Long-Term Outcomes and Associations With Major Adverse Limb Events After Peripheral Artery Revascularization.

BACKGROUND: Long-term cardiovascular and limb outcomes after revascularization for peripheral artery disease and, in particular, prognosis after post-procedure major adverse limb events (MALE) are not well-studied. OBJECTIVES: This study sought to describe outcomes after peripheral revascularization and assess relationships between post-procedure MALE hospitalization and subsequent events. METHODS: Patients undergoing peripheral artery revascularization between January 1, 2009, and September 30, 2015, in the Premier Healthcare Database were examined for the co-primary outcomes of interest, composite myocardial infarction (MI) or stroke and composite major amputation or peripheral revascularization. Multivariable adjusted Cox proportional hazards models with post-procedure MALE hospitalization included as a time-dependent covariate were developed to estimate hazard ratios for outcomes. RESULTS: Among 393,017 revascularized patients followed for a median of 2.7 years (interquartile range: 1.3 to 4.4 years), the cumulative incidence of MI or stroke was 9.8% and that of major amputation or peripheral revascularization was 41.9%. A total of 50,750 patients (12.9%) had at least 1 post-procedure MALE hospitalization. In time-dependent covariate adjusted models, post-procedure MALE hospitalization was associated with greater risk of subsequent MI or stroke (hazard ratio: 1.34; 95% confidence interval: 1.28 to 1.40) and major amputation or peripheral revascularization (hazard ratio: 8.13; 95% confidence interval: 7.96 to 8.29). After peripheral revascularization with or without post-procedure MALE hospitalization, risk of limb events increased rapidly post-procedure and more slowly after the first year, whereas cardiac risk increased steadily during follow-up. CONCLUSIONS: Revascularized peripheral artery disease patients face earlier limb and later cardiovascular ischemic risk that is heightened among patients with post-procedure MALE hospitalization. Increased provider awareness of these long-term risks may guide efforts to improve post-procedural outcomes.

Major Adverse Limb Events and 1-Year Outcomes After Peripheral Artery Revascularization.

BACKGROUND: Revascularization is important for symptom treatment and limb salvage in peripheral artery disease, yet little data exist on the incidence of post-procedure major adverse limb events (MALE) and longer-term outcomes. OBJECTIVES: This study sought to characterize hospitalizations and outpatient endovascular revascularizations after peripheral artery revascularization, assess temporal trends for outcomes, and identify factors associated with subsequent MALE hospitalization. METHODS: Patients undergoing peripheral artery revascularization between January 1, 2009, and September 30, 2014, in the Premier Healthcare Database were examined for the primary outcome of 1-year MALE hospitalization. Secondary outcomes included 1-year outpatient endovascular revascularization and limb-related, cardiovascular, and all-cause inpatient hospitalizations. Multivariable logistic regression was used to identify factors associated with 1-year MALE hospitalization. RESULTS: Among 381,415 revascularized patients, within 1 year post-index revascularization, 10.3% (n = 10,182) had a hospitalization for MALE, 11.0% (n = 42,056) had an outpatient endovascular revascularization, 18.8% (n = 71,663) had a limb-related hospitalization, 12.8% (n = 48,875) had a cardiovascular hospitalization, and 38.9% (n = 148,457) had any inpatient hospitalization. Over the study period, limb-related, cardiovascular, and all-cause hospitalizations decreased, whereas rates of outpatient endovascular revascularizations increased. Male sex, black race, Medicare and Medicaid insurance, diabetes, renal insufficiency, heart failure, smoking, baseline critical or acute limb ischemia, surgical revascularization, and noncardiology operator specialty were significantly associated with increased risk of MALE hospitalization. CONCLUSIONS: In contemporary practice, hospitalization for MALE occurs in 1 in 10 patients within 1 year after peripheral revascularization and is associated with patient and procedural factors. These data may inform efforts to improve post-procedure outcomes and limb-related clinical trial design.

Reasons for 30-day postoperative readmissions for Medicare patients at a community-based teaching hospital.

Healthcare reform initiatives have proposed reducing reimbursement for certain 30-day readmissions among Medicare patients. Our objective was to evaluate the incidence and reasons for 30-day postoperative readmissions at our institution. The medical records of Medicare patients who underwent surgery from January 1, 2010, through May 16, 2011, were reviewed. Statistical analysis included χ(2), Wilcoxon rank sum, and t tests. Two thousand eight hundred sixty-five patients were included; 199 (7%) had a 30-day readmission. The readmission group included a higher proportion of men (53.8 vs 43.6%, P = 0.005), and patients with an American Society of Anesthesiologists (ASA) Class 3 or greater (84 vs 66%, P < 0.001) versus the nonreadmission group. Mean index length of stay and operative time were longer in the readmitted versus nonreadmitted group (4.8 vs 2.8 days, P < 0.001; 122.8 vs 98.2 minutes, P < 0.001). Readmission reasons were surgically related (53%), surgically unrelated (35%), planned (7%), and patient-related (5%). Higher 30-day postoperative readmission rates were associated with male sex, higher ASA class, and longer index length of stay and operative time. Reasons for readmission included surgical- and patient-related factors. Decreased reimbursement should be discouraged for readmissions directly related to patient noncompliance.

Determining the clinical significance of monoclonal gammopathy of undetermined significance: a SEER-Medicare population analysis.

BACKGROUND: Clinical guidelines have recommended annual follow-up examinations of most patients with monoclonal gammopathy of undetermined significance (MGUS); however, evidence supporting this practice is lacking. We performed a population-based study to examine the patterns of disease presentation and outcomes of patients with multiple myeloma, Waldenström macroglobulinemia, and lymphoplasmacytic lymphoma (monoclonal gammopathy-associated malignancies) comparing those with or without a previous MGUS follow-up examination. MATERIALS AND METHODS: Patients with monoclonal gammopathy-associated malignancy from 1994 through 2007 were identified using the Surveillance, Epidemiology, and End Results-Medicare linked database and divided into 2 cohorts: those with follow-up (MGUS follow-up examination preceding the diagnosis) and those with no follow-up (no such follow-up examination). We compared the outcomes, including the rates of major complications at cancer diagnosis (acute kidney injury, cord compression, dialysis use, fracture, and hypercalcemia) and survival using propensity score adjustment and Cox proportional hazard models. All statistical tests were 2-sided. RESULTS: Of the 17,457 study patients, 6% had undergone MGUS follow-up. After multivariable modeling, the follow-up group had significantly fewer major complications at diagnosis (odds ratio 0.68; 95% confidence interval [CI], 0.57-0.80) and better disease-specific (median, 38 vs. 29 months, P < .001; hazard ratio [HR] 0.85; 95% CI, 0.76-0.94) and overall (median, 23 vs. 19 months, P < .001; HR 0.87; 95% CI, 0.80-0.95) survival. CONCLUSION: Patients with MGUS follow-up preceding the diagnosis of a monoclonal gammopathy-associated malignancy can experience fewer major complications and have longer survival than those without such follow-up examinations. Future studies replicating our findings in the non-Medicare population and determining the optimal schedule and cost-effectiveness of MGUS follow-up are warranted.

Levetiracetam as adjunctive therapy for acute alcohol withdrawal syndrome in hospitalized patients.

BACKGROUND: Benzodiazepines are often considered the standard of care for managing symptoms of acute alcohol withdrawal syndrome. Because of potential adverse effects, other agents have been evaluated in this patient population. Previous studies have produced mixed results on the efficacy of levetiracetam in alcohol withdrawal. OBJECTIVE: The objective of this study was to determine whether adjunctive levetiracetam reduces the amount of symptom-triggered benzodiazepines required by patients experiencing symptoms of alcohol withdrawal. METHODS: We conducted a retrospective chart review of patients who experienced symptoms of alcohol withdrawal while hospitalized. The outcomes of patients who received adjunctive levetiracetam were compared with those of patients who received only the standard of care (control group). RESULTS: Two hundred fifty patients (125 in each cohort) were included. No significant differences were found in the benzodiazepine requirements of the 2 cohorts. The control group required a median average daily dose of 2.0 mg of lorazepam (range, 0.1-17 mg/d) compared with the levetiracetam group, which required a median average daily dose of 1.3 mg of lorazepam (range, 0.0-53.5 mg/d) (P = 0.09). The patients in the control group required a median total of 6 mg of lorazepam during their hospitalization compared with a median total of 5.5 mg in the levetiracetam group. Both cohorts had a median length of stay of 3 days, although those in the levetiracetam group had a shorter length of intensive care unit stay and spent less time mechanically ventilated. CONCLUSIONS: The adjunctive use of levetiracetam does not significantly reduce the benzodiazepine requirements of patients experiencing symptoms of alcohol withdrawal in the inpatient setting.

Comparison of time to endoscopy and outcome between weekend/weekday hospital admissions in patients with upper GI hemorrhage.

OBJECTIVE: Recent findings suggest that time to endoscopy is prolonged in patients admitted on the weekend with upper gastrointestinal hemorrhage (UGIH), which may result in increased adverse outcomes. This study was designed to determine if these findings hold true for a community gastroenterology practice. METHODS: This retrospective study reviewed patients admitted to a community teaching hospital from January 1, 2008, through October 31, 2008 with the primary diagnosis of UGIH. UGIH was further defined as acute variceal hemorrhage (AVH) or non-variceal hemorrhage (NVUGIH). The primary groups were based on weekend vs weekday admission. Time to endoscopy, adverse outcomes, presenting symptom, and length of stay were analyzed. RESULTS: One hundred seventy-four patients were included (50 weekend; 124 weekday). Most patients (94.25%) received upper endoscopy within 24 hours of admission. Mean time to endoscopy was shorter for weekend admission compared to weekday (7.52 hours vs 10.82 hours; P=0.012) for the entire group. No statistically significant difference was detected in AVH patients (6.37 hours vs 4.37 hours; P=0.09), but a difference was observed in the NVUGIH group (7.65 hours vs 11.45 hours, P=0.015). Adverse outcomes were not associated with weekend admission (P=0.583). There was no difference in mean length of stay (3.08 days vs 3.85 days; P=0.131) or mean units of blood transfused (2.44 units vs 2.07 units, P=0.417) between admission groups. CONCLUSIONS: Patients admitted to this community teaching hospital with UGIH on the weekend did not experience delayed endoscopy, increased adverse outcomes, or longer length of stay compared to those admitted on a weekday. The previously reported "weekend effect" was not observed. In fact, patients admitted with NVUGIH on the weekend received upper endoscopy earlier than patients admitted during the week.

Use of broad-spectrum antibiotics and the development of irritable bowel syndrome.

BACKGROUND: Irritable bowel syndrome (IBS) is a functional bowel disorder with an estimated prevalence of 9% to 22% in the United States. It is responsible for 28% of gastroenterology visits, with associated health care costs of $8 billion annually. Yet, IBS etiology is the subject of much debate. OBJECTIVES: Our study examines a possible relationship between IBS and exposure to broad-spectrum antibiotics. It is known that antibiotics alter the colonic flora; we hypothesize that this can create the manifestations seen in IBS patients. METHODS: Following approval by the Gundersen Clinic, Ltd Human Subjects Committee/IRB, the medical records of adults who were started on a broad-spectrum antibiotic at Gundersen Lutheran Health System between January 1, 2008, and December 31, 2008, were reviewed retrospectively. From this population, we identified those who developed IBS within 12 months and compared their demographic and clinical characteristics with the characteristics of those who did not. RESULTS: Of the 26,107 adult patients exposed to broad-spectrum antibiotics during the study period, 115 received an IBS diagnosis within 12 months. Most were women (84%; n = 97), and they had a higher prevalence of associated comorbidities than those who did not develop IBS. Patients indicated for macrolide or tetracycline use had a higher proportion of IBS development within 12 months; indication for tetracycline use maintained significance even after controlling for sex and comorbid conditions (odds ratio; 1.48; P = .046). CONCLUSION: Use of broad-spectrum antibiotics--particularly macrolides or tetracyclines--may be associated with IBS development. To date, we know of no other study that has associated these antibiotics with IBS development. Further studies are necessary.

The POLST program: a retrospective review of the demographics of use and outcomes in one community where advance directives are prevalent.

OBJECTIVES: Determine the use and utility of the Physician Orders for Life-Sustaining Treatment (POLST) program in a community where powers of attorney for health care (POAHCs) are prevalent. METHODS: A retrospective review of medical record and death certificate data of 400 adults who died between September 1, 2007, and March 31, 2008, in the La Crosse County, Wisconsin community. Demographic and cause-of-death data were collected from death certificates. Information about POAHC, POLST forms, and medical treatments provided in the last 30 days of life were abstracted from decedents' medical records. RESULTS: Sixty-seven percent of decedents had a POLST form, whereas 22% had POAHC alone. In comparison with decedents with POAHC alone, decedents with a POLST form were significantly older (83 versus 77 years, p<0.001), more likely to die in a nursing home than in a hospital (p<0.001), and more likely to die from a terminal or chronic illnesses (97%). Decedents with POLST orders for higher levels of medical treatment received more treatment, and in only two cases was there evidence that treatment was discrepant with POLST orders. In 31% of all POLST forms, the person appointed in the POAHC consented to the POLST orders. CONCLUSIONS: POLST can be a highly effective program to ensure that patient preferences are known and honored in all settings. POAHCs are valuable because they identify appropriate surrogates when patients are incapacitated.

Utility of routine left ventricular ejection fraction measurement before anthracycline-based chemotherapy in patients with diffuse large B-cell lymphoma.

PURPOSE: Despite the lack of evidence, routine left ventricular ejection fraction (LVEF) measurement in diffuse large B-cell lymphoma (DLBCL) before anthracycline-based chemotherapy (ABC) is recommended by practice guidelines and required in DLBCL trials in the United States. METHODS: We determined the frequency of the following in 197 consecutive patients with newly diagnosed DLBCL treated at our institution: one, LVEF measurement before ABC; two, finding of asymptomatic LV dysfunction (ALVD); and three, modification in treatment strategy as a result of LVEF measurement. RESULTS: The median age was 71 years, and 54% of patients were men. LVEF was measured in 128 patients (65%) pretreatment, including in 15 with prior congestive heart failure (CHF). The reasons for not measuring LVEF were: clinically low risk for ALVD (n = 32), medical frailty (n = 15), palliative care (n = 3), ABC not standard therapy (n = 12), and prior CHF (n = 7). Among patients without prior CHF who had LVEF assessed (n = 113), ALVD was detected in four (4%), with LVEF ranging from 41% to 48%. Four patients were not treated despite normal LVEF because of comorbidities and anticipated toxicities. In contrast, all four patients with ALVD received ABC. No patient had a modification in treatment strategy as a result of LVEF measurement. After a median follow-up of 60 months, among those who remained alive, CHF developed in 15% versus 6% of patients receiving ABC who did and did not have LVEF measured, respectively (P = .246). CONCLUSION: Our findings challenge the utility of routine LVEF measurement in patients with DLBCL before ABC. Potential cost savings to our health care system could be substantial.

Core needle biopsy rate for new cancer diagnosis in an interdisciplinary breast center: evaluation of quality of care 2007-2008.

OBJECTIVE: The purpose of this study is to evaluate the rate of minimally invasive biopsy for diagnosis of breast cancer at an interdisciplinary breast center. BACKGROUND: Percutaneous core needle biopsy (CNB) is optimal for minimizing surgery for the diagnosis of benign and malignant lesions of the breast while preserving surgery for definitive resection. Core needle biopsy increases patient satisfaction and reduces the cost of diagnosis and treatment. Despite the endorsement of CNB by many professional organizations, the literature documents underutilization. METHODS: Institutional review board approval was obtained. An audit of a single institution's prospectively maintained cancer databases was performed for all breast cancers diagnosed in 2007 and 2008. Methods of diagnosis included image-guided and freehand-guided CNB, image-guided vacuum assisted needle biopsy, image-guided fine needle aspiration, punch biopsy, and open surgical biopsy. RESULTS: Three hundred sixty new breast cancers were diagnosed in 2007 and 2008. Malignancy was diagnosed by minimally invasive techniques in 350/360 (97%) cancers. CONCLUSION: A very high rate of accurate tissue diagnosis of breast cancer by minimally invasive techniques is achievable.

The effect of residual osteomyelitis at the resection margin in patients with surgically treated diabetic foot infection.

The appropriate antibiotic treatment of surgically resected diabetic foot osteomyelitis is controversial. We conducted a retrospective cohort study to evaluate the prognostic impact of residual osteomyelitis at the surgical margin of surgically resected diabetic foot osteomyelitis, and to assess the effectiveness of postoperative antibiotic therapy for residual osteomyelitis after surgical resection of infected bone. Of the 111 patients included in the study, 39 (35.14%) had pathologically confirmed margins positive for residual osteomyelitis. The median total duration of antibiotic treatment was 19 (range 10-134) days in patients with positive margins, whereas it was 14 (range 2-63) days in those with negative margins (P = .01). No statistically significant difference (P = .695) was found in the primary outcome of definite failure, defined as pathologically or microbiologically confirmed infection relapse at the proximal amputation site, between 3 (7.69%) of 39 patients with positive margins and 4 (5.56%) of 47 patients with negative margins. A statistically significant difference (P = .001) in the secondary outcome, definite treatment failure, or the need for more proximal amputation was found between 17 (43.59%) of 39 patients with positive margins and 11 (15.28%) of 72 patients with negative margins. Residual osteomyelitis at the pathologic margin was associated with a higher rate of treatment failure, despite the longer duration of antibiotic therapy.

Appropriately prescribing antibiotics for patients with pharyngitis: a physician-based approach vs a nurse-only triage and treatment algorithm.

OBJECTIVE: To assess the safety and appropriateness of antibiotic use in adult patients with pharyngitis who opted for a nurse-only triage and treatment algorithm vs patients who underwent a physician-directed clinical evaluation. PATIENTS AND METHODS: Using International Classification of Diseases, Ninth Revision codes to query the electronic medical record database at our institution, a large multispecialty health care system in LaCrosse, WI, we identified adult patients diagnosed as having pharyngitis from September 1, 2005, through August 31, 2007. Diagnosis, treatment, and outcome data were collected retrospectively. RESULTS: Of 4996 patients who sought treatment for pharyngitis, 3570 (71.5%) saw a physician and 1426 (28.5%) opted for the nurse-only triage and treatment algorithm. Physicians adhered to antibiotic-prescribing guidelines in 3310 (92.7%) of 3570 first visits, whereas nurses using the algorithm adhered to guidelines in 1422 (99.7%) of 1426 first visits (P<.001). Physicians were significantly less likely to follow guidelines at patients' subsequent visits for a single pharyngitis illness than at their initial one (92.7% [3310/3570] vs 83.7% [406/485]; P<.001). CONCLUSION: Instituting a simple nurse-only triage and treatment algorithm for patients presenting with pharyngitis appears to reduce unnecessary antibiotic use.

A comparative, retrospective, observational study of the prevalence, availability, and specificity of advance care plans in a county that implemented an advance care planning microsystem.

OBJECTIVES: To determine whether outcomes have changed over time for a managed, systematic approach to advance care planning (ACP). DESIGN: Retrospective comparison of medical record and death certificate data of adults who died over a 7-month period in 2007/08 with those of adults who died over an 11-month period in 1995/96. SETTING: All healthcare organizations in La Crosse County, Wisconsin. PARTICIPANTS: Five hundred forty adults who died in 1995/96 and 400 adults who died in 2007/08. INTERVENTION: A systematic ACP approach, Respecting Choices, collaboratively implemented in 1993 and continuously improved in subsequent years. MEASUREMENTS: Demographic and cause-of-death data were collected from death certificates. Type and content of any advance directive (AD), existence and content of Physician Orders for Life-Sustaining Treatment, and medical treatment provided at the location of death in the last 30 days of life were abstracted from the medical record. RESULTS: The recent data show a significantly greater prevalence of ADs (90% vs 85%, P=.02) and of availability of these directives in the medical record at the time of death (99.4% vs 95.2%, P<.001) than the data collected over 10 years ago. The new data suggest that quality efforts have improved the prevalence, clarity, and specificity of ADs. CONCLUSION: A system for ACP can be managed in a geographic region so that, at the time of death, almost all adults have an advance care plan that is specific and available and treatment is consistent with their plan.

Local and paravertebral block anesthesia for outpatient elective breast cancer surgery.

Most breast cancer operations in the United States are performed with the patient given general anesthesia. We retrospectively reviewed our prospective breast cancer database to determine the percentage of patients who underwent breast cancer operations with either local or paravertebral block regional anesthesia from January 1 through June 30, 2008. Fifty-two of 70 patients (74%) were able to undergo breast cancer surgery with local or paravertebral block regional anesthesia. Operations included mastectomy, full axillary dissections, and expander or implant reconstruction. There were no conversions to general anesthesia and no unplanned overnight admissions. Only 5 of 52 patients (10%) undergoing surgery with local or paravertebral block regional anesthesia developed postoperative nausea or vomiting. We conclude that most elective outpatient breast cancer surgery operations can be performed with the patients given local or regional anesthesia.

Perioperative quality metrics for one step breast cancer surgery: a patient-centered approach.

BACKGROUND AND OBJECTIVES: Patient-centered care is recommended by the Institute of Medicine to build a better healthcare system. The aim of this study was to audit patient-centered quality measures (QM) to create a breast center report card that could be provided to patients for education and informed consent. METHODS: An IRB approved retrospective review of 695 patients undergoing sentinel lymph node biopsy for breast cancer was conducted to audit the components of one step surgery and other QM. RESULTS: The intraoperative sensitivity to detect node positive patients was 25% (2/8), 27% (9/34), and 87% (68/78) for pN0(i+), pN1mi, pN1 patients, respectively. The re-excision lumpectomy rate was 15% (72/471) and the one step surgery success rate, which included lumpectomy and mastectomy patients, was 86% (598/695). Patient self-assessment of "very good to excellent" cosmesis and pain control were 77% (103/134) and 83% (60/72). Local recurrence rate was 2% (12/695) at a mean 3.1-year follow-up. CONCLUSIONS: The components of care that contribute to a patient-centered assessment of breast cancer surgery are measurable. "Bundling" of QM creates a perioperative report card that aids patients' informed consent and provides a framework for future comparative effectiveness studies.

Primary testicular diffuse large B-cell lymphoma: a population-based study on the incidence, natural history, and survival comparison with primary nodal counterpart before and after the introduction of rituximab.

PURPOSE: We performed a population-based study of primary testicular diffuse large B-cell lymphoma (DLBCL) in the United States to determine its incidence and survival trends, prognostic factors, and clinical outcome compared with males with nodal DLBCL. PATIENTS AND METHODS: The Surveillance, Epidemiology, and End Results database was reviewed to identify patients diagnosed between 1980 and 2005. To study the potential impact of the introduction of rituximab on survival, we used the year 2000 as cutoff point. RESULTS: We identified 769 patients with testicular DLBCL. The median age at diagnosis was 68.0 years. The incidence of DLBCL increased over time, with the highest rate among whites (twice that of blacks). The median overall survival (OS) for the whole group was 4.6 years, whereas the disease-specific survival (DSS) rates at 3, 5, and 15 years were 71.5%, 62.4%, and 43.0%, respectively. Independent predictors of worse DSS were older age, diagnosis before 1986, advanced stage, left testicular involvement, and not having surgery and radiation. The use of radiation did not change significantly over time. When testicular and nodal DLBCL patients were analyzed together, testicular primary was an independent predictor of better OS and DSS. Unlike nodal DLBCL, DSS did not improve in the patients with testicular DLBCL diagnosed after the year 2000. CONCLUSION: The incidence of testicular DLBCL is increasing. Compared with nodal DLBCL, testicular DLBCL patients have a better overall prognosis but are at higher risk of late disease-related deaths. The introduction of rituximab in clinical practice does not seem to improve their early outcome.