Stent fracture in the superficial femoral and proximal popliteal arteries: literature summary and economic impacts.

OBJECTIVES: To summarize available evidence regarding stent fracture in the femoropopliteal region. METHODS: We searched PubMed, 2000-2011, using MeSH search terms "stents," "popliteal artery," and "femoral artery." RESULTS: We identified 29 original studies reporting 0% to 65% incidence of stent fracture. Fracture-related repeat revascularization could be avoided in the absence of device failure. Recently published data suggest that even a 5% rate of fracture-related reintervention would generate $118.4 million in health care cost in the United States. These excess procedures would also result in major complications and deaths that might have been avoided in the absence of stent fracture. CONCLUSIONS: Reported incidence and clinical relevance of femoropopliteal stent fractures vary across studies. Stent fracture may lead to repeat revascularization. These reinterventions create considerable--and potentially avoidable--economic burden for patients and payers. Further, these costs are effectively invisible wherever stent fractures are not systematically documented as the reason for reintervention.

Clinical simulation model of long-acting opioids for treatment of chronic non-cancer pain in the United States.

OBJECTIVE: To evaluate costs and outcomes associated with initial tapentadol ER vs oxycodone CR for the treatment of chronic non-cancer pain (CNCP) in the US. METHODS: This study developed a Monte-Carlo simulation based on the scientific foundation established by published models of long-acting opioids (LAO) in patients having moderate-to-severe CNCP. It estimates costs and outcomes associated with the use of tapentadol ER vs oxycodone CR over a 1-year period from the perspective of a US payer. LAO effectiveness and treatment-emergent adverse event (TEAE) rates are derived from clinical trials of tapentadol ER vs oxycodone CR; other inputs are based on published literature supplemented sparingly with clinical opinion. Sensitivity analyses consider the impact of real-world dosing patterns for LAO on treatment costs. RESULTS: Initial tapentadol ER consistently demonstrates better outcomes than initial oxycodone CR (proportion of patients achieving adequate pain relief and no GI TEAE; acute TEAE-free days; days free of chronic constipation; quality-adjusted life days; productive working hours). While total costs with initial tapentadol ER are slightly (2.2%) higher than with initial oxycodone CR, nearly twice as many modeled patients in the initial tapentadol ER arm (29% vs 15%) achieve adequate pain relief and no GI TEAE compared to initial oxycodone CR. In sensitivity analyses, tapentadol ER becomes a dominant strategy when real-world dosing patterns are considered. CONCLUSION: The additional costs to produce better outcomes (pain relief and no GI TEAE) associated with tapentadol ER are small in the context of double the likelihood of a patient response with tapentadol ER. When daily average consumption (DACON) for oxycodone CR is factored into the analysis, initial tapentadol ER becomes a dominant strategy. Our findings are both strengthened, and limited by the use of randomized trial-centric input parameters. These results should be validated as inputs from clinical practice settings become available.

Human immunodeficiency virus-associated primary lung cancer in the era of highly active antiretroviral therapy: a multi-institutional collaboration.

BACKGROUND: Human immunodeficiency virus (HIV)-infected individuals are at increased risk for primary lung cancer (LC). We wished to compare the clinicopathologic features and treatment outcome of HIV-LC patients with HIV-indeterminate LC patients. We also sought to compare behavioral characteristics and immunologic features of HIV-LC patients with HIV-positive patients without LC. PATIENTS AND METHODS: A database of 75 HIV-positive patients with primary LC in the HAART era was established from an international collaboration. These cases were drawn from the archives of contributing physicians who subspecialize in HIV malignancies. Patient characteristics were compared with registry data from the Surveillance Epidemiology and End Results program (SEER; n = 169,091 participants) and with HIV-positive individuals without LC from the Adult and Adolescent Spectrum of HIV-related Diseases project (ASD; n = 36,569 participants). RESULTS: The median age at HIV-related LC diagnosis was 50 years compared with 68 years for SEER participants (P < .001). HIV-LC patients, like their SEER counterparts, most frequently presented with stage IIIB/IV cancers (77% vs. 70%), usually with adenocarcinoma (46% vs. 47%) or squamous carcinoma (35% vs. 25%) histologies. HIV-LC patients and ASD participants had comparable median nadir CD4+ cell counts (138 cells/µL vs. 160 cells/µL). At LC diagnosis, their median CD4+ count was 340 cells/µL and 86% were receiving HAART. Sixty-three HIV-LC patients (84%) received cancer-specific treatments, but chemotherapy-associated toxicity was substantial. The median survival for both HIV-LC patients and SEER participants with stage IIIB/IV was 9 months. CONCLUSION: Most HIV-positive patients were receiving HAART and had substantial improvement in CD4+ cell count at time of LC diagnosis. They were able to receive LC treatments; their tumor types and overall survival were similar to SEER LC participants. However, HIV-LC patients were diagnosed with LC at a younger age than their HIV-indeterminate counterparts. Future research should explore how screening, diagnostic and treatment strategies directed toward the general population may apply to HIV-positive patients at risk for LC.

Does a perioperative belladonna and opium suppository improve postoperative pain following robotic assisted laparoscopic radical prostatectomy? Results of a single institution randomized study.

INTRODUCTION: Robotic assisted laparoscopic radical prostatectomy (RALP) is a common treatment for localized prostate cancer. Despite a primary advantage of improved postoperative pain, patients undergoing RALP still experience discomfort. Belladonna, containing the muscarinic receptor antagonists atropine and scopolamine, in combination with opium as a rectal suppository (B & O) may improve post-RALP pain. This study evaluates whether a single preoperative B & O results in decreased postoperative patient-reported pain and analgesic requirements. MATERIALS AND METHODS: Patients undergoing RALP at Virginia Mason Medical Center between November 2008 and July 2009 were offered the opportunity to enter a randomized, double-blind, placebo-controlled trial. Exclusion criteria included: glaucoma, bronchial asthma, convulsive disorders, chronic pain, chronic use of analgesics, or a history of alcohol or opioid dependency. Surgeons were blinded to suppository placement which was administered after induction of anesthesia. All patients underwent a standardized anesthesia regimen. Postoperative pain was assessed by a visual analog scale (VAS) and postoperative narcotic use was calculated in intravenous morphine equivalents. RESULTS: Ninety-nine patients were included in the analysis. The B & O and control groups were not significantly different in terms of age, body mass index, operative time, nerve sparing status or prostatic volume. Postoperative pain was significantly improved during the first two postoperative hours in the B & O group. Similarly, 24-hour morphine consumption was significantly lower in patients who received a B & O. No adverse effects secondary to suppository placement were identified. CONCLUSION: Preoperative administration of B & O suppository results in significantly decreased postoperative pain and 24-hour morphine consumption in patients undergoing RALP.

Defining success following sling surgery: association of satisfaction with patient reported outcomes.

AIMS: The assessment of incontinence therapies is complicated by the variety of patient reported outcomes (PRO) measures used in research protocol. Patient satisfaction may be one of the most relevant albeit complex PRO measures and is a function of many related variables. We sought to assess the relationship between patient satisfaction and other PRO. METHODS: A retrospective review of patients undergoing SPARC (n = 314) and autologous rectus pubovaginal sling (PVS) (n = 127) was performed, with 204 (SPARC) and 67 (PVS) patients completing questionnaire surveillance and minimum 12 month follow up. Outcomes were assessed using validated incontinence questionnaires (UDI-6, IIQ-7) supplemented with additional items addressing subjective improvement. Comparisons were made between patients reporting a willingness to recommend and repeat surgical intervention (combined variable, satisfaction surrogate) and achievement of defined endpoints in the remaining outcome measures. RESULTS: A large difference in outcomes was seen depending on PRO measure analyzed. Dry was the strictest measure used (33%, SPARC; 39%, PVS; p = NS), while >or= 50% improvement was reported with the greatest frequency (75%, SPARC; 73%, PVS; p = NS). With the exception of pad use, a statistically significant association between all PRO measures and the willingness to recommend/repeat surgery was identified. CONCLUSIONS: Our data demonstrate an association between a variety of PRO measures and patient reported satisfaction. Based on this finding, the development of a simplified and standardized PRO instrument, one that maintains an accurate reflection of patient satisfaction and is less cumbersome for the patient may be possible.

A retrospective analysis of AIDS-associated Kaposi's sarcoma in patients with undetectable HIV viral loads and CD4 counts greater than 300 cells/mm(3).

OBJECTIVE: To compare the clinical course of patients with AIDS-related Kaposi's sarcoma (KS) with CD4 counts >300 cells/mm(3) and undetectable HIV viral loads (VLs) to patients with AIDS-KS with lesser CD4 counts and detectable HIV VLs. METHODS: We retrospectively analyzed a cohort of 91 patients with AIDS-KS in a multispeciality clinic. We used chi(2) and Student t tests to analyze intragroup differences; survival was determined by Kaplan-Meier analysis. RESULTS: Twenty (22%) of the 91 patients had newly diagnosed, persistent or progressive KS despite CD4 counts >300 cells/mm(3) and undetectable HIV VLs. Age, gender, ethnicity, mode and duration of HIV acquisition, type of antiretroviral therapy (ART), and KS therapy did not differ significantly (P < or = .005) between this group and the remaining 71 patients. Although tumor stage and response to KS therapy were similar, there was a significantly greater risk of death among the patients with CD4 counts <300 cells/mm(3) and detectable HIV VLs (P = .048). CONCLUSIONS: In the highly active antiretroviral (HAART) era, a substantial proportion of patients with KS had undetectable HIV VLs and CD4 counts greater than the level typically associated with opportunistic diseases. They required systemic therapy to control their KS but were significantly less likely to die and demonstrated a trend toward better 15-year survival than patients having KS with lesser CD4 counts and detectable HIV VLs.

Post-operative drain output as a predictor of bladder neck contracture following radical prostatectomy.

BACKGROUND: Bladder neck contracture (BNC) following prostatectomy has been reported in 0.5-32% of cases. While the etiology of a BNC is unclear, several factors have been associated with this complication, including blood loss, devascularization of bladder neck tissue, poor mucosal apposition and urinary extravasation. To study the impact of urinary extravasation on BNC formation, we used postoperative drain output as a surrogate measure for anastomotic leakage. METHODS: All patients undergoing a radical retropubic prostatectomy (RRP) or a robotic assisted radical prostatectomy (RARP) from January 2000 to April 2006 have been entered into a prospective review board-approved database. All RRP patients had their anastomosis performed in an interrupted fashion using six monofilament 2-0 sutures. All robotic-assisted radical prostatectomy anastomoses were performed in a running fashion using 2-0 monofilament sutures. A single, closed suction Jackson Pratt drain was placed over the surgical bed at the conclusion of the case. Post-operative drain outputs were recorded. All patients were evaluated at 3, 6, 9, 12 and 24 months post-operatively. All patients who reported a diminished urinary stream or incontinence were evaluated by office cystoscopy. The inability to navigate an 18 French cystoscope through the bladder neck was defined as a bladder neck contracture. RESULTS: A total of 576 patients underwent a radical prostatectomy over this time span. Complete records were available for 535 (93%) of these patients. There were 21 bladder neck contractures (3.9%) overall. The post-operative drain output ranged from 5-5,465 ml (median 119 ml). Eight patients who had drain outputs less than 119 ml developed a BNC while 13 BNC developed in patients with Jackson Pratt drain output > 119 ml (P = 0.343). In patients who underwent an open RRP, 19/424 (4.5%) developed contractures while 2/108 (1.9%) RARP patients developed a BNC (P = 0.105). CONCLUSION: The amount of post-operative drain output is not statistically associated with the development of a bladder neck contracture.

Liposomal doxorubicin, cyclophosphamide, and etoposide and antiretroviral therapy for patients with AIDS-related lymphoma: a pilot study.

PURPOSE: To evaluate in a pilot study the safety and efficacy of liposomal doxorubicin, cyclophosphamide, and etoposide (LACE) when combined with antiretroviral therapy (ART) in patients with AIDS-related lymphoma (ARL). The impact of HIV viral control on therapy and survival was also assessed. PATIENTS AND METHODS: Between 1994 and 2005, 40 patients at Virginia Mason Medical Center were diagnosed with ARL. Twelve received LACE every 28 days. All patients received intrathecal chemoprophylaxis, ART, and G-CSF. RESULTS: The median patient CD4+ count was 190 cells/microl (range, 20-510 cells/microl), and the median HIV viral load (VL) was 61,613 copies/ml (range, <50-500,000 copies/ml). Seven patients (58%) had an International Prognostic Index score of 3 or 4. Six patients (50%) were ART-naïve, five were viremic despite ART, and one had an undetectable HIV-1 VL. Nine patients (75%) achieved a complete response (CR), and median overall survival was 107 months. At a median follow-up of 46 months, the recurrence-free survival rate was 50%. Two patients died from relapsed/refractory ARL and one patient achieved a CR with salvage therapy. One CR patient died from complications of pneumonia, and another CR patient died from uncertain causes 5 years after treatment. Grade 3 or 4 neutropenia occurred in 23 of 61 (38%) chemotherapy cycles. Hospitalization was required after 5% of treatment cycles due to neutropenic fever. CONCLUSION: LACE is an effective and tolerable treatment for ARL. HIV viral control can be maintained in the majority of patients during and after completion of LACE.

Improving rates of screening and prevention by leveraging existing information systems.

BACKGROUND: In 1997 Virginia Mason Health System (VMMC), a vertically integrated hospital and multispecialty group practice, had no process or system to deliver the right patient clinical data, in the right form, at the right place--when providers needed it for effective patient care. Without any new investment in technology, a work group of five individuals leveraged existing, primarily paper-based information systems to launch development and implementation of a provider prompting tool--a primary care and prevention (PCP) report--which prompted providers to complete screening, prevention, and disease management services at every patient appointment. PLANNING AND IMPLEMENTING THE TOOL: The work group developed and pilot tested the report and created a mechanism by which the report could be delivered just in time before each patient's appointment. The report integrated information from independent appointment scheduling, laboratory results reporting, patient demographics, and billing data sources. MEASURING THE PCP REPORT'S IMPACT: The results of two separate analyses demonstrate improvement in rates of screening and prevention across VMMC soon after the PCP report became available. These results led senior leadership to make the PCP report's utilization a systemwide imperative. DISCUSSION: The PCP report is used by nearly all primary care providers as a prompt to complete screening, prevention, and disease management services at every patient appointment.

Clinical and economic outcomes of multivessel coronary stenting compared with bypass surgery: a single-center US experience.

BACKGROUND: Randomized trials comparing multivessel stenting with coronary artery bypass surgery (CABG) have demonstrated similar rates of death and myocardial infarction but higher rates of repeat revascularization after stenting. The impact of these alternative strategies on overall medical care costs is uncertain, particularly within the US health care system. METHODS: We performed a retrospective, matched cohort study to compare the clinical and economic outcomes of multivessel stenting and bypass surgery. The stent group consisted of 100 consecutive patients who underwent stenting of >or=2 major native coronary arteries at our institution. The CABG group consisted of 200 patients who underwent nonemergent isolated bypass surgery during the same time frame, matched (2:1) for age, sex, ejection fraction, diabetes mellitus, and extent of coronary disease. Detailed clinical follow-up and resource utilization data were collected for a minimum of 2 years. Total costs were calculated by use of year 2000 unit prices. RESULTS: Over a median follow up period of 2.8 years, there were no significant differences in all-cause mortality rates (3.0% vs 3.0%), Q-wave myocardial infarction (5.1% vs 4.0%), or the composite of death or myocardial infarction (7.1% vs 7.0%) between the stent and CABG groups (P = not significant for all comparisons). However, at 2-year follow up, patients with stents were more likely to require >or=1 repeat revascularization procedure (32.0% vs 4.5%, P <.001). The initial cost of multivessel stenting was 43% less than the cost of CABG (11,810 dollars vs 20,574 dollars, P <.001) and remained 27% less (17,634 dollars vs 24,288 dollars, P =.005) at 2 years. CONCLUSIONS: Multivessel stenting and CABG result in comparable risks of death and myocardial infarction. Despite a higher rate of repeat revascularization, multivessel stenting was significantly less costly than CABG through the first 2 years of follow-up.

Resource utilization, cost, and health status impacts of coronary stent versus "optimal" percutaneous coronary angioplasty: results from the OPUS-I trial.

In the OPUS-I trial, primary coronary stent implantation reduced 6-month composite incidence of death, myocardial infarction, cardiac surgery, or target vessel revascularization relative to a strategy of initial PTCA with provisional stenting in patients undergoing single vessel coronary angioplasty. The purpose of this research was to compare the economic and health status impacts of each treatment strategy. Resource utilization data were collected for the 479 patients randomized in OPUS-I. Itemized cost estimates were derived from primary hospital charge data gathered in previous multicenter trials evaluating coronary stents, and adjusted to approximate 1997 Medicare-based costs for a cardiac population. Health status at 6 months was assessed using the Seattle Angina Questionnaire (SAQ). Initial procedure related costs for patients treated with a primary stent strategy were higher than those treated with optimal PTCA/provisional stent ($5,389 vs $4,339, P < 0.001). Costs of initial hospitalization were also higher for patients in the primary stent group ($9,234 vs $8,434, P < 0.01) chiefly because of the cost differences in the index revascularization. Mean 6-month costs were similar in the two groups; however, there was a slight cost advantage associated with primary stenting. Bootstrap replication of 6-month cost data sustained the economic attractiveness of the primary stent strategy. There were no differences in SAQ scores between treatment groups. In patients undergoing single vessel coronary angioplasty, routine stent implantation improves important clinical outcomes at comparable, or even reduced cost, compared to a strategy of initial balloon angioplasty with provisional stenting.

Surgical treatment of hyperparathyroidism improves health-related quality of life.

HYPOTHESIS: The surgical treatment of primary hyperparathyroidism results in an improved health-related quality of life. DESIGN: Prospective cohort analysis of consecutive patients with primary hyperparathyroidism analyzed preoperatively and 1 year postoperatively. SETTING: Academic multispecialty referral clinic. PATIENTS: We prospectively evaluated 74 consecutive patients who underwent parathyroid exploration for primary hyperparathyroidism during a 15-month period. INTERVENTIONS: The Medical Outcomes Study Short-Form Health Survey (SF-36) was administered before consultation with a surgeon. Patients were categorized based on reason for referral as either asymptomatic (group 1; n = 43) or symptomatic (group 2; n = 29). All patients underwent parathyroid exploration and normalization of calcium levels postoperatively. The SF-36 was then re-administered after 1 year. MAIN OUTCOME MEASURES: Statistical analysis of preoperative and postoperative SF-36 scores, and comparisons with national norms. RESULTS: The SF-36 was completed preoperatively and 1 year postoperatively by 72 (97%) of 74 patients. When the results were compared with published national norms, the preoperative population was significantly impaired in 5 of 8 domains, whereas the postoperative one had improved and was nearly indistinguishable from the norm. In 7 of 8 domains, the postoperative scores were significantly improved compared with preoperative scores. Group 1 patients showed significant preoperative impairment in 3 domains and significantly improved in 2, whereas group 2 patients showed significant impairment and improvement in 7 domains. CONCLUSION: The surgical treatment of primary hyperparathyroidism is associated with durable, statistically significant improvements in health-related quality of life.