Nicola Mangialardi

Endovascular Repair of Acute Uncomplicated Aortic Type B Dissection Promotes Aortic Remodelling: 1 Year Results of the ADSORB Trial

OBJECTIVES Uncomplicated acute type B aortic dissection (AD) treated conservatively has a 10% 30-day mortality and up to 25% need intervention within 4 years. In complicated AD, stent grafts have been encouraging. The aim of the present prospective randomised trial was to compare best medical treatment (BMT) with BMT and Gore TAG stent graft in patients with uncomplicated AD. The primary endpoint was a combination of incomplete/no false lumen thrombosis, aortic dilatation, or aortic rupture at 1 year. METHODS The AD history had to be less than 14 days, and exclusion criteria were rupture, impending rupture, malperfusion. Of the 61 patients randomised, 80% were DeBakey type IIIB. RESULTS Thirty-one patients were randomised to the BMT group and 30 to the BMT+TAG group. Mean age was 63 years for both groups. The left subclavian artery was completely covered in 47% and in part in 17% of the cases. During the first 30 days, no deaths occurred in either group, but there were three crossovers from the BMT to the BMT+TAG group, all due to progression of disease within 1 week. There were two withdrawals from the BMT+TAG group. At the 1-year follow up there had been another two failures in the BMT group: one malperfusion and one aneurysm formation (p = .056 for all). One death occurred in the BMT+TAG group. For the overall endpoint BMT+TAG was significantly different from BMT only (p < .001). Incomplete false lumen thrombosis, was found in 13 (43%) of the TAG+BMT group and 30 (97%) of the BMT group (p < .001). The false lumen reduced in size in the BMT+TAG group (p < .001) whereas in the BMT group it increased. The true lumen increased in the BMT+TAG (p < .001) whereas in the BMT group it remained unchanged. The overall transverse diameter was the same at the beginning and after 1 year in the BMT group (42.1 mm), but in the BMT+TAG it decreased (38.8 mm; p = .062). CONCLUSIONS Uncomplicated AD can be safely treated with the Gore TAG device. Remodelling with thrombosis of the false lumen and reduction of its diameter is induced by the stent graft, but long term results are needed.

Use of the Parodi anti-embolism system in carotid stenting: Italian trial results.

PURPOSE To investigate the safety and efficacy of the Parodi anti-embolism system (PAES) in establishing flow reversal in the internal carotid artery (ICA) as a means of protecting against embolic phenomena during carotid stenting. METHODS Seven centers participated in a nonrandomized, prospective trial of carotid angioplasty and stenting under PAES protection in 30 patients (22 men; mean age 72 years, range 49-88) with 15 symptomatic (>70%) and 15 asymptomatic (>80%) stenotic ICAs. Safety was defined as achieving sufficient brain oxygenation during flow reversal as determined by level of awareness and motor control. The presence of new or enhanced neurological deficits and death were endpoints. Performance was based on angiographic evidence of successful retrograde flow. RESULTS The PAES was positioned in all 30 patients, but technical error and access-related difficulties prevented establishment of reversed flow in 2. Among the 28 (93%) patients treated under PAES protection, 1 patient developed aphasia after flow reversal, necessitating balloon deflation between subsequent stages of the procedure. Three other adverse events included 1 case of bradycardia and 2 cases of hypotension, with dysarthria and facial paresis in one and temporary loss of consciousness in the other. All events resolved with appropriate therapy, and there was no change from baseline in the neurological status or brain scans at 24 hours. There were no strokes or neurological deficits at 30 days. CONCLUSIONS The PAES appears to be a safe and effective means of providing protection from embolic complications during carotid stenting.

Chimney Technique for Aortic Arch Pathologies: An 11-Year Single-Center Experience

Purpose To report our single-center experience with the chimney technique for aortic arch pathologies and the mid- to long-term results in these patients. Methods From June 2002 to May 2013, 26 patients (18 men; mean age 71.2 years, 53–86) underwent thoracic endovascular aortic repair (TEVAR) combined with chimney technique. Indications for treatment were: a proximal landing zone <15 mm long distal to the left subclavian artery (LSA), thoracic aortic aneurysm (n=13), complicated type B aortic dissection (n=10), type I endoleak after previous TEVAR (n=2), and penetrating aortic ulcer (n=1). Treatment was performed in the emergency setting in 7 cases. The 28 chimney stent-grafts (double chimneys in 2 patients) were deployed in the innominate artery (n=7), left common carotid artery (n=10), and LSA (n=11). All patients underwent computed tomography before discharge, at 1, 6, and 12 months, and yearly thereafter. Results Technical success was 100%. One (3.8%) perioperative death was due to a cerebral hemorrhage. No major stroke was registered, but 3 (11.5%) minor strokes occurred (all resolved). Paraparesis developed in 2 (7.7%) patients. Median follow-up was 36.8 months (range 1–131), during which an additional 4 (15.4%) patients died, but only 1 death was aneurysm-related. Chimney graft patency was 89.3% (25/28); an asymptomatic fracture was found in a patent chimney stent-graft at the 18-month follow-up. The type I endoleak rate was 23% (n=6); 3 endoleaks associated with aneurysm sac enlargement were treated. Conclusion The chimney technique for aortic arch pathologies is safe and feasible and may be an option in patients considered at high risk for surgery or who are ineligible for conventional TEVAR, especially in the emergency setting. Concern persists regarding type I endoleak, and long-term follow-up remains mandatory.

Endovascular treatment of patients with types A and B thoracic aortic dissection using Relay thoracic stent-grafts: results from the RESTORE Patient Registry.

Purpose To evaluate the safety and performance of Relay stent-grafts in patients with acute or chronic aortic dissections. Methods Patients with types A or B aortic dissections suitable for treatment with Relay stent-grafts and followed for 2 years after thoracic endovascular aortic repair (TEVAR) were identified from a company-sponsored registry database established in January 2006. Ninety-one consecutive patients (69 men; mean age 65 years) underwent TEVAR with Relay stent-grafts for dissection. Most patients (76, 84%) had type B dissections; 61 of all patients were classified as chronic and 30 as acute. Results The technical success rate was 95% (97% in acute, 95% in chronic, and 93% in type B dissections). The type I endoleak rate was 7% (7% in acute and 8% in chronic dissections); all occurred in patients with type B dissections. Paraplegia, paraparesis, and stroke occurred in 4, 1, and 2 patients, respectively; 2 cases of paraplegia occurred in patients with acute type B dissections. Thirty-day mortality was 8% (13% in acute and 5% in chronic dissections); all deaths occurred in patients with type B dissections. The 2-year survival rate was 82% in the overall population and 84% in patients with type B dissections. Conclusion The combination of Relays features, such as stent conformability, radial force, atraumatic design, and controlled deployment and fixation, may contribute to the safety of the Relay stent-grafts for the treatment of thoracic aortic dissections, including acute and chronic type B dissections.

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.

A 12-Year Experience With Chimney and Periscope Grafts for Treatment of Type I Endoleaks.

Purpose: To evaluate the midterm outcomes of chimney and/or periscope grafts (CPGs) in patients presenting type I endoleak after a previous endovascular aneurysm repair (EVAR). Methods: Between June 2002 and April 2014, 24 consecutive patients (mean age 73.9±9.2 years; 23 men) presenting a type I endoleak were addressed with CPGs to extend the proximal and/or distal landing zone and to maintain side branch perfusion. Indication for treatment was a type Ia endoleak in 23 (96%) patients and a type Ib endoleak in one. Median interval from the previous EVAR to endoleak treatment with CPGs was 52.2±48.9 months (range 0.2–179). All patients had proximal/distal landing zones precluding any standard endovascular reintervention. Measured outcomes included technical success and perioperative mortality and morbidity. Technical success was defined as a procedure completed as intended, with no secondary procedures within 30 days. Midterm outcomes included survival, CPG patency, endoleaks, and freedom from reintervention. Results: Technical success was 96%; a single patient required an additional procedure to seal a recurrent type Ia endoleak. Intraoperative revascularization of all 55 target vessels (2.3/patient) with CPGs was successful. One (4%) patient died within 30 days. Estimated survival at 12, 24, and 36 months was 83%; estimated CPG patency at the same intervals was 94%. Over a mean follow-up of 23.4±29 months, 6 (25%) reinterventions were performed; of these, 4 were secondary to type I endoleak. Aneurysm diameters reduced from 88.3±26 to 85.5±33 mm (p=0.49) over the mean follow-up. Conclusion: The CPG technique is a safe and effective tool for treatment of type I endoleak after previous EVAR. The CPG technique is feasible even in nonelective patients, with excellent outcomes in terms of patency. Close imaging follow-up is warranted to rule out recurrent or de novo endoleaks.

Endovascular repair of traumatic thoracic aortic injury: final results from the relay endovascular registry for thoracic disease.

BACKGROUND In blunt thoracic aortic injury, thoracic endovascular aortic repair (TEVAR) offers a less invasive alternative to open chest surgery. New reliable and accurate stent grafts have widened the endovascular treatment options. We report our experience with the Relay stent graft Bolton Medical, Sunrise, FL; Barcelona, Spain) for treatment of this injury. METHODS Relay Endovascular Registry for Thoracic Disease (RESTORE) is a multicenter, prospective European registry, which enrolled patients treated with the Relay stent graft for thoracic aortic diseases from April 2005 to January 2009. Regular follow-up examinations were conducted for up to 24 months. This paper analyzes the cohort of patients treated for traumatic aortic injury. RESULTS Forty adult trauma patients from 12 European centers underwent TEVAR. Mean age was 40 years and 34 patients were male. The proximal landing zone involved aortic arch zones 1 to 2 in 40% and zone 3 in 55% of procedures. Technical success was achieved in all cases. One (2.5%) patient suffered a rupture of the iliac artery. No patient developed procedure-related paraplegia or required conversion to open surgery. Follow-up imaging demonstrated complete exclusion of the traumatic tear and regression of the false aneurysms without endoleak or graft infolding. One late device-related complication was reported; penetration of the distal end of the stent graft treated by stent-graft extension. Thirty-day mortality was 2.5 % (n = 1), and late mortality 2.5% due to a secondary accident. Actuarial 2-year survival was 93.7%. CONCLUSIONS Thoracic endovascular aortic repair with the Relay stent graft is a safe and effective treatment for patients with traumatic aortic injury.

Predictors of aortic growth in uncomplicated type B aortic dissection from the Acute Dissection Stent Grafting or Best Medical Treatment (ADSORB) database.

Background: The high‐risk patient cohort of uncomplicated type B aortic dissections (uTBADs) needs to be clarified. We compared uTBAD patients treated with best medical treatment (BMT), with and without aortic growth, from the Acute Dissection Stent Grafting or Best Medical Treatment (ADSORB) trial database. Furthermore, we looked for trends in outcome for aortic growth and remodeling after BMT and thoracic endovascular aortic repair (TEVAR) and BMT (TEVAR+BMT). Methods: BMT patients with available baseline and a 1‐year follow‐up arterial computed tomography scan were identified. True lumen and false lumen diameter was assessed at baseline and at follow‐up. Patients with false lumen growth (group I) and without false lumen growth (group II) were compared. Predictors of false lumen and total lumen (aortic) growth were identified. Lastly, BMT outcomes were compared with BMT+TEVAR for false lumen thrombosis and change in false lumen and total aortic diameter in four sections: 0 to 10 cm (A), 10 to 20 cm (B), 20 to 30 cm (C), and 30 to 40 cm (D) from the left subclavian artery. Results: The dissection was significantly longer in group I than in group II (43.2 ± 4.9 cm vs 30.4 ± 8.8 cm; P = .002). The number of vessels originating from the false lumen at baseline was identified as an independent predictor of false lumen growth (odds ratio, 22.1; 95% confidence interval, 1.01–481.5; P = .049). Increasing age was a negative predictor of total aortic diameter growth (odds ratio, 0.902; 95% confidence interval, 0.813–1.00; P = .0502). The proximal sections A and B showed complete thrombosis in 80.6% in the BMT+TEVAR group compared with 9.5% in the BMT group. In these sections, changes from patent to partial or partial to complete thrombosis were observed in 90.3% of the TEVAR+BMT group vs 31.0% in the BMT group. In sections C and D, the change in thrombosis was 74.1% for the TEVAR+BMT group vs 20.6% for the BMT group. The false lumen diameter increase at section C was larger in the BMT group. Total lumen diameter decreased in sections A and B in the TEVAR+BMT group compared with an increase in the BMT group (–4.8 mm vs +2.9 mm, and –1.5 mm vs +3.8 mm, respectively). Sections C and D showed minimal and comparable expansion in both treatment groups. Conclusions: The new imaging analysis of the ADSORB trial patients identified the number of vessels originating from the false lumen as an independent predictor of false lumen growth in uTBAD patients. Increasing age was a negative predictor of aortic growth. Our analysis may help to identify which uTBAD patients are at higher risk and should receive TEVAR or be monitored closely during follow‐up.

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.

Outcomes of 1000 Carotid Wallstent Implantations: Single-Center Experience.

Purpose: To evaluate the outcomes of carotid artery stenting (CAS) with Wallstents in a single-center experience. Methods: From January 2003 to December 2013, 1000 carotid artery lesions were treated with Carotid Wallstents under cerebral protection in 877 patients (mean age 71.7±8 years; 621 men). Indications for treatment were de novo lesions (>70% asymptomatic and >60% symptomatic); stenoses following carotid endarterectomy, radiation, or neck surgery; contralateral laryngeal nerve palsy; and high surgical risk. All the patients underwent duplex ultrasound and clinical evaluation during follow-up; radiography was performed when fracture or stent migration was suggested by ultrasound. Results: Procedure success was achieved in 99.3% of patients. Major and minor 30-day adverse events occurred in 2.1% of patients, including stroke (1.8%: 1.3% minor, 0.5% major), myocardial infarction (0.1%), and death (0.2%). Plaque morphology, nature of stenosis, and symptomatic status were significantly associated with the risk of postoperative neurologic events. Restenosis occurred in 3.2% at a mean 45.5-month follow-up and was significantly associated with diabetes, smoking, symptomatic stenosis, de novo stenosis, and calcification (plaque III/IV). No fracture or migration was registered during follow-up. Conclusion: CAS is a valid method for treating carotid artery disease, with very low rates of major adverse events and neurologic complications. The Carotid Wallstent seems to have excellent results, even with complex plaque morphology, and a low incidence of restenosis at follow-up.