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1.
BMJ Open ; 14(9): e085806, 2024 Sep 26.
Artigo em Inglês | MEDLINE | ID: mdl-39327057

RESUMO

OBJECTIVES: To assess the feasibility of assessing long-term outcomes of peripheral vascular intervention (PVI) by linking data from a clinical registry to electronic health records (EHR) data from a clinical research network. DESIGN: Observational cohort study. SETTING: Vascular Quality Initiative registry linked to INSIGHT Clinical Research Network, which aggregated EHR data from multiple institutions in New York City. PARTICIPANTS: Patients receiving PVI during 1 January 2013-30 November 2021 in four centres in New York City. PRIMARY AND SECONDARY OUTCOME MEASURES: We examined the proportion of registry patients retained in EHR over time and predictors of EHR retention after year 1. We evaluated the implications of EHR attrition by examining amputation-free survival (AFS) in the observed data and predicted data when patients discontinued in the EHR were hypothesised to have increased risks of events than the observed average. RESULTS: We included 1405 patients receiving PVI (age=70.8±11.2 years, 51.3% male). Among eligible patients, 75.2% were retained in EHR through year 3. Patients who aged 75 years or above (vs <65: OR 0.34, 95% CI 0.18 to 0.62), had Medicaid (vs Medicare: OR 0.41, 95% CI 0.22 to 0.79), congestive heart failure (OR 0.54, 95% CI 0.32 to 0.90), dialysis (OR 0.47, 95% CI 0.24 to 0.91) and reduced ambulation (OR 0.34, 95% CI 0.15 to 0.75) were less likely to be retained in EHR. When discontinued patients were hypothesised to have increased risks of death or amputation than observed, AFS estimates diverged from the observed data around 6-12 months. CONCLUSIONS: Studies using registry-EHR data may benefit from the timeliness of the data but may be most appropriate to focus on short-term to intermediate-term outcomes of interventions and devices. Future research is needed to investigate the value of registry-EHR linkage in facilitating short-term to intermediate-term outcome assessment following vascular interventions and advanced statistical approaches to account for non-random missing long-term data.


Assuntos
Registros Eletrônicos de Saúde , Sistema de Registros , Humanos , Registros Eletrônicos de Saúde/estatística & dados numéricos , Masculino , Feminino , Idoso , Pessoa de Meia-Idade , Cidade de Nova Iorque , Amputação Cirúrgica/estatística & dados numéricos , Idoso de 80 Anos ou mais , Estudos de Coortes , Estudos de Viabilidade , Estados Unidos
2.
Clin Colon Rectal Surg ; 37(5): 346-354, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-39132196

RESUMO

Major innovation into how we pursue diagnosis and therapies for gastrointestinal (GI) diseases is urgently needed to seek better, less invasive, and less costly innovations in diagnostic and therapeutic interventions in the GI tract. Learning from prior paradigm shifts in cardiac and vascular we present here several initial steps we have undertaken to follow the endoluminal path, using advanced imaging methods, including endoscopy, and data management with avoidance of entry into a body cavity when possible. We will review the benefit and ease of incorporating routine fluoroscopy with endoscopy to improve safety and efficiency. We describe the development of "hybrid" procedure rooms for GI interventions and rationale for their use. We also emphasize the importance of collaborating with interventional radiologists, software engineers, and data specialists. We predict major improvement in outcomes in both diagnosis and treatment will follow.

3.
Ann Surg ; 2024 Aug 23.
Artigo em Inglês | MEDLINE | ID: mdl-39176567

RESUMO

OBJECTIVE: To determine whether the timing of parathyroid surgery impacts the risk of renal stone retreatment and cardiovascular interventions. SUMMARY BACKGROUND DATA: Long-term, untreated primary hyperparathyroidism is associated with significant morbidity including nephrolithiasis and cardiovascular disease. METHODS: We conducted a Population-based Cohort study of New York and California state-wide data from 2000-2020. Adult patients who underwent renal stone treatment and subsequently diagnosed with primary hyperparathyroidism (pHPT) and underwent parathyroidectomy (PTX) were included. Patients were excluded if PTX was prior to index stone procedure, they underwent second stone treatment within 6 months, with stage V CKD, with secondary or tertiary hyperparathyroidism, with prior kidney transplant or hemodialysis, or with prior cancer diagnosis. Rate of renal stone retreatment and cardiovascular interventions after PTX in pHPT patients with nephrolithiasis who underwent parathyroid surgery at ≤ 2 years and >2 years after index stone procedure was measured. RESULTS: We identified 2,093 patients who underwent first-time stone treatment and subsequent PTX. The median time to PTX was 560 days (IQR 187-1477) and follow-up was 7.4 years (IQR 4.5-13.1). Delaying PTX for more than 2 years increased the risk of renal stone retreatment by 59% (HR 1.59; P<0.001), increased the risk of experiencing coronary disease or associated interventions by 118% (HR=2.18; P=0.01), and increased the risk of experiencing an overall cardiovascular event by 52% (HR 1.52; P<0.01). CONCLUSIONS AND RELEVANCE: In symptomatic pHPT, delaying PTX significantly increases the risk of requiring future stone retreatment and cardiac/vascular surgical interventions. This highlights the importance of early surgical referral and multidisciplinary approaches to optimize outcomes and resource utilization in pHPT.

4.
AJR Am J Roentgenol ; 223(2): e2431272, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-38899842

RESUMO

BACKGROUND. Differences in survival and morbidity among treatment options (ablation, surgical resection, and transplant) for early-stage hepatocellular carcinoma (HCC) have been well studied. Additional understanding of the costs of such care would help to identify drivers of high costs and potential barriers to care delivery. OBJECTIVE. The purpose of this article was to quantify total and patient out-of-pocket costs for ablation, surgical resection, and transplant in the management of early-stage HCC and to identify factors predictive of these costs. METHODS. This retrospective U.S. population-based study used the SEER-Medicare linked dataset to identify a sample of 1067 Medicare beneficiaries (mean age, 73 years; 674 men, 393 women) diagnosed with early-stage HCC (size ≤ 5 cm) treated with ablation (n = 623), resection (n = 201), or transplant (n = 243) between January 2009 and December 2016. Total costs and patient out-of-pocket costs for the index procedure as well as for any care within 30 and 90 days after the procedure were identified and stratified by treatment modality. Additional comparisons were performed among propensity score-matched subgroups of patients treated by ablation or resection (each n = 172). Multivariable linear regression models were used to identify factors predictive of total costs and out-of-pocket costs for index procedures as well as for 30- and 90-day post-procedure periods. RESULTS. For ablation, resection, and transplant, median index-procedure total cost was US$6689, US$25,614, and US$66,034; index-procedure out-of-pocket cost was US$1235, US$1650, and US$1317; 30-day total cost was US$9456, US$29,754, and US$69,856; 30-day out-of-pocket cost was US$1646, US$2208, and US$3198; 90-day total cost was US$14,572, US$34,984, and US$88,103; and 90-day out-of-pocket cost was US$2138, US$2462, and US$3876, respectively (all p < .001). In propensity score-matched subgroups, ablation and resection had median index-procedure, 30-day, and 90-day total costs of US$6690 and US$25,716, US$9995 and US$30,365, and US$15,851 and US$34,455, respectively. In multivariable analysis adjusting for socioeconomic factors, comorbidities, and liver-disease prognostic indicators, surgical treatment (resection or transplant) was predictive of significantly greater costs compared with ablation at all time points. CONCLUSION. Total and out-of-pocket costs for index procedures as well as for 30-day and 90-day postprocedure periods were lowest for ablation, followed by resection and then transplant. CLINICAL IMPACT. This comprehensive cost analysis could help inform future cost-effectiveness analyses.


Assuntos
Carcinoma Hepatocelular , Gastos em Saúde , Neoplasias Hepáticas , Transplante de Fígado , Medicare , Programa de SEER , Humanos , Masculino , Carcinoma Hepatocelular/cirurgia , Carcinoma Hepatocelular/economia , Feminino , Estados Unidos , Neoplasias Hepáticas/cirurgia , Neoplasias Hepáticas/economia , Medicare/economia , Idoso , Estudos Retrospectivos , Transplante de Fígado/economia , Hepatectomia/economia , Custos de Cuidados de Saúde/estatística & dados numéricos , Idoso de 80 Anos ou mais , Estadiamento de Neoplasias , Técnicas de Ablação/economia
5.
J Neurointerv Surg ; 2024 Jun 11.
Artigo em Inglês | MEDLINE | ID: mdl-38862209

RESUMO

BACKGROUND: Real-world data can be helpful in evaluating endovascular therapy (EVT) in ischemic stroke care. We conducted a pilot study to aggregate data on basilar artery occlusion (BAO) EVT from existing registries in the USA. We evaluated the availability, completeness, quality, and consistency of common data elements (CDEs) across data sources. METHODS: We harmonized patient-level data from five registry data sources and assessed the availability, completeness (defined by the presence in at least four data sources), and consistency of CDEs. We assessed data quality based on seven pre-defined critical domains for BAO EVT investigation: baseline patient and disease characteristics; time metrics; description of intervention; adjunctive devices, revascularization scores, complications; post-intervention National Institutes of Health Stroke Scale scores; discharge disposition; 30-day and 90-day mortality and modified Rankin Scale (mRS) scores. RESULTS: The aggregated dataset of five registries included 493 BAO procedures between January 2013 and January 2020. In total, 88 CDEs were screened and 35 (40%) elements were considered prevalent. Of these 35 CDEs, the majority were collected for >80% of cases when aggregated. All seven pre-defined domains for BAO device investigation could be fulfilled with harmonized data elements. Most data elements were collected with consistent or compatible definitions across registries. The main challenge was the collection of 90-day outcomes. CONCLUSIONS: This pilot shows the feasibility of aggregating and harmonizing critical CDEs across registries to create a Coordinated Registry Network (CRN). The CRN with partnerships between multiple registries and stakeholders could help improve the breadth and/or depth of real-world data to help answer relevant questions and support clinical and regulatory decisions.

6.
JAMA Netw Open ; 7(5): e2412898, 2024 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-38780939

RESUMO

Importance: Despite increased use of antibiotic-loaded bone cement (ALBC) in joint arthroplasty over recent decades, current evidence for prophylactic use of ALBC to reduce risk of periprosthetic joint infection (PJI) is insufficient. Objective: To compare the rate of revision attributed to PJI following primary total knee arthroplasty (TKA) using ALBC vs plain bone cement. Design, Setting, and Participants: This international cohort study used data from 14 national or regional joint arthroplasty registries in Australia, Denmark, Finland, Germany, Italy, New Zealand, Norway, Romania, Sweden, Switzerland, the Netherlands, the UK, and the US. The study included primary TKAs for osteoarthritis registered from January 1, 2010, to December 31, 2020, and followed-up until December 31, 2021. Data analysis was performed from April to September 2023. Exposure: Primary TKA with ALBC vs plain bone cement. Main Outcomes and Measures: The primary outcome was risk of 1-year revision for PJI. Using a distributed data network analysis method, data were harmonized, and a cumulative revision rate was calculated (1 - Kaplan-Meier), and Cox regression analyses were performed within the 10 registries using both cement types. A meta-analysis was then performed to combine all aggregated data and evaluate the risk of 1-year revision for PJI and all causes. Results: Among 2 168 924 TKAs included, 93% were performed with ALBC. Most TKAs were performed in female patients (59.5%) and patients aged 65 to 74 years (39.9%), fully cemented (92.2%), and in the 2015 to 2020 period (62.5%). All participating registries reported a cumulative 1-year revision rate for PJI of less than 1% following primary TKA with ALBC (range, 0.21%-0.80%) and with plain bone cement (range, 0.23%-0.70%). The meta-analyses based on adjusted Cox regression for 1 917 190 TKAs showed no statistically significant difference at 1 year in risk of revision for PJI (hazard rate ratio, 1.16; 95% CI, 0.89-1.52) or for all causes (hazard rate ratio, 1.12; 95% CI, 0.89-1.40) among TKAs performed with ALBC vs plain bone cement. Conclusions and Relevance: In this study, the risk of revision for PJI was similar between ALBC and plain bone cement following primary TKA. Any additional costs of ALBC and its relative value in reducing revision risk should be considered in the context of the overall health care delivery system.


Assuntos
Antibacterianos , Artroplastia do Joelho , Cimentos Ósseos , Infecções Relacionadas à Prótese , Sistema de Registros , Reoperação , Humanos , Artroplastia do Joelho/efeitos adversos , Cimentos Ósseos/uso terapêutico , Feminino , Idoso , Masculino , Antibacterianos/uso terapêutico , Infecções Relacionadas à Prótese/epidemiologia , Infecções Relacionadas à Prótese/etiologia , Reoperação/estatística & dados numéricos , Pessoa de Meia-Idade , Estudos de Coortes
7.
Surg Innov ; 31(3): 245-255, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38498843

RESUMO

BACKGROUND: Adhesive small bowel obstruction (aSBO) is a common surgical problem, with some advocating for a more aggressive operative approach to avoid recurrence. Contemporary outcomes in a real-world setting were examined. STUDY DESIGN: A retrospective cohort study was performed using the New York Statewide Planning and Research Cooperative database to identify adults admitted with aSBO, 2016-2020. Patients were stratified by the presence of inflammatory bowel disease (IBD) and cancer history. Diagnoses usually requiring resection were excluded. Patients were categorized into four groups: non-operative, adhesiolysis, resection, and 'other' procedures. In-hospital mortality, major complications, and odds of undergoing resection were compared. RESULTS: 58,976 patients were included. 50,000 (84.8%) underwent non-operative management. Adhesiolysis was the most common procedure performed (n = 4,990, 8.46%), followed by resection (n = 3,078, 5.22%). In-hospital mortality in the lysis and resection groups was 2.2% and 5.9% respectively. Non-IBD patients undergoing operation on the day of admission required intestinal resection 29.9% of the time. Adjusted odds of resection were highest for those with a prior aSBO episode (OR 1.29 95%CI 1.11-1.49), delay to operation ≥3 days (OR1.78 95%CI 1.58-1.99), and non-New York City (NYC) residents being treated at NYC hospitals (OR1.57 95%CI 1.19-2.07). CONCLUSION: Adhesiolysis is currently the most common surgery for aSBO, however nearly one-third of patients will undergo a more extensive procedure, with an increased risk of mortality. Innovative therapies are needed to reduce the risk of resection.


Assuntos
Obstrução Intestinal , Intestino Delgado , Humanos , Obstrução Intestinal/cirurgia , Obstrução Intestinal/mortalidade , Estudos Retrospectivos , Feminino , Masculino , Pessoa de Meia-Idade , New York/epidemiologia , Intestino Delgado/cirurgia , Aderências Teciduais/cirurgia , Idoso , Adulto , Complicações Pós-Operatórias/epidemiologia , Mortalidade Hospitalar , Idoso de 80 Anos ou mais
8.
J Am Coll Radiol ; 21(2): 295-308, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37922972

RESUMO

OBJECTIVE: To identify independent predictors of all-cause and cancer-specific mortality after ablation or surgical resection (SR) for small hepatocellular carcinomas (HCCs), after adjusting for key confounders. METHODS: Using Surveillance, Epidemiology, and End Results Program-Medicare, HCCs less than 5 cm treated with ablation or SR in 2009 to 2016 (n = 956) were identified. Univariate and multivariable Cox regression models for all-cause and cancer-specific mortality were performed including demographics, clinical factors (tumor size, medical comorbidities, and liver disease factors), social determinants of health, and treatment characteristics. We also determined the most influential predictors of survival using a random forest analysis. RESULTS: Larger tumor size (3-5 cm) is predictive of all-cause (hazard ratio [HR] 1.31, P = .002) and cancer-specific mortality (HR 1.59, P < .001). Furthermore, chronic kidney disease is predictive of all-cause mortality (HR 1.43, P = .013), though it is not predictive of cancer-specific death. Multiple liver disease factors are predictive of all-cause and cancer-specific mortality including portal hypertension and esophageal varices (HRs > 1, P < .05). Though Asian race is protective in univariate models, in fully adjusted, multivariable models, Asian race is not a significant protective factor. Likewise, other social determinants of health are not significantly predictive of all-cause or cancer-specific mortality. Finally, treatment with SR, in later procedure years or at high-volume centers, is protective for all-cause and cancer-specific mortality. In machine learning models, year procedure was performed, ascites, portal hypertension, and treatment choice were the most influential factors. DISCUSSION: Treatment characteristics, liver disease factors, and tumor size are more important predictors of all-cause and cancer-specific death than social determinants of health for small HCCs.


Assuntos
Carcinoma Hepatocelular , Hipertensão Portal , Neoplasias Hepáticas , Idoso , Humanos , Estados Unidos/epidemiologia , Programa de SEER , Estudos Retrospectivos , Medicare , Neoplasias Hepáticas/patologia , Carcinoma Hepatocelular/cirurgia , Resultado do Tratamento
9.
J Vasc Surg ; 79(4): 826-834.e3, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-37634620

RESUMO

BACKGROUND: Carotid endarterectomy (CEA) is associated with lower risk of perioperative stroke compared with transfemoral carotid artery stenting (TFCAS) in the treatment of carotid artery stenosis. However, there is discrepancy in data regarding long-term outcomes. We aimed to compare long-term outcomes of CEA vs TFCAS using the Medicare-matched Vascular Quality Initiative Vascular Implant Surveillance and Interventional Outcomes Network database. METHODS: We assessed patients undergoing first-time CEA or TFCAS in Vascular Quality Initiative Vascular-Vascular Implant Surveillance and Interventional Outcomes Network from January 2003 to December 2018. Patients with prior history of carotid revascularization, nontransfemoral stenting, stenting performed without distal embolic protection, multiple or nonatherosclerotic lesions, or concomitant procedures were excluded. The primary outcome of interest was all-cause mortality, any stroke, and a combined end point of death or stroke. We additionally performed propensity score matching and stratification based on symptomatic status. RESULTS: A total of 80,146 carotid revascularizations were performed, of which 72,615 were CEA and 7531 were TFCAS. CEA was associated with significantly lower risk of death (57.8% vs 70.4%, adjusted hazard ratio [aHR], 0.46; 95% confidence interval [CI], 0.41-0.52; P < .001), stroke (21.3% vs 26.6%; aHR, 0.63; 95% CI, 0.57-0.69; P < .001) and combined end point of death and stroke (65.3% vs 76.5%; HR, 0.49; 95% CI, 0.44-0.55; P < .001) at 10 years. These findings were reflected in the propensity-matched cohort (combined end point: 34.6% vs 46.8%; HR, 0.53; 95% CI, 0.46-0.62) at 4 years, as well as stratified analyses of combined end point by symptomatic status (asymptomatic: 63.2% vs 74.9%; HR, 0.49; 95% CI, 0.43-0.58; P < .001; symptomatic: 69.9% vs 78.3%; HR, 0.51; 95% CI, 0.45-0.59; P < .001) at 10 years. CONCLUSIONS: In this analysis of North American real-world data, CEA was associated with greater long-term survival and fewer strokes compared with TFCAS. These findings support the continued use of CEA as the first-line revascularization procedure.


Assuntos
Estenose das Carótidas , Endarterectomia das Carótidas , Acidente Vascular Cerebral , Humanos , Idoso , Estados Unidos , Endarterectomia das Carótidas/efeitos adversos , Estenose das Carótidas/complicações , Estenose das Carótidas/diagnóstico por imagem , Estenose das Carótidas/cirurgia , Fatores de Risco , Resultado do Tratamento , Stents/efeitos adversos , Fatores de Tempo , Medicare , Acidente Vascular Cerebral/etiologia , Estudos Retrospectivos , Medição de Risco
10.
J Vasc Surg ; 79(4): 748-754.e2, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38013041

RESUMO

BACKGROUND: The mortality after ruptured abdominal aortic aneurysm (rAAA) repair is high, despite improvements in perioperative care, centralization of emergency vascular surgical services, and the introduction of endovascular aneurysm repair (EVAR). The diameter of intact AAA has been shown to be a predictor of short- and long-term survival. The aim of this study was to analyze the impact of AAA diameter on mortality for rAAA repair using contemporary data collected from the International Consortium of Vascular Registries and compare outcomes by sex and the type of repair patients received. METHODS: Prospective registry data on repair of rAAA from seven countries were collected from 2010 to 2016. The primary outcome was perioperative mortality after EVAR and open surgical repair (OSR). Data were stratified by type of repair and sex. Logistic regression models were used to estimate odds ratio (OR) for the association between AAA diameter and perioperative mortality and the association between type of repair and mortality. Multivariable logistic regression models were used to adjust for differences in patient characteristics. RESULTS: The study population consisted of 6428 patients with a mean age ranging from 70.2 to 75.4 years; the mean AAA diameter was 7.7 ± 1.8 cm. Females had a significantly smaller AAA diameter at presentation compared with males (6.9 ± 1.6 cm vs 7.9 ± 1.8 cm; P < .001). who underwent OSR had larger AAA diameters compared with those who underwent EVAR (P < .001). Females who underwent repair were significantly older (P < .001). Males were more likely to have cardiac disease, diabetes mellitus, and renal impairment. Overall, AAA diameter was a predictor of mortality in univariate and multivariate analysis. When analyzing EVAR and OSR separately, the impact of AAA diameter per cm increase on mortality was apparent in both males and females undergoing EVAR, but not OSR (EVAR: male OR, 1.09 [95% confidence interval, 1.03-1.16] and EVAR: female OR, 1.17 [95% confidence interval, 1.02-1.35]). The early mortality rate for males and females who underwent EVAR was 18.9% and 25.9% (P < .001), respectively. The corresponding mortality for males and females who underwent OSR was 30.2% and 38.6% (P < .001), respectively. CONCLUSIONS: In these real-world international data, there is a significant association between rAAA diameters and early mortality in males and females. This association was more evident in patients undergoing EVAR, but not shown in OSR. Despite improvements in overall AAA repair outcomes, the risk of mortality after rAAA repair is consistently higher for females.


Assuntos
Aneurisma da Aorta Abdominal , Ruptura Aórtica , Implante de Prótese Vascular , Procedimentos Endovasculares , Humanos , Masculino , Feminino , Idoso , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/efeitos adversos , Fatores de Risco , Procedimentos Endovasculares/efeitos adversos , Resultado do Tratamento , Ruptura Aórtica/diagnóstico por imagem , Ruptura Aórtica/cirurgia , Sistema de Registros , Estudos Retrospectivos , Complicações Pós-Operatórias/cirurgia
11.
J Vasc Surg ; 78(5): 1212-1220.e5, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37442215

RESUMO

OBJECTIVE: Although the differences in short-term outcomes between male and female patients in abdominal aortic aneurysm (AAA) repair have been well studied, it remains unclear if these sex disparities extend to other long-term adverse outcomes after AAA repair, such as reintervention and late rupture. METHODS: We performed a retrospective cohort study of 13,007 patients who underwent either endovascular (EVAR) or open AAA repair (OAR) between 2003 and 2015 using data from the Vascular Quality Initiative registries. Eligible patients were linked to fee-for-service Medicare claims to identify late outcomes of rupture and aneurysm-specific reintervention. RESULTS: The mean age of our cohort was 76 ± 6.7 years, 22% were female, 94% were White, and 77% underwent EVAR. The 10-year rupture incidence was slightly higher for women at 4.8 per 1000 person-years, vs 3.9 for men, but this difference was not statistically significant after risk adjustment (hazard ratio [HR] = 1.13, 95% confidence interval [CI]: 0.74-1.73). Likewise, we found no sex difference in reintervention rates (5.1 vs 4.8 in women per 1000 person-years) even after risk adjustment (HR = 0.95, 95% CI: 0.83-1.09). Regression models suggest effect modification by repair type for reintervention, where women who underwent index EVAR had a higher risk of reintervention than men (HR = 1.08, 95% CI: 0.93-1.26), whereas women who underwent OAR were at a lower risk of reintervention than men (HR = 0.79, 95% CI: 0.58-1.08); however, neither effect reached statistical significance within each subgroup. In addition, we found that the risk of reintervention for women vs men varied by clinical presentation, where women were less likely to undergo reintervention after an elective or symptomatic AAA repair but were more likely to undergo reintervention after a repair for AAA rupture (HR = 1.70, 95% CI: 1.05-2.75). CONCLUSIONS: Male and female patients who underwent AAA repair had similar rates of reintervention and late aneurysm rupture in the 10 years after their procedure. However, our findings suggest that repair type and clinical presentation may affect the role of sex in clinical outcomes and warrant further exploration in these subgroups.

12.
J Vasc Interv Radiol ; 34(11): 1997-2005.e3, 2023 11.
Artigo em Inglês | MEDLINE | ID: mdl-37468093

RESUMO

PURPOSE: To compare secondary outcomes after ablation (AB), surgical resection (SR), and liver transplant (LT) for small hepatocellular carcinomas (HCCs), including resource utilization and adverse event (AE) rates. MATERIALS AND METHODS: Using Surveillance, Epidemiology, and End Results Program (SEER)-Medicare, HCCs <5 cm that were treated with AB, SR, or LT in 2009-2016 (n = 1,067) were identified using Healthcare Common Procedure Coding System codes through Medicare claims. Index procedure length of stay, need for intensive care unit (ICU) level care, readmission rates, and AE rates at 30 and 90 days were compared using chi-square tests or Fisher exact tests. Examined AEs included hemorrhage, abscess formation, biliary injury, pneumonia, sepsis, liver disease-related AEs, liver failure, and anesthesia-related AEs, identified by International Classification of Diseases, Ninth/10th Revision, codes. RESULTS: The median length of stay for initial treatment was 1 day, 6 days, and 7 days for AB, SR, and LT, respectively (P < .001). During initial hospital stay, 5.0%, 40.8%, and 63.4% of AB, SR, and LT cohorts, respectively, received ICU-level care (P < .001). By 30 and 90 days, there were significant differences among the AB, SR, and LT cohorts in the rate of postprocedural hemorrhage, abscess formation, biliary injury, pneumonia, sepsis, liver disease-related AEs, and anesthesia-related AEs (P < .05). By 90 days, the readmission rates after AB, SR, and LT were 18.6%, 28.2%, and 40.6% (P < .001), respectively. CONCLUSIONS: AB results in significantly less healthcare utilization during the initial 90 days after procedure compared with that after SR and LT due to shorter length of stay, lower intensity care, fewer readmissions, and fewer AEs.


Assuntos
Neoplasias Hepáticas , Pneumonia , Sepse , Idoso , Humanos , Estados Unidos , Abscesso , Medicare , Neoplasias Hepáticas/terapia , Hemorragia , Pneumonia/epidemiologia , Pneumonia/etiologia , Sepse/epidemiologia , Sepse/etiologia , Estudos Retrospectivos
13.
BMJ Surg Interv Health Technol ; 5(1): e000150, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37223824

RESUMO

Objective: To avoid the need for extensive adhesiolysis in patients with small bowel obstruction (SBO). We evaluated the feasibility of using advanced imaging, percutaneous access, and endoscopy as alternative therapies for SBO. Design: Retrospective case series (IDEAL [Idea, Development, Exploration, Assessment, and Long-term Study Collaborative] stages 1 and 2a). Setting: Single tertiary referral center. Participants: Twelve adults with chronic SBO resulting from inflammatory bowel disease, disseminated cancer, radiation, and/or adhesive disease. Participants were included if they underwent one of three novel access procedures. There were no exclusion criteria. The median age of participants was 67.5 years (range 42-81); two-thirds were women; and median American Society of Anesthesiology class was 3. Interventions: All participants underwent one of three novel access methods, followed by wire-guided balloon dilation of a narrowed area of small bowel. These methods combined endoscopic, fluoroscopic, and surgical techniques. The techniques were (1) a purely endoscopic approach aided by an over-the-scope double-balloon device, (2) a combined endoscopic and percutaneous approach, and (3) a cut-down approach. Main outcome measures: Procedural success (defined as successful access to the small bowel and successful balloon dilation of the stenotic area). Secondary outcomes included major complications, recurrence, length of stay, and procedure time. Results: Procedural success was achieved in 10 of 12 patients (83%). At the time of median follow-up of 10 months, recurrence of SBO was observed in two patients. In only one patient, the novel method did not change the treatment plan. No major complications occurred. Conventional operative intervention was avoided in all patients who achieved technical success with one of the novel approaches. The median postprocedure length of hospital stay was 4 days. Median procedure time was 135 min. Conclusions: Novel minimally invasive approaches to SBO represent feasible alternatives to surgical procedures in select patients. Further study should compare these approaches to standard ones as new methods are refined.

14.
Int J Surg ; 109(5): 1125-1135, 2023 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-37026873

RESUMO

BACKGROUND: Objective performance criteria (OPC) is a novel method to provide minimum performance standards and improve the regulated introduction of original or incremental device innovations in order to prevent patients from being exposed to potentially inferior designs whilst allowing timely access to improvements. We developed 2-year safety and effectiveness OPC for total hip and knee replacement (THR and TKR). METHODS: Analyses of large databases were conducted using various data sources: a systematic literature review; a direct data analysis from The Functional Outcomes Research for Comparative Effectiveness in Total Joint Replacement and Quality Improvement Registry (FORCE-TJR) and the Kaiser Permanente Implant Registry (KPIR); and claims data analyses from longitudinal discharge data in New York and California states. The literature review included U.S. patients (≥18 years) who received THR or TKR for primary end-stage osteoarthritis and prospectively collected data on patient-reported outcome measures (PROMs) from at least 100 subjects and/or 2-year implant survival for at least 250 implants. Random effects models were used for meta-analysis. RESULTS: Data were available from a total of 951 100 patients. After screening of 7979 abstracts, 294 studies underwent full-text review and 31 studies contributed to the evidence synthesis (333 995 implants). Direct data analysis of FORCE-TJR contributed 9223 joint replacement patients to the construction of OPC for effectiveness; KPIR contributed 262 044 patients for the construction of OPC for safety. Claims database analysis contributed 345 838 patients to the construction of safety OPC. OPC for safety were constructed for cumulative incidences of 2-year all-cause and septic revision (THR/TKR 2.0%/1.6% and 0.6%/0.7%), and OPC for effectiveness were constructed based on four disease-specific and three general health-related quality of life PROMs (HOOS/KOOS 87.1/80.6; HSS/KSS function 94.4/90.6; SF-12/SF-36, PCS 46.5/41.9, EQ-5D 0.88/0.84). CONCLUSION: This study is the first to construct a 2-year OPC for the safety and effectiveness of THR and TKR based on U.S. real-world data. Based on these OPC, potential benchmarks for (single-arm study) evaluation of new device innovations are suggested for a regulated and safe introduction to the (commercial) market.


Assuntos
Artroplastia de Quadril , Artroplastia do Joelho , Osteoartrite do Joelho , Humanos , Qualidade de Vida , Artroplastia do Joelho/efeitos adversos , Artroplastia de Quadril/efeitos adversos , Artroplastia de Quadril/métodos , Avaliação de Resultados em Cuidados de Saúde , New York , Osteoartrite do Joelho/cirurgia
15.
Ann Surg ; 278(3): e626-e633, 2023 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-36538620

RESUMO

OBJECTIVE: To examine long-term outcomes after endovascular (EVAR) and open repairs (OAR) for intact abdominal aortic aneurysms in Australia, Germany, and the United States, using a unified study design. BACKGROUND: Similarities and differences in long-term outcomes after EVAR versus OAR across countries remained unclear, given differences in designs across existing studies. METHODS: We identified patients aged >65 years undergoing intact abdominal aortic aneurysm repairs during 2010-2017/2018. We compared long-term patient mortality and reintervention after EVAR and OAR using Kaplan-Meier analyses and Cox regressions. Propensity score matching was performed within each country to adjust for differences in baseline patient characteristics between procedure groups. RESULTS: We included 3311, 4909, and 145363 patients from Australia, Germany, and the United States, respectively. The median patient age was 76 to 77 years, and most patients were males (77%-84%). Patient mortality was lower after EVAR than OAR within the first 60 days and became similar at 3-year follow-up (Australia 14.7% vs 16.5%, Germany 18.2% vs 19.7%, United States: 24.4% vs 24.4%). At the end of follow-up, patient mortality after EVAR was higher than OAR in Australia [ hazard ratio (HR) 95% CI: 1.21 (0.96-1.54)] but similar to OAR in Germany [HR 95% CI: 0.92 (0.80-1.07)] and the United States [HR 95% CI: 1.02 (0.99-1.05)]. The risk of reintervention after EVAR was more than twice that after OAR in Australia [HR 95% CI: 2.60 (1.09-6.15)], Germany [HR 95% CI: 4.79 (2.56-8.98)], and the United States [HR 95% CI: 2.67 (2.38-3.00)]. The difference in reintervention risk appeared early in German and United States patients. CONCLUSIONS: This multinational study demonstrated important similarities in long-term outcomes after EVAR versus OAR across 3 countries. Variation in long-term mortality and reintervention comparisons indicates possible differences in patient profiles, surveillance, and best medical therapy across countries.


Assuntos
Aneurisma da Aorta Abdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Masculino , Humanos , Estados Unidos/epidemiologia , Feminino , Fatores de Risco , Procedimentos Endovasculares/métodos , Resultado do Tratamento , Fatores de Tempo , Estudos Retrospectivos , Aneurisma da Aorta Abdominal/cirurgia , Alemanha/epidemiologia , Implante de Prótese Vascular/efeitos adversos
16.
World J Urol ; 41(1): 179-188, 2023 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-36463348

RESUMO

BACKGROUND: There are growing interests for minimally invasive surgical techniques (MISTs) for the treatment of benign prostatic hyperplasia (BPH)-associated lower urinary tract symptoms (LUTS). Prostatic artery embolization (PAE) uses selective angioembolization of prostatic arteries, thereby reducing size to improve LUTS/BPH. However, real-world data comparing surgical outcomes between MISTs and tissue resective techniques are lacking. We assessed the differences in surgical outcomes between PAE, transurethral resection of the prostate (TURP), and prostatic urethral lift (PUL) in a real-world population for LUTS/BPH. METHODS: We present an observational population-based study of 12,902 men with BPH in New York State who received PAE, TURP, and PUL in outpatient and ambulatory surgery settings from 2014 to 2018. For short-term outcomes, we report 30-day and 90-day risks of readmission to inpatient and emergency room (ER) with/without complications and compared them across groups using χ2 tests and mixed-effect logistic regressions. For long-term outcomes, we report surgical retreatment and stricture rates using Kaplan-Meier failure curves and compared them using Log rank tests and Cox regression models. RESULTS: Of 12 902 men, 335 had PAE, 11,205 had TURP, and 1362 had PUL. PAE patients had the highest 30-day (19.9%) and 90-day (35.6%) risks of readmission to inpatient or ER (p < 0.01). Non-specific abdominal pain was the main diagnosis associated with 30-day and 90-day readmissions to inpatient or ER after PAE (14.3% and 26.8%, respectively). After 2 years of follow-up, PAE patients had the highest retreatment rate of 28.5% (95%CI 23.7-34.2%) compared to TURP (3.4% (95%CI 3.1-3.8%)) and PUL (8.5% (95%CI 5.6-12.9%)) (p < 0.001). CONCLUSION: In a real-world population, PAE was associated with the most frequent 30-day and 90-day readmission to inpatient or ER and the highest retreatment rate among all surgical techniques even when controlled for individual patient comorbidities and surgical volume.


Assuntos
Embolização Terapêutica , Sintomas do Trato Urinário Inferior , Hiperplasia Prostática , Ressecção Transuretral da Próstata , Masculino , Humanos , Próstata/cirurgia , Próstata/irrigação sanguínea , Ressecção Transuretral da Próstata/métodos , Hiperplasia Prostática/complicações , Hiperplasia Prostática/cirurgia , Embolização Terapêutica/efeitos adversos , Resultado do Tratamento , Sintomas do Trato Urinário Inferior/epidemiologia , Sintomas do Trato Urinário Inferior/etiologia , Sintomas do Trato Urinário Inferior/cirurgia , Artérias
17.
J Thorac Cardiovasc Surg ; 166(3): 728-737.e13, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-35216820

RESUMO

OBJECTIVES: The objectives of this study were to compare rates of mortality and reoperations for patients aged younger than 65 years who underwent surgical aortic valve replacement (AVR). AVR with a bioprosthetic valve (BV) is increasing among younger patients, however evidence to inform the choice between BV or mechanical valve is limited. METHODS: We performed a retrospective cohort study using linked hospital and mortality data from Australia, for 3969 AVR patients between 2003 and 2018. We compared outcomes for valves in inverse probability of treatment-weighted cohorts, stratified according to age (18-54 years; 55-64 years). We used weighted Cox regression models to estimate hazard ratios (HRs) and weighted cumulative incidence function for subdistribution hazards, for follow-up intervals: 0 to 10 and >10 to 15 years. RESULTS: Among patients aged 55 to 64 years, there was no difference in mortality at 0 to 10 years. However, at >10 to 15 years, mortality was higher among BV recipients (HR, 1.56; 95% CI, 1.01-2.42). There was no difference among patients aged 18 to 54 years. Reoperation rates for patients aged 55 to 64 years did not differ according to valve type at 0 to 10 years, but were higher for BV than mechanical valve at >10 to 15 years (HR, 2.87; 95% CI, 1.69-4.86). For patients aged 18 to 54 years, reoperation rates were consistently higher for BV at both time intervals (HR, 2.54 [95% CI, 1.03-6.25] and HR, 4.48 [95% CI, 2.15-9.32], respectively). CONCLUSIONS: Patients aged 55 to 64 years who received a BV had a higher risk of mortality beyond 10 years. Rates of reoperations were higher among patients implanted with a BV in the entire cohort. Further investigation of long-term outcomes among patients with a BV is necessary. Continuous long-term monitoring of BV technologies will ensure evidence-based decision-making and regulation.


Assuntos
Bioprótese , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Humanos , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Estudos Retrospectivos , Bioprótese/efeitos adversos , Próteses Valvulares Cardíacas/efeitos adversos , Reoperação , Resultado do Tratamento
18.
Ann Surg ; 277(4): e955-e962, 2023 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-35129507

RESUMO

OBJECTIVE: Compare long-term mortality, secondary intervention and secondary rupture following elective endovascular aneurysm repair (EVAR) and open surgical repair (OSR). BACKGROUND: EVAR has surpassed OSR as the most common procedure used to repair abdominal aortic aneurysm (AAA), but evidence regarding long-term outcomes is inconclusive. METHODS: We included patients in linked clinical registry and administrative data undergoing EVAR or OSR for intact AAA between January 2010 and June 2019. We used an inverse probability of treatment-weighted survival analysis to compare all-cause mortality, cause-specific mortality, secondary interventions and secondary rupture, and evaluate the impact of secondary interventions and secondary rupture on all-cause mortality. RESULTS: The study included 3460 EVAR and 427 OSR patients. Compared to OSR, the EVAR all-cause mortality rate was lower in the first 30 days [adjusted hazard ratio (HR) = 0.22, 95% confidence interval (CI) 0.140.33], but higher between 1 and 4 years (HR = 1.29, 95% CI 1.12-1.48) and after 4years (HR = 1.41, 95% CI 1.23-1.63). Secondary intervention rates were higher over the first 30 days (HR = 2.26, 95% CI 1.11-4.59), but lower between 1 and 4years (HR = 0.59, 95% CI 0.48-0.74). Secondary aortic intervention rates were higher across the entire follow-up period (HR = 2.52, 95% CI 2.06-3.07). Secondary rupture rates did not differ significantly (HR = 1.06, 95% CI 0.73-1.55). All-cause mortality beyond 1 year remained significantly higher for EVAR after adjusting for any secondary interventions, or secendary rupture. CONCLUSIONS: EVAR has an early survival benefit compared to OSR. However, elevated long-term mortality and higher rates of secondary aortic interventions and subsequent aneurysm repair suggest that EVAR may be a less durable method of aortic aneurysm exclusion.


Assuntos
Aneurisma da Aorta Abdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Humanos , Aneurisma da Aorta Abdominal/cirurgia , Dados de Saúde Coletados Rotineiramente , Procedimentos Endovasculares/métodos , Sistema de Registros , Resultado do Tratamento , Fatores de Risco , Estudos Retrospectivos , Complicações Pós-Operatórias
19.
Eur J Vasc Endovasc Surg ; 65(2): 272-280, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-36334901

RESUMO

OBJECTIVE: To compare rates of mortality, rupture, and secondary intervention following endovascular repair (EVAR) of intact abdominal aortic aneurysms (AAA) using contemporary endograft devices from three major manufacturers. METHODS: This was a retrospective cohort study using linked clinical registry (Australasian Vascular Audit) and all payer administrative data. Patients undergoing EVAR for intact AAA between 2010 and 2019 in New South Wales, Australia were identified. Rates of all cause death, secondary rupture, and secondary intervention (subsequent aneurysm repair; other secondary aortic intervention) were compared for patients treated with Cook, Medtronic, and Gore standard devices. Inverse probability of treatment weighted proportional hazards and competing risk regression were used to adjust for patient, clinical, and aneurysm characteristics, using Cook as the referent device. RESULTS: This study identified 2 874 eligible EVAR patients, with a median follow up of 4.1 (maximum 9.5) years. Mortality rates were similar for patients receiving different devices (ranging between 7.0 and 7.3 per 100 person years). There was no statistically significant difference between devices in secondary rupture rates, which ranged between 0.4 and 0.5 per 100 person years. Patients receiving Medtronic and Gore devices tended to have higher crude rates of subsequent aneurysm repair (1.5 per 100 person years) than patients receiving Cook devices (0.8 per 100 person years). This finding remained in the adjusted analysis, but was only statistically significant for Medtronic devices (HR 1.57, 95% CI 1.02 - 2.47; HR 1.73, 95% CI 0.94 - 3.18, respectively). CONCLUSION: Major endograft devices have similar overall long term safety profiles. However, there may be differences in rates of secondary intervention for some devices. This may reflect endograft durability, or patient selection for different devices based on aneurysm anatomy. Continuous comparative assessments are needed to guide evidence for treatment decisions across the range of available devices.

20.
Ann Vasc Surg ; 90: 85-92, 2023 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-36410641

RESUMO

BACKGROUND: Implanted devices undergo clinical trials to assess their safety and effectiveness. However, pivotal device trials are limited in their follow-up while postmarket surveillance may incompletely capture late failure. Linking clinical trials to Medicare claims can address these limitations. This study matched patients from investigational device exemption (IDE) clinical trials for endovascular aortic aneurysm repair (EVAR) to Medicare claims-based registry data to compare long-term device outcomes between the 2 sources. METHODS: Patient-level data from 2 industry-sponsored IDE trials of EVAR devices was provided by a single industry partner. Trial data were matched at the patient level to data from the Vascular Implant Surveillance and Interventional Outcomes Network (VISION), a registry that is a part of the Society for Vascular Surgery Patient Safety Organization. The primary outcomes analyzed were survival and freedom from aneurysm-related reintervention. RESULTS: Of 159 clinical trial patients, 134 were eligible for claims-based matching and 115 (85.5%) were successfully matched to VISION registry data. For the matched cohort, the Kaplan-Meier estimated survival was 94.8% at 1 year, 82.6% at 3 years, and 68.1% at 5 years. Estimates for freedom from reintervention were 90% at 1 year, 82.4% at 3 years, and 78.1% at 5 years. The estimates for survival were nearly identical between the clinical trial data and that found in the VISION data (log-rank P = 0.89). Freedom from reintervention was similar between the groups, with IDE trial reported freedom from reintervention of 87.3% and 73.3%, compared to VISION of 92.6% and 83% at 1 and 5 years, respectively (log-rank P = 0.13). CONCLUSIONS: Clinical trial patients who undergo EVAR can be successfully matched to claims-based registry data to improve long-term device surveillance and outcomes reporting. Claims-based results agreed well with IDE trial results for patients through 5 years, supporting the accuracy of claims-based data for longer-term surveillance. Linking clinical trial and claims-based registry data can lead to robust device monitoring.


Assuntos
Aneurisma da Aorta Abdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Idoso , Humanos , Estados Unidos , Aneurisma da Aorta Abdominal/cirurgia , Complicações Pós-Operatórias , Dados de Saúde Coletados Rotineiramente , Resultado do Tratamento , Medicare , Prótese Vascular , Fatores de Risco , Estudos Retrospectivos
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