Extracorporeal Life Support in Infarct-Related Cardiogenic Shock.

BACKGROUND: Extracorporeal life support (ECLS) is increasingly used in the treatment of infarct-related cardiogenic shock despite a lack of evidence regarding its effect on mortality. METHODS: In this multicenter trial, patients with acute myocardial infarction complicated by cardiogenic shock for whom early revascularization was planned were randomly assigned to receive early ECLS plus usual medical treatment (ECLS group) or usual medical treatment alone (control group). The primary outcome was death from any cause at 30 days. Safety outcomes included bleeding, stroke, and peripheral vascular complications warranting interventional or surgical therapy. RESULTS: A total of 420 patients underwent randomization, and 417 patients were included in final analyses. At 30 days, death from any cause had occurred in 100 of 209 patients (47.8%) in the ECLS group and in 102 of 208 patients (49.0%) in the control group (relative risk, 0.98; 95% confidence interval [CI], 0.80 to 1.19; P = 0.81). The median duration of mechanical ventilation was 7 days (interquartile range, 4 to 12) in the ECLS group and 5 days (interquartile range, 3 to 9) in the control group (median difference, 1 day; 95% CI, 0 to 2). The safety outcome consisting of moderate or severe bleeding occurred in 23.4% of the patients in the ECLS group and in 9.6% of those in the control group (relative risk, 2.44; 95% CI, 1.50 to 3.95); peripheral vascular complications warranting intervention occurred in 11.0% and 3.8%, respectively (relative risk, 2.86; 95% CI, 1.31 to 6.25). CONCLUSIONS: In patients with acute myocardial infarction complicated by cardiogenic shock with planned early revascularization, the risk of death from any cause at the 30-day follow-up was not lower among the patients who received ECLS therapy than among those who received medical therapy alone. (Funded by the Else Kröner Fresenius Foundation and others; ECLS-SHOCK ClinicalTrials.gov number, NCT03637205.).

Extracorporeal life support in patients with acute myocardial infarction complicated by cardiogenic shock - Design and rationale of the ECLS-SHOCK trial.

BACKGROUND: In acute myocardial infarction complicated by cardiogenic shock the use of mechanical circulatory support devices remains controversial and data from randomized clinical trials are very limited. Extracorporeal life support (ECLS) - venoarterial extracorporeal membrane oxygenation - provides the strongest hemodynamic support in addition to oxygenation. However, despite increasing use it has not yet been properly investigated in randomized trials. Therefore, a prospective randomized adequately powered clinical trial is warranted. STUDY DESIGN: The ECLS-SHOCK trial is a 420-patient controlled, international, multicenter, randomized, open-label trial. It is designed to compare whether treatment with ECLS in addition to early revascularization with percutaneous coronary intervention or alternatively coronary artery bypass grafting and optimal medical treatment is beneficial in comparison to no-ECLS in patients with severe infarct-related cardiogenic shock. Patients will be randomized in a 1:1 fashion to one of the two treatment arms. The primary efficacy endpoint of ECLS-SHOCK is 30-day mortality. Secondary outcome measures such as hemodynamic, laboratory, and clinical parameters will serve as surrogate endpoints for prognosis. Furthermore, a longer follow-up at 6 and 12 months will be performed including quality of life assessment. Safety endpoints include peripheral ischemic vascular complications, bleeding and stroke. CONCLUSIONS: The ECLS-SHOCK trial will address essential questions of efficacy and safety of ECLS in addition to early revascularization in acute myocardial infarction complicated by cardiogenic shock.

[Coronary physiology in the catheter laboratory]. / Koronarphysiologie im Herzkatheterlabor.

The regulation of coronary flow is mainly located in the resistance vessels of the microcirculation, so that the functional relevance of a coronary stenosis arises from the interaction between the epicardial stenosis and the downstream microcirculation. These complex interactions are precisely detectable by physiological measurements, such as the instantaneous wave-free ratio (iwFR) or the fractional flow reserve (FFR). In contrast, the purely visual assessment of the coronary anatomy could lead to misinterpretation and possibly to incorrect revascularization decisions. Consequently, in the current guidelines on myocardial revascularization of the European Society of Cardiology (ESC) the measurement of iwFR and FFR has a class IA indication in intermediate stenoses with unclear hemodynamic relevance. Despite this clear recommendation, physiological measurements are not yet regularly used in the clinical routine. Besides the purely hemodynamic assessment, novel methods such as co-registration and coronary mapping can be used for virtual planning of percutaneous coronary interventions, especially in vessels with diffuse lesions and serial stenoses. Furthermore, invasive flow measurements are also helpful for risk stratification between conservative and interventional treatment of patients with acute coronary syndrome, where additional factors of flow limitation, such as coronary spasm, thrombus and acute disturbance of the microcirculation play an important role.

Left atrial appendage morphology, echocardiographic characterization, procedural data and in-hospital outcome of patients receiving left atrial appendage occlusion device implantation: a prospective observational study.

BACKGROUND: Implantation of left atrial appendage (LAA) occlusion devices was shown to be a feasible and effective alternative to oral anticoagulation in patients with non-valvular atrial fibrillation. However, only few data about in-hospital and peri-procedural data are currently available. This study aims to report about echocardiographic, procedural and in-hospital data of patients receiving LAA occlusion devices. METHODS: This single-center, prospective and observational study includes consecutively patients being eligible for percutaneous implantation of LAA occlusion devices (either Watchman™ or Amplatzer™ Cardiac Plug 2). Data on pre- and peri-procedural transesophageal echocardiography (TEE), implantation and procedure related in-hospital complications were collected. The primary efficacy outcome measure was a successful device implantation without relevant peri-device leaks (i.e., < 5 mm). RESULTS: In total, 37 patients were included, 22 receiving the Watchman™ and 15 ACP 2 device. Baseline characteristics did not differ significantly in both patient groups. The primary efficacy outcome measure was reached in 91.9% of patients (90.9% for the Watchman™, 93.3 % for the ACP 2 group). One device embolization (Watchman™ group) with successful retrieval occurred (2.7% of patients). No thromboembolism or device thrombosis were present. The majority of bleedings was caused by access site bleedings (88.3% of all bleedings), consisting mostly of mild hematomas corresponding to a BARC type 1 bleeding (80.0% of all access-site complications). One patient died due to septic shock (non-procedure related). CONCLUSIONS: In daily real-life practice, percutaneous treatment with LAA occlusion devices appears to be an effective and safe.

Closing in on the K edge: coronary CT angiography at 100, 80, and 70 kV-initial comparison of a second- versus a third-generation dual-source CT system.

PURPOSE: To prospectively evaluate radiation and contrast medium requirements for performing high-pitch coronary computed tomographic (CT) angiography at 70 kV using a third-generation dual-source CT system in comparison to a second-generation dual-source CT system. MATERIALS AND METHODS: All patients gave informed consent for this institutional review board-approved study. Forty-five patients (median age, 52 years; 27 men) were imaged in high-pitch mode with a third-generation dual-source CT system at 70 kV (n = 15) or with a second-generation dual-source CT system at 80 or 100 kV (n = 15 for each). Tube voltage was based on body mass index: 80 or 70 kV for less than 26 kg/m(2) versus 100 kV for 26-30 kg/m(2). For the 80- and 100-kV protocols, 80 mL of contrast material was injected, versus 45 mL for the 70-kV protocol. Data were reconstructed by using a second-generation iterative reconstruction algorithm for second-generation dual-source CT and a recently introduced third-generation iterative reconstruction algorithm for third-generation dual-source CT. Objective image quality was measured for various regions of interest, and subjective image quality was evaluated with a five-point Likert scale. RESULTS: The signal-to-noise ratio of the coronary CT angiography studies acquired with 70 kV was significantly higher (70 kV: 14.3-17.6 vs 80 kV: 7.1-12.9 vs 100 kV: 9.8-12.9; P < .0497) than those acquired with the other two protocols for all coronary arteries. Qualitative image quality analyses revealed no significant differences between the three CT angiography protocols (median score, 5; P > .05). The mean effective dose was 75% and 108% higher (0.92 mSv ± 0.3 [standard deviation] and 0.78 mSv ± 0.2 vs 0.44 mSv ± 0.1; P < .0001), respectively, for the 80- and 100-kV CT angiography protocols than for the 70-kV CT angiography protocol. CONCLUSION: In nonobese patients, third-generation high-pitch coronary dual-source CT angiography at 70 kV results in robust image quality for studying the coronary arteries, at significantly reduced radiation dose (0.44 mSv) and contrast medium volume (45 mL), thus enabling substantial radiation dose and contrast medium savings as compared with second-generation dual-source CT.

The CINCH-FMR postmarket registry: Real-world long-term outcomes with percutaneous mitral valve repair with the Carillon Mitral Contour System®.

BACKGROUND: The Carillon® Mitral Contour System® has been studied in 4 prospective controlled studies in the treatment of functional mitral regurgitation (FMR) where it has been found to reduce mitral regurgitation, reduce left ventricular and atrial volumes, and be associated with improvements in clinical parameters. AIMS: The CINCH post-market registry is designed to evaluate immediate, mid-term and long-term outcomes from a post-approval study of the Carillon® device evaluated in real-world practice. METHODS: The CINCH post-market registry is a single-arm study of percutaneous mitral annuloplasty with the Carillon device in patients with functional (secondary) mitral regurgitation and symptomatic congestive heart failure when utilized in real-world conditions. Patient selection, echocardiographic hemodynamic measurements, and patient follow-up requirements were performed per standard of care at each institution. RESULTS: A total of 101 patients treated with the Carillon device at 13 sites in Germany were enrolled in the CINCH registry. The mean age was 75 ± 9 years, 57 % were male, and patient presentation included primarily NYHA class III (69 %) with MR grade 3 (68 %). Over 5 years of follow-up, all-cause mortality was 40.1 %, the incidence of HFH was 53.9 %, and the composite outcome of HFH or death was 66.4 %. At each follow-up interval through 5 years, statistically significant reductions in NYHA class (p < 0.05) and MR grade (p < 0.01) were reported. CONCLUSIONS: In this "real world" registry of the Carillon Mitral Contour System, procedural safety and medium-term follow-up outcomes is similar to the outcomes seen in the prospective, controlled clinical trials, despite being used in populations of patients that extend outside of those studied in the trials. The use of this therapy in patients with atrial functional mitral regurgitation, and heart failure with preserved ejection fraction, was notable, since these types of patients were excluded from the prospective, controlled trials. This supports possible additional patient populations who might benefit from this type of mechanical therapy. The safety profile of this therapy in this registry and in the earlier trials may support a potential role in earlier forms of secondary mitral regurgitation.

Prognostic Impact of Admission Time in Infarct-Related Cardiogenic Shock: An ECLS-SHOCK Substudy.

BACKGROUND: The outcomes of patients with acute myocardial infarction complicated by cardiogenic shock (AMI-CS) and the efficacy and safety of extracorporeal life support (ECLS) may be affected by the timing of hospital admission. OBJECTIVES: The present ECLS-SHOCK substudy sought to investigate the prognostic impact of on-hours vs off-hours admission and the efficacy of ELCS according to the timing of hospital admission time in AMI-CS. METHODS: Patients with AMI-CS enrolled in the multicenter, randomized ECLS-SHOCK trial from 2019 to 2022 were included. The prognosis of patients admitted during regular hours (ie, on-hours) was compared to patients admitted during off-hours. Thereafter, the prognostic impact of ECLS was investigated stratified by the timing of hospital admission. The primary endpoint was 30-day all-cause mortality. Statistical analyses included Kaplan-Meier, univariable, and multivariable logistic regression analyses. RESULTS: Of 417 patients enrolled in the ECLS-SHOCK trial, 48.4% (n = 202) were admitted during off-hours. Patients admitted during off-hours were younger (median age = 62 years [Q1-Q3: 55-69 years] vs 63 years [Q1-Q3: 58-71 years]; P = 0.036) and more commonly treated using initial femoral access for coronary angiography (79.0% [n = 158/200] vs 67.9% [n = 146/215]; P = 0.011). However, off-hours admission was not associated with an increased risk of 30-day all-cause mortality (off-hours vs on-hours: 46.0% [n = 93/202] vs 50.7% [n = 109/215]; OR: 0.83; 95% CI: 0.56-1.22). Furthermore, ECLS had no prognostic impact on 30-day all-cause mortality in patients with AMI-CS admitted during on-hours (50.5% [n = 52/103] vs 50.9% [n = 57/112]; P = 0.95; OR: 0.98; 95% CI: 0.58-1.68) or in patients admitted during off-hours (45.3% [n = 48/106] vs 46.9% [n = 45/96]; P = 0.82; OR: 0.94; 95% CI: 0.54-1.63). Finally, ECLS was associated with an increased risk of bleeding events, especially in patients admitted during on-hours. CONCLUSIONS: The prognosis in AMI-CS was not affected by admission time with a similar effect of ECLS during on- and off-hours.

Risk stratification following complex PCI: clinical versus anatomical risk stratification including "post PCI residual SYNTAX-score" as quantification of incomplete revascularization.

BACKGROUND: EuroSCORE and completeness of revascularization predicts long-term survival after multivessel PCI (MV-PCI). The SYNTAX-Score has also been proposed to predict clinical outcome. The prognostic impact of these scores to predict long-term survival after PCI has not yet been compared. METHODS AND RESULTS: Long-term survival was assessed in 740 patients undergoing MV-PCI. We calculated EuroSCORE, SYNTAX-Score, STS-Score, the clinical SYNTAX-Score (CSS), and the "post-PCI residual SYNTAX-Score." Mean follow-up time was 4.5 ± 2.5 years. 341 patients (46%) were treated for ACS (STEMI N = 191; NSTEMI N = 150). 113 patients (15%) underwent PCI of left main coronary artery. The EuroSCORE was significantly lower for stable patients compared to patients with ACS (stable 4.1 ± 4.5, NSTEMI 13.9 ± 13.3, STEMI 18.1 ± 18.7, p < 0.001). The differences in the SYNTAX-Score were less obvious but even significant (stable 14.9 ± 8.6, NSTEMI 17.8 ± 9.9, STEMI 18.3 ± 9.0; p < 0.001). Patients in the highest tertiles of each risk score experienced a dramatically elevated mortality rate compared to the extremely low mortality rate in the lower tertiles (p log-rank <0.001). This comparison remained significant for the EuroSCORE and STS-Score but not for the SYNTAX-Score, when analysis was restricted to stable patients. The multivariate Cox-regression-analysis confirmed the logistic EuroSCORE, EuroSCORE II, and the STS-Score as independent predictors of long-term mortality, whereas the SYNTAX-Score (including residual form) and the CSS had no predictive value. CONCLUSION: The EuroSCORE and the STS-Score outperforms the SYNTAX-Score and the CSS in predicting long-term survival following MV-PCI. In addition, the residual SYNTAX-Score predicts long-term survival not independently.

Transcoronary concentration gradients of circulating microRNAs.

BACKGROUND: Circulating levels of microRNA (miR) have been proposed as biomarkers for cardiovascular disease. To identify the heart as a potential source for miRs released into the circulation, we measured concentration gradients across the coronary circulation for muscle-enriched (miR-133a, miR-499, miR-208a), vascular (miR-126, miR-92a), leukocyte-related (miR-155), and platelet-enriched (miR-223) miRs. METHODS AND RESULTS: Circulating miRs were measured by TaqMan polymerase chain reaction in EDTA-plasma simultaneously obtained from the aorta and the coronary venous sinus in patients without coronary artery disease (n=7), with stable coronary artery disease (n=31), and with troponin-positive acute coronary syndromes (n=19). Circulating levels of the muscle-enriched miR-499 (>20-fold; P<0.01), miR-133a (11-fold; P<0.01), and miR-208a (5-fold; P<0.01) were significantly elevated in the aorta of troponin-positive acute coronary syndrome patients compared with patients with coronary artery disease. Importantly, there was a significant increase in circulating levels of miR-499 and miR-133a across the coronary circulation in troponin-positive acute coronary syndrome patients, suggestive of a release into the coronary circulation during myocardial injury. Indeed, miR-499 concentration gradients were significantly correlated with the extent of myocardial damage as measured by high-sensitivity troponin T (r=0.70, P<0.01). In contrast, circulating levels of miR-126 (P=0.16) decreased during transcoronary passage in patients with evidence of myocardial injury, suggesting consumption during transcoronary passage. CONCLUSIONS: Muscle-enriched miR-499 and miR-133a are released from the heart into the coronary circulation on myocardial injury, whereas the vascular miR-126 is consumed during transcoronary passage. The differential regulation of circulating miRs during the transcoronary passage might provide important insights to exploit their role as cardiac biomarkers. Clinical Trial Registration- URL: http://www.germanctr.de. Unique identifier: DRKS00000207; in German Clinical Trials Registry.

Risk for permanent pacemaker after transcatheter aortic valve implantation: a comprehensive analysis of the literature.

BACKGROUND: Permanent pacemaker (PM) requirement is a known complication after transcatheter aortic valve implantation (TAVI). There are, however, no systematic data concerning this complication. OBJECTIVE: To determine the incidence and potential predictors of permanent PM requirement after TAVI based on published literature. METHODS: We conducted a MEDLINE search to identify potentially relevant literature dealing with PM requirement after TAVI. Data were collected on paper extraction forms by 2 independent investigators. RESULTS: There were 32 relevant published studies comprising data of 5,258 patients without an implanted PM before TAVI. An Edwards-Sapiens® prosthesis (ESP) was implanted in 2,887 patients, whereas 2,371 patients received a CoreValve® prosthesis (CVP). The crude incidence of PM implantation after TAVI was 15%. Six hundred and fourteen of 2,371 (25.8%) CVP patients and 189 of the 2,887 (6.5%) ESP patients had to receive a permanent PM (odds ratio [OR] 4.91, 95% confidence interval [CI] 4.12-5.86, P < 0.001). Presence of right bundle branch block (RBBB) before TAVI was a significant predictor for development of complete atrioventricular (AV) block and subsequent PM need (OR 1.358, 95% CI 1.001-1.841, P = 0.02). More than 90% of all AV-block requiring PM implantation occurred immediately or within 7 days after TAVI. CONCLUSION: Patients undergoing TAVI with implantation of CVP are at significantly higher risk for development of AV block and subsequent need for permanent PM, particularly if RBBB preexists. Since AV block occurs in >90% within the first week after the procedure, careful monitoring should be performed for at least 7 days after TAVI.

Implementation of the transradial approach for coronary procedures is not associated with an elevated complication rate and elevated radiation patient exposure.

BACKGROUND: The transradial approach for coronary procedures is associated with a low complication rate, but specific training is considered mandatory. METHODS: Procedural characteristics (contrast dye: CD; fluoroscopy time: FT, patient radiation dose: RD) and local complication rates were prospectively assessed in 784 consecutive patients who underwent transradial coronary procedures. The study was divided into an implementation (2008-IP) and an evaluation period (2009-EP). Transradial (N = 624) and transfemoral (N = 842) procedural characteristics were compared in the EP. RESULTS: The amount of CD (mL) of transradial coronary angiography was similar between IP (75 [IQR 60-100]) and EP (70 [55-100]; P = 0.630). In contrast, FT (min) of transradial coronary angiography could be reduced from IP (4.4 [3.2-6.8]) to EP (4.1 [2.7-6.5]; P = 0.036), whereas RD (µGy * qcm) was similar (IP: 1623 [1042-3026]); EP (1576 [944-2530]; P = 0.149). Safety data showed a low complication rate: 0.2% access failure, 0.1% dissection, 0.7% vessel closure. Transfemoral procedures were followed by significantly more procedure- related transfusions (1.3% vs. 0%; P = 0.003). The comparison between transfemoral and transradial procedures demonstrated prolonged FT for transradial procedures (transfemoral 2.9 [1.7-5.5]; transradial 4.1 [2.7-6.5]; P = 0.002), whereas CD was similar (transfemoral 70 [55-100]; transradial 70 [55-100]; P = 0.248). The prolonged FT was restricted to coronary angiography but did not differ for PCI (transfemoral 9.7 [5.8-18.1]; transradial 8.9 [5.3-16.5]; P = 0.433). CONCLUSION: A transradial program can be implemented with safety; therefore, the transradial approach should be preferred in suitable patients. Since spasm occurrence was the major determinant of procedural failure, further effort is need to develop better strategies for spasm prevention.

Dual energy CT for the assessment of reperfused chronic infarction - a feasibility study in a porcine model.

BACKGROUND: Detection of myocardial infarction has been the focus of considerable research over the past few decades. Recently developed dual source computed tomography (DSCT) scanners with dual energy mode have been used to detect myocardial infarction, but the studies on this topic are few. PURPOSE: To evaluate the feasibility and performance of dual energy CT (DECT) during arterial phase in coronary CT angiography for the detection of chronic infarction compared with late enhancement MRI (LE-MRI) and histopathology in a porcine model of reperfused myocardial infarction. MATERIAL AND METHODS: Myocardial infarctions were induced by 30 min occlusion of the proximal left anterior descending coronary artery in eight minipigs. DECT, post-contrast LE-MRI and histopathology were performed 60 days after infarct induction. The CT scan was performed in dual energy mode using a dedicated protocol. Myocardial iodine distribution was superimposed as color maps on grey scale multiplanar reformats of the heart. Two radiologists in consensus interpreted all imaging studies for presence of gadolinium uptake at LE-MRI reduced iodine content at DECT and hypoenhanced areas in the initial 100 kV coronary CT angiography images that were acquired during the DECT-acquisition. Results were compared with histopathology. RESULTS: Based on evaluable segments, DECT showed a sensitivity and specificity of 0.72 and 0.88; LE-MRI showed a sensitivity and specificity of 0.78 and 0.92; and the 100 kV data-set of the DECT scan showed a sensitivity and specificity of 0.60 and 0.93, respectively, for the detection of histological proved ischemia. CONCLUSION: DECT during arterial phase coronary CT angiography, which is ordinarily used for coronary artery evaluation, is feasible for the detection of a chronic reperfused myocardial infarction.

Impact of the COVID-19 pandemic on cardiovascular mortality and catherization activity during the lockdown in central Germany: an observational study.

AIMS: During the COVID-19 pandemic, hospital admissions for cardiac care have declined. However, effects on mortality are unclear. Thus, we sought to evaluate the impact of the lockdown period in central Germany on overall and cardiovascular deaths. Simultaneously we looked at catheterization activities in the same region. METHODS AND RESULTS: Data from 22 of 24 public health-authorities in central Germany were aggregated during the pandemic related lockdown period and compared to the same time period in 2019. Information on the total number of deaths and causes of death, including cardiovascular mortality, were collected. Additionally, we compared rates of hospitalization (n = 5178) for chronic coronary syndrome (CCS), acute coronary syndrome (ACS), and out of hospital cardiac arrest (OHCA) in 26 hospitals in this area. Data on 5,984 deaths occurring between March 23, 2020 and April 26, 2020 were evaluated. In comparison to the reference non-pandemic period in 2019 (deaths: n = 5832), there was a non-significant increase in all-cause mortality of 2.6% [incidence rate ratio (IRR) 1.03, 95% confidence interval (CI) 0.99-1.06; p = 0.16]. Cardiovascular and cardiac mortality increased significantly by 7.6% (IRR 1.08, 95%-CI 1.01-1.14; p = 0.02) and by 11.8% (IRR 1.12, 95%-CI 1.05-1.19; p < 0.001), respectively. During the same period, our data revealed a drop in cardiac catherization procedures. CONCLUSION: During the COVID-19-related lockdown a significant increase in cardiovascular mortality was observed in central Germany, whereas catherization activities were reduced. The mechanisms underlying both of these observations should be investigated further in order to better understand the effects of a pandemic-related lockdown and social-distancing restrictions on cardiovascular care and mortality.

Complete revascularization in patients undergoing multivessel PCI is an independent predictor of improved long-term survival.

BACKGROUND: The prognostic relevance of complete revascularization (CR) in patients with multivessel coronary artery disease (MV-CAD) has been established so far for surgical treatment strategies rather than for percutaneous coronary revascularization (PCI). In addition, different definitions of CR have further complicated the interpretation of clinical studies. METHODS: Procedural characteristics and long-term overall survival were assessed in 679 consecutive "all-comer" patients, who underwent PCI in at least two main vessels. We adapted three definitions of CR from the coronary artery bypass grafting (CABG) trials. CR was achieved if following MV-PCI one of the three criteria was met: (1) no residual stenosis in a main coronary vessel, (2) no residual stenosis in any coronary segment, or (3) no residual stenosis in the left anterior descending (LAD) and at least one further main branch. The main objective was the evaluation of predictors of incomplete revascularization and the prognostic impact of CR in MV-PCI patients. RESULTS: CR was achieved in 76%, 67%, and 95%, respectively, (definitions 1-3). Patients without CR were older, had a lower ejection fraction, and presented more often with acute coronary syndromes (ACS). Clinical long-term follow-up regarding survival was available in 664 patients (98%) with a mean follow-up of 2.5 +/- 1.6 years. Independent of the specific definition, CR was associated with a reduced long-term mortality by approximately 50%. After adjusting for relevant baseline parameters, only absence of residual stenosis in all coronary segments remained as an independent predictor of long-term prognosis (hazard ratio [HR]= 0.51, 95% confidence interval [CI]: 0.28-0.93; P = 0.025). CONCLUSIONS: CR of all coronary segments is associated with improved overall survival after MV-PCI.

Incidence, clinical characteristics, and long-term prognosis of travel-associated pulmonary embolism.

AIMS: Prolonged air travel is considered a risk factor for pulmonary embolism (PE). The clinical characteristics as well as the long-term prognosis of patients suffering from travel-associated PE ('economy-class syndrome', ECS) remain largely unknown. Owing to its proximity, our hospital is the primary referral centre for Frankfurt Airport, Europe's third-largest airport. The goal of our study was to follow-up all patients with ECS, who were admitted to our hospital between 1997 and 2006. METHODS AND RESULTS: We systematically reviewed all medical charts from patients presenting with acute PE to our emergency room or intensive care unit (ICU) and performed a telephone follow-up on patients discharged alive. Together with the data provided from the statistics department of Fraport Inc., the operating company of the Frankfurt International Airport, we were also able to put the medical data in context with the corresponding number of passengers and flight distances. A total of 257 patients with acute PE were admitted to our emergency and ICU between 1997 and 2006. Out of these, 62 patients suffered from ECS (45 flight-associated PE and 17 from other travel-associated PE). ECS patients were prone to more haemodynamic relevant acute events, reflected by a higher rate of initial cardiopulmonary resuscitation (4.8% vs. 1.5%; P = 0.153) and higher percentage of massive PE (8% vs. 3%; P = 0.064). Nevertheless, intrahospital mortality was similar in both groups (ECS 4.8%, others 4.1%; P = 0.730). Interestingly, the long-term outcome of ECS patients was excellent (Kaplan-Meier analysis; P log-rank: 0.008 vs. other entities). In general, ECS was a rare event (one event/5 million passengers), where long-haul flights over 5000 km lead to a 17-fold risk increase compared with shorter flights. CONCLUSIONS: Travel-associated PE was a common cause of PE in our hospital, with patients showing excellent long-term prognosis after discharge. The risk of ECS is rather low and strictly dependent on the flight distance.

Comparison of transthoracic and transesophageal echocardiography for transcatheter aortic valve replacement sizing in high-risk patients.

BACKGROUND: Untreated symptomatic high-grade aortic stenosis remains a lethal disease requiring individually adapted valve replacement. High-risk surgical patients benefit from transcatheter aortic valve replacement (TAVR), but there is no uniform standard for patient selection and valve sizing and it is still unclear whether transthoracic (TTE) or transesophageal (TEE) echocardiography is superior in preprocedural aortic annulus sizing. As preprocedural sizing of the native aortic annulus diameter is crucial to outcome and survival, we report the results of a direct comparison between preprocedural sizing with TTE and TEE including subsequent outcomes in a high-risk TAVR population. METHODS: A total of 149 TAVR patients were enrolled for TTE and TEE comparison, and an additional 15 patients without structural heart disease were investigated as control group to determine the influence of aortic valve calcification on TTE and TEE aortic annulus diameter measurements. RESULTS: Overall standardized TTE and TEE measurements for aortic annulus sizing showed excellent correlation at good image quality (p < 0.01, r = 0.934). Calcification of the aortic annulus diameter was not found to exert a noteworthy negative influence on measurements for both standardized TTE and TEE and complication rates did not differ for mortality, periprocedural stroke and paraprosthetic regurgitation. CONCLUSIONS: Transthoracic echocardiography and TEE are both equally suitable methods of preprocedural aortic annulus size evaluation in preparation of TAVR procedures.

Transcoronary transplantation of progenitor cells after myocardial infarction.

BACKGROUND: Pilot studies suggest that intracoronary transplantation of progenitor cells derived from bone marrow (BMC) or circulating blood (CPC) may improve left ventricular function after acute myocardial infarction. The effects of cell transplantation in patients with healed myocardial infarction are unknown. METHODS: After an initial pilot trial involving 17 patients, we randomly assigned, in a controlled crossover study, 75 patients with stable ischemic heart disease who had had a myocardial infarction at least 3 months previously to receive either no cell infusion (23 patients) or infusion of CPC (24 patients) or BMC (28 patients) into the patent coronary artery supplying the most dyskinetic left ventricular area. The patients in the control group were subsequently randomly assigned to receive CPC or BMC, and the patients who initially received BMC or CPC crossed over to receive CPC or BMC, respectively, at 3 months' follow-up. RESULTS: The absolute change in left ventricular ejection fraction was significantly greater among patients receiving BMC (+2.9 percentage points) than among those receiving CPC (-0.4 percentage point, P=0.003) or no infusion (-1.2 percentage points, P<0.001). The increase in global cardiac function was related to significantly enhanced regional contractility in the area targeted by intracoronary infusion of BMC. The crossover phase of the study revealed that intracoronary infusion of BMC was associated with a significant increase in global and regional left ventricular function, regardless of whether patients crossed over from control to BMC or from CPC to BMC. CONCLUSIONS: Intracoronary infusion of progenitor cells is safe and feasible in patients with healed myocardial infarction. Transplantation of BMC is associated with moderate but significant improvement in the left ventricular ejection fraction after 3 months.

Levels of circulating pro-angiogenic cells predict cardiovascular outcomes in patients with chronic heart failure.

BACKGROUND: Circulating pro-angiogenic cells (PACs) contribute to vascular and myocardial regeneration. A low level of PACs is associated with worse outcome in patients with coronary heart disease. However, little is known about PACs in heart failure (HF). METHODS AND RESULTS: Blood was sampled at baseline in 111 patients with HF, 67 from 5 Italian Centers and 44 from Frankfurt, Germany. In cultured mononuclear cells from peripheral blood, PACs were counted as double-stained by tetramethylindocarbocyanine-labeled acetylated LDL and fluorescein-5-isothiocyanate-labeled lectin. Mean age of the patients was 62 years, 12 were females, 66 had ischemic etiology, 26 were in New York Heart Association Class >II. Cutoffs for PACs were assessed by receiver operating characteristic curves, to identify the optimal cutoffs for PAC level in predicting outcomes. Mean level of PACs was 35+/-29 (mean+/-SD) cells/mm(2), 2- to 3-fold lower than in age-matched healthy volunteers, but unrelated to severity of HF, age, or sex. Over 2.5 years, 12 cardiovascular deaths and 47 first hospitalizations for cardiovascular reasons were recorded. After adjustment for demographic and clinical variables, elevated creatinine and natriuretic peptides, and PACs

Favorable long-term survival in patients undergoing stent PCI of unprotected left main coronary artery compared to predicted short-term prognosis of CABG estimated by EuroSCORE: clinical determinants of long-term outcome.

AIMS/METHODS: The long-term outcome of patients (pts) undergoing percutaneous coronary intervention (PCI) of unprotected left main coronary artery (LMCA) is unclear so far. We prospectively investigated the outcome of 102 consecutive patients who underwent stent PCI of unprotected LMCA. Patients were divided according to clinical indication for PCI: stable coronary artery disease (CAD) (N = 60), NSTEMI (N = 18), STEMI (N = 24). Expected in-hospital mortality of coronary artery bypass grafting (CABG) was calculated using the European System for Cardiac Operative Risk Evaluation (EuroSCORE) and compared to the observed survival rate during long-term follow-up (mean 1.8 +/- 1.2 years). RESULTS: The observed 30-day mortality was 1.7% (1/60 pts) in patients with stable CAD, 11% (2/18 pts) in NSTEMI patients, and 13% (3/24 pts) in STEMI patients. The observed mortality was lower than the predicted mortality of CABG as calculated by the logistic EuroSCORE. Using receiver-operator characteristics curves (ROC), EuroSCORE demonstrated a high predictive value for both 30-day mortality as well as 1-year mortality (AUC > 0.8; P < 0.01). Prognostically relevant patient related factors (P < 0.01) included severely reduced left ventricular ejection fraction (HR 3.24), ACS (HR 3.18), STEMI (HR: 3.01), Killip class IV (HR 7.69), occurrence of neoplastic disease (HR 3.97), and elevated CRP (HR 3.86). CONCLUSIONS: LMCA-PCI was associated with lower long-term mortality rates compared to the estimated mortality of CABG. This prospective observational study suggests that DES-PCI of unprotected LMCA in "all-comers" can be carried out with reasonable risk.