RESUMO
BACKGROUND: Fenestrated-branched endovascular aortic repair (FB-EVAR) has been used as a minimally invasive alternative to open surgical repair to treat patients with thoracoabdominal aortic aneurysms (TAAAs). The aim of this study was to evaluate aortic-related mortality (ARM) and aortic aneurysm rupture after FB-EVAR of TAAAs. METHODS: Patients enrolled in 8 prospective, nonrandomized, physician-sponsored investigational device exemption studies between 2005 and 2020 who underwent elective FB-EVAR of asymptomatic intact TAAAs were analyzed. Primary end points were ARM, defined as any early mortality (30 days or in hospital) or late mortality from aortic rupture, dissection, organ or limb malperfusion attributable to aortic disease, complications of reinterventions, or aortic rupture. Secondary end points were early major adverse events, TAAA life-altering events (defined as death, permanent spinal cord injury, permanent dialysis, or stroke), all-cause mortality, and secondary interventions. RESULTS: A total of 1109 patients were analyzed; 589 (53.1%) had extent I-III and 520 (46.9%) had extent IV TAAAs. Median age was 73.4 years (interquartile range, 68.1-78.3 years); 368 (33.2%) were women. Early mortality was 2.7% (n=30); congestive heart failure was associated with early mortality (odds ratio, 3.30 [95% CI, 1.22-8.02]; P=0.01). Incidence of early aortic rupture was 0.4% (n=4). Incidence of early major adverse events and TAAA life-altering events was 20.4% (n=226) and 7.7% (n=85), respectively. There were 30 late ARMs; 5-year cumulative incidence was 3.8% (95% CI, 2.6%-5.4%); older age and extent I-III TAAAs were independently associated with late ARM (each P<0.05). Fourteen late aortic ruptures occurred; 5-year cumulative incidence was 2.7% (95% CI, 1.2%-4.3%); extent I-III TAAAs were associated with late aortic rupture (hazard ratio, 5.85 [95% CI, 1.31-26.2]; P=0.02). Five-year all-cause mortality was 45.7% (95% CI, 41.7%-49.4%). Five-year cumulative incidence of secondary intervention was 40.3% (95% CI, 35.8%-44.5%). CONCLUSIONS: ARM and aortic rupture are uncommon after elective FB-EVAR of asymptomatic intact TAAAs. Half of the ARMs occurred early, and most of the late deaths were not aortic related. Late all-cause mortality rate and the need for secondary interventions were 46% and 40%, respectively, 5 years after FB-EVAR. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT02089607, NCT02050113, NCT02266719, NCT02323581, NCT00583817, NCT01654133, NCT00483249, NCT02043691, and NCT01874197.
RESUMO
BACKGROUND: Patients with chronic limb-threatening ischemia (CLTI) require revascularization to improve limb perfusion and thereby limit the risk of amputation. It is uncertain whether an initial strategy of endovascular therapy or surgical revascularization for CLTI is superior for improving limb outcomes. METHODS: In this international, randomized trial, we enrolled 1830 patients with CLTI and infrainguinal peripheral artery disease in two parallel-cohort trials. Patients who had a single segment of great saphenous vein that could be used for surgery were assigned to cohort 1. Patients who needed an alternative bypass conduit were assigned to cohort 2. The primary outcome was a composite of a major adverse limb event - which was defined as amputation above the ankle or a major limb reintervention (a new bypass graft or graft revision, thrombectomy, or thrombolysis) - or death from any cause. RESULTS: In cohort 1, after a median follow-up of 2.7 years, a primary-outcome event occurred in 302 of 709 patients (42.6%) in the surgical group and in 408 of 711 patients (57.4%) in the endovascular group (hazard ratio, 0.68; 95% confidence interval [CI], 0.59 to 0.79; P<0.001). In cohort 2, a primary-outcome event occurred in 83 of 194 patients (42.8%) in the surgical group and in 95 of 199 patients (47.7%) in the endovascular group (hazard ratio, 0.79; 95% CI, 0.58 to 1.06; P = 0.12) after a median follow-up of 1.6 years. The incidence of adverse events was similar in the two groups in the two cohorts. CONCLUSIONS: Among patients with CLTI who had an adequate great saphenous vein for surgical revascularization (cohort 1), the incidence of a major adverse limb event or death was significantly lower in the surgical group than in the endovascular group. Among the patients who lacked an adequate saphenous vein conduit (cohort 2), the outcomes in the two groups were similar. (Funded by the National Heart, Lung, and Blood Institute; BEST-CLI ClinicalTrials.gov number, NCT02060630.).
Assuntos
Isquemia Crônica Crítica de Membro , Salvamento de Membro , Procedimentos Cirúrgicos Vasculares , Humanos , Isquemia Crônica Crítica de Membro/cirurgia , Isquemia Crônica Crítica de Membro/terapia , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/métodos , Salvamento de Membro/efeitos adversos , Salvamento de Membro/métodos , Estudos Retrospectivos , Fatores de Risco , Resultado do Tratamento , Procedimentos Cirúrgicos Vasculares/efeitos adversos , Procedimentos Cirúrgicos Vasculares/métodos , Veia Safena/transplanteRESUMO
OBJECTIVE: Cumulative, probability-based metrics are regularly used to measure quality in professional sports, but these methods have not been applied to health care delivery. These techniques have the potential to be particularly useful in describing surgical quality, where case volume is variable and outcomes tend to be dominated by statistical "noise." The established statistical technique used to adjust for differences in case volume is reliability-adjustment, which emphasizes statistical "signal" but has several limitations. We sought to validate a novel measure of surgical quality based on earned outcomes methods (deaths above average [DAA]) against reliability-adjusted mortality rates, using abdominal aortic aneurysm (AAA) repair outcomes to illustrate the measure's performance. METHODS: Earned outcomes methods were used to calculate the outcome of interest for each patient: DAA. Hospital-level DAA was calculated for non-ruptured open AAA repair and endovascular aortic repair (EVAR) in the Vascular Quality Initiative database from 2016 to 2019. DAA for each center is the sum of observed - predicted risk of death for each patient; predicted risk of death was calculated using established multivariable logistic regression modeling. Correlations of DAA with reliability-adjusted mortality rates and procedure volume were determined. Because an accurate quality metric should correlate with future results, outcomes from 2016 to 2017 were used to categorize hospital quality based on: (1) risk-adjusted mortality; (2) risk- and reliability-adjusted mortality; and (3) DAA. The best performing quality metric was determined by comparing the ability of these categories to predict 2018 to 2019 risk-adjusted outcomes. RESULTS: During the study period, 3734 patients underwent open repair (106 hospitals), and 20,680 patients underwent EVAR (183 hospitals). DAA was closely correlated with reliability-adjusted mortality rates for open repair (r = 0.94; P < .001) and EVAR (r = 0.99; P < .001). DAA also correlated with hospital case volume for open repair (r = -.54; P < .001), but not EVAR (r = 0.07; P = .3). In 2016 to 2017, most hospitals had 0% mortality (55% open repair, 57% EVAR), making it impossible to evaluate these hospitals using traditional risk-adjusted mortality rates alone. Further, zero mortality hospitals in 2016 to 2017 did not demonstrate improved outcomes in 2018 to 2019 for open repair (3.8% vs 4.6%; P = .5) or EVAR (0.8% vs 1.0%; P = .2) compared with all other hospitals. In contrast to traditional risk-adjustment, 2016 to 2017 DAA evenly divided centers into quality quartiles that predicted 2018 to 2019 performance with increased mortality rate associated with each decrement in quality quartile (Q1, 3.2%; Q2, 4.0%; Q3, 5.1%; Q4, 6.0%). There was a significantly higher risk of mortality at worst quartile open repair hospitals compared with best quartile hospitals (odds ratio, 2.01; 95% confidence interval, 1.07-3.76; P = .03). Using 2016 to 2019 DAA to define quality, highest quality quartile open repair hospitals had lower median DAA compared with lowest quality quartile hospitals (-1.18 DAA vs +1.32 DAA; P < .001), correlating with lower median reliability-adjusted mortality rates (3.6% vs 5.1%; P < .001). CONCLUSIONS: Adjustment for differences in hospital volume is essential when measuring hospital-level outcomes. Earned outcomes accurately categorize hospital quality and correlate with reliability-adjustment but are easier to calculate and interpret. From 2016 to 2019, highest quality open AAA repair hospitals prevented >40 perioperative deaths compared with the average hospital, and >80 perioperative deaths compared with lowest quality hospitals.
RESUMO
BACKGROUND: Polyvascular disease is strongly associated with increased risk of cardiovascular morbidity and mortality. However, its prevalence in patients undergoing carotid and lower extremity surgical revascularization and its impact on outcomes are unknown. METHODS: The Vascular Quality Initiative was queried for carotid endarterectomy (CEA) or infrainguinal lower extremity bypass (LEB), 2013-2019. Polyvascular disease was defined as presence of atherosclerotic occlusive disease in more than one arterial bed: carotid, coronary, and infrainguinal. Primary outcomes were (1) composite perioperative myocardial infarction (MI) or death and (2) 5-year survival. Patient characteristics and perioperative outcomes were evaluated using the χ2 test and multivariable logistic regression. Survival was analyzed using Kaplan-Meier method and Cox proportional hazards multivariable models. RESULTS: Polyvascular disease was identified in 47% of CEA (39.0% in 2 arterial beds, 7.6% in 3 arterial beds; n = 93,736) and 47% of LEB (41.0% in 2 arterial beds, 5.7% in 3 arterial beds; n = 25,223). For both CEA and LEB, patients with polyvascular disease had more comorbidities including hypertension, congestive heart disease, chronic obstructive pulmonary disease, smoking, diabetes mellitus, and end-stage renal disease (P < .0001). Perioperative MI/death rates increased with increasing number of vascular beds affected following CEA (0.9% in 1 bed vs 1.5% in 2 beds vs 2.7% in 3 beds; P < .001) and LEB (2.2% in 1 bed vs 5.3% in 2 beds vs 6.6% in 3 beds; P < .001). Polyvascular disease was associated independently with perioperative MI/death after CEA (odds ratio, 1.59; 95% confidence interval [CI], 1.40-1.81;P < .0001) and LEB (odds ratio, 1.78; 95% CI, 1.52-2.08; P < .0001). Five-year survival was decreased in patients with polyvascular disease after CEA (82% in 3 beds vs 88% in 2 beds vs 92% in 1 bed; P < .01) and LEB (72% in 3 beds vs 75% in 2 beds vs 84% in 1 bed; P < .01) in a dose-dependent manner, with the lowest 5-year survival observed in those with three arterial beds involved. Polyvascular disease was independently associated with 5-year mortality after CEA (hazard ratio, 1.33; 95% CI, 1.24-1.40; P = .0001) and LEB (hazard ratio, 1.30; 95% CI, 1.20-1.41; P = .0001). CONCLUSIONS: Polyvascular disease is common in patients undergoing CEA and LEB and is associated with a higher risk of perioperative MI/death and decreased long-term survival. After revascularization, patients with polyvascular disease should be considered for more aggressive cardioprotective medications and closer follow-up.
RESUMO
OBJECTIVES: Postoperative readmissions are common and costly. Office-initiated phone calls to patients shortly after discharge may identify concerns and allow for early intervention to prevent readmission. We sought to evaluate our 30-day readmission rate after the implementation of a standardized postoperative discharge phone call (PODPC) intervention, compared with a historical aggregated cohort. METHODS: From July 2020 to 21, postoperative patients were prospectively identified at 48 hour after discharge. Medical assistants performed PODPCs, administering a survey designed to identify medical/surgical issues that could signify a complication and warrant escalation to a nurse practitioner (NP) for further management. Demographics, comorbidities, and procedure type were obtained retrospectively. Descriptive statistics were used to evaluate PODPC responses, frequency of escalation, readmission, and reasons. The electronic medical record identified a historical aggregated cohort (July 2018 to 2019) and the 30-day readmission rate. A χ2 analysis was used to compare readmission rates between the preintervention historical and PODPC intervention groups. Predictors of 30-day readmission were modeled with multivariable logistic regression. RESULTS: Of 411 PODPCs conducted, 106 patients (26%) reported not feeling well; having concerns. Eighty-four PODPCs (20%) triggered escalation to a NP; of these, 60 patients (71%) were counseled over the phone by an NP, 16 (19%) were brought into clinic, 6 (7%) were sent to the emergency department, and 2 (2%) did not answer the NP call. Of 411 patients, 17% (n = 68) were readmitted within 30 days. Comparatively, the historical aggregated cohort readmission rate was significantly higher at 28% (n = 346; P < .001). On multivariable analysis, chronic obstructive pulmonary disease (odds ratio [OR], 1.92; 95% confidence interval [CI], 1.01-3.65; P = .046), and feeling run down; having difficulty with movement; needing assistance for most activities (OR, 3.94; 95% CI, 2.09-7.43; P < .0001) were predictive of 30-day readmission when controlling for procedure type. CONCLUSIONS: Although readmissions remained common (>15%), being in the intervention cohort was associated with a significantly lower readmission rate compared with the historical aggregated cohort. One-fifth of PODPCs identified a concern; however, >90% of these could be managed by an NP by phone or in clinic. This PODPC intervention holds promise as a viable mechanism for decreasing readmissions.
Assuntos
Alta do Paciente , Readmissão do Paciente , Humanos , Estudos Retrospectivos , Comorbidade , Complicações Pós-Operatórias/etiologia , Fatores de RiscoRESUMO
OBJECTIVE: Based on data supporting a volume-outcome relationship in elective aortic aneurysm repair, the Society of Vascular Surgery (SVS) guidelines recommend that endovascular aortic repair (EVAR) be localized to centers that perform ≥10 operations annually and have a perioperative mortality and conversion-to-open rate of ≤2% and that open aortic repair (OAR) be localized to centers that perform ≥10 open aortic operations annually and have a perioperative mortality ≤5%. However, the number and distribution of centers meeting the SVS criteria remains unclear. This study aimed to estimate the temporal trends and geographic distribution of Centers Meeting the SVS Aortic Guidelines (CMAG) in the United States. METHODS: The SVS Vascular Quality Initiative was queried for all OAR, aortic bypasses, and EVAR from 2011 to 2019. Annual OAR and EVAR volume, 30-day elective operative mortality for OAR or EVAR, and EVAR conversion-to-open rate for all centers were calculated. The SVS guidelines for OAR and EVAR, individually and combined, were applied to each institution leading to a CMAG designation. The proportion of CMAGs by region (West, Midwest, South, and Northeast) were compared by year using a χ2 test. Temporal trends were estimated using a multivariable logistic regression for CMAG, adjusting by region. RESULTS: Overall, 67,865 patients (49,264 EVAR; 11,010 OAR; 7591 aortic bypasses) at 336 institutions were examined. The proportion of EVAR CMAGs increased nationally by 1.7% annually from 51.6% (n = 33/64) in 2011 to 67.1% (n = 190/283) in 2019 (ß = .05; 95% confidence interval [CI], 0.01-0.09; P = .02). The proportion of EVAR CMAGs across regions ranged from 27.3% to 66.7% in 2011 to 63.9% to 72.9% in 2019. In contrast, the proportion of OAR CMAGs has decreased nationally by 1.8% annually from 32.8% (n = 21/64) in 2011 to 16.3% (n = 46/283) in 2019 (ß = -.14; 95% CI, -0.19 to -0.10; P < .01). Combined EVAR and OAR CMAGs were even less frequent and decreased by 1.5% annually from 26.6% (n = 17/64) in 2011 to 13.1% (n = 37/283) in 2019 (ß = -.12; 95% CI, -0.17 to -0.07; P < .01). In 2019, there was no significant difference in regional variation of the proportion of combined EVAR and OAR CMAGs (P = .82). CONCLUSIONS: Although an increasing proportion of institutions nationally meet the SVS guidelines for EVAR, a smaller proportion meet them for OAR, with a concerning downward trend. These data question whether we can safely offer OAR at most institutions, have important implications about sufficient OAR exposure for trainees, and support regionalization of OAR.
Assuntos
Aneurisma da Aorta Abdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Especialidades Cirúrgicas , Humanos , Estados Unidos/epidemiologia , Procedimentos Endovasculares/efeitos adversos , Prevalência , Resultado do Tratamento , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/cirurgia , Estudos Retrospectivos , Fatores de Risco , Implante de Prótese Vascular/efeitos adversosRESUMO
OBJECTIVE: Treatment goals of prophylactic endovascular aortic repair of complex aneurysms involving the renal-mesenteric arteries (complex endovascular aortic repair [cEVAR]) include achieving both technical success and long-term survival benefit. Mortality within the first year after cEVAR likely indicates treatment failure owing to associated costs and procedural complexity. Notably, no validated clinical decision aid tools exist that reliably predict mortality after cEVAR. The purpose of this study was to derive and validate a preoperative prediction model of 1-year mortality after elective cEVAR. METHODS: All elective cEVARs including fenestrated, branched, and/or chimney procedures for aortic disease extent confined proximally to Ishimaru landing zones 6 to 9 in the Society for Vascular Surgery Vascular Quality Initiative were identified (January 2012 to August 2023). Patients (n = 4053) were randomly divided into training (n = 3039) and validation (n = 1014) datasets. A logistic regression model for 1-year mortality was created and internally validated by bootstrapping the AUC and calibration intercept and slope, and by using the model to predict 1-year mortality in the validation dataset. Independent predictors were assigned an integer score, based on model beta-coefficients, to generate a simplified scoring system to categorize patient risk. RESULTS: The overall crude 1-year mortality rate after elective cEVAR was 11.3% (n = 456/4053). Independent preoperative predictors of 1-year mortality included chronic obstructive pulmonary disease, chronic renal insufficiency (creatinine >1.8 mg/dL or dialysis dependence), hemoglobin <12 g/dL, decreasing body mass index, congestive heart failure, increasing age, American Society of Anesthesiologists class ≥IV, current tobacco use, history of peripheral vascular intervention, and increasing extent of aortic disease. The 1-year mortality rate varied from 4% among the 23% of patients classified as low risk to 23% for the 24% classified as high risk. Performance of the model in validation was comparable with performance in the training data. The internally validated scoring system classified patients roughly into quartiles of risk (low, low/medium, medium/high and high), with 52% of patients categorized as medium/high to high risk, which had corresponding 1-year mortality rates of 11% and 23%, respectively. Aneurysm diameter was below Society for Vascular Surgery recommended treatment thresholds (<5.0 cm in females, <5.5 cm in males) in 17% of patients (n = 679/3961), 41% of whom were categorized as medium/high or high risk. This subgroup had significantly increased in-hospital complication rates (18% vs 12%; P = .02) and 1-year mortality (13% vs 5%; P < .0001) compared with patients in the low- or low/medium-risk groups with guideline-compliant aneurysm diameters (≥5.0 cm in females, ≥5.5 cm in males). CONCLUSIONS: This validated preoperative prediction model for 1-year mortality after cEVAR incorporates physiological, functional, and anatomical variables. This novel and simplified scoring system can effectively discriminate mortality risk and, when applied prospectively, may facilitate improved preoperative decision-making, complex aneurysm care delivery, and resource allocation.
Assuntos
Aneurisma da Aorta Abdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Masculino , Feminino , Humanos , Medição de Risco , Aneurisma da Aorta Abdominal/cirurgia , Resultado do Tratamento , Fatores de Risco , Estudos Retrospectivos , Complicações Pós-Operatórias/etiologiaRESUMO
BACKGROUND: Endovascular techniques have transformed the management of thoracoabdominal aortic aneurysms (TAAAs). However, spinal cord ischemia (SCI) remains a prevalent and devastating complication. Prophylactic drainage of cerebrospinal fluid (CSF) is among the proposed strategies for prevention of SCI. Although prophylactic CSF drainage is widely used and conceptually attractive, prophylactic CSF drains have not been demonstrated to definitively prevent the occurrence nor mitigate the severity of SCI in endovascular TAAA repair. Whether or not outcomes of prophylactic drains are superior to therapeutic drains remains unknown. This pilot study was performed to determine the feasibility of a randomized clinical trial designed to investigate the role of prophylactic vs therapeutic CSF drains in the prevention of SCI in patients undergoing endovascular TAAA repair using branched and fenestrated endovascular aortic repair (FBEVAR). METHODS: This was a prospective multicenter randomized pilot clinical trial conducted at The University of Alabama at Birmingham and The University of Massachusetts. Twenty patients were enrolled and randomized to either the prophylactic drainage or therapeutic drainage groups, prior to undergoing FBEVAR for extensive TAAAs and arch aortic aneurysms. This was a pilot feasibility study that was not powered to detect statistical differences in clinical outcomes. The primary outcome was feasibility of randomization and compliance with a shared lumbar drain protocol. Secondary outcomes included rate of drain complications and SCI. RESULTS: Twenty patients were enrolled and successfully randomized, without any crossovers, to either the control cohort (n = 10), without prophylactic drains, or the experimental cohort (n = 10), with prophylactic drains. There were no differences in age, comorbidities, or history of prior aortic surgery across the cohorts. All patients were treated with FBEVAR. Aneurysm classifications were as follows: Extent I (10%), Extent II (50%), Extent III (35%), and Extent IV (5%). The average length of aortic coverage was 207 ± 21.6 mm. The length of aortic coverage did not vary across cohorts, nor did procedural times or blood loss volume. Compliance with the SCI prevention protocol was 100% across both groups. Within the prophylactic drain cohort, one patient experienced an adverse event related to lumbar drain placement, manifested as an epidural hematoma requiring laminectomy, without neurologic deficit (n = 1/10; 10%). There was one SCI event (n = 1/20; 5%), which occurred in the prophylactic drain cohort on postoperative day 9 following an episode of hypotension related to a gastrointestinal bleed. CONCLUSIONS: The role of prophylactic CSF drains for the prevention of SCI following endovascular TAAA repair is a topic of ongoing research, with many current practices based on expert opinion and experience, rather than rigorous scientific data. This study demonstrates the feasibility of a multicenter randomized clinical trial to evaluate the role of prophylactic vs therapeutic CSF drains in the prevention of SCI in patients undergoing endovascular TAAA repair.
Assuntos
Aneurisma da Aorta Torácica , Implante de Prótese Vascular , Drenagem , Procedimentos Endovasculares , Estudos de Viabilidade , Isquemia do Cordão Espinal , Humanos , Aneurisma da Aorta Torácica/cirurgia , Projetos Piloto , Procedimentos Endovasculares/efeitos adversos , Drenagem/efeitos adversos , Drenagem/instrumentação , Masculino , Estudos Prospectivos , Feminino , Idoso , Resultado do Tratamento , Implante de Prótese Vascular/efeitos adversos , Isquemia do Cordão Espinal/prevenção & controle , Isquemia do Cordão Espinal/etiologia , Pessoa de Meia-Idade , Fatores de Tempo , Aneurisma da Aorta ToracoabdominalRESUMO
INTRODUCTION: Utilization of standard bifurcate pieces in fenestrated/branched endovascular aortic repair (F/BEVAR) requires adequate length from the lowest branch or fenestration to the aortic bifurcation. In patients with prior aortic surgery, the aortic bifurcation is often artificially established in a more proximal position, compromising the infrarenal length, which hinders the placement of a standard bifurcate component below the fenestrated/branched component. Short bifurcate bodies utilizing an inverted contralateral limb have been purpose-built to address this challenge. However, reported outcomes for this device remain limited, with specific concerns about the durability of the inverted iliac limb sealing region. We sought to evaluate outcomes of F/BEVAR utilizing an investigational inverted iliac limb bifurcate, manufactured by Cook Medical. METHODS: This study was a retrospective review of prospectively maintained data from the US-Aortic Research Consortium (US-ARC) from 2005-2022. Patients were included if they underwent F/BEVAR for thoracoabdominal or complex abdominal aortic aneurysms. Patients were excluded if they did not have a bifurcate device placed. Patients were then compared based on the utilization of an inverted iliac limb or standard bifurcate component. The primary outcome for this study was technical success. Secondary outcomes included 30-day mortality, freedom from ischemic leg complications, freedom from type 1 endoleaks (T1ELs), freedom from type 2 endoleaks (T2ELs), freedom from type 3 endoleaks (T3ELs), and graft component separations. RESULTS: A total of 1,944 patients met study criteria with 442 (22.8%) inverted iliac limb bifurcates and 1,502 (77.2%) standard bifurcates. Patients who received inverted iliac limbs were more likely to have had prior aortic surgery (63.8% versus 28.5%, P<.001). Patients receiving inverted iliac limbs had longer procedure times (265 minutes [IQR 201-342 minutes] versus 241 minutes [IQR 186-313 minutes], P<.001), more contrast usage (89 mL [IQR 55-135] versus 109 mL [IQR 75-156 mL], P<.001), and higher estimated blood loss (250 mL [IQR 150-500 mL] versus 250 mL [IQR 110-400 mL], P=.042). There were no differences in rates of technical success (97.3% versus 96.1%, P=.310), rates of endoleaks upon completion of the case (18.0% versus 21.4%, P=.123) or 30-day mortality (1.8% versus 2.5%, P=.466) between patients receiving inverted bifurcates and standard bifurcated components. There were no differences in cumulative survival, freedom from limb ischemia, freedom from aneurysm rupture, and freedom from T3ELs over the course of 5 years between patients receiving inverted bifurcates and standard bifurcated components. Patients with inverted iliac limb bifurcate components had decreased freedom from reinterventions, T1ELs, and T2ELs. After adjustment of potential confounders, the use of an inverted iliac limb was not associated with reinterventions (HR 1.044, 95 % CI 0.849-1.285, P=.682). There was a total of 2 (0.1%) component separations of the bifurcate component from the fenestrated/branched component over the study period, both of which occurred in the standard bifurcate components. CONCLUSION: The use of investigational inverted iliac limb bifurcate components is a safe option with favorable mid-term outcomes in patients who are not anatomic candidates for standard bifurcate components. Patients undergoing investigational inverted iliac limb bifurcate component implantation had decreased freedom from reinterventions which likely corresponds to the complexity of repair associated with them.
RESUMO
BACKGROUND: Early survival (1-year) after elective repair of complex abdominal aortic aneurysms (AAA) or thoracoabdominal aortic aneurysms (TAAA) can be used as an indicator of successful repair and provides a reasonable countermeasure to the annual rupture risk based on diameter. We aimed to identify preoperative factors associated with 1-year mortality after fenestrated or branched endovascular aortic repair (F/BEVAR) and develop a predictive model for 1-year mortality based on patient-specific risk profiles. METHODS: The US-Aortic Research Consortium database was queried for all patients undergoing elective F/BEVAR for complex AAA (cAAA) or TAAA from 2005 to 2022. The primary outcome was 1-year survival based on preoperative risk profile. Multivariable Cox regression was used to determine preoperative variables associated with 1-year mortality overall and by extent of aortic pathology. Logistic regression was performed to build a predictive model for 1-year mortality based on number of risk factors present. RESULTS: A total of 2099 patients met the inclusion criteria for this study (cAAA: n = 709 [34.3%]; type 1-3 TAAA: n = 777 [37.6%]; type 4-5 TAAA: n = 580 [28.1%]). Multivariable Cox regression identified the following significant risk factors associated with 1-year mortality: current smoker, chronic obstructive pulmonary disease, congestive heart failure (CHF), aortic diameter >7 cm, age >75 years, extent 1-3, creatinine >1.7 mg/dL, and hematocrit <36%. When stratified by extent of aortic involvement, multivariable Cox regression revealed risk factors for 1-year mortality in cAAA (CHF maximum aortic diameter >7 cm, hematocrit <36 mg/dL, and current smoking status), type 1-3 TAAA (chronic obstructive pulmonary disease, CHF, and age >75 years), and type 4-5 TAAA (age >75 years, creatinine >1.7 mg/dL, and hematocrit <36 mg/dL). Logistic regression was then used to develop a predictive model for 1-year mortality based on patient risk profile. Appraisal of the model revealed an area under the curve of 0.64 (P < .001), and an observed to expected ratio of 0.85. CONCLUSIONS: This study describes multiple risk factors associated with an increase in 1-year mortality after F/BEVAR. Given that elective repair of cAAA or TAAA is offered to some patients in whom future rupture risk outweighs operative risk, these findings suggest that highly comorbid patients with smaller aneurysms may not benefit from repair. Descriptive and predictive models for 1-year mortality based on patient risk profiles can serve as an adjunct in clinical decision-making when considering elective F/BEVAR.
RESUMO
OBJECTIVE: Antiplatelet and/or anticoagulant therapy are commonly prescribed after fenestrated/branched endovascular aortic repair (F/BEVAR). However, the optimal regimen remains unknown. We sought to characterize practice patterns and outcomes of antiplatelet and anticoagulant use in patients who underwent F/BEVAR. METHODS: Consecutive patients enrolled (2012-2023) as part of the United States Aortic Research Consortium (US-ARC) from 10 independent physician-sponsored investigational device exemption studies were evaluated. The cohort was characterized by medication regimen on discharge from index F/BEVAR: (1) Aspirin alone OR P2Y12 alone (single-antiplatelet therapy [SAPT]); (2) Anticoagulant alone; (3) Aspirin + P2Y12 (dual-antiplatelet therapy [DAPT]); (4) Aspirin + anticoagulant OR P2Y12 + anticoagulant (SAPT + anticoagulant); (5) Aspirin + P2Y12 + anticoagulant (triple therapy [TT]); and (6) No therapy. Kaplan-Meier analysis and Cox proportional hazards modeling were used to compare 1-year outcomes including survival, target artery patency, freedom from bleeding complication, freedom from all reinterventions, and freedom from stent-specific reintervention. RESULTS: Of the 1525 patients with complete exposure and outcome data, 49.6% were discharged on DAPT, 28.8% on SAPT, 13.6% on SAPT + anticoagulant, 3.2% on TT, 2.6% on anticoagulant alone, and 2.2% on no therapy. Discharge medication regimen was not associated with differences in 1-year survival, bleeding complications, composite reintervention rate, or stent-specific reintervention rate. However, there was a significant difference in 1-year target artery patency. On multivariable analysis comparing with SAPT, DAPT conferred a lower hazard of loss of target artery patency (hazard ratio [HR], 0.48; 95% confidence interval [CI], 0.27-0.84; P = .01). On sub-analyses of renal stents alone or visceral stents alone, DAPT no longer had a significantly lower hazard of loss of target artery patency (renal: HR, 0.66; 95% CI, 0.35-1.27; P = .22; visceral: HR, 0.31; 95% CI, 0.05-1.9; P = .21). Lastly, duration of DAPT therapy (1 month, 6 months, or 1 year) did not significantly affect target artery patency. CONCLUSIONS: Practice patterns for antiplatelet and anticoagulant regimens after F/BEVAR vary widely across the US-ARC. There were no differences in bleeding complications, survival or reintervention rates among different regimens, but higher branch vessel patency was noted in the DAPT cohort. These data suggest there is a benefit in DAPT therapy. However, the generalizability of this finding is limited by the retrospective nature of this data, and the clinical significance of this finding is unclear, as there is no difference in survival, bleeding, or reintervention rates amongst the different regimens. Hence, an "optimal" regimen, including the duration of such regimen, could not be clearly discerned. This suggests equipoise for a randomized trial, nested within this cohort, to identify the most effective antiplatelet/anticoagulant regimen for the growing number of patients being treated globally with F/BEVAR.
RESUMO
OBJECTIVES: Aneurysm sac changes after fenestrated-branched endovascular aneurysm repair (FBEVAR) for postdissection thoracoabdominal aortic aneurysms (PD-TAAs) are poorly understood. Partial thrombosis of the false lumen and endoleaks may impair sac regression. To characterize sac changes after FBEVAR for PD-TAAs, this study examined midterm results and predictors for sac enlargement. METHODS: FBEVARs performed for PD-TAAs in 10 physician-sponsored investigational device exemption studies from 2008 to 2023 were analyzed. The maximum aortic aneurysm diameter was compared between the 30-day computed tomography angiogram and follow-up imaging studies. Aneurysm sac enlargement was defined as an increase in diameter of ≥5 mm. Kaplan-Meier curves and Cox regression were used to evaluate sac enlargement and midterm FBEVAR outcomes. RESULTS: Among 3296 FBEVARs, 290 patients (72.4% male; median age, 68.4 years) were treated for PD-TAAs. Most aneurysms treated were extent II (72%) and III (12%). Mean aneurysm diameter was 66.5 ± 11.2 mm. Mortality at 30 days was 1.4%. At a mean follow-up of 2.9 ± 1.9 years, at least one follow-up imaging study revealed sac enlargement in 43 patients (15%), sac regression in 115 patients (40%), and neither enlargement nor regression in 137 (47%); 5 (2%) demonstrated both expansion and regression during follow-up. Freedom from aneurysm sac enlargement was 93%, 82%, and 80% at 1, 3, and 5 years, respectively. Overall, endoleaks were detected in 27 patients (63%) with sac enlargement and 143 patients (58%) without enlargement (P = .54). Sac enlargement was significantly more frequent among older patients (mean age at the index procedure, 70.2 ± 8.9 years vs 66.5 ± 11 years; P = .04) and those with type II endoleaks at 1 year (74% vs 52%; P = .031). Cox regression revealed age >70 years at baseline (hazard ratio [HR], 2.146; 95% confidence interval [CI], 1.167-3.944; P = .010) and presence of type II endoleak at 1 year (HR, 2.25; 95% CI, 1.07-4.79; P = .032) were independent predictors of sac enlargement. Patient survival was 92%, 81%, and 68% at 1, 3, and 5 years, respectively. Cumulative target vessel instability was 7%, and aneurysm-related mortality was 2% at 5 years. At least 42% of patients required secondary interventions. Sac enlargement did not affect patient survival. CONCLUSIONS: Aneurysm sac enlargement occurs in 15% of patients after FBEVAR for PD-TAAs. Elderly patients (>70 years at baseline) and those with type II endoleaks at 1 year may need closer monitoring and secondary interventions to prevent sac enlargement. Despite sac enlargement in some patients, aneurysm-related mortality at 5 years remains low and overall survival was not associated with sac enlargement.
RESUMO
OBJECTIVE: The clinical significance of family history (FH) of aortic disease on the outcomes of fenestrated and branched endovascular aneurysm repair (FB-EVAR) has not been well described. This study aimed to assess how FH of aortic disease affects outcomes following FB-EVAR for complex aortic aneurysms (CAAs). METHODS: This study retrospectively reviewed the clinical data of consecutive patients enrolled in 10 ongoing, prospective, non-randomised, physician sponsored, investigational device exemption studies to evaluate FB-EVAR (2005 - 2022) in the United States Aortic Research Consortium database. Patients were stratified by presence or absence of FH of any aortic disease in any relative. Patients with confirmed genetically triggered aortic diseases were excluded. Primary outcomes were 30 day major adverse events (MAEs) and late survival. Secondary outcomes included late secondary interventions and aneurysm sac enlargement. RESULTS: During the study period, 2 901 patients underwent FB-EVAR. A total of 2 355 patients (81.2%) were included in the final analysis: 427 (18.1%) with and 1 928 (81.9%) without a FH of aortic disease. Patient demographics, clinical characteristics, and aneurysm extent were similar between the groups. Patients with a FH of aortic disease more frequently had prior open abdominal aortic repair, but less frequently had prior endovascular aneurysm repair (p < .050). There were no statistically significant differences in 30 day mortality (4% vs. 2%; p = .12) and MAEs (12% vs. 12%; p = .89) for patients with or without a FH of aortic disease. Three year survival estimates were 71% (95% confidence interval [CI] 67 - 78%) and 71% (95% CI 68 - 74%), respectively (p = .74). Freedom from secondary intervention and aneurysm sac enlargement were also not statistically significantly different between groups. CONCLUSION: A FH of aortic disease had no impact on 30 day or midterm outcomes of FB-EVAR of CAAs. In the absence of an identified genetically triggered aortic disease, treatment selection for CAAs should be based on clinical risk and patient anatomy rather than FH of aortic disease.
RESUMO
OBJECTIVE: BEST-CLI, an international randomised trial, compared bypass surgery with endovascular treatment in chronic limb threatening ischaemia (CLTI). In this substudy, overall amputation rates and risk of major amputation as an initial or subsequent outcome were evaluated. METHODS: A total of 1 830 patients were randomised to receive surgical or endovascular treatment:(1) patients with adequate single segment great saphenous vein (SSGSV) (n = 1 434); and (2) patients without adequate SSGSV (n = 396). Differences in time to first event and number of amputations were evaluated. RESULTS: In cohort 1, 410 (45.6%) total amputation events occurred in the surgical group vs. 490 (54.4%) in the endovascular group (p = .001) during mean follow up of 2.7 years. Every third patient underwent minor amputation after index revascularisation: 31.5% of the surgical group vs. 34.9% in the endovascular group (p = .17). Subsequent major amputation was required significantly less often in the surgical group compared with the endovascular group (15.0% vs. 25.6%; p = .002). The first amputation was major in 5.6% of patients in the surgical and 6.0% in the endovascular group (p = .72). Major amputation was required in 10.3% (n = 74/718) of patients in the surgical group and 14.9% (n = 107/716) in the endovascular group (p = .008). In cohort 2, 199 amputation events occurred in 132 (33.3%) patients during mean follow up of 1.6 years: 95 (47.7%) in the surgical vs. 104 (52.3%) in the endovascular group (p = .49). Major amputation was required in 15.2% (n = 30/197) of the patients in the surgical and 14.1% (n = 28/199) in the endovascular group (p = .74). CONCLUSION: In patients with CLTI, surgical bypass with SSGSV was more effective than endovascular treatment in preventing major amputations because of a decrease in major amputations subsequent to minor amputations.
RESUMO
OBJECTIVE: To report mid-term outcomes of renal-mesenteric target arteries (TAs) after fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal and thoracoabdominal aortic aneurysm. BACKGROUND: TA instability (TAI) is the most frequent indication for reintervention after FB-EVAR. METHODS: Data from consecutive patients enrolled in 9 prospective nonrandomized physician-sponsored investigational device exemption studies between 2005 and 2020 were reviewed. TA outcomes through 5 years of follow-up were analyzed for vessels incorporated by fenestrations or directional branches (DBs), including TA patency, endoleak, integrity failure, reintervention, and instability. RESULTS: A total of 1681 patients had 6349 renal-mesenteric arteries were targeted using 3720 fenestrations (59%), 2435 DBs (38%), and 194 scallops (3%). Mean follow was 23 ± 21 months. At 5 years, TAs incorporated by fenestrations had higher primary (95 ± 1% vs 91 ± 1%, P < 0.001) and secondary patency (98 ± 1% vs 94 ± 1%, P < 0.001), and higher freedom from TAI (87 ± 2% vs 84 ± 2%, P = 0.002) compared with TAs incorporated by DBs, with no differences in other TA events. DBs targeted by balloon-expandable stent-grafts had significantly lower freedom from TAI (78 ± 4% vs 88 ± 1%, P = 0.006), TA endoleak (87 ± 3% vs 97 ± 1%, P < 0.001), and TA reintervention (83 ± 4% vs 95 ± 1%, P < 0.001) compared with those targeted by self-expandable stent-grafts. CONCLUSIONS: Incorporation of renal and mesenteric TA during FB-EVAR is safe and durable with high 5-year patency rates and low freedom from TAI. DBs have lower patency rates and lower freedom from TAI than fenestrations, with better performance for self-expandable stent grafts as compared with balloon-expandable stent grafts.
Assuntos
Aneurisma da Aorta Abdominal , Aneurisma da Aorta Torácica , Aneurisma da Aorta Toracoabdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Humanos , Estados Unidos , Prótese Vascular , Aneurisma da Aorta Torácica/cirurgia , Correção Endovascular de Aneurisma , Endoleak , Estudos Prospectivos , Fatores de Risco , Complicações Pós-Operatórias , Resultado do Tratamento , Desenho de Prótese , Aneurisma da Aorta Abdominal/cirurgiaRESUMO
OBJECTIVE: To describe outcomes after elective and non-elective fenestrated-branched endovascular aortic repair (FB-EVAR) for thoracoabdominal aortic aneurysms (TAAAs). BACKGROUND: FB-EVAR has been increasingly utilized to treat TAAAs; however, outcomes after non-elective versus elective repair are not well described. METHODS: Clinical data of consecutive patients undergoing FB-EVAR for TAAAs at 24 centers (2006-2021) were reviewed. Endpoints including early mortality and major adverse events (MAEs), all-cause mortality, and aortic-related mortality (ARM), were analyzed and compared in patients who had non-elective versus elective repair. RESULTS: A total of 2603 patients (69% males; mean age 72±10 year old) underwent FB-EVAR for TAAAs. Elective repair was performed in 2187 patients (84%) and non-elective repair in 416 patients [16%; 268 (64%) symptomatic, 148 (36%) ruptured]. Non-elective FB-EVAR was associated with higher early mortality (17% vs 5%, P <0.001) and rates of MAEs (34% vs 20%, P <0.001). Median follow-up was 15 months (interquartile range, 7-37 months). Survival and cumulative incidence of ARM at 3 years were both lower for non-elective versus elective patients (50±4% vs 70±1% and 21±3% vs 7±1%, P <0.001). On multivariable analysis, non-elective repair was associated with increased risk of all-cause mortality (hazard ratio, 1.92; 95% CI] 1.50-2.44; P <0.001) and ARM (hazard ratio, 2.43; 95% CI, 1.63-3.62; P <0.001). CONCLUSIONS: Non-elective FB-EVAR of symptomatic or ruptured TAAAs is feasible, but carries higher incidence of early MAEs and increased all-cause mortality and ARM than elective repair. Long-term follow-up is warranted to justify the treatment.
Assuntos
Aneurisma da Aorta Abdominal , Aneurisma da Aorta Torácica , Aneurisma da Aorta Toracoabdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Masculino , Humanos , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Feminino , Aneurisma da Aorta Torácica/cirurgia , Aneurisma da Aorta Abdominal/cirurgia , Correção Endovascular de Aneurisma , Implante de Prótese Vascular/efeitos adversos , Resultado do Tratamento , Fatores de Risco , Procedimentos Endovasculares/efeitos adversos , Fatores de Tempo , Estudos Retrospectivos , Prótese VascularRESUMO
OBJECTIVE: Peripheral artery disease (PAD) is associated with worse survival following abdominal aortic aneurysm (AAA) repair. However, little is known about the impact of PAD and sex on outcomes following open infrarenal AAA repair (OAR). METHODS: All elective open infrarenal AAA cases were queried from the Society for Vascular Surgery Vascular Quality Initiative from 2003 to 2022. PAD was defined as history of non-cardiac arterial bypass, non-coronary percutaneous vascular intervention (PVI), or non-traumatic major amputation. Cohorts were stratified by sex and history of PAD. Multivariable logistic regression and Cox proportional hazards models were constructed to assess the primary endpoints: 30-day and 5-year mortality, respectively. RESULTS: Of 4910 patients who underwent elective OAR, 3421 (69.7%) were men without PAD, 298 (6.1%) were men with PAD, 1098 (22.4%) were women without PAD, and 93 (1.9%) were women with PAD. Men with PAD had prior bypass (45%), PVI (62%), and amputation (6.7%). Women with PAD had prior bypass (32%), PVI (76%), and amputation (5.4%). Thirty-day mortality was significantly higher in men with PAD compared with men without PAD (4.4% vs 1.7%; P = .001) and in women with PAD compared with women without PAD (7.5% vs 2.4%; P = .01). After risk adjustment, when compared with men without PAD, women with PAD had nearly four times the odds of 30-day mortality (odds ratio, 3.86; 95% confidence interval [CI], 1.55-9.64; P = .004) and men with PAD had almost three times the odds of 30-day mortality (odds ratio, 2.77; 95% CI, 1.42-5.40; P = .003). Five-year survival was 87.8% in men without PAD, 77.8% in men with PAD, 85% in women without PAD, and 76.2% in women with PAD (P < .001). After risk adjustment, only men with PAD had an increased hazard of death at 5 years (hazard ratio, 1.52; 95% CI, 1.07-2.17; P = .019) compared with men without PAD. CONCLUSIONS: PAD is a potent risk factor for increased perioperative mortality in both men and women following OAR. In women, this equates to nearly four times the odds of perioperative mortality compared with men without PAD. Future study evaluating risk/benefit is needed to determine if women with PAD reflect a high-risk cohort that may benefit from a more conservative OAR threshold for treatment.
Assuntos
Aneurisma da Aorta Abdominal , Procedimentos Endovasculares , Doença Arterial Periférica , Masculino , Humanos , Feminino , Procedimentos Endovasculares/efeitos adversos , Resultado do Tratamento , Fatores de Tempo , Fatores de Risco , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/cirurgia , Doença Arterial Periférica/complicações , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/cirurgia , Aneurisma da Aorta Abdominal/complicações , Estudos RetrospectivosRESUMO
OBJECTIVE: Fiber Optic RealShape (FORS) technology has recently been introduced as an adjunctive guidance technology that allows real-time three-dimensional visualization of dedicated endovascular devices while avoiding radiation exposure. It consists of equipment which sends pulses of light through hair-thin optical fibers that run within a dedicated hydrophilic wire and selective catheters. The purpose of the study was to report the observed benefits and limitations related to the first edition of FORS technology. METHODS: Data were collected prospectively from the first 50 patients undergoing FORS-guided endovascular repair at a single center between February 2020 and February 2021 as part of the global multicenter FORS Learn registry. All consecutive, elective procedures with one or more navigation tasks attempted with FORS were included. Factors related to FORS navigation task success were assessed. The time required for the catheterization of each task as well as the amount of radiation exposure (fluoroscopy time, dose area product, and estimated skin dose) were collected. A per-task analysis was conducted. End points included the success rate in achieving a stable FORS-guided catheterization, catheterization time, and radiation dose during catheterization. RESULTS: During the study period from February 2020 to February 2021, 50 patients were treated using FORS technology. Forty-five patients were treated for aortic aneurysm, 4 for iliac artery aneurysm, and 1 for splenic artery aneurysm. Overall, 201 navigation tasks were completed for these procedures and FORS was used in 186 tasks (92.5%). No FORS-related complication was recorded and a success rate of 60.2% (n = 116) was observed. Target vessel (TV) angle of 45° or greater, TV stenosis, and the renal arteries as navigation tasks (compared with celiac artery or superior mesenteric artery) were associated with a lower success rate. Catheterization of a TV through a branch more frequently required a standard catheter in combination with the FORS-enabled guidewire. Successful task catheterization using FORS guidance was associated with a shorter catheterization time 6 minutes (interquartile range, 3-11 minutes) versus 16 minutes (interquartile range, 10-24 minutes) (P < .001) and lower radiation exposure compared with unsuccessful catheterization (dose area product, 4.4 cGy/cm2 vs 12.5 cGy/cm2; P < .001). CONCLUSIONS: FORS technology was implemented successfully as a new guidance technology in a complex endovascular aortic repair program and was associated with an encouraging success rate and a high potential for radiation reduction.
Assuntos
Aneurisma Aórtico , Implante de Prótese Vascular , Procedimentos Endovasculares , Humanos , Aneurisma Aórtico/cirurgia , Cateterismo , Catéteres , Tecnologia , Implante de Prótese Vascular/efeitos adversos , Resultado do TratamentoRESUMO
OBJECTIVE: The United States healthcare system uses different methods for assigning medical center reimbursement (MCR) and professional reimbursement (PR) for clinical services. We hypothesized that PR has not increased proportionately to MCR for the same vascular services. METHODS: MCR and PR were compared for commonly performed inpatient and outpatient vascular procedures between 2012 and 2021. MCR was calculated using the Medicare inpatient prospective payment system and outpatient prospective payment system. MCR is based on the Centers for Medicare and Medicaid Services definition and criteria for comorbidities and the occurrence of complications; thus, changes in MCR were reported as a range based on the degree of comorbidities and complications using the Diagnosis Related Group. PR was calculated using the Medicare physician fee schedule, which assigns a numerical work relative value unit to each surgical service, with final compensation determined by an annually adjusted conversion factor to yield a final dollar amount. The expected reimbursement based on the observed inflation during the study period using the consumer price index was calculated and compared to the actual reimbursement. RESULTS: From 2012 to 2021, MCR for inpatient procedures increased 20% to 26% for carotid endarterectomy, 24% to 27% for femoral endarterectomy, 24% to 27% for femoropopliteal bypass with vein, 14% to 19% for thoracic endovascular aortic repair, and 15% for aortobifemoral bypass. During the same period, PR increased 3.3% for carotid endarterectomy but decreased for femoral endarterectomy (-5.0%), femoropopliteal bypass (-4.6%), thoracic endovascular aortic repair (-4.2%), and aortobifemoral bypass (-5.0%). Comparing the expected reimbursement, adjusted for inflation, to the actual reimbursement, PR experienced a 10% to 17% reduction but MCR outpaced inflation by 3.7% to 10%. For outpatient procedures, MCR increased 117% for tibial angioplasty, 24% for superficial femoral artery (SFA) stenting, 62% for tunneled dialysis catheter (TDC) insertion, and 24% for iliac stenting but decreased 0.43% for arteriovenous fistula (AVF) creation and 7.6% for radiofrequency ablation (RFA). PR increased 0.91% for SFA stenting but decreased for tibial angioplasty (-17%), AVF creation (-6.4%), TDC insertion (-7.1%), iliac stenting (-3.8%), and RFA (-22%). Comparing the expected reimbursement, adjusted for inflation, to the actual reimbursement, PR experienced a 13% to 32% reduction. In contrast, MCR outpaced inflation 7.5% to 88% for tibial angioplasty, SFA stenting, TDC insertion, and iliac stenting but experienced a reduction for AVF (-13%) and RFA (-19%). CONCLUSIONS: MCR for commonly performed vascular procedures has increased and outpaced inflation. In contrast, PR for these same services has decreased across all procedure types. This decrease in PR was exacerbated when adjusted for inflation. This inequity in the reimbursement methods between MCR and PR poses a threat to the viability of the physician workforce. Either changes to the reimbursement methods or a reallocation of reimbursement to physicians are imperative to sustain physician practices.
Assuntos
Endarterectomia das Carótidas , Médicos , Idoso , Humanos , Estados Unidos , Medicare , Procedimentos Cirúrgicos Vasculares , Angioplastia , Reembolso de Seguro de SaúdeRESUMO
OBJECTIVE: Although the Society for Vascular Surgery recommends repair of abdominal aortic aneurysms (AAA) at 5.5 cm or greater in men and 5.0 cm or greater in women, AAA repair below these thresholds has been well-documented. There are clear indications for repair other than these strict size criteria, but the expected proportion of such repairs in one's practice has not been studied. We sought to characterize the indications for repairs of aneurysms below diameter recommendations at a single academic center. Using the assumption that this real-world experience would approximate that of other practices, we then used national data to extrapolate these findings. METHODS: A single-center retrospective review was conducted of all elective open AAA (oAAA) and endovascular aneurysm repair (EVAR) from 2010 to 2020 to assess the incidence of and indications for repair of aneurysms below diameter recommendations (defined as <5.5 cm in men and <5.0 cm in women). Reasons for these repairs were defined as (1) iliac aneurysm, (2) saccular morphology, (3) rapid expansion, (4) patient anxiety, (5) distal embolization, (6) other, and (7) no documented reason. The Vascular Quality Initiative (VQI) was queried for all asymptomatic oAAA and EVAR (2010-2020) and repairs below diameter recommendations were identified. Findings from the single-center analysis were applied to the VQI cohort to extrapolate estimates of reasons for repairs done nationally. In-hospital mortality and major adverse cardiac events (MACE) were compared between those below size recommendations and those meeting size recommendations. RESULTS: Of 456 elective AAA repairs at our center, 147 (32%) were below size recommendations. This finding was more common for EVAR (35% vs 28%). Reasons were: not documented (41%), iliac aneurysm (23%), saccular (10%), rapid expansion (10%), patient anxiety (7%), other (6%), and distal embolism (3%). Of 44,820 elective AAA repairs in the VQI, 17,057 (38%) were below size recommendations (40% EVAR, 26% oAAA). Patients who were repaired below size recommendations had lower in-hospital death (oAAA, 2.4% vs 4.6% [P < .0001]; EVAR, 0.3% vs 0.8% [P < .0001]). When single-center findings were applied to the VQI dataset, an estimated 10,064 repairs were performed nationally for acceptable indications other than size criteria. Conversely, there may have been 6993 repairs (with an associated 35 deaths) performed without documented indication. CONCLUSIONS: Repairs for AAA below the recommended diameter guidelines account for approximately one-third of all elective AAA procedures in both the VQI and our single-center experience. Assuming our practice is typical, nearly 60% of repairs below size recommendations meet the criteria for other clear reasons. The remaining 40% lack a documented reason, meaning that 13% of all elective AAA repairs were done for aneurysms below size recommendations without an acceptable indication. As awareness of overuse and underuse is heightened, these data help to estimate the expected proportion of repairs for less common pathologies. They also provide a potential baseline data point for efforts at decreasing overuse.