Endovascular Treatment Of Complicated Type Research Articles

Five-year results from the Study of Thoracic Aortic Type B Dissection Using Endoluminal Repair (STABLE I) study of endovascular treatment of complicated type B aortic dissection using a composite device design

ObjectiveWe report the final 5-year results from the Study of Thoracic Aortic Type B Dissection Using Endoluminal Repair (STABLE I) study, a prospective, single-arm, multicenter study of the Zenith Dissection Endovascular System (William Cook Europe, Aps, Bjaeverskov, Denmark), a pathology-specific device comprising a proximal stent graft with barbs and a distal bare stainless steel stent for the treatment of patients with complicated type B aortic dissection. MethodsThe study prospectively enrolled 86 patients (mean age, 59 years; 73% male) at sites in the United States, Europe, and Australia from 2007 to 2012. Treatment occurred during the acute phase (≤14 days after symptom onset) in 55 patients and during the nonacute phase (>14 days; all treated ≤90 days) in 31 patients. Five-year clinical and imaging follow-up was available for 88.5% of eligible patients. ResultsThe 30-day all-cause mortality rate was 5.5% (3 of 55) for acute and 3.2% (1 of 31) for nonacute patients (P > .99). The 5-year freedom from all-cause mortality was 79.9% ± 6.2% for acute and 70.1% ± 8.4% for nonacute patients (log-rank test, P = .40). The 5-year freedom from dissection-related mortality (including deaths of indeterminate relatedness to dissection repair) was 83.9% ± 5.9% for acute and 90.1% ± 5.9% for nonacute patients (log-rank test, P = .55). Complete false lumen thrombosis in the thoracic aorta increased over time and was observed in 74.1% of acute and in 58.8% of nonacute patients at 5 years. From preprocedure through 5 years, there was an overall increase in true lumen diameter and a concomitant decrease in false lumen diameter in both acute and nonacute patients at the level of the largest diameter in both the thoracic and abdominal aortas. At 5 years, 65.5% of acute and 81.3% of nonacute patients exhibited a stable or shrinking transaortic diameter in the thoracic aorta, and 48.3% of acute and 76.5% of nonacute patients had a stable or shrinking transaortic diameter in the abdominal aorta. Freedom from secondary intervention at 5 years was 65.5% ± 7.5% for acute and 71.2% ± 9.0% for nonacute patients (log-rank test, P = .71). ConclusionsEndovascular repair of complicated type B aortic dissection with a composite device design demonstrated low all-cause mortality at 30 days, as well as low dissection-related mortality throughout follow-up. Overall, the acute and nonacute cohorts appeared to respond similarly to treatment involving use of the stent-graft and bare metal stent, demonstrating similar clinical outcomes and favorable improvement in aortic remodeling in the thoracic and abdominal aortas.

VESS08. Five-Year Results From the STABLE I Study of Endovascular Treatment of Complicated Type B Aortic Dissection Using a Composite Device Design

VESS08. Five-Year Results From the STABLE I Study of Endovascular Treatment of Complicated Type B Aortic Dissection Using a Composite Device Design

Emergency endovascular treatment of complicated type B Acute dissection of the aorta

Abstract Although Type B dissection accounts for 25–40% of all aortic dissections, their treatment remains to date quite controversial. In acute complicated cases (visceral malperfusion, refractory pain, etc.), surgical treatment is generally recommended, but is still associated with a high rate of morbimortality. Implantation of endoprosthesis has been proposed as an alternative therapy for patients with high surgical risk. Reports support that endovascular stent-graft treatments of a complicated type B acute dissection produce a short and medium term satisfactory results.

Endovascular management of acute complicated type B aortic dissection: adjunct procedures

Background: This study aims to evaluate the results of endovascular treatment (TEVAR) and the contribution of adjunct procedures in acute complicated type B aortic dissections. Methods: Thirty patients (26 males, 4 females; mean age 55.2±14.7 years, range 24 to 86 years) with acute complicated type B dissection underwent endovascular treatment. The dissection was complicated by malperfusion in eight patients (26.7%), impending rupture in four (13.3%), uncontrollable hypertension in 12 (40%), and severe treatmentresistant pain in six (20%). Self-expanding stent-grafts (Talent® and Valiant®, Medtronic Inc.) were used. Ostium of the left subclavian artery was covered intentionally in 19 patients (63.3%). Additional stenting was necessary in eight patients (26.7%). Of a total of 12 bare metal stents used in these patients, stents were inserted in the renal arteries in six (20%), iliac arteries in three (10%), and celiac arteries in two (6.7%) patients. Median follow-up was 55 months (range, 25 to 99 months). Results: The mean number of stent-grafts implanted was 1.42 (range, 1 to 3). One patient had inadvertent partial closure of the left common carotid artery ostium due to proximal migration of the stent-graft which caused no early neurological complications. Right hemiplegia occurred 15 months later due to his discontinuation of the anticoagulant therapy in the same patient. In another patient with visceral malperfusion, early laparoscopic exploration following the stenting of the celiac and the left renal arteries revealed no ischemia of the bowels. One patient with postoperative angina pectoris required stenting of the right coronary artery. There was no stroke in any patients, while reversal of paraplegia was observed in one patient early after the procedure. The mean lengths of intensive care unit and hospital stays were 3.2±3.4 and 9.8±7.1 days, respectively. There was no 30-day mortality. The one-year survival rate was 96.7%. Conclusion: Although endovascular treatment of complicated type B aortic dissections has a high success rate, TEVAR may not be the sole solution. Findings of malperfusion should be carefully sought in the early postoperative period. The adjunct procedures such as stenting of the visceral arteries or open surgical revascularization should always be considered particularly in young patients.

Aortic remodeling after endovascular treatment of complicated type B aortic dissection with the use of a composite device design

The purpose of this study is to report updated clinical and aortic remodeling results from the Study for the Treatment of complicated Type B Aortic Dissection using Endoluminal repair (STABLE) trial, a prospective, multicenter study evaluating safety and effectiveness of a pathology-specific endovascular system (proximal stent graft and distal bare metal stent) for the treatment of complicated type B aortic dissection. All 86 enrolled patients (mean age, 59 years; 73.3% men) were treated within 90 days of symptom onset (55 with acute dissections and 31 with nonacute dissections). Inclusion criteria were branch vessel obstruction/compromise, impending rupture as evidenced by periaortic effusion/hematoma, resistant hypertension, persistent pain/symptoms, or aortic growth ≥5 mm within 3 months (or transaortic diameter ≥40 mm). Remodeling of the dissected aorta, including thrombosis of the false lumen and changes in the true lumen, false lumen, and transaortic diameter, were assessed in patients with available computed tomographic imaging through 2 years. The 30-day mortality rate was 4.7% (4/86) in the overall patient group (5.5% in acute patients and 3.2% in non-acute patients). Freedom from all-cause mortality was 88.3% at 1 year and 84.7% at 2 years (no significant difference between acute and nonacute patients). From baseline to 2 years, the true lumen diameter increased significantly in the descending thoracic aorta and the more distal abdominal aorta, along with a decrease in the false lumen diameter in both aortic segments. A majority of patients had either a stable or shrinking transaortic diameter in the thoracic (80.3% at 1 year and 73.9% at 2 years) or abdominal aorta (79.1% at 1 year and 66.7% at 2 years). Transaortic growth (>5 mm) occurred predominantly in acute dissections. Consistently, a shorter time from symptom onset to treatment was found to predict transaortic growth in the abdominal aorta (P = .03). Endovascular repair of complicated type B aortic dissection with the use of a composite construct demonstrates favorable early clinical outcomes and aortic remodeling. However, patients treated in the acute setting may be prone to aortic growth and may require close observation. Follow-up through 5 years is ongoing.

Medium-Term Results of Treatment for Complicated Acute Type B Dissection: A Spanish Experience in a Single Centre

Objective. To analyze and evaluate medium-term results obtained in endovascular treatment of complicated type B dissection. Methods. Prospective registry and retrospective analysis of the dissections treated with endoprosthesis in 1998 and 2010. Comorbidity, clinical presentation, anatomical characteristics, and evolution were recorded. Actuarial analysis was conducted for survival, follow-up and survival free of endoleaks, and free of reintervention due to relapse and/or progression. Results. Eighteen (18) patients were treated (14 male : 4 female), with a median age of 53 years (range 29–80). Their main symptoms were acute pain in 16 cases and hypertensive crisis in 15. The indications were 10 dissections not controlled by medication, 4 aneurysm dissecans, 2 acute lower limb ischemias, and 2 Type A progressions. Median 1.7 devices were used (range 1–4). Coverage of left subclavian artery was required in 3 cases, and of subclavian and left carotid artery in other 2 cases. There was a 100% technical success. Median follow-up was 43.1 months (1.5–127 range). There were two deaths caused by multiorganic failure, early mortality of 0%, and hospital mortality of 11%. There was a case of Type I Endoleak and 5 cases which required a new intervention due to relapse and/or progression. Cumulative survival at 30 months was 88%; follow-up free of endoleaks at 36 months was 91%. Follow-up free of progression/relapse at 12 months was 88%. Conclusion. Endovascular treatment of complicated type B acute dissection is an effective therapy for this condition, with a low associated mortality and with acceptable survival.

Morphologic Outcome after Endovascular Treatment of Complicated Type B Aortic Dissection

To investigate the long-term morphologic changes of the aorta after thoracic endovascular aortic repair (TEVAR) for acute complicated type B aortic dissection and to analyze whether these changes differed between DeBakey class IIIa and IIIb dissections. During the period 1999-2009, 58 patients with acute complicated type B aortic dissection were treated with TEVAR. Seven patients lacked follow-up data, leaving 51 patients-17 patients with DeBakey IIIa aortic dissection and 34 patients with DeBakey IIIa aortic dissection IIIb-for inclusion in the study. Computed tomography scans performed before and after TEVAR were evaluated. Maximum thoracic and abdominal aortic diameters and diameters of the true lumen and false lumen at the level of the maximum aortic diameter in the thorax and abdomen were analyzed as well as degree of thrombosis of the false lumen. There was an overall significant reduction of the thoracic aortic diameter, increased true lumen diameter, and reduced false lumen diameter (P < .05). Total thrombosis of the false lumen, with or without reintervention, was seen in 53% of all patients, in 41% primarily and in 12% after reintervention. The IIIa group had a higher degree of total false lumen thrombosis. All patients in the IIIb group had total thrombosis of the false lumen along the stent graft. Long-term follow-up showed favorable aortic remodeling after TEVAR for acute complicated type B aortic dissection. Total thrombosis of the false lumen occurred more often in patients with DeBakey IIIa aortic dissection compared with patients with DeBakey IIIb aortic dissection.

Aortic Remodeling After Endovascular Treatment of Complicated Type B Aortic Dissection Using a Composite Device Design: A Report from the STABLE Trial

Aortic Remodeling After Endovascular Treatment of Complicated Type B Aortic Dissection Using a Composite Device Design: A Report from the STABLE Trial

Persistent Type B Aortic Dissection Treatment by Renal Artery Reentry Stent Grafting as an Alternative to Open Surgery

Type B aortic dissections complicated by pain, malperfusion, or aneurysm expansion mandate surgical intervention. Success of this therapy is predicated on exclusion and thrombosis of the false lumen of the aneurysm. This report presents a case in which cessation of flow was achieved using a covered stent graft to close a renal reentry tear after a previous closing and overstenting of the main tear. This approach may provide a helpful adjunct to the endovascular treatment of complicated type B aortic dissections.

ADSORB: A Prospective Randomised Study on the Efficacy of Endovascular Grafting vs. Best Medical Treatment in Uncomplicated Acute Dissection of the Descending Aorta

Many of the arterial lesions that vascular surgeons treat are on the decline, and those that currently are may soon be offered more effective drug therapy. In contrast, dissections of the aorta are increasing and are likely to represent a significant future workload and challenge for vascular surgeons. Traditionally acute Stanford type B dissections of the aorta were managed by a variety of specialists, often cardiologists. Vascular surgeons only became involved where peripheral ischaemia supervened. Dake demonstrated the feasibility of placing endovascular stentgrafts in to dissected aortas. 1 This approach appeared to offer an attractive alternative to traditional open surgical approaches for complicated aortic dissection which carried high rates of complications. 2 Consequently stent-grafts have been used increasingly in this group of patients. 3 Early efforts to reduce mortality from acute type B dissection demonstrated that effective blood pressure control in the early stages reduced mortality. Medical therapy did not necessarily prevent long-term aortic related complications. The INSTEAD Trial attempted to answer the question whether there was any benefit from placing a stent-graft in type B aortic dissection in the subacute phase (2e52 weeks). 4 There was no reduction in aortic related mortality 2 years after the initial dissection but preliminary data from INSTEAD suggests that stent-grafting might be protective in the longer term (5 years). The next question is whether there would be any additional benefit (or harm) from stenting patients within the first 2 weeks of their initial uncomplicated type B dissection? There remains scope for improvement in the 10% in-hospital mortality when treated with medical therapy. 5 It is possible that stenting might reduce mortality. However, concerns remain (due in part to a lack of data) that stenting within the first 2 weeks may be associated with significant risks even when the aortic dissection is uncomplicated. It is for these reasons that we have been following the development of the ADSORB trial keenly since its inception in 2002. Recruitmenthasbeenslow,suggestingalackofclinicalequipoiseand the change of power calculation is regrettable but seems realistic if the triallists are to complete their study. It is a pity that the trial will not have the power to demonstrate significant differences in the more robustclinicalendpoints (aortic relatedorall-causemortality). It is not clear whether the primary trial composite endpoint of a variety of aortic related events (false lumen thrombosis, aortic dilatation >5 mm, aortic rupture) at 1-year will be a clinically relevant one for patients. In the INSTEAD Trial 20% of patients managed non-operativelyachievedfalselumenthrombosis.Itisquite possible that this group of patients receiving early stent-grafting in the ADSORBtrialmightnotderiveanybenefitatall(andmaybeharmed).

Prospective multicenter clinical trial (STABLE) on the endovascular treatment of complicated type B aortic dissection using a composite device design

This study evaluates the safety and effectiveness of a unique composite thoracic endovascular aneurysm repair (TEVAR) construct (proximal stent graft and distal bare metal stent) for the treatment of patients with complicated type B aortic dissection (cTBAD). In this prospective, single-arm, multicenter study, patients with cTBAD were treated with an endovascular system consisting of proximal TX2 thoracic stent grafts and distal bare metal dissection stents (Zenith Dissection Endovascular System; Cook Medical, Bloomington, Ind). Indications for enrollment were branch vessel malperfusion, impending rupture, aortic diameter ≥40 mm, rapid aortic expansion, and persistent pain or hypertension despite maximum medical therapy. One-year follow-up results, including clinical and radiographic (computerized tomography [CT] and X-ray) evaluation, were available for this report. Ten centers enrolled 40 patients (70% men; mean age 58 years old) between December 2007 and August 2009. The onset of symptoms was acute (≤14 days) in 24 patients (60%), subacute (15-30 days) in six patients (15%), and chronic (31-90 days) in 10 patients (25%); the overall mean time from symptom onset to treatment was 20 days (range, 0-78 days). A majority of patients (77.5%; 31 of 40 patients) presented with impending aortic rupture (indicated by periaortic effusion/hematoma) or branch vessel malperfusion. Seven combinations of stent grafts and dissection stents were used, and all devices were successfully deployed and patent. The 30-day mortality rate was 5% (2 of 40); two deaths occurred after 30 days, leading to a 1-year survival rate of 90%. Two deaths, occurring at 11 and 81 days postprocedure, respectively, were secondary to aortic rupture. Morbidity occurring within 30 days included stroke (7.5%), transient ischemic attack (2.5%), paraplegia (2.5%), retrograde progression of dissection (5%), and renal failure (12.5%). Additional morbidity after 30 days included one case of retrograde progression of dissection and one case of renal failure. None of the patients with renal failure became dialysis-dependent. Four patients (10%) underwent secondary interventions within 1 year. Favorable aortic remodeling was observed during the course of follow-up, indicated by an increase in the true lumen size and a concomitant decrease in the false lumen size along the dissected aorta, with completely thrombosed thoracic false lumen observed in 31% of patients at 12 months as compared to 0% at baseline. Initial data with a composite TEVAR construct have demonstrated favorable clinical and anatomic results. Continued enrollment and long-term data are needed to assess the overall effectiveness of this treatment strategy.

SS18. Endovascular Treatment of Complicated Type B Aortic Dissection Using a Composite Device Design: Initial Results of a Prospective Multicenter Clinical Trial (STABLE)

SS18. Endovascular Treatment of Complicated Type B Aortic Dissection Using a Composite Device Design: Initial Results of a Prospective Multicenter Clinical Trial (STABLE)

Coil-assisted false lumen thrombosis in complicated chronic type B dissection

Type B dissections complicated by pain, malperfusion, or aneurysm expansion mandate surgical intervention. Success of this therapy is predicated on exclusion and thrombosis of the false lumen of the aneurysm. We report a case where cessation of flow was achieved using covered stent grafts in conjunction with coil embolization of the false lumen. The introduction of coils into the false lumen is a novel approach and may provide a helpful adjunct in endovascular treatment of complicated type B aortic dissections.