Background:Randomized trials have demonstrated safety and efficacy of pulsed field ablation (PFA) for atrial fibrillation (AF) using the FARAPULSE™ system (PFA-F). We evaluated implementation of the PulseSelect™ system (PFA-P) in a PFA-F experienced center. Methods:This single-center study included 150 consecutive patients undergoing first pulmonary vein isolation (PVI) with PFA-P (n = 75) or PFA-F (n = 75). Procedural characteristics, acute efficacy, safety endpoints, AF recurrence rate, myocardial, neural and hemolysis biomarkers (high-sensitive troponin T, creatine kinase (CK), creatine kinase MB, bilirubin, haptoglobin, lactate dehydrogenase and S100) post ablation were analyzed and compared. Results:Baseline characteristics were comparable, except for a higher proportion of males in the PFA-F group. Acute PVI was comparable between groups (98% vs. 100%). Skin-to-skin time and radiation dose were similar, while fluoroscopy (14.3 vs. 11.9 min, p = 0.009) and LA-dwell time (18 vs. 14 min, p < 0.001) were higher in PFA-P. No major complication occurred, while minor complication rates were comparable. Cardiac biomarker release was significantly higher in PFA-P (ΔCK: 203 vs. 127 U/l, p = 0.005; Δtroponin: 1212 vs. 1014 pg/ml, p = 0.035 (day 1)), whereas neural injury markers were similar. Hemolysis markers indicated greater changes with PFA-F (Δbilirubin: 0.3 vs. 0.2 mg/dl, p = 0.004; Δhaptoglobin: -46.5 vs. -27.5 mg/dl, p = 0.001 (day1)). Procedural parameters improved with increasing PFA-P experience. Conclusion:Implementation of PFA-P is feasible with an evident learning curve in a PFA-F experienced center. Higher post-procedural cardiac biomarker levels may suggest a greater extent of local myocardial tissue damage after PFA-P. The impact of biomarkers on long-term outcome requires further studies.
Sudden cardiac death (SCD) remains a leading cause of cardiovascular mortality. The implantation of a defibrillator (ICD) proved to significantly reduce mortality in well selected patients. To overcome typical complications associated with transvenous (TV) ICDs, the subcutaneous ICD (S-ICD) has been developed. However, due to the extra-thoracic position, some studies claim that a higher BMI might be a risk factor for ineffective defibrillation threshold testing (DFT) and ineffective shock discharge. Aim of this study was to investigate whether obesity is a risk factor for ineffective DFT testing at implantation and for ineffective or inadequate shock delivery during follow-up. This international, bicentric study, retrospectively analyzed an all-comers collective for S-ICD implantation from November 2013 to Mai 2024. The patient cohort was divided in two groups due to their respective BMI (<30 kg/m² and ≥30 kg/m²) based on the WHO definition for obesity. A total of 120 patients were included. Obese patients (n=30, mean BMI 35.0±4.1) suffered from diabetes mellitus more often (31% vs. 14%; p=0.02) compared to non-obese patients (n=90, mean BMI 24.0±2.9). Patient groups were comparable in age (51.1±16.7 vs. 50.3±16.6 years), cardiac disease etiology (ischemic: 37% vs. 42%; non-ischemic: 37.0% vs. 42%) and gender (70% vs. 75% male). 76 non-obese (86%) and 25 obese patients (83%) underwent DFT at implantation. Mean shock energy of first successful shock was 65J in both groups, whereas shock impedance was significantly higher in the obese patient group (63 vs. 73 ohm; p=0.02) with a significant correlation between higher BMI and higher shock impedance (r=0.37; p<0.001, see figure 1). Consequently, mean PRAETORIAN score was higher in the obese group, proposing a mean intermediate risk for failure to convert in this group (123 vs. 53; p=0.04, see table 1). During the mean follow-up time of 46 months (± 37), no significant difference was found between both groups regarding first shock effectiveness (100% vs. 100%) and the occurrence of inappropriate shocks (10% vs. 10%). There was a trend towards more lead complications in obese patients (n=5 vs. n=4; OR 3.8(0.946-15.3, p=0.06)), while patients with lower BMI had more device-associated infections necessitating revision during follow-up (n=5 vs. n=0), both not statistically significant. This retrospective bicentric study demonstrates that obesity is associated with significantly higher shock impedance during DFT at S-ICD implantation while shock efficacy remains stable during implantation and subsequent follow-up. Obese patients did not experience ineffective appropriate shock despite higher PRAETORIAN scores nor more inappropriate shocks compared to non-obese patients, suggesting that the S-ICD provides a safe and effective therapy option also for at-risk patients with higher BMI values.
AIMS:Initial clinical studies of pulsed field ablation (PFA) to treat atrial fibrillation (AF) indicated a >90% durability rate of pulmonary vein isolation (PVI). However, these studies were largely conducted in single centres and involved a limited number of operators. We aimed to describe the electrophysiological findings and outcomes in patients undergoing repeat ablation after an initial PF ablation for AF. METHODS AND RESULTS:In the MANIFEST-REDO study, we investigated patients who underwent repeat ablation due to clinical recurrence-AF or atrial tachycardia (AT)-following first-ever PVI with a pentaspline PFA catheter (Farawave, Boston Scientific Inc.). At 22 centres, 427 patients (age 64 ± 11 years; 37% female) were included. Of note, the recurrent arrhythmia leading to the repeat ablation was paroxysmal AF (51%), persistent AF (30%), or AT (19%). At the repeat procedure, the PV reconnection rates were 30% (left superior pulmonary vein), 28% (left inferior pulmonary vein), 33% (right superior pulmonary vein), and 32% (right inferior pulmonary vein). In 45% of patients, all PVs were durably isolated at the beginning of the repeat procedure, with the previous use of any imaging or mapping modality being univariately associated with durable PVI. After a post-redo follow-up period of 284 (90-366) days, the primary effectiveness endpoint (freedom from documented AF/AT lasting ≥30 s after 3-month blanking without class I/III antiarrhythmic drugs or symptoms) was achieved in 65% of patients, with significant differences between groups (PAF 65% vs. PersAF 56% vs. AT 76%; P = 0.04). Persistent AF as recurrent arrhythmia after the initial PFA ablation predicted AT/AF recurrence after repeat ablation [hazard ratio 1.241 (95% confidence interval 1.534-1.005); P = 0.045]. The procedural complication rate was 2.8%. CONCLUSION:In repeat procedures for AF/AT performed after an index procedure with PFA for AF, PV reconnections are not uncommon. Repeat procedures can be performed safely and with an acceptable subsequent success rate.
Pulse field ablation (PFA) has emerged as a non-inferior single shot ablation modality compared to thermal modalities. Based on our previous work, where we showed that the rate of fibroblast activation seems to be more pronounced after pulmonary vein isolation (PVI) with cryoballoon ablation (CBA) compared to PFA, we hypothesized that the rate of occurrence of atypical atrial flutter might be higher after PFA due to less pronounced/ nonhomogeneous lesion formation. Baseline and periprocedural ablation data of 300 patients (200 PFA, 100 CBA) having undergone 1st-do PVI in 2 German centers for either paroxysmal or persistent atrial fibrillation (AF) were analyzed. Primary endpoint of our study was to observe the rate of atypical flutter or atrial tachycardia after PVI with PFA vs. CBA. Secondary endpoint was to observe the rate of AF recurrence after PFA compared to CBA. The events were censored after 500 days of follow-up (FU). The study included predominantly male patients with mean age of 66 years. The baseline characteristics were well balanced within the groups as well as the history of previous cardiac surgery (7.5% vs 4.0%, p=0.7; Table 1). More of the patients treated with CBA tended to have longer history of AF without reaching the level of significance (38.6 vs. 30.4 months, p=0.1). The procedural characteristics in respect to radiation time and procedure time were balanced within the groups, while the radiation dose was significantly higher in CBA group (1412.5 µGym2vs. 723 µGym2, p<0.001). Median FU was 319 days. Atypical atrial flutter after PVI with PFA occurred significantly more often than after PVI with CBA (9.5% vs 4%, p=0.04) (Figure 1A), while AF recurrence was similar after PVI with CBA vs. PFA (17.5% vs. 22.0%, p=1.0) (Figure 1B). Our study shows that within 500 days of follow up the rate of atypical atrial flutter after PVI with PFA is significantly higher than after CBA, possibly suggesting nonhomogeneous ablation lesion formation with current PFA-devices. The recurrence of atrial fibrillation was similar between the groups within 500 days of FU. Longer FU and larger patient cohorts with 3-D Mapping are needed to observe if this difference persists and if the individual mechanism of atrial flutter is different in PFA due to different method of cell death.
Cardiac resynchronization therapy (CRT) has become a cornerstone in heart failure (HF) therapy reducing morbidity and mortality. While the rate of CRT-Defibrillator (CRT-D) implantations is reported to be higher in men than women evidence from randomized controlled trials on the effects of gender on CRT response is scarce. The purpose of this study was to investigate the gender-specific response rate to cardiac resynchronization therapy. Perioperative and outcome data were prospectively collected from 802 consecutive patients (168 female, 634 male) after CRT-D implantation in three tertiary European centers. The primary endpoint was all-cause mortality. Secondary endpoint was response to CRT as measured in improvement of left ventricular ejection fraction (LVEF), NYHA functional class, and QRS shortening 6 months after implantation. Female patients had significantly higher baseline LVEF values (27.0±7.1% vs. 25.2±7.2%, p<0.001), as well as significantly lower rates of ischemic cardiomyopathy (ICM; 39.3% vs 64.0%, p<0.001) and atrial fibrillation (AF; 28.5% vs. 39.0%, p=0.014). During the median follow-up period of 27.6 months (IQR: 13.2-53.1 the primary endpoint of all-cause death occurred in 267 patients (33.3%) and more often in males (n= 225, 35.5%) than in females (n=42, 25.0% p=0.010, figure 1). In the univariate analysis, AF, ICM, diabetes, chronic renal insufficiency and age were significantly associated with the primary outcome. After adjustment for those covariates, gender remained significantly associated with all-cause mortality (HR 1.34 [95% CI, 0.95- 1.87], p=0.012). With respect to the secondary endpoint, echocardiographic response to CRT was significantly greater in female than in male patients (ΔLVEF +9.4±10.6% vs. +5.8±9.1%; p=0.002). Regarding other parameters indicating response to CRT (change in NYHA functional class, QRS shortening), we found no significant difference between male and female patients. This multicentric cohort results with 10-year follow-up time suggest that women with symptomatic heart failure have a lower long-term all-cause mortality following CRT implantation compared to men. CRT response as measured as improvement in LVEF is more frequent and more pronounced in women than men during follow-up. Based on these data women seem to be optimal CRT candidates. Further investigations with larger patient cohort and a 50% female inclusion rate are urgently warranted to confirm these findings.
AIMS:The aim of this study was to assess the risk of haemolysis and the extent of myocardial and neural injury after monopolar, monophasic pulsed field ablation (PFA) using a lattice-tip catheter in comparison to single-shot PF ablation platforms employing bipolar, biphasic waveforms. METHODS AND RESULTS:This prospective study included consecutive patients undergoing PFA for atrial fibrillation (AF) using the Affera™ mapping and ablation system (n = 40). Biomarkers for haemolysis (haptoglobin, lactate dehydrogenase, bilirubin), myocardial injury [high-sensitive troponin T, creatine kinase (CK), creatine kinase MB (CK-MB)], neurocardiac injury (S100), and renal function (creatinine) were assessed pre- and within 24 h post-ablation. A subgroup analysis of first-time pulmonary vein isolation-only procedures compared biomarker changes across Affera™, Farapulse™ (PFA-F), and PulseSelect™ (PFA-P). Post-procedural haemolysis occurred across all PFA platforms. The decrease in Δhaptoglobin was most pronounced in PFA-F [AfferaTM: (-) 13.8 ± 18.5 vs. PFA-P: (-) 36.8 ± 35.9 vs. PFA-F: (-) 60.7 ± 26.3 mg/dL, P = <0.001], without haemolysis-related complications. AfferaTM shows a trend towards a higher increase in myocardial injury markers (Δtroponin, 1537 [580] vs. 970 [1023] vs. 1051 [592] pg/mL, P = 0.180; ΔCK, 232 [168] vs. 153 [132] vs. 102 [144] U/L, P = 0.006; ΔCK-MB, 28.5 [15.3] vs. 14.6 [12.4] vs. 13.6 [10.5] U/L, P = 0.055, for Affera TM, PFA-P, and PFA-F, respectively). After ablation, S100 increased in PFA-P and PFA-F, but not in AfferaTM. CONCLUSION:Post-procedural haemolysis after PFA for AF treatment is common and occurs across all PFA platforms. Pulsed field ablation using AfferaTM results in more myocardial injury than bipolar PFA systems with no indication of neural damage.
This study evaluated the efficacy and safety of the subcutaneous implantable cardioverter defibrillator (S-ICD) in patients with obesity. In this bicentric, retrospective study, S-ICD recipients were divided into two groups based on body mass index (BMI: < 30 kg/m2 and ≥ 30 kg/m2). Defibrillation testing (DFT) failure, shock impedance, rates of appropriate and inappropriate shock, long-term complications, survival, and device-related or cardiac rehospitalizations were compared. Of the 120 patients included, most baseline characteristics were similar between patients with (n = 30) and without obesity (n = 90), except for a higher prevalence of diabetes in the group with obesity. The first shock during DFT was similarly effective (99 vs. 100
Patients with heart failure (HF) and severely reduced left ventricular ejection fraction (LVEF) ≤ 35% (HFrEF) are at elevated risk for arrhythmias and sudden cardiac death. To evaluate potential recovery in LVEF under optimal guideline-directed medical therapy (GMDT) after initial diagnosis, patients can be provided with a wearable cardioverter-defibrillator (WCD) within the first 3 months to bridge this time. According to the ESC-HF guideline (HF-GL) introduced in 2021 GMDT consists of the "fantastic four" including Sodium-Glucose-linked-transporter-2 inhibitors (SGLT-2i). The objective of this analysis was to evaluate the change/adherence in GMDT therapy before/after HF-GL, rate of LVEF recovery to > 35% and the occurrence of ventricular arrhythmia in a well-defined WCD patient cohort. We retrospectively analyzed all patients in our tertiary care center fitted with a WCD from 03/2018 until 03/2024. 104 patients were included before and 63 patients after implementation of the HF-GL in 09/2021. Baseline (BL) characteristics are listed in figure 1. For every patient we calculated Quad Medical Score (QMS) as surrogate of guideline adherence in HF therapy, which is calculated on the presence of all four substance classes and their dosages. LVEF was assessed at baseline and 3 months (FU) after the initiation of GDMT. A total of 167 patients were analyzed: Men 80% (n= 134), women 20% (n=33); ischemic heart disease (ICM) in 56% of included patients (n=94). Median LVEF overall at baseline was 24% and after a median of 84 days of follow up (FU) mean LVEF improved to 34% with ΔLVEF of +9%. Patients treated with WCD before HF-GL implantation LVEF was 24.0% at baseline and 32% with ΔLVEF of +8% at FU, while patients treated after HF-GL implementation had a recovery to mean LVEF 36% resulting in a ΔLVEF of 11% at FU (p<0.05) BL vs. FU; figure 1). Analysis of ΔLVEF revealed a significant difference between the groups only for the ICM cohort (p<0.05 before vs. after HF-GL). The rate of ICD indication was significantly reduced in patients treated after HF-GL update (55 vs. 21 patients; (p<0.05). In total, 5 (3.4%) ventricular tachycardia occurred during WCD prescription. Mean QMS in all patients before and after guideline initiation was 9 vs. 21 respectively (p<0.001). Higher QMS resulted in significant LVEF improvement (p<0.05). In patients with HFrEF equipped with a WCD significantly more patients were prescribed with a SGLT-2 inhibitor after HF-GL update 2021, these patients showed a significantly higher rate of LVEF recovery resulting in fewer ICD indications after 3 months. During the period of risk, the WCD is an important opportunity to protect patients against SCD in this cohort.Figure 1:Baseline characteristics Figure 2:LVEF improvement
(1) Background: Early reintervention increases the risk of infection of cardiac implantable electronic devices (CIEDs). Some operators therefore delay lead repositioning in the case of dislocation by weeks; however, there is no evidence to support this practice. The aim of our study was to evaluate the impact of the timing of reoperation on infection risk. (2) Methods: The data from consecutive patients undergoing lead repositioning in two European referral centers were retrospectively analyzed. The odds ratio (OR) of CIED infection in the first year was compared among patients undergoing early (≤1 week) vs. delayed (>1 week to 1 year) reoperation. (3) Results: Out of 249 patients requiring CIED reintervention, 85 patients (34%) underwent an early (median 2 days) and 164 (66%) underwent a delayed lead revision (median 53 days). A total of nine (3.6%) wound/device infections were identified. The risk of infection was numerically lower in the early (1.2%) vs. delayed (4.9%) intervention group yielding no statistically significant difference, even after adjustment for typical risk factors for CIED infection (adjusted OR = 0.264, 95% CI 0.032–2.179, p = 0.216). System explantation/extraction was necessary in seven cases, all being revised in the delayed group. (4) Conclusions: In this bicentric, international study, delayed lead repositioning did not reduce the risk of CIED infection.
BACKGROUND:During the first coronavirus disease 2019 (COVID-19) wave there was a high prevalence of mental health impairments and post-traumatic stress disorder (PTSD), particularly in patients with comorbid cardiac diseases. METHODS:During waves 2-5, all hospitalized patients with cardiac problems and suspected COVID-19 were eligible to participate in this study. RESULTS:The prevalence of PTSD was 31.4% (n=48) in 153 participants. No age- and gender-related differences for PTSD were found. CONCLUSIONS:The prevalence is lower than during the first wave but higher than in patients reported in other studies who were isolated at home. Routine mental health assessments are strongly recommended for patients at risk.
Purpose of the Report:Combined cardiac 68Ga-Fibroblast-Activation Protein-alpha inhibitor (FAPI) positron-emission tomography (PET) and cardiac magnetic resonance imaging (MRI) constitute a novel diagnostic tool in patients for the assessment of myocardial damage after an acute myocardial infarction (AMI). Purpose of this pilot study was to evaluate simultaneous Ga-68-FAPI-46-PET/MR imaging in the delayed phase after AMI. Material and Methods:Eleven patients underwent hybrid 68Ga-FAPI-46 PET/MRI post AMI. Standardized uptake values and fibroblast activation volume (FAV) were calculated and correlated with serum biomarkers and MRI parameters. Results:Significant 68Ga-FAPI-46 uptake could be demonstrated in 11 (100 %) patients after a mean period of 30.9 ± 22.0 days. FAV significantly exceeded the infarction size in MRI and showed a good correlation to MRI parameters as well as to serum biomarkers of myocardial damage. Conclusions:68Ga-FAPI-46 PET/MRI offers molecular and morphological imaging of affected myocardium after AMI. This study demonstrates ongoing fibroblast activation in a delayed phase after AMI and generates hypotheses for future studies while aiming for a better understanding of myocardial remodeling following ischemic tissue damage.
Abstract Introduction Ventricular tachycardia (VT) ablation in patients with progressed heart failure (HF) is known to be complex and associated with a high periprocedural risk and mortality, in part due due to hemodynamic instability during ongoingVTs. Use of mechanical circulatory support (MCS) systems has been already implemented in complex high-risk percutaneous coronary intervention (CHIP-PCI) workflows. Use and benefit of MCS in VT ablation is still under debate. MCS protected VT ablation (proVT-A) might be associated with improved clinical outcomebut potentially comes along with an increased risk of periprocedural complications. Based on data of four German high-volume centers we aimed to analyze retrospective data on patient characteristics and impact of proVT-A with respect to safety and mid-term efficacy. Methods All patients undergoing proVT-A as a primary approach from four German EP centers were included in the analysis. Use of MCS in bailout scenariosin VT ablation were not included. Patient characteristics, procedural parameters and clinical outcome were evaluated. The primary endpoint was a combined endpoint of VT/VF recurrence and all-cause death. Results 41 patients who underwent proVT-A were included. Mean age was 64±11a, 92% of patients were male (38/41), 65% (27/41) suffered from ischemic cardiomyopathy, mean left ventricular ejection fraction was 33±13%,76% (31/41) of patients presented with a documented hemodynamically not tolerated VT, mean PAAIN-ESD score was 13±7, and 46% (19/41) had a history of a previous VT ablation w/o MCS. During proVT-A procedure at least one VT was inducible and mappable in 35 patients (85%). Acute procedural success was 85%, with only n=6 patients remaining inducible for VT. Mean procedure duration was 245±46min. With respect to periprocedural safety (30days)a total of n=12 relevant procedural complications were reported in 8 patients. This included n=5 vascular access complications, of which n=3 requiring transfusion or surgery. One case of periprocedural death was reported 6h post proVT-A due to PEA. Three patients developed pericardial effusion, one requiring drainage. Freedom from VT/VF was 78% (n=9 VT/VF recurrences) after a mean follow-up (FU) of 15±14 months (figure 1A). Death of any cause occurred in n=9 patients (figure 1B). In summary, after a mean FU of 15±14 months n=16 patients (39%) met the combined endpoint of VT/VF recurrence and all-cause death (figure 1C). Conclusion Patients enrolled in the German PROTECT VT Registry had significant cardiovascular comorbidities and therefore represent a high-risk population for VT ablation. Use of MCS was feasible, comparably safe, associated with high procedural and promising long-term success rate. These results highlight the need for larger registries and future prospective trials evaluating the potential benefit of proVT-A in selected patients. Further, it should be aimed for optimization of periprocedural vascular access site management.
Abstract Background Distraction using audiovisual stimuli has mostly been researched in a paediatric population with the results showing an inhibiting effect on stress and anxiety as well as the subjective perception of pain. Purpose We designed a study to test if audiovisual distraction may reduce the level of sedatives and analgesics by reducing anxiety and stress during electrophysiological intervention (EP). Methods We conducted a clinical intervention pilot study that was carried out in a randomized controlled manner. Consecutive 70 patients undergoing EP with subsequent ablation were randomized 1:1 to control (CTL) or intervention group (AVD). In addition to standardized sedation, all patients in AVD group received audiovisual glasses. Feeling of fear and stress was assessed through blood pressure changes. The patient satisfaction was assessed with Client Satisfaction Questionnaire, ZUF-8. Numeric scale (NRS) was used to quantify the perceived pain during the procedure. The difference between the subjective estimated duration of the procedure and the actual duration of the procedure was compared. Results The study included predominantly male patients (58.6%) with a mean age of 56 years. Technical aptitude was well balanced between both groups with the majority of patients in both groups owning a smartphone or a tablet (86.1% vs 85.7% for CTL and AVD respectively, p=0.92), and majority of patients in both groups using a computer, laptop or tablet on a weekly basis (58% vs 57.1% for CTL and AVD group respectively, p=0.97). The baseline feelings of anxiety were well balanced within both groups (Figure 1). Our analysis revealed no significant difference between the mean blood pressure values of the CTL and AVD groups (systolic: 135 vs. 141 mmHg; p = 0.32; diastolic: 74 vs. 72 mmHg; p = 0.45). Patient satisfaction score was comparable in both groups (26.5 vs. 26.8 points, p = 0.36). Average response for perceived pain using NRS scale as well as perceived procedure duration was similar between the groups (Figure 2). AVD group required a lower dose of Midazolam than CTL group (0.005 mg/kg/h vs 0.007 mg/kg/h, p = 0.07). Majority of patients (31.4%) in AVD group stated: "The audiovisual glasses made me feel distracted at times." 10% of the AVD patients stated: "The audiovisual glasses made me feel completely distracted and more relaxed." Conclusion The use of audiovisual glasses has no influence on the patients’ feelings of anxiety and stress during EP. The use of audiovisual glasses can temporarily induce distraction during EP, while they do not seem to be sufficient in reducing pain intensity during ablation therapy. Patients undergoing EP do not seem to be the target patient group for AVD use.
Abstract Background Different ablation modalities for pulmonary vein isolation (PVI) have been established. Since recent data from a randomized trial showed non-inferiority for pulse field ablation (PFA) vs. cryoballoon (CBA) or radiofrequency ablation (RFA) it seems reasonable to evaluate procedural parameters of these modalities in specific subgroups. Purpose The aim of this study was to evaluate radiation dose and procedural parameters in patients with body mass index (BMI) >26 kg/m² vs. ≤26 kg/m² undergoing PVI with different modalities. Methods Data of n=409 patients (140 PFA, 125 CBA, 144 RFA) having undergone PVI in three German centers for either paroxysmal or persistent atrial fibrillation were analysed. The primary endpoint was total radiation dose (Dose Area Product, DAP). Patients were analyzed with respect to BMI> vs. ≤26 kg/m² in PFA, CBA and RFA (with high-power short duration applications) groups, respectively. Secondary endpoints were radiation time and procedure time. Results The study included predominantly male patients (63.1%) with a mean age of 67.8±10.5 years. Cardiovascular risk factors were comparable within the groups, while the overall CHA2DS2-VASc-score was higher in CBA patients, which was largely influenced by a higher proportion of women in the CBA group. BMI was well balanced between the modalities (PFA: 28.7±5.6 kg/m² vs CBA: 28.5±6.0 kg/m² vs HPSD-RFA: 28.3±4.8 kg/m², p=0.78) as well as the proportion of patients with extreme obesity (BMI >30 kg/m²). The overall DAP was the lowest in the PFA group (370.2±274.6 µGym2) followed by HPSD-RFA (471.4±385.3 µGym2) and the highest in the CBA (1260.9±1053.5 µGym2) group. The radiation time was longest in the CBA group (16.6±17.0min) while being comparatively lower in PFA and HPSD-RFA groups (9.4±6.8 vs. 9.4±5.8 min). Procedure time was the shortest in the PFA group (79.6±30.5min), while being longest in the HPSD-RFA group (111.9±55.3 min). When stratifying patients according to BMI> 26 kg/m², there was a significant increase in DAP in all modalities, with the lowest mean increase in DAP in the PFA group (Δ143.84 µGym2), followed by HPSD-RFA (Δ329.54 µGym2) and the highest increase in the CBA group (Δ691.17 µGym2) (Figure 1). No difference was observed in radiation or procedure time when stratifying patients to BMI. (Figure 2) Conclusion Our study analyzing differences of radiation exposure according to elevated BMI among various PVI techniques shows that while there is a significant increase of DAP in patients with BMI >26 kg/m² in all modalities, the lowest increase is registered in the PFA collective. These results suggest that PVI performed with PFA, if available, or HPSD-RFA should be the energy sources of choice in obese patients with respect to radiation exposure.
BACKGROUND:The general regulations for an active participation in the road traffic in the Federal Republic of Germany are laid down in the Driving License Ordinance ("Fahrerlaubnisverordnung" ) (including appendices). Cardiovascular diseases with a need for precautionary measures and the circumstances according to which the driving fitness is to be determined are reviewed in appendix 4 of the ordinance. The guidelines of the Federal Highway Research Institute ("Bundesanstalt für Straßenwesen") must also be considered when assessing the fitness to drive. OBJECTIVES:Presentation of the current legal recommendations in the assessment of the driving fitness in the respect to cardiovascular diseases. MATERIALS AND METHODS:The current official regulations and the recommendations on the fitness to drive in the case of cardiovascular diseases were assessed. In addition, the pocket guidelines of the German Society for Cardiology (DGK) on the subject were reviewed. RESULTS:As the type of vehicle and time at the wheel influence the probability and the extent of damage in the case of a traffic accident, the official requirements for driving aptitude distinguish between private (group 1) and professional drivers (group 2). The official recommendations for assessing fitness to drive in the case of cardiac arrhythmias, device therapy, coronary heart disease, cardiac insufficiency, valve diseases and syncope are presented. CONCLUSION:Driving fitness plays an important role in the cardiological patient collective and should be determined in accordance with the official recommendations. For everyday clinical practice, the DGK recommendations for fitness to drive are presented in a clearer and more practice-relevant manner.
Background Although atrial inflammation has been implicated in the pathophysiology of atrial fibrillation (AF), the identification of atrial inflammation remains challenging. We aimed to establish a positron emission tomography/computed tomography (PET/CT) protocol with 18 Fluor-labeled fluorodeoxyglucose ( 18 F-FDG) for the detection of atrial hypermetabolism as surrogate for inflammation in AF. Methods We included n = 75 AF and n = 75 non-AF patients undergoing three common PET/CT protocols (n = 25 per group) optimized for the detection of (a) inflammation and (b) malignancy in predefined fasting protocols, and (c) cardiac viability allowing for maximized glucose uptake. 18 F-FDG-uptake was analyzed in predefined loci. Results Differences of visual atrial uptake in AF vs non-AF patients were observed in fasting (inflammation [13/25 vs 0/25] and malignancy [10/25 vs 0/25]) protocols while viability protocols showed non-specific uptake in both the groups. In the inflammation protocol, AF patients showed higher uptake in the right atrium [(SUVmax: 2.5 ± .7 vs 2.0 ± .7, P = .01), atrial appendage (SUVmax: 2.4 ± .7 vs 2.0 ± .6, P = .03), and epicardial adipose tissue (SUVmax: 1.4 ± .5 vs 1.1 ± .4, P = .04)]. Malignancy and viability protocols failed to differentiate between AF and non-AF. Conclusion Glucose uptake suppression protocols appear suitable in detecting differential atrial 18 F-FDG uptake between AF and non-AF patients. Imaging-based assessment of inflammation might help to stratify AF patients offering individualized therapeutic approaches.
Die allgemeinen Regelungen für die aktive Teilnahme am Straßenverkehr in der Bundesrepublik Deutschland sind in der Fahrerlaubnisverordnung (FeV; inkl. Anlagen) festgelegt. In der Anlage 4 der FeV wurden die kardiovaskuläre Erkrankungen mit Vorsorgebedarf aufgelistet sowie auch die Umstände, wann eine Fahreignung vorliegt. Zur Beurteilung der Fahreignung ist auch die Begutachtungsleitlinie der Bundesanstalt für Straßenwesen (BASt) zu berücksichtigen. Darstellung der aktuellen rechtlichen Empfehlungen für die Beurteilung der Fahreignung bei kardiovaskulären Erkrankungen. Die aktuellen behördlichen Verordnungen und Empfehlungen zur Fahreignung bei kardiovaskulären Erkrankungen werden dargestellt. Zusätzlich wurden die Pocket-Leitlinien der Deutschen Gesellschaft für Kardiologie (DGK) für Fahreignung berücksichtigt. Da die Art des Fahrzeugs und die Zeit am Steuer einen Einfluss auf die Schadenswahrscheinlichkeit haben, unterscheiden die behördlichen Vorgaben zur Fahreignung zwischen Privat- (Gruppe 1) und Berufsfahrern (Gruppe 2). Die behördlichen Empfehlungen für die Beurteilung der Fahreignung bei Herzrhythmusstörungen, Devicetherapie, koronarer Herzerkrankung, Herzinsuffizienz, Klappenerkrankungen, Synkopen wurden dargestellt. Das Thema Fahreignung spielt eine wichtige Rolle im kardiologischen Patientenkollektiv und soll entsprechend den Vorgaben in der FEV mit Anlage 4 sowie Begutachtungsleitlinien BASt berücksichtigt werden. Für den klinischen Alltag sind die DGK-Empfehlungen zur Fahreignung übersichtlicher und praxisrelevanter dargestellt.
Background Pulsed-field ablation (PFA) is a novel ablation modality for atrial fibrillation (AF) ablating myocardium by electroporation without tissue-heating. With its different mechanism of tissue ablation, it is assumed that lesion creation is divergent to thermal energy sources. 68 Ga-fibroblast-activation protein inhibitor (FAPI) PET/CT targets FAP-alpha expressed by activated fibroblasts. We aimed to assess 68 Ga-FAPI uptake in pulmonary veins as surrogate for ablation damage after PFA and cryoballoon ablation (CBA). Methods 26 patients (15 PFA, 11 CBA) underwent 68 Ga-FAPI-PET/CT after ablation. Standardized uptake values (SUV) and fibroblast-activation volumes of localized tracer uptake were assessed. Results Patient characteristics were comparable between groups. In PFA, focal FAPI uptake was only observed in 3/15 (20%) patients, whereas in the CBA cohort, 10/11 (90.9%) patients showed atrial visual uptake. We observed lower values of SUV max (2.85 ± 0.56 vs 4.71 ± 2.06, P = 0.025) and FAV (1.13 ± 0.84 cm 3 vs 3.91 ± 2.74 cm 3 , P = 0.014) along with a trend towards lower SUV peak and SUV mean in PFA vs CBA patients, respectively. Conclusion Tissue response with respect to fibroblast activation seems to be less pronounced in PFA compared to established thermal ablation systems. This functional assessment might contribute to a better understanding of lesion formation in thermal and PFA ablation potentially contributing to better safety outcomes.
BackgroundA novel catheter technology (direct sense, DS) enables periprocedural local impedance (LI) measurement for estimation of tissue contact during radiofrequency ablation (RFA) for real-time assessment of lesion generation. This measure reflects specific local myocardial conduction properties in contrast to the established global impedance (GI) using a neutral body electrode. Our study aimed to assess representative LI values for the cardiac chambers, to evaluate LI drop in response to RF delivery and to compare those values to established GI measures in patients undergoing RFA procedures.Methods and ResultsSeventy-three patients undergoing RFA with the DS technology were included. Within the cardiac chambers, baseline LI was significantly different, with the highest values in the left atrium (LA 107.5 ± 14.3 Ω; RV 104.6 Ω ± 12.9 Ω; LV 100.7 Ω ± 11.7 Ω, and RA 100.5 Ω ± 13.4 Ω). Baseline LI was positively correlated to the corresponding LI drop during RF delivery (R2 = 0.26, p = 0.01) representing a promising surrogate of lesion generation. The observed mean LI drop (15.6 ± 9.5 Ω) was threefold higher as GI drop (4.9 ± 7.4 Ω), p < 0.01. We evaluated the clinical outcome in a subgroup of patients undergoing DS-guided pulmonary vein isolation, which was comparable regarding arrhythmia recurrence to a conventional ablation cohort (57 % vs 50 %, p = 0.2).ConclusionWe provide detailed information on LI measures in electrophysiological procedures with significant differences within the cardiac chambers highlighting that RFA-related LI drop can serve as a promising surrogate for real-time assessment of lesion generation. Guiding the electrophysiologist in RFA procedures, this additional information promises to improve safety profile and success rates in the interventional treatment of arrhythmias.