Efficacy and safety of high-power short duration atrial fibrillation ablation in elderly patients.

INTRODUCTION: Data about atrial fibrillation (AF) ablation using high-power short duration (HPSD) radiofrequency ablation in the elderly population is still scarce. The aim of our study was to investigate the efficacy and safety of HPSD ablation in patients over 75 years compared to younger patients. METHODS: Consecutive patients older than 75 years with paroxysmal or persistent AF undergoing a first-time AF ablation using 50 W HPSD ablation approach were analyzed in this retrospective observational analysis and compared to a control group <75 years. Short-term endpoints included intraprocedural reconnection of at least one pulmonary vein (PV) and intrahospital and AF recurrence during 3 months blanking period, as well as a long-term endpoint of freedom from atrial arrhythmias of antiarrhythmic drugs after 12 months. RESULTS: A total of 540 patients underwent a first AF ablation with HPSD (66 ± 10 years; 58% male; 47% paroxysmal AF). Mean age was 78 ± 2.4 and 63 ± 6.3 years (p < .001), respectively. Elderly patients were significantly more often women (p < .001). The procedure, fluoroscopy, and ablation were comparable. Elderly patients revealed significantly more often extra-PV low-voltage areas requiring additional left atrial ablations (p < .001). Overall complication rates were low; however, elderly patients revealed higher major complication rates mainly due to unmasking sick sinus syndrome (p = .003). Freedom from arrhythmia recurrences was comparable (68% vs. 76%, log-rank p = .087). Only in the subgroup of paroxysmal AF, AF recurrences were more common after 12 months (69% vs. 82%; log-rank p = .040; hazard ratio: 1.462, p = .044) in the elderly patients. In multivariable Cox regression analysis of the whole cohort persistent AF, female gender, diabetes mellitus and presence of left atrium low-voltage areas, but not age >75 years were associated with AF recurrences. CONCLUSION: HPSD AF ablation of patients >75 years in experienced centers is safe and effective. Therefore, age alone should not be the reason to withhold AF ablation from vital elderly patients due to only a slightly worse outcome and safety profile. In paroxysmal AF, elderly patients have more recurrences compared to the younger control group.

Safety of very high-power short-duration radiofrequency ablation for pulmonary vein isolation: a two-centre report with emphasis on silent oesophageal injury.

AIMS: Very high-power short-duration (vHPSD) via temperature-controlled ablation (TCA) is a new modality to perform radiofrequency pulmonary vein isolation (PVI), conceivably at the cost of a narrower safety margin towards the oesophagus. In this two-centre trial, we aimed to determine the safety of vHPSD-based PVI with specific emphasis on silent oesophageal injury. METHODS AND RESULTS: Ninety consecutive patients with atrial fibrillation (AF) underwent vHPSD-PVI (90 W, 3-4 s, TCA) using the QDOT MICRO catheter, in conjunction with the nGEN (Bad Neustadt, n = 45) or nMARQ generator (Bruges, n = 45). All patients underwent post-ablation oesophageal endoscopy. Procedural parameters and complications were recorded. A subgroup of 21 patients from Bad Neustadt underwent cerebral magnetic resonance imaging (cMRI) to detect silent cerebral events (SCEs). Mean age was 67 ± 9 years, 59% patients were male, and 66% patients had paroxysmal AF. Pulmonary vein isolation was obtained in all cases after 96 ± 29 min. No steam pop, cardiac tamponade, stroke, or fistula was reported. None of the 90 patients demonstrated oesophageal ulceration (0%). Charring was not observed in the nMARQ cohort (0% vs. 11% in the nGEN group). In 5 out of 21 patients (24%), cMRI demonstrated SCE (exclusively nGEN cohort). CONCLUSION: Temperature-controlled vHPSD catheter ablation allows straightforward PVI without evidence of oesophageal ulcerations or symptomatic complications. Catheter tip charring and silent cerebral lesions when using the nGEN generator have led to further modification.

Acute and long-term outcomes of VT radiofrequency catheter ablation in patients with versus without an intramural septal substrate.

INTRODUCTION: Aim of this study was to evaluate efficacy and safety of ventricular tachycardia (VT) catheter ablation in patients with structural heart disease (SHD) in relation to the presence of an intramural septal substrate. METHODS: Consecutive patients undergoing VT ablation between January 2019 and October 2020 were included. All patients were stratified based on the presence of relevant septal substrate and freedom from VT recurrences were analyzed. RESULTS: In total, 199 consecutive patients (64.2 ± 13.0 years; 89% male; 55% ischemic cardiomyopathy (ICM)) undergoing VT ablation were included. 129/199 patients (65%) showed significant septal substrate (55/90 patients (61%) with non-ischemic cardiomyopathy (NICM) compared to 74/109 patients (68%) with ICM; p = 0.37). Acute procedural success with elimination of all inducible VTs was achieved in 66/70 patients (94%) without and in 103/129 patients (80%) with a septal substrate (p = 0.007). In the cohort including patients with a clinical FU, 15/60 patients (25%) without a septal substrate and 48/123 patients (39%) with a septal substrate experienced VT recurrence during a FU of 8.1 ± 5.9 months (p = 0.069). CONCLUSION: Presence of septal VT substrate in patients with a structural heart disease or coronary artery disease is common. Acute success of VT catheter ablation was significantly higher and mid-term success tended to be higher in patients without a septal substrate.

Incidence of ablation-induced esophageal injury associated with high-power short duration temperature-controlled pulmonary vein isolation using a specialized open-irrigated ablation catheter: A retrospective single-center study.

INTRODUCTION: To evaluate short-term efficacy and incidence of ablation-induced endoscopically detected esophageal injury in patients undergoing high-power, short-duration (HPSD) pulmonary vein isolation using a novel irrigated radiofrequency ablation catheter and ablation generator setup. METHODS AND RESULTS: Atrial fibrillation (AF) patients, who underwent AF ablation using an irrigated radiofrequency ablation catheter specifically designed for a HPSD ablation approach (50 W, with a target Ablation Index of 350 at posterior wall), received postablation esophageal endoscopy after ablation. In total 45 consecutive patients (67 ± 10 years; 58% male; 42% paroxysmal AF) undergoing AF ablation using a specialized ablation catheter (QDOT) were included in the study. Thirty-one of 45 patients (69%) underwent a first-time pulmonary vein isolation (Group 1, 67 ± 11 years; 55% male; 48% paroxysmal AF). Fourteen patients (31%) underwent a redo AF procedure (Group 2, 66 ± 8 years; 64% male; 29% paroxysmal AF). Patients undergoing first-time pulmonary vein isolation were included in the final analysis. In these patients an endoscopically detected esophageal lesion (EDEL) was detected in 5 of 31 (16%) patients (erosion n = 2, ulcer n = 3). Mean contact force at posterior wall ablation sites was significantly lower in patients with postprocedural EDEL compared with patients without EDEL (11.9 ± 0.8 g vs. 15.6 ± 4.7 g). CONCLUSION: PVI using a specialized high-power ablation catheter in conjunction with a HPSD ablation approach results in a 16% incidence of EDEL in first AF ablation candidates. Future studies evaluating high-power short duration ablation strategies should include esophageal endoscopy to estimate the risk of clinically relevant esophageal complications.

Correlation of magnetic resonance imaging and post-ablation endoscopy to detect oesophageal thermal injury in patients after atrial fibrillation ablation: MRI-EDEL-study.

AIMS: To correlate oesophageal magnetic resonance imaging (MRI) abnormalities with ablation-induced oesophageal injury detected in endoscopy. METHODS AND RESULTS: Ablation-naïve patients with atrial fibrillation (AF), who underwent ablation using a contact force sensing irrigated radiofrequency ablation catheter, received a cardiac MRI on the day of ablation, and post-ablation oesophageal endoscopy (OE) 1 day after ablation. Two MRI expert readers recorded presence of abnormal oesophageal tissue signal intensities, defined as increased oesophageal signal in T2-fat-saturated (T2fs), short-tau inversion-recovery (STIR), or late gadolinium enhancement (LGE) sequences. Oesophageal endoscopy was performed by experienced operators. Finally, we correlated the presence of any affection with endoscopically detected oesophageal thermal lesions (EDEL). Among 50 consecutive patients (age 67 ± 7 years, 60% male), who received post-ablation MRI and OE, complete MRI data were available in 44 of 50 (88%) patients. In OE, 7 of 50 (14%) presented with EDEL (Category 1 lesion: erosion n = 3, Category 2 lesion: ulcer n = 4). Among those with EDEL, 6 of 7 (86%) patients presented with increased signal intensities in all three MRI sequences, while only 2 of 37 (5%) showed hyperintensities in all three MRI sequences and negative endoscopy. Correspondingly, sensitivity, specificity, positive predictive value, and negative predictive value (NPV) for MRI (increased signal in T2fs, STIR, and LGE) were 86%, 95%, 75%, and 97%, respectively. CONCLUSION: Increased signal intensity in T2fs, STIR, and LGE represents independent markers of EDEL. In particular, the combination of all three has the highest diagnostic value. Hence, MRI may represent an accurate, non-invasive method to exclude acute oesophageal injury after AF ablation (NPV: 97%).

Impact of surround flow catheter tip irrigation in contact force ablation on the incidence of asymptomatic oesophageal lesions after atrial fibrillation ablation: a prospective comparative study.

AIMS: Aim of this study was to evaluate the impact of a recently introduced contact force ablation catheter with modified irrigation technology compared with a conventionally irrigated ablation catheter on the incidence of endoscopically detected oesophageal lesions (EDEL). METHODS AND RESULTS: Patients with symptomatic, drug-refractory paroxysmal or persistent atrial fibrillation (AF) who underwent left atrial radiofrequency (RF) catheter ablation were prospectively enrolled. Patients were ablated using a single-tip RF contact force ablation catheter with conventional irrigation (Group 1; n = 50) or with a recently introduced intensified 'surround flow' irrigation technology (Group 2; n = 50). Assessment of EDEL was performed by oesophagogastroduodenoscopy in all patients after ablation. A total of 100 patients (mean age 63.6 ± 12.1 years; men 58%) with paroxysmal (n = 41; 41%) or persistent AF were included. Groups 1 and 2 patients were comparable in regard to baseline characteristics and procedural parameters, especially ablation time at posterior left atrial wall. Overall, 13 patients (13%) developed EDEL after AF ablation (8 oesophageal ulcerations, 5 erythema). The incidence of EDEL including oesophageal ulcerations was higher in Group 2 compared with Group 1 patients without statistical significance (18 vs. 8%, P = 0.23). One pericardial tamponade and one access site bleeding occurred in Group 2. No further adverse events were reported in both groups. CONCLUSION: According to these preliminary results, the use of an improved ablation catheter irrigation technology (surround flow) in conjunction with contact force measurement was associated with a higher but not statistically significant probability of oesophageal thermal lesions. Further studies including larger patient cohorts are needed.

Cardiac resynchronization therapy improves psycho-cognitive performance in patients with heart failure.

BACKGROUND: Reduced cognitive performance and high prevalence of depression have been reported in patients with congestive heart failure (CHF) and severe left ventricular dysfunction. However, effects of contemporary device therapy on cognitive performance and depression symptoms have not been studied thoroughly. METHODS: Seventy-four consecutive CHF patients-45 receiving a biventricular defibrillator (CRT-D) and 29 receiving an implantable single or dual-chamber defibrillator (ICD) as a control group-were enrolled in this investigator-initiated, prospective, controlled, and investigator-blinded study. A set of neuropsychological tests (mini-mental state examination, DemTect, age-concentration test, and Beck depression inventory) was performed before, at 3 and at 6 months after device implantation. RESULTS: DemTect-score improved significantly (F = 7.8; P = 0.007) after CRT-D-implantation compared with ICD. Age-concentration test revealed better concentration ability after CRT-D-implantation (F = 8.3; P = 0.005) compared with ICD. Under CRT-D mini-mental state examination showed a significant improvement (F = 4.2; P = 0.043). CRT with defibrillator therapy also improved depression revealed by beck depression inventory (F = 14.7; P< 0.001) compared with ICD. CONCLUSION: This prospective study is the first to demonstrate psycho-cognitive improvement by resynchronization therapy in CHF patients with severe left ventricular dysfunction. In contrast to ICD therapy, the beneficial effect of CRT-D on psycho-cognitive performance might be attributed to improved cardiac function and haemodynamics.

Utility of a guiding catheter for conduction system pacing: An early multicenter experience.

Background: Conduction system pacing (CSP), either as His bundle pacing (HBP) or as left bundle branch area pacing (LBBAP), may be superior to right ventricular apical or septal pacing. Objective: The study sought to present acute results for a new guiding catheter (Biotronik Selectra 3D) designed for CSP implantations of a retractable screw-in lead (Biotronik Solia S). Methods: The primary endpoint of the prospective, international nonrandomized BIO|MASTER.Selectra 3D study was freedom from catheter-related serious adverse device effects (SADEs) within 1 week of lead implantation. Results: Of 157 enrolled patients, CSP was achieved in 147 (93.6%) patients. No SADEs occurred within 7 days. LBBAP was achieved in 82 patients (45 as crossover from an HBP attempt) and HBP in 65 (44.2%) patients. In centers considering both HBP and LBBAP, the CSP implantation success approached 99%. Successful CSP implantations lasted on average ∼50 minutes (fluoroscopy ∼6 minutes). Most procedures (87.9%) needed only 1 catheter, even after switch from HBP to LBBAP. The catheter's handling was rated largely positive. In patients without bundle branch block, mean QRS duration increased from 106 ms (intrinsic) to 122 ms (CSP) (P = .001). In patients with bundle branch block, mean QRS duration decreased from 151 ms (intrinsic) to 137 ms (CSP) (P = .004). Conclusion: The Selectra 3D catheter is a valuable tool for HBP and LBBAP implantations of the stylet-supported pacemaker leads. When implanters considered both HBP and LBBAP, the success rate was ∼99%. Flexibility to change between different approaches may be advisable in heterogeneous and challenging areas, such as CSP implantations.

Clinical relevance of slow ventricular tachycardia in heart failure patients with primary prophylactic implantable cardioverter defibrillator indication.

AIMS: Implantable cardioverter defibrillators (ICDs) have shown to reduce all-cause mortality in heart failure patients. In SCD-HeFT study, ICDs were programmed with a detection zone of ≥ 187 b.p.m. Thus, the incidence and clinical significance of slower ventricular tachycardias (VTs) in these patients remains largely unknown, though clinically important for device selection, programming, and follow-up. METHODS AND RESULTS: We prospectively studied symptomatic heart failure patients with an indication for a primary prophylactic ICD with or without concomitant resynchronization therapy according to SCD-HeFT inclusion criteria. Devices were programmed to an additional monitor zone for slow VTs at heart rates 130-186 b.p.m. Two hundred consecutive patients (86% male) were followed for a mean of 509 ± 308 days. One hundred and thirty-seven patients (68.5%) were New York Heart Association class III, 75 patients (37.5%) were on cardiac resynchronization therapy, and 124 (62%) had ischaemic cardiomyopathy. We observed 473 VT episodes in 36 patients (18%) and 131 ventricular fibrillation episodes in 30 patients (15%). Ventricular tachycardia overall occurred in 40 patients (20%). The incidence of slow VTs was low in only 12 patients (6%). No patient with slow VT suffered from syncope, palpitation, or decompensation leading to hospitalization. We did not find any reliable predictor for increased long-term risk of slow VTs. CONCLUSION: Incidence of slow VTs in a typical heart failure population with primary prophylactic ICD-implantation ± resynchronization therapy is very low. Slow VTs detected in the ICD monitor zone remained clinically asymptomatic. Thus, single chamber and atriobiventricular ICDs with a VT/ventricular fibrillation zone of ≥ 187 b.p.m. and one burst before shock delivery might be sufficient and pragmatic for the vast majority of these patients.

Prognostic benefits of early vascular surgical intervention in patients with major peripheral vascular complications following transcatheter aortic valve implantation.

OBJECTIVES: This study aimed to analyze the incidence, surgical management of major vascular complications, and outcomes in patients undergoing transfemoral (TF) transcatheter aortic valve replacement (TAVR) at our center after strict selection of the access route, carefully considering all known major predictors. METHODS: Data of 494 consecutive patients with pre-interventional multi-slice computed tomography (CT) of the aorta who had undergone TF TAVR from 2009 to 2019 were analyzed. RESULTS: In total, 23/494 (4.7%) patients had major vascular and access-related complications of peripheral vessels and/or infrarenal aorta. These included hematomas that met the Valve Academic Research Consortium 3-criteria of major vascular complications (7/494, 1.4%), arterial dissections (3/494, 0.6%), pseudoaneurysm (6/494, 1.2%), thrombus of the external iliac artery leading to acute limb ischemia (1/494, 0.2%), fistula (1/494, 0.2%), and perforation (5/494, 1.0%). In total, 17/23 (73.9%) major vascular complications required immediate endovascular and/or open surgery. In 16/17 (94%) cases, only 1 surgical procedure was performed. The long-term survival of patients with and without major vascular complications of the peripheral vessels was determined after 2 years. CONCLUSIONS: Early vascular surgery intervention reversed the mortality disadvantage in patients with major complications of the peripheral vessels after TAVR. This underscores the importance of immediate vascular surgery stand-by as an indispensable requirement.

New-Onset Atrial Fibrillation in the Setting of COVID-19 Infection Is a Predictor of Mortality in Hospitalized Patients: CovAF-Study.

Recent studies show that hospitalized COVID-19 patients have an increased incidence of arrhythmia, especially atrial fibrillation (AF). This single-center study included 383 hospitalized patients with positive polymerase chain reaction tests for COVID-19 from March 2020 to April 2021. Patient characteristics were documented, and data were analyzed for episodes of AF on admission or during the hospital stay, intrahospital mortality, need for intensive care and/or invasive ventilation, inflammatory parameters (hs-CRP, IL-6, and procalcitonin), and differential blood count. We demonstrated that in the setting of hospitalized cases of COVID-19 infection, there is an incidence of 9.8% (n = 36) for the occurrence of new-onset AF. Furthermore, it was shown that a total of 21% (n = 77) had a history of episodes of paroxysmal/persistent AF. However, only about one-third of patients with pre-existing AF had relevant documented tachycardic episodes during the hospital stay. Patients with new-onset AF had a significantly increased intrahospital mortality compared to the control and the pre-existing AF without rapid ventricular rate (RVR) group. Patients with new-onset AF required intensive care and invasive ventilation more frequently. Further analysis examined patients with episodes of RVR and demonstrated that they had significantly elevated CRP (p < 0.05) and PCT (p < 0.05) levels on the day of hospital admission compared to patients without RVR.

Insertable cardiac monitor with a long sensing vector: Impact of obesity on sensing quality and safety.

Background: Fat layers in obese patients can impair R-wave detection and diagnostic performance of a subcutaneous insertable cardiac monitor (ICM). We compared safety and ICM sensing quality between obese patients [body mass index (BMI) ≥ 30 kg/m2] and normal-weight controls (BMI <30 kg/m2) in terms of R-wave amplitude and time in noise mode (noise burden) detected by a long-sensing-vector ICM. Materials and methods: Patients from two multicentre, non-randomized clinical registries are included in the present analysis on January 31, 2022 (data freeze), if the follow-up period was at least 90 days after ICM insertion, including daily remote monitoring. The R-wave amplitudes and daily noise burden averaged intraindividually for days 61-90 and days 1-90, respectively, were compared between obese patients (n = 104) and unmatched (n = 268) and a nearest-neighbour propensity score (PS) matched (n = 69) normal-weight controls. Results: The average R-wave amplitude was significantly lower in obese (median 0.46 mV) than in normal-weight unmatched (0.70 mV, P < 0.0001) or PS-matched (0.60 mV, P = 0.003) patients. The median noise burden was 1.0% in obese patients, which was not significantly higher than in unmatched (0.7%; P = 0.056) or PS-matched (0.8%; P = 0.133) controls. The rate of adverse device effects during the first 90 days did not differ significantly between groups. Conclusion: Although increased BMI was associated with reduced signal amplitude, also in obese patients the median R-wave amplitude was >0.3 mV, a value which is generally accepted as the minimum level for adequate R-wave detection. The noise burden and adverse event rates did not differ significantly between obese and normal-weight patients.Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04075084 and NCT04198220.

Functional and hemodynamic result with the PASCAL Ace percutaneous mitral valve repair: A single-center experience.

OBJECTIVES: The PASCAL device is a transcatheter edge-to-edge repair system (TEER) for treatment of mitral regurgitation (MR). The PASCAL Ace as a newer version of the PASCAL device consists of a thinner profile without a spacer. The aim of the study was to examine the functional and hemodynamic outcome after TEER with the PASCAL Ace device in a real-world cohort. METHODS: Between September 2020 and August 2021, all consecutive patients with MR 3+/4+ treated percutaneously with PASCAL Ace were included in this study. Primary endpoints included successful device implantation, device success, improvement of exercise capacity, quality of life, and a composite of all-cause mortality, non-fatal stroke, myocardial infarction, new need for renal replacement therapy or severe bleeding at 30 days and 5 month. RESULTS: 49/66 patients had a functional etiology. Overall success rate was 98.5%. At follow-up, 84.7% of the patients had MR grade ≤ 1. TEER was associated with an improvement of LV ejection fraction (45% to 53%, p = 0.048). 86.5% were in NYHA class I or II. 6-minute-walking distance improved by 79m (p = 0.009). Kansas City Cardiomyopathy Questionnaire (KCCQ) improved by 19 points (p = 0.012). NT-proBNP levels decreased from 4832 to 2137 pg/dl (p = 0.003). Mean pulmonary capillary wedge pressures improved from 21 to 15mmHg (p = 0.001). At 5 month, a total of 3 patients died, none of cardiovascular cause. CONCLUSION: PASCAL Ace is safe and effective in treating MR, resulting in a sustained MR reduction, a reverse cardiac remodelling, improvement of exercise capacity, quality of life, NT-proBNP levels and hemodynamics at follow-up.

Functional and hemodynamic results after transcatheter mitral valve leaflet repair with the PASCAL device depending on etiology in a real-world cohort.

BACKGROUND: The PASCAL system (Edwards Lifescience, Irvine, CA, USA) is a novel device for edge-to-edge treatment of mitral regurgitation (MR). The aim of our study was to examine the functional and hemodynamic outcome after repair of functional (FMR) and degenerative mitral regurgitation (DMR) using the PASCAL system in a real-world setting. METHODS: A total 92 consecutive patients with symptomatic MR 3+/4+ were treated in our institute using the PASCAL device. Primary endpoints included procedural success, clinical success, and major adverse event rate at 30 days and 7 months. RESULTS: 68.5% had a functional and 31.5% a degenerative etiology. Overall success rate was achieved in 97.8% patients (98.4% FMR, 96.6% DMR). At follow-up, 85.7% of the patients (89.2% FMR, 78.3% DMR) had MR grade ≤ 1. 96.4% (97.4% FMR, 94.4% DMR) were in New York Heart Association class I or II. Six-minute walking distance improved by 96 m (92 m FMR, 106 m DMR), Kansas City Cardiomyopathy Questionnaire improved by 19 points (19 points FMR, 19 points DMR). Pro-B-type natriuretic peptide (proBNP) levels decreased from 4673 to 2179 pg/dl (5239-2018 pg/ml FMR, 3418-2530 pg/ml DMR) and mean pulmonary capillary wedge pressure from 21 to 16 mmHg (21-17 mmHg FMR, 19-13 mmHg DMR). At 30 days, there was 1 cardiovascular death (1.2%) with DMR. At 1 year, Kaplan-Meier survival was 86% (86% FMR, 86% DMR). CONCLUSIONS: Severe MR can successfully and safely be treated with the PASCAL device regardless of etiologies. This interventional approach resulted in a sustained MR reduction, improvement in exercise capacity, quality of life, proBNP levels, and hemodynamics in FMR and DMR at follow-up.

Mid-term hemodynamic and functional results after transcatheter mitral valve leaflet repair with the new PASCAL device.

AIMS: To examine the functional and hemodynamic mid-term outcome at 5 months of mitral regurgitation (MR) reduction using the PASCAL repair system. METHODS AND RESULTS: Between July 2019 and February 2020 31 consecutive patients with MR 3 +/4 + (mean age 77.5 years, all in New York Heart Association (NYHA) class III-IV, STS score 9.1 ± 7.4) underwent MR reduction in our institute using the PASCAL device. 61.3% had a functional, 29.0% a degenerative, and 9.7% a mixed etiology. Successful implantation was achieved in 30/31 (96.8%) patients. 27/31 patients (87.1%) completed 5-month follow-up with clinical, echocardiographic, laboratory and hemodynamic assessment. At 5 months, 70.4% of the patients had MR grade ≤ 1 (p < 0.001). 85.2% were in NYHA class I or II (p < 0.001). Six-minute walk distance improved by 145 m (p = 0.010), Kansas City cardiomyopathy questionnaire and European quality of life 5 dimensions questionnaire (EQ5D) improved by 31 (p < 0.001) and 9 points (p = 0.001), respectively. Mean pulmonary capillary wedge pressure decreased significantly from 22.1 ± 9 mmHg to 17.3 ± 8 mmHg (p = 0.041) and right atrial pressure from 10.3 ± 6 mmHg to 8.0 ± 6 mmHg (p = 0.013) from baseline to 5 months. In addition, propensity score matching showed that PASCAL and MitraClip procedures resulted in equally hemodynamic and functional improvement. CONCLUSION: MR reduction of severe MR with the PASCAL device is feasible and safe regardless of etiologies. Mid-term follow-up at 5 months showed a sustained MR reduction, improvement of exercise capacity, quality of life, proBNP levels and hemodynamics regarding pulmonary capillary wedge pressure and right atrial pressure.

Left atrial substrate ablation in addition to pulmonary vein isolation in paroxysmal atrial fibrillation using a large 28-mm cryoballoon.

We report a case of successful isolation of all pulmonary veins (PV) for symptomatic paroxysmal atrial fibrillation using a 23-mm cryoballoon with continued paroxysmal atrial fibrillation during a 3-month follow-up. Left atrial-to-PV-junction ablation was then performed 3 months after the first procedure using a larger 28-mm balloon despite unrecovered isolation of all four PV, thereby curing symptomatic atrial fibrillation in this case.

Home monitoring after ambulatory implanted primary cardiac implantable electronic devices: The home ambulance pilot study.

BACKGROUND: The Home Monitoring (HM) system of cardiac implantable electronic devices (CIEDs) permits early detection of arrhythmias or device system failures. The aim of this pilot study was to examine how the safety and efficacy of the HM system in patients after ambulatory implanted primary CIEDs compare to patients with a standard procedure and hospitalization. HYPOTHESIS: We hypothesized that HM and their modifications would be a useful extension of the present concepts for ambulatory implanted CIEDs. METHODS: This retrospective analysis evaluates telemetric data obtained from 364 patients in an ambulatory single center over 6 years. Patients were assigned to an active group (n = 217), consisting of those who were discharged early on the day of implantation of the primary CIED, or to a control group (n = 147), consisting of those discharged and followed up with the HM system according to usual medical practices. RESULTS: The mean duration of hospitalization was 73.2% shorter in the active group than in the control group, corresponding to 20.5 ± 13 fewer hours (95% confidence interval [CI]: 6.3-29.5; P < 0.01) spent in the hospital (7.5 ± 1.5 vs 28 ± 4.5 h). This shorter mean hospital stay was attributable to a 78.8% shorter postoperative period in the active group. The proportion of patients with treatment-related adverse events was 11% (n = 23) in the active group and 17% (n = 25) in the control group (95% CI: 5.5-8.3; P = 0.061). This 6% absolute risk reduction (95% CI: 3.3-9.1; P = 0.789) confirmed the noninferiority of the ambulatory implanted CIED when compared with standard management of these patients. CONCLUSIONS: Early discharge with the HM system after ambulatory CIED implantation was safe and not inferior to the classic medical procedure. Thus, together with lower costs, HM and its modifications would be a useful extension of the present concepts for ambulatory implanted CIEDs.

New Task Force Criteria Provide Evolution in Diagnosis of Arrhythmogenic Cardiomyopathy in Patients without Typical Progression of the Disease.

BACKGROUND The original Task Force Criteria from 1994 for the clinical diagnosis of ARVC were highly specific and based on structural, histological, EKG, and familial features of disease. However, recommendations for clinical diagnosis and management of ARVC are sparse and lacked sensitivity for early disease. CASE REPORT Ventricular electrical instability and sudden cardiac death are the hallmarks of ARVC, and are often present before structural abnormalities. In this case report, we describe a patient who had detectable electrical abnormalities and structural changes that remained unchanged for over 10 years. CONCLUSIONS The disease progression in this case was defined as the development of a new 2010 TFC, which was absent at enrolment in 1994 and in 2008.

Progression From Esophageal Thermal Asymptomatic Lesion to Perforation Complicating Atrial Fibrillation Ablation: A Single-Center Registry.

BACKGROUND: Up to 40% of patients demonstrate endoscopically detected asymptomatic esophageal lesions (EDEL) after atrial fibrillation ablation. METHODS AND RESULTS: Patients undergoing first atrial fibrillation ablation and postinterventional esophageal endoscopy were included in the study. Occurrence of esophageal perforating complications during follow-up was related to documented EDEL (category 1: erythema/erosion; category 2: ulcer). In total, 1802 patients underwent first atrial fibrillation ablation procedure between January 2013 and August 2016 at our institution. Out of this group, 832 patients (506 male patients, 61%; 64.0±10.0 years) with symptomatic paroxysmal (n=345; 42%) or persistent atrial fibrillation underwent postprocedural esophageal endoscopy. Patients were ablated using single-tip ablation with conventional or surround flow irrigation and circular ablation catheters with open irrigation (nMARQ). In 295 of 832 patients (35%), a temperature probe was used. EDEL occurred in 150 patients (18%; n=98 category 1 EDEL, n=52 category 2 EDEL). In 5 of 832 patients (0.6%), an esophageal perforation (n=3) or an esophagopericardial or atrioesophageal fistula (n=2) occurred 15 to 28 days (19±6 days) after ablation. Two patients (1 atrioesophageal fistula and 1 esophagopericardial fistula) died. Esophageal perforation occurred only in patients with category 2 lesions (absolute risk, 9.6%). In a logistic regression analysis, ulcers were identified to be a significant predictor for esophageal perforating complications. CONCLUSIONS: Postablation endoscopy seems to identify patients at high risk of esophageal perforating complications only occurring in patients with category 2 EDEL. One out of 10 postablation esophageal ulcers progressed to perforation, and no patient without esophageal thermal ulcers showed the occurrence of perforating esophageal complications.

Stable cystatin C serum levels confirm normal renal function in patients with dronedarone-associated increase in serum creatinine.

Dronedarone is a new antiarrhythmic drug for patients with nonpermanent atrial fibrillation (AF). A relatively consistent finding in all trials studying dronedarone was a moderate but significant elevation of serum creatinine. Since dronedarone competes for the same organic cation transporter in the distal renal tubule with creatinine, serum creatinine and its derived estimated glomerular filtration rate might not reflect true renal function in patients on dronedarone. We therefore investigated alternative markers for renal function in these patients. We prospectively included 20 patients with nonpermanent AF in whom dronedarone 400 mg twice daily was started. Patients had normal renal function and serum creatinine; serum cystatin C and creatinine clearance were measured before treatment and 10 and 90 days after treatment started. Mean serum creatinine level for all 20 patients at baseline (day 0) was 84.55 ± 12.14 and 87.8 ± 17.59 µmol/L on day 10. This slight increase in all patients was not significant. Patients were now divided into the predefined groups of "increased creatinine" (increase in serum creatinine level > 1 standard deviation) and "not increased creatinine." Patients with increased creatinine levels (n = 5) showed a significant elevation of serum creatinine levels from day 0 to day 10 (82.4 ± 9.18 to 104.4 ± 12.74 µmol/L; P = .003), whereas change in serum creatinine levels in the not increased creatinine group (n = 15) was not significant. Serum cystatin C levels remained stable in both of these groups (increased creatinine group: 0.76 ± 0.08 to 0.78 ± 0.08 mg/L; P = .65; not increased creatinine group: 0.77 ± 0.108 to 0.77 ± 0.107 mg/L; P = .906). In conclusion, cystatin C represents an easily available and reliable biomarker for estimation of true renal function in patients on dronedarone treatment.