Benjamin Nutter

Patient management after noninvasive cardiac imaging: Results from SPARC (Study of myocardial perfusion and coronary anatomy imaging roles in coronary artery disease)

OBJECTIVES This study examined short-term cardiac catheterization rates and medication changes after cardiac imaging. BACKGROUND Noninvasive cardiac imaging is widely used in coronary artery disease, but its effects on subsequent patient management are unclear. METHODS We assessed the 90-day post-test rates of catheterization and medication changes in a prospective registry of 1,703 patients without a documented history of coronary artery disease and an intermediate to high likelihood of coronary artery disease undergoing cardiac single-photon emission computed tomography, positron emission tomography, or 64-slice coronary computed tomography angiography. RESULTS Baseline medication use was relatively infrequent. At 90 days, 9.6% of patients underwent catheterization. The rates of catheterization and medication changes increased in proportion to test abnormality findings. Among patients with the most severe test result findings, 38% to 61% were not referred to catheterization, 20% to 30% were not receiving aspirin, 35% to 44% were not receiving a beta-blocker, and 20% to 25% were not receiving a lipid-lowering agent at 90 days after the index test. Risk-adjusted analyses revealed that compared with stress single-photon emission computed tomography or positron emission tomography, changes in aspirin and lipid-lowering agent use was greater after computed tomography angiography, as was the 90-day catheterization referral rate in the setting of normal/nonobstructive and mildly abnormal test results. CONCLUSIONS Overall, noninvasive testing had only a modest impact on clinical management of patients referred for clinical testing. Although post-imaging use of cardiac catheterization and medical therapy increased in proportion to the degree of abnormality findings, the frequency of catheterization and medication change suggests possible undertreatment of higher risk patients. Patients were more likely to undergo cardiac catheterization after computed tomography angiography than after single-photon emission computed tomography or positron emission tomography after normal/nonobstructive and mildly abnormal study findings. (Study of Perfusion and Anatomys Role in Coronary Artery [CAD] [SPARC]; NCT00321399).

Robotic-assisted, laparoscopic, and abdominal myomectomy: a comparison of surgical outcomes.

OBJECTIVE: To compare the surgical outcomes of robot-assisted laparoscopic myomectomy (robot-assisted), standard laparoscopic myomectomy (laparoscopic), and open myomectomy (abdominal). METHODS: Myomectomy patients were identified from the case records of the Cleveland Clinic and stratified into three groups. Operative and immediate postoperative outcomes were compared. Data analysis was performed using analysis of variance, Kruskal-Wallis analysis of ranks, &khgr;2, and Fisher exact tests where appropriate. RESULTS: From a total of 575 myomectomies, 393 (68.3%) were abdominal, 93 (16.2%) were laparoscopic, and 89 (15.5%) were robot-assisted. The three groups were comparable regarding the size, number, and location. Significantly heavier myomas were removed in the robot-assisted group (223 [85.25, 391.50] g) compared with the laparoscopic group (96.65 [49.50, 227.25] g, P<.001) and were lower than in the abdominal group (263 [ 90.50, 449.00] g, P=.002). Higher blood loss was reported in the abdominal group compared with the other two groups, with a median (interquartile range) of blood loss in milliliters of 100 (50, 212.50), 200 (100, 437.50) and 150 (100, 200) in the laparoscopic, abdominal, and robot-assisted groups, respectively. The actual surgical time in minutes was 126 (95, 177) in the abdominal group, 155 (98, 200) in the laparoscopic group, and 181 (151, 265) in robot-assisted group (P<.001). Patients in the abdominal group had a higher median length of hospital stay of 3 (2, 3) days, compared with 1 (0, 1) day in the laparoscopic group and 1 (1, 1) days in the robot-assisted group (P<.001). CONCLUSION: Robotic-assisted myomectomy is associated with decreased blood loss and length of hospital stay compared with traditional laparoscopy and to open myomectomy. Robotic technology could improve the utilization of the laparoscopic approach for the surgical management of symptomatic myomas. LEVEL OF EVIDENCE: II

Association between immune-associated disorders and adverse outcomes of ileal pouch-anal anastomosis.

OBJECTIVES:Autoimmune disorders (ADs) frequently coexist with inflammatory bowel disease. The aim of the study was to determine whether coexisting AD in patients with ileal pouches increases the risk for chronic antibiotic-refractory pouchitis (CARP) and other inflammatory conditions of the pouch.METHODS:A total of 622 patients seen in our Pouchitis Clinic were enrolled. We compared the prevalence of adverse outcomes of the pouch (including CARP, Crohns disease of the pouch, and pouch failure) in patients with or without concurrent AD and assessed the factors for these adverse outcomes.RESULTS:There were seven pouch disease categories: normal (N=60), irritable pouch syndrome (N=112), active pouchitis (N=131), CARP (N=67), Crohns disease (N=131), cuffitis (N=83), surgical complications (N=36), and anismus (N=2). The prevalence of AD in these pouch disease categories was 4.5%, 12.5%, 9.2%, 13.4%, 10.7%, 3.8%, 1.5%, and 0%, respectively. The presence of at least one AD at time of pouch surgery was shown to be associated with a twofold increase in the risk for CARP (hazard ratio=2.29; 95% CI: 1.52, 3.46; P<0.001) and for pouch-associated hospitalization (hazard ratio=2.39; 95% CI: 1.59, 3.58; P<0.001). The presence of AD was not associated with increased risk for irritable pouch syndrome, active pouchitis, Crohns disease, cuffitis, surgical complications, or pouch failure. Patients with Crohns disease of the pouch had a 2.42 times higher risk for pouch failure (P=0.042) than these without. Active smoking or a history of smoking was shown to be associated with an increased risk for pouch-associated hospitalization and pouch failure.CONCLUSIONS:AD appears to be associated with an increased risk for CARP, and the presence of the association between these AD and pouch disorders may stimulate further research on the link of these organ systems on an immunological basis.

Granulomatosis With Polyangiitis (Wegener’s): Impact of Maintenance Therapy Duration

AbstractTo determine outcomes in relation to duration of maintenance therapy in patients with granulomatosis with polyangiitis (Wegener’s) (GPA), we conducted a retrospective chart review of patients with GPA seen at a single vasculitis center from 1992 to 2010. All patients achieved remission defined by a Birmingham Vasculitis Activity Score for Wegener Granulomatosis (BVAS/WG) of 0 with either cyclophosphamide or methotrexate. After achieving remission all patients were started on maintenance therapy with either methotrexate or azathioprine.The study comprised 157 patients with a median follow-up of 3.1 years. Using a univariate model, the continuation of maintenance medications for >18 months showed a 29% reduction in hazard ratio (HR) for relapse (HR, 0.71; 95% confidence interval [CI], 0.42–1.19; p = 0.19). Treatment for >36 months showed a 66% reduction in hazard ratio for relapse (HR, 0.34; 95% CI, 0.15–0.76; p = 0.008). When length of treatment was considered as a continuous factor, longer courses had an inverse relationship with the risk of relapse (HR, 0.70; 95% CI, 0.58–0.84; p < 0.001), which remained significant after adjusting for prednisone dose (HR, 0.59; 95% CI, 0.42–0.83; p = 0.003). Fifty-two percent of relapses occurred while the patients were off maintenance therapy. Among all patients who relapsed on therapy, 52% of those receiving methotrexate were on <15 mg/week, and 67% of those receiving azathioprine were on ⩽50 mg/d. There were no differences between the short- and long-term maintenance therapy groups in overall adverse events or GPA-related morbidity.Discontinuation or use of low doses of maintenance therapy is associated with a higher relapse rate.

Risk Factors for Complications of Radiation Therapy on Tissue Expander Breast Reconstructions

Abstract:  Radiation therapy has been shown to increase complication rates of tissue expander/implant breast reconstructions. The purpose of this study was to evaluate patient characteristics to assess their impact on complications. A retrospective review of patients who underwent mastectomy plus tissue expander/implant reconstruction from January 2000 to December 2006 was performed. The main outcome of interest was the development of postoperative complications. Analyses were performed to detect risk factors for complications. A total of 560 patients were included in the study. A total of 385 patients underwent unilateral and 174 underwent bilateral tissue expander/implant reconstructions, for a total of 733 reconstructions. A total complication rate of 31.8% and a major complication rate of 24.4% were calculated. The risk factors associated with a significantly increased incidence of complications were age greater than 50 years, body mass index (BMI) greater than 30, and radiation. Women younger than 50 years had a complication rate of 28.4%, whereas women older than 50 years had a complication rate of 37.0%. Women with a BMI less than 30 had a complication rate of 27.5%, whereas women with a BMI greater than 30 had a complication rate of 49%. The major complication rate in nonradiated and radiated patients was 21.2% and 45.4%, respectively. Despite higher complication rates, tissue expander/implant reconstructions were successful in 70.1% of radiated patients. Based on this study, the ideal radiated patient would have a BMI less than 30 and be younger than 50 years of age to maximize the likelihood of a successful tissue expander/implant reconstruction.

Clinical characteristics and prediction of pulmonary hypertension in severe emphysema.

BACKGROUND We explored the prevalence, clinical and physiologic correlates of pulmonary hypertension (PH), and screening strategies in patients with severe emphysema evaluated for the National Emphysema Treatment Trial (NETT). METHODS Patients undergoing Doppler echocardiography (DE) and right heart catheterization were included. Patients with mean pulmonary arterial pressure ≥ 25 mmHg (PH Group) were compared to the remainder (non-PH Group). RESULTS Of 797 patients, 302 (38%) had PH and 18 (2.2%) had severe PH. Compared to the non-PH Group, patients with PH had lower % predicted FEV1 (p < 0.001), % predicted diffusion capacity for carbon monoxide (p = 0.006), and resting room air PaO2 (p < 0.001). By multivariate analysis, elevated right ventricular systolic pressure, reduced resting room air PaO2, reduced post-bronchodilator % predicted FEV1, and enlarged pulmonary arteries on computed tomographic scan were the best predictors of PH. A strategy using % predicted FEV1, % predicted DLCO, PaO2, and RVSP was predictive of the presence of pre-capillary PH and was highly predictive of its absence. CONCLUSIONS Mildly elevated pulmonary artery pressures are found in a significant proportion of patients with severe emphysema. However, severe PH is uncommon in the absence of co-morbidities. Simple non-invasive tests may be helpful in screening patients for pre-capillary PH in severe emphysema but none is reliably predictive of its presence.

Patient-Centered Prenatal Counseling: Aligning Obstetric Healthcare Professionals With Needs of Pregnant Women

The first trimester aneuploidy screen (FTS) continues to be a leading approach to identify the risk of fetal aneuploidy. This study evaluated how obstetric (OB) professionals counsel women about FTS as one of a growing number of options to assess fetal health. A survey was completed by OB professionals (board-certified obstetrician/gynecologists and certified nurse midwives) between February and March 2011: (1) to identify knowledge and practice patterns with regard to FTS, and (2) to compare pregnant women’s educational needs and decision-making preferences with clinicians’ perceptions of these factors. A total of 216 surveys (11 percent) were completed by OB professionals and analyzed. Several barriers to effective patient counseling were identified, including gaps in obstetric professionals’ mastery of the screening test characteristics and variable approaches to discuss concepts of aneuploidy risk. OB participants reported limited confidence in discussing patient-valued topics, specifically post-screen options and pregnancy termination. Discordance was identified between OB professionals’ perceptions of pregnant women’s educational needs and decision-making preferences specific to FTS and historical data recently collected from 139 pregnant women who underwent the FTS. Study findings illustrate the need for clinician-targeted strategies to support pregnant women as they formulate informed decisions about the tests that may have a salient impact on their prenatal care decisions.

Myocardial scar burden predicts survival benefit with implantable cardioverter defibrillator implantation in patients with severe ischaemic cardiomyopathy: influence of gender

Objective We sought to assess the impact of myocardial scar burden (MSB) on the association between implantable cardioverter defibrillator (ICD) implantation and mortality in patients with ischaemic cardiomyopathy (ICM) and left ventricular EF ≤40%. In addition, we sought to determine the impact of gender on survival benefit with ICD implantation. Design Retrospective observational study. Setting Single US tertiary care centre. Patients Consecutive patients with significant ICM who underwent delayed hyperenhancement-MRI between 2002 and 2006. Interventions ICD implantation. Main outcome measures All-cause mortality and cardiac transplantation. Results Follow-up of 450 consecutive patients, over a mean of 5.8 years, identified 186 deaths. Cox proportional hazard modelling was used to evaluate associations among MSB, gender and ICD with respect to all-cause death as the primary endpoint. ICDs were implanted in 163 (36%) patients. On multivariable analysis, Scar% (χ2 28.21, p<0.001), Gender (χ2 12.39, p=0.015) and ICD (χ2 9.57, p=0.022) were independent predictors of mortality after adjusting for multiple parameters. An interaction between MSB×ICD (χ2 9.47, p=0.009) demonstrated significant differential survival with ICD based on MSB severity. Additionally, Scar%×ICD×Gender (χ2 6.18, p=0.048) suggested that men with larger MSB had significant survival benefit with ICD, but men with smaller MSB derived limited benefit with ICD implantation. However, the inverse relationship was found in women. Conclusions MSB is a powerful independent predictor of mortality in patients with and without ICD implantation. In addition, MSB may predict gender-based significant differences in survival benefit from ICDs in patients with severe ICM.

A phase II trial of paclitaxel, carboplatin, and bevacizumab in advanced and recurrent endometrial carcinoma (EMCA)

OBJECTIVE To evaluate the effect of adding bevacizumab to adjuvant paclitaxel and carboplatin and as maintenance on progression-free survival (PFS) in advanced or recurrent endometrial carcinoma (EMCA). METHODS A phase II trial was conducted in patients with measurable disease. Paclitaxel (175mg/m(2)/3h), carboplatin (AUC 5) and bevacizumab (15mg/kg) were administered q 21 days. Patients with a complete response after 6-8cycles received maintenance therapy with bevacizumab 15mg/kg q 21 days for 16cycles. Based on GOG 177 which had a 6-month PFS rate of 59%, an increase in 6-month PFS to 72% with the treatment regimen was considered of clinical interest. RESULTS 15 patients were enrolled on protocol when accrual to the study was discontinued due to the initiation of a national randomized phase II trial. A total of 127 courses (median 8, range 1-20) of carboplatin, paclitaxel, and bevacizumab combination therapy were administered. One patient suffered a bowel perforation after her first course of therapy and was inevaluable for response. Fourteen of the 15 patients (93%, 95% CI: 82-100) were progression free at 6months. The median follow-up was 36months (7-58+). The median PFS was 18months (CI: 11-25). Five complete responses and 6 partial responses were seen for an overall response rate of 73% (CI: 45-91). The median overall survival was 58months (CI: 48-68). CONCLUSIONS The bevacizumab, paclitaxel, and carboplatin regimen is active and tolerable in advanced and recurrent EMCA. Its impact awaits results of the recently completed randomized phase II trial.

Determining the fertility benefit of controlled ovarian hyperstimulation with intrauterine insemination after operative laparoscopy in patients with endometriosis.

STUDY OBJECTIVE To determine the fertility benefit of controlled ovarian hyperstimulation (COH) and intrauterine insemination (IUI) in surgically treated endometriosis. DESIGN Retrospective cohort study (Canadian Task Force classification II-2). SETTING Cleveland Clinic Foundation, tertiary care center. PATIENTS Ninety-six women of reproductive age who underwent operative laparoscopy to treat endometriosis-related infertility (endometriosis stage I/II n = 67; stage III/IV n = 29) from 2001 to 2011 at the Cleveland Clinic Foundation. INTERVENTIONS COH via letrozole, clomiphene, or gonadotropins, with or without IUI. MEASUREMENTS AND MAIN RESULTS Kaplan-Meier estimations of cumulative pregnancy rates were compared by stage between COH/IUI and spontaneous cycles. Patients with stage I/II endometriosis attempted spontaneous pregnancy for 669 months and 216 COH + IUI cycles, and patients with stage III/IV endometriosis attempted spontaneous pregnancy for 379 months and 74 COH + IUI cycles. Crude pregnancy rates were 45.7% in stage I/II and 40.5% in stage III/IV. Twelve-month cumulative pregnancy rates in stage I/II were 45% for spontaneous attempts and 42% for COH + IUI, and in stage III/IV were 20% for spontaneous attempts and 10% for COH + IUI (not significant). Cumulative pregnancy rates for COH/IUI in stage I/II were significantly higher than in stage III/IV. Monthly fecundity rates were 3.81% for stage I/II spontaneous, 4.59% for COH/IUI, 3.05% for stage III/IV spontaneous, and 1.68% for COH/IUI (not significant). CONCLUSIONS COH + IUI did not improve pregnancy rates in any stage of endometriosis. In stage III/IV we recommend postoperative in vitro fertilization.