Early results of a low-profile stent-graft for thoracic endovascular aortic repair

Purpose To assess outcomes of a low-profile thoracic stent-graft in the treatment of thoracic aortic pathologies. Methods A retrospective analysis of all consecutive patients with aortic thoracic pathologies treated with the RelayPro device in two university hospitals between October 2018 and July 2019. Results 23 patients (65% men; mean age 63.4 ± 15 years) were treated. Pathologies included aortic dissections (n = 10), 5 residual type A (22%) and 5 type B (22%), 6 degenerative aortic aneurysms (26%), 4 penetrating aortic ulcers (17%), and aortic erosion, intramural hematoma and aortic rupture (n = 1 and 4% in each case). Two cases (9%) were emergent and two urgent. Proximal landing was achieved in zones 0 (4%), 1 (4%), 2 (43%), and 3 (26%). Five grafts were frozen elephant trunk extensions. Technical success was 100% with accurate device deployment in the intended landing zone of the aortic arch in all 23 patients and with no Ia/III endoleaks and three (13%) type II endoleaks. Apposition was adequate in 96%. Two patients had post-implantation syndromes (one fever, one leukocytosis). Mean follow-up was 11.6 ± 3.7 months (range, 2–16) with no other complications, secondary interventions or conversions to open surgery. There was no 30-day mortality and no aortic-related mortality; all-cause mortality was 4% during follow-up. Conclusion A 3–4 French reduced profile in the current generation of stent-grafts facilitates TEVAR particularly in patients with smaller vessels access. Early safety and effectiveness outcomes are favorable, even in endpoints such as deployment accuracy and apposition which may be surrogates for longer-term clinical success and durability.

Download Full-text

Results From a Nationwide Registry on Scalloped Thoracic Stent-Grafts for Short Landing Zones

Journal of Endovascular Therapy ◽

10.1177/1526602816674942 ◽

2016 ◽

Vol 24 (1) ◽

pp. 97-106 ◽

Cited By ~ 14

Author(s):

Emma van der Weijde ◽

Olaf J. Bakker ◽

Ignace F. J. Tielliu ◽

Clark J. Zeebregts ◽

Robin H. Heijmen

Keyword(s):

Stent Graft ◽

Innominate Artery ◽

Celiac Trunk ◽

Stent Grafts ◽

Conversion To Open Surgery ◽

Landing Zone ◽

Early Results ◽

Aortic Pathology ◽

Custom Made

Purpose: To report the perioperative results and short-term follow-up of patients treated with scalloped thoracic stent-grafts. Methods: A multicenter registry in the Netherlands captured data on 30 patients (mean age 68 years; 17 men) with thoracic aortic pathology and a short (<20 mm) proximal or distal landing zone who received a custom-made scalloped stent-graft between January 2013 and February 2016. Patients were treated for saccular (n=13) aneurysms, fusiform (n=9) aneurysms, pseudoaneurysms (n=4), or chronic type B dissections (n=4). The scallop was used to preserve flow in the left subclavian artery (LSA) (n=17), left common carotid artery (n=5), innominate artery (n=1), and celiac trunk (n=7). In 7 (23%) patients, the scallop also included the adjacent artery. Results: Technical success was achieved in 28 (93%) patients. In 1 patient, a minor type Ia endoleak was observed intraoperatively, which was no longer visible on computed tomography angiography at 3 months. In another patient, the LSA was unintentionally obstructed due to migration of the stent-graft on deployment. Concomitant carotid-carotid or carotid-subclavian bypass was performed in 4 patients. There was no retrograde type A dissection or conversion to open surgery. In-hospital mortality was 3%, and the perioperative ischemic stroke rate was 3%. At a mean follow-up of 9.7 months (range <1 to 31), 29 of 30 target vessels were patent. Conclusion: The scalloped stent-graft appears to be a safe and relatively simple alternative for the treatment of thoracic aortic lesions with short landing zones. Larger patient series and long-term follow-up are required to confirm these early results.

Download Full-text

Aortic Arch and Descending Thoracic Aortic Aneurysms: Experience with Stent Grafting for Second-Stage “Elephant Trunk” Repair

Vascular ◽

10.1258/rsmvasc.13.1.5 ◽

2005 ◽

Vol 13 (1) ◽

pp. 5-10 ◽

Cited By ~ 23

Author(s):

Alfio Carroccio ◽

David Spielvogel ◽

Sharif H. Ellozy ◽

Robert A. Lookstein ◽

Iris Y. Chin ◽

...

Keyword(s):

Aortic Arch ◽

Stent Graft ◽

Clinical Success ◽

Perioperative Complications ◽

Aortic Aneurysms ◽

Elephant Trunk ◽

Stent Grafting ◽

Thoracic Aortic Aneurysms ◽

Second Stage ◽

Antegrade Approach

Reconstruction of aortic arch and descending thoracic aortic aneurysms (TAAs) is technically challenging and associated with significant morbidity and mortality. We report our experience with extensive TAAs using a two-stage “elephant trunk” repair, with the second stage completed using an endovascular stent graft (ESG). Over 6 years, 111 patients underwent ESG treatment of TAAs at Mount Sinai Medical Center. Twelve of these patients were referred for ESG placement for the second stage of elephant trunk reconstruction because comorbidities placed them at high risk of open surgical repair. Our database was analyzed for technical and clinical success and perioperative complications. The mean follow-up was 11.8 months (range 1–64 months). Twelve patients (five women and seven men) with a mean age of 69 ± 10 years underwent repair of their distal aortic arch and descending TAAs. These aneurysms included nine atherosclerotic aneurysms, one pseudoaneurysm, and two penetrating atherosclerotic ulcers. Three patients were symptomatic. Stent graft repair was technically successful in 91.7% or 11 of 12 patients. Excessive aortic arch tortuosity resulted in failure to deploy a stent graft in one patient. An antegrade approach through the open elephant trunk was used in two patients with severe iliac occlusive disease. Endoleaks (type 2) were identified in two patients with no aneurysm expansion; however, a 14 mm expansion over 1 year occurred in a patient with no identifiable endoleak. One early mortality occurred in a patient with a ruptured 6 cm infrarenal AAA after successful exclusion of the 8 cm TAA. Second-stage elephant trunk reconstruction of an extensive TAA using an ESG is effective in the short term. Its long-term durability remains to be determined.

Download Full-text

Endovascular Hybrid Repair of True Ascending Aortic Aneurysms Using Double Graft Wrapping to Prepare a Landing Zone for Ascending Aortic Stent-Graft Placement: A Cohort Study

Journal of Endovascular Therapy ◽

10.1177/1526602819856075 ◽

2019 ◽

Vol 26 (5) ◽

pp. 658-664 ◽

Cited By ~ 1

Author(s):

Ralf Kolvenbach ◽

Ron Karmeli ◽

Assaf Rabin ◽

Raluca Lica

Keyword(s):

Cardiopulmonary Bypass ◽

Stent Graft ◽

Ascending Aorta ◽

Hybrid Procedure ◽

Aortic Aneurysms ◽

Graft Placement ◽

Landing Zone ◽

Aortic Stent Graft ◽

Hybrid Repair

Purpose: To describe a hybrid procedure that avoids cardiopulmonary bypass to treat patients with true ascending aortic aneurysms without a suitable proximal landing zone for endovascular repair. Material and Methods: Thirteen consecutive patients (mean age 75.9±6.5 years; 8 women) with true ascending aortic aneurysms were treated with the endovascular hybrid repair of true aortic aneurysms (EHTA) approach, which consists of a conventional sternotomy with double wrapping of the ascending aorta followed by staged stent-graft placement. Via sternotomy, a polypropylene mesh trimmed to downsize the aneurysm is placed around the dilated ascending aorta and sutured to the adventitia. A similarly trimmed polytetrafluoroethylene graft is placed loosely around the first wrap to avoid adhesions and secure the proximal landing zone. There is no need for cardiopulmonary bypass. A few days later, a standard thoracic stent-graft is deployed via either a transaxillary or transfemoral access; chimney or bypass grafts are used as needed to revascularize the supra-aortic vessels. Results: The ascending aortic diameter was reduced from a mean 5.7 cm (range 4.8–6.5) to 3.9 cm (range 3.2–4.3) after wrapping. The mean interval between surgery and stent-graft placement was 5 days. In this interval, 2 patients with significant reduction in the diameter of the ascending aorta elected to forego placement of a stent-graft. Of the 11 patients who underwent the full hybrid EHTA procedure, the ascending aortic stent-graft was combined with a chimney graft in the innominate artery in 4 cases. In 1 patient, a supra-aortic debranching procedure using a bifurcated Dacron graft to the innominate and left common carotid arteries was performed after wrapping with the polypropylene mesh. There was no mortality or neurological complication. A sternal wound infection required a prolonged hospital stay. At a mean follow-up of 13.8 months (range 3–24), there has been no death, type I endoleak, or sign of aneurysm enlargement on imaging. Conclusion: This technique permits complete endovascular exclusion of an ascending aortic aneurysm in a less invasive approach than standard open repair. Although this is only a small cohort of patients without long-term follow-up, it seems that this hybrid procedure is associated with low morbidity and mortality. It offers a beating-heart approach to treat true ascending aortic aneurysms in selected high-risk patients.

Download Full-text

Global Post-Market Clinical Follow-up of the Treovance Stent-Graft for Endovascular Aneurysm Repair: One-Year Results From the RATIONALE Registry

Journal of Endovascular Therapy ◽

10.1177/1526602818803939 ◽

2018 ◽

Vol 25 (6) ◽

pp. 726-734 ◽

Cited By ~ 4

Author(s):

Raman Uberoi ◽

Carlo Setacci ◽

Mario Lescan ◽

Antonio Lorido ◽

David Murray ◽

...

Keyword(s):

Stent Graft ◽

Clinical Performance ◽

Clinical Success ◽

Endovascular Aneurysm Repair ◽

Aortic Aneurysms ◽

Type I ◽

Technical Success ◽

Major Morbidity ◽

Aneurysm Repair

Purpose: To evaluate the safety and performance of the Treovance stent-graft. Methods: The global, multicenter RATIONALE registry ( ClinicalTrials.gov; identifier NCT03449875) prospectively enrolled 202 patients (mean age 73.0±7.8 years; 187 men) with abdominal aortic aneurysms (AAA) suitable for endovascular aneurysm repair (EVAR) using the Treovance. The composite primary safety endpoint was site-reported all-cause mortality and major morbidity. The primary efficacy outcome was clinical success. Further outcomes evaluated included technical success; stent-graft migration, patency, and integrity; endoleak; and aneurysm size changes. Results: Technical success was 96% (194/202); 8 patients had unresolved type I endoleaks at the end of the procedure. There was no 30-day mortality and 1% major morbidity (1 myocardial infarction and 1 bowel ischemia). Clinical success at 1 year was confirmed in 194 (96%) patients; 6 of 8 patients had new/persistent endoleaks and 2 had aneurysm expansion without identified endoleak. A total of 8 (4%) reinterventions were required during the mean 13.7±3.1 months of follow-up (median 12.8). At 1 year, the Kaplan-Meier estimate for freedom from reintervention was 95.6% (95% CI 91.4% to 97.8%). Other estimates were 95.5% (95% CI 91.7% to 97.6%) for freedom from endoleak type I/III and 97.4% (95% CI 94.2% to 98.9%) for freedom from aneurysm expansion. Thirteen (6.4%) patients died; no death was aneurysm related. Conclusion: The RATIONALE registry showed favorable safety and clinical performance of the Treovance stent-graft for the treatment of infrarenal AAAs in a real-world setting.

Download Full-text

Early experience shows rapid shrinking of abdominal aortic aneurysms after endovascular treatment with Anaconda® device

VASA ◽

10.1024/0301-1526.36.3.199 ◽

2007 ◽

Vol 36 (3) ◽

pp. 199-204 ◽

Cited By ~ 8

Author(s):

Stehr ◽

Schnitzbauer ◽

Steinbauer ◽

Töpel ◽

Pfister ◽

...

Keyword(s):

Endovascular Treatment ◽

Clinical Success ◽

Abdominal Aortic Aneurysms ◽

Aortic Aneurysms ◽

Infrarenal Aortic Aneurysm ◽

Early Results ◽

Abdominal Aortic ◽

Aneurysm Diameter ◽

Endovascular Device

Background: The Anaconda® prosthesis is a new endovascular device for abdominal aortic aneurysms repair. Aim of the study was to evaluate successful access to the arterial site, safety and efficacy of stent placement and fixation, assessment of endoleaks, patency of the graft due to twists, kinks or obstruction within the first 30 days after the procedure. Secondary objectives were the assessment of clinical success after 6 months due to graft patency and aneurysm exclusion without endoleak as well as the continuing clinical success without showing aneurysm expansion or any graft failure. Patients and methods: Between 2003 and 2006 a total of 14 patients with infrarenal aortic aneurysm (median diameter prior to endovascular treatment: 56.7 mm (range: 50 to 70 mm)) were treated with the Anaconda® endovascular device. 8 of these patients were treated in accordance to a prospective Phase II clinical study protocol (Anaconda ANA 004). 6 more patients received the same endovascular device after CE-certification. Results: Primary and secondary objectives were achieved in 12 of 14 patients after 6 months. In one patient insertion of the graft system was impossible due to kinking and circular calcification of the iliac arteries. Iliac access utilizing an alternative stent graft system (Cook, Zenith) was also unsuccessful. This patient underwent a conversion to open surgery and died. Another patient died 6 months after treatment unrelated to the procedure. A significant reduction of the median aneurysm diameter from 56.7 to 49.0 mm (range: 45 to 54 mm) was achieved after 6 months (p = 0.05). No endoleak was seen in the follow up. Conclusions: Early results show that he Anaconda® endovascular device for aneurysm repair is a safe and effective device for patients with suitable abdominal aortic aneurysms and proper distal access vessels which results in significant aneurysm diameter decrease and a low complication rate after 6 months of follow-up.

Download Full-text

Frozen Elephant Trunk in Aortic Arch Disease: Different Devices for Different Pathologies

Medicina ◽

10.3390/medicina57101090 ◽

2021 ◽

Vol 57 (10) ◽

pp. 1090

Author(s):

Carlo Mariani ◽

Giacomo Murana ◽

Alessandro Leone ◽

Luca Di Di Marco ◽

Davide Pacini

Keyword(s):

Aortic Arch ◽

Thoracic Aorta ◽

Stent Graft ◽

Intramural Hematoma ◽

Distal Anastomosis ◽

Frozen Elephant Trunk ◽

Descending Thoracic Aorta ◽

Elephant Trunk ◽

Remarkable Feature ◽

Early Results

The frozen elephant trunk technique (FET) requires the use of a pre-assembled hybrid prosthesis consisting of a standard Dacron vascular portion to replace the aortic arch and a stent graft component, which is placed into the proximal descending thoracic aorta (DTA) anterogradely in the proximal descending thoracic aorta. In Europe, two hybrid prostheses are available: the E-evita Open Plus hybrid stent graft system provided by JOTEC (Hechingen, Germany) and the ThoraflexTM Hybrid (Vascutek, Inchinnan Scotland). Recommendations for use are extensive pathologies of the arch in case of acute and chronic aortic dissection, degenerative aneurysm and intramural hematoma. The FET approach allows the replacement of the whole arch in one stage with the option of direct treatment of the proximal descending thoracic aorta based on the stent component, creating a safe landing zone for further endovascular treatment more distally. The remarkable feature of this technique is the possibility to perform more proximally (from zone 3 to zone 0) the distal anastomosis in to the arch. This allows for an easier distal anastomosis, reduced hypothermic circulatory arrest time and decreased risk of paraplegia (<5%). Early results are promising and according to the most recent series the rate of developing post-operative renal insufficiency ranges from 3 to 10%, the risk of stroke from 3% to 8% and mortality from 8–15%. The aim of the article will be to provide some knowledge about the use and application of FET procedures in different aortic situations.

Download Full-text

Hybrid repair of extensive thoracic aortic aneurysms

European Journal of Cardio-Thoracic Surgery ◽

10.1093/ejcts/ezaa178 ◽

2020 ◽

Vol 58 (5) ◽

pp. 940-948

Author(s):

Gabriele Piffaretti ◽

Santi Trimarchi ◽

Guido Gelpi ◽

Claudia Romagnoni ◽

Sandro Ferrarese ◽

...

Keyword(s):

Aortic Rupture ◽

Survival Rates ◽

Final Analysis ◽

Study Data ◽

Aortic Aneurysms ◽

Single Stage ◽

Two Stage ◽

Early Results ◽

Hybrid Repair

Abstract OBJECTIVES Our goal was to report the midterm results of hybrid treatment of extensive thoracic aortic aneurysm (ETAA) with the completion of thoracic endovascular aortic repair after proximal ascending-arch graft replacement. METHODS This was a multicentre, observational study. Data were collected prospectively between January 2002 and March 2019 and analysed retrospectively. Inclusion criteria for the final analysis were the treatment of elective or urgent ETAA performed in a single-stage or a planned two-stage approach. Early and late survival rates were the primary outcomes. RESULTS Indications for repair were degenerative ETAA in 27 (64.3%) patients and dissection-related ETAA in 15 (35.7%). The mean aortic diameter was 68 ± 16 mm (interquartile range 60–75). Five (11.9%) patients had a single-stage repair; and 37 underwent a two-stage approach. Three (7.1%) patients died in-hospital. The median follow-up was 49 months (range 0–204). During the follow-up period, 4 (9.5%) patients underwent aortic reintervention after a median of 32 months; however, no aortic rupture of the treated segment occurred. Overall, the estimated survival rate was 85% ± 6% [95% confidence interval (CI) 70.8–93] at 12 and 36 months and 69.5% ± 9% (95% CI 49.7–84) at 60 months. CONCLUSIONS Hybrid repair of ETAA had satisfactory early results in this cohort of patients. At the midterm follow-up, the aneurysm-related mortality rate was acceptable with the reconstruction proving to be durable and safe with few distal aortic events.

Download Full-text

Hybrid Endovascular Repair of Thoracoabdominal Aorta: Early Results

The Heart Surgery Forum ◽

10.1532/hsf98.2014315 ◽

2014 ◽

Vol 17 (3) ◽

pp. 146

Author(s):

Osman Tansel Darcin ◽

Mehmet Kalender ◽

Ayse Gul Kunt ◽

Okay Guven Karaca ◽

Ata Niyazi Ecevit ◽

...

Keyword(s):

Endovascular Repair ◽

Therapeutic Option ◽

Complete Recovery ◽

Aortic Aneurysms ◽

Thoracoabdominal Aorta ◽

Mortality And Morbidity ◽

Early Results ◽

The Mean ◽

Procedural Success

Background: Thoracoabdominal aortic aneurysms (TAAA) present a significant clinical challenge, as they are complex and require invasive surgery. In an attempt to prevent considerably high mortality and morbidity in open repair, hybrid endovascular repair has been developed by many authors. In this study, we evaluated the early-term results obtained from this procedure.Methods: From November 2010 to February 2013, we performed thoracoabdominal hybrid aortic repair in 18 patients. The mean age was 68 years (12 men, 6 women). All of the patients had significant comorbidities. Follow-up computed tomography (CT) scans were performed at 1 week, 3 months, 6 months, and annually thereafter.Results: All patients were operated on in a staged procedure and stent graft deployment was achieved. Procedural success was achieved in all cases. All patients were discharged with complete recovery. No endoleaks weres detected in further CT examination.Conclusion: Our results suggests that hybrid debranching and endovascular repair of extensive thoracoabdominal aneurysms represents a suitable therapeutic option to reduce the morbidity and mortality of TAAA repair, particularly in those typically considered at high risk for standard repair.

Download Full-text

Endovascular repair of de novo post-stenotic aortic coarctation aneurysms with complex collateral supply: two cases with long and medium term follow-up

CVIR Endovascular ◽

10.1186/s42155-020-00193-4 ◽

2021 ◽

Vol 4 (1) ◽

Author(s):

Omar Abdel-Hadi ◽

John Thomson ◽

Simon J. McPherson

Keyword(s):

Stent Graft ◽

Endovascular Repair ◽

Aortic Coarctation ◽

De Novo ◽

Aortic Aneurysms ◽

Medium Term ◽

First Case ◽

Case Presentations ◽

Selective Embolisation

Abstract Purpose To report the technical details and outcomes of the endovascular repair of two cases of de novo post-stenotic aortic coarctation aneurysms complicated by complex collateral supply. Case presentations Two patients with thoracic aortic aneurysms complicated by complex aneurysm sac collaterals distal to a previously untreated thoracic aortic coarctation have been treated at our institution. Open surgical intervention was deemed to carry a high risk of haemorrhage due to the degree and complexity of arterial collateralisation. In the first case, selective embolisation of collateral vasculature was performed prior to successful exclusion of the aneurysm with a thoracic endovascular stent-graft and then balloon-expandable stent dilatation of the coarctation stenosis. In the second case, the additional technique of using a jailed sheath within the aneurysm sac allowed for selective embolisation of previously inconspicuous collaterals after deployment of the stent-graft and stent combination. Results Technical success was achieved in both patients with successful occlusion of the aneurysm, with no recorded complications or aneurysm sac perfusion in the long and medium term follow up periods respectively. Conclusion De novo post stenotic aortic coarctation aneurysms are rare. Endovascular repair is a safe and durable technique that provides a less invasive alternative to open surgical repair. The use of a jailed sheath allows for complete selective embolisation of complex collaterals avoiding a type II aneurysm endoleak.

Download Full-text

The first commercial use of the Valiant Navion stent graft system for endovascular repair of a descending thoracic aortic aneurysm

Vascular ◽

10.1177/1708538120981127 ◽

2020 ◽

pp. 170853812098112

Author(s):

Cassra N Arbabi ◽

Navyash Gupta ◽

Ali Azizzadeh

Keyword(s):

Stent Graft ◽

Standard Of Care ◽

Aortic Aneurysms ◽

Descending Thoracic Aortic Aneurysm ◽

Thoracic Aortic Aneurysms ◽

Commercial Use ◽

Early Results ◽

Multiple Configuration ◽

One Year

Objectives Thoracic endovascular aortic repair (TEVAR) is the standard of care for descending thoracic aortic aneurysms (DTAA), and newer generation stent grafts have significant design improvements compared to earlier generation devices. Methods We report the first commercial use of the Medtronic Valiant Navion stent graft for treatment of an 85-year-old woman with a 5.8 cm DTAA and a highly tortuous thoracic aorta. Results A percutaneous TEVAR was performed using a two-piece combination of the Valiant Navion FreeFlo and CoveredSeal stent graft configurations for zones 2–5 coverage. The devices were successfully delievered through highly tortuous anatomy and deployed, excluding the entire length of the aneurysm with precise landing, excellent apposition and no evidence of endoleak. The patient tolerated the procedure well and has had no stent graft-related complications through one-year follow-up. Conclusions Design enhancements such as a lower profile delivery system, better conformability, and a shorter tapered tip are some of the improvements to this third-generation TEVAR device. Coupled with the multiple configuration options available, this gives physicians a better tool to treat thoracic aortic pathologies in patients with challenging anatomy. The early results are encouraging, and evaluation of long-term outcomes will continue.

Download Full-text