RESUMEN
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.
RESUMEN
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.
RESUMEN
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.
Asunto(s)
Alta del Paciente , Readmisión del Paciente , Humanos , Estudios Retrospectivos , Comorbilidad , Complicaciones Posoperatorias/etiología , Factores de RiesgoRESUMEN
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.
RESUMEN
BACKGROUND: Peripheral arterial disease, characterized as arterial atherosclerotic disease, can lead to insufficient flow in the lower extremities and ischemia, with the most common clinical manifestation being intermittent claudication (IC). In 2022, the Society for Vascular Surgery (SVS) developed appropriate use criteria for the management of IC that used this systematic review as a source of evidence. The objective of this study is to synthesize the findings of the systematic review and identify evidence gaps. METHODS: A comprehensive search of literature databases including MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Scopus was conducted from January 1, 2000, to November 30, 2022. Noncomparative and comparative observational studies and randomized controlled trials were included. Included studies evaluated exercise therapy, endovascular or open revascularization for the treatment of IC. Outcomes of interest (freedom from major adverse limb event, health-related quality of life, and walking distance) were compared in various subgroups (age, sex, diabetes, smoking status, anatomical location of disease, and optimal medical therapy). RESULTS: Twenty-six studies reported the outcomes of interest for the evidence map. The general conclusions of the studies that reported freedom from major adverse limb events were that reintervention rates for endovascular therapy at ≥2 years were >20%, major amputation rates were often not reported, and, after endovascular therapy, the 1-month mortality was low (<2%). Quality of life and walking distance data were sparse, limited to only endovascular intervention, and insufficient to make any strong conclusions. CONCLUSIONS: IC in patients with peripheral arterial disease poses a significant socioeconomic and health care burden. Major, consequential gaps exist in the IC literature with respect to the assessment of patient reported outcome measures, standardized measures of walking distance and the comparative effectiveness of initial exercise therapy vs invasive intervention. The evidence gaps identified by the Society for Vascular Surgery appropriate use criteria on IC systematic review serve as a guide for future research efforts to optimize care for this patient population.
Asunto(s)
Claudicación Intermitente , Enfermedad Arterial Periférica , Humanos , Claudicación Intermitente/diagnóstico , Claudicación Intermitente/terapia , Extremidad Inferior , Atención Dirigida al Paciente , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/terapia , Calidad de Vida , Revisiones Sistemáticas como Asunto , Resultado del Tratamiento , CaminataRESUMEN
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.
Asunto(s)
Aneurisma de la Aorta Abdominal , Procedimientos Endovasculares , Enfermedad Arterial Periférica , Masculino , Humanos , Femenino , Procedimientos Endovasculares/efectos adversos , Resultado del Tratamiento , Factores de Tiempo , Factores de Riesgo , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/cirugía , Enfermedad Arterial Periférica/complicaciones , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/complicaciones , Estudios RetrospectivosRESUMEN
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.
Asunto(s)
Endarterectomía Carotidea , Médicos , Anciano , Humanos , Estados Unidos , Medicare , Procedimientos Quirúrgicos Vasculares , Angioplastia , Reembolso de Seguro de SaludRESUMEN
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.
Asunto(s)
Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Aneurisma Ilíaco , Masculino , Humanos , Femenino , Factores de Riesgo , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/complicaciones , Mortalidad Hospitalaria , Aneurisma Ilíaco/cirugía , Implantación de Prótesis Vascular/efectos adversos , Resultado del Tratamiento , Estudios Retrospectivos , Procedimientos Quirúrgicos Electivos/métodosRESUMEN
INTRODUCTION: Endoleaks are more common after fenestrated/branched endovascular aneurysm repair (F/B-EVAR) than infrarenal EVAR secondary to the length of aortic coverage and number of component junctions. Although reports have focused on type I and III endoleaks, less is known regarding type II endoleaks after F/B-EVAR. We hypothesized that type II endoleaks would be common and often complex (associated with additional endoleak types), given the potential for multiple inflow and outflow sources. We sought to describe the incidence and complexity of type II endoleaks after F/B-EVAR. METHODS: F/B-EVAR data prospectively collected at a single institution in an investigational device exemption clinical trial (G130210) were retrospectively analyzed (2014-2021). Endoleaks were characterized by type, time to detection, and management. Primary endoleaks were defined as those present on completion imaging or at first postoperative imaging, and secondary were those on subsequent imaging. Recurrent endoleaks were those that developed after a successfully resolved endoleak. Reinterventions were considered for type I or III endoleaks or any endoleak associated with sac growth >5 mm. Technical success defined as the absence of flow in the aneurysm sac at procedure conclusion and methods of intervention were captured. RESULTS: Among 335 consecutive F/B-EVARs (mean ± standard deviation follow-up: 2.5 ± 1.5 years), 125 patients (37%) experienced 166 endoleaks (81 primary, 72 secondary, and 13 recurrent). Of these 125 patients, 50 (40% of patients) underwent 71 interventions for 60 endoleaks. Type II endoleaks were the most frequent (n = 100, 60%), with 20 identified during the index procedure, 12 (60%) of which resolved before 30-day follow-up. Of the 100 type II endoleaks, 20 (20%; 12 primary, 5 secondary, and 3 recurrent) were associated with sac growth; 15 (75%) of those with associated sac growth underwent intervention. At intervention, 6 (40%) were reclassified as complex, with a concomitant type I or type III endoleak. Initial technical success for endoleak treatment was 96% (68 of 71). There were 13 recurrences, all of which were associated with complex endoleaks. CONCLUSIONS: Nearly half of the patients who underwent F/B-EVAR experienced an endoleak. The majority were classified as type II, with nearly a fifth associated with sac expansion. Interventions for a type II endoleak frequently led to reclassification as complex, with a concomitant type I or III endoleak not appreciated on computed tomography angiography and/or duplex. Further study is needed to determine if the primary treatment goal for complex aneurysm repair is sac stability or sac regression, as this would inform both the importance of properly classifying endoleaks noninvasively and the intervention threshold for managing type II endoleaks.
Asunto(s)
Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Humanos , Endofuga/diagnóstico por imagen , Endofuga/etiología , Endofuga/terapia , Reparación Endovascular de Aneurismas , Prótesis Vascular/efectos adversos , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/complicaciones , Resultado del Tratamiento , Estudios Retrospectivos , Factores de RiesgoRESUMEN
OBJECTIVE: In the present study, we have described the technical success using Fiber Optic RealShape (FORS) endovascular guidance and its effects on the overall procedural time and radiation usage during complex endovascular aortic repair (EVAR). METHODS: Fenestrated and branched EVARs performed at a single center from 2017 to 2022 were prospectively studied. FORS-guided procedures were matched retrospectively 1:3 to non-FORS-guided procedures by the incorporated target arteries and body mass index. Technical success was defined as successful target vessel cannulation using FORS for the entirety of navigation (wire insertion to exchange for a stiff wire). The predictors of technical success were evaluated via logistic regression. The procedural times and radiation doses were compared between the matched cohorts using the Wilcoxon rank sum test. RESULTS: A total of 21 FORS-guided procedures were matched to 61 non-FORS-guided procedures. A total of 95 FORS cannulations were attempted (87 for the visceral target artery and 8 for the bifurcate gate). Technical success was achieved in 81 cannulations (85%); 15 (16%) were completed without the use of live fluoroscopy. The univariate predictors of FORS technical success included <50% target artery stenosis, <50% target artery calcification, and the target vessel attempted (P < .05 for each). FORS failures were attributed to device material properties in six cases, device failure in two cases, and the wire/catheter combination in six. The use of FORS guidance was associated with shorter median procedural and fluoroscopy times and a lower dose area product and air kerma (P ≤ .0001 for each). CONCLUSIONS: The results from our initial experience with FORS during complex EVAR, including our learning curve, has shown promise, with acceptable technical success and reductions in procedural times and radiation usage.
Asunto(s)
Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Humanos , Prótesis Vascular , Reparación Endovascular de Aneurismas , Aneurisma de la Aorta Abdominal/cirugía , Estudios Retrospectivos , Aortografía/métodos , Resultado del Tratamiento , Factores de Riesgo , Diseño de PrótesisRESUMEN
BACKGROUND: Abdominal aortic aneurysms (AAA) are often identified incidentally on imaging studies. Patients and/or providers are frequently unaware of these AAA and the need for long-term follow-up. We sought to evaluate the outcome of a nurse-navigator-run AAA program that uses a natural language processing (NLP) algorithm applied to the electronic medical record (EMR) to identify patients with imaging report-identified AAA not being followed actively. METHODS: A commercially available AAA-specific NLP system was run on EMR data at a large, academic, tertiary hospital with an 11-year historical look back (January 1, 2010, to June 2, 2021), to identify and characterize AAA. Beginning June 3, 2021, a direct link between the NLP system and the EMR enabled for real-time review of imaging reports for new AAA cases. A nurse-navigator (1.0 full-time equivalent) used software filters to categorize AAA according to predefined metrics, including repair status and adherence to Society for Vascular Surgery imaging surveillance protocol. The nurse-navigator then interfaced with patients and providers to reestablish care for patients not being followed actively. The nurse-navigator characterized patients as case closed (eg, deceased, appropriate follow-up elsewhere, refuses follow-up), cases awaiting review, and cases reviewed and placed in ongoing surveillance using AAA-specific software. The primary outcome measures were yield of surveillance imaging performed or scheduled, new clinic visits, and AAA operations for patients not being followed actively. RESULTS: During the prospective study period (January 1, 2021, to December 30, 2021), 6,340,505 imaging reports were processed by the NLP. After filtering for studies likely to include abdominal aorta, 243,889 imaging reports were evaluated, resulting in the identification of 6495 patients with AAA. Of these, 2937 cases were reviewed and closed, 1183 were reviewed and placed in ongoing surveillance, and 2375 are awaiting review. When stratifying those reviewed and placed in ongoing surveillance by maximum aortic diameter, 258 were 2.5 to 3.4 cm, 163 were 3.5 to 3.9 cm, 213 were 4 to 5 cm, and 49 were larger than 5 cm; 36 were saccular, 86 previously underwent open repair, 274 previously underwent endovascular repair, and 104 were other. This process yielded 29 new patient clinic visits, 40 finalized imaging studies, 29 scheduled imaging studies, and 4 AAA operations in 3 patients among patients not being followed actively. CONCLUSIONS: The application of an AAA program leveraging NLP successfully identifies patients with AAA not receiving appropriate surveillance or counseling and repair. This program offers an opportunity to improve best practice-based care across a large health system.
Asunto(s)
Aneurisma de la Aorta Abdominal , Procesamiento de Lenguaje Natural , Humanos , Estudios Prospectivos , Aneurisma de la Aorta Abdominal/cirugía , Aorta Abdominal/cirugía , Procedimientos Quirúrgicos Vasculares , Estudios RetrospectivosRESUMEN
OBJECTIVE: Acute kidney injury (AKI) occurs frequently in complex aortic surgery and has been implicated in perioperative and long-term survival. This study sought to characterize the relationship between AKI severity and mortality after fenestrated and branched endovascular aortic aneurysm repair (F/B-EVAR). METHODS: Consecutive patients enrolled by the US Aortic Research Consortium in 10, prospective, nonrandomized, physician-sponsored investigational device exemption studies evaluating F/B-EVAR, between 2005 and 2023, were included in this study. Perioperative AKI during hospitalization was defined by and staged using the 2012 Kidney Disease Improving Global Outcomes criteria. Determinants of AKI were evaluated with backward stepwise mixed effects multivariable ordinal logistic regression. Survival was analyzed with conditionally adjusted survival curves and backward stepwise mixed effects Cox proportional hazards modelling. RESULTS: In the study period, 2413 patients with a median (interquartile range [IQR]) age of 74 years (IQR, 69-79 years) underwent F/B-EVAR. The median follow-up duration was 2.2 years (IQR, 0.7-3.7 years). The median baseline estimated glomerular filtration rate (eGFR) and creatinine were 68 mL/min/1.73 m2 (IQR, 53-84 mL/min/1.73 m2) and 1.1 mg/dL (IQR, 0.9-1.3 mg/dL), respectively. Stratification of AKI identified 316 patients (13%) with stage 1 injury, 42 (2%) with stage 2 injury, and 74 (3%) with stage 3 injury. Renal replacement therapy was initiated during the index hospitalization in 36 patients (1.5% of cohort, 49% of stage 3 injuries). Thirty-day major adverse events were associated with AKI severity (all P ≤ .0001). Multivariable predictors of AKI severity included baseline eGFR (proportional odds ratio, 0.9 per 10 mL/min/1.73 m2 [95% confidence interval (CI), 0.85-0.95 per 10 mL/min/1.73 m2]; P < .0001), baseline serum hematocrit (0.58 per 10% [95% CI, 0.48-0.71 per 10%]; P < .0001), renal artery technical failure during aneurysm repair (3 [95% CI,1.61-5.72]; P = .0006), and total operating time (1.05 per 10 minutes [95% CI, 1.04-1.07 per 10 minutes]; P < .0001). One-year unadjusted survivals for AKI severity strata were 91% (95% CI, 90%-92%) for no injury, 80% (95% CI, 76%-85%) for stage 1 injury, 72% (95% CI, 59-87%) for stage 2 injury, and 46% (95% CI, 35-59%) for stage 3 injury (P<.0001). Multivariable determinants of survival included AKI severity (stage 1, hazard ratio [HR], 1.6 [95% CI, 1.3-2]); stage 2, HR, 2.2 [95% CI, 1.4-3.4]); stage 3 HR, 4 [95% CI, 2.9-5.5]; P < .0001), decreased eGFR (HR, 1.1 [95% CI, 0.9-1.3]; P = .4), patient age (HR, 1.6 per 10 years [95% CI, 1.4-1.8 per 10 years]; P < .0001), baseline chronic obstructive pulmonary disease (HR, 1.5 [95% CI, 1.3-1.8]; P < .0001), baseline congestive heart failure (HR, 1.7 [95% CI, 1.6-2.1]; P < .0001), postoperative paraplegia (HR, 2.1 [95% CI, 1.1-4]; P = .02), and procedural technical success (HR, 0.6 [95% CI, 0.4-0.8]; P = .003). CONCLUSIONS: AKI, as defined by the 2012 Kidney Disease Improving Global Outcomes criteria, occurred in 18% of patients after F/B-EVAR. Greater severity of AKI after F/B-EVAR was associated with decreased postoperative survival. The predictors of AKI severity identified in these analyses suggest a role for improved preoperative risk mitigation and staging of interventions in complex aortic repair.
Asunto(s)
Lesión Renal Aguda , Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Humanos , Anciano , Niño , Aneurisma de la Aorta Abdominal/cirugía , Estudios Prospectivos , Factores de Riesgo , Procedimientos Endovasculares/efectos adversos , Resultado del Tratamiento , Lesión Renal Aguda/diagnóstico , Lesión Renal Aguda/etiología , Estudios Retrospectivos , Implantación de Prótesis Vascular/efectos adversos , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/cirugíaRESUMEN
BACKGROUND: Several concerns have been raised over the past several years about the potential for overuse of vascular interventions for peripheral artery disease. These interventions can have serious complications, including limb loss. Given that the natural history of intermittent claudication rarely includes limb loss, it is critically important that interventions to treat it have appropriate indications. METHODS: To address this matter, the Society for Vascular Surgery published an appropriate use criteria (AUC) document for the management of intermittent claudication in 2022. Using the rigorously studied University of California Los Angeles RAND Appropriateness Method, the rating panel assessed the appropriateness of 2,280 scenarios for [1] the initial management and [2] the management after a failed trial of exercise therapy. RESULTS: The findings of the rating panel included that medical management and exercise therapy are appropriate initial management in all scenarios. There were several scenarios in which revascularization was also considered appropriate, mainly influenced by severity of physical limitations and favorable lesion characteristics. When considering management after a failed trial of exercise, guiding principles cited by the rating panel included durability of intervention, smoking cessation, and evidence of prior good-faith effort at exercise therapy. There were many scenarios which were indeterminate. With respect to the infrapopliteal segment, the rating panelists unanimously agreed to forgo individual scenario ratings, since they deemed the risks outweigh the benefits in all cases. CONCLUSIONS: The Society for Vascular Surgery (SVS) AUC for intermittent claudication represents an important effort to identify and reduce overuse. There are several considerations for how they should be used. The simplest application is by practicing clinicians, at the bedside, as they engage in shared decision-making with patients. The matter of their use by payors is more complex. Ideally, decisions on how to best use AUC require additional study of their performance before they are used by payors for anything. Finally, these AUC have identified a myriad of areas where evidence is lacking. The AUC provide important targets for future research to improve the care of patients with intermittent claudication.
RESUMEN
OBJECTIVE: Hemoglobin A1c (HbA1c) is used as a marker of glycemic control, but the role of HbA1c before lower extremity bypass (LEB) in patients with diabetes remains unclear. We sought to characterize patients with diabetes undergoing LEB with and without HbA1c monitoring and to determine if HbA1c monitoring practices correlate with better outcomes. METHODS: The Vascular Quality Initiative was queried for all LEB in patients with diabetes (2010-2020). Patients with diabetes were characterized based on therapy: diet-controlled, noninsulin medication use, or insulin use. Glycemic control was characterized by preoperative HbA1c within 6 months of surgery: unknown control (no HbA1c), well-controlled (HbA1c <7%), poorly-controlled (HbA1c 7%-10%), and uncontrolled (HbA1c >10%). Centers with >5 LEB/y were stratified into terciles according to rate of HbA1c monitoring. The unadjusted associations between glycemic control and in-hospital major adverse limb events, major adverse cardiac events, and mortality were assessed with univariate methods. The independent association of center-level HbA1c monitoring with 5-year survival and 3-year amputation-free survival (AFS) was determined with Kaplan-Meier analyses and Cox regression modeling, adjusted for differences in patient characteristics and center volume. RESULTS: Of 16,092 patients with diabetes undergoing LEB, 4055 (25%) did not have a documented HbA1c. Insulin use was less common in no A1c (48%) and well-controlled diabetes (39%) compared with poorly controlled (67%) and uncontrolled diabetes (78%) (P < .01). In univariate analyses, glycemic control was not associated with differences for in-hospital major adverse limb events, major adverse cardiac events, or mortality. Of 162 centers, HbA1c monitoring practices varied widely (range: 12.5%-100% of LEB). The 3-year AFS and 5-year survival were worse in the highest monitoring tercile vs the lowest (73.6% vs 77.3%, P < .01, 72.1% vs 77.5%, P < .01, respectively). On multivariable analyses, centers in the highest tercile of monitoring had the greatest hazard of AFS (hazard ratio: 1.21, 95% confidence interval: 1.1-1.3, P < .001) and overall mortality (hazard ratio: 1.19, 95% confidence interval: 1.1-1.3, P < 0.001), compared with the centers in the lowest tercile of monitoring. CONCLUSIONS: Patients with diabetes and no preoperative HbA1c monitoring do not have worse LEB outcomes compared with those with HbA1c monitoring. Preoperative HbA1c monitoring varies widely, suggesting broad differences in practice and documentation. Centers with the highest rates of monitoring demonstrated inferior outcomes, likely due to other confounding unmeasured variables. These findings indicate that HbA1c monitoring before LEB, unto itself, should not be used as a measure of surgical quality.
Asunto(s)
Diabetes Mellitus , Insulinas , Enfermedad Arterial Periférica , Diabetes Mellitus/diagnóstico , Hemoglobina Glucada , Humanos , Isquemia/cirugía , Extremidad Inferior/irrigación sanguínea , Enfermedad Arterial Periférica/diagnóstico , Enfermedad Arterial Periférica/cirugía , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVE: Patients undergoing revascularization for chronic limb-threatening ischemia (CLTI) are at elevated risk for both mortality and limb loss. To facilitate therapeutic decision-making, a mortality prediction model derived from the Vascular Quality Initiative (VQI) database has stratified patients into low, medium, and high risk, defined by 30-day mortality estimates of ≤3%, 3%-5%, or >5% and 2-year mortality estimates of ≤30%, 30%-50%, or ≥50%, respectively. The purpose of this study was to compare expected mortality risk derived from this model with observed outcomes in a tertiary center. METHODS: Consecutive patients treated at a single center between 2016 and 2019 were analyzed. Baseline demographics, approach, and mortality events were reviewed. Observed mortality was obtained using life-table methods and compared using a log-rank test with the expected mortality risk that was calculated using the VQI model. RESULTS: This study cohort consisted of 195 revascularization procedures in 169 unique patients stratified into 128 (66%) low-, 50 (26%) medium-, and 17 (8%) high-risk cases based on the VQI model. Ninety percent of revascularizations were performed for tissue loss. Compared with the VQI population, comorbidities were prevalent and included unstable angina or myocardial infarction within 6 months (6% vs 2.4% in VQI; P < .001), congestive heart failure (30% vs 23%; P < .001), and dialysis dependence (14% vs 0.9%; P < .001). Patients were also older (31% vs 21% ≥80 years old; P < .001) and more likely to be frail (45% vs 64% independent; P < .001). High-risk patients were more prevalent in the endovascular group (11% of 132 endovascular interventions vs 3% of 63 bypasses; P = .056). Thirty-day observed mortality exceeded expected VQI prediction model mortality in all groups, although was not statistically significant. The VQI model adequately stratified the studied population into risk groups (P < .001). Low-risk patients with CLTI (65% of the overall cohort) experienced 2-year mortality of 18.9%. However, observed mortality rates for medium- and high-risk VQI strata were similar. After a median follow-up of 28 months, medium-risk patients incurred a significantly higher mortality than predicted (53.5% ± 2.1% vs 36.8% ± 1.1%; P = .016). CONCLUSIONS: The VQI mortality prediction model discriminates mortality risk after limb revascularization in CLTI, accurately identifying a majority subgroup of patients who are suitable for either open or endovascular intervention. However, it may underestimate mortality in a tertiary referral population with high comorbidity burden and was not well calibrated for the medium-risk group. It may be more appropriate to dichotomize patients with CLTI who are candidates for limb salvage into an average-risk and high-risk group.
Asunto(s)
Procedimientos Endovasculares , Enfermedad Arterial Periférica , Anciano de 80 o más Años , Amputación Quirúrgica , Procedimientos Endovasculares/efectos adversos , Humanos , Isquemia/diagnóstico por imagen , Isquemia/cirugía , Recuperación del Miembro/métodos , Extremidad Inferior/irrigación sanguínea , Enfermedad Arterial Periférica/diagnóstico por imagen , Enfermedad Arterial Periférica/cirugía , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
The Society for Vascular Surgery appropriate use criteria (AUC) for the management of intermittent claudication were created using the RAND appropriateness method, a validated and standardized method that combines the best available evidence from medical literature with expert opinion, using a modified Delphi process. These criteria serve as a framework on which individualized patient and clinician shared decision-making can grow. These criteria are not absolute. AUC should not be interpreted as a requirement to administer treatments rated as appropriate (benefit outweighs risk). Nor should AUC be interpreted as a prohibition of treatments rated as inappropriate (risk outweighs benefit). Clinical situations will occur in which moderating factors, not included in these AUC, will shift the appropriateness level of a treatment for an individual patient. Proper implementation of AUC requires a description of those moderating patient factors. For scenarios with an indeterminate rating, clinician judgement combined with the best available evidence should determine the treatment strategy. These scenarios require mechanisms to track the treatment decisions and outcomes. AUC should be revisited periodically to ensure that they remain relevant. The panelists rated 2280 unique scenarios for the treatment of intermittent claudication (IC) in the aortoiliac, common femoral, and femoropopliteal segments in the round 2 rating. Of these, only nine (0.4%) showed a disagreement using the interpercentile range adjusted for symmetry formula, indicating an exceptionally high degree of consensus among the panelists. Post hoc, the term "inappropriate" was replaced with the phrase "risk outweighs benefit." The term "appropriate" was also replaced with "benefit outweighs risk." The key principles for the management of IC reflected within these AUC are as follows. First, exercise therapy is the preferred initial management strategy for all patients with IC. Second, for patients who have not completed exercise therapy, invasive therapy might provide net a benefit for selected patients with IC who are nonsmokers, are taking optimal medical therapy, are considered to have a low physiologic and technical risk, and who are experiencing severe lifestyle limitations and/or a short walking distance. Third, considering the long-term durability of the currently available technology, invasive interventions for femoropopliteal disease should be reserved for patients with severe lifestyle limitations and a short walking distance. Fourth, in the common femoral segment, open common femoral endarterectomy will provide greater net benefit than endovascular intervention for the treatment of IC. Finally, in the infrapopliteal segment, invasive intervention for the treatment of IC is of unclear benefit and could be harmful.
Asunto(s)
Claudicación Intermitente , Procedimientos Quirúrgicos Vasculares , Terapia por Ejercicio/métodos , Arteria Femoral , Humanos , Claudicación Intermitente/diagnóstico , Claudicación Intermitente/cirugía , Extremidad Inferior/irrigación sanguínea , Procedimientos Quirúrgicos Vasculares/efectos adversosRESUMEN
OBJECTIVE: Medical schools and surgical residencies have seen an increase in the proportion of female matriculants, with 30% of current vascular surgery trainees being women over the past decade. There is widespread focus on increasing diversity in medicine and surgery in an effort to provide optimal quality of patient care and the advancement of science. The presence of gender diversity and opportunities to identify with women in leadership positions positively correlates with women choosing to enter traditionally male-dominated fields. The purpose of this study was to evaluate the representation of women in regional and national vascular surgical societies over the last 20 years. METHODS: A retrospective review of the meeting programs of vascular surgery societies was performed. Data were collected on abstract presenters, moderators, committee members and chairs, and officers (president, president-elect, vice president, secretary, and treasurer). The data were divided into early (1999-2009) and late (2010-2019) time periods. RESULTS: Five regional and five national societies' data were analyzed, including 139 meetings. The mean percentage of female abstract presenters increased significantly from 10.9% in the early period to 20.6% in the late period (P < .001). Female senior authors increased slightly from 8.7% to 11.5%, but this change was not statistically significant (P = .22). Female meeting moderators increased significantly from 7.8% to 17.2% (P < .001), as well as female committee members increased from 10.9% to 20.3% (P = .003). Female committee chairs increased slightly from 10.9% to 16.9%, but this difference was not statistically significant (P = .13). Female society officers increased considerably from 6.4% to 14.8%. (P = .002). Significant variation was noted between societies, with five societies (three regional and two national) having less than 10% women at the officer level in 2019. There was a wide variation noted between societies in the percentage of female abstract presenters (range, 7.6%-34.9%), senior authors (3.9%-17.9%), and meeting moderators (5.4%-40.7%). CONCLUSIONS: Over the past two decades, there has been a significant increase in the representation of women in vascular surgery societies among those presenting scientific work, serving as meeting moderators, and serving as committee members. However, the representation of women among committee chairs, senior authors, and society leadership has not kept up pace with the increase noted at other levels. Efforts to recruit women into the field of vascular surgery as well as to support the professional development of female vascular surgeons are facilitated by the presence of women in leadership roles. Increasing the representation of women in vascular society leadership positions may be a key strategy in promoting gender diversity in the vascular surgery field.
Asunto(s)
Equidad de Género , Médicos Mujeres/tendencias , Sexismo/tendencias , Sociedades Médicas/tendencias , Cirujanos/tendencias , Procedimientos Quirúrgicos Vasculares/tendencias , Comités Consultivos/tendencias , Miembro de Comité , Congresos como Asunto/tendencias , Femenino , Humanos , Liderazgo , Masculino , Mentores , Estudios Retrospectivos , Factores Sexuales , Cirujanos/educación , Procedimientos Quirúrgicos Vasculares/educaciónRESUMEN
OBJECTIVE: The degree of carotid artery stenosis, calculated using catheter-based angiography and the North American Symptomatic Carotid Endarterectomy Trial (NASCET) method, has been shown to predict the stroke risk in several, large, randomized controlled trials. In the present era, patients have been increasingly evaluated using computed tomography (CT) angiography (CTA) before carotid artery revascularization, especially as the use of transcarotid artery revascularization has increased. Interpretation of CTA findings regarding the degree of carotid stenosis has not been standardized, with both NASCET methods and the area stenosis used. We performed a single-institution, blinded, retrospective analysis of CTA studies using both the NASCET method and the CT-derived area stenosis to assess the concordance and discordance between the two methods when evaluating ≥70% and ≥80% stenosis. METHODS: The UMass Memorial Medical Center vascular laboratory database was queried for all carotid duplex ultrasound scans performed from 2008 to 2017. The included patients were limited to those with duplex-defined ≥70% stenosis (defined as a peak systolic velocity of ≥125 cm/s and an internal carotid artery/common carotid artery ratio of ≥4), and a correlative CTA study performed within 1 year of the duplex ultrasound examination. A blinded review of all correlative CTA studies using centerline measurements on a three-dimensional workstation (Aquarius iNtuition Viewer; Terarecon, Durham, NC) was performed to characterize the degree of carotid stenosis using the NASCET method and the area stenosis method. Patients were excluded if revascularization had been performed between the two imaging studies. RESULTS: Of the 37,204 carotid duplex ultrasound scans reviewed (performed from 2008 to 2017), 3480 arteries met the criteria for duplex ultrasound-defined ≥70% stenosis. A correlative CTA study within 1 year of the duplex ultrasound examination was identified in 460 arteries, of which 320 were adequate quality for blinded review. The median interval between the duplex ultrasound and CTA examinations was 9.5 days. Concordance between the area stenosis and NASCET methods was poor for both ≥70% (κ = 0.32) and ≥80% (κ = 0.25) stenosis. Of the 247 arteries considered to have ≥70% area stenosis, 127 (51.4%) were considered to have ≥70% stenosis using the NASCET method. Of the 169 arteries considered to have ≥80% area stenosis, 44 (26.0%) were considered to have ≥80% stenosis using the NASCET method. CONCLUSIONS: The area stenosis CTA calculations of carotid artery stenosis dramatically overestimated the degree of carotid stenosis compared with that calculated using the NASCET method. Given that stroke risk estimates have been determined from trials that used the NASCET method, the area stenosis method likely overestimates the risk of stroke. Therefore, area stenosis calculations could lead to unnecessary carotid revascularization procedures. This model highlights the need for standardized usage of the NASCET method when using CTA as the imaging modality to determine the threshold for carotid revascularization.
Asunto(s)
Estenosis Carotídea/diagnóstico por imagen , Angiografía por Tomografía Computarizada , Ultrasonografía Doppler Dúplex , Anciano , Anciano de 80 o más Años , Estenosis Carotídea/complicaciones , Estenosis Carotídea/terapia , Toma de Decisiones Clínicas , Bases de Datos Factuales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Pronóstico , Interpretación de Imagen Radiográfica Asistida por Computador , Reproducibilidad de los Resultados , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Índice de Severidad de la Enfermedad , Accidente Cerebrovascular/etiologíaRESUMEN
BACKGROUND: Fenestrated/branched endovascular aneurysm repair (F/BEVAR) is a minimally invasive alternative for patients at high risk of open repair of complex aortic aneurysms. Nearly all investigative study protocols evaluating F/BEVAR have required a predicted life expectancy of >2 years for study inclusion. However, accurate risk models for predicting 2-year survival in this patient population are lacking. We sought to identify the preoperative predictors of 2-year survival for patients undergoing F/BEVAR. METHODS: The prospectively collected data for all consecutive F/BEVAR procedures, performed in an institutional review board-approved registry and/or a physician-sponsored investigational device exemption (IDE) trial (IDE no. G130210), were reviewed (November 2010 to February 2019). We assessed 44 preoperative patient characteristics, including comorbidities, preoperative functional status, aneurysm morphologies, and repair techniques. Preoperative functional status was defined as totally dependent (any impairment in activities of daily living or residing in a skilled nursing facility), partially dependent (any impairment in instrumental activities of daily living), or independent (no impairment in activities of daily living or instrumental activities of daily living). Using the results of univariate analysis (P < .2), a Cox proportional hazards model was constructed to identify the independent predictors of 2-year all-cause mortality. RESULTS: For the 256 consecutive patients who had undergone F/BEVAR (6 common iliac [2.3%], 94 juxtarenal [41%], 35 pararenal [14%], 119 thoracoabdominal [47%], and 2 arch [0.8%] aneurysms), the 2-year mortality was 18%. On Cox modeling, the only independent preoperative predictor contributing to 2-year mortality was functional status (totally dependent: hazard ratio [HR], 5.4; 95% confidence interval [CI], 1.8-16; P = .0024; partially dependent: HR, 4.5; 95% CI, 2.4-8.7; P < .0000019). A history of an implanted anti-arrhythmic device was protective (HR, 0.4; 95% CI, 0.2-0.99; P = .0495). Factors such as age, congestive heart failure, chronic kidney disease, diabetes, chronic obstructive pulmonary disease, aneurysm extent, and previous aortic surgery, were not significant. The 2-year mortality for the independent (n = 176; 69%), partially dependent (n = 69; 27%), and totally dependent (n = 10; 3.9%) groups was 11%, 33%, and 40%, respectively. CONCLUSIONS: For patients undergoing F/BEVAR, decreased preoperative functional status was the strongest predictor of 2-year mortality, with totally dependent patients experiencing poor survival. The traditional risk factors were not independently significant, perhaps reflecting the high prevalence of severe chronic illness in these high-risk patients participating in an IDE trial. For the independent patients, the 2-year F/BEVAR survival rate was 89%, equivalent to patient survival after infrarenal EVAR. Therefore, for independent patients, it would be reasonable to expand the indication for F/BEVAR to low-risk patients.
Asunto(s)
Aneurisma de la Aorta/cirugía , Implantación de Prótesis Vascular/mortalidad , Prótesis Vascular , Procedimientos Endovasculares/mortalidad , Estado Funcional , Stents , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta/diagnóstico por imagen , Aneurisma de la Aorta/mortalidad , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/instrumentación , Ensayos Clínicos como Asunto , Bases de Datos Factuales , Procedimientos Endovasculares/efectos adversos , Procedimientos Endovasculares/instrumentación , Femenino , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/mortalidad , Complicaciones Posoperatorias/terapia , Diseño de Prótesis , Sistema de Registros , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Fenestrated/branched endovascular aneurysm repair (F/BEVAR) volume has increased rapidly, with favorable outcomes at centers of excellence. We evaluated changes over time in F/BEVAR complexity and associated outcomes at a single-center complex aortic disease program. METHODS: Prospectively collected data of all F/BEVAR (definition: requiring ≥1 fenestration/branch), procedures performed in an institutional review board-approved registry and/or physician-sponsored investigational device exemption trial (IDE# G130210), were reviewed (11/2010-2/2019). Patients were stratified by surgery date into thirds: early experience, mid experience, and recent experience. Patient and operative characteristics, aneurysm morphology, device types, perioperative and midterm outcomes (survival, freedom from type I or III endoleak, target artery patency, freedom from reintervention), were compared across groups. RESULTS: For 252 consecutive F/BEVARs (early experience, n = 84, mid experience, n = 84, recent experience, n = 84), 194 (77%) company-manufactured custom-made devices, 11 (4.4%) company-manufactured off-the-shelf devices, and 47 (19%) physician-modified devices, were used to treat 5 (2.0%) common iliac, 97 (39%) juxtarenal, 31 (12%) pararenal, 116 (46%) thoracoabdominal, and 2 (0.8%) arch aneurysms. All patients had follow-up for 30-day events. The mean follow-up time for the entire cohort was 589 days (interquartile range, 149-813 days). On 1-year Kaplan-Meier analysis, survival was 88%, freedom from type I or III endoleak was 91%, and target vessel patency was 92%. When stratified by time period, significant differences included aneurysm extent (thoracoabdominal, 33% early experience, 40% mid experience, and 64% recent experience; P < .001) and target vessels per case (four-vessel case, 31% early experience, 39% mid experience, and 67% recent experience; P < .0001). There was no difference, but a trend toward improvement, in composite 30-day events (early experience, 39%; mid experience, 23%; recent experience, 27%; P = .05). On Kaplan-Meier analysis, there was no difference in survival (P = .19) or target artery patency (P = .6). There were differences in freedom from reintervention (P < .01) and from type I or III endoleak (P = .02), with more reinterventions in the early experience, and more endoleaks in the recent period. CONCLUSIONS: Despite increasing repair complexity, there has been no significant change in perioperative complications, overall survival, or target artery patency, with favorable outcomes overall. Type I or III endoleaks remain a significant limitation, with increased incidence as the number of branch arteries incorporated into the repairs has increased.