Charlotte Eitel

Steerable Versus Nonsteerable Sheath Technology in Atrial Fibrillation Ablation A Prospective, Randomized Study

Background— Steerable sheath technology is designed to facilitate catheter access, stability, and tissue contact in target sites of atrial fibrillation (AF) catheter ablation. We hypothesized that rhythm control after interventional AF treatment is more successful using a steerable as compared with a nonsteerable sheath access. Methods and Results— One hundred thirty patients with paroxysmal or persistent drug-refractory AF undergoing their first ablation procedure were prospectively included in a randomized fashion in 2 centers. Ablation was performed by 10 operators with different levels of clinical experience. Treatment outcome was measured with serial 7-day Holter ECGs and additional symptom-based arrhythmia documentation. Single procedure success (freedom from AF and/or atrial macroreentrant tachycardia) was significantly higher in patients ablated with a steerable sheath (78% versus 55% after 3 months, P=0.005; 76% versus 53% after 6 months, P=0.008). Rate of pulmonary vein isolation, procedure duration, and radiofrequency application time did not differ significantly, whereas fluoroscopy time was lower in the steerable sheath group (33±14 minutes versus 45±17 minutes, P<0.001). Complication rates showed no significant difference (3.2% versus 5%, P=0.608). On multivariable analysis, steerable sheath usage remained the only powerful predictor for rhythm outcome after 6 months of follow-up (hazard ratio, 2.837 [1.197 to 6.723]). Conclusions— AF catheter ablation using a manually controlled, steerable sheath for catheter navigation resulted in a significantly higher clinical success rate, with comparable complication rates and with a reduction in periprocedural fluoroscopy time. Clinical Trial Registration— URL: http://clinicaltrials.gov. Unique identifier: NCT00469638.

Prevalence and Clinical Significance of Life-Threatening Arrhythmias in Takotsubo Cardiomyopathy

Although prognosis of Takotsubo cardiomyopathy (TTC) is generally thought to be favorable, the initial presentation can be accompanied by various complications, including life-threatening arrhythmias. Previously, the prevalence of ventricular tachycardia (VT), ventricular fibrillation (VF), or

Initial experience in ablation of typical atrial flutter using a novel three-dimensional catheter tracking system

AIMS Three-dimensional (3D) mapping has been established for clinical routine in an interventional electrophysiology (EP). Recently, a novel sensor-based 3D catheter tracking system has been introduced integrating 3D non-fluoroscopic catheter navigation into the environment of pre-recorded 2D fluoroscopy [MediGuide™ Technology (MG)]. We are reporting on the first clinical experience for ablation of typical atrial flutter. First we aimed to demonstrate safety and feasibility of this new technique. Secondly, procedural aspects such as effectiveness, procedure, and fluoroscopy time should be evaluated. METHODS AND RESULTS Ten consecutive patients (100% male, age 68 ± 8 years) were ablated using MG technology. Two steerable diagnostic EP catheters (MediGuide Enabled Livewire™ Catheter, SJM) were used for coronary sinus cannulation and anatomical cavo-tricuspidal isthmus (CTI) reconstruction within the EnSite NavX™ System (NavX). Ablation was performed with a conventional 8 mm tip ablation catheter (IBI, SJM). In all 10 patients both sensor-equipped MG catheters could be tracked non-fluoroscopically. Successful anatomical CTI reconstruction was performed and complete isthmus block was documented after the ablation. Total procedure duration was comparable with conventional procedures (55 ± 8 min). Usage of the MG tracking system resulted in a fluoroscopy time of 2.5 ± 2 min. No adverse events occurred during the procedures. CONCLUSIONS For the first clinical application of the MG technology in an interventional electrophysiology we found a stable system enabling excellent 3D orientation for spatial catheter positioning on the basis of underlying pre-recorded cine loops. Clinically, the MG technology allowed successful procedures with short fluoroscopy times, even though a sensor-equipped ablation catheter was not yet available for use in the study.

Successful Nonsurgical Treatment of Esophagopericardial Fistulas After Atrial Fibrillation Catheter Ablation A Case Series

Background—Esophageal perforations are a rare but devastating complication of atrial fibrillation catheter ablation. Rapid treatment is crucial to avoid permanent disabilities and death. Surgical treatment is considered the treatment of choice. Alternatively, single case reports describe successful esophageal stenting, but others discourage this approach because of fatal consequences. Methods and Results—We present 3 patients who developed esophagopericardial fistulas after radiofrequency catheter ablation of atrial fibrillation. Diagnosis and management with pericardial drainage and esophageal stenting, as well as long-term follow-up are described. Esophagopericardial fistulas occurred 26, 9, and 18 days after the ablation procedure. Symptoms leading to admission were recurrence of atrial fibrillation (n=1), elective control endoscopy for thermal lesion (n=1), and pain with swallowing (n=1). Computed tomography revealed esophagopericardial fistulas with pericardial effusion in all patients, while contrast leakage and air in the left atrium could be excluded. Broad-spectrum antibiotics were initialized, and minimally invasive pericardial drainage and esophageal stenting were performed. Stent dislocation occurred in 2 patients and was resolved by repositioning and clipping of the proximal stent end. After 45, 22, and 28 days, respectively, fistulas appeared closed and stents were removed. During follow-up, no embolic or septic events occurred. However, 2 patients underwent dilation of symptomatic esophageal stenosis in the formerly stented region. Conclusions—An early minimally invasive approach consisting of pericardial drainage and esophageal stenting proved effective in treating patients with esophagopericardial fistulas. However, constant interdisciplinary communication and attention is needed to recognize and manage potential evolving complications promptly.

MR Imaging–guided Electrophysiological Ablation Studies in Humans with Passive Catheter Tracking: Initial Results

PURPOSE To assess if real-time magnetic resonance (MR) imaging-guided radiofrequency (RF) ablation for atrial flutter is feasible in patients. MATERIALS AND METHODS The study complied with the Declaration of Helsinki and was approved by the local ethics committee. All patients were informed about the investigational nature of the procedures and provided written informed consent. Ten patients (six men; mean age ± standard deviation, 68 years ± 10) with symptomatic atrial flutter underwent isthmus ablation. In all patients, two MR imaging conditional steerable diagnostic and ablation catheters were inserted into the coronary sinus via femoral sheaths and into the right atrium with fluoroscopic guidance. The patients were then transferred to a 1.5-T whole-body MR imager for an ablation procedure, in which the catheters were manipulated by an electrophysiologist by using a commercially available interactive real-time steady-state free precession MR imaging sequence. RESULTS All catheters were placed in standard positions successfully. Furthermore, simple programmed stimulation maneuvers were performed. In one of 10 patients, a complete conduction block was performed with MR imaging guidance. In nine of 10 patients, creating only a small number of additional touch-up lesions was necessary to complete the isthmus block with conventional fluoroscopy (median, three lesions; interquartile range, two to four lesions). CONCLUSION Real-time MR imaging-guided placement of multiple catheters is feasible in patients, with subsequent performance of stimulation maneuvers and occasional complete isthmus ablation.

Incidence, determinants and prognostic relevance of cardiogenic shock in patients with Takotsubo cardiomyopathy.

Background: Takotsubo cardiomyopathy (TTC) can be accompanied by various life-threatening complications, including cardiogenic shock. The exact incidence and prognostic relevance of cardiogenic shock in TTC patients has not been studied in detail. Methods: The frequency and determinants of cardiogenic shock were evaluated in 178 patients with TTC. The clinical course and treatment strategies of TTC patients with cardiogenic shock were systematically analysed. Furthermore, short and long-term mortality rates were assessed with a structured telephone follow-up. Results: The incidence of cardiogenic shock in this large TTC population was 12.4%. Multivariable logistic regression analysis identified left ventricular ejection fraction as the only significant predictor of cardiogenic shock (odds ratio 0.80; 95% confidence interval (CI) 0.73–0.88; P<0.01). The majority of the TTC patients with cardiogenic shock were treated with catecholamine therapy (86%) and 59% received early initiated mechanical circulatory support. TTC patients with cardiogenic shock showed significantly increased 28-day mortality rates compared to patients without cardiogenic shock (28.6% vs. 4.1%; relative risk 7.05, 95% CI 2.50–19.84; P<0.01). Furthermore, cardiogenic shock patients were at ongoing increased risk of death beyond the first 28 days resulting in considerably elevated 1-year (61.9% vs. 7.4%; P<0.01) and long-term mortality rates at 3.6 years of follow-up (66.7% vs. 19%; P<0.01). Conclusion: Cardiogenic shock is a frequent complication in TTC patients and is associated with increased short and long-term mortality rates. Patients at risk of developing cardiogenic shock may be identified by means of a severely impaired left ventricular function.

Cavotricuspid Isthmus Ablation Guided by Real-Time Magnetic Resonance Imaging

Magnetic resonance imaging (MRI) has evolved as a standard cardiac imaging technique. Interventional procedures guided by real-time MRI may derive potential benefit from a fluoroscopy-free working environment, more detailed insights into the target anatomy, and additional information on organ tissue properties relevant for pathomorphology as well as therapy delivery. Electrophysiological (EP) procedures in a magnetic resonance (MR) scanner require new workflows with different, MR safe, interventional materials and hardware setup, different approaches to intracardiac orientation and catheter tracking, and an adapted patient management. Recently, invasive diagnostic EP procedures have been described in animal studies and in a clinical setting.1,2 Actual catheter ablation has so far only been reported in a limited number of animal series.3 Hereby, we report on a MRI-guided cavotricuspid isthmus ablation. A 74-year-old man without structural heart disease was admitted with documented episodes of paroxysmal symptomatic typical right atrial flutter. At the ablation procedure the patient presented in sinus rhythm. The patient was enrolled into a clinical study approved by the local ethics committee and by the German Federal Institute for Drugs and Medical Devices (BfArM). He provided written and verbal informed consent. In this study, we used MR conditional catheters (Vision, Imricor Medical Systems, Burnsville, MN) and an MR conditional EP recording system (Bridge MR EP Recording System, Imricor Medical Systems, Burnsville, MN). The material is designed for use in 1.5 T closed bore scanners and imposes no limitations on the catheter trajectory, scanner landmark, or patient position. The catheter allows for all clinical scan protocols and is safe for use in normal and first level controlled operating modes. ### MR Conditional Catheters Although the appearance and functionality are similar to conventional ablation catheters, the design of the MR conditional catheter differs substantially. All ferromagnetic materials are removed to eliminate the potential for force and torque …

ST-segment depression resolution predicts infarct size and reperfusion injury in ST-elevation myocardial infarction

Objective ST-elevation myocardial infarction (STEMI) is frequently associated with reciprocal ST-segment depression in contralateral ECG leads. However, the relationship of the resolution of ST-segment depression (STD-R) with myocardial damage is unknown and the potential prognostic value incompletely understood. We sought to evaluate the association between STD-R and markers of myocardial injury as well as to determine the prognostic impact of STD-R in patients with acute reperfused STEMI. Methods We enrolled 611 patients with STEMI in this multicentre cardiac magnetic resonance (CMR) study. STD-R, defined as either worsened (<0%), incomplete (0–50%) or complete (≥50%), was determined 90 min after primary percutaneous coronary intervention (PCI). Patients underwent CMR in median 3 (2–4) days after infarction. Major adverse cardiac events (MACE) were defined as a composite of death, reinfarction and new congestive heart failure within 12 months after enrolment. Results Patients with worsened or incomplete STD-R (n=148 (24.2%)) had a significantly larger area at risk (42 (31–50) vs 37 (29–52) vs 34 (24–46) %LV, p=0.001), larger infarct size (20 (13–30) vs 17(10–26) vs 16 (8–24) %LV, p=0.003), larger extent of microvascular obstruction (0.6(0–3.4) vs 0.4 (0–2.4) vs 0.0 (0–1.4) %LV, p=0.003), and a lower LVEF (46 (39–54) vs 48 (40–56) vs 52 (45–58) %, p<0.001). MACE rate (n=37 (6%)) was significantly higher in patients with worsened (n=10 (19%)) or incomplete STD-R (n=7 (7%)) than in patients with complete STD-R (n=20 (4%), p<0.001). In multivariate Cox regression analysis, categorised STD-R emerged as an independent predictor of MACE at 12 months after adjusting for clinical variables (p=0.007). Conclusions Patients with acute STEMI and worsened or incomplete STD-R after PCI show a more pronounced myocardial as well as microvascular damage as detected by CMR with subsequent independent prognostic information on MACE over a 12-month follow-up period.

Left Ventricular Thrombus Formation After ST-Segment-Elevation Myocardial Infarction Insights From a Cardiac Magnetic Resonance Multicenter Study

Background— Data on left ventricular (LV) thrombus formation after primary percutaneous coronary intervention for ST-segment–elevation myocardial infarction (STEMI) are scarce. The aims of this study were to assess the (1) incidence of LV thrombi using cardiac magnetic resonance in a multicenter cohort of STEMI patients and (2) prognostic relevance of LV thrombi at 1-year follow-up. Methods and Results— In total, 738 STEMI patients reperfused by primary angioplasty were enrolled in 8 centers. Cardiac magnetic resonance was completed within 1 week after infarction. Central core laboratory-masked analyses for the presence of LV thrombi were performed. The primary clinical end point was the occurrence of major adverse cardiac events within 1 year. LV thrombi were detected in 26 patients (3.5%) in the overall cohort and in 7.1% in anterior STEMI patients. The presence of thrombi was associated with larger infarcts ( P <0.001), less myocardial salvage ( P <0.01), impaired LV ejection fraction ( P <0.001), and more pronounced late microvascular obstruction ( P =0.002). The presence of thrombi was independently associated with the incidence of major adverse cardiac events at 12 months (hazard ratio, 2.73; 95% confidence interval, 1.11–6.73; P =0.03). Conclusions— In this multicenter cohort of patients with STEMI, thrombus prevalence assessed by cardiac magnetic resonance was 3.5% and associated with decreased myocardial salvage, larger infarcts, and more pronounced reperfusion injury. Importantly, LV thrombus was independently associated with major adverse cardiac events at 1-year follow-up. Clinical Trial Registration— URL: . Unique identifier: [NCT00712101][1]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00712101&atom=%2Fcirccvim%2F8%2F10%2Fe003417.atomBackground—Data on left ventricular (LV) thrombus formation after primary percutaneous coronary intervention for ST-segment–elevation myocardial infarction (STEMI) are scarce. The aims of this study were to assess the (1) incidence of LV thrombi using cardiac magnetic resonance in a multicenter cohort of STEMI patients and (2) prognostic relevance of LV thrombi at 1-year follow-up. Methods and Results—In total, 738 STEMI patients reperfused by primary angioplasty were enrolled in 8 centers. Cardiac magnetic resonance was completed within 1 week after infarction. Central core laboratory-masked analyses for the presence of LV thrombi were performed. The primary clinical end point was the occurrence of major adverse cardiac events within 1 year. LV thrombi were detected in 26 patients (3.5%) in the overall cohort and in 7.1% in anterior STEMI patients. The presence of thrombi was associated with larger infarcts (P<0.001), less myocardial salvage (P<0.01), impaired LV ejection fraction (P<0.001), and more pronounced late microvascular obstruction (P=0.002). The presence of thrombi was independently associated with the incidence of major adverse cardiac events at 12 months (hazard ratio, 2.73; 95% confidence interval, 1.11–6.73; P=0.03). Conclusions—In this multicenter cohort of patients with STEMI, thrombus prevalence assessed by cardiac magnetic resonance was 3.5% and associated with decreased myocardial salvage, larger infarcts, and more pronounced reperfusion injury. Importantly, LV thrombus was independently associated with major adverse cardiac events at 1-year follow-up. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00712101.

Management of arrhythmias in patients with Takotsubo cardiomyopathy: Is the implantation of permanent devices necessary?

BACKGROUND Arrhythmias are frequent in Takotsubo cardiomyopathy (TTC) and a major determinant of outcome. OBJECTIVE The purpose of this study was to provide a rationale for management strategies, particularly for permanent device implantation given the reversible nature of TTC. METHODS Treatment strategies of arrhythmias including ventricular fibrillation (VF), ventricular tachycardia (VT), asystole, pulseless electrical activity, and complete atrioventricular (AV) or sinoatrial block were assessed in a bicentric cohort of consecutive patients with TTC (n = 286) with a mean follow-up period of 3.3 ± 2.4 years. RESULTS The prevalence of arrhythmias during the acute phase of TTC was 12.2% (n = 35), consisting predominantly of VT (n = 16 [5.6%]), VF (n = 7 [2.4%]), and complete AV block (n = 8 [2.8%]). Seven patients received a permanent pacemaker because of complete AV (n = 6) or sinoatrial (n = 1) block. Regular device checkups were available in 2 patients and demonstrated ongoing high-degree AV block despite recovery of left ventricular function. Three patients with transient bradyarrhythmias who did not receive devices died shortly after hospital discharge from unknown causes. One patient received an implantable cardioverter-defibrillator after resuscitation for VF and did not require device interventions during 2-year follow-up. Patients with polymorphic VT (n = 7), monomorphic VT (n = 6), or VF (n = 2) who were discharged from hospital survived or died of noncardiac reasons, with the cause of death remaining unclear in 1 patient with monomorphic sustained VT. CONCLUSION Our data suggest that bradyarrhythmias in the acute setting of TTC may require permanent pacemaker implantation. In contrast, polymorphic ventricular arrhythmias might be managed with a temporary approach (eg, wearable cardioverter-defibrillators) until recovery of repolarization time and left ventricular function.