Publications by authors named "Roland Macharzina"

Background: Prospective, randomized, multicenter trials show no beneficial impact of drug-coated balloon (DCB) therapy alone on the technical and clinical outcomes of infrapopliteal artery lesions in comparison to plain old balloon angioplasty. The aim of this study was to evaluate the performance of directional atherectomy (DA) plus DCB angioplasty versus DCB alone in treatment of long infrapopliteal artery lesions.

Methods: We conducted a prospective, randomized, 2-center trial comparing the performance of DA+DCB and DCB alone in treatment of 80 patients with de novo infrapopliteal artery lesions.

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: A recent meta-analysis of randomized controlled trials suggested an increased long-term mortality risk following femoropopliteal angioplasty using paclitaxel coated devices. To assess the long-term mortality after paclitaxel drug-coated (DCB) and uncoated balloon angioplasty (POBA) of femoropopliteal lesions in patients with ulcerations and gangrene in real world practice. : A retrospective mortality analysis of patients with at least 3-year follow-up who underwent balloon based endovascular therapy of femoropopliteal lesions was performed.

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Objectives: To evaluate the long-term mortality after paclitaxel-coated drug-eluting stent (DES) angioplasty and use of uncoated devices of femoropopliteal lesions in real world practice.

Background: A meta-analysis of randomized controlled trials reported an increased risk of long-term mortality after femoropopliteal angioplasty with paclitaxel-coated devices.

Methods: Retrospective mortality analysis of claudicants Rutherford-Becker class (RBC) 1-4 who underwent DES angioplasty or uncoated balloon or stent angioplasty of femoropopliteal lesions with a follow-up of 3-7 years.

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Endovascular treatment has become first line therapy for the treatment of femoropopliteal disease. Drug-coated devices play a key role in maintaining vessel patency. In the past antiproliferative coating of drug-coated balloons (DCBs) exclusively consisted of paclitaxel.

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Objectives: This study sought to evaluate the long-term mortality after paclitaxel drug-coated balloon (DCB) angioplasty and plain old balloon angioplasty (POBA) of femoropopliteal lesions in real-world practice.

Background: A recent meta-analysis of randomized controlled trials suggested an increased long-term mortality risk following femoropopliteal angioplasty using paclitaxel-coated devices.

Methods: A retrospective mortality analysis of patients with at least 3-year follow-up who underwent balloon based endovascular therapy of femoropopliteal lesions was performed.

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Assessment of the severity of internal carotid artery stenosis is relevant to therapeutic decisions. Direct measurement of stenosis in static three-dimensionally rendered ultrasonographic color-Doppler images after an orientation with 4-D gray-scale views (4D/3D-C-US) was recently observed to be metrically non-inferior to angiography. In the study described here, power-Doppler (Christian Doppler was a physicist) ultrasonography (4D/3D-P-US) was prospectively compared with angiography, 4D/3D-C-US and 2-D duplex ultrasonography (DUS) in a similar fashion using blinded observers.

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Aims: Identifying factors associated with worse outcome following carotid endarterectomy (CEA) is important to improve prevention of major adverse cardiovascular and cerebrovascular events (MACCE), yet rarely used for registries. We intended to identify predictors of MACCE following CEA as recently analysed for stenting.

Methods And Results: Patients undergoing CEA at 2 centers over 13 years were entered into a database.

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Purpose:  The accuracy of internal carotid artery stenosis (ICAS) quantification depends on the method of stenosis measurement, impacting therapeutic decisions and outcomes. The NASCET method references the stenotic to the distal ICAS lumen, the ECST method to the local outer and the common carotid artery (CC) method to the CC diameter. Direct morphometric stenosis measurement with four-dimensionally guided three-dimensional ultrasonography (4D/3DC-US) demonstrated good validity for the commonly used NASCET method.

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Objectives: The purpose was to analyze the agreement and binary accuracy of the degree of internal carotid artery stenosis (ICAS) as determined by 4-dimensionally (4D) real-time gray-scale guided 3-dimensional (3D) color-Doppler ultrasonography (3DC-US) (4D/3DC-US) compared with catheter angiography (CA) and duplex ultrasonography (DUS). This study hypothesized that 4D/3DC-US is noninferior to CA and DUS in grading ICAS in selected patients.

Background: Clinical stratification in patients with ICAS largely depends on a patient's symptomatic status and the degree of stenosis.

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Background: The purpose of this study was to assess the correlation between the transstenotic pressure gradient as determined by a pressure wire and the decrease in the intrarenal resistance index (RI) > 0.05 measured by duplex ultrasound in significant unilateral renal artery stenosis (RAS). Intravascular ultrasound (IVUS) was correlated to the angiographic degree of RAS.

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Aims: This prospective registry study was intended to evaluate outcomes and predictors of adverse events following carotid artery stenting (CAS).

Methods And Results: Patients received neurological and duplex exams before CAS, prior to discharge and at 30- and 180-day follow-up. Multiple regression analysis included patient- and procedure-related characteristics.

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Introducing anti-restenotic drug-based treatment modalities in femoropopliteal interventions is the potential revolutionizing reperfusion treatment of peripheral artery disease. Durability of recanalization procedures using drug-coated balloons (DCB) and drug-eluting stents (DES) yields in excellent mid-term and long-term technical and clinical outcomes and may be cost saving on the long term as compared to traditional treatment modalities such as plain old balloon angioplasty (POBA) and bare metal nitinol stent implantation. Drug-eluting bioresorbable scaffolds are another drug-based promising treatment option but are still investigational.

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Drug-coated balloons (DCBs) provide a novel method to locally deliver paclitaxel into the arterial wall without the need of a chronically implanted delivery system. Following the first positive pilot studies, two large pivotal trials have confirmed superiority of DCBs over plain old balloon angioplasty (POBA) in the treatment of TASC II A and B femoro-popliteal lesions. Even for more complex femoro-popliteal lesions such as long lesions and in-stent restenosis, single-center studies and small randomized studies have shown promising mid-term technical and clinical results.

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Purpose: To compare the performance of drug-coated balloons (DCB) and drug-eluting stents (DES) in long femoropopliteal lesions.

Methods: A retrospective dual center study included 228 patients (139 men; median age 69 years) with femoropopliteal lesions ≥10 cm suffering from peripheral artery disease (Rutherford categories 1-5) treated either with DCB or DES. Propensity score stratification was used to minimize bias.

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Significant renal artery stenosis (RAS) can cause or result in deterioration of arterial hypertension and may promote the development of renal insufficiency. The activation of the renin-angiotensin-aldosterone system results in structural heart disease and may impact patient survival. Technical improvements of diagnostic and interventional endovascular tools have led to a more widespread use of endoluminal renal artery revascularization and extension of the indications for this type of therapy during the past two decades.

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Several position statements provided recommendations regarding the anatomical conditions qualifying for renal denervation catheter application based on the HTN-1 and HTN-2 trials. This manuscript summarises anatomical access artery and renal artery conditions which qualify for catheter-based renal denervation according to the instructions for use and those where treatment is not yet generally recommended, mostly due to limitations of the catheter technologies currently available, e.g.

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Background: Restenosis remains an unresolved problem despite different treatment modalities and new stent technology in femoropopliteal arteries. No standard therapy has proven to provide acceptable outcome data for this entity. Directional atherectomy alone did not result in satisfactory long-term patency rates.

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Background: To report feasibility and safety of the Pathway PV™ Atherectomy System during percutaneous peripheral vascular interventions of in-stent restenosis.

Patients And Methods: 33 patients (66.7 % men; mean age 68.

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Purpose: To determine the clinical and technical outcomes following endovascular therapy for aortoiliac occlusive disease, including complex reconstruction of the aortic bifurcation.

Methods: A retrospective database search identified 1184 consecutive patients (864 men; mean age 64±10 years) who underwent 1712 procedures to treat target lesions in the distal aorta and iliac arteries from September 1996 to December 2006. The intended strategy was to open only one femoral access site primarily, so a second puncture was needed only for the kissing balloon technique at the aortic bifurcation.

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Purpose: Isolated atherosclerotic common femoral artery (CFA) disease is a rare cause of symptomatic peripheral arterial disease. Although surgical endarterectomy is considered the therapy of choice, little is known about outcomes of percutaneous treatment.

Materials And Methods: A prospectively maintained single-center database was retrospectively analyzed for outcomes of consecutive patients undergoing isolated percutaneous revascularization of CFA disease between 1996 and 2007.

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Objectives: The study investigated the long-term clinical impact of sirolimus-eluting stents (SES) in comparison with bare-metal stents (BMS) in treatment of focal infrapopliteal lesions.

Background: There is evidence that SES reduce the risk of restenosis after percutaneous infrapopliteal artery revascularization. No data from randomized trials are available concerning the clinical impact of this finding during long-term follow-up.

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Objectives: The purpose of this study was to evaluate the technical feasability, safety, and 1-year efficacy of the endovascular treatment of atherosclerotic common femoral artery (CFA) obstructions.

Background: Atherosclerotic CFA obstruction is a known cause of symptomatic peripheral arterial disease. Although surgical endarterectomy is considered the therapy of choice for this condition, little is known about the percutaneous options.

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Purpose: To report our experience with a catheter system (The Outback catheter) designed to allow fluoroscopically controlled re-entry after subintimal guide wire passage during recanalization of chronically occluded femoro-popliteal arteries.

Methods: Between March 2007 and August 2008, 65 legs in 61 patients (60% male, mean age 73 (49-98 years) with chronic occlusion of the SFA and proximal popliteal artery were treated. Clinical presentation was severe intermittent claudication (Rutherford category 3, 59%), rest pain (Rutherford category 4, 16%), and minor ulcerations (Rutherford category 5, 25%).

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Long QT syndrome (LQTS) is a heritable disease associated with ECG QT interval prolongation, ventricular tachycardia, and sudden cardiac death in young patients. Among genotyped individuals, mutations in genes encoding repolarizing K+ channels (LQT1:KCNQ1; LQT2:KCNH2) are present in approximately 90% of affected individuals. Expression of pore mutants of the human genes KCNQ1 (KvLQT1-Y315S) and KCNH2 (HERG-G628S) in the rabbit heart produced transgenic rabbits with a long QT phenotype.

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