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2.
J Endovasc Ther ; : 15266028231215972, 2023 Dec 12.
Article in English | MEDLINE | ID: mdl-38084383

ABSTRACT

PURPOSE: Spinal cord injury (SCI) is a devastating complication of thoracoabdominal aortic (TAA) repair. The use of prophylactic cerebrospinal fluid drainage (CSFD) as part of a protective protocol during endovascular repair is controversial. This article reports the results of the prophylactic use of CSFD as part of the of a prevention protocol implemented in 2016. METHODS: Retrospective review of spinal cord outcomes (SCI rate and CSFD-related complications) in patients treated endovascularly for TAA disease at a single institution from 2016 (implementation of an institutional SCI risk reduction protocol) to 2021. Patients were classified as high risk (≥2 factors), intermediate risk (1 factor), or low risk (0 factor). Only high-risk patients without contraindications underwent a prophylactic CSFD placement. RESULTS: One hundred eighty-one patients were analyzed (124 males; 69.6 years): 130 (69%) aneurysms (n=24 thoracic, n=28 Crawford 1-2-3, and n=78 Crawford 4/pararenal), 35 (19.9%) chronic aneurysmal dissections, and 16 (8.8%) acute complicated type B dissections. Interventions were staged in 31 (17.2%) cases, and consisted of 74 (41%) Thoracic EndoVascular Aneurysm Repair (TEVAR) and 107 (59%) Fenestrated Branched EndoVascular Aneurysm Repair (F-BEVAR). Sixty-nine (38.1%) patients were identified as being at high risk of SCI and CSFD was used prophylactically in 64 of them (4 failures and 1 contraindication). Spinal cord injury occurred in 8 cases (4 paraparesis, 4 paraplegias including 2 permanent), of which 3 had a prophylactic CSFD and 5 underwent rescue drainage. In addition, 4 patients developed SCI related to prophylactic CSFD (intradural hematoma), resulting in 1 paraparesis and 3 paraplegias. Other CSFD-related complications were mild (6) or moderate (2), for a total of 12 complications (17%). Factors associated with major drain complications were: curative anticoagulation 36 hours after drain removal (n=1), multiple punctures (n=1), platelet count <100 000 at drain removal (n=1), and bipolar disorder (n=2). Overall, 4 patients had permanent paraplegia and 1 had sphincter dysfunction at the last follow-up. Mean follow-up was 17 months. Mortality was 4.4% at 30 days and 13.3% at 18 months, including 3 (1.6%) aortic-related deaths. CONCLUSIONS: With the protocol we used to protect the spinal cord, we report results comparable with the SCI literature and highlight the risks associated with prophylactic CSFD use, which requires a better understanding of contraindications.

3.
Article in English | MEDLINE | ID: mdl-38042252

ABSTRACT

OBJECTIVE: This study reports the development of an innovative, interactive Massive Open Online Course (MOOC) teaching radiation safety principles in the vascular workplace, using stepwise e-learning with multiple choice question tests (MCQs), educational videos, and a serious game. The aim was to study the MOOC impact on radiation safety knowledge and assess its feasibility and acceptability. METHODS: An international multicentre prospective study included team members active in the hybrid operating room. The MOOC was offered voluntarily via a secure online learning platform. A standardised MCQ test (15 questions) assessed radiation safety knowledge pre- and post-course (range 0 - 100%). Acceptability and feasibility were tested via the previously validated, Evaluating e-learning system success (EESS) model, using five point Likert scales. RESULTS: In eight centres across four countries, 150 of 203 invited endovascular team members consented. Over a seven week study period, surgeons (28%, including vascular surgery trainees and consultants), nurses (27%, including scrub, circulating and anaesthetic nurses), anaesthetists (43%, including trainees and consultants), and radiographers (3%) participated. Of those, 67% completed the course. The average radiation knowledge improved by 22.8% (95% CI 19.5 - 26.0%; p < .001) after MOOC completion, from 48% to 71% (standard deviation [SD] 14 and 15% respectively), requiring a mean time investment of 169 minutes (SD 89 minutes). In centres with a radiographer, mean knowledge gain after MOOC completion was significantly smaller (14%, SD 19% vs. 24%, SD 16%, p = .036). The course was deemed feasible and acceptable according to the EESS model with a total mean score of 3.68/5. CONCLUSION: This newly developed, multimodal MOOC was deemed feasible and effective across multiple international centres. The MOOC significantly contributes to radiation safety education of the entire endovascular team, improving radiation safety knowledge. The course may optimise workplace radiation safety behaviour and therefore enhance team and patient safety.

4.
J Clin Med ; 12(24)2023 Dec 05.
Article in English | MEDLINE | ID: mdl-38137589

ABSTRACT

Despite recent improvements, spinal cord ischemia remains the most feared and dramatic complication following extensive aortic repair. Although endovascular procedures are associated with a lower risk compared with open procedures, this risk is still significant and must be considered. A combined medical and surgical approach may help to optimize the tolerance of the spinal cord to ischemia. The aim of this review is to describe the underlying mechanism involved in spinal cord injury during extensive endovascular aortic repair, to describe the different techniques used to improve spinal cord tolerance to ischemia-including the prophylactic or curative use of spinal drainage-and to propose our algorithm for spinal cord protection and the rational use of spinal drainage.

5.
J Endovasc Ther ; : 15266028231208653, 2023 Oct 30.
Article in English | MEDLINE | ID: mdl-37902436

ABSTRACT

PURPOSE: To describe and compare mid-term outcomes from 2 real-world data collection efforts on fenestrated and branched endovascular aortic repair (fbEVAR) for complex abdominal aortic aneurysms (AAAs) in France and to evaluate the potential of health care databases for long-term post-market surveillance (PMS) and continued reimbursement approval. METHODS: Two real-world studies were conducted in France: a retrospective health care database study (SNDS) and a prospective clinical study. In the SNDS study, data from implantation and/or hospital stays occurring during follow-up were extracted for all patients treated with the study devices from April 2012 to December 2018. In the clinical study, high-risk patients undergoing fbEVAR with the study devices were enrolled consecutively at 15 sites in France from December 2016 to November 2018. RESULTS: Data from 1073 patients were extracted from SNDS and compared with analogous variables from 186 patients in the clinical study. Most demographic details were similar between studies (SNDS vs clinical: mean age, 71.9 vs 71.8 years; men, 91.0% vs 89.8%), as was 30-day mortality (SNDS: 5.5%, clinical: 4.3%). Patients received custom-made fenestrated or branched devices (SNDS: 80.7%, clinical: 96.2%) or CE-marked Zenith Fenestrated devices (SNDS: 19.3%, clinical: 3.8%). Initial or technical success was above 94% for both studies. Two-year freedom from all-cause mortality was 80.0% (SNDS) and 85.1% (clinical study). Two-year freedom from aneurysm-related mortality was 93.8% (SNDS) and 94.6% (clinical study). Detailed imaging outcomes were not captured within SNDS; however, information on secondary procedures to restore patency was available and used as a surrogate measure for secondary interventions. Two-year freedom from secondary interventions was 73% for the SNDS study. In the clinical study, at 2 years, aneurysm stability or shrinkage was observed in 92.3% of patients, freedom from target vessel primary patency loss was above 95% for all visceral target vessels, and freedom from secondary interventions was 79.1%. CONCLUSION: Real-world outcomes from the SNDS and clinical study suggest positive mid-term outcomes in high-risk populations following fbEVAR for complex AAAs. The similarities between these studies suggest that the use of health care databases may be an alternative to prospective clinical studies for long-term follow-up and PMS. CLINICAL IMPACT: Positive results following endovascular repair of complex abdominal aortic aneurysms are observed from data extracted from both the French health care database and a post-market clinical study despite initial high-risk patient status and diverse center experience. These outcomes parallel more rigorously designed studies and suggest that with careful study design, real-world data collections have high translatable value to add to the clinical understanding of fenestrated and branched endovascular aortic repair (fbEVAR).

6.
J Vasc Surg ; 78(4): 863-873.e3, 2023 10.
Article in English | MEDLINE | ID: mdl-37330705

ABSTRACT

OBJECTIVE: Analyze the outcomes of endovascular complex abdominal and thoracoabdominal aortic aneurysm repair using the Cook fenestrated device with the modified preloaded delivery system (MPDS) with a biport handle and preloaded catheters. METHODS: A multicenter retrospective single arm cohort study was performed, including all consecutive patients with complex abdominal aortic aneurysm repair and thoracoabdominal aortic aneurysms treated with the MPDS fenestrated device (Cook Medical). Patient clinical characteristics, anatomy, and indications for device use were collected. Outcomes, classified according to the Society for Vascular Surgery reporting standards, were collected at discharge, 30 days, 6 months, and annually thereafter. RESULTS: Overall, 712 patients (median age, 73 years; interquartile range [IQR], 68-78 years; 83% male) from 16 centers in Europe and the United States treated electively were included: 35.4% (n = 252) presented with thoracoabdominal aortic aneurysms and 64.6% (n = 460) with complex abdominal aortic aneurysm repair. Overall, 2755 target vessels were included (mean ,3.9 per patient). Of these, 1628 were incorporated via ipsilateral preloads using the MPDS (1440 accessed from the biport handle and 188 from above). The mean size of the contralateral femoral sheath during target vessel catheterization was 15F ± 4, and in 41 patients (6.7%) the sheath size was ≤8F. Technical success was 96.1%. Median procedural time was 209 minutes (IQR, 161-270 minutes), contrast volume was 100 mL (IQR, 70-150mL), fluoroscopy time was 63.9 minutes (IQR, 49.7-80.4 minutes) and median cumulative air kerma radiation dose was 2630 mGy (IQR, 838-5251 mGy). Thirty-day mortality was 4.8% (n = 34). Access complications occurred in 6.8% (n = 48) and 30-day reintervention in 7% (n = 50; 18 branch related). Follow-up of >30 days was available for 628 patients (88%), with a median follow-up of 19 months (IQR, 8-39 months). Branch-related endoleaks (type Ic/IIIc) were observed in 15 patients (2.6%) and aneurysm growth of >5 mm was observed in 54 (9.5%). Freedom from reintervention at 12 and 24 months was 87.1% (standard error [SE],1.5%) and 79.2% (SE, 2.0%), respectively. Overall target vessel patency at 12 and 24 months was 98.6% (SE, 0.3%) and 96.8% (SE, 0.4%), respectively, and was 97.9% (SE, 0.4%) and 95.3% (SE, 0.8%) for arteries stented from below using the MPDS, respectively. CONCLUSIONS: The MPDS is safe and effective. Overall benefits include a decrease in contralateral sheath size in the treatment of complex anatomies with favorable results.


Subject(s)
Aortic Aneurysm, Abdominal , Aortic Aneurysm, Thoracic , Aortic Aneurysm, Thoracoabdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Humans , Male , Aged , Female , Blood Vessel Prosthesis , Endovascular Aneurysm Repair , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/surgery , Retrospective Studies , Cohort Studies , Treatment Outcome , Time Factors , Prosthesis Design
7.
Ann Vasc Surg ; 95: 3-13, 2023 Sep.
Article in English | MEDLINE | ID: mdl-37169252

ABSTRACT

BACKGROUND: Long-term outcomes after acute type A aortic dissection (ATAAD) are related to remodelling of the descending thoracic aorta and aortic reinterventions. We compared the impact of an extensive repair at the index procedure using the Frozen Elephant Trunk (FET) technique, versus a conventional arch repair, on long-term remodelling of the descending thoracic and reintervention related to the aorta. METHODS: Consecutive patients who underwent conventional arch repair (conventional group) or FET repair (FET group) for an ATAAD from September 2018 to November 2021 were included. Patients who died before discharge or were lost to follow-up prior to the first appointment were excluded from the analysis. Preoperative and postoperative computed tomography angiography was reconstructed and diameter of the true/false lumen of the remaining aorta was compared up to 1 year. Negative (increased total diameter ≥ 5 mm) aortic remodelling was collected for each computed tomography angiography, as well as aortic reinterventions. Comparison of demographic, anatomical, and perioperative complications data were performed using Wilcoxon test for continuous variables or Chi-square test for categorical covariates. The Kaplan-Meier method estimator was used to assess survival rates. The Log rank test was used to compare survival curves between the 2 groups. RESULTS: Thirty nine patients were included, 22 in the conventional group and 17 in the FET group (82% males, mean age 60 ± 12 years). In the FET group, distal anastomosis was performed in zone 0 or 1 for 82% of patients using the simplified delivery technique. Median maximum preoperative descending aortic diameter was larger in the FET group (33 mm [30; 37] vs. 30 mm [28; 32] [P = 0.0172]). At 30 days, the rate of negative remodelling on the descending thoracic aorta was significantly higher in the conventional group (50%) than in the FET group (8%, P = 0.02). At 1 year, Kaplan-Meier analysis shown a freedom from descending aortic negative remodeling of 35.1% (95% confidence interval (CI) 18.7-66.1%) in conventional group and 44.9% (CI 95% 26.1-77.2%) in FET group with no significant difference. However, early negative remodelling was observed for the conventional group. Within a year, freedom from reintervention was observed for 74.4% (95% CI 57.1-97%) of patients in the conventional group and 75.5 (95% CI 57.1-99.7%) of patients in the FET group with no significant difference. CONCLUSIONS: Negative evolution of descending aorta remains a challenge after ATAAD. An extensive repair using the FET technique during the index procedure seems to be associated with satisfying short-term remodelling of descending aorta.


Subject(s)
Aortic Aneurysm, Thoracic , Aortic Dissection , Blood Vessel Prosthesis Implantation , Male , Humans , Middle Aged , Aged , Female , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/surgery , Aorta, Thoracic/diagnostic imaging , Aorta, Thoracic/surgery , Treatment Outcome , Retrospective Studies , Aorta/surgery , Aortic Dissection/diagnostic imaging , Aortic Dissection/surgery
8.
Ann Vasc Surg ; 95: 42-49, 2023 Sep.
Article in English | MEDLINE | ID: mdl-37068628

ABSTRACT

BACKGROUND: Obesity is a risk factor for higher morbidity and mortality following open aortic repair but currently there is limited literature on its impact on clinical and procedural outcomes following thoracic endovascular aortic repair (TEVAR) and branched-fenestrated endovascular aortic repair (B-FEVAR). METHODS: We conducted a retrospective case-control analysis of a prospectively collected nonrandomized database to evaluate the effects of obesity on procedural and clinical outcomes after B-FEVAR/TEVAR in treatment of pararenal/thoracoabdominal aortic aneurysm and dissection at the University hospital of Nantes (France) between January 2016 and December 2021. Patients were divided in 2 groups according to their body mass index (BMI) and the rate of technical success, complications (renal, pulmonary, cardiac, and neurological events), 30-day and long-term survival, freedom from target vessel instability and reintervention were compared. RESULTS: 195 patients were included (mean age 69.6 DS±11.2; n = 135, 69.2% men; mean BMI: 26.6 kg/m2 range 19-41) totalling n = 72 (36.8%) TEVAR, n = 107 (55.4%) FEVAR and n = 14 (7.3%) BEVAR. Patients were divided in 2 groups [obese: BMI≥30 kg/m2n = 52 (26.7%); and nonobese, BMI<30 kg/m2, n = 143 (73.3%) that statistically differed only in terms of coronary artery disease (obese 42.3% vs. 26.6% nonobese, P = 0.035) and diabetes (obese 25% vs. 12.6% nonobese, P = 0.03). No statistical differences were noted in primary technical (94.2% vs. 94.4%, P = 1.00) and clinical (92.3% vs. 95.1%, P = 0.49) success. Overall morbidity (30.8% vs. 21.1%, P = 0.16), visceral vessels instability (1.9% vs. 1.4% P = 1.00), reintervention rate within 30 days (9.6% vs. 5.6% P = 0.33), 90 days (7.7% vs. 9.8%, P = 0.78) and during follow-up (9.8% vs. 20%, P = 0.14) were comparable. No statistical difference were noted in 30-day mortality (3.8% vs. 4.9%, P = 1.00) and the 2-year follow-up survival (86.8% vs. 78.4%, P = 0.180) between the 2 groups. CONCLUSIONS: In this series, obesity was not associated to worst clinical outcomes or higher mortality rate following TEVAR/B-FEVAR. However, considering our small patient sample, a conclusive analysis on obesity as risk factors for adverse events after endovascular treatment is not possible. A larger sample from the collaboration of multiple centers will be required to obtain definitive conclusions.


Subject(s)
Aortic Aneurysm, Thoracic , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Male , Humans , Aged , Female , Blood Vessel Prosthesis/adverse effects , Blood Vessel Prosthesis Implantation/adverse effects , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/surgery , Aortic Aneurysm, Thoracic/complications , Endovascular Aneurysm Repair , Retrospective Studies , Treatment Outcome , Endovascular Procedures/adverse effects , Postoperative Complications , Risk Factors , Obesity/complications , Obesity/diagnosis
9.
J Vasc Surg ; 78(2): 344-350.e2, 2023 08.
Article in English | MEDLINE | ID: mdl-37076106

ABSTRACT

OBJECTIVE: Clinical and experimental studies of the stent-graft fixation impact on the renal volume after endovascular abdominal aortic aneurysm repair have focused on glomerular filtration rate, and the results were controversial. The aim of this study was to analyze and compare the impact of the suprarenal (SRF group) and infrarenal (IRF group) stent-graft fixation on the renal volume. METHODS: Between December 2016 and December 2019, all patients treated with endovascular aneurysm repair were retrospectively analyzed. Patients with atrophic or multicystic kidney, renal transplantation, ultrasound examination, or incomplete follow-up were excluded. The renal volume in both groups was extracted with a semiautomatic segmentation from contrast-enhanced computed tomography scan performed before the procedure, at 1 month, and at 12 months of follow-up. A subgroup analysis of the SRF group was performed in order to study the impact of the stent strut position relative to the renal arteries. RESULTS: A total of 63 patients were analyzed (SRF: 32 and IRF: 31). Demographic and anatomic characteristics were similar between the groups. The procedure contrast volume was higher in the IRF group (P = .01). At 12 months, we observed a decrease in the renal volume of 1.4% in the SRF group and 2.3% in the IRF group (P = .86). The SRF subgroup analysis showed only two patients with no stent struts crossing the renal arteries. In the remaining cases, struts crossed one renal artery in 60% of cases (19 patients) and two renal arteries in 34% of cases (11 patients). The renal volume decrease was not correlated with the presence of stent wire struts, crossing a renal artery. CONCLUSIONS: Stent graft with suprarenal fixation seems not to be correlated with renal volume deterioration. A randomized clinical trial with a higher effective and longer follow-up is needed to assess the impact of SRF on renal function.


Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Humans , Blood Vessel Prosthesis/adverse effects , Endovascular Aneurysm Repair , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/methods , Retrospective Studies , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Aortic Aneurysm, Abdominal/etiology , Endovascular Procedures/adverse effects , Kidney/diagnostic imaging , Kidney/physiology , Stents/adverse effects , Treatment Outcome
10.
Vascular ; 31(3): 463-466, 2023 Jun.
Article in English | MEDLINE | ID: mdl-35220821

ABSTRACT

BACKGROUND: Behçet's disease (BD) is a rare form of systemic vasculitis that affects small to large vessels. It is characterized by mucocutaneous, pulmonary, cardiovascular, gastrointestinal, and neurological manifestations. Large vessel involvement may occur in a third of cases. Veins are usually more affected than arteries. Furthermore aneurysms are the most frequent arterial complication. CASE PRESENTATION: A 41-year-old man presented with multiple arterial aneurysms. He had previous medical history of a right popliteal aneurysm treated with a reversed femoro-popliteal venous bypass, long-term steroids and immunosuppressive treatment. On admission, diagnostic computed tomography angiography revealed multiple aneurysms, including an 87 mm aneurysm of the femoro-popliteal bypass and an abdominal aortic and left common iliac artery aneurysm. He received an intensification of medical treatment with methylprednisolone and infliximab intravenous infusion. Aorto iliac artery aneurysms were treated by infrarenal bifurcated stent graft implantation. The aneurysm of the venous femoro-popliteal bypass was treated by explantation and prosthetic repair. One month later, he presented with acute right limb ischemia related to occlusion of the right limb of the stent graft despite anticoagulation which was treated by mechanical thrombectomy. CONCLUSIONS: Vascular BD can worsen the vascular outcome after surgery. Except in an urgent context, BD must be controlled before surgery. This case report illustrates the importance of combined medical and surgical management, with first BD activity control with corticosteroids and immunosuppressive treatment, then surgical or endovascular treatment.


Subject(s)
Aortic Aneurysm, Abdominal , Behcet Syndrome , Blood Vessel Prosthesis Implantation , Iliac Aneurysm , Male , Humans , Adult , Behcet Syndrome/complications , Behcet Syndrome/diagnosis , Behcet Syndrome/drug therapy , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/etiology , Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/methods , Aorta, Abdominal/surgery , Iliac Aneurysm/diagnostic imaging , Iliac Aneurysm/etiology , Iliac Aneurysm/surgery
11.
J Endovasc Ther ; 30(1): 98-105, 2023 Feb.
Article in English | MEDLINE | ID: mdl-35114841

ABSTRACT

PURPOSE: The performance of self-expanding interwoven nitinol stent (Supera) in femoropopliteal interventions has been proven through trials with short lesions and with relatively low proportion of occlusions. There is limited evidence of Supera stent in long lesions. The aim of this study was to assess the clinical safety and efficiency of the Supera stent in the treatment of long femoropopliteal lesions (Trans-Atlantic Inter-Society Consensus [TASC] C/D) in patients with symptomatic peripheral arterial disease (PAD). METHODS: The STELLA SUPERA (STEnting Long de L'Artère fémorale superficielle par le stent métallique Supera) is a prospective, 2-center, single-arm study. Patients with symptomatic (Rutherford stages 2-6) de novo and TASC C/D lesions of the femoropopliteal segment were treated with Supera stent. The primary endpoint was the primary sustained clinical improvement at 12 months. Follow-up included clinical examination, duplex scan, and biplane X-ray up to 24 months. RESULTS: Between December 2016 and October 2018, 48 symptomatic patients with 49 femoropopliteal lesions (TASC D = 32, 65%) were treated. The mean lesion length was 234 ± 123 mm, and 78% were total occlusion. The mean stented lesion length was 273 ± 127 mm. At 12 and 24 months, the primary sustained clinical improvement rate was 87.2% and 79.7%, respectively. The Rutherford category assessment was significantly improved at 24 months compared with baseline (p=0.02). At 24 months, the primary patency and freedom from target lesion revascularization (TLR) rates were 77.9% and 86.9%, respectively. The ankle-brachial pressure index increased from 0.62 ± 0.15 at baseline to 0.93 ± 0.15 at 24 months (p<0.0001). There were no stent fractures at 24 months. CONCLUSION: The use of Supera stent in long lesions (TASC C/D) is a safe and effective endovascular alternative. These results reinforce the need for randomized clinical trials to assess the value of interwoven stents for long femoropopliteal lesions.


Subject(s)
Peripheral Arterial Disease , Popliteal Artery , Humans , Femoral Artery/diagnostic imaging , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/therapy , Popliteal Artery/diagnostic imaging , Prospective Studies , Prosthesis Design , Stents , Treatment Outcome , Vascular Patency
12.
J Cardiovasc Surg (Torino) ; 64(1): 82-92, 2023 Feb.
Article in English | MEDLINE | ID: mdl-36168949

ABSTRACT

BACKGROUND: The hybrid room (HR) is a complex, high-risk environment, requiring teams (surgeons, anesthesiologists, nurses, technologists) to master various skills, including the 'As Low As Reasonably Achievable' principle of radiation safety. This prospective single center cohort reports the first use of the Operating Room Black Box (ORBB) in a HR. This medical data recording system captures procedural and audio-visual data to facilitate structured team performance analysis. METHODS: Patients planned for endovascular repair of an infrarenal abdominal aortic aneurysm (EVAR) or treatment of symptomatic iliac-femoral-popliteal atherosclerotic disease (Peripheral Vascular Interventions or PVI) were included. Validated measures and established assessment tools were used to assess (non-)technical skills, radiation safety performance and environmental distractions. RESULTS: Six EVAR and sixteen PVI procedures were captured. Technical performance for one EVAR was rated 19/35 on the procedure-specific scale, below the 'acceptable' score of 21. Technical skills were rated above acceptable in all PVI procedures. Shared decision making and leadership were rated highly in 12/22 cases, whereas surgical communication and nurses' task management were rated low in 14/22 cases. Team members rarely stepped back from the C-arm during digital subtraction angiography. Radiation safety behavior was scored below 'acceptable' in 14/22 cases. A median (interquartile range) number of 12 (6-23) auditory distractions was observed per procedure. CONCLUSIONS: The ORBB facilitates holistic workplace-based assessment of endovascular performance in a HR by combining objective assessment parameters and rating scale-based evaluations. Strengths and weaknesses were identified in team members' (non-)technical and radiation safety practices. This technology has the potential to improve vascular surgical practice, though human input remains crucial. (NCT04854278).


Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Humans , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/methods , Endovascular Procedures/adverse effects , Endovascular Procedures/methods , Prospective Studies , Treatment Outcome
14.
J Surg Oncol ; 126(6): 1048-1057, 2022 Nov.
Article in English | MEDLINE | ID: mdl-35779039

ABSTRACT

BACKGROUND: This study aims to identify prognostic factors and define the best extent of surgery for optimizing treatment of local recurrence (LR) following colorectal cancer (CRC). METHODS: An institutional database of consecutive patients who underwent radical resection (R0/R1) of LR following CRC was analyzed prospectively from 2010 to 2021 at one tertiary cancer center. RESULTS: In this study, 75 patients were included with LR following CRC and analyzed. Patients were categorized as compartmental resections (CompRe) (n = 47) if all adjacent organs were systematically removed, with or without tumor involvement, or noncompartmental resections (NoCompRe) (n = 28) if only contiguously involved organs were resected. NoCompRe were mainly related to contact between major vessels or bone and the tumor, with only 8/19 (42.1%) resections. Five-year overall survival and locoregional-free survival were 37.5% and 38.8% respectively. Local control was better in the CompRe than the NocompRe group (61.4% vs. 11%; p < 0.01). CompRe (hazard ratio: 2.34 [1.16-4.68]; p = 0.017) and absence of peritoneal metastasis (3.05 [1.03-9.02]; p = 0.044) were the two factors associated with decreased abdominal recurrences in multivariate analysis. CONCLUSION: Complete compartmental surgery is safe and improves local control. Optimal LR resection needs to remove all contiguous organs, with or without tumor involvement.


Subject(s)
Colorectal Neoplasms , Digestive System Surgical Procedures , Colorectal Neoplasms/pathology , Humans , Neoplasm Recurrence, Local/pathology , Prognosis , Proportional Hazards Models , Retrospective Studies , Survival Rate
15.
J Endovasc Ther ; : 15266028221106306, 2022 Jun 23.
Article in English | MEDLINE | ID: mdl-35735195

ABSTRACT

PURPOSE: Radiation exposure for vascular interventionalists is still a concern. The aim of this study was to assess the value of advanced imaging guidance on radiation exposure and iodinated contrast volume during endovascular treatment of lower extremity arterial disease (LEAD). MATERIALS AND METHODS: It was a prospective, randomized, monocentric, pilot, single-operator study, conducted from June 2018 to October 2019. Consecutive patients requiring a preoperative computed tomography angiography (CTA) for a symptomatic LEAD and scheduled for an iliac and/or femoropopliteal endovascular repair in a hybrid room were included. Patients were randomly assigned to the use of fusion imaging guidance (Vessel Navigator®, Philips) or not. The primary endpoint was the dose area product (DAP, Gy.cm²). Secondary endpoints were DAP for fluoroscopy, DAP for fluorography, Air Kerma, fluoroscopy time, volume of contrast, and number of digital subtraction angiography (DSA). Data were expressed in median [Q1-Q3]. RESULTS: In all, 64 of the 77 patients enrolled (34 in fusion group, 30 in control group, 82% men, 65.8 years [61-71]) were included. Groups were similar in terms of comorbidities, BMI (26 kg/cm2 [24-28]), but lesion location were not equally distributed (p=0.004). There was no significant difference between the groups regarding DAP (31.6 Gy.cm2 [23.4; 46.9] for fusion group vs 25.6[16.9; 34.0] Gy.cm2; p=0.07), Air Kerma (160 mGy [96;3365] vs 115 mGy [76;201]; p=0.12, fluoroscopy time (560 seconds [326;960] vs 454 seconds [228;1022]; p=0.44), contrast volume (60 ml [42;80] vs 50 ml [40;66]; p=0.10), or operative time (68 minutes [55;90] vs 46 minutes [30;80]; p=0.06). The median number of DSA was 14 [10-18] in the fusion group versus 11 [6-18]; p=0.049. CONCLUSION: Fusion imaging guidance does not affect radiation exposure and contrast volume during endovascular revascularisation of iliac and femoropopliteal occlusive disease in a hybrid room environment.

17.
J Vasc Surg ; 76(3): 645-655.e3, 2022 09.
Article in English | MEDLINE | ID: mdl-35367562

ABSTRACT

OBJECTIVE: Real-time aortic deformation during endovascular aortic aneurysm repair (EVAR) has not been reported. Successful EVAR relies on predicting intraoperative aortic-endograft deformation from preoperative imaging. Correct prediction is essential, because malalignment of endografts decreases patient survival. We describe intraoperative aortic deformation during infrarenal EVAR and complex fenestrated/branched EVAR (F/BEVAR), relating deformation to preoperative anatomy and follow-up outcomes. METHODS: A multicenter, retrospective cohort of aortic aneurysm patients undergoing operation between January 2019 and February 2021, substratified by repair, infrarenal EVAR (n = 50), F/BEVAR (n = 80), and iliac branch graft with F/B/EVAR (IBG + F/B/EVAR; n = 27), were compared using software-based nonrigid two- and three-dimensional aortic deformational intraoperative assessment (CYDAR). Preoperative computed tomography reconstructions of aortic and iliac tortuosities were assessed against intraoperative deformation, the primary outcome, and related to perioperative and follow-up adverse outcomes. RESULTS: All treatment groups had low preoperative visceral aortic tortuosity; the EVAR group had higher iliac tortuosity (1.43 ± 0.05; P = .018). Intraoperative aortic visceral deformation was consistently cranial and anterior; IBG + F/B/EVAR patients had the largest magnitude deformation (superior mesenteric artery, EVAR 5.1 ± 0.9 mm; F/BEVAR 4.4 ± 0.4 mm; IBG 8.3 ± 1.2 mm; P = .004). Celiac artery, superior mesenteric artery, and bilateral renal artery deformations were correlated (R = 0.923-0.983). Iliac deformation was variable in magnitude and direction. Preoperative tortuosity was not correlated with the magnitude of intraoperative deformation nor was deformation magnitude related to endograft instability during follow-up, including endoleak development, reinterventions, or visceral vessel complications. CONCLUSIONS: The aorta deforms consistently during EVAR at the visceral aortic segment but unpredictably at the iliac bifurcation. Aortoiliac deformation is unrelated to adverse perioperative outcomes, branch instability, or reinterventions during short-term follow-up.


Subject(s)
Aortic Aneurysm, Abdominal , Aortic Aneurysm , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Aorta/surgery , Aortic Aneurysm/surgery , Aortic Aneurysm, Abdominal/complications , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Aortography/methods , Blood Vessel Prosthesis/adverse effects , Blood Vessel Prosthesis Implantation/adverse effects , Endovascular Procedures/adverse effects , Humans , Postoperative Complications/etiology , Retrospective Studies , Risk Factors , Time Factors , Treatment Outcome
18.
Quant Imaging Med Surg ; 12(3): 1664-1673, 2022 Mar.
Article in English | MEDLINE | ID: mdl-35284255

ABSTRACT

Background: Endovenous interventional procedures can be used in addition to therapeutic anticoagulation to treat deep vein thrombosis in selected patients with proximal vein involvement (vena cava, iliac and/or common femoral). The aim of this study was to compare venous patency and the post-thrombotic syndrome (PTS) in patients treated with pharmaco-mechanical catheter-directed thrombolysis (PMT) versus recanalization-stenting for PTS after a proximal lower limb deep vein thrombosis. Methods: Between January 2014 and December 2020, this retrospective and monocentric study included patients with very symptomatic acute iliofemoral deep vein thrombosis treated with PMT within 21 days after diagnosis (PMT group) and patients with PTS caused by chronic venous obstruction treated with recanalization and stenting (CRS group). Results: A total of 116 patients were included (26 PMT, 90 CRS). The rate of primary patency was 81.8% (18/22 patients) in the PMT group and 78.4% (69/88) in the CRS group (P>0.99). The rate of venous patency at the last follow-up was 76.9% (20/26) in the PMT group and 82.2% (74/90) in the CRS group (P=0.57). The median number of stents was 2 (range, 0-5) in the PMT group and 3 (range, 0-7) in the CRS group (P<0.001). The median stent length was 150 mm (range, 60-390 mm) and 280 mm (range, 120-820 mm), respectively (P<0.001). The median last Villalta score was 2 (range, 0-10) in the PMT group and 2 (range, 0-21) in the CRS group (P=0.55). The rate of venous claudication at the last follow-up was 19.0% (4/21) in the PMT group and 12.0% (10/83) in the CRS group (P=0.47). Conclusions: In this study, there was no difference in venous patency and in the rate and severity of PTS between the PMT and CRS groups. The number of stent and their length were significantly lower in the PMT group compared with the CRS group.

19.
J Endovasc Ther ; 29(6): 921-928, 2022 12.
Article in English | MEDLINE | ID: mdl-35012391

ABSTRACT

PURPOSE: Carotid artery stenting (CAS) appears as a promising alternative treatment to carotid endarterectomy for radiation therapy (RT)-induced carotid stenosis. However, this is based on a poor level of evidence studies (small sample size, primarily single institution reports, few long-term data). The purpose of this study was to report the long-term outcomes of a multicentric series of CAS for RT-induced stenosis. METHODS: All CAS for RT-induced stenosis performed in 11 French academic institutions from 2005 to 2017 were collected in this retrospective study. Patient demographics, clinical risk factors, elapsed time from RT, clinical presentation and imaging parameters of carotid stenosis were preoperatively gathered. Long-term outcomes were determined by clinical follow-up and duplex ultrasound. The primary endpoint was the occurrence of cerebrovascular events during follow-up. Secondary endpoints included perioperative morbidity and mortality rate, long-term mortality rate, primary patency, and target lesion revascularization. RESULTS: One hundred and twenty-one CAS procedures were performed in 112 patients. The mean interval between irradiation and CAS was 15 ± 12 years. In 31.4% of cases, the lesion was symptomatic. Mean follow-up was 42.5 ± 32.6 months (range 1-141 months). The mortality rate at 5 years was 23%. The neurologic event-free survival and the in-stent restenosis rates at 5 years were 87.8% and 38.9%, respectively. Diabetes mellitus (p=0.02) and single postoperative antiplatelet therapy (p=0.001) were found to be significant predictors of in-stent restenosis. Freedom from target lesion revascularization was 91.9% at 5 years. CONCLUSION: This study showed that CAS is an effective option for RT-induced stenosis in patients not favorable to carotid endarterectomy. The CAS was associated with a low rate of neurological events and reinterventions at long-term follow-up.


Subject(s)
Carotid Stenosis , Coronary Restenosis , Endarterectomy, Carotid , Humans , Carotid Stenosis/diagnostic imaging , Carotid Stenosis/therapy , Stents/adverse effects , Retrospective Studies , Constriction, Pathologic , Coronary Restenosis/complications , Treatment Outcome , Recurrence , Time Factors , Endarterectomy, Carotid/adverse effects , Risk Factors , Carotid Arteries
20.
Ann Vasc Surg ; 79: 17-24, 2022 Feb.
Article in English | MEDLINE | ID: mdl-34644627

ABSTRACT

BACKGROUND: The true incidence and natural history of renal artery aneurysm (RAA) remain unclear and still exists controversy over indication for treatment. Several techniques of conventional surgical reconstructions are described in literature, and more recently endovascular therapies have been reported with satisfying results and lower complication rate. This paper aims to investigate the outcomes of both endovascular and open repair of RAA achieved in a single institution involving 3 medical teams (urology, vascular surgery and neuroradiology). MATERIAL AND METHODS: We conducted a single-centre retrospective observational study about all patients surgically or endovascularly treated for RAA over a 15-year period. Pre-operative, procedural and post-operative data at the early, mid- and long-term follow-up were collected and analysed, focusing on operative technique used for repair and related outcomes. RESULTS: A total of 27 patients (n = 17 (63%) women, mean age 58 ± 13.2, n = 26 saccular RAA) were included. Mean aneurysm was size was 18.8 ± 6.3 mm. Most diagnosis were accidental. Symptomatic RAA showed with macroscopic haematuria (n = 3, 25.9%), unstable hypertension (n = 2; 7%), chronic lumbar pain (n = 1, 3.7%) and renal infarct (n = 1, 3.7%). Conventional surgery (ex-vivo repair, aneurysmorraphy, aneurysm resection and end-to-end anastomosis) was performed in 14 (51.8%) cases and endovascular coiling embolization in 13 (48.2%). Mean hospital length of stay was 5.4 ± 3.6 days. Intensive Care Unit stay was needed only in the surgically treated patients (mean 1.1 ± 1.2 days). During the early follow-up, morbidity rate was 7/14 in surgically treated patients vs. 1/13 in endovascular group; it included bleeding, retroperitoneal hematoma, arterial thrombosis and bowel obstruction. The discharge imaging showed complete aneurysm exclusion and renal artery patency in all cases. At a mean follow-up of 39 ± 42 months, 3 patients (11%) were lost to follow up and 2 (7.4 %) died from unrelated cause. None of these patients required dialysis but a statistically significant (P = 0.09) decrease in GFR was noted between the preoperative period and last follow-up control. RAA repair neither showed blood pressure control improvement nor reduced the need for anti-hypertensive drug use. CONCLUSION: Open or endovascular techniques are both safe and efficient to treat RAA. Even though, surgical management is burdened with higher morbidity rate, the operative technique should be selected according to anatomical features, diameters and location of RRA; and the number of renal branches involved. Further larger studies are needed to define the feasibility and safety for a wider application of the endovascular approach.


Subject(s)
Aneurysm/surgery , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Renal Artery/surgery , Aged , Aneurysm/diagnostic imaging , Blood Vessel Prosthesis Implantation/adverse effects , Endovascular Procedures/adverse effects , Female , France , Humans , Male , Middle Aged , Postoperative Complications/etiology , Renal Artery/diagnostic imaging , Retrospective Studies , Time Factors , Treatment Outcome
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