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The hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, and drugs/alcohol (HAS-BLED); anticoagulation and risk factors in atrial fibrillation (ATRIA); modified Outpatient Bleeding Risk Index (mOBRI); and reduction of atherothrombosis for continued health (REACH) schemes are validated bleeding risk-prediction tools, but their predictive performance in patients with AF receiving multiple antithrombotic drugs after percutaneous coronary intervention (PCI) is unknown. We sought to compare the predictive performance of bleeding risk-estimation tools in a cohort of patients with atrial fibrillation (AF) undergoing PCI. Management of patients with AF undergoing coronary artery stenting is a multicenter European prospective registry enrolling patients with AF undergoing PCI. We calculated HAS-BLED, ATRIA, mOBRI, and REACH bleeding risk-prediction scores and assessed the rate of bleeding complications as defined by Bleeding Academic Research Consortium at 12 months follow-up in 929 consecutive patients undergoing PCI. Increasing age, femoral access site, and previous peptic ulcer were independent determinants of bleeding. Low bleeding risk scores as determined by HAS-BLED 0 to 2, ATRIA 0 to 3, mOBRI 0, and REACH 0 to 10 were detected in 23.7%, 73.0%, 7.8%, and 5.7% of patients of the cohort, respectively. No significant differences were detected in the rates of any bleeding or major bleeding events for low versus intermediate/high scores with each risk-prediction tool. In conclusion, the performance of ATRIA, HAS-BLED, mOBRI, and REACH scores in predicting bleeding complications in this high-risk patient subset was useless. [ABSTRACT FROM AUTHOR]

Thrombocytopenia is often regarded as a risk factor for bleeding complications in patients undergoing percutaneous coronary intervention (PCI). The risk of mild to moderate baseline and acquired thrombocytopenia on bleeding and thrombotic or thromboembolic complications in patients with atrial fibrillation on oral anticoagulation therapy undergoing PCI, however, remains largely unknown. Management of Patients With Atrial Fibrillation undergoing Coronary Artery Stenting is a multicenter European prospective registry enrolling patients with atrial fibrillation undergoing PCI. We assessed the rate of bleeding complications as defined by Bleeding Academic Research Consortium and a composite of major adverse cardiac and cerebrovascular events (MACCE) including all-cause mortality, myocardial infarction, transient ischemic attack or stroke, stent thrombosis, systemic arterial embolism, or revascularization; and a composite of any harmful event (Bleeding Academic Research Consortium and MACCE) at 12-month follow-up in 861 consecutive patients undergoing PCI. Patients were divided into those with mild to moderate baseline thrombocytopenia (platelet count <150 × 109/L; n = 99) and control group (platelet count >150 × 109/L; n = 762). At hospital discharge, thrombocytopenia had no effect on prescribed antithrombotic treatment, and triple therapy (vitamin K antagonist + aspirin + clopidogrel) was the most common combination in both patient groups (69% vs 73%, p = 0.40). No differences in all-cause mortality (12% vs 11%, p = 0.79), MACCE (23% vs 22%, p = 0.87), or bleeding complications (23% vs 19%, p = 0.26) were detected. Acquired in-hospital thrombocytopenia occurred in 9.7% of patients, and it was associated with similar risk of adverse outcomes compared with control group. In conclusion, mild to moderate baseline thrombocytopenia does not seem to have a clinically significant effect on bleeding or thrombotic or thromboembolic complications after PCI in these frail patients receiving multiple antithrombotic drugs. [ABSTRACT FROM AUTHOR]

Uninterrupted oral anticoagulation (OAC) therapy can be the preferred strategy in patients with atrial fibrillation at moderate to high risk of thromboembolism undergoing percutaneous coronary intervention (PCI). To evaluate the need for additional heparins in addition to therapeutic peri-PCI OAC, we assessed bleeding complications and major adverse cardiac and cerebrovascular events in 414 consecutive patients undergoing PCI during therapeutic (international normalized ratio 2 to 3.5) periprocedural OAC. Patients were divided into those with no (n = 196) and with (n = 218) additional use of periprocedural heparins. No differences in major adverse cardiac and cerebrovascular events (4.1% vs 3.2%, p = 0.79) or major bleeding (1.0% vs 3.7%, p = 0.11) were detected, but access site complications (5.1% vs 11.0%, p = 0.032) were less frequent in those without additional heparins. When adjusted for propensity score, patients with additional heparins had a higher risk of access site complications (odds ratio 2.6, 95% confidence interval 1.1 to 6.1, p = 0.022) without any increased risk of any other adverse event. Analysis of 1-to-1 propensity-matched pairs showed a significantly higher risk of access site complication in patients receiving additional AC (13.1% vs 5.7%, p = 0.049). In conclusion, therapeutic warfarin treatment seems to provide sufficient AC for PCI. Additional heparins are not needed and may increase access site complications. [Copyright &y& Elsevier]

Long-term oral anticoagulation (OAC) prevents recurrent thrombosis, pulmonary embolism, and stroke, but it also increases bleeding risk. An outpatient bleeding risk index (OBRI) may help to identify patients at high risk of bleeding complications. The aim of this study was to evaluate the predictive value of OBRI in patients with OAC undergoing percutaneous coronary intervention (PCI). In addition, we analyzed the impact of OBRI on treatment choices in this patient group. Four hundred twenty-one patients with OAC underwent PCI at 6 centers in Finland. Complete follow-up was achieved in all patients (median 1,276 days). Sixty-four patients (15%) had a low bleeding risk (OBRI 0), 319 patients (76%) moderate bleeding risk (OBRI 1 to 2), and 38 (9%) high bleeding risk (OBRI 3 to 4). OBRI had no significant effect on periprocedural or long-term antithrombotic medications, choice of access site, or stent type. During follow-up, the incidence of major bleeding increased (p = 0.02) progressively with higher OBRI category (6.3%, 14.1%, and 26.3%, respectively). Similarly, mortality was highest in patients with high OBRI (14.1%, 20.7%, and 39.5%, p = 0.009, respectively), but rates of major adverse cardiovascular and cerebrovascular events were comparable in the OBRI categories. In conclusion, bleeding risk seems not to modify periprocedural or long-term treatment choices in patients after PCI on home warfarin. In contrast, patients with high OBRI often have major bleeding episodes and this simple index seems to be suitable for risk evaluation in this patient group. [Copyright &y& Elsevier]

Levosimendan, a new calcium sensitizer, was administered orally to 10 patients with severe congestive heart failure (CHF), who had a mean baseline pulmonary capillary wedge pressure (PCWP) of 22 mm Hg and a left ventricular ejection fraction of 23%. Each patient received 3 escalating doses of 1 mg, 2 mg, and 4 mg of levosimendan within 18-24 hours in an open-label pilot study. After administration of a 1-mg dose of levosimendan, PCWP decreased by 18% (p = 0.002) and cardiac output increased by 22% (p = 0.005). Diastolic blood pressure was decreased by about 5 mm Hg. Plasma catecholamine levels were unaffected. Plasma concentrations of levosimendan were unexpectedly Iow after administration of the 2-mg dose, and responses were weak. This was probably due to delayed drug absorption and altered baseline hemodynamics caused by ingestion of a meal before drug intake. The 4-mg dose of levosimendan was associated with a 27% increase in cardiac output (p = 0.009). PCWP showed only a small decrease, probably a result of relatively Iow baseline values (carryover from previous doses). Right atrial pressure decreased substantially by 40%. Heart rate increased by only 1-8 beats/min after administration of the 1- and 4-mg doses of levosimendan. It is concluded that oral levosimendan has favorable cardiac and hemodynamic effects in patients with severe CHF, and that these effects are similar to those seen after intravenous dosing with levosimendan in this patient group. [ABSTRACT FROM AUTHOR]

Competing Interests: Declaration of competing interest Dr. Savontaus received advisory fees from Medtronic and Boston Scientific. The remaining authors have no competing interest to declare.

Recent studies showed the favorable outcomes of transcatheter aortic valve implantation (TAVI) in patients with bicuspid aortic valve (BAV) stenosis. However, data on the relation between BAV morphology and optimal transcatheter heart valve (THV) selection are limited. This study sought to evaluate the determinants of device performance in patients with BAV who underwent TAVI. Consecutive patients with BAV who underwent TAVI with the SAPIEN 3 from multicenters were evaluated. Outcomes were the incidence and predictors of device failure. Device failure was defined as peak aortic velocity >3.0 m/s, mean pressure gradient >20 mm Hg, moderate or severe paravalvular leakage and/or procedure mortality. A total of 187 patients with BAV were identified, aged 77 years, and 38.0% were women. A total of 37 patients (19.8%) were treated with 23-mm valve, 58 (31.0%) with 26-mm valve, and 92 (49.2%) with 29-mm valve. Predischarge echocardiogram demonstrated 37 patients (19.8%) with device failure. BAV with excessive leaflet calcification plus calcified raphe (EC-BAV) (OR 16.7, 95% CI 1.99 to 39.6) and smaller THV (OR 4.41, 95% CI 1.43 to 13.6) were independently associated with increased risk of device failure. In addition, 4.0%, 5.1%, and 11.1% of device failures were observed in patients without EC-BAV who underwent TAVI with 23-, 26- and 29-mm THV (p = 0.47), respectively, and 91.7%, 31.6% and 23.2% in those with EC-BAV, respectively (p <0.001). In conclusion, EC-BAV morphology was the major determinant of a device failure after TAVI. Moreover, TAVI in patients with EC-BAV requiring small SAPIEN 3 could be challenging. Further data on device and treatment selection in patients with BAV are still warranted., (Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.)

Increasing data support transcatheter aortic valve implantation (TAVI) as a valid option over surgical aortic valve replacement (SAVR) in the treatment for severe aortic stenosis (AS) also in patients with low operative risk. However, limited data exist on the outcome of TAVI and SAVR in low-risk patients without coronary artery disease (CAD). The FinnValve registry included data on 6463 patients who underwent TAVI or SAVR with bioprosthesis between 2008 and 2017. Herein, we evaluated the outcome of low operative risk as defined by STS-PROM score <3% and absence of CAD, previous stroke and other relevant co-morbidities. Only patients who underwent TAVI with third-generation prostheses and SAVR with Perimount Magna Ease or Trifecta prostheses were included in this analysis. The primary endpoints were 30-day and 3-year all-cause mortality. Overall, 1,006 patients (175 TAVI patients and 831 SAVR patients) met the inclusion criteria of this analysis. Propensity score matching resulted in 140 pairs with similar baseline characteristics. Among these matched pairs, 30-day mortality was 2.1% in both TAVI and SAVR cohorts (p = 1.00) and 3-year mortality was 17.0% after TAVI and 14.6% after SAVR (p = 0.805). Lower rates of bleeding and atrial fibrillation, and shorter hospital stay were observed after TAVI. The need of new permanent pacemaker implantation and the incidence of early stroke did not differ between groups. In conclusion, TAVI using third-generation prostheses achieved similar early and mid-term survival compared with SAVR in low-risk patients without CAD., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Stent underexpansion is associated with worse outcome after stent implantation. Whether post-dilation (PD) improves outcome in patients with acute coronary syndrome (ACS) remains unclear. We performed post hoc analysis of outcome in patients from the BASE ACS (A prospective randomized comparison of titanium-nitride-oxide-coated bioactive stents with everolimus-eluting stents in acute coronary syndrome) trial who underwent PD versus those who did not. The BASE ACS trial randomized 827 patients (1:1) with ACS to receive either titanium-nitride-oxide-coated bioactive stents or everolimus-eluting stents. The primary end point was major adverse cardiac events (MACE): a composite of cardiac death, nonfatal myocardial infarction (MI), or ischemia-driven target lesion revascularization. Follow-up was planned at 12 months and yearly thereafter for up to 7 years. Of 827 patients enrolled in the BASE ACS trial, 357 (43.2%) underwent PD. Median follow-up duration was 5 years. Patients who underwent PD had less frequent nonfatal MI events at long-term follow-up, compared with those who did not (4.5% vs 8.5%, respectively, p = 0.02). The rates of MACE (15.7% vs 15.1%, respectively, p = 0.81), and the other endpoints, were not significantly different (p >0.5 for all). The results were consistent in propensity score-matched analysis (270 pairs). In patients treated with bioactive stents, those who underwent PD had a trend for a fewer nonfatal MI events (p = 0.076). Comparably, in patients treated with everolimus-eluting stents, MACE and all the individual end points were comparable (p >0.5 for all). In conclusion, patients treated with early percutaneous coronary intervention for ACS who underwent PD had less frequent nonfatal MI events at long-term follow-up, compared with those who did not; MACE rates were not significantly different., (Copyright © 2016 Elsevier Inc. All rights reserved.)