Sex-Related Outcomes Following Drug Balloon Angioplasty in Patients from the BIOLUX P-III Registry: A Subgroup Analysis.

PURPOSE: To evaluate the use of drug-coated balloons in a real-world patient population with peripheral arterial disease and analyse the impact of sex on mid-term outcomes following their utilisation. METHODS: The BIOLUX P-III is a prospective, international, multi-centre, registry of patients with infra-inguinal lesions treated using the Passeo-18 Lux, a drug-coated balloon. Our study is a 24-month subgroup analysis of these patients; primary endpoints were freedom from major adverse events and clinically driven target lesion re-vascularisation within 12 months post-intervention. RESULTS: Of the 877 patients in the registry, 561 (64.0%) were male and 316 (36.0%) were female. Chronic limb threatening ischaemia (Rutherford class ≥ 4) occurred in 35.7% of males and 40.6% of females. Rates of freedom from major adverse events and clinically driven target lesion re-vascularisation at 12 months were 87.3% (95% confidence interval [CI] 84.2-89.9) and 90.4% (95% CI 86.5-93.3), and 92.3% (95% CI 89.9-94.1) and 92.9% (95% CI 89.7-95.1) in males and females, respectively. All-cause mortality at 24 months was 12.0% (95% CI 9.4-15.3) in males and 11.9% (95% CI 8.6-16.5) in females. The major target limb amputation rate at 24 months was 9.1% (95% CI 6.9-11.9) in males and 4.0% (95% CI 2.3-7.0) in females. CONCLUSION: Treatment with the Passeo-18 Lux DCB demonstrated high efficacy and low complication rates. Despite the greater proportion of chronic limb threatening ischaemia observed in females, males were at a greater risk of ipsilateral major limb amputation and major adverse events following drug-coated balloon utilisation. CLINICAL TRIAL REGISTRATION: NCT02276313. LEVEL OF EVIDENCE: Level 4.

Clinical Outcomes of Ambulatory Endovascular Treatment Using 4-French and 6-French Femoral Access Strategies: The Bio4amb Multicentre Trial.

PURPOSE: Ambulatory peripheral vascular interventions have been steadily increasing. In ambulatory procedures, 4F devices might be particularly useful having the potential to reduce access-site complications; however, further evidence on their safety and efficacy is needed. MATERIALS AND METHODS: BIO4AMB is a prospective, non-randomized mulitcentre, non-inferiority trial conducted in 35 centres in Europe and Australia comparing the use of 4F- and 6F-compatible devices. The main exclusion criteria included an American Society of Anaesthesiologists class ≥ 4, coagulation disorders, or social isolation. The primary endpoint was access-site complications within 30 days. RESULTS: The 4F group enrolled 390 patients and the 6F group 404 patients. Baseline characteristics were similar between the groups. Vascular closure devices were used in 7.7% (4F group) and 87.6% (6F group) of patients. Patients with vascular closure device use in the 4F group were subsequently excluded from the primary analysis, resulting in 361 patients in the 4F group. Time to haemostasis was longer for the 4F group, but the total procedure time was shorter (13.2 ± 18.8 vs. 6.4 ± 8.9 min, p < 0.0001, and 39.1 ± 25.2 vs. 46.4 ± 27.6 min, p < 0.0001). Discharge on the day of the procedure was possible in 95.0% (4F group) and 94.6% (6F group) of patients. Access-site complications were similar between the groups (2.8% and 3.2%) and included predominantly groin haematomas and pseudoaneurysms. Major adverse events through 30 days occurred in 1.7% and 2.0%, respectively. CONCLUSIONS: Ambulatory peripheral vascular interventions are feasible and safe. The use of 4F devices resulted in similar outcomes compared to that of 6F devices.

Real-World Experience With a Paclitaxel-Coated Balloon in Critical Limb Ischemia: 24-Month Subgroup Outcomes of BIOLUX P-III.

OBJECTIVES: The aim of the BIOLUX P-III (A Prospective, International, Multi-Centre, Post-Market All-Comers Registry to Assess the Clinical Performance of the Passeo-18 Lux Paclitaxel Releasing Balloon Catheter in Infrainguinal Arteries - III) registry was to collect real-world data on the Passeo-18 Lux paclitaxel-coated balloon. BACKGROUND: Critical limb ischemia (CLI) is a severe condition associated with high morbidity and mortality. Prospective data are needed to provide further insights on drug-eluting devices. METHODS: BIOLUX P-III is a prospective, post-market, all-comers registry assessing the safety and performance of the Passeo-18 Lux. Clinical information was collected at 6, 12, and 24 months. The authors report 24-month outcomes of the CLI subgroup with patients in Rutherford classes 4 to 6. RESULTS: The CLI subgroup included 328 patients with 422 lesions. Patients were 71.1 ± 10.5 years of age, and 61.0% had diabetes. Femoropopliteal lesions were present in 53.8% (n = 227), below-the-knee lesions were present in 27.0% (n = 114), and lesions were moderate or heavily calcified in 45.0% (n = 190). Major adverse events, defined as 30-day device- or procedure-related mortality, major target limb amputation, and clinically driven target lesion revascularization, occurred in 9.8% of patients through 6 months, in 14.9% through 12 months, and in 19.4% through 24 months. Clinically driven target lesion revascularization occurred in 4.4%, 8.5%, and 12.1%, major amputation in 4.9%, 5.2%, and 6.1%, and mortality in 8.1%, 11.1%, and 20.1%, respectively. Predictors of mortality were age ≥75 years and higher Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease class, and higher Rutherford class was associated with increased mortality and amputation rates. CONCLUSIONS: In a large, multimorbid patient population with complex lesions and CLI, the safety and performance of the Passeo-18 Lux paclitaxel-coated balloon has been confirmed, with low rates of major amputation and target lesion revascularization.

Prevalence and clinical impact of iron deficiency and anaemia among outpatients with chronic heart failure: The PrEP Registry.

BACKGROUND: Iron deficiency (ID) and anaemia are common in heart failure (HF). The prospective, observational PReP registry (Prävalenz des Eisenmangels bei Patienten mit Herzinsuffizienz) studied prevalence and clinical impact of ID and anaemia in HF outpatients attending cardiology practices in Germany. METHODS AND RESULTS: A total of 42 practices enrolled consecutive patients with chronic HF [left ventricular ejection fraction (LVEF) ≤45%]. ID was defined as serum ferritin <100 µg/l, or serum ferritin ≥100 µg/l/<300 µg/l plus transferrin saturation <20%, and anaemia as haemoglobin <13 g/dl (12 g/dl) in men (women). Exercise capacity was assessed using spiroergometry (69.4%) or 6-min walk test (30.4%). Amongst 1198 PReP-participants [69.0 ± 10.6 years, 25.3% female, New York Heart Association (NYHA) class 2.4 ± 0.5, LVEF 35.3 ± 7.2%], ID was found in 42.5% (previously unknown in all), and anaemia in 18.9% (previously known in 4.8%). ID was associated with female gender, lower body weight and haemoglobin, higher NYHA class and natriuretic peptide (NP) levels (all p < 0.05). ID was also more common in anaemic than non-anaemic patients (p < 0.0001), and 9.8% of PrEP-participants had both, ID and anaemia. On spiroergometry, ID independently predicted maximum exercise capacity even after multivariable adjustment, including anaemia (p = 0.0004). In all PrEP-participants, ID predicted reduced physical performance (adjusted for age, gender, anaemia, serum creatinine, C-reactive protein, LVEF, and NP level). CONCLUSIONS: Despite high prevalence, ID was previously unknown in all PrEP-participants, and anaemia was often unappreciated. Given the clinical relevance, treatability, and independent association with reduced physical performance, ID should be considered more in real-world ambulatory healthcare settings and ID-screening be advocated to cardiologists in such populations.

Real-time magnetic resonance imaging of deep venous flow during muscular exercise-preliminary experience.

BACKGROUND: The accurate assessment of peripheral venous flow is important for the early diagnosis and treatment of disorders such as deep-vein thrombosis (DVT) which is a major cause of post-thrombotic syndrome or even death due to pulmonary embolism. The aim of this work is to quantitatively determine blood flow in deep veins during rest and muscular exercise using a novel real-time magnetic resonance imaging (MRI) method for velocity-encoded phase-contrast (PC) MRI at high spatiotemporal resolution. METHODS: Real-time PC MRI of eight healthy volunteers and one patient was performed at 3 Tesla (Prisma fit, Siemens, Erlangen, Germany) using a flexible 16-channel receive coil (Variety, NORAS, Hoechberg, Germany). Acquisitions were based on a highly undersampled radial FLASH sequence with image reconstruction by regularized nonlinear inversion at 0.5×0.5×6 mm3 spatial resolution and 100 ms temporal resolution. Flow was assessed in two cross-sections of the lower leg at the level of the calf muscle and knee using a protocol of 10 s rest, 20 s flexion and extension of the foot, and 10 s rest. Quantitative analyses included through-plane flow in the right posterior tibial, right peroneal and popliteal vein (PC maps) as well as signal intensity changes due to flow and muscle movements (corresponding magnitude images). RESULTS: Real-time PC MRI successfully monitored the dynamics of venous flow at high spatiotemporal resolution and clearly demonstrated increased flow in deep veins in response to flexion and extension of the foot. In normal subjects, the maximum velocity (averaged across vessel lumen) during exercise was 9.4±5.7 cm·s-1 for the right peroneal vein, 8.5±4.6 cm·s-1 for the right posterior tibial vein and 17.8±5.8 cm·s-1 for the popliteal vein. The integrated flow volume per exercise (20 s) was 1.9, 1.6 and 50 mL (mean across subjects) for right peroneal, right posterior tibial and popliteal vein, respectively. A patient with DVT presented with peak flow velocities of only about 2 cm·s-1 during exercise and less than 1 cm·s-1 during rest. CONCLUSIONS: Real-time PC MRI emerges as a new tool for quantifying the dynamics of muscle-induced flow in deep veins. The method provides both signal intensity changes and velocity information for the assessment of blood flow and muscle movements. It now warrants extended clinical trials to patients with suspected thrombosis.

Radiation exposure in relation to the arterial access site used for diagnostic coronary angiography and percutaneous coronary intervention: a systematic review and meta-analysis.

BACKGROUND: Transradial access for cardiac catheterisation results in lower bleeding and vascular complications than the traditional transfemoral access route. However, the increased radiation exposure potentially associated with transradial access is a possible drawback of this method. Whether transradial access is associated with a clinically significant increase in radiation exposure that outweighs its benefits is unclear. Our aim was therefore to compare radiation exposure between transradial access and transfemoral access for diagnostic coronary angiograms and percutaneous coronary interventions (PCI). METHODS: We did a systematic review and meta-analysis of the scientific literature by searching the PubMed, Embase, and Cochrane Library databases with relevant terms, and cross-referencing relevant articles for randomised controlled trials (RCTs) that compared radiation parameters in relation to access site, published from Jan 1, 1989, to June 3, 2014. Three investigators independently sorted the potentially relevant studies, and two others extracted data. We focused on the primary radiation outcomes of fluoroscopy time and kerma-area product, and used meta-regression to assess the changes over time. Secondary outcomes were operator radiation exposure and procedural time. We used both fixed-effects and random-effects models with inverse variance weighting for the main analyses, and we did confirmatory analyses for observational studies. FINDINGS: Of 1252 records identified, we obtained data from 24 published RCTs for 19 328 patients. Our primary analyses showed that transradial access was associated with a small but significant increase in fluoroscopy time for diagnostic coronary angiograms (weighted mean difference [WMD], fixed effect: 1·04 min, 95% CI 0·84-1·24; p<0·0001) and PCI (1·15 min, 95% CI 0·96-1·33; p<0·0001), compared with transfemoral access. Transradial access was also associated with higher kerma-area product for diagnostic coronary angiograms (WMD, fixed effect: 1·72 Gy·cm(2), 95% CI -0·10 to 3·55; p=0·06), and significantly higher kerma-area product for PCI (0·55 Gy·cm(2), 95% CI 0·08-1·02; p=0·02). Mean operator radiation doses for PCI with basic protection were 107 µSv (SD 110) with transradial access and 74 µSv (68) with transfemoral access; with supplementary protection, the doses decreased to 21 µSv (17) with transradial access and 46 µSv (9) with transfemoral. Meta-regression analysis showed that the overall difference in fluoroscopy time between the two procedures has decreased significantly by 75% over the past 20 years from 2 min in 1996 to about 30 s in 2014 (p<0·0001). In observational studies, differences and effect sizes remained consistent with RCTs. INTERPRETATION: Transradial access was associated with a small but significant increase in radiation exposure in both diagnostic and interventional procedures compared with transfemoral access. Since differences in radiation exposure narrow over time, the clinical significance of this small increase is uncertain and is unlikely to outweigh the clinical benefits of transradial access. FUNDING: None.

Electrical myostimulation improves left ventricular function and peak oxygen consumption in patients with chronic heart failure: results from the exEMS study comparing different stimulation strategies.

AIMS: Electromyostimulation (EMS) of thigh and gluteal muscles is a strategy to increase exercise capacity in patients with chronic heart failure (CHF). The aim of this non-randomised pilot study was to investigate the effects of different stimulation strategies in CHF patients using a newly developed stimulation suit also involving trunk and arm muscles [extended electromyostimulation (exEMS)] in comparison with EMS therapy limited to gluteal and leg muscles (limEMS). METHODS: 60 individuals joined the EMS training programme. Stable CHF patients (NYHA class II-III) received either exEMS (22 patients, 15 males, mean age 59.95 ± 13.16 years) or limEMS (12 patients, 9 males, 62.75 ± 8.77 years). 26 participants served as healthy control group (CG) receiving exEMS. Training was performed for 10 weeks twice weekly for 20 min, and the level of daily activity remained unchanged. Effects on exercise capacity, oxygen uptake, left ventricular function (EF) and biomarkers were evaluated. RESULTS: There was a significant increase of oxygen uptake at aerobic threshold in all groups (exEMS: 13.7 ± 3.9-17.6 ± 5.1 ml/kg/min (+28.46%, p < 0.001); limEMS 13.6 ± 3.0-16.0 ± 3.8 ml/kg/min (+17.6 %, p = 0.003); CG 15.0 ± 4.9-17.0 ± 6.4 ml/kg/min (+13.3%, p = 0.005). LVEF increased from 38.3 ± 8.4 to 43.4 ± 8.8% (+13.3%, p = 0.001) (limEMS 37.1 ± 3.0-39.5 ± 5.3% (+6.5%, p = 0.27); CG 53.9 ± 6.7-53.7 ± 3.9% (-0.4%, p = 0.18). In CHF patients changes in oxygen consumption and LVEF were higher in the exEMS group than in limEMS (not significant). Maximal workload improved in healthy controls (p = 0.002) but not in CHF patients. CONCLUSION: Extended EMS can improve oxygen uptake and EF in CHF. In patients with limited EMS and in control patients without heart failure but extended EMS, oxygen uptake can be improved but EF is unaltered. For all groups, NT proBNP is unaffected by EMS.

The occurrence of atrial fibrillation in former top-level handball players above the age of 50.

OBJECTIVE: Cardiac adaptation to sports activity in endurance athletes is considerably different from that in power athletes. The effects of a high-level team sport like handball, one of the most popular sports in the world, performed at a younger age, on cardiac rhythm in individuals above the age of 50 have not been investigated to date. METHODS: Thirty-three former top-level handball players from the first German league (6 former world champions and numerous Olympians) (57.5 +/- 5.5 y) joined our screening programme for former athletes and underwent electrocardiography, echocardiography and spiroergometry. Data were compared to 24 sedentary healthy controls. RESULTS: Ten of the 33 athletes suffered from atrial fibrillation (AF). Left ventricular diameter was 53.68 +/- 4.88 mm in the athletes group and 50.58 +/- 4.12 mm in the healthy controls. Analysing the subgroups of handball players ('AF group' and 'non-AF group'), spiroergometry showed oxygen consumption at the anaerobic threshold of 27.54 +/- 6.77 ml/kg/min in the AF group and 31.24 +/- 10.33 ml/kg/min in the non-AF group (P = 0.228). Absolute left atrial diameter was 44.34 +/- 4.41 mm in the AF group (non-AF group 38.94 +/- 3.77 mm, P < 0.001) (healthy controls 37.54 +/- 4.34 mm, compared with all athletes P = 0.015). In all individuals left ventricular wall thickness was within normal limits. However, myocardial walls were thicker in the AF group (11.28 +/- 1.83 mm) than in the non-AF group (9.44 +/- 1.26 mm, P = 0.002). Athletes in the AF group (187.6 +/- 6.42 cm) were significantly taller than in the non-AF group (180.91 +/- 7.31 cm, P = 0.018). CONCLUSION: Not only endurance training, but also sports activity with a relevant static component, like team handball, might predispose for AF above the age of 50. LA size, height and myocardial wall thickness seem to affect the risk of developing AF. More data in non-endurance sports are mandatory to confirm this hypothesis.

Low resolution limits and inaccurate algorithms decrease significantly the value of late loss in current drug-eluting stent trials.

Quantitative coronary and vascular angiography (QCA resp., QVA) remains the current gold standard for evaluation of restenosis. Late loss as one of the most commonly accepted parameters to highlight efficacy of the various devices has shown high correlation to clinical parameters but, surprisingly, has no impact on the evaluation of the remaining amount of restenostic tissue. The current clinical practice leads to unrealistic late loss calculations. Smaller late loss differences are usually not greater than the inherited resolution limits of QCA, which is especially the case in small differences between the various stents in the drug-eluting stent era. Late loss include additional systematic and random errors, due to the fact that measurements were taken at two different time points including the inherited resolution and calibration limits of QCA on two occasions. Due to the limited value of late loss in discriminating the small differences between the one and other DES, late lumen area loss and clearly defined calculation algorithms (e.g., MLD-relocation) should be used in future DES studies also to fulfill the more stringent regulatory requirements.

Transradial percutaneous coronary interventions: technique, materials & procedure in the light of anatomical and technical considerations.

Transradial access is associated with enhanced patients' comfort, significant lower complication rates in diagnostic coronary angiography and better immediate and long-term outcomes after transradial percutaneous coronary interventions. Access failure has been reported to occur in less than 3-7% of cases due to anatomical circumstances (e.g., anomalous radial branching patterns, tortuosity e.g. radial loops, and small radial artery diameters). Radial coronary angiography and angioplasty entail a secondary learning curve of at least 150 cases in order to become familiar and comfortable with this technique. In contrast to previous established techniques (e.g. Sones-arteriotomy), the patient should be positioned in a comfortable supine position with his right arm next to his hip and the interventionist next to the right side of the patient. 19 gauge needles and 0.018 inch wires enhance the chance of successful cannulation the radial artery. A spasmolytic cocktail (3 mg Dinitrate, 3 mg verapamil, at least 3.000 U Heparine) should always be given intraarterially. Longer sheaths (> 13 cm) are not necessary. Essential for easy passage of the vertebralian artery and the common brachio-cephalic trunc (as the most dangerous part of the procedure) in order to reach the ascending aorta, the patient should be asked for a deep inspiration and/or dorsoflexion of his head An Amplatz-II catheter can be used for LCA, RCA and in some cases for LV-angiogram. The sheath should always be removed immediately and hemostasis achieved by radial compression (e.g. clamp). There is a close relationship between access failure respective radial spasm or occlusions and anatomical circumstances (i.e., hypoplastic radial artery, radioulnar loop, or small radial diameters: radial diameter-to-catheter ration < 1.0; assessment by Duplex). Although the radial access can be used in the majority of patients, the use is limited in patients with very small radial diameters and/or with complex lesions (e.g kissing balloon, etc).

Transradial percutaneous coronary interventions: indications, success rates & clinical outcome.

Before ten years, radial artery was discovered as a useful vascular access site for percutaneous coronary procedures. It has the advantage of reduced access site complications but is associated with specific technical challenges in comparison with the transfemoral approach. Although earlier data from a meta-analysis indicated higher procedure failure rates with radial--as compared to femoral access (7.2 vs. 2.4%), more recent data from prospective multicenter studies and large meta analysis showed significantly better outcomes with radial access versus femoral access in contemporary, real-world clinical settings of percutaneous cardiovascular procedures (e.g. PREVAIL-, PRESTO-ACS-studies). This includes also challenging coronary procedures in acute coronary syndromes (NSTEMI and STEMI) where the radial access was associated with fewer bleeding complications leading to better long-term outcomes. Transradial procedure failures can sometimes be due to variation in radial artery anatomy (e.g. vessel diameter, anomalous branching patterns, tortuosity) or risk factors for radial spasms (e.g. smoking, anxiety, vessel diameter, age, gender). Postprocedural radial occlusions (0.6-1.2%) seems strongly be related to these anatomical variances, which possibly may be reduced by the use of smaller catheter, however 5 French lumen diameter guiding catheter include limitations regarding treating options in complex coronary lesion. In conclusion, the transradial access for coronary angiography and interventions is not only to enhance patients comfort, but shows significant better long-term results due to less bleeding complications as compared to the femoral access.

Clinical investigation into the observation that silicon carbide coating on cobalt chromium stents leads to early differentiating functional endothelial layer, increased safety and DES-like recurrent stenosis rates: results of the PRO-Heal Registry (PRO-Kinetic enhancing rapid in-stent endothelialisation).

AIMS: Recurrent stenosis and stent thrombosis are still major concerns after drug eluting stent placement which inhibits not only the restenostic process but endothelialisation as well. In contrast, through accelerating rapid endothelialisation and development of an earlier functional endothelial layer, passive coatings have shown encouraging results. The objective of the present study was to investigate the clinical outcome and rate of recurrent stenosis of silicon carbide passive coated cobalt chromium stents (PROKinetic Coronary Stent with PROBIO coating, Biotronik AG, Switzerland) on restenosis after percutaneous coronary intervention. METHODS AND RESULTS: Percutaneous coronary stent deployment was carried out in 161 lesions in 145 consecutive patients. The primary combined endpoint was the rate of target-lesion revascularisation (TLR) and late lumen loss; the secondary endpoints were the procedural success and the major adverse cardiac events at 6-months follow-up. Out of 145 patients, 141 were successfully amenable to a silicon carbide coated stent (PRO-Kinetic, Biotronik AG, Switzerland) implantation (97.2% procedural success). At follow-up, the late loss was 0.75 +/- 0.71 mm. (in-stent) respectively 0.79 +/- 0.72 mm (in-segment), TLR was 4.9% and MACE was 5.6%. CONCLUSIONS: By augmenting rapid endothelialisation and development of an earlier functional endothelial layer, silicon carbide (PROBIO) as a passive coating on cobalt chromium stents has shown encouraging results relative to success rates, clinical outcome, TLR and late-loss in a cohort of patients with extended coronary artery disease.

Early detection and efficient therapy of cardiac angiosarcoma due to routine transesophageal echocardiography after cerebrovascular stroke.

Primary malignant cardiac tumors (cardiac angiosarcomas) are exceedingly rare. Since there are initially nonspecific or missing symptoms, these tumors are usually diagnosed only in an advanced, often incurable stage, after the large tumor mass elicits hemodynamic obstructive symptoms. A 59-year-old female presented with symptoms of cerebral ischemia. A computed tomography (CT) scan showed changes suggestive of stroke. Transesophageal echocardiography revealed an inhomogeneous, medium-echogenic, floating mass at the roof of the left atrium near the mouth of the right upper pulmonary vein, indicative of a thrombus. At surgery, a solitary tumor was completely enucleated. Histologically, cardiac angiosarcoma was diagnosed. The patient received adjuvant chemotherapy and was free of symptoms and recurrence of disease at 14 months follow-up. Due to the fortuitous appearance of clinical signs indicative of stroke, cardiac angiosarcoma was diagnosed and effectively treated at an early, nonmetastatic, and therefore potentially curable stage. Although cardiac angiosarcoma is a rare disease, it should be taken into consideration as a potential cause of cerebral embolic disease.

Excimer laser in myocardial infarction: a comparison between STEMI patients with established Q-wave versus patients with non-STEMI (non-Q).

Patients sustaining acute myocardial infarction (AMI) often require urgent percutaneous revascularization within the first 24 h from onset of the infarction due to continuous ischemia and hemodynamic instability. Upon arrival to the cardiac catheterization, the electrocardiogram of AMI patients may exhibit acute ST-elevation (STEMI) with or without accompanying Q-wave or depression of the ST segment (non-STEMI or non-Q-wave infarction). Data comparing acute outcome of device application in patients presenting for urgent revascularization with established Q-wave myocardial infarction (QWMI) versus those with non-STEMI (NQMI) are sparse. Excimer laser is a revascularization modality applied for debulking of atherosclerotic plaque and vaporization of associated thrombus in the setting of AMI. One hundred fifty-one AMI patients with continuous chest pain and ischemia who enrolled into a multicenter study and underwent urgent revascularization were divided for the purpose of a retrospective analysis into two groups. One group presented with established electrocardiographic Q-wave, whereas the other had ST-depression (NQMI). In comparison with the NQMI group, the QWMI patients had a higher incidence of failed thrombolytic therapy (17% vs 3, p = 0.006), cardiogenic shock (20 vs 6%, p = 0.01), left anterior descending as a culprit infarct-related vessel (46 vs 14%, p < 0.0001), a higher incidence of TIMI 0 flow (48 vs 24%, p = 0.04), a heavier thrombus burden (grade 4 TIMI thrombus, 58 vs 23%; p = 0.0001), and higher CPK (1272 +/- 2180 vs 404 +/- 577, p = 0.001) and troponin levels (62 +/- 95 vs 14 +/- 48, p = 0.0003). Both groups underwent laser angioplasty and stenting for relief of continuous chest pain and ischemia within 24 h of infarction onset. Quantitative coronary arteriography in an independent core laboratory measured similar improvement in baseline minimal luminal diameter and percent diameter stenosis by application of laser energy in both groups. Among the QWMI patients, a significantly higher acute gain was recorded with the laser treatment in lesions containing a large/extensive thrombus burden as compared with lesions containing only a small clot burden (1.2 +/- 0.7 vs 0.8 +/- 0.5, p = 0.01). Such a phenomenon was not detected among the NQMI patients (1.0 +/- 0.5 vs 0.8 +/- 0.6, p=ns). Baseline TIMI flow grade (0.9 +/- 1.0 for QWMI vs 1.5 +/- 1.2 for NQMI, p = 0.0001) increased with laser emission to 2.8 +/- 0.5 and subsequently reached a final level of TIMI 3 in both groups. In comparison with the QWMI patients, there was a trend toward a reduced rate of major adverse coronary events among the NQMI patients (12% QWMI vs 4% NQMI, p = 0.09). Significant differences in baseline clinical characteristics, extent of myocardial damage, location of infarct related vessel, thrombus burden, and TIMI flow exist between QWMI and NQMI patients who require urgent intervention. However, application of excimer laser results in similar high procedural success and low complication rates in both groups. Maximal acute laser gain is achieved among QWMI patients whose lesions are laden with a heavy thrombus burden.

Cutting-balloon angioplasty effectively facilitates the interventional procedure and leads to a low rate of recurrent stenosis in ostial bifurcation coronary lesions: A subgroup analysis of the NICECUT multicenter registry.

BACKGROUND: Displacement of plaque is a major concern during coronary intervention of ostial bifurcation lesions. For this reason, angioplasty involves complex stenting procedures, which may trigger development of restenosis in a previously non-diseased parent vessel. OBJECTIVES: To examine, whether plaque displacement may be prevented by scoring atherosclerotic plaque with a cutting-balloon (CB) stand-alone procedure. METHODS: Data of patients with Duke E and B type ostial bifurcation lesions (>/=70% stenosis involving a diagonal and/or marginal branch >2 mm deriving from a non-diseased parent vessel), who were treated with CB as stand-alone procedure within the prospective NICECUT multicenter trial were analyzed. Primary endpoint was the rate of binary stenosis and target lesion revascularization (TLR). Secondary endpoints were procedural success and major adverse cardiac events (MACE) at 6-months follow-up. RESULTS: 63 out of 65 lesions (56 patients) were successfully amenable to treatment with CB (96.4% procedural success). 76.9% of patients were successfully treated with CB as a stand-alone procedure, while provisional stenting was necessary in 23.1%. At follow-up, binary stenosis was found in 23.2%, among the total population. Total rate of TLR and MACE were 7.7% and 3.6%, respectively, compared to 4.0% and 2.0% in patients for whom CB stand-alone procedure was feasible, while it was 20.0% and 6.7% for stented lesions. CONCLUSIONS: CB angioplasty as a stand-alone procedure may facilitate interventional treatment of ostial bifurcation lesions and may help to avoid complex stenting procedures. It is associated with a low rate of binary stenosis and TLR.

Cerivastatin reduces cytokine-induced surface expression of ICAM-1 via increased shedding in human endothelial cells.

Activation of endothelial cells is an incipient process in atherogenesis and leads to induction of the cellular adhesion molecules ICAM-1 and VCAM-1. Their expression can be induced by cytokines as well as other inflammatory mediators. The effects of HMG-CoA reductase inhibitors (statins) include mediation of anti-inflammatory properties. The aim of this study was the comparison of cerivastatin and simvastatin-mediated effects on inflammation-induced ICAM-1 and VCAM-1 expression in human umbilical venous endothelial cells (HUVEC). In HUVEC, TNF-alpha induced ICAM-1 and VCAM-1 mRNA and surface expression. Co-incubation with cerivastatin, but not simvastatin reduced TNF-alpha-induced up-regulation of ICAM-1 surface expression whereas both statins reduced VCAM-1 surface expression; all reductions in surface expression correlated with an increase in the soluble forms of ICAM-1 and VCAM-1 in cell culture supernatants. Mevalonate and nonsteroidal isoprenoids significantly reversed protein expression and shedding. Both statins caused an aggravation of TNF-alpha-induced ICAM-1 and VCAM-1 mRNA expression which was dependent on RNA synthesis. The statin-mediated increase in ICAM-1 and VCAM-1 mRNA expression correlated with the degradation of IkappaBa. Nuclear translocation of p65 was not significantly affected by statin-treatment of cytokine-treated cells. We conclude that cerivastatin and simvastatin reduce TNF-alpha-induced up-regulation of ICAM-1 and VCAM-1 surface expression via increased protein shedding mediated by HMG-CoA reductase inhibition and subsequent isoprenoid depletion.

Excimer laser thrombus elimination for prevention of distal embolization and no-reflow in patients with acute ST elevation myocardial infarction: results from the randomized LaserAMI study.

BACKGROUND: Results for standard revascularization therapies in acute myocardial infarction (AMI) have been limited in part by distal embolization, a process which might be reduced by the application of ultraviolet laser light. The aim was to assess feasibility and safety of excimer laser coronary angioplasty (ELCA) in a randomized study in AMI. METHODS: Twenty-seven consecutive patients with ST-segment elevation AMI (aged 57.8+/-9.2 years) were randomized either to balloon angioplasty and stent implantation alone (n=13) or adjunct ELCA (n=14). Quantitative coronary angiography was analyzed by an independent core laboratory. RESULTS: ELCA was feasible and safe in all cases. No procedure-associated complications were observed. Similar results were found for main parameters in laser (L) and control (C) patients: diameter stenosis decreased from 94.3+/-9.6 to 20.7+/-10.3% (L) and from 82.7+/-16.8 to 18.9+/-5.5% (C) (p=ns; L vs. C). TIMI flow increased from 0.7+/-1.2 to 2.8+/-0.4 and from 1.7+/-1.5 to 3.0+/-0 (p=ns; L vs. C), respectively. The post-procedural myocardial blush score did not differ between the groups (2.1+/-1.3 and 2.7+/-1.0; p=ns; L vs. C) and the final corrected TIMI frame count (cTFC) was also similar in both groups (23+/-7 and 22+/-4; p=ns; L vs. C), but the cTFC gain was higher in the laser group (53+/-14% and 35+/-20%; p<0.05; L vs. C). CONCLUSIONS: Laser angioplasty is feasible and safe for the treatment of patients with ST elevation AMI. Procedural results were at least on par with conventional treatment. Further randomized controlled trials are needed to assess the benefit of laser angioplasty in AMI.