Monique Prinssen

Long-term outcome of open or endovascular repair of abdominal aortic aneurysm.

BACKGROUND For patients with large abdominal aortic aneurysms, randomized trials have shown an initial overall survival benefit for elective endovascular repair over conventional open repair. This survival difference, however, was no longer significant in the second year after the procedure. Information regarding the comparative outcome more than 2 years after surgery is important for clinical decision making. METHODS We conducted a long-term, multicenter, randomized, controlled trial comparing open repair with endovascular repair in 351 patients with an abdominal aortic aneurysm of at least 5 cm in diameter who were considered suitable candidates for both techniques. The primary outcomes were rates of death from any cause and reintervention. Survival was calculated with the use of Kaplan-Meier methods on an intention-to-treat basis. RESULTS We randomly assigned 178 patients to undergo open repair and 173 to undergo endovascular repair. Six years after randomization, the cumulative survival rates were 69.9% for open repair and 68.9% for endovascular repair (difference, 1.0 percentage point; 95% confidence interval [CI], -8.8 to 10.8; P=0.97). The cumulative rates of freedom from secondary interventions were 81.9% for open repair and 70.4% for endovascular repair (difference, 11.5 percentage points; 95% CI, 2.0 to 21.0; P=0.03). CONCLUSIONS Six years after randomization, endovascular and open repair of abdominal aortic aneurysm resulted in similar rates of survival. The rate of secondary interventions was significantly higher for endovascular repair. (ClinicalTrials.gov number, NCT00421330.)

The Glasgow Aneurysm Score as a tool to predict 30-day and 2-year mortality in the patients from the Dutch Randomized Endovascular Aneurysm Management trial

OBJECTIVE Randomized trials have shown that endovascular repair (EVAR) of an abdominal aortic aneurysm (AAA) has a lower perioperative mortality than conventional open repair (OR). However, this initial survival advantage disappears after 1 year. To make EVAR cost-effective, patient selection should be improved. The Glasgow Aneurysm Score (GAS) estimates preoperative risk profiles that predict perioperative outcomes after OR. It was recently shown to predict perioperative and long-term mortality after EVAR as well. Here, we applied the GAS to patients from the Dutch Randomized Endovascular Aneurysm Repair (DREAM) trial and compared the applicability of the GAS between open repair and EVAR. METHODS A multicenter, randomized trial was conducted to compare OR with EVAR in 345 AAA patients. The GAS was calculated (age + [7 points for myocardial disease] + [10 points for cerebrovascular disease] + [14 points for renal disease]). Optimal cutoff values were determined, and test characteristics for 30-day and 2-year mortality were computed. RESULTS The mean GAS was 74.7 +/- 9.3 for OR patients and 75.9 +/- 9.7 for EVAR patients. Two EVAR patients and eight OR patients died < or =30 days postoperatively. The area under the receiver-operator characteristic curve (AUC) was 0.79 for OR patients and 0.87 for EVAR patients. The optimal GAS cutoff value was 75.5 for OR and 86.5 for EVAR. By 2 years postoperatively, 18 patients had died in both the EVAR and the OR patient groups. The AUC was 0.74 for OR patients and 0.78 for EVAR patients. The optimal GAS cutoff value was 74.5 for OR and 77.5 for EVAR. CONCLUSION This is the first evaluation of the GAS in a randomized trial comparing AAA patients treated with OR and EVAR. The GAS can be used for prediction of 30-day and 2-year mortality in both OR and EVAR, but in patients that are suitable for both procedures, it is a better predictor for EVAR than for OR patients. In this study, the GAS was most valuable in identifying low-risk patients but not very useful for the identification of the small number of high-risk patients.

Sexual Dysfunction after Conventional and Endovascular AAA Repair: Results of the DREAM Trial

Purpose: To assess sexual function in the first postoperative year after elective endovascular aneurysm repair (EVAR) and open repair (OR) of abdominal aortic aneurysm (AAA). Methods: In the Dutch Randomized Endovascular Aneurysm Management (DREAM) trial, 153 patients (141 men; mean age 71 years, range 53–85) were randomly allocated to EVAR (n=77) or OR (n=76). Sexual functioning was evaluated preoperatively and at 5 times in the first postoperative year (3, 6, 13, 26, and 52 weeks) using a questionnaire derived from the Medical Outcomes Study. The proportions of patients reporting sexual dysfunction for any of 5 aspects (interest, pleasure, engagement, orgasm, and erection) and any increase in the magnitude of dysfunction were compared between EVAR and OR. Results: Preoperatively, the proportion of patients reporting sexual dysfunction in at least 1 aspect was 66% for the OR group and 74% in the EVAR group (p=NS). Surgery had a clear impact on sexual dysfunction. The proportion of patients reporting sexual dysfunction on at least 1 aspect increased to 79% in the OR group and 82% in the EVAR group. The magnitude of sexual dysfunction increased in both groups on all 5 aspects at 3 weeks postoperatively, but this was more pronounced in the OR group (interest: OR p=0.038 vs. EVAR p=0.071; pleasure: OR p=0.009 vs. EVAR p = 0.065; engagement: OR p=0.006 vs. EVAR p=0.054; orgasm OR p=0.023 vs. EVAR p=0.112, and erection: OR p=0.046 vs. EVAR p=0.030). At 6 weeks, the OR group still reported a significant increase in 3 aspects (pleasure p=0.031, engagement p=0.010, and orgasm p=0.003), whereas the EVAR group no longer showed a significant difference. From 3 months on, both groups had returned to baseline. Conclusions: EVAR and open elective AAA repair both have an impact on sexual function in the early postoperative period. After EVAR, recovery to preoperative levels is faster than after open repair, but at 3 months, sexual dysfunction levels are similar in both groups.

Statin therapy is associated with improved survival after endovascular and open aneurysm repair

BACKGROUND The relationship between numerous risk factors and perioperative mortality after cardiovascular surgery has been studied extensively. While improved perioperative survival and fewer cardiovascular events have been related to statin therapy, its effect on long-term survival after aneurysm repair remains to be elucidated. The aim of this study is to determine the effect of statin therapy on long-term survival after open and endovascular aneurysm repair and to identify other cardiovascular and patient-related risk factors in this respect. METHODS A post-hoc analysis of a randomized trial comparing open and endovascular abdominal aortic aneurysm repair was performed. In this multicenter trial, 351 patients were randomly assigned to undergo either open abdominal aortic aneurysm repair or endovascular repair. Patients who were on lipid-lowering medication at their inclusion in the trial (n = 135) were compared with those who were not (n = 216). RESULTS During 6 years of follow-up, 118 (33.6%) patients died after randomization. Statin therapy, baseline characteristics, Society for Vascular Surgery/International Society for Cardiovascular Surgery risk factors, aneurysm size, reinterventions, antiplatelet or anticoagulant agents, and β-blockers were used to identify prognostic factors influencing survival. After identification of significant factors in a Kaplan-Meier analysis, a multivariable Cox regression analysis was applied. Statin therapy at inclusion in the trial was independently associated with better overall survival after open or endovascular aneurysm repair (hazard ratio [HR], 0.5; 95% confidence interval [CI], 0.3-0.8; P = .004). Statins were especially associated with fewer cardiovascular deaths (HR, 0.4; 95% CI, 0.2-0.9; P = .025). Several risk factors were associated with poor survival after open and endovascular aneurysm repair: age >70 (HR, 3.4; 95% CI, 2.2-5.0; P < .001), a history of cardiac disease at baseline (HR, 1.9; 95% CI, 1.3-2.8; P = .001), and moderate/severe tobacco use (HR, 1.7; 95% CI, 1.2-2.5; P = .004). Gender, aneurysm size, the need for reintervention, pulmonary disease, renal disease, carotid disease, hypertension, diabetes mellitus, antiplatelet or anticoagulant agents, and β-blockers were not significantly associated with impaired long-term survival (P > .05). CONCLUSIONS Despite the limitations of a post-hoc analysis of a prospectively maintained trial, we conclude that statin therapy at the beginning of the trial is independently associated with improved long-term survival after open or endovascular aneurysm repair, while age above 70 years, a history of cardiovascular disease, and tobacco use are associated with decreased long-term survival.

Renal function 5 years after open and endovascular aortic aneurysm repair from a randomized trial

Deterioration of renal function after major vascular surgery is an important complication, and may vary between patients undergoing endovascular (EVAR) or open surgical (OR) repair of an abdominal aortic aneurysm (AAA). The objective was to determine the impact of OR and EVAR on renal function after 5 years.

Does the Type of Endograft Affect AAA Volume Change after Endovascular Aneurysm Repair

Purpose: To compare thrombus volume changes in a longitudinal study over 2 years after endovascular aneurysm repair using the Ancure and Excluder endografts. Methods: In 2 institutions, all consecutive patients treated with a bifurcated Ancure or Excluder endograft were included in this retrospective comparison of computed tomographic angiography (CTA) data recorded and stored to disk postoperatively and at the 12 (12M) and 24-month (24M) follow-up examinations. In one institution, among 45 Ancure endograft patients, 35 (group A) had the 3 requisite scans available. In the second institution, 23 (group B) of 36 patients with the Excluder endograft were eligible for analysis. The proportional volume change was calculated at 12M and 24M and compared to the postoperative CT data. More than 10% shrinkage was considered significant. Results: In both groups, the median absolute volume changed significantly. In group A, significant shrinkage was found in 66% (23/35) at 12M and 74% (26/35) at 24M; in group B, 46% (10/23) had significant shrinkage at 12M as well as at 24M (p=0.027 for the difference between groups A and B at 24M). Statistical analysis of the proportional volume change showed a significant difference between the Ancure and the Excluder devices at 12M (p=0.009) and 24M (p=0.001). Multivariate analysis found aneurysm size (p<0.012) and endograft type (p=0.026) to be independently predictive of the absolute volume change. Conclusions: Sac volume shrinkage after endovascular aneurysm repair is less pronounced and less frequent with the Excluder endoprosthesis than with the Ancure endograft.

Endoleak after endovascular repair of ruptured abdominal aortic aneurysm: is it a problem?

Purpose: To illustrate the clinical significance of type I and type II endoleaks following endovascular treatment of a ruptured abdominal aortic aneurysm (AAA). Case Report: An 81-year-old patient presented with a ruptured AAA that was urgently treated with an Ancure aortomonoiliac endograft. After the postoperative computed tomographic (CT) scan, a distal type I endoleak was suspected, but the follow-up angiogram demonstrated only lumbar backbleeding. As the patient was stable, conservative treatment was recommended. After 3 months, a distal as well as a proximal type I endoleak were demonstrated, strangely enough, in the presence of a shrinking aneurysm and clearance of the retroperitoneal hematoma. Both endoleaks were treated endoluminally, after which the CT scan still showed contrast in the aneurysm sac, presumably from lumbar backbleeding. Twelve months after the initial procedure, the patient continues to do well. Conclusions: Although not well understood, the presence of an endoleak after endovascular repair of a ruptured AAA may not always be a life-threatening situation.

Does Fresh Clot Shrink Faster Than Preexistent Mural Thrombus after Endovascular AAA Repair

Purpose: To correlate the amount of preexistent thrombus in abdominal aortic aneurysms (AAA) to sac shrinkage after endovascular repair. Methods: From January 1993 through April 2000, 76 patients underwent endovascular AAA repair and were examined at 12 months to identify aneurysms that had decreased in size by >10%. Volume measurements were performed using a standardized spiral computed tomographic angiography (CTA) protocol with 3-dimensional postprocessing. Volume measurements were unavailable or incomplete in 16 patients, and another 16 did not have sac shrinkage >10%, leaving 44 patients in the study group. The percentage of preexistent mural thrombus in shrinking sacs (OldThr%) was calculated by dividing the preoperative thrombus volume by the postoperative nonluminal thrombus volume. The 12-month volume change, expressed as a percentage of the postoperative thrombus volume and as an absolute value, was correlated with OldThr% using the Pearson product moment test. Results: The median proportional shrinkage at 12 months was 56% (range 15%–89%) and the absolute nonluminal thrombus volume shrinkage was 49 mL (range 6–186). The median OldThr% was 53% (range 6%–94%). The correlation coefficients of OldThr% were 0.130 (p=0.40) with the proportional shrinkage in thrombus volume and 0.235 (p=0.13) with the absolute volume change. Conclusions: The rate of shrinkage of successfully excluded aneurysm sacs after endovascular repair is independent of the preoperative mural thrombus volume in the aneurysm. Other factors are responsible for the large variation in shrinkage.

Quality of life from a randomized trial of open and endovascular repair for abdominal aortic aneurysm

Long‐term survival is similar after open or endovascular repair of abdominal aortic aneurysm. Few data exist on the effect of either procedure on long‐term health‐related quality of life (HRQoL) and health status.

Long-term survival and secondary procedures after open or endovascular repair of abdominal aortic aneurysms

Objective Randomized trials have shown an initial survival benefit of endovascular over conventional open abdominal aortic aneurysm repair but no long‐term difference up to 6 years after repair. Longer follow‐up may be required to demonstrate the cumulative negative impact on survival of higher reintervention rates associated with endovascular repair. Methods We updated the results of the Dutch Randomized Endovascular Aneurysm Management (DREAM) trial, a multicenter, randomized controlled trial comparing open with endovascular aneurysm repair, up to 15 years of follow‐up. Survival and reinterventions were analyzed on an intention‐to‐treat basis. Causes of death and secondary interventions were compared by use of an events per person‐year analysis. Results There were 178 patients randomized to open and 173 to endovascular repair. Twelve years after randomization, the cumulative overall survival rates were 42.2% for open and 38.5% for endovascular repair, for a difference of 3.7 percentage points (95% confidence interval, −6.7 to 14.1; P = .48). The cumulative rates of freedom from reintervention were 78.9% for open repair and 62.2% for endovascular repair, for a difference of 16.7 percentage points (95% confidence interval, 5.8‐27.6; P = .01). No differences were observed in causes of death. Cardiovascular and malignant disease account for the majority of deaths after prolonged follow‐up. Conclusions During 12 years of follow‐up, there was no survival difference between patients who underwent open or endovascular abdominal aortic aneurysm repair, despite a continuously increasing number of reinterventions in the endovascular repair group. Endograft durability and the need for continued endograft surveillance remain key issues.