The Cox-Maze III remains the gold standard for the surgical treatment of atrial fibrillation. However, the “cut-and-sew” technique is time consuming and technically challenging. The pulmonary veins ...are the source of ectopy in the majority of patients with atrial fibrillation. The safety and efficacy of bipolar radiofrequency to electrically isolate the pulmonary veins was evaluated in a prospective multi-center trial.
Beginning in January 2002, 30 patients at three medical centers underwent pulmonary vein isolation using bipolar radiofrequency and were followed for 6 months. Twenty-four of the patients also underwent a modified Cox-Maze III. Electrical isolation of the pulmonary veins was confirmed with intraoperative pacing. Pulmonary vein patency was assessed by magnetic resonance imaging or three-dimensional computed tomography in 15 patients at 1 month.
Mean age was 60.9 ± 11.7 years. Nineteen patients had paroxysmal atrial fibrillation. All pulmonary veins were isolated in every patient. The left pulmonary veins underwent 3.0 ± 1.4 applications for a total of 26.4 ± 10.5 seconds. The right pulmonary veins underwent 2.8 ± 1.1 applications for a total of 26.3 ± 12.6 seconds. There was no operative mortality. At 1 month, imaging revealed no evidence of pulmonary vein stenosis. At 6 months, 96% of patients were in normal sinus rhythm.
The use of bipolar radiofrequency for electrical isolation of pulmonary veins and to replace other Cox-Maze III incisions is safe and effective at controlling atrial fibrillation. This emerging technology may shorten and simplify the surgical management of atrial fibrillation.
The Cox-Maze procedure is the gold standard for the surgical treatment of atrial fibrillation with proven long-term efficacy. However, its application has been limited by its complexity and ...significant morbidity. The purpose of this study was to test the feasibility and safety of performing the Cox-Maze procedure using bipolar radiofrequency ablation on the beating heart without cardiopulmonary bypass.
After median sternotomy, 6 Hanford mini-pigs underwent a modified Cox-Maze procedure using bipolar radiofrequency energy. The animals survived for 30 days. Atrial function, coronary artery, pulmonary vein anatomy, and valve function were assessed by magnetic resonance imaging. At reoperation, pacing documented electrical isolation of the pulmonary veins. Induction of atrial fibrillation was attempted by burst pacing with cholinergic stimulation. Histologic assessment was performed after sacrifice.
There were no perioperative mortalities or neurologic events. At 30 days, atrial fibrillation was unable to be induced, and pulmonary vein isolation was confirmed by pacing. Magnetic resonance imaging assessment revealed no coronary artery or pulmonary vein stenoses. Although atrial ejection fraction decreased slightly from 0.344 ± 0.0114 to 0.300 ± 0.055 (
p = 0.18), atrial contractility was preserved in every animal. Histologic assessment showed all lesions to be transmural, and there were no significant stenoses of the coronary vessels or injuries to the valves.
Virtually all of the lesions of the Cox-Maze procedure can be performed without cardiopulmonary bypass using bipolar radiofrequency energy. There were no late stenoses of the pulmonary veins. Clinical trials of this new technology on the beating heart are warranted.
The safety and effectiveness of automated glycemic management have not been tested in multiday studies under unrestricted outpatient conditions.
In two random-order, crossover studies with similar ...but distinct designs, we compared glycemic control with a wearable, bihormonal, automated, "bionic" pancreas (bionic-pancreas period) with glycemic control with an insulin pump (control period) for 5 days in 20 adults and 32 adolescents with type 1 diabetes mellitus. The automatically adaptive algorithm of the bionic pancreas received data from a continuous glucose monitor to control subcutaneous delivery of insulin and glucagon.
Among the adults, the mean plasma glucose level over the 5-day bionic-pancreas period was 138 mg per deciliter (7.7 mmol per liter), and the mean percentage of time with a low glucose level (<70 mg per deciliter 3.9 mmol per liter) was 4.8%. After 1 day of automatic adaptation by the bionic pancreas, the mean (±SD) glucose level on continuous monitoring was lower than the mean level during the control period (133±13 vs. 159±30 mg per deciliter 7.4±0.7 vs. 8.8±1.7 mmol per liter, P<0.001) and the percentage of time with a low glucose reading was lower (4.1% vs. 7.3%, P=0.01). Among the adolescents, the mean plasma glucose level was also lower during the bionic-pancreas period than during the control period (138±18 vs. 157±27 mg per deciliter 7.7±1.0 vs. 8.7±1.5 mmol per liter, P=0.004), but the percentage of time with a low plasma glucose reading was similar during the two periods (6.1% and 7.6%, respectively; P=0.23). The mean frequency of interventions for hypoglycemia among the adolescents was lower during the bionic-pancreas period than during the control period (one per 1.6 days vs. one per 0.8 days, P<0.001).
As compared with an insulin pump, a wearable, automated, bihormonal, bionic pancreas improved mean glycemic levels, with less frequent hypoglycemic episodes, among both adults and adolescents with type 1 diabetes mellitus. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; ClinicalTrials.gov numbers, NCT01762059 and NCT01833988.).
Summary
Despite complex interactions between obesity, dyslipidemia, hyperinsulinaemia, and the reproductive axis, the impact of metabolic syndrome on human male reproductive function has not been ...analysed comprehensively. Complete demographic, clinical, and laboratory data from 1337 consecutive primary infertile men were analysed. Health‐significant comorbidities were scored with the Charlson Comorbidity Index (categorised 0 vs. 1 vs. 2 or higher). NCEP‐ATPIII criteria were used to define metabolic syndrome. Semen analysis values were assessed based on the 2010 World Health Organisation (WHO) reference criteria. Descriptive statistics and logistic regression models tested the association between semen parameters and clinical characteristics and metabolic syndrome. Metabolic syndrome was found in 128 (9.6%) of 1337 men. Patients with metabolic syndrome were older (p < 0.001) and had a greater Charlson Comorbidity Index of 1 or higher (chi‐square: 15.6; p < 0.001) compared with those without metabolic syndrome. Metabolic syndrome patients had lower levels of total testosterone (p < 0.001), sex hormone‐binding globulin (p = 0.004), inhibin B (p = 0.03), and anti‐Müllerian hormone (p = 0.009), and they were hypogonadal at a higher rate (chi‐square: 32.0; p < 0.001) than patients without metabolic syndrome. Conversely, the two groups did not differ significantly in further hormonal levels, semen parameters, and rate of either obstructive or non‐obstructive azoospermia. At multivariate logistic regression analysis, testicular volume (OR: 0.90; p = 0.002) achieved independent predictor status for WHO pathological semen concentration; conversely, age, Charlson Comorbidity Index scores, metabolic syndrome, and inhibin B values did not. No parameters predicted normal sperm morphology and total progressive motility. Metabolic syndrome accounts for roughly 9% of men presenting for primary couple's infertility. Although metabolic syndrome patients have a lower general male health status, semen analysis values seem independent of the presence of metabolic syndrome.
The purpose of this study was to profile altered patterns of gene expression that characterize degenerative ascending thoracic aortic aneurysms and to compare these patterns with those observed for ...infrarenal abdominal aortic aneurysms.
Full-thickness aortic wall tissues were obtained during surgical repair of degenerative thoracic aortic aneurysms and infrarenal abdominal aortic aneurysms (n = 4 each), with normal thoracic and abdominal aortas from organ transplant donors used as control preparations. Radiolabeled complementary DNA was prepared for each specimen and hybridized to complementary DNA microarrays, and differential levels of gene expression between aneurysmal and normal aortic tissues at each site were assessed by parametric statistics.
Of 1185 genes examined, 112 (9.5%) were differentially expressed (
P < .05) between thoracic aortic aneurysms and normal thoracic aorta, with 105 increased and 7 decreased. There were 104 genes (8.8%) differentially expressed between infrarenal abdominal aortic aneurysms and normal abdominal aorta (65 increased and 39 decreased). Quantitative increases in expression for 97 genes were unique to thoracic aortic aneurysms, whereas increases for 61 genes were unique to infrarenal abdominal aortic aneurysms. Although 8 gene products were significantly altered in both thoracic and infrarenal abdominal aortic aneurysms, these changes were directionally concordant for only 4 (matrix metalloproteinase 9/gelatinase B, v-
yes-1 oncogene, mitogen-activated protein kinase 9, and intercellular adhesion molecule 1/CD54). Results for 9 genes were independently confirmed by quantitative reverse transcriptase–polymerase chain reaction.
Thoracic aortic aneurysms and infrarenal abdominal aortic aneurysms exhibit distinct patterns of gene expression relative to normal aorta from the same sites, with most alterations being unique to each disease. Degenerative aneurysms arising in different locations are thus characterized by a high degree of molecular heterogeneity, reflecting different pathophysiologic mechanisms.
Pregnancy and the postpartum period are times of significant body, and body image changes for women. Adult women (N = 885) aged 21 to 47 years old completed an online questionnaire. Mothers of young ...children (0–5 years) had significantly lower levels of body shame, self-objectification, and dietary restraint than women without children, and women with school-aged (6–10 years) children had significantly lower self objectification than women without children, once we controlled for age. BMI predicted body shame more than motherhood status. This research has implications for the development of appropriate body image interventions for adult women.
Abstract Introduction To evaluate the applicability of a modified Clavien classification system (CCS) in grading postoperative complications of transurethral resection of bladder tumours (TURB). ...Materials and methods A series of patients undergoing monopolar TURB from April 2011 to March 2012 at five Italian centers were enrolled. All complications occurring within the first 30-day postoperative period were prospectively recorded and graded according to the CCS. Results Overall, 275 patients were included. Median age was 71 (63/78) years; median BMI was 28 (25.4/30.8) Kg/m2 , median tumour size was 2 (1–3) cm; median number of tumour lesions was 1 (1–3). Median operative time was 30 (20/45) min. Fifty-seven complications were recorded in 43 patients. Overall postoperative morbidity rate was 16%. Most of the complications were not serious and classified as Clavien type I (42 cases; 74%) or II (8 cases, 14%). Higher grade complications were scarce: CCS IIIa in 1 case (2%) and CCS IIIb in six cases (10%). No TURB related death was reported. Six patients were re-operated due to significant bleeding or clot retention on postoperative days 2–7. On univariate (73.5 ± 38 versus 36.7 ± 21.6 min) and multivariate analysis longer operative time was an independent predictor of complications (OR: 1.06 per min, 95%CI 1.04–1.08, p = 0.001). Conclusions A modified CCS can be used as a standardized tool to objectively define the complications of TURB which confirms to be a safe procedure with a low surgical morbidity. This tool can be used to aid in patient counselling and to facilitate scientific assessment.
To determine the effectiveness of mitomycin-C (MMC), 0.02%, in preventing recurrence of corneal subepithelial fibrosis after debridement and/or keratectomy in patients who have undergone refractive ...corneal surgery.
Noncomparative case series.
Eight eyes of five patients with corneal subepithelial fibrosis who had previously undergone radial keratotomy (n = 4) or photorefractive keratectomy (n = 4).
All eyes underwent epithelial debridement followed by a single intraoperative application of MMC (0.02%) for 2 minutes followed by saline irrigation. The eyes were then patched, or a bandage contact lens placed until epithelial healing was complete.
Corneal clarity and best-corrected visual acuity (BCVA).
In all cases, the cornea remained clear with no recurrence throughout the follow-up period (6-25 mos., mean, 13.8 mos). No adverse reactions were reported. BCVA improved in all cases.
Subepithelial fibrosis can be a visually disabling condition after refractive corneal surgery. Topical application of MMC (0.02%) may be a successful method of preventing recurrence of subepithelial fibrosis after debridement.
Research on and commercial development of the artificial pancreas (AP) continue to progress rapidly, and the AP promises to become a part of clinical care. In this report, members of the JDRF ...Artificial Pancreas Project Consortium in collaboration with the wider AP community 1) advocate for the use of continuous glucose monitoring glucose metrics as outcome measures in AP trials, in addition to HbA1c, and 2) identify a short set of basic, easily interpreted outcome measures to be reported in AP studies whenever feasible. Consensus on a broader range of measures remains challenging; therefore, reporting of additional metrics is encouraged as appropriate for individual AP studies or study groups. Greater consistency in reporting of basic outcome measures may facilitate the interpretation of study results by investigators, regulatory bodies, health care providers, payers, and patients themselves, thereby accelerating the widespread adoption of AP technology to improve the lives of people with type 1 diabetes.
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