Peter Rief

Neointimal Hyperplasia after Silverhawk Atherectomy versus Percutaneous Transluminal Angioplasty (PTA) in Femoropopliteal Stent Reobstructions: A Controlled, Randomized Pilot Trial

BackgroundDue to intimal hyperplasia instent reobstruction in the femoropopliteal arterial segment is still an unsolved problem. Different techniques have been discussed in case of reintervention to guarantee longlasting patency rate.MethodsWe conducted a randomized, controlled, pilot trial comparing Silverhawk atherectomy with percutaneous transluminal angioplasty (PTA) in patients with a first instent reobstruction in the femoropopliteal arterial segment, to evaluate intima media thickness (IMT) within the treated segment, as a parameter of recurrence of intimal hyperplasia.ResultsIn a total 19 patients were included: 9 patients in the atherectomy device and 10 patients in the PTA arm. IMT within the treated segment was statistically significantly elevated in all patients treated with the Silverhawk device versus the patients treated with PTA. The obvious differentiation in elevation of IMT in nonfavor for patients treated with the Silverhawk device started at month 2 (max IMT SH 0.178xa0mm vs. IMT PTA 0.1xa0mm, pxa0=xa00.001) with a spike at month 5 (max IMT SH 0.206xa0mm vs. IMT PTA 0.145xa0mm, pxa0=xa00.003) and a decline once again at month 6 (max IMT SH 0.177xa0mm vs. IMT PTA 0.121xa0mm, pxa0=xa00.02). The values for mean IMT performed the same way.ConclusionsAlthough Silverhawk atherectomy provides good results at first sight, in the midterm follow-up of treatment of first instent restenosis it did not perform better than PTA as it showed elevated reoccurrence of intimal media hyperplasia.

Feasibility and Safety of Robotic Peripheral Vascular Interventions: Results of the RAPID Trial.

OBJECTIVESnThe goal of this study was to evaluate the feasibility and safety of a robotic-assisted platform (CorPath 200, Corindus Vascular Robotics, Waltham, Massachusetts) for treating peripheral artery disease.nnnBACKGROUNDnA robotic-assisted platform for percutaneous coronary intervention is available for treating coronary artery disease.nnnMETHODSnIn this prospective single-arm trial, patients with symptomatic peripheral artery disease (Rutherford class 2 to 5) affecting the femoropoplital artery were enrolled. Endpoints evaluated were: 1) device technical success, defined as successful cannulation of the target vessel with the robotic system; 2) device safety, defined as absence of device related serious adverse event (hospitalization, prolonged hospitalization, life threatening, or resulted in death); and 3) clinical procedural success, defined asxa0<50% residual stenosis without an unplanned switch to manual assistance or device-related serious adverse event in the periprocedural period.nnnRESULTSnThe study enrolled 20 subjects (65.5 ± 9.3 years of age; 70% male) with primarily Rutherford class 2 to 3 (90%) symptoms. A total of 29 lesions (lesion length: 33.1 ± 15.5 mm) were treated with the majority (89.7%) being located in the superficial femoral artery. Device technical success, safety and clinical procedural success were all 100%xa0with provisional stenting required in 34.5% of lesions. Fluoroscopy time (7.1 ± 3.2 min) and contrast use (73.3xa0±xa09.2 ml) compared favorably with studies in similar patient cohorts. There were no adverse events associated with the use of the robotic system.nnnCONCLUSIONSnThese data demonstrate the feasibility and safety of using a robotic-assisted platform for performing peripheral arterial revascularization.

Exoseal for puncture site closure after antegrade procedures in peripheral arterial disease patients.

PURPOSEnExoseal is a vascular clo-sure device consisting of a plug applier and a bio-absorbent polyglycolic acid plug available in sizes 5 F, 6 F, and 7 F. In this study, we aimed to evaluate the effectiveness and safety of the Exoseal vascular closure device (Cordis Corporation, Bridgewater, New Jersey, USA) for puncture site closure after antegrade endovascular procedures in peripheral arterial occlusive disease (PAOD) patients.nnnMATERIALS AND METHODSnIn this retrospective study, a total of 168 consecutive patients who underwent an interventional procedure due to PAOD, were included. In each case, an antegrade peripheral endovascular procedure was performed via the common femoral artery using the Seldinger technique, and Exoseal 5 F, 6 F, or 7 F was used for access site closure. The primary endpoint was a technically successful application of Exoseal. All complications at the access site within 24 hours were registered as a secondary endpoint.nnnRESULTSnIn a group of 168 patients (64.9% men, average age 71.9±11.9 years), the technical application of Exoseal was successful in 166 patients (98.8%). Within the first 24 hours after the procedure, 12 complications (7.2%) were recorded including, three pseudoaneurysms (1.8%) and nine hematomas (5.4%). None of the complications required surgical intervention.nnnCONCLUSIONnExoseal is a safe and effective device with high technical success and acceptable complication rates for access site closure after antegrade peripheral endovascular procedures.

Lipoproteins and the Development of Restenosis After Stent Implantation in the Superficial Femoral Artery in Patients with Peripheral Artery Disease

PurposeHigh levels of apolipoprotein B (apo B) are a risk factor for the development of major vascular events. We evaluated the association between plasma lipoproteins and the development of superficial femoral artery (SFA) in-stent restenosis and reocclusion in patients with peripheral artery disease.Materials and MethodsWe included 139 patients with SFA stenting. Plasma lipoproteins were measured after stent implantation. Stent restenosis was assessed with duplex scan after 3, 6, and 12xa0months. A stenosis grade was considered relevant if >50%.ResultsSeventy-two patients experienced recurrence of their atherosclerotic disease, meaning restenosis of >50% within 1xa0year of follow-up. Ten of these patients had a stent occlusion. In the patients who experienced recurrence, the mean apo B level was 105.8 versus 94.9xa0mg/dl in patients without recurrence (Pxa0<xa00.05). Patients without recurrence had higher high-density lipoprotein cholesterol levels than patients with recurrence (39.7 vs. 34.7xa0mg/dl, Pxa0<xa00.05). Comparing patients with a stent occlusion (nxa0=xa010) and those with a restenosis of 75–99% (nxa0=xa028), the patients with a stent occlusion had higher levels of plasma cholesterol (234.1 vs. 185.9xa0mg/dl, Pxa0<xa00.05), apo B (135.3 vs. 99.8xa0mg/dl, Pxa0<xa00.05), low-density lipoprotein cholesterol (160.3 vs. 113.6xa0mg/dl, Pxa0<xa00.05), and low-density lipoprotein apo B (115.5 vs. 82.4xa0mg/dl, Pxa0<xa00.001) than the patients with restenosis of 75–99% (nxa0=xa028).ConclusionChanges in the lipid profile could be one reason for the development of restenosis and for the development of reocclusion after SFA stenting.

Elevated Blood Urea Nitrogen is Associated With Critical Limb Ischemia in Peripheral Arterial Disease Patients.

AbstractAs renal function is often impaired in atherosclerosis patients, accelerating atherosclerosis per se and creating a vicious cycle, we investigated the association of blood urea nitrogen (BUN) and critical limb ischemia (CLI) in peripheral arterial occlusive disease (PAOD) patients.Our cross-sectional study included 1521 PAOD patients, with normal and impaired renal function treated at our institution from 2005 to 2010. Patients on renal replacement therapy were excluded. The cohort was divided into tertiles according to the serum BUN levels. An optimal cutoff value for the continuous BUN was calculated by applying a receiver-operating curve analysis to discriminate between CLI and non-CLI.In our cohort, CLI increased significantly with an increase in BUN (13.1% in the first tertile, 18.7% in the second tertile, 29.0% in the third tertile, P for trend <0.001). A BUN of 17.7u200amg/dL was identified as an optimal cutoff. Accordingly, there were 2 groups of patients: 636 patients with BUNu200a⩽u200a17.7 and 885 patients with BUNu200a>u200a17.7. CLI was more frequent in BUNu200a>u200a17.7 patients (342 [38.6%]) than in BUNu200a⩽u200a17.7 patients (134 [21.1%]) (Pu200a<u200a0.001); the same applied to prior myocardial infarction (45 [5.1%] vs 15 [2.4%], Pu200a=u200a0.007) and congestive heart failure (86 [9.7%] vs 31 [4.9%], Pu200a<u200a0.001). A BUNu200a>u200a17.7 was associated with an odds ratio of 1.6 (95% confidence interval: 1.3–1.9, Pu200a<u200a0.001) for CLI even after the adjustment for other established vascular risk factors such as age ≥75 and type 2 diabetes.An increased BUN is significantly associated with a high risk for CLI and other vascular endpoints. The BUN is an easily determinable, broadly available, and inexpensive marker that could be used to identify patients at high risk for vascular endpoints.

The value of FDG-PET in the diagnosis of thromboangiitis obliterans—a case series

Thromboangiitis obliterans (TAO) is an inflammatory vascular disease affecting dominantly the vessels of the extremities and is etiologically strongly associated with tobacco consumption. Different imaging techniques are generally used to exclude potential differential diagnoses. We investigated the value of 18u2009F-flourodeoxyglucose positron emission tomography ([18u2009F]FDG-PET) in the diagnosis of TAO. All consecutive patients with diagnosed TAO between Nov 2001 and Nov 2003 at our institution who underwent [18u2009F]FDG-PET in the diagnostic workup were analyzed retrospectively. Whole-body scans were conducted after a fasting period of at least 6xa0h and blood glucose levels lower than 180xa0mg/dl. The primary endpoint was defined as significantly increased vascular FDG uptake. Tracer uptake was visually determined and, in accordance with strength, divided into grades 0 to 3. In total, ten patients were statistically evaluated. The median patient age at the date of the first [18u2009F]FDG-PET was 41.5xa0years. Repetitive FDG-PET imaging was performed in seven out of ten patients (70xa0%). The endpoint was objectified in one of the initial examinations (10xa0%) and in another one out of seven follow-up scans (14.3xa0%). One positive [18u2009F]FDG-PET was observed in the pelvic vessels and the other in the infrapopliteal arteries. Therefore, increased tracer uptake could be observed in two examinations on two different patients (both with grade 3 tracer uptake) out of 17 conducted [18u2009F]FDG-PETs in total. The [18u2009F]FDG-PET was not a suitable investigative procedure for the diagnosis of TAO in the present patient cohort.

Changes in lipid metabolism and extension of venous thromboembolism.

Background/Aims: Deep vein thrombosis (DVT) and pulmonary embolism (PE) are common diseases with a vast number of acquired and congenital risk factors. Disorders of the lipid metabolism are not established risk factors for venous thromboembolism (VTE) so far. However, in recent literature, associations between VTE and the metabolic syndrome, especially with elevated lipid parameters, have been described. The aim of our study was to investigate the association between the extension of VTE and changes in the lipid profile. Methods: We included 178 VTE patients in our study; 59 patients had isolated PE, 39 patients had isolated DVT of the leg and 80 patients had both (DVT and PE). Concerning PE, we distinguished between massive and submassive PE. We evaluated plasma lipids and lipoproteins in PE and DVT patients as well as in massive and submassive PE patients. Results: PE patients had higher levels of plasma triglycerides [median (interquartile range): 162 (109-254) vs. 136.5 (96.5-162) mg/dl, p = 0.047] and lower levels of high-density lipoprotein cholesterol (HDL-C; 52.1 ± 17.2 vs. 63.9 ± 22.7 mg/dl, p = 0.004) than DVT patients. Furthermore, PE patients were significantly older than DVT patients (59.6 ± 16.9 vs. 52.2 ± 15.5 years, p = 0.02). We were not able to find differences in lipid parameters in patients with massive PE compared to those with submassive PE. However, patients with massive PE were more obese than patients with submassive PE (body mass index 29.1 ± 4.6 vs. 26.9 ± 4.9, p = 0.012). Conclusions: Lipid parameters and lipoproteins differ between DVT and PE patients. PE patients had higher triglyceride and lower HDL-C levels compared with DVT patients.

Auricular vagal nerve stimulation in peripheral arterial disease patients

BACKGROUNDnAuricular nerve stimulation has been proven effective in different diseases. We investigated if a conservative therapeutic alternative for claudication in peripheral arterial occlusive disease (PAD) via electroacupuncture of the outer ear can be established.nnnPATIENTS AND METHODSnIn this prospective, double-blinded trial an ear acupuncture using an electroacupuncture device was carried out in 40 PAD patients in Fontaine stage IIb. Twenty patients were randomized to the verum group using a fully functional electroacupuncture device, the other 20 patients received a sham device (control group). Per patient, eight cycles (1 cycle = 1 week) of electroacupuncture were performed. The primary endpoint was defined as a significantly more frequent doubling of the absolute walking distance after eight cycles in the verum group compared to controls in a standardized treadmill testing. Secondary endpoints were a significant improvement of the total score of the Walking Impairment Questionnaire (WIQ) as well as improvements in health related quality of life using the Short Form 36 Health Survey (SF-36).nnnRESULTSnThere were no differences in baseline characteristics between the two groups. The initial walking distance significantly increased in both groups (verum group [means]: 182 [95 % CI 128-236] meters to 345 [95 % CI 227-463] meters [+ 90 %], p < 0.01; control group [means]: 159 [95 % CI 109-210] meters to 268 [95 % CI 182-366] meters [+ 69 %], p = 0.01). Twelve patients (60 %) in the verum group and five patients (25 %) in controls reached the primary endpoint of doubling walking distance (p = 0.05). The total score of WIQ significantly improved in the verum group (+ 22 %, p = 0.01) but not in controls (+ 8 %, p = 0.56). SF-36 showed significantly improvements in six out of eight categories in the verum group and only in one of eight in controls.nnnCONCLUSIONSnElectroacupuncture of the outer ear seems to be an easy-to-use therapeutic option in an age of increasingly invasive and mechanically complex treatments for PAD patients.

Calculation of HAS-BLED Score Is Useful for Early Identification of Venous Thromboembolism Patients at High Risk for Major Bleeding Events: A Prospective Outpatients Cohort Study

Abstract The aim of this study was prospective evaluation of the performance of the HAS‐BLED score in predicting major bleeding complications in a real‐world outpatient cohort, during long‐term anticoagulation for venous thromboembolism (VTE), treated with a broad spectrum of anticoagulants. We analyzed 111 outpatients objectively diagnosed with VTE and treated long‐term with various anticoagulants. Patients were grouped in three cohorts based on the anticoagulant regimen. Calculation of the HAS‐BLED score and documentation of bleeding events were performed every 6 months for 1 year. Patients with a HAS‐BLED score ≥ 3 had an increased risk for major bleeding events (odds ratio [OR]: 13.05, 95% confidence interval [CI]: 0.96‐692.58, p = 0.028) and a trend to higher risk for minor bleeding events as well (OR: 2.25, 95% CI: 0.87‐5.85, p = 0.091) when compared with patients with a HAS‐BLED score < 3.This indicates that a HAS‐BLED score ≥ 3 allows for identification of patients with VTE on long‐term anticoagulation at an increased risk for major bleeding events, irrespective of the anticoagulant agent used.

The AST/ALT (De-Ritis) ratio: A novel marker for critical limb ischemia in peripheral arterial occlusive disease patients

AbstractThe aspartat aminotransferase (AST)/alanin aminotransferase (ALT) (De-Ritis) ratio (AAR) is an easily applicable blood test. An elevated AAR on the one hand has been associated with an increase in nonalcoholic fatty liver disease (NAFLD). NAFLD on the other hand is associated with an increase in cardiovascular disease, all-cause mortality, and diabetes. As the AAR is also elevated in case of muscular damage, we investigated AAR and its association with critical limb ischemia (CLI) in peripheral arterial occlusive disease (PAOD) patients.In our cross-sectional study, we included 1782 PAOD patients treated at our institution from 2005 to 2010. Patients with chronic alcohol consumption (>20u200ag/day) were excluded. AAR was calculated and the cohort was categorized into tertiles according to the AAR. An optimal cut-off value for the continuous AAR was calculated by applying a receiver operating curve analysis to discriminate between CLI and non-CLI.In our cohort, occurrence of CLI significantly increased with an elevation in AAR. As an optimal cut-off value, an AAR of 1.67 (sensitivity 34.1%, specificity 81.0%) was identified. Two groups were categorized, 1st group containing 1385 patients (AARu200a<u200a1.67) and a 2nd group with 397 patients (AARu200a>u200a1.67). CLI was more frequent in AARu200a>u200a1.67 patients (166 [41.9%]) compared to AARu200a<u200a1.67 patients (329 [23.8%]) (Pu200a<u200a0.001), as was prior myocardial infarction (28 [7.1%] vs 54 [3.9%], P = 0.01). Regarding inflammatory parameters, C-reactive protein (median 8.1u200amg/L [2.9–28.23] vs median 4.3u200amg/L [2.0–11.5]) and fibrinogen (median 427.5u200amg/dL [344.25–530.0] vs 388.0u200amg/dL [327.0–493.0]) also significantly differed in the 2 patient groups (both Pu200a<u200a0.001). Finally, an AARu200a>u200a1.67 was associated with an odds ratio (OR) of 2.0 (95% confidence interval [CI] 1.7–2.3) for CLI even after adjustment for other well-established vascular risk factors.An increased AAR is significantly associated with patients at high risk for CLI and other cardiovascular endpoints. The AAR is a broadly available and cheap marker, which might be useful to highlight patients at high risk for vascular endpoints.