RESUMO
OBJECTIVES: Physician modified endografts (PMEGs) have expanded the scope of endovascular abdominal aortic repair beyond the infrarenal aorta. Patients with prohibitively high surgical risk and visceral segment disease are often candidates for this intervention, which mitigates much of the morbidity and mortality associated with conventional open repair. Here we present the institutional PMEG experience of a high-volume aortic center. METHODS: We studied all PMEGs performed at our institution from 2012-2023. This includes cases that were submitted to the FDA in support of an IDE trial, as well as those in the subsequently approved IDE trial. Over this 11-year period we assessed the changes in operative characteristics and perioperative outcomes over time. Additionally, we compared the outcomes from PMEG cases to those of Zenith Fenestrated (ZFEN) grafts (done by the surgeon with the PMEG IDE), an alternative device used for aneurysms involving the lower visceral segment. Here we assessed operative characteristics, perioperative outcomes, and 5-year survival and reintervention rates. RESULTS: When assessing the change over time for PMEG operative characteristics, we found a trend towards decreased fluoroscopy time and decreased proportions of completion type-I and type-III endoleaks (all p<.05). Perioperative outcomes have remained stable over this period with an overall perioperative mortality rate of 4.9% (noting that this registry also includes cases that were urgent and emergent). Despite the increased complexity of PMEGs relative to ZFENs we found comparable perioperative outcomes with regards to mortality (4.9% vs 4.3%, p=.86), permanent spinal cord ischemia (1.1% vs 0%, p=.38), postoperative MI (4.3% vs 2.9%, p=.60), postoperative respiratory failure (7.1% vs 4.3%, p=.43), and new dialysis usage (2.2% vs 4.3%, p=.35). Additionally, 5-year survival (PMEG 54% vs ZFEN 65%, p=.15) and freedom from reintervention (63% vs 74%, p=.07) were similar between these cohorts. CONCLUSIONS: Throughout our greater than 10-year experience with PMEGs we have noted improvements in operative outcomes, which can likely be attributed to technological advances and increased physician experience. Additionally, we have found that PMEGs perform well when compared to ZFENs, despite being a more complicated repair that is able to treat a larger segment of the aorta. PMEGs are crucial for the comprehensive care of vascular patients with complex aortic disease. As further operative advancements are made, we only expect the usage of this intervention to increase.
RESUMO
BACKGROUND: Physician modified endografts (PMEGs) have been widely used in the treatment of complex abdominal aortic aneurysm and thoracoabdominal aortic aneurysm, however, previous data are limited to small single center studies and robust data on safety and effectiveness of PMEGs are lacking. We aimed to perform an international multicenter study analyzing the outcomes of PMEGs in complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. METHODS: An international multicenter single-arm cohort study was performed analyzing the outcomes of PMEGs in the treatment of elective, symptomatic, and ruptured complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. Variables and outcomes were defined according to the Society for Vascular Surgery reporting standards. Device modification and procedure details were collected and analyzed. Efficacy outcomes included technical success and safety outcomes included major adverse events and 30-day mortality. Follow-up outcomes included reinterventions, endoleaks, target vessel patency rates and overall and aortic-related mortality. Multivariable analysis was performed aiming at identifying predictors of technical success, 30-day mortality, and major adverse events. RESULTS: Overall, 1274 patients were included in the study from 19 centers. Median age was 74 (IQR, 68-79), and 75.7% were men; 45.7% were complex abdominal aortic aneurysms, and 54.3% were thoracoabdominal aortic aneurysms; 65.5% patients presented electively, 24.6% were symptomatic, and 9.9% were ruptured. Most patients (83.1%) were submitted to a fenestrated repair, 3.6% to branched repair, and 13.4% to a combined fenestrated and branched repair. Most patients (85.8%) had ≥3 target vessels included. The overall technical success was 94% (94% in elective, 93.4% in symptomatic, and 95.1% in ruptured cases). Thirty-day mortality was 5.8% (4.1% in elective, 7.6% in symptomatic, and 12.7% in ruptured aneurysms). Major adverse events occurred in 25.2% of cases (23.1% in elective, 27.8% in symptomatic, and 30.3% in ruptured aneurysms). Median follow-up was 21 months (5.6-50.6). Freedom from reintervention was 73.8%, 61.8%, and 51.4% at 1, 3, and 5 years; primary target vessel patency was 96.9%, 93.6%, and 90.3%. Overall survival and freedom from aortic-related mortality was 82.4%/92.9%, 69.9%/91.6%, and 55.0%/89.1% at 1, 3, and 5 years. CONCLUSIONS: PMEGs were a safe and effective treatment option for elective, symptomatic, and ruptured complex aortic aneurysms. Long-term data and future prospective studies are needed for more robust and detailed analysis.
RESUMO
OBJECTIVE: The high frequency of reinterventions after fenestrated endovascular aortic repair (FEVAR) with physician-modified endografts (PMEGs) has been well-studied. However, the impact of prior EVAR on reinterventions and sac behavior following these procedures remains unknown. We analyzed 3-year rates of reinterventions and sac dynamics following PMEG for index aneurysm repair compared with PMEG for prior EVAR with loss of proximal seal. METHODS: We performed a retrospective analysis of 122 consecutive FEVARs with PMEGs at a tertiary care center submitted to the United States Food and Drug Administration in support of an investigational device exemption trial. We excluded patients with aortic dissection (n = 5), type I to III thoracoabdominal aneurysms (n = 13), non-elective procedures (n = 4), and prior aortic surgery other than EVAR (n = 8), for a final cohort of 92 patients. Patients were divided into those who underwent PMEG for index aneurysm repair (primary FEVAR) and those who underwent PMEG for rescue of prior EVAR with loss of proximal seal (secondary FEVAR). The primary outcomes were freedom from reintervention and sac dynamics (regression as ≥5 mm decrease, expansion as ≥5 mm increase, and stability as <5 mm increase or decrease) at 3 years. Secondary outcomes were perioperative mortality and 3-year survival. RESULTS: Of the 92 patients included, 56 (61%) underwent primary FEVAR and 36 (39%) underwent secondary FEVAR. Secondary FEVAR patients were older (78 years [interquartile range (IQR), 74.5-83.5 years] vs 73 years [IQR, 69-78.5 years]; P < .001), more frequently male (86% vs 68%; P = .048), and had larger aneurysms (72.5 mm [IQR, 65.5-81 mm] vs 59 mm [IQR, 55-65 mm]; P < .001). Perioperative mortality was 1.8% for primary FEVAR and 2.7% for secondary FEVAR (P = .75). At 3 years, overall survival was 84% for primary FEVAR and 71% for secondary FEVAR (P = .086). Freedom-from reintervention was significantly higher for primary FEVAR than secondary FEVAR, specifically 82% vs 38% at 3 years (P < .001). Primary FEVAR also had more desirable sac dynamics relative to secondary FEVAR at 3 years (primary: 54% stable, 46% regressed, 0% expanded vs secondary: 33% stable, 28% regressed, and 39% expanded; P = .038). CONCLUSIONS: FEVAR for primary aortic repair and FEVAR for rescue of prior EVAR with loss of proximal seal are two distinct entities. Following primary FEVAR, less than a quarter of patients have undergone reintervention at 3 years, and sac expansion was not seen in our cohort. Comparatively, 3 years after secondary FEVAR, over one-half of patients have undergone reintervention and over one-third have had ongoing sac expansion. Vigilant surveillance and a low threshold for further interventions are crucial following secondary FEVAR.
Assuntos
Implante de Prótese Vascular , Prótese Vascular , Procedimentos Endovasculares , Desenho de Prótese , Reoperação , Humanos , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/instrumentação , Procedimentos Endovasculares/mortalidade , Estudos Retrospectivos , Masculino , Feminino , Idoso , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/instrumentação , Implante de Prótese Vascular/mortalidade , Fatores de Tempo , Idoso de 80 Anos ou mais , Fatores de Risco , Aneurisma da Aorta Abdominal/cirurgia , Aneurisma da Aorta Abdominal/mortalidade , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/fisiopatologia , Stents , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/cirurgia , Falha de Tratamento , Resultado do Tratamento , Correção Endovascular de AneurismaRESUMO
OBJECTIVE: Despite the advantages that fenestrated endovascular aortic repair has over open repair, it is accompanied by the consequence of radiation exposure, which can result in long-term complications for both the patient and surgical staff. Fiber Optic RealShape (FORS) technology is a novel advancement that uses emitted light from a fiber optic wire and enables the surgeon to cannulate vessels in real time without live fluoroscopy. This technology has been implemented at select centers to study its effectiveness for cannulation of target vessels and its impact on procedural radiation. METHODS: We collected prospective data on physician-modified endograft (PMEG) cases before and after the introduction of FORS technology. FORS PMEGs were matched with up to three conventional fluoroscopy cases by number of target vessels, inclusion of a bifurcated device below, aneurysm extent, and patient body mass index. The procedural radiation parameters were compared between these cohorts. Within the FORS cohort, we analyzed the rate of successful target vessel cannulation for all cases done with this technology (including cases other than PMEGs), and we compared the radiation between the cannulations using only FORS with those that abandoned FORS for conventional fluoroscopy. RESULTS: Nineteen FORS PMEGs were able to be matched to 45 conventional fluoroscopy cases. Procedures that used FORS technology had significantly reduced total air kerma (527 mGy vs 964 mGy), dose area product (121 Gy∗cm2 vs 186 Gy∗cm2), fluoroscopy dose (72.1 Gy∗cm2 vs 132.5 Gy∗cm2), and fluoroscopy time (45 minutes vs 72 minutes). There was no difference in procedure length, total contrast, or digital subtraction angiography. Within FORS cases, 66% of cannulations were completed using only FORS. Cannulations using only FORS had significant reduction of navigation air kerma (5.0 mGy vs 26.5 mGy), dose area product (1.2 Gy∗cm2 vs 5.1 Gy∗cm2), and fluoroscopy time (0.6 minutes vs 2.3 minutes) compared with cannulations abandoning FORS for conventional fluoroscopy. CONCLUSIONS: This study demonstrates the advantages of FORS for total procedural radiation as well as during individual cannulation tasks. The implementation of FORS for target vessel catheterization has the potential to decrease the total degree of radiation exposure for the patient and surgical staff during complex endovascular aortic surgeries.
Assuntos
Implante de Prótese Vascular , Procedimentos Endovasculares , Exposição à Radiação , Humanos , Estudos Prospectivos , Aortografia/métodos , Resultado do Tratamento , Tecnologia , Doses de Radiação , Fluoroscopia , Exposição à Radiação/efeitos adversos , Exposição à Radiação/prevenção & controle , Estudos RetrospectivosRESUMO
PURPOSE: Hostile proximal neck anatomy has historically been associated with worse outcomes for endovascular aortic aneurysm repair (EVAR) of abdominal aortic aneurysms (AAA). We investigated the impact of proximal neck anatomy on the outcomes following EVAR with the Ovation abdominal stent graft (Endologix, Irving, Calif). METHODS: We used prospectively collected data from the Effectiveness of Custom Seal with Ovation: Review of the Evidence database, compromised of pooled data from 6 clinical trials and the European Post-Market Registry of patients undergoing elective infrarenal EVAR (2009-2017). We investigated the impact of short neck length (<10 mm), wide neck diameter (≥28 mm), reverse taper shape (>10%), and neck angulation (>45°) on the outcomes. The primary outcome was type IA endoleak. Secondary outcomes included any type I/III endoleak, sac expansion, aneurysm-related reinterventions, and all-cause and aneurysm-related mortality, and a combined endpoint of type IA endoleak, graft migration, AAA-related reintervention, conversion, and aneurysm rupture. We used Kaplan-Meier analysis and Cox proportional hazards models to estimate the 30 day and 5 year rates and assess univariate and risk-adjusted differences. RESULTS: Of the 1020 patients, 60 patients had a short neck, 113 had a wide neck diameter, 279 were reverse taper shaped, and 99 had neck angulation >45°. Wide proximal neck was associated with higher 5 year type IA endoleak estimates compared with favorable neck anatomy (7.1% vs 4.3%; p=0.02). No association with 5 year type IA endoleak was found for short neck length (1.7% vs 4.3%; p=0.52), reverse taper shape (3.2% vs 4.3%; p=0.99), or neck angulation (6.1% vs 4.3%; p=0.13). A wide neck diameter compared with favorable anatomy was also associated with higher 5 year estimates of graft migration (3.8% vs 0.4%; p=0.03) and the combined neck-related adverse outcome endpoint (16% vs 9.5%; p=0.002). The estimates of aneurysm sac expansion, rupture, and overall and aneurysm-related mortality were similar between the hostile proximal neck anatomy cohorts and favorable anatomy. CONCLUSION: Wide proximal neck is associated with higher 5 year type IA endoleak rates for patients treated with the Ovation stent graft. However, short neck length, reverse taper shape, and neck angulation are not associated with higher 5 year type IA endoleak rates. CLINICAL IMPACT: Hostile proximal neck anatomy has historically been associated with worse outcomes for endovascular aortic aneurysm repair of abdominal aortic aneurysms. The Ovation stent graft platform uses a different proximal sealing method using a polymer inflatable ring, aiming to improve sealing between the graft and aortic wall. This study demonstrated that short, angulated, and reverse taper-shaped neck anatomy did not result in increased type IA endoleak estimates in patients treated with the Ovation stent graft platform. Potentially, the different sealing mechanisms played a role in mitigating the historically worse outcomes in patients with short, angulated, and reverse taper-shaped neck anatomy.
RESUMO
OBJECTIVE: Endovascular aortic aneurysm repair (EVAR) has lower rates of postoperative mortality and morbidity when compared with open repair. However, endovascular repair still carries the risk of postoperative dialysis, paralysis, and stroke. This study examined the rates of postoperative mortality and morbidity stratified by type of endovascular aortic aneurysm repair. METHODS: All patients who underwent EVAR in the Vascular Quality Initiative registry from January 2011 to May 2022 were identified. Patients were stratified by repair type: infrarenal EVAR, complex EVAR, thoracic endovascular aortic repair (TEVAR), extent I to III thoracoabdominal aortic aneurysm (TAAA) repair, or aortic arch repair. The primary outcome was postoperative thoracoabdominal aortic aneurysm life-altering events (TALE) across the different treatment groups. TALE was defined as a composite outcome of postoperative mortality, dialysis, paralysis, and/or stroke. Mixed effect logistic regression modeling was used to identify procedural and anatomic factors that were independently associated with TALE. RESULTS: A total of 52,592 EVARs, 3768 complex EVARs, 3899 TEVARs, 1139 extent I to III TAAA repairs, and 479 arch repairs were identified. TALE was observed in 1.2% of EVARs, 4.8% of complex EVARs, 6.0% of TEVARs, 10% of extent I to III TAAA repairs, and 14% of arch repairs. More proximal landing zone was associated with higher odds of TALE after complex EVAR (odds ratio [OR], 1.9; 95% confidence interval [CI], 1.2-3.1; P = .008), TEVAR (OR, 2.2; 95% CI, 1.4-3.5; P = .001), and extent I to III TAAA repair (OR, 2.7; 95% CI, 1.5-4.9; P = .001). Aortic diameter >65 mm was associated with higher odds of TALE after infrarenal EVAR (OR, 1.8; 95% CI, 1.4-2.3; P < .001), complex EVAR (OR, 1.6; 95% CI, 1.1-2.3; P = .010), TEVAR (OR, 2.7; 95% CI, 2.0-3.8; P < .001), and arch repair (OR, 2.4; 95% CI, 1.3-4.4; P = .007). The use of parallel grafting technique (chimney/snorkel/periscope) during extent I to III TAAA repair was also associated with higher odds of TALE (OR, 1.8; 95% CI, 1.1-3.2; P = .032). Preoperative chronic kidney disease was also associated with higher odds of TALE after infrarenal EVAR (OR, 4.3; 95% CI, 3.0-5.7; P < .001), complex EVAR (OR, 5.2; 95% CI, 3.3-8.2; P < .001), TEVAR (OR, 4.5; 95% CI, 2.8-7.1; P < .001), and extent I to III TAAA repair (OR, 3.2; 95% CI, 1.6-6.7; P = .001). CONCLUSIONS: Although TALE was originally described for TAAA repairs, TALE may occur after complex EVAR, TEVAR, and arch repairs as well. Therefore, TALE and its component parts should be used to evaluate the efficacy of all aortic repairs and for preoperative counseling. Additionally, surgeons should be aware of anatomic and procedural characteristics that are associated with higher odds of TALE. The anticipated need for such interventions during aortic repair should be factored into preoperative risk assessment of patients.
Assuntos
Aneurisma da Aorta Abdominal , Aneurisma da Aorta Torácica , Aneurisma da Aorta Toracoabdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Acidente Vascular Cerebral , Humanos , Correção Endovascular de Aneurisma , Implante de Prótese Vascular/efeitos adversos , Procedimentos Endovasculares/efeitos adversos , Fatores de Risco , Complicações Pós-Operatórias , Acidente Vascular Cerebral/etiologia , Resultado do Tratamento , Estudos Retrospectivos , Aneurisma da Aorta Torácica/diagnóstico por imagem , Aneurisma da Aorta Torácica/cirurgia , Aneurisma da Aorta Torácica/etiologia , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/cirurgia , Aneurisma da Aorta Abdominal/etiologiaRESUMO
OBJECTIVE: Reports of endovascular treatment of chronic post-dissection aneurysms are limited to high volumes centres, posing questions about generalisability. METHODS: All endovascular repairs of intact pararenal and thoraco-abdominal aneurysms in the Vascular Quality Initiative from 2014 to 2021 were studied, and peri-operative and long term outcomes were compared between repairs of degenerative and post-dissection aneurysms. Peri-operative outcomes were compared using mixed effects logistic regression, and long term outcomes using Medicare linkage. RESULTS: There were 123 patients who completed treatment for post-dissection aneurysms and 3 635 for degenerative aneurysms, with 36% of post-dissection repairs and 6.7% of degenerative repairs performed in a staged fashion (p < .001). The majority (84%) of post-dissection aneurysms were extensive thoraco-abdominal aneurysms (TAAAs: Crawford Type 1, 2, 3, 5), compared with 22% of degenerative aneurysms (p < .001). Physician modified endografts were the primary repair type for post-dissection (73%), while commercially available fenestrated grafts were the dominant repair for degenerative (48%). The first stage of staged procedures was associated with a 2.8% peri-operative mortality rate, 5.1% spinal cord ischaemia, and 8.9% thoraco-abdominal life altering events (the composite of peri-operative death, stroke, permanent spinal cord ischaemia, and dialysis). Th final stage procedure and fluoroscopy times were similar, but technical success was lower in post-dissection repairs (75% vs. 83%, p = .018), both due to issues with the main endograft or bridging vessels (11% vs. 6.6%, p = .055), and types 1and 3 endoleak at completion (17% vs. 10%, p = .035). In addition, high volume surgeons had two fold higher odds of technical success than their low volume counterparts. Adjusted peri-operative outcomes were similar between pathology types, including when comparisons were restricted to extensive TAAAs. Crude and adjusted three year survival were similar, but three year re-interventions were significantly higher following post-dissection repairs (p < .001). CONCLUSION: Complex endovascular repair of chronic post-dissection aneurysms is feasible but is associated with high rates of re-interventions and non-trivial rates of lack of technical success. More data are needed to evaluate the long term durability of these procedures, and the utility of centralising these complex procedures.
Assuntos
Aneurisma da Aorta Abdominal , Aneurisma da Aorta Torácica , Implante de Prótese Vascular , Procedimentos Endovasculares , Isquemia do Cordão Espinal , Humanos , Idoso , Estados Unidos , Prótese Vascular , Aneurisma da Aorta Torácica/diagnóstico por imagem , Aneurisma da Aorta Torácica/cirurgia , Aneurisma da Aorta Torácica/etiologia , Implante de Prótese Vascular/efeitos adversos , Resultado do Tratamento , Fatores de Risco , Procedimentos Endovasculares/efeitos adversos , Medicare , Aneurisma da Aorta Abdominal/cirurgia , Isquemia do Cordão Espinal/etiologiaRESUMO
OBJECTIVE: The long-term survival differences between endovascular repair (EVAR) and open repair for abdominal aortic aneurysms (AAAs) and specifically the impact of age on these differences remain a topic of debate. Therefore, we compared the long-term mortality between EVARand open abdominal aneurysm repair for patients of different ages. METHODS: This was a retrospective cohort study of prospectively collected data from patients undergoing elective EVAR or open repair for infrarenal AAAs within the Vascular Quality Initiative multinational clinical registry (2003-2021). The primary outcome was long-term all-cause mortality comparing EVAR and open repair for patients aged less than 65 years, between 65 and 79 years, and those aged 80 and older. In addition, we investigated the interaction between repair modality and 10-year hazard of mortality for sex, aneurysm diameter, and several preoperative comorbid conditions within each age category. To account for the nonrandom assignment of treatment, we used propensity scores and inverse probability weighted Cox proportional hazard analysis. RESULTS: We identified 48,074 patients undergoing elective infrarenal abdominal aneurysm repair (89% EVAR) within the study period, including 7940 patients aged less than 65, 29,555 aged between 65 and 79, and 10,579 aged 80 years or more. EVAR was associated with a higher propensity score-adjusted long-term hazard of mortality compared with open repair in the cohort aged less than 65 years (hazard ratio [HR], 1.39; 95% confidence interval [CI], 1.04-1.86; P = .026). The mortality was similar in the age cohort between 65 and 79 (HR, 0.94; 95% CI, 0.79-1.10; P = .43), whereas EVAR was associated with a lower hazard of mortality in the cohort aged 80 years or more (HR, 0.63; 95% CI, 0.46-0.86; P = .004). In patients aged less than 65 years, the hazard of mortality was higher with EVAR compared with open repair in those with female sex (HR, 4.40; 95% CI, 1.75-11.0), an aneurysm diameter of more than 65 mm (HR, 2.19; 95% CI, 1.11-4.34), and an absence of coronary artery disease (HR, 1.26; 95% CI, 0.83-1.91), congestive heart failure (HR, 1.41; 95% CI, 1.03-1.92), and renal dysfunction (HR, 1.46; 95% CI, 1.04-2.05). In the patient cohort aged 80 and older, a lower hazard of mortality for EVAR versus open repair was observed for male patients or those with small aneurysms or certain comorbidities. CONCLUSIONS: In a selected group of young patients with a substantial life expectancy, the long-term mortality is higher with EVAR compared with open repair for infrarenal AAAs. Long-term mortality with EVAR is similar in the middle cohort and lower in the elderly cohort compared with open repair.
Assuntos
Aneurisma da Aorta Abdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/complicações , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/efeitos adversos , Procedimentos Endovasculares/efeitos adversos , Feminino , Humanos , Masculino , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVE: Aortic neck anatomy has a significant impact on the complexity of endovascular aortic aneurysm repair (EVAR), with concern that neck characteristics outside of the instructions for use (IFU) may result in worse outcomes. Therefore, this study determined the impact of neck characteristics outside of the IFU on perioperative and 1-year outcomes and mid-term survival after EVAR. METHODS: We identified all patients undergoing elective infrarenal EVAR from December 2014 to May 2020 in the Vascular Quality Initiative database. Neck characteristics outside of the IFU were determined based the specific device IFU neck characteristics (neck diameter, length, and angulation). Patients without 1-year follow-up were excluded for the 1-year outcomes analyses (n = 6138 [40%]). We used multivariable adjusted logistic regression and Cox proportional hazard models to identify the independent associations between neck characteristics outside of the IFU and our outcomes. RESULTS: Of the 15,448 patients identified, 22.1% had neck characteristics outside of the IFU, including 6.6% with a infrarenal angle, 6.8% with a neck length, 10.4% with a neck diameter, and 1.1% with a suprarenal angulation outside of the IFU. Of these, 2.4% had more than one neck characteristic outside of the IFU. Patients with neck characteristics outside of the IFU were more often female (27.9% vs 15.0%; P < .001) and were older (median age, 75 years vs 73 years; P < .001). EVAR patients with neck characteristics outside of the IFU had higher rates of type Ia endoleaks at completion (4.8% vs 2.5%; P < .001), perioperative mortality (1.2% vs 0.6%; P < .001), 1-year sac expansion (7.1% vs 5.3%; P = .017), and 1-year reinterventions (4.4% vs 3.2%; P = .03). In multivariable adjusted analyses, neck characteristics outside of the IFU were independently associated with type Ia completion endoleaks (OR, 1.6; 95% CI, 1.3-2.0; P < .001), perioperative mortality (OR, 1.8; 95% CI, 1.2-2.7; P = .005), 1-year sac expansion (OR, 1.4; 95% CI, 1.0-1.8; P = .025), and 1-year reinterventions (OR, 1.4; 95% CI, 1.0-1.9; P = .039). The unadjusted midterm survival was lower for patients with neck characteristics outside of the IFU than for patients without (5-year survival 84.0% vs 86.7%; log-rank P < .001). However, after adjustment, survival was similar for patients with neck characteristics outside of the IFU to those within (hazard ratio, 1.1; 95% CI, 1.0-1.3; P = .22). CONCLUSIONS: Neck characteristics outside of the IFU are independently associated with completion type Ia endoleaks, perioperative mortality, 1-year sac expansion, and 1-year reinterventions among patients undergoing elective EVAR. These results indicate that continued effort is needed to improve the proximal seal in patients with neck characteristics outside of the IFU undergoing EVAR. Also, in patients with severe hostile neck characteristics, alternative approaches such as open repair, use of a fenestrated or branched device, or endoanchors should be considered.
Assuntos
Aneurisma da Aorta Abdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Idoso , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/cirurgia , Prótese Vascular , Endoleak/cirurgia , Feminino , Humanos , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVE: Statin use is associated with higher long-term survival after abdominal aortic aneurysm repair. However, the association between statin use and survival after thoracic endovascular aortic repair (TEVAR) has not been established. METHODS: We performed a review of prospectively collected data of all patients who had undergone TEVAR in the Vascular Quality Initiative between 2014 and 2020. We excluded patients aged <18 years, those who had presented with trauma, and those who had received custom-manufactured or physician-modified devices. We evaluated the association between preoperative statin therapy and in-hospital mortality and complications and 5-year mortality. We also analyzed the trend of preoperative statin use in elective cases for the previous 7 years. To account for nonrandom assignment to treatment, we used propensity score matching of patient characteristics, comorbidities, pathology, and urgency for preoperative statin use. We used logistic regression and Cox regression for the short-term and 5-year outcomes, respectively. RESULTS: Of 6266 patients who had undergone TEVAR and met the inclusion criteria, 3331 (53%) patients had been taking a statin preoperatively, including 1148 of 2267 (64%) treated for aneurysmal disease. After propensity score matching, 1875 patients were in each cohort. Preoperative statin use was associated with lower rates of any perioperative complication (16.7% vs 19.6%; odds ratio, 0.82; 95% confidence interval [CI] 0.69-0.97; P = .022). Overall, preoperative statin use was also associated with lower 5-year mortality (18.8% vs 24.5%; hazard ratio [HR], 0.74; 95% CI, 0.63-0.89; P = .001). When stratified by urgency, preoperative statin use was associated with lower 5-year mortality after elective TEVAR (14.9% vs 22.4%; HR, 0.62; 95% CI, 0.49-0.79; P < .001) but not after urgent or emergent TEVAR (27.4% vs 29.1%; HR, 0.89; 95% CI, 0.70-1.14; P = .37). When stratified by pathology, preoperative statin use was associated with significantly lower 5-year mortality for patients with aneurysms (HR, 0.63; 95% CI, 0.48-0.83; P = .001). Although the mortality was also lower for patients with dissection and "other" pathology, these differences did not reach statistical significance. Between 2014 and 2019, a significant increase had occurred in statin use among patients undergoing elective TEVAR, from 56% in 2014 to 64% in 2019 (P = .007). CONCLUSIONS: Preoperative statin therapy is associated with lower perioperative complication rates and 5-year mortality for patients undergoing TEVAR. All patients with known thoracic aortic pathology should receive statin therapy unless contraindications for the drug are present. For patients undergoing elective TEVAR, the statin prescription percentage should be considered a quality metric, and further implementation research should occur to improve preoperative statin use.
Assuntos
Aorta Torácica/cirurgia , Doenças da Aorta/cirurgia , Implante de Prótese Vascular , Procedimentos Endovasculares , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Aorta Torácica/diagnóstico por imagem , Doenças da Aorta/diagnóstico por imagem , Doenças da Aorta/mortalidade , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/mortalidade , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/etiologia , Fatores de Proteção , Sistema de Registros , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Contemporary national trends in the repair of ruptured abdominal aortic aneurysms (AAAs) and intact AAAs are relatively unknown. Furthermore, screening is only covered by insurance for patients aged 65 to 75 years with a family history of AAAs and for men with a positive smoking history. It is unclear what proportion of patients who present with a ruptured AAA would have been candidates for screening. METHODS: Using the National Inpatient Sample from 2004 to 2015, we identified ruptured and intact AAA admissions and repairs using the International Classification of Diseases codes. We generated the screening-eligible cohort using previously identified proportions of male smokers (87%) and all patients with a family history of AAAs (10%) and applied these proportions to patients aged 65 to 75 years. We accounted for those who could have had a previous AAA diagnosis (17%), either from screening or an incidental detection in patients aged >75 years who had presented with AAA rupture. The primary outcomes were treatment and in-hospital mortality between patients meeting the criteria for screening vs those who did not. RESULTS: We evaluated 65,125 admissions for ruptured AAAs and 461,191 repairs for intact AAAs. Overall, an estimated 45,037 admitted patients (68%) and 25,777 patients who had undergone repair for ruptured AAAs (59%) did not meet the criteria for screening. Of the patients who did not qualify, 27,653 (63%) were aged >75 years, 10,603 (24%) were aged <65 years, and 16,103 (36%) were women. Endovascular AAA repair (EVAR) increased for ruptured AAAs from 10% in 2004 to 55% in 2015 (P < .001), with operative mortality of 35%. EVAR increased for intact AAAs from 45% in 2004 to 83% in 2015 (P < .001), with operative mortality of 2.0%. CONCLUSIONS: Most patients who had undergone repair for ruptured AAAs did not qualify for screening. EVAR was the primary treatment of both ruptured and intact AAAs with relatively low in-hospital mortality. Therefore, expansion of the screening criteria to include selected women and a wider age range should be considered.
Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Ruptura Aórtica/cirurgia , Implante de Prótese Vascular/tendências , Programas de Triagem Diagnóstica/tendências , Definição da Elegibilidade/tendências , Idoso , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/mortalidade , Ruptura Aórtica/diagnóstico por imagem , Ruptura Aórtica/mortalidade , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/mortalidade , Tomada de Decisão Clínica , Bases de Dados Factuais , Feminino , Mortalidade Hospitalar/tendências , Humanos , Masculino , Admissão do Paciente/tendências , Valor Preditivo dos Testes , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados Unidos/epidemiologiaRESUMO
BACKGROUND: Protamine use in carotid endarterectomy has been shown to be associated with fewer perioperative bleeding complications without higher rates of thromboembolic events. However, the effect of protamine use on complications after transfemoral carotid artery stenting (CAS) is unclear, and concerns remain about thromboembolic events. METHODS: A retrospective review was performed for patients undergoing transfemoral CAS in the Vascular Quality Initiative from March 2005 to December 2018. We assessed in-hospital outcomes using propensity score-matched cohorts of patients who did and did not receive protamine. The primary outcome was in-hospital stroke or death. Secondary outcomes included bleeding complications, stroke, death, transient ischemic attack, myocardial infarction, and congestive heart failure exacerbation. Bleeding complications were categorized as bleeding resulting in intervention or blood transfusions. RESULTS: Of the 17,429 patients undergoing transfemoral CAS, 2697 (15%) patients received protamine. We created 2300 propensity score-matched pairs of patients who did and did not receive protamine. There were no statistically significant differences in stroke or death between the two cohorts (protamine, 2.5%; no protamine, 2.9%; relative risk [RR], 0.85; 95% confidence interval [CI], 0.60-1.21; P = .37). Protamine use was not associated with statistically significant differences in perioperative bleeding complications resulting in interventional treatment (0.9% vs 0.5%; RR, 2.10; 95% CI, 0.99-4.46; P = .05) or blood transfusion (1.2% vs 1.2%; RR, 0.92; 95% CI, 0.53-1.61; P = .78). There were also no statistically significant differences for the individual outcomes of stroke (1.8% vs 2.3%; RR, 0.78; 95% CI, 0.52-1.16; P = .22), death (0.9% vs 0.8%; RR, 1.17; 95% CI, 0.62-2.19; P = .63), transient ischemic attack (1.4% vs 1.3%; RR, 1.10; 95% CI, 0.67-1.82; P = .70), myocardial infarction (0.5% vs 0.4%; RR, 1.20; 95% CI, 0.52-2.78; P = .67), or heart failure exacerbation (1.0% vs 0.9%; RR, 1.05; 95% CI, 0.58-1.90; P = .88). Protamine use in patients presenting with symptomatic carotid stenosis was associated with lower risk of stroke or death (3.0% vs 4.3%; RR, 0.69; 95% CI, 0.47-0.998; P = .048), whereas there were no statistically significant differences in stroke or death with protamine use in asymptomatic patients (1.6% vs 1.0%; RR, 1.63; 95% CI, 0.67-3.92; P = .28). CONCLUSIONS: Heparin reversal with protamine after transfemoral CAS is not associated with an increased risk of thromboembolic events, and its use in symptomatic carotid disease is associated with a lower risk of stroke or death.
Assuntos
Estenose das Carótidas/cirurgia , Procedimentos Endovasculares/métodos , Pontuação de Propensão , Protaminas/uso terapêutico , Sistema de Registros , Medição de Risco/métodos , Tromboembolia/prevenção & controle , Idoso , Estenose das Carótidas/mortalidade , Feminino , Artéria Femoral , Antagonistas de Heparina/uso terapêutico , Mortalidade Hospitalar/tendências , Humanos , Masculino , Estudos Retrospectivos , Fatores de Risco , Taxa de Sobrevida/tendências , Tromboembolia/epidemiologia , Resultado do Tratamento , Estados Unidos/epidemiologiaRESUMO
OBJECTIVE: To evaluate the 30 day mortality of elective open complex abdominal aortic aneurysm (cAAA) repair and identify factors associated with death. METHODS: This was a retrospective cohort study using a Targeted Vascular Module from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP). All patients undergoing elective repair for juxta- and suprarenal abdominal aortic aneurysm (AAA), or type IV thoraco-abdominal aneurysms (TAAA) from 2011 to 2017 were identified. Thirty day mortality and complication rates for open repair were established. A comparison endovascular aneurysm repair (EVAR) group was extracted from the same time period, and inverse probability weighting was applied for comparison. Logistic regression was used to identify factors independently associated with open repair mortality. RESULTS: Of the 957 patients who underwent an elective open cAAA repair over the study period, 65 (6.8%) died. The mean age of the patient was 71.3 ± 8.0 years. The distribution by aneurysm type was 605 juxtarenal AAA (28 deaths, 4.6%); 284 suprarenal AAA (16 deaths, 9.5%), and 68 type IV TAAA (10 deaths, 14.7%). During the same time period, there were 1149 endovascular repairs for cAAA, with 43 deaths (3.7%). After inverse probability weighting and weighted logistic regression, open repair 30 day mortality yielded an OR 1.9, 95% CI 1.2-3.1, p = .01 compared with EVAR. Factors independently associated with death included more proximal extent aneurysm (referent [ref]: juxtarenal: OR 2.0 per extent increase, 95% CI 1.4-3.0, p < .001), BMI < 18.5 (OR 4.0, 95% CI 1.6-10.1, p = .003), history of severe chronic obstructive pulmonary disease (COPD) (OR 2.6, 95% CI 1.5-4.4, p = .001), more severe chronic kidney disease (CKD) (ref: none/mild): OR 1.9, 95% CI 1.2-2.8, p = .004), and age (OR 1.06/year, 95% CI 1.02-1.09, p = .002. CONCLUSION: The 30 day mortality was 4.6% for juxtarenal AAA, 9.5% for suprarenal AAA, and 14.7% for type IV TAAA. The open repair odds of 30 day mortality was nearly twice that of endovascular repair for cAAA. Independent associations with death included BMI <18.5, more severe CKD level, more proximally extending aneurysm, age, and history of advanced COPD.
Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Procedimentos Cirúrgicos Eletivos/mortalidade , Idoso , Aorta Abdominal/patologia , Aorta Abdominal/cirurgia , Aneurisma da Aorta Abdominal/mortalidade , Aneurisma da Aorta Abdominal/patologia , Procedimentos Cirúrgicos Eletivos/métodos , Procedimentos Endovasculares/mortalidade , Feminino , Humanos , Modelos Logísticos , Masculino , Estudos Retrospectivos , Fatores de RiscoRESUMO
OBJECTIVE: Persistent type II endoleaks (T2ELs) after endovascular aneurysm repair (EVAR) with sac growth have been associated with adverse events, including rupture. Whereas intervention in the presence of aneurysm growth has become an accepted treatment paradigm for T2ELs, the efficacy and clinical success of such interventions remain unclear. Therefore, we examined the treatment patterns and clinical outcomes of patients undergoing T2EL interventions after EVAR. METHODS: We performed a retrospective review of all patients treated for expanding aneurysm sacs with T2ELs after EVAR at an academic medical center between 2006 and 2017. The primary outcomes assessed were need for repeated intervention; intervention types; and achievement of clinical success, defined as stable aneurysm sac size on computed tomography angiography after treatment. RESULTS: Fifty-six patients underwent 119 interventions, of which 107 (90%) were technically successful. The median time from EVAR to index T2EL procedure was 37 months (interquartile range, 17-56 months), and the median follow-up time from first T2EL procedure was 27 months (interquartile range, 10-51 months). The most common index procedure was transarterial lumbar embolization (64%), followed by transarterial inferior mesenteric artery (20%), transcaval (14%), and translumbar embolization (1.8%). Thirty-three (59%) patients required further procedures for persistent aneurysm sac expansion. For subsequent T2EL interventions, the most common endovascular procedure was transarterial lumbar embolization (21%), followed by transcaval (21%), translumbar (11%), and transarterial inferior mesenteric artery embolization (8.6%). Twelve patients (21%) were found to have loss of proximal or distal seal on subsequent imaging and required graft extensions to stabilize aneurysm sac size. Ten patients (18%) ultimately underwent graft explantation or sacotomy with oversewing of the endoleak source. Freedom from any endoleak-related reintervention was 57% at 1 year and 36% at 3 years. Freedom from open treatment was 93% at 1 year and 82% at 3 years. Of the 44 patients with ≥6-month follow-up, 39 (89%) achieved clinical success. However, only 11 patients (25%) achieved clinical success without any further reintervention, and 29 patients (66%) achieved clinical success without open treatment. CONCLUSIONS: Despite high technical success, endoleak recurrence after T2EL treatment is common, and multiple interventions are often needed to stabilize aneurysm sac size in patients diagnosed with T2EL-associated sac growth. Notably, one in five patients treated for T2ELs was discovered, on further evaluation, to have proximal or distal seal zone loss that necessitated repair to achieve sac stability. Thus, thorough assessment of all endoleak types should be performed in patients with T2ELs associated with sac growth before T2EL treatment to ensure appropriate care and to minimize ineffective interventions.
Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/efeitos adversos , Remoção de Dispositivo , Embolização Terapêutica , Endoleak/cirurgia , Procedimentos Endovasculares/efeitos adversos , Padrões de Prática Médica , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Prótese Vascular , Implante de Prótese Vascular/instrumentação , Remoção de Dispositivo/efeitos adversos , Embolização Terapêutica/efeitos adversos , Endoleak/diagnóstico por imagem , Endoleak/etiologia , Procedimentos Endovasculares/instrumentação , Feminino , Humanos , Masculino , Recidiva , Reoperação , Estudos Retrospectivos , Fatores de Tempo , Resultado do TratamentoRESUMO
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.
Assuntos
Demandas Administrativas em Assistência à Saúde , Aneurisma da Aorta Abdominal/cirurgia , Ruptura Aórtica/cirurgia , Melhoria de Qualidade/tendências , Indicadores de Qualidade em Assistência à Saúde/tendências , Procedimentos Cirúrgicos Vasculares/tendências , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/mortalidade , Ruptura Aórtica/diagnóstico por imagem , Ruptura Aórtica/mortalidade , Bases de Dados Factuais , Feminino , Mortalidade Hospitalar/tendências , Humanos , Pacientes Internados , Masculino , Complicações Pós-Operatórias/mortalidade , Sistema de Registros , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados Unidos , Procedimentos Cirúrgicos Vasculares/efeitos adversos , Procedimentos Cirúrgicos Vasculares/mortalidadeRESUMO
OBJECTIVE: Mortality after open repair for emergent complex abdominal aortic aneurysm (AAA) is poorly defined. This study evaluated the 30-day mortality of open complex AAA repair performed for rupture or other emergent indication using a national surgical registry. We subsequently identified factors associated with mortality. METHODS: The targeted vascular module from the American College of Surgeons National Surgical Quality Improvement Program was queried to identify patients undergoing open repair for juxtarenal and suprarenal AAAs or type IV thoracoabdominal aneurysms (TAAAs) for rupture or other emergent indication from 2011 to 2017. Univariate analyses were performed using the Fisher's exact test for categorical variables and the Wilcoxon rank sum test for continuous variables. Multivariable logistic regression was performed to identify factors independently associated with mortality. RESULTS: We included 374 patients who underwent an emergent complex open AAA repair during the study period. There were 142 (38%) cases performed for rupture with hypotension, 141 (38%) for rupture without hypotension, 40 (11%) for symptomatic AAA, and 51 (14%) for another indication. The distribution by aneurysm type was 224 juxtarenal AAAs, 122 suprarenal AAAs, and 28 type IV TAAAs. Overall, there was a 30-day mortality of 32% (118 deaths). For those with juxtarenal AAA repair, 67 (30%) patients died within 30 days; there were 38 (31%) deaths within 30 days in those with suprarenal AAA, and 13 (46%) deaths within 30 days in those with type IV TAAA. On univariate analysis, preoperative variables associated with death were increasing age, use of a transperitoneal surgical approach, lower preoperative estimated glomerular filtration rate, low baseline albumin concentration (<3.5 g/dL), need for preoperative transfusion, low body mass index (<18.5 kg/m2), and hypotension at presentation. Intraoperative variables associated with mortality were supraceliac clamp location and concurrent renal revascularization. On multivariable analysis, factors independently associated with death included rupture with associated hypotension (reference: other emergent indication; adjusted odds ratio [AOR], 3.28; confidence interval [CI], 1.75-5.41; P < .001), age >60 years (reference: <60 years; AOR, 1.59; CI, 1.18-2.13; P = .002), longitudinal laparotomy incision (reference: retroperitoneal; AOR, 3.28; CI, 1.75-6.16; P < .001), and supraceliac cross-clamp (reference: clamp above one renal artery; AOR, 2.14; CI, 1.31-3.50; P = .003). CONCLUSIONS: Nearly one-third of patients die within 30 days of emergent open complex AAA repair. Mortality is particularly high for patients with type IV TAAAs, approaching 50%. Predictors of 30-day mortality include rupture with associated hypotension, increasing age, supraceliac clamp location, and longitudinal transperitoneal repair approach. These results will help inform surgical decisions preoperatively and intraoperatively.
Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Emergências , Procedimentos Endovasculares/métodos , Complicações Pós-Operatórias/mortalidade , Sistema de Registros , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/diagnóstico , Aneurisma da Aorta Abdominal/mortalidade , Procedimentos Cirúrgicos Eletivos/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Taxa de Sobrevida/tendências , Resultado do Tratamento , Estados Unidos/epidemiologiaRESUMO
OBJECTIVE: The available data on outcomes after transfemoral carotid artery stenting (TFCAS) originate from the early experience with TFCAS. Although most previous studies stratified outcomes according to a symptomatic or asymptomatic presentation, they often did not specify the degree of presenting neurologic injury. We previously reported that the outcomes after carotid endarterectomy differed according to neurologic injury severity, the contemporary perioperative outcomes of TFCAS stratified by the specific presenting symptom status are unknown. METHODS: Patients with data in the Vascular Quality Initiative database who had undergone TFCAS from 2016 to 2020 were included. We stratified patients according to their preprocedural symptom status as asymptomatic, formerly symptomatic (last symptoms >180 days before the procedure), or recently symptomatic (symptoms <180 days before the procedure). The symptoms included stroke, hemispheric transient ischemic attack (TIA), and ocular TIA. We compared the occurrence of in-hospital stroke or death (stroke/death) among the asymptomatic, formerly symptomatic, and specific subtypes of recently symptomatic patients. Multivariable logistic regression models were constructed to adjust for the baseline differences among the groups. RESULTS: Of the 9807 included patients, 2650 (27%) had had recent stroke, 842 (9%), recent hemispheric TIA, and 360 (4%), recent ocular TIA. In addition, 795 patients (8%) were formerly symptomatic and 5160 (53%) were asymptomatic. The patients with recent stroke had a perioperative stroke/death rate of 5.5%, higher than that of patients with recent hemispheric TIA (2.4%; P < .001) or recent ocular TIA (2.8%; P = .03) and asymptomatic patients (1.4%; P < .001). The stroke/death rate was greater for patients with recent ocular TIA than for asymptomatic patients (2.8% vs 1.4%; P = .04). Formerly symptomatic patients had higher stroke/death rates compared with asymptomatic patients (3.5% vs 1.4%; P < .001). On multivariable-adjusted analysis, recent stroke was associated with higher stroke/death compared with recent hemispheric TIA (odds ratio [OR], 2.6; 95% confidence interval [CI], 1.6-4.3; P < .001) and asymptomatic status (OR, 4.1; 95% CI, 3.0-5.6; P < .001) and demonstrated a trend toward higher stroke/death compared with recent ocular TIA (OR, 2.0; 95% CI, 1.0-3.9; P = .06). Furthermore, asymptomatic status was associated with lower stroke/death compared with formerly symptomatic status (OR, 0.4; 95% CI, 0.2-0.6; P < .001). CONCLUSIONS: For patients undergoing TFCAS, recent stroke was associated with greater odds of in-hospital stroke/death after TFCAS compared with recent hemispheric TIA. Also, formerly symptomatic status was associated with greater odds of stroke/death compared with asymptomatic status. These findings support further symptom stratification by the degree of the presenting neurologic injury in the preoperative risk assessment.
Assuntos
Estenose das Carótidas/terapia , Cateterismo Periférico , Procedimentos Endovasculares/instrumentação , Artéria Femoral , Stents , Idoso , Estenose das Carótidas/complicações , Estenose das Carótidas/diagnóstico por imagem , Estenose das Carótidas/mortalidade , Cateterismo Periférico/efeitos adversos , Cateterismo Periférico/mortalidade , Bases de Dados Factuais , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Feminino , Mortalidade Hospitalar , Humanos , Ataque Isquêmico Transitório/etiologia , Masculino , Pessoa de Meia-Idade , Punções , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Acidente Vascular Cerebral/etiologia , Fatores de Tempo , Resultado do TratamentoRESUMO
Purpose: To evaluate the perioperative stroke incidence following thoracic endovascular aortic repair (TEVAR) with differing left subclavian artery (LSA) coverage and revascularization approaches in a real-world setting of a nationwide clinical registry. Materials and Methods: The National Surgical Quality Improvement Program registry was interrogated from 2005 to 2017 to identify all nonemergent TEVAR and/or open LSA revascularization procedures. In this time frame, 2346 TEVAR cases met the selection criteria for analysis. The 30-day stroke incidence was compared between patients undergoing TEVAR with (n=888) vs without (n=1458) LSA coverage, for those with (n=228) vs without (n=660) concomitant LSA revascularization among those with coverage, and following isolated LSA revascularization for occlusive disease (n=768). Multivariable logistic regression was employed for risk-adjusted analyses and to identify factors associated with stroke following TEVAR. Results of the regression analyses are presented as the adjusted odds ratio (OR) with 95% confidence interval (CI). Results: The stroke incidence was 2.3% following TEVAR without vs 5.2% with LSA coverage (p<0.001). In TEVARs with LSA coverage, the stroke incidence was 7.5% when the LSA was concomitantly revascularized and 4.4% without concomitant revascularization, while stroke occurred in 0.5% of isolated LSA revascularizations. Of 33 TEVAR patients experiencing a perioperative stroke, 8 (24%) died within 30 days. LSA coverage was associated with stroke both with concomitant revascularization (OR 4.0, 95% CI 2.2 to 7.5, p<0.001) and without concomitant revascularization (OR 2.2, 95% CI 1.3 to 3.8, p=0.002). Other preoperative factors associated with stroke were dyspnea (OR 1.8, 95% CI 1.1 to 3.0, p=0.014), renal dysfunction (OR 2.2, 95% CI 1.0 to 3.8, p=0.049), and international normalized ratio ≥2.0 (OR 3.6, 95% CI 1.0 to 13, p=0.045). Conclusion: Stroke following TEVAR with LSA coverage occurs frequently in the real-world setting, and concurrent LSA revascularization was not associated with a lower stroke incidence.
Assuntos
Aneurisma da Aorta Torácica/cirurgia , Implante de Prótese Vascular/efeitos adversos , Procedimentos Endovasculares/efeitos adversos , Desenho de Prótese , Acidente Vascular Cerebral/epidemiologia , Artéria Subclávia/cirurgia , Idoso , Aneurisma da Aorta Torácica/diagnóstico por imagem , Aneurisma da Aorta Torácica/mortalidade , Aneurisma da Aorta Torácica/fisiopatologia , Prótese Vascular , Implante de Prótese Vascular/instrumentação , Implante de Prótese Vascular/mortalidade , Procedimentos Endovasculares/instrumentação , Procedimentos Endovasculares/mortalidade , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Medição de Risco , Fatores de Risco , Stents , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/mortalidade , Artéria Subclávia/diagnóstico por imagem , Artéria Subclávia/fisiopatologia , Fatores de Tempo , Resultado do Tratamento , Estados Unidos/epidemiologiaRESUMO
OBJECTIVE: The stroke rate after endovascular aneurysm repair (EVAR), particularly complex EVAR such as fenestrated EVAR (FEVAR) and chimney EVAR (chEVAR), is not well defined. Whereas stroke is a well-established risk of thoracic endovascular aortic repair (TEVAR), the impact of procedural characteristics on stroke remains unclear. Therefore, we characterized the risk of stroke after endovascular aortic interventions in the Vascular Quality Initiative database and identified procedural characteristics associated with stroke. METHODS: We performed a retrospective cohort study of patients undergoing infrarenal EVAR, complex EVAR, and TEVAR within the Vascular Quality Initiative between 2011 and 2019. Complex EVAR included FEVAR (with either a Food and Drug Administration-approved custom-manufactured device or physician-modified endovascular graft) and chEVAR. We excluded emergent procedures. The primary outcome was in-hospital stroke. We used multivariable logistic regression to identify procedural characteristics associated with stroke. RESULTS: We identified 41,540 EVARs, 1371 complex EVARs, and 4600 TEVARs. The in-hospital stroke rate was 0.1% after EVAR, 0.9% after complex EVAR, and 2.9% after TEVAR. In patients undergoing EVAR, aneurysm diameter >6.5 mm (odds ratio [OR], 1.7; 95% confidence interval [CI], 1.1-2.7; P = .03) and use of a proximal extension cuff (OR, 3.3; 95% CI, 1.4-7.9; P < .01) were independently associated with stroke. Among complex EVARs, stroke rate was 0.7% after FEVAR with a custom-manufactured device, 0.4% after FEVAR with a physician-modified endovascular graft, and 2.1% after chEVAR (P = .08). In multivariable analysis, arm access was associated with 8.4-fold higher odds of stroke (95% CI, 1.7-41; P < .01). Whereas chEVAR was associated with higher odds of stroke in crude analysis, this association did not persist after adjustment for arm access (OR, 1.0; 95% CI, 0.2-4.4; P = .99). In patients undergoing TEVAR, more proximal landing zones were associated with higher risk of stroke compared with zone 4/5 (zone 3: OR, 2.0 [95% CI, 0.9-4.2]; zone 2: OR, 3.8 [95% CI, 1.8-8.2]; zone 0/1: OR, 6.3 [95% CI, 2.8-14]). In terms of procedural characteristics, any involvement of the left subclavian artery was associated with stroke (bypass: OR, 2.5 [95% CI, 1.5-4.0]; stent: OR, 2.7 [95% CI, 0.9-8.5]; covered or occluded: OR, 2.5 [95% CI, 1.5-4.1]). CONCLUSIONS: Stroke, although rare after elective EVAR, is substantially more common after complex EVAR and TEVAR. Increasing procedural complexity in complex EVAR and TEVAR is associated with a higher stroke rate, a risk that should be factored into clinical decision-making. The strong association between stroke and upper extremity access during complex EVAR is alarming and warrants further study.
Assuntos
Aneurisma da Aorta Abdominal/cirurgia , Aneurisma da Aorta Torácica/cirurgia , Procedimentos Endovasculares/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Acidente Vascular Cerebral/epidemiologia , Idoso , Idoso de 80 Anos ou mais , Procedimentos Endovasculares/instrumentação , Procedimentos Endovasculares/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Razão de Chances , Complicações Pós-Operatórias/etiologia , Estudos Retrospectivos , Medição de Risco/estatística & dados numéricos , Fatores de Risco , Stents/efeitos adversos , Acidente Vascular Cerebral/etiologia , Resultado do TratamentoRESUMO
OBJECTIVE: Increasing experience and improving technology have led to the expansion of endovascular aneurysm repair (EVAR) for ruptured abdominal aortic aneurysms (AAA). We investigated whether the 5-year survival after both EVAR and open repair for ruptured AAA changed over the last 14 years. METHODS: We identified repairs for ruptured infrarenal AAA within the Vascular Quality Initiative registry between 2004 and 2018. We compared the 5-year survival of both EVAR and open repair between the early (2004-2012) and late (2013-2018) cohorts. In addition, we compared EVAR with open repair in the early and late cohorts. We used propensity score modeling to create matching cohorts for each analysis. Kaplan-Meier analysis was used to estimate survival proportions and univariate Cox proportional hazards analysis was used to compare differences in hazard of mortality in the matched cohorts. RESULTS: We identified 4638 ruptured AAA repairs. This included 409 EVARs in the early cohort and 2250 in the late cohort, as well as 558 open repairs in the early cohort and 1421 in the late cohort. Propensity matching resulted in 366 matched pairs of late vs early EVAR and 391 matched-pairs of late vs early open repair. When comparing EVAR with open repair, propensity matching resulted in 277 matched pairs of early EVAR versus open, and 1177 matched pairs of late EVAR versus open. In matched EVAR patients, 5-year survival was higher in the late cohort (63% vs 49%; hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.61-0.97; P = .027), whereas there was no difference between matched late vs early for open repair patients (52% vs 59%; HR, 1.04; 95% CI, 0.85-1.28; P = .69). In the early cohort, there was no survival difference between EVAR and open repair (51% vs 46%; HR, 0.88; 95% CI, 0.69-1.11; P = .28). However, in the late cohort EVAR was associated with higher survival compared with open repair (63% vs 54%; HR, 0.69; 95% CI, 0.60-0.79; P < .001). CONCLUSIONS: The 5-year survival after EVAR for ruptured AAA has improved over time, whereas survival after open repair remained constant. Consequently, the relative survival benefit of EVAR over open repair has increased over time, which should encourage further adoption of EVAR for ruptured AAA.