Short- and Long-Term Risk of Lead Dislodgement Events: Real-World Experience From Product Surveillance Registry.

BACKGROUND: Lead dislodgement (LD) has been one of the most common early complications after cardiovascular implantable electronic device implant. However, limited data are available on the clinical characteristics and long-term outcomes of LD events. The aim of this study was to examine the risk factors, clinical significance, and management strategies of LD events after cardiovascular implantable electronic device implant. METHODS: This study was a retrospective cohort analysis of 20 683 patients who underwent cardiovascular implantable electronic device implant between January 1, 2010 and January 31, 2020 in Medtronic's Product Surveillance Registry, with a mean follow-up time of 3.3±2.5 SD years. The study population was divided into 2 groups: group A with LD events (N=350) and group B without LD events (N=20 333). RESULTS: During this period, 350 patients (1.69%) had LD events involving 371 leads (0.95%), among a total of 39 060 leads implanted. Passive fixation type (right atrium pacing lead, P=0.041), lower sensing amplitude (right ventricle defibrillating lead, P=0.020), and lower lead impedance at implant (right atrium pacing lead, P=0.009) were associated with increased LD risk. Multivariate analysis showed female sex (hazard ratio, 1.520, P=0.008) and higher body mass index (hazard ratio, 1.012, P=0.001) were independently associated with increased risk of LD events. LD events were not associated with significant changes in the long-term risks of cardiac and overall mortality. In group A, repositioning the dislodged leads increased the risk of a second LD event compared with implanting new leads (P=0.012). CONCLUSIONS: Female sex and higher body mass index were associated with higher risk of LD events in the Product Surveillance Registry. Among patients with dislodged leads, implanting new leads was associated with lower risk of future LD events. Further studies on how to reduce LD risk and to improve management of these events are needed. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT01524276.

Air Quality Monitoring During High-Level Biocontainment Ground Transport: Observations From Two Operational Exercises.

OBJECTIVE: Stretcher transport isolators provide mobile, high-level biocontainment outside the hospital for patients with highly infectious diseases, such as Ebola virus disease. Air quality within this confined space may pose human health risks. METHODS: Ambient air temperature, relative humidity, and CO2 concentration were monitored within an isolator during 2 operational exercises with healthy volunteers, including a ground transport exercise of approximately 257 miles. In addition, failure of the blower unit providing ambient air to the isolator was simulated. A simple compartmental model was developed to predict CO2 and H2O concentrations within the isolator. RESULTS: In both exercises, CO2 and H2O concentrations were elevated inside the isolator, reaching steady-state values of 4434 ± 1013 ppm CO2 and 22 ± 2 mbar H2O in the first exercise and 3038 ± 269 ppm CO2 and 20 ± 1 mbar H2O in the second exercise. When blower failure was simulated, CO2 concentration exceeded 10 000 ppm within 8 minutes. A simple compartmental model predicted CO2 and H2O concentrations by accounting for human emissions and blower air exchange. CONCLUSIONS: Attention to air quality within stretcher transport isolators (including adequate ventilation to prevent accumulation of CO2 and other bioeffluents) is needed to optimize patient safety.

Field Report: Medical Response to Super Typhoon Haiyan.

This report describes the experience and observations during a humanitarian medical response 10 days after landfall of Typhoon Haiyan in the Leyte Island region of the Philippines. Loss of availability of local health care providers was observed to affect the ability of the local community to provide for immediate, post-event medical relief.

Anterior colporrhaphy: why surgeon performance is paramount.

Anterior compartment repair is one of the most challenging issues in reconstructive pelvic surgery. Previous studies using strict anatomic criteria suggested a high failure rate after anterior colporrhaphy, prompting increased use of augmented repairs in the past decade. More recent studies suggest anterior colporrhaphy may provide symptom relief similar to that seen with augmented repairs without the risks associated with placement of mesh. There is a wide range of success rates for anterior colporrhaphy in the literature. The wide variation implies surgeon performance is a key issue in the success or failure of anterior compartment repair. It is critical to begin measuring and reporting surgeon performance in research trials and monitoring surgeon performance in clinical practice in order to make meaningful comparisons of surgical techniques and improve patient care.

Progressive reduction in abdominal hysterectomy rates: impact of laparoscopy, robotics and surgeon factors.

The objective of this study is to describe changes in rates of types of hysterectomy at a tertiary care community teaching hospital since the introduction of laparoscopic and robotic techniques and to determine the effect of surgeon characteristics on route of hysterectomy. This is a retrospective analysis of types of hysterectomies performed for benign disease during five different years (1989, 1994, 1999, 2004, 2009) at a large community teaching hospital. Hospital discharge data was reviewed to identify all hysterectomies performed during the first six months of each year of the study. Hospital charts were reviewed and patient characteristics, indication for surgery, type of hysterectomy and surgeon characteristics were recorded. Hysterectomies performed for malignancy, suspected malignancy, or postpartum hemorrhage were excluded. Types of hysterectomies included abdominal (AH), vaginal (VH), laparoscopic-assisted vaginal (LAVH), total laparoscopic (TLH), laparoscopic supracervical (LSH) and robotic-assisted (RH). The progressive introduction of newer minimally invasive surgical techniques (LAVH, TLH, LSH, and RH) resulted in an overall reduction in the abdominal hysterectomy rate from 77 to 35.2 % during the time of the study. The majority of abdominal, laparoscopic supracervical and robotic hysterectomies were performed by generalists, while the majority of vaginal, laparoscopic-assisted vaginal and total laparoscopic hysterectomies were performed by fellowship trained subspecialists. Minimally invasive hysterectomy techniques significantly reduced the rate of abdominal hysterectomies. The LSH and RH were the techniques utilized by generalists as their most preferred minimally invasive surgical approaches to hysterectomy.

Pelvic floor muscle function in women presenting with pelvic floor disorders.

INTRODUCTION AND HYPOTHESIS: This observational study was undertaken to determine knowledge, prior instruction, frequency of performance, and ability to perform pelvic floor muscle exercises in a group of women presenting for evaluation of pelvic floor disorders. METHODS: Three hundred twenty-five women presenting for evaluation of pelvic floor disorders were questioned concerning knowledge and performance of pelvic floor muscle exercises (PMEs) and then examined to determine pelvic floor muscle contraction strength. RESULTS: The majority of women (73%) had heard of PMEs, but only 42% had been instructed to perform them and 62.5% stated they received verbal instruction only. Only 23.4% of patients could perform pelvic muscle contractions with Oxford Scale 3, 4, or 5 strengths. Increased age, parity, and stage of prolapse were associated with lower Oxford scores. CONCLUSIONS: Although most women with pelvic floor disorders are familiar with PMEs, less than one fourth could perform adequate contractions at the time of initial evaluation.

Natural orifice hysterectomy.

Minimally invasive surgery (MIS) such as natural orifice surgery is perceived as a relatively recent development partly because many MIS techniques utilize new technology and devices. However, a natural orifice/MIS approach for hysterectomy (vaginal hysterectomy, VH) has existed for over a century. VH is typically thought of in the realm of the urogynecologist as a component of reconstructive pelvic surgery for pelvic organ prolapse. However, current evidence supports the use of VH in women with other benign conditions such as uterine fibroids and abnormal bleeding. Despite the evidence and availability of several MIS options for hysterectomy, the majority of hysterectomies continue to be performed via laparotomy. VH is the least invasive approach to hysterectomy, and its use should be encouraged as the preferred MIS option for women requiring uterine removal for benign conditions.

A randomized trial comparing methods of vaginal cuff closure at vaginal hysterectomy and the effect on vaginal length.

OBJECTIVE: The objective of the study was to compare the effect of horizontal versus vertical closure of the vaginal cuff during vaginal hysterectomy on vaginal length. STUDY DESIGN: Forty-three women were randomized to undergo horizontal (n = 23) or vertical (n = 20) vaginal cuff closure during vaginal hysterectomy at a community hospital. The primary outcome of vaginal length before and after surgery was compared by the Student t test and the paired t test. RESULTS: Preoperatively mean vaginal lengths in the horizontal and vertical groups were statistically similar (7.76 +/- 1.23 cm versus 8.28 +/- 1.39 cm, respectively; P = .21). Postoperatively the groups statistically differed (6.63 +/- 1.02 cm versus 7.93 +/- 1.18 cm, P < .001). The mean change in vaginal length was -1.13 +/- 1.15 cm and -0.35 +/- 0.91 cm, respectively (P = .01). Within-group comparisons revealed a statistical difference between pre- versus postmean vaginal length in the horizontal group (7.76 +/- 1.23 cm versus 6.63 +/- 1.02 cm; P < .001) and no difference within the vertical group (8.28 +/- 1.39 cm versus 7.93 +/- 1.18 cm; P = .11). CONCLUSION: Closing the vaginal cuff vertically is superior to horizontal closure for the purpose of preserving vaginal length.

Respiratory epithelial adenomatoid hamartoma: a case report.

Respiratory epithelial adenomatoid (READ) hamartoma is a recently described entity characterized by abnormal glandular formations arising from the epithelium of the nasal cavity. The etiology of the lesion is unclear and may be secondary to either sinonasal inflammation or developmental error. We present a case of a 54-year-old man with a unilateral nasal mass found to be consistent with READ hamartoma upon pathologic review. Although READ hamartomas are thought to be rare, awareness of the lesion is important since it may be confused with sinonasal adenocarcinoma, leading to overly aggressive treatment. Therefore, READ hamartoma should be included in the differential diagnosis of a unilateral nasal mass.

Research subject privacy protection in otolaryngology.

BACKGROUND: Health Insurance Portability and Accountability Act regulations, which took effect on April 14, 2003, placed new constraints on the use of protected health information for research purposes. OBJECTIVE: To review practices of research subject privacy protection in otolaryngology in order to determine steps necessary to achieve compliance with Health Insurance Portability and Accountability Act regulations. STUDY DESIGN: Literature review. METHODS: Articles appearing in 2001 in 3 widely circulated otolaryngology journals were classified according to study design. The "Methods" section of each article was reviewed to determine whether the informed consent and institutional review board processes were clearly documented. RESULTS: Descriptive studies involving case reports and case series were more common than observational studies that include a control group (66% vs 11%). Few case series documented the consent process (18%) and institutional review board process (19%). Observational designs demonstrated better documentation of the consent process (P<.001) and the institutional review board exemption and approval process (P<.001). CONCLUSIONS: Methods used to protect subject privacy are not commonly documented in case series in otolaryngology. More attention needs to be given to research subject privacy concerns in the otolaryngology literature in order to comply with Health Insurance Portability and Accountability Act regulations.

Anaphylaxis.

Anaphylaxis is an amplified, harmful immunologic reaction that occurs after re-exposure to an antigen to which an organism has become sensitive. True anaphylaxis is a systemic reaction caused by antigen-specific cross-linking of IgE molecules or complement proteins on the surface of tissue mast cells and peripheral blood basophils, resulting in the immediate release of potent mediators. Immediate systemic reactions that resemble anaphylaxis but are not caused by an IgE-mediated immune response are referred to as anaphylactoid reactions. It is important for physicians, especially those who treat allergies, to understand the pathophysiology, know the treatment for, and recognize the clinical signs of anaphylaxis.

Povidone-iodine spray technique versus traditional scrub-paint technique for preoperative abdominal wall preparation.

OBJECTIVE: The study was conducted to compare povidone-iodine spray and traditional scrub-paint techniques in reducing abdominal wall bacteria during preoperative preparation. STUDY DESIGN: Sixty patients scheduled to undergo vaginal surgery were recruited for study. Cultures of the abdominal skin were performed before and after preparation with two techniques: A traditional 5-minute iodophor soap scrub-paint on one half and povidone-iodine aqueous spray on the other. Multiple pairwise comparisons were performed with the Wilcoxon signed rank test. A P value of.05 was considered statistically significant in all analyses. RESULTS: The mean number of colonies for spray after 1 minute was 1.83 +/- 3.16, for spray after 3 minutes was 0.40 +/- 1.15, and after 5-minute scrub was 0.87 +/- 2.97. Both techniques, the spray after 3 minutes and the 5-minute scrub, were statistically more effective at reducing bacterial counts than the spray after 1 minute. There was no statistically significant difference between the spray after 3 minutes and the scrub techniques. CONCLUSION: Povidone-iodine applied as a spray and left to dry for 3 minutes appears as effective as the traditional scrub-paint technique in reducing abdominal wall bacteria before abdominal surgery.

Pericranial flap for closure of paramedian anterior skull base defects.

OBJECTIVE: We sought to examine the position of a pericranial flap reconstruction of anterior skull base defects with respect to the original floor of the anterior cranial fossa. STUDY DESIGN: A retrospective chart and radiology review of 17 patients (1993-2001) with pericranial flap reconstruction for anterior skull base defects and 17 controls was performed. RESULTS: At 6 or more months after surgery, the new positions of the pericranial flaps ranged from 5 mm above to 11.3 mm below the positions of the original cribriform plates. There were no complications related to the pericranial flaps such as hemorrhage, flap loss, or brain herniation except for 2 (11.8%) cerebrospinal fluid leaks, 1 of which required operative correction. CONCLUSION: Pericranial flap reconstruction is a reliable method with low morbidity for closure of the most common skull base defect from the craniofacial resection that entails removal-unilateral or bilateral-of the fovea ethmoidalis, cribriform plate, and/or superior septum. This flap creates a watertight seal between the extradural space and the nasal cavity, prevents clinically significant brain herniation, and is associated with a low rate of cerebrospinal fluid leakage even without postoperative lumbar subarachnoid drainage of the cerebrospinal fluid.