Giacomo Isernia

Type II endoleak is an enigmatic and unpredictable marker of worse outcome after endovascular aneurysm repair

BACKGROUND This study analyzed predictors and the long-term consequence of type II endoleak in a large series of elective endovascular abdominal aneurysm repairs (EVARs). METHODS Baseline characteristics and operative and follow-up data of consecutive patients undergoing EVAR were prospectively collected. Patients who developed type II endoleak according to computed tomography angiography and those without type II endoleak were compared for baseline characteristics, mortality, reintervention, conversion, and aneurysm growth after repair. RESULTS In 1997-2011, 1412 consecutive patients (91.4% males; mean age, 72.9 years) underwent elective EVAR and were subsequently followed up for a median of 45 months (interquartile range, 21-79 months). Type II endoleak developed in 218. Adjusted analysis failed to identify significant independent predictors for type II endoleak with the exception of age (odds ratio, 1.03; 95% confidence interval, 1.01-1.05; P = .003) and intraluminal thrombus (odds ratio, 0.69; 95% confidence interval, 0.53-0.92; P = .010). Type II endoleak rates were comparable regardless of the device model. Late aneurysm-related survival was comparable (98.4% vs 99.5% at 60 months; P = .73) in patients with and without type II endoleak. However, at 60 months after EVAR, rates of aneurysm sac growth >5 mm (35.3% vs 3.3%; P < .0001) were higher in patients with type II endoleak. Cox regression identified type II endoleak as an independent predictor of aneurysm growth along with age and cardiac disease. The presence of type II endoleak led to reinterventions in 40% of patients and conversion to open surgery in 8%. However, assessment of these patients after reintervention showed similar 60-month freedom rates of persisting type II endoleak (present in more than two after computed tomography angiography scan studies) among those with and without reinterventions (49.8% vs 45.6%; P = .639). Aneurysm growth >5 mm persisted with comparable rates in type II endoleak patients after reintervention and in those who remained untreated (42.9% vs 57.4% at 60 months; P = .117). CONCLUSIONS Reintervention for type II endoleak was common in our practice, yet such intervention did not reliably prevent the continued expansion of the abdominal aortic aneurysm. Our data indicate type II endoleak appears to be a marker of EVAR failure that is difficult to predict and treat effectively.

Effects of statins on early and late results of carotid stenting

OBJECTIVES Increasing data suggest that statins can significantly decrease cardiovascular and cerebrovascular events due to a plaque stabilization effect. However, the benefit of statins in patients undergoing carotid angioplasty and stenting (CAS) for carotid stenosis is not well defined. The aim of this study was to investigate whether statins use was associated with decreased perioperative and late risks of stroke, mortality, and restenosis in patients undergoing CAS. METHODS All patients undergoing CAS for primary carotid stenosis from 2004 to 2009 were reviewed. The independent association of statins and perioperative morbidity was assessed using multivariable analysis. Survival curves and Cox regression models were used to assess late morbidity and restenosis. Propensity score adjustment was employed. RESULTS A total of 1083 consecutive CAS were performed (29% females, mean age 71.5 years; 24.7% symptomatic); 465 (43%) were on statins medication before treatment that was not discontinued at discharge. Statins use was associated with a reduction of perioperative stroke and death (odds ratio [OR] 0.327, 95% confidence interval [CI] 0.13-0.80, P = .016) according to multivariable analysis. Statins effect was more significant in reducing stroke and death in symptomatic patients (OR 0.13; P = .032) and in males (OR 0.27, P = .01). At 5 years, survival (87.2% vs 78.3%; P = .009) and ischemic stroke-free interval (88.9% vs 99.7%; P = .02) rates were higher in the statins group of patients. Adjusting for propensity score and covariates in Cox regression analyses, statins use was independently associated with reduced long-term mortality risk (HR 0.56, 95% CI 0.32-0.97; P = .039) and borderline associated with decreased late ischemic stroke risk (HR 0.14; 95% CI 0.018-1.08, P = .059). There was no effect on restenosis rates. CONCLUSIONS These data suggest that statins use is associated with decreased perioperative and late ischemic strokes risk and reduced mortality rates in patients undergoing CAS. Statins therapy should be considered part of the best medical treatment in current CAS practice.

Aortic neck evolution after endovascular repair with TriVascular Ovation stent graft

OBJECTIVE Aortic neck dilation has been reported after endovascular aneurysm repair (EVAR) with self-expanding devices. With a core laboratory analysis of morphologic changes, this study evaluated midterm results of aortic neck evolution after EVAR by endograft with no chronic outward force. METHODS This was a multicenter registry of all patients undergoing EVAR with the Ovation endograft (TriVascular, Santa Rosa, Calif). Inclusion criteria were at least 24 months of follow-up. Standard computed tomography (CT) scans were reviewed centrally using a dedicated software with multiplanar and volume reconstructions. Proximal aortic neck was segmented into zone A (suprarenal aorta/fixation area), zone B (infrarenal aorta, from lowest renal artery to the first polymer-filled ring), and zone C (infrarenal aorta, at level of the first polymer-filled ring/sealing zone). Images were analyzed for neck enlargement (≥2 mm), graft migration (≥3 mm), endoleak, barb detachment, neck bulging, and patency of the celiac trunk and superior mesenteric and renal arteries. RESULTS Inclusion criteria were met in 161 patients (mean age, 75.2 years; 92% male). During a mean follow-up period of 32 months (range, 24-50), 17 patients died (no abdominal aortic aneurysm-related death). Primary clinical success at 2 years was 95.1% (defined as absence of aneurysm-related death, type I or type III endoleak, graft infection or thrombosis, aneurysm expansion >5 mm, aneurysm rupture, or conversion to open repair). Assisted primary clinical success was 100%. CT scan images at a minimum follow-up of 2 years were available in 89 cases. Patency of visceral arteries at the level of suprarenal fixation (zone A) was 100%. Neither graft migration nor barb detachment or neck bulging was observed. None of the patients had significant neck enlargement. The mean change in the diameter was 0.18 ± 0.22 mm at zone A, -0.32 ± 0.87 mm at zone B, and -0.06 ± 0.97 mm at zone C. Changes at zone B correlated significantly with changes at zone C (correlation coefficient, 0.183; P = .05), whereas no correlation was found with zone A (correlation coefficient, 0.000; P = 1.0). CONCLUSIONS No aortic neck dilation occurred in this series at CT scan after a minimum 24-month follow-up. This may suggest that aortic neck evolution is not associated with EVAR at midterm follow-up when an endograft with no chronic outward radial force is implanted.

Abdominal Aortic Endografting Beyond the Trials: A 15-Year Single-Center Experience Comparing Newer to Older Generation Stent-Grafts

Purpose To evaluate the late results of endovascular aneurysm repair (EVAR) with the endografts currently in use and compare outcomes to older devices. Methods Clinical, demographic, and imaging data on consecutive patients undergoing elective EVAR from January 1997 to December 2011 at a single center were retrieved from an electronic database and reviewed. Newer stent-grafts (NSG) were defined as those introduced after 2004 (second-generation Excluder and Anaconda) or currently in use without modifications (Zenith, Endurant). Of the 1412 consecutive patients (1290 men; mean age 73 years) who underwent elective EVAR in a tertiary university hospital, 882 were treated with NSGs and 530 with older stent-grafts (OSGs). Results In the NSG group, the abdominal aortic aneurysms (AAA) were larger (55.7 vs. 53.2 mm, p<0.0001) and the patients were older (p<0.0001) and less frequently smokers or had pulmonary disease, while hypertension and diabetes were more frequent (all p<0.0001). Thirty-day mortality was 0.8% in the NSG group vs. 1.1% in the OSG group (p=NS). Follow-up ranged from 1 to 174 months (mean 54.1±42.4); the OSG patients had longer mean follow-up compared to the NSG group (80.2±47.9 vs. 38.4±29.1 months, p<0.0001). All-cause survival rates were comparable in both groups. Freedom from late conversion (96.1% vs. 89.1% at 7 years, p<0.0001) or reintervention (83.6% vs. 74.2% at 7 years, p=0.015) and freedom from AAA diameter growth >5 mm (p=0.022) were higher in the NSG group. In adjusted analyses, the use of a new-generation device was a negative independent predictor of reintervention [hazard ratio (HR) 0.67, 95% confidence interval (CI) 0.49 to 0.93, p=0.015] and aneurysm growth (HR 0.63, 95% CI 0.45 to 0.89, p=0.010). Conclusion Newer-generation endografts can perform substantially better than the older devices. In the long term, incidences of reintervention, conversion, and AAA growth are decreased in patients treated with devices currently in use. However, the need for continuous surveillance is still imperative for all endografts.

Diabetes is not a predictor of outcome for carotid revascularization with stenting as it may be for carotid endarterectomy

BACKGROUND Diabetes is prevalent in most patients undergoing carotid revascularization and is suggested as a marker of poor outcome after carotid endarterectomy (CEA). Data on outcome of diabetic patients undergoing carotid artery stenting (CAS) are limited. The aim of this study was to investigate early and 6-year outcomes of diabetic patients undergoing carotid revascularization with CAS and CEA. METHODS The database of patients undergoing carotid revascularization for primary carotid stenosis was queried from 2001 to 2009. Diabetic patients were defined as those with established diagnosis and/or receiving oral hypoglycemic or insulin therapy. Multivariate and Kaplan- Meier analyses, stratified by type of treatment, were performed on perioperative (30 days) and late outcomes. RESULTS A total of 2196 procedures, 1116 by CEA and 1080 by CAS (29% female, mean age 71.3 years), were reviewed. Diabetes was prevalent in 630 (28.7%). Diabetic patients were younger (P < .0001) and frequently had hypertension (P = .018) or coronary disease (P = .019). Perioperative stroke/death rate was 2.7% (17/630) in diabetic patients vs 2.3% (36/1566) in nondiabetic, (P = .64); the rate was 3.4% in diabetic CEA group and 2.1% in diabetic CAS group (P = .46). At multivariate analyses, diabetes was a predictor of perioperative stroke/death in the CEA group (odds ratio [OR], 2.83; 95% confidence interval [CI], 1.05-7.61; P = .04) but not in the CAS group (P = .72). Six-year survival was 76.0% in diabetics and 80.8% in nondiabetics (P = .15). Six-year late stroke estimates were 3.2% in diabetic and 4.6% in nondiabetic patients (P = .90). The 6-year risk of restenosis was similar (4.6% % vs 4.2%) in diabetic and nondiabetic patients (P = .56). Survival, late stroke, and restenosis rates between diabetics and nondiabetics were similar in CAS and CEA groups. CONCLUSIONS Diabetic patients are not at greater risk of perioperative morbidity and mortality or late stroke after CAS, however, the perioperative risk can be higher after CEA. This may help in selecting the appropriate technique for carotid revascularization in patients best suited for the type of procedure.

Safety of Chronic Anticoagulation Therapy After Endovascular Abdominal Aneurysm Repair (EVAR)

OBJECTIVE Current data supporting the effect of anticoagulation drug use on aneurysm sealing and the durability of endovascular abdominal aneurysm repair (EVAR) are conflicting. This study assessed the safety of chronic anticoagulation therapy after EVAR. METHODS Records of 1409 consecutive patients having elective EVAR during 1997-2011 who were prospectively followed were reviewed. Survival, reintervention, conversion, and endoleak rates were analyzed in patients with and without chronic anticoagulants. Cox proportional hazards models were used to estimate the effect of anticoagulation therapy on outcomes. RESULTS One-hundred and three (7.3%) patients were on chronic anticoagulation drugs (80 on vitamin K antagonists) at the time of EVAR. An additional 46 patients started on anticoagulants after repair were identified. Patients on chronic anticoagulation therapy at repair (mean age 73.6 years; 91 males) had more frequent cardiac disease (74.8% vs. 44.2%; p < 00001), but no other differences in demographic and major baseline comorbidities with respect to the others. At baseline, mean abdominal aortic aneurysm (AAA) diameter was 56.43 mm vs. 54.65 mm (p = .076) and aortic neck length 26.54 mm vs. 25.21 mm (p = .26) in patients with and without anticoagulants, respectively. At 5 years, freedom from endoleak rates were 55.5% vs. 69.9% (p < .0001), and freedom from reintervention/conversion rates were 69.4% vs. 82.4% (p < .0001) in patients with (including those with delayed drug use) and without chronic anticoagulants, respectively. Controlling for covariates with the Cox regression method, at a mean follow-up of 64.3 ± 45.2 months after EVAR, use of anticoagulation drugs was independently associated with an increased risk of endoleak (odds ratio, OR 1.6; 95% confidence interval, CI: 1.23-2.07; p < .0001) and reintervention or late conversion rates (OR 1.8; 95% CI: 1.31-2.48; p < .0001). CONCLUSIONS The safety of anticoagulation therapy after EVAR is debatable. Chronic anticoagulation drug use risks exposure to a poor long-term outcome. A critical and balanced decision-making approach should be applied to patients with AAA and cardiac disease who may require prolonged anticoagulation treatment.

Midterm results of proximal aneurysm sealing with the ovation stent-graft according to On-vs off-label use

Purpose: To compare the use of the Ovation stent-graft according to the ≥7-mm neck length specified by the original instructions for use (IFU) vs those treated off-label (OL) for necks <7 mm long. Methods: A multicenter retrospective registry (TriVascular Ovation Italian Study) database of all patients who underwent endovascular aneurysm repair with the Ovation endograft at 13 centers in Italy was interrogated to identify patients with a minimum computed tomography (CT) follow-up of 24 months, retrieving records on 89 patients (mean age 76.4±2.4 years; 84 men) with a mean follow-up of 32 months (range 24–50). Standard CT scans (preoperative, 1-month postoperative, and latest follow-up) were reviewed by an independent core laboratory for morphological changes. For analysis, patients were stratified into 2 groups based on proximal neck length ≥7 mm (IFU group, n=57) or <7 mm (OL group, n=32). Outcome measures included freedom from type Ia endoleak, any device-related reintervention, migration, and neck enlargement (>2 mm). Results: At 3 years, there was no aneurysm-related death, rupture, stent-graft migration, or neck enlargement. There were no differences in terms of freedom from type Ia endoleak (98.2% IFU vs 96.8% OL, p=0.6; hazard ratio [HR] 0.55, 95% CI 0.02 to 9.71 or freedom from any device-related reintervention (92.8% IFU vs 96.4% OL, p=0.4; HR 2.42, 95% CI 0.34 to 12.99). In the sealing zone, the mean change in diameters was −0.05±0.8 mm in the IFU group and −0.1±0.5 mm in the OL group. Conclusion: Use of the Ovation stent-graft in patients with neck length <7 mm achieved midterm outcomes similar to patients with ≥7-mm-long necks. These midterm data show that the use of the Ovation system for the treatment of infrarenal abdominal aortic aneurysm is not restricted by the conventional measurement of aortic neck length, affirming the recent Food and Drug Administration–approved changes to the IFU.

Paradoxical pulmonary embolism with spontaneous aortocaval fistula.

BACKGROUND Paradoxical pulmonary embolisms are uncommon emergencies and can occur as a consequence of an aortocaval fistula due to unrecognized dislodgement of thrombus from aortic sac into pulmonary circulation. This study reviewed current literature and therapeutic options in this emergency condition requiring prompt management and repair. METHODS Literature was systematically searched for paradoxical pulmonary embolism associated with aortocaval rupture. RESULTS Eight published cases were identified. However, many other paradoxical pulmonary emboli could have remained undiagnosed due to challenging clinical presentation. Symptoms of high-output cardiac failure and respiratory distress in the presence of large aortoiliac aneurysm and venous hypertension are findings of a possible major abdominal arteriovenous fistula with paradoxical pulmonary embolism. Successful treatment depends on prevention of new embolism and proper management of perioperative hemodynamics and massive bleeding during fistula repair. Endovascular procedures have been recently used as useful tools in this field. Cava filter placement may be a first step to prevent further thrombus dislodgements during aortocaval repair. Immediate subsequent aortic stent-grafting can allow repair of aortocaval communication and exclusion of the abdominal aortic aneurysm from circulation with successful reversal of altered hemodynamic features. However, experience (especially in the long-term) is limited. CONCLUSIONS Paradoxical pulmonary embolism from aortocaval fistula represents an extremely rare but true clinical emergency with high fatality rate. Recent advances in diagnostic technology and endovascular techniques can substantially improve outcomes of the disease. Clinical competence in early detection and diagnosis is essential for appropriate emergent management.

Results of aberrant right subclavian artery aneurysm repair

OBJECTIVE The objective of this multicenter registry was to review current treatments and late results of repair of aneurysm of aberrant right subclavian artery (AARSA). METHODS All consecutive AARSA repairs from 2006 to 2013 in seven centers were reviewed. End points were 30-day and late mortality, reintervention rate, and AARSA-related death. RESULTS Twenty-one AARSA repairs were included (57% men; mean age, 67 years); 3 ruptures (14%) required emergent treatment; 12 (57%) were symptomatic for dysphagia (33%), dysphonia (24%), or pain (19%). Eight cases (38%) presented with thoracic aortic aneurysm, two with intramural hematoma, and one with acute type B aortic dissection. Mean AARSA diameter was 4.2 cm; a single bicarotid common trunk was present in 38% of cases. The majority of patients underwent hybrid intervention (n = 15; 71%) consisting of single (n = 2) or bilateral (n = 12) subclavian to carotid transposition or bypass or ascending aorta to subclavian bypass (n = 1) plus thoracic endovascular aortic repair (TEVAR); 19% of cases underwent open repair and 9% simple TEVAR with AARSA overstenting. Perioperative death occurred in two patients (9%): in one case after TEVAR in ruptured AARSA, requiring secondary sternotomy and aortic banding; and in an elective case due to multiorgan failure after a hybrid procedure. Median follow-up was 30 (interquartile range, 15-46) months. The Kaplan-Meier estimate of survival at 36 months was 90% (standard error, 0.64). Late AARSA-related death in one case was due to AARSA-esophageal fistula presenting with continuing backflow from distal AARSA and previous TEVAR. At computed tomography controls, one type I endoleak and one type II endoleak were detected; the latter required reintervention by aneurysm wrapping and ligature of collaterals. AARSA-related death was more frequent after TEVAR, a procedure reserved for ruptures, compared with elective open or hybrid repair. CONCLUSIONS Hybrid repair is the preferred therapeutic option for patients presenting with AARSA. Midterm results show high rates of clinical success with low risk of reintervention. Simple endografting presents high risk of related death; these findings underline the importance of achieving complete sealing to avoid treatment failures.

Fourteen-year outcomes of abdominal aortic endovascular repair with the Zenith stent graft

Objective: Long‐term results of abdominal aortic aneurysm (AAA) endovascular repair are affected by graft design renewals that tend to improve the performance of older generation prostheses but usually reset the follow‐up times to zero. The present study investigated the long‐term outcomes of endovascular AAA repair (EVAR) using the Zenith graft, still in use without major modification, in a single center experience. Methods: Between 2000 and 2011, 610 patients underwent elective EVAR using the Zenith endograft (Cook Inc, Bloomington, Ind) and represent the study group. Primary outcomes were overall survival, freedom from AAA rupture, and freedom from AAA‐related death. Secondary outcomes included freedom from late (>30 days) reintervention, freedom from late (>30 days) conversion to open repair, freedom from aneurysm sac enlargement >5.0 mm and freedom from EVAR failure, defined as a composite of AAA‐related death, AAA rupture, AAA growth >5 mm, and any reintervention. Results: Mean age was 73.2 years. Mean aneurysm diameter was 55.3 mm. There were five perioperative deaths (0.8%) and three intraoperative conversions. At a mean follow‐up of 99.2 (range, 0‐175) months, seven AAA ruptures occurred, all fatal except one. Overall survival was 92.8% ± 1.1% at 1 year, 70.1% ± 1.9% at 5 years, 37.8% ± 2.9% at 10 years, and 24 ± 4% at 14 years. Freedom from AAA‐rupture was 99.8% ± 0.02 at 1 year (one case), 99.4% ± 0.04 at 5 years (three cases), and 98.1% ± 0.07 at 10 and 14 years. Freedom from late reintervention and conversion was 98% ± 0.6 at 1 year, 87.7% ± 1.5 at 5 years, 75.7% ± 3.2 at 10 years, and 69.9% ± 5.2 at 14 years. Freedom from aneurysm sac growth >5.0 mm was 99.8% at 1 year, 96.6% ± 0.7 at 5 years, 81.0% ± 3.4 at 10 years, and 74.1% ± 5.8% at 14 years. EVAR failure occurred in 132 (21.6%) patients at 14 years. At multivariate analysis, independent predictors of EVAR failure resulted type I and III endoleak (hazard ratio [HR], 6.7; 95% confidence interval [CI], 4.6‐ 9.7; P < .001], type II endoleak (HR, 2.3; 95% CI, 1.6‐3.4; P < .001), and American Society of Anesthesiologists grade 4 (HR, 1.6; 95% CI, 1.0‐2.6; P = .034). Conclusions: EVAR with Zenith graft represents a safe and durable repair. Risk of rupture and aneurysm‐related death is low, whereas overall long‐term survival remains poor. Novel endograft models should be tested and evaluated considering that one‐fourth of the operated patients will still be alive after 14 years.