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1.

Objective

The purpose of this study was to compare findings at presentation and surgical outcomes in patients in whom abdominal aortic aneurysms (AAAs) ruptured after endovascular repair and in patients in whom AAAs ruptured before any treatment during a defined period at a single center.

Methods

This is a retrospective analysis of consecutive patients who presented to Royal Prince Alfred Hospital with ruptured AAA from September 2003 to September 2014. Medical records of each patient were reviewed to retrieve demographics, findings at presentation, and surgical outcome. Comparison of the outcomes between those occurring after endovascular repair (group 1) and those occurring without previous endovascular treatment (group 2) was made using the data collected and combining the results obtained by a previous study that analyzed the same findings between 1992 and 2003 from the same center to provide a total 22-year experience (1992-2014) at a single quaternary referral center.

Results

From May 1992 to September 2014, there were 1921 elective repairs of intact infrarenal AAAs, with 1288 endovascular and 633 open repairs. During 22 years, 40 of the 1288 patients (3.1%) who underwent endovascular repair for AAA had rupture. The proportion of patients with hypotension at presentation in group 1 (13/40) was significantly less than in group 2 (108/138; P < .01). The difference in perioperative 30-day mortality rate in group 1 (8/40 [20%]) compared with group 2 (68/138 [49%]) was significant (P < .01).

Conclusions

This study confirmed that endovascular AAA repair does not prevent rupture in all patients. The data suggest that rupture, when it does occur, may not be accompanied by such major hemodynamic changes and higher mortality rate as with rupture of an untreated AAA. Strict surveillance and follow-up are required, especially in patients with relatively large initial AAA diameter or presence of endoleak and graft migration, to reduce the rate of ruptures after endovascular repair. Complete prevention will remain challenging because rupture may occur without any predisposing abnormalities. With the advent of new-generation devices, continuous larger long-term studies are required to document reduction in rupture rates after endovascular aneurysm repair.  相似文献   

2.

Objective

A significant reduction in the incidence of cardiovascular disease, including abdominal aortic aneurysm (AAA), has been observed in the past decades. In this study, a small but geographically well defined and carefully characterized population, previously screened for AAA and risk factors, was re-examined 11 years later. The aim was to study the reduction of AAA prevalence and associated factors.

Methods

All men and women aged 65 to 75 years living in the Norsjö municipality in northern Sweden in January 2010 were invited to an ultrasound examination of the abdominal aorta, registration of body parameters and cardiovascular risk factors, and blood sampling. An AAA was defined as an infrarenal aortic diameter ≥30 mm. Results were compared with a corresponding investigation conducted in 1999 in the same region.

Results

A total of 602 subjects were invited, of whom 540 (90%) accepted. In 2010, the AAA prevalence was 5.7% (95% confidence interval [CI], 2.8%-8.5%) among men compared with 16.9% (95% CI, 12.3%-21.6%) in 1999 (P < .001). The corresponding figure for women was 1.1% (95% CI, 0.0%-2.4%) vs 3.5% (95% CI, 1.2%-5.8%; P = .080). A low prevalence of smoking was observed in 2010 as well as in 1999, with only 13% and 10% current smokers, respectively (P = .16). Treatment for hypertension was significantly more common in 2010 (58% vs 44%; P < .001). Statins increased in the population (34% in 2010 vs 3% in 1999; P < .001), and the lipid profile in women had improved significantly between 1999 and 2010.

Conclusions

A highly significant reduction in AAA prevalence was observed during 11 years in Norsjö. Treatment for hypertension and with statins was more frequent, whereas smoking habits remained low. This indicates that smoking is not the only driver behind AAA occurrence and that lifestyle changes and treatment of cardiovascular risk factors may play an equally important role in the observed recent decline in AAA prevalence.  相似文献   

3.

Objective

This review describes ongoing efforts to develop a medical therapy to limit abdominal aortic aneurysm (AAA) growth.

Methods

Data from animal model studies, human investigations, and clinical trials are described.

Results

Studies in rodent models and human samples have suggested a number of potential targets for slowing or halting AAA growth. A number of clinical trials are now examining the value of medications targeting some of the pathways identified. These trials have a number of challenges, including identifying medications safe to use in older patients with multiple comorbidities, developing accurate outcome assessments, and minimizing the dropout of patients during the trials. Three recent trials have reported no benefit of the antibiotic doxycycline, a mast cell inhibitor, an angiotensin-converting enzyme inhibitor, or a calcium channel blocker in limiting AAA growth. A number of other trials examining angiotensin receptor blockers, cyclosporine, and an antiplatelet agent are currently underway.

Conclusions

Further refinement of drug discovery pathways and testing paradigms are likely needed to develop effective nonsurgical therapies for AAA.  相似文献   

4.

Objective

The purpose of this study was to evaluate whether maximal aortic diameter affects outcome after endovascular aneurysm repair (EVAR) of abdominal aortic aneurysm (AAA).

Methods

Clinical data of patients undergoing EVAR between 1997 and 2011 for nonruptured asymptomatic AAAs in a tertiary center were reviewed. Patients were classified according to diameter of AAA: group 1, <5.0 cm; group 2, 5.0 to 5.4 cm; group 3, 5.5 to 5.9 cm; and group 4, ≥6.0 cm. The primary end point was all-cause mortality; secondary end points were complications, reinterventions, and ruptures.

Results

There were 874 patients studied (female, 108 [12%]; group 1, 119; group 2, 246; group 3, 243; group 4, 266); mean age was 76 ± 7.2 years. The 30-day mortality rate was 1.0%, not significantly different between groups (P = .22); complication and reintervention rates were 13% and 4.1%, respectively, similar between groups (P < .05). Five-year survival was 68%; freedom from complications and reinterventions was 65% and 74%, respectively; rupture rate was 0.5%. Multivariate analysis revealed that factors associated with all-cause mortality included maximal aortic diameter, age, gender, surgical risk, cancer history, and endograft type (P < .05). Group 4 had increased risks of mortality (hazard ratio [HR], 2.0; 95% confidence interval [CI], 1.38-2.85; P = .002) and complications (HR, 1.6; 95% CI, 1.2-2.7; P = .009) relative to group 1. Reinterventions were more frequent for aneurysms ≥6.0 cm (HR, 2.0; 95% CI, 1.2-3.3; P = .01). Late rupture rate after EVAR was not different between groups.

Conclusions

Maximal aortic diameter is associated with long-term outcomes after elective EVAR. Patients with large AAAs (≥6.0 cm) have higher all-cause mortality, complication, and reintervention rates after EVAR than those with smaller aneurysms. We continue to recommend that AAAs be repaired when they reach 5.5 cm as recommended by the guidelines of the Society for Vascular Surgery. On the basis of our data, EVAR should be considered even in high-risk patients with a maximal aortic diameter between 5.5 and 6.0 cm because surgical risk with aneurysm size above 6.0 cm will increase significantly.  相似文献   

5.

Objective

Finite element analysis (FEA) has been suggested to be superior to maximal diameter measurements in predicting rupture of abdominal aortic aneurysms (AAAs). Our objective was to investigate to what extent previously described rupture risk factors were associated with FEA-estimated rupture risk.

Methods

One hundred forty-six patients with an asymptomatic AAA of a 40- to 60-mm diameter were retrospectively identified and consecutively included. The patients' computed tomography angiograms were analyzed by FEA without (neutral) and with (specific) input of patient-specific mean arterial pressure (MAP), gender, family history, and age. The maximal wall stress/wall strength ratio was described as a rupture risk equivalent diameter (RRED), which translated this ratio into an average aneurysm diameter of corresponding rupture risk.

Results

In multivariate linear regression, RREDneutral increased with female gender (3.7 mm; 95% confidence interval [CI], 0.13-7.3) and correlated with patient height (0.27 mm/cm; 95% CI, 0.11-0.43) and body surface area (BSA, 16 mm/m2; 95% CI, 8.3-24) and inversely with body mass index (BMI, ?0.40 mm/kg m?2; 95% CI, ?0.75 to ?0.054) in a wall stress-dependent manner. Wall stress-adjusted RREDneutral was raised if the patient was currently smoking (1.1 mm; 95% CI, 0.21-1.9). Age, MAP, family history, and patient weight were unrelated to RREDneutral. In specific FEA, RREDspecific increased with female gender, MAP, family history positive for AAA, height, and BSA, whereas it was inversely related to BMI. All results were independent of aneurysm diameter. Peak wall stress and RRED correlated with aneurysm diameter and lumen volume.

Conclusions

Female gender, current smoking, increased patient height and BSA, and low BMI were found to increase the mechanical rupture risk of AAAs. Previously described rupture risk factors may in part be explained by patient characteristic-dependent variations in aneurysm biomechanics.  相似文献   

6.

Background

The number of ruptured abdominal aortic aneurysm (r-AAA) patients who are treated by endovascular means is increasing as ruptured endovascular aneurysm repair (r-EVAR) enters the mainstream. However, even today, data on the incidence and behavior of endoleaks after r-EVAR are scarce. This study analyzed whether endoleaks behave differently after EVAR for rupture vs elective AAA repair.

Methods

From 2002 to 2013, there were 2052 patients who underwent EVAR for treatment of rupture (n = 166 [8.1%]) and elective repair (n = 1886 [91.9%]) of infrarenal AAA. Follow-up included computed tomography angiography at 1 month, at 6 months, and yearly thereafter. All type I and type III endoleaks were treated at the time of or shortly after the diagnosis. Persistent type II endoleaks at >6 months after EVAR without a decrease in AAA sac underwent translumbar or transfemoral embolization procedures. Data were prospectively collected in a vascular database.

Results

During a mean follow-up of 30 months, patients had a significantly lower incidence of type II endoleaks after r-EVAR compared with elective endovascular aneurysm repair (e-EVAR; n = 15 [9.0%] vs n = 380 [20.2%]; P < .01). Although the incidence of type I endoleaks is similar after r-EVAR (n = 9 [5.4%] and e-EVAR (n = 83 [4.4%]; P = .68), the r-EVAR patients required stent graft explantation more frequently (n = 9 [5.4%] vs n = 20 [1.1%]; P < .01). Whereas the need for secondary intervention was comparable in both r-EVAR (n = 33 [19.9%]) and e-EVAR (n = 439 [23.3%]; P = .37) groups, patients undergoing percutaneous embolization procedures trended toward significance between the two groups (n = 11 [6.6%] vs n = 216 [11.5%]; P = .06) with endoleaks.

Conclusions

Compared with e-EVAR, patients who undergo r-EVAR experience a similar incidence of type I endoleaks and a significantly lower incidence of type II endoleaks. The endoleaks in both e-EVAR and r-EVAR patients can frequently be managed by endovascular means. However, r-EVAR patients with type I and type II endoleaks are at a significantly higher risk for stent graft explantation.  相似文献   

7.

Objective

This study compared reoperation rates associated with open abdominal aortic aneurysm (AAA) repair (OR) outcomes vs endovascular AAA repair (EVAR).

Methods

A retrospective review of the Veterans Affairs Surgical Quality Improvement Project data was performed with inclusion criteria defined as all patients who underwent AAA repair from October 1, 2007, to October 1, 2013. The primary outcome was the incidence of reoperations. Reoperations included subsequent OR or EVAR procedures performed on the abdominal aorta or iliac arteries, surgical treatment of temporally related bowel obstruction, as well as treatment of abdominal or groin wound complications ≤6 months and treatment of bowel or lower limb ischemia ≤10 days.

Results

Of 6677 patients who underwent AAA repair, 476 (7.1%) required reoperations. OR was associated with a higher rate of reoperations overall (10.0% vs 6.3%; P < .01), with most being intra-abdominal and wound complications. OR also had higher rates of bowel ischemia requiring operation (0.7% vs 0.3%; P = .01) and lower extremity ischemia (0.5% and 0.06%; P < .01). Significantly more endovascular stents were placed during EVAR (2.8% vs 0.5%; P < .01). Logistic regression showed EVAR is a negative predictor for reoperation after controlling for comorbidities (P < .001).

Conclusions

The long-term burden of reoperations after OR may actually be more significant than current understanding when including all possible abdominal complications in an extended analysis. Future prospective trials should include all potential reoperations extended >30 days with associated cost analysis. As surgical innovation in EVAR technology advances, complication comparisons with OR should undergo frequent re-evaluation given that endovascular indications and outcomes continue to expand and improve.  相似文献   

8.

Objective

Despite vast improvement in the field of vascular surgery, elective abdominal aortic aneurysm (AAA) repair still leads to perioperative death. Patients with asymptomatic AAAs, therefore, would benefit from an individual risk assessment to help with decisions regarding operative intervention. The purpose of this study was to describe such a 30-day postoperative (POD) risk prediction model using American College of Surgeons National Surgical Quality Improvement Project (NSQIP) data.

Methods

The NSQIP database (2005-2011) was queried for patients undergoing elective AAA repair using open or endovascular techniques. Clinical variables and known predictors of mortality were included in a full prediction model. These variables included procedure type, patient's age, functional dependence and comorbidities, and surgeon's specialty. Backward elimination with alpha-level of 0.2 was used to construct a parsimonious model. Model discrimination was evaluated in equally sized risk quintiles.

Results

The overall mortality rate for 18,917 elective AAA patients was 1.7%. In this model, surgeon's specialty was not predictive of POD. The most significant factors affecting POD included open repair (odds ratio [OR], 2.712; 95% confidence interval [CI], 2.119-3.469; P < .001), age >70 (OR, 2.243; 95% CI, 1.695-3.033; P < .001), functional dependency (OR, 2.290; 95% CI, 1.442-3.637; P < .001), creatinine above 2.0 mg/dL (OR, 2.1; 95% CI, 1.403-3.142; P < .001) and low hematocrit levels (OR, 2.157; 95% CI, 1.365-3.408; P = .001).The discriminating ability of the NSQIP model was reasonable (C-statistic = 0.751) and corrected to 0.736 after internal validation. The NSQIP model performed well predicting mortality among risk-group quintiles.

Conclusions

The NSQIP risk prediction model is a robust vehicle to predict POD among patient undergoing elective AAA repair. This model can be used for risk stratification of patients undergoing elective AAA repair.  相似文献   

9.

Background

Functional status is a simple and rapidly assessable metric that may be used as a predictor for surgical outcomes. This study examined the association of functional status with short-term mortality after abdominal aortic aneurysm (AAA) repair in octogenarians to characterize the utility of functional status as a means of preoperative risk assessment.

Methods

All patients who underwent endovascular and open AAA repair from 2002 to 2010 within the Veterans Affairs Surgical Quality Improvement Program (VASQIP) database were identified. Functional status, defined as an ordinal scale from 1 to 3 (1, independent; 2, partially dependent; 3, totally dependent), was examined using multivariate regression models with 30-day mortality as the primary outcome. For the purpose of analysis, this 3-point scale was converted into a binomial scale of function, with “normal” including 1 (completely independent) and “abnormal” including 2 or 3 (partially to totally dependent).

Results

We identified 9030 patients who underwent AAA repair (46.6% open and 53.4% endovascular). Mortality at 30 days was 2.8% for the entire cohort (4.2% open, 1.7% endovascular; P < .001). There were 1340 patients aged ≥80 years, of which 67.3% underwent endovascular AAA repair. Among all age groups, functional status was a significant predictor of 30-day mortality (<80 years, P < .001; ≥80 years, P < .001). The ≥80 cohort with abnormal function status also demonstrated increased operative mortality (P = .002), length of stay (P = .001), and incidence of pulmonary complications (P = .025) compared with the cohort with normal functional status. Multivariate logistic regression demonstrated that within the ≥80-year-old cohort, only functional status remained a significant predictor of mortality (P < .001). In addition, the strength of the association between functional status and mortality was greater in the older cohort than in the younger one (Cox regression hazard ratio: 3.13 vs 2.18).

Conclusions

Functional status is a simple and rapidly applicable predictor of mortality within AAA patients and may be a useful tool to help preoperatively risk-stratify elderly patients presenting with AAA in need of repair. Further studies are needed to understand how best to apply these data to the clinical setting to guide preoperative decision making.  相似文献   

10.

Introduction

When a patient with ruptured abdominal aortic aneurysm (rAAA) presents at a facility ill-equipped to provide care, transfer may provide the best chance for survival. Large distances and long travel times provide challenging barriers to prompt and appropriate care in the western United States.

Methods

The Western Vascular Society (WVS) adopted a set of guidelines in considering transfer of a patient with an rAAA using published literature, membership survey and input, and existing recommendations. This article reports the guidelines and describes the process and rationale behind their development.

Results

Fifteen guidelines for transfer and care of rAAAs were endorsed by the WVS.

Conclusions

When local care cannot be provided, transfer guidelines may standardize care for rAAAs and may be applicable across may practice settings.  相似文献   

11.

Background

As endovascular aneurysm repair (EVAR) continues to advance, eligibility of patients with anatomically complex abdominal aortic aneurysms (AAAs) for EVAR is increasing. However, whether complex EVAR is associated with favorable outcome over conventional open repair and how outcomes compare with infrarenal EVAR remains unclear. This study examined perioperative outcomes of patients undergoing complex EVAR, focusing on differences with complex open repair and standard infrarenal EVAR.

Methods

We identified all patients undergoing nonruptured complex EVAR, complex open repair, and infrarenal EVAR in the American College of Surgeons National Surgical Quality Improvement Program Targeted Vascular Module. Aneurysms were considered complex if the proximal extent was juxtarenal or suprarenal or when the Zenith Fenestrated endograft (Cook Medical, Bloomington, Ind) was used. Independent risks were established using multivariable logistic regression analysis.

Results

Included were 4584 patients, with 411 (9.0%) undergoing complex EVAR, 395 (8.6%) undergoing complex open repair, and 3778 (82.4%) undergoing infrarenal EVAR. Perioperative mortality was 3.4% after complex EVAR, 6.6% after open repair (P = .038), and 1.5% after infrarenal EVAR (P = .005). Postoperative acute kidney injuries occurred in 2.3% of complex EVAR patients, in 9.5% of those undergoing complex open repair (P < .001), and in 0.9% of infrarenal EVAR patients (P = .007). Compared with complex EVAR, complex open repair was an independent predictor of 30-day mortality (odds ratio [OR], 2.2; 95% confidence interval [CI], 1.1-4.4), renal function deterioration (OR, 4.8; 95% CI, 2.2-10.5), and any complication (OR, 3.7; 95% CI, 2.5-5.5). When complex vs infrarenal EVAR were compared, infrarenal EVAR was associated with favorable 30-day mortality (OR, 0.5; 95% CI, 0.2-0.9), and renal outcome (OR, 0.4; 95% CI, 0.2-0.9).

Conclusions

In this study assessing the perioperative outcomes of patients undergoing repair for anatomically complex AAAs, complex EVAR had fewer complications than complex open repair but carried a higher risk of adverse outcomes than infrarenal EVAR. Further research is warranted to determine whether the benefits of EVAR compared with open repair for complex AAA treatment are maintained during long-term follow-up.  相似文献   

12.

Objective

The targeted vascular module in the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) consists of self-selected hospitals that choose to collect extra clinical details for better risk adjustment and improved procedure-specific outcomes. The purpose of this study was to compare patient selection and outcomes between targeted and nontargeted hospitals in the NSQIP regarding the operative management of abdominal aortic aneurysm (AAA).

Methods

We identified all patients who underwent endovascular aneurysm repair (EVAR) or open AAA repair from 2011 to 2013 and compared cases by whether the operation took place in a targeted or nontargeted hospital. EVAR and open repair as well as intact and ruptured aneurysms were evaluated separately. Only variables contained in both modules were used to evaluate rupture status and operation type. All thoracoabdominal aneurysms were excluded. Univariate analysis was performed for intact and ruptured EVAR and open repair grouped by complexity, defined as visceral involvement in open repair and a compilation of concomitant procedures for EVAR. Multivariable models were developed to identify effect of hospital type on mortality.

Results

There were 17,651 AAA repairs identified. After exclusion of aneurysms involving the thoracic aorta (n = 352), there were 1600 open AAA repairs at targeted hospitals (21% ruptured) and 2725 at nontargeted hospitals (19% ruptured) and 4986 EVARs performed at targeted hospitals (6.7% ruptured) and 7988 at nontargeted hospitals (5.2% ruptured). There was no significant difference in 30-day mortality rates between targeted and nontargeted hospitals for intact aneurysms (EVAR noncomplex, 1.8% vs 1.4% [P = .07]; open repair noncomplex, 4.2% vs 4.5% [P = .7]; EVAR complex, 5.0% vs 3.2% [P = .3]; open repair complex, 8.0% vs 6.0% [P = .2]). For ruptured aneurysms, again there was no difference in mortality between the targeted and nontargeted hospitals (EVAR noncomplex, 23% vs 25% [P = .4]; open repair noncomplex, 38% vs 34% [P = .2]; EVAR complex, 29% vs 33% [P = 1.0]; open repair complex, 27% vs 41% [P = .09]). Multivariable analysis further demonstrated that having an operation at a targeted vs nontargeted hospital had no impact on mortality for both intact and ruptured aneurysms (odds ratio, 1.1 [0.9-1.4] and 1.0 [0.8-1.3], respectively).

Conclusions

This analysis highlights the similarities between targeted and nontargeted hospitals within the NSQIP for AAA operative management and suggests that data from the targeted NSQIP, in terms of AAA management, are generalizable to all NSQIP hospitals.  相似文献   

13.

Objective

To evaluate the impact of preoperative pulmonary function on outcomes after open repair of descending thoracic (DTA) and thoracoabdominal aortic (TAAA) aneurysms.

Methods

The outcomes of patients undergoing open repair of DTA or TAAA were analyzed in relation to the results of preoperative pulmonary function tests. Receiver operating characteristic was adopted to assess the effect of forced expiratory volume in one second (FEV1) on the incidence of mortality. Logistic regression analysis and propensity score matching were used.

Results

Between 1997 and 2015, 726 patients underwent open DTA or TAAA repair. Pulmonary function tests were available in 711 (97.9%). Receiver operating characteristic analysis revealed the cutoff value of FEV1 to be 50%. Propensity score matching led to 149 pairs of patients with FEV1 below and above 50% with only limited residual imbalance. In the matched population operative mortality was 11.4% and 6.0% in patients with FEV1 ≤ 50% and FEV1 ≥ 51%, respectively (P = .10). The incidence of major adverse events was 33.1% in cases with FEV1 ≤ 50% and 19.5% in those with FEV1 ≥ 51% (P = .008). FEV1 ≤ 50% was associated with a 6.99× increase in the risk of major postoperative adverse events at logistic regression analysis.

Conclusions

Preoperative FEV1 < 50% is strongly predictive of increased respiratory failure, tracheostomy, and operative mortality in patients undergoing open DTA/TAAA repair. For these very high-risk patients with either extensive TAAAs or anatomy unsuitable for endovascular repair, medical therapy may offer the best long-term survival.  相似文献   

14.

Objective

The neutrophil-to-lymphocyte ratio (NLR) has been used as a surrogate marker of systemic inflammation. We sought to investigate the association between NLR and wound healing in diabetic wounds.

Methods

The outcomes of 120 diabetic foot ulcers in 101 patients referred from August 2011 to December 2014 were examined retrospectively. Demographic, patient-specific, and wound-specific variables as well as NLR at baseline visit were assessed. Outcomes were classified as ulcer healing, minor amputation, major amputation, and chronic ulcer.

Results

The subjects' mean age was 59.4 ± 13.0 years, and 67 (66%) were male. Final outcome was complete healing in 24 ulcers (20%), minor amputation in 58 (48%) and major amputation in 16 (13%), and 22 chronic ulcers (18%) at the last follow-up (median follow-up time, 6.8 months). In multivariate analysis, higher NLR (odds ratio, 13.61; P = .01) was associated with higher odds of nonhealing.

Conclusions

NLR can predict odds of complete healing in diabetic foot ulcers independent of wound infection and other factors.  相似文献   

15.

Objective

The Nellix EndoVascular Aneurysm Sealing (EVAS) System (Endologix, Inc, Irvine, Calif) is a novel approach to abdominal aortic aneurysm (AAA) treatment whereby polymer is used to fill the AAA sac. We report 1-year results of the investigational device exemption pivotal trial.

Methods

Eligible patients were treated at 30 sites in the United States and Europe. Inclusion criteria required an asymptomatic infrarenal AAA, with a neck length ≥10 mm and ≤60° angle, iliac artery blood lumen diameter 9 to 35 mm, access artery diameter ≥6 mm, and serum creatinine ≤2 mg/dL. Follow-up included computed tomography angiography scans at 30 days, 6 months, and 1 year that were evaluated by a core laboratory. The primary safety end point was 30-day major adverse events (MAEs), which were compared with a performance goal of <56% (the Society for Vascular Surgery open repair control group rate). The primary effectiveness end point was treatment success at 1 year, which was compared with a performance goal of >80%. Treatment success required procedural technical success and absence of AAA rupture during follow-up, conversion to open surgical repair, endoleak (type I or III) at 1 year, migration >10 mm causing complications or requiring secondary intervention, aneurysm enlargement, or secondary procedures through 1 year for resolution of endoleak, device obstruction or occlusion, or device defect.

Results

Of 150 treated patients, 149 (99.3%) completed 1-year follow-up. The MAEs rate at 30 days was 2.7% (95% confidence interval, 0.7%-6.7%), satisfying the primary safety end point (<56%). The 1-year treatment success was 94% (95% confidence interval, 88.6%-97.4%), achieving the primary effectiveness end point (>80%). At 1 year, key secondary outcomes included 6.7% MAEs, 4.7% serious device-related events, 1.3% AAA-related mortality, 3.7% secondary interventions, and 0.7% surgical conversions. MAEs through 1 year included death (n = 6), stroke (n = 3), bowel ischemia (n = 2), renal failure (n = 2), respiratory failure (n = 2), and myocardial infarction (n =1). One iatrogenic AAA rupture occurred and one AAA rupture was reported during follow-up. AAA sac enlargement (>5 mm) was 1.5% at 1 year. Endoleaks were present in four patients (3.1%) at 1 year (1 type Ib and 3 type II). Migration >10 mm occurred in three patients (2.3%), but none required secondary intervention.

Conclusions

Outcomes with this novel endovascular therapy for AAA, the Nellix EVAS System, are encouraging. The primary safety and effectiveness end points have been met. Low morbidity, low mortality, and high procedural and treatment success were achieved despite the inevitability of a learning curve and unique risks associated with a new device and technique. Long-term follow-up is in progress.  相似文献   

16.

Objective

Long-term data regarding the safety and durability of thoracic endovascular aortic repair (TEVAR) are limited. The study objective was to evaluate the long-term outcomes of TEVAR in high-risk patients with descending thoracic aortic pathology.

Methods

High-risk patients were treated with thoracic endografts (2001-2011) under a prospective, physician-sponsored, investigational device exemption trial. Three-dimensional reconstructions and measurements were performed on computed tomography scans acquired before discharge, at 1, 6, and 12 months, and then yearly thereafter.

Results

The study included 200 patients, of whom 171 were treated for thoracic aneurysm, 28 for chronic dissection, and 1 for aortobronchial fistula. Patients were monitored for an average of 4.8 ± 3.3 years, and 93 (46.5%) were monitored for >5 years. Operative mortality was 6.5%. Survival at 30 days and at 1, 5, and 9 years was 94.0%, 85.8%, 55.6%, and 31.4%, and freedom from aneurysm-related death was 94.0%, 92.4%, 91.7%, 91.7%, respectively. Sixty-one endoleaks occurred in 54 patients (28%). Sixty-seven reinterventions were performed in 50 patients. Overall freedom from reintervention at 30 days, 1, 5, and 9 years was 87.9%, 82.9%, 75.5%, and 64.0%, respectively. Forty-seven reinterventions (70%) were thoracic aneurysm-related, 35 (74%) of which were endovascular procedures. Thirty of these were to correct endoleaks at a median of 1.4 years (interquartile range, 0.2-5.0 years).

Conclusions

TEVAR is durable and associated with high long-term aneurysm-related survival. Long-term imaging follow-up remains critical to identify endoleaks or rare device durability issues, most of which can be monitored or managed with endovascular therapies.  相似文献   

17.

Objective

Limited data exist comparing perioperative morbidity and mortality after open and endovascular abdominal aortic aneurysm (AAA) repair (EVAR) among regions of the United States. This study evaluated the regional variation in mortality and perioperative outcomes after repair of AAAs.

Methods

The Vascular Quality Initiative (VQI) was used to identify patients undergoing open AAA repair and EVAR between 2009 and 2014. Ruptured and intact aneurysms were evaluated separately, and the analysis of intact aneurysms was limited to infrarenal AAAs. All 16 regions of the VQI were deidentified, and those with <100 open repairs were combined to eliminate the effect of low-volume regions. Regional variation was evaluated using χ2 and Fisher exact tests. Regional rates were compared against current quality benchmarks.

Results

Perioperative outcomes from 14 regions were compared. After open repair of intact aneurysms, no significant variation was seen in 30-day or in-hospital mortality; however, multiple regions exceeded the Society for Vascular Surgery benchmark for in-hospital mortality after open repair of intact aneurysms of <5% (range, 0%-7%; P = .55). After EVAR, all regions met the Society for Vascular Surgery benchmark of <3% (range, 0%-1%; P = .75). Significant variation in in-hospital mortality existed after open (14%-63%; P = .03) and endovascular (3%-32%; P = .03) repair of ruptured aneurysms across the VQI regional groups. After repair of intact aneurysms, wide variation was seen in prolonged length of stay (>7 days for open repair: 32%-53%, P = .54; >2 days for EVAR: 16-43%, P < .01), transfusion (open: 10%-35%, P < .01; EVAR: 7%-18%, P < .01), use of vasopressors (open: 19%-37%, P < .01; EVAR: 3%-7%, P < .01), and postoperative myocardial infarction (open: 0%-13%, P < .01; EVAR: 0%-3%, P < .01). After open repair, worsening renal function (6%-18%; P = .04) and respiratory complications (6%-20%; P = .20) were variable across regions. The frequency of endoleak at completion of EVAR also had considerable variation (15%-38%; P < .01).

Conclusions

Despite limited variation, multiple regions do not meet current benchmarks for in-hospital mortality after open AAA repair for intact aneurysms. Significant regional variation exists in perioperative outcomes and length of stay, and mortality is widely variable after repair for rupture. These data identify important areas for quality improvement initiatives and clinical practice guidelines.  相似文献   

18.

Background

Information on the growth rate of the diameter of the residual dissected supra-aortic trunk after surgical repair of type A aortic dissection is limited.

Methods

We retrospectively reviewed 95 consecutive postsurgical patients with type A aortic dissection (acute, 91; chronic, 4) between 2005 and 2016 who were followed up with computed tomography. The diameter of the residual dissected supra-aortic trunk was measured by axial images and multiplanar reformatting, and the growth rate was calculated.

Results

The mean age was 67.2 ± 12.8 years (range, 34-89 years). Forty-one brachiocephalic arteries (43%), 14 left common carotid arteries (15%), and 7 left subclavian arteries (10%) exhibited residual dissection. The diameter of the residual dissected branch with a patent false lumen (FL) gradually increased over time, whereas that with a thrombosed FL decreased and reached a plateau. The growth rate of brachiocephalic, left common carotid, and left subclavian arteries with a patent FL was 1.3 ± 1.2, 0.8 ± 0.3, and 0.6 ± 0.4 mm/y, respectively. One patient required surgical intervention for dilation of the brachiocephalic artery 8 years postoperatively. Multivariate analysis showed that male sex was an independent risk factor for a patent FL in the brachiocephalic artery (P = .0431; odds ratio, 2.04).

Conclusions

A residual dissected supra-aortic trunk with a thrombosed FL seems to be a benign condition. However, long-term follow-up is necessary for patients with a patent FL of residual dissected supra-aortic trunk, which might occasionally require surgical intervention.  相似文献   

19.

Objective

Renal complications after repair of abdominal aortic aneurysms (AAAs) have been associated with increased morbidity and mortality. However, limited data have assessed risk factors for renal complications in the endovascular era. This study aimed to identify predictors of renal complications after endovascular AAA repair (EVAR) and open repair.

Methods

Patients who underwent EVAR or open repair of a nonruptured infrarenal AAA between 2011 and 2013 were identified in the National Surgical Quality Improvement Project Targeted Vascular module. Patients on hemodialysis preoperatively were excluded. Renal complications were defined as new postoperative dialysis or creatinine increase >2 mg/dL. Patient demographics, comorbidities, glomerular filtration rate (GFR), operative details, and outcomes were compared using univariate analysis between those with and without renal complications. Multivariable logistic regression was used to identify independent predictors of renal complications.

Results

We identified 4503 patients who underwent elective repair of an infrarenal AAA (EVAR: 3869, open repair: 634). Renal complication occurred in 1% of patients after EVAR and in 5% of patients after open repair. There were no differences in comorbidities between patients with and without renal complications. A preoperative GFR <60 mL/min/1.73m2 occurred more frequently among patients with renal complications (EVAR: 81% vs 37%, P < .01; open: 60% vs 34%, P < .01). The 30-day mortality was also significantly increased (EVAR: 55% vs 1%, P < .01; open: 30% vs 4%, P < .01). After adjustment, renal complications were strongly associated with 30-day mortality (odds ratio [OR], 38.3; 95% confidence interval [CI], 20.4-71.9). Independent predictors of renal complications included GFR <60 mL/min/1.73m2 (OR, 4.6; 95% CI, 2.4-8.7), open repair (OR, 2.6; 95% CI, 1.3-5.3), transfusion (OR, 6.1; 95% CI, 3.0-12.6), and prolonged operative time (OR, 3.0; 95% CI, 1.6-5.6).

Conclusions

Predictors of renal complications include elevated baseline GFR, open approach, transfusion, and prolonged operative time. Given the dramatic increase in mortality associated with renal complications, care should be taken to use renal protective strategies, achieve meticulous hemostasis to limit transfusions, and to use an endovascular approach when technically feasible.  相似文献   

20.

Objective

Medicare studies have shown increased perioperative mortality in women compared with men following endovascular and open abdominal aortic aneurysm (AAA) repair. However, a recent regional study of high-volume centers, adjusting for anatomy but limited in sample size, did not show sex to be predictive of worse outcomes. This study aimed to evaluate sex differences after intact AAA repair in a national clinical registry.

Methods

The targeted vascular module of the National Surgical Quality Improvement Program was queried to identify patients undergoing endovascular aneurysm repair (EVAR) or open repair for intact, infrarenal AAA from 2011 to 2014. Univariate analysis was performed using the Fisher exact test and Mann-Whitney test. Multivariable logistic regression was used to account for differences in comorbidities, aneurysm details, and operative characteristics.

Results

We identified 6661 patients (19% women) who underwent intact AAA repair (87% EVAR; 83% women vs 88% men; P < .001). Women were older (median age, 76 vs 73 years; P < .001), had smaller aneurysms (median, 5.4 vs 5.5 cm; P < .001), and had more chronic obstructive pulmonary disease (22% vs 17%; P < .001). Among patients undergoing EVAR, women had longer operative times (median, 138 [interquartile range, 103-170] vs 131 [106-181] minutes; P < .01) and more often underwent renal (6.3% vs 4.1%; P < .01) and lower extremity (6.6% vs 3.8%; P < .01) revascularization. After open repair, women had shorter operative time (215 [177-304] vs 226 [165-264] minutes; P = .02), but women less frequently underwent lower extremity revascularization (3.1% vs 8.2%; P = .03). Thirty-day mortality was higher in women after EVAR (3.2% vs 1.2%; P < .001) and open repair (8.0% vs 4.0%; P = .04). After adjusting for repair type, age, aneurysm diameter, and comorbidities, female sex was independently associated with mortality (odds ratio [OR], 1.7; 95% confidence interval [CI], 1.1-2.6; P = .02) and major complications (OR, 1.4; CI, 1.1-1.7; P < .01) after intact AAA repair. However, after adjusting for aortic size index rather than for aortic diameter, the association between female sex and mortality (OR, 1.5; CI, 0.98-2.4; P = .06) and major complications (OR, 1.1; CI, 0.9-1.4; P = .24) was reduced.

Conclusions

Women were at higher risk for 30-day death and major complications after intact AAA repair. Some of this disparity may be explained by differences in aortic size index, which should be further evaluated to determine the ideal threshold for repair.  相似文献   

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