Background Primary prevention implantable cardioverter defibrillators (ICDs) reduce all-cause mortality by reducing sudden cardiac death. There are conflicting data regarding whether patients with ...more advanced heart failure (HF) derive ICD benefit owing to the competing risk of non-sudden death. Methods We performed a patient level meta-analysis of New York Heart Association class (NYHA) class II/III HF patients (left ventricular ejection fraction ≤35%) from 4 primary prevention ICD trials (MADIT-I, MADIT-II, DEFINITE, SCD-HeFT). Bayesian–Weibull survival regression models were employed to assess the impact of NYHA class on the relationship between ICD use and mortality. Results Of the 2763 patients who met study criteria, 68% (n = 1867) were NYHA II and 52% (n = 1435) were randomized to an ICD. In a multivariable model including all study patients, the ICD reduced mortality HR 0.65, 95% posterior credibility interval (PCI) 0.40–0.99. The interaction between NYHA class and the ICD on mortality was significant (posterior probability of no interaction = 0.036). In models including an interaction term for the NYHA class and ICD, the ICD reduced mortality among NYHA class II patients (HR 0.55, PCI 0.35–0.85) and the point estimate suggested reduced mortality in NYHA class III patients (HR 0.76, PCI 0.48–1.24) although this was not statistically significant. Conclusions Primary prevention ICDs reduce mortality in NYHA class II patients and trend towards reducing mortality in the heterogeneous group of NYHA class III patients. Improved risk stratification tools are required to guide patient selection and shared decision making among NYHA class III primary prevention ICD candidates.
Catheter ablation of ventricular tachycardia (VT) has evolved in recent years, especially in patients with ischemic heart disease. Data from prospective studies show that VT catheter ablation reduces ...the risk of recurrent VT; however, there is a paucity of data on the effect of VT catheter ablation on mortality and patient-centered outcomes such as quality of life. Performing randomized clinical trials of VT catheter ablation can be fraught with challenges, and, as a result, several prior trials of VT catheter ablation had to be stopped prematurely. The main challenges are inability to blind the patient to therapy to obtain a traditional control group, high crossover rates between the 2 arms of the study, patient refusal to participate in trials in which they have an equal chance of receiving a "pill" vs an invasive procedure, heterogeneity of mapping and ablation techniques as well as catheters and equipment, rapid evolution of technology that may make findings of any long trial less relevant to clinical practice, lack of consensus on what constitutes acute procedural and long-term success, and presentation of patients to electrophysiologists late in the course of their disease. In this article, a panel of experts on VT catheter ablation and/or clinical trials of VT catheter ablation review challenges faced in conducting prior trials of VT catheter ablation and offer potential solutions for those challenges. It is hoped that the proposed solutions will enhance the feasibility of randomized clinical trials of VT catheter ablation.
Abstract Background Cardiac disease is a leading cause of stroke in children, yet limited data support the current stroke prevention and treatment recommendations. A multidisciplinary panel of ...clinicians was convened in February 2014 by the International Pediatric Stroke Study group to identify knowledge gaps and prioritize clinical research efforts for children with cardiac disease and stroke. Results Significant knowledge gaps exist, including a lack of data on stroke incidence, predictors, primary and secondary stroke prevention, hyperacute treatment, and outcome in children with cardiac disease. Commonly used diagnostic techniques including brain computed tomography and ultrasound have low rates of stroke detection, and diagnosis is frequently delayed. The challenges of research studies in this population include epidemiologic barriers to research such as small patient numbers, heterogeneity of cardiac disease, and coexistence of multiple risk factors. Based on stroke burden and study feasibility, studies involving mechanical circulatory support, single ventricle patients, early stroke detection strategies, and understanding secondary stroke risk factors and prevention are the highest research priorities over the next 5-10 years. The development of large-scale multicenter and multispecialty collaborative research is a critical next step. The designation of centers of expertise will assist in clinical care and research. Conclusions There is an urgent need for additional research to improve the quality of evidence in guideline recommendations for cardiogenic stroke in children. Although significant barriers to clinical research exist, multicenter and multispecialty collaboration is an important step toward advancing clinical care and research for children with cardiac disease and stroke.
Background The COURAGE trial reported similar clinical outcomes for patients with stable ischemic heart disease (SIHD) receiving optimal medical therapy (OMT) with or without percutaneous coronary ...intervention (PCI). The current post hoc substudy analysis examined the relationship between baseline stress myocardial ischemia and clinical outcomes based on randomized treatment assignment. Methods A total of 1,381 randomized patients (OMT n = 699, PCI + OMT n = 682) underwent baseline stress myocardial perfusion single-photon emission computed tomographic imaging. Site investigators interpreted the extent of ischemia by the number of ischemic segments using a 6-segment myocardial model. Patients were divided into those with no to mild (< 3 ischemic segments) and moderate to severe ischemia (≥ 3 ischemic segments). Cox proportional hazards models were calculated to assess time to the primary end point of death or myocardial infarction. Results At baseline, moderate to severe ischemia occurred in more than one-quarter of patients (n = 468), and the incidence was comparable in both treatment groups ( P = .36). The primary end point, death or myocardial infarction, was similar in the OMT and PCI + OMT treatment groups for no to mild (18% and 19%, P = .92) and moderate to severe ischemia (19% and 22%, P = .53, interaction P value = .65). There was no gradient increase in events for the overall cohort with the extent of ischemia. Conclusions From the COURAGE trial post hoc substudy, the extent of site-defined ischemia did not predict adverse events and did not alter treatment effectiveness. Currently, evidence supports equipoise as to whether the extent and severity of ischemia impact on therapeutic effectiveness.
Femtosecond laser capsulotomy Friedman, Neil J; Palanker, Daniel V; Schuele, Georg ...
Journal of cataract and refractive surgery,
07/2011, Volume:
37, Issue:
7
Journal Article
Peer reviewed
To evaluate a femtosecond laser system to create the capsulotomy.
Porcine and cadaver eye studies were performed at OptiMedica Corp., Santa Clara, California, USA; the human trial was performed at ...the Centro Laser, Santo Domingo, Dominican Republic.
Experimental and clinical study.
Capsulotomies performed by an optical coherence tomography-guided femtosecond laser were evaluated in porcine and human cadaver eyes. Subsequently, the procedure was performed in 39 patients as part of a prospective randomized study of femtosecond laser-assisted cataract surgery. The accuracy of the capsulotomy size, shape, and centration were quantified and capsulotomy strength was assessed in the porcine eyes.
Laser-created capsulotomies were significantly more precise in size and shape than manually created capsulorhexes. In the patient eyes, the deviation from the intended diameter of the resected capsule disk was 29 μm ± 26 (SD) for the laser technique and 337 ± 258 μm for the manual technique. The mean deviation from circularity was 6% and 20%, respectively. The center of the laser capsulotomies was within 77 ± 47 μm of the intended position. All capsulotomies were complete, with no radial nicks or tears. The strength of laser capsulotomies (porcine subgroup) decreased with increasing pulse energy: 152 ± 21 mN for 3 μJ, 121 ± 16 mN for 6 μJ, and 113 ± 23 mN for 10 μJ. The strength of the manual capsulorhexes was 65 ± 21 mN.
The femtosecond laser produced capsulotomies that were more precise, accurate, reproducible, and stronger than those created with the conventional manual technique.
Abstract Background Data regarding cardiac resynchronization therapy (CRT) in patients with multiple comorbidities are limited. Objectives This study evaluated the association of multiple ...comorbidities with the benefits of CRT over implantable cardioverter-defibrillator (ICD) alone. Methods We examined 1,214 MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy) study patients with left bundle branch block (LBBB) and 0, 1, 2, or ≥3 comorbidities, including renal dysfunction, hypertension (HTN), diabetes, coronary artery disease, history of atrial arrhythmias, history of ventricular arrhythmias, current smoking, and cerebrovascular accident. In an adjusted analysis, we analyzed risk of heart failure (HF) events or death by comorbidity group in all patients and in patients with CRT with defibrillator (CRT-D) versus ICD. Then we examined percent change in left ventricular (LV) end-diastolic volume, LV end-systolic volume, LV ejection fraction, left atrial volume, and LV dyssynchrony at 1-year in CRT-D patients by comorbidity group. Results There was an inverse relationship between comorbidity burden and improvements in LV end-systolic volume, LV end-diastolic volume, left ventricular ejection fraction, left atrial volume, and LV dyssynchrony. In an adjusted model, there was an increasing risk of death or nonfatal HF events with increasing comorbidity burden regardless of treatment group (p < 0.001). During a mean follow-up of 4.65 years, there was no interaction with respect to comorbidity burden and the benefit of CRT-D versus ICD only for death or nonfatal HF events (interaction p = 0.943). In the groups with greatest comorbidity burden (2 and ≥3), the absolute risk reduction associated with CRT-D over ICD alone appeared greater than that seen for groups with less comorbidity burden (0 and 1). Conclusions During long-term follow-up of MADIT-CRT study patients with LBBB randomized to CRT-D, there were differences in HF or death risk and in the degree of reverse remodeling among comorbidity groups. However, the burden of comorbidity does not appear to compromise the clinical benefits of CRT-D compared with ICD alone.
Background Mesoamerican nephropathy (MeN) is a kidney disease of unknown cause that mainly affects working-age men in Central America. Despite being a major cause of morbidity and mortality in this ...region, its clinical characteristics have not been well defined. Study Design Cross-sectional family-based study. Setting & Participants 266 members of 24 families with high chronic kidney disease (CKD) burdens in a MeN hotspot in Northwestern Nicaragua. We compared clinical and biochemical characteristics of affected individuals first with their unaffected relatives and then with NHANES (National Health and Nutrition Examination Survey) participants with CKD in order to reveal identifying features of MeN. Predictor CKD defined as serum creatinine level ≥ 1.5 mg/dL in men and ≥1.4 mg/dL in women. Outcomes Clinical and biochemical parameters, including serum sodium, potassium, bicarbonate, calcium, magnesium, phosphorus, and uric acid. Results Hyperuricemia, in many cases severe, was common among patients with MeN. Uric acid levels in patients with MeN were higher than those in NHANES participants (mean, 9.6 vs 7.4 mg/dL for men in each group) despite more frequent use of uric acid–lowering medications in Nicaraguan individuals (71.7% vs 11.2%). In multivariable linear mixed-effects regression analysis, uric acid levels were 2.0 mg/dL (95% CI, 1.0-3.0; P < 0.001) higher in patients with MeN compared with their NHANES counterparts after adjusting for age, estimated glomerular filtration rate, and uric acid–lowering therapies. In contrast to prior reports, hyponatremia and hypokalemia were not common. Limitations CKD defined by single serum creatinine measurement; population likely not representative of full MeN phenotype spectrum across Central America; major differences between MeN and NHANES groups in important characteristics such as age, ancestry, and recruitment method. Conclusions Hyperuricemia out of proportion to the degree of decreased kidney function was common among Nicaraguan patients with MeN. Our results suggest that rather than being solely a consequence of CKD, hyperuricemia may play a role in MeN pathogenesis, a hypothesis that deserves further study.
To compare 2 optical patient interface designs used for femtosecond laser-assisted cataract surgery.
Optimedica Corp., Santa Clara, California, USA, and Centro Laser, Santo Domingo, Dominican ...Republic.
Experimental and clinical studies.
Laser capsulotomy was performed during cataract surgery with a curved contact lens interface (CCL) or a liquid optical immersion interface (LOI). The presence of corneal folds, incomplete capsulotomy, subconjunctival hemorrhage, and eye movement during laser treatment were analyzed using video and optical coherence tomography. The induced rise of intraocular pressure (IOP) was measured in porcine and cadaver eyes.
Corneal folds were identified in 70% of the CCL cohort; 63% of these had areas of incomplete capsulotomies beneath the corneal folds. No corneal folds or incomplete capsulotomies were identified in the LOI cohort. The mean eye movement during capsulotomy creation (1.5 sec) was 50 μm with a CCL and 20 μm with an LOI. The LOI cohort had 36% less subconjunctival hemorrhage than the CCL cohort. During suction, the mean IOP rise was 32.4 mm Hg ± 3.4 (SD) in the CCL group and 17.7 ± 2.1 mm Hg in the LOI group.
Curved contact interfaces create corneal folds that can lead to incomplete capsulotomy during laser cataract surgery. A liquid interface eliminated corneal folds, improved globe stability, reduced subconjunctival hemorrhage, and lowered IOP rise.
Stress Thallium-201/Rest Technetium-99m Sequential Dual Isotope High-Speed Myocardial Perfusion Imaging Daniel S. Berman, Xingping Kang, Balaji Tamarappoo, Arik Wolak, Sean W. Hayes, Ryo Nakazato, ...Louise E. J. Thomson, Faith Kite, Ishac Cohen, Piotr J. Slomka, Andrew J. Einstein, John D. Friedman A novel, reverse dual isotope stress thallium-201 (Tl-201) and rest technetium-99m (Tc-99m) myocardial perfusion protocol was performed in a large number of consecutive patients using a high-speed gamma camera. The study protocol was accomplished within <20 min without sacrificing image quality or confidence in interpretation. When compared with another group of patients undergoing a standard rest and stress Tc-99m agent studies, the extracardiac activity was less on stress Tl-201 and rest Tc-99m studies while the normalcy rate and radiation burden were comparable. Stress Tl-201 and rest Tc-99m protocol offers promise as an efficient, relatively low radiation dose method, in which the superior qualities of Tl-201 for stress imaging and of the Tc-99m agents for rest imaging can be preserved.
To determine whether functional status on admission to a Comprehensive Integrated Inpatient Rehabilitation Program (CIIRP) is associated with unplanned readmission to acute care.
Retrospective cohort ...study.
Academic hospital-based CIIRP.
Consecutive patients (N=1515) admitted to a CIIRP between January 2009 and June 2012.
Patients' functional status, the primary exposure variable, was assessed using tertiles of the total FIM score at CIIRP admission, with secondary analyses using the FIM motor and cognitive domains. A propensity score, consisting of 25 relevant clinical and demographic variables, was used to adjust for confounding in the analysis.
Readmission to acute care was categorized as (1) readmission before planned discharge from the CIIRP, (2) readmission within 30 days of discharge from the CIIRP, and (3) total readmissions from both groups, with total readmissions being the a priori primary outcome.
Among the 1515 patients, there were 347 total readmissions. Total readmissions were significantly associated with FIM scores, with adjusted odds ratios (AORs) and 95% confidence intervals (CIs) for the lowest and middle FIM tertiles versus the highest tertile (AOR=2.6; 95% CI, 1.9-3.7; P<.001 and AOR=1.7; 95% CI, 1.2-2.4; P=.002, respectively). There were similar findings for secondary analyses of readmission before planned discharge from the CIIRP (AOR=3.5; 95% CI, 2.2-5.8; P<.001 and AOR=2.1; 95% CI, 1.3-3.5l P=.002, respectively), and a weaker association for readmissions after discharge from the CIIRP (AOR=1.6; 95% CI, 1.0-2.4; P=.047 and AOR=1.3; 95% CI, 0.8-1.9; P=.28, respectively). The FIM motor domain score was more strongly associated with readmissions than the FIM cognitive score.
Functional status on admission to the CIIRP is strongly associated with readmission to acute care, particularly for motor aspects of functional status and readmission before planned discharge from the CIIRP. Efforts to reduce hospital readmissions should consider patient functional status as an important and potentially modifiable risk factor.
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