Norbert Klein

Effect of Aspiration Thrombectomy on Microvascular Obstruction in NSTEMI Patients: The TATORT-NSTEMI Trial

BACKGROUND Aspiration thrombectomy in ST-segment elevation myocardial infarction is recommended by current guidelines based on several randomized trials. There are no trials assessing thrombectomy in non-ST-segment elevation myocardial infarction (NSTEMI) patients. OBJECTIVES The TATORT-NSTEMI (Thrombus Aspiration in Thrombus Containing Culprit Lesions in Non-ST-Elevation Myocardial Infarction) trial sought to assess the effect of aspiration thrombectomy on microvascular injury in patients with NSTEMI compared with standard percutaneous coronary intervention (PCI). METHODS This prospective, controlled, multicenter study randomized 440 patients to adjunctive thrombectomy (n = 221) compared with conventional PCI (n = 219) in NSTEMI patients with thrombus-containing lesions. The primary endpoint of the extent of microvascular obstruction (MO) in the percentage of left ventricular mass (%LV) was assessed by cardiac magnetic resonance imaging within 4 days. Secondary endpoints included infarct size, myocardial salvage index, and angiographic parameters including myocardial blush grade and Thrombolysis In Myocardial Infarction flow grade. The combined clinical endpoint consisted of death, reinfarction, target vessel revascularization, and new congestive heart failure within 6 months. RESULTS The primary endpoint of MO was not different between the thrombectomy and the standard PCI group with 2.0%LV (interquartile range [IQR]: 0.8 to 4.1) versus 1.4%LV (IQR: 0.7 to 2.6) (p = 0.17). Similarly, no significant differences were observed for infarct size (8.6%LV; IQR: 4.0 to 14.7 vs. 7.4%LV; IQR: 4.1 to 13.1; p = 0.46), myocardial salvage index (63.3; IQR: 35.4 to 87.2 vs. 65.6; IQR: 46.9 to 82.6; p = 0.45), or angiographic parameters such as blush grade (p = 0.63) and Thrombolysis In Myocardial Infarction flow grade (p = 0.66). Clinical follow-up at 6 months revealed no differences in the combined clinical endpoints (p = 0.22). CONCLUSIONS Aspiration thrombectomy in conjunction with PCI in NSTEMI with a thrombus-containing lesion does not lead to a reduction in MO. (Thrombus Aspiration in Thrombus Containing Culprit Lesions in Non-ST-Elevation Myocardial Infarction [TATORT-NSTEMI]; NCT01612312).

Clinical efficacy of left ventricular pacing vector programmability in cardiac resynchronization therapy defibrillator patients for management of phrenic nerve stimulation and/or elevated left ventricular pacing thresholds: insights from the Efface Phrenic Stim study.

AIMS Elevated left ventricular (LV) pacing thresholds or phrenic nerve stimulation (PNS) might be possible reasons for absence of continuous and effective biventricular stimulation. This study investigated the benefit and clinical efficacy of the ability to choose one out of three different LV pacing vectors for the management of suboptimal LV pacing thresholds and PNS. METHODS AND RESULTS This prospective, observational multicentre study enrolled 132 patients (Pts) implanted with a cardiac resynchronization therapy defibrillator, that offers three LV pacing vectors: (i) Bipolar; (ii) LVtip ↔ RVcoil; (iii) LVring ↔ RVcoil (RV = right ventricular). Left ventricular pacing thresholds and PNS thresholds were obtained in sitting and left lateral body position for all programmable LV pacing vectors at hospital discharge and follow up (FU). In 97%, a bipolar transvenous LV lead was successfully implanted. In 87% of Pts at least one acceptable pacing vector could be identified that provides good pacing threshold (≤ 2.5 V at 5 ms) and acceptable margin to PNS (≥ 2:1). This is an increase of 18% compared with conventional bipolar systems (74%) with two LV vectors and of 25% compared with unipolar systems (70%). The LVtip ↔ RVcoil vector provided the best LV pacing thresholds, but the highest rate of PNS. CONCLUSIONS The programmability of LV pacing vectors is a powerful feature to avoid PNS and obtain acceptable LV pacing thresholds. In order to retain reprogramming options for LV vectors during FU, LV pacing leads with at least two electrodes should be chosen whenever possible.

Thrombus Aspiration in ThrOmbus containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI): study protocol for a randomized controlled trial

BackgroundCurrent guidelines recommend thrombus aspiration in patients with ST-elevation myocardial infarction (STEMI); however, there are insufficient data to unequivocally support thrombectomy in patients with non-STEMI (NSTEMI).Methods/DesignThe TATORT-NSTEMI (Thrombus Aspiration in ThrOmbus containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction) trial is a prospective, controlled, multicenter, randomized, open-label trial enrolling 460 patients. The hypothesis is that, against a background of early revascularization, adjunctive thrombectomy leads to less microvascular obstruction (MO) compared with conventional percutaneous coronary intervention (PCI) alone, as assessed by cardiac magnetic resonance imaging (CMR) in patients with NSTEMI. Patients will be randomized in a 1:1 fashion to one of the two treatment arms. The primary endpoint is the extent of late MO assessed by CMR. Secondary endpoints include early MO, infarct size, and myocardial salvage assessed by CMR as well as enzymatic infarct size and angiographic parameters, such as thrombolysis in myocardial infarction flow post-PCI and myocardial blush grade. Furthermore, clinical endpoints including death, myocardial re-infarction, target vessel revascularization, and new congestive heart failure will be recorded at 6 and 12 months. Safety will be assessed by the incidence of bleeding and stroke.SummaryThe TATORT-NSTEMI trial has been designed to test the hypothesis that thrombectomy will improve myocardial perfusion in patients with NSTEMI and relevant thrombus burden in the culprit vessel reperfused by early PCI.Trial registrationThe trial is registered under http://www.clinicaltrials.gov: NCT01612312.

A stepwise electrocardiographic algorithm for differentiation of mid-septal vs. apical right ventricular lead positioning: the SPICE ECG substudy

AIMS Right ventricular (RV) septum is a non-apical site targeted during lead implantation. Electrocardiographic (ECG) recognition of mid-septal lead location is challenging. The aim of the study is to determine ECG correlates of RV mid-septal pacing. METHODS AND RESULTS The present study is a pre-specified analysis of a prospective, multicenter study, which randomized recipients of an implantable cardioverter defibrillator to an apical vs. mid-septal RV lead positioning. Following implantation, a 12-lead ECG was recorded during intrinsic rhythm and RV pacing. In total, 227 patients, 121 in the apical group (76.9% males, 67.1 ± 11.3 years) and 106 in the mid-septal group (82.1% males, age 64.7 ± 12.7 years) were included. Apically as compared with septally paced patients had significantly longer paced QRS duration (177.0 ± 25.0 vs. 170.4 ± 21.7, respectively, P = 0.03) and significantly more leftward paced QRS axis (-71.6 ± 33.3° vs. 9.4 ± 86.5°, respectively, P < 0.001). A significantly higher proportion of patients in the mid-septal as compared with the apical group displayed predominantly positive QRS in lead V6 (62.3 vs. 4.1%, P < 0.001), predominantly positive QRS in any of the inferior leads (53.8 vs. 4.1%, P < 0.001), and a QR pattern in lead aVL (53.3 vs. 3.3%, P < 0.001). These ECG correlates were incorporated in a stepwise algorithm with total sensitivity of 87% and specificity of 90% for the identification of a mid-septal lead location. CONCLUSION A mid-septal lead location may be identified using a simple stepwise algorithm, based on the presence of positive QRS in lead V6, positive QRS in any of the inferior leads, and a QR pattern in lead aVL.

Impact of the Right Ventricular Lead Position on Clinical End Points in CRT Recipients--A Subanalysis of the Multicenter Randomized SPICE Trial.

The impact of right ventricular (RV) lead location on clinical end points in patients undergoing cardiac resynchronization therapy (CRT) is unclear. We evaluated the impact of different RV lead locations on clinical outcome in CRT patients enrolled in the Septal Positioning of ventricular implantable cardioverter‐defibrillator (ICD) Electrodes (SPICE) trial, which randomized recipients of implantable cardioverter defibrillators to apical versus midseptal RV lead positioning.

Neuroprotective Strategies during Cardiac Surgery with Cardiopulmonary Bypass.

Aortocoronary bypass or valve surgery usually require cardiac arrest using cardioplegic solutions. Although, in principle, in a number of cases beating heart surgery (so-called off-pump technique) is possible, aortic or valve surgery or correction of congenital heart diseases mostly require cardiopulmonary arrest. During this condition, the heart-lung machine also named cardiopulmonary bypass (CPB) has to take over the circulation. It is noteworthy that the invention of a machine bypassing the heart and lungs enabled complex cardiac operations, but possible negative effects of the CPB on other organs, especially the brain, cannot be neglected. Thus, neuroprotection during CPB is still a matter of great interest. In this review, we will describe the impact of CPB on the brain and focus on pharmacological and non-pharmacological strategies to protect the brain.

Thrombus aspiration in non-ST-elevation myocardial infarction – 12-month clinical outcome of the randomised TATORT-NSTEMI trial

Background: In the randomised TATORT-NSTEMI trial routine thrombus aspiration in comparison with standard percutaneous coronary intervention (PCI) did not reduce the primary endpoint of microvascular obstruction assessed by cardiac magnetic resonance imaging in patients with non-ST-elevation myocardial infarction (NSTEMI). So far, no data on long-term outcome of head-to-head comparisons between both treatment strategies in NSTEMI patients have been reported. Methods: The prospective, controlled, multicentre, randomised, open-label TATORT-NSTEMI trial assigned patients with NSTEMI and thrombus-containing lesions to aspiration thrombectomy plus PCI (n=221) or standard PCI only (n=219). The primary endpoint of the current analysis was the occurrence of major adverse cardiac events defined as the composite of death, myocardial reinfarction, target vessel revascularisation, and new congestive heart failure at 12-month follow-up. In addition, functional outcome and quality of life were assessed. Results: At one year, major adverse cardiac events occurred in 19 patients in the thrombectomy arm and 29 patients in the standard PCI group (8.7% vs. 13.4%, relative risk 0.63, 95% confidence interval 0.35–1.12, p=0.11). The individual components of the combined endpoint such as death (p=0.20), myocardial reinfarction (p=0.73), target vessel revascularisation (p=0.42), and congestive heart failure (p=0.18) were similar in both groups. Functional outcome and quality of life did not differ significantly between both groups (Canadian Cardiovascular Society class: p=0.68, New York Heart Association class: p=0.70 and EuroQol5D score: p=0.96). Post-hoc analyses revealed consistent results with regard to the occurrence of major adverse cardiac events across a wide range of subgroups (all p>0.05). Conclusions: In this first randomised trial on thrombectomy in NSTEMI patients, routine thrombus aspiration before PCI did not improve clinical outcome at 12-month follow-up.

Atriale Stimulation zur Prävention von Vorhofflimmern

BACKGROUND Atrial overdrive and optimized interatrial conduction time can reduce atrial fibrillation (AF). Increased ventricular stimulation results in a higher incidence of atrial fibrillation. PATIENTS AND METHODS In 25 patients with paroxysmal AF, a dual-chamber pacemaker (Identity DR 5370, St. Jude Medical) was implanted. Atrial leads were placed randomly either septal (n=12) or conventional (n=13). Dynamic atrial overdrive (DAO) was activated and the AV delay was optimized according to Kogleks method. After 3, 6, 9, and 12 months automatic mode switch (AF burden) was analysed. RESULTS No difference in implantation parameters were observed between groups. Technical implantation parameters were in the normal range for both groups. After 12 months patients in the septal group had less AF burden (1% vs. 7%, p=0.06), and the total number of AF episodes was reduced. CONCLUSION Septal pacing is safe. In combination with DAO and AV delay optimization it may reduce the AF burden, which can be observed after 12 months.

Influence of Patientâs Exercise Tolerance on Exercise Heart Rate in Closed LoopStimulation vs. Accelerometer-based Rate Adaptive Pacing

Background: In an earlier study comparing acceleration sensor (AS)- and closed loop stimulation (CLS)-based rateadaptive pacing, a sub analysis showed that heart rate (HR) after 6-minute walk (6MW) was higher in symptomatic (NYHA II/III) than symptom-free (NYHA I) patients in the CLS group only. The present study evaluated prospectively whether CLS unlike AS is able to differentiate between symptomatic and symptom-free patients, for whom 6MW represents demanding exercise versus low-to-moderate exercise, requiring marked versus moderate HR increase, respectively. Methods: The study randomized 205 chronotropically incompetent patients 1:1 to AS or CLS. Primary endpoint was HR after 6MW for symptomatic versus symptom-free patients in each randomization group. A subanalysis tested primary endpoint only in patients with heart failure (HF). Secondary endpoint was HF progression over 2 years. Results: The primary endpoint showed the expected tendency without statistical significance. In the subanalysis, HR after 6MW was significantly higher in symptomatic than symptom-free patients for CLS sensor (median, 92 vs. 84 bpm [P=0.021]), with an opposite non-significant trend for AS. HF development did not differ significantly between AS and CLS. Conclusions: CLS increased HR more selectively than AS in symptomatic patients with HF. Progression of HF over 2 years was minimal in both modes.

Implantierbarer Kardioverter-Defibrillator am Ende des Lebens

Brady- and tachyarrhythmias at the end of life are common observations. Implantable cardioverter-defibrillators answer with antibrady and antitachycardia pacing, which will not be associated with any complaints of the dying patient. In contrast, defibrillation and cardioversion shocks are extremely painful. Therefore shocks should be inactivated at the end of life. Family doctors, internists, emergency physicians and paramedics are unable to inactivate shocks. Deactivation of shocks at the end of life is not comparable to euthanasia or assisted suicide, but allow the patient to die at the end of an uncurable endstage disease. Deactivation of shocks should be discussed with the patient before initial implantation of the devices. The precise moment of the inactivation at the end of life should be discussed with patients and relatives. There is no common recommendation for the time schedule of this decision; therefore it should be based on the individual situation of the patient. Emergency health care physicians need magnets and sufficient information to inactivate defibrillators. The wishes of the patient have priority in the decision process and should be written in the patients advance directive, which must be available in the final situation. However the physician must not necessarily follow every wish of the patient. As long as the laws in the European Union are not uniform, German recommendations are needed.ZusammenfassungAm Lebensende kommt es regelhaft zu bradykarden oder tachykarden Arrhythmien. Implantierbare Kardioverter-Defibrillatoren (ICD) reagieren darauf mit antibradykardem oder antitachykarden Pacing, welches für den Sterbenden nicht mit Missempfindungen verbunden ist. Dagegen ist die Auslösung eines Schocks sehr schmerzhaft. Daher müssen Schocks in der Terminalphase abgeschaltet werden, wozu Hausärzte, Allgemeininternisten und Notärzte in aller Regel nicht in der Lage sind. Die Inaktivierung eines Defibrillators ist nach einem Urteil des Bundesgerichtshofs weder mit Euthanasie noch Sterbehilfe gleichzusetzen, sondern gestattet, dass der Patient in Frieden und ohne vermeidbare Schmerzen an seiner Grunderkrankung versterben kann. Die Inaktivierung der Schockalgorithmen sollte mit Patienten und Angehörigen daher frühzeitig, am besten bereits vor der Erstimplantation des Defibrillators, besprochen werden. Der konkrete Zeitpunkt einer Inaktivierung des Defibrillators am Lebensende ist eine Einzelfallentscheidung und bislang nicht präzise definiert. Notärzte sollten mit einem Magneten und der notwendigen Sachkenntnis ausgerüstet werden, um in der Terminalphase des Lebens den Defibrillator inaktivieren zu können. Der Wunsch des Patienten hat Priorität und sollte in einer Patientenverfügung rasch verfügbar sein. Der Arzt ist jedoch selbst nicht verpflichtet, jedem Wunsch des Patienten nachzukommen. Solange eine juristische Harmonisierung der Europäischen Union aussteht und keine einheitliche Gesetzgebung zu diesen Fragen enthält, sind Empfehlungen für Deutschland erforderlich.AbstractBrady- and tachyarrhythmias at the end of life are common observations. Implantable cardioverter–defibrillators answer with antibrady and antitachycardia pacing, which will not be associated with any complaints of the dying patient. In contrast, defibrillation and cardioversion shocks are extremely painful. Therefore shocks should be inactivated at the end of life. Family doctors, internists, emergency physicians and paramedics are unable to inactivate shocks. Deactivation of shocks at the end of life is not comparable to euthanasia or assisted suicide, but allow the patient to die at the end of an uncurable endstage disease. Deactivation of shocks should be discussed with the patient before initial implantation of the devices. The precise moment of the inactivation at the end of life should be discussed with patients and relatives. There is no common recommendation for the time schedule of this decision; therefore it should be based on the individual situation of the patient. Emergency health care physicians need magnets and sufficient information to inactivate defibrillators. The wishes of the patient have priority in the decision process and should be written in the patients advance directive, which must be available in the final situation. However the physician must not necessarily follow every wish of the patient. As long as the laws in the European Union are not uniform, German recommendations are needed.