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OBJECTIVE: One-year aneurysm sac changes have previously been found to be associated with mortality and may have the potential to guide personalized follow-up following endovascular aneurysm repair (EVAR). In this study, we examined the association of these early sac changes with long-term reintervention and rupture. METHODS: We identified all patients undergoing first-time EVAR for intact abdominal aortic aneurysm between 2003 and 2018 in the Vascular Quality Initiative with linkage to Medicare claims for long-term outcomes. We included patients with an imaging study at 1 year postoperatively. Aneurysm sac behavior was defined as per the Society for Vascular Surgery guidelines: stable sac (<5 mm change), sac regression (≥5 mm), and sac expansion (≥5 mm). Outcomes included mortality, reintervention, and rupture within 8 years, which were assessed with Kaplan-Meier methods and multivariable Cox regression analysis. Secondarily, we utilized polynomial spline interpolation to demonstrate the continuous relationship of diameter change to 8-year hazard of reintervention, rupture, or mortality as a composite outcome. RESULTS: Of 31,185 EVAR patients, 16,102 (52%) had an imaging study at 1 year and were included in this study. At 1 year, 44% of sacs remained stable, 49% regressed, and 6.2% displayed expansion. Following risk adjustment, compared with a stable sac at 1 year, sac regression was associated with lower 8-year mortality (49% vs 53%; hazard ratio [HR], 0.92; 95% confidence interval [CI], 0.85-0.99; P = .036), reintervention rate (8.9% vs 15%; HR, 0.58; 95% CI, 0.50-0.68; P < .001), and rupture rate (2.0% vs 4.0%; HR, 0.45; 95%CI, 0.29-0.69; P < .001). Conversely, compared with a stable sac, sac expansion was associated with higher 8-year mortality (64% vs 53%; HR, 1.31; 95% CI, 1.14-1.51; P < .001) and reintervention rate (27% vs 15%; HR, 1.98; 95% CI, 1.57-2.51; P < .001), but similar risk of rupture (7.2% vs 4.0%; HR, 1.61; 95% CI, 0.88-2.96; P = .12). Polynomial spline interpolation demonstrated that, compared with no diameter change at 1 year, increased sac regression was associated with an incrementally lower risk of late outcomes, whereas increased sac expansion was associated with an incrementally higher risk of late outcomes. CONCLUSIONS: Following EVAR, compared with a stable sac at 1-year imaging, sac regression and expansion are associated with a lower and higher risk respectively of long-term mortality, reinterventions, and ruptures. Moreover, the amount of regression or expansion seems to be incrementally associated with these late outcomes, too. Future studies are needed to determine how to improve 1-year sac regression, and whether it is safe to extend follow-up intervals for patients with regressing sacs.
Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Humans , Aged , United States , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Aortic Aneurysm, Abdominal/complications , Endovascular Aneurysm Repair , Treatment Outcome , Medicare , Risk Factors , Retrospective StudiesABSTRACT
OBJECTIVE: Age stratified mortality was examined following fenestrated endovascular aneurysm repair (F-EVAR) vs. open repair of juxtarenal abdominal aortic aneurysms (AAAs) METHODS: All patients undergoing first time elective F-EVAR and complex open aneurysm repair (c-OAR) for juxtarenal AAA in the Vascular Quality Initiative between 2014 and 2021 were identified. Open repairs were compared with commercially available fenestrated endovascular aneurysm repair and physician modified endografts (PMEGs). Patients were stratified into three age groups (< 65, 65 - 75, > 75 years). Primary outcomes were peri-operative and five year mortality, and inverse probability weighted risk adjustment was performed to account for baseline differences. RESULTS: Overall, 1 961 patients underwent F-EVAR (82% commercial F-EVAR, 18% PMEG) and 3 385 patients underwent c-OAR. Across age groups, the distribution of F-EVAR (vs. c-OAR) was: < 65 years: 23%, 65 - 75 years: 33%, > 75 years: 52%. After adjustment, among patients < 65 years, compared with c-OAR, F-EVAR was associated with similar peri-operative mortality (0.9% vs. 2.1%; hazard ratio [HR] 0.40, 95% confidence interval [CI] 0.07 - 1.44], p = .22), and five year mortality (13% vs. 9.5%; HR 1.44, 95% CI 0.71 - 2.90, p = .31). Among patients aged 65 - 75 years, between juxtarenal AAA repair modalities, compared with c-OAR, F-EVAR was associated with a significantly lower risk of peri-operative mortality (2.2% vs. 5.0%; HR 0.50, 95% CI 0.30 - 0.79, p = .004), and five year mortality (13% vs. 13%; HR 0.94, 95% CI 0.65 - 1.36, p = .74). Similarly, among patients > 75 years, compared with c-OAR, F-EVAR was associated with lower peri-operative mortality (2.2% vs. 6.5%; HR 0.26, 95% CI 0.13 - 0.47, p < .001), but with similar five year mortality (18% vs. 21%; HR 0.83, 95% CI 0.57 - 1.20, p = .31). CONCLUSION: Among patients with a juxtarenal AAA, F-EVAR was associated with a lower peri-operative mortality compared with c-OAR in patients ≥ 65 years, but was similar in those < 65 years. At five years, F-EVAR was associated with similar mortality in all age groups, though there was a non-significant trend for a higher mortality rate in younger patients.
ABSTRACT
BACKGROUND: Endovascular aneurysm sealing (EVAS), using the Nellix endovascular aneurysm sealing system, has been associated with high reintervention and migration rates. However, prior reports have suggested that EVAS might be related to a lower all-cause mortality compared with endovascular aneurysm repair (EVAR). In the present study, we examined the 5-year all-cause mortality trends after EVAS and EVAR. METHODS: We compared the 333 EVAS patients in the EVAS-1 Nellix U.S. investigational device exemption trial with 16,497 infrarenal EVAR controls from the Vascular Quality Initiative, treated between 2014 and 2016, after applying the exclusion criteria from the investigational device exemption trial (ie, hemodialysis, creatinine >2.0 mg/dL, rupture). As a secondary analysis, we stratified the patients by aneurysm diameter (<5.5 cm and ≥5.5 cm). We calculated propensity scores after adjusting for demographics, comorbidities, and anatomic characteristics and applied inverse probability weighting to compare the risk-adjusted long-term mortality using Kaplan-Meier and Cox regression analyses. RESULTS: After weighting, the EVAS group had experienced similar 5-year mortality compared with the controls from the Vascular Quality Initiative (EVAS vs EVAR, 18% vs 14%; hazard ratio [HR], 1.1; 95% confidence interval [CI], 0.71-1.7; P = .70). The subgroup analysis demonstrated that for patients with an aneurysm diameter of <5.5 cm, EVAS was associated with higher 5-year mortality compared with EVAR (19% vs 11%; HR, 2.4; 95% CI, 1.7-4.7; P = .013). In patients with an aneurysm diameter of ≥5.5 cm, EVAS was associated with lower mortality within the first 2 years (2-year mortality: HR, 0.29; 95% CI, 0.13-0.62; P = .002). However, compared with EVAR, EVAS was associated with higher mortality between 2 and 5 years (HR, 1.9; 95% CI, 1.2-3.0; P = .005), with no mortality difference at 5 years (18% vs 17%; HR, 0.82; 95% CI, 0.4-1.4; P = .46). CONCLUSIONS: Within the overall population, EVAS was associated with similar 5-year mortality compared with EVAR. EVAS was associated with higher mortality for those with small aneurysms (<5.5 cm). For those with larger aneurysms (≥5.5 cm), EVAS was initially associated with lower mortality within the first 2 years, although this advantage was lost thereafter, with higher mortality after 2 years. Future studies are required to evaluate the specific causes of death and to elucidate the potential beneficial mechanism behind sac obliteration that leads to this potential initial survival benefit. This could help guide the development of future grafts with better proximal fixation and sealing that also incorporate sac obliteration.
Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Humans , Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis , Endovascular Aneurysm Repair , Retrospective Studies , Risk Factors , Stents , Treatment OutcomeABSTRACT
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.
ABSTRACT
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.
Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Aged , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis , Endoleak/surgery , Female , Humans , Retrospective Studies , Risk Factors , Time Factors , Treatment OutcomeABSTRACT
OBJECTIVE: Several studies have demonstrated the advantages of a retroperitoneal (RP) vs a transperitoneal (TP) approach during open repair of infrarenal abdominal aortic aneurysms (AAAs). We compared the outcomes after open repair of complex AAAs (cAAAs) using an RP vs a TP approach and evaluated the relative use of these approaches over time. METHODS: We identified all patients who had undergone open intact cAAA repair in the Vascular Quality Initiative from 2003 to -2019 and created 1:1-propensity score-matched cohorts stratified by the operative approach (RP vs TP). The primary outcome was perioperative mortality. The secondary outcomes included perioperative complications and approach usage over time. To create 1:1 propensity score-matched cohorts, the patients were matched for demographics, comorbidities, and anatomic and/or intraoperative characteristics, including proximal clamp site and renal revascularization. The approach usage over time was determined by plotting the proportion of RP usage over time for the overall open cAAA cohort and subgroups of repairs using a supraceliac cross clamp, repair with concomitant renal revascularization, and repairs performed at high-volume centers (highest quintile, >11 cases annually). RESULTS: Of a total of 4613 patients, 2843 (62%) had undergone open cAAA repair using the TP approach and 1770 (38%) using the RP approach. Of the 1256 matched pairs, the RP approach was associated with lower risk of perioperative mortality compared with the TP approach (3.9% vs 6.8%; relative risk [RR], 0.57; 95% confidence interval [CI], 0.41-0.80; P = .001). Furthermore, the RP approach was associated with a lower risk of cardiac complications (7.2% vs 9.6%; RR, 0.75; 95% CI, 0.58-0.98), bowel ischemia (3.1% vs 5.4%; RR, 0.56; 95% CI, 0.39-0.84), and postoperative dialysis (3.3% vs 5.5%; RR, 0.59; 95% CI, 0.41-0.87). Overall, the proportion of patients who had undergone repair via an RP approach became lower over time (-1.0%/y; 95% CI, -1.5 to -0.5; P < .001). A similar trend in the decrease was found for the patients who had undergone repair with a supraceliac clamp (-2.3%/y; 95% CI, -3.6 to -1.0; P < .001) and in the high-volume hospitals (-2.1%/y; 95% CI, -3.4 to -0.8; P = .001), although no statistically significant decrease in RP usage was found for the patients who had undergone concomitant renal revascularization (-0.9%/y; 95% CI, -2.6 to 0.8; P = .28). CONCLUSIONS: For open cAAA repair, an RP approach was associated with lower perioperative mortality and complications compared with a TP approach. However, the relative usage of the RP approach has been decreasing over time. An increased adoption of the RP approach, when appropriate, might lead to improved outcomes with open cAAA repair.
Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Aortic Aneurysm, Abdominal/complications , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/adverse effects , Humans , Postoperative Complications , Retrospective Studies , Risk Factors , Time Factors , Treatment Outcome , Vascular Surgical Procedures/adverse effectsABSTRACT
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.
Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/complications , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/adverse effects , Endovascular Procedures/adverse effects , Female , Humans , Male , Retrospective Studies , Risk Factors , Time Factors , Treatment OutcomeABSTRACT
OBJECTIVE: Although proximal neck dilatation following infrarenal endovascular aneurysm repair (EVAR) is common and is associated with proximal graft failure, little is known about sealing zone dilatation and its clinical relevance following fenestrated EVAR (FEVAR). We studied proximal seal dilatation (PSD) dynamics following FEVAR and assessed its clinical significance. METHODS: We included all consecutive patients treated for a juxta-/supra-renal aneurysm with fenestrated EVAR using the Zenith Fenestrated Endovascular Graft (Cook Medical, Bloomington, Ind) from 2008 to 2018 in two large teaching hospitals in the Netherlands. The primary outcome was PSD over time and was determined using a linear mixed-effects model. Secondary outcomes included associations for early PSD and difference in aortic dilatation at the level of the covered stent compared with the bare stent. Proximal seal-related adverse events were also obtained. RESULTS: Our cohort included 84 patients with a median computed tomography angiography follow-up time of 24.5 months (interquartile range [IQR], 17-42 months). Maximum aneurysm diameter was 60.1 mm (IQR, 56.9-67.2 mm). Mean proximal seal diameter at baseline was 26.2 mm (standard deviation [SD], ±2.8 mm), mean stent oversizing was 20.1% (SD, ±9.1%), and mean proximal seal length was 29.5 mm (SD, ±11.7 mm). Proximal seal dilatation of 1.7 mm (95% confidence interval [CI], 1.4-2.1 mm) was found in the first year, decelerating thereafter (second year, 0.9 mm/year; 95% CI, 0.7-1.1 mm/y). Over 10% PSD at 1 year occurred in 22 patients (27%) and was associated with stent graft oversizing (odds ratio, 1.1; 95% CI, 1.03-1.2; P = .008) and a lower number of target vessels (four fenestrations/ref two fenestrations: odds ratio, 0.13; 95% CI, 0.02-0.74; P = .029). At last available imaging, dilatation difference was higher at the level of the covered stent compared with the bare stent (3.0 mm [IQR, 1.3-5.1 mm] vs 1.6 mm [IQR, 0.8-2.5 mm]; P < .001). During the study period, only one patient (1.2%) developed a proximal seal-related adverse event (type IA endoleak). CONCLUSIONS: PSD is present following FEVAR, occurring at a faster rate in the first year and subsequently decelerating thereafter, similarly to neck dilatation after standard infrarenal EVAR. Although its clinical implication seems to remain limited in the first years following implantation, further research is required to assess the effect of PSD on long-term FEVAR outcomes.
Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/etiology , Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/adverse effects , Dilatation , Dilatation, Pathologic , Endovascular Procedures/adverse effects , Humans , Prosthesis Design , Retrospective Studies , Stents , Time Factors , Treatment OutcomeABSTRACT
OBJECTIVE: Several studies have demonstrated advantages of the retroperitoneal approach (RP) over the transperitoneal approach (TP) for infrarenal abdominal aortic aneurysm (AAA) repair. A retrospective analysis was performed comparing the outcomes of a TP vs. RP surgical approach for open complex AAA (cAAA) repair and evaluated their relative use over time. METHODS: Patients undergoing open repair for intact cAAA (juxtarenal, suprarenal, or type IV thoraco-abdominal aortic aneurysms) between 2011 and 2019 were identified in the National Surgical Quality Improvement Program. The primary outcome was peri-operative death. Secondary outcomes included peri-operative complications and approach use over time. Multivariable adjustment was performed by creating propensity scores and using inverse probability weighted logistic regression. RESULTS: Among 1 195 patients identified, 729 (61%) underwent cAAA repair via a TP approach and 466 (39%) via an RP approach. Compared with a TP approach, RP patients more frequently had a supracoeliac clamp position (32% vs. 20%, p < .001) and concomitant renal revascularisation (30% vs. 18%, p < .001). After adjustment, an RP approach was associated with lower odds of peri-operative death (4.0% vs. 7.2%; odds ratio [OR] 0.54; 95% confidence interval [CI] 0.32 - 0.91; p = .022). Furthermore, an RP approach was associated with lower odds of any major complication (24% vs. 30%; OR 0.73; 95% CI 0.56 - 0.94), cardiac complications (4.9% vs. 8.2%; OR 0.60; 95% CI 0.37 - 0.96), wound complications (2.1% vs. 6.0%; OR 0.34; 95% CI 0.17 - 0.64), and post-operative sepsis (0.8% vs. 2.4%; OR 0.37; 95% CI 0.12 - 0.99). The proportion of repairs using an RP approach decreased between 2011 - 2015 and 2016 - 2019 (42% vs. 35%, p = .020), particularly for suprarenal and type IV thoraco-abdominal aneurysms (49% vs. 37%, p = .023). CONCLUSION: In open cAAA repair, the RP approach may be associated with lower peri-operative mortality and morbidity rates compared with the TP approach. However, it was found that the relative use of the RP approach is decreasing over time, even in suprarenal/type IV thoraco-abdominal aneurysms, and repairs using a supracoeliac clamp. Increased use of the RP approach, when appropriate, may lead to improved outcomes following open cAAA repair.
Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Humans , Postoperative Complications , Retroperitoneal Space , Retrospective Studies , Risk Factors , Treatment OutcomeABSTRACT
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.
Subject(s)
Aortic Aneurysm, Abdominal/surgery , Emergencies , Endovascular Procedures/methods , Postoperative Complications/mortality , Registries , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnosis , Aortic Aneurysm, Abdominal/mortality , Elective Surgical Procedures/methods , Female , Humans , Male , Middle Aged , Retrospective Studies , Risk Factors , Survival Rate/trends , Treatment Outcome , United States/epidemiologyABSTRACT
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.
Subject(s)
Carotid Stenosis/surgery , Endovascular Procedures/methods , Propensity Score , Protamines/therapeutic use , Registries , Risk Assessment/methods , Thromboembolism/prevention & control , Aged , Carotid Stenosis/mortality , Female , Femoral Artery , Heparin Antagonists/therapeutic use , Hospital Mortality/trends , Humans , Male , Retrospective Studies , Risk Factors , Survival Rate/trends , Thromboembolism/epidemiology , Treatment Outcome , United States/epidemiologyABSTRACT
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.
Subject(s)
Carotid Stenosis/therapy , Catheterization, Peripheral , Endovascular Procedures/instrumentation , Femoral Artery , Stents , Aged , Carotid Stenosis/complications , Carotid Stenosis/diagnostic imaging , Carotid Stenosis/mortality , Catheterization, Peripheral/adverse effects , Catheterization, Peripheral/mortality , Databases, Factual , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Female , Hospital Mortality , Humans , Ischemic Attack, Transient/etiology , Male , Middle Aged , Punctures , Retrospective Studies , Risk Assessment , Risk Factors , Stroke/etiology , Time Factors , Treatment OutcomeABSTRACT
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.
Subject(s)
Aortic Aneurysm, Abdominal/surgery , Aortic Rupture/surgery , Blood Vessel Prosthesis Implantation/trends , Diagnostic Screening Programs/trends , Eligibility Determination/trends , Aged , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/mortality , Aortic Rupture/diagnostic imaging , Aortic Rupture/mortality , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/mortality , Clinical Decision-Making , Databases, Factual , Female , Hospital Mortality/trends , Humans , Male , Patient Admission/trends , Predictive Value of Tests , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome , United States/epidemiologyABSTRACT
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.
Subject(s)
Aortic Aneurysm, Abdominal/surgery , Elective Surgical Procedures/mortality , Aged , Aorta, Abdominal/pathology , Aorta, Abdominal/surgery , Aortic Aneurysm, Abdominal/mortality , Aortic Aneurysm, Abdominal/pathology , Elective Surgical Procedures/methods , Endovascular Procedures/mortality , Female , Humans , Logistic Models , Male , Retrospective Studies , Risk FactorsABSTRACT
OBJECTIVE: Female patients undergoing endovascular aneurysm repair (EVAR) for infrarenal abdominal aortic aneurysms present with more challenging anatomy and historically have worse outcomes compared with men. The Ovation Abdominal Stent Graft platform (Endologix, Irving, Calif) contains a polymer-filled proximal sealing ring and has a low-profile delivery system, potentially beneficial in female patients. We therefore investigated differences in long-term outcomes between men and women treated with this device. METHODS: We used data collected prospectively in the Effectiveness of Custom Seal with Ovation: Review of the Evidence (ENCORE) database, comprising five trials and the European Post-Market Registry. Anatomic characteristics of the proximal aneurysm neck and iliac arteries were compared between male and female patients. Outcomes were 5-year freedom from type IA and type I/III endoleaks, abdominal aortic aneurysm-related reinterventions, and overall survival. We used Kaplan-Meier analysis to estimate survival proportions and tested univariate differences in survival using log-rank tests. Cox proportional hazards modeling was used to adjust for baseline differences. RESULTS: We identified 1045 (81%) male and 251 (19%) female patients undergoing EVAR. Female patients were older (mean age, 75 ± 8.4 years vs 73 ± 8.1 years; P < .006). Aneurysm diameter (52 ± 7.5 mm vs 55 ± 9.2 mm; P < .001) and proximal neck diameter (21 ± 3.3 mm vs 23 ± 2.9 mm; P < .001) were smaller in female patients, but adjusted for body surface area, female patients had relatively larger aneurysms and aneurysm necks. Furthermore, female patients presented with shorter proximal necks, smaller iliac artery diameters, more angulated necks, and higher rates of reverse-tapered necks. Five-year freedom from type IA endoleak was similar between men and women (97% vs 96%; P = .38), as was freedom from type I/III endoleaks (91% vs 94%; P = .37) and reinterventions (91% vs 93%; P = .67). Five-year survival was 81% for female patients, similar to the 79% in male patients (P = .55), with one aneurysm-related death in female patients (0.4%) and five in male patients (0.8%; P = .76). Risk-adjusted analyses showed no association between sex and type IA endoleak (hazard ratio [HR], 1.4; 95% confidence interval [CI], 0.6-3.1; P = .41), type I/III endoleak (HR, 1.4; 95% CI, 0.7-2.8; P = .33), reintervention (HR, 1.0; 95% CI, 0.6-2.0; P = .77), and overall mortality (HR, 0.7; 95% CI, 0.4-1.1; P = .14). CONCLUSIONS: Female patients undergoing EVAR with the Ovation platform presented with substantially more adverse proximal neck characteristics. Despite these differences, 5-year freedom from endoleaks and overall survival did not differ between sexes.
Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Stents , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/mortality , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/mortality , Clinical Trials as Topic , Elective Surgical Procedures , Endoleak/etiology , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Female , Humans , Male , Product Surveillance, Postmarketing , Registries , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment OutcomeABSTRACT
OBJECTIVE: Outcome studies using databases collecting only hospital discharge data underestimate morbidity and mortality because of failure to capture postdischarge events. The proportion of postdischarge major adverse events is well characterized in patients undergoing carotid endarterectomy (CEA) but has yet to be characterized after carotid artery stenting (CAS). METHODS: We retrospectively reviewed all patients undergoing CAS from 2011 to 2017 using the American College of Surgeons National Surgical Quality Improvement Program procedure targeted database to evaluate rates of 30-day major adverse events, stratified by in-hospital and postdischarge occurrences. The primary outcome was 30-day stroke/death. Multivariable analysis using purposeful selection was used to identify independent factors associated with in-hospital, postdischarge, and 30-day stroke/death events. RESULTS: Of the 899 patients undergoing CAS, reporting of in-hospital outcomes alone would yield a stroke/death rate of 2.7%, substantially underestimating the 30-day stroke/death rate of 4.0%. In fact, 35% of stroke/deaths, 27% of strokes, 73% of deaths, 35% of cardiac events, and 35% of stroke/death/cardiac events occurred after discharge. More postdischarge stroke/death events occurred after treatment of symptomatic compared with asymptomatic patients (47% vs 27%; P < .001). During this same study period, the 30-day stroke/death rate after CEA was 2.6%, with similar proportions of postdischarge strokes (28% vs 27%; P = .51) compared with CAS but lower proportions of postdischarge deaths (55% vs 73%; P < .001). After CAS, patients experiencing postdischarge stroke/death events had a shorter postoperative length of stay compared with patients with in-hospital stroke/death (1 [1-2] vs 5 [3-10] days; P < .001). Chronic obstructive pulmonary disease was independently associated with postdischarge stroke/death (odds ratio [OR], 4.4; 95% confidence interval [CI], 1.2-16; P = .02) after CAS. Nonwhite ethnicity was independently associated with overall 30-day stroke/death (OR, 3.4; 95% CI, 1.4-7.9; P < .01), whereas statin use was associated with not having stroke/death within 30 days (OR, 0.5; 95% CI, 0.2-1.0; P = .049). CONCLUSIONS: More than one-quarter of perioperative strokes occur following discharge after both CAS and CEA. A higher proportion of postdischarge deaths occur after CAS in symptomatic patients, which may reflect treatment of a population of higher risk patients. Further investigation is needed to elucidate the cause of postdischarge stroke to develop methods to reduce these complications.
Subject(s)
Carotid Stenosis/surgery , Endarterectomy, Carotid/mortality , Patient Discharge , Postoperative Complications/mortality , Stents , Aged , Aged, 80 and over , Carotid Stenosis/mortality , Female , Humans , Length of Stay/statistics & numerical data , Male , Retrospective Studies , Stroke/mortalityABSTRACT
OBJECTIVE: Female sex is associated with worse outcomes after infrarenal abdominal aortic aneurysm (AAA) repair. However, the impact of female sex on complex AAA repair is poorly characterized. Therefore, we compared outcomes between female and male patients after open and endovascular treatment of complex AAA. METHODS: We identified all patients who underwent complex aneurysm repair between 2011 and 2017 in the American College of Surgeons National Surgical Quality Improvement Program targeted vascular module. Complex repairs were defined as those for juxtarenal, pararenal, or suprarenal aneurysms. We compared rates of perioperative adverse events between female and male patients stratified by open AAA repair and endovascular aneurysm repair (EVAR). We calculated propensity scores and used inverse probability-weighted logistic regression to identify independent associations between female sex and our outcomes. RESULTS: We identified 2270 complex aneurysm repairs, of which 1260 were EVARs (21.4% female) and 1010 were open repairs (30.7% female). After EVAR, female patients had higher rates of perioperative mortality (6.3% vs 2.4%; P = .001) and major complications (15.9% vs 7.6%; P < .001) compared with male patients. In contrast, after open repair, perioperative mortality was not significantly different (7.4% vs 5.6%; P = .3), and the rate of major complications was similar (29.4% vs 27.4%; P = .53) between female and male patients. Furthermore, even though perioperative mortality was significantly lower after EVAR compared with open repair for male patients (2.4% vs 5.6%; P = .001), this difference was not significant for women (6.3% vs 7.4%; P = .60). On multivariable analysis, female sex remained independently associated with higher perioperative mortality (odds ratio [OR], 2.5; 95% confidence interval [CI], 1.3-4.9; P = .007) and major complications (OR, 2.0; 95% CI, 1.3-3.2; P = .002) in patients treated with EVAR but showed no significant association with mortality (OR, 0.9; 95% CI, 0.5-1.6; P = .69) or major complications (OR, 1.1; 95% CI, 0.8-1.5; P = .74) after open repair. However, the association of female sex with higher perioperative mortality in patients undergoing complex EVAR was attenuated when diameter was replaced with aortic size index in the multivariable analysis (OR, 1.9; 95% CI, 0.9-3.9; P = .091). CONCLUSIONS: Female sex is associated with higher perioperative mortality and more major complications than for male patients after complex EVAR but not after complex open repair. Continuous efforts are warranted to improve the sex discrepancies in patients undergoing endovascular repair of complex AAA.
Subject(s)
Aortic Aneurysm, Abdominal/surgery , Postoperative Complications/epidemiology , Aged , Aged, 80 and over , Cohort Studies , Endovascular Procedures , Female , Humans , Male , Retrospective Studies , Sex Distribution , Sex Factors , Treatment Outcome , Vascular Surgical Procedures/methodsABSTRACT
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.
Subject(s)
Aortic Aneurysm, Abdominal/surgery , Aortic Rupture/diagnostic imaging , Aortic Rupture/surgery , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/mortality , Aortic Rupture/mortality , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/mortality , Canada , Databases, Factual , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Female , Humans , Male , Middle Aged , Registries , Retrospective Studies , Risk Factors , Singapore , Time Factors , Treatment Outcome , United StatesABSTRACT
OBJECTIVE: There is a growing body of literature raising concerns about the long-term durability of endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms (AAAs), suggesting that long-term outcomes may be better after open AAA repair. However, the data investigating these long-term outcomes largely originate from early in the endovascular era and therefore do not account for increasing clinical experience and technologic improvements. We investigated whether 4-year outcomes after EVAR and open repair have improved over time. METHODS: We identified all EVARs and open repairs for intact infrarenal AAA within the Vascular Quality Initiative database (2003-2018). We then stratified patients by procedure year into treatment cohorts of four years: 2003-2006, 2007-2010, 2011-2014, and 2015-2018. We used Kaplan-Meier analysis and Cox proportional hazards models to assess whether the survival after EVAR or open repair changed over time. In addition, we propensity matched EVAR and open repairs for each time cohort to investigate whether the relative survival benefit of EVAR over open repair changed over time. RESULTS: We included 42,293 EVARs (increasing from 549 performed between 2003 and 2006 to 25,433 between 2015 and 2018) and 5189 open AAA repairs (increasing from 561 to 2306). Four-year survival increased for the periods 2003-2006, 2007-2010, 2011-2014, and 2015-2018 after both EVAR (76.6% vs 79.7% vs 83.5% vs 87.3%; P < .001) and open repair (82.2% vs 85.8% vs 87.7% vs 88.9%; P = .026). After risk adjustment, compared with 2003-2006, hazard of mortality up to 4 years after EVAR was lower for those performed between 2011 and 2014 (hazard ratio [HR], 0.72; 95% confidence interval [CI], 0.59-0.87; P = .001) and for those performed between 2015 and 2018 (HR, 0.56; 95% CI, 0.46-0.68; P < .001). In contrast, the risk-adjusted hazard of mortality was similar between open repair cohorts (2011-2014: HR, 0.81 [95% CI, 0.61-1.08; P = .15]; and 2015-2018: HR, 0.86 [95% CI, 0.64-1.17; P = .34]). Finally, in matched EVAR and open repairs, there was no difference in mortality in the first three cohorts, whereas the hazard of mortality was lower for the 2015-2018 cohort (HR, 0.65; 95% CI, 0.51-0.84; P = .001). CONCLUSIONS: Four-year survival improved in more recent years after EVAR but not after open repair. This finding suggests that midterm outcomes after EVAR are improving, perhaps because of technologic improvements and increased experience, information that should be considered by surgeons and policymakers alike in evaluating the value of contemporary EVAR and open AAA repair.
Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/mortality , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/mortality , Databases, Factual , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Female , Humans , Male , Postoperative Complications/mortality , Postoperative Complications/therapy , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment OutcomeABSTRACT
OBJECTIVE: Perioperative complications in elderly patients undergoing endovascular aneurysm repair (EVAR) occur frequently. Although perioperative mortality has been well-described in the elderly patient population, factors associated with in-hospital complications and their impact on long-term survival remain poorly characterized. METHODS: We identified all patients undergoing elective EVAR for infrarenal AAA within the Vascular Quality Initiative registry (2003-2018) and compared in-hospital complication rates between elderly (age ≥75) and nonelderly patients (<75). We used logistic regression to identify independent factors associated with in-hospital complications, whereas Kaplan-Meier analysis and Cox proportional hazards models were used to determine associations between complications and long-term survival. To assess the effect of complications on early and late survival, we stratified survival periods into the first 30 days after discharge, and between 1 and 6 months, 7 and 12 months, and 1 and 8 years after the index procedure. To investigate the implications of in-hospital morbidity on long-term outcomes, we estimated the adjusted population-attributable fractions of individual complications on both perioperative and long-term survival. RESULTS: We identified 17,156 elderly patients and 19,922 nonelderly patients. Elderly patients experienced higher complication rates compared with nonelderly patients (17% vs 10%; P < .001). The factors with the strongest associations with morbidity in elderly patients were anemia (odds ratio [OR], 2.4; 95% confidence interval [CI], 2.2-2.6), female gender (OR, 1.9; 95% CI, 1.7-2.1), and large AAA diameter (OR, 1.7; 95% CI, 1.6-1.9). Patients with any in-hospital complication had lower unadjusted survival estimates than patients without complications at 1 year (83% vs 95%; P < .001), 5 years (66% vs 80%; P < .001), and 8 years (60% vs 72%; P < .001). After risk adjustment, in-hospital complications were independently associated with higher mortality, although the association attenuated over time (first month after discharge: hazard ratio [HR], 5.9; 95% CI, 3.9-9.1; 1-6 months after the procedure: HR, 2.1; 95% CI, 1.7-2.7; P < .001; 7-12 months after the procedure: HR, 1.5; 95% CI, 1.1-1.9; 1-8 years after the procedure: HR, 1.2; 95% CI, 1.01-1.3). Of all deaths occurring within 8 years after procedure, 9.5% were independently associated with in-hospital complications. Complications with the greatest impact on long-term mortality were renal dysfunction (2.4%), blood transfusion (3.4%), and reintubations (2.4%). CONCLUSIONS: Elderly patients are at higher risk for in-hospital complications after EVAR. These in-hospital complications have a significant impact on both short- and long-term survival. To further improve the delivery of EVAR care nationally, quality improvement efforts should be focused on preventing postoperative morbidity in elderly patients, as well as refining out of hospital surveillance strategies for subjects who experience in-hospital complications to improve overall survival.