Acute and long-term outcome of Silverhawk assisted atherectomy for femoro-popliteal lesions according the TASC II classification: a single-center experience.

BACKGROUND: Directional atherectomy (DA) has become popular in some centers to remove atherosclerotic plaques in femoro-popliteal lesions. Although immediate and also short - term outcome data are promising, solid long-term data are warranted to justify the widespread use in daily practice. PATIENTS AND METHODS: In this prospective study de novo and restenotic lesions of the femoro-popliteal segments were treated with the Silverhawk device. 161 consecutive patients (164 lesions) with peripheral artery disease (PAD) Rutherford classes 2 to 5 were included from June 2002 to October 2004 and October 2006 to June 2007 (59 % male, mean age 67 +/- 11 years, range 40 to 88) and the outcome analyzed according to the TASC II classification. RESULTS: DA alone was performed successfully in 28 % (n = 46), adjunctive balloon angioplasty in 65 % (n = 107) and stenting in 7 % (n = 11). The overall technical success rate was 76 % (124 / 164) and the procedural success rate 95 % (154 / 164). At 12 months primary patency rate was 61 % (85 / 140) and the secondary patency rate was 75 % (105 / 140) in the entire cohort, being less favourable in TASC D compared to TASC A to C lesions (p = 0.034 and p < 0.001, respectively). Furthermore the restenosis rate differed trendwise (p = 0.06) between de novo and restenotic lesions. Changes in the ABI and the Rutherford classes were significantly in favour of TASC A to C lesions compared to TASC D after 12 months (p = 0.004). The event free survival (MI, TIA, or restenosis) was 48 % at 12 months and 38.5 % at 24 months. Predictor for restenosis in the multivariable analysis was only male gender (p=0.04). CONCLUSIONS: The results in TASC D lesions are inferior to those in the lesser stages. DA of femoro-popliteal arteries leads shows a trend to better long-term technical and clinical outcome in de novo lesions compared to restenotic lesions.

Mechanical compression versus haemostatic wound dressing after femoral artery sheath removal: a prospective, randomized study.

BACKGROUND: Bleeding complications in the groin are one of the major disadvantages of femoral catheter procedures. The immobilisation of the patient and the compression bandages can jeopardize the patients' comfort. Aim of the study was a randomized comparison of safety and patient comfort of mechanical pressure followed by pressure bandage overnight using two different haemostatic pads after femoral artery sheath removal. PATIENTS AND METHODS: Nine hundred and eight consecutive patients undergoing diagnostic or therapeutic procedures via a 5 or 6 F femoral sheath were randomly selected either for mechanical compression therapy followed by a compression bandage (302 patients, group 1), or manual compression with application of a calcium ion releasing device (compression bandage only after application of > 5000 IU of heparin; 303 patients; group 2), or manual compression with a thrombin covered PAD without compression bandage (303 patients, group 3). RESULTS: No major hemorrhage or death occurred. A false aneurysm was found in 10 (3.3%), 13 (4.3%), and 10 patients (3.3%) of group 1, 2, and 3, respectively (p = 0.38). Three patients (0.3%) needed surgical treatment. 69 (22.7%) patients in thrombin covered PAD-group required a compression bandage overnight due to seeping hemorrhage after 15 minutes. In the calcium ion releasing PAD-group 124 (40.9%) patients had continued bandaging, 46 (15.2%) due to seeping hemorrhage after 15 min, and 78 (25.7%) due to application of heparin > 5000 IU. CONCLUSIONS: The use of mechanical compression combined with a pressure bandage, and the use of haemostatic wound dressing assisted sheath removal technique offer a comparable level of safety. Patient comfort is improved with the usage of PAD devices, however the technical failure rate of the PAD should be taken into account.

Long term outcome after balloon angioplasty and stenting of subclavian artery obstruction: a single centre experience.

INTRODUCTION: Percutaneous transluminal angioplasty is an accepted and successful treatment strategy in obstructive disease of the subclavian artery. The purpose of this study was to evaluate the technical and clinical long-term outcome following endovascular therapy. PATIENTS AND METHODS: We retrospectively analyzed 99 patients (mean age of 65 +/- 10 years) with 100 interventions of the subclavian arteries and the brachiocephalic trunk with different aetiologies [atherosclerosis (90%); Takayasu's arteritis (5%); thromboembolism (2%); external compression (1%); iatrogenic dissection (1%) and occlusion after graft implantation in type B dissection (1%)]. RESULTS: Primary success rate was 97% (100% for stenoses and 90% for total occlusions). Treatment modalities included balloon angioplasty (PTA) alone (16%), stent implantation (78%), rotational thrombectomy (2%) and atherectomy (1%). The primary 1-year patency rate of the whole study cohort was 87% being not significantly lower after PTA (75%) compared to stent assisted angioplasty (89%). After thrombectomy and atherectomy no relevant restenosis were found. Multivariable analysis of 1-year restenosis-free survival revealed younger age (p = 0.03) and stenting (p = 0.04) as independent predictor. The blood pressure difference between both limbs at baseline was 42 +/- 24 mmHg and dropped to 10 +/- 14 mmHg after the intervention and 15 +/- 20 mmHg after 12 months, respectively (p = 0.01). CONCLUSIONS: Endovascular therapy of subclavian artery obstructions of various aetiologies offers good acute success rates even in total occlusions. Long-term patency rate is in favour of stent placement.

Coil embolisation of an internal iliac artery aneurysm after surgical repair of an infrarenal aortic aneurysm.

We report a case of an 86-year-old asymptomatic patient, who underwent a repair of the infrarenal abdominal aortic aneurysm 13 years ago. He presented with a left internal iliac artery (IIA) aneurysm with a short neck of 3 mm, and a partially thrombosed lumen with a cross sectional diameter of 5.6 cm and a length of 8.9 cm. With respect to the high morbidity and mortality and awareness of the recommendation to treat aneurysms larger than 3 cm in diameter, we discussed the optimal treatment options. As endoprosthesis implantation was not feasible we performed a selective coil embolisation of the distal branches of the left internal artery, which successively lead to a complete thrombosis of the aneurysm. Although coiling additive to other procedures is applied frequently, only few cases of internal iliac aneurysm were treated with coil embolisation alone. During a first outpatient visit 2 months following the procedure the aneurysm was still completely thrombosed.

Histological verification of non-specific aorta-arteritis (Takayasu's arteritis) using percutaneous transluminal atherectomy.

Diagnosis of non-specific aorto-arteritis (NSAA, Takaysu's arteritis) is typically based on clinical and investigational parameters. We report here about two patients with clinically suspected diagnosis of a Takayasu's arteritis already under anti-inflammatory therapy in whom percutaneous transluminal atherectomy of subclavian and axillary artery stenoses was performed to relief the patients from symptoms--intermittent dyspraxia of the arms--and to verify the clinical diagnosis by histology. In the first case aorto-arteritis could be histologically confirmed through the analysis of plaque material including media structures excised from the subclavian and axillary arteries using a new device for atherectomy. The biopsy showed diffuse inflammation and granulomatous lesions with giant cells typically for Takayasu's disease. In the second patient, biopsy showed no acute or chronic inflammatory signs but only atherosclerotic lesions. Percutaneous transluminal atherectomy is therefore not only an interventional but also a diagnostic tool and should be used in every case of interventional therapy of suspected aorto-arteritis to make the clinical diagnosis and as a major consequence the initiation of an aggressive anti-inflammatory medical therapy more reliable.

[Initial clinical experience with a new percutaneous peripheral atherectomy device for the treatment of femoro-popliteal stenoses]. / Erste klinische Erfahrungen mit einem neuen Atherektomiekatheter zur Behandlung femoro-poplitealer Stenosen.

BACKGROUND: Evaluation of the efficacy and safety of a new 7F-atherectomy device (30-day endpoint) for the treatment of short and mid-length arterial lesions with a reference diameter of 2.5-7 mm. MATERIAL AND METHODS: Fifty-eight femoto-popliteal stenoses in 46 patients (67% male, mean age 66 +/- 9 years) with chronic peripheral occlusive disease of the lower limbs [Rutherford stage 2: n = 13 (28%); stage 3: n = 29 (63%), stage 4: 2 (4%), stage 5: n = 2 (4%)], were treated with directional atherectomy. Target lesion characteristics: Common femoral artery: n = 1 (2%), superficial femoral artery: n = 47 (81%); popliteal artery, n = 10 (17%); in stent n = 3 (5 %). Thirty (65 %) of the interventions were performed using an antegrade approach, 16 (35%) interventions in cross-over technique. Mean degree of stenosis was 83 +/- 11 mm, mean length of lesion was 37 +/- 37 mm. RESULTS: 6.5 +/- 2 (4-10) passes of the lesion were performed with the catheter. Three lesions were treated after predilatation, 55 (95%) interventions as primary atherectomy. In 31/58 lesions (53%) additional balloon angioplasty was performed, in 1 lesion (2%) additional stent placement was needed. The mean degree of stenosis after atherectomy was reduced to 29 +/- 20% (0-60%) after additional balloon angioplasty, it was 11 +/- 10% (0-30 %). A residual stenosis of < 50% after plain atherectomy was achieved in 55 (95%) lesions, of < 30% in 49 (84%). COMPLICATIONS: 3 (6.5%) cases of embolism of debris were detected and treated successfully by aspiration. The mean ankle-brachial index increased from 0.62 +/- 0.12 to 0.92 +/- 0.36 before discharge, and to 0.86 +/- 0.17 after 30 days. Rutherford stage after 30 days: stage 0: n = 038 (83%); Stage 1: n = 4 (8%); Stage 2: n = 3 (6%); Stage 5: n = 1 (2%). CONCLUSION: Lesions up to 8 cm in length of the femoropopliteal arteries can be treated successfully in most cases with the new atherectomy catheter. Embolism, the only complication that occurred, can be avoided by cleaning the nose cone after at least 4 passes of the lesion.

Treatment of acute embolic occlusions of the subclavian and axillary arteries using a rotational thrombectomy device.

Acute embolic or local thrombotic ischaemia of the upper limbs can be treated by embolectomy or by endovascular techniques. We report here on the endovascular thrombectomy of acute embolic occlusions of subclavian and axillary arteries in two patients using a rotational thrombectomy device and give an overview about the actual literature. Two female patients, each with a history of multivessel coronary disease and intermittent atrial fibrillation, complained of sudden onset of pain at rest and paleness of the left and right arm, respectively. Duplex ultrasound showed a localized embolic occlusion of the left subclavian artery and the bifurcation of the brachial artery in the first patient and a localized embolic occlusion of the distal right subclavian and axillary artery in the second patient. In the first patient, the left subclavian artery was reopened using a 8F-Rotarex device via the femoral access, while the bifurcation of the brachial artery was reopened by local thrombolysis using 25 mg rt-PA because of the insufficient length of the thrombectomy device of 80 cm. In the second patient, the right subclavian and axillary arteries were reopened using a 6F-Rotarex device. Follow-up examinations before discharge and after 6 months showed normalized perfusion of the arms of both patients.

[Long-term results after recanalization of acute and subacute thrombotic occlusions of the infra-aortic arteries and bypass-grafts using a rotational thrombectomy device]. / Langzeitergebnisse nach Rekanalisation akuter und subakuter thrombotischer arterieller Verschlüsse der unteren Extremitäten mit einem Rotations-Thrombektomiekatheter.

BACKGROUND: Evaluation of the acute and long-term results after recanalization of thrombotic occlusions of infra-aortic native arteries, stented arteries and bypass-grafts using a rotational thrombectomy device (8F Straub-Rotarex TM). MATERIALS AND METHODS: From July 2000 to February 2002, in 98 patients (64 % male, mean age 66 +/- 9 (range 47 to 90) years, mean duration of occlusion 31 +/- 33 (range 0 to 140) days, mean occlusion length 21 +/- 11 [range 2 to 40] cm) 100 vessel recanalizations were performed. 42 % of the interventions were performed during the first 14 days after the onset of the symptoms (acute occlusions). These patients were classified according to the after the TASC protocol modified SVS/ISCVS-classification: Class I: n = 22 (52 %); class lla: n = 13 (32 %); class llb: n = 6 (14 %); class III: n = 1 (2 %). Subacute and chronic occlusions were classified according to Rutherford (58 %): Stage 1: n = 5 (9 %); stage 2 and 3: n = 39 (68 %); stage 4: n = 6 (10 %); stage 5: n = 8 (13 %). RESULTS: Primary success rate was 96 % (ipsilateral interventions 99 %, cross-over 40 %). The restenosis rate after a mean follow-up of 13 +/- 4 months was 33 % for native arteries (group 1), 74 % for instent-recanalizations (group 2) and 86 % for bypass-graft occlusions (group 3). 3 % severe complications occurred: two amputations below the knee after unsuccessful recanalizations of a native artery and a bypass-graft, respectively. One death because of multiorgan failure in patient who was already in cardiac shock before the successful intervention. Further 16 complications could be solved periinterventionally. The ancle-brachial index was significantly improved during follow-up (from 0.37 +/- 0.19 to 0.82 +/- 0.22 before discharge, 0.70 +/- 0.21 after 12 months, p < 0.001). CONCLUSION: The Straub-Rotarex TM device is useful in the treatment of acute and subacute thrombotic occlusions of infra-aortic arterial and bypass-graft occlusions, with promising long-term results in native vessels but unchanged high restenosis of stented arteries and bypass-grafts.

[Duplex ultrasound for follow-up examination after stent-angioplasty of ostial renal artery stenoses]. / Farbduplexsonographie zur Verlaufskontrolle nach Stent-PTRA ostialer Nierenarterienstenosen.

AIM: Renal artery stenosis (RAS) may lead to deterioration of renal function and/or hypertension. Stent angioplasty has become the method of choice in the treatment of atherosclerotic ostial RAS. We describe the changes of the following duplex parameters: intrarenal resistance index RI according to Pourcelot and the renal-aortic flow velocity ratio (RAR) directly after intervention and during follow-up (FU). We also examine the value of the method in detecting restenosis. PATIENTS AND METHODS: We present the results of a prospective study of 241 patients with stent angioplasty for the treatment of 355 severe RAS (extent of stenosis >/= 70 % of vessel diameter). Duplex examinations during FU were performed before discharge, after 6 and 12 months, and then annually resulting in 1292 examinations. RESULTS: RAR could be calculated in 98.9 % (1278/1292), RI was calculated in 100 % of the examinations. The RAR decreased significantly from 5.9 +/- 2.1 to 1.2 +/- 0.4 after intervention (p < 0.00001) with a slight increase during follow-up. RI increased significantly from 0.64 +/- 0.11 to 0.74 +/- 0.06 after intervention (p < 0.00001), equalling the RI of the contralateral side (0.74 +/- 0.07). During a mean FU of 27 +/- 15 months, 37 restenosis (10.4 %) and 12 re-restenosis were detected and confirmed angiographically, resulting in 48 reinterventions. In case of restenosis, RAR increased from 1.3 +/- 0.4 to 6.3 +/- 2.8 (p < 0.001) with a decrease to 1.3 +/- 0.6 after reintervention (p < 0.001), and RI decreased from 0.75 +/- 0.08 to 0.64 +/- 0.11 (p < 0.001) with an increase to 0.75 +/- 0.07 after reintervention (p < 0.001). CONCLUSIONS: Duplex ultrasound is a reliable method for FU of patients after renal artery stent-angioplasty and for detecting restenosis.

[First experiences with a 6F-sheath compatible self-expanding nitinol stent]. / Erste Erfahrungen mit einem 6F kompatiblen selbstexpandierenden Nitinol-Stent.

BACKGROUND: To evaluate the efficacy, safety and limitation of a new 6F-compatible nitinol stent (Dynalink(TM). MATERIAL AND METHODS: We treated 50 patients (17 women, 33 men, mean age 72 +/- 8 years) by implanting 80 Dynalink(TM)-stents into 75 vessels during a 6-month period. Target lesions were: iliac artery: 25, femoral artery: 31, popliteal artery: 16, femoro-popliteal bypass: 5, subclavian vein: 3. Preinterventional Rutherford classifications: Class 1 : 3 legs (5 %), class 2 : 27 legs (51 %), class 3 : 16 legs (31 %), class 4 : 2 legs (4 %), class 5 : 5 legs (9 %). 40 % stents each were implanted ipsilateral, 60 % cross-over. RESULTS: All interventions were successful regardless of a sometimes anatomically difficult access to the lesion. The device was characterised by a high flexibility and radial force and the stent did not shorten. COMPLICATIONS: One distal stent dislocation during placement occurred, no puncture site complication. The mean diameter stenosis was reduced from 91 +/- 10 % (75 - 100 %) to 4 +/- 8 % (0 - 30 %). The ankle-brachial index was improved from 0.46 +/- 0.22 to 0.75 +/- 0.23 (p < 0.001). Post-interventional Rutherford classifications: Class 0 : 43 legs (81 %), class 1 : 5 legs (4,5 %), class 5 : 5 legs (4,5 %). CONCLUSIONS: The new 6F-sheath compatible nitinol stent is characterised by a good flexibility, radial force, and a lack of shortening. By the reduction of the diameter of the device to 6F, the potential risk of a local bleeding complication may be reduced and 6F sealing devices will be usable. Disadvantages are the 0.018 inch guide-wire lumen and the limited stent sizes.

[The Straub-Rotarex thrombectomy system: initial experiences]. / Das Straub-Rotarex-Thrombektomie-System: Erste Erfahrungen.

BACKGROUND: To evaluate the efficacy, safety and limitations of a new rotational thrombectomy device (Straub-Rotarex) in clinical practice. MATERIAL AND METHODS: The Straub-Rotarex catheter is a new, wire-guided rotational thrombectomy device for the treatment of acute and subacute occlusions of the femoro-popliteal arteries. Over a 6-month period, 28 patients (64% male, mean age 69 +/- 9.5, 51-91 years) with 31 legs, mean duration of occlusion 4.4 +/- 4 (0-20) weeks, mean occlusion length 22 +/- 11 (5-40) cm were treated with the device, 5 of them in a cross-over technique. Target lesions: Aortic-femoral bypass, common iliac artery, external iliac artery, common femoral artery: 1 each, superficial femoral artery: 23, popliteal artery: 17. Initial stage of claudication: IIa: 6%, IIb: 72%, III: 16%, IV: 6%. RESULTS: Primary success rate: 90% (ipsilateral: 100%, cross-over: 40%). Stage of claudication after intervention: I: 85%, IIa: 7%, III: 4%, IV 4%, one amputation. 3-months follow-up: stage I: 86% (n = 24), IIa: 14% (n = 4), one femoro-popliteal bypass. Restenosis rate 18%. 6-months follow-up: stage I: 56% (n = 9), IIa: 31% (n = 5), IIb: 13% (n = 2). Restenosis rate 56%. COMPLICATIONS: 32% (5 perforations, three cases of embolism after PTA, one wire-induced dissection, one retroperitoneal bleeding coming from the puncture site). CONCLUSIONS: The new device is a useful tool for the treatment of (sub)acute long-distance occlusions of the SFA and popliteal artery and in-stent restenosis as well in antegrade technique. Main complications are perforations. Cross-over interventions can only be done in special cases.

Oral immunotherapy with grass pollen in enterosoluble capsules. A prospective study of the clinical and immunological response.

In a prospective study spanning 2 years, 60 patients with grass pollen allergy were treated with either a low dose oral, a high dose oral or a subcutaneous hyposensitization regime. No significant improvement was seen in the orally treated patients whereas those on the subcutaneous hyposensitization regime demonstrated a decreased specific cutaneous reactivity, a rise in specific IgG antibodies and a reduction in symptoms. This study suggests that oral hyposensitization, even with enterosoluble grass pollen capsules, is ineffective.