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Saint Helena, CA, United States

The percutaneous lead management kit (PLMK) was developed for the HeartMate II (HMII) LVAD to reduce trauma at the exit site and to maintain a clean environment.RESIST (REduce Driveline Trauma through StabIlization and Exit Site ManagemenT) was a multi-center, prospective, non-randomized study designed to evaluate the feasibility of the PLMK for managing the HM2 driveline exit site. Fifty patients were enrolled at 5 sites at a median of 495 days post HM2 implant.92% (46/50) of patients used the PLMK for a minimum of 30 days. At 30 days, more patients found the PLMK to be extremely comfortable (80% vs. 37%, p<0.001) and extremely effective at stabilizing the driveline (82% vs. 40%, p<0.001) compared to each center’s standard of care. Frequency of dressing changes was 6-7 days or higher for 85% of the patients with PLMK. Three patients developed driveline infection while on PLMK (6%, 0.15 events per patient year), and 35 patients continued to use the PMLK after 6 months.The PLMK is easy to use, increases patient comfort, and increases driveline stability with a dressing change frequency of 6–7 days. Copyright © 2016 by the American Society for Artificial Internal Organs Source


Jarvis W.R.,Jarvis | Jarvis A.A.,Nova Southeastern University | Chinn R.Y.,Sharp Memorial Hospital
American Journal of Infection Control | Year: 2012

Background: Methicillin-resistant Staphylococcus aureus (MRSA) remains one of the most prevalent multidrug-resistant organisms causing health care-associated infections. Limited data are available about how the prevalence of MRSA has changed over the past several years and what MRSA prevention practices have been implemented since the 2006 Association for Professionals in Infection Control and Epidemiology, Inc, MRSA survey. Methods: We conducted a national prevalence survey of MRSA colonization or infection in inpatients at US health care facilities. The survey was developed, received institutional review board approval, and then was distributed to all US Association for Professionals in Infection Control and Epidemiology, Inc, members. Members were asked to complete the survey on 1 day during the period August 1 to December 30, 2010, reporting the number of inpatients with MRSA infection or colonization and facility- and patient-specific information. Results: Personnel at 590 facilities indicated a state and responded to the survey. All states were represented, except for Alaska and Washington, DC (mean, 12 facilities per state; range, 1-38). Respondents reported 4,476 MRSA-colonized/infected patients in 67,412 inpatients; the overall MRSA prevalence rate was 66.4 per 1,000 inpatients (25.3 infections and 41.1 colonizations per 1,000 inpatients). Active surveillance testing was conducted by 75.7% of the respondents; 39.6% used nonselective media, 37.2% used selective media, and 23.3% used polymerase chain reaction. Detailed data were provided on 3,176 MRSA-colonized/infected patients. Of those in whom colonization/infection status was reported (1,908/3,086 [61.8%] were MRSA colonized and 1,778/3,086 [38.2%] were MRSA infected), most MRSA-colonized or infected patients (78.3%) were detected within 48 hours of admission; the most common site of infection was skin and soft tissue (42.9%); and, using the Centers for Disease Control and Prevention's definitions, approximately 50% would be classified as health care-associated infections. Conclusion: Our survey documents that the MRSA prevalence in 2010 is higher than that reported in our 2006 survey. However, the majority of facilities currently are performing active surveillance testing, and, compared with 2006, the rate of MRSA infection has decreased while the rate of MRSA colonization has increased. In addition, compared with 2006, the proportion of MRSA strains recovered from MRSA-colonized/infected patients that are health care-associated strains has deceased, and community-associated strains have increased. © 2012 by the Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved. Source


Low R.N.,Sharp and Childrens Center | Barone R.M.,Sharp Memorial Hospital | Lee M.J.,University of California at San Diego
Annals of Surgical Oncology | Year: 2013

Background: The purpose of this study was to determine if MRI surveillance is better than serum tumor makers in detecting early recurrence in patients with mucinous appendiceal neoplasm. Materials and Methods: A total of 50 patients with appendiceal neoplasm (DPAM 11, PMCA 39) underwent abdominal and pelvic MRI prior to surgical cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC). Patients then entered follow-up surveillance with serial MRI every 6 months and serial laboratory studies including CA 125, CEA, and CA19-9. Written reports for surveillance MRI exams were reviewed for tumor recurrence and compared with results of serial laboratory tests. Proof of tumor recurrence was by a consensus of surgery and histopathology, as well as clinical and imaging findings on serial examinations. Results: During surveillance tumor recurrence was documented in 30 patients (60 %) with median time to recurrence of 13 months (range 3-56 months). MRI detected recurrent tumor in 28 patients, including 11 patients with normal laboratory values (sensitivity 0.93, specificity 0.95, accuracy 0.94, PPV 0.97, and NPV 0.90). Serial laboratory values showed tumor recurrence in 14 patients (sensitivity 0.48, specificity 1.00, accuracy 0.69, PPV 1.0, and NPV 0.57). Median survival was 50 months for 11 patients with earlier MRI detection of recurrence vs 33 months for the other 19 patients with recurrence. Conclusions: Following cytoreductive surgery and HIPEC MRI detects tumor recurrence earlier and with greater accuracy than serial tumor markers alone. © 2013 Society of Surgical Oncology. Source


Vincenti F.,University of California at San Francisco | Rostaing L.,French Institute of Health and Medical Research | Grinyo J.,University of Barcelona | Rice K.,Baylor University | And 9 more authors.
New England Journal of Medicine | Year: 2016

BACKGROUND: In previous analyses of BENEFIT, a phase 3 study, belatacept-based immunosuppression, as compared with cyclosporine-based immunosuppression, was associated with similar patient and graft survival and significantly improved renal function in kidney-transplant recipients. Here we present the final results from this study. METHODS: We randomly assigned kidney-transplant recipients to a more-intensive belatacept regimen, a less-intensive belatacept regimen, or a cyclosporine regimen. Efficacy and safety outcomes for all patients who underwent randomization and transplantation were analyzed at year 7 (month 84). RESULTS: A total of 666 participants were randomly assigned to a study group and underwent transplantation. Of the 660 patients who were treated, 153 of the 219 patients treated with the more-intensive belatacept regimen, 163 of the 226 treated with the less-intensive belatacept regimen, and 131 of the 215 treated with the cyclosporine regimen were followed for the full 84-month period; all available data were used in the analysis. A 43% reduction in the risk of death or graft loss was observed for both the more-intensive and the less-intensive belatacept regimens as compared with the cyclosporine regimen (hazard ratio with the more-intensive regimen, 0.57; 95% confidence interval [CI], 0.35 to 0.95; P = 0.02; hazard ratio with the less-intensive regimen, 0.57; 95% CI, 0.35 to 0.94; P = 0.02), with equal contributions from the lower rates of death and graft loss. The mean estimated glomerular filtration rate (eGFR) increased over the 7-year period with both belatacept regimens but declined with the cyclosporine regimen. The cumulative frequencies of serious adverse events at month 84 were similar across treatment groups. CONCLUSIONS: Seven years after transplantation, patient and graft survival and the mean eGFR were significantly higher with belatacept (both the more-intensive regimen and the less-intensive regimen) than with cyclosporine. (Funded by Bristol-Myers Squibb; ClinicalTrials.gov number, NCT00256750.). Copyright © 2016 Massachusetts Medical Society. Source


Rogers J.G.,Duke University | Rogers J.G.,Duke Clinical Research Institute | Bostic R.R.,Thoratec Corporation | Tong K.B.,Quorum Inc. | And 3 more authors.
Circulation: Heart Failure | Year: 2012

Background-Continuous-flow left ventricular assist devices (LVADs) have become the dominant devices for mechanical circulatory support, but their cost-effectiveness is undetermined. This study assessed the cost-effectiveness of continuous-flow devices for destination therapy versus optimal medical management in advanced heart failure and compared the results with previous estimates for pulsatile devices. Methods and Results-A Markov model was developed to assess cost-effectiveness. Survival, hospitalization rates, quality of life, and cost data were obtained for advanced heart failure patients treated medically or with a continuous-flow LVAD. Rates of clinical outcomes for all patients were obtained from clinical trial databases. Medicare prospective payments were used to estimate the cost of heart failure admissions. The cost of LVAD implantation was obtained prospectively from hospital claims within a clinical trial. Compared with medically managed patients, continuous-flow LVAD patients had higher 5-year costs ($360 407 versus $62 856), quality-adjusted life years (1.87 versus 0.37), and life years (2.42 versus 0.64). The incremental cost-effectiveness ratio of the continuous-flow device was $198 184 per quality-adjusted life year and $167 208 per life year. This equates to a 75% reduction in incremental cost-effectiveness ratio compared with the $802 700 per quality-adjusted life year for the pulsatile-flow device. The results were most sensitive to the cost of device implantation, long-term survival, cost per rehospitalization, and utility associated with patients' functional status. Conclusions-The cost-effectiveness associated with continuous-flow LVADs for destination therapy has improved significantly relative to the pulsatile flow devices. This change is explained by significant improvements in survival and functional status and reduction in implantation costs. © 2011 American Heart Association, Inc. © 2011 American Heart Association, Inc. Source

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