Addendum to the German Consensus Recommendations on Ponatinib in the Treatment of Chronic Myeloid Leukemia.

BACKGROUND: Based on the new data from the primary analysis of the OPTIC (Optimizing Ponatinib Treatment in CP-CML) trial on dose optimization of ponatinib in patients with chronic phase (CP)-CML, the German consensus paper on ponatinib published in 2020 (Saussele S et al., Acta Haematol. 2020) has been updated in this addendum. SUMMARY: Focus is on the update of efficacy and safety of ponatinib, reflecting the new data set, as well as the update of the benefit-risk assessment and recommendations for ponatinib starting dose in CP-CML - provided that the decision to use ponatinib has already been made. Furthermore, based on OPTIC and additional empirical data, the expert panel collaborated to develop a decision tree for ponatinib dosing, specifically for intolerant and resistant patients. The recommendations on cardiovascular management have also been updated based on the most recent 2021 guidelines of the European Society of Cardiology (ESC) on cardiovascular disease prevention in clinical practice. KEY MESSAGES: The OPTIC data confirm the high efficacy of ponatinib in patients with CP-CML and provide the basis for individualized dose adjustment during the course of treatment.

Brain-derived neurotrophic factor, depressive symptoms and somatic comorbidity in patients with coronary heart disease.

OBJECTIVE: Depression and coronary heart disease (CHD) are highly comorbid conditions. Brain-derived neurotrophic factor (BDNF) plays an important role in cardiovascular processes. Depressed patients typically show decreased BDNF concentrations. We analysed the relationship between BDNF and depression in a sample of patients with CHD and additionally distinguished between cognitive-affective and somatic depression symptoms. We also investigated whether BDNF was associated with somatic comorbidity burden, acute coronary syndrome (ACS) or congestive heart failure (CHF). METHODS: The following variables were assessed for 225 hospitalised patients with CHD: BDNF concentrations, depression [Patient Health Questionnaire-9 (PHQ-9)], somatic comorbidity (Charlson Comorbidity Index), CHF, ACS, platelet count, smoking status and antidepressant treatment. RESULTS: Regression models revealed that BDNF was not associated with severity of depression. Although depressed patients (PHQ-9 score >7) had significantly lower BDNF concentrations compared to non-depressed patients (p = 0.04), this was not statistically significant after controlling for confounders (p = 0.15). Cognitive-affective symptoms and somatic comorbidity burden each closely missed a statistically significant association with BDNF concentrations (p = 0.08, p = 0.06, respectively). BDNF was reduced in patients with CHF (p = 0.02). There was no covariate-adjusted, significant association between BDNF and ACS. CONCLUSION: Serum BDNF concentrations are associated with cardiovascular dysfunction. Somatic comorbidities should be considered when investigating the relationship between depression and BDNF.

Association of FKBP5 genotype with depressive symptoms in patients with coronary heart disease: a prospective study.

Depression and coronary heart disease (CHD) are prevalent and often co-occurring disorders. Both have been associated with a dysregulated stress system. As a central element of the stress system, the FKBP5 gene has been shown to be associated with depression. In a prospective design, this study aims to investigate the association of FKBP5 with depressive symptoms in CHD patients. N = 268 hospitalized CHD patients were included. Depressive symptoms were measured using the Hospital Anxiety and Depression Scale (HADS-D) at four time points (baseline, and after 1 month, 6 months, and 12 months). The functional FKBP5 single-nucleotide polymorphism (SNP) rs1360780 was selected for genotyping. Linear regression models showed that a higher number of FKBP5 C alleles was associated with more depressive symptoms in CHD patients both at baseline (p = 0.015) and at 12-months follow-up (p = 0.025) after adjustment for confounders. Further analyses revealed that this effect was driven by an interaction of FKBP5 genotype with patients' prior CHD course. Specifically, only in patients with a prior myocardial infarction or coronary revascularization, more depressive symptoms were associated with a higher number of C alleles (baseline: p = 0.046; 1-month: p = 0.026; 6-months: p = 0.028). Moreover, a higher number of C alleles was significantly related to a greater risk for dyslipidemia (p = .016). Our results point to a relevance of FKBP5 in the association of the two stress-related diseases depression and CHD.

Ponatinib in the Treatment of Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Leukemia: Recommendations of a German Expert Consensus Panel with Focus on Cardiovascular Management.

Treatment of chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute leukemia (Ph+ ALL) has been revolutionized with the advent of tyrosine kinase inhibitors (TKIs). Most patients with CML achieve long-term survival similar to individuals without CML due to treatment with TKIs not only in frontline but also in further lines of therapy. The third-generation TKI ponatinib has demonstrated efficacy in patients with refractory CML and Ph+ ALL. Ponatinib is currently the most potent TKI in this setting demonstrating activity against T315I mutant clones. However, ponatinib's safety data revealed a dose-dependent, increased risk of serious cardiovascular (CV) events. Guidance is needed to evaluate the benefit-risk profile of TKIs, such as ponatinib, and safety measures to prevent treatment-associated CV events. An expert panel of German hematologists and cardiologists summarize current evidence regarding ponatinib's efficacy and CV safety profile. We propose CV management strategies for patients who are candidates for ponatinib.

Cardiac Implantable Electronic Device Interrogation at Forensic Autopsy: An Underestimated Resource?

BACKGROUND: Postmortem interrogations of cardiac implantable electronic devices (CIEDs), recommended at autopsy in suspected cases of sudden cardiac death, are rarely performed, and data on systematic postmortem CIED analysis in the forensic pathology are missing. The aim of the study was to determine whether nonselective postmortem CIED interrogations and data analysis are useful to the forensic pathologist to determine the cause, mechanism, and time of death and to detect potential CIED-related safety issues. METHODS: From February 2012 to April 2017, all autopsy subjects in the department of forensic medicine at the University Hospital Charité who had a CIED underwent device removal and interrogation. Over the study period, 5368 autopsies were performed. One hundred fifty subjects had in total 151 CIEDs, including 109 pacemakers, 35 defibrillators, and 7 implantable loop recorders. RESULTS: In 40 cases (26.7%) time of death and in 51 cases (34.0%) cause of death could not be determined by forensic autopsy. Of these, CIED interrogation facilitated the determination of time of death in 70.0% of the cases and clarified the cause of death in 60.8%. Device concerns were identified in 9 cases (6.0%), including 3 hardware, 4 programming, and 2 algorithm issues. One CIED was submitted to the manufacturer for a detailed technical analysis. CONCLUSIONS: Our data demonstrate the necessity of systematic postmortem CIED interrogation in forensic medicine to determine the cause and timing of death more accurately. In addition, CIED analysis is an important tool to detect potential CIED-related safety issues.

Prevalence, 12-Month Prognosis, and Clinical Management Need of Depression in Coronary Heart Disease Patients: A Prospective Cohort Study.

BACKGROUND: Screening for depression in patients with coronary heart disease (CHD) remains controversial. There is limited data on the actual depression management need in routine care. The aim of this study was to examine the prevalence, treatment rates, prognosis, and management need of clinical and subclinical depression in CHD patients according to the American Heart Association recommendations and the National Institute for Health and Care Excellence (NICE) guideline "Depression in Adults with a Chronic Physical Health Problem". METHODS: Patients were recruited at 2 German university clinics between 2012 and 2014. Depressive disorders were assessed according to the DSM-IV and depressive symptom severity at baseline and during follow-up was evaluated with the Patient Health Questionnaire (PHQ-9). Depression management need was determined by the severity and longitudinal course of depression symptoms. RESULTS: Of 1,024 patients (19% women), 12% had clinical depression (depressive disorder) and 45% had subclinical depression (PHQ-9 score ≥5) at baseline. Among those with clinical depression, 46% were in treatment at least once during 12 months; 26% were continuously in treatment during follow-up. Depressive disorder and depressive symptoms were significant risk factor-adjusted predictors of the 12-months mortality (adjusted HR = 3.19; 95% CI 1.32-7.69, and adjusted HR = 1.09; 95% CI 1.02-1.16, respectively). Depressive symptoms persisted in 85% of the clinically depressed and in 47% of the subclinically depressed patients. According to current recommendations, 29% of all CHD patients would require depression management within 1 year. CONCLUSIONS: There is a need for enhanced recognition, referral, and continuous and improved clinical management of depression in CHD patients.

MRI Brain Changes After Marathon Running: Results of the Berlin Beat of Running Study.

Several studies report neurological complications such as brain injury induced by ischemia or edema following exhaustive endurance sport. We aimed to detect the frequency of acute brain lesions after a marathon race. In the prospective observational Berlin Beat of Running study, 110 experienced endurance athletes underwent 3-Tesla brain MRI exams 2-3 days prior and within 2 days after a marathon run. MRI results were compared to an age- and sex-matched control group of 68 non-athletes, including the "Age-Related White Matter Changes" (ARWMC) scale to assess white matter lesions (WML) in the brain. 108 athletes (median age 48 years, 24% female, 8% with hypertension; 0% with diabetes) completed the race. No athlete reported neurological deficits, but a single acute ischemic lesion was detected in diffusion-weighted MRI after the race in one athlete. No other acute brain lesions compared to prior MRI were found. An ARWMC score ≥4 was found in 15% of athletes and 12% of non-athletic controls (p=0.7). Chronic ischemic lesions were not found in athletes but in four controls (6%) (p=0.02). In conclusion, acute ischemic brain lesions may be found in endurance runners. Every seventh endurance athlete and every ninth control showed evidence for substantial white matter lesions.

Approaches to catheter ablation for persistent atrial fibrillation.

BACKGROUND: Catheter ablation is less successful for persistent atrial fibrillation than for paroxysmal atrial fibrillation. Guidelines suggest that adjuvant substrate modification in addition to pulmonary-vein isolation is required in persistent atrial fibrillation. METHODS: We randomly assigned 589 patients with persistent atrial fibrillation in a 1:4:4 ratio to ablation with pulmonary-vein isolation alone (67 patients), pulmonary-vein isolation plus ablation of electrograms showing complex fractionated activity (263 patients), or pulmonary-vein isolation plus additional linear ablation across the left atrial roof and mitral valve isthmus (259 patients). The duration of follow-up was 18 months. The primary end point was freedom from any documented recurrence of atrial fibrillation lasting longer than 30 seconds after a single ablation procedure. RESULTS: Procedure time was significantly shorter for pulmonary-vein isolation alone than for the other two procedures (P<0.001). After 18 months, 59% of patients assigned to pulmonary-vein isolation alone were free from recurrent atrial fibrillation, as compared with 49% of patients assigned to pulmonary-vein isolation plus complex electrogram ablation and 46% of patients assigned to pulmonary-vein isolation plus linear ablation (P=0.15). There were also no significant differences among the three groups for the secondary end points, including freedom from atrial fibrillation after two ablation procedures and freedom from any atrial arrhythmia. Complications included tamponade (three patients), stroke or transient ischemic attack (three patients), and atrioesophageal fistula (one patient). CONCLUSIONS: Among patients with persistent atrial fibrillation, we found no reduction in the rate of recurrent atrial fibrillation when either linear ablation or ablation of complex fractionated electrograms was performed in addition to pulmonary-vein isolation. (Funded by St. Jude Medical; ClinicalTrials.gov number, NCT01203748.).

Pushing the limits: establishing an ultra-low framerate and antiscatter grid-less radiation protocol for left atrial ablations.

Aims: Despite the use of 3D mapping systems and new developments of non-fluoroscopic options, most centres still rely at least in part on fluoroscopy for catheter visualization during catheter ablations. The purpose of this study was to assess the feasibility of using an ultra-low frame rate and antiscatter grid-less radiation protocol during complex left atrial ablations to minimize radiation exposure for the patient and staff. Methods and results: A total of 150 consecutive patients undergoing left atrial ablations in our hospital were included in the analysis. The procedures were performed between January 2015 and November 2016. Of the included patients 75 (50%) underwent ablation before and 75 (50%) after the ultra-low frame rate (reduced from 4 to 2 FPS) and antiscatter grid-less radiation protocol was established. Procedures performed after the dose reduction protocol was established showed a 64% reduction of the dose area product (630.28 ± 550.96 vs. 226.44 ± 277.44 µGym2, P < 0.001), while fluoroscopy duration (14.22 ± 4.47 vs. 13.62 ± 7.11 min, P = 0.066) and procedural duration (1:48 ± 0:28 vs. 1:53 ± 0:34 min, P = 0.525) were not prolonged. Acute procedural success was achieved in all procedures. Two complications occurred before and one complication after the protocol was established. During four procedures, operators decided to re-introduce the antiscatter grid. This was due to impaired visibility in morbidly obese patients (n = 2) or technically difficult transseptal puncture (n = 2). Conclusion: The use of an ultra low framerate and antiscatter grid-less radiation protocol effectively reduced radiation dose for complex left atrial ablation procedures and lead to very low average patient doses. Reduced image quality did not impair procedural and fluoroscopy duration or acute procedural success.

Effects of propofol on ventricular repolarization and incidence of malignant arrhythmias in adults.

BACKGROUND: Propofol is commonly used for procedural sedation in interventional electrophysiology. However, ventricular arrhythmias under Propofol have been reported. Our aim was to investigate ventricular repolarization and incidence of ventricular arrhythmias under Propofol infusion in adults with cardiac arrhythmias. METHODS: QRS, QTcB (Bazett), QTcFri (Fridericia), JTc, measurement of T peak to Tend time (Tp-e) at baseline and under Propofol infusion was performed in 235 patients. Screening for unexpected ventricular arrhythmias was performed in 1165 patients undergoing EP procedures under Propofol. RESULTS: A significant prolongation of Tp-e under Propofol infusion (79.7±17.3 vs. 86.4±22.5ms, p<0.001) and of QTcFri (429.3±35.8 vs. 435.5±36.5, p=0.033) was detected. No significant change of the QTcB interval, JTc interval or QRS duration was observed. One case (0.09%) of ventricular fibrillation during rapid ventricular pacing under Propofol occurred. CONCLUSION: Although transmural dispersion of ventricular repolarisation is increased under Propofol, incidence of malignant ventricular arrhythmias is low. For evaluation of QT interval under Propofol, Fridericia's correction formula should be used rather than Bazett's formula.

Electrocardiographic assessments and cardiac events after fingolimod first dose - a comprehensive monitoring study.

BACKGROUND: First dose observation for cardiac effects is required for fingolimod, but recommendations on the extent vary. This study aims to assess cardiac safety of fingolimod first dose. Individual bradyarrhythmic episodes were evaluated to assess the relevance of continuous electrocardiogram (ECG) monitoring. METHODS: START is an ongoing open-label, multi-center study. At the time of analysis 3951 patients were enrolled. The primary endpoints are the incidence of bradycardia (heart rate < 45 bpm) and second-/third-degree AV blocks during treatment initiation. The relevance of Holter was assessed by matching ECG findings with the occurrence of clinical symptoms as well as by rigorous analysis of AV blocks with regard to the duration of pauses and the minimal heart rate recorded during AV block. RESULTS: Thirty-one patients (0.8%) developed bradycardia (<45 bpm), 62 patients (1.6%) had second-degree Mobitz I and/or 2:1 AV blocks with a lowest reading (i.e. mean of ten consecutive beats) of 35 bpm and the longest pause lasting for 2.6 s. No Mobitz II or third-degree AV blocks were observed. Only one patient complained about mild chest discomfort and fatigue. After 1 week, there was no second-/third-degree AV block. CONCLUSIONS: Continuous Holter ECG monitoring in this large real-life cohort revealed that bradycardia and AV conduction abnormalities were rare, transient and benign. No further unexpected abnormalities were detected. The data presented here give an indication that continuous Holter ECG monitoring does not add clinically relevant value to patients' safety. TRIAL REGISTRATION: NCT01585298 ; registered April 23, 2012.

Does the extent of left atrial arrhythmogenic substrate depend on the electroanatomical mapping technique: impact of pulmonary vein mapping catheter vs. ablation catheter.

AIMS: In persistent atrial fibrillation (AF), left atrial low-voltage areas and complex fractionated atrial electrograms (CFAEs) have been thoroughly discussed as critical substrate points for AF perpetuation. Thus, in patients undergoing pulmonary vein isolation, these sites are often considered additional ablation targets. Currently, mapping techniques for these substrate indicators are still under discussion. The aim of this study was to evaluate the impact of different mapping catheters on the detection of low-voltage areas and CFAE. METHODS AND RESULTS: Two bipolar voltage maps and two CFAE left atrial maps were obtained each in 30 patients undergoing catheter ablation of AF using the following two different catheters: A four-pole ablation catheter (MAP, mapping and ablation catheter) (electrode size: tip: 4 mm, band: 1 mm; inter-electrode spacing: 0.5-5-2 mm) and a 10-pole circular pulmonary vein mapping catheter (CMC) (electrode size: 1 mm; inter-electrode spacing: 7-7-7 mm). Successively, low-voltage and CFAE area sizes were then compared between the two catheters. Areas with a bipolar voltage of <0.5 mV were significantly smaller when obtained with the CMC compared with the MAP (8.9 ± 8.9 vs. 17.4 ± 11.7 cm², P < 0.001). This was also significantly different for a bipolar voltage of <0.2 mV (2.3 ± 4.6 vs. 6.2 ± 9.6 cm², P < 0.001). Complex fractionated atrial electrogram area sizes were significantly larger when obtained with the CMC compared with the MAP group (14.6 ± 10.9 vs. 19.4 ± 9.4 cm², P = 0.011). CONCLUSION: Low-voltage and CFAE area size varies significantly between different mapping catheters. Mapping electrode settings have to be taken into consideration for the assessment of electroanatomical substrate of AF.

Safety and efficacy of applying a low-dose radiation fluoroscopy protocol in device implantations.

AIMS: For cardiac implantable electronic device (CIED) implantations, visualization of lead placement is necessary and fluoroscopy remains by far the most commonly used technique. With simple changes in the X-ray system settings, total radiation dose can be reduced significantly. The purpose of this study was to assess the safety and efficacy of various CIED implantations performed after implementation of a new dose reduction protocol (DRP). METHODS AND RESULTS: We conducted a retrospective chart review of 584 patients undergoing CIED implantation or revision in our hospital. Of these patients, 280 (48%) underwent the implantation prior to and 304 (52%) after the DRP introduction. The DRP included various changes for optimized image processing and exposure system settings to enable dose reduction, as well as a reduced frame rates (4 FPS for fluoroscopy and 7.5 FPS for cinematographic images). Of the 584 patients, 53 (9.1%) had a one-chamber pacemaker, 232 (39.7%) a two-chamber pacemaker, 133 (22.8%) a one-chamber ICD, 35 (6.0%) a two-chamber ICD, 82 (14.0%) a CRT (de novo) implantation, and 49 (8.3%) had an upgrade to a CRT device. DRP was associated with a 64% reduction of the dose-area product (1372 ± 2659 vs. 3792 ± 5025 cGcm2, P < 0.001), while fluoroscopy duration (13 ± 15 vs. 13 ± 15 min) and procedural duration (93 ± 52 vs. 92 ± 52 min.) did not significantly increase. Complication rates did not differ significantly between the two groups. CONCLUSION: The DRP proved to effectively reduce radiation dose for all types of CIED implantations. Fluoroscopy time, total procedure time, and the number of complications did not increase after introducing the DRP.

High Patient Satisfaction with Deep Sedation for Catheter Ablation of Cardiac Arrhythmia.

BACKGROUND: Patients' satisfaction with invasive procedures largely relies on periprocedural perception of pain and discomfort. The necessity for intraprocedural sedation during catheter ablation of cardiac arrhythmias for technical reasons is widely accepted, but data on patients' experience of pain and satisfaction with the procedural sedation are scarce. We have assessed patients' pain and discomfort during and after the procedure using a standardized questionnaire. METHODS: One hundred seventeen patients who underwent catheter ablation answered a standardized questionnaire on periprocedural perception of pain and discomfort after different anesthetic protocols with propofol/midazolam with and without additional piritramide and ketamine/midazolam. RESULTS: Patients report a high level of satisfaction with periprocedural sedation with 83% judging sedation as good or very good. The majority of patients was unconscious of the whole procedure and did not recollect experiencing pain. Procedural pain was reported by 7.7% of the patients and 16% reported adverse effects, e.g., postprocedural nausea and episodes of headache. CONCLUSION: The results of our study show that deep sedation during catheter ablation of cardiac arrhythmias is generally well tolerated and patients are satisfied with the procedure. Yet, a number of patients reports pain or adverse events. Therefore, studies comparing different sedation strategies should be conducted in order to optimize sedation and analgesia.

The effect of an ultra-low frame rate and antiscatter grid-less radiation protocol for cardiac device implantations.

BACKGROUND AND AIMS: Antiscatter grids improve image contrast by absorbing scattered x-ray beams, although by removing the antiscatter grid patient dose can be reduced as more x-ray beams reach the image receptor. Additionally, there is a trend toward ultra-low frame rates for radiation dose reduction during various electrophysiology procedures. As for most cardiac device implantations (CIED) image quality demands are usually modest, the purpose of this study was to assess the safety and efficacy of an ultra-low frame rate and scatter grid-less radiation protocol. METHODS/RESULTS: A total of 140 patients undergoing CIED implantation between 2014 and 2017 were included in the study. Seventy patients (50%) implanted after implementation of the antiscatter grid-less and ultra-low frame rate protocol were matched to controls before the dose-reduction protocol was established. Forty patients (28.6%) had a one-chamber pacemaker or one-chamber implantable cardioverter defibrillator (ICD) implantation/revision, 60 (42.9%) had a two-chamber pacemaker or two-chamber ICD implantation/revision, and 40 (28.6%) patients had a cardiac resynchronization therapy device implantation/revision. Removing the antiscatter-grid and lowering the frame rate led to a 73% reduction of the overall dose area product (1,206 ± 2,015 vs 324 ± 422 µGym, P < 0.001). Procedural duration (95 ± 51 minutes vs 82 ± 44 minutes, P  =  0.053) and rate of complications were not significantly different between the two groups. CONCLUSION: The use of an ultra-low frame rate and antiscatter grid-less radiation protocol significantly reduced radiation dose for implantation of CIED and led to very low average patient doses, while procedural duration and complication rates did not increase.

Catheter ablation of atrial flutter: A survey focusing on post ablation oral anticoagulation management and ECG monitoring.

BACKGROUND: A considerable amount of patients with typical atrial flutter develop atrial fibrillation after cavotricuspid isthmus (CTI) ablation. No uniform recommendations are available to guide anticoagulation regimes or electrocardiogram (ECG) monitoring strategies after this procedure. METHODS: We conducted a web-based survey in electrophysiology (EP) centers in Germany, Switzerland, and Austria. Responses were received from 47 centers. The survey was designed to investigate variations in management of the following: ablation strategy, oral anticoagulation (OAC) management, and ECG monitoring after successful CTI ablation. RESULTS: More than 55% of the participating centers assume that at least every third patient will develop atrial fibrillation during follow-up. Despite this assumption, most EP experts (81%) would still stop OAC after CTI ablation even in patients with higher CHADS2-VA2SC-score, or even perform CTI in asymptomatic patients with the purpose to stop OAC (52%). Most experts agree that ECG monitoring is necessary during follow-up. A majority still rely on short-term monitoring tools like resting ECGs (7%) or Holter ECGs (43%), while continuous monitoring by implantable loop recorders (10%) are rarely used for postablation OAC management. CONCLUSION: A majority of the centers stop OAC in patients with higher CHADS2-VA2SC-score after CTI ablation. There is evidence that this practice might not be safe and lead to an increased number of ischemic strokes during follow-up. This reflects the need for prospective studies to allow for clear guidelines regarding these issues.

Performance of the New BioMonitor 2-AF Insertable Cardiac Monitoring System: Can Better be Worse?

BACKGROUND: Implantable loop recorders (ILR) are valuable tools for the investigation of patients with suspected arrhythmias. The BioMonitor 2-AF is a novel insertable ILR with enhanced atrial fibrillation (AF) detection algorithm and remote monitoring capability. OBJECTIVE: The objective of this first-in-human study with the BioMonitor 2-AF was to analyze course of P-wave sensing performance and R-wave amplitude, prevalence of false and correctly sensed and classified episodes, and effectiveness of remote monitoring. METHODS: All 19 patients who underwent ILR insertion were included in the BIOTRONIK Home Monitoring® system (BIOTRONIK GmbH, Berlin, Germany). Daily changes in P-wave and R-wave sensing were analyzed over 6 weeks. A breathing test (in- and expiration) was performed in two different body positions at baseline and during a 6-week in-house follow-up to investigate alterations of P-wave and R-wave sensing. RESULTS: R-wave amplitude and the high P-wave visibility (94.4%) remained unchanged during the follow-up period. In most patients both an increase and decrease of R-wave amplitude, and in some cases a complete R-wave vector change (31.6%), was documented during the "breathing test." Change of body position did not alter R-wave sensing amplitude mostly. "Breathing test" and change of body position had no effect on P-wave sensing performance. In 15.8% of the patients, misclassification of episodes as AF or high ventricular rates due to P-wave oversensing occurred. No ILR-related complication occurred. Automatic transmission via BIOTRONIK Home Monitoring® was successful 100% of the time. CONCLUSION: This study demonstrates that the BioMonitor 2-AF is a safe and effective tool for continuous cardiac monitoring.

Coronary sinus signal amplitude predicts left atrial scarring.

BACKGROUND: Left atrial scarring is recognised as a critical component in the maintenance of atrial fibrillation and is associated with the failure of interventional treatment. Diminished bipolar voltage (LV) has been proposed as a useful tool for left atrial scar quantification. We hypothesised that, due to its anatomic location, signals on the coronary sinus catheter might be used to predict the amount of left atrial low voltage. METHODS AND RESULTS: A total of 124 patients (42% women, average age 66 ± 9 years) were included. Forty-one with paroxysmal and 83 with persistent atrial fibrillation. Left atrial low-voltage (<0.5 mV, measured during sinus rhythm) area size and distribution varied considerably among the included patients (mean: 34.9%; maximum: 94.6%; minimum: 0.4%). Spearman correlation revealed a strong negative correlation between bipolar voltage of the signals on the coronary sinus catheter and the amount of left atrial scarring (R = -0.778, p < .0001). The optimal CS voltage cut off for prediction of left atrial low-voltage size of ≥50% was 1.9 mV with an area-under-the receiver-operating-characteristic (ROC) curve of 0.982, a sensitivity of 97% and a specificity of 98%. CONCLUSIONS: There is a strong negative correlation between the size of left atrial low-voltage areas (LVA) and coronary sinus signal amplitude. With increasing left atrial LVA size, CS signal amplitudes decrease, and vice versa. On the basis of these findings, average CS signal amplitudes of ≤1.9 mV can be used as a predictor for a left atrial low-voltage size of ≥50%.