Citations

Background and Purpose— Evidence indicates that center volume of cases affects outcomes for both carotid endarterectomy and stenting. We evaluated the effect of enrollment volume by site on complication rates in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST). Methods— The primary composite end point was any stroke, myocardial infarction, or death within 30 days or ipsilateral stroke in follow-up. The 477 approved surgeons performed >12 procedures per year with complication rates <3% for asymptomatic patients and <5% for symptomatic patients; 224 interventionists were certified after a rigorous 2 step credentialing process. CREST centers were divided into tertiles based on the number of patients enrolled into the study, with Group 1 sites enrolling <25 patients, Group 2 sites enrolling 25 to 51 patients, and Group 3 sites enrolling >51 patients. Differences in periprocedural event rates for the primary composite end point and its components were compared using logistic regression adjusting for age, sex, and symptomatic status within site-volume level. Results— The safety of carotid angioplasty and stenting and carotid endarterectomy did not vary by site-volume during the periprocedural period as indicated by occurrence of the primary end point ( P =0.54) or by stroke and death ( P =0.87). A trend toward an inverse relationship between center enrollment volume and complications was mitigated by adjustment for known risk factors. Conclusions— Complication rates were low in CREST and were not associated with center enrollment volume. The data are consistent with the value of rigorous training and credentialing in trials evaluating endovascular devices and surgical procedures. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00004732.

Background: Ankle arthrodesis is considered to be a well-accepted technique for end-stage ankle arthritis. Our purpose was to evaluate outcomes of patients with bilateral ankle arthrodeses with attention to radiographic and functional outcomes. Methods: Medical records of 31 patients were reviewed from 1977 through 2007. All patients had 1 year of clinical follow-up after their contralateral ankle arthrodesis, with an average follow-up of 11.2 years following the initial arthrodesis. Pertinent patient demographics and information pertaining to the operative procedure, complications, and subsequent adjacent joint fusions was collected. Radiographs were reviewed for time to fusion and adjacent joint arthritis. Functional outcomes were measured using the Foot and Ankle Ability Measure (FAAM) and the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle and Hindfoot scale. Results: Ten females and 21 males underwent bilateral ankle fusions at an average age of 57 years at the time of the initial fusion. The contralateral fusion occurred on average 3.1 years following the initial fusion. Radiographic fusion occurred 12 weeks following the initial fusion and 14 weeks following the contralateral fusion. There was a significant increase ( P = .0001) in the average AOFAS score postoperatively in both ankles. The average FAAM score at last follow-up was 70. Adjacent joint arthritis developed in the majority of patients; however, most of the patients were free from adjacent fusions and reported their function as “normal” or “nearly normal” at last follow-up. Conclusion: Bilateral ankle arthrodesis was an acceptable treatment option for patients with bilateral, end-stage ankle arthritis. Level of Evidence: Level IV, retrospective case series.

BackgroundDevice infection is associated with increased mortality in patients receiving cardiovascular implantable electronic device (CIED) therapy. However, long‐term mortality associated with CIED infections has not been systematically analyzed in larger studies. This study sought to determine the long‐term mortality associated with CIED infection in a large cohort of Medicare beneficiaries.MethodsWe used a retrospective study design to analyze 3‐year mortality in 200,219 Medicare fee‐for‐service patients admitted for CIED generator implantation, replacement, or revision between January 1, 2007 and December 31, 2007. Multivariate analysis adjusting for age, sex, race, and 28 comorbidities was performed to determine the relative risk (RR) of death in the 12 quarters following CIED infection.ResultsPatients with CIED infection, compared to device recipients without infection, had increased mortality that persisted for at least 3 years after the admission quarter for all device types: pacemakers (PMs: 53.8% vs 33%; P < 0.001), implantable cardioverter defibrillator (ICD: 47.7% vs 31.6%; P < 0.001), and cardiac resynchronization therapy‐defibrillator (CRT‐D: 50.8% vs 36.5%; P < 0.001). After adjusting for patient demographics and comorbidities, significantly increased RR of death following CIED infection persisted for at least 3 years following PM infection, and for at least 2 years with single‐ and dual‐chamber ICD infection.ConclusionsCIED recipients who develop device infection have increased, device‐dependent, long‐term mortality even after successful treatment of infection. The etiology of this persistent increased risk of death associated with CIED infection is unknown and merits further investigation.

Abstract Purpose: To establish the concept of minimum clinically meaningful outcome (mCMO) of treatment in advanced solid tumors, to establish its threshold and evaluate how many superiority trials of new antineoplastic agents pass this threshold. Experimental Design: We chose overall survival as the primary indicator of patient benefit. Four conceptually different types of treatment effect can be identified in OS curves: HR, gains in median OS, proportional, and absolute increases at long-term OS. We postulated threshold levels for these four parameters defining the mCMO and set the bar at three different levels of required benefit: high, medium, and low. The postulated values were then studied by comparing our thresholds with the actual results of the pivotal superiority phase III trials on new drugs reporting on mature OS data. Results: Forty-three trials on 35,419 patients in 12 cancer types on 23 novel agents met these criteria. Only two trials reached the postulated “high” thresholds for HR and median OS. The number of “positive trials” increased to eight and 15 when the bar was lowered to the “medium” and “low” levels, respectively. The same analysis was done for proportional and absolute increases in long-term OS. No trial satisfied the criteria for long-term benefit, whereas only two and nine trials satisfied both parameters for the “medium and low” required benefit levels, respectively. Conclusions: All four OS-related parameters contribute to define the mCMO. If the bar for the mCMO is raised too much, positive trials are exceptional. Clin Cancer Res; 21(5); 1036–43. ©2014 AACR. See related commentary by Schilsky, p. 947