Showing papers by "Ochsner Medical Center published in 2013"

Sofosbuvir in combination with peginterferon alfa-2a and ribavirin for non-cirrhotic, treatment-naive patients with genotypes 1, 2, and 3 hepatitis C infection: a randomised, double-blind, phase 2 trial

Abstract: Summary Background Protease inhibitors have improved treatment of infection with hepatitis C virus (HCV), but dosing, a low barrier to resistance, drug interactions, and side-effects restrict their use. We assessed the safety and efficacy of sofosbuvir, a uridine nucleotide analogue, in treatment-naive patients with genotype 1–3 HCV infection. Methods In this two-cohort, phase 2 trial, we recruited treatment-naive patients with HCV genotypes 1–3 from 22 centres in the USA. All patients were recruited between Aug 16, 2010, and Dec 13, 2010, and were eligible for inclusion if they were aged 18–70 years, had an HCV RNA concentration of 50 000 IU/mL or greater, and had no cirrhosis. We randomly allocated all eligible patients with HCV genotype 1 (cohort A) to receive sofosbuvir 200 mg, sofosbuvir 400 mg, or placebo (2:2:1) for 12 weeks in combination with peginterferon (180 μg per week) and ribavirin (1000–1200 mg daily), after which they continued peginterferon and ribavirin for an additional 12 weeks or 36 weeks (depending on viral response). Randomisation was done by use of a computer-generated randomisation sequence and patients and investigators were masked to treatment allocation until week 12. Patients with genotypes 2 or 3 (cohort B) received open-label sofosbuvir 400 mg plus peginterferon and ribavirin for 12 weeks. Our primary outcomes were safety and tolerability. Secondary efficacy analyses were by intention to treat and endpoints included sustained virological response, defined as undetectable HCV RNA at post-treatment weeks 12 and 24. This study is registered with ClinicalTrials.gov, number NCT01188772. Findings In cohort A, 122 patients were assigned 200 mg sofosbuvir (48 patients), 400 mg sofosbuvir (48), or placebo (26). We enrolled 25 patients into cohort B. The most common adverse events—fatigue, headache, nausea, and chills—were consistent with those associated with peginterferon and ribavirin. Eight patients discontinued treatment due to adverse events, two (4%) receiving sofosbuvir 200 mg, three (6%) receiving sofosbuvir 400 mg, and three (12%) receiving placebo. In cohort A, HCV RNA was undetectable at post-treatment week 12 in 43 (90%; 95% CI 77–97) of 48 patients in the 200 mg sofosbuvir group; 43 (91%; 80–98) of 47 patients in the 400 mg sofosbuvir group, and 15 (58%; 37–77) of 26 patients in the placebo group. In cohort B, 23 (92%) of 25 patients had undetectable HCV RNA at post-treatment week 12. Interpretation Our findings lend support to the further assessment, in phase 2 and 3 trials, of sofosbuvir 400 mg plus peginterferon and ribavirin for 12 weeks in treatment-naive patients with HCV genotype-1. Funding Gilead Sciences.

Histoplasmosis After Solid Organ Transplant

Abstract: Results One hundred fifty-two cases were identified: kidney (51%), liver (16%), kidney/pancreas (14%), heart (9%), lung (5%), pancreas (2%), and other (2%) The median time from transplant to diagnosis was 27 months, but 34% were diagnosed in the first year after transplant Twenty-eight percent of patients had severe disease (requiring intensive care unit admission); 81% had disseminated disease Urine Histoplasma antigen detection was the most sensitive diagnostic method, positive in 132 of 142 patients (93%) An amphotericin formulation was administered initially to 73% of patients for a median duration of 2 weeks; step-down therapy with an azole was continued for a median duration of 12 months Ten percent of patients died due to histoplasmosis with 72% of deaths occurring in the first month after diagnosis; older age and severe disease were risk factors for death from histoplasmosis Relapse occurred in 6% of patients Conclusions Although late cases occur, the first year after SOT is the period of highest risk for histoplasmosis In patients who survive the first month after diagnosis, treatment with an amphotericin formulation followed by an azole for 12 months is usually successful, with only rare relapse

Dietary Approaches to Prevent Hypertension

Abstract: Elevated blood pressure arises from a combination of environmental and genetic factors and the interactions of these factors. A substantial body of evidence from animal studies, epidemiologic studies, meta-analyses, and randomized controlled trials has demonstrated that certain dietary patterns and individual dietary elements play a prominent role in the development of hypertension. Changes in diet can lower blood pressure, prevent the development of hypertension, and reduce the risk of hypertension-related complications. Dietary strategies for the prevention of hypertension include reducing sodium intake, limiting alcohol consumption, increasing potassium intake, and adopting an overall dietary pattern such as the DASH (Dietary Approaches to Stop Hypertension) diet or a Mediterranean diet. In order to reduce the burden of blood pressure-related complications, efforts that focus on environmental and individual behavioral changes that encourage and promote healthier food choices are warranted.

An evaluation of the use of topical tranexamic acid in total knee arthroplasty.

Abstract: The purpose of this study was to evaluate the effectiveness of topical tranexamic acid in primary TKA from a clinical and economic standpoint. We retrospectively reviewed 683 primary total knee arthroplasties performed at a single institution over a 2-year period. We compared 373 cases performed in 2010 without tranexamic acid to 310 cases performed in 2011 with tranexamic acid. Demographic data, hemoglobin levels, transfusion rates, hospital length of stay, cost, and perioperative complications during the first 3 months were collected. Statistical analysis was performed using two sample t-tests and Fisher's exact tests. There was no difference in age, sex, height, or pre-operative hemoglobin between the two groups. The tranexamic acid group had significantly higher post-operative hemoglobin (P<0.0001), lower transfusion rate (P<0.0001), decreased length of stay (P<0.0001), decreased blood bank costs (P<0.0001), increased pharmacy cost (P<0.0001), and decreased total direct cost to the hospital (P<0.0001). The average savings was approximately $1500 per patient. There were no differences in thromboembolic events or infection. The use topical tranexamic acid in primary TKA is safe, effective, and results in significant cost savings.

Association of Coffee Consumption With All-Cause and Cardiovascular Disease Mortality

Abstract: Objective: To evaluate the association between coffee consumption and mortality from all causes and from cardiovascular disease. Patients and Methods: Data from the Aerobics Center Longitudinal Study representing 43,727 participants with 699,632 person-years of follow-up were included. Baseline data were collected by an in-person interview on the basis of standardized questionnaires and a medical examination, including fasting blood chemistry analysis, anthropometry, blood pressure, electrocardiography, and a maximal graded exercise test, between February 3, 1971, and December 30, 2002. Cox regression analysis was used to quantify the association between coffee consumption and all-cause and cause-specific mortality. Results: During the 17-year median follow-up, 2512 deaths occurred (804 [32%] due to cardiovascular disease). In multivariate analyses, coffee intake was positively associated with all-cause mortality in men. Men who drank more than 28 cups of coffee per week had higher all-cause mortality (hazard ratio [HR], 1.21; 95% CI, 1.04-1.40). However, after stratification based on age, younger ( 28 cups per week) and allcause mortality after adjusting for potential confounders and fitness level (HR, 1.56; 95% CI, 1.30-1.87 for men; and HR, 2.13; 95% CI, 1.26-3.59 for women). Conclusion: In this large cohort, a positive association between coffee consumption and all-cause mortality was observed in men and in men and women younger than 55 years. On the basis of these findings, it seems appropriate to suggest that younger people avoid heavy coffee consumption (ie, averaging >4 cups per day). However, this finding should be assessed in future studies of other populations. a 2013 Mayo Foundation for Medical Education and Research n Mayo Clin Proc. 2013;88(10):1066-1074

A microenvironment-mediated c-Myc/miR-548m/HDAC6 amplification loop in non-Hodgkin B cell lymphomas

Abstract: A dynamic interaction occurs between the lymphoma cell and its microenvironment, with each profoundly influencing the behavior of the other. Here, using a clonogenic coculture growth system and a xenograft mouse model, we demonstrated that adhesion of mantle cell lymphoma (MCL) and other non-Hodgkin lymphoma cells to lymphoma stromal cells confers drug resistance, clonogenicity, and induction of histone deacetylase 6 (HDAC6). Furthermore, stroma triggered a c-Myc/miR-548m feed-forward loop, linking sustained c-Myc activation, miR-548m downregulation, and subsequent HDAC6 upregulation and stroma-mediated cell survival and lymphoma progression in lymphoma cell lines, primary MCL and other B cell lymphoma cell lines. Treatment with an HDAC6-selective inhibitor alone or in synergy with a c-Myc inhibitor enhanced cell death, abolished cell adhesion–mediated drug resistance, and suppressed clonogenicity and lymphoma growth ex vivo and in vivo. Together, these data suggest that the lymphoma-stroma interaction in the lymphoma microenvironment directly impacts the biology of lymphoma through genetic and epigenetic regulation, with HDAC6 and c-Myc as potential therapeutic targets.

Sexual activity and function in women with and without pelvic floor disorders.

Abstract: We describe differences in sexual activity and function in women with and without pelvic floor disorders (PFDs). Heterosexual women ≥40 years of age who presented to either urogynecology or general gynecology clinics at 11 clinical sites were recruited. Women were asked if they were sexually active with a male partner. Validated questionnaires and Pelvic Organ Prolapse Quantification (POP-Q) examinations assessed urinary incontinence (UI), fecal incontinence (FI), and/or pelvic organ prolapse (POP). Sexual activity and function was measured by the Female Sexual Function Index (FSFI). Student’s t test was used to assess continuous variables; categorical variables were assessed with Fisher’s exact test and logistic regression. Univariate and multivariate analyses were used to assess the impact of pelvic floor disorders (PFDs) on FSFI total and domain scores. Five hundred and five women met eligibility requirements and gave consent for participation. Women with and without PFDs did not differ in race, body mass index (BMI), comorbid medical conditions, or hormone use. Women with PFDs were slightly older than women without PFDs (55.6 + 10.8 vs. 51.6 + 8.3 years, P <0.001); all analyses were controlled for age. Women with PFDs were as likely to be sexually active as women without PFDs (61.6 vs. 75.5 %, P = 0.09). There was no difference in total FSFI scores between cohorts (23.2 + 8.5 vs. 24.4 + 9.2, P = 0.23) or FSFI domain scores (all P = NS). Rates of sexual activity and function are not different between women with and without PFDs.

Medication errors in anesthesia: a review.

Abstract: Medication errors in anesthesia practice have long afflicted our specialty. Over the span of the last 60 years, from the earliest reports of misadventures to current reports of medication errors during anesthesia practice, the rate of human error during the conduct of anesthesia does not seem to be improving. This review highlights the limited studies published on anesthesia medication errors, summarizes the national and international initiatives to reduce errors, addresses the challenges associated with data collection and reporting of errors, and reiterates previously published strategies for reduction or prevention of medication errors. With the advent of innovative technologies, a continued focus on patient safety and recognition of the challenges associated with reporting, opportunities exist to decrease human error during anesthesia practice.

Cancer Incidence Among Those Initiating Insulin Therapy With Glargine Versus Human NPH Insulin

Abstract: OBJECTIVE To add to the evidence on comparative long-term effects of insulin analogue glargine versus human neutral protamine Hagedorn (NPH) insulin on the risk for cancer. RESEARCH DESIGN AND METHODS We identified cohorts of initiators of glargine and human NPH without an insulin prescription during the prior 19 months among patients covered by the Inovalon MORE2 Registry between January 2003 and December 2010. Patients were required to have a second prescription of the same insulin within 180 days and to be free of cancer. We balanced cohorts on risk factors for cancer outcomes based on comorbidities, comedication, and health care use during the prior 12 months using inverse probability of treatment weighting. Incident cancer was defined as having two claims for cancer (any cancer) or the same cancer (breast, prostate, colon) within 2 months. We estimated adjusted hazard ratios (HRs) and their 95% CI using weighted Cox models censoring for stopping, switching, or augmenting insulin treatment, end of enrollment, and mortality. RESULTS More patients initiated glargine (43,306) than NPH (9,147). Initiators of glargine were followed for 1.2 (1.1) years and 50,548 (10,011) person-years; 993 (178) developed cancer, respectively. The overall HR was 1.12 (95% CI 0.95–1.32). Results were consistent for breast cancer, prostate cancer, and colon cancer; various durations of treatment; and sensitivity analyses. CONCLUSIONS Patients initiating insulin glargine rather than NPH do not seem to be at an increased risk for cancer. While our study contributes significantly to our evidence base for long-term effects, this evidence is very limited mainly based on actual dynamics in insulin prescribing.

Cost savings realized by use of the PhaSeal(®) closed-system transfer device for preparation of antineoplastic agents.

Abstract: Purpose: Medication cost is a major factor associated with increasing health care costs in the United States. Expenditures for prescription drugs in 2013 are estimated to be $283.7 billion. Closed system transfer devices are widely used for preparation of hazardous drugs. Reports indicate the Phaseal closed system transfer device maintains

Polycyclic aromatic hydrocarbons-induced ROS accumulation enhances mutagenic potential of T-antigen from human polyomavirus JC

Abstract: Polycyclic aromatic hydrocarbons (PAHs) are the products of incomplete combustion of organic materials, which are present in cigarette smoke, deep-fried food, and in natural crude oil. Since PAH-metabolites form DNA adducts and cause oxidative DNA damage, we asked if these environmental carcinogens could affect transforming potential of the human Polyomavirus JC oncoprotein, T-antigen (JCV T-antigen). We extracted DMSO soluble PAHs from Deepwater Horizon oil spill in the Gulf of Mexico (oil-PAHs), and detected several carcinogenic PAHs. The oil-PAHs were tested in exponentially growing cultures of normal mouse fibroblasts (R508), and in R508 stably expressing JCV T-antigen (R508/T). The oil-PAHs were cytotoxic only at relatively high doses (1:50-1:100 dilution), and at 1:500 dilution the growth and cell survival rates were practically unaffected. This non-toxic dose triggered however, a significant accumulation of reactive oxygen species (ROS), caused oxidative DNA damage and the formation of DNA double strand breaks (DSBs). Although oil-PAHs induced similar levels of DNA damage in R508 and R508/T cells, only T-antigen expressing cells demonstrated inhibition of high fidelity DNA repair by homologous recombination (HRR). In contrast, low-fidelity repair by non-homologous end joining (NHEJ) was unaffected. This potential mutagenic shift between DNA repair mechanisms was accompanied by a significant increase in clonal growth of R508/T cells chronically exposed to low doses of the oil-PAHs. Our results indicate for the first time carcinogenic synergy in which oil-PAHs trigger oxidative DNA damage and JCV T-antigen compromises DNA repair fidelity.

Cardiac rehabilitation and cardiovascular disability: role in assessment and improving functional capacity: a position statement from the American Association of Cardiovascular and Pulmonary Rehabilitation.

Abstract: The Social Security Administration (SSA) oversees the disability determination process and the payment of disability benefits to Americans. According to recent SSA data, approximately 900 000 persons are receiving cardiovascular disability payments and about 145 000 adult claims for cardiovascular disability are processed by the SSA annually. An objective and comprehensive examination of functional capacity is an important part of the disability assessment process. This statement reviews various protocols for disability assessment of aerobic capacity, muscle function, and the physical requirements of job tasks. Cardiac rehabilitation programs are ideal settings for conducting comprehensive disability assessments of functional capacity in persons with cardiovascular disease. In addition, exercise training provided by cardiac rehabilitation programs can increase functional capacity in most patients.

Comparison of limb-length discrepancy after THA: with and without computer navigation.

Abstract: Limb-length discrepancy following total hip arthroplasty (THA) is often cited as a reason for patient dissatisfaction and for hip instability. Various intraoperative techniques have been described to help restore normal limb length after THA. The purpose of this study was to assess whether a computer-navigated surgical technique would help restore limb-length equality following THA.A retrospective study of 150 consecutive patients compared a free-hand (non-navigated) THA technique vs a computer-navigated THA technique. Each group contained 75 patients. The primary outcome measurement was limb-length discrepancy, which was evaluated using a digital anteroposterior pelvic radiograph. Secondary outcome measurements included a Harris Hip Score questionnaire and a single question evaluating the subjective feeling of the operative limb (longer, shorter, or equal). At a minimum 1-year follow-up, results showed that computer-navigated THA helped restore limb-length equality. An average leg-length difference of 0.3 mm (SD=0.3 mm) was found with computer-navigated THA compared with a leg-length difference of 1.8 mm (SD=0.7 mm) when a non-navigated THA was used. This was statistically significant. Both groups had similar Harris Hip Scores (computer-navigated group, 84.8; non-navigated group, 84.2; P=.835), and no difference was found between the 2 groups regarding the patient's perception of the operative limb length.This study demonstrated that computer-navigated THA resulted in improved restoration of normal limb length and limited significant outliers but did not show improvement in Harris Hip Scores or patient's perception of limb-length equality.

Abdominal versus perineal approach for treatment of rectal prolapse: comparable safety in a propensity-matched cohort.

Abstract: Abdominal operations for rectal prolapse are associated with lower recurrence rates than perineal procedures but presumed higher morbidity. Therefore, perineal procedures are recommended for patients deemed unfit for abdominal repair. Consequently, bias confounds retrospective comparisons of the two approaches. To clarify the impact of operative approach on outcomes, we analyzed abdominal and perineal procedures in a propensity score-matched analysis. We selected patients undergoing surgery for rectal prolapse from the American College of Surgeons National Surgical Quality Improvement Program data set from 2005 to 2010. We grouped procedures as abdominal or perineal. We identified preoperative variables predictive of complications and regressed against operative approach. The resulting propensity score was used to select a matched cohort with similar clinical risk. We identified 2188 patients (848 abdominal [38.8%]; 1340 perineal [61.2%]). Patients undergoing the perineal approach had higher rates of most risk variables. Propensity matching resulted in 563 matched pairs (1126 patients) with similar clinical risk. In this matched cohort, no significant difference was found in the rate of any complication between the operative approaches; mortality was 0.9 per cent in each group (P = 1.0). Relative risk for major morbidity after abdominal approach was 1.39 (95% confidence interval, 0.92 to 2.10; P = 0.15). Although many patients with rectal prolapse are high risk for abdominal surgery, our study indicates that many patients treated by perineal repair could be safely treated with a more durable operation.

Effect of rate-adaptive pacing on performance and physiological parameters during activities of daily living in the elderly: results from the CLEAR (Cylos Responds with Physiologic Rate Changes during Daily Activities) study.

Abstract: Aims For most elderly pacemaker patients, evaluation of rate-adaptive pacing using treadmill and bicycle tests is impractical and not representative of typical daily activities. This study was designed to compare the performance and physiological response of the closed-loop stimulation (CLS) rate-adaptive sensor to accelerometer (XL) and no rate sensor (DDD) during typical daily activity testing. Methods and results Subjects recently implanted with a Cylos pacemaker completed timed activities of daily life testing, which included walking, sweeping, and standing from a seated position. Activity performance and physiological response from each sensor mode was evaluated for subjects requiring ≥80% pacing. Overall, 74 subjects needed ≥80% pacing during at least one test. An increase in the area swept (CLS vs. XL, 1.67 m2 difference, P = 0.009; CLS vs. DDD, 1.59 m2 difference, P = 0.025) and a decrease in the prevalence of orthostatic hypotension (OH) after standing 1 min (CLS vs. XL, odds ratio = 0.16, P = 0.006; CLS vs. DDD, odds ratio = 0.18, P = 0.012) was observed in the CLS mode as compared with XL and DDD. No statistical difference in walk distance was observed between CLS and XL or CLS and DDD. Conclusion In acute testing, as compared with XL and DDD, CLS provides a more physiological response during the performance of activities of daily living for subjects with ≥80% pacing. This is clinically reflected in better performance during the sweep test as well as a decrease in the prevalence of OH in our elderly population. Clinicaltrials.gov identifier: [NCT00355797][1] [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00355797&atom=%2Feuropace%2F15%2F6%2F849.atom

Hyponatremia-Associated Healthcare Burden Among US Patients Hospitalized for Cirrhosis

Abstract: Introduction Hyponatremia is a frequent comorbid condition of patients hospitalized for cirrhosis and a predictor of disease severity and mortality. This study evaluated the healthcare burden of hyponatremia among patients hospitalized for cirrhosis in the real world.

Joint hypermobility, obstetrical outcomes, and pelvic floor disorders.

Abstract: Introduction and hypothesis Benign joint hypermobility syndrome may be a risk factor for pelvic floor disorders. It is unknown whether hypermobility impacts the progress of childbirth, a known risk factor for pelvic floor disorders. Our objective was to investigate the association between joint hypermobility syndrome, obstetrical outcomes, and pelvic floor disorders. Our hypotheses were: (1) women with joint hypermobility are less likely to experience operative delivery and prolonged second-stage labor; and (2) pelvic floor disorders are associated with benign hypermobility syndrome, controlling for obstetrical history.

Accuracy and Clinical Utility of a Peri-Operative Risk Calculator for Total Knee Arthroplasty

Abstract: Utilizing the Medicare Provider Analysis and Review dataset, a, peri-operative total knee arthroplasty (TKA) risk calculator was created based on select preoperative comorbidities. We retrospectively identified and reviewed 2284 primary TKAs at a single institution from 2000-2008. A numerical, predicted complication risk was established for each patient. Actual complications occurring within the first 14 post-operative days were recorded. Statistical analysis was performed using the C-statistic and ANOVA test. Patients with higher predicted probability of a complication did show higher complication rates. The corresponding C-statistic was 0.609. (95% Confidence Interval: 0.542-0.677). When the patients were divided into 4 groups based on their calculated complication risk (0-5%, 5-10%, 10-25%, >25%) the statistical significance of the associated ANOVA was P < .001, showing that patients with higher predicted risk experienced more complications, and those with lower predicted risk experienced fewer complications. Based on our results, the calculator has predictive value and is clinically relevant.

Multisociety consensus quality improvement guidelines for intraarterial catheter‐directed treatment of acute ischemic stroke, from the American Society of Neuroradiology, Canadian Interventional Radiology Association, Cardiovascular and Interventional Radiological Society of Europe, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, European Society of Minimally Invasive Neurological Therapy, and Society of Vascular and Interventional Neurology

Abstract: Purpose In this international multispecialty document, quality benchmarks for processes of care and clinical outcomes are defined. It is intended that these benchmarks be used in a quality assurance program to assess and improve processes and outcomes in acute stroke revascularization. Materials and Methods Members of the writing group were appointed by the American Society of Neuroradiology, Canadian Interventional Radiology Association, Cardiovascular and Interventional Radiological Society of Europe, Society of Cardiac Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, European Society of Minimally Invasive Neurological Therapy, and Society of Vascular and Interventional Neurology. The writing group reviewed the relevant literature from 1986 through February 2012 to create an evidence table summarizing processes and outcomes of care. Performance metrics and thresholds were then created by consensus. The guideline was approved by the sponsoring societies. It is intended that this guideline be fully updated in 3 years. Results In this international multispecialty document, quality benchmarks for processes of care and clinical outcomes are defined. These include process measures of time to imaging, arterial puncture, and revascularization and measures of clinical outcome up to 90 days. Conclusions Quality improvement guidelines are provided for endovascular acute ischemic stroke revascularization procedures. © 2013 Wiley Periodicals, Inc.

State‐of‐the‐art paper: Therapeutic hypothermia in out of hospital cardiac arrest survivors

Abstract: Out of hospital cardiac arrest (OHCA) is associated with an extremely poor survival rate, with mortality in most cases being related to neurological injury. Among patients who experience return of spontaneous circulation (ROSC), therapeutic hypothermia (TH) is the only proven intervention shown to reduce mortality and improve neurological outcome. First described in 1958, the field of TH has rapidly evolved in recent years. While recent technological advances in TH will likely improve outcomes in OHCA survivors, several fundamental questions remain to be answered including the optimal speed of cooling, which patients benefit from an early invasive strategy, and whether technological advances will facilitate application of TH in the field. An increased awareness and understanding of TH strategies, devices, monitoring, techniques, and complications will allow for a more widespread adoption of this important treatment modality.

Submammary device implantation in women: a step-by-step approach.

Abstract: Submammary Device Implantation in Women. Introduction: The frequency of device implantation is increasing in younger patients as our ability to diagnose long-QT syndrome, hypertrophic cardiomyopathy, Brugada Syndrome, and other life-threatening disorders earlier has improved. Similarly, use of cardiac resynchronization therapy and ICD therapies has increased in cardiomyopathy patients. Methods and Results: Device implantation in young women has unique considerations. Standard pectoral implants lead to excessive scar formation due to skin tension and interfere with purse straps, bra straps, and seat belts. There are also privacy and body image concerns as the subclavian region is exposed with many contemporary fashions. Results: Over an 11-year period, we implanted pacemakers, implantable converter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices (defibrillators or pacemakers) in 60 women, aged 13–70 years, using a 2-incision submammary approach. Follow-up surveys were performed using the Florida Patient Acceptance Survey (FPAS). Women with submammary device placement reported significantly greater device acceptance (M = 92.41, SD = 6.46) than women with standard implant technique (M = 70.29, SD = 17.85); t (54) =–6.08, P < 0.001, on the FPAS. Across subscales on the FPAS, women with submammary device placement also reported significantly less body image concern (P < 0.001), less device-related emotional distress (P < 0.001), and greater confidence in returning to life appropriately (P = 0.01) than women with standard device placement. Conclusion: We present here our technique for submammary device implantation. (J Cardiovasc Electrophysiol, Vol. 24, pp. 476-479, April 2013)