Jean Paul de Vries

Postoperative pain and early quality of life after radiofrequency ablation and mechanochemical endovenous ablation of incompetent great saphenous veins

OBJECTIVE Thermal ablative techniques of varicose veins carry a risk of heat-related complications, including postoperative pain. Mechanochemical endovenous ablation (MOCA) might avoid these complications and reduce postoperative pain because of the absence of thermal energy. This study evaluated postoperative pain and quality of life after radiofrequency ablation (RFA) and MOCA for great saphenous vein (GSV) incompetence. METHODS Sixty-eight patients with unilateral GSV incompetence were treated with either RFA or MOCA in this prospective observational study. Patients monitored their pain for the first 14 postoperative days on a 100-mm visual analog scale (VAS). They also completed the general (RAND 36-Item Short-Form Health Survey) and disease-specific (Aberdeen Varicose Vein Questionnaire) quality of life questionnaires before and 6 weeks after treatment. RESULTS Patients treated with MOCA reported significantly less postoperative pain than patients treated with RFA during the first 14 days after treatment (4.8 ± 9.7 mm vs 18.6 ± 17.0 mm; P < .001) (mean VAS over 14 days). The lower postoperative pain score was associated with a significantly earlier return to normal activities (1.2 ± 1.8 vs 2.4 ± 2.8 days; P = .02) and work resumption (3.3 ± 4.7 vs 5.6 ± 5.8 days, respectively; P = .02). At 6 weeks, patients in both groups perceived an improved change in health status and an improved disease-specific quality of life. CONCLUSIONS MOCA is associated with significantly less postoperative pain, faster recovery, and earlier work resumption compared with RFA in the treatment of GSV incompetence. MOCA and RFA are both related to a rapid improvement in quality of life.

Statin treatment is not associated with consistent alterations in inflammatory status of carotid atherosclerotic plaques : A retrospective study in 378 patients undergoing carotid endarterectomy

Background and Purpose— Anti-inflammatory qualities are held partially responsible for the reduction of cardiovascular events after statin treatment. We examined the phenotype of carotid atherosclerotic plaques harvested during carotid endarterectomy in relation to the previous use of different statins prescribed in clinical practice. Methods— Three hundred and seventy-eight patients were included. Atherosclerotic plaques were harvested, immunohistochemically stained and semiquantitively examined for the presence of macrophages (CD68), smooth muscle cells, collagen and fat. Adjacent atherosclerotic plaques were used to study protease activity and interleukin levels. Patients’ demographics were recorded and blood samples were stored. Results— Serum cholesterol, low-density lipoprotein, apolipoprotein B, and C-reactive protein levels were lower in patients treated with statins compared with patients without statin treatment. Atheromatous plaques were less prevalent in patients receiving statins compared with patients without statin therapy (29% versus 42%, P=0.04). An increase of CD68 positive cells was observed in patients receiving statins compared with nonstatin treatment (P=0.05). This effect was specifically related to atorvastatin treatment. In patients treated with atorvastatin, the increased amount of CD68 positive cells were not associated with increased protease activity. In contrast, a dose-dependent decrease in protease activity was shown in the atorvastatin group. Interleukin 6 expression was lower in plaques obtained from patients treated with statins (P=0.04). Conclusions— Statin use may exert pleiotropic effects on plaque phenotype. However, not the presence of macrophages but activation with subsequent protease and cytokine release may be attenuated by statin use.

Symptomatic Carotid Atherosclerotic Disease Correlations Between Plaque Composition and Ipsilateral Stroke Risk

Background and Purpose— For symptomatic patients with carotid artery stenosis, the risk benefit for surgical intervention may vary among patient groups. Various modalities of plaque imaging have been promoted as potential tools for additional risk stratification, particularly in patients with moderate stenosis. However, it remains uncertain to what extent carotid plaque components predict risk of future ipsilateral ischemic stroke. Methods— In 2 large atherosclerotic carotid plaque biobank studies, we related histological characteristics of 1640 carotid plaques with a validated risk model for the prediction of individual 1- and 5-year stroke risk. Results— No significant heterogeneity between the studies was found. Predicted 5-year stroke risk (top versus bottom quartile) was related to plaque thrombus (odds ratio, 1.42; 95% confidence interval, 1.11–1.89; P=0.02), fibrous content (0.65; 0.49–0.87; P=0.004), macrophage infiltration (1.41; 1.05–1.90; P=0.02), high microvessel density (1.49; 1.05–2.11; P=0.03), and overall plaque instability (1.40; 1.05–1.87; P=0.02). This association was not observed for cap thickness, calcification, intraplaque hemorrhage, or lymphocyte infiltration. Plaques removed within 30 days of most recent symptomatic event were most strongly correlated with predicted stroke risk. Conclusions— Features of the vulnerable carotid plaque, including plaque thrombus, low fibrous content, macrophage infiltration, and microvessel density, correlate with predicted stroke risk. This study provides a basis for plaque imaging studies focused on stroke risk stratification.

Outcome-based anatomic criteria for defining the hostile aortic neck

OBJECTIVE There is abundant evidence linking hostile proximal aortic neck anatomy to poor outcome after endovascular aortic aneurysm repair (EVAR), yet the definition of hostile anatomy varies from study to study. This current analysis was undertaken to identify anatomic criteria that are most predictive of success or failure at the aortic neck after EVAR. METHODS The study group comprised 221 patients in the Aneurysm Treatment using the Heli-FX Aortic Securement System Global Registry (ANCHOR) clinical trial, a population enriched with patients with challenging aortic neck anatomy and failure of sealing. Imaging protocols were not protocol specified but were performed according to the institutions standard of care. Core laboratory analysis assessed the three-dimensional centerline-reformatted computed tomography scans. Failure at the aortic neck was defined by type Ia endoleak occurring at the time of the initial endograft implantation or during follow-up. Receiver operating characteristic curve analysis was used to assess the value of each anatomic measure in the classification of aortic neck success and failure and to identify optimal thresholds of discrimination. Binary logistic regression was performed after excluding highly intercorrelated variables, creating a final model with significant predictors of outcome after EVAR. RESULTS Among the 221 patients, 121 (54.8%) remained free of type Ia endoleak and 100 (45.2%) did not. Type Ia endoleaks presented immediately after endograft deployment in 58 (58.0%) or during follow-up in 42 (42.0%). Receiver operating characteristic curve analysis identified 12 variables where the classification of patients with type Ia endoleak was significantly more accurate than chance alone. Increased aortic neck diameter at the lowest renal artery (P = .013) and at 5 mm (P = .008), 10 mm (P = .008), and 15 mm (P = .010) distally; aneurysm sac diameter (P = .001), common iliac artery diameters (right, P = .012; left, P = .032), and a conical (P = .049) neck configuration were predictive of endoleak. By contrast, increased aortic neck length (P = .050), a funnel-shaped aortic neck (P = .036), and neck mural thrombus content, as measured by average thickness (P = .044) or degrees of circumferential coverage (P = .029), were protective against endoleak. Binary logistic regression identified three variables independently predictive of type Ia endoleak. Neck diameter at the lowest renal artery (P = .002, cutpoint 26 mm) and neck length (P = .017, cutpoint 17 mm) were associated with endoleak, whereas some mural neck thrombus content was protective (P = .001, cutpoint 11° of circumferential coverage). CONCLUSIONS A limited number of independent anatomic variables are predictive of type Ia endoleak after EVAR, including aortic neck diameter and aortic neck length, whereas mural thrombus in the neck is protective. This study suggests that anatomic measures with identifiable threshold cutpoints should be considered when defining the hostile aortic neck and assessing the risk of complications after EVAR.

Long-term results of Talent endografts for endovascular abdominal aortic aneurysm repair

BACKGROUND Since the introduction of endovascular aneurysm repair (EVAR), long-term follow-up studies reporting single-device results are scarce. In this study, we focus on EVAR repair with the Talent stent graft (Medtronic, Santa Rosa, Calif). METHODS Between July 2000 and December 2007, 365 patients underwent elective EVAR with a Talent device. Patient data were gathered prospectively and evaluated retrospectively. By American Society of Anesthesiologists category, 74% were categories III and IV. Postoperative computed tomography (CT) scanning was performed before discharge, at 3, 12 months, and yearly thereafter. Data are presented according to reporting standards for EVAR. RESULTS The mean proximal aortic neck diameter was 27 mm (range, 16-36 mm), with a neck length <15 mm in 31% (data available for 193 patients). Deployment of endografts was successful in 361 of 365 patients (99%). Initially, conversion to laparotomy was necessary in four patients. Primary technical success determined by results from computed tomography (CT) scans before discharge was achieved in 333 patients (91%). Proximal type I endoleaks were present in 28 patients (8%) during follow-up, and 14 of these patients needed additional treatment for type I endoleak. The 30-day mortality for the whole Talent group was 1.1% (4 of 365). Follow-up to 84 months is reported for 24 patients. During follow-up, 122 (33%) patients died; in nine, death was abdominal aortic aneurysm (AAA)-related (including 30-day mortality). Kaplan-Meier estimates revealed primary clinical success rates of 98% at 1 year, 93% at 2 years, 88% at 3 years, 79% at 4 years, 64% at 5 years, 51% at 6 years, and 48% at 7 years. Secondary interventions were performed in 73 of 365 patients (20%). Ten conversions for failed endografts were performed. Life-table yearly risk for AAA-related reintervention was 6%, yearly risk for conversion to open repair was 1.1%, yearly risk for total mortality was 8.9%, and yearly risk for AAA-related mortality was 0.8%. CONCLUSION Initially, technical success of endovascular aneurysm repair (EVAR) using the Talent endograft is high, with acceptable yearly risk for AAA-related mortality and conversion. However, a substantial amount of mainly endovascular reinterventions is necessary during long-term follow-up to achieve these results.

Mechanochemical endovenous Ablation versus RADiOfrequeNcy Ablation in the treatment of primary great saphenous vein incompetence (MARADONA): study protocol for a randomized controlled trial

BackgroundRadiofrequency ablation (RFA) is associated with an excellent outcome in the treatment of great saphenous vein (GSV) incompetence. The use of thermal energy as a treatment source requires the instillation of tumescence anesthesia. Mechanochemical endovenous ablation (MOCA) combines mechanical endothelial damage, using a rotating wire, with the infusion of a liquid sclerosant. Tumescence anesthesia is not required. Preliminary experiences with MOCA showed good results and low post-procedural pain.Methods/DesignThe MARADONA (Mechanochemical endovenous Ablation versus RADiOfrequeNcy Ablation) trial is a multicenter randomized controlled trial in which 460 patients will be randomly allocated to MOCA or RFA. All patients with primary GSV incompetence who meet the eligibility criteria will be invited to participate in this trial. The primary endpoints are anatomic and clinical success at a one-year follow-up, and post-procedural pain. The secondary endpoints are technical success, complications, operation time, procedural pain, disease-specific quality of life, time taken to return to daily activities and/or work, and cost-efficiency analyses after RFA or MOCA. Both groups will be evaluated on an intention to treat base.DiscussionThe MARADONA trial is designed to show equal results in anatomic and clinical success after one year, comparing MOCA with RFA. In our hypothesis MOCA has an equal anatomic and clinical success compared with RFA, with less post-procedural pain.Trial registrationClinicaltrials NCT01936168

Analysis of EndoAnchors for endovascular aneurysm repair by indications for use.

OBJECTIVE The proximal aortic neck remains one of the challenges of endovascular aneurysm repair (EVAR), and the risk of type Ia endoleak and endograft migration is increased in patients with short, large-diameter, or highly angulated necks. EndoAnchors have been used as an adjunct to EVAR in such patients, and the aim of this study was to assess their benefit analyzed by indication for use. METHODS During a 2-year period, 319 patients were enrolled at 43 sites in the Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR) study. This prospective, multinational, real-world analysis of EndoAnchors comprised two groups of patients, those undergoing first-time EVAR (primary arm, 242) and those with proximal neck complications remote from the time of an initial endograft implantation (revision arm, 77). The primary arm was further subdivided into patients undergoing prophylactic EndoAnchor use for hostile proximal neck anatomy (178), with a type Ia endoleak evident during initial endograft deployment (60), and in conjunction with extender cuffs after unsatisfactory endograft deployment distally in the neck (four). The revision arm was subdivided into patients presenting with a type Ia endoleak alone (45), endograft migration alone (11), and migration with endoleak (21). Technical success was site reported as satisfactory deployment of the desired number of EndoAnchors without fracture or loss of integrity. Procedural success was defined as technical success without type Ia endoleak at completion arteriography. Core laboratory analysis was performed on 249 baseline and 192 follow-up computed tomographic studies, 66 of which were available within the 1-year window. RESULTS Technical and procedural success rates were highest in the prophylactically treated subset (172 of 178; 96.6%). Whereas the technical success of EndoAnchor deployment was also high in the other subsets, residual type Ia endoleaks were more frequent at completion angiography when the indication for EndoAnchor use was type Ia endoleak, both in the primary arm (17 of 60; 28%) and in the revision arm (9 of 45; 20%). During a median imaging follow-up of 7 months, 183 of 202 patients (90.1%) remained free of type Ia endoleaks. Primary prophylactic patients were free from type Ia endoleak in 110 of 114 cases (96.5%). The most challenging subset was revision patients treated for type Ia endoleak; type Ia endoleaks were evident during follow-up in 10 of 29 of the cases (34%). Sac regression >5 mm in patients with 1-year imaging was observed in 26 of 66 patients (39%) and was highest in the primary prophylaxis subset (20 of 43; 47%). CONCLUSIONS EndoAnchor implantation can be a useful adjunct to EVAR as prophylaxis against proximal attachment site complications in patients with hostile aortic neck anatomy, as treatment for early and late type Ia endoleaks, or, in conjunction with aortic extension cuffs, for endograft migration. Whereas the most challenging patients are those who present with type Ia endoleaks remote from initial EVAR, EndoAnchors are still effective in treating the majority of these cases.

Systematic review of clinical applications of monitoring muscle tissue oxygenation with near-infrared spectroscopy in vascular disease

BACKGROUND The use of wavelengths of the near-infrared region by near-infrared spectroscopy (NIRS) has been studied for several applications in vascular disease. This systematic review aims to explore the clinical relevance of monitoring muscle tissue oxygenation in vascular disease with NIRS. METHODS A systematic search in PubMed, EMBASE, CINAHL and Cochrane databases was performed to identify clinical NIRS studies, published until April 2015, involving muscle tissue oxygenation in vascular disease. RESULTS After screening 183 manuscripts, 38 studies (n=2010) were included. Studies concerned peripheral arterial disease (PAD) (twelve studies, n=848), compartment syndrome of lower extremities (seven studies, n=205), deep vein thrombosis (DVT) (six studies, n=429), buttock and lower extremity ischaemia in abdominal aortic aneurysm repair (six studies, n=139), free flap failure (five studies, n=354), and spinal cord ischaemia in thoracoabdominal aortic aneurysm repair (two studies, n=35). Nine studies compared NIRS with gold standards and provided cut-off values. Four studies regarding chronic compartment syndrome and DVT determined higher sensitivity (78%-97%) than specificity (56%-76%). Two studies regarding PAD and buttock claudication determined higher specificity (87%-95%) than sensitivity (33%-88%). Three studies regarding free flap failure determined sensitivity and specificity of 100%. CONCLUSION We found sufficient evidence to use NIRS in clinical setting for assessment of chronic compartment syndrome of lower extremities, and as surveillance tool for detection of free flap failure. So far, clinical relevance of routine use of NIRS in other vascular applications is less clear. Cut-off values to discriminate are not yet unanimous and better validation has to be awaited for.

Carotid angioplasty and stenting: Treatment of postcarotid endarterectomy restenosis is at least as safe as primary stenosis treatment

OBJECTIVES This study compared transcranial Doppler (TCD) imaging and outcomes of carotid angioplasty and stenting (CAS) in stenosis after carotid endarterectomy (CEA) vs primary atherosclerotic stenoses. METHODS A prospectively accumulated database of 812 CAS procedures was analyzed retrospectively. Two groups were created. Group 1 had 72 restenoses at a mean of 71 months (range, 5-245 months) after initial CEA. Group 2 had 740 primary stenoses. Clinical end points were cerebral ischemic events and death. TCD end points were numbers of isolated microemboli and microembolic showers during five procedural phases. RESULTS Groups 1 and 2 were evenly matched for demographic data: median age, 70 vs 71 years; 44 (61%) vs 525 men (71%); 14 (19%) vs 147 symptomatic (20%). Seven (0.9%) deaths and 10 major (1.2%) and 21 minor (2.6%) strokes occurred in group 2 (P = .049). Mean (standard deviation) numbers of isolated microemboli for groups 1 vs 2 were wiring, 37.0 (31.1) vs 50.4 (52.6); predilation, 14.8 (18.7) vs 21.7 (21.8); stent placement, 58.6 (31.1) vs 64.7 (38.8); postdilation, 20.4 (16.5) vs 27.2 (34.9), cerebral protection device (CPD) use, 44.2 (30.2) vs 37.5 (36.8); total, 134.8 (68.7) vs 175.3 (113.8). Microembolic showers: wiring, 1.7 (4.5) vs 2.2 (6.4); predilation, 2.1 (4.1) vs 3.3 (5.8); stent placement, 21.5 (22.0) vs 26.9 (25.1); postdilation, 5.3 (15.7) vs 5.0 (8.1); CPD use, 5.8 (6.9) vs 6.2 (8.9); total, 30.4 (36.0) vs 39.6 (35.0). TCD data for CPD use vs without for isolated emboli: wiring, 53.2 (45.1) vs 44.3 (51.7); predilation, 24.7 (20.2) vs 18.2 (22.5); stent placement, 77.5 (34.8) vs 53.5 (37.3); postdilation, 33.6 (36.6) vs 20.7 (21.8); CPD use, 38.3 (36.6) vs 0; total, 222.5 (113.8) vs 132.3 (89.1). Showers: wiring, 2.4 (6.6) vs 1.9 (5.8); predilation, 4.2 (6.4) vs 2.4 (5.0); stent placement, 38.9 (25.8) vs 16.2 (18.7); post-dilation, 7.0 (11.2) vs 3.4 (6.4); CPD use, 6.3 (8.9) vs 0; total, 58.4 (37.7) vs 23.3 (23.1). P = .01 for showers during wiring and P < .001 for all other variables. After correction for the difference in CPD use between groups 1 and 2 (17 out of 72 [24%] vs 369 out of 740 [50%]), no statistically significant differences remained in numbers of isolated emboli and embolic showers in the procedural phases or for the entire procedure. No statistically significant differences were found when TCD-detected microembolic load for early (<3 years between CEA and CAS) and late (>5 years) restenoses were compared. CONCLUSIONS CAS for restenosis after CEA has a complication rate lower than primary CAS. The time interval between CEA and CAS did not influence micro embolic load.

Endovascular Treatment of Common Iliac Artery Aneurysms With an Iliac Branch Device: Multicenter Experience of 140 Patients

Purpose: To evaluate the efficacy, feasibility, and long-term outcomes of the Zenith ZBIS iliac branch device (IBD) to preserve internal iliac artery (IIA) perfusion in a large Dutch multicenter cohort. Methods: Between September 2004 and August 2015, 140 patients (mean age 70.9±7.4 years; 130 men) with 162 IBD implantations were identified in 7 vascular centers. The indication for IBD implantation was an abdominal aortic aneurysm >55 mm with a concomitant common iliac artery (CIA) aneurysm >20 mm (n=40), a CIA aneurysm with a diameter >30 mm (n=89), or revision of a type Ib endoleak after endovascular aneurysm repair (n=11). Results: Technical success (aneurysm exclusion, no type I or III endoleak, and a patent IIA) was obtained in 157 (96.9%) of 162 IBD implantations. Six (4.3%) patients developed major complications; 2 (1.4%) died. Mean follow-up was 26.6±24.1 months, during which 17 (12.1%) IBD-associated secondary interventions were performed. Including technical failures and intentional IIA embolizations, 15 (9.3%) IIA branch occlusions were identified; buttock claudication developed in 6 of these patients. The freedom from secondary intervention estimate was 75.9% (95% confidence interval 59.7 to 86.3) at 5 years. Conclusion: CIA aneurysms can be treated safely and effectively by IBDs with preservation of antegrade flow to the IIA. Secondary interventions are indicated in >10% of patients during follow-up but can be performed endovascularly in most.