Piergiorgio Cao

Comparison of Surveillance Versus Aortic Endografting for Small Aneurysm Repair (CAESAR): Results from a Randomised Trial

BACKGROUND Randomised trials have failed to demonstrate benefit from early surgical repair of small abdominal aortic aneurysm (AAA) compared with surveillance. This study aimed to compare results after endovascular aortic aneurysm repair (EVAR) or surveillance in AAA <5.5 cm. METHODS Patients (50-79 years) with AAA of 4.1-5.4 cm were randomly assigned, in a 1:1 ratio, to receive immediate EVAR or surveillance by ultrasound and computed tomography (CT) and repair only after a defined threshold (diameter ≥5.5 cm, enlargement >1 cm /year, symptoms) was achieved. The main end point was all-cause mortality. Recruitment is closed; results at a median follow-up of 32.4 months are here reported. RESULTS Between 2004 and 2008, 360 patients (early EVAR = 182; surveillance = 178) were enrolled. One perioperative death after EVAR and two late ruptures (both in the surveillance group) occurred. At 54 months, there was no significant difference in the main end-point rate [hazard ratio (HR) 0.76; 95% confidence interval (CI) 0.30-1.93; p = 0.6] with Kaplan-Meier estimates of all-cause mortality of 14.5% in the EVAR and 10.1% in the surveillance group. Aneurysm-related mortality, aneurysm rupture and major morbidity rates were similar. Kaplan-Meier estimates of aneurysms growth ≥5 mm at 36 months were 8.4% in the EVAR group and 67.5% in the surveillance group (HR 10.49; 95% CI 6.88-15.96; p < 0.01). For aneurysms under surveillance, the probability of delayed repair was 59.7% at 36 months (84.5% at 54 months). The probability of receiving open repair at 36 months for EVAR feasibility loss was 16.4%. CONCLUSION Mortality and rupture rates in AAA <5.5 cm are low and no clear advantage was shown between early or delayed EVAR strategy. However, within 36 months, three out of every five small aneurysms under surveillance might grow to require repair and one out of every six might lose feasibility for EVAR. Surveillance is safe for small AAA if close supervision is applied. Long-term data are needed to confirm these results. CLINICAL TRIAL REGISTRATION INFORMATION This study is registered, NCT Identifier: NCT00118573.

Eversion versus conventional carotid endarterectomy: Late results of a prospective multicenter randomized trial

OBJECTIVE The durability of carotid endarterectomy (CEA) may be affected by carotid restenosis. The data from randomized trials show that the highest incidence of restenosis after CEA occurs from 12 to 18 months after surgery. The optimal CEA technique to reduce perioperative complications and restenosis rates is still undefined. This study examines the long-term clinical outcome and incidence of recurrent stenosis in patients who undergo eversion CEA. Previously published perioperative results of this study did not show statistically significant differences in study endpoints between the eversion and standard techniques. METHODS From October 1994 to March 1997, 1353 patients with surgical indications for carotid stenosis were randomly assigned to undergo eversion (n = 678) or standard CEA (n = 675; primary closure, 419; patch, 256). Withdrawal from the assigned treatment occurred in 1.6% of the patients (in 13 assigned to eversion CEA, and in nine assigned to standard CEA). The clinical and duplex scan follow-up examination was 99% complete, and the mean follow-up interval was 33 months (range, 12 to 55 months). The primary outcomes were perioperative and late major stroke and death, carotid restenosis (stenosis >/= 50% of the lumen diameter detected at duplex scanning), and carotid occlusion. The primary evaluation of study outcomes was conducted on the basis of an intention-to-treat analysis. RESULTS Restenosis was found at duplex scanning in 56 patients (19 in the eversion group, and 37 in the standard group). Within the standard group, the restenosis rates were 7.9% in the primary closure population and 1.5% in the patched population. Of the patients with restenosis, 36% underwent cerebral angiography that confirmed restenosis in all cases. The cumulative restenosis risk at 4 years was significantly lower in the group that underwent treatment with eversion CEA as compared with the standard group (3.6% vs 9.2%; P =.01), with an absolute risk reduction of 5. 6% and a relative risk reduction of 62%. Eighteen patients would have had to undergo treatment with eversion CEA to prevent one restenosis during the 4-year period. The incidence rate of ipsilateral stroke was 3.3% in the eversion population and 2.2% in the standard group. There were no significant differences in the cumulative risks of ipsilateral stroke (3.9% for eversion, and 2.2% for standard; P =.2) and death (13.1% for eversion, and 12.7% for standard; P =.7)) in the two groups. Of the 18 variables that were examined for their influence on restenosis, eversion CEA (hazard ratio, 0.3; 95% confidence interval, 0.2 to 0.6; P =.0004) and patch CEA (hazard ratio, 0.2; 95% confidence interval, 0.07 to 0.6; P =. 002) were negative independent predictors of restenosis with multivariate Cox proportional hazards regression analysis. CONCLUSION The EVEREST (EVERsion carotid Endarterectomy versus Standard Trial) showed that eversion CEA is safe, effective, and durable. No statistically significant differences were found in late outcome between the eversion and standard techniques at the available follow-up examination.

Endovascular treatment of iliac aneurysm : Concurrent comparison of side branch endograft versus hypogastric exclusion

OBJECTIVE To analyze early and mid-term outcome of endovascular treatment in patients with iliac aneurysms, comparing the results of hypogastric revascularization by branch endografting with those of hypogastric occlusion. METHODS Consecutive patients with iliac aneurysms receiving side branch endograft (Group I) were compared with those receiving endograft with hypogastric exclusion (Group II) during the interval from January 2000 to May 2008. Procedural details and outcomes were prospectively collected and were analyzed at one year to avoid mismatch in follow-up length. RESULTS A total of 74 patients (mean age, 75.8 years, 95% males) were treated: 32 in Group I and 42 in Group II. No differences in baseline risk factors and aneurysm diameter (40.2 +/- 7.9 mm in Group I vs. 38.4 +/- 10.8 in Group II) were found. Concurrent treatment of aortic aneurysm was performed in 25/32 (78%) of Group I and 36/42 (86%) of Group II. Fluoro time was 48 minutes (interquartile range [IQR] 31-57) in Group I vs. 31 minutes (IQR 23-38) in Group II (P = .04). The amount of contrast was similar in both Groups: 184 ml (IQR 155-210) in Group I vs. 183 ml (IQR 155-200) in Group II. No intestinal ischemia or deaths occurred. There were no significant differences in failures of hypogastric side branch deployment (2/32) compared with hypogastric coiling (3/42). Limb occlusions all occurring in the external iliac artery side were 2/32 in Group I vs. 3/42 in Group II. Reintervention rates were similar (5/32 vs. 4/42) at one year. Shrinkage of 5 mm or more was detected in 7/23 (30%) of Group I and in 13/37 (34%) of Group II. Iliac endoleak was present in eight patients (19%) in Group II and in one patient in Group I (4%) (P = .1). Similarly, buttock claudication or impotence were more frequent after hypogastric exclusion, recorded in eight patients in Group II and in one patient in Group I (P = .1). CONCLUSIONS Endovascular treatment of iliac aneurysm with hypogastric revascularization through side branched endografts is feasible and safe in the mid-term. When compared with hypogastric embolization, this option leads to similar technical success and reintervention rates. Endoleak and buttock claudication occur frequently in patients with iliac aneurysm treated with hypogastric exclusion, while are uncommon in those with hypogastric revascularization. Side branch endografting for iliac aneurysm may be considered a primary choice in younger, active patients with suitable anatomy, but larger studies and longer postoperative observation periods are needed.

Predictive factors and clinical consequences of proximal aortic neck dilatation in 230 patients undergoing abdominal aorta aneurysm repair with self-expandable stent-grafts.

OBJECTIVE Several studies have suggested that proximal aortic neck dilatation (AND) is a frequent event after balloon-expandable endografting. Yet few data are available on AND after repair with self-expandable stent grafts. To investigate incidence, predictive factors, and clinical consequences of AND, computed tomography (CT) scans obtained at intervals during follow-up of 230 patients who had undergone endoluminal abdominal aortic aneurysm (AAA) repair with self-expandable stents were reviewed. SUBJECTS Between April 1997 and March 2001, 318 patients underwent endoluminal AAA repair with a self-expandable endograft at our unit. CT scans obtained at 1 and 12 months after surgery and yearly thereafter were prospectively stored in a computer imaging data base. Two hundred thirty patients were available for minimum 1-year assessment. Two vascular surgeons with tested interobserver agreement reviewed 686 CT scans. Diameter of the proximal aortic neck was measured as the minor axis of the first CT section that contained at least half of the proximal portion of the endograft. For endografts with suprarenal attachment the first scan below the lowest renal artery was considered. Diameter change of 3 mm or more between the CT scan at 1 month and subsequent evaluations was defined as AND. Nine possible independent predictors of AND were analyzed with Cox regression analysis. RESULTS Median follow-up was 24 months (range, 12-54 months). In 2 patients, AAA ruptured during follow-up. CT scans for 65 patients (28%) showed AND. Thirteen patients with AND (5.6%) underwent repeat intervention, including positioning of the proximal cuff in 8 patients and late conversion to open repair in five patients. Of the nine variables examined with multivariate analysis, only 3, ie, presence of neck circumferential thrombus (hazard ratio [HR], 2.51; 95% confidence interval [CI], 1.26-5.01; P =.008), preoperative proximal neck diameter (HR, 1.21; 95% CI, 1.07-135; P =.001), and preoperative AAA diameter (HR, 1.03; 95% CI, 1.00-1.06; P =.046) were positive independent predictors of AND, whereas the other 6, ie, neck angulation more than 60 degrees, neck length, suprarenal fixation, oversizing more than 15%, endoleak at 30 days, and increased AAA diameter during follow-up, showed no significant correlation. Probability of AND at 48 months was 59 +/- 6.1 at analysis with the Kaplan-Meier method. CONCLUSIONS AND is a frequent sequela of endoluminal repair in the mid-term. Severe AND developed in a small percentage of our patients, compromising integrity of AAA repair. Patients with large aneurysms and aortic necks and patients with aortic neck circumferential thrombus are at high risk for aortic neck enlargement after endoluminal repair of AAA.

The role of carotid artery stenting and carotid endarterectomy in cognitive performance: a systematic review.

Background and Purpose— Change in cognition is being increasingly recognized as an important outcome measure; however, the role of carotid revascularization on this issue remains to be determined. It is still under debate whether carotid artery stenting and carotid endarterectomy have the same influence on neuropsychological functions. Summary of Review— This article systematically reviews recent literature in an attempt to clarify this issue. A total of 32 papers reporting on neurocognition after carotid endarterectomy (n=25), carotid artery stenting (n=4), or carotid artery stenting versus carotid endarterectomy (n=3) were identified. The studies were different for many methodological factors, eg, sample size, type of patients and control group, statistical measure, type of test, timing of assessment, and so on. There was a lack of consensus in defining the improvement or impairment after either carotid artery stenting or carotid endarterectomy. Furthermore, there were nonuneqivocal results regarding the same domain of assessment (memory, visuomotor, attention). Based on available evidence, it is probable that carotid endarterectomy as well as carotid artery stenting do not change neuropsychological function “per se.” Conclusions— Assessment of cognition after carotid revascularization is probably influenced by many confounding factors such as learning effect, type of test, type of patients, and control group, which are often minimized in their importance. The role of carotid revascularization is to prevent stroke in patients with severe carotid stenosis as highlighted by previous large randomized trials. Although an effect of carotid revascularization on cognition could be missed as a consequence of underpowered studies included in this review, at this time, no prediction can be done regarding its repercussions on higher intellectual functions. Larger studies appropriately designed and powered to assess cognition after carotid revascularization might change this view.

Plasma levels of lipophilic antioxidants in very old patients with Type 2 diabetes.

Experimental research indicates that oxidative stress is implicated in aging and in the pathogenesis of diabetes and its complications. This evidence is limited in elderly patients with non‐insulin dependent diabetes, in which age‐ and disease‐related production of reactive oxygen species might exert synergistic damaging effects on tissues and organs.

Systematic review of clinical outcomes in hybrid procedures for aortic arch dissections and other arch diseases

OBJECTIVE Available data on clinical outcomes of hybrid aortic arch repair are limited, especially for patients with aortic dissection. The objective of this review was to provide pooled analysis of periprocedural mortality and neurologic outcomes in hybrid procedures involving the aortic arch for dissection and other aortic diseases. METHODS Studies involving hybrid aortic arch procedures (2002-2011) were systematically searched and reviewed. End points were periprocedural mortality, stroke, and spinal cord ischemia. RESULTS A total of 50 studies including 1886 patients were included. Perioperative mortality ranged from 1.6% to 25.0% with a pooled event ratio of 10.8% (95% confidence intervals [CI], 9.3-12.5). Perioperative stroke, regardless of severity, ranged from 0.8% to 25.0% (pooled ratio 6.9%; 95% CI, 5.7%-8.4), and spinal cord ischemia, including permanent and transitory events, ranged from 1.0% to 25.0% (pooled ratio, 6.8%; 95% CI, 5.6-8.2). Neurologic but no mortality risk was affected by timing and center volume with decreased rates in more recent and higher volume studies. In dissected aorta, perioperative mortality rate was 9.8% (95% CI, 7.7-12.4), stroke 4.3% (95% CI, 3.0-6.3), and spinal cord ischemia 5.8% (95% CI, 4.2-7.9). Perioperative mortality was higher in diseases that extended to the ascending aorta (15.1% vs 7.6%; odds ratio, 2.8; 95% CI, 1.17-6.7; P = .021), whereas there were no significant differences in the neurologic risks of stroke or spinal cord ischemia. CONCLUSIONS Hybrid repair of the aortic arch carries not negligible risks of perioperative mortality and neurologic morbidity. Risk of neurologic complications has decreased with timing and center volume and may be limited in dissection repairs. However, contemporary information on aortic hybrid arch procedures is mainly provided by small case series or retrospective studies with wide range of results.

Chapter IV: Treatment of Critical Limb Ischaemia

Recommendations stated in the TASC II guidelines for the treatment of peripheral arterial disease (PAD) regard a heterogeneous group of patients ranging from claudicants to critical limb ischaemia (CLI) patients. However, specific considerations apply to CLI patients. An important problem regarding the majority of currently available literature that reports on revascularisation strategies for PAD is that it does not focus on CLI patients specifically and studies them as a minor part of the complete cohort. Besides the lack of data on CLI patients, studies use a variety of endpoints, and even similar endpoints are often differentially defined. These considerations result in the fact that most recommendations in this guideline are not of the highest recommendation grade. In the present chapter the treatment of CLI is not based on the TASC II classification of atherosclerotic lesions, since definitions of atherosclerotic lesions are changing along the fast development of endovascular techniques, and inter-individual differences in interpretation of the TASC classification are problematic. Therefore we propose a classification merely based on vascular area of the atherosclerotic disease and the lesion length, which is less complex and eases the interpretation. Lesions and their treatment are discussed from the aorta downwards to the infrapopliteal region. For a subset of lesions, surgical revascularisation is still the gold standard, such as in extensive aorto-iliac lesions, lesions of the common femoral artery and long lesions of the superficial femoral artery (>15 cm), especially when an applicable venous conduit is present, because of higher patency and limb salvage rates, even though the risk of complications is sometimes higher than for endovascular strategies. It is however more and more accepted that an endovascular first strategy is adapted in most iliac, superficial femoral, and in some infrapopliteal lesions. The newer endovascular techniques, i.e. drug-eluting stents and balloons, show promising results especially in infrapopliteal lesions. However, most of these results should still be confirmed in large RCTs focusing on CLI patients. At some point when there is no possibility of an endovascular nor a surgical procedure, some alternative non-reconstructive options have been proposed such as lumbar sympathectomy and spinal cord stimulation. But their effectiveness is limited especially when assessing the results on objective criteria. The additional value of cell-based therapies has still to be proven from large RCTs and should therefore still be confined to a research setting. Altogether this chapter summarises the best available evidence for the treatment of CLI, which is, from multiple perspectives, completely different from claudication. The latter also stresses the importance of well-designed RCTs focusing on CLI patients reporting standardised endpoints, both clinical as well as procedural.

Mechanisms of symptomatic spinal cord ischemia after TEVAR: insights from the European Registry of Endovascular Aortic Repair Complications (EuREC).

Purpose To test the hypothesis that simultaneous closure of at least 2 independent vascular territories supplying the spinal cord and/or prolonged hypotension may be associated with symptomatic spinal cord ischemia (SCI) after thoracic endovascular aortic repair (TEVAR). Methods A pattern matching algorithm was used to develop a risk model for symptomatic SCI using a prospective 63-patient single-center cohort to test the positive predictive value (PPV) of prolonged intraoperative hypotension and/or simultaneous closure of at least 2 of 4 the vascular territories supplying the spinal cord (left subclavian, intercostal, lumbar, and hypogastric arteries). This risk model was then applied to data extracted from the multicenter European Registry on Endovascular Aortic Repair Complications (EuREC). Between 2002 and 2010, the 19 centers participating in EuREC reported 38 (1.7%) cases of symptomatic spinal cord ischemia among the 2235 patients in the database. Results In the single-center cohort, direct correlations were seen between the occurrence of symptomatic SCI and both prolonged intraoperative hypotension (PPV 1.00, 95% CI 0.22 to 1.00, p=0.04) and simultaneous closure of at least 2 independent spinal cord vascular territories (PPV 0.67, 95% CI 0.24 to 0.91, p=0.005). Previous closure of a single vascular territory was not associated with an increased risk of symptomatic spinal cord ischemia (PPV 0.07, 95% CI 0.01 to 0.16, p=0.56). The combination of prolonged hypotension and simultaneous closure of at least 2 territories exhibited the strongest association (PPV 0.75, 95% CI 0.38 to 0.75, p<0.0001). Applying the model to the entire EuREC cohort found an almost perfect agreement between the predicted and observed risk factors (kappa 0.77, 95% CI 0.65 to 0.90). Conclusion Extensive coverage of intercostal arteries alone by a thoracic stent-graft is not associated with symptomatic SCI; however, simultaneous closure of at least 2 vascular territories supplying the spinal cord is highly relevant, especially in combination with prolonged intraoperative hypotension. As such, these results further emphasize the need to preserve the left subclavian artery during TEVAR.

Comparison of Target Organ Damage in Renovascular and Essential Hypertension

In many reports, the prevalence of target organ damage in renovascular hypertension (RVH) appears to be higher than in essential hypertension (EH). Since in most studies the renal artery stenosis is part of a diffuse atherosclerotic disease, it is not known whether these complications are due to RVH itself or to the vascular disease. We have undertaken a case control study of 92 patients divided into two groups (46 in each), one with RVH and the other with EH and abdominal aortic aneurysm, with a comparable degree of diffuse atherosclerotic vascular disease. The vascular state of the extracranial carotid arteries and abdominal and inferior limb districts was investigated with angiography and sonography. The prevalence of left ventricular hypertrophy (LVH) and ischemic heart disease (IHD) were assessed by electrocardiography. Serum creatinine and urinary protein excretion were employed in the renal evaluation. While the analysis of the results confirmed an even diffusion of atherosclerotic vascular disease between the two groups, a significant difference was found in the prevalence of heart and renal damage. LVH was present in 32.6% of RVH patients versus 10.8% in EH (P = .02). Serum creatinine > 1.4 mg/dL was found in 50% of RVH and in 23.9% of EH, (P = .01). The prevalence of proteinuria in RVH was also higher although not reaching the statistical significance. The results suggest that, in patients with comparable degrees of atherosclerotic vascular disease, RVH is responsible for the higher prevalence of target organ damage in this condition compared to those with EH.