RESUMO
OBJECTIVE: Determine mid-term postoperative outcomes among coronavirus disease 2019 (COVID-19)-positive (+) patients compared with those who never tested positive before surgery. BACKGROUND: COVID-19 is thought to be associated with prohibitively high rates of postoperative complications. However, prior studies have only evaluated 30-day outcomes, and most did not adjust for demographic, clinical, or procedural characteristics. METHODS: We analyzed data from surgeries performed at all Veterans Affairs hospitals between March 2020 and 2021. Kaplan-Meier curves compared trends in mortality and Cox proportional hazards models estimated rates of mortality and pulmonary, thrombotic, and septic postoperative complications between patients with a positive preoperative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test [COVID (+)] and propensity score-matched COVID-negative (-) patients. RESULTS: Of 153,741 surgical patients, 4778 COVID (+) were matched to 14,101 COVID (-). COVID (+) status was associated with higher postoperative mortality ( P <0.0001) with a 6-month survival of 94.2% (95% confidence interval: 93.2-95.2) versus 96.0% (95% confidence interval: 95.7.0-96.4) in COVID (-). The highest mortality was in the first 30 postoperative days. Hazards for mortality and postoperative complications in COVID (+) decreased with increasing time between testing COVID (+) and date of surgery. COVID (+) patients undergoing elective surgery had similar rates of mortality, thrombotic and septic complications, but higher rates of pulmonary complications than COVID (-) patients. CONCLUSIONS: This is the first report of mid-term outcomes among COVID-19 patients undergoing surgery. COVID-19 is associated with decreased overall and complication-free survival primarily in the early postoperative period, delaying surgery by 5 weeks or more reduces risk of complications. Case urgency has a multiplicative effect on short-term and long-term risk of postoperative mortality and complications.
Assuntos
COVID-19 , Humanos , COVID-19/epidemiologia , Estudos Retrospectivos , SARS-CoV-2 , Complicações Pós-Operatórias/etiologia , Procedimentos Cirúrgicos Eletivos/efeitos adversosRESUMO
BACKGROUND AND PURPOSE: The CREST-2 (Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial) consists of 2 parallel randomized stroke prevention trials in patients with asymptomatic high-grade stenosis of the cervical carotid artery. The purpose of this report is to detail the outcomes of a health screening effort to increase trial enrollment of women and minorities. METHODS: Life Line screening (LLS) conducts nationwide screening for vascular disease. Screenings within a 50-mile radius of each CREST-2 center were identified for participation in a joint CREST-LLS program over the course of one year (November 2018 to October 2019) whereby patients with an abnormal carotid ultrasound were referred to the local CREST-2 center for further workup, management, and potential consideration for trial enrollment. RESULTS: LLS completed the screening of 588 198 individuals in 29 732 zip codes across the United States. Of those, 230 021 individuals were screened at events occurring near a CREST-2 clinical center and 646 (0.3%) were found to have abnormal carotid ultrasound findings. Each of the 646 individuals was contacted by CREST-LLS program staff for permission to be referred to their local CREST-2 center; 200 (31%) consented to be contacted by CREST-2. Of those, 39 (19.5%) agreed to be, and were, evaluated at their local CREST-2 center. High-grade stenosis was confirmed in 27 patients. A total of 3 patients were eligible for the trial and were enrolled, one woman but no racial/ethnic minorities. CONCLUSIONS: The LLS program appears to identify community-living individuals with high-grade carotid stenosis through ultrasonography. However, the prevalence of abnormal carotid findings was low. In addition, screening and offering participation into the CREST-2 trial had no substantial impact on the proportion of women and minorities enrolled in the trial. Additional innovative strategies are needed to promote enrollment of diverse patients with carotid stenosis into stroke prevention trials.
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Estenose das Carótidas/tratamento farmacológico , Estenose das Carótidas/cirurgia , Endarterectomia das Carótidas , Saúde das Minorias/tendências , Acidente Vascular Cerebral/prevenção & controle , Mulheres , Adulto , Idoso , Estenose das Carótidas/diagnóstico por imagem , Feminino , Humanos , Vida Independente , Masculino , Programas de Rastreamento , Pessoa de Meia-Idade , Prevalência , Resultado do Tratamento , Ultrassonografia , Estados UnidosRESUMO
BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic caused disruptions in treatment for cancer. Less is known about its impact on new cancer diagnoses, where delays could cause worsening long-term outcomes. This study quantifies decreases in encounters related to prostate, lung, bladder and colorectal cancers, procedures that facilitate their diagnosis, and new diagnoses of those cancers in the COVID era compared to pre-COVID era. METHODS: All encounters at Veterans' Affairs facilities nationwide from 2016 through 2020 were reviewed. The authors quantified trends in new diagnoses of cancer and in procedures facilitating their diagnosis, from January 1, 2018 onward. Using 2018 to 2019 as baseline, reductions in procedures and new cancer diagnoses in 2020 were estimated. Calculated absolute and percentage differences in annual volume and observed-to-expected volume ratios were calculated. Heat maps and funnel plots of volume changes were generated. RESULTS: From 2018 through 2020, there were 4.1 million cancer-related encounters, 3.9 million relevant procedures, and 251,647 new cancers diagnosed. Compared to the annual averages in 2018 through 2019, colonoscopies in 2020 decreased by 45% whereas prostate biopsies, chest computed tomography scans, and cystoscopies decreased by 29%, 10%, and 21%, respectively. New cancer diagnoses decreased by 13% to 23%. These drops varied by state and continued to accumulate despite reductions in pandemic-related restrictions. CONCLUSION: The authors identified substantial reductions in procedures used to diagnose cancer and subsequent reductions in new diagnoses of cancer across the United States because of the COVID-19 pandemic. A nomogram is provided to identify and resolve these unmet health care needs and avoid worse long-term cancer outcomes. LAY SUMMARY: The disruptions due to the COVID-19 pandemic have led to substantial reductions in new cancers being diagnosed. This study quantifies those reductions in a national health care system and offers a method for understanding the backlog of cases and the resources needed to resolve them.
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COVID-19 , Neoplasias , Veteranos , Atenção à Saúde , Humanos , Masculino , Neoplasias/diagnóstico , Neoplasias/epidemiologia , Pandemias , SARS-CoV-2 , Estados Unidos/epidemiologiaRESUMO
OBJECTIVE: The purpose of this study was to determine the effect of COVID-19 vaccination on postoperative mortality, pulmonary and thrombotic complications, readmissions and hospital lengths of stay among patients undergoing surgery in the United States. BACKGROUND: While vaccination prevents COVID-19, little is known about its impact on postoperative complications. METHODS: This is a nationwide observational cohort study of all 1,255 Veterans Affairs facilities nationwide. We compared patients undergoing surgery at least 2âweeks after their second dose of the Pfizer BioNTech or Moderna vaccines, to contemporary propensity score matched controls. Primary endpoints were 30-day mortality and postoperative COVID-19 infection. Secondary endpoints were pulmonary or thrombotic complications, readmissions, and hospital lengths of stay. RESULTS: 30,681 patients met inclusion criteria. After matching, there were 3,104 in the vaccination group (1,903 received the Pfizer BioNTech, and 1,201 received the Moderna vaccine) and 7,438 controls. Full COVID-19 vaccination was associated with lower rates of postoperative 30-day COVID-19 infection (Incidence Rate Ratio and 95% confidence intervals, 0.09 [0.01,0.44]), pulmonary complications (0.54 [0.39, 0.72]), thrombotic complications (0.68 [0.46, 0.99]) and decreased hospital lengths of stay (0.78 [0.69, 0.89]). Complications were also low in vaccinated patients who tested COVID-19 positive before surgery but events were too few to detect a significant difference compared to controls. CONCLUSION: COVID-19 vaccination is associated with lower rates of postoperative morbidity. The benefit is most pronounced among individuals who have never had a COVID-19 infection before surgery.
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Vacinas contra COVID-19 , COVID-19/prevenção & controle , Complicações Pós-Operatórias/prevenção & controle , Adulto , Idoso , Idoso de 80 Anos ou mais , COVID-19/epidemiologia , Feminino , Humanos , Tempo de Internação/estatística & dados numéricos , Masculino , Análise por Pareamento , Pessoa de Meia-Idade , Readmissão do Paciente/estatística & dados numéricos , Distribuição de Poisson , Complicações Pós-Operatórias/epidemiologia , Pontuação de Propensão , Análise de Regressão , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Transcarotid artery revascularization (TCAR) is a new hybrid approach to carotid artery revascularization. Proctored training on live cases is an effort-, time-, and resource-intensive approach to learning new procedures. We analyzed the worldwide experience with TCAR to develop objective performance metrics for the procedure and compared the effectiveness of training physicians using cadavers or synthetic models to that of traditional in-person training on live cases. METHODS: Physicians underwent one of three mandatory training programs: (1) in-person proctoring on live TCAR procedures, (2) supervised training on human cadavers, and (3) supervised training on synthetic models. The training details and information from all subsequent independently performed TCAR procedures were recorded. The composite clinical adverse events (ie, transient ischemic attack, stroke, myocardial infarction, death) and composite technical adverse events (ie, aborted procedure, conversion to surgery, bleeding, dissection, cranial nerve injury, or device failure, occurring within 24 hours were recorded). Four procedural proficiency measures were recorded: procedure time, flow-reversal time, fluoroscopy time, and contrast volume. We compared the adverse event rates between the procedures performed by physicians after undergoing the three training modes and tested whether the proficiency measures achieved during TCAR after training on cadavers and synthetic models were noninferior to proctored training. RESULTS: From March 3, 2009 to May 7, 2020, 1160 physicians had undergone proctored (19.1%), cadaver-based (27.4%), and synthetic model-based (53.5%) TCAR training and had subsequently performed 17,283 TCAR procedures. The proctored physicians had treated younger patients and more patients with asymptomatic carotid stenosis and had had more prior experience with transfemoral carotid stenting. The overall 24-hour composite clinical and technical adverse event rates, adjusted for age, sex, and symptomatic status, were 1.0% (95% confidence interval, 0.8%-1.3%) and 6.0% (95% confidence interval, 5.4%-6.6%), respectively, and did not differ significantly by training mode. The proficiency measures of cadaver-trained and synthetic model-trained physicians were not inferior to those for the proctored physicians. CONCLUSIONS: We have presented key objective proficiency metrics for performing TCAR and an analytic framework to assess adequate training for the procedure. Training on cadavers or synthetic models achieved clinical outcomes, technical outcomes, and proficiency measures for subsequently performed TCAR procedures similar to those achieved with training using traditional proctoring on live cases.
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Artérias Carótidas/cirurgia , Estenose das Carótidas/cirurgia , Educação de Pós-Graduação em Medicina/métodos , Endarterectomia das Carótidas/educação , Procedimentos Endovasculares/educação , Sistema de Registros , Medição de Risco/métodos , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Saúde Global , Mortalidade Hospitalar/tendências , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Risco , Stents , Fatores de TempoRESUMO
BACKGROUND: The COVID-19 pandemic has resulted in over 225,000 excess deaths in the United States. A moratorium on elective surgery was placed early in the pandemic to reduce risk to patients and staff and preserve critical care resources. This report evaluates the impact of the elective surgical moratorium on case volumes and intensive care unit (ICU) bed utilization. METHODS: This retrospective review used a national convenience sample to correlate trends in the weekly rates of surgical cases at 170 Veterans Affairs Hospitals around the United States from January 1 to September 30, 2020 to national trends in the COVID-19 pandemic. We reviewed data on weekly number of procedures performed and ICU bed usage, stratified by level of urgency (elective, urgent, emergency), and whether an ICU bed was required within 24 hours of surgery. National data on the proportion of COVID-19 positive test results and mortality rates were obtained from the Center for Disease Control website. RESULTS: 198,911 unique surgical procedures performed during the study period. The total number of cases performed from January 1 to March 16 was 86,004 compared with 15,699 from March 17 to May 17. The reduction in volume occurred before an increase in the percentage of COVID-19 positive test results and deaths nationally. There was a 91% reduction from baseline in the number of elective surgeries performed allowing 78% of surgical ICU beds to be available for COVID-19 positive patients. CONCLUSION: The moratorium on elective surgical cases was timely and effective in creating bed capacity for critically ill COVID-19 patients. Further analyses will allow targeted resource allocation for future pandemic planning.
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COVID-19 , Procedimentos Cirúrgicos Eletivos/estatística & dados numéricos , Capacidade de Resposta ante Emergências , Hospitais de Veteranos/estatística & dados numéricos , Humanos , Unidades de Terapia Intensiva/estatística & dados numéricos , Pandemias , Estudos Retrospectivos , Estados Unidos/epidemiologiaRESUMO
BACKGROUND: The COVID-19 pandemic has necessitated the adoption of protocols to minimize risk of periprocedural complications associated with SARS-CoV-2 infection. This typically involves a preoperative symptom screen and nasal swab RT-PCR test for viral RNA. Asymptomatic patients with a negative COVID-19 test are cleared for surgery. However, little is known about the rate of postoperative COVID-19 positivity among elective surgical patients, risk factors for this group and rate of complications. METHODS: This prospective multicenter study included all patients undergoing elective surgery at 170 Veterans Health Administration (VA) hospitals across the United States. Patients were divided into groups based on first positive COVID-19 test within 30 days after surgery (COVID[-/+]), before surgery (COVID[+/-]) or negative throughout (COVID[-/-]). The cumulative incidence, risk factors for and complications of COVID[-/+], were estimated using univariate analysis, exact matching, and multivariable regression. RESULTS: Between March 1 and December 1, 2020 90,093 patients underwent elective surgery. Of these, 60,853 met inclusion criteria, of which 310 (0.5%) were in the COVID[-/+] group. Adjusted multivariable logistic regression identified female sex, end stage renal disease, chronic obstructive pulmonary disease, congestive heart failure, cancer, cirrhosis, and undergoing neurosurgical procedures as risk factors for being in the COVID[-/+] group. After matching on current procedural terminology code and month of procedure, multivariable Poisson regression estimated the complication rate ratio for the COVID[-/+] group vs. COVID[-/-] to be 8.4 (C.I. 4.9-14.4) for pulmonary complications, 3.0 (2.2, 4.1) for major complications, and 2.6 (1.9, 3.4) for any complication. DISCUSSION: Despite preoperative COVID-19 screening, there remains a risk of COVID infection within 30 days after elective surgery. This risk is increased for patients with a high comorbidity burden and those undergoing neurosurgical procedures. Higher intensity preoperative screening and closer postoperative monitoring is warranted in such patients because they have a significantly elevated risk of postoperative complications.
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Teste de Ácido Nucleico para COVID-19/estatística & dados numéricos , COVID-19/epidemiologia , Procedimentos Cirúrgicos Eletivos/efeitos adversos , Programas de Rastreamento/estatística & dados numéricos , Complicações Pós-Operatórias/epidemiologia , Adulto , COVID-19/complicações , COVID-19/imunologia , COVID-19/virologia , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/imunologia , Período Pós-Operatório , Período Pré-Operatório , Estudos Prospectivos , Fatores de Risco , SARS-CoV-2/genética , SARS-CoV-2/imunologia , SARS-CoV-2/isolamento & purificação , Estados Unidos/epidemiologiaRESUMO
BACKGROUND: Reports on emergency surgery performed soon after a COVID-19 infection that are not controlled for premorbid risk-factors show increased 30-day mortality and pulmonary complications. This contributed to a virtual cessation of elective surgery during the pandemic surge. To inform evidence-based guidance on the decisions for surgery during the recovery phase of the pandemic, we compare 30-day outcomes in patients testing positive for COVID-19 before their operation, to contemporary propensity-matched COVID-19 negative patients undergoing the same procedures. METHODS: This prospective multicentre study included all patients undergoing surgery at 170 Veterans Health Administration (VA) hospitals across the United States. COVID-19 positive patients were propensity matched to COVID-19 negative patients on demographic and procedural factors. We compared 30-day outcomes between COVID-19 positive and negative patients, and the effect of time from testing positive to the date of procedure (≤10 days, 11-30 days and >30 days) on outcomes. RESULTS: Between March 1 and August 15, 2020, 449 COVID-19 positive and 51,238 negative patients met inclusion criteria. Propensity matching yielded 432 COVID-19 positive and 1256 negative patients among whom half underwent elective surgery. Infected patients had longer hospital stays (median seven days), higher rates of pneumonia (20.6%), ventilator requirement (7.6%), acute respiratory distress syndrome (ARDS, 17.1%), septic shock (13.7%), and ischemic stroke (5.8%), while mortality, reoperations and readmissions were not significantly different. Higher odds for ventilation and stroke persisted even when surgery was delayed 11-30 days, and for pneumonia, ARDS, and septic shock >30 days after a positive test. DISCUSSION: 30-day pulmonary, septic, and ischaemic complications are increased in COVID-19 positive, compared to propensity score matched negative patients. Odds for several complications persist despite a delay beyond ten days after testing positive. Individualized risk-stratification by pulmonary and atherosclerotic comorbidities should be considered when making decisions for delaying surgery in infected patients.
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COVID-19/complicações , Procedimentos Cirúrgicos Eletivos/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Guias de Prática Clínica como Assunto , Tempo para o Tratamento/normas , Idoso , COVID-19/diagnóstico , COVID-19/virologia , Teste para COVID-19/estatística & dados numéricos , Tomada de Decisão Clínica/métodos , Procedimentos Cirúrgicos Eletivos/normas , Procedimentos Cirúrgicos Eletivos/estatística & dados numéricos , Medicina Baseada em Evidências/normas , Medicina Baseada em Evidências/estatística & dados numéricos , Feminino , Seguimentos , Mortalidade Hospitalar , Hospitais de Veteranos/estatística & dados numéricos , Humanos , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle , Pontuação de Propensão , Estudos Prospectivos , Medição de Risco/normas , Medição de Risco/estatística & dados numéricos , SARS-CoV-2/isolamento & purificação , Fatores de Tempo , Tempo para o Tratamento/estatística & dados numéricos , Estados Unidos/epidemiologiaRESUMO
BACKGROUND: Advanced care planning through Physician Order For Life-Sustaining Therapies (POLST) has been encouraged by professional societies. But these documents may be overlooked or ignored during hospitalization and "full-code" orders written as a default, putting patients at risk for unwanted resuscitation. After 2 instances of unwanted resuscitation in which limited support POLSTs were ignored, a series of improvements were implemented. This study measured the effectiveness of those steps in reducing POLST code status discrepancy. METHODS: Pre-post implementation chart review of randomly chosen medical admissions to determine the rate of discordance between POLST orders (when present) and admission code status orders. Physician Order For Life-Sustaining Therapies were classified as either "full" or "limited" based on orders for life-sustaining therapies on the form. Chi-square tests or Fisher exact tests were performed on binary data to identify statistically significant differences at the 95% confidence level between pre- and postimplementation admissions. RESULTS: In all, 444 preimplementation and 448 postimplementation admissions were evaluated. Discrepant code status orders for those with limited POLST fell from 10 (22.7%) of 44 preimplementation to 3 (4.6%) of 65 after implementation, P = .006. The number of documented code status discussions in admission notes increased from 19.6% to 63.6% (P < .001). The median age of all POLST in the chart was 1.2 years. CONCLUSIONS: Among those patients with limited POLST orders, discrepant full-code orders increase the potential for unwanted resuscitation. Multistep improvements including documentation templates improved the process of verifying end-of-life wishes and increased meaningful code status discussions. The rate of discrepant orders fell in response to process improvements.
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Diretivas Antecipadas/ética , Cuidados para Prolongar a Vida/ética , Melhoria de Qualidade/organização & administração , Ordens quanto à Conduta (Ética Médica)/ética , Adulto , Planejamento Antecipado de Cuidados/ética , Feminino , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
Injectable hydrogels can be useful tools for facilitating wound healing since they conform to the irregular shapes of wounds, serving as a temporary matrix during the healing process. However, the lack of inherent pore structures of most injectable hydrogels prohibits desired interactions with the cells of the surrounding tissues limiting their clinical efficacy. Here, we introduce a simple, cost-effective and highly biofunctional injectable macroporous hydrogel made of gelatin microgels crosslinked by microbial transglutaminase (mTG). Pores are created by the interstitial space among the microgels. A water-in-oil emulsion technique was used to create gelatin microgels of an average size of 250µm in diameter. When crosslinked with mTG, the microgels adhered to each other to form a bulk hydrogel with inherent pores large enough for cell migration. The viscoelastic properties of the porous hydrogel were similar to those of nonporous gelatin hydrogel made by adding mTG to a homogeneous gelatin solution. The porous hydrogel supported higher cellular proliferation of human dermal fibroblasts (hDFs) than the nonporous hydrogel over two weeks, and allowed the migration of hDFs into the pores. Conversely, the hDFs were unable to permeate the surface of the nonporous hydrogel. To demonstrate its potential use in wound healing, the gelatin microgels were injected with mTG into a cut out section of an excised porcine cornea. Due to the action of mTG, the porous hydrogel stably adhered to the cornea tissue for two weeks. Confocal images showed that a large number of cells from the cornea tissue migrated into the interstitial space of the porous hydrogel. The porous hydrogel was also used for the controlled release of platelet-derived growth factor (PDGF), increasing the proliferation of hDFs compared to the nonporous hydrogel. This gelatin microgel-based porous hydrogel will be a useful tool for wound healing and tissue engineering.