Nonagenarians are a growing population. Symptoms leading to pacing in patients aged ≥ 90 were similar to those of younger patients, but different frequency was found in the electrocardiographic indications. Ventricular chamber pacemakers were significantly more implanted than dual-chamber pacemakers but without negative survival influence.
Recent innovations and advancements in 3-dimensional (3D) echocardiography allow for better understanding of anatomic relationships and improve communication with the interventional cardiologist for guidance of catheter-based interventions. The mitral valve lends itself best for imaging with transesophageal echocardiography (TEE). Consequently, the role of 3D TEE in guiding catheter-based mitral interventions has been evolving rapidly. Although several publications have reported on the advantages and role of 3D TEE in guiding one or more of the steps involved in percutaneous mitral valve repair using the MitraClip, none offer a comprehensive and practical user-friendly guide. This review article provides the reader with practical intraprocedural tips on use of 3D TEE to guide all relevant steps involved in the procedure including how to acquire the images needed and what to look for.
The overall rate of bleeding complications during interventional therapeutic procedures for coronary heart disease by the femoral approach is 1.5 to 9%. 1 Although bleeding is considered a minor complication related to percutaneous coronary intervention (PCI), 2 on rare occasions, it might lead to life-threatening situations that must be treated by intensive medical or surgical approaches. 3 These events are multifactorial, involving patient-, physician-, and nursing staff-related prognosis-worsening factors. Patient-related factors include: female gender, age > 70 years, and comorbidities such as diabetes mellitus, obesity, hypertension, and diseases with poor clot formation, such as uremia and thrombocytopenia. 4 Physician-related factors include: port of access, mode of arterial puncture (single vs. multiple trials) and anticoagulation regimen. 5 Early data using abciximab during high-risk coronary angioplasty (EPIC trial) showed that bleeding complications occur more often in the IIb-/IIIatreated groups, 6 a trend that persisted under low-dose (EPI-LOG trial), weight-adjusted heparin infusion. 7 One of the alternatives to unfractionated heparin (UFH) is bivalirudin (BIV), a direct and reversible thrombin-inhibition oligopeptide with a relatively short half-life. In previous AbstractLow/medium-bleeding-risk populations undergoing percutaneous coronary intervention (PCI) show significantly less bleeding with bivalirudin (BIV) than with unfractionated heparin (UFH), but this has not been established for high-risk patients. We performed a randomized double-blind prospective trial comparing efficacy and safety of BIV versus UFH combined with dual antiplatelet therapy during PCI among 100 high-risk patients with non-ST elevation myocardial infarction (NSTEMI) or angina pectoris. The baseline characteristics were similar in both treatment arms. A radial approach was used in 84% of patients with a higher rate in the BIV group (90 vs. 78%, p < 0.05). Study end points were: major and minor bleeding, port-of-entry complications, major adverse cardiac events (MACE) in-hospital, and at long-term follow-up. There was one case of major gastrointestinal bleeding in the BIV group and 7% minor bleeding complications in both categories. Rate of periprocedural myocardial infarction (PPMI) in the BIV group was twice that in the UFH group (20 vs. 10%, p < 0.16). In-hospital MACE rate was higher in BIV patients as well (12 vs. 2%, p ¼ 0.1). By univariate analysis, the femoral approach was the predictor of PPMI and in-hospital MACE. In a multivariate model, the independent predictor of PPMI was previous MI (odds ratio, 7.7; p < 0.0158). PPMI was 49.7 times more likely with the femoral approach plus BIV than the nonfemoral approach plus UFH (p < 0.0021). At 41.5 AE 14 months' follow-up, end points did not significantly differ between the groups. In patients at high risk for bleeding undergoing PCI, BIV was not superior to UFH for bleeding complications, and early and late clinical outcomes.
Background: It is generally perceived that sample sizes of randomized clinical trials (RCTs) have increased over the years, particularly in specialties such as cardiology, with a robust evidence base. The aim of this study was to analyze temporal trends in sample sizes of RCTs in cardiology journals compared to other specialties. Methods: Abstracts of RCTs involving humans from PubMed for 1970-2013 were analyzed using a digital search algorithm. Sample sizes of studies were extracted from each abstract. Date of publication and journal name were collected. Journals from several medical subspecialties were selected for comparison, using the journal impact factor as a measure of clinical relevance. Sample sizes of studies in 1990 were compared to 2010 for each of the journals using the Mann-Whitney U test. Graphical comparisons of sample size trends are presented. Results: 272,054 abstracts of human RCTs were identified. Median sample sizes for the years 1990 and 2010 is shown in table 1. The median sample size for all RCTs published in Circulation was 99 subjects per study in 1990, increasing to 630 subjects per study in 2010 (p < 0.01). All cardiology journals had a significant increase in study sample size over the 20 year period, as did the multispecialty journals (JAMA, NEJM, Lancet). In contrast, only a few non-cardiology specialty journals published studies with increasing sample sizes (table 1). Figure 1 shows the sample size trend for 1970-2013. Conclusions: Our study demonstrates a dramatic temporal trend of increasing sample sizes in RCTs in cardiology compared to other specialties. Since sample size is estimated based on the effect size studied, one explanation for this observation is that the more obvious larger effects have been previously elucidated, leaving only smaller associations to be studied. This requires increasing resources, highlighting the importance of alternate study designs and collaborative registries to develop a cost effective evidence base.
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