47]; P=0.04), higher volumes of fluid replacement (OR 1.70, 95% CI [1.10-2.61]; P=0.01) and higher levels of preoperative hemoglobin (OR 1.24, 95% CI [1.04-1.47]; P=0.01) were all independently associated with postoperative ECG changes. CONCLUSIONS: Pre-, but most importantly, postoperative ECG changes are common in intermediate-high risk surgical patients. Postoperative ECG may be valuable to disclose silent cardiovascular events that occurred during surgery.

Impact of Marital Status on the Outcome of Acute Coronary Syndrome: Results From the Acute Coronary Syndrome Israeli Survey.

Background Marriage is one of the common forms of social support. Conflicting evidence exists about the impact of marital status on the outcomes of patients with acute coronary syndrome ( ACS ). It is further not clear if sex disparity exists in the outcome of married and nonmarried patients with ACS. Methods and Results Data from the ACS Israeli Survey, collected between 2004 and 2016, were used to compare baseline characteristics, clinical indexes, and outcomes of married and nonmarried patients with ACS. Cox regression analysis and propensity score matching were used to explore if marital status was independently associated with long-term outcome. Of 7233 patients included with reported marital status, 5643 (78%) were married. Married patients were younger (62.69±12.07 versus 68.47±14.84 years; P<0.001), more frequently men (83.1% versus 54.8%; P<0.001), and less likely to be hypertensive (61.1% versus 69.3%; P<0.001). All-cause mortality incidence at 30 days and at 1 year was lower in married patients (3.1% versus 7.6% [ P<0.001]; and 7.1% versus 15.3% [ P<0.001], respectively). After adjusting for multiple covariates, the hazard ratio for 5-year all-cause mortality for married patients was 0.74 (95% CI , 0.62-0.88). Similar results were observed after propensity score matching. Kaplan-Meier estimates for all-cause mortality at 5 years demonstrated the best prognosis for married men and the worst for nonmarried women. Conclusions Marriage is independently associated with better short- and long-term outcomes across the spectrum of ACS . Attempts to intensify secondary prevention measures should focus on nonmarried patients and especially nonmarried women.

Usefulness of Serum Procalcitonin as a Markerfor Coexisting Infection in Patients With Acute Myocardial Infarction.

A significant proportion of patients with acute myocardial infarction (AMI) also present with clinical manifestations of inflammatory response, which may be confused with a concomitant infection. This leads to a dilemma regarding the empiric use of antibiotics. We explored if serum procalcitonin (PCT), which is known to be elevated in bacterial infections, may be utilized to rule-out bacterial infection in AMI patients. In this prospective, single center study, PCT was collected within 48 hours from AMI patients. Patients' demographic, clinical, and laboratory data were collected prospectively. Two experienced infectious diseases specialists blinded to the PCT results independently determined the presence of infection in every patient. Sensitivity, specificity, positive predictive value, negative predictive value, and the area under the receiver operating characteristic curve were calculated to determine the accuracy of PCT, fever, white blood cell (WBC) count, and C-reactive protein (CRP) levels for the diagnosis of the infection. The analysis included 230 AMI patients (age 63.0 ± 13.0 years) of whom 36 (15.6%) had coexisting infections. The best cutoff for PCT as a differentiating marker between patients with and without coexisting infection was 0.09 ng/dl (sensitivity 94.4%, specificity 85.1%, area under the curve 0.94). PCT outperformed CRP, WBC, and fever for diagnosing infection. In conclusion, compared with CRP, fever, and WBC, serum PCT had a better performance in differentiating infected from noninfected AMI patients and thus should be considered as an adjunct test when facing the dilemma of initiating empiric antibiotic in AMI patient demonstrating inflammatory signs.

Learning curves for transapical transcatheter aortic valve replacement in the PARTNER-I trial: Technical performance, success, and safety.

OBJECTIVES: Introduction of hybrid techniques, such as transapical transcatheter aortic valve replacement (TA-TAVR), requires skills that a heart team must master to achieve technical efficiency: the technical performance learning curve. To date, the learning curve for TA-TAVR remains unknown. We therefore evaluated the rate at which technical performance improved, assessed change in occurrence of adverse events in relation to technical performance, and determined whether adverse events after TA-TAVR were linked to acquiring technical performance efficiency (the learning curve). METHODS: From April 2007 to February 2012, 1100 patients, average age 85.0 ± 6.4 years, underwent TA-TAVR in the PARTNER-I trial. Learning curves were defined by institution-specific patient sequence number using nonlinear mixed modeling. RESULTS: Mean procedure time decreased from 131 to 116 minutes within 30 cases (P = .06) and device success increased to 90% by case 45 (P = .0007). Within 30 days, 354 patients experienced a major adverse event (stroke in 29, death in 96), with possibly decreased complications over time (P âˆ¼ .08). Although longer procedure time was associated with more adverse events (P < .0001), these events were associated with change in patient risk profile, not the technical performance learning curve (P = .8). CONCLUSIONS: The learning curve for TA-TAVR was 30 to 45 procedures performed, and technical efficiency was achieved without compromising patient safety. Although fewer patients are now undergoing TAVR via nontransfemoral access, understanding TA-TAVR learning curves and their relationship with outcomes is important as the field moves toward next-generation devices, such as those to replace the mitral valve, delivered via the left ventricular apex.

Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER-I trial: Technical performance.

OBJECTIVES: To assess technical performance learning curves of teams performing transfemoral transcatheter aortic valve replacement (TF-TAVR). BACKGROUND: TF-TAVR is a new procedure for treating severe aortic stenosis. The number of cases required for procedural efficiency is unknown. METHODS: In the PARTNER-I trial, 1,521 patients underwent TF-TAVR from 4/2007-2/2012. Learning curve analysis of technical performance metrics was performed using institution-specific patient sequence number, interval between procedures, and institutional trial entry date. Learning curve characteristics were assessed using semi-parametric and parametric mixed-effects models. RESULTS: As patient sequence number increased, average procedure time decreased from 154 to 85 minutes (P < 0.0001), and fluoroscopy time from 28 to 20 minutes (P < 0.0001). Procedure time plateaued at an average of 83 minutes (range 52-140). Procedure time plateau was dynamic during the course of the trial, averaging 25 cases (range 21-52) by its end. The later institutions enrolled in the trial, the shorter the initial procedure time. During the trial, percutaneous rather than surgical access increased from 7.9% to 69%. CONCLUSIONS: Technical performance learning curves exist for TF-TAVR; procedural efficiency increased with experience, with concomitant decreases in radiation and contrast media exposure. The number of cases needed to achieve efficiency decreased progressively, with optimal procedural performance reached after approximately 25 cases for late-entering institutions. Knowledge and experience accumulated by early TF-TAVR institutions were disseminated, shortening the learning curve of late-entering institutions. Technological advances resulting from learning during the trial moved the field from initial conservative surgical cut-down to percutaneous access for most patients. © 2015 Wiley Periodicals, Inc.

Does the disparity in baseline characteristics of patients undergoing transcatheter aortic valve replacement with 23 mm vs. 26 mm valves impact clinical outcome?

OBJECTIVES: We sought to identify if baseline characteristic differences in patients who receive a 23 mm vs. 26 mm valve impact clinical outcomes. BACKGROUND: Transcatheter aortic valve replacement (TAVR) is currently an approved therapy for patients with severe aortic stenosis who are considered inoperable or are at high risk. METHODS: We retrospectively examined baseline characteristics and outcomes of patients receiving a 23 mm (n = 132) vs. 26 mm valve (n = 81) via the transfemoral approach. RESULTS: Gender (P < 0.01), previous coronary artery bypass surgery (P < 0.01), history of atrial fibrillation (P = 0.04), and mean Society of Thoracic Surgeons (STS) score (P < 0.01) were significantly different between groups. There were no significant differences in the rates of minor/major vascular complications (2.2 vs. 3.7%, P = 0.68 and 13.0 vs. 12.3%, P = 0.89, respectively). Bleeding complications were also comparable (major bleed 2.3 vs. 1%, P >0.99, minor bleed 19.0 vs. 22.0%, P = 0.67 and life threatening bleed 7.0 vs. 5.0%, P = 0.77). In-hospital death (6.0 vs. 5.0%, P >0.99), 30-day all-cause death (7.6 vs. 6.2%, P = 0.69), and all-cause death at 1 year (17.4 vs. 25.9%, P = 0.13) were also similar between groups. Gender, valve size, previous coronary bypass surgery and atrial fibrillation were not independently associated with mortality; however, on multivariate analysis STS score was (HR 1.11; 95% CI 1.02-1.19; P = 0.01). CONCLUSION: Patients undergoing TAVR with 23 and 26 mm valves have similar clinical outcomes despite significant differences in baseline characteristics. © 2015 Wiley Periodicals, Inc.

The choice of arterial access for percutaneous coronary intervention and its impact on outcome: An expert opinion perspective.

The prevention of major bleeding during percutaneous coronary intervention is one of the most widely discussed and often controversial topics within interventional cardiology. The choice of arterial access should be considered a mechanism for bleeding avoidance, and various strategies have been proposed to prevent or lower major bleeding and vascular complications with varying levels of strength. Herein, we review the current literature on arterial access as a bleeding avoidance strategy during percutaneous coronary intervention and its impact on outcome and provide a consensus opinion based on the strength of the evidence supporting various techniques.

Meta-analysis of direct and indirect comparison of ticagrelor and prasugrel effects on platelet reactivity.

Studies have linked on-treatment platelet reactivity (PR) to adverse clinical outcomes. Because new P2Y12 inhibitors (prasugrel and ticagrelor) have been predominantly tested against clopidogrel, data on pharmacodynamic comparisons between these 2 drugs are scarce. We compared ticagrelor with prasugrel in a network meta-analysis. PubMed, Cochrane, and EMBASE were searched for studies assessing PR in patients with coronary artery disease treated with ticagrelor or prasugrel. All studies using prasugrel and/or ticagrelor providing platelet function measurement data using VerifyNow P2Y12 reaction units (PRUs), platelet reactivity index (PRI) vasodilator-stimulated phosphoprotein phosphorylation, or maximal platelet aggregation (MPA) by light transmission aggregometry were considered eligible. Mixed treatment comparison models directly compared ticagrelor and prasugrel and indirectly compared them using clopidogrel as a comparator with data presented as mean difference (95% confidence interval). Data were extracted from 29 studies, including 5,395 patients. Compared with clopidogrel 75 mg, both prasugrel 10 mg and ticagrelor 90 mg twice daily were associated with lower PRU (mean difference -117 [-134.1, -100.5] and -159.7 [-182.6, -136.6], respectively), a lower PRI (-24.2 [-28.2, -20.3] and -33.6 [-39.9, -27.6], respectively), and lower MPA (-11.8 [-17, -6.3] and -20.7 [-28.5, -12.8], respectively). Similar results were obtained with clopidogrel 150 mg. Ticagrelor 90 mg twice daily was associated with lower PRU (-42.5 [-62.9, -21.9]), lower PRI (-9.3 [-15.6, -3.5]), and lower MPA (-8.9 [-16.4, -1.2]) compared with prasugrel 10 mg. In conclusion, our meta-analysis suggests that ticagrelor achieved significantly lower on-treatment PR compared with prasugrel, with both being superior to clopidogrel standard or high dose.

Impact of blood transfusions on short- and long-term mortality in patients who underwent transcatheter aortic valve implantation.

Baseline anemia is associated with transfusions and increased risk of mortality in patients who underwent cardiac surgery and percutaneous coronary intervention. The impact of blood transfusions in anemic patients who underwent transcatheter aortic valve implantation (TAVI) remains unclear. All patients who underwent transfemoral TAVI at our institution were retrospectively included. We determined the effect of blood transfusions on short- and long-term mortality and its interaction with baseline hemoglobin levels and bleeding complications. Additionally, we evaluated baseline hemoglobin effect on mortality. A total of 332 patients were included. All patients (99%) except 2 (1%) met the definition for anemia. Of the 332 patients, 124 (37%) received a blood transfusion and 208 (63%) did not. Blood transfusions were associated with increased in-hospital (p <0.001), 30-day (p <0.001), and 1-year (28% vs 13%, p = 0.001) mortality; however, after a landmark analysis, the effect of blood transfusion on mortality was only seen within 30 days of the procedure (p = 0.001). The increased risk of mortality associated with blood transfusion was present after multivariate adjustment at 30 days (hazard ratio 3.59 [1.04 to 12.4]; p = 0.04). Major vascular complications were a correlate for short- and long-term death. In contrast, baseline hemoglobin level and bleeding complications were not independently associated with mortality. The p value for interaction was not significant between transfusion and hemoglobin level and for transfusion and bleeding complication and transfusion and major vascular complication. In conclusion, the presence of anemia in patients who underwent TAVI does not affect mortality. Transfusion is a correlate of all-cause mortality in this patient population and should be used with caution.

Does baseline hematocrit influence the assays of on-treatment platelet reactivity to clopidogrel?

BACKGROUND: High on-treatment platelet reactivity (HTPR) has been shown to be associated with adverse cardiac events in patients undergoing percutaneous coronary intervention, but the effect of baseline hematologic parameters upon platelet reactivity remains controversial. OBJECTIVE: The present study aims to evaluate the impact of hematocrit on 2 different assay methods used to assess on-treatment platelet reactivity to clopidogrel. METHODS: We tested clopidogrel on-treatment platelet reactivity in 466 consecutive patients using VerifyNow P2Y12 (VN) and light transmission aggregometry (LTA) with adenosine diphosphate (ADP) 5 and 20 µM assays 6 to 24 hours after percutaneous coronary intervention. Patients were categorized into 4 groups according to baseline hematocrit. One-year major adverse cardiac events, including death, nonfatal myocardial infarction, and definite stent thrombosis, were collected. RESULTS: Lower hematocrit was associated with higher P2Y12 reaction unit (PRU) and a higher rate of HTPR (P < .001) as measured by VN assay. No differences were seen among the 4 groups in platelet reactivity measured by LTA using ADP 5 µM (P = .23) and ADP 20 µM (P = .21). In a multivariable logistic regression model, baseline hematocrit was independently associated with PRU ≥208 (odds ratio [OR] 0.92, 95% CI 0.86-0.97, P = .005) but had no correlation with LTA ADP 5 µM ≥46% (OR 1.0, 95% CI 0.95-1.06, P = .88) or LTA ADP 20 µM ≥59% (OR 1.03, 95% CI 0.97-1.09, P = .39). In a logistic regression model, the addition of VN assay results, hematocrit, and interaction between the hematocrit and assay results had shown a significant influence on the area under curve for prediction of 1-year major adverse cardiac events compared with baseline clinical variables only for PRU (0.63 vs 0.76, P = .006) but not with LTA (0.64 vs 0.74, P = .13). CONCLUSION: Baseline hematocrit has a differential influence on results of the ex vivo platelet functional assays. Lower baseline hematocrit was independently associated with HTPR by VN but not LTA. This may affect the interpretation of platelet function testing in patients with significant anemia.

Evaluation of the Edwards Lifesciences SAPIEN transcatheter heart valve.

Severe aortic stenosis is a common valvular disease and is associated with both morbidity and mortality. Surgical aortic valve replacement was the only available therapeutic option until technological advances allowed for the development of a transcatheter heart valve system. The first available THV was the Edwards SAPIEN. The merits of this system in terms of safety and efficacy were explored in the pivotal Placement of AoRTic TraNscathetER (PARTNER) randomized trial whose results then led to the approval of this device for commercial use in the US. The valve is now indicated for inoperable patients and may be considered an alternative for surgery for high-risk patients. Two successive models, the XT and more recently the S3, were developed with the intent to improve procedural outcomes. In this article, the SAPIEN transcatheter heart valve family is described in terms of technology, scientific data and future directions.

The impact of diabetes mellitus on long-term clinical outcomes after percutaneous coronary saphenous vein graft interventions in the drug-eluting stent era.

OBJECTIVES: We aimed to compare early and late clinical outcomes in diabetic and nondiabetic patients who underwent saphenous vein graft (SVG) percutaneous coronary interventions (PCI) with the use of drug-eluting stents (DES). BACKGROUND: Patients with diabetes mellitus are shown to have less favorable outcomes after SVG intervention with the use of bare metal stents. In the DES era, the impact of diabetes mellitus on restenosis and clinical outcomes post-SVG intervention is not clearly defined. METHODS: From our institutional PCI registry database, we retrospectively analyzed 477 consecutive patients with prior coronary artery bypass graft surgery undergoing SVG PCI with the implantation of DES stratified by the presence or absence of diabetes mellitus. The primary end-point was 1-year major adverse cardiac event (MACE) rate, defined as death, Q wave myocardial infarction, and target lesion revascularization. RESULTS: Baseline clinical characteristics, including mean graft age (120 ± 77 vs. 131 ± 86 months, P = 0.14), were similar between groups, save for a higher prevalence of systemic hypertension and chronic renal insufficiency, and higher body mass index in the diabetic group. Among the 604 SVG lesions treated with DES, the angiographic and procedural characteristics were well matched between groups except for the higher rate of distal protection device use (32% vs. 29%, P = 0.007) in the diabetic group. The rates of 1-year MACE (21% vs. 15%, P = 0.12) and all-cause mortality (7.6% vs. 6.7%, P = 0.86) were similar between groups. After adjustment for the relevant clinical co-variables, diabetic status was not associated with the composite end-point. CONCLUSION: In conclusion, DES, when used for the treatment of vein graft lesions, equate the short- and long-term outcomes between diabetic and nondiabetic patients, suggesting that DES should be considered the default stent in diabetic populations undergoing PCI for the treatment of SVG lesions.

Comparison of outcomes after percutaneous coronary intervention among different coronary subsets (stable and unstable angina pectoris and ST-segment and non-ST-segment myocardial infarction).

Percutaneous coronary intervention in the setting of acute myocardial infarction is known to predict stent thrombosis (ST). This study aims to compare the ST rates across different coronary subsets. This was an observational cohort study from a large, single-center registry. Included were 12,198 consecutive patients who underwent percutaneous coronary intervention with stenting. Patients were categorized according to their clinical presentation: stable angina pectoris (SAP, n = 3,700), unstable angina pectoris (UAP, n = 2,845), non-ST-segment elevation myocardial infarction (NSTEMI, n = 4,083), and ST-segment elevation myocardial infarction (STEMI, n = 1,570). The study end points were ST rates at 1 year. Patients with STEMI were younger with a lower prevalence of cardiovascular risk factors, except for smoking. More type C lesions were treated in STEMI, whereas drug-eluting stents were used less frequently in patients with STEMI compared with the other groups. Definite ST at 1 year was highest in patients with STEMI (1.4%; vs SAP, 0.4%; UAP, 0.5%; NSTEMI, 0.5%; p <0.001). One-year definite/probable ST rates were SAP, 0.8%; UAP, 1.1%; NSTEMI, 1.4%; and STEMI, 3.2% (p <0.001). On multivariable analysis, STEMI independently predicts definite ST (hazards ratio [HR] 3.07, 95% confidence interval [CI] 1.32 to 7.10), whereas both STEMI (HR 3.36, 95% CI 1.84 to 6.12) and NSTEMI (HR 2.04, 95% CI 1.20 to 3.07) were independent predictors of definite/probable ST. Clopidogrel cessation was the strongest predictor of ST (definite ST, HR 17.00, 95% CI 7.54 to 38.31; definite/probable ST, HR 4.69, 95% CI 2.39 to 9.20). In conclusion, in patients who underwent percutaneous coronary intervention, the acuity of clinical presentation corresponds to an increase in ST incidence. Adherence to clopidogrel is critical to prevent ST in patients who underwent percutaneous coronary intervention, especially in STEMI.

Long-term safety and efficacy of the everolimus-eluting stent compared to first-generation drug-eluting stents in contemporary clinical practice.

OBJECTIVE: This study aimed to assess the long-term safety and clinical effectiveness of the Xience V everolimus-eluting stent (EES) compared to both Taxus paclitaxel-eluting stent (PES) and Cypher sirolimus-eluting stent (SES) in an unselected patient population. BACKGROUND: There are limited long-term data comparing Xience V EES vs the first-generation Cypher SES. METHODS: This retrospective analysis included 6069 patients treated with Cypher SES, Taxus PES, or Xience V EES from 2003-2009 at our institution. Patients were followed by telephone contact or office visit up to 2 years after the index procedure. RESULTS: Baseline characteristics were generally comparable, with the exception of a significantly higher prevalence of diabetes mellitus, systemic hypertension, history of angioplasty, and coronary bypass surgery among Xience V EES patients. At 2 years, the incidence of major adverse cardiovascular events was 13.3% (Xience V EES) vs 17.8% (Cypher SES) vs 22% (Taxus PES) (P<.001). The main drivers for the differences in event rates were lower mortality, the need for target vessel revascularization, and Q-wave myocardial infarction. Stent thrombosis was lowest in Xience V EES patients (0.2% vs 1.2% SES vs 0.7% PES, respectively; P=.01). A landmark analysis after 1 year showed that the benefits of Xience V EES continued in long-term follow-up. CONCLUSIONS: In a contemporary clinical United States practice with an unselected patient population, Xience V EES use was associated with improved safety profile and reduction of all-cause mortality and stent thrombosis when compared to both first-generation drug-eluting stents. This superiority continues to widen from 1 to 2 years.

Impact of previous coronary artery bypass grafting on patients undergoing transcatheter aortic valve implantation for aortic stenosis.

Re-operation after coronary artery bypass grafting (CABG) is associated with increased risk for morbidity and mortality. Transcatheter aortic valve implantation (TAVI) is an alternative for patients with aortic stenosis, but the outcomes of patients with a history of CABG are unknown. The aim of this study was to explore the association between previous CABG and the outcome of patients undergoing TAVI. Out of 372 consecutive patients who underwent TAVI from 2007 to 2013, 122 (32.8%) had previous CABG, whereas 250 (67.2%) did not. A comparison was made between groups. Subgroup analysis compared patients with and without previous CABG in 3 patient subsets: inoperable, operable, and those who underwent transapical TAVI. Patients with previous CABG were younger (81.99±6.78 vs 84.81±7.06 years, respectively, p<0.001). These patients also had more high-risk features (e.g., peripheral vascular disease, previous myocardial infarction, past cerebrovascular disease, and lower average left ventricular ejection fraction (p<0.05 for all). Procedural aspects were mostly similar between groups. No disparities in mortality rates at 1 year were noted (22.1% vs 21.6%, respectively, p=0.91). Subgroup analyses yielded similar outcomes for all 3 groups. In conclusion, although patients with previous CABG present with more high-risk features, they share similar short- and long-term outcomes with patients without previous CABG, irrespective of their surgical risk. This includes patients who underwent transapical access. TAVI in patients with previous CABG is safe and does not confer a significant risk for adverse outcome.

Commercial versus PARTNER study experience with the transfemoral Edwards SAPIEN valve for inoperable patients with severe aortic stenosis.

In patients with aortic stenosis who cannot have surgery, transcatheter aortic valve replacement using the Edwards SAPIEN valve has been shown to improve survival rate and is approved for commercial use in the United States. This study aims to assess the clinical profile, procedural characteristics, and in-hospital complications in patients treated with a commercial SAPIEN valve outside the clinical trial context. We retrospectively analyzed 69 consecutive patients who underwent transcatheter aortic valve replacement with a commercial SAPIEN valve compared with 55 Placement of AoRTic traNscathetER valves (PARTNER) trial patients from cohort B enrolled in the same institution by the same Heart Team. Compared with the commercial group, patients in the PARTNER cohort B had higher mean Society of Thoracic Surgeons score (10 ± 5 vs 9 ± 4, p = 0.04) and a lower rate of peripheral arterial disease (19% vs 44%, p = 0.004). Most patients in the commercial group had the procedure under conscious sedation (83% vs 66%, p = 0.03). Planned surgical cut down for vascular access was rare in the commercial group (1.4% vs 46%, p <0.001). The overall rates of major vascular complications, life-threatening or major bleeding, and blood transfusions were lower in commercial group (7.2% vs 27%, p = 0.003; 2.9% vs 16%, p = 0.01; and 28% vs 60%, p <0.001, respectively). In-hospital all-cause mortality (5.8% vs 9.1%, p = 0.51) and stroke rates (7.2% vs 14.5%, p = 0.19) were not statistically different between groups. The median length of hospitalization (p <0.001) and postprocedural length of stay (p = 0.01) was shorter in the commercial group. In conclusion, transfemoral commercial use of the Edwards SAPIEN valve for inoperable patients shows similar in-hospital mortality and stroke rates compared with PARTNER cohort B. The refinements in the procedure such as more conscious sedation, experience of the operators, and careful vascular planning in the commercial group led to lesser vascular and bleeding complications and shorter length of stay.