Sharp Memorial Hospital

San Diego, CA, United States

Sharp Memorial Hospital

San Diego, CA, United States
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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; number, NCT00256750.). Copyright © 2016 Massachusetts Medical Society.

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.

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.

Cowger J.,University of Michigan | Sundareswaran K.,Thoratec Corporation | Rogers J.G.,Duke University | Park S.J.,Mayo Medical School | And 5 more authors.
Journal of the American College of Cardiology | Year: 2013

Objectives: The aim of this study was to derive and validate a model to predict survival in candidates for HeartMate II (HMII) (Thoratec, Pleasanton, California) left ventricular assist device (LVAD) support. Background: LVAD mortality risk prediction is important for candidate selection and communicating expectations to patients and clinicians. With the evolution of LVAD support, prior risk prediction models have become less valid. Methods: Patients enrolled into the HMII bridge to transplantation and destination therapy trials (N = 1,122) were randomly divided into derivation (DC) (n = 583) and validation cohorts (VC) (n = 539). Pre-operative candidate predictors of 90-day mortality were examined in the DC with logistic regression, from which the HMII Risk Score (HMRS) was derived. The HMRS was then applied to the VC. Results: There were 149 (13%) deaths within 90 days. In the DC, mortality (n = 80) was higher in older patients (odds ratio [OR]: 1.3, 95% confidence interval [CI]: 1.1 to 1.7 per 10 years), those with greater hypoalbuminemia (OR: 0.49, 95% CI: 0.31 to 0.76 per mg/dl of albumin), renal dysfunction (OR: 2.1, 95% CI: 1.4 to 3.2 per mg/dl creatinine), coagulopathy (OR: 3.1, 95% CI: 1.7 to 5.8 per international normalized ratio unit), and in those receiving LVAD support at less experienced centers (OR: 2.2, 95% CI: 1.2 to 4.4 for <15 trial patients). Mortality in the DC low, medium, and high HMRS groups was 4%, 16%, and 29%, respectively (p < 0.001). In the VC, corresponding mortality was 8%, 11%, and 25%, respectively (p < 0.001). HMRS discrimination was good (area under the receiver-operating characteristic curve: 0.71, 95% CI: 0.66 to 0.75). Conclusions: The HMRS might be useful for mortality risk stratification in HMII candidates and may serve as an additional tool in the patient selection process. © 2013 American College of Cardiology Foundation.

Park S.J.,Mayo Medical School | Milano C.A.,Duke University | Tatooles A.J.,Advocate Christ Medical Center | Rogers J.G.,Duke University | And 3 more authors.
Circulation: Heart Failure | Year: 2012

Background-The HeartMate II (HMII) destination therapy (DT) trial demonstrated significant improvements in outcomes in continuous-flow left ventricular assist devices compared with patients implanted with the pulsatile-flow HeartMate XVE. The primary hypothesis of the current study is that trial patients enrolled after the initial data cohort would have better clinical outcomes. Methods and Results-Two hundred eighty-one patients who underwent HMII for DT from May 2007 to March 2009 (Mid Trial [MT] group) were compared with the initial 133 HMII patients from March 2005 to May 2007 (Early Trial [ET] group). Patient entry criteria were the same during the 2 time periods. Survival, adverse events, and quality of life were compared between the 2 groups. Baseline characteristics were similar between the groups. Compared with the ET group, patients in the MT group had reduced adverse event rates for bleeding requiring transfusions (1.66 versus 1.13 events per patient-year, P<0.001), sepsis (0.38 versus 0.27, P=0.025), device-related infections (0.47 versus 0.27, P<0.001), and hemorrhagic stroke (0.07 versus 0.03, P=0.01). Other event rates were similar between groups including ischemic stroke (0.06 versus 0.05 events per patient-year, P=0.57). Survival at 1 year in the MT group was 73% versus 68% in the ET group (P=0.21). Additionally, there was a significant reduction in deaths caused by hemorrhagic stroke (P=0.01). Quality of life improvements were significant in both the groups (P<0.001). Conclusions-The benefit of DT therapy with the HMII is confirmed in subsequent trial patients, with improved adverse event rates and a strong trend for improvements in survival. Clinical Trial Registration-URL: http://www. Unique identifier: NCT00121485. © 2012 American Heart Association, Inc.

Low R.N.,Sharp Memorial Hospital | Barone R.M.,Sharp Memorial Hospital | Lucero J.,Sharp Memorial Hospital
Annals of Surgical Oncology | Year: 2015

Purpose: To compare the accuracy of MRI and CT for predicting the Peritoneal Cancer Index (PCI) preoperatively compared with the PCI tabulated at surgery. Methods: Twenty-two patients underwent preoperative MRI and CT scanning followed by cytoreductive surgery for appendiceal (n = 17) and ovarian (n = 5) cancer. MR and CT examinations were retrospectively reviewed to determine the PCI. The results of these scores were compared with PCI tabulated at surgery. Patients were categorized as small volume tumor (PCI 0–9), moderate volume (PCI 10–20), and large volume (PCI > 20). Respective anatomic site scores for MRI and CT were compared with surgical findings. Results: Compared with surgical PCI, MRI correctly categorized tumor volume in 20 (0.91) of 22 patients, including 3 of 4 patients with small volume tumor, 2 of 2 patients with moderate volume tumor, and 15 of 16 patients with large volume tumor. CT correctly categorized tumor volume in 11 of 22 (0.50) patients, including 2 of 4 patients with small-volume tumor, 2 of 2 patients with moderate volume tumor, and 7 of 16 patients with large-volume tumor. In 19 of 22 patients, CT underestimated the volume of tumor found at surgery. For all patients, the median PCI score at surgery was 33 compared with 36 for MRI and 15 for CT. Surgery confirmed 222 sites of tumor. MRI demonstrated per site sensitivity of 0.95, specificity 0.70, and accuracy 0.88. CT showed a corresponding per site sensitivity 0.55, specificity 0.86, and accuracy 0.63. Conclusions: MRI more accurately predicts PCI preoperatively in patients undergoing evaluation for cytoreductive surgery. © 2014, Society of Surgical Oncology.

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

Adamson R.M.,Sharp Memorial Hospital | Stahovich M.,Sharp Memorial Hospital | Chillcott S.,Sharp Memorial Hospital | Baradarian S.,Sharp Memorial Hospital | And 4 more authors.
Journal of the American College of Cardiology | Year: 2011

Objectives: The primary objective of this study was to determine outcomes in left ventricular assist device (LVAD) patients older than age 70 years. Background: Food and Drug Administration approval of the HeartMate II (Thoratec Corporation, Pleasanton, California) LVAD for destination therapy has provided an attractive option for older patients with advanced heart failure. Methods: Fifty-five patients received the HeartMate II LVAD between October 5, 2005, and January 1, 2010, as part of either the bridge to transplantation or destination therapy trials at a community hospital. Patients were divided into 2 age groups: <70 years of age (n = 30) and <70 years of age (n = 25). Outcome measures including survival, length of hospital stay, adverse events, and quality of life were compared between the 2 groups. Results: Pre-operatively, all patients were in New York Heart Association functional class IV refractory to maximal medical therapy. Kaplan-Meier survival for patients <70 years of age (97% at 1 month, 75% at 1 year, and 70% at 2 years) was not statistically different from patients <70 years of age (96% 1 month, 72% at 1 year, and 65% at 2 years, p = 0.806). Average length of hospital stay for the <70-year age group was 24 ± 15 days, similar to that of the <70-year age group (23 ± 14 days, p = 0.805). There were no differences in the incidence of adverse events between the 2 groups. Quality of life and functional status improved significantly in both groups. Conclusions: The LVAD patients <70 years of age have good functional recovery, survival, and quality of life at 2 years. Advanced age should not be used as an independent contraindication when selecting a patient for LVAD therapy at experienced centers. © 2011 American College of Cardiology Foundation.

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.

Purpose. To determine whether abdominal and pelvic magnetic resonance imaging (MRI) with diffusion-weighted and dynamic gadolinium-enhanced imaging can be used to accurately calculate the peritoneal cancer index (PCI) before surgery compared to the PCI tabulated at surgery. Methods. Thirty-three patients underwent preoperative MRI followed by cytoreductive surgery for primary tumors of the appendix (n = 25), ovary (n = 5), colon (n = 2), and mesothelioma (n = 1). MRIs were retrospectively reviewed to determine the MRI PCI. These scores were then compared to PCI tabulated at surgery. Patients were categorized as having small-volume tumors (PCI 0-9), moderate-volume tumors (PCI 10-20), and large-volume tumors (PCI >20). The respective anatomic site scores for both MRI and surgery were compared. Results. There was no significant difference between the MRI PCI and surgical PCI for the 33 patients (P = 0.12). MRI correctly predicted the PCI category in 29 (0.88) of 33 patients. Compared to surgical findings, MRI correctly predicted small-volume tumor in 6 of 7 patients, moderatevolume tumor in 3 of 4 patients, and large-volume tumor in 20 of 22 patients. MRI and surgical PCI scores were identical in 8 patients (24%). A difference of <5 was noted in 16 patients (49%) and of 5-10 in 9 patients (27%). Compared to surgical-site findings, MRI depicted 258 truly positive sites of peritoneal tumor, 35 falsely negative sites, 35 falsely positive sites, and 101 truly negative sites, with a corresponding sensitivity of 0.88, specificity of 0.74, and accuracy of 0.84. Conclusions. Combined diffusion-weighted and gadolinium- enhanced peritoneal MRI accurately predicts the PCI before surgery in patients undergoing evaluation for cytoreductive surgery. © Society of Surgical Oncology 2012.

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