Impact of Access Site on Periprocedural Bleeding and Cerebral and Coronary Events in High-Bleeding-Risk Percutaneous Coronary Intervention: Findings from the RIVA-PCI Trial.

INTRODUCTION: The preference for using transradial access (TRA) over transfemoral access (TFA) in patients requiring percutaneous coronary intervention (PCI) is based on evidence suggesting that TRA is associated with less bleeding and fewer vascular complications, shorter hospital stays, improved quality of life, and a potential beneficial effect on mortality. We have limited study data comparing the two access routes in a patient population with atrial fibrillation (AF) undergoing PCI, who have a particular increased risk of bleeding, while AF itself is associated with an increased risk of thromboembolism. METHODS: Using data from the RIVA-PCI registry, which includes patients with AF undergoing PCI, we analyzed a high-bleeding-risk (HBR) cohort. These patients were predominantly on oral anticoagulants (OAC) for AF, and the PCI was performed via radial or femoral access. Endpoints examined were in-hospital bleeding (BARC 2-5), cerebral events (TIA, hemorrhagic or ischemic stroke) and coronary events (stent thrombosis and myocardial infarction). RESULTS: Out of 1636 patients, 854 (52.2%) underwent TFA, while 782 (47.8%) underwent the procedure via TRA, including nine patients with brachial artery puncture. The mean age was 75.5 years. Groups were similar in terms of age, sex distribution, AF type, cardiovascular history, risk factors, and comorbidities, except for a higher incidence of previous bypass surgeries, heart failure, hyperlipidemia, and chronic kidney disease (CKD) with a glomerular filtration rate (GFR) < 60 ml/min in the TFA group. No clinically relevant differences in antithrombotic therapy and combinations were present at the time of PCI. However, upon discharge, transradial PCI patients had a higher rate of triple therapy, while dual therapy was preferred after transfemoral procedures. Radial access was more frequently chosen for non-ST-segment elevation myocardial infarction (NSTEMI) and unstable angina pectoris (UAP) cases (NSTEMI 26.6% vs. 17.0%, p < 0.0001; UAP 21.5% vs. 14.5%, p < 0.001), while femoral access was more common for elective PCI (60.3% vs. 44.1%, p < 0.0001). No differences were observed for ST-segment elevation myocardial infarction (STEMI). Both groups had similar rates of cerebral events (TFA 0.2% vs. TRA 0.3%, p = 0.93), but the TFA group had a higher incidence of bleeding (BARC 2-5) (4.2% vs. 1.5%, p < 0.01), mainly driven by BARC 3 bleeding (1.5% vs. 0.4%, p < 0.05). No significant differences were found for stent thrombosis and myocardial infarction (TFA 0.2% vs. TRA 0.3%, p = 0.93; TFA 0.4% vs. TRA 0.1%, p = 0.36). CONCLUSIONS: In HBR patients with AF undergoing PCI for acute or chronic coronary syndrome, the use of TRA might be associated with a decrease in in-hospital bleeding, while not increasing the risk of embolic or ischemic events compared to femoral access. Further studies are required to confirm these preliminary findings.

Association of atrial myopathy in mitral valve disease on safety outcomes in left atrial appendage closure.

BACKGROUND: Patients undergoing left atrial appendage (LAA) occlusion (LAAO) are multi-morbid, including mitral valve disease (MVD) which is associated with anatomic changes of the left atrium (LA). This study aims to identify how atrial myopathy in MVD influences outcomes in LAAO. METHODS: Atrial myopathy in MVD was defined as LA diameter > 45 mm (♀) and > 48 mm (♂) and existing MVD or history of surgical/interventional treatment. Patients were compared with controls from the prospective, multicentre LAArge registry of LAAO. RESULTS: A total of 528 patients (52 MVD, 476 no-MVD) were included. The MVD group was significantly more likely to be older (78.2 years vs 75.9 years, p = 0.036) and female (59.6% vs 37.8%, p = 0.002). Altered LA anatomy was observed in MVD with significantly larger LA diameter (53 mm vs. 48 mm, p < 0.001) and LAA Ostia [at 135° 23.0 mm (20.5, 26.0) vs 20.0 mm (18.0, 23.0), p = 0.002]. Implant success was high with 96.2% and 97.9%, respectively, without differences in severe complications (7.7% vs 4.6%, p = 0.31). One-year mortality (17.8% vs 11.5%, p = 0.19) and a combined outcome of death, stroke, and systemic embolism (20.3% vs 12.4%, p = 0.13) were not different. Independent predictors of the combined outcome were peripheral artery disease (HR 2.41, 95% CI 1.46-3.98, p < 0.001) and chronic kidney disease (HR 3.46, 95% CI 2.02-5.93, p < 0.001) but not MVD and atrial myopathy. CONCLUSION: Patients with MVD present with altered LA anatomy with increased LA and LAA diameter. However, procedural success and safety in LAAO are not compromised. One-year mortality is numerically higher in patients with MVD but driven by comorbidities.

Rivaroxaban in Patients With Atrial Fibrillation Who Underwent Percutaneous Coronary Intervention in Clinical Practice.

Little is known about the efficacy and safety of rivaroxaban in patients with atrial fibrillation (AF) who underwent percutaneous coronary intervention (PCI) in clinical practice. We therefore conducted a prospective observational study to determine the rate of ischemic, embolic, and bleeding events in patients with AF and PCI treated with rivaroxaban in a real-world experience. The RIVA-PCI ("rivaroxaban in patients with AF who underwent PCI") (clinicaltrials.gov NCT03315650) is a prospective, noninterventional, multicenter study with a follow-up until 14 months, including patients with AF who underwent PCI discharged with rivaroxaban. Between January 2018 and March 2020, 700 patients with PCI treated with rivaroxaban (elective in 50.1%, non-ST-elevation acute coronary syndrome 43.0%, ST-elevation myocardial infarction in 6.9%) were enrolled at 51 German hospitals. After PCI, a dual antithrombotic therapy consisting of rivaroxaban and a P2Y12 inhibitor was administered in 70.7% and triple antithrombotic therapy in 27.9%, respectively. Follow-up information could be obtained in 695 patients (99.3%). Rivaroxaban has been stopped prematurely in 21.6% of patients. Clinical events under rivaroxaban during the 14-month follow-up compared with those observed in the PIONEER-AF PCI trial included cardiovascular death (2.0% % vs 2.0%), myocardial infarction (0.9% vs 3.0%), stent thrombosis (0.2% vs 0.8%), stroke (1.3% vs 1.3%), International Society on Thrombosis and Haemostasis major (4.2% vs 3.9%), and International Society on Thrombosis and Haemostasis nonmajor clinically relevant bleeding (15.3% vs 12.9%). Therefore, in this real-world experience, rivaroxaban in patients with AF who underwent PCI is associated with ischemic and bleeding event rates comparable with those observed in the randomized PIONEER-AF PCI trial.

Current status of antithrombotic therapy and in-hospital outcomes in patients with atrial fibrillation undergoing percutaneous coronary intervention in Germany.

BACKGROUND: Little is known about current patterns of antithrombotic therapy in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) in clinical practice in Germany. METHODS: The RIVA-PCI is a prospective, non-interventional, multicenter study with follow-up until hospital discharge including consecutive patients with AF undergoing PCI. RESULTS: Between January 2018 and March 2020, 1636 patients (elective in 52.6%, non-ST elevation acute coronary syndrome [NSTE-ACS] in 39.3%, ST-elevation myocardial infarction in 8.2%) from 51 German hospitals were enrolled in the study. After PCI a dual antithrombotic therapy (DAT) consisting of OAC and a P2Y12 inhibitor was given to 66.0%, triple antithrombotic therapy (TAT) to 26.0%, dual antiplatelet therapy to 5.5%, and a mono-therapy to 2.5% of the patients. Non-vitamin K antagonist oral anticoagulants (NOACs) were given to 82.4% and vitamin K antagonists to 11.5% of the patients. In-hospital events included death in 12 cases (0.7%), myocardial infarction, stent thrombosis, and ischemic stroke in four (0.2%) patients each, while 2.8% of patients had bleeding complications. The recommended durations for DAT or TAT at discharge were 1 month (1.5%), 3 months (2.1%), 6 months (43.1%), and 12 months (45.6%), with a 6-month course of DAT (47.7%) most often recommended after elective PCI and a 12-month course of DAT (40.1%) after ACS. CONCLUSION: The preferred therapy after PCI in patients with AF is DAT with a NOAC and clopidogrel. In-hospital ischemic and bleeding events were rare. The recommended durations for combination therapy vary considerably.

Guideline-adherence regarding critical time intervals in the German Chest Pain Unit registry.

BACKGROUND: Since 2008, the German Cardiac Society certified 256 Chest Pain Units (CPUs). Little is known about adherence to recommended performance measures in patients with suspected acute coronary syndrome (ACS) presenting to CPUs. We investigated guideline-adherence regarding critical time intervals and selected performance measures in German Chest Pain Units. METHODS: From 2008 to 2014, 23,804 consecutive patients with suspected ACS were prospectively enrolled in the Chest Pain Unit registry of the German Cardiac Society. RESULTS: Median time from symptom onset to first medical contact was 2 h in patients with ST-elevation myocardial infarction (STEMI) and 4 h in patients with unstable angina and non-STEMI (NSTEMI). In patients with STEMI, median time from hospital admission to percutaneous coronary intervention (PCI) was 40 min and median time from first medical contact to PCI was 1 h 35 min. Primary PCI was performed in 94.7% of patients with STEMI, 70.0% of patients with NSTEMI and 37.4% of patients with unstable angina. PCI was performed during the first 24 h in 79.5% of patients with NSTEMI and the first 72 h in 89.0% of patients with unstable angina. Electrocardiograms were performed in 99.5% after a median of 6 min after admission and obtained within 10 min in 71%. Interestingly, 56.1% of patients were found to have non-ACS diagnoses, underlining the importance of access to additional diagnostic modalities including echocardiography, stress testing or computed tomography. CONCLUSIONS: Guideline-adherence regarding critical time intervals and primary PCI rates is good in German Chest Pain Units. More than half of patients admitted with suspected ACS had non-ACS diagnoses. Improvements in pre-hospital time delays through public awareness programmes are warranted.

Effectiveness of the Pulsar-18 self-expanding stent with optional drug-coated balloon angioplasty in the treatment of femoropopliteal lesions - the BIOFLEX PEACE All-Comers Registry.

Background: Previous studies showed favorable results after treatment of femoropopliteal lesions with the Pulsar-18 self-expanding (SE) nitinol stent. The objective of this registry was to evaluate whether these results will be confirmed in a real-world setting with varying stenting strategies. Patients and methods: In this prospective, observational trial, 160 patients with 186 femoropopliteal lesions were treated with the Pulsar-18 SE nitinol stent at 9 German sites. Mean lesion length was 116 ± 103 mm, and 41.9 % of the lesions were moderately or heavily calcified. Eighty lesions were concomitantly treated with drug-coated balloon (DCB). Main effectiveness outcome was primary patency at 12 months, and main safety outcome was freedom from the composite of device or procedure related death, major target limb amputation, and clinically driven target lesion revascularization (TLR) at 30 days and 6 months. Results: Kaplan-Meier estimate of primary patency was 89.1 %, 67.3 %, and 57.1 % at 6, 12, and 24 months. Freedom from TLR was 95.5 %, 91.4 %, and 85.2 % at 6, 12, and 24 months, respectively. Lesions, which were additionally treated with DCB (plus DCB-group), were longer (150 versus 82 mm on average, p < 0.0001), and associated with lower primary patency estimates than those without DCB angioplasty (stent-only-group) (log-rank p = 0.006). However, there was no difference in freedom from TLR between groups (log-rank p = 0.542). Improvement by ≥ 1 Rutherford category was achieved in 84.8 %, 81.0 %, and 81.7 % of patients at 6, 12, and 24 months, respectively. Walking distance and patient-reported pain improved persistently through 24 months (p < 0.001). Hemodynamic improvement was achieved in 68.2 %, 73.7 %, and 70.7 % of the patients at 6, 12, and 24 months, respectively. Conclusions: The Pulsar-18 self-expanding nitinol stent with optional drug-coated balloon angioplasty can be considered an efficacious and safe therapy option for endovascular treatment of femoropopliteal artery disease.

Assessment of Systemic Adenosine Effect Using Color Doppler Ultrasound of the Splenic Artery-Feasibility and Potential Clinical Utility for Coronary Interventions.

Adenosine induces coronary vasodilation and simultaneously reduces splanchnic perfusion. This effect can be absent in adenosine non-responders. Imaging of splanchnic arteries under adenosine assessing this effect has not been performed in humans previously. In 26 patients, splenic artery color Doppler was performed during an infusion of adenosine. Peak velocity in the splenic artery was measured before the infusion and at 2 min. Results were compared qualitatively with perfusion imaging in magnetic resonance. A total of 24 patients showed a drop of splenic artery peak velocity from 62.3 ± 18.1 to 40.4 ± 15.7 cm/s (p <0.001), which corresponded to perfusion restriction in magnetic resonance. Two patients with constant splenic artery velocity did not show perfusion restriction. We showed feasibility of assessing changes in splenic artery velocity under adenosine for the first time in humans. Further studies are needed to investigate whether this novel application is a robust tool to rule out inadequate adenosine effect during measurement of fractional flow reserve in coronary catheterization.

Safety and efficacy of clip-based vs. suture mediated vascular closure for femoral access hemostasis: A prospective randomized single center study comparing the StarClose and the ProGlide device.

OBJECTIVES: This study is the first head-to-head analysis of StarClose vs. ProGlide in patients undergoing 5F or 6F percutaneous coronary catheterization or peripheral artery interventions. BACKGROUND: The clip based StarClose and the suture mediated ProGlide vascular closure device are well established for femoral hemostasis in endovascular therapy. However, until now no prospective randomized study compared the safety and efficacy of the two devices. METHODS: This prospective, randomized, single-center study enrolled 505 patients (69.6 ± 11.2 years) resulting in 538 procedures due to more than one intervention in several patients: We analyzed 422 cardiac catheterization and 116 peripheral artery interventions via a common femoral artery access. Patients were randomized to StarClose or ProGlide (1:1). In-hospital complications (major bleeding, hematoma, pseudoaneurysm, vessel occlusion, and arteriovenous fistula) and device failure were recorded. The puncture site was assessed by ultrasound in all patients prior to discharge. RESULTS: Overall complication rate was 3.9%. There were more complications after utilization of StarClose compared to ProGlide (5.6 vs. 2.2%, P = 0.064), which was significant in adjusted logistic regression analysis with a 2.9-fold increased risk of complications for StarClose (P < 0.05). In the subgroup of coronary catheterizations there were significantly more complications for StarClose compared to ProGlide (1.4 vs. 5.2%, P < 0.05) with a 4.7-fold increased risk. Device failure rate was not significantly different between the two devices. CONCLUSION: In this first randomized trial comparing the two closure systems complication rate was higher for StarClose with equal efficacy compared to ProGlide. © 2017 Wiley Periodicals, Inc.

An Integrated Maximum Current Density Approach for Noninvasive Detection of Myocardial Infarction.

We present a new approach of integrated maximum current density (IMCD) for the noninvasive detection of myocardial infarction (MI) using magnetocardiography (MCG) data acquired from a superconducting quantum interference device (SQUID) system. In this paper, we investigated the relationship of the maximum current density (MCD) in the current density map and the underlying equivalent current dipole (ECD) based on a novel method of reconstructing the ECD in the extremum circle of the magnetic field map. The performance of IMCD and the integrated ECD (IECD) approaches were also evaluated by using 61-channel MCG data from 39 healthy subjects and 102 patients with ST elevation myocardial infarction (STEMI). Statistical analysis of the healthy and STEMI groups demonstrate that the IMCD approach obtains sensitivity and specificity up to 91.2% and 84.6%, somewhat higher than that of IECD, respectively. The results indicate that IMCD provides spatiotemporal information regarding cardiac electrical activity during ventricular repolarization. This approach may be helpful to diagnose MI in clinic application. The physical concept of the approach is also explained in this paper.

Deactivation vs. asynchronous pacing - prospective evaluation of a protocol for rhythm management in patients with magnetic resonance conditional pacemakers undergoing adenosine stress cardiovascular magnetic resonance imaging.

BACKGROUND: Cardiovascular Magnetic Resonance (CMR) imaging with adenosine stress is an important diagnostic tool in patients with known or suspected coronary artery disease (CAD). However, the method is not yet established for CAD patients with pacemakers (PM) in clinical practice. A possible reason is that no recommendations exist for PM setting (paused pacing or asynchronous mode) during adenosine stress. We elaborated a protocol for rhythm management in clinical routine for PM patients that considers heart rate changes under adenosine using a test infusion of adenosine in selected patients. METHODS: 47 consecutive patients (mean age 72.3 ± 10,0 years) with MR conditional PM and known or suspected CAD who underwent CMR in clinical routine were studied in this prospective observational study. PM indications were sinus node dysfunction (SND, n = 19; 40,4%), atrioventricular (AV) block (n = 26; 55.3%) and bradyarrhythmia in permanent atrial fibrillation (AF, n = 2; 4.3%). In patients with SND, normal AV-conduction and resting HR >45 bpm at the time of CMR and in AF the PM was deactivated for the scan. In intermittent AV-block a test infusion of adenosine was given prior to the scan. All patients with permanent higher degree sinuatrial or AV-block or deterioration of AV-conduction in the adenosine test were paced asynchronously during CMR, in patients with preserved AV-conduction under adenosine the pacemaker was deactivated. CMR protocol included cine imaging, adenosine stress perfusion and late gadolinium enhancement. RESULTS: The adenosine test was able to differentiate between mandatory PM stimulation during CMR and safe deactivation of the device. In patients with permanent sinuatrial or AV-block (n = 11; 23.4%) or deterioration of AV conduction in the adenosine test (n = 5, 10.6%) asynchronous pacing above resting heart rate did not interfere with intrinsic rhythm, no competitive stimulation was seen during the scan. 10 of 15 (66,7%) patients with intermittent AV-block showed preserved AV-conduction under adenosine. As in SND and AF deactivation of the PM showed to be safe during CMR, no bradycardia was observed. CONCLUSION: Our protocol for rhythm management during adenosine stress CMR showed to be feasible and safe and may be recommended for pacemaker patients undergoing routine CMR.

On versus off-hour care of patients with acute coronary syndrome and persistent ST-segment elevation in certified German chest pain units.

BACKGROUND: Regional healthcare projects improve the off-hour care of patients with acute coronary syndromes and persistent ST-segment elevation myocardial infarction (STEMI). To analyse differences in quality of care between on and off-hour care of STEMI patients admitted to certified German chest pain units. METHODS: A total of 1107 STEMI patients from the German chest pain unit registry were enrolled. Analyses comprised critical time intervals (symptoms to first medical contact (FMC), FMC to admission, symptoms to admission, symptoms to balloon, FMC to balloon, door to balloon times) and major adverse cardiac and cerebrovascular events at follow-up. RESULTS: 54.8% of patients were admitted off-hours. Symptoms to admission (2:28 (1:28-5:20 h) vs. 3:16 h (1:35-8:06 h), P<0.001), symptoms to FMC (1:15 h (0:33-3:00 h) vs. 2:00 h (0:40-6:46 h), P<0.001) and FMC to admission intervals (0:45 h (0:30-1:20 h) vs. 0:52 h (0:32-1:35 h), P=0.09) were shorter during off-hours. Percutaneous revascularisation rates were high and without difference between on and off-hours (95.5% vs. 96.8%, P=0.30). Door to balloon times were significantly less during on-hours (0:32 h (0:18-1:06 h) vs. 0:44 h (0:23-1:20 h), P<0.01) without negative impact on the proportion of patients with a door to balloon time of <60 min (72.6% vs. 68.4%, P=0.19), symptoms to balloon (3:49 h (2:12-10:46 h) vs. 3:30 h (2:04-7:41 h), P=0.08) or FMC to balloon times (1:26 h (0:56-2:22 h) vs. 1:30 h (1:03-2:29 h), P=0.14). Major adverse cardiac and cerebrovascular event rates did not differ significantly between on and off-hours (log-rank test P=0.36). CONCLUSIONS: The German chest pain unit network ensures rapid and structured preclinical and in-hospital care independent from the circadian variation of admission. Slower door to balloon times off-hours are compensated by faster symptoms to admission or symptoms to FMC intervals. Further efforts should focus on patient awareness programmes on-hours and STEMI alarming tracks off-hours.

Cardiovascular magnetic resonance in patients with magnetic resonance conditional pacemaker systems at 1.5 T: influence of pacemaker related artifacts on image quality including first pass perfusion, aortic and mitral valve assessment, flow measurement, short tau inversion recovery and T1-weighted imaging.

There are only limited data on the impact of device-related artifacts on image quality in cardiovascular magnetic resonance imaging (CMR) in patients with pacemakers (PM). Adenosine stress perfusion, T1-weighted imaging and flow measurement as well as valve characterization have not been evaluated previously concerning artifact burden. We aimed to assess image quality in all routinely used CMR sequences. We analyzed 2623 myocardial segments in CMR scans of 61 patients with MR conditional PM (mean age 72.1 ± 11.5 years), 23 (37.7%) with right sided, 38 (62.3%) with left-sided devices. There were no relevant artifacts in patients with right-sided devices irrespective of the imaging sequence. In left-sided implants no PM-induced artifacts were found in first pass perfusion sequence, flow analysis and T1 weighted imaging. Only few patients with left-sided devices showed significant PM-artifacts in aortic (3/38, 7.9%)/mitral (n = 2/38, 5.3%) valve imaging and STIR (n = 3/35, 8.6%). In STIR only 14/805 (1.7%) segments were involved. In left-sided PM SSFP cine sequences had more artifact burden than LGE with 377/1505 (25.0%) vs. 162/1505 (10.8%) myocardial segments involved by relevant artifacts respectively (p < 0.001). Apart from cine and LGE imaging in anterior myocardial segments with left-sided implants presence of MRI conditional pacemakers does not affect CMR image quality in multimodal CMR examinations to a significant extent. Our data supports evidence that reduced image quality does not need to be a major concern in PM patients undergoing CMR.

A novel cross-sector telemedical approach to detect arrhythmia in primary care patients with palpitations using a patient-activated event recorder.

BACKGROUND: Patient-activated event recorders (ER) can facilitate diagnosis in unclear palpi-tations, however impact of ER screening on further treatment in clinical routine is unknown. We investigated the feasibility and clinical value of a network-based telemetric monitoring using a patient activated ER. METHODS: The network consisted of 12 general practitioners (GP) and a department of car-diology (DC). GP-patients sent electrocardiograms (ECGs) twice daily and in case of palpitations. ECGs were transferred by email to GP and DC and analyzed independently by both. The therapeutic strategy was discussed between GP and DC. The monitoring period ended after 4 weeks or in case of detected arrhythmia. RESULTS: A group of 184 consecutive patients were retrospectively analyzed. Mean age was 57.5 ± 14.4 years (range 17-82), 104 (56.5%) were female. Significant arrhythmia occurred in 71 (38.5%) patients: Recurrence of known paroxysmal atrial fibrillation (AF; n = 27, 14.7%), de novo AF (n = 19, 10.3%), premature complexes/bigeminus (n = 13, 7.1%), sinus tachycar-dia (n = 7, 3.8%), atrioventricular nodal reentrant tachycardia (n = 3, 1.6%), and ventricular tachycardia (n = 2, 1.1%). A therapeutic consequence resulted in 63 (88.7%) patients with de-tected arrhythmia: new oral anticoagulation (n = 29, 40.8%), new antiarrhythmic medication (n = 27, 38.0%), behavioral intervention (n = 19, 26.8%), electrophysiology-study/catheter ablation (n = 4, 5.6%), cardioversion (n = 2, 2.8%), implantable cardioverter-defibrillator- -implantation (n = 1, 1.4%), and left atrial appendage occluder (n = 1, 1.4%). CONCLUSIONS: The investigated cross-sector telemetric network is a feasible approach to detect arrhythmia in patients with palpitations and may have high impact on further treatment, notably in those at risk for stroke due to AF.

Cardiac Computed Tomography in Certified German Chest Pain Units.

OBJECTIVE: The German Cardiac Society runs a nation-wide certification campaign for specialized chest pain units (CPUs). So far, cardiac computed tomography (CT) is not an integral part of such certification. The aim of our study was to analyze whether or not cardiac CT is nevertheless routinely used for further stratification in low-risk patients. METHODS: For the time interval from January 2010 to April 2011, data were retrieved from the mandatory German CPU registry. Patients with and without cardiac CT during CPU index stay were compared. RESULTS: Out of 5800 patients, 314 patients (5.4%) underwent cardiac CT during the index CPU stay. Unstable angina pectoris was the most common diagnosis when performing cardiac CT [34.4% vs. 17.7%; odds ratio (OR), 2.44; confidence interval (CI), 1.91-3.11; P < 0.001). Patients undergoing cardiac CT received significantly less often coronary angiography (31.8% vs. 54.8%; OR, 0.39; CI, 0.30-0.49; P < 0.001) or coronary revascularization (15.6% vs. 36.5%; OR, 0.32; CI, 0.23-0.46; P < 0.001). The use of cardiac CT did not prolong the length of stay in the CPU (20:48 vs. 20:25 h, P = 0.21). CONCLUSIONS: Cardiac CT is underrepresented within the diagnostic work up in certified CPUs in Germany, although its use reduces unnecessary invasive diagnostics. The use of cardiac CT should be reconsidered during the next update of the CPU certification criteria.

The Use of Echocardiography in Certified Chest Pain Units: Results from the German Chest Pain Unit Registry.

OBJECTIVES: To analyze the current usage of transthoracic echocardiography (TTE) as a rapid, noninvasive tool in the early stratification of acute chest pain in certified German chest pain units (CPUs). METHODS: A total of 23,997 patients were enrolled. Analyses comprised TTE evaluation rates in relation to clinical presentation, risk profile, left ventricular impairment, final diagnosis and invasive management. Critical times were assessed. Multivariable analyses for independent determinants for the use of TTE were performed. RESULTS: TTE evaluation was available in CPUs in 70.1% of cases. It was associated with lower rates of invasive management in unstable angina pectoris (UAP) and with higher rates in patients with initially suspected non-cardiac origin of symptoms and/or reduced systolic function (p < 0.05). Non-ST-segment elevation acute coronary syndrome (NSTE-ACS) was an independent determinant favoring TTE evaluation [NSTE-myocardial infarction: odds ratio (OR) 1.62; UAP: OR 1.34; p < 0.001 for both]. Clinical signs of heart failure (OR 1.31; p < 0.001), referral by emergency medical service (OR 1.18; p < 0.001) and kidney failure (OR 1.16; p < 0.05) were independently associated with higher TTE rates. TTE did not delay door-to-balloon times. CONCLUSIONS: About two thirds of the patients admitted to certified CPUs received TTE evaluation, with the highest rates being in ACS patients, and thereby providing diagnostic information supporting or refuting further invasive management.

Feasibility and safety of adenosine cardiovascular magnetic resonance in patients with MR conditional pacemaker systems at 1.5 Tesla.

BACKGROUND: Cardiovascular Magnetic Resonance (CMR) with adenosine stress is a valuable diagnostic tool in coronary artery disease (CAD). However, despite the development of MR conditional pacemakers CMR is not yet established in clinical routine for pacemaker patients with known or suspected CAD. A possible reason is that adenosine stress perfusion for ischemia detection in CMR has not been studied in patients with cardiac conduction disease requiring pacemaker therapy. Other than under resting conditions it is unclear whether MR safe pacing modes (paused pacing or asynchronous mode) can be applied safely because the effect of adenosine on heart rate is not precisely known in this entity of patients. We investigate for the first time feasibility and safety of adenosine stress CMR in pacemaker patients in clinical routine and evaluate a pacing protocol that considers heart rate changes under adenosine. METHODS: We retrospectively analyzed CMR scans of 24 consecutive patients with MR conditional pacemakers (mean age 72.1 ± 11.0 years) who underwent CMR in clinical routine for the evaluation of known or suspected CAD. MR protocol included cine imaging, adenosine stress perfusion and late gadolinium enhancement. RESULTS: Pacemaker indications were sinus node dysfunction (n = 18) and second or third degree AV block (n = 6). Under a pacing protocol intended to avoid competitive pacing on the one hand and bradycardia due to AV block on the other no arrhythmia occurred. Pacemaker stimulation was paused to prevent competitive pacing in sinus node dysfunction with resting heart rate >45 bpm. Sympatho-excitatory effect of adenosine led to a significant acceleration of heart rate by 12.3 ± 8.3 bpm (p < 0.001), no bradycardia occurred. On the contrary in AV block heart rate remained constant; asynchronous pacing above resting heart rate did not interfere with intrinsic rhythm. CONCLUSION: Adenosine stress CMR appears to be feasible and safe in patients with MR conditional pacemakers. Heart rate response to adenosine has to be considered for the choice of pacing modes during CMR.

PEACE I all-comers registry: patency evaluation after implantation of the 4-French Pulsar-18 self-expanding nitinol stent in femoropopliteal lesions.

PURPOSE: To evaluate the 1-year patency of the 4-F Pulsar-18 self-expanding nitinol stent for treatment of femoropopliteal occlusive disease in a national, prospective, multicenter, all-comers registry. METHODS: Between January and June 2012, the German PEACE I all-comers prospective registry enrolled 148 patients with symptomatic femoropopliteal lesions (Rutherford category 2-5) undergoing recanalization and implantation of the Pulsar-18 SE nitinol stent at 6 clinical centers. Thirty patients did not have the 12-month follow-up visit (18 declined reevaluation, 5 withdrew consent, and 7 died), leaving 118 patients (64 men; mean 71.9±9.6 age years) for the 1-year evaluation. The average lesion length was 111.5±71.4 mm, and 38 of the 118 lesions were classified as TASC II D. More than half the lesions (67, 56.7%) were chronic total occlusions (CTO). The popliteal segment was involved in 22 (18.7%) lesions. The mean stented length was 122.7±64.5 mm. Routine follow-up included duplex ultrasound at 6 and 12 months. Outcome measures were primary patency and no clinically driven target lesion revascularization (TLR) within 12 months. RESULTS: The overall primary patency rates after 6 and 12 months were 87.4% and 79.5%, respectively; in the popliteal segments, the rate was 71.4% after 12 months. The overall freedom from TLR was 93.2% after 6 months and 81% after 12 months. Ankle-brachial index, pain-free walking distance, and Rutherford category all improved significantly (p<0.0001) after 6 and 12 months. The primary patency rates in patients with diabetes (p=1.0) and those with renal insufficiency (p=0.8) were not significantly lower compared to the overall rate. There was no significant difference (p=0.67) in restenosis rate for recanalization of CTOs compared to non-CTO lesions. CONCLUSIONS: In this all-comers registry, the use of the Pulsar-18 self-expanding nitinol stent in femoropopliteal lesions averaging 111.5 mm long showed promising primary patency and freedom from TLR after 6 and 12 months. Diabetes had no negative impact on patency. Primary patency in the popliteal segments was acceptable at 12 months.

Predictive value of the complex magnetocardiographic index in patients with intermediate pretest probability of chronic coronary artery disease: results of a two-center study.

INTRODUCTION: The aim of this paper is to investigate the predictive value of the new integrated magnetocardiographic (MCG) index (CI) in the diagnosis of coronary artery disease (CAD) in patients with suspected CAD with intermediate pretest probability of the disease and uninformative results of routine tests. PATIENTS AND METHODS: The study was carried out in the Clinic of Cardiology of the Main Military Clinical Hospital of Ukraine, Kiev (clinic 1), and in the Second Medical Clinic of the 'Katholisches Klinikum Essen', Germany (clinic 2).The main group (group 1) included 89 patients without a history of myocardial infarction. Coronary angiography was performed because of chest pain. Depending on the results of coronary angiography, this group was divided into two subgroups: (i) those with at least 70% stenosis in at least one of the main coronary arteries (subgroup 1a) and (ii) those without hemodynamically significant stenosis (subgroup 1b). The control group included 43 healthy volunteers.In all participants, the MCG examination was performed using a seven-channel MCG system located in an unshielded room. An integrated MCG index (CI), consisting of six parameters, was calculated. RESULTS: It can be shown that CI was significantly higher in patients with stenosis 70% or more compared with the patients without stenosis and healthy volunteers. Sensitivity was 93%, specificity was 84%, positive predictive value was 85%, and negative predictive value was 93%. CONCLUSION: The MCG test at rest has the potential to be useful in the noninvasive diagnosis of CAD in patients with intermediate pretest probability of disease and uninformative results of routine tests.

Evaluation of the 4-French Pulsar-18 Self-expanding Nitinol Stent in Long Femoropopliteal Lesions.

PURPOSE: To evaluate the patency and the freedom of target lesion revascularization of the 4-French Pulsar-18 self-expandable (SE) nitinol stent for the treatment of long femoropopliteal occlusive disease in a two-center, prospective, all-comers registry with a follow-up period of 12 months. METHODS: This registry enrolled 36 patients with symptomatic femoropopliteal long lesions for recanalization and implantation of the 4-French Pulsar-18 SE nitinol stent. Routine follow-up examination including duplex ultrasound was performed after 6 and 12 months. Primary patency was defined as no binary restenosis on duplex ultrasound (Peak systolic velocitiy ration (PSVR) <2.5) and no target lesion revascularization was performed within 12 months' follow-up. No drug-eluting devices were allowed in this registry. RESULTS: Average lesion length of the femoropopliteal segment was 182.3 ± 51.8 mm. Mean stent implantation length was 181.5 ± 35.4 mm. Total occlusion was present in 46 of the 48 (95.8%) treated lesions. Involvement of popliteal segment I-III was present in 3 (6.3%) lesions. The primary patency after 6 and 12 months was 87.5% and 85.4%, respectively. The clinically driven overall freedom from target lesion revascularization (fTLR) was 89.6% after 6 months and 87.5% after 12 months. ABI, pain-free walking distance and Rutherford category, all improved significantly (P < 0.001) after 6 and 12 months. The primary patency rate in patients with diabetes (P = 0.18) and renal insufficiency (P = 0.3) was not significantly lower as compared to the overall primary patency. CONCLUSIONS: In this two-center, all-comers registry, the use of the Pulsar-18 SE nitinol stent for endovascular intervention of femoropopliteal disease with a mean lesion length of 182.3 ± 51.8 mm showed promising primary patency and fTLR rates after 6 and 12 months. Diabetes and renal insufficiency had no negative impact on the patency rate.

Twelve months outcome after percutaneous mechanical thrombectomy for treatment of acute femoropopliteal bypass occlusion.

Acute and subacute ischemia of the legs in acute and subacute femoropopliteal bypass occlusion is a dramatic situation that endangers the survival of the limbs, depending on the severity of the ischemia. Different therapy options like percutaneous mechanical thrombectomy procedures, which include rotational thrombectomy, have become available in recent years in addition to local lysis and surgical thrombectomy. Rotational thrombectomy with the Straub Rotarex(®) System as an endovascular therapy option has demonstrated promising results leading to amputation-free survival in multiple studies. We recently provided data of 22 patients with acute femoropopliteal bypass occlusion where we examined the feasibility of the Rotarex(®) System in this indication. A technical success rate of 82% was demonstrated. During a follow-up period of 6 months, no reinterventions in these patients had to be performed. We now provide patency rates in 21 patients of our study group after a follow-up period of 12 months. The average ABI after 12 months was 0.80 ± 0.1. One patient showed a hemodynamic restenosis in a Nitinolstent distal to the femoropopliteal bypass which was implanted in the index procedure. No reocclusion of the femoropopliteal bypasses occurred in all patients.