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Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study

20 Sep, 17 | by lfountain

Use of transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) has grown rapidly over the last decade and the technology has correspondingly matured. Nevertheless, recent data suggest that subclinical thrombosis may form on some leaflets of the TAVR prostheses following implant. The frequency, implications, and required treatment of this process are largely unknown, as is the relevance to surgical aortic valve replacement (SAVR).

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Idarucizumab for Dabigatran Reversal

20 Sep, 17 | by lfountain

The first direct oral anticoagulant (DOAC) was approved nearly a decade ago, yet there remains apprehension in transitioning to wide-spread use despite demonstrated efficacy and ease of use. One limitation is the absence of a reversal agent for patients on DOACs who develop significant bleeding or require emergent surgery. Idarucizumab is a humanized monoclonal antibody fragment which binds dabigatran and rapidly reverses anticoagulant activity.

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Levosimendan for Hemodynamic Support after Cardiac Surgery

27 Jul, 17 | by lfountain

Left ventricular dysfunction following cardiac surgery remains a significant perioperative challenge, one often treated with inotropic support, however practice patterns vary widely and there are few outcome data to support a standardized practice. Levosimendan represents a newer class of “inodilators”, calcium sensitizers, thought to improve cardiac output without increasing myocardial oxygen consumption.

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Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients (SURTAVI Investigators)

24 May, 17 | by flee

Transcatheter aortic valve replacement (TAVR) is superior to medical therapy in inoperable patients with severe, symptomatic aortic stenosis (AS), and may be the preferred option in high-risk surgical patients. The comparative efficacy of TAVR and surgical aortic valve replacement (SAVR) in intermediate risk AS patients has been less well studied. The PARTNER 2 randomized trial showed non-inferiority of balloon expandable TAVR compared to SAVR in intermediate risk patients at 2 years. In the Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trial, a self-expandable TAVR prosthesis (Medtronic’s CoreValve [84%] and Evolut R [16%]) was randomized against SAVR in 1660 intermediate risk patients. The primary endpoint was a composite of death from any cause and disabling stroke at 24 months. The mean age was 79.8±6.2 years with an average Society of Thoracic Surgeons (STS) estimated risk of death of 4.5±1.6%. At 24 months, the TAVR group was non-inferior to the SAVR group for the primary endpoint (12.6% vs. 14.0%, posterior probability of non-inferiority, >0.999). Rates of both individual components of this endpoint were also similar. TAVR, compared to surgery was associated with lower rates of acute kidney injury (1.7% vs. 4.4%), atrial fibrillation (12.9% vs. 43.4%), and transfusion requirements (12.5% vs. 41.1%), but higher rates of residual aortic regurgitation (5.3% vs. 0.6%) and need for pacemaker implantation (25.9% vs. 6.6%).

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Association Between Achieved Low-Density Lipoprotein Levels and Major Adverse Cardiac Events in Patients With Stable Ischemic Heart Disease Taking Statin Treatment

25 Apr, 17 | by flee

Current societal guidelines advise differing dosing strategies when it comes to statin usage. The European Society of Cardiology/European Atherosclerosis Society recommends targeting a low-density lipoprotein cholesterol (LDL-C) level less than 70 mg/dL or a 50% LDL-C reduction in very high risk patients while the American College of Cardiology/American Heart Association task force advises high intensity statins without a particular LDL-C target in similar populations. This study reports on the association between achieved LDL-C levels after a year on statin therapy and subsequent major adverse cardiac events (MACE) among 31,000 Israeli patients with previous ischemic heart disease aged 30 to 84 who were at least 80% adherent to their statin therapy.The primary outcome was a combination of myocardial infarction, unstable angina, stroke, percutaneous coronary intervention and coronary artery bypass grafting, or all-cause mortality over a mean 1.6 years of follow up, after adjusting for socioeconomic factors, comorbidities and medication usage. There was no difference in incidence of adverse outcomes between low (≤ 70.0 mg/dL), and moderate (70.1 – 100.0 mg/dL) LDL-C groups (hazard ratio [HR], 1.02; 95% CI, 0.97-1.07; P = .54) but a lower incidence in moderate comared to high (≥ 100.0 mg/dL) LDL-C groups (HR, 0.89; 95% CI, 0.84-0.94; P < .001). Sensitivity analyses for age cutoffs and propensity matching reached similar conclusions. In a nonlinear regression analysis, the authors found that lower LDL-C levels did correlate with reduced MACE rates, but only to a level of approximately 90 mg/dL.

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No benefit from bilateral mammary grafts at 5 years

25 Apr, 17 | by flee

Coronary artery bypass grafting (CABG) is an established therapy for obstructive cardiovascular disease and ischemic cardiomyopathy. Utilization of the left-internal mammary artery as a graft has been a particularly successful aspect of CABG due to impressively durable patency rates. Despite this, adoption of bilateral mammary artery grafting has lagged in surgical practice.  The Arterial Revascularization Trial (ART) randomized a total of 3102 patients to either single or bilateral mammary grafting. At five years there were no differences between groups in the rates of death (8.7% vs. 8.4%; P=0.77) or major adverse cardiovascular events including myocardial infarction and stroke (12.2% vs. 12.7%; P=0.69).   Rates of sternal wound infections and sternal reconstruction were significantly higher in the bilateral mammary group (P=0.005) while rates of clinical angina were no different at 5 years.

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Bleeding versus thromboembolic protection in atrial fibrillation and coronary stent procedures.

18 Apr, 17 | by flee

Five to 8% of people undergoing percutaneous coronary intervention (PCI) also have atrial fibrillation (AF).  The optimal antiplatelet / anticoagulant regimen in these individuals remains unclear as stroke and stent thrombosis prevention need to be balanced against the risks of major bleeding.  The PIONEER AF-PCI trial (Open-Label, Randomized, Controlled, Multicenter Study Exploring Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects with Atrial Fibrillation who Undergo Percutaneous Coronary Intervention) randomized 2124 patients with AF who had undergone PCI to 1 of 3 arms: 15mg rivaroxaban + a P2Y12 inhibitor alone for 12 months, 2.5mg of twice daily rivaroxaban + a P2Y12 inhibitor and aspirin (DAPT) for 1, 6 or 12 months or warfarin + DAPT for 1, 6 or 12 months.  The predominant P2Y12 inhibitor was clopidogrel (approx. 90%). The primary endpoint was clinically significant bleeding while efficacy – both myocardial infarction and stroke were secondary end-points.  Both rivaroxaban arms demonstrated significant reductions in major bleeding relative to the warfarin arm (16.8% vs. 18.0% vs. 26.7%; P<0.001).  Furthermore, overall rates of stroke and myocardial infarction were similarly low across all sub-groups.

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No differences in on-pump versus off-pump bypass grafting at 5 years.

18 Apr, 17 | by flee

Coronary artery bypass grafting (CABG) may significantly improve quality of life and longevity.  As with all therapies, however, these benefits must be weighed against potential risks. Some hypothesize that aortic cross clamping and cardiopulmonary bypass, historically utilized during CABG, increase the potential for certain complications and can be successfully avoided with newer “off-pump” CABG techniques.  Various studies have examined the benefits of off-pump vs. on-pump CABG with the largest to date being the international, multi-center, randomized CABG Off or On Pump Revascularization Study (CORONARY)  study, involving 4,752 patients.  The previously reported 30 day and 1 year data from this study demonstrated no difference between techniques, but here the 5-year data are published.   Using a composite outcome of death, stroke, myocardial infarction, renal failure, or repeat coronary revascularization, there was no difference between the two surgical techniques (23.1% vs. 23.6%, P=0.72) or indeed, in any of the individuals components of the outcome.  There were also no significant between-group differences in quality-of-life measures.  A secondary analysis of economic cost also found no significant difference between the two modalities (US$15,107 vs. US$14,992).

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Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis

18 Apr, 17 | by flee

The use of percutaneous coronary intervention (PCI) for unprotected left main coronary artery stenosis is increasing but it remains unclear whether this approach is non-inferior to coronary artery bypass grafting (CABG). Both the Nordic-Baltic-British left main revascularization study (NOBLE, n=1201) and Evaluation of an everolimus eluting stent versus coronary artery bypass surgery for effectiveness of left main revascularization study (EXCEL, n=1905) randomized patients with severe left main coronary artery stenosis to PCI or CABG to address this question. Though similar, there are important differences in these studies’ design and results.  Primary outcomes were defined as all cause death, stroke and non-procedural myocardial infarction (MI) in both trials with the addition of repeat revascularization in NOBLE and post-procedural MI in EXCEL. Other study differences include intended duration of follow up, non-inferiority margins, allowable coronary complexity, and stent type. The prevalence of distal left main stenosis was quite high (~80%) in both trials.  In EXCEL, PCI was non-inferior to CABG with respect to the primary composite endpoint at 3 years (15.4% for PCI, 14.7% for CABG, confidence interval (CI) 0.79 to 1.26 while, NOBLE found that PCI was inferior to CABG for the 5-year estimated primary event rate (29% for PCI, 19% for CABG, CI 1.11 to 1.96). Adding repeat revascularization to the primary end-point in EXCEL did not change the finding of non-inferiority between PCI and CABG. All-cause mortality did not differ by treatment in either trial.

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Amiodarone and lidocaine in refractory cardiac arrest

18 Apr, 17 | by flee

Out of hospital cardiac arrest with shock-refractory ventricular tachycardia (VT) or fibrillation (VF) carries a severe prognosis.  Despite their frequent use and guideline inclusion in this scenario, evidence that amiodarone or lidocaine improve survival is lacking. In this large multicenter randomized controlled double-blind trial, 3026 adult patients with spontaneously occurring out-of-hospital cardiac arrest and shock-refractory VT or VF were randomized by paramedics to treatment with amiodarone (974), lidocaine (993) or saline placebo (1059), along with standard care.  After presentation to the hospital, patients received open-label drugs, emergent angiography, and cooling as clinically indicated.  The primary outcome was survival to discharge with secondary outcomes including neurological and functional status in survivors.  Mean time to paramedic arrival and study drug administration were 8 and 19 minutes respectively.  There was no significant survival difference between the three groups (24.4%, 23.7%, and 21.0% respectively), nor differences in important neurologic outcomes. Treatment with amiodarone did result in shorter CPR times and fewer shocks but also had a higher rate of subsequent cardiac pacing.  In the sub-group of patients with a witnessed arrest, both amiodarone and lidocaine significantly improved survival (27.7% vs. 27.8% vs. 22.7%) and this effect was even more apparent when the arrest was witnessed by the paramedic crew (absolute risk reduction of 21.9%), though the trial was not sufficiently powered for these secondary analyses.

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