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Competing Interests: Armin Steffen is study investigator and received honoraria and travel expenses for invited talks on behalf of Inspire Medical, Inc., outside the submitted work. Armin Steffen is a consultant for Merz Pharmaceuticals and Respicardia, Inc.

The new European Society of Cardiology (ESC) guidelines on cardiac pacing and cardiac resynchronization therapy were presented together with the new ESC heart failure guidelines at the ESC congress in September. The new document includes detailed sections on patient evaluation and clinical assessment, implantation, minimizing complications and patient follow-up. The guidelines have been updated and expanded particularly on the approach to reflex syncope, the indications after transcatheter aortic valve implantation (TAVI) and the perioperative management. The indications for cardiac resynchronization therapy (CRT) are now in line with the simultaneously published ESC heart failure guidelines. New physiological forms of stimulation and leadless pacing are now included in the guidelines., (© 2022. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Aims: To evaluate outcomes of percutaneous left atrial appendage closure (LAAC) in patients with congestive heart failure (CHF) and non-valvular atrial fibrillation (AF) in a consecutive, industry-independent registry associated with periprocedural success and complications during long-term follow-up., Methods and Results: For this analysis, we included patients who underwent transcatheter LAAC from January 2014 to December 2019 at the University Heart Center in Lübeck, Germany, and compared patients with presence of CHF defined as patients with a reduced left ventricular ejection fraction (LVEF ≤ 40%), patients with a mid-range LVEF (LVEF 41-49%), patients with diastolic dysfunction and preserved LVEF (LVEF ≥ 50%), and patients with right-sided heart failure and impaired right ventricular function (tricuspid annular plane systolic excursion < 17) to patients undergoing LAAC with no CHF. Primary endpoints were defined as periprocedural complications, and complications during long-term follow-up presented as major adverse cardiac and cerebrovascular events (MACCE). A total of 300 consecutive patients underwent LAAC. Of these, 96 patients in the CHF group were compared with 204 patients in the non-CHF group. Implantation success was lower in CHF group in comparison with non-CHF group (99.5% vs. 96%, P = 0.038); otherwise, there were no differences in periprocedural complications between groups. Patients with CHF showed a significantly higher incidence of MACCE rate (31.9% vs. 15.1%, P = 0.002) and more deaths (24.2% vs. 7%, P ≤ 0.001) during long-term follow-up. In Cox multivariable regression analysis, CHF was an independent predictor of mortality after LAAC implantation at long-term follow-up (hazard ratio 3.23, 95% confidence intervals 1.52-6.86, P = 0.002)., Conclusions: Implantation of LAAC devices in patients with non-valvular AF and CHF is safe. The increased mortality in patients with CHF compared with patients without CHF during the long-term follow-up is mainly attributed to comorbidities associated with CHF., (© 2021 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Heart failure (HF) will be one of the biggest medical challenges in the coming years, with increasing prevalence in an aging society. It is associated with a poor prognosis and impaired quality of life-despite steadily improving medical therapy which has resulted in a steady decrease in mortality and an increase in quality of life. In medically refractory patients with impaired left ventricular (LV) function, left bundle branch block and wide QRS complex (≥130 ms) cardiac resynchronization therapy (CRT) in addition to medical therapy has become the gold standard. Additionally, other therapeutic modalities such as vagal stimulation are being clinically tested but as yet have no general therapeutic recommendation. Overall, CRT patients represent only one-third of all HF patients and about 25% are "non-responders" who do not benefit from CRT.In HF patients with an LVEF between 25 and 45% and a QRS duration <130 ms who are not suitable for CRT, cardiac contractility modulation (CCM) is currently a therapeutic option that has been shown in several randomized trials to be efficacious and safe. It reduces the frequency of HF hospitalizations and improves HF symptoms, functional capacity, and quality of life. The goal of this article is to present mechanisms of action, major clinical studies, current indications, and recent developments of CCM for the treatment of patients with chronic HF., (© 2021. Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Background: Recently, the Food and Drug Administration issued a recall for the subcutaneous implantable cardioverter-defibrillator (S-ICD) because of the possibility of lead ruptures and accelerated battery depletion., Objective: The aim of this study was to evaluate device-related complications over time in a large real-world multicenter S-ICD cohort., Methods: Patients implanted with an S-ICD from January 2015 to June 2020 were enrolled from a 19-institution European registry (Experience from the Long-term Italian S-ICD registry [ELISIR]; ClinicalTrials.gov identifier NCT0473876). Device-related complication rates over follow-up were collected. Last follow-up of patients was performed after the Boston Scientific recall issue., Results: A total of 1254 patients (median age 52.0 [interquartile range 41.0-62.2] years; 973 (77.6%) men; 387 (30.9%) ischemic) was enrolled. Over a follow-up of 23.2 (12.8-37.8) months, complications were observed in 117 patients (9.3%) for a total of 127 device-related complications (23.6% managed conservatively and 76.4% required reintervention). Twenty-seven patients (2.2%) had unanticipated generator replacement after 3.6 (3.3-3.9) years, while 4 (0.3%) had lead rupture. Body mass index (hazard ratio [HR] 1.063 [95% confidence interval 1.028-1.100]; P < .001), chronic kidney disease (HR 1.960 [1.191-3.225]; P = .008), and oral anticoagulation (HR 1.437 [1.010-2.045]; P = .043) were associated with an increase in overall complications, whereas older age (HR 0.980 [0.967-0.994]; P = .007) and procedure performed in high-volume centers (HR 0.463 [0.300-0.715]; P = .001) were protective factors., Conclusion: The overall complication rate over 23.2 months of follow-up in a multicenter S-ICD cohort was 9.3%. Early unanticipated device battery depletions occurred in 2.2% of patients, while lead fracture was observed in 0.3%, which is in line with the expected rates reported by Boston Scientific., (Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: To date, only a few comparisons between subcutaneous implantable cardioverter-defibrillator (S-ICD) patients undergoing and those not undergoing defibrillation testing (DT) at implantation (DT+ vs DT-) have been reported., Objective: The purpose of this study was to compare long-term clinical outcomes of 2 propensity-matched cohorts of DT+ and DT- patients., Methods: Among consecutive S-ICD patients implanted across 17 centers from January 2015 to October 2020, DT- patients were 1:1 propensity-matched for baseline characteristics with DT+ patients. The primary outcome was a composite of ineffective shocks and cardiovascular mortality. Appropriate and inappropriate shock rates were deemed secondary outcomes., Results: Among 1290 patients, a total of 566 propensity-matched patients (283 DT+; 283 DT-) served as study population. Over median follow-up of 25.3 months, no significant differences in primary outcome event rates were found (10 DT+ vs 14 DT-; P = .404) as well as for ineffective shocks (5 DT- vs 3 DT+; P = .725). At multivariable Cox regression analysis, DT performance was associated with a reduction of neither the primary combined outcome nor ineffective shocks at follow-up. A high PRAETORIAN score was positively associated with both the primary outcome (hazard ratio 3.976; confidence interval 1.339-11.802; P = .013) and ineffective shocks alone at follow-up (hazard ratio 19.030; confidence interval 4.752-76.203; P = .003)., Conclusion: In 2 cohorts of strictly propensity-matched patients, DT performance was not associated with significant differences in cardiovascular mortality and ineffective shocks. The PRAETORIAN score is capable of correctly identifying a large percentage of patients at risk for ineffective shock conversion in both cohorts., (Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

A 80-year-old female patient with symptomatic atrial tachycardia develops cold sweat and hypotension in the recovery room after pulmonary vein isolation. The procedure included an anterior line and an endo- and epicardial mitral isthmus line. Echocardiography excluded a hemodynamically relevant pericardial effusion. The patient's symptoms deteriorated over time. A rare cause was found., (© 2021. Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

BACKGROUND Treatment of atrial fibrillation and atrial tachycardia (AT) with catheter ablation results in high rates of success with the procedure and on long-term follow-up. A novel ablation catheter with a very high-power, short-duration (vHPSD) ablation mode using 90 W for 4 s has been introduced, which could improve safety and efficacy of catheter ablation, especially for pulmonary vein isolation (PVI). To date, vHPSD mode has only been evaluated for treatment of PVI, but it could be an efficient technique for linear lesions. Here, we present the first use of the novel vHPSD mode alone for catheter ablation in a patient with peri-mitral AT (PMAT). CASE REPORT A 74-year-old man presented with symptomatic AT. An electroanatomic reconstruction of his left atrium showed PMAT with a potential critical isthmus on the anterior wall. Therefore, ablation of an anterior line was performed. The patient's AT stopped after 10 applications and less than 40 s of radiofrequency (RF) ablation. Afterward, the anterior line was completed with a total of 29 applications of vHPSD and a RF time of 116 s. PVI and blockage of the cavotricuspid isthmus also were performed. The total procedure time was 107 min. No periprocedural complications occurred. CONCLUSIONS The present case demonstrates the safety and efficacy of treatment of AT with a novel catheter that delivers vHPSD ablation to an anterior line.

Introduction: The PRAETORIAN score (PS) was developed to assess the implant position and predict defibrillation success of the subcutaneous implantable cardioverter defibrillators (S-ICD). The main critique moved to the routine use of PS has been its postprocedural timing, that limits its usefulness on procedure guidance. The aim of this proof-of-concept study was to assess the feasibility of an intraprocedural use of PS., Methods: Forty consecutive patients undergoing S-ICD implantation were enrolled. Intraprocedural PS (IP-PS) obtained with fluoroscopy before closure of the pocket and postprocedural PS (PP-PS) obtained with two-views chest X-ray were compared. Intraprocedural data and PS were compared with the historic cohorts of the involved institutions., Results: When assessing IP-PS and PP-PS, a complete overall agreement was observed (100%, 1.00-κ; p < .001). When assessing a per-step agreement, a very high-degree of concordance in evaluating Step 1 of the PS was observed (95%, 0.81-κ; p < .001). A complete agreement in Step 2-3 (100%, 1.00-κ; p < .001) of the PS was reported. In comparison with our historical cohort, procedural time in the IP-PS cohort did not increase (45 [41-52] vs. 45 [39-49] min; p = .351) while the expected increase in fluoroscopy time resulted scarce (15 [10-15] s)., Conclusion: An IP-PS can be reliably obtained using fluoroscopy guidance during S-ICD implantation, without a significant increase in procedural duration and may serve as guidance for implanting physicians, to avoid postprocedural S-ICD repositioning, leading to patient discomfort and significantly enhancing infective risks. IP-PS showed a very high agreement with the PP-PS obtained from two-views chest X-ray., (© 2021 Wiley Periodicals LLC.)

Background: Data reporting a head-to-head comparison between Amulet and Watchman devices are scarce. The aim of this study was to compare the Watchman™ versus Amulet™ left atrial appendage closure (LAAC) devices in a consecutive, industry-independent registry., Methods: Patients who underwent LAAC using Watchman or Amulet devices from January 2014 to December 2019 at the University Heart Center Lübeck, Lübeck, Germany were included in the present analysis. Primary endpoints included periprocedural complications (in-hospital death, pericardial tamponade, device embolization, stroke, major bleeding and vascular access complications), and complications during long-term follow-up (ischemic stroke, hemorrhagic stroke, thromboembolism, device thrombus, bleeding and death)., Results: After matching the patients for age (±5 years), gender, CHA2DS2Vasc score (±1) and HASBLED score (±1), each of the Watchman and the Amulet groups included 113 patients. Patients in the Amulet group had significantly more periprocedural complications (2.7% vs 10.6%, p = 0.029; respectively) and more major bleeding complications (0% vs 5.3%, p = 0.029; respectively). During long-term follow-up, the rate of events was comparable between the Watchman and Amulet groups (18.3% versus 20.8%, p = 0.729; respectively)., Conclusion: Amulet LAAC device was associated with increased periprocedural complications as compared to Watchman LAAC device. On long-term follow-up, both devices showed comparable efficacy and safety., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: RRT: consultant to Boston Scientific, speaker‘s bureau: Boston Scientific, Abbot Medical. MS: proctor in Boston Scientific for Watchman 2.5 and Watchman FLX. All other authors declare no competing financial and/or non-financial interests in relation to the work described., (© 2021 The Author(s).)

Aims: Weight management seems to be beneficial for obese atrial fibrillation (AF) patients; however, randomized data are sparse. Thus, this study aimed to investigate the influence of weight reduction on AF ablation outcomes., Methods and Results: SORT-AF is an investigator-sponsored, prospective, randomized, multicentre, and clinical trial. Patients with symptomatic AF (paroxysmal or persistent) and body mass index (BMI) 30-40 kg/m2 underwent AF ablation and were randomized to either weight-reduction (group 1) or usual care (group 2), after sleep-apnoea-screening and loop recorder (ILR) implantation. The primary endpoint was defined as AF burden between 3 and 12 months after AF ablation. Overall, 133 patients (60 ± 10 years, 57% persistent AF) were randomized to group 1 (n = 67) and group 2 (n = 66), respectively. Complications after AF-ablation were rare (one stroke and no tamponade). The intervention led to a significant reduction of BMI (34.9 ± 2.6-33.4 ± 3.6) in group 1 compared to a stable BMI in group 2 (P < 0.001). Atrial fibrillation burden after ablation decreased significantly (P < 0.001), with no significant difference regarding the primary endpoint between the groups (P = 0.815, odds ratio: 1.143, confidence interval: 0.369-3.613). Further analyses showed a significant correlation between BMI and AF recurrence for patients with persistent AF compared with paroxysmal AF patients (P = 0.032)., Conclusion: The SORT-AF study shows that AF ablation is safe and successful in obese patients using continuous monitoring via ILR. Although the primary endpoint of AF burden after ablation did not differ between the two groups, the effects of weight loss and improvement of exercise activity were beneficial for obese patients with persistent AF demonstrating the relevance of life-style management as an important adjunct to AF ablation in this setting., Trial Registration Number: NCT02064114., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Introduction: A growing body of evidence suggests a strong association between atrial fibrillation (AF) and cancer. A relevant number of patients with a present or former malignant disease with highly symptomatic drug-refractory AF are in need of interventional therapy. Data on the safety and efficacy of catheter ablation in these patients are sparse. The present study aims to analyze the safety and efficacy of cryoballoon-based pulmonary vein isolation (CB-PVI) for symptomatic AF in patients with past or present cancer disease., Methods and Results: Consecutive patients undergoing CB-PVI for symptomatic AF at University Hospital Lübeck, Germany between July 2015 and January 2019 were included in this study. Propensity-score based matching was performed to identify comparable patients with and without cancer disease and further analyze clinical characteristics, periprocedural complications and arrhythmia-free survival. A total of 70 patients with a history of cancer undergoing CB-PVI were matched to 70 patients without a history of cancer. The frequency of complications was similar between patients with and without a history of cancer ( p = 0.11), with four phrenic nerve palsies occurring in patients with a history of cancer (5.6% of the cohort) vs. one phrenic nerve palsy in patients without cancer ( p = 0.36). Arrhythmia free survival after 12 months did not differ significantly in patients with and without a history of cancer (67.1 ± 5.8% vs. 77.8% ± 5.1%, p = 0.16)., Conclusion: This study indicates that CB-PVI for symptomatic AF is equally safe and effective in patients with and without a history of cancer and cancer treatment.

We report a case of percutaneous epicardial left atrial appendage exclusion in a patient with the atrial septal closure., Competing Interests: R. R. Tilz received travel grants from SentreHeart. The other authors have nothing to disclose., (© 2021 The Authors. Journal of Arrhythmia published by John Wiley & Sons Australia, Ltd on behalf of Japanese Heart Rhythm Society.)

Purpose: Studies on predictive scores for very late recurrence (VLR) (recurrence later than 12 months) after second-generation cryoballoon-based pulmonary vein isolation (CB2-PVI) are sparse. We aimed to evaluate the frequency of late recurrence (LR) (later than 3 months) and VLR, and to validate predictive scores for LR and VLR after initial CB2-PVI., Methods: A total of 288 patients undergoing initial CB2-PVI (66 ± 11 years, 46% paroxysmal) were retrospectively enrolled in the LR cohort. In the VLR cohort, 83 patients with recurrence within 3-12 months or with < 12-month follow-up were excluded. The predictive scores of arrhythmia recurrence were assessed, including the APPLE, DR-FLASH, PLAAF, BASE-AF 2 , ATLAS, SCALE-CryoAF, and MB-LATER scores., Results: During a mean follow-up of 15.3 ± 7.1 months, 188 of 288 (65.2%) patients remained in sinus rhythm without any recurrences. Thirty-two of 205 (15.6%) patients experienced VLR after a mean of 16.6 ± 5.6 months. Comparing the predictive values of these specific scores, the MB-LATER score showed a reliable trend toward greater risk of both LR and VLR (area under the curve in LR; 0.632, 0.637, 0.632, 0.637, 0.604, 0.725, and 0.691 (p = ns), VLR; 0.612, 0.636, 0.644, 0.586, 0.541, 0.633, and 0.680 (p = 0.038, vs. BASE-AF 2 , respectively)). Kaplan-Meier analysis estimated patients with higher MB-LATER scores which had favorable outcomes (24-month freedom from LR; 26.0% vs. 56.7%, p < 0.0001, VLR; 53.4% vs. 82.1%, p = 0.013)., Conclusion: The MB-LATER score provided more reliable predictive value for both LR and VLR. Patients with higher MB-LATER scores may benefit from more intensive long-term follow-up., (© 2020. The Author(s).)

Background: Catheter ablation for atrial fibrillation (AF) treatment provides effective and durable pulmonary vein isolation (PVI) and is associated with encouraging clinical outcome. A novel CF sensing temperature-controlled radiofrequency (RF) ablation catheter allows for very high-power short-duration (vHP-SD, 90 W/4 s) ablation aiming a potentially safer, more effective and faster ablation. We thought to evaluate preliminary safety and efficacy of vHP-SD ablation for PVI utilizing a novel vHP-SD catheter. The data was compared to conventional power-controlled ablation index (AI) guided PVI utilizing conventional contact force (CF) sensing catheters., Methods and Results: Fifty-six patients with paroxysmal or persistent AF were prospectively enrolled in this study. Twenty-eight consecutive patients underwent vHP-SD based PVI (vHP-SD group) and were compared to 28 consecutive patients treated with conventional CF-sensing catheters utilizing the AI (control group). All PVs were successfully isolated using vHP-SD. The median RF ablation time for vHP-SD was 338 (IQR 286, 367) seconds vs control 1580 (IQR 1350, 1848) seconds (p < 0.0001), the median procedure duration was vHP-SD 55 (IQR 48-60) minutes vs. control 105 (IQR 92-120) minutes (p < 0.0001). No differences in periprocedural complications were observed., Conclusions: This preliminary data of the novel vHP-SD ablation mode provides safe and effective PVI. Procedure duration and RF ablation time were substantially shorter in the vHP-SD group in comparison to the control group., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: CHH received travel grants and research grants by Boston Scientific, Biosense Webster and Cardiofocus and Speakeŕs Honoraria from Boston Scientific, Biosense Webster and Cardiofocus. RRT is a consultant of Boston Scientific, Biotronik and Biosense Webster and received Speakeŕs Honoraria from Biosense Webster, Medtronic, Boston Scientific and Abbot Medical. KHK reports grants and personal fees from Abbott Vascular,. Medtronic, Biosense Webster outside submitted work. All other authors have no relevant disclosures., (© 2021 Published by Elsevier B.V.)

Background: The arctic front cryoballoon (AF-CB) provides effective and durable pulmonary vein isolation (PVI) associated with encouraging clinical outcome. The POLARx cryoballoon incorporates unique features and design changes that may translate into improved efficacy, safety and further simplified balloon-based procedures. Efficacy and safety of the novel POLARx cryoballoon was compared to the fourth generation AF-CB (AF-CB4)., Methods and results: Twenty-five consecutive patients with paroxysmal or persistent atrial fibrillation were prospectively enrolled, underwent POLARx-based PVI (POLARx group) and were compared to 25 consecutive patients treated with the AF-CB4 (AF-CB4 group). All PVs were successfully isolated utilizing the POLARx and AF-CB4. A significant difference regarding the mean minimal cryoballoon temperatures reached using the AF-CB4 and POLARx (-50±6℃ vs. -57±7℃, P=0.004) was observed. Real-time PVI was visualized in 81% of POLARx patients and 42% of AF-CB4 patients (P<0.001). Utilizing the POLARx, a trend towards shorter median procedure time (POLARx: 45 [39, 53] min vs. AF-CB4: 55 [50, 60] min; P=0.062) was found. No differences were observed between AF-CB4 and POLARx concerning catheter maneuverability, catheter stability and periprocedural complications., Conclusions: The novel POLARx showed similar safety and efficacy compared to the AF-CB4. A higher rate of real-time PV recordings and significantly lower minimal balloon temperatures were observed using the POLARx.

Background: The second-generation cryoballoon (CB2) provides effective and durable pulmonary vein isolation (PVI) associated with encouraging clinical outcome. The novel fourth-generation cryoballoon (CB4) incorporates a 40% shorter distal tip. This design change may translate into an increased rate of PVI real-time signal recording, facilitating an individualized ablation strategy using the time to effect (TTE)., Methods and Results: Three hundred consecutive patients with paroxysmal or persistent atrial fibrillation were prospectively enrolled. The first 150 consecutive patients underwent CB2 based PVI (CB2 group) and the last 150 consecutive patients were treated with the CB4 (CB4 group). A total of 594/594 (100%, CB4) and 589/594 (99.2%, CB2) pulmonary veins (PVs) were successfully isolated utilizing the CB4 and CB2, respectively (p = .283). The real-time PVI visualization rate was 47% (CB4) and 39% (CB2; p = .005) and the mean freeze cycle duration 200 ± 90 s (CB4) and 228 ± 110 s (CB2; p < .001), respectively. The total procedure time did not differ between the groups (CB4: 64 ± 32 min) and (CB2: 62 ± 29 min, p = .370). No differences in periprocedural complications were detected., Conclusions: A higher rate of real-time electrical PV recordings are seen using the CB4 as compared to CB2, which may facilitate an individualized ablation strategy using the TTE., (© 2021 The Authors. Journal of Cardiovascular Electrophysiology Published by Wiley Periodicals LLC.)

Aims: Pulmonary vein isolation (PVI) is the gold standard for atrial fibrillation (AF) ablation. Recently, catheter ablation targeting rotors or focal sources has been developed for treatment of AF. This study sought to compare the safety and effectiveness of Focal Impulse and Rotor Modulation (FIRM)-guided ablation as the sole ablative strategy with PVI in patients with paroxysmal AF., Methods and Results: We conducted a multicentre, randomized trial to determine whether FIRM-guided radiofrequency ablation without PVI (FIRM group) was non-inferior to PVI (PVI group) for treatment of paroxysmal AF. The two primary efficacy end points were (i) acute success defined as elimination of AF rotors (FIRM group) or isolation of all pulmonary veins (PVI group) and (ii) long-term success defined as single-procedure freedom from AF/atrial tachycardia (AT) recurrence 12 months after ablation. The study was closed early by the sponsor. At the time of study closure, any pending follow-up visits were waived. A total of 51 patients (mean age 63 ± 10.6 years, 57% male) were enrolled. All PVs were successfully isolated in the PVI group and all rotors were successfully eliminated in the FIRM group. Single-procedure effectiveness was 31.3% (5/16) in the FIRM group and 80% (8/10) in the PVI group at 12 months. Three vascular access complications occurred in the FIRM group., Conclusion: These partial study effectiveness results reinforce the importance of PVI in paroxysmal AF patients and indicate that FIRM-guided ablation alone (without PVI) is not an effective strategy for treatment of paroxysmal AF in most patients., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Cardiology.)

We demonstrated that phospholipid-free small unilamellar vesicles (PFSUVs) composed of TWEEN 80 and cholesterol (25/75, mol%) could be fabricated using a staggered herringbone micromixer with precise controlling of their mean size between 54 nm and 147 nm. Increasing the temperature or decreasing the flow rate led to an increase in the resulting particle diameter. In zebrafish embryos, 120-nm PFSUVs showed 3-fold higher macrophage clearance compared to the 60-nm particles, which exhibited prolonged blood circulation. In mice, the 60-nm particles showed dominant accumulation in the liver hepatocytes (66% hepatocytes positive), while the 120-nm particles were delivered equally to the liver and spleen macrophages. Accordingly, in a murine model of acetaminophen-induced hepatotoxicity the 60-nm particles loaded with chlorpromazine reduced the serum alanine aminotransferase level and liver necrosis 2- to 4-fold more efficiently than their 120-nm counterparts and the free drug, respectively. This work showed that the intra-liver distribution of PFSUVs was largely determined by the size. Most other nanoparticles published to date are predominantly cleared by the liver Kupffer cells. The 60-nm PFSUVs, on the other hand, focused the delivery to the hepatocytes with significant advantages for the therapy of liver diseases., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Introduction: Cardiac sympathetic denervation (CSD) is an effective therapy for selected patients with drug refractory ventricular arrhythmias (VA). Data about the role of CSD in patients with structural heart disease and VAs are sparse. We herein present our experience of CSD in patients with nonischemic cardiomyopathy and VAs despite prior ablation procedure and/or antiarrhythmic drug (AAD) therapy., Methods: A total of ten patients (mean age 61.6 ± 19.6, mean LVEF 29.5 ± 12.1%) with nonischemic dilated cardiomyopathy (NICM) (n = 9) and hypertrophic cardiomyopathy (HCM) (n = 1) underwent CSD (left sided in six and bilateral in four patients) due to refractory VA despite multiple AADs (mean number of AADs was 1.6 ± 0.7) and prior VT ablation (mean number of procedures per patient was 1.5 ± 1.3)., Results: Mean follow-up was 10.1 ± 6.9 months. The median number of VA and ICD shocks decreased significantly from 9.0 and 2.5 episodes 6 months prior to CSD to 0 and 0 episodes within 6 months after CSD (p = 0.012 and p = 0.011). Five patients remained free from sustained VA recurrences. Two patients experienced single ICD shock due to a polymorphic VT (triggered by severe hypokalemia in one patient) and one patient a single shock due to monomorphic VT. One patient had five episodes of slow VT under amiodarone therapy (three of them terminated by antitachycardia pacing) and underwent endo- epicardial re-ablation. Two patients died 1 month after CSD. One of them due to electrical storm and cardiogenic shock and the second one due to refractory cardiogenic shock, without recurrence of VAs though. No major complications of CSD occurred. No patient suffered from Horner syndrome., Conclusion: In this study, CSD was effective for treatment of VAs in patients with structural heart disease refractory to antiarrhythmic drugs and catheter ablation. Further larger studies are required to confirm these findings.

Objectives: This study sought to evaluate the safety and effectiveness of electrical isolation of the left atrial appendage (LAAEI) as well as the status of left atrial appendage closure (LAAC) in these patients., Background: Catheter-based LAAEI is increasingly performed for treatment of symptomatic atrial fibrillation and pulmonary vein isolation nonresponders. Previous studies indicate an increased incidence of thromboembolic events after LAAEI despite effective oral anticoagulation. Interventional LAAC may prevent cardioembolic events after LAAEI but data regarding safety, feasibility, and efficacy of LAAC in this clinical setting are scarce., Methods: Consecutive patients who underwent LAAEI at 2 German tertiary care hospitals were analyzed., Results: A total of 270 patients underwent LAAEI by radiofrequency ablation in 255 (94.4%), cryoballoon ablation in 12 (4.4%), and by a combination of both techniques in 3 cases (1.1%). Stroke or transient ischemic attack occurred in 24 of 244 (9.8%) individuals with available follow-up. LAA thrombus formation was found in 53 patients (19.6%). A total of 150 patients underwent LAAC after LAAEI. No LAA thrombus was documented in any patient who underwent LAAC. Of the patients who underwent LAAEI, 67.6% were in sinus rhythm after a mean of 682.7 ± 61.7 days. LAA flow after LAAEI but not arrhythmia recurrence was identified as an independent predictor of stroke and/or transient ischemic attack or LAA thrombus (p < 0.0001)., Conclusions: Sinus rhythm was documented in about two-third of patients undergoing LAAEI as treatment of therapy refractory atrial arrhythmias. LAAC potentially prevents LAA thrombus formation and thromboembolism., Competing Interests: Author Disclosures Dr. Fink received travel grants from SentreHeart. Dr. Heeger has received travel grants and research grants from Medtronic, Claret Medical, SentreHeart, Biosense Webster, and Cardiofocus; and has received speaker honoraria from Cardiofocus, Medtronic, and Novartis. Dr. Eitel has received speaker honoraria from Bayer, Biosense Webster, Impulse Dynamic, St. Jude Medical/Abbott, Pfizer, Liva Nova, Zoll, Boston Scientific, Novartis, Daiichi Sankyo, and AstraZeneca; and has received travel grants from St. Jude Medical, Biotronik, and Medtronic. Dr. Rillig has received travel grants from Biosense, Hansen Medical, EP Solutions, Medtronic, and St. Jude Medical; has received lecture fees from St. Jude Medical, Medtronic, and Boehringer Ingelheim; and took part in the Boston Scientific electrophysiology fellowship. Dr. Mathew has received speaker honoraria and travel grants from Medtronic. Dr. Metzner has received speaker honoraria and travel grants from Medtronic. Prof. Kuck received research grants and personal fees from St. Jude Medical, Medtronic, and Biosense Webster. Prof. Tilz has received research grants from Medtronic and Biotronik; received travel grants from Biosense Webster, Medtronic, Abbott, SentreHeart, and Daiichi Sankyo; received Speakers Bureau and/or proctor honoraria from Biosense Webster, Medtronic, Abbott, SentreHeart, and Daiichi Sankyo; and has served as a consultant of Biosense Webster and Biotronik. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Catheter ablation of atrial fibrillation (AF) in patients with pulmonary lobectomy or pneumectomy is challenging due to anatomical alterations. After lung resection, electrically active pulmonary vein (PV) stumps remain and need to be localized for PV isolation (PVI). The present study aims to describe clinical challenges of PVI in patients with pulmonary lobectomy or pneumectomy., Methods: We performed a retrospective study on 19 patients with previous pulmonary lobectomy or pneumectomy undergoing catheter ablation for AF in three German hospitals., Results: Nineteen patients with paroxysmal, persistent, or longstanding-persistent AF and history of pulmonary lobectomy (n = 11) or pneumectomy (n = 8) were enrolled. Catheter ablation was performed as radiofrequency (RF) ablation using 3D mapping, robotic RF ablation, or by using balloon devices. Decent anatomical changes were observed in patients with lobectomy while cardiac rotation and mediastinal shifting was dominant in patients with pneumectomy. Visualization of all PVs including PV stumps by PV angiography was possible in 10 of 19 patients (52.6%). PV spikes were observed in all identified PV remnants. In nine patients (47.4%), at least one PV remnant could not be identified and electrical isolation was not performed. During 24 months follow-up, patients with incomplete PVI had a significantly shorter arrhythmia-free survival than patients with complete PVI (76.2% [95% Confidence interval (CI) 47.2-100.0%] vs 40.0% [95% CI 5.6-74.1%], P = .043)., Conclusion: In patients with AF and previous lobectomy or pneumectomy, identification and isolation of all PVs are challenging but crucial for ablation success. Additional imaging techniques may be necessary to achieve complete PVI., (© 2020 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals LLC.)

Aims: Left atrial appendage (LAA) electrical isolation (LAAEI) in addition to pulmonary vein isolation is an emerging catheter-based therapy to treat symptomatic atrial fibrillation. Previous studies found high incidences of LAA thrombus formation after LAAEI. This study sought to analyse therapeutic strategies aiming at the resolution of LAA thrombi and prevention of thromboembolism., Methods and Results: Left atrial appendage electrical isolation was conducted via creation of left atrial linear lesions or cryoballoon ablation. Follow-up including transoesophageal echocardiography was conducted. In patients with LAA thrombus, oral anticoagulation (OAC) was adjusted until thrombus resolution was documented. Percutaneous LAA closure (LAAC) under use of a cerebral protection device was conducted in case of medically refractory LAA thrombi. Left atrial appendage thrombus was documented in 54 of 239 analysed patients who had undergone LAAEI. Thrombus resolution was documented in 39/51 patients (72.2%) with available follow-up after adjustment of OAC. Twenty-nine patients underwent LAAC and 10 patients were kept on OAC after LAAEI. No thromboembolic events or further LAA thrombi were documented after 553 ± 443 days of follow-up in these patients. Persistent LAA thrombi despite adaption of OAC was documented in 12/51 patients. One patient remained on OAC until the end of follow-up, while LAAC with a cerebral protection device was performed in 11 patients in the presence of LAA thrombus without complications., Conclusion: Left atrial appendage thrombus formation is common after LAAEI. Adjustment of OAC leads to LAA thrombus resolution in most patients. Left atrial appendage closure in the presence of LAA thrombi might be a feasible option in case of failed medical treatment., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)

Background: Balloon-based ablation systems for pulmonary vein isolation (PVI) are providing procedural safety and efficacy as well as favourable clinical outcome. Although second-generation laser balloon (LB2) based PVI has been shown safety and efficacy relatively long procedural duration was a strong limitation. The third-generation laser balloon (LB3) offers and automized ablation for rapid PVI. We determined safety, efficacy and procedural characteristics of this new promising ablation system., Methods and Results: A total of 15 consecutive patients were prospectively enrolled. All patients underwent PVI using the LB3. A total 59/59 PVs (100%) were successfully isolated. Procedural data was compared to the last 15 consecutive patients treated by the LB2. The median procedure time significantly declined from LB2 (91 (86, 105) min) to LB3 (77 (68, 87) min), p < 0.001. Similarly, the median left atrial dwelling time significantly decreased from LB2 (72 (62, 84) min) to LB3 (45 (38, 52) min), p < 0.0001. The total laser time decreased from LB2 (1920 (1765, 2193) sec) to LB3 (1077 (896, 1165) sec), p < 0.00001. A pure single shot PVI was performed in 18/59 PVs (31%). For major adverse events no differences were detected between the groups (LB2 1/15 (6.7%) and LB3 1/15 (6.7%), p = 0.999)., Conclusion: The LB3 was safe and effective for PVI. Procedure time, LA dwelling time and total laser time significantly decreased compared to LB2., Competing Interests: CHH received travel grants and research grants by Medtronic, Boston Scientific, Claret Medical, SentreHeart, Biosense Webster and Cardiofocus and Speaker’s Honoraria from Biosense Webster, Cardiofocus and Boston Scientific. RRT received travel grants from St. Jude Medical, Topera, Biosense Webster, Daiichi Sankyo, SentreHeart and Speaker’s Bureau Honoraria from Biosense Webster, Biotronik, Pfizer, Topera, Bristol-Myers Squibb; Bayer, Sano Aventis and research grants by Cardiofocus. CE received travel grants and educational grants by Medtronic. All other authors have no relevant disclosures. KHK received travel grants and research grants from Biosense Webster, Stereotaxis, Prorhythm, Medtronic, Edwards, Cryocath, and is a consultant to St. Jude Medical, Biosense Webster, Prorhythm, and Stereotaxis. He received speaker's honoraria from Medtronic., (© 2020 The Author(s).)

Objectives: This study sought to assess the incidence, procedural characteristics, contributing factors, and clinical outcome of cryoballoon-based pulmonary vein isolation (CB-PVI)-related hemoptysis in a multicenter study., Background: Hemoptysis has been described as a rare complication of CB-PVI. However, the precise mechanism and the etiology of this complication are poorly characterized., Methods: Consecutive patients undergoing CB-PVI for paroxysmal or persistent atrial fibrillation at 4 German hospitals were included in this observational analysis., Results: A total of 4,331 CB-PVI procedures were performed between 2006 and 2019. Fifteen patients (9 men, mean age 68.1 ± 9.8 years) developed acute hemoptysis during or within 24 h after CB-PVI, resulting in a hemoptysis frequency of 0.35%. Hemoptysis occurred in 6 of 720 procedures using the first-generation CB (0.83%) and in 9 of 3,611 procedures using the second-, third-, or fourth-generation CB (0.25%) (p = 0.015). Bronchoscopy was performed in 8 patients and showed bleeding exclusively due to mucosal injury or due to a coagulum at a bronchus adjacent to the ablation site. Hemoptysis resolved spontaneously without any long-term sequelae in all patients, except for a 92-year-old patient who died 13 days after CB-PVI due to pneumonia. No specific endobronchial treatment was necessary., Conclusions: Acute hemoptysis after CB-PVI is a rare but potentially life-threatening complication that is usually self-limiting. Direct thermal injury of bronchi adjacent to a pulmonary vein seems to be the most likely mechanism., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

We estimate the effect of the Affordable Care Act Medicaid expansion on county-level mortality in the first four years following expansion using restricted-access microdata covering all deaths in the United States. To adjust for pre-expansion differences in mortality rates between treatment and control, we use a propensity-score weighting model together with techniques from machine learning to match counties in expansion and non-expansion states. We find a reduction in all-cause mortality in ages 20 to 64 equaling 11.36 deaths per 100,000 individuals, a 3.6 percent decrease. This estimate is largely driven by reductions in mortality in counties with higher pre-expansion uninsured rates and for causes of death likely to be influenced by access to healthcare. A cost-benefit analysis shows that the improvement in welfare due to mortality responses may offset the entire net-of-transfers expenditure associated with the expansion., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Aims: We report the collective European experience of percutaneous left atrial appendage (LAA) suture ligation using the recent generation LARIAT+ suture delivery device., Methods and Results: A total of 141 patients with non-valvular atrial fibrillation and contraindication to oral anticoagulation (OAC), thrombo-embolic events despite OAC or electrical LAA isolation were enrolled at seven European hospitals to undergo LAA ligation. Patients were followed up by clinical visits and transoesophageal echocardiography (TOE) following LAA closure. Left atrial appendage ligation was completed in 138/141 patients (97.8%). Three patients did not undergo attempted deployment of the LARIAT device due to pericardial adhesion after previous epicardial ventricular tachycardia ablation (n = 1), a pericardial access-related complication (n = 1), and multiple posterior LAA lobes (n = 1). Serious 30-day procedural adverse events occurred in 4/141 patients (2.8%). There were two device-related LAA perforations (1.4%) not resulting in any corrective intervention as the LAA was completely sealed with the LARIAT. Minor adverse events occurred in 19 patients (13.5%), including two pericardial effusions due to procedure-related pericarditis requiring pericardiocentesis. Transoesophageal echocardiography was performed after LAA ligation in 103/138 patients (74.6%) after a mean of 181 ± 72 days. Complete LAA closure was documented in 100 patients (97.1%). Two patients (1.8% of patients with follow-up) experienced a transient ischaemic attack at 4 and 7 months follow-up, although there was no leak observed with TOE. There were two deaths during long-term follow-up which were both not device related., Conclusion: Initial experience with the LARIAT+ device demonstrates feasibility of LAA exclusion. Further larger prospective studies with longer follow-up are warranted., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)

Background: Osteochondral injury is a very common orthopaedic pathology, mainly affecting young, active population, with limited current treatment options. Herein we are presenting cellular and early clinical data of a patient series treated for chronic osteochondral lesions in the knee with a filter-based intra-operative bone marrow aspirate (BMA) separation device., Methods: Fifteen patients with chronic knee osteochondral lesions (60% females, 19-59 years) were included in this prospective case series. Filtered BMA (f-BMA), containing mesenchymal stem/stromal cells (MSCs), was combined with a biomimetic collagen-hydroxyapatite scaffold (CHAS) and implanted into the site of the lesion. Harvested BMA and post-separation f-BMA were analysed for blood cell counts, flow cytometry, and fibroblast colony forming units (CFU-Fs). Patients were followed for serious adverse events and graft failures. Clinical evaluation was assessed using the knee injury and osteoarthritis outcome score (KOOS). In 8 patients a magnetic resonance imaging (MRI)/arthroscopy were performed., Results: Cell suspension contained 0.027% CD271 + CD45 - 7-AAD - cells, 0.15% CD73 + CD90 + CD105 + cells and 0.0012% CFU-Fs of all nucleated cells with 86% viability. Filtration process resulted in 12.8 (4.0-40.8) fold enrichment in terms of CFU-F content in comparison to initial BMA. No serious adverse events related directly to the osteochondral treatment were reported. After an average follow-up of 20 months (14-25) all KOOS subscales (Symptoms/Pain/Daily activities/Sport and recreation/Quality of life) increased significantly from pre-operative 55/56/67/30/30 to post-operative 73/76/79/51/52 (p values < 0.05), respectively. MRI or arthroscopic evaluation revealed nearly normal to normal overall International Cartilage Repair Society assessment in 7/8 patients., Conclusion: The filter-based BMA separation procedure significantly increased the frequency of mesenchymal stem/stromal cells (MSCs), however their concentration was not increased. The clinical evaluation revealed high safety profile of the treatment and resulted in improved clinical status of the patients.

To measure the internal fit of the computer-aided designed/computer-aided manufactured (CAD/CAM) crowns, a new scanner-based chairside approach was investigated in patients, and the results were compared to the established silicone replica technique and a digital laboratory replica method. Thirty full-coverage crown preparations were included. Based on a digital impression with an intraoral scanner (IOS, Trios 3), three CAD/CAM measurement copings ('COM', resin composite; 'ZIR', zirconium dioxide; 'NPA', non-precious alloy) were fabricated for each tooth preparation. The internal fit of the measurement copings was analyzed with three different evaluation methods: IOS-based digital approach (D-IOS), digital replica method with laboratory software (D-GOM), and conventional silicone replica technique (CV-SR). The congruence between the determined target parameter of the 80-µm cement space and the actual measured internal gap was investigated. Statistical analysis was performed by ANOVA ( p -value < 0.05). No significant difference was determined between the three evaluation methods. However, significant differences were observed for the three coping materials ( p -value < 0.05), the single measurement position (marginal, axial, and occlusal fit) ( p -value < 0.05), and the interaction between the coping material and the measurement position ( p -value < 0.05). COM revealed the smallest internal gap, followed by ZIR and NPA. Regardless of the coping material, the occlusal gap was higher than the axial and marginal gaps. Furthermore, only the internal gaps of the marginal area almost matched the target parameter of 80-µm for the cement space. D-IOS is effective for measuring internal fit of single crowns in different clinical settings., Competing Interests: The authors declare no conflict of interest.

BACKGROUND Pulmonary vein isolation (PVI) is an effective treatment strategy for patients with paroxysmal atrial fibrillation (AF), yet it is associated with limited success rates in patients with persistent AF (PersAF). The left atrial appendage (LAA) was recently identified as a target of catheter ablation especially in PVI non-responders and LAA-isolation (LAAI) by cryoballoon or radiofrequency was shown to be effective. Recently the fourth-generation cryoballoon (CB4) was introduced to clinical practice. Here we are demonstrating the first case report of CB4-based LAAI followed by LAA-closure in a patient with PersAF. CASE REPORT A 67-year-old male patient presented with symptomatic PersAF and thromboembolism due to LAA-thrombus. After resolving the LAA-thrombus cryoballoon based PVI and empirical LAAI was successfully performed. To prevent further thromboembolism LAA-closure was successfully performed after 6 weeks. On short-term follow-up (12 weeks) the patients stayed in stable sinus rhythm. CONCLUSIONS Fourth-generation cryoballoon based ablation seems to be an effective treatment strategy for LAAI.

Background: Radiofrequency (RF)-based pulmonary vein isolation (PVI) results in a favorable clinical outcome, although its complexity demands a long learning curve. Balloon-based systems have been developed to possibly solve these limitations. The 2nd-generation laser balloon (LB2) offers optimized features for improved tissue contact and visibility. We determined the safety, efficacy and learning curve of the LB2 for PVI.Methods and Results:A total of 45 consecutive patients (89% persistent AF) were prospectively enrolled and divided into 3 groups (T1, T2, T3) of n=15 patients per group. All patients underwent PVI by 2 operators using the LB2. The operators were experienced in RF and cryothermal procedures, but not in laser ablations. A total of 174/177 PVs (98%) were successfully isolated. The median procedure time significantly declined from 132 (114, 158) to 119 (102, 127) and 91 (86, 105) min in T1-3, respectively (P=0.0009). Similarly, the median fluoroscopy time significantly decreased from T1 to T3 (22 (17, 27) vs. 21 (16, 24) vs. 13 (10, 17) min, respectively, P=0.045). Adverse events occurred in 6.7%, with a trend towards a lower complication rate with increasing experience., Conclusions: The LB2 was safe and effective for PVI, even for operators without any previous experience in laser balloon-based PVI. Procedure time, left atrial dwelling time and fluoroscopy time decreased after a learning curve of 15 cases.

It is reported that cholesterol (Chol) and TWEEN 80 at a molar ratio of 5:1 can form small unilamellar vesicles (SUVs) using a staggered herringbone micromixer. These phospholipid-free SUVs (PFSUVs) can be actively loaded with a model drug for targeting hepatocytes via the endogenous apolipoprotein mechanism. PFSUVs particles with compositions of Chol:TWEEN 80 ranging between 1.5:1 and 5:1 (mol/mol) can be produced with a mean diameter of ≈80 nm, but only the high-Chol formulations (3:1 and 5:1) can retain a transmembrane gradient of ammonium sulfate for active loading of doxorubicin (DOX). Under cryo-transmission electron microscopy, PFSUVs-DOX displays a unilamellar bilayer structure with DOX molecules forming spindle-shape aggregates inside the aqueous core. Relative to PEGylated liposomal doxorubicin (PLD) that exhibits little interaction with cells in various conditions, the cellular uptake of PFSUVs-DOX is dependent on the presence of serum and enhanced with an increased concentration of apolipoproteins. After intravenous injection, the vast majority of PFSUVs-DOX accumulates in the liver and DOX is detected in all liver cells (predominantly the hepatocytes), while PLD is captured only by the sinusoidal cells (i.e., macrophages). This report discloses an innovative lipid bilayer vesicle for highly efficient and selective hepatocyte targeting., (© 2019 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.)

Background: Second-generation cryoballoon (CB2)-based pulmonary vein isolation (PVI) has demonstrated encouraging results in the treatment of atrial fibrillation (AF). This study sought to assess data on the safety, efficacy and clinical success of CB2-based PVI in patients with heart failure (HF) and reduced ejection fraction (HFrEF).Methods and Results:CB2-based PVI was performed in 551 consecutive patients in 3 highly experienced EP centers. Patients with HF and LVEF ≤40% were included (HFrEF group, n=50/551, 9.1%). Data were compared with propensity score-matched patients without HF and preserved left ventricular EF (LVEF) (n=50, control group). The median LVEF was HFrEF: 37% (35, 40) and control: 55% (55, 55), P<0.0001. Major periprocedural complications were registered in 4/50 (8%, HFrEF group) and 3/50 (6%, control group), P=0.695. The 12-month freedom from AF recurrence was 73.1% (95% confidence interval (CI): 61-88, HFrEF group) and 72.6% (95% CI: 61-87, control group), P=0.25. NYHA class decreased from 2.4±0.8 (baseline) to 1.7±0.8 at 12-month follow-up (P<0.0001). LVEF improved from a median of 37% (35, 40) prior to ablation to a median of 55% (40, 55), P<0.0001., Conclusions: CB2-based PVI in patients with HFrEF appeared to be safe, was associated with comparable periprocedural complications and showed promising clinical success rates equal to those for patients with preserved LVEF. NYHA class and LVEF significantly improved at 12-month follow-up.

Catheter ablation of ventricular tachycardia (VT) aims to treat the underlying arrhythmia substrate to prevent ICD therapies. The aim of this meta-analysis was to assess the safety and efficacy of VT ablation prior to or at the time of secondary prevention ICD implantation in patients with coronary artery disease, as compared with deferred VT ablation. Based on a systematic literature search, three randomised trials were considered eligible for inclusion in this analysis, and data on the number of patients with appropriate ICD shocks, appropriate ICD therapy, arrhythmic storm, death and major complications were extracted from each study. On pooled analysis, there was a significant reduction of appropriate ICD shocks (OR 2.58; 95% CI [1.54-4.34]; p<0.001) and appropriate ICD therapies (OR 2.04; 95% CI [1.15-3.61]; p=0.015) in patients undergoing VT ablation at the time of ICD implantation without significant differences with respect to complications (OR 1.39; 95% CI [0.43-4.51]; p=0.581). Mortality did not differ between both groups (OR 1.30; 95% CI [0.60-2.45]; p=0.422). Preventive catheter ablation of VT in patients with coronary heart disease at the time of secondary prevention ICD implantation results in a significant reduction of appropriate ICD shocks and any appropriate ICD therapy compared with patients without or with deferred VT ablation. No significant difference with respect to complications or mortality was observed between both treatment strategies., Competing Interests: Disclosure: RT received research grants from Hansen, Abbot, Medtronic and Biotronik; travel grants from Biosense Webster, Medtronic, Abbot, Sentrheart and Daiichi Sankyo; speakers’ bureau honoraria/proctor for Biosense Webster, Medtronic, Abbot, Biotronik, Boston Scientific, Pfizer, Bristol-Myers Squibb, Bayer, Sanofi Aventis and AstraZeneca; and worked as a consultant for Biosense Webster and Biotronik. CE received presentation fees from Bayer, Biosense Webster, Impulse Dynamic, St Jude Medical/Abbott, Pfizer, Liva Nova, Zoll, Boston Scientific, Novartis, Daiichi Sankyo and AstraZeneca; and travel grants from St Jude Medical, Biotronik and Medtronic. EL received travel grants from Biosense Webster, Abbott, Medtronic and Boston Scientific; and speakers’ bureau honoraria from Biosense Webster and Abbott. KY received an educational and research grant from the Turkish Society of Cardiology. All other authors have no conflicts of interest to declare.

BACKGROUND Response to cardiac resynchronization therapy (CRT) is variable among patients. Extensive scar tissue burden has been characterized as a negative predictor of significant response. Whereas mid-term and long-term response has been thoroughly investigated in randomized clinical trials; however, little is known about acute hemodynamic effects of biventricular pacing. CASE REPORT We report a case of an elderly female patient with severe ischemic cardiomyopathy and a large anterior wall aneurysm, who received right ventricular and biventricular pacing during ablation of incessant pleomorphic ventricular tachycardia. During the procedure, biventricular pacing was associated with a 20% acute increase in systolic blood pressure compared to right ventricular pacing, although there was no acute or long-term effect on left ventricular function. CONCLUSIONS The acute hemodynamic effect of CRT in our patient suggests an effect of CRT even in patients with negative predictors of CRT response such as severe ischemic cardiomyopathy with a large aneurysm. Although no marked increase in left ventricular function might be observed, the acute effect of CRT might contribute to stabilization of heart failure in these patients.

Cardiac resynchronization therapy (CRT) device implantation is associated with severe complications including pneumo- and hemothorax. Data on a sole cephalic vein approach (sCV), potentially preventing these complications, are limited. The aim of our study was to compare a sole cSV with a subclavian vein approach (SV) in CRT implantations with respect to feasibility and safety. We performed a prospective cohort study enrolling twenty-four consecutive de-novo CRT implantations (group A) using a sCV at two centers. Fifty-four age-matched CRT patients implanted via the SV served (group B) as reference. Procedural success rate and complications were recorded during a follow-up of 4 weeks. All CRTs could be implanted in group A, with 91.7% using cephalic access alone. In group B, CRT implantation was successfully performed in 96.3%. Procedure and fluoroscopy duration were similar for both groups (sCV vs. SV: 119 ± 45 vs. 106 ± 31 minutes, 17 ± 9 vs 14 ± 9 minutes). Radiation dosage was higher in sCV group vs. SV (2984 ± 2370 vs. 1580 ± 1316 cGy*cm 2 ; p = 0.001). There was no case of a pneumothorax in group of sCV, while two cases were observed using SV. Overall complication rate was similar (sCV: 13.0% vs. SV: 12.5%). de-novo CRT implantation using a triple cephalic vein approach is feasible. Procedure duration and complication rates were similar, while radiation dosage was higher in the sCV compared to the SV approach. Despite its feasibility in the clinical routine, controlled prospective studies with longer follow-up are required to elucidate a potential benefit with respect to lead longevity.

Second generation cryoballoon (CB) has been shown to be effective for treatment of paroxysmal and persistent atrial fibrillation (AF). However, the fixed size of the non-compliant balloon may limit its use in patients with pulmonary vein (PV) abnormalities. In this study we investigated the acute success, procedural complications and long term outcome of CB based PV isolation (PVI) in patients with PV abnormality. A total of 238 patients [64.8 ± 11.1 years; 91 paroxysmal (38.2%), 147 persistent AF (61.8%)] underwent PVI using the second generation CB without preprocedural imaging. In 43/238 (18.1%) patients PV abnormality (left common PV in 26, right middle PV in 20) was observed. All targeted veins including abnormal PVs were isolated (100%). Transient phrenic nerve palsy (PNP) occurred in one (2.3%) patient in the PV anomalous group and 6 (3.0%) in the control group (p = NS). There was no other adverse event including PV stenosis, atrio-esophageal fistula or cerebrovascular events related to the procedure. During mean follow-up of 11.8 ± 5.4 month a total of 59 patients (24.7%) had atrial tachyarrhythmia (ATA) recurrence [27 (11.3%) had AT recurrence]. In the PV anomalous group, 20/43 (46.5%) patients had ATA recurrence compared to 39/195 (20%) in the control group (p < 0.001). AT recurrence was observed in 27 (11.3) patients [11 (25.5%) in the PV anomalous group and 16 (8.2%) in controls respectively, p = 0.003]. In patients with PV abnormality CB-based AF ablation results in a similar acute PVI rate but a higher ATA recurrence rate during follow up as compared to patients without PV abnormality., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Objectives: As the number of transvenous lead extractions continues to increase, preprocedural protocols for this procedure must be assessed. The objective of this study was to determine whether an electrocardiogram (ECG)-triggered computed tomography (Et-CT) with three-dimensional (3D) reconstructions could aid lead extractors in choosing the optimal tools to improve procedural success and avoid complications., Methods: In this study, 31 patients scheduled for transvenous lead extraction underwent a preprocedural Et-CT between January 2016 and May 2017. Both 3D-reconstructions and the two-dimensional files were reviewed for possible lead adhesions, calcifications, migrations or perforations., Results: Mean age was 46.7 ± 14.0 years. Seventy-one percent of patients were men, and 29.0% had undergone prior cardiac surgery. Indications for extraction included infection (n = 18, 58.1%), lead dysfunction (n = 8, 25.8%), upgrade (n = 3, 9.7%), severe tricuspid regurgitation (n = 1, 3.2%) and superior vena cava occlusion (n = 1, 3.2%). Eighteen patients had an implantable cardioverter defibrillator (58.1%). Sixty-eight of 70 targeted leads were extracted with a mean of 2.2 leads per patient and an average lead age of 109.3 ± 58.7 months. Et-CT files supported transvenous lead extraction by revealing possible adhesions in 16 patients, 5 perforations and 2 venous occlusions. Lead extraction was performed using the excimer laser, mechanical tools and femoral snares. Complete procedural success was achieved in 93.5% (n = 29) of cases. Clinical success was 100%, and intraoperative mortality was 0%., Conclusions: A preprocedural Et-CT with 3D reconstructions can help to visualize lead alignment and identify abnormalities that may foreshadow procedural difficulties. A preprocedural Et-CT may therefore aid lead extractors in choosing the optimal extraction tool and strategy.

We investigated the effect of systemic infection or lead endocarditis on the complexity and the success of laser lead extraction (LLE) procedures. Medical records of all patients undergoing LLE between January 2012 and March 2017 were screened with regard to information on systemic infection or lead endocarditis. We treated 184 patients using high-frequency 80 Hz laser sheaths in patients with lead implant duration of ≥ 12 months. Indications for lead extraction were systemic infection and lead endocarditis in 52 cases (28.3%), local infection in 74 cases (40.2%), lead dysfunction in 37 cases (20.1%) and other indications in 21 cases (11.4%). 386 leads were scheduled for LLE: 235 (60.9%) pacing, 105 (27.2%) ICD and 46 (11.9%) CS leads. The mean time from initial lead implantation (systemic infection 96.8 ± 74.7 months vs. 102.1 ± 82.6 non-infected: months; p = 0.4155) and ratio of ICD leads (26.8 vs. 27.4%; p = 0.3411) did not differ significantly between the two groups. Complete procedural success was significantly higher in the systemic infection group (100 vs. 94.7%; p = 0.0077). The mean laser treatment (60.2 ± 48.7 vs. 72.4 ± 61.5 s; p = 0.2038) was numerically lower in the infection group, while fluoroscopy time (9.3 ± 7.6 vs. 12.8 ± 10.3 min; p = 0.0275) was significantly lower in this group. Minor and major complications were low in both groups and did not reveal any statistically significant difference (infected group: one minor complication; pocket hematoma, non-infected: three major complications; emergent sternotomy due to pericardial tamponade). No extraction related mortality was observed. The presence of systemic infection or lead endocarditis in LLE procedures allows for higher complete procedural success. When compared with LLE of non-infected leads, the infected leads require less laser and fluoroscopy times. Due to the scarcity of minor and major complications in general, no statistical significance was found in that regard.

Injuries to the superior vena cava (SVC) during transvenous lead extraction (TLE) procedures are a rare but life-threatening complication. The Bridge Occlusion Balloon (BOB) is specifically designed for temporary SVC occlusion in TLE procedures. We report the first case of a 27-year-old man using the BOB as a safety net in a high-risk TLE procedure. This patient, with a congenitally corrected transposition of the great arteries and a third-degree atrioventricular block, presented with 4 dysfunctional pacemaker leads, venous stenosis and the necessity for a new pacemaker system. The leads were implanted for 10 and 19 years. The BOB was placed with a radiopaque marker at the cavoatrial junction and was inflated with 46 ml of an 80/20 saline/contrast agent mixture. An angiography was performed to confirm SVC occlusion. With the deflated balloon in place, the TLE procedure with laser and mechanical sheaths was performed. Successful extraction of 2 dysfunctional leads, as well as venous recanalization, for the new right atrial and right ventricular lead implantation was achieved. We have shown the feasibility of using powered extraction sheaths with a deflated BOB in place. This allows for immediate balloon inflation, in case of an SVC perforation., (© The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: In the 1990s, damage control laparotomy (DCL) became a proved approach to treat intra-abdominal injuries caused by trauma. In the ensuing two decades, this approach has been applied to non-traumatic abdominal processes as well. Although the benefits of DCL are clear, the benefit of rapid source-control laparotomy (RSCL) for non-traumatic abdominal diseases is much less clear. However, two recent cohort analyses identified significant increases in the mortality rate with RCSL compared with primary fascial closure (PFC). The purpose of this study was to assess the efficacy of RSCL in patients with septic shock., Methods: The 2015 National Surgical Quality Improvement Project (NSQIP) database was queried for 11 International Statistical Classifications of Diseases (ICD)-10 codes associated with septic shock. Collected data included age, gender, body mass index (BMI), wound class, American Society of Anesthesiologists (ASA) class, operative time, number of risk factors, and presence or absence of post-operative pneumonia. The risk factors were diabetes mellitus, alcohol or tobacco abuse, blood dyscrasias, disseminated cancer, and cardiac, gastrointestinal, pulmonary, hepatobiliary, or renal dysfunction. The primary outcomes were rate of re-operation, prevalence of post-operative pneumonia, hospital length of stay (LOS), and death by 30 days., Results: The RSCL and PFC cohorts were each comprised of 56 patients matched for propensity scores for ICD-10 code. There were no significant differences in wound or ASA class, BMI, gender, or number of risk factors between the two cohorts. The operative time for RSCL was significantly shorter than for PFC (median 84 vs. 128 min, respectively; p = 0.002). There was no significant difference in re-operation rate, prevalence of post-operative pneumonia, LOS, or mortality rate between the two cohorts., Conclusions: Although this analysis showed no clear advantage to RSCL in the management of septic shock, it may be a means to salvage certain patients. The best way to assess the relative value of RSCL is a prospective trial.

Lateral flow type detection is becoming interesting not only in regions with a poor medical infrastructure but also for practitioners in day-to-day clinical work or for veterinary control in case of possible epidemics. In this work, we describe the first steps of development of a multi-channel strip with potential internal calibration of multiparametric and colorimetric lateral flow assays for the simultaneous detection of the lipopolysaccharides (LPS) of Salmonella typhimurium (S. typhimurium) and Salmonella enteritidis (S. enteritidis). We structured four channels in the nitrocellulose membrane with a Yb:KGW solid-state femtosecond laser ("cold" ablation process) to form distinct tracks of porous material and used gold nanoparticles for the labeling of the antibodies. In addition, calibration curves of the spot intensities of both serovars are presented, and it was shown that no cross reactivity between the different capture antibodies and LPS occurred. Finally, we detected LPS of both Salmonella serovars simultaneously. The color changes (spot intensities of the reaction zones) were evaluated using the open-source image-processing program ImageJ. Graphical abstract Multiparametric testing, strip A was tested with LPS S. enteritidis ( c=0.01 g/L) and LPS S.typhimurium ( c=0.0001 g/L), strip B with LPS S. enteritidis ( c=0.001 g/L) and LPS S. typhimurium ( c=0.001g/L) and strip C with LPS S. enteritidis (c=0.0001 g/L) and LPS S. typhimurium ( c=0.01 g/L), and read-out.