Béatrice Guyomarch

Endovascular Repair of Common Femoral Artery and Concomitant Arterial Lesions

OBJECTIVEnThe common femoral artery (CFA) is an unusual location for endovascular repair (ER). We report the early results after ER of the CFA in a single centre.nnnDESIGNnThis is a cohort study.nnnMATERIALS/METHODSnFrom 2006 to 2008, ER of the CFA was proposed to 36 patients (mean age 67.9, range 51-92). CFA lesions were classified into four types: in type I, lesions were located at the iliac external artery and were extended to the CFA; in type II, lesions were limited to the CFA; in type III, lesions were located at the CFA and its bifurcation; type IV represents restenosis bypass anastomosis. All patients were treated by stenting.nnnRESULTSnIndications for ER of the CFA included 25 patients (70%) for claudication and 11 patients (30%) for critical limb ischaemia. Forty-three stents were implanted. The mean follow-up was 22 months (range, 12-42). At 1 year, primary and secondary sustained clinical improvements were 80% and 90%; target lesion revascularisation and target extremity revascularisation free cumulative survival were 85% and 80%, respectively, and in-stent restenosis rate was 20%. One stent fracture was noted.nnnCONCLUSIONSnER of CFA and concomitant arterial lesions seems to be a safe technique with acceptable clinical outcome at 1 year.

Incidence and the clinical impact of stent fractures after primary stenting for TASC C and D femoropopliteal lesions at 1 year.

BACKGROUNDnThe clinical impact of stent fractures is still controversial. This study analyzed the incidence and the clinical impact of stent fractures after stenting of long femoropopliteal lesions.nnnMETHODSnFrom November 2008 to October 2009, 58 patients (62 limbs) were treated in a single center with a primary nitinol self-expanding stent for Trans-Atlantic Inter-Consensus (TASC) C and D de novo femoropopliteal lesions. Patients were prospectively followed by medical and duplex scan examinations. Stent fractures were assessed by biplane X-rays at 12 months. Logistic regression analysis was performed.nnnRESULTSnAt 1 year a complete follow-up was obtained in 42 limbs/90 stents. The median length of the stented segment was 240 ± 180 cm with a mean of 2.1 (1-4) stents per patient. Sixteen stents (17.8%) were fractured: one type I (asymptomatic); seven type II (2 restenosis); five type III (asymptomatic), and three type IV stent fractures (1 restenosis). Stent diameter (p = .04) and stent implantation in the distal part of the superficial femoral artery (p = .05) were positively associated with stent fractures. Stent fracture had no influence on restenosis.nnnCONCLUSIONnThis study suggests that the high stent fracture rate associated with endovascular treatment of long femoropopliteal lesions should be balanced with its low clinical impact.

Osteoprotegerin, Pericytes and Bone-Like Vascular Calcification Are Associated with Carotid Plaque Stability

Background and Purpose Vascular calcification, recapitulating bone formation, has a profound impact on plaque stability. The aim of the present study was to determine the influence of bone-like vascular calcification (named osteoid metaplasiau200a=u200aOM) and of osteoprotegerin on plaque stability. Methods Tissue from carotid endarterectomies were analysed for the presence of calcification and signs of vulnerability according to AHA grading system. Osteoprotegerin (OPG), pericytes and endothelial cells were sought using immuno-histochemistry. Symptoms and preoperative imaging findings (CT-scan, MRI and Doppler-scan) were analyzed. Human pericytes were cultured to evaluate their ability to secrete OPG and to influence mineralization in the plaque. Results Seventy-three carotid plaques (49 asymptomatic and 24 symptomatic) were harvested. A significantly higher presence of OM (18.4% vs 0%, p<0.01), OPG (10.2% of ROI vs 3.4% of ROI, p<0.05) and pericytes (19% of ROI vs 3.8% of ROI, p<0.05) were noted in asymptomatic compared to symptomatic plaques. Consistently, circulating OPG levels were higher in the plasma of asymptomatic patients (3.2 ng/mL vs 2.5 ng/mL, pu200a=u200a0.05). In vitro, human vascular pericytes secreted considerable amounts of OPG and underwent osteoblastic differentiation. Pericytes also inhibited the osteoclastic differentiation of CD14+ cells through their secretion of OPG. Conclusions OPG (intraplaque an plasmatic) and OM are associated with carotid plaque stability. Pericytes may be involved in the secretion of intraplaque OPG and in the formation of OM.

Bone Like Arterial Calcification in Femoral Atherosclerotic Lesions: Prevalence and Role of Osteoprotegerin and Pericytes

OBJECTIVE/BACKGROUNDnArterial calcification, a process that mimics bone formation, is an independent risk factor of cardiovascular morbidity and mortality, and has a significant impact on surgical and endovascular procedures and outcomes. Research efforts have focused mainly on the coronary arteries, while data regarding the femoral territory remain scarce.nnnMETHODSnFemoral endarterectomy specimens, clinical data, and plasma from a cohort of patients were collected prospectively. Histological analysis was performed to characterize the cellular populations present in the atherosclerotic lesions, and that were potentially involved in the formation of bone like arterial calcification known as osteoid metaplasia (OM). Enzyme linked immunosorbent assays and cell culture assays were conducted in order to understand the cellular and molecular mechanisms underlying the formation of OM in the lesions.nnnRESULTSnTwenty-eight of the 43 femoral plaques (65%) displayed OM. OM included osteoblast and osteoclast like cells, but very few of the latter exhibited the functional ability to resorb mineral tissue. As in bone, osteoprotegerin (OPG) was significantly associated with the presence of OM (p = .04). Likewise, a high plasma OPG/receptor activator for the nuclear factor kappa B ligand (RANKL) ratio was significantly associated with the presence of OM (p = .03). At the cellular level, there was a greater presence of pericytes in OM+ compared with OM- lesions (5.59 ± 1.09 vs. 2.42 ± 0.58, percentage of area staining [region of interest]; p = .04); in vitro, pericytes were able to inhibit the osteoblastic differentiation of human mesenchymal stem cells, suggesting that they are involved in regulating arterial calcification.nnnCONCLUSIONnThese results suggest that bone like arterial calcification (OM) is highly prevalent at femoral level. Pericyte cells and the OPG/RANK/RANKL triad seem to be critical to the formation of this ectopic osteoid tissue and represent interesting potential therapeutic targets to reduce the clinical impact of arterial calcification.

Treatment of TASC C and D Femoropoliteal Lesions with Paclitaxel eluting Stents: 12 month Results of the STELLA-PTX Registry

OBJECTIVEnThe aim was to evaluate the safety and the efficacy of primary stenting with paclitaxel eluting stents for TASC C and D femoropopliteal lesions.nnnMETHODSnPatients with TASC C/D de novo femoropopliteal lesions were treated by implanting paclitaxel eluting stents. Patients were included in a single center registry and prospectively followed by clinical and ultrasound evaluation. X-ray of the stented zone was systematically performed 12 months after implantation. The primary endpoint was primary sustained clinical improvement after 12 months.nnnRESULTSnA total of 45 patients (48 limbs) suffering from claudication (25 limbs) or CLI (23 limbs) were enrolled. Lesions were either TASC C (28 limbs) or TASC D (20 limbs). The mean length of the treated segment was 252xa0±xa090xa0mm. The mean number of stents was 2.9xa0±xa01 (2-5). Mean follow up was 12.7 months. No patient was lost to follow up. At 1 year post procedure, primary and secondary sustained clinical improvements were 56.3xa0±xa07.4% and 80.1xa0±xa05.9% respectively. Freedom from target lesion and target extremity revascularization were 63.6% and 90.1%, respectively. Primary and secondary patency rates were 52.5% and 79.6%. One year primary sustained clinical improvement rates for TASC C/D were 63.3xa0±xa09.2% and 45.6xa0±xa011.7%, respectively (pxa0=xa0.34). One year primary sustained clinical improvement rates for claudication/CLI patients were 68xa0±xa09.3% and 41.6xa0±xa011.1%, respectively (pxa0=xa0.13). The incidence of in stent re-stenosis and in stent thrombosis were 25% and 14%, respectively. The incidence of stent fracture was 12.5% on a limb basis and 9% on a per stent basis.nnnCONCLUSIONSnThe paclitaxel eluting stent did not achieve its goal in terms of prevention of in stent re-stenosis for TASC C/D femoropopliteal lesions. It requires frequent re-interventions during the first year to maintain satisfactory clinical results.

Sodium-channel blocker challenge in the familial screening of Brugada syndrome: Safety and predictors of positivity

BACKGROUNDnSodium-channel blocker challenge (SCBC) is frequently performed to unmask Brugada syndrome.nnnOBJECTIVEnWe aim to identify predictors of positivity and complications of SCBC in the setting of familial screening of Brugada syndrome.nnnMETHODSnAll consecutive patients from 2000 to 2014 who benefit from a sodium-channel blocker and belong to a family with at least 2 subjects affected by the syndrome were enrolled and followed prospectively. Data were reviewed by 2 physicians blinded to the clinical and genetic status.nnnRESULTSnOf the 672 SCBCs performed in 137 families, 337 (50%) were positive. Multivariate analysis identified ajmaline (odds ratio [OR] 2.98; 95% CI 1.65-4.91) and a significant S wave in lead DII (OR 3.11; 95% CI 2.12-4.58), DIII (OR 2.75; 95% CI 1.78-4.25), or V5 (OR 3.71; 95% CI 2.54-5.44) as predictors of a positive SCBC (P < .0001). Eleven patients (1.6%) presented complications (10 ventricular arrhythmias and 1 atrial flutter), but no deaths occurred. Familial history of complications (OR 41; lower quartile, upper quartile 10, 203; P < .0001), young age (P = .04), and decreased electrocardiographic conduction parameters at baseline (P = .04) were predictors of complications. QRS enlargement during SCBC was not associated with complications. During a median follow-up of 106 months (lower quartile, upper quartile 54, 143 months), 11 life-threatening arrhythmias occurred.nnnCONCLUSIONnSCBC in the screening of familial Brugada syndrome is safe. The risk of complication is considerably increased in the case of familial history of complicated SCBC, in young patients, and in the presence of decreased electrocardiographic conduction parameters. However, QRS enlargement during the test is not directly related to complications and should not be used to prematurely stop the test unless leading to false-negative results.

Bare metal stent versus paclitaxel eluting stent for intermediate length femoropopliteal arterial lesions (BATTLE trial): study protocol for a randomized controlled trial

BackgroundCurrently, endovascular treatment is indicated to treat femoropopliteal lesions ≤15xa0cm. However, the Achilles’ heel of femoropopliteal endovascular repair remains restenosis. Paclitaxel eluting stents have shown promising results to prevent restenosis in femoropopliteal lesions compared to percutaneous transluminal angioplasty. A recently released prospective registry using a newer generation of self-expandable nitinol stents (Misago®; Terumo Corp., Tokyo, Japan) supports primary bare metal stenting as a first-line treatment for femoropopliteal lesions. To date, no studies have been designed to compare bare metal stents to paclitaxel eluting stents for the treatment of femoropoliteal lesions. The BATTLE trial was designed to compare paclitaxel eluting stents (Zilver® PTX®) and a last generation bare self-expandable nitinol stents (Misago® RX, Terumo Corp., Tokyo, Japan) in the treatment of intermediate length femoropopliteal lesions (≤14xa0cm).Methods/DesignA prospective, randomized (1:1), controlled, multicentric and international study has been designed. One hundred and eighty-six patients fulfilling the inclusion criteria will be randomized to one of the two assessments of endovascular repair to treat de novo femoropopliteal lesions ≤14xa0cm in symptomatic patients (Rutherford 2 to 5): bare stent group and paclitaxel eluting stent group. The primary endpoint is freedom from in-stent restenosis at 1xa0year defined by a peak systolic velocity index >2.4 (restenosis of >50%) at the target lesion and assessed by duplex scan. Our main objective is to demonstrate the clinical superiority of primary stenting using Zilver® PTX® stent system versus bare metal self-expandable stenting in the treatment of femoropopliteal lesions in patients with symptomatic peripheral arterial disease.DiscussionThis is the first randomized and controlled study to compare the efficacy of bare metal stents and paclitaxel eluting stents for the treatment of femoropopliteal lesions. It may clarify the indication of stent choice for femoropopliteal lesions of intermediate length.Trial registrationClinicaltrials.gov identifier: NCT02004951. 3 December 2013.

Clinical and Economic Evaluation of Ambulatory Endovascular Treatment of Peripheral Arterial Occlusive Lesions

BACKGROUNDnAmbulatory management of patients is an alternative to conventional hospitalization. In this study we evaluate the results of a prospective cohort study of patients receiving ambulatory endovascular treatment for peripheral arterial lesions.nnnMETHODSnFrom June 2008 to October 2010, ambulatory management was proposed for endovascular treatment of peripheral arterial lesions. An arterial closure device (Angio-Seal(®); St. Jude Medical) was used. For ambulatory treatment, patients were prohibited from driving a vehicle at discharge, had to be accompanied the first night after the procedure, had to live <1 hour from a medical facility, had to be reachable by telephone the day after the intervention, and had to remain hospitalized in the event of a complication. The principal criterion was morbimortality at 1 month. Secondary criteria were clinical improvement, patency, complications related to the arterial closure, and costs evaluation at 1 month.nnnRESULTSnForty-five patients were included and 50 ambulatory procedures were carried out. The patients presented with claudication (92%) or a critical ischemia (8%) of the lower extremities. All procedures were carried out by femoral puncture (retrograde in 94% and anterograde in 6% of the cases). The patients presented with iliac (68%) and femoropopliteal (64%) lesions. Lesions included stenoses (70%), thromboses (16%), and intrastent restenoses (14%). The rate of failure of ambulatory hospitalization was 16% (n = 8) without a serious undesirable event: 2 patients were hospitalized after a surgical conversion for iliac rupture and disinsertion of stent; 3 patients developed a hematoma during the intervention at the point of puncture; and in 3 cases the system of percutaneous closure failed. The mean duration of hospitalization was 1.36 ± 1.33 days. At 1 month, clinical improvement was observed in 97.5% of cases, with a primary patency of 100%. No perioperative rehospitalization or puncture site complications were observed. Ambulatory management made it possible to save 42 days of hospitalization, with associated costs of 10,971€, compared with conventional hospitalization. The additional costs related to use of the Angio-Seal amounted to 7427€.nnnCONCLUSIONnAmbulatory endovascular treatment of patients presenting with peripheral arterial lesions is reliable and effective and may contribute to savings in healthcare spending.

Clinical Yield of Familial Screening After Sudden Death in Young Subjects: The French Experience

Background: After sudden cardiac death with negative autopsy, clinical screening of relatives identifies a high proportion of inherited arrhythmia syndrome. However, the efficacy of this screening in families not selected by autopsy has never been assessed. We aim to investigate the value of clinical screening in relatives of all subjects who died suddenly before 45 years of age. Methods and results: One hundred and three consecutive families who experienced unexplained sudden cardiac death before 45 years of age were included from May 2009 to December 2014 in a prospective multicenter registry. Clinical screening was provided to all relatives and performed in 64 families (230 relatives, 80 unexplained sudden cardiac death). Diagnosis was established in 16 families (25%), including Brugada syndrome (7), long QT syndromes (5), dilated cardiomyopathy (2), and hypertrophic cardiomyopathy (2). The diagnostic yield was mainly dependent on the number of screened relatives (3.8±3.4 screened relatives in diagnosed families versus 2.0±1.5; P<0.005) rising to 47% with at least 3 relatives. It additionally increased from 3 of 32 (9%) to 9 of 22 (41%) when both parents were screened (P=0.01). Diagnostic performance was also dependent on the exhaustiveness of screening (70% of complete screening in the diagnosed families versus 25%; P<0.0001) with 17 Brugada syndromes and 15 long QT syndromes diagnosed based on pharmacological tests. Conclusions: Even without autopsy, familial screening after sudden death in young patients is effective. Broad screening of relatives and systematic tests, including pharmacological challenges, greatly increases the likelihood of diagnosis in families.

Bare Metal Versus Paclitaxel-Eluting Stents for Long Femoropopliteal Lesions: Prospective Cohorts Comparison Using a Propensity Score-Matched Analysis.

BACKGROUNDnThe study aims to compare outcomes of primary stenting of long femoropopliteal (FP) lesions with bare metal stent (BMS) versus paclitaxel eluting stent (PES).nnnMETHODSnIn a single centre study, we established 2 consecutive and prospective cohorts with TASC C/D FP de novo lesions. The inclusion and exclusion criteria were similar. Bare metal stent (LifeStent®, Bard Peripheral) and PES (Zilver® PTX®, Cook Peripheral Vascular) were implanted. Prospective clinical and morphological follow-ups were carried out at 1, 3, 6, 12, and 18xa0months. Propensity score (inverse probability of treatment weighted method) stratification was used to minimize bias.nnnRESULTSnIn total, 110 limbs were treated (STELLA: nxa0=xa062; STELLA PTX: nxa0=xa048). We noted some difference between both cohorts regarding type 2 diabetes (Pxa0=xa00.05), vitamin K antagonist use (Pxa0=xa00.05), and angiotensin II receptor blocker use (Pxa0=xa00.002). More stents were implanted in the STELLA PTX cohort (Pxa0<xa00.0013). At 12xa0months, in univariate analysis, freedom from target lesion revascularization (TLR) was higher in the STELLA cohort (Pxa0=xa00.005). No differences were found between both cohorts in terms of primary sustained clinical improvement (Pxa0=xa00.25), primary patency (Pxa0=xa00.07), and survival (Pxa0=xa00.79). With the propensity score, no difference was observed in terms of primary sustained clinical improvement (Pxa0=xa00.79), freedom from TLR (Pxa0=xa00.59), and primary patency (Pxa0=xa00.69). With Cox logistic regression, the number of implanted stents influenced the primary sustained clinical improvement, the freedom from TLR, and the primary patency.nnnCONCLUSIONSnPaclitaxel-eluting stents do not seem to provide benefits in terms of clinical and morphological outcomes for TASC C/D lesions compared to BMS.