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1.
Br J Surg ; 107(6): 662-668, 2020 05.
Article in English | MEDLINE | ID: mdl-32162310

ABSTRACT

BACKGROUND: The effectiveness of carotid endarterectomy (CEA) for stroke prevention depends on low procedural risks. The aim of this study was to assess the frequency and timing of procedural complications after CEA, which may clarify underlying mechanisms and help inform safe discharge policies. METHODS: Individual-patient data were obtained from four large carotid intervention trials (VACS, ACAS, ACST-1 and GALA; 1983-2007). Patients undergoing CEA for asymptomatic carotid artery stenosis directly after randomization were used for the present analysis. Timing of procedural death and stroke was divided into intraoperative day 0, postoperative day 0, days 1-3 and days 4-30. RESULTS: Some 3694 patients were included in the analysis. A total of 103 patients (2·8 per cent) had serious procedural complications (18 fatal strokes, 68 non-fatal strokes, 11 fatal myocardial infarctions and 6 deaths from other causes) [Correction added on 20 April, after first online publication: the percentage value has been corrected to 2·8]. Of the 86 strokes, 67 (78 per cent) were ipsilateral, 17 (20 per cent) were contralateral and two (2 per cent) were vertebrobasilar. Forty-five strokes (52 per cent) were ischaemic, nine (10 per cent) haemorrhagic, and stroke subtype was not determined in 32 patients (37 per cent). Half of the strokes happened on the day of CEA. Of all serious complications recorded, 44 (42·7 per cent) occurred on day 0 (20 intraoperative, 17 postoperative, 7 with unclear timing), 23 (22·3 per cent) on days 1-3 and 36 (35·0 per cent) on days 4-30. CONCLUSION: At least half of the procedural strokes in this study were ischaemic and ipsilateral to the treated artery. Half of all procedural complications occurred on the day of surgery, but one-third after day 3 when many patients had been discharged.


ANTECEDENTES: La efectividad de la endarterectomía carotídea (carotid endarterectomy, CEA) en la prevención de un accidente cerebrovascular depende de que este procedimiento tenga pocos riesgos. El objetivo de este estudio fue evaluar la frecuencia y el momento de aparición de las complicaciones tras una CEA, lo que podría clarificar los mecanismos subyacentes y ayudar a establecer una política de altas hospitalarias segura. MÉTODOS: Se utilizaron los datos de los pacientes incluidos en cuatro grandes ensayos de intervención carotídea (VACS, ACAS, ACST-1 y GALA; 1983-2007). Para el presente análisis se utilizaron los datos de pacientes sometidos a CEA por estenosis de la arteria carótida asintomática recogidos inmediatamente tras la aleatorización. Se consideraron diferentes intervalos entre el procedimiento, la muerte o el accidente cerebrovascular: intraoperatorio día 0, postoperatorio día 0, postoperatorio días 1-3 y postoperatorio días 4-30. RESULTADOS: En el análisis se incluyeron 3.694 pacientes. Se detectaron complicaciones graves relacionadas con el procedimiento en 103 (2,8%) pacientes (18 accidentes cerebrovasculares fatales, 68 accidentes cerebrovasculares no fatales, 11 infartos de miocardio fatales y 6 muertes por otras causas). De los 86 accidentes cerebrovasculares, 67 (78%) fueron ipsilaterales, 17 (20%) contralaterales y dos (2%) vertebrobasilares. Los accidentes cerebrovasculares fueron isquémicos en 45 (52%) casos, hemorrágicos en 9 (10%) y no se pudo determinar el subtipo de ictus en 32 (37%). La mitad de los accidentes cerebrovasculares ocurrieron el día de la CEA. De todas las complicaciones graves registradas, 44 (43%) ocurrieron en el día 0 (20 intraoperatorias, 17 postoperatorias y 7 en períodos poco definidos), 23 (22%) entre los días 1-3 y 36 (35%) entre los días 4-30. CONCLUSIÓN: En este estudio, al menos la mitad de los accidentes cerebrovasculares relacionados con la CEA fueron isquémicos e ipsilaterales respecto a la arteria tratada. La mitad de todas las complicaciones de la CEA ocurrieron el día de la cirugía, pero un tercio de los casos se presentaron después del día 3, cuando muchos pacientes ya habían sido dados de alta.


Subject(s)
Carotid Stenosis/surgery , Endarterectomy, Carotid/adverse effects , Endarterectomy, Carotid/mortality , Postoperative Complications , Stroke/etiology , Adult , Aged , Aged, 80 and over , Asymptomatic Diseases , Carotid Stenosis/complications , Female , Humans , Male , Middle Aged , Postoperative Complications/diagnosis , Postoperative Complications/epidemiology , Randomized Controlled Trials as Topic , Stroke/epidemiology , Stroke/prevention & control , Time Factors , Treatment Outcome
4.
Br J Surg ; 104(3): 166-178, 2017 02.
Article in English | MEDLINE | ID: mdl-28160528

ABSTRACT

BACKGROUND: The erosion of the early mortality advantage of elective endovascular aneurysm repair (EVAR) compared with open repair of abdominal aortic aneurysm remains without a satisfactory explanation. METHODS: An individual-patient data meta-analysis of four multicentre randomized trials of EVAR versus open repair was conducted to a prespecified analysis plan, reporting on mortality, aneurysm-related mortality and reintervention. RESULTS: The analysis included 2783 patients, with 14 245 person-years of follow-up (median 5·5 years). Early (0-6 months after randomization) mortality was lower in the EVAR groups (46 of 1393 versus 73 of 1390 deaths; pooled hazard ratio 0·61, 95 per cent c.i. 0·42 to 0·89; P = 0·010), primarily because 30-day operative mortality was lower in the EVAR groups (16 deaths versus 40 for open repair; pooled odds ratio 0·40, 95 per cent c.i. 0·22 to 0·74). Later (within 3 years) the survival curves converged, remaining converged to 8 years. Beyond 3 years, aneurysm-related mortality was significantly higher in the EVAR groups (19 deaths versus 3 for open repair; pooled hazard ratio 5·16, 1·49 to 17·89; P = 0·010). Patients with moderate renal dysfunction or previous coronary artery disease had no early survival advantage under EVAR. Those with peripheral artery disease had lower mortality under open repair (39 deaths versus 62 for EVAR; P = 0·022) in the period from 6 months to 4 years after randomization. CONCLUSION: The early survival advantage in the EVAR group, and its subsequent erosion, were confirmed. Over 5 years, patients of marginal fitness had no early survival advantage from EVAR compared with open repair. Aneurysm-related mortality and patients with low ankle : brachial pressure index contributed to the erosion of the early survival advantage for the EVAR group. Trial registration numbers: EVAR-1, ISRCTN55703451; DREAM (Dutch Randomized Endovascular Aneurysm Management), NCT00421330; ACE (Anévrysme de l'aorte abdominale, Chirurgie versus Endoprothèse), NCT00224718; OVER (Open Versus Endovascular Repair Trial for Abdominal Aortic Aneurysms), NCT00094575.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Elective Surgical Procedures/methods , Endovascular Procedures , Vascular Grafting/methods , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/mortality , Female , Humans , Male , Middle Aged , Models, Statistical , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Reoperation , Treatment Outcome
6.
Eur J Vasc Endovasc Surg ; 50(5): 583-92, 2015 Nov.
Article in English | MEDLINE | ID: mdl-26259766

ABSTRACT

OBJECTIVES: The aim was to determine whether physician modified stent grafts (PMSGs) are safe and effective for the treatment of high risk patients with thoraco-abdominal aortic aneurysms (TAAAs). DESIGN: This was a retrospective single institution study. MATERIAL: Consecutive patients with TAAA undergoing endovascular repair using a PMSG between January 2012 and June 2014 were evaluated. METHODS: Fenestrations to preserve branch vessels were created in TX2 thoracic (Cook Medical) stent grafts. Pre- intra- and post-operative data were recorded by means of a prospectively maintained database. RESULTS: Eleven high risk patients with TAAA (type I, n = 4; type III, n = 3; type IV, n = 3; type V, n = 1) underwent fenestrated endovascular repair using PMSGs. Indications were painful aneurysm (n = 5), >70 mm rapidly enlarging aneurysm (n = 4), saccular aneurysm (n = 1), and visceral patch false aneurysm after open repair of a type IV TAAA (n = 1). In four asymptomatic patients, an additional fenestration was created for temporary selective sac perfusion and occluded 2-4 weeks later. Median duration for stent graft modifications was 2 hours (range 1-3 hours). The median number of fenestrations was three (range 2-4). One patient died during the post-operative period from colonic ischemia, giving a 9% in hospital mortality rate. Four (36%) patients presented with moderate to severe complications. One (9%) patient presented with a paraparesis that resolved completely after spinal fluid drainage. Among surviving patients, four required early endovascular re-intervention for type III endoleak (n = 2), type Ia endoleak (n = 1), or target vessel cannulation failure (n = 1). The median follow up time was 6 months (range 3-20 months). During follow up, no other complications occurred and all target vessels remained patent. One patient presented with a persistent type II endoleak. CONCLUSION: PMSGs provided acceptable short-term results and may be a management option for the treatment of TAAA in selected high risk patients. Durability concerns need to be assessed in additional studies with long-term follow up.


Subject(s)
Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis , Stents , Aged , Aged, 80 and over , Endovascular Procedures/instrumentation , Endovascular Procedures/methods , Female , Humans , Male , Middle Aged , Prosthesis Design , Retrospective Studies , Time Factors , Treatment Outcome
7.
Eur J Vasc Endovasc Surg ; 50(2): 189-96, 2015 Aug.
Article in English | MEDLINE | ID: mdl-26100447

ABSTRACT

OBJECTIVE: To compare 30 day outcomes and costs of fenestrated and branched stent grafts (f/b EVAR) and open surgery (OSR) for the treatment of complex abdominal aortic aneurysms (AAA) and thoraco-abdominal aortic aneurysms (TAAA). METHODS: The multicenter prospective registry WINDOW was set up to evaluate f/b EVAR in high risk patients with para/juxtarenal AAA, and infradiaphragmatic and supradiaphragmatic TAAA. A control group of patients treated by OSR was extracted from the national hospital discharge database. The primary endpoint was 30 day mortality. Secondary endpoints included severe complications, length of stay, and costs. Mortality was assessed by survival analysis and uni/multivariate Cox regression analyses using pre- and post-operative characteristics. Bootstrap methods were used to estimate the cost-effectiveness of f/b EVAR versus OSR. RESULTS: Two hundred and sixty eight cases and 1,678 controls were included. There was no difference in 30 day mortality (6.7% vs. 5.4%, p = 0.40), but costs were higher with f/b EVAR (€38,212 vs. €16,497, p < .001). After group stratification, mortality was similar with both treatments for para/juxtarenal AAA (4.3% vs. 5.8%, p = .26) and supradiaphragmatic TAAA (11.9% vs. 19.7%, p = .70), and higher with f/b EVAR for infradiaphragmatic TAAA (11.9% vs. 4.0%, p = .010). Costs were higher with f/b EVAR for para/juxtarenal AAA (€34,425 vs. €14,907, p < .0001) and infradiaphragmatic TAAA (€37,927 vs. €17,530, p < .0001), but not different for supradiaphragmatic TAAA (€54,710 vs. €44,163, p = .18). CONCLUSION: f/b EVAR does not appear justified for patients with para/juxtarenal AAA and infradiaphragmatic TAAA fit for OSR but may be an attractive option for patients with para/juxtarenal AAA not eligible for surgery and patients with supradiaphragmatic TAAA. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov/ct2/show/NCT01168037; identifier: NCT01168037 (WINDOW registry).


Subject(s)
Aortic Aneurysm, Abdominal/economics , Aortic Aneurysm, Abdominal/surgery , Aortic Aneurysm, Thoracic/economics , Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis Implantation/economics , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis/economics , Endovascular Procedures/economics , Endovascular Procedures/instrumentation , Hospital Costs , Stents/economics , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnosis , Aortic Aneurysm, Abdominal/mortality , Aortic Aneurysm, Thoracic/diagnosis , Aortic Aneurysm, Thoracic/mortality , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/mortality , Case-Control Studies , Chi-Square Distribution , Cost-Benefit Analysis , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Female , France , Humans , Kaplan-Meier Estimate , Length of Stay/economics , Male , Middle Aged , Models, Economic , Multivariate Analysis , Proportional Hazards Models , Prospective Studies , Prosthesis Design , Registries , Time Factors , Treatment Outcome
8.
Eur J Vasc Endovasc Surg ; 50(3): 303-10, 2015 Sep.
Article in English | MEDLINE | ID: mdl-26001320

ABSTRACT

OBJECTIVES/BACKGROUND: ECAR (Endovasculaire ou Chirurgie dans les Anévrysmes aorto-iliaques Rompus) is a prospective multicentre randomized controlled trial including consecutive patients with ruptured aorto-iliac aneurysms (rAIA) eligible for treatment by either endovascular (EVAR) or open surgical repair (OSR). Inclusion criteria were hemodynamic stability and computed tomography scan demonstrating aorto-iliac rupture. METHODS: Randomization was done by week, synchronously in all centers. The primary end point was 30 day mortality. Secondary end points were post-operative morbidity, length of stay in the intensive care unit (ICU), amount of blood transfused (units) and 6 month mortality. RESULTS: From January 2008 to January 2013, 107 patients (97 men, 10 women; median age 74.4 years) were enrolled in 14 centers: 56 (52.3%) in the EVAR group and 51 (47.7%) in the OSR group. The groups were similar in terms of age, sex, consciousness, systolic blood pressure, Hardman index, IGSII score, type of rupture, use of endoclamping balloon, and levels of troponin, creatinine, and hemoglobin. Delay to treatment was higher in the EVAR group (2.9 vs. 1.3 hours; p < .005). Mortality at 30 days and 1 year were not different between the groups (18% in the EVAR group vs. 24% in the OSR group at 30 days, and 30% vs. 35%, respectively, at 1 year). Total respiratory support time was lower in the EVAR group than in the OSR group (59.3 hours vs. 180.3 hours; p = .007), as were pulmonary complications (15.4% vs. 41.5%, respectively; p = .050), total blood transfusion (6.8 vs. 10.9, respectively; p = .020), and duration of ICU stay (7 days vs. 11.9 days, respectively; p = .010). CONCLUSION: In this study, EVAR was found to be equal to OSR in terms of 30 day and 1 year mortality. However, EVAR was associated with less severe complications and less consumption of hospital resources than OSR.


Subject(s)
Aneurysm, Ruptured/surgery , Aortic Aneurysm, Abdominal/surgery , Aortic Rupture/surgery , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Iliac Aneurysm/surgery , Aged , Aged, 80 and over , Aneurysm, Ruptured/diagnosis , Aneurysm, Ruptured/economics , Aneurysm, Ruptured/mortality , Aortic Aneurysm, Abdominal/diagnosis , Aortic Aneurysm, Abdominal/economics , Aortic Aneurysm, Abdominal/mortality , Aortic Rupture/diagnosis , Aortic Rupture/economics , Aortic Rupture/mortality , Blood Transfusion , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/economics , Blood Vessel Prosthesis Implantation/mortality , Cost-Benefit Analysis , Endovascular Procedures/adverse effects , Endovascular Procedures/economics , Endovascular Procedures/mortality , Female , France , Hospital Costs , Hospital Mortality , Humans , Iliac Aneurysm/diagnosis , Iliac Aneurysm/economics , Iliac Aneurysm/mortality , Kaplan-Meier Estimate , Length of Stay , Male , Middle Aged , Postoperative Complications/mortality , Postoperative Complications/therapy , Prospective Studies , Time Factors , Treatment Outcome
9.
Eur J Vasc Endovasc Surg ; 49(6): 655-660, 2015 Jun.
Article in English | MEDLINE | ID: mdl-25805327

ABSTRACT

OBJECTIVE: Reports of thoracic endovascular aortic repair (TEVAR) for complicated acute type B aortic dissection (ABAD) bring together a large range of clinical presentations. With a 30 day mortality of 50% when managed with open surgery, rupture is the most devastating complication of ABAD. This study investigated the outcome of TEVAR for ABAD complicated by rupture (r-ABAD) to assess the results of this particularly critical subgroup. METHODS: A review of consecutive TEVAR for r-ABAD in two tertiary referral centers was performed using a prospectively maintained database. RESULTS: Between 2000 and 2013, 24 patients (mean age 71 years; 14 males) underwent TEVAR for r-ABAD. Sixteen (67%) were in shock (Systolic blood pressure <80 mmHg) before surgery. Seven patients had coverage of the left subclavian artery, of whom four had partial arch debranching procedures via cervical access concomitant with TEVAR. Median length of aortic coverage was 150 mm, median proximal oversizing was 13.3% (range 6.2-33.3%). Technical success was achieved in 100%. There were four in hospital deaths (16%). Two patients (8%) had paraplegia, but neither stroke nor renal insufficiency requiring dialysis occurred. During a mean follow up of 28 months, there was one aortic dissection related death and eight patients (40% of the surviving patients) required re-intervention. All re-interventions were managed endovascularly. At last follow up CT scan, eight patients (40%) had complete remodeling of the aortic wall. CONCLUSION: With 16% in hospital mortality and 8% early major complications, this study confirms the feasibility of TEVAR for r-ABAD with a lower peri-operative morbidity and mortality rate compared with open surgery. Given the high rate of re-intervention, close follow up is required in surviving patients.


Subject(s)
Aortic Aneurysm, Thoracic/surgery , Aortic Dissection/surgery , Aortic Rupture/surgery , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Acute Disease , Adult , Aged , Aged, 80 and over , Aortic Dissection/diagnosis , Aortic Dissection/mortality , Aortic Aneurysm, Thoracic/diagnosis , Aortic Aneurysm, Thoracic/mortality , Aortic Rupture/diagnosis , Aortic Rupture/mortality , Aortography/methods , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis Implantation/mortality , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Endovascular Procedures/mortality , Feasibility Studies , Female , France , Hospital Mortality , Humans , Male , Middle Aged , Postoperative Complications/mortality , Postoperative Complications/surgery , Reoperation , Retrospective Studies , Risk Factors , Tertiary Care Centers , Time Factors , Tomography, X-Ray Computed , Treatment Outcome
10.
Ann Surg ; 261(1): 197-206, 2015 Jan.
Article in English | MEDLINE | ID: mdl-24670864

ABSTRACT

OBJECTIVE: To present results and to identify predictive factors of early outcome after fenestrated and/or branched endovascular repair (f/b-EVAR) for complex aortic aneurysms, abdominal (AAA) and thoracoabdominal (TAAA). BACKGROUND: Feasibility of f/b-EVAR for complex aneurysms is now established, but little is known about which patients will benefit from this technique. METHODS: Univariate and multivariate analysis of preoperative and intraoperative factors on postoperative mortality and complications was performed on 268 patients (group 1: juxta- and pararenal AAA; group 2: suprarenal and TAAA IV; group 3: TAAA I, II, III) enrolled in a prospective multicenter trial of f/b-EVAR. RESULTS: Thirty-day mortality, in-hospital mortality (IM), and combined mortality and severe complications (CMSC) rates were 6.7%, 10.1%, and 22.0%, respectively. Group belonging (2 or 3 vs 1) was the only preoperative predictive factor of CMSC [hazard ratio (HR) = 2.10; 95% confidence interval (CI): 1.26-3.48; P = 0.0043]. Occurrence of a technical complication and duration of intervention significantly influenced both IM (HR = 4.39; 95% CI: 2.05-9.38; P = 0.0001) and CMSC (HR = 3.07; 95% CI: 1.84-5.11; P < 0.0001). Postoperative events associated with increased IM were spinal cord ischemia (HR = 9.46; 95% CI: 3.98-22.47; P < 0.0001), hemodialysis (HR = 27.44; 95% CI: 12.63-59.61; P < 0.0001), and reintervention (HR = 4.45; 95% CI: 2.03-9.73; P = 0.0002). CONCLUSIONS: Although promising, f/b-EVAR still carries a significant rate of mortality and complications, mostly related to the complexity of the procedure. In these complex cases, new strategies should be investigated to improve outcomes.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis Implantation/methods , Stents , Aged , Blood Vessel Prosthesis Implantation/adverse effects , Female , Hospital Mortality , Humans , Male , Middle Aged , Operative Time , Prospective Studies , Treatment Outcome
11.
Eur J Vasc Endovasc Surg ; 27(3): e21-e23, 2014 Mar.
Article in English | MEDLINE | ID: mdl-24920877

ABSTRACT

INTRODUCTION: Chronic mesenteric ischemia (CMI) is a challenging problem, with revascularization the mainstay of treatment. Management of CMI is especially challenging in the patient with superior mesenteric artery (SMA) and celiac artery (CA) occlusions. REPORT: We report a case series of four patients with chronic mesenteric ischemia who were not candidates for CA or SMA revascularization who were successfully treated with inferior mesenteric artery (IMA) angioplasty and stent placement to improve collateral circulation and palliate symptoms. DISCUSSION: To our knowledge, this is the largest case series to date reporting the use of an IMA stent to improve collateral circulation in patients with CMI.

12.
Eur J Vasc Endovasc Surg ; 48(3): 292-9, 2014 Sep.
Article in English | MEDLINE | ID: mdl-24923233

ABSTRACT

OBJECTIVES: To evaluate overall survival and complications of cryopreserved arterial allografts in aortic graft infections and infected aortic aneurysms. METHODS: A retrospective review of consecutive patients was conducted with native or prosthetic aortic infections, who underwent local debridement and in situ implantation of a cryopreserved aortic allograft from September 2004 to June 2012 at the Henri Mondor University Hospital. Patient characteristics, indications for allograft implantation, perioperative events, bacteriological data, and events related to follow-up were identified. The primary outcome was overall survival. Overall survival was estimated using the Kaplan-Meier method. Predictors of postoperative mortality were identified using uni- and multivariate analysis with a Cox proportional hazard regression. RESULTS: During the study period, 54 patients (45 [83%] men, mean age 66.2 ± 10.2 years) underwent aortic reconstruction using cryopreserved allografts. Indications were native aortic infection in 17 patients and prosthetic graft infection in 37 patients, including seven aortoenteric fistulae. Twelve aortic reconstructions (22%) were performed as emergency procedures. The median duration of follow-up was 12.1 months (range 0.4-83.6). The 30-day mortality rate was 28%. The overall mortality rate was 39% at a median follow-up of 12.1 months. Early significant postoperative complications occurred in 52% of patients. The graft-related mortality rate was 7%. The graft-related complication rate was 19%. During follow-up, there were two recurrences of aortic infection and two recurrences of allograft limb occlusion. Multivariate survival analysis identified age, chronic renal disease, prosthetic infection, emergent procedure, and coronary disease as independent predictors for postoperative mortality. CONCLUSION: This experience with cryopreserved aortic allografts in aortic reconstructions shows an unsatisfactory 30-day survival rate, as well as a substantial early graft-related complication rate. Longer follow-up is needed in order to support the preferential use of cryopreserved allografts based on their long-term behavior.


Subject(s)
Aneurysm, Infected/surgery , Aortic Aneurysm/surgery , Blood Vessel Prosthesis/adverse effects , Prosthesis-Related Infections/surgery , Vascular Surgical Procedures/methods , Aged , Allografts , Cryopreservation , Female , Humans , Male , Postoperative Complications/mortality , Retrospective Studies , Survival Rate , Treatment Outcome
13.
Eur J Vasc Endovasc Surg ; 47(5): 470-8, 2014 May.
Article in English | MEDLINE | ID: mdl-24656593

ABSTRACT

OBJECTIVES: The aim of this study was to assess the results of hybrid techniques for the treatment of thoracic, thoracoabdominal, and abdominal aortic aneurysms based on multicenter results and the various series regarding hybrid procedures reported in the literature. METHODS: The results of 76 hybrid procedures performed in 19 French university hospital centers between November 2001 and October 2011 were collected. There were 50 men and 26 women, mean age 68.2 (35-86) years. All patients were considered at high risk (ASA≥3) for conventional surgery. Aneurysms involved the thoracic, abdominal, and thoracoabdominal aorta in five, 14, and 57 cases respectively. There were 11 emergent repairs. The revascularization of four visceral arteries was performed in 38 cases. Between one and three visceral arteries were revascularized in the other cases. Visceral artery debranching and stent graft deployment were performed in a one-stage procedure in 53 cases and in a two-stage procedure in 23 cases. RESULTS: There were 26 (34.2%) postoperative deaths. Nine of the survivors developed paraplegia, of which one resolved completely. Bowel ischemia occurred in 13 cases (17.1%), and one patient was treated by a superior mesenteric artery bypass. Four patients required long-term hemodialysis. Postoperative computed tomography scan showed a type II endoleak in two patients. CONCLUSIONS: Morbidity and mortality in this study were greater than previously reported. Candidates for hybrid aortic repair should be carefully selected.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis , Vascular Surgical Procedures/methods , Adult , Aged , Aged, 80 and over , Angiography , Aortic Aneurysm, Abdominal/diagnosis , Aortic Aneurysm, Abdominal/epidemiology , Aortic Aneurysm, Thoracic/diagnosis , Aortic Aneurysm, Thoracic/epidemiology , Female , France/epidemiology , Humans , Male , Middle Aged , Morbidity/trends , Retrospective Studies , Survival Rate/trends , Tomography, X-Ray Computed , Treatment Outcome
14.
J Cardiovasc Surg (Torino) ; 55(2): 229-34, 2014 Apr.
Article in English | MEDLINE | ID: mdl-24670831

ABSTRACT

AIM: The indication for use of drug-eluting stents (DES) in lower limb arteries is still undefined. We report our series of patients treated with Zilver PTS DES, in treating in-stent restenosis (ISR) and Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC) C/D femoropopliteal lesions. METHODS: The Zilver PTX DES is a self-expanding nitinol stent with a polymer-free Paclitaxel coating. Patients with symptomatic de novo TASC C/D lesions or IRS lesions of femoropopliteal segment were eligible for enrollment. We evaluated patients at one month, six months and one year after treatment. We used clinical evaluation criteria and US Doppler for primary and secondary patency-free rates. RESULTS: From November 2010 to November 2012, we treated 69 patients with DES Zilver PTX. Indication to treat was given in 36 lesions (52%) by an ISR and in 33 cases (48%) by a TASC C/D lesion. Lesions were staged in the superficial femoral artery (SFA) level in 59 patients (85.6%), in the popliteal artery in 6 patients (8.7%), in a femoropopliteal bypass in 4 patients (5.7%). The mean follow-up was 5.3 months (range 1-24). At 12 months the overall primary patency was 85.5%, secondary patency 89.8% and limb salvage 100%. CONCLUSION: Zilver PTX DES seems to be effective in treating TASC C/D lesions and ISR in femoropopliteal lesions at short term. Therefore DES should be recommended when treating those complex lesions.


Subject(s)
Cardiovascular Agents/administration & dosage , Drug-Eluting Stents , Endovascular Procedures/instrumentation , Paclitaxel/administration & dosage , Peripheral Arterial Disease/therapy , Aged , Aged, 80 and over , Alloys , Constriction, Pathologic , Disease-Free Survival , Endovascular Procedures/adverse effects , Female , Humans , Kaplan-Meier Estimate , Limb Salvage , Male , Middle Aged , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/physiopathology , Prosthesis Design , Recurrence , Time Factors , Treatment Outcome , Ultrasonography, Doppler , Vascular Patency
15.
Stroke ; 45(2): 527-32, 2014 Feb.
Article in English | MEDLINE | ID: mdl-24347422

ABSTRACT

BACKGROUND AND PURPOSE: Randomized clinical trials show higher 30-day risk of stroke or death after carotid artery stenting compared with surgery. We examined whether operator experience is associated with 30-day risk of stroke or death in the Carotid Stenting Trialists' Collaboration database. METHODS: The Carotid Stenting Trialists' Collaboration is a pooled individual patient database including all patients recruited in 3 randomized trials of stenting versus endarterectomy for symptomatic carotid stenosis (Endarterectomy Versus Angioplasty in patients with Symptomatic Severe Carotid Stenosis trial, Stent-Protected Angioplasty versus Carotid Endarterectomy trial, and International Carotid Stenting Study). Lifetime carotid artery stenting experience, lifetime experience in stenting procedures excluding the carotid, and annual number of procedures performed within the trial (in-trial volume), divided into tertiles, were used to measure operator experience. The outcome event was the occurrence of any stroke or death within 30 days of the procedure. The analysis was done per protocol. RESULTS: Among 1546 patients who underwent carotid artery stenting, 120 (7.8%) had a stroke or death within 30 days of the procedure. The 30-day risk of stroke or death did not differ according to operator lifetime carotid artery stenting experience (P=0.8) or operator lifetime stenting experience excluding the carotid (P=0.7). In contrast, the 30-day risk of stroke or death was significantly higher in patients treated by operators with low (mean ≤3.2 procedures/y; risk 10.1%; adjusted risk ratio=2.30 [1.36-3.87]) and intermediate annual in-trial volumes (3.2-5.6 procedures/y; 8.4%; adjusted risk ratio=1.93 [1.14-3.27]) compared with patients treated by high annual in-trial volume operators (>5.6 procedures/y; 5.1%). CONCLUSIONS: Carotid stenting should only be performed by operators with annual procedure volume ≥6 cases per year.


Subject(s)
Carotid Stenosis/surgery , Stents , Aged , Aged, 80 and over , Angioplasty , Carotid Stenosis/complications , Carotid Stenosis/mortality , Clinical Protocols , Databases, Factual , Endarterectomy, Carotid , Female , Humans , Male , Middle Aged , Risk , Risk Factors , Stroke/mortality , Stroke/prevention & control , Treatment Outcome
16.
Eur J Vasc Endovasc Surg ; 47(1): 45-52, 2014 Jan.
Article in English | MEDLINE | ID: mdl-24268517

ABSTRACT

BACKGROUND: Several studies have examined inter-observer variability in measurements for standard EVAR, but little is known about measurements for complex aortic aneurysm. METHODS: Two independent observers reviewed all preoperative CT scans of 268 patients in a French trial of fenestrated and/or branched aortic stent-grafts (f/b-EVAR). Those data were compared with those obtained (1) by investigators (extent of aneurysm, target vessel stenosis, and aortic diameters), and (2) from manufacturers (proximal landing zone, device diameter, and target vessel position). We assessed the reproducibility using kappa statistics for qualitative data and both Bland-Altman plot and Passing-Bablok regression analysis for quantitative data. RESULTS: Reproducibility was moderate to almost perfect for all factors. However, a few critical discrepancies were found, such as target vessel clock position (≥45 minutes) and location (≥5 mm), level of proximal landing zone, and diameters of the endograft. CONCLUSIONS: This is the first large-scale analysis focused on inter-observer variability in sizing for f/b-EVAR. The measurement data showed good agreement, but there were some critical discrepancies between observers that may affect clinical results.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis , Endovascular Procedures/instrumentation , Stents , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortography/methods , France , Humans , Observer Variation , Predictive Value of Tests , Prospective Studies , Prosthesis Design , Radiographic Image Interpretation, Computer-Assisted , Reproducibility of Results , Tomography, X-Ray Computed
17.
Ultrasound Med Biol ; 39(8): 1325-36, 2013 Aug.
Article in English | MEDLINE | ID: mdl-23743100

ABSTRACT

The clinical reliability of 3-D ultrasound imaging (3-DUS) in quantification of abdominal aortic aneurysm (AAA) was evaluated. B-mode and 3-DUS images of AAAs were acquired for 42 patients. AAAs were segmented. A 3-D-based maximum diameter (Max3-D) and partial volume (Vol30) were defined and quantified. Comparisons between 2-D (Max2-D) and 3-D diameters and between orthogonal acquisitions were performed. Intra- and inter-observer reproducibility was evaluated. Intra- and inter-observer coefficients of repeatability (CRs) were less than 5.18 mm for Max3-D. Intra-observer and inter-observer CRs were respectively less than 6.16 and 8.71 mL for Vol30. The mean of normalized errors of Vol30 was around 7%. Correlation between Max2-D and Max3-D was 0.988 (p < 0.0001). Max3-D and Vol30 were not influenced by a probe rotation of 90°. Use of 3-DUS to quantify AAA is a new approach in clinical practice. The present study proposed and evaluated dedicated parameters. Their reproducibility makes the technique clinically reliable.


Subject(s)
Algorithms , Aortic Aneurysm, Abdominal/diagnostic imaging , Image Interpretation, Computer-Assisted/methods , Imaging, Three-Dimensional/methods , Pattern Recognition, Automated/methods , Ultrasonography/methods , Aged , Female , Humans , Image Enhancement/methods , Male , Reproducibility of Results , Sensitivity and Specificity
18.
Eur J Vasc Endovasc Surg ; 45(6): 666-72, 2013 Jun.
Article in English | MEDLINE | ID: mdl-23598054

ABSTRACT

PURPOSE: Abdominal aortic aneurysms (AAAs) expand because of aortic wall destruction. Enrichment in Vascular Smooth Muscle Cells (VSMCs) stabilizes expanding AAAs in rats. Mesenchymal Stem Cells (MSCs) can differentiate into VSMCs. We have tested the hypothesis that bone marrow-derived MSCs (BM-MSCs) stabilizes AAAs in a rat model. MATERIAL AND METHODS: Rat Fischer 344 BM-MSCs were isolated by plastic adhesion and seeded endovascularly in experimental AAAs using xenograft obtained from guinea pig. Culture medium without cells was used as control group. The main criteria was the variation of the aortic diameter at one week and four weeks. We evaluated the impact of cells seeding on inflammatory response by immunohistochemistry combined with RT-PCR on MMP9 and TIMP1 at one week. We evaluated the healing process by immunohistochemistry at 4 weeks. RESULTS: The endovascular seeding of BM-MSCs decreased AAA diameter expansion more powerfully than VSMCs or culture medium infusion (6.5% ± 9.7, 25.5% ± 17.2 and 53.4% ± 14.4; p = .007, respectively). This result was sustained at 4 weeks. BM-MSCs decreased expression of MMP-9 and infiltration by macrophages (4.7 ± 2.3 vs. 14.6 ± 6.4 mm(2) respectively; p = .015), increased Tissue Inhibitor Metallo Proteinase-1 (TIMP-1), compared to culture medium infusion. BM-MSCs induced formation of a neo-aortic tissue rich in SM-alpha active positive cells (22.2 ± 2.7 vs. 115.6 ± 30.4 cells/surface units, p = .007) surrounded by a dense collagen and elastin network covered by luminal endothelial cells. CONCLUSIONS: We have shown in this rat model of AAA that BM-MSCs exert a specialized function in arterial regeneration that transcends that of mature mesenchymal cells. Our observation identifies a population of cells easy to isolate and to expand for therapeutic interventions based on catheter-driven cell therapy.


Subject(s)
Aorta, Abdominal/pathology , Aortic Aneurysm, Abdominal/surgery , Bone Marrow Transplantation , Mesenchymal Stem Cell Transplantation , Muscle, Smooth, Vascular/transplantation , Myocytes, Smooth Muscle/transplantation , Animals , Aorta, Abdominal/metabolism , Aorta, Abdominal/transplantation , Aortic Aneurysm, Abdominal/genetics , Aortic Aneurysm, Abdominal/metabolism , Aortic Aneurysm, Abdominal/pathology , Cell Differentiation , Cells, Cultured , Disease Models, Animal , Guinea Pigs , Immunohistochemistry , Male , Matrix Metalloproteinase 9/genetics , Matrix Metalloproteinase 9/metabolism , Muscle, Smooth, Vascular/metabolism , Muscle, Smooth, Vascular/pathology , Myocytes, Smooth Muscle/metabolism , Myocytes, Smooth Muscle/pathology , Rats , Rats, Inbred F344 , Regeneration , Reverse Transcriptase Polymerase Chain Reaction , Time Factors , Tissue Inhibitor of Metalloproteinase-1/genetics , Tissue Inhibitor of Metalloproteinase-1/metabolism
20.
Eur J Vasc Endovasc Surg ; 42(6): 742-50, 2011 Dec.
Article in English | MEDLINE | ID: mdl-21889369

ABSTRACT

OBJECTIVES: To analyse perioperative and midterm outcomes of carotid artery stenting (CAS) for symptomatic >50% and asymptomatic >70% restenosis after open carotid surgery (OCS). DESIGN: A multicentric retrospective study. METHODS: Outcome measures 30-day death, neurologic and anatomic (thrombosis, restenosis) events. Univariant and multivariant logistic regression analyses were performed to identify predictive factors for neurologic and anatomic events. RESULTS: A total of 249 patients with a mean age of 69 years (range, 45-88) were treated for asymptomatic (86%) or symptomatic (14%) restenosis. The 30-day combined operative mortality and stroke morbidity was 2.8% in asymptomatic patients and 2.9% in symptomatic patients. Events during follow-up (mean duration, 29 months) included stroke in four cases, TIA in two, stent thrombosis in four and restenosis in 21. Kaplan-Meier estimates of overall survival, neurologic-event-free survival, anatomic-event-free survival and reintervention-free survival were 95.4%, 94.7%, 96.7% and 99.5%, respectively, at 1 year and 80.3%, 93.8%, 85.1% and 96%, respectively, at 4 years. Multivariant analysis showed that statin use was correlated with a lower risk of anatomic events (odds ratio (OR) = 0.15 (95% confidence interval (CI) 0.03-0.68), p = 0.01) and that bypass was associated with a higher risk of anatomic events than endarterectomy (OR = 5.0 (95% CI 1.6-16.6), p = 0.009). CONCLUSION: CAS is a feasible therapeutic alternative to OCS for carotid restenosis with acceptable risks in the perioperative period. Restenosis rate may be higher in patients treated after bypass.


Subject(s)
Carotid Artery, Internal , Carotid Stenosis/therapy , Coronary Artery Bypass , Endarterectomy, Carotid , Postoperative Complications/therapy , Stents , Aged , Aged, 80 and over , Belgium , Carotid Artery, Internal/surgery , Carotid Stenosis/diagnostic imaging , Carotid Stenosis/mortality , Cerebral Angiography , Disease-Free Survival , Feasibility Studies , Female , France , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Male , Middle Aged , Multivariate Analysis , Neurologic Examination , Odds Ratio , Postoperative Complications/diagnostic imaging , Postoperative Complications/mortality , Retrospective Studies , Secondary Prevention , Statistics as Topic , Tomography, X-Ray Computed
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