Transcatheter Patch Occlusion of the Left Atrial Appendage Using Surgical Adhesives in High-Risk Patients With Atrial Fibrillation

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Echocardiographic estimation of balloon-stretched diameter of secundum atrial septal defect for transcatheter occlusion

Stretched diameter of the atrial septal defect (ASD), determined by balloon sizing at cardiac catheterization, is commonly used to select the sizes of the devices used for transcatheter closure of the secundum ASD. We have previously evaluated the utility of pulmonary/systemic flow ratio and angiographic and echocardiographic (echo) sizes of the ASD in estimating stretched ASD diameter in a group of 16 patients and determined that echo diameter had the best correlation with stretched diameter (r = 0.82; p p > 0.1) from the measured stretched diameter. The correlation between predicted and measured stretched ASD sizes was excellent (r = 0.9; p < 0.001). The mean squared error was 2.4. The differences between measured and predicted values were within 2 mm in all but three patients. It is concluded that stretched ASD diameter can be estimated accurately by two-dimensional subcostal echo measurements, which in turn could be used for selection of device size for occlusion of the ASD.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/29960/1/0000322.pd

International experience with secundum atrial septal defect occlusion by the buttoned device

Several devices are available for transcatheter occlusion of atrial septal defect. This report describes the international experience with the buttoned device. During a 4.5-year period ending in February 1993, 180 transcatheter atrial septal defect occlusions were performed with the buttoned device. Patient age varied between 0.6 and 76 years and stretched atrial defect diameter between 5 and 25 mm. The defects were closed with 25 to 50 mm devices delivered through 8F (148 patients) or 9F (32 patients) sheaths. Twelve patients were adults whose defects were closed to prevent recurrence of cerebrovascular accidents caused by presumed paradoxic embolism. In the remaining patients the atrial defect was closed to treat the left-to-right shunt. The atrial septal defects were effectively occluded as demonstrated by (1) decrease in pulmonary-to-systemic flow ratio from 2.1 +/- 0.6 (mean +/- SD) to 1.05 +/- 0.1 (p 2 and disappearance of the diastolic murmur by auscultation; and (3) improvement in right ventricular volume overloading by echocardiogram. However, trivial to small shunts could be detected by color Doppler studies in 76 (45%) of 168 patients in whom such data are available. Complications included unbuttoning in 13 and whole-device embolization in 1. All patients remained stable, and retrieval of the device and surgical closure of the atrial septal defect were accomplished in 10 patients. Transcatheter retrieval was used in the remaining 4 patients. The incidence of unbuttoning, a major complication of the procedure, appeared to decrease with the increasing experience of the investigators and with device modification (third-generation). The follow-up duration varied between 1 month and 4 years. Six patients required surgery during the follow-up period. In the remaining patients (n = 160), clinical examination did not reveal signs of atrial shunts. Color Doppler studies revealed either complete disappearance of the previously demonstrated shunts or further diminution of their size. The results indicate that transcatheter occlusion of the atrial septal defects with buttoned devices is feasible, relatively safe, and effective, and it appears to be a viable alternative to surgery for some patients with secundum atrial septal defect. Complications are infrequent and should improve with experience.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/31234/1/0000139.pd

Addition of Docetaxel to First-line Long-term Hormone Therapy in Prostate Cancer (STAMPEDE) : Modelling to Estimate Long-term Survival, Quality-adjusted Survival, and Cost-effectiveness

Background Results from large randomised controlled trials have shown that adding docetaxel to the standard of care (SOC) for men initiating hormone therapy for prostate cancer (PC) prolongs survival for those with metastatic disease and prolongs failure-free survival for those without. To date there has been no formal assessment of whether funding docetaxel in this setting represents an appropriate use of UK National Health Service (NHS) resources. Objective To assess whether administering docetaxel to men with PC starting long-term hormone therapy is cost-effective in a UK setting. Design, setting, and participants We modelled health outcomes and costs in the UK NHS using data collected within the STAMPEDE trial, which enrolled men with high-risk, locally advanced metastatic or recurrent PC starting first-line hormone therapy. Intervention SOC was hormone therapy for ≥2 yr and radiotherapy in some patients. Docetaxel (75 mg/m2) was administered alongside SOC for six three-weekly cycles. Outcome measurements and statistical analysis The model generated lifetime predictions of costs, changes in survival duration, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs). Results and limitations The model predicted that docetaxel would extend survival (discounted quality-adjusted survival) by 0.89 yr (0.51) for metastatic PC and 0.78 yr (0.39) for nonmetastatic PC, and would be cost-effective in metastatic PC (ICER £5514/QALY vs SOC) and nonmetastatic PC (higher QALYs, lower costs vs SOC). Docetaxel remained cost-effective in nonmetastatic PC when the assumption of no survival advantage was modelled. Conclusions Docetaxel is cost-effective among patients with nonmetastatic and metastatic PC in a UK setting. Clinicians should consider whether the evidence is now sufficiently compelling to support docetaxel use in patients with nonmetastatic PC, as the opportunity to offer docetaxel at hormone therapy initiation will be missed for some patients by the time more mature survival data are available. Patient summary Starting docetaxel chemotherapy alongside hormone therapy represents a good use of UK National Health Service resources for patients with prostate cancer that is high risk or has spread to other parts of the body.This study was supported by the UK Medical Research Council (delegation to Swiss Group for Cancer Clinical Research [SAKK] in Switzerland) grant number MRC_MC_UU_12023/25 and the following funders: Cancer Research UK (grant number CRUK_A12459), Medical Research Council, Astellas, Clovis Oncology, Janssen, Novartis, Pfizer, and Sanofi-Aventis. The sponsors played no direct role in the study

Atrial septal defect occlusion with the buttoned device (a multi-institutional U.S. trial)

A clinical trial was conducted of the buttoned device for transcatheter closure of ostium secundum atrial septal defect. Occlusion was attempted in 57 patients aged 1 to 62 years (median 5). The procedure was abandoned in 7 patients after 1 or more unsuccessful attempts, and devices were released in 50 patients. Urgent surgical retrieval was necessary in 4 patients because of unstable device position: 3 devices "unbuttoned," with migration of the counteroccluder to the pulmonary artery or inferior vena cava, and 1 intact device embolized to the main pulmonary artery. All patients remained stable and underwent successful operation. Successful device implantation was therefore achieved in 46 patients, with immediate reduction in Qp/Qs from 1.8 +/- 0.6 to 1.1 +/- 0.2 (mean +/- SD, p < 0.0001). At most recent follow-up (1 to 20 months), 45 of 46 patients (98%) have no shunt or a trivial residual shunt. The prevalence of residual shunts declined from 65% at 1 month to 19% at 12 months after the occlusion procedure (p < 0.0001). Complications included unbuttoning of a fourth device, transient tricuspid regurgitation in 2 patients, and transient mitral regurgitation in 2 patients. An episode of asymptomatic atrial flutter was noted in a 46-year-old patient which may have been related to device implantation, but which has not recurred. There have been no cases of endocarditis or thromboembolism in 350 patient-months of follow-up. The buttoned device provided effective closure of the atrial septal defect in 45 of 57 patients (79%) in whom implantation was attempted and in 45 of 46 patients (98%) in whom device implantation was successfully accomplished. Unbuttoning remains the major complication of the procedure; increased operator experience and design modifications to the device may reduce the frequency of this problem in the future.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/31816/1/0000762.pd