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1.
J Vasc Surg ; 2024 Oct 03.
Article in English | MEDLINE | ID: mdl-39368637

ABSTRACT

OBJECTIVE: Female patients are less likely to be diagnosed with and treated for peripheral artery disease. When treated, there are also reported sex disparities in short- and long-term outcomes. We designed this study to compare outcomes after open and endovascular revascularization in the Best Endovascular versus best Surgical Therapy in patients with Critical Limb Ischemia (BEST-CLI) trial between females and males, and to examine outcomes of each revascularization type in an all-female cohort. METHODS: In a secondary analysis of cohorts 1 and 2 of the BEST-CLI Trial, patients with chronic limb threatening ischemia (CLTI) undergoing open surgical bypass (with or without adequate conduit) and endovascular therapy were stratified by sex. In addition, in a female-only cohort, we evaluated differences in outcomes between treatment arm (combined all bypasses from cohorts 1 and 2 and compared to all endovascular treatment in cohorts 1 and 2). Outcomes included major amputation, reintervention, major adverse limb event (MALE, a composite of major amputation and reintervention), all-cause death, and composite outcome of MALE or all-cause death. Univariable and adjusted Cox regressions were used to assess outcome between males and females. Similar methods were used to assess differences in outcomes between treatment arm in females. RESULTS: Among 1830 patients, females were significantly underrepresented, comprising only 28% (n=519) of the BEST-CLI cohort. Overall, the characteristics of females enrolled in the trial had some differences compared to males: females were more likely to have rest pain alone (72% vs 60%, p <.0001) and when presenting with an ischemic wound, were less likely to have a wound infection (38% vs 47%, p = .01). Females were less likely to have an adequate single segment greater saphenous vein (SSGSV) available (82% vs 89%, p = .01). Controlled for baseline clinical factors, at one year, females had significantly lower rates of major limb amputation compared to males (HR .70, p = .023), which drove better amputation- and MALE- free survival rates. All-cause death at one year was not statistically different between sexes (11.8% vs 11.2%, p=.286). In the all-female cohort, results paralleled the overall trial; open surgical bypass (with any conduit) had significantly better outcomes compared to endovascular therapy. Specifically, among females undergoing endovascular therapy, the rate of major reintervention was particularly high compared to females undergoing open surgical bypass (24.8% vs. 10.5%, p < .001). CONCLUSIONS: Despite being underrepresented in BEST-CLI, the primary results of the trial, namely, improved MALE-free survival with open surgical bypass with SSGSV, were mirrored in the all female subset. Female patients enrolled in BEST-CLI had better amputation-free survival at one year compared to male patients. These findings suggest that in treating female CLTI patients considered appropriate for both open and endovascular revascularization, surgical bypass with optimal conduit is the preferred treatment option and can potentially ameliorate poor limb preservation outcomes associated with sex.

2.
J Vasc Surg ; 2024 Jun 26.
Article in English | MEDLINE | ID: mdl-38942397

ABSTRACT

BACKGROUND: Given changes in intervention guidelines and the growing popularity of endovascular treatment for aortic aneurysms, we examined the trends in admissions and repairs of abdominal aortic aneurysms (AAAs), thoracoabdominal aortic aneurysms (TAAAs), and thoracic aortic aneurysms (TAAs). METHODS: We identified all patients admitted with ruptured aortic aneurysms and intact aortic aneurysms repaired in the Nationwide Inpatient Sample between 2004 and 2019. We then examined the use of open, endovascular, and complex endovascular repair (OAR, EVAR, and cEVAR) for each aortic aneurysm location (AAA, TAAA, and TAA), alongside their resulting in-hospital mortality, over time. cEVAR included branched, fenestrated, and physician-modified endografts. RESULTS: 715,570 patients were identified with AAA (87% intact repairs and 13% rupture admissions). Both intact AAA repairs and ruptured AAA admissions decreased significantly between 2004 and 2019 (intact 41,060-34,215, P < .01; ruptured 7175-4625, P = .02). Of all AAA repairs performed in a given year, the use of EVAR increased (2004-2019: intact 45%-66%, P < .01; ruptured 10%-55%, P < .01) as well as cEVAR (2010-2019: intact 0%-23%, P < .01; ruptured 0%-14%, P < .01). Mortality after EVAR of intact AAAs decreased significantly by 29% (2004-2019, 0.73%-0.52%, P < .01), whereas mortality after OAR increased significantly by 16% (2004-2019, 4.4%-5.1%, P < .01). In the study, 27,443 patients were identified with TAAA (80% intact and 20% ruptured). In the same period, intact TAAA repairs trended upward (2004-2019, 1435-1640, P = .055), and cEVAR became the most common approach (2004-2019, 3.8%-72%, P = .055). A total of 141,651 patients were identified with ascending, arch, or descending TAAs (90% intact and 10% ruptured). Intact TAA repairs increased significantly (2004-2019, 4380-10,855, P < .01). From 2017 to 2019, the mortality after OAR of descending TAAs increased and mortality after thoracic endovascular aneurysm repair decreased (2017-2019, OAR 1.6%-3.1%; thoracic endovascular aneurysm repair 5.2%-3.8%). CONCLUSIONS: Both intact AAA repairs and ruptured AAA admissions significantly decreased between 2004 and 2019. The use of endovascular techniques for the repair of all aortic aneurysm locations, both intact and ruptured, increased over the past two decades. Most recently in 2019, 89% of intact AAA repairs, infrarenal through suprarenal, were endovascular (EVAR or cEVAR, respectively). cEVAR alone increased to 23% of intact AAA repairs in 2019, from 0% a decade earlier. In this period of innovation, with many new options to repair aortic aneurysms while maintaining arterial branches, endovascular repair is now used for the majority of all intact aortic aneurysm repairs. Long-term data are needed to evaluate the durability of these procedures.

3.
J Vasc Surg ; 2024 Jun 21.
Article in English | MEDLINE | ID: mdl-38908805

ABSTRACT

OBJECTIVE: The recent publication of randomized trials comparing open bypass surgery to endovascular therapy in patients with chronic limb-threatening ischemia, namely, Best Endovascular vs Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) and Bypass versus Angioplasty in Severe Ischaemia of the Leg-2 (BASIL-2), has resulted in potentially contradictory findings. The trials differed significantly with respect to anatomical disease patterns and primary end points. We performed an analysis of patients in BEST-CLI with significant infrapopliteal disease undergoing open tibial bypass or endovascular tibial interventions to formulate a relevant comparator with the outcomes reported from BASIL-2. METHODS: The study population consisted of patients in BEST-CLI with adequate single segment saphenous vein conduit randomized to open bypass or endovascular intervention (cohort 1) who additionally had significant infrapopliteal disease and underwent tibial level intervention. The primary outcome was major adverse limb event (MALE) or all-cause death. MALE included any major limb amputation or major reintervention. Outcomes were evaluated using Cox proportional regression models. RESULTS: The analyzed subgroup included a total of 665 patients with 326 in the open tibial bypass group and 339 in the tibial endovascular intervention group. The primary outcome of MALE or all-cause death at 3 years was significantly lower in the surgical group at 48.5% compared with 56.7% in the endovascular group (P = .0018). Mortality was similar between groups (35.5% open vs 35.8% endovascular; P = .94), whereas MALE events were lower in the surgical group (23.3% vs 35.0%; P<.0001). This difference included a lower rate of major reinterventions in the surgical group (10.9%) compared with the endovascular group (20.2%; P = .0006). Freedom from above ankle amputation or all-cause death was similar between treatment arms at 43.6% in the surgical group compared with 45.3% the endovascular group (P = .30); however, there were fewer above ankle amputations in the surgical group (13.5%) compared with the endovascular group (19.3%; P = .0205). Perioperative (30-day) death rates were similar between treatment groups (2.5% open vs 2.4% endovascular; P = .93), as was 30-day major adverse cardiovascular events (5.3% open vs 2.7% endovascular; P = .12). CONCLUSIONS: Among patients with suitable single segment great saphenous vein who underwent infrapopliteal revascularization for chronic limb-threatening ischemia, open bypass surgery was associated with a lower incidence of MALE or death and fewer major amputation compared with endovascular intervention. Amputation-free survival was similar between the groups. Further investigations into differences in comorbidities, anatomical extent, and lesion complexity are needed to explain differences between the BEST-CLI and BASIL-2 reported outcomes.

4.
J Vasc Surg ; 2024 Jun 14.
Article in English | MEDLINE | ID: mdl-38880180

ABSTRACT

OBJECTIVE: In patients undergoing elective thoracic endovascular aortic repair (TEVAR) and left subclavian artery (LSA) coverage, routine preoperative LSA revascularization is recommended. However, in the current endovascular era, the optimal surgical approach is debated. We compared baseline characteristics, procedural details, and perioperative outcomes of patients undergoing open or endovascular LSA revascularization in the setting of TEVAR. METHODS: Adult patients undergoing TEVAR with zone 2 proximal landing and LSA revascularization between 2013 and 2023 were identified in the Vascular Quality Initiative. We excluded patients with traumatic aortic injury, aortic thrombus, or ruptured presentations, and stratified based on revascularization type (open vs any endovascular). Open LSA revascularization included surgical bypass or transposition. Endovascular LSA revascularization included single-branch, fenestration, or parallel stent grafting. Primary outcomes were stroke, spinal cord ischemia (SCI), and perioperative mortality (Pearson's χ2 test). Multivariable logistic regression was used to evaluate associations between revascularization type and primary outcomes. Secondarily, we studied other in-hospital complications and 5-year mortality (Kaplan-Meier, multivariable Cox regression). Sensitivity analyses were performed in patients undergoing concomitant LSA revascularization to TEVAR. RESULTS: Of 2489 patients, 1842 (74%) underwent open and 647 (26%) endovascular LSA revascularization. Demographics and comorbidities were similar between open and endovascular cohorts. Compared with open, endovascular revascularization had shorter procedure times (median, 135 minutes vs 174 minutes; P < .001), longer fluoroscopy times (median, 23 minutes vs 16 minutes; P < .001), lower estimated blood loss (median, 100 mL vs 123 mL; P < .001), and less preoperative spinal drain use (40% vs 49%; P < .001). Patients undergoing endovascular revascularization were more likely to present urgently (24% vs 19%) or emergently (7.4% vs 3.4%) (P < .001). Compared with open, endovascular patients experienced lower stroke rates (2.6% vs 4.8%; P = .026; adjusted odds ratio [aOR], 0.50 [95% confidence interval (CI), 0.25-0.90]), but had comparable SCI (2.9% vs 3.5%; P = .60; aOR, 0.64 [95% CI, 0.31-1.22]) and perioperative mortality (3.1% vs 3.3%; P = .94; aOR, 0.71 [95% CI, 0.34-1.37]). Compared with open, endovascular LSA revascularization had lower rates of overall composite in-hospital complications (20% vs 27%; P < .001; aOR, 0.64 [95% CI, 0.49-0.83]) and shorter overall hospital stay (7 vs 8 days; P < .001). After adjustment, 5-year mortality was similar among groups (adjusted hazard ratio, 0.85; 95% CI, 0.64-1.13). Sensitivity analyses supported the primary analysis with similar outcomes. CONCLUSIONS: In patients undergoing TEVAR starting in zone 2, endovascular LSA revascularization had lower rates of postoperative stroke and overall composite in-hospital complications, but similar SCI, perioperative mortality, and 5-year mortality rates compared with open LSA revascularization. Future comparative studies are needed to evaluate the mid- to long-term safety of endovascular LSA revascularization and assess differences between specific endovascular techniques.

5.
Ann Vasc Surg ; 107: 136-139, 2024 Oct.
Article in English | MEDLINE | ID: mdl-38582196

ABSTRACT

Retrograde tibio-pedal access represents a feasible method for endovascular revascularization when antegrade methods fail. The article offers an extensive review of retrograde tibio-pedal access, emphasizing the technique and documented outcomes.


Subject(s)
Endovascular Procedures , Peripheral Arterial Disease , Humans , Peripheral Arterial Disease/therapy , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/physiopathology , Endovascular Procedures/instrumentation , Endovascular Procedures/adverse effects , Treatment Outcome , Tibial Arteries/diagnostic imaging , Tibial Arteries/surgery , Tibial Arteries/physiopathology , Punctures , Risk Factors , Catheterization, Peripheral/adverse effects
6.
J Vasc Surg ; 80(2): 413-421.e3, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38552885

ABSTRACT

INTRODUCTION: Clinical practice guidelines have recommended an endovascular-first approach (ENDO) for the management of patients with chronic mesenteric ischemia (CMI), whereas an open mesenteric bypass (OMB) is proposed for subjects deemed to be poor ENDO candidates. However, the impact of a previous failed endovascular or open mesenteric reconstruction on a subsequent OMB is unknown. Accordingly, this study was designed to examine the results of a remedial OMB (R-OMB) after a failed ENDO or a primary OMB (P-OMB) for patients with recurrent CMI. METHODS: All patients who underwent an OMB from 2002 to 2022 at the University of Florida were reviewed. Outcomes after an R-OMB (ie, history of a failed ENDO or P-OMB) and P-OMB were compared. The primary end point was 30-day mortality, whereas secondary outcomes included complications, reintervention, and survival. The Kaplan-Meier methodology was used to estimate freedom from reintervention and all-cause mortality, whereas multivariable Cox proportional hazards modeling identified predictors of death. RESULTS: A total of 145 OMB procedures (R-OMB, n = 48 [33%]; P-OMB, n = 97 [67%]) were analyzed. A majority of R-OMB operations were performed for a failed stent (prior ENDO, n = 39 [81%]; prior OMB, n = 9 [19%]). R-OMB patients were generally younger (66 ± 9 years vs P-OMB, 69 ± 11 years; P = .09) and had lower incidence of smoking exposure (29% vs P-OMB, 48%; P = .07); however, there were no other differences in demographics or comorbidities. R-OMB was associated with less intraoperative transfusion (0.6 units vs P-OMB, 1.4 units; P = .01), but there were no differences in conduit choice or bypass configuration.The overall 30-day mortality and complication rates were 7% (n = 10/145) and 53% (n = 77/145), respectively, with no difference between the groups. Notably, R-OMB had decreased cardiac (6% vs P-OMB, 21%; P < .01) and bleeding complication rates (2% vs P-OMB, 15%; P = .01). The freedom from reintervention (1 and 5 years: R-OMB: 95% ± 4%, 83% ± 9% vs P-OMB: 97% ± 2%, 93% ± 5%, respectively; log-rank P = .21) and survival (1 and 5 years: R-OMB: 82% ± 6%, 68% ± 9% vs P-OMB: 84% ± 4%, 66% ± 7%; P = .91) were similar. Independent predictors of all-cause mortality included new postoperative hemodialysis requirement (hazard ratio [HR], 7.4, 95% confidence interval [CI], 3.1-17.3; P < .001), pulmonary (HR, 2.7, 95% CI, 1.4-5.3; P = .004) and cardiac (HR, 2.4, 95% CI, 1.1-5.1; P = .04) complications, and female sex (HR, 2.1, 95% CI, 1.03-4.8; P = .04). Notably, R-OMB was not a predictor of death. CONCLUSIONS: The perioperative and longer-term outcomes for a remedial OMB after a failed intraluminal stent or previous open bypass appear to be comparable to a P-OMB. These findings support the recently updated clinical practice guideline recommendations for an endovascular-first approach to treating recurrent CMI due to the significant perioperative complication risk of OMB. However, among the subset of patients deemed ineligible for endoluminal reconstruction after failed mesenteric revascularization, R-OMB results appear to be acceptable and highlight the utility of this strategy in selected patients.


Subject(s)
Endovascular Procedures , Mesenteric Ischemia , Treatment Failure , Humans , Male , Female , Mesenteric Ischemia/surgery , Mesenteric Ischemia/mortality , Aged , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Retrospective Studies , Middle Aged , Chronic Disease , Risk Factors , Time Factors , Risk Assessment , Reoperation , Mesenteric Vascular Occlusion/surgery , Mesenteric Vascular Occlusion/mortality , Mesenteric Vascular Occlusion/diagnostic imaging , Mesenteric Vascular Occlusion/physiopathology , Postoperative Complications/etiology , Postoperative Complications/mortality , Recurrence , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/mortality , Blood Vessel Prosthesis Implantation/instrumentation , Florida , Treatment Outcome
7.
J Vasc Surg ; 79(5): 1142-1150.e2, 2024 May.
Article in English | MEDLINE | ID: mdl-38190927

ABSTRACT

OBJECTIVE: The aim of this study was to report the results of a prospective, single-arm, registry-based study assessing the safety and performance of a paclitaxel drug-coated balloon (DCB) for the treatment of superficial femoral artery (SFA) or popliteal artery in-stent restenosis (ISR) in a United States population. METHODS: We conducted a prospective, non-randomized, multi-center, single-arm, post-market registry of the IN.PACT Admiral DCB for the treatment of ISR lesions in the SFA or popliteal artery at 43 sites within the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) Registry from December 2016 to January 2020. Clinical outcomes were assessed at 12, 24, and 36 months. The primary endpoint was target lesion revascularization at 12 months. Secondary endpoints included technical success, target vessel revascularization, major limb amputation, and all-cause mortality. Results are presented as survival probabilities based on Kaplan-Meier survival estimates. RESULTS: Patients (N = 300) were 58% male, with a mean age of 68 ± 10 years. Diabetes was present in 56%, 80% presented with claudication, and 20% with rest pain. Lesions included ISR of the SFA in 68%, SFA-popliteal in 26%, and popliteal arteries in 7%. The mean lesion length was 17.8 ± 11.8 cm. Lesions were categorized as occlusions in 43% (mean occluded length, 16 ± 10 cm). TASC type was A (17%), B (29%), C (38%), and D (15%). Technical success was 99%. Re-stenting was performed in 5% and thrombolysis in 0.6% of patients. Kaplan-Meier estimates for freedom from target lesion revascularization were 90%, 72%, and 62% at 12, 24, and 36 months. Freedom from target vessel revascularization was 88%, 68%, and 59% and freedom from major target limb amputation was 99.6%, 98.9%, and 98.9%, respectively, at 12, 24, and 36 months. Survival was 95%, 89%, and 85% at 12, 24, and 36 months. CONCLUSIONS: This post-market registry-based study shows promising results in treating femoral-popliteal ISR with paclitaxel DCB in comparison to the results of plain balloon angioplasty reported in the literature. These results demonstrate the ability of the SVS VQI to conduct post-market evaluation of peripheral devices in partnership with industry and federal regulators.


Subject(s)
Angioplasty, Balloon , Coronary Restenosis , Peripheral Arterial Disease , Humans , Male , Middle Aged , Aged , Female , Femoral Artery/diagnostic imaging , Popliteal Artery/diagnostic imaging , Paclitaxel/adverse effects , Prospective Studies , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/therapy , Limb Salvage , Time Factors , Constriction, Pathologic , Registries , Coated Materials, Biocompatible , Treatment Outcome
8.
J Vasc Surg ; 77(6): 1710-1719.e6, 2023 06.
Article in English | MEDLINE | ID: mdl-36796592

ABSTRACT

OBJECTIVE: Despite current guidelines recommending the use of distal embolic protection during transfemoral carotid artery stenting (tfCAS) to prevent periprocedural stroke, there remains significant variation in the routine use of distal filters. We sought to assess in-hospital outcomes in patients undergoing tfCAS with and without embolic protection using a distal filter. METHODS: We identified all patients undergoing tfCAS in the Vascular Quality Initiative from March 2005 to December 2021 and excluded those who received proximal embolic balloon protection. We created propensity score-matched cohorts of patients who underwent tfCAS with and without attempted placement of a distal filter. Subgroup analyses of patients with failed vs successful filter placement and failed vs no attempt at filter placement were performed. In-hospital outcomes were assessed using log binomial regression, adjusted for protamine use. Outcomes of interest were composite stroke/death, stroke, death, myocardial infarction (MI), transient ischemic attack (TIA), and hyperperfusion syndrome. RESULTS: Among 29,853 patients who underwent tfCAS, 28,213 (95%) had a filter attempted for distal embolic protection and 1640 (5%) did not. After matching, 6859 patients were identified. No attempted filter was associated with significantly higher risk of in-hospital stroke/death (6.4% vs 3.8%; adjusted relative risk [aRR], 1.72; 95% confidence interval [CI], 1.32-2.23; P < .001), stroke (3.7% vs 2.5%; aRR, 1.49; 95% CI, 1.06-2.08; P = .022), and mortality (3.5% vs 1.7%; aRR, 2.07; 95% CI, 1.42-3.020; P < .001). In a secondary analysis of patients who had failed attempt at filter placement vs successful filter placement, failed filter placement was associated with worse outcomes (stroke/death: 5.8% vs 2.7%; aRR, 2.10; 95% CI, 1.38-3.21; P = .001 and stroke: 5.3% vs 1.8%; aRR, 2.87; 95% CI, 1.78-4.61; P < .001). However, there were no differences in outcomes in patients with failed vs no attempted filter placement (stroke/death: 5.4% vs 6.2%; aRR, 0.99; 95% CI, 0.61-1.63; P = .99; stroke: 4.7% vs 3.7%; aRR, 1.40; 95% CI, 0.79-2.48; P = .20; death: 0.9% vs 3.4%; aRR, 0.35; 95% CI, 0.12-1.01; P = .052). CONCLUSIONS: tfCAS performed without attempted distal embolic protection was associated with a significantly higher risk of in-hospital stroke and death. Patients undergoing tfCAS after failed attempt at filter placement have equivalent stroke/death to patients in whom no filter was attempted, but more than a two-fold higher risk of stroke/death compared with those with successfully placed filters. These findings support current Society for Vascular Surgery guidelines recommending routine use of distal embolic protection during tfCAS. If a filter cannot be placed safely, an alternative approach to carotid revascularization should be considered.


Subject(s)
Carotid Stenosis , Embolism , Stroke , Humans , Carotid Stenosis/complications , Carotid Stenosis/diagnostic imaging , Carotid Stenosis/therapy , Treatment Outcome , Stents , Stroke/etiology , Stroke/prevention & control , Embolism/etiology , Embolism/prevention & control , Carotid Arteries
9.
J Vasc Surg ; 77(4): 1099-1106.e4, 2023 04.
Article in English | MEDLINE | ID: mdl-36435274

ABSTRACT

OBJECTIVE: The WIfI (Wound, Ischemia, foot Infection) stage measures the extent of wounds, ischemia, and foot infection in patients with chronic limb threatening ischemia (CLTI) and has been associated with the risk of major amputation. Patients with CLTI have impaired health-related quality of life (HRQoL), which can be multifactorial. We hypothesized that the severity of the limb threat (WIfI stage) would be associated with poor HRQoL among patients with CLTI presenting for revascularization. METHODS: The dataset of the BEST-CLI (best endovascular versus best surgical therapy in patients with CLTI) trial, a prospective, randomized trial comparing open and endovascular revascularization strategies, was queried for HRQoL assessments at patient enrollment. The HRQoL assessments included (1) Vascular Quality of Life; (2) 12-item short form survey (SF-12), containing the utility index score (short-form six-dimension R2 utility index, incorporating physical, emotional, and mental well-being) and mental and physical components; and (3) the EQ-5D. Multivariable regression analysis was used to identify the independent associations with the baseline HRQoL assessments. RESULTS: A total of 1568 patients with complete WIfI data were analyzed, of whom 71.5% were men. The WIfI distribution was 35.5% with stage 4, 29.6% with stage 3, 28.6% with stage 2, and 6.3% with stage 1. Patients presenting with WIfI stage 4, compared with stage 1 to 3, were more often men (74.9% vs 69.6%) and current smokers (25.4% vs. 17.6%), had had end-stage renal disease (13.3% vs 8.5%) and diabetes (83.6% vs 60.2%), were not independently ambulatory (56.8% vs 38.5%), and had had higher median morbidity scores (4 vs 3; P < .05 for all). On multivariable analysis, WIfI stage 4, compared with stage 1 to 3, was associated with lower SF-12 mental component scale scores (estimate, -2.43; 95% confidence interval, -3.73 to -1.13; P < .001) and short-form six-dimension R2 utility index scores (estimate, -0.02; 95% confidence interval, -0.03 to 0.001; P = .04). The WIfI stage was not independently associated with the baseline Vascular Quality of Life, SF-12 physical component scale, or EQ-5D assessments. CONCLUSIONS: WIfI stage was independently associated with poorer quality of life because of mental, rather than physical, health for patients with CLTI. Clinicians should be aware of the burden of mental stress borne by those with the greatest limb impairment.


Subject(s)
Endovascular Procedures , Peripheral Arterial Disease , Male , Humans , Female , Limb Salvage/methods , Quality of Life , Risk Factors , Prospective Studies , Treatment Outcome , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/surgery , Ischemia/diagnosis , Ischemia/surgery , Chronic Limb-Threatening Ischemia , Retrospective Studies , Endovascular Procedures/adverse effects
10.
N Engl J Med ; 387(25): 2305-2316, 2022 12 22.
Article in English | MEDLINE | ID: mdl-36342173

ABSTRACT

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.).


Subject(s)
Chronic Limb-Threatening Ischemia , Limb Salvage , Vascular Surgical Procedures , Humans , Chronic Limb-Threatening Ischemia/surgery , Chronic Limb-Threatening Ischemia/therapy , Endovascular Procedures/adverse effects , Endovascular Procedures/methods , Limb Salvage/adverse effects , Limb Salvage/methods , Retrospective Studies , Risk Factors , Treatment Outcome , Vascular Surgical Procedures/adverse effects , Vascular Surgical Procedures/methods , Saphenous Vein/transplantation
11.
Ann Vasc Surg ; 86: 85-93, 2022 Oct.
Article in English | MEDLINE | ID: mdl-35809741

ABSTRACT

BACKGROUND: Intermittent claudication (IC) is a commonly treated vascular condition. Patient sex has been shown to influence outcomes of interventions for other vascular disorders; however, whether outcomes of interventions for IC vary by sex is unclear. We sought to assess the association of patient sex with outcomes after IC interventions. METHODS: The Vascular Quality Initiative was queried from 2010-2020 for all peripheral endovascular interventions (PVI), infra-inguinal bypasses (IIB), and supra-inguinal bypasses (SIB) for any degree IC. Univariable and multivariable analyses compared peri-operative and long-term outcomes by patient sex. RESULTS: There were 24,701 female and 40,051 male patients undergoing PVI, 2,789 female and 6,525 male patients undergoing IIB, and 1,695 female and 2,370 male patients undergoing SIB for IC. Guideline-recommended pre-operative medical therapy differed with female patients less often prescribed aspirin for PVI (73.4% vs. 77.3%), IIB (71.5% vs. 74.8%), and SIB (70.9% vs. 74.3%) or statins for PVI (71.8% vs. 76.7%) and IIB (73.1% vs. 76.0%) (all P < 0.05). Female compared with male patients had lower 1-year reintervention-free survival after PVI (84.4% ± 0.3% vs. 86.3% ± 0.2%, P < 0.001), IIB (79.0% ± 0.9% vs. 81.2% ± 0.6%, P = 0.04), and SIB (89.4% ± 0.9% vs. 92.6% ± 0.7%, P = 0.005), but similar amputation-free survival and survival across all procedures. Multivariable analysis confirmed that female sex was associated with increased 1-year reintervention for PVI (HR 1.16, 95% CI 1.09-1.24, P < 0.001), IIB, (HR 1.16, 95% CI 1.03-1.31, P = 0.02), and SIB (HR 1.60, 95% CI 1.20-2.13, P = 0.001). CONCLUSIONS: Female patients undergoing interventions for IC were less often pre-operatively medically optimized than male patients, though the difference was small. Furthermore, female sex was associated with more reinterventions after interventions. Interventionists treating female patients should increase their efforts to maximize medical therapy. Future research should clarify reasons for poorer intervention durability in female patients.


Subject(s)
Endovascular Procedures , Peripheral Arterial Disease , Humans , Male , Female , Intermittent Claudication/diagnostic imaging , Intermittent Claudication/surgery , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/surgery , Risk Factors , Retrospective Studies , Treatment Outcome , Time Factors , Endovascular Procedures/adverse effects , Limb Salvage , Ischemia/surgery
12.
J Vasc Surg ; 74(6): 1874-1884, 2021 12.
Article in English | MEDLINE | ID: mdl-34302935

ABSTRACT

OBJECTIVE: Accurate and contemporary prognostic risk prediction is essential to inform clinical decision-making surrounding abdominal aortic aneurysm (AAA) care. Therefore, we validated and compared three different in-hospital mortality risk scores in one administrative and two quality improvement registries. METHODS: We included patients who had undergone elective AAA repair from 2012 to 2015 in the National Inpatient Sample (NIS), Vascular Quality Initiative (VQI; excluding the New England region), and the National Surgical Quality Improvement Program (NSQIP) datasets to validate three risk scores: Medicare, the Vascular Study Group of New England (VSGNE), and Glasgow Aneurysm Score (GAS). The receiver operating characteristic area under the curve (AUC) of all risk scores was calculated, and their discrimination was compared within a dataset using the Delong test and between datasets using a Z test. We constructed graphic calibration curves for the Medicare and VSGNE risk scores and compared the calibration using an integrated calibration index, which indicates the weighted average of the absolute difference between the calibration curve and the diagonal line of perfect calibration. RESULTS: We identified a total of 25,461 NIS, 18,588 VQI, and 8051 NSQIP patients who had undergone elective open or endovascular AAA repair. Overall, the Medicare risk score was more likely to overestimate mortality in the quality improvement registries and the VSGNE risk score underestimated mortality in all the databases. After endovascular AAA repair, the Medicare risk score had a higher AUC in the NIS than in the GAS (P < .001) but not compared with the VSGNE risk score (P = .54). The VSGNE risk score was associated with a significantly higher receiver operating characteristic AUC compared with the Medicare (P < .001) and GAS (P < .001) risk scores in the VQI registry. Also, the VSGNE risk score showed improved calibration compared with the Medicare risk score across all three databases (P < .001 for all). After open repair, the Medicare risk score showed improved calibration compared with the VSGNE risk score in the NIS (P < .001). However, in the VQI registry, the VSGNE risk score compared with the Medicare risk score had significantly better discrimination (P = .008) and calibration (P < .001). CONCLUSIONS: Overall, the VSGNE risk score performed best in the quality improvement registries but underestimated mortality. However, the Medicare risk score demonstrated better calibration in the administrative dataset after open repair. Although the VSGNE risk score appeared to perform better in the quality improvement registries, its overly optimistic mortality estimates and its reliance on detailed anatomic and clinical variables reduces its broader applicability to other databases.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Decision Support Techniques , Endovascular Procedures/mortality , Hospital Mortality , Postoperative Complications/mortality , Vascular Surgical Procedures/mortality , Administrative Claims, Healthcare , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnosis , Aortic Aneurysm, Abdominal/mortality , Databases, Factual , Endovascular Procedures/adverse effects , Female , Humans , Male , Medicare , Predictive Value of Tests , Quality Improvement , Quality Indicators, Health Care , Registries , Reproducibility of Results , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome , United States , Vascular Surgical Procedures/adverse effects
13.
J Vasc Surg ; 74(4): 1301-1308.e1, 2021 10.
Article in English | MEDLINE | ID: mdl-33887424

ABSTRACT

OBJECTIVE: Significant physiologic perturbations can occur in patients with chronic mesenteric ischemia (CMI) undergoing open mesenteric bypass (OMB). These events have frequently been attributed to ischemia-reperfusion events and have been directly implicated in the occurrence of multiple organ dysfunction (MOD). Scoring systems (MOD score [MODS] and sequential organ failure assessment [SOFA]) have been derived within the critical care field to provide a composite metric for these pathophysiologic changes. The purpose of the present study was to describe the early pathophysiologic changes that occur after OMB for CMI and determine whether these are predictive of the outcomes. METHODS: Patients with CMI who had undergone elective OMB from 2002 to 2018 at a single institution were reviewed. Changes in the hemodynamic, pulmonary, hepatic, renal, and hematologic parameters in the first 96 hours postoperatively were analyzed. The MODSs and SOFA scores were calculated. Cox regression was used to determine the association of the MODSs and SOFA scores with the outcomes. RESULTS: The use of OMB was analyzed for 72 patients (age, 66 ± 11 years; 68% women; body mass index, 23.8 ± 6 kg/m2; 48 ± 34-lb weight loss in 59%). Previous mesenteric stent placement or bypass had been performed in 39% [stenting in 21; bypass in 8; (one patient had both)]. An antegrade configuration (93%) was most common (retrograde configuration, 7%), with revascularization of the superior mesenteric artery/celiac vessels in 85% (superior mesenteric artery only in 15%). Postoperative pathophysiologic and metabolic changes were common, and the mean MODSs and SOFA scores were 3.6 ± 2.4 (range, 1-10) and 4.0 ± 2.7 (range, 1-13), respectively. The median length of stay was 14 days (interquartile range, 9-21). The 30-day mortality was 4% (n = 3) and in-hospital morbidity was 53% (n = 38; gastrointestinal, 25%; infectious, 22%; cardiac, 18%; pulmonary, 18%; renal, 11%). The clinical follow-up period was 16 ± 20 months. The MODSs and SOFA scores correlated linearly with overall mortality (MODS: odds ratio [OR], 1.4; 95% confidence interval [CI], 1.2-1.7; P < .01; SOFA score: OR, 1.4; 95% CI, 1.2-1.7; P < .01 per unit), with a score of ≥5 the inflection point most predictive of mortality (MODS: OR, 3.9; 95% CI, 1.6-9.9; P ≤ .01; SOFA score: OR, 2.8; 95% CI, 1.2-6.6; P = .02). The 1- and 3-year primary bypass patency and freedom from reintervention was 91% ± 5% and 83% ± 7%, respectively, with no association with the MODSs or SOFA scores. The 1- and 3-year survival was 86% ± 4% and 71% ± 6% with significantly worse outcomes for patients with higher MODSs and/or SOFA scores. CONCLUSIONS: Most CMI patients undergoing OMB will experience significant metabolic derangements resulting from sequelae of the ischemia-reperfusion phenomenon postoperatively. These can be objectively assessed in the early postoperative period using simply applied scoring systems to reliably predict the early and long-term outcomes. A derivation of the MODS and/or SOFA score after OMB for CMI can identify the most vulnerable patients at the greatest risk of mortality.


Subject(s)
Hemodynamics , Mesenteric Ischemia/surgery , Reperfusion Injury/etiology , Splanchnic Circulation , Vascular Surgical Procedures/adverse effects , Aged , Chronic Disease , Databases, Factual , Energy Metabolism , Female , Humans , Male , Mesenteric Ischemia/diagnostic imaging , Mesenteric Ischemia/mortality , Mesenteric Ischemia/physiopathology , Middle Aged , Multiple Organ Failure/etiology , Organ Dysfunction Scores , Reperfusion Injury/diagnosis , Reperfusion Injury/mortality , Reperfusion Injury/physiopathology , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome , Vascular Patency , Vascular Surgical Procedures/mortality
14.
Ann Thorac Surg ; 111(5): 1560-1569, 2021 05.
Article in English | MEDLINE | ID: mdl-32961141

ABSTRACT

BACKGROUND: The efficacy of thoracic endovascular aortic repair (TEVAR) of chronic type B aortic dissection (cTBAD) is controversial. Only limited evidence describes temporal anatomic changes after TEVAR for cTBAD and their relationship to outcomes. We sought to investigate early aortic remodeling events after TEVAR for cTBAD with thoracic aneurysm and determine the association with reintervention and survival. METHODS: Records from 95 cTBAD patients undergoing TEVAR from 2005 to 2017 were reviewed. Using 3-dimensional centerline analysis, anatomic phenotyping of the thoracoabdominal aorta was performed. Reverse aortic remodeling (RAR) was defined by a ≥5-mm reduction in maximal thoracic aortic diameter. Kaplan-Meier analysis estimated freedom from reintervention and survival. RESULTS: Visceral segment dissection involvement was present in 89% of patients (n = 85), and the mean preoperative thoracic diameter was 63 mm (SD, 10). Complete thoracic false lumen thrombosis occurred in 71% of patients (n = 67), whereas abdominal false lumen thrombosis was documented in 60% (n = 57) by 6 months. RAR occurred in 41%. Aortic reintervention rate was 39% (n = 37). The 1- and 3-year freedom from reintervention was significantly higher in subjects experiencing early RAR (log-rank P = .02), but reintervention did not impact overall survival (log-rank P = .9). Similarly, overall survival was similar between patients with or without RAR (log-rank P = .4). CONCLUSIONS: Early RAR is associated with decreased rates of reintervention; however, overall survival is not impacted by these changes. TEVAR for cTBAD results in a high rate of reintervention, which mandates vigilant surveillance protocols.


Subject(s)
Aortic Aneurysm, Thoracic/surgery , Aortic Dissection/surgery , Endovascular Procedures , Aged , Aortic Dissection/classification , Aortic Dissection/mortality , Aortic Dissection/pathology , Aorta, Thoracic/pathology , Aortic Aneurysm, Thoracic/mortality , Aortic Aneurysm, Thoracic/pathology , Chronic Disease , Female , Humans , Male , Middle Aged , Prospective Studies , Reoperation , Survival Rate , Vascular Remodeling
15.
J Vasc Surg ; 73(4): 1213-1226.e2, 2021 04.
Article in English | MEDLINE | ID: mdl-32707388

ABSTRACT

BACKGROUND: Widespread adoption of endovascular aneurysm repair has led to a consequential decline in the use of open aneurysm repair (OAR). This evolution has had significant ramifications on vascular surgery training paradigms and contemporary practice patterns among established surgeons. Despite being the subject of previous analyses, the surgical volume-outcome relationship has remained a focus of controversy. At present, little is known about the complex interaction of case volume and surgeon experience with patient selection, procedural characteristics, and postoperative complications of OAR. The purpose of the present analysis was to examine the association between surgeon annual case volume and years of practice experience with OAR. METHODS: All infrarenal OARs (n = 11,900; elective, 70%; nonelective, 30%) included in the Society for Vascular Surgery Vascular Quality Initiative from 2003 to 2019 were examined. Surgeon experience was defined as years in practice after training. The experience level at repair was categorized chronologically (≤5 years, n = 1667; 6-10 years, n = 1887; 11-15 years, n = 1806; ≥16 years, n = 6540). The annual case volume was determined by the number of OARs performed by the surgeon annually (median, five cases). Logistic regression was used to perform risk adjustment of the outcomes across surgeon experience and volume (five or fewer vs more than five cases annually) strata for in-hospital major complications and 30-day and 1-year mortality. RESULTS: Practice experience had no association with unadjusted mortality (30-day death: elective, P = .2; nonelective, P = .3; 1-year death: elective, P = .2; nonelective, P = .2). However, more experienced surgeons had fewer complications after elective OAR (25% with ≥16 years vs 29% with ≤5 years; P = .004). A significant linear correlation was identified between increasing surgeon experience and performance of a greater proportion of elective OAR (P-trend < .0001). Risk adjustment (area under the curve, 0.776) revealed that low-volume (five or fewer cases annually) surgeons had inferior outcomes compared with high-volume surgeons across the experience strata for all presentations. In addition, high-volume, early career surgeons (≤5 years' experience) had outcomes similar to those of older, low-volume surgeons (P > .1 for all pairwise comparisons). Early career surgeons (≤5 years) had operated on a greater proportion of elective patients with American Society of Anesthesiologists class ≥4 (35% vs 30% [≥16 years' experience]; P = .0003) and larger abdominal aortic aneurysm diameters (mean, 62 vs 59 mm [≥16 years' experience]; P < .0001) compared with all other experience categories. Similarly, the use of a suprarenal cross-clamp occurred more frequently (26% vs 22% [≥16 years' experience]; P = .0009) but the total procedure time, estimated blood loss, and renal and/or visceral ischemia times were all greater for less experienced surgeons (P-trend < .0001). CONCLUSIONS: Annual case volume appeared to be more significantly associated with OAR outcomes compared with the cumulative years of practice experience. To ensure optimal OAR outcomes, mentorship strategies for "on-boarding" early career, as well as established, low-volume, aortic aneurysm repair surgeons should be considered. These findings have potential implications for widespread initiatives surrounding regulatory oversight and credentialing paradigms.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Clinical Competence , Outcome and Process Assessment, Health Care/trends , Quality Indicators, Health Care/trends , Surgeons/trends , Vascular Surgical Procedures/trends , Workload , Aged , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/mortality , Female , Hospitals, High-Volume/trends , Hospitals, Low-Volume/trends , Humans , Male , Postoperative Complications/mortality , Registries , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome , Vascular Surgical Procedures/adverse effects , Vascular Surgical Procedures/mortality
16.
J Vasc Surg ; 73(3): 1031-1040.e4, 2021 03.
Article in English | MEDLINE | ID: mdl-32707390

ABSTRACT

OBJECTIVE: Vascular surgical groin wound infection (VS-GWI) has multiple causes and frequently is manifested as a limb- or life-threatening problem, resulting in significant morbidity and mortality. For patients undergoing operative extirpation, in situ repair, extra-anatomic bypass, or ligation can be used; however, limited data exist describing comparative results of the different operative choices or conduit subtypes. Therefore, we sought to describe our experience with management of VS-GWI and to detail outcomes of the different strategies. METHODS: Patients (2003-2017) undergoing surgical treatment of VS-GWI (Szilagyi grade III) secondary to primary infectious arteritis or infected pseudoaneurysm after percutaneous intervention as well as previous prosthetic graft placement were reviewed. The primary end point was major adverse limb events (MALEs; major amputation, graft occlusion, or unplanned reintervention). Secondary end points included 30-day mortality, wound healing, amputation-free survival (AFS), and all-cause mortality. Cox proportional hazards modeling was used to determine relative risk of end points; Kaplan-Meier methodology was employed to estimate freedom from outcomes. RESULTS: There were 149 patients (age, 65 ± 11 years; body mass index, 27 ± 6 kg/m2; 70% male; 32% diabetes) identified, of whom 120 (81%) had unilateral and 29 (19%) had bilateral VS-GWI. Indications included infected prosthetic bypass (88% [n = 131]; infrainguinal, 107; suprainguinal, 24) and primary infectious femoral artery complications (12% [n = 18]). A majority underwent single-stage operations (87% [n = 129]). In situ reconstruction occurred in 87% (n = 129); 9% (n = 13) underwent ligation, and 6% (n = 7) received extra-anatomic revascularization. Autogenous conduit was used most commonly (68% [n = 101/149]; 88% single stage), of which 81% (n = 80) were femoral vein. The remaining patients received cadaveric (15% [n = 23]; 87% single stage) or prosthetic (8% [n=12]; 67% single stage) grafts. Adjunctive myocutaneous flap was used in 37% (n = 54). Length of stay was 19 ± 15 days and 30-day mortality was 7% (n = 10), with no difference between conduit repair types. All femoral wounds healed (mean follow-up, 17 ± 11 months); however, 33% (n = 49) underwent reoperation (unplanned graft reintervention, 33%; graft occlusion, 16%; wound débridement, 15%; major amputation, 11%). Reinfection occurred in 17% (n = 27), with no difference between groups. MALE rate was 22% (n = 33; most were arterial reinterventions, 19%), with no difference in single-stage vs multistage, in situ vs extra-anatomic, or autogenous vs nonautogenous conduit strategies Predictors of MALE included younger age (hazard ratio [HR], 1.6 per decade; 95% confidence interval [CI], 1.1-2.5; P = .02) and lower body mass index (<25 kg/m2; HR, 1.6 per BMI category; 95% CI, 1.1-2.5; P = .02). Overall, 1- and 3-year freedom from MALE, AFS, and survival were as follows: MALE, 74% ± 5% and 63% ± 6%; AFS, 68% ± 4% and 58% ± 5%; survival, 78% ± 3% and 70% ± 4%. Autogenous conduit use was associated with better survival (HR, 0.5; 95% CI, 0.3-0.8; 1-year: 83% ± 4% vs nonautogenous, 78% ± 4%; 3-year: 68% ± 8% vs 53% ± 9%; log-rank, P = .006). CONCLUSIONS: An individualized approach to operative strategy and conduit choice leads to comparable outcomes in this challenging group of patients. VS-GWI can be safely managed with in situ, autogenous reconstruction in a majority of patients with acceptable mortality, excellent wound healing rates, and improved overall survival. However, a significant proportion of patients experience reinfection and MALEs, the preponderance of which are arterial reintervention, mandating need for close follow-up and graft surveillance.


Subject(s)
Aneurysm, False/surgery , Aneurysm, Infected/surgery , Arteritis/surgery , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis/adverse effects , Device Removal , Endovascular Procedures/adverse effects , Groin/blood supply , Prosthesis-Related Infections/surgery , Surgical Wound Infection/surgery , Aged , Amputation, Surgical , Aneurysm, False/diagnosis , Aneurysm, False/microbiology , Aneurysm, False/mortality , Aneurysm, Infected/diagnosis , Aneurysm, Infected/microbiology , Aneurysm, Infected/mortality , Arteritis/diagnosis , Arteritis/microbiology , Arteritis/mortality , Blood Vessel Prosthesis Implantation/instrumentation , Databases, Factual , Device Removal/adverse effects , Device Removal/mortality , Endovascular Procedures/instrumentation , Female , Graft Occlusion, Vascular/etiology , Humans , Ligation , Limb Salvage , Male , Middle Aged , Progression-Free Survival , Prosthesis-Related Infections/diagnosis , Prosthesis-Related Infections/microbiology , Prosthesis-Related Infections/mortality , Reinfection , Reoperation , Retrospective Studies , Risk Assessment , Risk Factors , Surgical Wound Infection/diagnosis , Surgical Wound Infection/microbiology , Surgical Wound Infection/mortality , Time Factors , Wound Healing
17.
J Vasc Surg ; 73(3): 874-888, 2021 03.
Article in English | MEDLINE | ID: mdl-32682065

ABSTRACT

OBJECTIVE: Databases are essential in evaluating surgical outcomes and gauging the implementation of new techniques. However, there are important differences in how data from administrative databases and surgical quality improvement (QI) registries are collected and interpreted. Therefore, we aimed to compare trends, demographics, and outcomes of open and endovascular abdominal aortic aneurysm (AAA) repair in an administrative database and two QI registries. METHODS: We identified patients undergoing open and endovascular repair of intact and ruptured AAAs between 2012 and 2015 within the National Inpatient Sample (NIS), the National Surgical Quality Improvement Program (NSQIP), and the Vascular Quality Initiative (VQI). We described the differences and trends in overall AAA repairs for each data set. Moreover, patient demographics, comorbidities, mortality, and complications were compared between the data sets using Pearson χ2 test. RESULTS: A total of 140,240 NIS patients, 10,898 NSQIP patients, and 26,794 VQI patients were included. Ruptured repairs composed 8.7% of NIS, 11% of NSQIP, and 7.9% of VQI. Endovascular aneurysm repair (EVAR) rates for intact repair (range, 83%-84%) and ruptured repair (range, 51%-59%) were similar in the three databases. In general, rates of comorbidities were lower in NIS than in the QI registries. After intact EVAR, in-hospital mortality rates were similar in all three databases (NIS 0.8%, NSQIP 1.0%, and VQI 0.8%; P = .06). However, after intact open repair and ruptured repair, in-hospital mortality was highest in NIS and lowest in VQI (intact open: NIS 5.4%, NSQIP 4.7%, and VQI 3.5% [P < .001]; ruptured EVAR: NIS 24%, NSQIP 20%, and VQI 16% [P < .001]; ruptured open: NIS 36%, NSQIP 31%, and VQI 26% [P < .001]). After stratification by intact and ruptured presentation and repair strategy, several discrepancies in morbidity rates remained between the databases. Overall, the number of cases in NSQIP represents 7% to 8% of the repairs in NIS, and the number of cases in VQI grew from 12% in 2012 to represent 23% of the national sample in 2015. CONCLUSIONS: NIS had the largest number of patients as it represents the nationwide experience and is an essential tool to evaluate trends over time. The lower in-hospital mortality seen in NSQIP and VQI questions the generalizability of the studies that use these QI registries. However, with a growing number of hospitals engaging in granular QI initiatives, these QI registries provide a valuable resource to potentially improve the quality of care provided to all patients.


Subject(s)
Administrative Claims, Healthcare , Aortic Aneurysm, Abdominal/surgery , Aortic Rupture/surgery , Quality Improvement/trends , Quality Indicators, Health Care/trends , Vascular Surgical Procedures/trends , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/mortality , Aortic Rupture/diagnostic imaging , Aortic Rupture/mortality , Databases, Factual , Female , Hospital Mortality/trends , Humans , Inpatients , Male , Postoperative Complications/mortality , Registries , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome , United States , Vascular Surgical Procedures/adverse effects , Vascular Surgical Procedures/mortality
18.
Eur J Vasc Endovasc Surg ; 60(6): 800-807, 2020 Dec.
Article in English | MEDLINE | ID: mdl-33127243

ABSTRACT

OBJECTIVE: Controversy persists regarding the use of protamine during carotid endarterectomy (CEA), despite real world evidence to support its use. The purpose of this study was to determine the impact of protamine reversal of heparin anticoagulation on the outcome of CEA in the USA. METHODS: A prospective national registry (Society for Vascular Surgery Vascular Quality Initiative) of 72 787 patients undergoing elective asymptomatic CEA by 1879 surgeons from 316 centres in the USA and Canada from 2012 to 2018 was reviewed. Protamine use varied by both surgeon (20% rare use [< 10%], 30% variable use [11%-79%], 50% routine use [> 80% cases]) and geographical region (44% vs. 96%). Temporal trends in protamine use were also determined. End points included post-operative re-operation for bleeding, as well as potential protamine related thrombotic complications, including stroke, death, and myocardial infarction (MI). Predictors of end points were determined by multivariable logistic regression. Propensity matching was additionally used to control for differences between groups. RESULTS: Of the 72 787 patients who underwent CEA, 69% received protamine, while 31% did not. Protamine use increased over time from 60% (2012) to 73% (2018). In total, 378 patients (0.7%) in the protamine treated group underwent re-operation for bleeding vs. 342 patients (1.4%) in the untreated cohort (p < .001). Protamine use did not affect the rate of MI (0.7% vs. 0.8%; p = .023), stroke (1.1% vs. 1.0%; p = .20), or in hospital death (0.2% vs. 0.2%; p = 0.70) between treated and untreated patients, respectively. On multivariable analysis, protamine use was independently associated with reduced risk of re-operation for bleeding (odds ratio 0.5, 95% confidence interval 0.39-0.55; p < .001). Independent of protamine exposure, the consequences of a return to the operating room (RTOR) for bleeding were statistically significant, with a sevenfold increase in MI (RTOR 4.9% vs. no RTOR 0.7%; p < .001), an eightfold increase in stroke (RTOR 7.2% vs. no RTOR 0.9%; p < .001), and a 13 fold increase in death (RTOR 2.4% vs. no RTOR 0.2%; p < .001). CONCLUSION: Protamine reduces serious bleeding complications at the time of CEA without increasing the risk of MI, stroke, or death, in this large North American analysis. Based on this and previous regional work regarding protamine use in CEA, it is believed that there is now sufficient evidence to support its routine use, and it should be considered as a benchmark for quality during CEA.


Subject(s)
Endarterectomy, Carotid/adverse effects , Heparin Antagonists/therapeutic use , Postoperative Hemorrhage/prevention & control , Protamines/therapeutic use , Reoperation/statistics & numerical data , Aged , Anticoagulants/adverse effects , Asymptomatic Diseases , Blood Loss, Surgical/prevention & control , Elective Surgical Procedures , Female , Heparin/adverse effects , Hospital Mortality , Humans , Male , Middle Aged , Myocardial Infarction/epidemiology , Postoperative Hemorrhage/etiology , Postoperative Hemorrhage/surgery , Registries , Stroke/epidemiology , United States/epidemiology
19.
J Vasc Surg ; 72(5): 1681-1690.e4, 2020 11.
Article in English | MEDLINE | ID: mdl-32294505

ABSTRACT

OBJECTIVE: The association of higher hospital volume with lower mortality after open abdominal aortic aneurysm (OAAA) repair is well known; however, the underlying mechanism for improved outcomes is poorly understood. Better patient selection, lower risk of complications, and improved ability to rescue patients after adverse events are assumed mechanisms, but few data exist to validate this hypothesis. The purpose of this analysis was to determine the association of hospital volume with patient selection, incidence of complications, and failure to rescue (FTR) after adverse events resulting from OAAA repair. METHODS: The Vizient (Irving, Tex) database (>95% of all academic hospitals) was reviewed for OAAA repairs (elective, n = 2827; nonelective, n = 1622) performed from 2012 to 2014. Presentation type (elective vs nonelective) was considered in all analyses. Elixhauser comorbidity index and van Walraven weighted scores were assigned to patients and volume-outcome relationships explored. By use of logistic regression, risk-adjusted complications (including preventable complications; Agency for Healthcare Research and Quality patient safety indicators [PSIs]) and FTR rates were determined. Predicted risk scores were assigned to delineate hospital volume association with these outcomes. RESULTS: Overall, no relationship between hospital volume and composite patient comorbidity severity score was identified (Elixhauser comorbidity index and van Walraven weighted scores: Pearson [ρ, 0.02], P = .2; [ρ, -0.01], P = .4; Spearman correlation coefficient [ρ, 0.02], P = .4; [ρ, -0.02], P = .2). The lack of correlation persisted in considering elective vs nonelective status. However, for elective cases, differences in specific comorbidities were noted because high-volume hospitals were more likely to repair patients with a history of peripheral vascular disease (P = .01), diabetes (P = .07), obesity (P = .004), and alcohol abuse (P = .05). Lower volume hospitals more frequently repaired patients with hypothyroidism (P = .05), fluid and electrolyte disorders (P = .007), and chronic blood loss anemia (P = .05). No specific individual comorbidity differences were detected for nonelective cases. In examining hospital volume effects on the likelihood for development of any complication (45%), PSIs (12%), and FTR (9%), a significant risk reduction was noted in high-volume institutions. Specifically, a nonlinear relationship between hospital volume and risk of any complication (P = .0004), PSI (P = .0004), and FTR (P =. 0003) was present. In exploring the risk of specific complications or PSI events, greater hospital volume was strongly correlated to a lower likelihood of multiple adverse outcomes. CONCLUSIONS: Although high-volume institutions performing OAAA repair do not necessarily operate on patients with more comorbidities, there are important differences in the patients selected compared with lower volume hospitals. The risk for development of multiple specific postoperative complications as well as for preventable adverse events preceding FTR is significantly lower in high-volume centers. These findings provide benchmarks for multiple selected quality indicators and further support national initiatives to incentivize regionalization of OAAA care.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/adverse effects , Hospitals, High-Volume , Hospitals, Low-Volume , Patient Selection , Postoperative Complications/epidemiology , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnosis , Aortic Aneurysm, Abdominal/mortality , Failure to Rescue, Health Care , Female , Hospital Mortality , Humans , Incidence , Length of Stay , Logistic Models , Male , Middle Aged , Retrospective Studies , Risk Factors
20.
J Vasc Surg ; 72(4): 1325-1336.e2, 2020 10.
Article in English | MEDLINE | ID: mdl-32115318

ABSTRACT

BACKGROUND: Growing calls for guidelines advocating minimum annual case volumes for surgeon credentialing remain controversial. Although most attention to date has focused on the impact of obligatory case volume, less attention has been devoted to the more complex association between surgeon years of independent practice experience and procedure outcomes after open abdominal aortic aneurysm repair (OAR). Therefore, the purpose of this study was to explore the association of surgeon experience with case selection and real-world outcomes after OAR. METHODS: All Society for Vascular Surgery-Vascular Quality Initiative infrarenal and juxtarenal OARs (n = 11,900; 71% elective; 29% nonelective) from 2003 to 2019 were examined. Surgeon experience was defined by years in practice after training completion. Experience level at time of repair was categorized (≤5 years, n = 1048; 6-10 years, n = 1309; 11-15 years, n = 1244; and ≥16 years, n = 4772) and intergroup univariate comparisons were made. Logistic regression identified independent predictors of complications, 30-day death, and 1-year mortality. Models were constructed with or without surgeon experience strata to determine association with outcomes. RESULTS: Increasing surgeon experience was associated with performing greater proportions of elective procedures, whereas less experienced surgeons had disproportionate exposure to nonelective operations (elective, 73% ≥16 years vs 62% ≤5 years [P < .0001]; nonelective, ≤5 years, 38% vs 27%, ≥16-years [P < .0001]). Among surgeons who perform five or fewer cases per year, the risk of any aggregate major complication after elective OAR decreased significantly as experience increased (P = .0004), although no differences were detected in nonelective cases or among higher volume surgeons. Similarly, the risk of in-hospital death decreased with increasing experience (P = .004), but only among low-volume surgeons performing elective procedures. Comorbidities were similar across all experience strata for both elective and nonelective presentations; however, more experienced surgeons operated on higher proportions of nonelective patients with coronary disease (P = .04). Early career surgeons more frequently operated on patients with American Society of Anesthesiologists IV designation, larger abdominal aortic aneurysm diameters and used suprarenal/celiac cross-clamps more frequently than later career surgeons. The 1-year survival after elective and nonelective OAR was not impacted by surgeon experience (Ptrend > .15 for all comparisons). CONCLUSIONS: Increasing surgeon years of practice experience correlated significantly with a reduced risk of developing multiple postoperative complications, including postoperative death in the elective setting. Surgeons within their first 5 years of practice are exposed to greater proportions of nonelective cases but seem to have similar outcomes after these repairs compared with surgeons with more experience. Notably, surgeons in their first 5 years of practice operate on more complex elective patients as underscored by higher aggregate comorbidity scores, larger aneurysm diameters, and need for suprarenal aortic cross-clamping. These data have important implications on training paradigms, faculty recruitment, and the organization of mentorship when on boarding new surgeons.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Clinical Competence/statistics & numerical data , Patient Selection , Postoperative Complications/epidemiology , Vascular Surgical Procedures/adverse effects , Aged , Aged, 80 and over , Aorta, Abdominal/surgery , Aortic Aneurysm, Abdominal/diagnosis , Aortic Aneurysm, Abdominal/mortality , Clinical Decision-Making , Elective Surgical Procedures/adverse effects , Elective Surgical Procedures/instrumentation , Elective Surgical Procedures/methods , Elective Surgical Procedures/statistics & numerical data , Female , Hospital Mortality , Humans , Male , Middle Aged , Postoperative Complications/etiology , Retrospective Studies , Risk Factors , Severity of Illness Index , Surgeons , Vascular Surgical Procedures/instrumentation , Vascular Surgical Procedures/methods , Vascular Surgical Procedures/statistics & numerical data
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