Domenico G. Tealdi

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.

Dual Antiplatelet Regime Versus Acetyl-acetic Acid for Carotid Artery Stenting

Carotid artery stenting has been proposed as an option treatment of carotid artery stenosis. The aim of this single-institution study is to compare the dual-antiplatelet treatment and heparin combined with acetyl-acetic acid, in patients who underwent carotid artery stenting. We compared 2 groups of 50 patents each who underwent carotid artery stenting for primary atherosclerotic disease. Group A received heparin for 24 h combined with 325 mg acetyl-acetic acid and group B received 250 mg ticlopidine twice a day combined with 325 mg acetyl-acetic acid. Outcome measurements included 30-day bleeding and neurological complications and 30-day thrombosis/occlusion rates. The neurological complications were 16% in group A and 2% in group B (p < 0.05). Bleeding complications occurred in 4% in group A and 2% in group B (p > 0.05). The 30-day thrombosis/occlusion rate was 2% in group A and 0% in group B (p > 0.05). Dual antiplatelet treatment is recommended in all patients undergoing carotid artery stenting.

Endovascular Techniques for the Treatment of Ruptured Abdominal Aortic Aneurysms: 7-year Intention-to-treat Results

ObjectivesThe purpose of this single-institution study was to describe our 7-year intention-to-treat results, obtained with the use of endovascular techniques for the treatment of ruptured abdominal aortic aneurysms (rAAA).Patients and MethodsFrom October 1998 until March 2005, a total of 28 patients were admitted or transferred to our department with an rAAA. They were all treated according to a management protocol of intention-to-treat with endovascular techniques. Twenty of the patients received endovascular treatment and the remaining 8 underwent an open surgery procedure.ResultsThe mortality rate of the endovascularly treated patients was 40% (8 in 20), whereas of the 8 surgical patients 3 survived (mortality = 62.5%). The overall mortality rate of the 28 patients admitted with an rAAA was 46.4% (13 of 28 patients).ConclusionsIn our experience the intension-to-treat protocol for rAAA offered acceptable results in terms of mortality rates. Multi-center studies are necessary to establish the role of endovascular treatment in patients with rAAA.

Aortic Neck Dilatation and Endograft Migration are Correlated with Self-Expanding Endografts:

Purpose: To compare self-expanding and balloon-expandable stent-grafts in terms of aortic neck dilatation and endograft migration. Method: Two-hundred and forty-two patients (178 men; mean age 68 years, range 56–91) underwent elective endovascular repair of abdominal aortic aneurysm. Two-hundred self-expanding (115 Excluder, 48 Endologix, 23 Vanguard, 10 Anaconda, and 4 Talent) and 42 balloon-expandable (Lifepath) endografts were used. All patients underwent contrast-enhanced computed tomography (CT) prior to the intervention, at 1, 3, and 6 months after the procedure, and annually thereafter. Comparison was made between the first and the last followup CT scans. Results: Fifty-five (27.5%) of the 200 patients treated with self-expanding endografts had aortic neck dilatation compared to only 3 (7.1%) of the 42 patients treated with balloon-expandable endografts (p=0.023). Forty-nine (24.5%) patients in the self-expanding group versus only 3 (7.1%) patients of the balloon-expandable group presented with endograft migration (p=0.034); all had dilated necks. The difference between the means of neck dilatation for the Lifepath balloon-expandable stent-graft and the Excluder self-expanding endoprosthesis was statistically significant (p=0.011, 95% CI 0.07 to 0.91). Conclusion: Aortic neck dilatation following endovascular AAA repair appears to be correlated with self-expanding endografts, which may contribute to a higher incidence of graft migration compared to that occurring with balloon-expandable endografts.

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.

Final operative and midterm results of the European experience in the RELAY Endovascular Registry for Thoracic Disease (RESTORE) study

PURPOSE Thoracic endovascular aortic repair is increasingly becoming the standard treatment of many thoracic aortic pathologies. New reliable and accurate stent grafts are emerging to widen the endovascular treatment options. We report the results of RELAY (Bolton Medical, Barcelona, Spain) in the large RELAY Endovascular Registry for Thoracic Disease (RESTORE) European registry. METHODS RESTORE is a multicenter, prospective European registry involving 22 centers in seven European countries. The RELAY device is composed of a stent graft (self-expanding nitinol stents and a polyester vascular graft) and a delivery device specifically designed for the thoracic aorta. Included were acute and elective patients presenting with a variety of pathologies (aneurysms, dissections, ulcerations, intramural hematomas, pseudoaneurysms) and lesions in different aortic and anatomic locations (ascending, arch, descending and thoracoabdominal). RESULTS The registry enrolled 304 patients from April 2005 to January 2009. All-cause mortality at 30 days was 7.2%. Freedom from all cause mortality and freedom from device- and procedure-related mortality at 2 years were 78.5% and 95.9%, respectively. An average of 1.26 graft components were used per patient, with a technical success of 97.7% irrespective of the etiology. Early endoleak rate was 4.6%. Perioperatively, stroke and paraplegia were registered in 1.6% and 2.0%, respectively. CONCLUSIONS The results of RESTORE support the safety of thoracic endovascular aortic repair with the RELAY stent graft, even in acute and complicated situations. The device was highly efficient in angulated aortic anatomies, with acceptable mortality and a low rate of neurologic complications.

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.

Late Gastrointestinal Bleeding After Infrarenal Aortic Grafting: A 16-Year Experience

PurposeTo review the manifestation and management of gastrointestinal (GI) bleeding caused by secondary aortoenteric fistula (AEF) after infrarenal aortic grafting.MethodsBetween 1991 and 2006, nine patients underwent emergency treatment for secondary AEF localized in the duodenum (78%), ileum (11%), or sigmoid colon (11%). Three (33%) patients suffered hypovolemic shock. There were two (22%) real fistulas and seven (78%) paraprosthetic fistulas. Graft infection was confirmed in four (45%) patients and four (45%) had proximal sterile pseudoaneurysms. Surgical management consisted of graft removal with (n = 5) or without simultaneous extra-anatomic bypass (n = 1), in situ Dacron graft interposition (n = 3), ileo-duodenorrhaphy (n = 8), sigmoidectomy with colostomy (n = 1), and segmentary ileectomy (n = 1). Endografting was used only as a temporary measure to control bleeding in two patients.ResultsThe mortality rate was 55% (n = 5). There were no intraoperative deaths, but 75% of the septic patients, 66% of those with preoperative hemodynamic instability, 50% of those with pseudoaneurysms, and 100% of those who required bowel resection died during the early postoperative period. Moreover, all of the surviving patients suffered early postoperative morbidity, resulting in prolonged intensive care unit stay and hospitalization.ConclusionsSecondary AEF is life-threatening, difficult to treat, and associated with high morbidity and mortality, especially in patients with sepsis or hemodynamic instability and those requiring bowel resection.

Endovascular Treatment of the Carotid Stump Syndrome

In patients with an occluded internal carotid artery, the carotid stump syndrome is a potential source of microemboli that pass through the ipsilateral external carotid artery and the ophthalmic artery to the territory of the middle cerebral artery. Thus, the syndrome is associated with carotid territory symptoms although the internal carotid artery is occluded. Surgical exclusion of the internal carotid artery associated with endarterectomy of the external carotid artery has been described as the gold standard of treatment by many authors. This report is the second case, to our knowledge, of endovascular treatment of the carotid stump syndrome with the use of a stent-graft.

Evaluation of inflammatory status of atherosclerotic carotid plaque before thromboendarterectomy using delayed contrast-enhanced subtracted images after magnetic resonance angiography

OBJECTIVE To investigate the correlation among carotid plaque contrast enhancement (CPCE) at MRI, inflammatory cell infiltration (ICI) at histopathology, and carotid stenosis degree. MATERIALS AND METHODS Twenty-eight patients (19 males; mean age 67±9 years) scheduled for thromboendarterectomy prospectively underwent 1.5-T MR imaging using: (a) axial T1-weighted gradient-echo (T1wGRE) sequence centered on carotid bifurcations; (b) contrast-enhanced MR angiography (CE-MRA) with 0.1 mmol/kg of gadobenate dimeglumine; (c) enhanced axial T1wGRE sequence as in (a), 3 min after contrast injection. A three-point score system (absent, focal, wide) was used to assess CPCE on native and subtracted MRI images (c minus a) and ICI at histopathology. Carotid stenosis degree was determined on CE-MRA. RESULTS Six CPCE studies were discarded due to patient movement. In the remaining 22 studies, CPCE was absent, focal and wide in 13, 6 and 3 cases, respectively; ICI was absent, focal and wide in 13, 7 and 2 cases, respectively (k=0.57). On CE-MRA 21/28 stenoses were severe and 7/28 moderate. There was no correlation either with ICI (p=1.000, n=28) or CPCE (p=0.747, n=22). CONCLUSION The correlation between CPCE and ICI suggests a role for CPCE as an independent marker of plaque inflammation.