Extracorporeal life support system during cardiovascular procedures: Insights from the German Lifebridge registry.

The frequency of mechanical circulatory support (MCS) device application has increased in recent years. Besides implantation in the emergency setting, such as circulatory arrest, MCS is also increasingly used electively to ensure hemodynamic stability in high-risk patients, for example, during percutaneous coronary interventions (PCI), valve interventions or off-pump coronary bypass surgery. Lifebridge (Zoll Medical GmbH, Germany) is a compact percutaneous MCS device widely used in daily clinical routine. The present study aimed to investigate the indications, feasibility, and outcomes after use of Lifebridge in cardiac interventions, evaluating a large-scale multicenter database. A total of 60 tertiary cardiovascular centers were questioned regarding application and short-term outcomes after the use of the Lifebridge system (n = 160 patients). Out of these 60 centers, eight consented to participate in the study (n = 39 patients), where detailed data were collected using standardized questionnaires. Demographic and clinical characteristics of the patient population, procedural as well as follow-up data were recorded and analyzed. In 60 interrogated centers, Lifebridge was used in 74% of emergency cases and 26% in the setting of planned interventions. The subcohort interrogated in detail displayed the same distribution of application scenarios, while the main cardiovascular procedure was high-risk PCI (82%). All patients were successfully weaned from the device and 92% (n = 36) of the patients studied in detail survived after 30 days. As assessed 30 days after insertion of the device, bleeding requiring red blood cell (RBC) transfusion constituted the main complication, occurring in 49% of cases. In our analysis of clinical data, the use of Lifebridge in cardiac intervention was shown to be feasible. Further prospective studies are warranted to identify patients who benefit from hemodynamic MCS support despite the increased rate of RBC transfusion due to challenges in access sites during cardiovascular procedures.

Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial.

BACKGROUND: An increasing number of patients with heart failure receive implantable cardioverter-defibrillators (ICDs) or cardiac resynchronisation defibrillators (CRT-Ds) with telemonitoring function. Early detection of worsening heart failure, or upstream factors predisposing to worsening heart failure, by implant-based telemonitoring might enable pre-emptive intervention and improve outcomes, but the evidence is weak. We investigated this possibility in IN-TIME, a clinical trial. METHODS: We did this randomised, controlled trial at 36 tertiary clinical centres and hospitals in Australia, Europe, and Israel. We enrolled patients with chronic heart failure, NYHA class II-III symptoms, ejection fraction of no more than 35%, optimal drug treatment, no permanent atrial fibrillation, and a recent dual-chamber ICD or CRT-D implantation. After a 1 month run-in phase, patients were randomly assigned (1:1) to either automatic, daily, implant-based, multiparameter telemonitoring in addition to standard care or standard care without telemonitoring. Investigators were not masked to treatment allocation. Patients were masked to allocation unless they were contacted because of telemonitoring findings. Follow-up was 1 year. The primary outcome measure was a composite clinical score combining all-cause death, overnight hospital admission for heart failure, change in NYHA class, and change in patient global self-assessment, for the intention-to-treat population. The trial is registered with ClinicalTrials.gov, number NCT00538356. FINDINGS: We enrolled 716 patients, of whom 664 were randomly assigned (333 to telemonitoring, 331 to control). Mean age was 65·5 years and mean ejection fraction was 26%. 285 (43%) of patients had NYHA functional class II and 378 (57%) had NYHA class III. Most patients received CRT-Ds (390; 58·7%). At 1 year, 63 (18·9%) of 333 patients in the telemonitoring group versus 90 (27·2%) of 331 in the control group (p=0·013) had worsened composite score (odds ratio 0·63, 95% CI 0·43-0·90). Ten versus 27 patients died during follow-up. INTERPRETATION: Automatic, daily, implant-based, multiparameter telemonitoring can significantly improve clinical outcomes for patients with heart failure. Such telemonitoring is feasible and should be used in clinical practice. FUNDING: Biotronik SE & Co. KG.

The German Aortic Valve Registry (GARY): in-hospital outcome.

BACKGROUND: Aortic stenosis is a frequent valvular disease especially in elderly patients. Catheter-based valve implantation has emerged as a valuable treatment approach for these patients being either at very high risk for conventional surgery or even deemed inoperable. The German Aortic Valve Registry (GARY) provides data on conventional and catheter-based aortic procedures on an all-comers basis. METHODS AND RESULTS: A total of 13 860 consecutive patients undergoing repair for aortic valve disease [conventional surgery and transvascular (TV) or transapical (TA) catheter-based techniques] have been enrolled in this registry during 2011 and baseline, procedural, and outcome data have been acquired. The registry summarizes the results of 6523 conventional aortic valve replacements without (AVR) and 3464 with concomitant coronary bypass surgery (AVR + CABG) as well as 2695 TV AVI and 1181 TA interventions (TA AVI). Patients undergoing catheter-based techniques were significantly older and had higher risk profiles. The stroke rate was low in all groups with 1.3% (AVR), 1.9% (AVR + CABG), 1.7% (TV AVI), and 2.3% (TA AVI). The in-hospital mortality was 2.1% (AVR) and 4.5% (AVR + CABG) for patients undergoing conventional surgery, and 5.1% (TV AVI) and AVI 7.7% (TA AVI). CONCLUSION: The in-hospital outcome results of this registry show that conventional surgery yields excellent results in all risk groups and that catheter-based aortic valve replacements is an alternative to conventional surgery in high risk and elderly patients.

Severe Plasmodium knowlesi infection with multi-organ failure imported to Germany from Thailand/Myanmar.

During the last two decades human infections with Plasmodium knowlesi are increasingly diagnosed in South East Asia and have also been reported in travellers. A severe case of imported P. knowlesi infection in a 73-year old German is presented, who had been travelling through Myanmar and Thailand for three weeks. Microscopy showed a parasitaemia of 3% and different parasite stages including band-forms resembling Plasmodium malariae. Due to the clinical picture of severe malaria and the microscopical aspect (combination of parasites resembling P. malariae and Plasmodium falciparum), P. knowlesi was suspected. The patient was treated with intravenous quinine; he was put on mechanical ventilation and catecholamines due to cardiorespiratory failure. Parasitaemia was cleared rapidly but renal function deteriorated resulting in intermittent haemodialysis. The patient was hospitalized for six weeks but he recovered completely without any physical sequelae. Plasmodium knowlesi mono-infection was confirmed by molecular methods later on.Plasmodium knowlesi infection has to be taken into account in feverish travellers returning from Thailand/Myanmar. Moreover this species can cause life-threatening or even lethal complications. Accordingly severe P. knowlesi infection should be treated like severe P. falciparum infections.

Treatment of functional mitral valve regurgitation with the permanent percutaneous transvenous mitral annuloplasty system: results of the multicenter international Percutaneous Transvenous Mitral Annuloplasty System to Reduce Mitral Valve Regurgitation in Patients with Heart Failure trial.

OBJECTIVES: PTOLEMY-2 was a prospective multicenter phase I single-arm feasibility trial to evaluate the second-generation permanent percutaneous transvenous mitral annuloplasty (PTMA) device in reducing functional mitral regurgitation (MR). BACKGROUND: Percutaneous MR reduction has been performed through a direct method of clipping and securing the mitral leaflets together or an indirect approach of reducing mitral annular dimension via the coronary sinus. The PTMA device is the only coronary sinus mitral repair device without a static fixation element. METHODS: Patients with at least moderate functional MR, New York Heart Association functional class II to IV, and left ventricular ejection fraction of 20% to 50% were enrolled at 14 centers in 5 countries. Device effects on patients were assessed by serial echocardiography, quality of life (QOL), and exercise capacity metrics. RESULTS: A total of 43 patients were recruited, and 30 patients (70%) were implanted with a permanent PTMA device with a mean follow-up of 5.8 ± 3.8 months. The primary safety end point (freedom from death, myocardial infarction, stroke, or emergency surgery) at 30 days was met in 28 patients, whereas 2 patients died of device-related complications. The primary efficacy end point (MR reduction of at least 1.0 grade or reduction of regurgitant orifice area by 0.1 cm(2) or regurgitant volume by 15 mL or regurgitant fraction by 10% compared with baseline) was obtained in 13 patients. No significant changes were noted in MR parameters, ventricular volumes, or QOL. Distance walked on 6 minutes testing at 6-month follow-up increased from 331 ± 167 m to 417 ± 132 m (P = .65). Compared with nonresponders, responders had a higher baseline regurgitant orifice area >0.2 cm(2) (P = .001) and less prior history of myocardial infarction (P = .02), coronary artery bypass surgery (P = .03), and ischemic MR (P = .04). CONCLUSIONS: Overall, PTMA had mild impact on MR reduction, left ventricular remodeling, QOL, and exercise capacity. During follow-up, the risk/benefit ratio remained suboptimal.

Impact of aortic valve calcification on the outcome of transcatheter aortic valve implantation: results from the prospective multicenter German TAVI registry.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) is an emerging technology in patients with severe aortic stenosis. BACKGROUND: Whether the degree of aortic valve calcification impacts the outcome after TAVI has not been thoroughly evaluated. METHODS: We analyzed data from the prospective multicenter German TAVI registry, including 1,365 patients as of July 2010. Patients were divided into three groups, based on the degree of aortic valve calcification: mild (n = 67), moderate (n = 392), and severe (n = 906) valve calcification, determined by visual estimation by the operator. RESULTS: Mean age was 81.7 ± 6.2 years; mean logistic EUROscore was 20.6 ± 13.7%. Patients with severe aortic valve calcification had a higher mean and peak-to-peak gradient before the intervention (P < 0.0001). Technical success was achieved in 97%, similar in each group. The Medtronic CoreValve was implanted in 80.8%, the Sapien Edwards prosthesis in the remaining cases. The duration of the procedure and fluoroscopy was higher in the group with severe calcification (P < 0.01 for procedure and P < 0.05 for fluoroscopy). During the periprocedural period there were no differences among the groups regarding in-hospital death, cerebrovascular events, myocardial infarction, thromboembolic events, aortic dissection, or severe vascular complications. Furthermore, there was no significant difference in postprocedural aortic mean gradient (7.0 mm Hg vs. 5.6 mm Hg vs. 6.3 mm Hg; P = 0.07), in residual aortic regurgitation (74% vs. 72% vs. 68%; P = 0.3) or postprocedure pacemaker implantation (38% vs. 30.4% vs. 34.2%; P = 0.35). During 30-day follow up there was no difference in regard to the number of death, strokes, and myocardial infarctions. CONCLUSIONS: Our results of a real-world registry suggest that the extent of aortic valve calcification does not influence the success or procedural outcome significantly.

Potential role of telemedical service centers in managing remote monitoring data transmitted daily by cardiac implantable electronic devices: results of the early detection of cardiovascular events in device patients with heart failure (detecT-Pilot) study.

OBJECTIVE: 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. SUBJECTS AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

The impact of peripheral arterial disease on early outcome after transcatheter aortic valve implantation: results from the German Transcatheter Aortic Valve Interventions Registry.

BACKGROUND: A significant proportion of patients undergoing transcatheter aortic valve implantation (TAVI) have concomitant peripheral arterial disease (PAD), which plays a crucial role in the preinterventional selection process of determining an optimal vascular access site. The aim of our study was to determine the impact of PAD on clinical outcome after TAVI in a real-world setting. METHODS: A total of 1,315 patients (mean logistic European System for Cardiac Operative Risk Evaluation 20.6% ± 13.7%) underwent TAVI in 27 centers and were included in the prospective German TAVI Registry. RESULTS: Of the 1,315 patients with TAVI, 330 (25.1%) had PAD. These patients had a higher logistic European System for Cardiac Operative Risk Evaluation score (27.7% ± 16.0% vs 18.3% ± 12.0%, P < .0001), mainly attributed to more frequent and severe comorbidities. Compared with patients without PAD, patients with PAD had a higher rate of vascular complications (28.5% vs 20.7%, P < .01), dialysis-dependent renal failure (11.2% vs 5.4%, P < .001), myocardial infarction (1.2% vs 0.3%, P < .05), and, subsequently, 30-day mortality (12.7% vs 6.9%, P < .001). Choosing a surgical approach, for example, transapical access, did not reduce the periprocedural risk associated with PAD; in-hospital mortality was 15.7% for surgical and 10.5% for percutaneous patients with TAVI having PAD (P < .001). In a multivariate regression analysis, PAD was an independent predictor of 30-day mortality (hazard ratio 1.8, 95% CI 1.2-2.7, P = .004) after TAVI. CONCLUSIONS: In this real-world TAVI Registry, PAD was an independent predictor of mortality in patients with percutaneous and surgical TAVI, including vascular complications. Assessment of PAD should play a crucial role in the preinterventional selection process, regardless of the access strategy.

Detection of atrial high-rate events by continuous home monitoring: clinical significance in the heart failure-cardiac resynchronization therapy population.

AIMS: Uncertainty exists over the importance of device-detected short-duration atrial arrhythmias. Continuous atrial diagnostics, through home monitoring (HM) technology (BIOTRONIK, Berlin, Germany), provides a unique opportunity to assess frequency and quantity of atrial fibrillation (AF) episodes defined as atrial high-rate events (AHRE). METHODS AND RESULTS: Prospective data from 560 heart failure (HF) patients (age 67 ± 10 years, median ejection fraction 27%) patients with a cardiac resynchronization therapy (CRT) device capable of HM from two multi-centre studies were analysed. Atrial high-rate events burden was defined as the duration of mode switch in a 24-h period with atrial rates of >180 beats for at least 1% or total of 14 min per day. The primary endpoint was incidence of a thromboembolic (TE) event. Secondary endpoints were cardiovascular death, hospitalization because of AF, or worsening HF. Over a median 370-day follow-up AHRE occurred in 40% of patients with 11 (2%) patients developing TE complications and mortality rate of 4.3% (24 deaths, 16 with cardiovascular aetiology). Compared with patients without detected AHRE, patients with detected AHRE>3.8 h over a day were nine times more likely to develop TE complications (P= 0.006). The majority of patients (73%) did not show a temporal association with the detected atrial episode and their adverse event, with a mean interval of 46.7 ± 71.9 days (range 0-194) before the TE complication. CONCLUSION: In a high-risk cohort of HF patients, device-detected atrial arrhythmias are associated with an increased incidence of TE events. A cut-off point of 3.8 h over 24 h was associated with significant increase in the event rate. Routine assessment of AHRE should be considered with other data when assessing stroke risk and considering anti-coagulation initiation and should also prompt the optimization of cardioprotective HF therapy in CRT patients.

Transcatheter aortic valve implantation: first results from a multi-centre real-world registry.

AIMS: Treatment of elderly symptomatic patients with severe aortic stenosis and co-morbidities is challenging. Transcatheter aortic valve interventions [balloon valvuloplasty and transcatheter aortic valve implantation (TAVI)] are evolving as alternative treatment options to surgical valve replacement. We report the first results of the prospective multi-centre German Transcatheter Aortic Valve Interventions-Registry. METHODS AND RESULTS: Between January 2009 and December 2009, a total of 697 patients (81.4 ± 6.3 years, 44.2% males, and logistic EuroScore 20.5 ± 13.2%) underwent TAVI. Pre-operative aortic valve area was 0.6 ± 0.2 cm² with a mean transvalvular gradient of 48.7 ± 17.2 mmHg. Transcatheter aortic valve implantation was performed percutaneously in the majority of patients [666 (95.6%)]. Only 31 (4.4%) procedures were done surgically: 26 (3.7%) transapically and 5 (0.7%) transaortically. The Medtronic CoreValve™ prosthesis was used in 84.4%, whereas the Sapien Edwards™ prosthesis was used in the remaining cases. Technical success was achieved in 98.4% with a post-operative mean transaortic pressure gradient of 5.4 ± 6.2 mmHg. Any residual aortic regurgitation was observed in 72.4% of patients, with a significant aortic insufficiency (≥Grade III) in only 16 patients (2.3%). Complications included pericardial tamponade in 1.8% and stroke in 2.8% of patients. Permanent pacemaker implantation after TAVI became necessary in 39.3% of patients. In-hospital death rate was 8.2%, and the 30-day death rate 12.4%. CONCLUSION: In this real-world registry of high-risk patients with aortic stenosis, TAVI had a high success rate and was associated with moderate in-hospital complications. However, careful patient selection and continued hospital selection seem crucial to maintain these results.

Telemedical cardiac risk assessment by implantable cardiac monitors in patients after myocardial infarction with autonomic dysfunction (SMART-MI-DZHK9): a prospective investigator-initiated, randomised, multicentre, open-label, diagnostic trial.

BACKGROUND: Cardiac autonomic dysfunction after myocardial infarction identifies patients at high risk despite only moderately reduced left ventricular ejection fraction. We aimed to show that telemedical monitoring with implantable cardiac monitors in these patients can improve early detection of subclinical but prognostically relevant arrhythmic events. METHODS: We did a prospective investigator-initiated, randomised, multicentre, open-label, diagnostic trial at 33 centres in Germany and Austria. Survivors of acute myocardial infarction with left ventricular ejection fraction of 36-50% had biosignal analysis for assessment of cardiac autonomic function. Patients with abnormal periodic repolarisation dynamics (≥5·75 deg2) or abnormal deceleration capacity (≤2·5 ms) were randomly assigned (1:1) to telemedical monitoring with implantable cardiac monitors or conventional follow-up. Primary endpoint was time to detection of serious arrhythmic events defined by atrial fibrillation 6 min or longer, atrioventricular block class IIb or higher and fast non-sustained (>187 beats per min; ≥40 beats) or sustained ventricular tachycardia or fibrillation. This study is registered with ClinicalTrials.gov, NCT02594488. FINDINGS: Between May 12, 2016, and July 20, 2020, 1305 individuals were screened and 400 patients at high risk were randomly assigned (median age 64 years [IQR 57-73]); left ventricular ejection fraction 45% [40-48]) to telemedical monitoring with implantable cardiac monitors (implantable cardiac monitor group; n=201) or conventional follow-up (control group; n=199). During median follow-up of 21 months, serious arrhythmic events were detected in 60 (30%) patients of the implantable cardiac monitor group and 12 (6%) patients of the control group (hazard ratio 6·33 [IQR 3·40-11·78]; p<0·001). An improved detection rate by implantable cardiac monitors was observed for all types of serious arrhythmic events: atrial fibrillation 6 min or longer (47 [23%] patients vs 11 [6%] patients; p<0·001), atrioventricular block class IIb or higher (14 [7%] vs 0; p<0·001) and ventricular tachycardia or ventricular fibrillation (nine [4%] patients vs two [1%] patients; p=0·054). INTERPRETATION: In patients at high risk after myocardial infarction and cardiac autonomic dysfunction but only moderately reduced left ventricular ejection fraction, telemedical monitoring with implantable cardiac monitors was highly effective in early detection of subclinical, prognostically relevant serious arrhythmic events. FUNDING: German Centre for Cardiovascular Research (DZHK) and Medtronic Bakken Research Center.

Silent and apparent cerebral ischemia after percutaneous transfemoral aortic valve implantation: a diffusion-weighted magnetic resonance imaging study.

BACKGROUND: The risk of stroke after transfemoral aortic valve implantation (TAVI) due to dislodgement and subsequent embolization of debris from aortic arch atheroma or from the calcified valve itself ranges between 2% and 10%. The rate of clinically silent cerebral ischemia is unknown but may be even higher. METHODS AND RESULTS: Thirty-two patients who underwent TAVI with the use of a balloon-expandable (n=22) or self-expandable (n=10) stent valve prosthesis were included in this descriptive study and compared with a historical control group of 21 patients undergoing open surgical aortic valve replacement. Periprocedural apparent and silent cerebral ischemia was assessed by neurological testing and serial cerebral diffusion-weighted magnetic resonance imaging at baseline, at 3.4 (2.5 to 4.4) days after the procedure, and at 3 months. TAVI was successful in all patients. After the procedure, new foci of restricted diffusion on cerebral diffusion-weighted magnetic resonance imaging were found in 27 of 32 TAVI patients (84%) and were more frequent than after open surgery (10 of 21 patients [48%]; P=0.011). These lesions were usually multiple (1 to 19 per patient) and dispersed in both hemispheres in a pattern suggesting cerebral embolization. Volumes of these lesions were significantly smaller after TAVI than after surgery (77 [59 to 94] versus 224 [111 to 338] mm(3); P<0.001). There were neither measurable impairments of neurocognitive function nor apparent neurological events during the in-hospital period among TAVI patients, but there was 1 stroke (5%) in the surgical patient group. On 3-month follow-up diffusion-weighted magnetic resonance imaging, there were no new foci of restricted diffusion, and there was no residual signal change associated with the majority (80%) of the foci detected in the periprocedural period. CONCLUSIONS: Clinically silent new foci of restricted diffusion on cerebral magnetic resonance imaging were detected in almost all patients (84%) undergoing TAVI. Although typically multiple, these foci were not associated with apparent neurological events or measurable deterioration of neurocognitive function during 3-month follow-up. Further work needs to be directed to determine the clinical significance of these findings in a larger patient population.

[Position paper on required competencies of nonphysician employees in telemedicine centers]. / Positionspapier zum Anforderungsprofil von nichtärztlichen Assistenzkräften in Telemedizinzentren.

The non-physician employees in telemedicine centers (TMC) play a decisive role in the care and treatment of patients with heart failure. For this reason, a holistic profile consisting of professional and methodological as well as social and personal competences is necessary, which should be built up or promoted in corresponding training concepts. This position paper underlines the urgency of appropriate and standardized further training of non-physician employees for quality assurance in TMCs and summarizes the requirements for the additional qualification of a telemedical assistant across the board.

High high-density lipoprotein-cholesterol reduces risk and extent of percutaneous coronary intervention-related myocardial infarction and improves long-term outcome in patients undergoing elective percutaneous coronary intervention.

AIMS: The study tested whether high-density lipoprotein-cholesterol (HDL-C) has an effect on percutaneous coronary intervention (PCI)-induced myocardial infarction and its prognosis. Elevation of cardiac troponin I (cTnI) > 3x upper normal limit after PCI is defined as PCI-related myocardial infarction (PMI) and is associated with a negative prognosis. No data exist on the relationship of HDL-C to PMI and PMI-related outcome. METHODS AND RESULTS: Pre-procedural HDL-C levels and post-procedural peak cTnI levels were collected in 350 patients undergoing PCI. Data were analysed for PMI and for acute myocardial infarction (AMI) during follow-up. Patients with PMI (n = 115) had lower HDL-C levels than patients without PMI [n = 235; 1.17 mmol/L (0.75-2.51) vs. 1.27 mmol/L (0.70-2.87), P < 0.001]. Pre-procedural HDL-C levels were inversely related to the occurrence of PMI [odds ratio for PMI: 0.884, 95% CI: 0.80, 0.98; P = 0.02 for an HDL-C-increment of 5 mg/dL (0.13 mmol/L)] and to AMI during follow-up [hazard ratio (HR): 0.697, 95% CI: 0.54, 0.90; P = 0.005]. The occurrence of PMI was associated with an elevated HR for AMI (4.702, 95% CI: 1.79, 12.37; P = 0.002). Low-risk levels of pre-procedural HDL-C [men >or=40 mg/dL (>or=1.03 mmol/L), women >or=45 mg/dL (>or=1.16 mmol/L)] did not influence the negative effects of PMI on outcome (HR: 5.510, 95% CI: 1.43, 21.31; P = 0.013) and reduction of AMI-free survival [mean AMI-free survival time with PMI: 1167.5 days (95% CI: 1098.27, 1236.67) vs. 1240.7 days (95% CI: 1220.94, 1290.49) without PMI; log-rank P = 0.005]. Conclusion Small increases in HDL-C in patients undergoing elective PCI convert into a substantial reduction of risk for PMI, which has adverse effects on the long-term prognosis. Patients with PMI are at a high risk for AMI at any HDL-C level and therefore should receive particular monitoring by the treating physician over a long period after PCI.

Attenuation of post-shock increases in brain natriuretic Peptide with post shock overdrive pacing.

BACKGROUND: Predischarge defibrillation threshold testing is often performed a few days after ICD implantation in order to validate defibrillation thresholds obtained at the time of implant. Ventricular fibrillation is induced with such testing and causes an increase in serum Brain Natriuretic Peptide (BNP) levels. BNP is an indicator for cardiac stress. We wanted to examine the feasibility to alter the trend of BNP after predischarge testing in VVI, DDD and CRT ICD's. METHODS: We measured BNP before predischarge testing and 5, 10, 20 and 40 minutes after predischarge testing in 13 groups with each 20 patients. We evaluated patients without post shock pacing and patients with a post shock pacing frequency of 60, 70, 80, 90 and 100 bpm and a duration of 30 and 60 sec as well as a post shock pacing frequency of 80 and 90 bpm and a duration of 120 sec post shock pacing. RESULTS: Patients without post shock pacing showed the highest BNP during the follow-up. The percentage values of BNP increased consistent significantly after 5 minutes compared with BNP before predischarge testing. The percentage values of BNP trend was significantly lower with a post shock pacing of 90 bpm and duration of 60 sec. In addition, we excluded a cardiac necrosis by predischarge testing because of similar values of myoglobin, cardiac troponin I and creatine kinase during the follow-up. CONCLUSIONS: Our results suggested that post shock pacing with 90 bpm and duration of 60 sec as the best optimized post shock pacing frequency and duration for VVI, DDD and CRT ICD's. A reduction of cardiac stress is going to be achieved with the optimization of the post shock pacing frequency and duration.

Real-world clinical experience with the percutaneous extracorporeal life support system: Results from the German Lifebridge® Registry.

BACKGROUND: The concept of percutaneous extracorporeal life support (ECLS) is based on immediate cardiovascular stabilization allowing for sufficient end-organ perfusion, thus improving the outcome in patients with circulatory arrest. Lifebridge® (Zoll Medical GmbH, Germany) is a portable ECLS device designed for rapid application due to its automated set-up. METHODS: A total of 60 tertiary cardiovascular centers were interrogated with regard to application and short-term results after use of Lifebridge ECLS system. Detailed data were collected by standardized case report forms in all centers consented to participate in the study. Demographic and clinical baseline characteristics of the patient population, procedural and follow-up data were recorded and analyzed. RESULTS: In total, 444 patients were analyzed regarding mortality. The detailed study cohort consisted of 112 patients. A total of 80% of the study subjects represented patients post cardiopulmonary resuscitation, 43% were in cardiogenic shock and 50% suffered from acute myocardial infarction. The survival rates were 36% immediately after device implementation and 16% after 30 days. Multivariable analysis revealed that only serum lactate concentration at admission could be proven as independent predictor of patients' outcome. Patients with lactate concentrations above 10 mmol/L exhibited > 95% mortality (p < 0.05 versus below 10 mmol/L). CONCLUSION: The present study provides real-world clinical data of patients treated with a transportable automated ECLS system. In conclusion, Lifebridge is a safely applicable cardiorespiratory stabilization tool associated with acceptable complication rates. Nevertheless, mortality rates were high in these critically ill patients, especially in those showing high lactate concentrations at admission.

[Percutaneous mitral annuloplasty with the VIACOR coronary sinus system for the treatment of functional mitral regurgitation in heart failure patients. Development and results]. / Die perkutane Mitralklappenanuloplastie mittels des VIACOR-Koronarsinussystems zur Behandlung der funktionellen Mitralklappeninsuffizienz bei Herzinsuffizienz. Entwicklung und Ergebnisse.

Functional mitral regurgitation (MR) in heart failure patients limits survival in a severity-graded fashion. Even mild MR doubles the mortality risk. The use of a nonstented coronary sinus device to reduce mitral annulus dimension in order to reestablish mitral valve competence is reported. The device (PTMA, Viacor, Inc., Wilmington, MA, USA) consists of a multilumen PTFE (Teflon) PTMA catheter in which nitinol (nickel-titanium alloy) treatment rods are advanced. For individual treatment, up to three rods of different length and stiffness can be used. Therefore, dimension reduction can be performed in an incremental fashion. Fluoroscopy and three-dimensional (3-D) echocardiography are performed through the procedure to visualize the positioning and confirm maximum treatment effect. This report describes an implant case and summarizes the safety and feasibility of the new PTMA treatment device in 27 patients. The cases reflect the learning curve in both device design and implantation technique. In permanent implant, a sustained reduction of mitral annulus septal-lateral dimension from 3-D echo reconstruction dimensions was observed (4.9 +/- 1.2 mm at 3 months).

[Transcatheter-based aortic valve implantation. Present and future technologies]. / Die kathetergestützte Implantation einer Aortenklappenprothese: Aktueller Stand und zukünftige Technologien.

The calcified aortic stenosis is the dominating valve disease. Patients affected are most common elderly people in the 8th or 9th decade of their life who often show associated comorbidities like reduced left ventricular function, impaired renal function, pulmonary hypertension, and further diseases (diabetes mellitus, stroke, chronic obstructive pulmonary disease). In many cases perioperative morbidity and mortality are too high for surgical valve replacement and patients are rejected. Nevertheless, prognosis of aortic stenosis is worse, if the typical symptoms like dyspnea on exertion, syncope, and angina occur. The transcatheter aortic valve implantation is an alternative treatment for this particular group of patients. The aortic valve bioprosthesis consists of a balloon-expandable stent or a self-expandable frame, in which a valve of bovine or porcine pericardium is incorporated. The implantation is performed by retrograde access via the femoral artery; the balloon-expandable prosthesis can also be implanted by transapical approach. Alternatively, the subclavian artery is chosen for access. More frequently, the implantation is performed in analgosedation with the patient awake that favors the transfemoral approach. A further reduction of the available prosthesis and new types of valves which are under current experimental tests and clinical evaluation contribute to this development.

[Decompensated valve failure: the revival of balloon valvuloplasty - percutaneous valve intervention]. / Dekompensiertes Klappenvitium: das Revival der Ballonvalvuloplastie - perkutane Klappeninterventionen.

Calcified aortic stenosis is the dominating valve disease. Patients affected are most commonly elderly people, who often show associated comorbidities like reduced left ventricular function, impaired renal function, and pulmonary hypertension. The risk of open heart surgery is elevated. Balloon aortic valvuloplasty enables a reduction of symptoms, an increase in physical performance, and, therefore, an improved quality of life. Recent data also demonstrated an improved survival of patients after valvuloplasty. New techniques and improved equipment induced a "revival" of balloon aortic valvuloplasty, which has been introduced more than 20 years ago. In acute emergencies, however, mortality is high. Hemodynamic stabilization in the intensive care unit prior to valvuloplasty is recommended. If restenosis in aortic bioprosthesis has occurred, hemodynamic improvement is very limited. Surgical valve replacement or percutaneous transcatheter valve implantation as valve-in-valve must be considered in the short term.

Transfemoral aortic valve implantation in a patient with prior mechanical mitral valve replacement.

Transfemoral aortic valve implantation has emerged as a promising alternative to surgical aortic valve replacement for high-risk patients with severe symptomatic aortic stenosis. In the setting of previous mechanical mitral valve replacement, the procedure represents a challenge due to the risk of interference and subsequent functional impairment of the mechanical prosthesis. The authors report a case of successful transfemoral implantation of a selfexpandable aortic bioprosthesis in a patient with a Björk-Shiley tilting-disk valve in mitral position demonstrating that the implantation is also feasible in this setting but requires careful preinterventional evaluation. Prior balloon aortic valvuloplasty with thorough observation of the mitral prosthesis during balloon inflation may be a helpful tool for indicating feasibility of this approach.