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1.
J Endovasc Ther ; 30(5): 664-675, 2023 10.
Article in English | MEDLINE | ID: mdl-35674455

ABSTRACT

BACKGROUND-AIM: Several studies have been published showing conflicting results on the outcome after endovascular aneurysm sealing (EVAS). The aim of the present study is to conduct a systematic review and meta-analysis of published evidence to assess the efficacy of EVAS in the management of patients with abdominal aortic aneurysm (AAA). METHODS: An electronic search of the English medical literature, from 2010 to March 2021, was conducted using MEDLINE, EMBASE, and Cochrane databases to find studies relevant to outcome after EVAS. RESULTS: The final analysis included 12 articles published between 2011 and 2021, including 1440 patients. In total, 79.3% of the included patients underwent aneurysm treatment according to the instructions for use. Technical success was 98.8%. Overall, 30-day mortality was 1.3%. Procedure-related complications were reported in 4% of the cohort. During median follow-up of 28.1 months (range 9-72 months), the pooled estimate of endoleak type I, migration and reinterventions was 16% (95% confidence interval [CI]=7-25), 16% (95% CI=9-23), and 19% (95% CI=11-28), respectively. In a sub-analysis, 7 studies (703 patients) reported outcome with a mean follow-up of more than 2 years (range 24-72 months). In these studies, the pooled estimate of endoleak type I, migration, and reinterventions was 25% (95% CI=13-38), 22% (95% CI=19-26), and 27% (95% CI=21-33), respectively. CONCLUSION: Patients who have been treated with EVAS are in high risk for reintervention especially beyond 2 years following implantation. Close surveillance for patients treated with EVAS is mandatory.


Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Humans , Blood Vessel Prosthesis/adverse effects , Endoleak/etiology , Endoleak/therapy , Blood Vessel Prosthesis Implantation/adverse effects , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Aortic Aneurysm, Abdominal/complications , Treatment Outcome , Endovascular Procedures/adverse effects , Time Factors , Prosthesis Design , Stents/adverse effects
2.
Eur J Vasc Endovasc Surg ; 52(5): 621-634, 2016 Nov.
Article in English | MEDLINE | ID: mdl-27600731

ABSTRACT

AIM: The aim was to conduct a systematic review of the literature investigating outcomes after interruption or preservation of the internal iliac artery (IIA) during endovascular aneurysm repair (EVAR). METHODS: A systematic review was undertaken using the MEDLINE and EMBASE databases to identify studies reporting IIA management during EVAR. The search identified 57 articles: 30 reported on IIA interruption (1468 patients) and 27 on IIA preservation (816 patients). RESULTS: The pooled 30 day buttock claudication (BC) rate was 29.2% (95% CI 24.2-34.7). Patients undergoing bilateral IIA interruption had a higher incidence of BC than patients with unilateral IIA interruption (36.5% vs. 27.2%, OR 1.7, 95% CI 1.11-2.6, p = .01). During a median follow up of 17 months, the pooled rate of persistent BC was 20.5% (95% CI 15.7-26.2). Of the patients, 93.9% underwent an endovascular revascularization procedure for IIA preservation. Most patients (87.6%) had an iliac branched device, and technical success was 96.2%. Within 30 days of EVAR, 4.3% of internal iliac branches occluded. During a median follow up of 15 months, the pooled occlusion rate at the site of IIA revascularization was 8.8% (95% CI 6.8-11.3). In patients treated with an iliac-branched device, 5.2% of internal iliac branches and 1.7% of external iliac arteries occluded. The pooled BC rate on the side of the IIA revascularization during follow up was 4.1% (95% CI 2.9-5.9). Pooled rates of late device related endoleak type I or III and secondary procedures on the side of the previous IIA revascularization were 4.6% (95% CI 3.2-6.5) and 7.8% (95% CI 5.7-10.7) respectively. CONCLUSION: Unilateral or bilateral IIA occlusion during EVAR seems to carry a substantial risk of significant ischemic complications in nearly one quarter of patients. Bilateral IIA occlusion was related to a significantly higher rate of BC. IIA preservation techniques represent a significant improvement in the treatment of aorto-iliac aneurysms and have been associated with high technical success and low morbidity.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation , Buttocks/blood supply , Endovascular Procedures , Iliac Aneurysm/surgery , Iliac Artery/surgery , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/physiopathology , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Chi-Square Distribution , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Humans , Iliac Aneurysm/diagnostic imaging , Iliac Aneurysm/physiopathology , Iliac Artery/diagnostic imaging , Iliac Artery/physiopathology , Intermittent Claudication/etiology , Intermittent Claudication/physiopathology , Ischemia/etiology , Ischemia/physiopathology , Odds Ratio , Prosthesis Design , Regional Blood Flow , Risk Factors , Stents , Time Factors , Treatment Outcome
3.
Eur J Vasc Endovasc Surg ; 52(2): 141-8, 2016 Aug.
Article in English | MEDLINE | ID: mdl-27105550

ABSTRACT

OBJECTIVE/BACKGROUND: The objective was to investigate renal outcomes following endovascular repair of thoraco-abdominal aortic aneurysms (TAAA) comparing fenestrations with branches for the renal arteries. METHODS: Renal outcomes following TAAA endovascular repair performed with renal branches were collected from five high volume European centers and compared with renal outcomes following TAAA endovascular repair performed with renal fenestrations at one center. Renal re-intervention and occlusion rates, and freedom from any renal outcome and death were analyzed by patient and target vessel. Estimated glomerular filtration rate (eGFR) was calculated and collected pre-operatively and at the last available follow up. RESULTS: In total, 449 patients were included in this retrospective study (235 treated with branched devices [BEVAR] and 214 with fenestrated devices [FEVAR]). Altogether, 856 renal vessels were analyzed (445 perfused by branches and 411 by fenestrations). Both groups were comparable except for sex and smoking habits. Technical success rates were 95% and 99%, respectively. Mean ± SD follow up was 19 ± 18 months after BEVAR and 24 ± 20 months after FEVAR. During follow up, renal re-intervention rates were similar in both groups (4.7% vs. 5.2%). The renal occlusion rate was significantly higher following BEVAR (9.6% vs. 2.3%; p < .01), and the 2 year freedom for renal occlusion rate was 90.4% (SE 85.8-95.3%) following BEVAR and 97.1% (SE 94.6-99.7%) following FEVAR (p < .01). During follow up, a 12% median decrease in eGFR was observed following BEVAR versus 9% following FEVAR (non-significant). The 2 year survival rates were 73.4% (SE 66.6-80.9%) and 81.8% (SE 76.1-87.9%) following BEVAR and FEVAR, respectively. CONCLUSION: Mid-term renal outcomes following endovascular repair of TAAA are satisfactory. Endograft designs incorporating renal fenestrations rather than renal branches are associated with significantly lower occlusion rates. A prospective trial is now required to confirm these results.


Subject(s)
Aortic Aneurysm, Thoracic/surgery , Kidney/physiopathology , Renal Artery/surgery , Aged , Angioplasty/methods , Aortic Aneurysm, Thoracic/complications , Aortic Aneurysm, Thoracic/physiopathology , Blood Vessel Prosthesis , Female , Glomerular Filtration Rate , Humans , Kidney/blood supply , Male , Renal Artery Obstruction/etiology , Retrospective Studies , Stents , Treatment Outcome , Vascular Grafting/methods
4.
Eur J Vasc Endovasc Surg ; 51(4): 536-42, 2016 Apr.
Article in English | MEDLINE | ID: mdl-26916389

ABSTRACT

OBJECTIVES: The use of branched stent grafts for the treatment of thoracoabdominal aneurysms [TAAA] is increasing, but mating stent graft choice has not been studied. This study combined experience of five high volume centres to assess a preferred mating stent. METHODS: Data from five centres were retrospectively combined. Patients were included if they underwent stent graft for treatment of TAAA that used only branches to mate with visceral and renal vessels. All patients with fenestrations in their device were excluded. Perioperative details, reintervention, occlusion, and death were recorded. Outcome of occlusion or reintervention, as well as a composite outcome of any death, occlusion, or reintervention was planned using a per-patient, and per-branch analysis. RESULTS: In 235 included patients, there were 940 vessels available for placement of mating stent. The average age of included patients was 70 years (SD 7.9), and 179 of the 235 were male. Medical comorbidities included diabetes in 29/234 (12.4%), current smoker in 81/233 (34.8%), and COPD in 77/234 (32.9%). The primary stent deployed was self-expanding in 556 branches, balloon expandable in 231 branches, and was unknown in 92 branches. After a mean of 20.7 months (SD 25) follow-up, there have been 44 incidents of occlusion or reintervention, of which 40 culprit stents are known. Where the stent placed is known, the event rate in renal branches (35/437, 8%) is higher than that of visceral branches (8/443, 1.8%). There is no difference in occlusion or reintervention between self-expanding and balloon expandable stents (HR 0.95, p = .91) but there is a statistically significant difference between renal and visceral artery occlusions (HR 3.51, p = 0.001). CONCLUSION: There appears to be no difference in occlusion or reintervention rate for branch vessels mated with balloon expandable compared with self-expanding stents. Renal events appear to outnumber visceral events in this population.


Subject(s)
Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Stents , Aged , Aortic Aneurysm, Thoracic/diagnosis , Aortic Aneurysm, Thoracic/mortality , Aortic Aneurysm, Thoracic/physiopathology , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/mortality , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Europe , Female , Humans , Male , Middle Aged , Prosthesis Design , Retrospective Studies , Risk Factors , Time Factors , Treatment Outcome , Vascular Patency
5.
Eur J Vasc Endovasc Surg ; 51(6): 775-81, 2016 Jun.
Article in English | MEDLINE | ID: mdl-26860255

ABSTRACT

OBJECTIVES: The outcomes of fenestrated endovascular aneurysm repair (FEVAR) as a first line strategy is reported. METHODS: All consecutive patients treated with FEVAR for short neck, juxtarenal, or suprarenal aortic aneurysms under the guidance of the senior author within the period January 2010 to December 2014 were included. Data were collected from a prospectively maintained database. Analyzed outcomes included technical success, defined by successful stent graft implantation with patent stented target vessels and no Type I/III endoleak, operative mortality and morbidity, target vessel patency, endoleak, re-intervention, and death. Survival, target vessel stent patency, and re-intervention during follow up were calculated by Kaplan-Meier analysis. RESULTS: A total of 281 patients (245 male, mean age 72.1 ± 7.7 years) were treated. The mean aneurysm diameter was 60.2 ± 9.3 mm and median proximal neck length 2 mm (range 0-10 mm). Technical success was 96.8% (272/281). Technical failure included one intra-operative death due to embolization and cardiac arrest, one open conversion due to iliac rupture, and seven target vessel complications. The thirty day mortality was 0.7% (2/281). Mean follow up was 21 ± 15.9 months. Estimated survival at 1 and 3 years was 94.7% ± 1.6% and 84.6% ± 3.0%, respectively. Estimated freedom from re-intervention at 1 and 3 years was 96.1% ± 1.4%, and 90% ± 2.7%. Estimated target vessel stent patency at 1 and 3 years was 98.6% ± 0.5%, and 98.1% ± 0.6%, respectively. Mean aneurysm sac diameter decreased from 60.2 ± 9.3 mm pre-operatively to 53.2 ± 12.8 mm (p < .001). CONCLUSIONS: FEVAR as a first line strategy was associated with high technical success and a low operative mortality rate. Efficacy and durability in the mid-term appear very good, with significant regression of aneurysm sac diameter, high target vessel patency, and acceptable rate of re-intervention.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis , Endoleak/surgery , Prosthesis Design , Stents , Aged , Aged, 80 and over , Blood Vessel Prosthesis Implantation/methods , Endovascular Procedures/methods , Female , Humans , Male , Middle Aged , Plastic Surgery Procedures/methods , Treatment Outcome
7.
Acta Chir Belg ; 115(2): 162-5, 2015.
Article in English | MEDLINE | ID: mdl-26021952

ABSTRACT

Stent-graft migration and type I endoleak are major complications after endovascular aneurysm repair (EVAR). We present a case of an 88-year-old female patient with a 56-mm-diameter progredient infrarenal AAA, with severely angulated proximal aneurysm neck and iliac arteries. EVAR was performed using a Gore Excluder stent-graft. -Computed tomography angiography (CTA) at one week postoperatively demonstrated a dislocation of the stent-graft and a proximal Type I endoleak. Placement of a proximal cuff with the use of 6 endostaples resulted in proximal neck seal and exclusion of the endoleak. CTA 2 years postoperatively showed no signs of a proximal type I endoleak. Use of an endostapling fixation system is a viable treatment option in cases of stent-graft dislocation resulting from angulation of the proximal neck.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/methods , Endoleak/surgery , Endovascular Procedures/adverse effects , Prosthesis Failure/adverse effects , Surgical Stapling , Aged, 80 and over , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/adverse effects , Endoleak/diagnosis , Endoleak/etiology , Female , Humans , Stents
8.
J Cardiovasc Surg (Torino) ; 56(3): 375-81, 2015 Jun.
Article in English | MEDLINE | ID: mdl-25644825

ABSTRACT

AIM: The aim of this paper was to report a 5-year single center experience with the use of percutaneous endovascular thrombosuction (PET) for acute lower limb ischemia (ALLI). METHODS: All patients that underwent PET for ALLI within the period January 2009-December 2013 in our institution were included. Data were collected retrospectively. RESULTS: A total of 262 patients (132 female, mean age 74.5±11 years) were treated. Level of severity of ALLI preoperatively was stratified as class I (viable) in 76% (199/262) of patients, class IIa (threatened marginally) in 19.4% (51/262), and class IIb (threatened immediately) in 4.6% (12/262). Initial technical success was 91% (237/262). Additional PTA was performed in 29.8% (78/262) of patients, and PTA with stenting in 27.5% (72/262). Open surgery due to technical failure of PET was required in 4.2% (11/262) of patients. Thirty-day mortality was 4.6% (12/262). Perioperative complications occurred in 9.2% (24/262). Thirty-day amputation rate was 3.8% (10/262). The mean duration of follow-up was 26.2±16 months. Estimated cumulative survival was 84.2±2.5% at 1 year, and 73.7±3.6% at 3 years. Estimated freedom from amputation during follow-up was 92.4±1.8% at 1 year, and 91.2±2% at 3 years. Estimated freedom from reintervention was 90.4±2% at 1 year, and 80±3.7% at 3 years. CONCLUSION: PET in selected patients with ALLI provides high initial technical success, low mortality and morbidity rates, and favorable early and mid-term limb salvage rates.


Subject(s)
Endovascular Procedures/methods , Ischemia/therapy , Lower Extremity/blood supply , Peripheral Arterial Disease/therapy , Thrombectomy/methods , Aged , Aged, 80 and over , Amputation, Surgical , Disease-Free Survival , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Female , Germany , Humans , Ischemia/diagnosis , Ischemia/mortality , Kaplan-Meier Estimate , Limb Salvage , Male , Middle Aged , Patient Selection , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/mortality , Retrospective Studies , Risk Assessment , Risk Factors , Severity of Illness Index , Suction , Thrombectomy/adverse effects , Thrombectomy/mortality , Time Factors , Treatment Outcome
10.
Eur J Vasc Endovasc Surg ; 49(5): 524-31, 2015 May.
Article in English | MEDLINE | ID: mdl-25599593

ABSTRACT

OBJECTIVE: To present a 10 year experience with endovascular thoracoabdominal aortic aneurysm (TAAA) repair using fenestrated and branched stent grafts. MATERIALS AND METHODS: Consecutive patients with TAAA treated with fenestrated and branched stent grafts within the period January 2004-December 2013. Data were collected prospectively. RESULTS: 166 patients (125 male, 41 female, mean age 68.8 ± 7.6 years) were treated. The mean TAAA diameter was 71 ± 9.3 mm. Types of TAAA were: type I, n = 12 (7.2%), type II, n = 50 (30.1%), type III, n = 53 (31.9%), type IV, n = 41 (24.8%), and type V, n = 10 (6%). Fifteen (9%) patients had an acute TAAA (11 contained rupture, 4 symptomatic). One hundred and eight (65%) patients were refused for open surgery earlier. Seventy eight (47%) patients had previously undergone one or more open/endovascular aortic procedures. Technical success was 95% (157/166). Thirty day operative mortality was 7.8% (13/166), with an in hospital mortality of 9% (15/166). Peri-operative spinal cord ischemia (SCI) was observed in 15 patients (9%), including permanent paraplegia in two (1.2%). Mean follow up was 29.2 ± 21 months. During follow up 40 patients died, two of them probably from aneurysm related cause. Re-intervention, mostly by endovascular means, was needed in 40 (24%) patients. Estimated survival at 1, 2, and 5 years was 83% ± 3%, 78% ± 3.5%, and 66.6% ± 6.1%, respectively. Estimated target vessel stent patency at 1, 2, and 5 years was 98% ± 0.6%, 97% ± 0.8%, and 94.2% ± 1.5%, respectively. Estimated freedom from re-intervention at 1 and 3 years was 88.3% ± 2.7%, and 78.4% ± 4.5%, respectively. CONCLUSIONS: Endovascular repair of TAAA with fenestrated and branched stent grafts in high volume centers appears safe and effective in the mid-term in a high risk patient cohort. A considerable reintervention rate should be acknowledged, however.


Subject(s)
Aortic Aneurysm, Thoracic/mortality , Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis Implantation/mortality , Postoperative Complications/mortality , Stents , Adult , Aged , Aged, 80 and over , Endovascular Procedures/methods , Female , Hospital Mortality/trends , Humans , Male , Middle Aged , Treatment Outcome , Vascular Patency/physiology
11.
J Cardiovasc Surg (Torino) ; 56(2): 249-55, 2015 Apr.
Article in English | MEDLINE | ID: mdl-25512317

ABSTRACT

Currently, there are a variety of open surgical, endovascular, and hybrid options to treat iliac artery aneurysms (IAA). Anatomy of the common iliac artery (CIA) with regard to proximal and distal neck, involvement of the iliac bifurcation, and choice to preserve the ipsilateral internal iliac artery (IIA) all play a role in the decision process towards the preferred treatment method. This manuscript describes the available open surgical and endovascular techniques for the treatment of IAA. Indications, advantages and limitations, and outcomes of each technique are discussed.


Subject(s)
Blood Vessel Prosthesis Implantation , Endovascular Procedures , Iliac Aneurysm/surgery , Iliac Artery/surgery , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Humans , Iliac Aneurysm/diagnosis , Iliac Aneurysm/physiopathology , Iliac Artery/diagnostic imaging , Iliac Artery/physiopathology , Prosthesis Design , Radiography , Regional Blood Flow , Stents , Treatment Outcome
12.
J Cardiovasc Surg (Torino) ; 56(3): 363-8, 2015 Jun.
Article in English | MEDLINE | ID: mdl-25519514

ABSTRACT

Effective proximal sealing, especially in the long-term, remains a limitation of contemporary endovascular aortic aneurysm repair (EVAR). Endostaples that fixate the proximal stent-graft to the aortic neck wall, aiming for better apposition and proximal sealing have been recently introduced in clinical practice to address this problem. Initial experimental studies have shown that endostaples can increase proximal stent-graft fixation to levels equivalent or superior to that of a hand-sewn anastomosis. Further clinical studies aimed to investigate whether this increased proximal fixation results in reduced migration and better sealing with lower rates of type I endoleak. The present chapter discusses the efficacy of endostaples in reducing migration and type I endoleak after EVAR, based on published clinical data.


Subject(s)
Aortic Aneurysm/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endoleak/prevention & control , Endovascular Procedures/instrumentation , Foreign-Body Migration/prevention & control , Stents , Surgical Stapling/instrumentation , Sutures , Animals , Aortic Aneurysm/diagnosis , Aortography/methods , Blood Vessel Prosthesis Implantation/adverse effects , Endoleak/diagnosis , Endoleak/etiology , Endovascular Procedures/adverse effects , Foreign-Body Migration/diagnosis , Foreign-Body Migration/etiology , Humans , Prosthesis Design , Risk Factors , Surgical Stapling/adverse effects , Tomography, X-Ray Computed , Treatment Outcome
13.
Eur J Vasc Endovasc Surg ; 48(6): 641-8, 2014 Dec.
Article in English | MEDLINE | ID: mdl-25176618

ABSTRACT

OBJECTIVES: Fenestrated/branched thoracic endovascular repair (F/Br-TEVAR) is increasingly applied for atherosclerotic thoracoabdominal aortic aneurysm (TAAA); however, use in post-dissection TAAAs is still very limited. Experience with F/Br-TEVAR in the treatment of post-dissection TAAA is presented. METHODS: Data were analysed from prospectively maintained databases including all patients with post-dissection TAAAs that underwent F/Br-TEVAR within the period January 2010 to July 2013 in two vascular institutions. Evaluated outcomes included initial technical success, operative mortality and morbidity, late survival, endoleak, aneurysm diameter regression, renal function, and reintervention during follow-up (FU). RESULTS: A total of 31 patients (25 male, mean age 65 ± 11.4 years) were treated. Technical success was 93.5% and 30-day mortality 9.6%. Temporary spinal cord ischaemia occurred in four (12.6%) patients, with no case of permanent paraplegia. Mean FU was 17.0 ± 10 months. There were seven late deaths, all aneurysm unrelated. Estimated overall survival rates were 83.9 ± 6.7, 76.4 ± 7.9 and 71.6 ± 8.7% at 6, 12, and 18 months, respectively. Impairment of renal function occurred in two (6.4%) patients. Endoleaks were diagnosed in 12 patients during FU, including six type IB endoleaks and six type II endoleaks. Reintervention was required in seven (22.5%) patients. Mean aneurysm sac regression was 9.3 ± 8.7 mm, with a false lumen thrombosis rate of 66.7% and 88.2% for patients with a FU longer than 6 and 12 months respectively. CONCLUSIONS: F/Br-EVAR is feasible for patients with a post-dissection TAAA. Although associated with additional technical challenges, and a significant need for reintervention, it leads to favourable aneurysm morphologic changes, and may play a more prominent role in the future for this type of pathology if long-term results confirm the good initial outcome.


Subject(s)
Aortic Aneurysm, Thoracic/surgery , Aortic Dissection/surgery , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Aged , Aged, 80 and over , Aortic Dissection/diagnosis , Aortic Dissection/mortality , Aortic Aneurysm, Thoracic/diagnosis , Aortic Aneurysm, Thoracic/mortality , Aortography/methods , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis Implantation/mortality , Databases, Factual , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Endovascular Procedures/mortality , Feasibility Studies , Female , Germany , Hospital Mortality , Hospitals, High-Volume , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Patient Selection , Postoperative Complications/mortality , Postoperative Complications/surgery , Reoperation , Risk Factors , Stents , Time Factors , Tomography, X-Ray Computed , Treatment Outcome
15.
Eur J Vasc Endovasc Surg ; 48(2): 131-7, 2014 Aug.
Article in English | MEDLINE | ID: mdl-24878234

ABSTRACT

OBJECTIVES: The European C3 module of the Global Registry for Endovascular Aortic Treatment (GREAT) provides "real-world" outcomes for the new C3 Gore Excluder stent-graft, and evaluates the new deployment mechanism. This report presents the 1-year results from 400 patients enrolled in this registry. METHODS: Between August 2010 and December 2012, 400 patients (86.8% male, mean age 73.9 ± 7.8 years) from 13 European sites were enrolled in this registry. Patient demographics, treatment indication, case planning, operative details including repositioning and technical results, and clinical outcome were analyzed. RESULTS: Technical success was achieved in 396/400 (99%) patients. Two patients needed intraoperative open conversion, one for iliac rupture, the second because the stent-graft was pulled down during a cross-over catheterization in an angulated anatomy. Two patients required an unplanned chimney renal stent to treat partial coverage of the left renal artery because of upward displacement of the stent-graft. Graft repositioning occurred in 192/399 (48.1%) patients, most frequently for level readjustment with regard to the renal arteries, and less commonly for contralateral gate reorientation. Final intended position of the stent-graft below the renal arteries was achieved in 96.2% of patients. Thirty-day mortality was two (0.5%) patients. Early reintervention (≤30 days) was required in two (0.5%) patients. Mean follow-up duration was 15.9 ± 8.8 months (range 0-37 months). Late reintervention (>30 days) was required in 26 (6.5%) patients. Estimated freedom from reintervention at 1 year was 95.2% (95% CI 92.3-97%), and at 2 years 91.5% (95% CI 86.8-94.5%). Estimated patient survival at 1 year was 96% (95% CI 93.3-97.6%) and at 2 years 90.6% (95% CI 85.6-93.9%). CONCLUSIONS: Early real-world experience shows that the new C3 delivery system offers advantages in terms of device repositioning resulting in high deployment accuracy. Longer follow-up is required to confirm that this high deployment accuracy results in improved long-term durability.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Stents , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/mortality , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/mortality , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Europe , Female , Humans , Kaplan-Meier Estimate , Male , Postoperative Complications/mortality , Postoperative Complications/surgery , Prosthesis Design , Registries , Reoperation , Risk Factors , Time Factors , Treatment Outcome
16.
J Cardiovasc Surg (Torino) ; 55(2 Suppl 1): 95-103, 2014 Apr.
Article in English | MEDLINE | ID: mdl-24796902

ABSTRACT

AIM: Aim of the study was to review our experience with fenestrated and branched stent-grafts to treat juxtarenal (JAA) and thoracoabdominal (TAAA) aortic aneurysms after previous open or endovascular aortic surgery. METHODS: A prospectively maintained database including all consecutive patients with JAA or TAAA treated with fenestrated/branched stent-grafts after previous open or endovascular aortic surgery within the period March 2002-November 2013 was analyzed. Evaluated outcomes included initial technical success, operative mortality and morbidity and late procedure-related events with regard to survival, target vessel patency, and re-intervention. RESULTS: A total of 122 patients (110 male, 12 female; mean age mean age 70±9.5 years) were treated. Median time interval from previous aortic surgery to current fenestrated/branched stent-grafting was 80 months (range 3-261 months). Seventy-seven (63.1%) patients had previous open infrarenal aortic surgery, 33 (27%) had previous endovascular abdominal aortic aneurysm repair (EVAR), nine (7.4%) had previous open thoracic aortic surgery, and three (2.5%) had previous endovascular thoracic aortic repair (TEVAR). Indication for current treatment was a JAA in 65 (53.3%) patients and a TAAA in 57 (46.7%) patients. Technical success was achieved in 115 (94.3%) patients. Seven patients were considered as technical failure (open conversion; N.=1, target vessel loss; N.=6). Operative target vessel perfusion success rate with endovascular means was 98.5% (391/397). Intraoperative technical difficulties due to pre-existing stent-graft/surgical graft were encountered in 28 (23%) patients (access, N.=12; target vessel catheterisation, N.=16). Thirty-day operative mortality was 4.1% (5/122), with zero mortality in 65 JAA, and 8.8% (5/57) in TAAA, respectively. Cause of death was multiple organ failure (N.=3), acute gastrointestinal bleeding (N.=1), and subdural hematoma (N.=1). Major complications occurred in 20 (16.4%) patients. Median hospital stay was 7 days (range 3-50 days), and mean ICU stay 1.5±3.2 days. Mean follow-up was 22.5±21 months. All-cause late mortality was encountered in 23 patients, including one aneurysm-related mortality. Estimated survival was 91.2±3%, 83.3±4.2% and 81.1±4.6% at one, two and three years, respectively. During follow-up, eight target vessels occluded. Estimated target vessel patency was 97.2±1.1%, and 96.3±1.2% at one and three years, respectively. Reintervention during follow-up was required in 13 (10.6%) cases accounting for an estimated freedom from reintervention of 91.6±3.1%, and 82.1±5.4% at one and three years, respectively. CONCLUSION: Fenestrated and branched stent-grafting represents a feasible option for the repair of JAA and TAAA after prior endovascular or open aortic surgery. Despite increased technical difficulties it is associated with high technical success rate and is advantageous in terms of mortality and morbidity compared to redo open aortic surgery.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Stents , Aged , Aortic Aneurysm, Abdominal/mortality , Aortic Aneurysm, Abdominal/physiopathology , Aortic Aneurysm, Thoracic/mortality , Aortic Aneurysm, Thoracic/physiopathology , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/mortality , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Postoperative Complications/mortality , Postoperative Complications/surgery , Prosthesis Design , Reoperation , Risk Factors , Time Factors , Treatment Outcome , Vascular Patency
17.
Eur J Vasc Endovasc Surg ; 47(4): 342-8, 2014 Apr.
Article in English | MEDLINE | ID: mdl-24456738

ABSTRACT

OBJECTIVES: To present results from the first 100 patients treated with the new C3 Gore Excluder stent-graft in a single institution. METHODS: All patients treated with the C3 Excluder stent-graft between August 2010 and July 2013 in our institution were included. Patient demographics, treatment indication, need for intraoperative stent-graft repositioning, immediate technical success, survival, endoleak and migration rate, and need for reintervention during follow-up were analyzed. RESULTS: A total of 100 patients (86% male, mean age 71.1 ± 9.3 years) were enrolled. Elective abdominal aortic aneurysm (AAA) was the most common indication for treatment (n = 90), followed by common iliac artery aneurysm (n = 5), ruptured AAA (n = 2), type Ia endoleak (n = 1), and type IV endoleak (n = 1) after prior EVAR, and penetrating aortic ulcer (n = 1). Technical success was achieved in 98 patients. In two patients a small type I endoleak persisted at completion angiography, but had disappeared at the first control computed tomography angiogram. Stent-graft repositioning after initial deployment was required in 49 patients, almost equally distributed for level and contralateral gate reorientation. Exact positioning of the proximal trunk was achieved in 98 patients, with the remaining two cases within 5 mm of the intended location. Adverse events related to repositioning maneuvers were noticed in two cases. Mean follow-up duration was 12.2 ± 9.4 months (range 0-36 months). Eight patients died, none from aneurysm related causes. Cumulative patient survival was 96.2 ± 2.1% at 1 year, and 84 ± 6.1% at 2 years, respectively. No migration, or type I or III endoleak was detected during follow-up. Estimated freedom from reintervention was 96 ± 2.4% at 1 year, and 91 ± 5.2% at 2 years, respectively. CONCLUSIONS: The new C3 Excluder stent-graft provides excellent short-term outcomes and offers important advantages in terms of stent-graft repositioning to achieve high proximal deployment accuracy. Longer follow-up is required to confirm improved long-term outcome compared with the previous generation Excluder stent-graft.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Stents , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/mortality , Aortography/methods , Blood Vessel Prosthesis Implantation/methods , Blood Vessel Prosthesis Implantation/mortality , Endoleak/prevention & control , Endovascular Procedures/methods , Female , Humans , Male , Middle Aged , Postoperative Complications/mortality , Treatment Outcome
18.
Chirurg ; 84(12): 1030-5, 2013 Dec.
Article in German | MEDLINE | ID: mdl-24337219

ABSTRACT

BACKGROUND: Demographic development leads to an increase in vascular interventions due to the increase in elderly and multimorbid patients. The aim of this study was to demonstrate the open interventional therapy options and their influence on staff and patients which have become possible due to the introduction of angio-hybrid operations including 3-D imaging Dyna-CT. MATERIAL AND METHODS: The modifications with respect to radiation protection for staff, improvements for patients and the possibilities of operative 3-D imaging Dyna-CT are described based on the current literature. RESULTS: The implementation of angio-hybrid operation theaters has resulted in new open interventional treatment options which can also be employed for high risk elderly patients with aortic and peripheral arterial pathologies. With hybrid operations the radiation exposure and contrast medium exposure can be reduced for patients and an improvement in the results can also be achieved. The implementation of 3-D imaging in the angio-hybrid operation theater could also lead to further improvements, especially for complex aortic procedures. DISCUSSION: Using angio-hybrid operational procedures complex interventions can be carried out with more safety for patients and personnel. The implementation of 3-D imaging Dyna-CT offers additional interesting options for complex aortic procedures.


Subject(s)
Angiography/instrumentation , Angiography/trends , Cooperative Behavior , Imaging, Three-Dimensional/trends , Interdisciplinary Communication , Operating Rooms/organization & administration , Operating Rooms/trends , Patient Care Team/organization & administration , Patient Care Team/trends , Surgery, Computer-Assisted/instrumentation , Surgery, Computer-Assisted/trends , Surgical Equipment/trends , Tomography, X-Ray Computed/instrumentation , Tomography, X-Ray Computed/trends , Vascular Surgical Procedures/instrumentation , Vascular Surgical Procedures/trends , Endovascular Procedures/instrumentation , Endovascular Procedures/trends , Forecasting , Germany , Humans , Patient Safety , Radiation Protection , Vascular Diseases/diagnostic imaging , Vascular Diseases/surgery
19.
J Cardiovasc Surg (Torino) ; 54(6): 785-91, 2013 Dec.
Article in English | MEDLINE | ID: mdl-24126514

ABSTRACT

The aim of the present study was to review the literature reporting the use of the Hemobahn/Viabahn endograft (W. L. Gore and Assoc Inc., Flagstaff, AZ, USA) for endovascular treatment of popliteal artery aneurysms (PAA). A PubMed database search was performed looking for studies reporting endovascular treatment of PAA with the Hemobahn/Viabahn endograft within the period January 2000-December 2012. All relevant studies were independently assessed and all references were examined for potentially missed relevant reports. Studies were included if they reported experience with five patients or more. Eight studies with 222 patients (mean age 72.4 years, 92.3% male) and 251 PAA (mean diameter 2.9 mm, 14.3% symptomatic) were included. Thirteen cases (5.2%) were treated on an urgent basis, including three cases of ruptured PAA and 10 cases of acute limb ischemia. Initial technical success was 99.2%. The mean number of implanted endografts/PAA was 1.8 (range 1-4). Thirty-day mortality was 1 (0.4%) patient. Perioperative complications occurred in 1.6%, consisting of three access site hematomas and one acute endograft thrombosis. Cumulative mean follow-up duration was 36.9 months. During this period, a total of 46 endograft failures (42 occlusions, 4 stenoses) were observed within a mean postoperative time interval of 10.8 months. Cumulative primary and secondary patency rates were 85.6% and 93.4% at one year, and 78.5% and 90.4% at 2 years, respectively. Limb salvage rate during follow-up was 99.2%. Endoleak was noticed in 15 (6%) cases and endograft migration in 13 (5.2%) cases. Endograft fracture was reported in 14 (5.6%) cases, resulting in occlusion in six patients, and in type III and IV endoleaks in two patients. Secondary intervention during follow-up was required in 47 (18.7%) cases, including 32 reinterventions for endograft occlusion, four for endograft stenosis, and 11 for endoleak repair. Endovascular PAA repair with the Hemobahn/Viabahn endograft is feasible and safe yielding excellent initial technical success rates, minimum perioperative mortality and morbidity, and mid-term patency and limb salvage rates comparable to open surgery. These results suggest that a significant proportion of patients might benefit from endovascular PAA repair.


Subject(s)
Aneurysm/surgery , Endovascular Procedures/methods , Popliteal Artery , Stents , Humans , Prosthesis Design , Treatment Outcome
20.
Zentralbl Chir ; 138(5): 516-20, 2013 Oct.
Article in German | MEDLINE | ID: mdl-23907845

ABSTRACT

The evolution of endovascular techniques has led to the concept of the "hybrid operating room" (hybrid OR). A hybrid OR combines the sterility of an OR in an operating theatre environment with a high-quality fixed imaging system. On the basis of these advantages it would be desirable that an angio-hybrid OR becomes a standard requirement for endovascular surgery. In Great Britain guidelines have already been published that require a hybrid OR even for normal endovascular management of the infrarenal aorta. However, in Germany there are no guidelines from professional societies or formal rules from the federal joint committee, thus in this article a classification of endovascular procedures according to their complexity and the necessary infrastructures are proposed in order to define particular procedures that should only be performed in an angio-hybrid OR. According to our experience, endovascular procedures can be classified into four categories based on their complexity and the requirements regarding fluoroscopy: level 1: standard EVAR, TEVAR, iliac and popliteal artery procedures; level 2: iliac branched (IBD) and standard (2 fenestrations for the renal arteries and a scallop for the superior mesenteric artery) fenestrated stent-grafting; level 3: more complex fenestrated procedures (three or four fenestrations); and level 4: branched stent-grafting for TAAA. At this moment it is still acceptable to perform level 1 and level 2 procedures outside of a hybrid OR. In our opinion, it is not recommended to perform level 3 and level 4 endovascular procedures without a hybrid OR.


Subject(s)
Diagnostic Imaging/instrumentation , Endovascular Procedures/instrumentation , Operating Rooms/organization & administration , Cooperative Behavior , Endovascular Procedures/classification , Equipment Design , Germany , Guidelines as Topic , Health Services Needs and Demand/organization & administration , Humans , Interdisciplinary Communication , National Health Programs , Radiation Protection/instrumentation
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