Bypass surgery versus percutaneous coronary intervention for the treatment of unprotected left main disease. A meta-analysis of randomized controlled trials.

OBJECTIVE: We performed a meta-analysis of randomized controlled trials to compare coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) for the treatment of de novo unprotected left main disease. BACKGROUND: Although CABG is accepted to be standard of care for revascularization of unprotected left main stenosis, PCI is increasingly being used as an alternative primary approach. METHODS: We searched for randomized, controlled trials comparing CABG and PCI for the treatment of unprotected left main disease. Major adverse cardiac and cerebrovascular events (all-cause death, myocardial infarction, stroke, and repeat revascularization) were analyzed. RESULTS: The search strategy identified 4 randomized controlled trials enrolling a total of 1,611 patients. Follow-up ranged between 1 and 2 years. There were no significant differences in the risk of death or myocardial infarction between the two treatment modalities. While the risk of stroke was significantly lower in patients undergoing PCI (risk ratio (RR) 0.26, 95% confidence interval (CI) 0.10-0.69, p = 0.007), the risk of repeat revascularization was higher among patients undergoing PCI (RR 1.94, 95% CI 1.43-2.61, p < 0.001). No relevant statistical heterogeneity across studies could be found. CONCLUSION: In this largest series of randomized patients with unprotected left main stenosis to date, the risk of death and myocardial infarction was comparable between CABG and PCI. However, patients undergoing CABG had a higher risk of stroke, whereas patients undergoing PCI were at a higher risk for repeat revascularization.

Experience with anatomically orientated devices for transapical aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) is a new technology, which is rapidly growing to a routine procedure amenable for patients with symptomatic aortic valve stenosis and higher than average risk for conventional aortic valve surgery. The crucial disadvantage of TAVI remains the not well foreseeable risk of more than trivial degree of paravalvular leakage and a high rate of atrioventricular block and consecutive pacemaker implantation. In addition, current implantation techniques do not allow controlling the rotation of first-generation devices that might be beneficial regarding optimal physiological valve performance, optimal coronary flow and avoidance of placement of covered commissures in front of the coronary ostia. These shortcomings had pushed the development of second-generation self-expandable nitinol-based devices for subcoronary implantation that aim a reduction of paravalvular leak and AV-block by anatomical orientated positioning into the aortic root. This review focuses on the description of three different TAVI concepts, which are presently under early clinical evaluation, or have recently received commercial approval, using the transapical approach.

Transapical versus conventional aortic valve replacement--a propensity-matched comparison.

INTRODUCTION: The goal of this study was to compare the short- and long-term outcomes after aortic valve (AV) surgery carried out via standard sternotomy/partial sternotomy versus transapical transcatheter AV implantation (taTAVI). PATIENTS AND METHODS: All 336 patients who underwent taTAVI between 2006 and 2010 were compared with 4533 patients who underwent conventional AV replacement (AVR) operations between 2001 and 2010. Using propensity score matching, we identified and consecutively compared 2 very similar groups of 167 patients each. The focus was on periprocedural complications and long-term survival. RESULTS: The 30-day mortality rate was 10.8% and 8.4% (P = .56) for the conventional AVR patients and the TAVI patients, respectively. The percentages of postoperative pacemaker implantations (15.0% versus 6.0%, P = .017) and cases of renal failure requiring dialysis (25.7% versus 12.6%, P = .004) were higher in the TAVI group. Kaplan-Meier curves diverged after half a year in favor of conventional surgery. The estimated 3-year survival rates were 53.5% ± 5.7% (TAVI) and 66.7% ± 0.2% (conventional AVR). CONCLUSION: Our study shows that even with all the latest successes in catheter-based AV implantation, the conventional surgical approach is still a very good treatment option with excellent long-term results, even for older, high-risk patients.

Activation of cardiomyocytes depending on their proximity to human bone marrow stem cells.

Our study aimed to elucidate whether bone marrow stem cell (BMC) treatment might result in a cellular response in cardiomyocytes IN VITRO. Subconfluent neonatal rat cardiomyocyte cultures were cocultured for three days with Vybrant CM-DiI labeled BMC from human sternal bone marrow and underwent immunohistological staining for the proto-oncogene c-Myc and the cell cycle proteins CDK2, CDK4 and ATF-3. ß-adrenoceptor density was analyzed using [125I]-iodocyanopindolol (ICYP) histoautoradiography. Quantitative analysis of immunohistochemical images revealed significantly increased expression and upregulation of c-Myc, and its downstream targets ATF-3, CDK2 and CDK4 in neighboring cardiomyocytes to BMC, depending on their distance to the BMC compared to cardiomyocytes far from the BMC. Histoautoradiography revealed a significantly higher ß-adrenoceptor density in cardiomyocytes in the immediate vicinity to the BMC. With increasing distance to the BMC, ß-adrenoceptor density in cardiomyocytes declined. Thus, a small number of BMC can affect a larger number of cardiomyocytes by activating an intracellular signaling cascade and enhancing ß-adrenoceptor density.

Drug-coated balloons in the lower limb.

Even if recently the first positive results were presented for a paclitaxel releasing drug eluting stent there are still concerns about stent implantation in the femoro-popliteal artery. This makes any stentless technology attractive that achieves at least as good acute and longer term results in this vessel area. Three randomized studies investigating the value of short time paclitaxel release using a drug coated balloon gave promising results with significantly improved patency rates compared to plain balloon angioplasty in femoro-popliteal lesions and at least as good patency results as for the majority of bare metal nitinol stents (THUNDER, FEMPAC, LEVANT 1). Below-the-knee this promising concept is still under evaluation (PICCOLO study) whereas the first positive results for drug eluting stents in shorter lesions had been recently presented (YUKON BTK, DESTINY). This article gives an overview upon already published and presented data and still ongoing trials on drug releasing balloons in the peripheral arteries.

Use of B-type natriuretic peptide to predict blood pressure improvement after percutaneous revascularisation for renal artery stenosis.

OBJECTIVES: The purpose of this study was to evaluate the utility of B-type natriuretic peptide (BNP) to predict blood pressure (BP) response in patients with renal artery stenosis (RAS) after renal angioplasty and stenting (PTRA). METHODS: In 120 patients with RAS and hypertension referred for PTRA, 24-h ambulatory BP recordings were obtained before and 6 months after intervention. BNP was measured before, 1 day and 6 months after PTRA. RESULTS: BP improved in 54% of patients. Median BNP levels pre-intervention were 97 pg ml(-1) (interquartile range (IQR) 35-250) and decreased significantly within 1 day of PTRA to 62 pg ml(-1) (IQR 24-182) (p < 0.001), remaining at 75 pg ml(-1) (IQR 31-190) at 6 months. The area under the receiver operating curve for pre-intervention BNP to predict BP improvement was 0.57 (95% confidence interval (CI) 0.46-0.67). Pre-intervention BNP >50 pg ml(-1) was seen in 79% of patients with BP improvement compared with 56% in patients without improvement (p = 0.01). In a multivariate logistic regression analysis, BNP >50 pg ml(-1) was significantly associated with BP improvement (odds ratio (OR) 4.0, 95% CI 1.2-13.2). CONCLUSIONS: BNP levels are elevated in patients with RAS and decrease after revascularisation. Although BNP does not seem useful as a continuous variable, pre-interventional BNP >50 pg ml(-1) may be helpful to identify patients in whom PTRA will improve BP.

Percutaneous interventions below the knee in patients with critical limb ischemia using drug eluting stents.

AIM: Midterm technical and clinical evaluation of stent angioplasty with drug-eluting stents in infrapopliteal lesions in patients with critical limb ischemia (CLI). METHODS: Percutaneous stent angioplasty was performed in 128 limbs in 114 patients presenting with 320 vascular lesions. Lesions with up to 6 cm in length and at least one patent vessel below the obstruction were treated; 341 drug-eluting Cypher(R) stents (diameter of 2.5-3.5 mm; length of 18-33 mm) were implanted. Follow-up examinations were performed up to 18 months postinterventionally using clinical examination, ankle-brachial index (ABI) calculation, and color coded Duplex sonography. Patency rates were calculated on the basis of the Kaplan-Meier life-table analysis. RESULTS: Technical success was achieved in 99.06%. Minor complications (hematoma, distal emboli, and vessel dissection) were documented in 8.77% of the patients. The 6, 12, and 18 months primary patency rate as controlled by Duplex sonography was 89.8, 84.2 and 83.3%, respectively; 77.6% of the lesions healed postinterventionally. The cumulative limb salvage rate was 95.6%. CONCLUSION: Drug-eluting stent (DES) angioplasty in infrapopliteal arteries is a safe and effective technique for the treatment of patients with CLI. The use of a DES results in favorable technical and clinical outcome in the midterm follow-up.

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.

Postoperative development of aspirin resistance following coronary artery bypass.

BACKGROUND: Aspirin therapy is known to substantially reduce mortality and the rate of ischaemic complications after coronary artery bypass grafting (CABG). Rates of perioperative aspirin resistance cited in the literature are up to 50% and could be influenced by extracorporeal circulation. Thus, aspirin resistance after CABG may have a significant clinical relevance. MATERIALS AND METHODS: In 59 patients undergoing CABG (on-pump, off-pump and combined procedures) aspirin resistance was investigated by arachidonic acid induced platelet aggregometry. Clinical relevance was assessed with 12-month follow up. RESULTS: Two types of resistance were observed: A preoperative resistance (despite oral aspirin or in vitro addition) was present in 29% and a postoperative developing type was seen in 49% resulting in only 22% of patients with a 'normal' reaction to aspirin. If patients were already on oral aspirin at admission, the rate of resistance was significantly reduced. Off-pump surgery or pump-times exceeding 120 min had no significant impact on resistance. During the 12-month follow up (98.3%), there were three deaths (one stroke, one intestinal ischaemia, one mediastinitis after postoperative delirium) in patients with the perioperative resistance and none in other patients (P = 0.345). In none of those patients who presented with perioperative aspirin resistance, could this aspirin resistance be demonstrated when tested again after 12 months? CONCLUSIONS: Aspirin resistance is a transient phenomenon present in the majority of patients undergoing CABG. The three deaths in the resistant group may - although not statistically significant - indicate the possibility of a worse outcome for patients with aspirin resistance.

Aprotinin-associated risks in off-pump coronary artery bypass grafting.

BACKGROUND: Little data is available regarding the safety of using the serine protease inhibitor aprotinin in off-pump cardiac surgery. We retrospectively assessed the risks of administering the drug to adult patients undergoing off-pump coronary artery bypass grafting (OPCABG). METHODS: Aprotinin was administered as a bolus of 1 or 2 million kallikrein inhibiting units to 391 patients following median sternotomy; 370 control patients underwent surgery during the same time period without receiving aprotinin. No other antifibrinolytic agents were administered. RESULTS: Preoperative characteristics, length of ICU and hospital stay were similar between the mostly medium-risk aprotinin and the control patients. Postoperative cardiac, renal, neurological, and respiratory complications and hospital mortality occurred with comparable frequencies in both groups. Levels of myocardial enzymes during the first 72 h after surgery also did not differ significantly. CONCLUSION: Use of aprotinin in OPCABG was not associated with a higher incidence of hospital mortality, cardiovascular, renal, or other complications. Given the good safety profile in this large patient population we suggest that aprotinin could still be a valid antifibrinolytic treatment option in OPCABG.

New techniques for endovascular treatment of peripheral artery disease with focus on chronic critical limb ischemia.

Chronic critical limb ischemia (CLI) represents the most advanced stage of peripheral arterial disease. CLI is associated with a high risk for limb loss and revascularization, either by surgical or endovascular means, is absolutely mandatory. With traditional techniques such as balloon angioplasty, limb salvage was reported in 80 to 90%. However, in case of failed revascularization attempt, limb loss was 40 to 50% and mortality approximately 20%. This review summarizes new developments in endovascular techniques which increase the acute and chronic success rate of endovascular procedures and therefore potentially further improve limb salvage rates. Special crossing and re-entry devices designed for femoro-popliteal application may even facilitate recanalization of long chronic occlusions. Improved stent design, atherectomy devices and drug coated balloons improve patency rates and may result in improved wound healing rates. Moreover, downsizing the catheter tools for infrapopliteal artery disease opens new horizons also for the treatment of complex below-the-knee lesions representing an increasing patient population due to the increasing prevalence of diabetes and end-stage renal failure.

Percutaneous iliac vein recanalization 17 years after thrombotic occlusion.

Persistent venous outflow obstruction of the iliac veins is one of the mechanisms that seem to portend the greatest risk for late development of severe complications. We report the case of a 42-year-old male with postthrombotic occlusion of the left external iliac artery since the age of 25. We managed to recanalize the obstructed vessel and establish a good flow into the inferior vena cava by venous stenting. After successful intervention the patient reported instant symptom relief and was free from venous claudication and leg heaviness at the 6 month follow-up examination. Even after long history of postthrombotic syndrome, venous stenting can be an option for patients with chronic outflow obstructions of the iliac veins.

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.

Incidence of venous thrombosis following peripheral arterial interventions. A prospective study.

BACKGROUND: The objective of the study was to investigate the incidence of deep vein thrombosis (DVT) at the puncture site following peripheral interventions and to assess if there is a difference between using a vascular closure by means of vascular closure systems or compression bandages. PATIENTS AND METHODS: We prospectively included 474 consecutive patients after peripheral arterial interventions. The day after peripheral arterial intervention we performed venous compression ultrasound to exclude DVT in the area of the groin. We recorded management of arterial closure and subsequent antithrombotic treatment of the patient. Four weeks after intervention follow-up was performed by phone to exclude clinical DVT, pulmonary embolism (PE), and death. RESULTS: We included 474 consecutive patients (mean age 69 y; 298 male / 176 female). All patients were under oral antiplatelet therapy. Vascular closure was achieved in 296 patients (62.44%) by Femostoptrade mark followed by compression bandage and in 178 (37.56 %) by using a vascular closure device alone. Sonography revealed no DVT the day after intervention, no clinical PE occurred. Four weeks follow-up showed no DVT, but there was one patient in the compression bandage group who had PE without proven deep vein thrombosis. Two patients died from other reasons than PE. CONCLUSIONS: The immediate and mid-term risk of DVT after peripheral arterial interventions is extremely low and is not increased if compression bandages are used for vascular closure.

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.

Autopsy findings in patients on postcardiotomy extracorporeal membrane oxygenation (ECMO).

OBJECTIVES: To assess the clinical sensitivity of causes of death, concomitant diseases and postoperative complications including thromboembolic events in ECMO patients. METHODS: Between January 2000 and December 2004 154/202 patients (76.2%) died after postcardiotomy ECMO circulatory support. Autopsy was performed in 78 (50.6%) consecutive patients. Clinical and post-mortem data were prospectively recorded and compared concerning causes of death and postoperative complications including venous and arterial thromboembolisms and significant comorbidities. RESULTS: Mean age was 62.1+/-11.3 years, ejection fraction was 43.4+/-17.3%. 39.7% were emergency operations including acute coronary syndrome in 25.6% and preoperative cardiogenic shock in 28.2%. Successful ECMO weaning rate was 43.6%. Mean postoperative survival was 11.3 days. Premortem unknown concomitant diseases were found in 63 patients (80.8%) with clinical relevance in 9 patients (11.5%). Clinically unrecognized postoperative complications were found in 59 patients (75.6%) including acute cerebral infarction (n=7), acute bowel ischemia (1), intestinal perforation (3), pneumonia (4), venous thrombus formation (25) and systemic thromboembolic events (24). Clinically based causes of death were cardiac in 62.8%, multi-organ failure in 10.3%, cerebral in 5.1%, respiratory in 10.3%, fatal pulmonary embolism in 2.6%, technical in 5.1%, and others in 3.8%. Unexpected causes of death were found by autopsy in 22 patients (28.2%) including myocardial infarction (n=5), acute heart failure (4), fatal pulmonary embolism (2), pneumonia (2), ARDS (1), lung bleeding (1), fatal cerebrovascular event (4) and multiorgan failure (3). CONCLUSIONS: In ECMO patients major discrepancies between clinical and post-mortem examination were found. The true incidence of thromboembolic events is highly underestimated by clinical evaluation.

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.

[Telemanipulatory application of a magnetic coupler on the beating heart with the daVinci surgical system]. / Telemanipulator-gestützte Applikation eines magnetischen Gefäss-Kopplers am schlagenden Herzen mit dem da Vinci-Surgical-System.

The construction of a coronary anastomosis on the beating heart under totally endoscopic conditions is technically demanding. In this study the potential benefits of an endoscopic magnetic vascular coupler (MVP, Ventrica, Inc, Fremont, CA) designed to facilitate construction of a coronary anastomosis with the help of the daVinci telemanipulator (Intuitive Surgical Inc., Sunnyvale, CA) were evaluated in a totally endoscopic coronary arterial bypass (TECAB) operation on the beating heart in eight dogs. The telemanipulated instruments were used to guide and place the endoscopic MVP-application platform (prototype). All animals underwent angiography, and gross inspection of the anastomotic site was done after excision of the hearts. The procedure was accomplished in 169 minutes (155-190). With the exception of one premature deployment, all MVP-anastomoses were accomplished in 3 minutes (1-28). The following adverse events were encountered: Bleeding from the right ventricle caused by occlusion tape (1), anastomotic leakage upon reperfusion requiring repair stitches (2), anastomotic occlusion due to a thrombus (1). All but one animal that died on reperfusion despite a patent graft and anastomosis, survived the procedure. Overall patency was 7 out of 8. The combination of telemanipulator technology allowing increased manipulation dexterity in a total endoscopic environment and the effective and time saving magnetic technique for anastomotic coupling has the potential to facilitate TECAB on the beating heart.

Plasma levels following application of paclitaxel-coated balloon catheters in patients with stenotic or occluded femoropopliteal arteries.

PURPOSE: Paclitaxel-coated balloon catheters inhibit restenosis after coronary and peripheral angioplasty (PCI,PTA). The aim of this study was to investigate paclitaxel plasma levels and laboratory parameters following PTA with paclitaxel-coated balloons (PCB) in peripheral arteries. MATERIALS AND METHODS: This single treatment arm, multicenter study included 14 patients with Rutherford stage 1 - 5 with occlusions of up to 5 cm or ≥ 70 % diameter stenosis of the superficial femoral or popliteal arteries (SFA, PA). PTA was performed using up to three PCB catheters. The paclitaxel plasma levels and safety laboratory parameters were determined by collecting blood samples pre-intervention, immediately post-intervention, at 0.5, 1, 2, 4, 8, 24 hours and 1 and 4 weeks post-intervention (p. i.). Vital signs were monitored to assess clinical safety. RESULTS: PTA was performed successfully in all patients. Paclitaxel plasma levels were always below a level and duration known to cause systemic side effects. A mean peak paclitaxel plasma level (40 ng/ml) was reached immediately p. i. and decreased rapidly below detectable levels in more than half of the patients already 2 hours p. i. The paclitaxel plasma concentrations returned to values below detectable levels at 24 hours p. i. in all patients. Laboratory parameters and vital signs did not give any reason for safety concerns. No adverse events associated with balloon coating were observed. CONCLUSION: The results of 14 patients with peripheral arterial occlusive disease show no systemic bioavailability of paclitaxel > 24 hours after PTA with one or more PCB catheters, indicating that the PCB catheter is safe with regard to possible systemic effects.