Bicaval TricValve Implantation in Patients With Severe Symptomatic Tricuspid Regurgitation: 1-Year Follow-Up Outcomes.

BACKGROUND: Several orthotopic transcatheter strategies have been developed to treat severe tricuspid regurgitation (TR); however, many patients are deemed unsuitable. Caval valve implantation with the TricValve system addresses this unmet need. OBJECTIVES: This study sought to determine the impact of TricValve on systemic congestion and quality of life (QOL) at 1 year. METHODS: The TRICUS (Safety and Efficacy of the TricValve® Transcatheter Bicaval Valves System in the Superior and Inferior Vena Cava in Patients With Severe Tricuspid Regurgitation) and TRICUS EURO studies were prospective, nonblinded, nonrandomized, single-arm trials representing the early-in-man experience of the TricValve system in NYHA functional class III or IV severe TR patients, optimally medicated and ineligible for open heart surgery, with significant caval backflow. The primary endpoint was QOL metrics and functional status. The 1-year results of the combined cohort are described here. RESULTS: Forty-four patients were included. Mean age was 76.2 ± 7.5 years, 81.0% were women, and the TRISCORE (risk score model for isolated tricuspid valve surgery) was 5.3 ± 1.3. Clinical improvement at 1 year was achieved in 42 (95.5%) patients, measured by (at least 1 of) an increase in ≥15 points from baseline in 12-item Kansas City Cardiomyopathy Questionnaire score, improvement to NYHA functional class to I or II, or an increase ≥40 m in the 6-minute walk test. There were 3 (6.8%) deaths at 1-year follow-up (1 cardiovascular), and the heart failure rehospitalization rate was 29.5%. Stent fracture, conduction system disturbances, or clinically significant leaflet thrombosis were not detected. Abolished hepatic vein backflow was achieved and persisted in 63.8% of the patients, contributing towards a reduction in congestive symptoms, N-terminal pro-B-type natriuretic peptide levels (P = 0.032), and diuretic treatment. CONCLUSIONS: Caval valve implantation with the TricValve system associated with meaningful 1-year clinical improvements in terms of QOL along with relatively low mortality rates. (TRICUS Study - Safety and Efficacy of the TricValve® Device; NCT03723239).

6-Month Outcomes of the TricValve System in Patients With Tricuspid Regurgitation: The TRICUS EURO Study.

BACKGROUND: Severe tricuspid regurgitation (TR) is frequently associated with significant morbidity and mortality; such patients are often deemed to be at high surgical risk. Heterotopic bicaval stenting is an emerging, attractive transcatheter solution for these patients. OBJECTIVES: The aim of this study was to evaluate the 30-day safety and 6-month efficacy outcomes of specifically designed bioprosthetic valves for the superior and inferior vena cava. METHODS: TRICUS EURO (Safety and Efficacy of the TricValve® Transcatheter Bicaval Valves System in the Superior and Inferior Vena Cava in Patients With Severe Tricuspid Regurgitation) is a nonblinded, nonrandomized, single-arm, multicenter, prospective trial that enrolled patients from 12 European centers between December 2019 and February 2021. High-risk individuals with severe symptomatic TR despite optimal medical therapy were included. The primary endpoint was quality-of-life (QOL) improvement measured by Kansas City Cardiomyopathy Questionnaire score and New York Heart Association (NYHA) functional class improvement at 6-month follow-up. RESULTS: Thirty-five patients (mean age 76 ± 6.8 years, 83% women) were treated using the TricValve system. All patients at baseline were in NYHA functional class III or IV. At 30 days, procedural success was 94%, with no procedural deaths or conversions to surgery. A significant increase in QOL at 6 months follow-up was observed (baseline and 6-month Kansas City Cardiomyopathy Questionnaire scores 42.01 ± 22.3 and 59.7 ± 23.6, respectively; P = 0.004), correlating with a significant improvement in NYHA functional class, with 79.4% of patients noted to be in functional class I or II at 6 months (P = 0.0006). The rates of 6-month all-cause mortality and heart failure hospitalization were 8.5% and 20%, respectively. CONCLUSIONS: The dedicated bicaval system for treating severe symptomatic TR was associated with a high procedural success rate and significant improvements in both QOL and functional classification at 6 months follow-up.

The use of semi-compliant versus non-compliant balloon systems for predilatation during the implantation of self-expandable transcatheter aortic valves: Data from the VIenna CardioThOracic Aortic Valve RegistrY (VICTORY).

BACKGROUND: This study aimed to evaluate the differences in outcome arising from the use of semi-compliant (SCB) versus non-compliant balloon (NCB) systems for predilatation during self-expanding transcatheter aortic valve replacement (TAVR). METHODS: 251 TAVR procedures with the implantation of self-expanding valves after predilatation were analyzed. SCB systems were used in 166 and NCB systems in 85 patients. The primary endpoint was defined as device success, a composite endpoint comprising the absence of procedural mortality, correct valve positioning, adequate valve performance and the absence of more than a mild paravalvular leak. The secondary endpoints were chosen in accordance with the valve academic research consortium (VARC-2) endpoint definitions. RESULTS: No significant differences were observed with regard to procedural device success between the SCB- and NCB cohort (SCB: 142 [85.5%%] vs. NCB: 77 [90.6%]; P = .257). There was a notable difference between the rates of conversion to open surgery and the postdilatation rate, both of which were higher for the NCB group (SCB: 1 [0.6%] vs. NCB: 4 [5.1%]; P = .042; SCB: 30 [18.1%] vs. NCB: 34 [40%]; P < .001). In a multivariate logistic regression analysis, the use of semi-compliant balloon systems for predilatation was associated with a lower risk for postdilatation (OR: 0.296; 95% CI: 0.149-0.588) and conversion to open surgery (OR: 0.205; 95% CI: 0.085-0.493; P = .001) but not for device success. CONCLUSION: While the balloon compliance did not affect the procedural mortality, device success or the rate of paravalvular leakage, the use of semi-compliant balloons for predilatation during TAVR should be investigated in larger randomized trials in the light of the lower rates of postdilatation and conversion to open surgery compared to their non-compliant counterparts.

2020 update of the Austrian Society of Cardiology (ÖKG) and the Austrian Society of Cardiac Surgery (ÖGHTG) on the position statement of the ÖKG and ÖGHTG for transcatheter aortic valve implantation 2011.

This position statement is an update to the 2011 consensus statement of the Austrian Society of Cardiology (ÖKG) and the Austrian Society of Cardiac Surgery (ÖGTHG) for transfemoral transcatheter aortic valve implantation.Due to a number of recently published studies, broadening of indications and recommendations of medical societies and our own national developments, the ÖKG and the ÖGHTG wish to combine the 2017 ESC/EACTS guidelines for the management of valvular heart disease with a national position paper and to focus on certain details for the application in Austria. Thus, this position statement serves as a supplement and further interpretation of the international guidelines.

IMPULSE: the impact of gender on the presentation and management of aortic stenosis across Europe.

AIMS: There is an increasing awareness of gender-related differences in patients with severe aortic stenosis and their outcomes after surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI). METHODS: Data from the IMPULSE registry were analysed. Patients with severe aortic stenosis (AS) were enrolled between March 2015 and April 2017 and stratified by gender. A subgroup analysis was performed to assess the impact of age. RESULTS: Overall, 2171 patients were enrolled, and 48.0% were female. Women were characterised by a higher rate of renal impairment (31.7 vs 23.3%; p<0.001), were at higher surgical risk (EuroSCORE II: 4.5 vs 3.6%; p=0.001) and more often in a critical preoperative state (7.0vs 4.2%; p=0.003). Men had an increased rate of previous cardiac surgery (9.4 vs 4.7%; p<0.001) and a reduced left ventricular ejection fraction (4.9 vs 1.3%; p<0.001). Concomitant mitral and tricuspid valve disease was substantially more common among women. Symptoms were highly prevalent in both women and men (83.6 vs 77.3%; p<0.001). AVR was planned in 1379 cases. Women were more frequently scheduled to undergo TAVI (49.3 vs 41.0%; p<0.001) and less frequently for SAVR (20.3 vs 27.5%; p<0.001). CONCLUSIONS: The present data show that female patients with severe AS have a distinct patient profile and are managed in a different way to males. Gender-based differences in the management of patients with severe AS need to be taken into account more systematically to improve outcomes, especially for women.

Impact of selected comorbidities on the presentation and management of aortic stenosis.

BACKGROUND: Contemporary data regarding the impact of comorbidities on the clinical presentation and management of patients with severe aortic stenosis (AS) are scarce. METHODS: Prospective registry of severe patients with AS across 23 centres in nine European countries. RESULTS: Of the 2171 patients, chronic kidney disease (CKD 27.3%), left ventricular ejection fraction (LVEF) <50% (22.0%), atrial fibrillation (15.9%) and chronic obstructive pulmonary disease (11.4%) were the most prevalent comorbidities (49.3% none, 33.9% one and 16.8% ≥2 of these). The decision to perform aortic valve replacement (AVR) was taken in a comparable proportion (67%, 72% and 69%, in patients with 0, 1 and ≥2 comorbidities; p=0.186). However, the decision for TAVI was more common with more comorbidities (35.4%, 54.0% and 57.0% for no, 1 and ≥2; p<0.001), while the decision for surgical AVR (SAVR) was decreased with increasing comorbidity burden (31.9%, 17.4% and 12.3%; p<0.001). The proportion of patients with planned AVRs that were performed within 3 months was significantly higher in patients with 1 or ≥2 comorbidities than in those without (8.7%, 10.0% and 15.7%; p<0.001). Furthermore, the mean time to AVR was significantly shorter in patients with one (30.5 days) or ≥2 comorbidities (30.8 days) than in those without (35.7 days; p=0.012). Patients with reduced LVEF tended to be offered an AVR more frequently and with a shorter delay while patients with CKD were less frequently treated. CONCLUSIONS: Comorbidities in severe patients with AS affect the presentation and management of patients with severe AS. TAVI was offered more often than SAVR and performed within a shorter time period.

Cut-down outperforms complete percutaneous transcatheter valve implantation.

Background The ideal approach for transfemoral transcatheter aortic valve implantation is still widely debated. The objective of this study was to compare access and bleeding complications of complete percutaneous versus the surgical cut-down approach for transfemoral transcatheter aortic valve implantation. Methods The study included 667 consecutive patients from November 2008 to December 2016, 466 in the percutaneous group and 201 in the cut-down group. There were no significant differences in baseline characteristics between the 2 groups. Primary study endpoints were vascular access site and bleeding complications according to the Valve Academic Research Consortium II criteria. Results Mean procedure time was shorter in the cut-down group: 93.5 ± 22.0 (percutaneous) vs. 69 ± 19 min (cut-down), p < 0.001. The rate of access complications was higher in the percutaneous group: 20.4% (95/466) vs. 8.5% (17/201), p = 0.037; with predominantly minor complications in the percutaneous cohort: 14.4% (67/466) vs. 2.5% (5/201), p = 0.04. Bleeding complications were more frequent in the percutaneous group: 21.9% (102/466) vs. 4.5% (9/201), p = 0.01. Hospital mortality was 5.2% in the percutaneous group and 1.9% in the cut-down group ( p = 0.075). Conclusions Surgical cut-down provided controlled access and resulted in fewer access site and bleeding complications. Nonetheless, major access complications were not significantly different between the two cohorts. The two approaches must be seen as complementary techniques. A portfolio containing both techniques is the only way to provide a tailor-made and patient-orientated approach ensuring the safest access based on the individual vessel condition.

Transcatheter Aortic Valve Implantation in Morphologically Complex Root Aneurysms.

Performing transcatheter aortic valve implantation in the presence of aneurysmatic aortopathy is widely contraindicated but needs to be taken into account as a bailout strategy in selected patients. Deliberate preoperative assessment of measurements becomes the crucial key element in this context. After meticulous valve selection, retrograde access is obtained through the right subclavian artery additionally serving as a backup arterial cannulation site in case of conversion. Transcatheter aortic valve implantation is then performed through the transapical route. Transcatheter aortic valve implantation in complex aneurysmatic aortic morphology is feasible in highly selected patients after comprehensive preoperative evaluation. The present article describes our initial experience, safeguards, and technical details.

Impact of age on short- and long-term mortality of patients with ST-elevation myocardial infarction in the VIENNA STEMI network.

BACKGROUND AND AIM: Our senescent society includes a growing number of elderly people suffering from ST-elevation myocardial infarction (STEMI); however, exactly this population is often underrepresented in randomized trials. Hence, our aim was to investigate the influence of age on patient characteristics, as well as short- and long-term outcome in the Vienna STEMI registry. METHODS: We included all patients of the Vienna STEMI registry (2003-2009). Patients were stratified into age cohorts (≤45, 46-59, 60-79 and ≥80 years, respectively). Differences between cohorts were investigated by descriptive statistics and regression models. Crude and adjusted mortality rates were investigated using log rank test and Cox regression models, respectively. The influence of treatment on mortality was further investigated using propensity score matching. RESULTS: A total of 4579 patients fulfilled the criteria for further investigation. With rising age of cohorts, the number of females, diabetes mellitus (DM), hypertension (HTN), previous myocardial infarction (MI), shock, no reperfusion therapy and anterior wall infarction significantly increased. In contrast, the number of patients with a positive family history, smoking and hyperlipidemia (HLP) significantly declined. Log rank analysis showed significant differences between age cohorts for short- and long-term mortality. Cox regression analysis for short-term mortality revealed an independent association for age at the event, HTN and shock, while age, smoking, DM, HTN, HLP, previous MI and shock independently influenced long-term mortality after correction for confounders. Also, we found a significant association of age and total ischemic time (TIT), which however had no influence on long-term mortality (interaction term p = 0.236). Propensity score matching revealed reduced mortality rates for patients who received reperfusion therapy compared to conservative management, irrespective of age. CONCLUSIONS: Increasing age independently influenced short- and long-term mortality in patients with STEMI in the Vienna STEMI network. The TIT significantly increased with baseline age, but had no impact on mortality. Furthermore, reperfusion therapy exerted beneficial effects irrespective of the patients' age.

Impact of preoperative use of P2Y12 receptor inhibitors on clinical outcomes in cardiac and non-cardiac surgery: A systematic review and meta-analysis.

OBJECTIVE: To review systematically the evidence and perform a meta-analysis of benefits and risks associated with use of P2Y12 receptor inhibitors in coronary artery bypass graft-, non-cardiac- and device surgery. Data selection and analysis: We performed a meta-analysis of published studies. Patients with preoperative use of clopidogrel, ticagrelor or prasugrel (late discontinuation: <5 days before surgery or no discontinuation) were compared with patients without preoperative use of the respective drug (early discontinuation: ⩾5 days before surgery or no users of P2Y12 receptor inhibitors). Outcomes evaluated were re-operation for major bleeding, death, myocardial infarction, combined major adverse cardiac events (MACEs) and major haematoma. Using a random effect model, relative risks (RRs) and 95% confidence intervals (CI) were calculated for each outcome. RESULTS: Fifty-four studies met the selection criteria and included 50,048 patients. Preoperative use of clopidogrel on top of aspirin in patients undergoing coronary artery bypass graft was associated with a 2.5-fold increased risk of re-operation for bleeding (95% CI: 1.92-3.25; p<0.001) and a 1.47-fold increased risk of death (95% CI: 1.25-1.72; p<0.001), but did not diminish the risk for myocardial infarction (RR: 0.96; 95% CI: 0.75-1.25; p=0.18) or MACE (RR: 1.16; 95% CI: 0.90--1.50; p=0.30). In patients undergoing non-cardiac surgery, preoperative use of clopidogrel increased the RR of re-operation for major bleeding by 2.05-fold (95% CI: 1.13-3.73; p=0.002) but did not reduce the RR for MACE or death. Clopidogrel use during cardiac device implantation raised the RR for procedure-related haematoma by 3.0-fold (95% CI: 1.30--6.94; p=0.001). Whereas preoperative ticagrelor use did not increase the risk for mortality (RR: 1.03; 95% CI: 0.49-2.14), preoperative prasugrel use tended to increase the risk for death (RR: 5.06; 95% CI: 0.54-47.65). CONCLUSION: Preoperative exposure to clopidogrel on top of aspirin did not reduce the risk of MACE but was associated with increased risk of bleeding and mortality.

Clinical predictors of patient related delay in the VIENNA ST-elevation myocardial infarction network and impact on long-term mortality.

BACKGROUND: While contributors to system delay in ST-elevation myocardial infarction (STEMI) are well described, predictors of patient-related delays are less clear. The aim of this study was to identify predictors that cause delayed diagnosis of STEMI in a metropolitan system of care (VIENNA STEMI network) and to investigate a possible association with long-term mortality. METHODS: The study population investigated consisted of 2366 patients treated for acute STEMI in the Vienna STEMI registry from 2003-2009. Multivariable regression modelling was performed for (a) onset of pain to first medical contact (FMC) as a categorical variable (pain-to-FMC⩽60 min versus >60 min: 'early presenters' versus 'late presenters'); and for (b) onset of pain-to-FMC (min) as a continuous variable. RESULTS: After multivariable adjustment, female sex (odds ratio (OR) 1.348; 95% confidence interval (CI) 1.013-1.792; p=0.04) and diabetes mellitus (OR 1.355; 95% CI 1.001-1.835; p=0.05) were independently associated with late presentation in STEMI patients, whereas cardiogenic shock (OR 0.582; 95% CI 0.368-0.921; p=0.021) was a predictor of early diagnosis. When onset of pain-to-FMC was treated as a continuous variable, female sex ( p=0.003), anterior infarction ( p=0.004) and diabetes mellitus ( p=0.035) were independently associated with longer delay, while hyperlipidaemia ( p=0.002) and cardiogenic shock ( p=0.017) were strong predictors of short pain-to-FMC times. Three-year-all cause mortality was 9.6% and 11.3% ( p=0.289) for early and late presenters, respectively. After adjustment for clinical factors (sex, age, diabetes, current smoking, hypertension, hyperlipidaemia, cardiogenic shock and location of myocardial infarction) only a trend for increased risk of all-cause death was observed for longer pain-to-FMC times in a cox regression model (hazard ratio (HR) 1.012; 95% CI 0.999-1.025 for every 10 min of delay; p=0.061). Interestingly, early presentation within one hour of symptom onset was not associated with three-year mortality survival (HR 1.031; 95% CI 0.676-1.573; p=0.886). CONCLUSION: In this all-comers study of STEMI patients in the VIENNA STEMI network, cardiogenic shock was the strongest predictor of short patient-related delays, whereas a history of diabetes and female sex were independent associated with late diagnosis in STEMI. After adjustment for clinical confounders, patient related delay did not significantly impact on long-term all-cause mortality.

Distribution of clinical events across platelet aggregation values in all-comers treated with prasugrel and ticagrelor.

The aim of this study was to investigate the distribution of clinical events across the platelet aggregation values in patients treated with prasugrel and ticagrelor. This prospective observational study enrolled 226 patients treated with prasugrel (n=121) or ticagrelor (n=105). Adenosine diphosphate (ADP)-induced platelet aggregation was determined by Multiplate Analyzer in the maintenance phase of treatment with prasugrel or ticagrelor. Clinical outcome was evaluated over 12 months. Platelet aggregation values were divided into quartiles. The first quartile comprised values <8 U, the second quartile values between 8 U and <15 U, the third one values between 15 U and 23 U, and the forth one values >23 U. Myocardial infarction events were observed in patients within the third quartile of aggregation values (15-23 U), and were not associated with high on-treatment platelet reactivity (HTPR>46 U). All bleeding events occurred in patients with aggregation values ≤ 23 U, which corresponded to the 75 percentile (p=0.031). There was no difference in the distribution of bleeding events between the 1st-3rd quartiles (p=0.873). In conclusion, patients with ADP-induced aggregation values over 23 U (fourth quartile) were at the lowest risk to develop bleeding during the follow-up.

Comparison of magnetic wire navigation with the conventional wire technique for percutaneous coronary intervention of chronic total occlusions: a randomised, controlled study.

Wire crossing of a chronic total coronary occlusion (CTO) is time consuming and limited by the amount of contrast agent and time of radiation exposure. Magnetic wire navigation (MWN) might accelerate wire crossing by maintaining a coaxial vessel orientation. This study compares MWN with the conventional approach for recanalization of CTOs. Forty symptomatic patients with CTO were randomised to MWN (n = 20) or conventional approach (n = 20) for antegrade crossing of the occlusion. In the intention-to-treat analysis, MWN showed a shorter crossing time (412 versus 1131 s; p = 0.001), and, consequently, lower usage of contrast agent (primary endpoint 42 versus 116 ml; p = 0.01), and lower radiation exposure (dose-area product: 29 versus 80 Gy*cm(2); p = 0.002) during wire crossing compared to the conventional approach. Accordingly, in the per-protocol analysis, the wire-crossing rate was, in trend, higher using the conventional approach (17 of 31) compared to MWN (9 of 28; p = 0.08). The use of MWN for revascularisation of CTOs is feasible and reduces crossing time, use of contrast agent, and radiation exposure. However, due to a broader selection of wires, the conventional approach enables wire crossing in cases failed by MWN and seems to be the more successful choice.

Inter-patient variability of platelet reactivity in patients treated with prasugrel and ticagrelor.

The aim of this study was to evaluate the distribution of platelet reactivity values in patients treated with prasugrel and ticagrelor. This prospective observational study enrolled 200 patients treated with prasugrel or ticagrelor. Platelet aggregation was determined by multiple electrode aggregometry after stimulation with adenosine diphosphate (ADP) in the maintenance phase of treatment with prasugrel or ticagrelor. Only 3% of patients in the prasugrel group and 2% of study participants in the ticagrelor group had high on treatment platelet reactivity (HTPR). The majority of patients displayed low on treatment platelet reactivity (LTPR; prasugrel: 69%; ticagrelor: 64%). The pharmacodynamic effect was similar in patients treated with prasugrel and ticagrelor: the median level of ADP-induced platelet aggregation was 15U (interquartile range IQR 9-21U) under prasugrel treatment and 17U (IQR 8-24U) under ticagrelor treatment (p=0.370). In conclusion, our study suggests that there is some degree of variability in ADP-induced platelet aggregation under treatment with prasugrel and ticagrelor.

The net clinical benefit of personalized antiplatelet therapy in patients undergoing percutaneous coronary intervention.

This was a prospective study comparing two groups: personalized and non-personalized treatment with P2Y12 receptor blockers during a 12-month follow-up. We aimed to investigate whether personalized antiplatelet treatment in patients with high on-treatment platelet reactivity (HTPR) improves clinical outcome. Platelet reactivity was assessed by adenosine diphosphate induced aggregation using a multiple electrode aggregometry (MEA) in 798 patients with coronary artery disease undergoing percutaneous coronary intervention (PCI). Patients with HTPR received up to four repeated loading doses of clopidogrel or prasugrel in the personalized treatment group (n=403), whereas no change in the treatment strategy was undertaken in patients with HTPR in the non-personalized treatment group (n=395). There were fewer major adverse cardiac events (MACE) in the personalized treatment group than in the non-personalized treatment group (7.4% compared with 15.3% respectively; P<0.001). The multivariate Cox regression analysis showed that the relative risk to develop MACE was 51% lower in the personalized treatment group as compared with the non-personalized treatment group [hazard ratio (HR)=0.49; 95% confidence interval (CI): 0.31-0.77; P<0.001]. Similarly, there was a clear net benefit of the personalized antiplatelet treatment over the non-personalized treatment (ischemic and bleedings events: 8.2% versus 18.7% respectively; HR=0.46; 95%CI: 0.29-0.70; P<0.001). Further analysis indicated that patients with aggregation values within the therapeutic window (21-49 units) experienced the lowest event rates (stent thrombosis and major bleeding: 2.5%) as compared with poor responders (≥50 units: 5.4%) or ultra-responders (0-20 units: 5.2%). In conclusion, personalized antiplatelet treatment might improve patients' outcome without increasing bleeding complications compared with the non-personalized treatment during a 12-month follow-up.

Cost-effectiveness of percutaneous coronary intervention with drug-eluting stents in patients with multivessel coronary artery disease compared to coronary artery bypass surgery five-years after intervention.

OBJECTIVES: Cost-effectiveness of percutaneous coronary intervention (PCI) using drug-eluting stents (DES), and coronary artery bypass surgery (CABG) was analyzed in patients with multivessel coronary artery disease over a 5-year follow-up. BACKGROUND: DES implantation reducing revascularization rate and associated costs might be attractive for health economics as compared to CABG. METHODS: Consecutive patients with multivessel DES-PCI (n = 114, 3.3 ± 1.2 DES/patient) or CABG (n = 85, 2.7 ± 0.9 grafts/patient) were included prospectively. Primary endpoint was cost-benefit of multivessel DES-PCI over CABG, and the incremental cost-effectiveness ratio (ICER) was calculated. Secondary endpoint was the incidence of major adverse cardiac and cerebrovascular events (MACCE), including acute myocardial infarction (AMI), all-cause death, revascularization, and stroke. RESULTS: Despite multiple uses for DES, in-hospital costs were significantly less for PCI than CABG, with 4551 €/patient difference between the groups. At 5-years, the overall costs remained higher for CABG patients (mean difference 5400 € between groups). Cost-effectiveness planes including all patients or subgroups of elderly patients, diabetic patients, or Syntax score >32 indicated that CABG is a more effective, more costly treatment mode for multivessel disease. At the 5-year follow-up, a higher incidence of MACCE (37.7% vs. 25.8%; log rank P = 0.048) and a trend towards more AMI/death/stroke (25.4% vs. 21.2%, log rank P = 0.359) was observed in PCI as compared to CABG. ICER indicated 45615 € or 126683 € to prevent one MACCE or AMI/death/stroke if CABG is performed. CONCLUSIONS: Cost-effectiveness analysis of DES-PCI vs. CABG demonstrated that CABG is the most effective, but most costly, treatment for preventing MACCE in patients with multivessel disease.

Dual non-responsiveness to antiplatelet treatment is a stronger predictor of cardiac adverse events than isolated non-responsiveness to clopidogrel or aspirin.

BACKGROUND: High platelet reactivity (HPR) under treatment with clopidogrel or aspirin is associated with adverse outcome. We aimed to investigate whether high platelet reactivity (HPR) to both aspirin and clopidogrel is a stronger predictor of adverse events compared to isolated HPR to clopidogrel or aspirin. METHODS: In this prospective cohort study platelet reactivity to adenosine diphosphate (ADP) and arachidonic acid (AA) was assessed by Multiple Electrode Aggregometry (MEA) in 403 patients undergoing percutaneous coronary intervention. The rates of the composite of cardiac adverse events (acute coronary syndrome, stent thrombosis, stroke, death and revascularization) were recorded during 12-month follow-up. RESULTS: The composite endpoint of cardiovascular adverse events occurred more often in patients with high platelet reactivity (HPR) to both agonists ADP and AA (37.5%) than in those with isolated HPR to ADP (33.3%), AA (25.6%) or without any HPR (18.6%; p=0.003). Classification tree analysis indicated that any HPR emerged as an independent predictor influencing outcome, which was associated with a 1.75 higher risk of cardiac adverse events (OR=1.75: 95%CI=1.1-2.9). Interestingly, the predictive value of HPR tended to be greater among patients with diabetes mellitus (OR=2.18; 95%CI=1.20-3.95). C-reactive protein and diabetes mellitus were independent predictors of high platelet reactivity to both agonists. CONCLUSIONS: Dual low responsiveness to clopidogrel and aspirin is a strong predictor of cardiac adverse events, especially in patients with diabetes mellitus, which underlines the need for personalized antiplatelet treatment.

Plasma concentrations of interleukin-6, organ failure, vasopressor support, and successful coronary revascularization in predicting 30-day mortality of patients with cardiogenic shock complicating acute myocardial infarction.

OBJECTIVE: Inflammation may play an important role in the pathogenesis, persistence, and prognosis of cardiogenic shock. We analyzed whether elevated plasma concentrations of inflammatory markers are independently associated with an adverse prognosis (increased 30-day mortality rate) in patients with cardiogenic shock. DESIGN: Retrospective study. SETTING: Single-center study, eight-bed intensive care unit at a university hospital. PATIENTS: Retrospective study on stored plasma samples from 38 patients with cardiogenic shock complicating acute myocardial infarction. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Thirty-day nonsurvivors (n = 23, 61%) had been less frequently successfully revascularized, exhibited more frequently renal failure, needed higher vasopressor doses, and presented with significantly higher interleukin-6 plasma concentrations on intensive care unit admission than 30-day survivors. Univariate hazard ratios (95% confidence interval) for 30-day mortality were 1.49 (1.24-1.80) for every 50 pg/mL increase in the interleukin-6 plasma concentration (p = .00003), 1.06 (1.02-1.10) for every 0.1 microg x kg x min increase in the total vasopressor dose (p = .007), 1.14 (1.04-1.25) for every mmol/L increase in serum lactate (p = .006), 2.47 (1.06-5.73) for acute renal failure (p = .036), and 0.34 (0.14-0.82) for successful revascularization (p = .016). However, interleukin-6 plasma concentrations were correlated with vasopressor need and were significantly higher in patients with acute renal failure and in patients without or unsuccessful revascularization. In a multivariate Cox-proportional hazard model, interleukin-6 was the only significant predictor of 30-day mortality with a hazard ratio of 1.42 (1.12-1.80, p = .004). Accordingly, interleukin-6 concentrations > or =200 pg/mL (the point of maximum interest by receiver operating characteristic analysis with a specificity of 87% and a sensitivity of 74%) were associated with a significantly increased 30-day mortality rate in both patients with and patients without successful revascularization. CONCLUSIONS: Interleukin-6 concentrations are an independent predictor of 30-day mortality in patients with acute myocardial infarction complicated by cardiogenic shock.

Ibutilide for rapid conversion of atrial fibrillation or flutter in a mixed critically ill patient population.

INTRODUCTION: Ibutilide is an intravenous class III antiarrhythmic agent that has been shown to be effective in converting acute onset atrial fibrillation/flutter in stable medical and cardio-surgical patients. Data on its use in critically ill patients are rare. The aim of this open, non-randomized, prospective trial was to assess the potential role of ibutilide for conversion of recent onset atrial fibrillation/flutter in a mixed critically ill ICU-population. METHODS: Twenty cardiac-surgical and 17 medical patients with acute tachycardic atrial fibrillation or flutter received up to two 10-min intravenous infusions of 1.0 mg ibutilide. RESULTS: The cumulative conversion efficacy of ibutilide was 56.8% (21 of 37 patients). The mean time to termination of the arrhythmia was 17.7 +/- 12.5 min (range 4 to 45 min) after the start of the first infusion. Conversion success was significantly higher in medical compared to cardiac-surgical patients (82.4 versus 35.0%, p=.0063). In a multivariate binary stepwise logistic regression analysis adjusted for age, heart rate and reduced left ventricular function, cardiac surgery remained significantly associated with a lower conversion probability (RR, .14; 95%CI, 0.02 to 0.76; p=.0190). Serious, ibutilide-induced ventricular arrhythmias developed in 3/37 patients (8.1%). Two of these 3 patients had a left ventricular ejection fraction < 20%. CONCLUSION: Ibutilide is an effective treatment for conversion of acute tachycardic atrial fibrillation/flutter in critically ill patients. Higher efficacy can be expected in medical than cardiac-surgical patients. Ventricular proarrhythmia, especially in patients with severely depressed left ventricular function represents the most important limitation of ibutilide treatment.

Multiple organ failure in patients with cardiogenic shock is associated with high plasma levels of interleukin-6.

OBJECTIVE: In patients with septic shock, multiple organ failure (MOF) is associated with high levels of interleukin-6 (IL-6). Although organ failure is also a common complication of cardiogenic shock (CS), IL-6 levels have been reported to be lower in patients with CS than in patients with septic shock. We studied IL-6 plasma levels in patients with CS with respect to organ failure. SETTING: Eight-bed intensive care unit at a university hospital. PATIENTS: Fifty-one patients with CS, 26 patients with septic shock, and 11 noncritically ill controls. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Patients with CS had higher IL-6 levels than noncritically ill controls ( p<.001) but lower levels than patients with septic shock ( p=.003). CS patients with MOF at the time of blood sampling exhibited, however, higher IL-6 levels than CS patients without organ failure, and IL-6 levels in patients with CS correlated to the total Sepsis-related Organ Failure Assessment score at the time of blood sampling ( r=.57, <.001). No significant differences in IL-6 levels were found when comparing CS patients with MOF at the time of blood sampling with patients with septic shock. Furthermore, CS patients who developed MOF during ICU stay exhibited significantly higher IL-6 levels than CS patients who never did develop MOF. An IL-6 level of >200 pg/mL had a 93% specificity and 100% sensitivity for the prediction of MOF in patients with CS. CONCLUSIONS: Once MOF is present, patients with CS exhibit similarly high IL-6 levels as patients with septic shock. High IL-6 levels in CS patients are associated with a progression to MOF.