[Fatigue and sensorimotor instability : Neurologically controlled conversion of post-COVID-19 patients]. / Fatigue und sensomotorische Instabilität : Neurologisch kontrollierte Konversion von Post-COVID-19-Patienten.

BACKGROUND: For the treatment of the symptoms of post-COVID-19 syndrome, no causal therapy is currently widely recommended according to evidence-based criteria. The overarching goal of the intervention study over a 3-year period (Q1-2021-Q4-2023) was to evaluate the changes in the key symptoms of fatigue and sensorimotor instability through individualized stress-controlled training therapy and through intensified cognitive behavioral therapy. MATERIAL AND METHODS: In the 3­year period 407 vaccinated nucleocapsid positive patients were treated at the Post-COVID-19 Center Lausitz (Senftenberg). In 78 (around 19%) fatigue/immunometabolic depression and sensorimotor instability were identified as the leading syndromes. The evaluation of the individualized stress-controlled training therapy was based on the specific post-COVID-19 syndrome and motor fatigue parameters. The secondary psychosomatic syndrome was assessed using cognitive fatigue parameters and cognitive behavioral therapy instruments. The investigation of -parameters influencing behavior took place in Q2-2023-Q4-2023 with a guide-supported qualitative interview among the participants. RESULTS: The post-COVID-19 key symptoms "fatigue," "sensorimotor instability," "neuropsychiatric symptoms," "cardiac/autonomic dysfunction," and "pain" improved significantly in the overall cohort and in the gender-specific analysis. A deterioration occurred in "secondary psychosomatic symptoms". A therapeutic effect was demonstrated for all motor fatigue parameters for the entire cohort using the Cohen's d value. An intensification of cognitive behavioral therapy achieved positive effects through an increasing development of the patients' own activity and their self-control using persuasion and gamification.

Randomized evaluation of redo ablation procedures of atrial fibrillation with focal impulse and rotor modulation-guided procedures: the REDO-FIRM study.

AIMS: REDO-FIRM evaluated safety and effectiveness of conventional vs. focal impulse and rotor modulation (FIRM)-guided ablation of recurrent persistent or paroxysmal atrial fibrillation (AF) after an initial AF ablation procedure. METHODS AND RESULTS: This prospective, multicentre, randomized study included patients with a single prior AF ablation, but with recurrent AF and reconnected pulmonary veins (PVs). Conventional ablation generally included PV re-isolation; however, additional ablation was permitted per physician discretion. In the FIRM arm, beyond PV re-isolation, basket catheter-based FIRM mapping created dynamic animations of putative rotors, which were targeted for ablation. Between May 2016 and July 2019, 269 subjects were randomized, with 243 subjects completing 12-month follow-up. Ablation beyond re-pulmonary vein isolation, the FIRM vs. Conventional arms did not differ significantly: cavo-tricuspid isthmus -9.0% vs. 15.3%, caval vein isolation -1.5% vs. 0.8%, non-PV trigger -2.2% vs. 3.8%, other -11.9% vs. 13.0%. Single procedure 12-month freedom from AF/atrial tachycardia/atrial flutter-recurrence was 63.3% (76/120) vs. 59.0% (72/122) in the FIRM and Conventional arms (P = 0.3503). Efficacy was similar in the paroxysmal and persistent AF subgroups (P = 0.22 and P = 0.48). The 10-day and 12-month safety endpoints were achieved in 93.3% vs. 93.8% (P = 0.89) and 88.4% vs. 93.4% (P = 0.22) in the FIRM and Conventional arms, respectively. CONCLUSIONS: In REDO-FIRM, as compared to standard ablation, FIRM-guided ablation did not provide additional efficacy in redo ablation procedures, but FIRM-guided ablation was equally safe. Additional studies are necessary to identify any potential population able to benefit from FIRM-guided ablation.

Selection and outcome of implantable cardioverter-defibrillator patients with and without cardiac resynchronization therapy: Comparison of 4384 patients from the German Device Registry to randomized controlled trials.

BACKGROUND: Registry data add important information to randomized controlled trials (RCT) on real-life aspects of implantable cardioverter-defibrillator (ICD) patients with and without cardiac resynchronization therapy (CRT-D). This analysis of the prospectively conducted German Device Registry aims at comparing mortality rates, comorbidities, complication rates to results from RCT. METHODS: The German Device registry (DEVICE) prospectively collected data on ICD and CRT-D first implantations from 50 German centres. Demographic data, details on cardiac disease, electrocardiogram (ECG), medication, and data about procedure, complications, and hospital stay were stored in electronic case report forms. One year after device implantation patients were contacted for follow-up. RESULTS: DEVICE included n = 4384 first ICD/CRT-D implantations (29.3% CRT-D devices). We found a strong adherence to guidelines with over 90% of patients being on ß-blocker and ACE-inhibitor medication and adequate QRS width in the majority of CRT-D patients. Patients receiving a CRT-D were older (67.6 ± 11.0 years vs. 63.9 ± 13.4 years, p < .001) and had lower ejection fractions (mean 25% vs. 30%, p < .001) compared to ICD patients. Dilated cardiomyopathy was the predominant underlying heart disease in CRT-D (53.3%), coronary artery disease in ICD patients (64.7%). Compared to RCT our DEVICE patients had more comorbidities (17.9% chronic kidney disease [CKD]) and higher 1-year mortality rates (10.7% ICD group, 12.3% CRT group). In multivariate analysis, CKD patients had an almost 2-fold higher risk of 1-year mortality. CONCLUSION: Despite relevant limitations of registry data, DEVICE highlights important differences between RCT and real-world registry data and the impact of comorbidities on mortality of ICD and CRT-D recipients.

Efficacy and safety of the GOLD FORCE multicentre randomized clinical trial: multielectrode phased radiofrequency vs. irrigated radiofrequency single-tip catheter with contact force ablation for treatment of symptomatic paroxysmal atrial fibrillation.

AIMS: Pulmonary vein isolation (PVI) for atrial fibrillation (AF) has become increasingly safe and effective with the evolution of single-tip ablation catheters aided by contact force sensing (ST-CF) and single-shot devices such as the second-generation pulmonary vein ablation catheter (PVAC) Gold multi-electrode array. The multicentre randomized GOLD FORCE trial was conducted to evaluate non-inferiority of safety and efficacy of PVAC Gold PVI compared to ST-CF ablation for paroxysmal AF. METHODS AND RESULTS: The primary efficacy endpoint documented AF recurrence ≥30 s was assessed by time-to-first-event analysis after a 90-day blanking period using repeated 7-day Holters. Secondary endpoints include acute success and procedural characteristics. Safety endpoints included procedural complications, stroke/transient ischaemic attack (TIA), tamponade, bleeding, and access site complications. Two hundred and eight patients underwent randomization and PVI (103 assigned to PVAC Gold, 105 to ST-CF). Acute success rates were 95% and 97% for PVAC Gold and ST-CF, respectively. At 12 months, AF recurrence was observed in 46.6% of the PVAC Gold group and in 26.2% of the ST-CF group [absolute efficacy difference 20.4% (95% confidence interval, CI 7.5-33.2%), hazard ratio 2.05 (95% CI 1.28-3.29), P = 0.003]. PVAC Gold had significantly shorter procedure and ablation times. Complication rates were 5.7% and 4.9% for PVAC Gold and ST-CF, respectively (P = 0.782). CONCLUSION: In this multicentre randomized clinical trial, ablation with ST-CF and PVAC Gold ablation catheters non-inferiority for efficacy was not met. AF recurrence was significantly more frequent in the PVAC Gold group compared to single-tip contact force group. Both groups had similarly low rates of adverse events. PVAC Gold ablation had significantly shorter procedure and ablation times.

[Bridging sectoral barriers with integrative care]. / Mit integrierter Versorgung sektorale Schranken überwinden.

In an international comparison, Germany is in the top group for health care. Not only since the economic burdens of the corona pandemic, however, has there been agreement of the necessity of exploiting the considerable efficiency and effectiveness reserves that also exist in this area. Particularly in the interface area between outpatient and inpatient care, increasingly divergent development paths are beeing discusssed. Despite scientific findings to the contrary, integrative cooperative structures threaten to fall behind.

Long-term symptom improvement and patient satisfaction following catheter ablation of supraventricular tachycardia: insights from the German ablation registry.

AIMS: To analyse outcomes of supraventricular tachycardia (SVT) ablations performed within a prospective German Ablation Quality Registry. METHODS AND RESULTS: Data from 12 566 patients who underwent catheter ablation of SVT between January 2007 and January 2010 to treat atrial fibrillation (AFIB, 37.2% of procedures), atrial flutter (AFL, 29.9%), atrioventricular nodal re-entrant tachycardia (AVNRT, 23.2%), atrioventricular re-entrant tachycardia (6.3%), and focal atrial tachycardia (AT, 3.4%) were prospectively collected. Patients were followed for at least 1 year. The periprocedural success rate was 96.3%, ranging from 84.3% (focal AT) to 98.9% (AVNRT). Kaplan-Meier mortality estimate at 1 year was 1.4% overall, and as high as 2.6% in the AFL group and 2.8% in the focal AT group. Recurrence of ablated or another symptomatic SVT was observed in 3783 (32.6%) of patients, ranging from 17.2% (AVNRT) to 45.6% (AFIB). Repeat ablation was performed in 12.0% of patients. After 1 year, 74.1% of survivors perceived ablation therapy as successful, 15.7% as partly successful, and 9.6% as unsuccessful. Even in those patients with arrhythmia recurrence, 76.0% perceived ablation as successful or partly successful and 89.6% would still undergo repeat ablation in the same institution. CONCLUSION: Ablation therapy for SVT is a safe procedure bringing symptomatic improvement and satisfaction to three quarters of patients after 1 year. Even in patients with arrhythmia recurrence, a high satisfaction level and adherence to the ablating institution could be documented. Strikingly high mortality and stroke rates in follow-up were observed in AFL patients, who apparently need consistent long-term anticoagulation and more medical attention.

Treatment of Recurrent Nonparoxysmal Atrial Fibrillation Using Focal Impulse and Rotor Mapping (FIRM)-Guided Rotor Ablation: Early Recurrence and Long-Term Outcomes.

INTRODUCTION: A patient-tailored ablation approach focused on the elimination of both pulmonary vein triggers as well as substrate drivers may result in favorable outcomes in recurrent persistent AF patients. OBJECTIVE: We evaluated the long-term outcomes of rotor ablation combined with conventional pulmonary vein isolation (PVI) in patients with recurrent nonparoxysmal AF. METHODS: Fifty-eight consecutive patients underwent FIRM-guided rotor ablation followed by conventional PVI for the treatment of recurrent nonparoxysmal AF. A software algorithm was used to display rotational activity at rotor sites by creating propagation maps from unipolar electrograms recorded using a 64-electrode basket catheter. These rotor sites were targeted for ablation, followed by conventional PVI. RESULTS: All patients had nonparoxysmal AF (83% longstanding persistent) and a previously failed conventional ablation procedure. Stable rotors were identified in all patients (mean of 3.0 ± 1.6 per patient), with 55.2% having right atrial rotors and 96.6% left atrial rotors, respectively. Complications occurred in 5.2% of patients, none related to the FIRM procedure. The median follow-up was 12 months. At 6 and 12 months of follow-up, 73.2% and 76.9% of patients remained free from AF/AT, respectively. Excluding 2 patients who underwent a successful redo ablation procedure/electrical cardioversion, at 12 months of follow-up, 69.2% were free from any AF/AT and 73.1% were free from AF after a single FIRM-guided ablation procedure. CONCLUSION: A high degree of success was observed in this cohort of primarily longstanding persistent AF patients treated for recurrent AF with FIRM-guided rotor ablation. Prospective randomized controlled trials are needed.

Complication Rates of Catheter Ablation of Atrial Fibrillation in Patients Aged ≥75 Years versus <75 Years-Results from the German Ablation Registry.

INTRODUCTION: Despite a rising demand for catheter ablation (CA) of atrial fibrillation (AF) in an elderly population, complication and success rates are not fully elucidated. We sought to compare complication rates of CA of AF in patients ≥75 versus <75 years of age. METHODS AND RESULTS: Patients with symptomatic, drug-refractory AF were prospectively enrolled from January 2007 to 2010 in this multicenter study. A total of 4,449 patients, group 1 ≥75 years and group 2 <75 years (n = 227, age 77.3 ± 2.2 vs. 59.7 ± 9.8 years, 52.0% vs. n = 4,222, 68.9% male, CHA2 DS2 -VASc-Score 3.7 ± 1.0 vs. 1.7 ± 1.2; P < 0.001, respectively), with paroxysmal AF (59.9% in group 1 vs. 63.3% in group 2, P = 0.30), and persistent AF (34.8% in group 1 vs. 29.4% in group 2, P = 0.082) underwent CA of AF. A centralized follow-up was obtained in 4,347 patients by the Institute for Myocardial Infarction Research (IHF, Ludwigshafen). There was a significant difference between periprocedural stroke rates in the elderly versus the younger cohort (1.3% vs. 0.1%, P < 0.01). In-hospital severe nonfatal complications did not differ significantly between the groups (4.4% vs. 2.7%, P = 0.14). Other procedure-related, in-hospital complications were not significantly different. After a mean follow-up of 472 ± 99 days (group 1) and 477 ± 94 days (group 2), no differences were found in complication rates. CONCLUSION: CA of AF in patients ≥75 years is associated with higher in-hospital stroke rates. In a 1-year follow-up, complication rates do not differ between the groups.

Long-term outcomes after event-free cardioverter defibrillator implantation: comparison between patients discharged within 24 h and routinely hospitalized patients in the German DEVICE registry.

AIMS: To analyse the long-term safety of implantable cardioverter defibrillators (ICDs) in patients discharged within 24 h or after 2- 5-day hospitalization, respectively, after complication-free implantation, in circumstances of actual care. METHODS AND RESULTS: Patients in the multicentre, nationwide German DEVICE registry were contacted 12-15 months after their first ICD implantation or device replacement. Data were collected on complications, potential arrhythmic events, syncope, resuscitation, ablation procedures, cardiac events, hospitalizations, heart failure status, change of medication, and quality of life. Of 2356 patients from 43 centres, 527 patients were discharged within 24 h and 1829 were hospitalized routinely for >24 h after complication-free implantations. The disease profiles and rates of co-morbidities were similar at baseline for both cohorts. During between 384 and 543 days of follow-up, there were no significant differences between the groups in terms of complications, hospitalizations, or quality of life. One-year rates of death were 4.5% in patients discharged early compared with 7.2% in hospitalized patients (hazard ratio 0.65; 95% confidence interval 0.42-1.02; P = 0.052). Rates of major adverse cardiovascular events or defibrillator events were not higher in patients discharged after 24 h. In both groups, a high rate of patients declared that they would opt for the procedure again in the same situation. CONCLUSION: Data from a large-scale registry reflecting current day-to-day practice in Germany suggest that most patients can be discharged safely within 24 h of successful ICD implantation if there are no procedure-related events. Follow-up data up to 1.5 years after implantation did not raise long-term safety concerns.

Surgical cut-down or percutaneous access-which is best for less vascular access complications in transfemoral TAVI?

OBJECTIVES: Objective of the present study was to compare VARC-2 access and bleeding complications of a complete percutaneous versus a surgical cut-down approach for transfemoral TAVI "in a real world-all comers" setting. BACKGROUND: The ideal approach for transfemoral TAVI is still part of a lively debate. Until today, for none of the available techniques superiority could be demonstrated. The present study adds a considerable number of patients to the available experience. METHODS: The study included 334 consecutive patients, including 199 patients in the percutaneous and 135 patients in the cut-down group. Mean patient's age was 81.4 ± 4.6. Calculated logistic EuroSCORE correlated an intermediate to high surgical risk (17.8% ± 12.3%). Primary study endpoints were vascular access site as well as bleeding complications according the actual VARC-2 criteria. RESULTS: Mean procedure time was significantly shorter in the cut-down group (69 ± 19 min vs. 91 ± 22 min; P < 0.01). Overall rate of VARC-2 access complications were significantly more frequent in the percutaneous group (n = 41/199; 20.6% vs. n = 11/135; 8.1%; P = 0.04); the incidence of major complications did not differ significantly (P = 0.19). VARC-2 bleeding complications were more frequent in the percutaneous group as well (18.1% vs. 4.4%; P = 0.029). Hospital stay differed not significantly (P = 0.214). Hospital mortality was 3.5% in the percutaneous group and 1.5% in the cut-down group (P = n.s.). CONCLUSION: Surgical cut-down provided a convenient and controlled access, resulting in less access and bleeding complications. Nontheless, major access complication differed not significantly. Both approaches must be seen as complementary techniques. A portfolio containing both techniques is the exclusive way to provide a tailor-made and patient-orientated approach. © 2015 Wiley Periodicals, Inc.

Low rate of asymptomatic cerebral embolism and improved procedural efficiency with the novel pulmonary vein ablation catheter GOLD: results of the PRECISION GOLD trial.

AIMS: This prospective, multicentre study (PRECISION GOLD) evaluated the incidence of asymptomatic cerebral embolism (ACE) after pulmonary vein isolation (PVI) using a new gold multi-electrode radiofrequency (RF) ablation catheter, pulmonary vein ablation catheter (PVAC) GOLD. Also, procedural efficiency of PVAC GOLD was compared with ERACE. The ERACE study demonstrated that a low incidence of ACE can be achieved with a platinum multi-electrode RF catheter (PVAC) combined with procedural manoeuvres to reduce emboli. METHODS AND RESULTS: A total of 51 patients with paroxysmal atrial fibrillation (AF) (age 57 ± 9 years, CHA2DS2-VASc score 1.4 ± 1.4) underwent AF ablation with PVAC GOLD. Continuous oral anticoagulation using vitamin K antagonists, submerged catheter introduction, and heparinization (ACT ≥ 350 s prior to ablation) were applied. Cerebral magnetic resonance imaging (MRI) scans were performed within 48 h before and 16-72 h post-ablation. Cognitive function assessed by the Mini-Mental State Exam at baseline and 30 days post-ablation. New post-procedural ACE occurred in only 1 of 48 patients (2.1%) and was not detectable on MRI after 30 days. The average number of RF applications per patient to achieve PVI was lower in PRECISION GOLD (20.3 ± 10.0) than in ERACE (28.8 ± 16.1; P = 0.001). Further, PVAC GOLD ablations resulted in significantly fewer low-power (<3 W) ablations (15 vs. 23%, 5 vs. 10% and 2 vs. 7% in 4:1, 2:1, and 1:1 bipolar:unipolar energy modes, respectively). Mini-Mental State Exam was unchanged in all patients. CONCLUSION: Atrial fibrillation ablation with PVAC GOLD in combination with established embolic lowering manoeuvres results in a low incidence of ACE. Pulmonary vein ablation catheter GOLD demonstrates improved biophysical efficiency compared with platinum PVAC. TRIAL REGISTRATION: ClinicalTrials.gov NCT01767558.

A prospective randomized evaluation of the TriGuard™ HDH embolic DEFLECTion device during transcatheter aortic valve implantation: results from the DEFLECT III trial.

AIMS: To evaluate the safety, efficacy, and performance of the TriGuard™ HDH Embolic Deflection Device (TriGuard) compared with no cerebral protection in patients undergoing transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: From February 2014 to March 2015, 85 subjects undergoing TAVI at 13 centres in Europe and Israel were randomized to TriGuard protection vs. no protection. Subjects underwent neurologic and cognitive evaluation at baseline, pre-discharge and 30 days; cerebral diffusion-weighted magnetic resonance imaging was performed at 4 ± 2 days post-procedure and at 30 days. Technical success, which included complete 3-vessel cerebral coverage, was achieved in 88.9% (40/45) of cases. The primary in-hospital procedural safety endpoint (death, stroke, life-threatening or disabling bleeding, stage 2 or 3 acute kidney injury, or major vascular complications) occurred in 21.7% of TriGuard and 30.8% of control subjects (P = 0.34). In the Per Treatment population (subjects with complete three-vessel cerebral coverage), TriGuard use was associated with greater freedom from new ischaemic brain lesions (26.9 vs. 11.5%), fewer new neurologic deficits detected by the National Institutes of Health Stroke Scale (3.1 vs. 15.4%), improved Montreal Cognitive Assessment (MoCA) scores, better performance on a delayed memory task (P = 0.028) at discharge, and a >2-fold increase in recovery of normal cognitive function (MoCA score >26) at 30 days. CONCLUSION: TriGuard cerebral protection during TAVI is safe and complete cerebral vessel coverage was achieved in 89% of subjects. In this exploratory study, subjects undergoing protected TAVI had more freedom from ischaemic brain lesions, fewer neurologic deficits, and improved cognitive function in some domains at discharge and 30 days compared with controls.

[Treatment of acute heart failure]. / Therapie der akuten Herzinsuffizienz.

Acute heart failure is a symptom complex of heterogeneous etiology. Clinically, it comprises a broad spectrum ranging from hypertensive pulmonary edema in patients with preserved left ventricular systolic function up to cardiogenic shock in patients with severely depressed left ventricular function. The pathophysiology of acute heart failure is based on a mismatch between myocardial pump function and afterload. Besides causal measures, vasodilators and diuretics are the mainstay of therapy. Catecholamines are indicated only when other drugs are unsuccessful. Opioids are often used in clinical practice but should be used cautiously as they are associated with a negative prognosis. Further adjunctive treatment consists of thromboembolism prophylaxis, non-invasive ventilation and in some cases mechanical circulatory support and renal replacement therapy. This article discusses the differential use of these treatment modalities.

Cryoballoon versus RF ablation in paroxysmal atrial fibrillation: results from the German Ablation Registry.

BACKGROUND: Catheter ablation is used extensively with curative intention in atrial fibrillation. Radiofrequency ablation has long been a standard of care, while cryoballoon technology has emerged as a feasible approach with promising results. Prospective multicenter registry data referring to both ablation technologies in AF ablation therapy are lacking. METHODS: Between January 2007 and August 2011, a total of 3,775 consecutive patients with symptomatic paroxysmal AF who underwent PV ablation in their respective centers were enrolled. The cohort was divided into 2 groups according to the ablation energy source used: cryoballoon ablation (group 1, n = 905 [24.0%], median age 63 years, 64.3% men) and RF ablation (group 2, n = 2870 [76.0%], median age 63 years, 62.7% men). Comorbidities and baseline clinical characteristics were similar in both groups. RESULTS: Acute success rate was similar in both groups (97.5% in cryo vs 97.6% in RF; P = 0.81). Procedure times were similar, ablation and fluoroscopy times were higher in cryoballoon when compared to RF ablation. Overall complication rate was similar in cryo- (4.6%) and RF-ablation (4.6%; P = 1.0). Phrenic nerve palsy was more often in cryo versus RF ablation (2.1% in cryo vs 0.0% in RF; P < 0.001). Other complications were more common in RF compared to cryoablation (4.6% in RF vs 2.7% in cryo; P < 0.05). CONCLUSION: RF ablation is the most widespread ablation method in Germany, but use of cryoballoon increased significantly. Procedure times were similar, but ablation and fluoroscopy times were longer in cryoballoon ablation. No significant differences were found in terms of acute success and overall complication rate.

Impact of structural heart disease on the acute complication rate in atrial fibrillation ablation: results from the German Ablation Registry.

INTRODUCTION: Catheter ablation (CA) has emerged as a widespread therapeutic option in the treatment of atrial fibrillation (AF). Currently, no safety data with regard to the impact of the underlying structural heart diseases (SHD) are available. We sought to assess the risk for acute and long-term complications during CA of AF in relation to underlying SHD. METHODS AND RESULTS: We included 6,211 patients in a prospective registry undergoing CA of AF in 41 nationwide centers. All patients were divided into 4 groups according to the underlying heart disease: No SHD (69.4%), hypertensive heart disease (HHD) (12.0%), coronary artery disease (CAD) (15.1%), and cardiomyopathy (CM) (3.6%). In univariate analysis, patients with HHD had an overall complication rate of 7.28%, whereas patients without an SHD had a significantly lower rate of 6.01% (P < 0.01). Multivariate analysis revealed that HHD (adjusted odds ratio [OR]: 1.97 [95% confidence interval (CI): 1.02-3.83], P = 0.0442) and age (years; OR: 1.04 [95% CI: 1.01-1.07], P = 0.0155) were independent predictors of severe, nonfatal complications and death. Other SHD including CAD (OR: 1.48 (0.73-3.00), P = 0.2797) and CM (OR: 2.37 [0.70-7.99], P = 0.1630) failed to reach statistical significance. Male sex was protective (OR: 0.47 [95% CI: 0.27-0.81], P = 0.0062). CONCLUSION: In general, CA of AF has a low number of severe complications. In our prospective registry HHD emerged as an independent predictor of severe, nonfatal complications during AF ablation but other SHD including CAD and CM did not. The influence of HHD on the complication rate should be considered in patient selection.

Feasibility, safety, and short-term outcome of leadless ultrasound-based endocardial left ventricular resynchronization in heart failure patients: results of the wireless stimulation endocardially for CRT (WiSE-CRT) study.

AIMS: Left ventricular (LV) endocardial pacing may address the limitations in the selection of an LV pacing site and provide improvements in cardiac resynchronization therapy (CRT) effectiveness. We report on the feasibility, the safety, and the short-term outcome of a leadless ultrasound-based technology for LV endocardial resynchronization in heart failure (HF) patients enroled into the Wireless Stimulation Endocardially for CRT (WiSE-CRT) study. METHODS AND RESULTS: Seventeen HF patients were enroled and categorized as: (i) patients in whom attempted coronary sinus lead implantation for CRT had failed (n = 7); (ii) patients with a previously implanted CRT device, not responding to CRT (n = 2); and (iii) patients with previously implanted pacemakers or implantable cardioverter-defibrillator and meeting the standard indications for CRT (n = 8). System implantation was achieved in 13 patients (76.5%); mean R-wave amplitude was 5.6 ± 3.2 mV and the mean pacing threshold was 1.6 ± 1.0 V, respectively. In one patient, no sufficient pacing thresholds were found; in three patients pericardial effusion occurred. Biventricular pacing was recorded in 83% and 92% of the patients at 1 month and 6 months, respectively. QRS duration was shorter during biventricular pacing compared with right ventricular pacing at 1 month (-41 ms; P = 0.0002) and 6 months (-42 ms; P = 0.0011), respectively. At the 6-month follow-up, two-thirds of the patients had at least one functional class change. Left ventricular ejection fraction significantly increased (P < 0.01) by 6 points at the 6-month follow-up. CONCLUSION: The feasibility of providing an endocardial stimulation for CRT with a leadless technology was successfully demonstrated. Despite the promising results for a novel technology, further study is required to definitively conclude the safety and the performance of the system. CLINICAL TRIAL REGISTRATION INFORMATION: NCT01294527.

Impact of atrial fibrillation on 1-year outcome in patients with implantable cardioverter defibrillator or cardiac resynchronization therapy with defibrillator: results from the German DEVICE Registry.

Background: Atrial fibrillation (AF) is a cardiac arrhythmia frequently documented in patients requiring implantable cardioverter defibrillators (ICDs) and/or cardiac resynchronization therapy with defibrillator (CRT-D). Patients with diagnosed AF at the point of ICD or CRT-D implantation may have an impaired follow-up outcome. Methods: The German DEVICE I-II registry is a nationwide prospective multicentre database of patients implanted with ICD and CRT-D with clinical follow-up data. We analysed a 1-year follow up of implanted patients with AF and with sinus rhythm (SR). Results: A total of 4,929 ICD/CRT patients are included in the present analysis: 946 (19.2%) were in AF and 3,983 (80.8%) were SR at time of device implantation. AF patients had a significantly more comorbid profile including older age {72 [interquartile range (IQR), 66-77] vs. 66 (IQR, 56-73) years; P<0.001}, and higher rate of patients with left ventricular ejection fraction <30% (68.2% vs. 61.0%; P<0.001), peripheral artery disease (4.5% vs. 2.7%; P=0.002), diabetes (33.6% vs. 25.5%; P<0.001), hypertension (58.4% vs. 51.1%; P<0.001) and renal failure (22.6% vs. 15.3%; P<0.001). The intra-hospital complication rate was 4.3% in the AF and 3.6% in the SR group (P=0.38). In 1-year follow-up AF patients experienced a significantly higher rate of defibrillator shocks (25% vs. 15.3%; P<0.001). One-year estimated mortality was 10.8% in the AF and 5.9% in the SR group (P<0.001), while estimated 1-year major adverse cardiac and cerebrovascular events (MACCE) rate was 11.2% vs. 7.0% (P<0.001). The effects of AF on electrical shocks and mortality persisted after adjusting for age, sex, advanced New York Heart Association (NYHA) class, severely impaired left ventricular ejection fraction (LVEF), coronary artery disease (CAD), chronic obstructive pulmonary disease (COPD), diabetes mellitus (DM), chronic renal failure (CRF), QRS duration, and type of indication for electronic device implantation. Conclusions: Our clinical data on an extended cohort of contemporary patients confirm the significant impact of AF, and its associated comorbidities, upon mortality and major adverse events after implantation of ICD/CRT.

A Randomized Trial of Electrographic Flow-Guided Redo Ablation for Nonparoxysmal Atrial Fibrillation (FLOW-AF).

BACKGROUND: Electrographic flow (EGF) mapping enables full spatiotemporal reconstruction of organized wavefront propagation to identify extrapulmonary vein sources of atrial fibrillation (AF). OBJECTIVES: FLOW-AF (A Randomized Controlled Study to Evaluate the Reliability of the Ablacon Electrographic FLOW [EGF] Algorithm Technology [Ablamap Software] to Identify AF Sources and Guide Ablation Therapy in Patients With Persistent Atrial Fibrillation) was multicenter, randomized controlled study of EGF mapping to: 1) stratify a nonparoxysmal AF population undergoing redo ablation; 2) guide ablation of these extrapulmonary vein AF sources; and 3) improve AF recurrence outcomes. METHODS: FLOW-AF enrolled persistent atrial fibrillation (PerAF)/long-standing PerAF patients undergoing redo ablation at 4 centers. One-minute EGF maps were recorded from standardized biatrial basket positions. Patients with source activity ≥26.5% were randomized 1:1 to PVI + EGF-guided ablation vs PVI only; patients without sources ≥26.5% threshold were not randomized. Follow-up and electrocardiographic monitoring occurred at 3, 6, and 12 months. RESULTS: We enrolled 85 patients (age 65.6 ± 9.3 years, 37% female, 24% long-standing PerAF). Thirty-four (40%) patients had no sources greater than threshold; at least 1 source greater than threshold was present in 46 (60%) (EGF-guided ablation, n = 22; control group, n = 26). Patients with sources were older (68.2 vs 62.6 years; P = 0.005) with higher CHA2DS2-VASc scores (2.8 vs 1.9; P = 0.001). The freedom from safety events was 97.2%, and 95% of EGF-identified sources were successfully ablated. In randomized patients, AF-free survival at 12 months was 68% for EGF-guided ablation vs 17% for the control group (P = 0.042); freedom from AF/atrial tachycardia/atrial flutter at 12 months was 51% vs 14% (P = 0.103), respectively. CONCLUSIONS: In nonparoxysmal AF patients undergoing redo ablation, EGF mapping identified AF sources in 60% of patients, and could be successfully ablated in 95%. Compared with PVI alone, PVI + source ablation improved AF-free survival by 51% on an absolute basis. (FLOW-AF: A Study to Evaluate the Ablacon Electrographic FLOW EGF Technology [A Randomized Controlled Study to Evaluate the Reliability of the Ablacon Electrographic FLOW (EGF) Algorithm Technology (Ablamap Software) to Identify AF Sources and Guide Ablation Therapy in Patients With Persistent Atrial Fibrillation]; NCT04473963).

An entirely subcutaneous implantable cardioverter-defibrillator.

BACKGROUND: Implantable cardioverter-defibrillators (ICDs) prevent sudden death from cardiac causes in selected patients but require the use of transvenous lead systems. To eliminate the need for venous access, we designed and tested an entirely subcutaneous ICD system. METHODS: First, we conducted two short-term clinical trials to identify a suitable device configuration and assess energy requirements. We evaluated four subcutaneous ICD configurations in 78 patients who were candidates for ICD implantation and subsequently tested the best configuration in 49 additional patients to determine the subcutaneous defibrillation threshold in comparison with that of the standard transvenous ICD. Then we evaluated the long-term use of subcutaneous ICDs in a pilot study, involving 6 patients, which was followed by a trial involving 55 patients. RESULTS: The best device configuration consisted of a parasternal electrode and a left lateral thoracic pulse generator. This configuration was as effective as a transvenous ICD for terminating induced ventricular fibrillation, albeit with a significantly higher mean (+/-SD) energy requirement (36.6+/-19.8 J vs. 11.1+/-8.5 J). Among patients who received a permanent subcutaneous ICD, ventricular fibrillation was successfully detected in 100% of 137 induced episodes. Induced ventricular fibrillation was converted twice in 58 of 59 patients (98%) with the delivery of 65-J shocks in two consecutive tests. Clinically significant adverse events included two pocket infections and four lead revisions. After a mean of 10+/-1 months, the device had successfully detected and treated all 12 episodes of spontaneous, sustained ventricular tachyarrhythmia. CONCLUSIONS: In small, nonrandomized studies, an entirely subcutaneous ICD consistently detected and converted ventricular fibrillation induced during electrophysiological testing. The device also successfully detected and treated all 12 episodes of spontaneous, sustained ventricular tachyarrhythmia. (ClinicalTrials.gov numbers, NCT00399217 and NCT00853645.)

Electrographic flow-guided ablation in redo patients with persistent atrial fibrillation (FLOW-AF): design and rationale.

Background: Electrographic flow (EGF) mapping enables the dynamic detection of functional or active atrial fibrillation (AF) sources outside the pulmonary veins (PVs), and the presence or absence of these sources offers a novel framework for classifying and treating persistent AF patients based on the underlying pathophysiology of their AF disease. Objective: The primary objective of the FLOW-AF trial is to evaluate the reliability of the EGF algorithm technology (Ablamap software) to identify AF sources and guide ablation therapy in patients with persistent AF. Methods: The FLOW-AF trial (NCT04473963) is a prospective, multicenter, randomized clinical study in which patients with persistent or long-standing persistent AF who have failed prior PV isolation (PVI) undergo EGF mapping after confirmation of intact PVI. In total, 85 patients will be enrolled and stratified based on the presence or absence of EGF-identified sources. Patients with an EGF-identified source above the predetermined activity threshold of ≥26.5% will be randomized in a 1:1 fashion to PVI only vs PVI + ablation of EGF-identified extra-PV sources of AF. Results: The primary safety endpoint is freedom from serious adverse events related to the procedure through 7 days following the randomization procedure; and the primary effectiveness endpoint is the successful elimination of significant sources of excitation with the target parameter the activity of the leading source. Conclusions: The FLOW-AF trial is a randomized study designed to evaluate the ability of the EGF mapping algorithm to identify patients with active extra-PV AF sources.