Jean-Pierre Becquemin’s research while affiliated with Assistance Publique – Hôpitaux de Paris and other places

BACKGROUND Physician modified endografts (PMEGs) have been widely used in the treatment of complex abdominal aortic aneurysm and thoracoabdominal aortic aneurysm, however, previous data are limited to small single center studies and robust data on safety and effectiveness of PMEGs are lacking. We aimed to perform an international multicenter study analyzing the outcomes of PMEGs in complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. METHODS An international multicenter single-arm cohort study was performed analyzing the outcomes of PMEGs in the treatment of elective, symptomatic, and ruptured complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. Variables and outcomes were defined according to the Society for Vascular Surgery reporting standards. Device modification and procedure details were collected and analyzed. Efficacy outcomes included technical success and safety outcomes included major adverse events and 30-day mortality. Follow-up outcomes included reinterventions, endoleaks, target vessel patency rates and overall and aortic-related mortality. Multivariable analysis was performed aiming at identifying predictors of technical success, 30-day mortality, and major adverse events. RESULTS Overall, 1274 patients were included in the study from 19 centers. Median age was 74 (IQR, 68–79), and 75.7% were men; 45.7% were complex abdominal aortic aneurysms, and 54.3% were thoracoabdominal aortic aneurysms; 65.5% patients presented electively, 24.6% were symptomatic, and 9.9% were ruptured. Most patients (83.1%) were submitted to a fenestrated repair, 3.6% to branched repair, and 13.4% to a combined fenestrated and branched repair. Most patients (85.8%) had ≥3 target vessels included. The overall technical success was 94% (94% in elective, 93.4% in symptomatic, and 95.1% in ruptured cases). Thirty-day mortality was 5.8% (4.1% in elective, 7.6% in symptomatic, and 12.7% in ruptured aneurysms). Major adverse events occurred in 25.2% of cases (23.1% in elective, 27.8% in symptomatic, and 30.3% in ruptured aneurysms). Median follow-up was 21 months (5.6–50.6). Freedom from reintervention was 73.8%, 61.8%, and 51.4% at 1, 3, and 5 years; primary target vessel patency was 96.9%, 93.6%, and 90.3%. Overall survival and freedom from aortic-related mortality was 82.4%/92.9%, 69.9%/91.6%, and 55.0%/89.1% at 1, 3, and 5 years. CONCLUSIONS PMEGs were a safe and effective treatment option for elective, symptomatic, and ruptured complex aortic aneurysms. Long-term data and future prospective studies are needed for more robust and detailed analysis.

Modern hybrid rooms have greatly facilitated complex aortic endovascular procedures such as FEVAR or BEVAR. Compared to mobile C-arm, they also allow a significant reduction of radiation exposure and contrast medium injection. The objective of this chapter is to describe imaging tools developed to optimize complex aortic interventions. This not only means optimizing procedure steps but also refers to adequate case preparation and ability to detect technical issues at the end of the procedure.

Objectives To assess mid-term results of physician-modified stent grafts (PMSG) for the treatment of emergent complex abdominal and thoraco-abdominal aortic aneurysms in high-risk patients. Methods All consecutive patients with emergent complex abdominal or thoracoabdominal aortic aneurysms undergoing PMSG technique between January 2012 and July 2019 were retrospectively included. Indications for PMSG were symptomatic aneurysms and rapidly growing aneurysms > 70 mm. Ruptured aneurysms were excluded. Results Thirty-three patients (mean age: 74 +/- 11 years) were included. The mean aneurysm diameter was 76 +- 20mm. Patients presented with thoracoabdominal aortic aneurysms (TAAA, n=20, 61%), complex abdominal aortic aneurysms (CAAA, n=9, 27%), type I endoleak after previous EVAR (n=3, 9%) and intramural aortic hematoma (n=1, 3%). Chimney technique was performed in addition to PMSG in seven cases (21%). Intraoperative adverse events were recorded in seven cases (35%) in the TAAA group and one case (11%) in the CAAA group. In-hospital mortality rate was 15% (n=3) in the TAAA group and 11% (n=1) in the CAAA group. Moderate to severe complications were recorded in 45% of cases (n=15). Spinal cord ischemia occurred in two cases (6%, one case without residual deficit and one with minor motor deficit). One (3%) patient required transient haemodialysis. One patient presented with early aortic rupture and required an open conversion. The mean follow-up duration was 31 months (1-79). Overall survival estimates were 81.4% (CI95%: 63.1.-91.2) at one year and 71.6% (CI95%: 52.6-84.1) at two years. Freedom from reintervention rates at 1 and 2 years were 61.2% (CI95%: 41.7-75.9) and 57.4% (CI95%: 37.9-72.8). Target vessel primary patency rates at 1 and 2 years were 99.2% (CI95%: 94.2-99.9) and 97.7% (CI95%: 90.7-99.4). Conclusions PMSG for high-risk patients with complex aneurysms provided acceptable technical success and excellent target vessel patency rates but were associated with a 12% in-hospital mortality rate. Reinterventions were frequent. This technique should be limited to selected high-risk patients for whom the risk of rupture in the short term is deemed too high to wait for graft manufacturing of custom-made device.

Objectif L’exclusion endovasculaire des anévrysmes de l’aorte abdominale est associée à une réduction de la mortalité et morbidité précoces. En vue d’une réduction supplémentaire du risque, notamment celui lié à l’anesthésie générale (AG), l’hypnose semble représenter une alternative, chez les patients à haut risque. L’objectif de cette étude est d’évaluer la contribution de l’hypnose associée à l’anesthésie locale (AL) dans cette chirurgie. Patients Tous les patients ayant bénéficié d’une implantation d’endoprothèse aortique sous-rénale ou fenêtrée/branchée sous hypnose + AL de janvier 2013 à décembre 2015 ont été inclus rétrospectivement (n = 28). Une cohorte-contrôle de patients sous AG ayant été opérée durant la même période (n = 43) a été constituée. Les données péri-opératoires ont été collectées dans une base de données renseignée prospectivement. Résultats Vingt-huit patients (âge moyen 70,9 ans) ont été inclus dans le groupe hypnose, versus 43 patients (âge moyen 75 ans) dans le groupe contrôle. Le suivi médian était de 2,8 ± 1,9 ans. Les caractéristiques des groupes (démographie, comorbidités, anatomie) étaient comparables. Huit (28 %) endoprothèses dans le groupe hypnose et 14 (32 %) dans le groupe AG étaient supra rénales. Aucune différence significative n’a été retrouvée en termes de durée de séjour en soins intensifs (p = 06), de survenue d’endofuites, de réintervention, ou de mortalité à 30 jours (p = 1,00, p = 0,73, et 0,24, respectivement). Le groupe hypnose a bénéficié d’un usage significativement moindre de noradrénaline (0,04 ± 0,1 mgh-1 vs 1,2 ± 4,0, p < 0,001), d’une durée opératoire inférieure (181,2 ± 71,4 min vs 214,3 ± 79,6 min, p = 0,04) et d’une durée d’hospitalisation plus courte (5,4 ± 3,2 jours vs. 8,4 ± 5,9 jours, p = 0,002). Conclusion L’hypnose pendant le traitement endovasculaire des anévrysmes de l’aorte n’a pas d’impact négatif sur les résultats cliniques. Elle semble réduire la nécessité de recours aux vasopresseurs, ainsi que la durée opératoire et de séjour hospitalier.

Background Among asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence. Methods ACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362. Findings Between Jan 15, 2008, and Dec 31, 2020, 3625 patients in 130 centres were randomly allocated, 1811 to CAS and 1814 to CEA, with good compliance, good medical therapy and a mean 5 years of follow-up. Overall, 1% had disabling stroke or death procedurally (15 allocated to CAS and 18 to CEA) and 2% had non-disabling procedural stroke (48 allocated to CAS and 29 to CEA). Kaplan-Meier estimates of 5-year non-procedural stroke were 2·5% in each group for fatal or disabling stroke, and 5·3% with CAS versus 4·5% with CEA for any stroke (rate ratio [RR] 1·16, 95% CI 0·86–1·57; p=0·33). Combining RRs for any non-procedural stroke in all CAS versus CEA trials, the RR was similar in symptomatic and asymptomatic patients (overall RR 1·11, 95% CI 0·91–1·32; p=0·21). Interpretation Serious complications are similarly uncommon after competent CAS and CEA, and the long-term effects of these two carotid artery procedures on fatal or disabling stroke are comparable. Funding UK Medical Research Council and Health Technology Assessment Programme.

Objective: Current guidelines recommending rapid revascularisation of symptomatic carotid stenosis are largely based on data from clinical trials performed at a time when best medical therapy was potentially less effective than today. The risk of stroke and its predictors among patients with symptomatic carotid stenosis awaiting revascularisation in recent randomised controlled trials (RCTs) and in medical arms of earlier RCTs was assessed. Methods: The pooled data of individual patients with symptomatic carotid stenosis randomised to stenting (CAS) or endarterectomy (CEA) in four recent RCTs, and of patients randomised to medical therapy in three earlier RCTs comparing CEA vs. medical therapy, were compared. The primary outcome event was any stroke occurring between randomisation and treatment by CAS or CEA, or within 120 days after randomisation. Results: A total of 4 754 patients from recent trials and 1 227 from earlier trials were included. In recent trials, patients were randomised a median of 18 (IQR 7, 50) days after the qualifying event (QE).Twenty-three suffered a stroke while waiting for revascularisation (cumulative 120 day risk 1.97%, 95% confidence interval [CI] 0.75 e 3.17). Shorter time from QE until randomisation increased stroke risk after randomisation ( c 2 ¼ 6.58, p ¼ .011). Sixty-one patients had a stroke within 120 days of randomisation in the medical arms of earlier trials (cumulative risk 5%, 95% CI 3.8 e 6.2). Stroke risk was lower in recent than earlier trials when adjusted for time between QE and randomisation, age, severity of QE, and degree of carotid stenosis (HR 0.47, 95% CI 0.25 e 0.88, p ¼ .019). Conclusion: Patients with symptomatic carotid stenosis enrolled in recent large RCTs had a lower risk of stroke after randomisation than historical controls.The added benefit of carotid revascularisation to modern medical care needs to be revisited in future studies. Until then, adhering to current recommendations for early revascularisation of patients with symptomatic carotid stenosis considered to require invasive treatment is advisable.

Objective: To investigate whether the well documented perioperative survival advantage of emergency endovascular aneurysm repair (EVAR) over open repair is sustained in follow-up. Methods: A systematic review conforming to the PRISMA statement standards was conducted to identify studies that reported follow-up outcomes of endovascular versus open repair for ruptured abdominal aortic aneurysm. Electronic bibliographic sources (MEDLINE, EMBASE, CINHAL, and CENTRAL) were interrogated using the Healthcare Databases Advanced Search interface. A time-to-event data meta-analysis was performed using the inverse-variance method and the result was reported as summary hazard ratio (HR) and associated 95% confidence intervals (CI). Mixed effects regression was applied to investigate outcome changes over time. The quality of the body of evidence was appraised using the GRADE system. Results: Three randomized controlled trials (RCTs) and 22 observational studies reporting a total of 31,383 patients were included in quantitative synthesis. The mean duration of follow-up ranged across the studies from 232 days to 4.9 years. The overall all-cause mortality was significantly lower after EVAR than after open repair (HR 0.79, 95% CI 0.73-0.86), but the post-discharge all-cause mortality was not significantly different (HR 1.10, 95% CI 0.85-1.43). The aneurysm related mortality, that was reported by one RCT, was not significantly different between EVAR and open repair (HR 0.89, 95% CI 0.69-1.15). Meta-regression showed the mortality difference in favour of EVAR was more pronounced in recent studies (P=0.069) and recently treated patients (P=0.062). The certainty for the body of evidence for overall and post-discharge all-cause mortality was judged to be low, and for aneurysm-related mortality it was high. Conclusions: EVAR has a sustained mortality benefit in follow-up over open repair. A wider adoption of an endovascular-first strategy is justified.

Objective Current guidelines recommending rapid revascularisation of symptomatic carotid stenosis are largely based on data from clinical trials performed at a time when best medical therapy was potentially less effective than today. The risk of stroke and its predictors among patients with symptomatic carotid stenosis awaiting revascularisation in recent randomised controlled trials (RCTs) and in medical arms of earlier RCTs was assessed. Methods The pooled data of individual patients with symptomatic carotid stenosis randomised to stenting (CAS) or endarterectomy (CEA) in four recent RCTs, and of patients randomised to medical therapy in three earlier RCTs comparing CEA vs. medical therapy, were compared. The primary outcome event was any stroke occurring between randomisation and treatment by CAS or CEA, or within 120 days after randomisation. Results A total of 4 754 patients from recent trials and 1 227 from earlier trials were included. In recent trials, patients were randomised a median of 18 (IQR 7, 50) days after the qualifying event (QE). Twenty-three suffered a stroke while waiting for revascularisation (cumulative 120 day risk 1.97%, 95% confidence interval [CI] 0.75 – 3.17). Shorter time from QE until randomisation increased stroke risk after randomisation (χ² = 6.58, p = .011). Sixty-one patients had a stroke within 120 days of randomisation in the medical arms of earlier trials (cumulative risk 5%, 95% CI 3.8 – 6.2). Stroke risk was lower in recent than earlier trials when adjusted for time between QE and randomisation, age, severity of QE, and degree of carotid stenosis (HR 0.47, 95% CI 0.25 – 0.88, p = .019). Conclusion Patients with symptomatic carotid stenosis enrolled in recent large RCTs had a lower risk of stroke after randomisation than historical controls. The added benefit of carotid revascularisation to modern medical care needs to be revisited in future studies. Until then, adhering to current recommendations for early revascularisation of patients with symptomatic carotid stenosis considered to require invasive treatment is advisable.