RESUMEN
Polyploidy results from whole-genome duplication and is a unique form of heritable variation with pronounced evolutionary implications. Different ploidy levels, or cytotypes, can exist within a single species, and such systems provide an opportunity to assess how ploidy variation alters phenotypic novelty, adaptability, and fitness, which can, in turn, drive the development of unique ecological niches that promote the coexistence of multiple cytotypes. Switchgrass, Panicum virgatum, is a widespread, perennial C4 grass in North America with multiple naturally occurring cytotypes, primarily tetraploids (4×) and octoploids (8×). Using a combination of genomic, quantitative genetic, landscape, and niche modeling approaches, we detect divergent levels of genetic admixture, evidence of niche differentiation, and differential environmental sensitivity between switchgrass cytotypes. Taken together, these findings support a generalist (8×)specialist (4×) trade-off. Our results indicate that the 8× represent a unique combination of genetic variation that has allowed the expansion of switchgrass' ecological niche and thus putatively represents a valuable breeding resource.
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Aclimatación , Panicum , Poliploidía , Aclimatación/genética , Variación Genética , Panicum/genética , Panicum/fisiología , TetraploidíaRESUMEN
For nearly 50 years, the vision of using single molecules in circuits has been seen as providing the ultimate miniaturization of electronic chips. An advanced example of such a molecular electronics chip is presented here, with the important distinction that the molecular circuit elements play the role of general-purpose single-molecule sensors. The device consists of a semiconductor chip with a scalable array architecture. Each array element contains a synthetic molecular wire assembled to span nanoelectrodes in a current monitoring circuit. A central conjugation site is used to attach a single probe molecule that defines the target of the sensor. The chip digitizes the resulting picoamp-scale current-versus-time readout from each sensor element of the array at a rate of 1,000 frames per second. This provides detailed electrical signatures of the single-molecule interactions between the probe and targets present in a solution-phase test sample. This platform is used to measure the interaction kinetics of single molecules, without the use of labels, in a massively parallel fashion. To demonstrate broad applicability, examples are shown for probe molecule binding, including DNA oligos, aptamers, antibodies, and antigens, and the activity of enzymes relevant to diagnostics and sequencing, including a CRISPR/Cas enzyme binding a target DNA, and a DNA polymerase enzyme incorporating nucleotides as it copies a DNA template. All of these applications are accomplished with high sensitivity and resolution, on a manufacturable, scalable, all-electronic semiconductor chip device, thereby bringing the power of modern chips to these diverse areas of biosensing.
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Técnicas Biosensibles/instrumentación , Electrónica/instrumentación , Pruebas de Enzimas/instrumentación , Análisis de Secuencia por Matrices de Oligonucleótidos/instrumentación , ADN , Diseño de Equipo/instrumentación , Cinética , Dispositivos Laboratorio en un Chip , Miniaturización/instrumentación , Nanotecnología/instrumentación , SemiconductoresRESUMEN
BACKGROUND: The reduction in cardiovascular disease (CVD) events with edetate disodium (EDTA) in the Trial to Assess Chelation Therapy (TACT) suggested that chelation of toxic metals might provide novel opportunities to reduce CVD in patients with diabetes. Lead and cadmium are vasculotoxic metals chelated by EDTA. We present baseline characteristics for participants in TACT2, a randomized, double-masked, placebo-controlled trial designed as a replication of the TACT trial limited to patients with diabetes. METHODS: TACT2 enrolled 1,000 participants with diabetes and prior myocardial infarction, age 50 years or older between September 2016 and December 2020. Among 959 participants with at least one infusion, 933 had blood and/or urine metals measured at the Centers for Diseases Control and Prevention using the same methodology as in the National Health and Nutrition Examination Survey (NHANES). We compared metal levels in TACT2 to a contemporaneous subset of NHANES participants with CVD, diabetes and other inclusion criteria similar to TACT2's participants. RESULTS: At baseline, the median (interquartile range, IQR) age was 67 (60, 72) years, 27% were women, 78% reported white race, mean (SD) BMI was 32.7 (6.6) kg/m2, 4% reported type 1 diabetes, 46.8% were treated with insulin, 22.3% with GLP1-receptor agonists or SGLT-2 inhibitors, 90.2% with aspirin, warfarin or P2Y12 inhibitors, and 86.5% with statins. Blood lead was detectable in all participants; median (IQR) was 9.19 (6.30, 13.9) µg/L. Blood and urine cadmium were detectable in 97% and median (IQR) levels were 0.28 (0.18, 0.43) µg/L and 0.30 (0.18, 0.51) µg/g creatinine, respectively. Metal levels were largely similar to those in the contemporaneous NHANES subset. CONCLUSIONS: TACT2 participants were characterized by high use of medication to treat CVD and diabetes and similar baseline metal levels as in the general US population. TACT2 will determine whether chelation therapy reduces the occurrence of subsequent CVD events in this high-risk population. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov. Identifier: NCT02733185. https://clinicaltrials.gov/study/NCT02733185.
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Terapia por Quelación , Humanos , Femenino , Masculino , Persona de Mediana Edad , Anciano , Terapia por Quelación/métodos , Método Doble Ciego , Ácido Edético/uso terapéutico , Plomo/sangre , Plomo/orina , Cadmio/orina , Cadmio/sangre , Quelantes/uso terapéutico , Enfermedades Cardiovasculares/prevención & control , Enfermedades Cardiovasculares/sangreRESUMEN
BACKGROUND: The ability to ambulate is an important indicator for wellness and quality of life. A major health event, such as a surgery, can derail this ability, and return to preoperative walking ability is a marker for recovery. Self-reported walking measurements by patients are subject to bias, thus wearable technology such as activity monitors have risen in popularity. We evaluated postoperative ambulation using an accelerometer in outpatient general surgery procedures with the hypothesis that those patients with less postoperative ambulation were at risk for adverse outcomes. METHODS: A retrospective review of patients undergoing outpatient abdominal surgeries from November 2016 to July 2019 at a Veteran Affairs Medical Center. Patients wore an accelerometer preoperatively and postoperatively to measure their ambulation (steps/day). Outcome measures were 30-day readmissions and Emergency Department (ED) utilization. Postoperative ambulation was defined as daily percentages of their preoperative baseline. Patients without preoperative baseline data, > 3 missing days or any missing days prior to reaching baseline were excluded. RESULTS: One-hundred-six patients underwent outpatient abdominal surgery. Twenty-two patients were excluded. Patients stratified into adult (18-64 years, 44 patients, 52%) and geriatric (≥ 65 years, 40 patients, 48%) cohorts. Geriatric patients were less likely to meet their preoperative baseline by postoperative day 7, 35% vs 61%, p = 0.016. Adult patients who failed to meet their preoperative baseline in first postoperative week had higher ED utilization; 4 (24%) vs 1 (4%), p = 0.04. Geriatric patients who failed to meet their baseline trended toward increased ED utilization; 5 (19%) vs. 1 (7%), p = 0.31. CONCLUSION: Patients aged < 65 who fail to return to their preoperative daily step count within one week of outpatient abdominal surgery are 6× more likely to be seen in the ED. Postoperative ambulation may be able to predict ED utilization and recovery after outpatient surgery.
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Procedimientos Quirúrgicos Ambulatorios , Calidad de Vida , Adulto , Humanos , Anciano , Caminata , Estudios Retrospectivos , Servicio de Urgencia en Hospital , Complicaciones Posoperatorias/etiologíaRESUMEN
INTRODUCTION: Over half of Americans and up to 78% of US Veteran population meet criteria for obesity. Perioperatively placed intragastric balloon (IGB) can accelerate weight loss goals for safe surgical candidacy, however weight regain is common after removal. Glucagon-like peptide-1-receptor agonists (GLP1RA) may provide a more sustainable weight loss solution after surgery. We hypothesize that weight regain will be less at 1 year after initiation of GLP1RA than IGB placement in Veterans. METHODS: Retrospective review of prospective databases of perioperatively placed intragastric balloon cohort from 1/2019-1/2023 compared to patients who received initiatory GLP1RA from 6/2021-8/2022 at a VA Medical Center(VAMC). All patients were enrolled in the VAMC MOVE! multidisciplinary weight management program for a minimum of 12 weeks. Outcomes measured were patients' weights at 0, 3, 6, and 12 months and weight change for these intervals. Exclusion criteria included history of bariatric surgery and incomplete weight loss data. RESULTS: Two-hundred-twenty-three patients met inclusion criteria; 110 (49%) patients excluded. Mean age was 54 ± 11 years, the majority (78, 69%) were male, and the mean initial BMI was 37 ± 5.9 kg/m2. Seventeen (15%) patients underwent IGB placement and 96 (85%) patients received semaglutide. Weight (kg) change was measured at intervals: 0-3 months:- 11.8(- 17,- 9.5) IGB vs. - 5.1(- 7.4,- 2.3) semaglutide, p < 0.0001; 0-6 months:- 12.7(- 18.4,- 9.9) vs. - 9.4(- 12.6,- 6.1), p = 0.03; 3-6 months:- 0.5(- 2.3,2.3) vs. - 4.3(- 6.8,- 1.6), p < 0.0001; 6-12 months:3(0,7.3) vs. - 1.9(- 4.7,1), p = 0.0006. CONCLUSION: Weight loss occurs more rapidly in the first 6 months after intragastric balloon placement compared to semaglutide (- 12.7 vs. - 9.4 kg, p = 0.03). Despite ongoing attendance in a comprehensive weight loss program, weight regain is common after IGB removal by an average of 3 kg (23.6%) at 1 year. In contrast, patients on GLP1RA (semaglutide) continue to lose weight during this period. Further studies are needed to determine if optimal long-term outcomes may result from combination therapy with intragastric balloon and semaglutide.
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Balón Gástrico , Péptidos Similares al Glucagón , Pérdida de Peso , Humanos , Péptidos Similares al Glucagón/uso terapéutico , Péptidos Similares al Glucagón/administración & dosificación , Femenino , Persona de Mediana Edad , Masculino , Estudios Retrospectivos , Pérdida de Peso/efectos de los fármacos , Obesidad , Aumento de Peso/efectos de los fármacos , Adulto , Receptor del Péptido 1 Similar al Glucagón/agonistasRESUMEN
Importance: In 2013, the Trial to Assess Chelation Therapy (TACT) reported that edetate disodium (EDTA)-based chelation significantly reduced cardiovascular disease (CVD) events by 18% in 1708 patients with a prior myocardial infarction (MI). Objective: To replicate the finding of TACT in individuals with diabetes and previous MI. Design, Setting, and Participants: A 2 × 2 factorial, double-masked, placebo-controlled, multicenter trial at 88 sites in the US and Canada, involving participants who were 50 years or older, had diabetes, and had experienced an MI at least 6 weeks before recruitment compared the effect of EDTA-based chelation vs placebo infusions on CVD events and compared the effect of high doses of oral multivitamins and minerals with oral placebo. This article reports on the chelation vs placebo infusion comparisons. Interventions: Eligible participants were randomly assigned to 40 weekly infusions of an EDTA-based chelation solution or matching placebo and to twice daily oral, high-dose multivitamin and mineral supplements or matching placebo for 60 months. This article addresses the chelation study. Main Outcomes and Measures: The primary end point was the composite of all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for unstable angina. Median follow-up was 48 months. Primary comparisons were made from patients who received at least 1 assigned infusion. Results: Of the 959 participants (median age, 67 years [IQR, 60-72 years]; 27% females; 78% White, 10% Black, and 20% Hispanic), 483 received at least 1 chelation infusion and 476 at least 1 placebo infusion. A primary end point event occurred in 172 participants (35.6%) in the chelation group and in 170 (35.7%) in the placebo group (adjusted hazard ratio [HR], 0.93; 95% CI, 0.76-1.16; P = .53). The 5-year primary event cumulative incidence rates were 45.8% for the chelation group and 46.5% for the placebo group. CV death, MI, or stroke events occurred in 89 participants (18.4%) in the chelation group and in 94 (19.7%) in the placebo group (adjusted HR, 0.89; 95% CI, 0.66-1.19). Death from any cause occurred in 84 participants (17.4%) in the chelation group and in 84 (17.6%) in the placebo group (adjusted HR, 0.96; 95% CI, 0.71-1.30). Chelation reduced median blood lead levels from 9.03 µg/L at baseline to 3.46 µg/L at infusion 40 (P < .001). Corresponding levels in the placebo group were 9.3 µg/L and 8.7 µg/L, respectively. Conclusions and Relevance: Despite effectively reducing blood lead levels, EDTA chelation was not effective in reducing cardiovascular events in stable patients with coronary artery disease who have diabetes and a history of MI. Trial Registration: ClinicalTrials.gov Identifier: NCT02733185.
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Angina Inestable , Quelantes , Terapia por Quelación , Ácido Edético , Infarto del Miocardio , Accidente Cerebrovascular , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Angina Inestable/epidemiología , Angina Inestable/prevención & control , Terapia por Quelación/métodos , Diabetes Mellitus/tratamiento farmacológico , Método Doble Ciego , Ácido Edético/administración & dosificación , Hospitalización/estadística & datos numéricos , Infarto del Miocardio/epidemiología , Infarto del Miocardio/prevención & control , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/prevención & control , Infusiones Intravenosas , Quelantes/administración & dosificación , Plomo , Cadmio , Prevención Secundaria/métodosRESUMEN
INTRODUCTION: Telehealth has been increasingly utilized with a renewed interest by surgical specialties given the COIVD-19 pandemic. Limited data exists evaluating the safety of routine postoperative telehealth follow-up in patients undergoing inguinal hernia repair, especially those who present urgent/emergently. Our study sought to evaluate the safety and efficacy of postoperative telehealth follow-up in veterans undergoing inguinal hernia repair. METHODS: Retrospective review of all Veterans who underwent inguinal hernia repair at a tertiary Veterans Affairs Medical Center over a 2-year period (9/2019-9/2021). Outcome measures included postoperative complications, emergency department (ED) utilization, 30-day readmission, and missed adverse events (ED utilization or readmission occurring after routine postoperative follow-up). Patients undergoing additional procedure(s) requiring intraoperative drains and/or nonabsorbable sutures were excluded. RESULTS: Of 338 patients who underwent qualifying procedures, 156 (50.6%) were followed-up by telehealth and 152 (49.4%) followed-up in-person. There were no differences in age, sex, BMI, race, urgency, laterality nor admission status. Patients with higher American Society of Anesthesiologists (ASA) classification [ASA class III 92 (60.5%) versus class II 48 (31.6%), P = 0.019] and open repair [93 (61.2%) versus 67 (42.9%), P = 0.003] were more likely to follow-up in-person. There was no difference in complications, [telehealth 13 (8.3%) versus 20 (13.2%), P = 0.17], ED visits, [telehealth 15 (10%) versus 18 (12%), P = 0.53], 30-day readmission [telehealth 3 (2%) versus 0 (0%), P = 0.09], nor missed adverse events [telehealth 6 (33.3%) versus 5 (27.8%), P = 0.72]. CONCLUSIONS: There were no differences in postoperative complications, ED utilization, 30-day readmission, or missed adverse events for those who followed-up in person versus telehealth after elective or urgent/emergent inguinal hernia repair. Veterans with a higher ASA class and who underwent open repair were more likely to be seen in person. Telehealth follow-up after inguinal hernia repair is safe and effective.
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Hernia Inguinal , Laparoscopía , Telemedicina , Veteranos , Humanos , Estudios de Seguimiento , Hernia Inguinal/cirugía , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/cirugía , Estudios Retrospectivos , Herniorrafia/efectos adversos , Herniorrafia/métodos , Laparoscopía/métodosRESUMEN
BACKGROUND: Stray energy transfer from monopolar instruments during laparoscopic surgery is a recognized cause of potentially catastrophic complications. There are limited data on stray energy injuries in robotic surgery. We sought to characterize stray energy injury in the form of superficial burns to the skin surrounding laparoscopic and robotic trocar sites. Our hypothesis was that stray energy burns will occur at all laparoscopic and robotic port sites. METHODS: We conducted a prospective, randomized controlled trial of patients undergoing elective unilateral inguinal hernia repair at a VAMC over a 4-year period. Surgery was performed via transabdominal preperitoneal approach either laparoscopic-assisted (TAPP) or robotic-assisted (rTAPP). A monopolar scissor was used to deliver energy at 30W coagulation for all cases. At completion of the procedure, skin biopsies were taken from all the port sites. A picro-Sirius red stain was utilized to identify thermal injury by a blinded pathologist. RESULTS: Over half (54%, 59/108) of all samples demonstrated thermal injury to the skin. In the laparoscopic group, 49% (25/51) samples showed thermal injury vs. 60% (34/57) in the robotic group (p = 0.548). The camera port was the most frequently involved with 68% (13/19) rTAPP samples showing injury vs. 47% (8/17) in the TAPP group (p = 0.503). There was no difference in the rate of injury at the working port site (rTAPP 53%, 10/19 vs. TAPP 47%, 8/17; p = 0.991) or the assistant port site (rTAPP 58%, 11/19 vs. TAPP 53%, 9/17; p = 0.873). CONCLUSIONS: Stray energy causes thermal injury to the skin at port sites in the majority robotic laparoscopic TAPP inguinal hernia repairs. There is no difference in stray energy transfer between the laparoscopic and robotic platform. This is the first study to confirm in-vivo transfer of stray energy during robotic surgical procedures. More study is needed to determine the clinical significance of these thermal injuries.
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Quemaduras , Hernia Inguinal , Laparoscopía , Procedimientos Quirúrgicos Robotizados , Humanos , Hernia Inguinal/cirugía , Laparoscopía/efectos adversos , Laparoscopía/métodos , Estudios Prospectivos , Procedimientos Quirúrgicos Robotizados/efectos adversos , Procedimientos Quirúrgicos Robotizados/métodos , Mallas QuirúrgicasRESUMEN
INTRODUCTION: Stray energy from surgical energy instruments can cause unintended thermal injuries. There are no published data regarding electrosurgical generators and their influence on stray energy transfer during robotic surgery. There are two approved generators for the DaVinci Xi robotic platform: a constant-voltage regulating generator (cVRG) and a constant-power regulating generator (cPRG). The purpose of this study was to quantify and compare stray energy transfer in the robotic Xi platform using a cVRG versus a cPRG. METHODS: An ex vivo bovine model was used to simulate a standard multiport robotic surgery. The DaVinci Xi (Intuitive Surgical, Sunnyvale, CA) robotic platform was attached to a trainer box using robotic ports. A 5 s, open-air activation of the monopolar scissors was done with commonly used electrosurgical settings using a cPRG (ForceTriad, Covidien-Medtronic, Boulder, CO) or cVRG (ERBE VIO 300 dV 2.0, ERBE USA, Marietta, GA). Stray energy transfer was quantified as the change in tissue temperature (°C) nearest the tip of the assistance grasper (which was not in direct contact with the active monopolar scissors). RESULTS: Stray energy transfer occurred with both generators. Utilizing common, comparable settings for standard coagulation, significantly less stray energy was transferred with the cVRG versus cPRG (4.4 ± 1.6 °C vs. 41.1 ± 13.0 °C, p < 0.001). Similarly, less stray energy was transferred using cut modes with the cVRG compared to the cPRG (5.61 ± 1.79 °C vs. 33.9 ± 18.4 °C, p < 0.001). CONCLUSION: Stray energy transfer increases tissue temperatures more than 45C in the DaVinci Xi robotic platform. Low voltage modalities, such as cut or blend; as well as a cVRG generator, significantly reduces stray energy. Robotic surgeons can minimize the risk of stray energy injuries by using these low risk modes and/or generator.
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Quemaduras , Procedimientos Quirúrgicos Robotizados , Robótica , Humanos , Animales , Bovinos , ElectrocirugiaRESUMEN
BACKGROUND: Obesity is an epidemic, with its accompanying medical conditions putting patients at increased risk of postoperative complications. For patients undergoing elective surgery, preoperative weight loss provides an opportunity to decrease complications. We sought to evaluate the safety and efficacy of an intragastric balloon in achieving a body mass index (BMI) < 35 kg/m2 prior to elective joint replacement or hernia repair. METHODS: Retrospective review of all patients who had intragastric balloon placement at a level 1A VA medical center from 1/2019 to 1/2023. Patients who had a scheduled qualifying procedure (knee/hip replacement or hernia repair) and had a BMI > 35 kg/m2 were offered intragastric balloon placement to achieve 30-50lbs (13-28 kg) weight loss prior to surgery. Participation in a standardized weight loss program for 12 months was required. Balloons were removed 6 months after placement, preferentially concomitant with the qualifying procedure. Baseline demographics, duration of balloon therapy, weight loss and progression to qualifying procedure were recorded. RESULTS: Twenty patients completed intragastric balloon therapy and had balloon removal. Mean age 54 (34-71 years), majority (95%) male. Mean balloon duration was 200 ± 37 days. Mean weight loss was 30.8 ± 17.7lbs (14.0 ± 8.0 kg) with an average BMI reduction of 4.4 ± 2.9. Seventeen (85%) patients were successful, 15 (75%) underwent elective surgery and 2 (10%) were no longer symptomatic after weight loss. Three patients (15%) did not lose sufficient weight to qualify or were too ill to undergo surgery. Nausea was the most frequent side effect. One (5%) patient was readmitted within 30 days for pneumonia. DISCUSSION: Intragastric balloon placement resulted in an average 30lbs (14 kg) weight loss over 6 months allowing more than 75% of patients to undergo joint replacement or hernia repair at an optimal weight. Intragastric balloons should be considered in patients requiring 30-50lbs (13-28 kg) weight loss prior to elective surgery. More study is needed to determine the long-term benefit of preoperative weight loss prior to elective surgery.
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Balón Gástrico , Obesidad Mórbida , Humanos , Masculino , Persona de Mediana Edad , Femenino , Obesidad Mórbida/cirugía , Obesidad Mórbida/epidemiología , Balón Gástrico/efectos adversos , Obesidad/complicaciones , Obesidad/cirugía , Pérdida de Peso , Índice de Masa Corporal , Hernia , Resultado del TratamientoRESUMEN
BACKGROUND: The COVID-19 pandemic has brought many challenges including barriers to delivering high-quality surgical care and follow-up while minimizing the risk of infection. Telehealth has been increasingly utilized for post-operative visits, yet little data exists to guide surgeons in its use. We sought to determine safety and efficacy of telehealth follow-up in patients undergoing cholecystectomy during the global pandemic at a VA Medical Center (VAMC). METHODS: This was a retrospective review of patients undergoing cholecystectomy at a level 1A VAMC over a 2-year period from August 2019 to August 2021. Baseline demographics, post-operative complications, readmissions, emergency department (ED) visits and need for additional procedures were reviewed. Patients who experienced a complication prior to discharge, underwent a concomitant procedure, had non-absorbable skin closure, had new diagnosis of malignancy or were discharged home with drain(s) were ineligible for telehealth follow-up and excluded. RESULTS: Over the study period, 179 patients underwent cholecystectomy; 30 (17%) were excluded as above. 20 (13%) missed their follow-up, 52 (35%) were seen via telehealth and 77 (52%) followed-up in person. There was no difference between the two groups regarding baseline demographics or intra-operative variables. There was no significant difference in post-operative complications [4 (8%) vs 6 (8%), p > 0.99], ED utilization [5 (10%) vs 7 (9%), p = 0.78], 30-day readmission [3 (6%) vs 6 (8%), p = 0.74] or need for additional procedures [2 (4%) vs 4 (5%), p = 0.41] between telehealth and in-person follow-up. CONCLUSION: Telehealth follow-up after cholecystectomy is safe and effective in Veterans. There were no differences in outcomes between patients that followed up in-person vs those that were seen via phone or video. Routine telehealth follow-up after uncomplicated cholecystectomy should be considered for all patients.
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COVID-19 , Telemedicina , Veteranos , Humanos , COVID-19/epidemiología , Estudios de Seguimiento , Pandemias , Colecistectomía , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/prevención & controlRESUMEN
BACKGROUND: Intravenous edetate disodium-based infusions reduced cardiovascular events in a prior clinical trial. The Trial to Assess Chelation Therapy 2 (TACT2) will replicate the initial study design. METHODS: TACT2 is an NIH-sponsored, randomized, 2x2 factorial, double masked, placebo-controlled, multicenter clinical trial testing 40 weekly infusions of a multi-component edetate disodium (disodium ethylenediamine tetra-acetic acid, or Na2EDTA)-based chelation solution and twice daily oral, high-dose multivitamin and mineral supplements in patients with diabetes and a prior myocardial infarction (MI). TACT2 completed enrollment of 1000 subjects in December 2020, and infusions in December 2021. Subjects are followed for 2.5 to 5 years. The primary endpoint is time to first occurrence of all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for unstable angina. The trial has >;85% power to detect a 30% relative reduction in the primary endpoint. TACT2 also includes a Trace Metals and Biorepository Core Lab, to test whether benefits of treatment, if present, are due to chelation of lead and cadmium from patients. Design features of TACT2 were chosen to replicate selected features of the first TACT, which demonstrated a significant reduction in cardiovascular outcomes in the EDTA chelation arm compared with placebo among patients with a prior MI, with the largest effect in patients with diabetes. RESULTS: Results are expected in 2024. CONCLUSION: TACT2 may provide definitive evidence of the benefit of edetate disodiumbased chelation on cardiovascular outcomes, as well as the clinical importance of longitudinal changes in toxic metal levels of participants.
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Diabetes Mellitus , Infarto del Miocardio , Quelantes/uso terapéutico , Terapia por Quelación/métodos , Diabetes Mellitus/tratamiento farmacológico , Método Doble Ciego , Ácido Edético/uso terapéutico , Humanos , Infarto del Miocardio/tratamiento farmacológico , Infarto del Miocardio/epidemiología , VitaminasRESUMEN
BACKGROUND: Recovery of preoperative ambulation levels 1 month after surgery represents an important patient-centered outcome. The objective of this study is to identify clinical factors associated with the inability to regain baseline preoperative ambulation levels 28 days postoperatively. METHODS: This is a prospective cohort study enrolling patients scheduled for elective inpatient abdominal operations. Daily ambulation (steps/day) was measured with a wristband accelerometer. Preoperative steps were recorded for at least 3 full calendar days before surgery. Postoperatively, daily steps were recorded for at least 28 days. The primary outcome was delayed recovery of ambulation, defined as inability to achieve 50% of preoperative baseline steps at 28 days postoperatively. RESULTS: A total of 108 patients were included. Delayed recovery (< 50% of baseline preoperative steps/day) occurred in 32 (30%) patients. Clinical factors associated with delayed recovery after multivariable logistic regression included longer operative time (OR 1.37, 95% CI 1.05-1.79), open operative approach (OR 4.87, 95% CI 1.64-14.48) and percent recovery on POD3 (OR 0.73, 95% CI 0.56-0.96). In addition, patients with delayed ambulation recovery had increased rates of postoperative complications (16% vs 1%, p < 0.01) and readmission (28% vs 5%, p < 0.01). CONCLUSION: After elective inpatient abdominal operations, nearly one in three patients do not recover 50% of their baseline preoperative steps 28 days postoperatively. Factors that can be used to identify these patients include longer operations, open operations and low ambulation levels on postoperative day #3. These data can be used to target rehabilitation efforts aimed at patients at greatest risk for poor ambulatory recovery.
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Abdomen , Procedimientos Quirúrgicos Electivos , Abdomen/cirugía , Ambulación Precoz/efectos adversos , Procedimientos Quirúrgicos Electivos/efectos adversos , Humanos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/cirugía , Periodo Posoperatorio , Estudios Prospectivos , CaminataRESUMEN
INTRODUCTION: Enteral access is required for a variety of reasons from neuromuscular disorders to dysphagia. Gastrostomy tubes (GTs) can be placed endoscopically, surgically, or radiographically and complications include infection, bleeding, leakage and unintentional removal. Routine post-procedural follow-up is limited by inconsistent guidelines and management by different specialty teams. We established a dedicated GT clinic to provide continuity of care and prophylactic GT exchange. We hypothesized that patients followed in the GT clinic would have reduced Emergency Department (ED) utilization. METHODS: A retrospective review of patients who underwent GT placement from January 2010 to January 2020 was conducted. Baseline demographics, indications for GT placement, number and reason for ED visits and utilization of a multidisciplinary GT clinic were studied. RESULTS: A total of 97 patients were included. The most common indication for placement was dysphagia (88, 91%) and the most common primary diagnosis was head and neck malignancy (51, 51%). The GT clinic is a multidisciplinary clinic staffed by surgeons and residents, dieticians, and wound care specialists and cared for 16 patients in this study. Three patients (19%) in the GT clinic group required ED visits compared to 44 (54%) in the standard of care (SOC) group (p < 0.05). There was an average of 0.9 ED visits per patient (range 0-7) in the GT clinic group vs 1.6 ED visits per patient (range 0-20) in the SOC group (p = 0.34). Feeding tubes were prophylactically exchanged an average of 7 times per patient in the GT clinic group vs 3 times per patient in the SOC group (p < 0.05). CONCLUSION: A multidisciplinary clinic dedicated to GT care limits ED visits for associated complications by more than 50%. Follow-up in a dedicated clinic with prophylactic tube exchange decreases ED visits and should be considered at facilities that care for patients with GTs.
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Trastornos de Deglución , Gastrostomía , Trastornos de Deglución/etiología , Trastornos de Deglución/terapia , Servicio de Urgencia en Hospital , Nutrición Enteral , Gastrostomía/efectos adversos , Humanos , Intubación Gastrointestinal , Estudios RetrospectivosRESUMEN
INTRODUCTION: More than 3 million patients have a cardiac implanted electronic device (CIED) such as a pacemaker or implanted cardioverter-defibrillator in the USA. These devices are susceptible to electromagnetic interference (EMI) leading to malfunction and injury. Radiofrequency energy, the most common modality for obtaining hemostasis during endoscopy, is the most common source of EMI. Few studies have evaluated the effect of endoscopic radiofrequency energy on CIEDs. We aim to characterize CIED dysfunction related to endoscopic procedures. We hypothesize that EMI from endoscopic energy can result in patient injury. METHODS: We queried the Manufacturer and User Facility Device Experience (MAUDE) database for CIED dysfunction related to electrosurgical devices over a 10-year period (2009-2019). CIED dysfunction events were identified using seven problem codes (malfunction, electromagnetic interference, ambient noise, pacing problem, over-sensing, inappropriate shock, defibrillation). These were cross-referenced for the terms "cautery, electrocautery, endoscopy, esophagus, colonoscopy, colon, esophagoscopy, and esophagogastroduodenoscopy." Reports were individually reviewed to confirm and characterize CIED malfunction due to an endoscopic procedure. RESULTS: A search for CIED dysfunction resulted in 43,759 reports. Three hundred and eleven reports (0.7%) were associated with electrocautery, and of these, 45 reports (14.5%) included endoscopy. Ten reports involving endoscopy (22%) specified upper (3, 7%) or lower (7, 16%) endoscopy while the remainder were non-specific. Twenty-six of reports involving endoscopy (58%) suffered injury because of CIED dysfunction: Of these, 17 (65%) received inappropriate shocks, 5 (19%) had pacing inhibition with bradycardia or asystole, 3 (12%) had CIED damage requiring explant and replacement, and 1 (4%) patient suffered ventricular tachycardia requiring hospital admission. CONCLUSION: The use of energy during endoscopy can cause dysfunction of CIEDs. This most commonly results in inappropriate defibrillation, symptomatic bradycardia, and asystole. Patients with CIEDs undergoing endoscopy should undergo pre- and post-procedure device interrogation and re-programming to avoid patient injury.
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Desfibriladores Implantables , Marcapaso Artificial , Preparaciones Farmacéuticas , Desfibriladores Implantables/efectos adversos , Fenómenos Electromagnéticos , Endoscopía , Humanos , Marcapaso Artificial/efectos adversosRESUMEN
INTRODUCTION: Stray energy transfer from monopolar radiofrequency energy during laparoscopy can be potentially catastrophic. Robotic surgery is increasing in popularity; however, the risk of stray energy transfer during robotic surgery is unknown. The purpose of this study was to (1) quantify stray energy transfer using robotic instrumentation, (2) determine strategies to minimize the transfer of energy, and (3) compare robotic stray energy transfer to laparoscopy. METHODS: In a laparoscopic trainer, a monopolar instrument (L-hook) was activated with DaVinci Si (Intuitive, Sunnyvale, CA) robotic instruments. A camera and assistant grasper were inserted to mimic a minimally invasive cholecystectomy. During activation of the L-hook, the non-electric tips of the camera and grasper were placed adjacent to simulated tissue (saline-soaked sponge). The primary outcome was change in temperature from baseline (°C) measured nearest the tip of the non-electric instrument. RESULTS: Simulated tissue nearest the robotic grasper increased an average of 18.3 ± 5.8 °C; p < 0.001 from baseline. Tissue nearest the robotic camera tip increased (9.0 ± 2.1 °C; p < 0.001). Decreasing the power from 30 to 15 W (18.3 ± 5.8 vs. 2.6 ± 2.7 °C, p < 0.001) or using low-voltage cut mode (18.3 ± 5.8 vs. 3.1 ± 2.1 °C, p < 0.001) reduced stray energy transfer to the robotic grasper. Desiccating tissue, in contrast to open air activation, also significantly reduced stray energy transfer for the grasper (18.3 ± 5.8 vs. 0.15 ± 0.21 °C, p < 0.001) and camera (9.0 ± 2.1 vs. 0.24 ± 0.34 °C, p < 0.001). CONCLUSIONS: Stray energy transfer occurs during robotic surgery. The assistant grasper carries the highest risk for thermal injury. Similar to laparoscopy, stray energy transfer can be reduced by lowering the power setting, utilizing a low-voltage cut mode instead of coagulation mode and avoiding open air activation. These practical findings can aid surgeons performing robotic surgery to reduce injuries from stray energy.
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Procedimientos Quirúrgicos Robotizados/efectos adversos , Procedimientos Quirúrgicos Robotizados/instrumentación , Aire , Quemaduras/etiología , Transferencia de Energía , Humanos , Laparoscopía/efectos adversos , Laparoscopía/instrumentación , TemperaturaRESUMEN
INTRODUCTION: Stray energy transfer from surgical monopolar radiofrequency energy instruments can cause unintended thermal injuries during laparoscopic surgery. Single-incision laparoscopic surgery transfers more stray energy than traditional laparoscopic surgery. There is paucity of published data concerning stray energy during single-incision robotic surgery. The purpose of this study was to quantify stray energy transfer during traditional, multiport robotic surgery (TRS) compared to single-incision robotic surgery (SIRS). METHODS: An in vivo porcine model was used to simulate a multiport or single-incision robotic cholecystectomy (DaVinci Si, Intuitive Surgical, Sunnyvale, CA). A 5 s, open air activation of the monopolar scissors was done on 30 W and 60 W coag mode (ForceTriad, Covidien-Medtronic, Boulder, CO) and Swift Coag effect 3, max power 180 W (VIO 300D, ERBE USA, Marietta, GA). Temperature of the tissue (°C) adjacent to the tip of the assistant grasper or the camera was measured with a thermal camera (E95, FLIR Systems, Wilsonville, OR) to quantify stray energy transfer. RESULTS: Stray energy transfer was greater in the SIRS setup compared to TRS setup at the assistant grasper (11.6 ± 3.3 °C vs. 8.4 ± 1.6 °C, p = 0.013). Reducing power from 60 to 30 W significantly reduced stray energy transfer in SIRS (15.3 ± 3.4 °C vs. 11.6 ± 3.3 °C, p = 0.023), but not significantly for TRS (9.4 ± 2.5 °C vs. 8.4 ± 1.6 °C, p = 0.278). The use of a constant voltage regulating generator also minimized stray energy transfer for both SIRS (0.7 ± 0.4 °C, p < 0.001) and TRS (0.7 ± 0.4 °C, p < 0.001). CONCLUSIONS: More stray energy transfer occurs during single-incision robotic surgery than multiport robotic surgery. Utilizing a constant voltage regulating generator minimized stray energy transfer for both setups. These data can be used to guide robotic surgeons in their use of safe, surgical energy.
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Laparoscopía , Procedimientos Quirúrgicos Robotizados , Robótica , Herida Quirúrgica , Animales , Transferencia de Energía , PorcinosRESUMEN
BACKGROUND: Family physicians have played a unique clinical role during the COVID-19 pandemic. We hypothesized that the pandemic would be associated with significant deleterious effects on clinical activity, educational training, personal safety and well-being. OBJECTIVE: We conducted a national survey to obtain preliminary data that would assist in future targeted data collection and subsequent evaluation of the impact of the pandemic on family medicine residents and teaching faculty. METHODS: An anonymous online survey of residents and faculty was distributed via the Association of Family Medicine Residency Directors list serve between 5/21/2020 and 6/18/2020. Survey questions focused on clinical and educational activities, safety and well-being. RESULTS: One hundred and fifty-three residents and 151 teaching faculty participated in the survey. Decreased clinical activity was noted by 81.5% of residents and 80.9% of faculty and the majority began conducting telehealth visits (97.9% of residents, 91.0% of faculty). Distance learning platforms were used by all residents (100%) and 39.6% noted an overall positive impact on their education. Higher levels of burnout did not significantly correlate with reassignment of clinical duties (residents P = 0.164; faculty P = 0.064). Residents who showed significantly higher burnout scores (P = 0.035) and a decline in levels of well-being (P = 0.031) were more likely to participate in institutional well-being support activities. CONCLUSIONS: Our preliminary data indicate that family medicine residents and teaching faculty were profoundly affected by the COVID-19 pandemic. Future studies can be directed by current findings with focus on mitigation factors in addressing globally disruptive events such as COVID-19.
Family physicians have played a unique clinical role during the COVID-19 pandemic. We hypothesized that the pandemic would be associated with significant deleterious effects on clinical activity, educational training, personal safety and well-being. Towards setting a foundation for further studies, we conducted a national survey to obtain preliminary data that would assist in future targeted data collection and subsequent evaluation of the impact of the pandemic on family medicine residents and teaching faculty. Our preliminary data indicate that family medicine residents and teaching faculty were profoundly affected by the COVID-19 pandemic in all domains studied. Future studies can be directed by current findings with focus on mitigation factors in addressing globally disruptive events such as COVID-19.
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COVID-19/epidemiología , Educación de Postgrado en Medicina/tendencias , Medicina Familiar y Comunitaria/educación , Adulto , Anciano , Estudios Transversales , Femenino , Humanos , Internado y Residencia , Masculino , Persona de Mediana Edad , Pandemias , SARS-CoV-2 , Encuestas y Cuestionarios , Estados Unidos/epidemiologíaRESUMEN
INTRODUCTION: Surgical fires are a rare event that still occur at a significant rate and can result in severe injury and death. Surgical fires are fueled by vapor from alcohol-based skin preparations in the presence of increased oxygen concentration and a spark from an energy device. Carbon dioxide (CO2) is used to extinguish electrical fires, and we sought to evaluate its effect on fire creation in the operating room. We hypothesize that CO2 delivered by the energy device will decrease the frequency of surgical fires fueled by alcohol-based skin preparations. METHODS: An ex vivo model with 15 × 15 cm section of clipped, porcine skin was used. A commercially available electrosurgical pencil with a smoke evacuation tip was connected to a laparoscopic CO2 insufflation system. The electrosurgical pencil was activated for 2 s at 30 watts coagulation mode immediately after application of alcohol-based surgical skin preparations: 70% isopropyl alcohol with 2% chlorhexidine gluconate (CHG-IPA) or 74% isopropyl alcohol with 0.7% iodine povacrylex (Iodine-IPA). CO2 was infused via the smoke evacuation pencil at flow rates from 0 to 8 L/min. The presence of a flame was determined visually and confirmed with a thermal camera (FLIR Systems, Boston, MA). RESULTS: Carbon dioxide eliminated fire formation at a flow rate of 1 L/min with CHG-IPA skin prep (0% vs. 60% with no CO2, p < 0.0001). Carbon dioxide reduced fire formation at 1 L/min (25% vs. 47% with no CO2, p = 0.1) with Iodine-IPA skin prep and fires were eliminated at 2 L/min of flow with Iodine-IPA skin prep (p < 0.0001). CONCLUSION: Carbon dioxide can eliminate surgical fires caused by energy devices in the presence of alcohol-based skin preps. Future studies should determine the optimal technique and flow rate of carbon dioxide in these settings.
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Dióxido de Carbono/administración & dosificación , Procedimientos Quirúrgicos Dermatologicos , Incendios , Quirófanos , 2-Propanol/administración & dosificación , Animales , Clorhexidina/administración & dosificación , Clorhexidina/análogos & derivados , Humanos , PorcinosRESUMEN
BACKGROUND: Health research is important for the achievement of the Sustainable Development Goals. However, there are many challenges facing health research, including securing sufficient funds, building capacity, producing research findings and using both local and global evidence, and avoiding waste. A WHO initiative addressed these challenges by developing a conceptual framework with four functions to guide the development of national health research systems. Despite some progress, more is needed before health research systems can meet their full potential of improving health systems. The WHO Regional Office for Europe commissioned an evidence synthesis of the systems-level literature. This Opinion piece considers its findings before reflecting on the vast additional literature available on the range of specific health research system functions related to the various challenges. Finally, it considers who should lead research system strengthening. MAIN TEXT: The evidence synthesis identifies two main approaches for strengthening national health research systems, namely implementing comprehensive and coherent strategies and participation in partnerships. The literature describing these approaches at the systems level also provides data on ways to strengthen each of the four functions of governance, securing financing, capacity-building, and production and use of research. Countries effectively implementing strategies include England, Ireland and Rwanda, whereas West Africa experienced effective partnerships. Recommended policy approaches for system strengthening are context specific. The vast literature on each function and the ever-growing evidence-base are illustrated by considering papers in just one key journal, Health Research Policy and Systems, and analysing the contribution of two national studies. A review of the functions of the Iranian system identifies over 200 relevant and mostly national records; an analysis of the creation of the English National Institute for Health Research describes the key leadership role played by the health department. Furthermore, WHO is playing leadership roles in helping coordinate partnerships within and across health research systems that have been attempting to tackle the COVID-19 crisis. CONCLUSIONS: The evidence synthesis provides a firm basis for decision-making by policy-makers and research leaders looking to strengthen national health research systems within their own national context. It identifies five crucial policy approaches - conducting situation analysis, sustaining a comprehensive strategy, engaging stakeholders, evaluating impacts on health systems, and partnership participation. The vast and ever-growing additional literature could provide further perspectives, including on crucial leadership roles for health ministries.