Clinical features and outcomes in patients with cardiogenic shock complicating acute myocardial infarction: early vs recent experience with impella.

OBJECTIVES: To compare clinical features and outcomes in patients with acute myocardial infarction complicated by cardiogenic shock (AMICS) treated in the early experience with Impella percutaneous ventricular assist device and patients treated recently. BACKGROUND: Since pre-market approval (PMA) of Impella device as treatment for AMICS, use of the device has grown considerably. METHODS: We retrospectively analyzed 649 AMICS patients treated with perioperative Impella, with 291 patients treated from 2008 to 2014 comprising the early experience cohort and 358 patients treated from 2017 to 2019 comprising the recent experience cohort. The primary end point was risk adjusted in-hospital mortality. RESULTS: Mean age and gender distribution of patients was similar in the two cohorts. The recent cohort had more invasive hemodynamic monitoring (64% vs 46%; P < .001) and less use of an intra-aortic balloon pump prior to Impella (15% vs 41%; P < .001). Recently treated patients were significantly more likely to receive Impella support prior to PCI (58% vs 44%; P = .005). In-hospital mortality was lower in the recent cohort (48% vs 56%; P = .043). This difference was however no longer significant after risk adjustment (adjusted OR 0.89, 95% CI 0.59-1.34, P = .59). Rates of acute kidney injury, major bleeding, and vascular complications requiring surgery were also significantly lower in the recent cohort. CONCLUSIONS: Use of Impella for AMICS during recent years is associated with lower unadjusted in-hospital mortality, which may reflect better patient selection, earlier device implantation, and improved management algorithms. In-depth understanding of these factors may inform the development of future treatment protocols.

Association between levosimendan, postoperative AKI, and mortality in cardiac surgery: Insights from the LEVO-CTS trial.

OBJECTIVES: We aimed to evaluate the association between levosimendan treatment and acute kidney injury (AKI) as well as assess the clinical sequelae of AKI in cardiac surgery patients with depressed left ventricular function (ejection fraction <35%). METHODS: Patients in the LEVO-CTS trial undergoing on-pump coronary artery bypass grafting (CABG), valve, or CABG/valve surgery were stratified by occurrence and severity of postoperative AKI using the AKIN classification. The association between levosimendan infusion and AKI was modeled using multivariable regression. RESULTS: Among 854 LEVO-CTS patients, 231 (27.0%) experienced postoperative AKI, including 182 (21.3%) with stage 1, 35 (4.1%) with stage 2, and 14 (1.6%) with stage 3 AKI. The rate of AKI was similar between patients receiving levosimendan or placebo. The odds of 30-day mortality significantly increased by AKI stage compared to those without AKI (stage 1: adjusted odds ratio [aOR] 2.0, 95% confidence interval [CI] 0.8-4.9; stage 2: aOR 9.1, 95% CI 3.2-25.7; stage 3: aOR 12.4, 95% CI 3.0-50.4). No association was observed between levosimendan, AKI stage, and odds of 30-day mortality (interaction P = .69). Factors independently associated with AKI included increasing age, body mass index, diabetes, and increasing baseline systolic blood pressure. Increasing baseline eGFR and aldosterone antagonist use were associated with a lower risk of AKI. CONCLUSIONS: Postoperative AKI is common among high-risk patients undergoing cardiac surgery and associated with significantly increased risk of 30-day death or dialysis. Levosimendan was not associated with the risk of AKI.

Frequency, Regional Variation, and Predictors of Undetermined Cause of Death in Cardiometabolic Clinical Trials: A Pooled Analysis of 9259 Deaths in 9 Trials.

BACKGROUND: Modern cardiometabolic clinical trials often include cardiovascular death as a component of a composite primary outcome, requiring central adjudication by a clinical events committee to classify cause of death. However, sometimes the cause of death cannot be determined from available data. The US Food and Drug Administration has indicated that this circumstance should occur only rarely, but its prevalence has not been formally assessed. METHODS: Data from 9 global clinical trials (2009-2017) with long-term follow-up and blinded, centrally adjudicated cause of death were used to calculate the proportion of deaths attributed to cardiovascular, noncardiovascular, or undetermined causes by therapeutic area (diabetes mellitus/pre-diabetes mellitus, stable atherosclerosis, atrial fibrillation, and acute coronary syndrome), region of patient enrollment, and year of trial manuscript publication. Patient- and trial-level variables associated with undetermined cause of death were identified using a logistic model. RESULTS: Across 127 049 enrolled participants from 9 trials, there were 9259 centrally adjudicated deaths: 5012 (54.1%) attributable to cardiovascular causes, 2800 (30.2%) attributable to noncardiovascular causes, and 1447 (15.6%) attributable to undetermined causes. There was variability in the proportion of deaths ascribed to undetermined causes by trial therapeutic area, region of enrollment, and year of trial manuscript publication. On multivariable analysis, acute coronary syndrome or atrial fibrillation trial (versus atherosclerotic vascular disease or diabetes mellitus/pre-diabetes mellitus), longer time from enrollment to death, more recent trial manuscript publication year, enrollment in North America (versus Western Europe), female sex, and older age were associated with greater likelihood of death of undetermined cause. CONCLUSIONS: In 9 cardiometabolic clinical trials with long-term follow-up, approximately 16% of deaths had undetermined causes. This provides a baseline for quality assessment of clinical trials and informs operational efforts to potentially reduce the frequency of undetermined deaths in future clinical research.

Levosimendan in Patients with Left Ventricular Dysfunction Undergoing Cardiac Surgery.

BACKGROUND: Levosimendan is an inotropic agent that has been shown in small studies to prevent or treat the low cardiac output syndrome after cardiac surgery. METHODS: In a multicenter, randomized, placebo-controlled, phase 3 trial, we evaluated the efficacy and safety of levosimendan in patients with a left ventricular ejection fraction of 35% or less who were undergoing cardiac surgery with the use of cardiopulmonary bypass. Patients were randomly assigned to receive either intravenous levosimendan (at a dose of 0.2 µg per kilogram of body weight per minute for 1 hour, followed by a dose of 0.1 µg per kilogram per minute for 23 hours) or placebo, with the infusion started before surgery. The two primary end points were a four-component composite of death through day 30, renal-replacement therapy through day 30, perioperative myocardial infarction through day 5, or use of a mechanical cardiac assist device through day 5; and a two-component composite of death through day 30 or use of a mechanical cardiac assist device through day 5. RESULTS: A total of 882 patients underwent randomization, 849 of whom received levosimendan or placebo and were included in the modified intention-to-treat population. The four-component primary end point occurred in 105 of 428 patients (24.5%) assigned to receive levosimendan and in 103 of 421 (24.5%) assigned to receive placebo (adjusted odds ratio, 1.00; 99% confidence interval [CI], 0.66 to 1.54; P=0.98). The two-component primary end point occurred in 56 patients (13.1%) assigned to receive levosimendan and in 48 (11.4%) assigned to receive placebo (adjusted odds ratio, 1.18; 96% CI, 0.76 to 1.82; P=0.45). The rate of adverse events did not differ significantly between the two groups. CONCLUSIONS: Prophylactic levosimendan did not result in a rate of the short-term composite end point of death, renal-replacement therapy, perioperative myocardial infarction, or use of a mechanical cardiac assist device that was lower than the rate with placebo among patients with a reduced left ventricular ejection fraction who were undergoing cardiac surgery with the use of cardiopulmonary bypass. (Funded by Tenax Therapeutics; LEVO-CTS ClinicalTrials.gov number, NCT02025621 .).

Comparison of nationwide trends in 30-day readmission rates after carotid artery stenting and carotid endarterectomy.

OBJECTIVE: Carotid revascularization procedures, carotid artery stenting (CAS) and carotid endarterectomy (CEA), are among the most common vascular interventions performed in the United States, with significant resource utilization. Whereas multiple studies have reported outcomes after these procedures, data regarding 30-day readmission rates after these interventions remain scant. METHODS: The U.S. Nationwide Readmission Database (2010-2014) was queried to identify all patients ≥18 years who were readmitted within 30 days after a hospital discharge for CEA or CAS. RESULTS: Among 476,260 patients included, 13.5% underwent CAS and 86.5% underwent CEA. The combined 30-day readmission rate for all carotid revascularization procedures was 9.2% (10.6% after CAS and 9.0% after CEA). After 1:3 propensity matching, CAS was associated with higher risk of readmission compared with CEA (10.4% vs 9.4%). Neurologic complications and cardiac conditions were the two most common causes of readmission after both CAS (29.7% and 23.7%, respectively) and CEA (28.2% and 21.7%, respectively). The 30-day readmission rates were higher in CAS patients across all age groups as well as in those with a low or high baseline burden of comorbidities. CONCLUSIONS: In this large nationwide study, CAS was associated with higher 30-day readmission rates compared with CEA irrespective of age or baseline burden of comorbidities. Neurologic or cardiac adverse events were responsible for >50% of readmissions after CAS and CEA.

Imaging Cardiovascular Emergencies: Real World Clinical Cases.

Cardiovascular emergencies represent life-threatening conditions requiring a high index of clinical suspicion. In an emergency scenario, a simple stepwise biomarker/imaging diagnostic algorithm may help prompt diagnosis and timely treatment along with related improved outcomes. This article describes several clinical cases of cardiovascular emergencies, such as coronary stent thrombosis-restenosis, takotsubo syndrome, acute myocarditis, massive pulmonary embolism, type A acute aortic dissection, cardiac tamponade, and endocarditis.

Meta-analysis of drug eluting stents compared with bare metal stents in high bleeding risk patients undergoing percutaneous coronary interventions.

OBJECTIVES: To determine the efficacy and safety of drug-eluting stents (DESs) and bare metal stents (BMSs) when used with short or tailored dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients. BACKGROUND: DES have been shown to reduce target lesion revascularization (TLR) as well as stent thrombosis (ST) compared to BMS in patients undergoing percutaneous coronary intervention (PCI). However, patients at HBR continue to receive BMS given the fear of bleeding or ST from premature discontinuation of DAPT in patients receiving DES. METHODS: We performed a meta-analysis of randomized controlled trials by performing systematic search for studies comparing DES with BMS in HBR patients using PUBMED, MEDLINE, and Cochrane Central, reported until March 1, 2018. RESULTS: Three randomized controlled studies met the inclusion criteria with total of 4,460 patients; 50% received DES. Major adverse cardiovascular event (MACE); composite of death, myocardial infarction (MI), and TLR, at 1 year was significantly lower (RR = 0.63, 95% CI 0.50-0.80) in DES group compared to BMS. This difference was primarily driven by lower TLR (RR = 0.46, 95% CI 0.35-0.61) in DES group. Definite or probable ST (RR = 0.59, 95% CI = 0.32-1.08) and major (RR = 0.94, 95% CI = 0.74-1.20) bleeding were similar. CONCLUSIONS: DES was associated with lower MACE without increased risk of bleeding or ST compared to BMS when used with short or tailored DAPT in patients with HBR.

Incidence and outcomes of emergent cardiac surgery during transfemoral transcatheter aortic valve implantation (TAVI): insights from the European Registry on Emergent Cardiac Surgery during TAVI (EuRECS-TAVI).

Aims: Life-threatening complications occur during transcatheter aortic valve implantation (TAVI) which can require emergent cardiac surgery (ECS). Risks and outcomes of patients needing ECS during or immediately after TAVI are still unclear. Methods and results: Incidence, risk factors, management, and outcomes of patients requiring ECS during transfemoral (TF)-TAVI were analysed from a contemporary real-world multicentre registry. Between 2013 and 2016, 27 760 patients underwent TF-TAVI in 79 centres. Of these, 212 (0.76%) patients required ECS (age 82.4 ± 6.3 years, 67.5% females, logistic EuroSCORE: 17.1%, STS-score 5.8%). The risk of ECS declined from 2013 (1.07%) to 2014 (0.70%) but remained stable since. Annual TF-TAVI numbers have more than doubled from 2013 to 2016. Leading causes for ECS were left ventricular perforation by the guidewire (28.3%) and annular rupture (21.2%). Immediate procedural mortality (<72 h) of TF-TAVI patients requiring ECS was 34.6%. Overall in-hospital mortality was 46.0%, and highest in case of annular rupture (62%). Independent predictors of in-hospital mortality following ECS were age > 85 years [odds ratio (OR) 1.87, 95% confidence interval (95% CI) (1.02-3.45), P = 0.044], annular rupture [OR 1.96, 95% CI (0.94-4.10), P = 0.060], and immediate ECS [OR 3.12, 95% CI (1.07-9.11), P = 0.037]. One year of survival of the 114 patients surviving the in-hospital period was only 40.4%. Conclusion: Between 2014 and 2016, the need for ECS remained stable around 0.7%. Left ventricular guidewire perforation and annular rupture were the most frequent causes, accounting for almost half of ECS cases. Half of the patients could be salvaged by ECS-nevertheless, 1 year of all-cause mortality was high even in those ECS patients surviving the in-hospital period.

Long-term outcomes of patients with diabetes mellitus undergoing percutaneous intervention for popliteal and infrapopliteal peripheral arterial disease.

OBJECTIVES: To evaluate the association of diabetes mellitus (DM) with clinical and angiographic characteristics and outcomes of patients with popliteal and infrapopliteal peripheral arterial disease (PAD) undergoing peripheral vascular intervention (PVI). BACKGROUND: Clinical features and outcomes in patients with DM and popliteal or infrapopliteal PAD undergoing PVI are not well described. METHODS: Using the data from the laser in popliteal and infrapopliteal stenosis study, we retrospectively examined the association of diabetes with clinical and angiographic characteristics and risk adjusted short- and intermediate term outcomes (all cause death, major adverse events (MAE) [composite of death, ipsilateral major amputation, or repeat revascularization]) in patients with popliteal and infrapopliteal PAD undergoing PVI for critical limb ischemia treated either with laser-assisted balloon angioplasty or balloon angioplasty alone. RESULTS: Of 714 patients, 418 had DM (58.5%). Patients with DM were younger with higher prevalence of history of coronary artery disease, heart failure, end-stage renal disease, and prior contralateral limb amputation compared to those without DM. At 5 years, mean event free survival for all cause mortality (39.9 vs. 45.5 months; P = 0.001), MAE (29.3 vs. 36.8 months; P < 0.001), ipsilateral major amputation (55.3 vs. 57.4 months; P = 0.001), and repeat revascularization (42.0 vs. 45.8 months; P = 0.03) were significantly lower in DM patients. On multivariate analysis, DM was associated with significantly higher all cause mortality (HR = 1.83, 95% CI 1.33-2.52), MAE (HR = 1.73, 95% CI 1.35-2.23), and ipsilateral major amputation (HR = 5.52, 95% CI 1.82-16.71). CONCLUSIONS: Among patients with popliteal and infrapopliteal PAD undergoing PVI, DM was associated with higher mortality, major amputations and MAE that was independent of baseline comorbidities. Our data suggested the need for future studies evaluating existing and/or novel therapies to improve the poor long-term outcomes in diabetic patients with popliteal and infrapopliteal PAD.

Association of Hospital and Physician Characteristics and Care Processes With Racial Disparities in Procedural Outcomes Among Contemporary Patients Undergoing Coronary Artery Bypass Grafting Surgery.

BACKGROUND: Previous studies have reported that black patients undergoing coronary artery bypass surgery had worse outcomes than white patients, even after accounting for patient factors. The degree to which clinician, hospital, and care factors account for these outcome differences remains unclear. METHODS AND RESULTS: We evaluated procedural outcomes in 11,697 blacks and 136,362 whites undergoing isolated coronary artery bypass surgery at 663 Society of Thoracic Surgery Database participating sites (January 1, 2010 to June 30, 2011) adjusted for patients' clinical and socioeconomic features, hospital and surgeon effects, and care processes (internal mammary artery graft and perioperative medications use). Relative to whites, blacks undergoing coronary artery bypass surgery were younger, yet had higher comorbidities and more adverse presenting features. Blacks were also more likely to be treated at hospitals with higher risk-adjusted mortality. The use of internal mammary artery was marginally lower in blacks than in whites (93.3% versus 92.2%, P<0.0001). Unadjusted mortality and major morbidity rates were higher in blacks than in whites (1.8% versus 2.5%, P<0.0001) and (13.6% versus 19.4%, P<0.0001), respectively. These racial differences in outcomes narrowed but still persisted after adjusting for surgeon, hospital, and care processes in addition to patient and socioeconomic factors (odds ratio, 1.17; 95% confidence interval, 1.00-1.36 and odds ratio, 1.26; 95% confidence interval, 1.19-1.34, respectively). CONCLUSIONS: The risks of procedural mortality and morbidity after coronary artery bypass surgery were higher among black patients than among white patients. These differences were in part accounted for by patient comorbidities, socioeconomic status, and surgeon, hospital, and care factors, as well, as suggested by the reduction in the strength of the race-outcomes association. However, black race remained an independent predictor of outcomes even after accounting for these differences.

Is mortality a useful parameter for public reporting in pacemaker implantation? Results of an obligatory external quality control programme.

AIMS: To evaluate if public reporting of pacemaker implantation-associated mortality is meaningful in a large contemporary patient cohort. METHODS AND RESULTS: The database of the obligatory external quality control programme in the Federal State of Hessen, Germany, of patients undergoing permanent pacemaker (PPM) implantation was evaluated retrospectively. We compared the baseline features of patients who died compared with those who did not during hospitalization after PPM. Of 5079 patients who underwent PPM implantation in 2009, 74 (1.5%) died during the hospital stay. Cause of death was available in 70/74 patients (94.6%) who died. Deceased patients were older (79.6 ± 8.7 vs. 76.3 ± 9.9 years, P = 0.006), had worse American Society of Anesthesiologists (ASA) physical status (P < 0.001), lower ejection fraction (P < 0.001), a greater prevalence of high-degree atrioventricular-block (44.3 vs. 35.0%, P = 0.001), and were more likely to receive single-chamber devices (41.4 vs. 25.0%, P < 0.002). Perioperative complications were similar in both cohorts. Death was not attributable directly to PPM procedure in any patients but was related to (i) non-device-related infections (28.6%), (ii) heart failure (25.7%), (iii) extracardiac diseases (21.4%), (iv) multiorgan failure (8.6%), (v) previous resuscitation with hypoxic brain damage (8.6%), and (vi) arrhythmogenic death (7.1%). CONCLUSION: Mortality associated with PPM implantation in vast majority of cases was not related to the procedure, but to comorbidities and other existing diseases at the time of PPM implantation. Thus, PPM implantation in-hospital mortality should not be chosen for public reporting comparing hospital quality, even after adjusting for baseline risk.

The association of race with quality of health in peripheral artery disease following peripheral vascular intervention: The Q-PAD Study.

Black patients have a higher prevalence of peripheral artery disease (PAD) than white patients, and also tend to have a greater extent and severity of disease, and poorer outcomes. The association of race with quality of health (QOH) after peripheral vascular intervention (PVI), however, is less well-known. In our study, we hypothesized that after PVI, black patients experience worse QOH than white patients. We retrospectively assessed racial differences in health status using responses to the Peripheral Arterial Questionnaire (PAQ) at baseline (pre-PVI) and up to 6 months following PVI among 387 patients. We used the PAQ summary score (which includes physical limitation, symptoms, social function and quality of life) as a measure of QOH. We compared QOH scores at baseline and at follow-up after PVI between black ( n=132, 34.1%) and white ( n=255, 65.9%) patients. We then computed the change in score from baseline to follow-up for each patient (the delta) and compared the median delta between the two groups. Multivariable regression was used to model the delta QOH after controlling for factors associated with race or with the delta QOH. There was no significant difference in mean QOH by race either at baseline ( p=0.09) or at follow-up ( p=0.45). There was no significant difference in the unadjusted median delta by race (white 25.3 vs black 21.5, p=0.28) and QOH scores improved significantly at follow-up in both groups, albeit the improvement was marginally lower in black compared with white patients after adjustment for baseline confounders ( b = -6.6, p=0.05, 95% CI -13.2, -0.11).

Outcomes of transfemoral transcatheter aortic valve implantation at hospitals with and without on-site cardiac surgery department: insights from the prospective German aortic valve replacement quality assurance registry (AQUA) in 17 919 patients.

AIMS: Performing transcatheter aortic valve implantation (TAVI) at hospitals with only cardiology department but no cardiac surgery (CS) on-site is at great odds with current Guidelines. METHODS AND RESULTS: We analysed data from the official, prospective German Quality Assurance Registry on Aortic Valve Replacement to compare characteristics and in-hospital outcomes of patients undergoing transfemoral TAVI at hospitals with (n = 75) and without CS departments (n = 22). An interdisciplinary Heart Team was established at all centres (internal staff physicians at hospitals with on-site CS; in-house cardiologists and visiting cardiac surgical teams from collaborating hospitals at non-CS hospitals). In 2013 and 2014, 17 919 patients (81.2 ± 6.1 years, 55% females, German aortic valve (GAV) score 2.0 5.6 ± 5.8%, logistic EuroSCORE I 21.1 ± 15.4%) underwent transfemoral TAVI in Germany: 1332 (7.4%) at hospitals without on-site CS department. Patients in non-CS hospitals were older (82.1 ± 5.8 vs. 81.1 ± 6.1 years, P < 0.001), with more frequent co-morbidities. Predicted mortality risks per GAV-score 2.0 (6.1 + 5.5 vs. 5.5 ± 5.9%, P < 0.001) and logEuroSCORE I (23.2 ± 15.8 vs. 21.0 ± 15.4%, P < 0.001) were higher in patients at non-CS sites. Complications, including strokes (2.6 vs. 2.3%, P = 0.452) and in-hospital mortality (3.8 vs. 4.2%, P = 0.396), were similar in both groups. Matched-pair analysis of 555 patients in each group with identical GAV-score confirmed similar rates of intraprocedural complications (9.2 vs. 10.3%, P = 0.543), strokes (3.2% for both groups, P = 1.00), and in-hospital mortality (1.8 vs. 2.9%, P = 0.234). CONCLUSION: Although patients undergoing TAVI at hospitals without on-site CS department were older and at higher predicted perioperative death risk, major complications, and in-hospital mortality were not statistically different, suggesting the feasibility and safety of Heart Team-based TAVI at non-CS sites. These findings need confirmation in future randomized study.

Doing the right things and doing them the right way: association between hospital guideline adherence, dosing safety, and outcomes among patients with acute coronary syndrome.

BACKGROUND: Performance metrics currently focus on the measurement of the application of guideline-indicated medications without considering the appropriate dosing of these drugs. METHODS AND RESULTS: We studied 39 291 patients from the Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC/AHA Guidelines (CRUSADE) registry with non-ST-segment elevation acute coronary syndromes. We evaluated hospital variability in the composite use of American College of Cardiology/American Heart Association guideline-recommended therapies (adherence) and the proportion of treated patients with the recommended dose of heparins or a glycoprotein IIb/IIIa antagonist (safety), and its association with risk-adjusted in-hospital mortality and bleeding. The rates of composite guideline adherence (median, 85%; 25th, 75th percentile, 82, 88) and antithrombotic dosing safety (median, 53%; 25th, 75th percentile, 45%, 60%) varied among hospitals. Correlation between hospital composite adherence and safety metrics was significant but low (r=0.16, P=0.008). Risk-adjusted in-hospital mortality was inversely related to both guideline adherence (odds ratio-10% increment, 0.80; 95% confidence interval, 0.67-0.94) and safety metrics (odds ratio-10% increment, 0.90; 95% confidence interval, 0.83-0.98). Safety was inversely related to major bleeding (adjusted odds ratio-10% increment, 0.93; 95% confidence interval, 0.87-0.98). In comparison with hospitals with low adherence and safety (≤median performance) metrics, those with mixed performance metrics (high adherence and low safety, low adherence and high safety) had intermediate risk-adjusted mortality rates, whereas hospitals with above-average performance on both metrics (>median performance) had a trend for lowest risk adjusted mortality rates (odds ratio 0.83; 95% confidence interval, 0.68-1.01). Hospitals with high safety had lower bleeding rates in comparison to those with low safety. CONCLUSIONS: Guideline adherence and dosing safety appeared to provide independent and complementary information on hospital bleeding and mortality, supporting the need for broader metrics of quality that should include measures of both guideline-based care and safety.

Renal failure in patients with ST-segment elevation acute myocardial infarction treated with primary percutaneous coronary intervention: Predictors, clinical and angiographic features, and outcomes.

BACKGROUND: Among patients presenting with ST-segment elevation myocardial infarction (STEMI) for primary percutaneous coronary intervention (PCI), the associations between clinical outcomes and both baseline renal function and the development of acute kidney injury (AKI) have not been reported in a trial population with unselected baseline renal function. METHODS: Patients enrolled in the APEX-AMI trial who underwent primary PCI for the treatment of STEMI were categorized according to (a) baseline renal function and (b) the development of AKI. Patient characteristics, clinical outcomes, and treatment patterns were analyzed according to baseline renal function and the development of AKI. A prediction model for AKI after primary PCI for STEMI was also developed. RESULTS: A total of 5,244 patients were included in this analysis and stratified according to baseline estimated glomerular filtration rate (eGFR) (milliliters per minute per 1.73 m(2)) of >90, 60 to 90, 30 to 59, or <30 or as dialysis dependent. Patients with lower eGFR were older, more often female, and less often treated with evidence-based medicines and had worse angiographic outcomes and higher mortality. The rates of AKI for patients with a baseline eGFR of >90, 60 to 90, 30 to 59, and <30 were 2.5%, 4.1%, 8.1%, and 1.6%, respectively (P < .0001). The strongest predictors of AKI were age and presenting in Killip class III or IV. CONCLUSIONS: Among patients undergoing primary PCI for STEMI, impaired renal function at presentation and development of post-PCI AKI were highly associated with worse clinical and angiographic outcomes, including death. The risk of developing AKI was low and only modestly associated with baseline renal function.

Levosimendan in patients with left ventricular systolic dysfunction undergoing cardiac surgery on cardiopulmonary bypass: Rationale and study design of the Levosimendan in Patients with Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass (LEVO-CTS) trial.

BACKGROUND: Low cardiac output syndrome is associated with increased mortality and occurs in 3% to 14% of patients undergoing cardiac surgery on cardiopulmonary bypass (CPB). Levosimendan, a novel calcium sensitizer and KATP channel activator with inotropic, vasodilatory, and cardioprotective properties, has shown significant promise in reducing the incidence of low cardiac output syndrome and related adverse outcomes in patients undergoing cardiac surgery on CPB. METHODS: LEVO-CTS is a phase 3 randomized, controlled, multicenter study evaluating the efficacy, safety, and cost-effectiveness of levosimendan in reducing morbidity and mortality in high-risk patients with reduced left ventricular ejection fraction (≤35%) undergoing cardiac surgery on CPB. Patients will be randomly assigned to receive either intravenous levosimendan (0.2 µg kg-1 min-1 for the first hour followed by 0.1 µg/kg for 23hours) or matching placebo initiated within 8hours of surgery. The co-primary end points are (1) the composite of death or renal replacement therapy through day 30 or perioperative myocardial infarction, or mechanical assist device use through day 5 (quad end point tested at α<.01), and (2) the composite of death through postoperative day 30 or mechanical assist device use through day 5 (dual end point tested at α<.04). Safety end points include new atrial fibrillation and death through 90days. In addition, an economic analysis will address the cost-effectiveness of levosimendan compared with placebo in high-risk patients undergoing cardiac surgery on CPB. Approximately 880 patients will be enrolled at approximately 60 sites in the United States and Canada between July 2014 and September 2016, with results anticipated in January 2017. CONCLUSION: LEVO-CTS, a large randomized multicenter clinical trial, will evaluate the efficacy, safety, and cost-effectiveness of levosimendan in reducing adverse outcomes in high-risk patients undergoing cardiac surgery on CPB. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (NCT02025621).

Laser in infrapopliteal and popliteal stenosis 2 study (LIPS2): Long-term outcomes of laser-assisted balloon angioplasty versus balloon angioplasty for below knee peripheral arterial disease.

BACKGROUND: Laser-assisted balloon angioplasty (LABA) has been shown to be more effective in achieving angiographic success for treatment for below knee peripheral artery disease (PAD) compared with balloon angioplasty alone(BA). However, long-term outcomes of LABA compared with BA for popliteal and infrapopliteal PAD are unknown. METHODS: We evaluated data on 726 patients undergoing LABA (n = 395) and BA (n = 331) for popliteal and infrapopliteal PAD retrospectively at a single center (2007-2012). Outcomes included long-term ipsilateral major limb amputation, revascularization and mortality (median follow-up = 36 months). RESULTS: Baseline features were similar in two groups with the exception of more TASC-D lesions (92.4 vs. 66.5%; P < 0.0001) and chronic total occlusions (86.4 vs. 49.5%; P < 0.0001) in LABA group. Angiographic success was higher in LABA compared with BA (97.7 vs. 89.2%; P < 0.0001). Ipsilateral major limb amputation (4.1 vs. 5.1%, P = 0.48) and repeat revascularization (25.1 vs. 23.3%, P = 0.47) were similar in LABA and BA patients despite unfavorable baseline angiographic characteristics in the former. Compared with BA, death was more frequently in LABA group (35.2 and 26.3%, P = 0.01), a reflection of higher comorbid conditions in this group (adjusted HR 1.05, 95% CI 0.79-1.39). CONCLUSION: Despite worse baseline angiographic characteristics compared with BA, LABA was associated with higher angiographic success and similar ipsilateral major amputation, repeat revascularization, and long-term mortality. Future randomized clinical trial should evaluate the efficacy of LABA compared with BA (particularly drug-eluting) in improving limb salvage and reducing repeat revascularization in these high-risk PAD patients.

Association between hospital procedure volume and early complications after pacemaker implantation: results from a large, unselected, contemporary cohort of the German nationwide obligatory external quality assurance programme.

AIMS: Several studies demonstrated an inverse relationship between cardioverter-defibrillator implantation volume and complication rates, suggesting better outcomes for higher volume centres. However, the association of institutional procedural volume with patient outcomes for permanent pacemaker (PPM) implantation remains less known, especially in decentralized implantation systems. METHODS AND RESULTS: We performed retrospective examination of data on patients undergoing PPM from the German obligatory quality assurance programme (2007-12) to evaluate the relationship of hospital PPM volume (categorized into quintiles of their mean annual volume) with risk-adjusted in-hospital surgical complications (composite of pneumothorax, haemothorax, pericardial effusion, or pocket haematoma, all requiring intervention, or device infection) and pacemaker lead dislocation. Overall 430 416 PPM implantations were documented in 1226 hospitals. Systems included dual (72.8%) and single (25.8%) chamber PPM and cardiac resynchronization therapy (CRT) devices (1.1%). Complications included surgical (0.92%), and ventricular (0.99%), and atrial (1.22%) lead dislocation. Despite an increase in relatively complex procedures (dual chamber, CRT), there was a significant decrease in the procedural and fluoroscopy times and complications from lowest to highest implantation volume quintiles (P for trend <0.0001). The greatest difference was observed between the lowest (1-50 implantations/year-reference group) and the second-lowest (51-90 implantations/year) quintile: surgical complications [odds ratio (OR) 0.69; confidence interval (CI) 0.60-0.78], atrial lead dislocations (OR 0.69; CI 0.59-0.80), and ventricular lead dislocations (OR 0.73; CI 0.63-0.84). CONCLUSIONS: Hospital annual PPM volume was directly related to indication-based implantation of relatively more complex PPM and yet inversely with procedural times and rates of early surgical complications and lead dislocations. Thus, our data suggest better performance and lower complications with increasing procedural volume.