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Objectives This study sought to identify risk factors for thrombus formation on the Amplatzer Cardiac Plug (ACP) (St. Jude Medical, St. Paul, Minnesota) after left atrial appendage occlusion. Background Left atrial appendage occlusion with the ACP aims to reduce the risk of embolic stroke and bleeding complications associated with vitamin K antagonists in patients with atrial fibrillation. Methods We performed transesophageal echocardiography before discharge and after 3, 6, and 12 months in 34 patients with atrial fibrillation undergoing ACP implantation and receiving dual antiplatelet therapy. Clinical, echocardiographic, and hemostaseological parameters were retrospectively analyzed to identify risk factors for thrombus formation. Results Three patients had thrombi before discharge, 3 more at the 3-month follow-up. No differences were found in left atrial volume, left atrial appendage velocity, spontaneous echo contrast, transmitral gradient, or mitral regurgitation between patients without or with thrombi. CHADS 2 (Congestion, Hypertension, Age, Diabetes, and Stroke) score (2.0 ± 1.1 vs. 4.3 ± 1.0), CHA 2 DS 2 -VASc (CHADS 2 plus Vascular Disease and Sex Category) score (5.2 ± 1.3 vs. 6.8 ± 0.8), and pre-interventional platelet count (215.9 ± 63.9/nl vs. 282.5 ± 84.4/nl) were higher and ejection fraction (50.6 ± 11.4% vs. 39.7 ± 10.6%) lower in those with thrombi. Factor 2, factor 5, or methylenetetrahydrofolate reductase mutations and genetic variants associated with reduced clopidogrel activity were not more frequent in patients with thrombi. Conclusions Transesophageal echocardiography identified 17.6% of patients with thrombus formation on the ACP despite dual antiplatelet therapy. CHADS 2 and CHA 2 DS 2 -VASc scores, platelet count, and ejection fraction are risk factors for such thrombus formation.

AIMS Residual paravalvular aortic regurgitation (PAR) after transcatheter aortic valve implantation (TAVI) is common. We therefore evaluated incidence, determinants and outcome of PAR after TAVI. METHODS AND RESULTS Data from 167 consecutive transcatheter TAVI patients were analysed. PAR was graded by angiography and the pressure gradient between diastolic aortic pressure and left ventricular end-diastolic pressure (∆PDAP-LVEDP) after implantation. TAVI was technically successful in all patients. Mortality was 9% and 20% at 30 days and one year, respectively. Post-procedural PAR was absent in 54 patients (32.3%). Mild PAR was found in 89 (53.3%), moderate in 21 (12.6%), and moderate-to-severe in three patients (1.8%). Cardiovascular mortality at 30 days and one year was increased in patients with moderate and moderate-to-severe PAR compared to patients with no and mild PAR (46% vs. 4% and 73% vs. 7%, respectively, p

A relevant (at least moderate) paravalvular regurgitation (PAR) after transcatheter aortic valve implantation (TAVI) is found in up to 20% of cases and associated with increased mortality. The ratio of the diastolic over the systolic pressure time integral (DPTI:SPTI) has been proposed to reflect an estimate of myocardial oxygen supply versus demand and the propensity for myocardial ischemia. We have now evaluated the potential of this ratio to predict PAR-associated cardiovascular mortality after TAVI, retrospectively analyzing data from 167 consecutive TAVI patients. PAR was graded angiographically, and the myocardial supply-demand ratio was estimated from the planimetric integration of the diastolic and systolic pressure-time area (DPTI and SPTI), respectively. PAR was observed in 113 patients (67%) and angiographically graded as mild in 89 (78.8%), moderate in 21 (18.6%) or moderate to severe in 3 (2.7%) cases. The DPTI:SPTI ratio decreased with increasing Sellers grade of PAR ( P < 0.001). A DPTI:SPTI of ≤0.7 predicted cardiovascular mortality (area under the curve = 0.96). Cardiovascular mortality at 30 days and 1 yr was increased in patients with DPTI:SPTI ≤ 0.7 over those with DPTI:SPTI > 0.7 (42 vs. 2% and 63 vs. 3%, respectively; P < 0.001). In conclusion, DPTI:SPTI provides an excellent cutoff value of ≤0.7 for the prediction of PAR-associated mortality.

Aortic valve replacement with coronary artery bypass graft surgery is currently the standard therapy for patients with aortic stenosis and concomitant coronary artery disease. We sought to determine whether transcatheter aortic valve implantation combined with percutaneous coronary intervention might be an equivalent strategy.A total of 243 high-risk patients (Society of Thoracic Surgeons [STS] score10% and/or European System for Cardiac Operative Risk Evaluation [EuroSCORE]15%) presenting with aortic stenosis with concomitant coronary artery disease were studied. Patients were treated either by surgical aortic valve replacement combined with coronary artery bypass graft (group 1, n = 184) or by percutaneous coronary intervention within 12 months before transapical or transfemoral transcatheter aortic valve implantation (group 2, n = 59). A propensity score adjusted regression analysis was used to compare 30-day mortality as the primary study endpoint between the groups.Group 1 mean age (75 ± 6 years), EuroSCORE (18.1% ± 13.8%), and STS score (13.1% ± 8.7%) were significantly different from group 2 (mean age 80 ± 6 years, EuroSCORE 27.5% ± 16.3%, and STS score 16.7% ± 10.5%; p0.001). Thirty-day mortality was 12.5% in group 1 compared with 11.9% in group 2 (odds ratio 0.94, 95% confidence interval: 0.38 to 2.32, p = 0.89). Univariate analysis revealed left ventricular ejection fraction, pulmonary hypertension, renal insufficiency, STS score, EuroSCORE, and previous cardiac surgery as predictors for 30-day mortality (p0.05). Risk-adjusted multivariate regression analysis showed only left ventricular ejection fraction to be strongly associated with 30-day mortality and confirmed no significant difference between the groups (p = 0.44). To further control for study bias, a 10-layer propensity score model based on the univariate analysis again indicated equivalence regarding the primary endpoint (p = 0.33).The present study demonstrates that transcatheter aortic valve implantation in combination with prior percutaneous coronary intervention within 12 months produces similar results in a propensity score matched high-risk patient population.

Summary Many clinicians consider severe aortic stenosis to be a contraindication to pulmonary artery catheterisation, except during open heart surgery with cardiopulmonary bypass. This is due to the perceived high risk of arrhythmia, although the true incidence of ventricular tachycardia and fibrillation remains unclear. We conducted a retrospective study to estimate the incidence of severe arrhythmias during pulmonary artery catheterisation in 380 patients with severe aortic stenosis scheduled for transcatheter aortic valve implantation. Ventricular fibrillation was seen in only one patient (0.26%), and this was successfully terminated by external defibrillation. No episodes of ventricular tachycardia were recorded and there were also no arrhythmias during removal of the catheter. We have therefore concluded that pulmonary artery catheterisation in patients with severe aortic stenosis is not associated with a high incidence of ventricular fibrillation or tachycardia, allowing pulmonary artery pressure monitoring to be performed relatively safely in such patients.

Objectives To evaluate feasibility, safety and efficacy of percutaneous arterial access site closure after transfemoral, transcatheter aortic valve implantation (TF-TAVI) using a single, commercially available six French monofilament suture-mediated vascular closure device (VCD) in “preclosure” technique. Background Currently, TF-TAVI is evolving into a completely percutaneous procedure. However, percutaneous access site closure still remains a major technical challenge with room for improvement. Methods 94 of 144 consecutive patients underwent completely percutaneous TF-TAVI using following technique for access site closure: After puncture of the common femoral artery using fluoroscopy and contralateral angiography for guidance, the VCD was deployed prior further predilatation of the vessel and insertion of the large-bore introducer sheath. At the end of the procedure, the preloaded sutures were tied for final hemostasis and crossover angiography was used for postprocedural evaluation of the access vessel. Results Application of the VCD was technically successful in all cases, resulting in an efficient hemostasis with cessation of any bleeding within 10 min of final knot-tying in 83 of the 94 patients, and there was only one closure-failure with continuous bleeding despite prolonged manual compression requiring endovascular treatment. In addition, we observed four closure-related access vessel stenoses of hemodynamic relevance requiring endovascular treatment in three and surgical repair in one patient. However, interventional and surgical repair was not associated with death or irreversible end-organ damage and all patients recovered without sequelae. Conclusion “Preclosure” of the arterial access site with a single six French suture-mediated VCD is relatively easy, safe and efficient method for access site closure after TF-TAVI which, along with ongoing profile reductions of TAVI devices, should further simplify and broaden the way toward a routine, completely percutaneous procedure. © 2012 Wiley Periodicals, Inc.

Objectives To evaluate feasibility, safety, efficacy as well as acute and short-term outcome of hemodynamically supported percutaneous coronary intervention (PCI) by a percutaneous, catheter-based left ventricular assist device (LVAD) (Impella LP 2.5, Abiomed Europe GmbH, Aachen, Germany) in a high-risk patient population with acute coronary syndrome. Background Although hemodynamic support by intraaortic balloon pump favorably affects myocardial oxygen supply and demand, it has modest effects on cardiac output, providing passive support only. In contrast, the Impella LP 2.5 microaxial pump, which is placed within the left ventricular outflow tract and actively ejects blood into the ascending aorta, might offer additional hemodynamic support and thereby procedural safety during PCI. Methods Thirty-eight consecutive high-risk patients (mean age, 69.7±10.3years, logistic EuroSCORE, 22.4±14.9%) with unstable angina pectoris or non-ST-segment elevation myocardial infarction and severe three-vessel-disease were included in the study. Clinical and laboratory examinations were performed at baseline as well as at 6, 24 and 48h after the procedure and 30days after discharge. Results Device insertion and explantation was feasible in all patients without vascular complications and continuous hemodynamic stability was obtained during PCI. PCI was uneventfully performed in all but one patient for technical reasons. One non procedure-related death occurred 7days after the intervention, accounting for a total 30-day mortality of 2.86%. Other major cardiac or cerebrovascular events did not occur. Conclusions LVAD support using a percutaneous microaxial flow pump is a promising and safe approach for high-risk PCI providing good short-term results.

Die Malperfusion der Aorta und ihrer Seitenaste ist eine haufige Komplikation der Aortendissektion. Die durch die akute Aortendissektion drohende Minderperfusion von Organen ist eine der Hauptursachen fur die hohe Mortalitat und Morbiditat bei diesen Patienten. Daher sind eine schnelle Diagnose, die Identifizierung der ischamiegefahrdeten Organe und die umgehende Einleitung einer Therapie zur Reperfusion erforderlich, bevor es zu bleibenden Endorganschaden kommt. Erschwert wird dies durch die haufig initial nur diskret bestehenden Symptome, die durch eine verzogerte Therapie letztendlich fatal enden konnen.

Implantation of bare metal stents (BMS) induces the release not only of particulate debris, but also of soluble vasoconstrictors which contribute to microvascular impairment. So this study aimed at addressing the potential attenuation of such vasoconstriction using paclitaxel eluting stents (PES). Using a distal protection/aspiration device, coronary arterial blood was retrieved before and during stent [n = 14 BMS, n = 14 PES, n = 3 sirolimus eluting stents (SES)] implantation in patients with saphenous vein aorto-coronary bypass stenosis and analyzed for plasma serotonin and thromboxane B(2) concentrations. The vasoconstriction of rat mesenteric arteries with intact (+E) and denuded (-E) endothelium in response to coronary arterial or aspirate plasma was quantified and normalized to that by potassium chloride (KCl(max) = 100%). Coronary arterial plasma before stent implantation induced a vasoconstriction of 30-43%, which was independent of endothelial integrity. Serotonin-release was 2.2 ± 0.5 μmol/l with BMS and 2.0 ± 0.4 μmol/l with PES, thromboxane B(2)-release was 26 ± 5 pg/ml with BMS and 22 ± 8 pg/ml with PES. BMS- and SES-aspirate plasma induced a vasoconstriction of 68 ± 18% (+E)/93 ± 14% (-E) and 81 ± 17% (+E)/124 ± 14% (-E), respectively. In contrast, PES-aspirate plasma induced only minor vasoconstriction of 8 ± 3% (+E)/12 ± 5% (-E). Addition of paclitaxel to BMS-aspirate plasma attenuated vasoconstriction. PES-aspirate induced microtubular condensation in immunofluorescence microscopy. Results indicate that aspirate from PES implantation attenuates vasoconstriction, possibly secondary to microtubular stabilization. Such acute downstream vascular paralysis could be beneficial in preventing a no-reflow phenomenon in patients undergoing stenting.

Due to the increasing number of patients and complexity of modern tachycardia devices, efficient therapy monitoring as offered by telemedicine monitoring is of increasing importance. The potential advantages of remote control for patient management include early detection of device-related technical problems and arrhythmias. We report the case of an ICD patient with incessant ventricular tachycardia in whom immediate arrhythmia transmission was monitored by remote control.

Background: Many invasive and noninvasive methods have been proposed for guiding optimal programming of cardiac resynchronization therapy (CRT) devices. However, results are not satisfying. Preliminary results suggest that cardiac output (CO) measurements using inert gas rebreathing (IGR) might be an eligible method to tailor atrioventricular (AV) and ventriculo-ventricular (VV) programming. The aims of the present study were: (1) to evaluate whether an optimization of CRT can be obtained by noninvasive CO measurements and (2) to evaluate whether acute hemodynamic improvements obtained by this approach relate into increase in cardiac exercise capacity. Methods: In 24 patients on CRT, iterative VV- and AV-delay optimization was done using the IGR method. This blinded, randomized, crossover study compared the responses to optimization during two periods: a 4-week optimized and a 4-week standard programming. Exercise capacity after optimization was assessed after each period by New York Heart Association (NYHA) classification, a 6-minute walking test, and quality of life (QoL) questionnaire. Results: CO could be determined by IGR in all patients. The NYHA class decreased by 17.8% (2.8 ± 0.3 vs 2.3 ± 0.4, P < 0.001), the mean (± standard deviation) distance walked in 6 minutes was 9.3% greater after optimization (456 ± 140 m vs 417 ± 134 m, P < 0.001), and the QoL improved by 14.5% (41.8 ± 10.4 vs 36.5 ± 9.5, P < 0.001). The portion of responders to CRT increased from 66.5% to 87.5%. Conclusion: CRT optimization by iterative CO measurements leads to an increase in CO and an improvement of exercise capacity. Our results suggest that this method might become an important additive tool to adjust CRT programming. (PACE 2010; 33:1188–1194)

Recent reports describe an increased rate of cardiovascular events in smoking HIV-infected subjects. However, a lot is still unknown about smoking in this patient population. The purpose of the study was to analyze smoking behavior in HIV-infected subjects as a risk factor of coro-nary atherosclerosis and determine its effect on the probability of coronary events. We analyzed the cardiovascular risk factors of 294 HIV-infected adults (age: 42.1 ? 10.1 years; 77% males). An elevated tobacco abuse was observed in 63.6% of the HIV-infected patients. Tobacco use was much more common in HIV-infected males than in females (67.8% vs. 49.2%; p 0.2). Analysing the way of infection and the status of smoking, patients with HIV-infection acquired by heterosexual contact exhibited sig-nificantly lower rates of smoking compared with patients with HIV-infection acquired by MSM (man having sex with man) or by intravenous drug abuse (52.7% vs. 67.4%/82.1%, p < 0.01). The effect of smoking on the 10yrs. probability of coronary events determined by Framingham- equation was superior compared with all other classic cardiovascular risk factors. HIV-infected patients exhibited an increased tobacco use. Knowledge about smoking behavior in this pa-tient population is essential to evaluate the risk of cardiovascular events and to implicate prevention strategies for HIV-infected subjects.

Objectives This retrospective multicenter registry evaluated the safety and feasibility of left ventricular (LV) support with the Impella 2.5 (Abiomed Europe GmbH, Aachen, Germany) during high-risk percutaneous coronary intervention (PCI). Background Patients with complex or high-risk coronary lesions, such as last remaining vessel or left main lesions, are increasingly being treated with PCI. Because periprocedural hemodynamic compromise and complications might occur rapidly, many of these high-risk procedures are being performed with mechanical cardiac assistance, particularly in patients with poor LV function. The Impella 2.5, a percutaneous implantable LV assist device, might be a superior alternative to the traditionally used intra-aortic balloon pump. Methods The Europella registry included 144 consecutive patients who underwent a high-risk PCI. Safety and feasibility end points included incidence of 30-day adverse events and successful device function. Results Patients were older (62% >70 years of age), 54% had an LV ejection fraction ≤30%, and the prevalence of comorbid conditions was high. Mean European System for Cardiac Operative Risk Evaluation score was 8.2 (SD 3.4), and 43% of the patients were refused for coronary artery bypass grafting. A PCI was considered high-risk due to left main disease, last remaining vessel disease, multivessel coronary artery disease, and low LV function in 53%, 17%, 81%, and 35% of the cases, respectively. Mortality at 30 days was 5.5%. Rates of myocardial infarction, stroke, bleeding requiring transfusion/surgery, and vascular complications at 30 days were 0%, 0.7%, 6.2%, and 4.0%, respectively. Conclusions This large multicenter registry supports the safety, feasibility, and potential usefulness of hemodynamic support with Impella 2.5 in high-risk PCI.

Percutaneous, transcatheter mitral valve repair has recently been introduced and various strategies – loosely based on surgical techniques – are currently under clinical and preclinical evaluation. Since percutaneous mitral valve repair techniques are rather specific regarding both the underlying cause of mitral regurgitation and patient anatomy, careful preinterventional imaging using various techniques is required for appropriate patient selection and essential for procedural success. While echocardiography is the dominant imaging modality for determination of mitral regurgitation severity and etiology, other imaging modalities like contrast-enhanced multidetector computed tomography, magnetic resonance imaging, and fluoroscopy/angiography may play an important role in the preinterventional evaluation process. In addition, imaging is of utmost importance for procedural guidance and the combined use of various imaging modalities, commonly fluoroscopy and echocardiography, is needed in the catheterization laboratory to ensure safety and efficacy of mitral valve repair procedures. Finally, imaging is essential for an adequate patient follow-up aiming to control stable device positioning, persistency of the geometric modifications induced, and continuous reduction of mitral regurgitation. This review highlights the role of various imaging techniques during preinterventional evaluation, procedural guidance and follow-up in the setting of percutaneous mitral valve repair with special focus on edge-to-edge leaflet repair and indirect annuloplasty via the coronary sinus as the best-studied approaches to date.

Renal artery stenosis (RAS) is both a common and progressive disease and its prevalence in patients > 65 years is 6.8%. In patients with known or suspected atherosclerosis undergoing coronary angiography, a frequency of even 11-23% is reported in the literature. Despite this high prevalence, there is an ongoing discussion about the indications for revascularization and it is currently unclear, whether renal artery revascularization reduces adverse cardiovascular and renal events. Nevertheless, the number of interventions for RAS is rising steadily, although up to 40% of patients do not profit from this intervention. This fact underlines the necessity of a thorough diagnostic work-up before intervention, integrating morphological and functional tests. For morphological evaluation, multislice computed tomography, magnetic resonance tomography or digital subtraction angiography can be done. In experienced centers, Doppler ultrasound can serve as an excellent functional tool, to assess the physiological relevance of an RAS, but also invasive measurements of pressure and flow provide valuable information about the significance of stenoses; however, these methods will have to be assessed with respect to their value to predict long-term outcome. Although percutaneous intervention of RAS is associated with a substantially lower risk of major adverse events as compared to surgery, by using contrast media this procedure holds the risk of deterioration of renal function and of a small number of procedure-dependent complications as well. Thus, a careful consideration of pros and cons of this procedure is mandatory.

Objectives Our study aimed to detect the morphological und functional effects of coronary microembolization (ME) in vivo by cardiac magnetic resonance (CMR) imaging in an established experimental animal model. Background Post-mortem morphological alterations of coronary ME include perifocal inflammatory edema and focal microinfarcts. Clinically, the detection of ME after successful coronary interventions identifies a population with a worse long-term prognosis. Methods In 18 minipigs, ME was performed by intracoronary infusion of microspheres followed by repetitive in vivo imaging on a 1.5-T MR system from 30 min to 8 h after ME. Additionally, corresponding ex vivo CMR imaging and histomorphology were performed. Results Cine CMR imaging demonstrated a time-dependent increase of wall motion abnormalities from 9 of 18 animals after 30 min to all animals after 8 h (0.5 h, 50%; 2 h, 78%; 4 h, 75%; 8 h, 100%). Whereas T2 images were negative 30 min after ME, 4 of 18 animals showed myocardial edema at follow-up (0.5 h, 0%; 2 h, 6%; 4 h, 25%; 8 h, 17%). In vivo late gadolinium enhancement (LGE) was observed in none of the animals after 30 min, but in 33%, 50%, and 83% of animals at 2 h, 4 h, and 8 h, respectively, after ME. Ex vivo CMR imaging showed patchy areas of LGE in all but 1 animal (2 h, 83%; 4 h, 100%; 8 h, 100%). A significant correlation was seen between the maximum troponin I level and LGE in vivo (r = 0.63) and the spatial extent of ex vivo LGE (r = 0.76). Conclusions Our results show that in vivo contrast-enhanced CMR imaging allows us to detect functional and structural myocardial changes after ME with a high sensitivity. Ex vivo, the pattern of LGE of high-resolution, contrast-enhanced CMR imaging is different from the well-known pattern of LGE in compact myocardial damage. Thus, improvements in spatial resolution are thought to be necessary to improve its ability to visualize ME-induced structural alterations even in vivo.

BACKGROUND: Cardiac marker release after percutaneous coronary interventions (PCI) reflects myocardial necrosis which is usually the result of periprocedural (micro)embolization of atherothrombotic debris and associated with impaired left ventricular function and adverse outcome. METHODS: In this prospective study, we examined 55 patients treated by direct stenting of single de-novo lesions to assess the relationship between plaque composition, as determined by preinterventional intravascular ultrasound (IVUS) with radiofrequency data (IVUS-RF) analysis (so-called Virtual Histology) versus coronary microembolization, as determined by serial measurement of cardiac markers. IVUS was performed with an electronic system and 20-MHz IVUS catheters. Serum creatine kinase (CK) and cardiac troponin I (CTnI) were determined before PCI and after 6, 12, and 24 hours. RESULTS: Plaques had a volume of 99 +/- 63 mm(3) and were composed of fibrous (61 +/- 9%) and fibro-fatty tissue (27 +/- 12%), dense calcium (4 +/- 3%), and necrotic core (NC) (8 +/- 6%). NC volume per se, volume per 10 mm of segment length, and volume % were correlated (r = 0.64, 0.66, and 0.52 respectively; all P < 0.01) with the maximum increase in cardiac markers (CK 55.4 +/- 55.7 U/l; CTnI 0.49 +/- 0.68 ng/ml). Patients in the 4th quartile of NC volume (>10.8 mm(3)) had a particularly high increase in markers (P < 0.001). In contrast, total plaque volume and plaque components other than NC had no relation with cardiac markers (ns). CONCLUSIONS: Patients with large NC in culprit lesions may experience more myocardial injury from peri-interventional microembolization. IVUS-RF assessment before PCI has the potential to identify lesions at particular high risk which may help to tailor PCI.

We investigated the safety, feasibility and usefulness for closure of PFO with the new nitinol meshwire PFO-occluder device (Occlutech Figulla®-single layer occluder) with an unique braiding technology which allows a 50% reduction of meshwork material on the left atrial side in combination with a greater flexibility as compared to the Amplatzer® occluder device. The retention discs of the new PFO Occlutech Figulla® single layer device (23/25 mm) are connected by a 3 mm waist in the centre with only one right atrial side hub. The left atrial disc is a single flat layer covered by an ultrathin polyethylene terephthalate (PET) patch. We investigated the safety, feasibility and usefulness for closure of PFO in a multicenter clinical trial. Indications for closure included cryptogenic stroke with evidence of a patent foramen ovale in transesophageal echocardiography (PFO max. diameter 13 mm according to sizing balloon). The device was implanted in 36 patients (mean age 57, 18–80 years) by means of fluoroscopy and transesophageal echocardiography (TEE) using a 9 French delivery sheath and employing a femoral vein approach. Both acetylsalicylacid 100 mg/d (6 months) and clopidogrel 75 mg/d (3 months) were administered post interventional. A transthoracal (TTE) and transesophageal echocardiography follow-up examination was performed after 1, 2 and 6 months (TTE day 30 and 180; TEE day 60). The device was successfully implanted in 36 pts. In one patient PFO implantations was attempted but not crossed with a guide wire. Perioperativly there were no major in-hospital-adverse events or complications thromboembolism, occluder dislodgement, infection or myocardial infarction. One patient had transient atrial fibrillation 2 h after implantation, which terminated medically after 12 h. TEE studies in the remaining 35 pts (one pt was unwilling to further participate) showed a residual shunt in 8.6% (3/35) after 60 days and a left-to-right shunt in 2.6% (1/35) of pts. After 180 days one pt with severe arteriosclerotic heart disease and A.carotic stenosis revealed a stroke without evidence of cardioembolic origin or devices thrombosis. The novel Occlutech Figulla® PFO N single layer device appears to be safe, feasible and useful for PFO closure despite a 50% reduction of the meshwire, no distal hub and an improved flexibility of the left atrial disc.

Background Idiopathic pulmonary arterial hypertension (PAH) is a rare disease. HIV-infected patients exhibit a considerably higher rate of development of this condition compared to the general population. Methods This cross-sectional study of 802 (83.4% male; age 44.3±10.3 years) HIV-positive patients aimed to evaluate the male-to-female ratio in HIV-related PAH and to elucidate whether PAH is more likely to occur in patients receiving highly active antiretroviral therapy (HAART) than in HIV-treatment-naive patients. All patients were examined by Doppler echocardiography to estimate systolic pulmonary arterial pressure (sPAP). Manifest PAH was defined as sPAP >35 mmHg at rest in combination with symptoms of dyspnoea. Results A total of 38 (4.7%) patients were diagnosed with elevated sPAP >35 mmHg. Fourteen (1.7%; 11 male) of these patients presented with symptoms of dyspnoea, resulting in a male-to-female ratio of manifest HIV-associated PAH of 1:1.4. Patients with symptoms of dyspnoea and sPAP>35 mmHg were more likely to receive HAART (13/14 patients). Conclusions In HIV patients, sPAP occurs more frequently than has been reported previously; the condition is possibly associated with HAART. Furthermore, HIV-positive females exhibit a higher prevalence of HIV-related PAH (HIV–PAH) than HIV-positive males.

Vascular closure devices (VCD) are well established to facilitate hemostasis after cardiac catheterization procedures. However, impairment of flow due to the reduction of femoral artery diameter remains a major concern. The present study aims to evaluate leg perfusion before and after application of collagen- and suture-based vascular closure devices.A total of 366 patients (age: 64.3 years+/-10.7, male: 71.3%) were randomized to receive femoral access site closure with either a collagen-based closure device (group A) (n=214) or a suture-mediated device (group B) (n=152), immediately following coronary catheterization procedures. In all patients, the ankle-brachial-index (ABI) was measured before and the day after closure device application.In group A, mean ABI at baseline was 1.09+/-0.2, in group B 1.11+/-0.2. In both groups, there was a significant, albeit clinically not relevant, reduction in post-procedural ABI (group A: 1.04+/-0.2, p0.01 vs baseline, group B: 1.06+/-0.2, p0.01 vs baseline). DeltaABI was not different between both VCD groups (p=0.55). In patients with peripheral vascular disease (PVD), neither the Angioseal device (mean ABI at baseline 0.76+/-0.1) nor the Perclose-device (mean ABI at baseline 0.79+/-0.1) induced a remarkable impairment of leg perfusion (Angioseal: 0.77+/-0.1, p=0.9 vs baseline, Perclose: 0.78+/-0.1, p=1.0 vs baseline). Clinically, no aggravation of claudication was observed in the PVD patient group.Both vascular closure devices are not associated with clinically relevant reduction in ABI. There was no difference between the two groups with respect to the level of flow impairment. Both devices may be safely used in patients with reduced ABI.

Wir berichten uber die iatrogene Perforation eines Pulmonalarterienastes bei einer 84-jahrigen Patientin nach Aortenklappenvalvuloplastie und das nachfolgende Krisenmanagement mit Restitutio ad integrum. Die Perforation verursachte eine intrapulmonale Hamorrhagie mit drohender Asphyxie. Die Ursache wurde rasch erkannt und die Blutung durch Repositionierung des Swan-Ganz-Katheters mit Balloninsufflation proximal der Perforationsstelle gestoppt, wahrend gleichzeitig eine Narkose mit Intubation und Bronchiallavage eingeleitet wurde. Die Perforationsstelle wurde definitiv durch die Injektion von Thrombin (5000 IE) uber den Swan-Ganz-Katheter verschlossen und dessen Ballon in insuffliertem Zustand fur sechs Stunden belassen. Die Patientin wurde nach 12 h extubiert und nach 48 h auf die Normalstation verlegt. Es traten keine neurologischen Defizite auf. Im Verlauf bildete sich kein Pseudoaneurysma aus.

Coronary stent implantation started in Germany 20 years ago. In the beginning, the progress was very slow and accelerated 10 years later. Meanwhile, coronary stent implantation is a standard procedure in interventional cardiology. From the beginning of permanent stent implantation, research started to provide temporary stenting of coronary arteries, first with catheter-based systems, later with stent-alone technology. Stents were produced from polymers or metal. The first polymer stent implantation failed except the Igaki-Tamai stent in Japan. Newly developed absorbable polymer stents seem to be very promising, as intravascular ultrasound (IVUS) and optical coherence tomography have demonstrated. Temporary metal stents were developed based on iron and magnesium. Currently, the iron stent is tested in peripheral arteries. The absorbable magnesium stent (Biotronik, Berlin, Germany) was tested in peripheral arteries below the knee and meanwhile in the multicenter international PROGRESS-AMS (Clinical Performance and Angiographic Results of Coronary Stenting with Absorbable Metal Stents) study. The first magnesium stent implantation was performed on July 30, 2004 after extended experimental testing in Essen. The magnesium stent behaved like a bare-metal stent with low recoil of 5-7%. The stent struts were absorbed when tested with IVUS. Stent struts were not visible by fluoroscopy or computed tomography (CT) as well as magnetic resonance imaging (MRI). That means, that the magnesium stent is invisible and therefore CT and MRI can be used for imaging of interventions. Only using micro-CT the stent struts were visible. The absorption process could be demonstrated in a patient 18 days after implantation due to suspected acute coronary syndrome, which was excluded. IVUS showed a nice open lumen. Stent struts were no longer visible, but replaced by tissue indicating the previous stent location. Coronary angiography after 4 months showed an ischemia-driven target lesion revascularization rate of 23.8% which was below the 30% cut point of the study protocol. No myocardial Q wave infarction or death were reported. The primary endpoint was reached. During the follow-up period, vasomotion was tested in some of the patients. The proof of principle was confirmed: restoration of vasomotion during acetylcholine testing. The development of the absorbable magnesium stent, which was pushed forward by B. Heublein, Hanover, Germany, has been successful and opens new possibilities for treatment of coronary arteries. Permanent foreign-body implantation is avoided allowing further revascularization procedures in the future, bypass grafting, and restoration of vasomotion. Even prophylactic stenting in nonsignificant stenosis, like vulnerable lesions, may become a regular procedure. Noninvasive coronary imaging by CT and MRI is now possible. Stenting of children and in peripheral arteries may become a standard procedure. Currently, the degradation process of the magnesium stent has to be prolonged, and the neointima proliferation rate has to be reduced so that the DREAM (Drug-Eluting Absorbable Magnesium Stent) concept of Ron Waksman, Washington, DC, USA, can be realized.

Objective: HIV infection is a well-recognised risk factor for pulmonary arterial hypertension (PAH). In order to evaluate the influence of highly active antiretroviral therapy on the development of PAH in HIV infection (APAH-HIV), we performed a systematic review of published literature contributing to the topic. Methods: Relevant publications were retrieved by a comprehensive literature search in major medical databases including Medline, AIDSinfo, AIDSline, Cochrane Library of Systematic Reviews, Database of Abstracts of Reviews of Effects, Health Technology Assessment Database, Healthstar and European Database on AIDS and HIV Infection. Inclusion criteria were studies on adult patients with HIV and PAH. The search of the literature was followed by standardised information extraction and analysis with reference to clinical characteristics, diagnostic procedures, therapy and outcome. Results: The majority of identified publications related to APAH-HIV reported case reports. Among 192 identified reports, 57% of the patients were male (mean age: 36 ± 7.6 years). Intravenous drug abuse was the most common causal factor for HIV infection (53%). At the time of diagnosis of PAH, the patients had a mean CD4 count of 355 cells/μl (SD 276) and were almost equally distributed over all stages of HIV infection. Two-thirds of the patients were in NYHA stages III and IV at the time of diagnosis. Echocardiography and right heart catheterisation showed right ventricular dilation in 85% and a mean pulmonary vascular resistance of 1001 dyn·s·cm -5 (SD 418), respectively. Therapy induded specific vasodilators in 32.0% of the patients. The 1 -year survival rate estimated with Kaplan-Meier statistics was 50%. Cardio-pulmonary complications were the most frequent cause of death (77%). Conclusion: PAH is a devastating complication of HIV infection. Patients with PAH do not die of opportunistic infections or malignancies but of right heart failure. Therefore, research should concentrate on diagnosis and treatment options for APAH-HIV patients.

Pulmonary arterial hypertension (PAH) is a rare and rapidly progressing disease characterized by an increase in pulmonary resistance, which, if untreated, inevitably progresses to right ventricular heart failure and death. New treatment options were developed in the last 10 years. Endothelin receptor antagonists (ERAs) and prostanoids are an effective treatment with a better survival. Phosphodiesterase inhibitors (PDIs) are of a great interest, and first results in the treatment of patients are promising. PDIs are different in pulmonary selectivity and half-life.Right heart catheterization is the "gold standard" in the diagnosis of pulmonary hypertension. Direct classification of the pulmonary hypertension is feasible, and the effects of the drugs are directly measurable. The results of right heart catheterization are comparable for inhalative and oral drugs. New generations of drugs resulted in special testing protocols. Furthermore, individual concepts of therapy can be developed.

Eine Heilung von Tumorpatienten ist haufig nur mit risikoreichen Therapiestrategien moglich. Hierbei konnen lebensbedrohliche Nebenwirkungen auftreten, die eine intensivmedizinische Behandlung erforderlich machen. Das Ziel dieser Arbeit war es, die Prognose von Patienten mit einer malignen Tumorerkrankung, die intensivmedizinisch behandelt werden mussten, zu bestimmen und prognostische Faktoren zu ermitteln. Retrospektiv wurden die Krankenakten von 94 Patienten mit einer malignen Tumorerkrankung ausgewertet, die in einem Zeitraum von 5 Jahren intensivmedizinisch behandelt werden mussten. Von 94 Tumorpatienten hatten 64 eine hamatologische und 30 eine solide Tumorerkrankung. 92 Patien- ten (98%) waren chemotherapeutisch vorbehandelt. Die Grunde fur die intensivmedizinische Behandlung waren respiratorische Insuffizienz (49%), Sepsis (21%), Blutungen (7.4%) und kardiale Dekompensation (6,4%). Eine Intubation mit maschineller Beatmung war bei 68% der Patienten erforderlich und 66% der Patienten benotigten kreislaufunterstutzende Medikamente (Noradrenalin, Dopamin). Die Letalitat wahrend des intensivmedizinischen Aufenthaltes und wahrend des gesamten Krankenhausaufenthaltes betrug 55 bzw. 67%. In der multivariaten Regressionsanalyse waren respiratorisches Versagen mit der Notwendigkeit der maschinellen Beatmung, eine erhohte Konzentration der Laktatdehydrogenase im Serum und multiples Organversagen gemessen mit dem SOFA-Score unabhangige ungunstige prognostische Faktoren fur die Letalitat auf der Intensivstation. Respiratorisches Versagen mit der Notwendigkeit der maschinellen Beatmung, multiples Organversagen gemessen mit dem SOFA-Score und der Remissionsstatus der zugrunde liegenden Tumorerkrankung waren prognostisch signifikant fur das Gesamtuberleben. Respiratorisches Versagen und multiples Organversagen sind die bedeutsamsten unabhangigen prognostischen Faktoren fur die Letalitat wahrend des Aufenthaltes auf der Intensivstation, wahrend der Remissionsstatus der zugrunde liegenden Tumorerkrankung die Langzeitprognose beeinflusst.

Compared with 2-dimensional (2D) transesophageal echocardiography (TEE), 3-dimensional (3D) TEE, providing realistic visualization of the valve prosthesis in the context of the surrounding anatomy, promises to provide even more accurate evaluation of prosthetic valve malfunction. This will be

Objectives The aim of this study was to evaluate the diagnostic accuracy of a 16-detector row computed tomography (CT) scanner for the assessment of coronary artery bypass grafts. Background A new generation of multislice spiral CT scanners, equipped with more and thinner detector rows, allows for reliable noninvasive detection of obstructive coronary artery disease. Methods The study included 51 consecutive patients. Three patients had to be excluded from the study due to arrhythmias or fast heart rates despite beta-blockade. A total of 48 patients with 131 coronary artery bypass grafts (internal mammary artery, n = 40; venous grafts, n = 91) were examined by computed tomography angiography (CTA) and by invasive coronary angiography (ICA) using a 16-detector row CT scanner. For cardiac protocols, only the 12 inner detector rings are applied. All CT examinations were performed with retrospective electrocardiogram gating at a mean heart rate of 64 ± 5 beats/min; 120 ml of Xenetix 300 (Guerbert GmbH, Sulzbach, Germany) were continuously injected. The bypass graft patency and the presence of stenoses as well as the proximal and distal anastomoses were evaluated by two experienced readers. Results All bypass grafts and 74% of the distal bypass anastomoses could be visualized by CTA; 21 bypass graft occlusions and 1 significant stenosis were detected by CTA and confirmed by ICA. Five false positive and one false negative finding resulted in a sensitivity of 96%, a specificity of 95%, a positive predictive value of 81%, and a negative predictive value of 99%. Conclusions Sixteen-detector row CT scanner technology allows for the reliable visualization of coronary bypass grafts. Dysfunctional bypass grafts can be detected with high diagnostic accuracy. This technology can be used as a noninvasive test for patients with suspected graft dysfunction.

ObjectivesWe compared a conventional stent (Jostent Flex, Jomed GmbH, Rangendingen, Germany) with a polytetrafluoroethylene (PTFE)-membrane-covered stent (Jostent Stentgraft) in patients undergoing intervention of a stenosis in an obstructed vein graft.BackgroundThe use of stents improved results of percutaneous revascularization of obstructed vein grafts, but did not demonstrate the reduced elevated restenosis rate. In addition, long-term clinical event rate is still high compared with intervention in native vessels. Observational studies suggested that stents covered with a PTFE membrane might be associated with a low complication and restenosis rate in venous bypass grafts.MethodsThis prospective multicenter study included a total of 211 patients who were randomly assigned to receive either a Flex stent or Stentgraft. The primary end point was binary restenosis rate at six months by core lab quantitative coronary angiography.ResultsAcute success and procedural events were comparable between the two groups. Restenosis rate was not significantly different between the Flex (20%) and the Stentgraft (29%) groups (p = 0.15), although there was a nonsignificant trend toward a higher late occlusion rate in the Stentgraft group (7% vs. 16%, p = 0.069) at follow-up. Likewise, after a mean observation period of 14 months, cumulative event rates (death, myocardial infarction, or target lesion revascularization) were comparable in the two groups (31% vs. 31%, p = 0.93).ConclusionsThis controlled trial does not indicate a superiority of the PTFE-membrane-covered Stentgraft compared with a conventional stent with respect to acute results, restenosis, or clinical event rates.

The objective of this study was to assess the initial safety and feasibility of a novel suture-mediated device for closure of femoral access sites immediately after diagnostic or interventional cardiac catheterization. In a prospective study, 150 patients (mean age, 61.5 years; 109 male) underwent femoral access closure with a novel suture closure device (Superstitch, Sutura) immediately after diagnostic (n = 106) or interventional (n = 44) catheterization procedures, independently of the coagulation status. All patients were monitored for 24 hr after the procedure. The closure device was successfully deployed in 92% of patients. Immediate hemostasis was achieved in 77% of patients with no differences between patients undergoing diagnostic catheterization or coronary interventions (79% vs. 73%; P = 0.659). After 2 min of additional light manual compression, hemostasis was achieved in 92% of patients. There was one major complication requiring vascular surgery (0.7%). The novel suture closure device is a safe and effective device that allows for immediate closure of femoral puncture sites after both diagnostic and interventional procedures with a low rate of major complications.

Die Entwicklung der interventionellen Kardiologie der Koronararterien geht weit zuruck in die Anfange der Herzkatheteruntersuchung, wurde aber im Grunde erst durch A. Gruntzig 1977 mit der ersten perkutanen koronaren Ballondilatation (PTCA) begonnen. Zunachst verlief die Entwicklung sehr langsam, an wenigen Zentren. Erst der einsetzende Boom in den USA durch den Wechsel von Gruntzig nach Atlanta bewirkte auch in Deutschlang eine starkere Verbreitung. Bereits 10 Jahre nach der ersten PTCA wurden in Deutschland die erste Stentimplantation und Rotablation sowie Laserangioplastie und Ultraschalltherapie durchgefuhrt. Geblieben ist heute als Standardverfahren die Stentimplantation und Rotablation (siehe Bericht T. Dill et a., Bad Nauheim, Seite 502). Neu ist die Behandlung der Instentrestenose mittels Strahlentherapie, bei chronischen Verschlussen die Laserdrahtrekanalisation. Uber die aktuellen Standards berichten W. Rutsch et al, Berlin, Seite 481.

To identify the incidence and clinical significance of myocardial injury following elective stent implantation.Prospective clinical study with 278 consecutive patients undergoing stenting of de novo coronary or saphenous vein graft lesions. Incidence of periprocedural myocardial injury was assessed by analysis of 12 lead ECG, creatine kinase (CK; upper limit of normal (ULN) 70 IU/l for women, 80 IU/l for men), and cardiac troponin T (cTnT; point of care test; threshold 0.1 ng/ml) before and 6, 12, and 24 hours after the intervention. Major adverse cardiac events (MACE: acute myocardial infarction, bypass surgery, and cardiac death) were recorded during clinical follow up (mean (SD) 7.8 (5.3) months).Following elective stenting, the rate of a positive cTnT status was 17.3%, the rate of CK increase of 1-3x ULN 14.7%, the rate of CK increase of3x ULN 1.4%, and the rate of Q wave myocardial infarction 0.4%. Cardiac mortality during follow up was higher in patients with postprocedurally increased CK (7.1% v 1.3%, p = 0.01, log rank) and cTnT (9.1% v 0.9%, p0.001, log rank). In addition, postprocedurally increased cTnT was associated with a higher overall incidence of MACE (13.1% v 4.0%, p0.01, log rank) and was identified as an independent factor for MACE during follow up (hazard ratio 3.27, 95% confidence interval 1.14 to 9.41, p = 0.028).Following elective stent implantation, a positive cTnT status identified patients at risk of a worse long term outcome. Treatment strategies have to be developed that lead to prognostic improvement by reducing periprocedural myocardial injury.

Transmyocardial laser revascularization is a modern therapeutic concept for patients with end-stage coronary artery disease not eligible for bypass surgery, percutaneous coronary interventions or heart transplantation. Although the principal idea of creating additional myocardial perfusion from the cavum of the left ventricle was derived from observations in reptile hearts, histological investigations suggest that channel patency is not the underlying mechanism for improved clinical symptoms. Sympathetic denervation and angioneogenesis may be additional explanations for improvement of angina and stress tolerance. The first experiences with transmyocardial laser revascularization were made using a surgical approach. Two randomized multicenter trials could show a significant improvement in angina and stress tolerance 12 months after creating channels using laser technique. While these results were obtained by performing thoracotomy, catheter-based systems have been designed for a less invasive approach of this technique. A further advantage of these new systems is that regions like the septum can be treated which are not eligible for a surgical approach. Using percutaneous transluminal catheter-based systems channels of up to 6 mm length can be created. Beside the fluoroscopic guided creation of myocardial channels a new mapping system has been applied using electromechanical features of viable myocardial tissue. This system is based on the observation that endocardial electrograms recorded from an infarcted area are characterized by very low amplitude and fractionated morphology. This system allows online mapping of viable myocardium and provides spatial, electrical, and mechanical information of the myocardium. This method of electromechanical mapping highly correlates with results obtained from myocardial perfusion scans. Recent preliminary clinical trials demonstrated that catheter-based creation of myocardial channels is a feasible and successful alternative to the surgical laser revascularization. Also with this approach a significant improvement in angina and stress tolerance can be achieved. The results of the PACIFIC study, the first randomized multicenter study using percutaneous transluminal laser revascularization, demonstrates that after 3 and 6 months more than half of the patients presented improved angina of at least 1 Canadian-Cardiovascular-Society class. Whether electromechanical guided myocardial laser revascularization is more efficient than fluoroscopic guided has not been proven yet. Further studies will have to evaluate this issue.

The objective of this study was to evaluate the potential benefit of stepwise intravascular ultrasound (IVUS)-guided coronary stent deployment compared to angiographic stent implantation with final IVUS assessment only. Acute procedural success and 6-month angiographic follow-up were compared in both groups. Intravascular ultrasound was performed using a 20- or 30-MHz mechanically rotated catheter in 85 patients who were prospectively randomized to group A (n=42; IVUS-guided) and group B (n=43; angiography +/- final IVUS assessment). There was no difference in the number of stents implanted (1.5+/-0.9 stents/lesion in group A and 1.3+/-0.6 stents/lesion in group B), the duration of the procedure, or the amount of contrast medium used. Defined criteria of optimal stent deployment (stent apposition, stent symmetry, complete coverage of dissections, >90% in-stent lumen area/reference lumen area) were achieved in 54.2% in group A and 56.6% in group B (NS). Angiographic follow-up was 87.1% at 6+/-2 months, and clinical follow-up was 100% at 8+/-1 months. There was no significant difference in restenosis rate (33.3% vs. 34.9%) applying a binary >50% diameter stenosis criterion for both groups. There was no significant difference in minimal in-stent lumen area at both baseline (7.91+/-2.64 mm2 vs. 7.76+/-2.21 mm2) and follow-up (5.84+/-2 mm2 vs. 5.52+/-1.87 mm2). With regard to immediate procedural lumen gain and rate of restenosis, multiple IVUS examinations during the procedure showed no advantage compared to final IVUS assessment only.

Background Patients with diabetes mellitus (DM) have an increased risk for periprocedural complications and adverse cardiac events after percutaneous coronary intervention. We addressed the potential for coronary microvascular obstruction and restenosis in patients with and without DM undergoing stenting for saphenous vein bypass graft (SVG) stenosis under protection with a distal occlusion/aspiration device. Methods SVG plaque volume and composition were analyzed using intravascular ultrasound before stent implantation. Percent diameter stenosis was determined from quantitative coronary angiography before, immediately after and 6 months after stent implantation. Coronary aspirate was retrieved during stent implantation and divided into particulate debris and plasma. Total calcium, several vasoconstrictors, and tumor necrosis factor (TNF)α in particulate debris and coronary aspirate plasma were determined. Results Patients with and without DM had similar plaque volume, but larger necrotic core and greater particulate debris release in patients with than without DM (20.3±2.7 vs. 12.7±2.6% and 143.9±19.3 vs. 75.1±10.4 mg, Pvs. 5.1±2.4 pmol/mg and 2.2±0.7 vs. 1.1±0.2 pmol/L, Pvs. 6.34±1.11%, PP Conclusion In diabetics, particulate debris and coronary aspirate plasma contained more TNFα, which might reflect the activity of the underlying atherosclerotic process. Trial registration URL: http://www.clinicaltrials.gov/ct2/results?term=NCT01430884; unique identifier: NCT01430884

Transcatheter aortic valve implantation (TAVI) is a novel treatment option for patients with severe, symptomatic aortic valve stenosis considered inoperable or at high risk for surgical aortic valve replacement. Despite rapid adoption of this technology into clinical application, however, recent randomized controlled clinical trials have raised safety concerns regarding an increased risk of neurological events with TAVI compared to both medical treatment and conventional, surgical aortic valve replacement. Moreover, neuro-imaging studies have revealed an even higher incidence of new, albeit clinically silent cerebral lesions as a surrogate for procedural embolization. In this article, we review currently available data on the incidence, timing, predictors, prognostic implications and potential mechanisms of neurological events after TAVI.

Implantable cardioverter-defibrillators (ICDs) alone or combined with cardiac resynchronization therapy (CRT-Ds) featuring automatic home monitoring (HM) function can be monitored remotely on a daily basis. Different ways of implementing HM into clinical routines are possible, with efficient patient management being the main objective. In this study, a concept using a telemedical service center (TmSC) to manage HM data was developed and investigated regarding patients' satisfaction, physicians' satisfaction, and alert filtering.Fifty-five ICD or CRT-D patients with symptomatic heart failure were enrolled. The TmSC received HM data, identified "actionable parameters" (APs) by following protocol-defined procedures, conducted structured patient interviews, and forwarded selected APs to the respective follow-up clinic. Satisfaction of patients and physicians with the TmSC was evaluated at the end of the study by purpose-designed questionnaires.During a mean follow-up of 402±200 days, 3,831 APs were identified and analyzed at the TmSC (5.28 per patient-month). Most APs were triggered by a pilot detection algorithm for worsening heart failure (2.80 per patient-month), followed by atrial tachyarrhythmia episodes (1.10 per patient-month) and ventricular pacing issues (0.87 per patient-month). The TmSC forwarded 682 APs (18% of all APs) to 10 study sites. Approximately 65% of physicians and patients deemed the TmSC improved patient care.The TmSC-based management concept was well accepted and appreciated by the majority of physicians and patients. It may be helpful in gaining symptomatic information on top of automatic HM data and in supporting smaller clinics in the follow-up of their device patients.

Transcatheter aortic valve implantation (TAVI) is currently expanding worldwide, however all available prostheses share some fundamental design drawbacks. We investigated the feasibility, safety and hemodynamic performance of the innovative transapical Acurate TA™ self-expandable device, which has the unique advantage of offering anatomically correct self-alignment within the aortic root.Transapical TAVI was performed in six acute swine and six chronic sheep procedures, with follow-up of 7, 14, 21, 28, 60 and 90 days. TAVI was performed under TEE and angiographic guidance without rapid pacing.A partial sternotomy approach was used to access the LV-apex. All valve implantations were performed as planned and all animals survived the implantation procedure. After deployment, no migration, embolization or coronary obstruction was observed during the observation period. Intraoperative TEE examination identified no signs of intravalvular leakage or valve dysfunction. Transvalvular mean pressure gradients were 5.4 ± 2.2 mmHg decreasing during follow-up (1.6 ± 0.8 mmHg, 1.8 ± 0.8 mmHg, 1.3 ± 0.2, 1.8 ± 0.7 mmHg, 1.6 ± 0.8 mmHg), with a slight increase atday 90 (4.0 ± 2.4 mmHg, P0.05). Macroscopic examination at necropsy showed correct anatomical positioning of the valve stent without any signs of structural valve deterioration.These first results of the innovative self-expandable transapical ACURATE TA™ device explore the feasibility and safety of anatomically correct off-pump implantation with optimal hemodynamic results.

A new and smaller percutaneous ventricular assist device (pVAD, Impella, Abiomed, Danvers, MA) has been developed to provide circulatory support in hemodynamically unstable patients and to prevent hemodynamic collapse during high-risk percutaneous coronary interventions (PCI). The objective of the study was to assess the cost-effectiveness of this specific device compared to the intra-aortic balloon pump (IABP) from the European perspective. Additional analysis on extracorporeal membrane oxygenation was conducted for observational purposes only, given its use in some European countries. A combination of a decision tree and Markov model was developed to assess the cost-effectiveness of the small, pVAD. The short-term (30-day) effectiveness and safety (early survival, risk of bleeding, and stroke) were modeled, as well as long-term risk of major adverse cardiovascular events (recurrent myocardial infarction, stroke, and heart failure). The short-term effectiveness and safety data for the device were obtained from two registries (the Europella and USpella), both of which are large multi-center studies in high-risk patient groups. Probabilities of long-term major adverse cardiovascular events were obtained from various published clinical studies. The economic analysis was conducted from a German statutory health insurance perspective and only direct medical costs were included. Cost-effectiveness was estimated over a 10-year time horizon. Compared with IABP, the pVAD generated an incremental quality-adjusted life-year (QALY) of 0.22 (with Euro-registry data) and 0.27 (with US-registry data). The incremental cost-effectiveness ratio (ICER) of the device varied between €38,069 (with Euro-registry data) and €31,727 (with US-registry data) per QALY compared with IABP. KEY LIMITATIONS: Unadjusted, indirect comparisons of short-term effectiveness and safety between the interventions were used in the model. Cost and utility data were retrieved from various sources. Therefore, differences in patient populations may bias the estimated cost-effectiveness. Compared with IABP, the pVAD is a cost-effective intervention for high-risk PCI patients, with ICERs well-below the conventional cost-effectiveness threshold

Plaque vulnerability plays an important role in acute coronary events and in coronary microembolization during percutaneous coronary intervention (PCI). Modern intravascular imaging modalities were used to identify vulnerable lesions, potentially predicting periinterventional coronary microembolization. In 14 patients undergoing PCI, optical coherence tomography (OCT) and near-infrared spectroscopy (NIRS) were performed to evaluate plaque vulnerability. After PCI, imaging was repeated with the aim to depict signs of coronary microembolization like plaque ruptures and protrusions. Lesions with ≥ 2 features of plaque vulnerability in OCT (thin fibrous cap, microvessels, thrombus, plaque rupture) were associated with a higher lipid core content in NIRS, compared to lesions with only few of these features: lipid core burden index of the lesion (LCBIlesion) and the maximal 4-mm LCBI (LCBI4 mm) were 152±37 vs. 68±18 (p

The concept of a single-lead implantable cardioverter-defibrillator (ICD), with a floating dipole, has been proven safe and functional.The studied active-fixation, steroid-eluting lead (Linox(smart) S DX, BIOTRONIK SECo KG, Berlin, Germany) is one French thinner than its predecessor and coated with lubricious SilGlide to improve lead handling. A dedicated ICD device has a self-adaptive atrial input stage including a fourfold amplifier. The amplification, filtering, and adapted atrial input stage are located in the Lumax 540 VR-T DX (BIOTRONIK). The Linox(smart) S DX ICD lead delivers only the signal. The lead was evaluated during implantation; at predischarge; and 1-, 3-, and 6-month follow-up examinations. The primary endpoint (efficacy) was the rate of appropriate atrial sensing tests. The secondary endpoint (safety) was freedom from lead-related invasive reinterventions. Both safety and efficacy were expected to be significantly higher than 90%. The study enrolled 116 patients at 25 clinical sites. Skin-to-skin operation time was 52.4 ± 26.2 minutes. The investigators graded lead insertion as "easy" in 87% of patients. Mean P-wave amplitudes (preamplified) varied from 5.0 to 6.1 mV in different body positions. Both primary and secondary endpoints were met, as 93.8% (364/388; P = 0.005) of specific sensing tests indicated appropriate atrial sensing, and 94.8% (110/116; P = 0.048) of patients were free from reinterventions (lead dislodgement). Analysis of arrhythmia episodes stored in ICDs and elective 24-hour Holter electrocardiogram tests raised no concerns about lead functionality.The studied ICD lead with a floating atrial sensing dipole met the predefined safety expectation and demonstrated appropriate atrial sensing performance.

Valve-size selection for TAVI is based on annular measurements by echocardiography or CT. Still, relevant PAR with negative impact on survival is common(20%). We sought to evaluate whether supraaortic angiography during BAV may provide improved sizing([figure][1]). ![Figure][2] Data of 167

Background: To analyze early technical success and late clinical success after endovascular entry sealing for chronic type B dissection with special emphasis on the development of pseudoaneurysm, reintervention, false lumen and aortic remodeling. Methods: Retrospective analysis of a prospective database. We observed 151 patients (mean age 62,2 12,6 years, 67% male) in the period July 1999 to May 2010 with acute or chronic type B dissection treated by endovascular entry sealing. Serial contrastenhanced computed tomography (CT) scans of 151 type B dissection patients (mean age 62,2 12,6 years, 67% male) who underwent TEVAR were analyzed. True and false lumen diameter at baseline and follow-up were quantified. In 6 of 8 patients with pseudoaneurysm a complete follow-Up by CT was available which was compared with the other 143 patients: The angle between distal stent ending and the further aorta in patients without and with pseudoaneurysm was measured. Results: Eight of 151 patients developed a distal pseudoaneurysm after TEVAR. The incidence of development of pseudoaneurysm after TEVAR was 5.3 %. Seven patients were treated by distal extension of the stent graft, one denied reintervention. There was a significant difference in the angle between distal stent ending and the further aorta in patients without and with pseudoaneurysm (167,1° 12,4 vs. 148,2° 16,5, p 0,05). In mean a pseudoaneurysm was diagnosed after 22,5 months (3,2-115,2 months). By TEVAR an aortic remodeling was achieved with a significant gain of the true lumen (1,6 0,8 cm vs. 2,9 0,5 cm, p 0,001). Conclusions: Endovascular treatment in chronic type B dissection has a high technical success rate and low mortality. Pseudoaneurysm of the thoracic aorta following endovascular stent graft placement is a rare and potentially fatal condition.