Predicting reinterventions after open and endovascular aneurysm repair using the St George's Vascular Institute score.

BACKGROUND: Identifying patients at risk for aneurysm rupture and sac expansion after open and endovascular abdominal aortic aneurysm (AAA) repair (EVAR) may help to attenuate this risk by intensifying follow-up and early detection of problems. The goal of this study was to validate the St George's Vascular Institute (SGVI) score to identify patients at risk for a secondary intervention after elective aneurysm repair. METHODS: A post hoc on-treatment analysis of a randomized trial comparing open AAA repair and EVAR was performed. In this multicenter trial, 351 patients were randomly assigned to undergo open AAA repair or EVAR. Information on survival and reinterventions was available for all patients at 5 years postoperatively, for 79% at 6 years, and for 53% at 7 years. Open repair was completed in 173 patients and EVAR in 171, based on an on-treatment analysis. Because 17 patients had incomplete anatomic data, 327 patients (157 open repair and 170 EVAR) were available for analysis. During 6 years of follow-up, 78 patients underwent at least one reintervention. The SGVI score, which is calculated from preoperative AAA morphology using aneurysm and iliac diameter, predictively dichotomized patients into groups at high-risk or low-risk for a secondary intervention. The observed freedom from reintervention was compared between groups at predicted high-risk and predicted low-risk. RESULTS: The 20 patients in the high-risk group were indeed at higher risk for a secondary intervention compared with the 307 patients predicted to be at low risk (hazard ratio [HR], 3.82; 95% confidence interval [CI], 2.05-7.11; P < .001). Discrimination between high-risk and low-risk groups was valid for EVAR (HR, 4.06; 95% CI, 1.93-8.51; P < .001) and for open repair (HR, 3.41; 95% CI, 1.02-11.4; P = .033). CONCLUSIONS: The SGVI score appears to be a useful tool to predict reintervention risk in patients after open repair and EVAR.

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 ß-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 ß-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.

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.)

[An abnormal lipid profile: when to perform additional research for a genetic cause?] / Een afwijkend lipidenprofiel.

Abnormalities in the lipid profile are common, but it is often not easy to determine their cause. After exclusion of secondary causes, a primary (genetic) cause of dyslipidaemia should be considered. The most common monogenic dyslipidaemia is familial hypercholesterolemia (FH), but there are other clinically relevant genetic dyslipidaemias, including familial dysbetalipoproteinaemia (FD), monogenic chylomicronaemia and hypoalphalipoproteinemia. It is important to make a genetic diagnosis because it may influence the prognosis of the patient, for determining appropriate treatment goals and because it is relevant for family members. This clinical viewpoint explains the diagnostic process of genetic dyslipidaemias using two cases.

Ongoing effects of eConsultation in nephrology on hospital referral rates: An observational study.

INTRODUCTION: eConsultation in nephrology is an innovative way for general practitioners (GPs) to consult a nephrologist. Studies have shown that questions from GPs can be answered and intended referrals can be avoided by eConsultation. However, follow-up data are lacking. The primary aim of this study was therefore to assess whether patients for whom a referral to the outpatient clinic of a medical specialist was avoided in the short term were not then referred for the same problem within one year after the eConsultation. METHODS: All eConsultations sent between June 2017 and April 2018 to seven nephrologists in three different hospitals in The Netherlands were included. Exclusion criteria were duplications and missing data on follow-up. Data were obtained from the eConsultation application forms and from GP medical records. RESULTS: A total of 173 eConsultations were included. Of the 32 patients for whom a referral was initially prevented, 91% (95% confidence interval 75-98) had not been referred to a specialist for the same problem within one year after the eConsultation. DISCUSSION: eConsultation in the field of nephrology can prevent referrals in the long term. It can therefore contribute to a more modern and efficient health-care system in which chronic care is provided by GPs in close proximity to patients, while specialist support is easily available and accessible through eConsultation when necessary.

Two-year outcomes after conventional or endovascular repair of abdominal aortic aneurysms.

BACKGROUND: Two randomized trials have shown better outcomes with elective endovascular repair of abdominal aortic aneurysms than with conventional open repair in the first month after the procedure. We investigated whether this advantage is sustained beyond the perioperative period. METHODS: We conducted a multicenter, randomized trial comparing open repair with endovascular repair in 351 patients who had received a diagnosis of abdominal aortic aneurysm of at least 5 cm in diameter and who were considered suitable candidates for both techniques. Survival after randomization was calculated with the use of Kaplan-Meier analysis and compared with the use of the log-rank test on an intention-to-treat-basis. RESULTS: Two years after randomization, the cumulative survival rates were 89.6 percent for open repair and 89.7 percent for endovascular repair (difference, -0.1 percentage point; 95 percent confidence interval, -6.8 to 6.7 percentage points). The cumulative rates of aneurysm-related death were 5.7 percent for open repair and 2.1 percent for endovascular repair (difference, 3.7 percentage points; 95 percent confidence interval, -0.5 to 7.9 percentage points). This advantage of endovascular repair over open repair was entirely accounted for by events occurring in the perioperative period, with no significant difference in subsequent aneurysm-related mortality. The rate of survival free of moderate or severe complications was also similar in the two groups at two years (at 65.9 percent for open repair and 65.6 percent for endovascular repair; difference, 0.3 percentage point; 95 percent confidence interval, -10.0 to 10.6 percentage points). CONCLUSIONS: The perioperative survival advantage with endovascular repair as compared with open repair is not sustained after the first postoperative year.

A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms.

BACKGROUND: Although the initial results of endovascular repair of abdominal aortic aneurysms were promising, current evidence from controlled studies does not convincingly show a reduction in 30-day mortality relative to that achieved with open repair. METHODS: We conducted a multicenter, randomized trial comparing open repair with endovascular repair in 345 patients who had received a diagnosis of abdominal aortic aneurysm of at least 5 cm in diameter and who were considered suitable candidates for both techniques. The outcome events analyzed were operative (30-day) mortality and two composite end points of operative mortality and severe complications and operative mortality and moderate or severe complications. RESULTS: The operative mortality rate was 4.6 percent in the open-repair group (8 of 174 patients; 95 percent confidence interval, 2.0 to 8.9 percent) and 1.2 percent in the endovascular-repair group (2 of 171 patients; 95 percent confidence interval, 0.1 to 4.2 percent), resulting in a risk ratio of 3.9 (95 percent confidence interval, 0.9 to 32.9). The combined rate of operative mortality and severe complications was 9.8 percent in the open-repair group (17 of 174 patients; 95 percent confidence interval, 5.8 to 15.2 percent) and 4.7 percent in the endovascular-repair group (8 of 171 patients; 95 percent confidence interval, 2.0 to 9.0 percent), resulting in a risk ratio of 2.1 (95 percent confidence interval, 0.9 to 5.4). CONCLUSIONS: On the basis of the overall results of this trial, endovascular repair is preferable to open repair in patients who have an abdominal aortic aneurysm that is at least 5 cm in diameter. Long-term follow-up is needed to determine whether this advantage is sustained.

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.

Cost-effectiveness of conventional and endovascular repair of abdominal aortic aneurysms: results of a randomized trial.

BACKGROUND: Two randomized trials have shown similar mid-term outcomes for survival and quality of life after endovascular and conventional open repair of abdominal aortic aneurysms (AAA). With reduced hospital and intensive care stay, endovascular repair has been hypothesized to be more efficient than open repair. The Dutch Randomized Endovascular Aneurysm Management (DREAM) trial was undertaken to assess the balance of costs and effects of endovascular vs open aneurysm repair. METHODS: We conducted a multicenter, randomized trial comparing endovascular repair with open repair in 351 patients with an AAA and studied costs, cost-effectiveness, and clinical outcome 1 year after surgery. In addition to clinical outcome, costs and quality of life were recorded up to 1 year in 170 patients in the endovascular repair group and in 170 in the open repair group. Incremental cost-effectiveness ratios were estimated for cost per life-year, event-free life-year, and quality adjusted life-year (QALY) gained. Uncertainty regarding these outcomes was assessed using bootstrapping. RESULTS: Patients in the endovascular repair group experienced 0.72 QALY vs 0.73 in the open repair group (absolute difference, 0.01; 95% confidence interval [CI], -0.038 to 0.058). Endovascular repair was associated with additional euro 4293 direct costs (euro 18,179 vs euro 13.886; 95% CI, euro 2,770 to euro 5,830). Most of the bootstrap estimates indicated that endovascular repair resulted in slightly longer overall and event-free survival associated with respective incremental cost-effectiveness ratios of euro76,100 and euro 171,500 per year gained. Open repair appeared the dominant strategy in costs per QALY. CONCLUSION: Presently, routine use of endovascular repair in patients also eligible for open repair does not result in a QALY gain at 1 year postoperatively, provides only a marginal overall survival benefit, and is associated with a substantial, if not prohibitive, increase in costs.

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 > or = 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 > or = 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.

Surveillance after endovascular aneurysm repair: diagnostics, complications, and associated costs.

The purpose of this study is to describe the diagnostic tests used, the complications that occurred the reinterventions performed, and the costs incurred after endovascular aneurysm repair. Retrospective review was performed of 77 consecutive individuals in whom endovascular aortic grafts had been successfully deployed. The series represents a single institution's experience with prospective application of a surveillance program using high-resolution CT scanning. Follow-up was available for all individuals. Mean interval of follow-up was 19.9 months (range 1-72 months), yielding a cumulative follow-up of 1540 months. There were no cases of aneurysm rupture. A total of 315 CT scans were performed during follow-up. On the basis of predetermined criteria, 28 interventions were performed in 21 patients. Indications for intervention included change in aneurysm sac volume (21 procedures), limb ischemia (5 procedures), and infection (2 procedures). Seven individuals were converted to open repair an average of 28.5 months after graft implantation (range 4-69 months). Twenty-one additional procedures were performed in 15 individuals after an average of 14.8 months (range 1-63 months). Cumulative risk of intervention and overall costs were estimated as a function time from implantation. Estimated costs at one and five years were 3631 dollars and 9729 dollars. The cumulative risk of intervention at one year was 7.2%. The frequency and cost of post-implantation procedures after endovascular aortic intervention are substantial. As longer follow-up becomes available, continued postoperative expenses may cancel out the already marginal cost STET benefits of EVAR benefits of EVAR.

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.

Noninvasive intrasac pressure measurement and the influence of type 2 and type 3 endoleaks in an animal model of abdominal aortic aneurysm.

The objective of this study was to noninvasively detect pressure changes within an excluded aneurysm sac in an animal model of abdominal aortic aneurysm (AAA) and to study the influence of type 2 and 3 endoleaks. A porcine model of AAA that allows for the creation of type 2 and 3 endoleaks was used. A miniaturized pressure monitoring device (3 x 9 x 1.5 mm; Remon Medical Technologies, Caesarea, Israel) was implanted within the surgically created and excluded aneurysm sac. The pressure monitoring device is an ultrasound-based system that allows for pressure measurements in a noninvasive, transcutaneous fashion. In addition, catheter-based pressures were taken within the aorta and directly in the AAA sac. Noninvasive measurements were taken in a transcutaneous fashion between the initial operation and the time of sacrifice, when the type 3 endoleak was created (2 weeks). The median mean arterial pressure was 66 mm Hg (range 55-120 mm Hg; N = 8). The median noninvasive sac pressure with a type 2 endoleak was 48 mm Hg (range 39-90 mm Hg; N = 8) and was almost identical to the catheter-based measurements. Noninvasive pressures could be measured as early as postprocedure day 1. Two animals had follow-up that suggested closure of the type 2 endoleak during the observation period. With the creation of the type 3 endoleak, the catheter and noninvasive sac pressure and waveform changed from a flatline trace to a higher-pressure pulsatile trace (median 54 mm Hg; range 46-81 mm Hg; N = 8), reproducing the arterial pressure and waveform. This is the first study, to our knowledge, that demonstrates the efficacy of a noninvasive, miniaturized pressure monitoring device in identifying pressure changes in an excluded aneurysm sac with type 2 and type 3 endoleaks. This technology holds great promise for follow-up of patients and identification of sac pressure changes after EVAR and may allow a change in the current follow-up strategy.

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.

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.