Prognostic value of chronic kidney disease in patients undergoing left atrial appendage occlusion.

AIMS: Atrial fibrillation (AF) and chronic kidney disease (CKD) often coexist and share an increased risk of thrombo-embolism (TE). CKD concomitantly predisposes towards a pro-haemorrhagic state. Our aim was to evaluate the prognostic value of CKD in patients undergoing percutaneous left atrial appendage occlusion (LAAO). METHODS AND RESULTS: A total of 2124 consecutive AF patients undergoing LAAO were categorized into CKD stage 1+2 (n = 1089), CKD stage 3 (n = 796), CKD stage 4 (n = 170), and CKD stage 5 (n = 69) based on the estimated glomerular filtration rate at baseline. The primary endpoint included cardiovascular (CV) mortality, TE, and major bleeding. The expected annual TE and major bleeding risks were estimated based on the CHA2DS2-VASc and HAS-BLED scores. A non-significant higher incidence of major peri-procedural adverse events (1.7 vs. 2.3 vs. 4.1 vs. 4.3) was observed with worsening CKD (P = 0.14). The mean follow-up period was 13 ± 7 months (2226 patient-years). In comparison to CKD stage 1+2 as a reference, the incidence of the primary endpoint was significantly higher in CKD stage 3 (log-rank P-value = 0.04), CKD stage 4 (log-rank P-value = 0.01), and CKD stage 5 (log-rank P-value = 0.001). Left atrial appendage occlusion led to a TE risk reduction (RR) of 72, 66, 62, and 41% in each group. The relative RR of major bleeding was 58, 44, 51, and 52%, respectively. CONCLUSION: Patients with moderate-to-severe CKD had a higher incidence of the primary composite endpoint. The relative RR in the incidence of TE and major bleeding was consistent across CKD groups.

Ability to remotely monitor atrial high-rate episodes using a single-chamber implantable cardioverter-defibrillator with a floating atrial sensing dipole.

AIMS: To allow timely initiation of anticoagulation therapy for the prevention of stroke, the European guidelines on atrial fibrillation (AF) recommend remote monitoring (RM) of device-detected atrial high-rate episodes (AHREs) and progression of arrhythmia duration along pre-specified strata (6 min…<1 h, 1 h…<24 h, ≥ 24 h). We used the MATRIX registry data to assess the capability of a single-lead implantable cardioverter-defibrillator (ICD) with atrial sensing dipole (DX ICD system) to follow this recommendation in patients with standard indication for single-chamber ICD. METHODS AND RESULTS: In 1841 DX ICD patients with daily automatic RM transmissions, electrograms of first device-detected AHREs per patient in each duration stratum were adjudicated, and the corresponding positive predictive values (PPVs) for the detections to be true atrial arrhythmia were calculated. Moreover, the incidence and progression of new-onset AF was assessed in 1451 patients with no AF history. A total of 610 AHREs ≥6 min were adjudicated. The PPV was 95.1% (271 of 285) for episodes 6min…<1 h, 99.6% (253/254) for episodes 1 h…<24 h, 100% (71/71) for episodes ≥24 h, or 97.5% for all episodes (595/610). The incidence of new-onset AF was 8.2% (119/1451), and in 31.1% of them (37/119), new-onset AF progressed to a higher duration stratum. Nearly 80% of new-onset AF patients had high CHA2DS2-VASc stroke risk, and 70% were not on anticoagulation therapy. Age was the only significant predictor of new-onset AF. CONCLUSION: A 99.7% detection accuracy for AHRE ≥1 h in patients with DX ICD systems in combination with daily RM allows a reliable guideline-recommended screening for subclinical AF and monitoring of AF-duration progression.

Incidence and clinical relevance of upper gastrointestinal pathology during preprocedural endoscopy in patients undergoing pulmonary vein isolation.

BACKGROUND: Reflux-induced esophagitis might facilitate ablation-induced esophageal lesions (ELs) following pulmonary vein isolation (PVI), and these may progress to atrio-esophageal fistula (AEF). In contrast, preexisting ELs are not prone to progression but may affect procedure planning. OBJECTIVE: To study the incidence of preexisting esophageal and upper gastrointestinal (UGI) pathology in patients undergoing PVI, and the relation to ablation-induced ELs. METHODS: From 08/2018 to 09/2021, consecutive patients undergoing (radiofrequency [RF] or cryoballoon [CB]) PVI were examined by esophagogastroscopy (EGD) before and following ablation. Postprocedural endoscopic ultrasound (EUS) was added in 2021. RESULTS: 412 patients (median age 67.5 [IQR 61.3-75.0] years, 56.1% male) were studied. Preprocedural EGD showed abnormalities in 226/399 patients, 15% in the lower third of the esophagus. Half (99/226) were relevant for PVI, 13 procedures were postponed, 6 due to pathological EGD results. A third of the patients with new esophageal injury following ablation had preexisting esophagitis which was associated with a trend for a higher incidence of ELs after RF ablation (12.5 vs. 6.9%, p = 0.232), and a six- and two-fold higher rate of food retention after CB-PVI (28.6 vs. 4.5%, p = 0.008) and RF ablation (8.3 vs. 4.4%, p = 0.279), respectively. CONCLUSION: (1) EGD before PVI showed UGI abnormalities in > 50% of patients, one-fourth of these relevant for PVI. (2) Esophageal inflammation was associated with a higher incidence of post-ablation (peri)-esophageal injury. Whether having this information before ablation is able to reduce ELs or AEF remains to be shown.

Temperature monitoring and temperature-driven irrigated radiofrequency energy titration do not prevent thermally induced esophageal lesions in pulmonary vein isolation: A randomized study controlled by esophagoscopy before and after catheter ablation.

BACKGROUND: Endoscopically detected esophageal lesions (EDELs) are common following pulmonary vein isolation (PVI) and may progress to atrioesophageal fistula (AEF). OBJECTIVE: The purpose of this study was to study (1) the benefit of luminal esophageal temperature (LET) monitoring and (2) the impact of esophagogastroduodenoscopy (EGD) in detecting EDEL and defining pre-existing lesions. The primary endpoint was the number of ablation-induced lesions. METHODS: Patients with atrial fibrillation were randomized to PVI with LET monitoring (LET[+]) or without LET monitoring (LET[-]). All patients underwent EGD before and after PVI. Ablation power at the left atrial (LA) posterior wall was limited to 25 W in all patients and was titrated to a minimum of 10 W guided by esophageal temperature in the LET[+] group. RESULTS: Eighty-six patients (age 67 ± 10 years; 57% male) were included (44 LET[+], 42 LET[-]). PVI was achieved in all, and additional linear LA lesions were done in 50%. Eight patients developed EDEL (6 LET[+], 2 LET[-]; P = NS). Whereas LET <41°C did not differentiate with regard to EDEL formation, temperature overshooting ≥42°C was associated with a higher risk for new EDEL. Two-thirds of patients showed incidental findings (esophagitis, gastric ulcer) on preprocedural EGD; 8 esophageal lesions were pre-existing. Four patients in the LET[+] group developed epistaxis following insertion of the probe. CONCLUSION: Monitoring of LET does not prevent ablation-induced esophageal lesions. Patients without temperature surveillance were not at higher risk, but temperatures ≥42°C were associated with increased likelihood of mucosal lesions.

Protected risk stratification with the wearable cardioverter-defibrillator: results from the WEARIT-II-EUROPE registry.

BACKGROUND: The prospective WEARIT-II-EUROPE registry aimed to assess the value of the wearable cardioverter-defibrillator (WCD) prior to potential ICD implantation in patients with heart failure and reduced ejection fraction considered at risk of sudden arrhythmic death. METHODS AND RESULTS: 781 patients (77% men; mean age 59.3 ± 13.4 years) with heart failure and reduced left ventricular ejection fraction (LVEF) were consecutively enrolled. All patients received a WCD. Follow-up time for all patients was 12 months. Mean baseline LVEF was 26.9%. Mean WCD wearing time was 75 ± 47.7 days, mean daily WCD use 20.3 ± 4.6 h. WCD shocks terminated 13 VT/VF events in ten patients (1.3%). Two patients died during WCD prescription of non-arrhythmic cause. Mean LVEF increased from 26.9 to 36.3% at the end of WCD prescription (p < 0.01). After WCD use, ICDs were implanted in only 289 patients (37%). Forty patients (5.1%) died during follow-up. Five patients (1.7%) died with ICDs implanted, 33 patients (7%) had no ICD (no information on ICD in two patients). The majority of patients (75%) with the follow-up of 12 months after WCD prescription died from heart failure (15 patients) and non-cardiac death (15 patients). Only three patients (7%) died suddenly. In seven patients, the cause of death remained unknown. CONCLUSIONS: Mortality after WCD prescription was mainly driven by heart failure and non-cardiovascular death. In patients with HFrEF and a potential risk of sudden arrhythmic death, WCD protected observation of LVEF progression and appraisal of competing risks of potential non-arrhythmic death may enable improved selection for beneficial ICD implantation.

Very early discharge after cardiac implantable electronic device implantations: is this the future?

PURPOSE: To limit the ever-increasing healthcare costs, strategies to minimize hospitalization length are warranted. In this perspective, early discharge (the same day or after < 24 h) post-cardiac implantable electronic device (CIED) implantation might represent a useful strategy; nevertheless, it is imperative first to understand the timing of (potentially lethal) complications and evaluate whether this is not only an effective but also a safe clinical decision. METHODS: A retrospective cohort analysis of all patients undergoing new CIED implantation from Jan 2008 to Dec 2014 was conducted. Patient demographics, comorbidities, and timing of complications post CIED implantation were evaluated, and the timing of complications was divided into intra-operative, 0-6 h (h), 6 to 24 h, and > 24 h post-implant. One-year post-implant follow-up (FU) was performed in our CIED clinic. RESULTS: A total of 1868 patients (68% men, average age 70 years, 85% hypertension, 39% diabetes, 57% coronary artery disease, and average left ventricular ejection fraction (LVEF) 41%) received 703 (38%) pacemaker, 448 (24%) implantable cardioverter-defibrillator (ICD), 639 (34%) cardiac resynchronization therapy (CRT) devices, and 78 (4.2%) cardiac contractility modulation. A total of 199 (11%) patients experienced 214 complications. Most (75%) occurred > 24 h post-implantation (with a median of 7 days). At univariate analysis, complications occurred more often in patients with a lower LVEF, on anticoagulation/antiplatelet therapy, and undergoing ICD/CRT-D implantation (p < 0.05 for all). CONCLUSION: Most complications occur > 24 h after first time CIED implantation. Therefore, it might not be optimal to discharge patients in ≤ 24 h, unless extensive ambulatory monitoring for complications is available.

Life in the fast lane: clinical and immunohistological characteristics of tachycardia-induced cardiomyopathy-a retrospective study in 684 patients.

BACKGROUND: Tachycardia-induced cardiomyopathy (TCM) has been known for decades as a reversible form of non-ischemic cardiomyopathy. However, its mechanism and characteristics remain poorly understood. OBJECTIVES: This retrospective study investigated endomyocardial biopsy (EMB) samples from consecutive patients with TCM and compared them with samples from patients with dilated cardiomyopathy (DCM) and inflammatory cardiomyopathy (InCM). MATERIALS AND METHODS: A total of 684 patients (18 TCM, 170 DCM, 496 InCM) with recent-onset heart failure and reduced ejection fraction unrelated to valvular or ischemic heart disease were analyzed. RESULTS: In the TCM group, 81% were male, the mean age was 60 ± 13 years, and 94% had heart failure symptoms ≥2 New York Heart Association (NYHA) class. At baseline (BL), 78% had atrial fibrillation/flutter and 12% other forms of tachycardia or frequent extrasystole. The ventricular rate was higher compared to DCM and InCM patients (122 ± 25 versus 78 ± 21; p < 0.001). Mean ejection fraction at BL was lower compared to DCM and InCM (27 ± 12% versus 39.0 ± 14.6%; p = 0.001), but improved to a significantly greater extent during follow-up (FU) (20% versus 6%; p < 0.001). At FU, heart rate and presence of sinus rhythm were similar in all groups; 69% of TCM patients underwent cardioversion or ablation. Compared with DCM patients, TCM patients had stronger myocardial expression of major histocompatibility complex (MHC) class II and an equal amount of infiltration with T­cells/macrophages. Compared with InCM patients, the presence of T­cells/macrophages was significantly lower in TCM. The marker of apoptosis (caspase 3) was comparably elevated in TCM/InCM patients. CONCLUSION: Tachycardia-induced cardiomyopathy is characterized by immunohistological changes comparable to DCM except for caspase 3 levels, which were similar to those in InCM.

Decision regret in implantable cardioverter-defibrillator recipients : A cross-sectional analysis on patients that regret their decision after ICD implantation.

BACKGROUND: Implantable cardioverter-defibrillators (ICDs) are designed to deliver therapy in the event of malignant ventricular arrhythmias. Despite their benefits, some ICD recipients regret their decision on device implantation. OBJECTIVES: The aim of this study was to evaluate the incidence, predictors, and consequences of recipients that regretted their decision after implantation. METHODS: A questionnaire-based cross-sectional survey of consecutive ICD recipients examined during a routine outpatient follow-up visit was conducted. Their level of depression and anxiety was assessed with the hospital anxiety and depression scale (HADS). Quality of life (QOL) was assessed using the Minnesota living with heart failure questionnaire. RESULTS: Of 434 ICD recipients invited to the study, 423 (97.5%) agreed and completed the survey, 349 (83%) had a primary prevention indication, and 339 (80%) ischemic cardiomyopathy. A total of 41 recipients (9.7%) regretted their decision to undergo ICD implantation. These patients were: (1) younger (63 versus 69 years), (2) more frequently in New York Heart Association (NYHA) ≥2 functional class (63% versus 22%), (3) had higher education levels (more than high-school: 76% versus 60%), (4) felt that preoperative information was lacking (22% versus 4%), (5) had more complications in the perioperative period (15% versus 3%), (6) felt less safe after ICD implantation (54% versus 5%), and (7) considered more frequently ICD deactivation during near end-of-life situations (54% versus 29%). Mean QOL and HADS scores were significantly worse in these patients (36 versus 30 and 12 versus 8.8 points, respectively; p < 0.01 for all). CONCLUSION: Almost 10% of ICD recipients regretted their decision after implantation. Predictors included younger age, higher education levels, complicated perioperative period, and lack of preoperative information.

Computed tomography-derived left atrial volume index, sex, and age to predict the presence and the extent of left atrial low-voltage zones in patients with atrial fibrillation: The ZAQ score.

BACKGROUND: Pulmonary vein isolation is the cornerstone of catheter ablation in patients with atrial fibrillation (AF). However, with advanced left atrial (LA) structural changes, additional targeted catheter ablation of low-voltage zones (LVZs) has produced favorable results. Therefore, with the advent of single-shot techniques, it would be helpful to predict the presence of LVZs before an ablation procedure. OBJECTIVE: We hypothesized that computed tomography (CT)-derived left atrial volume index (LAVI), in combination with other objective parameters, could be used to develop a score able to predict the presence of LVZs. METHODS: In a large cohort of patients undergoing their first AF ablations, comprehensive echocardiographic evaluations and cardiac CT were performed. During the electrophysiological studies, LA geometry and electroanatomic voltage maps were created. LVZs were defined as areas ≥1 cm2 with bipolar peak-to-peak voltage amplitudes ≤0.5 mV. RESULTS: In a derivation cohort of 374 patients, predictors of LVZs were identified by regression analysis and used to build the Zentralklinik Bad Berka and University of L'Aquila (ZAQ) score (age ≥65 years; female sex; and CT-LAVI ≥57 mL/m2 ). The ZAQ score of 2 points accurately identified the presence and the extent of LVZs (area under the curve [AUC], 0.809; 95% confidence interval [CI], 0.758-0.861; P < .001 and 3 [interquartile range, IQR, 1.5-4.5] vs 7 cm2 [IQR 4-9]; P = .001). In a validation cohort of 103 patients, the predictive value of the score was confirmed (AUC, 0.793; 95% CI, 0.709-0.878; P < .001 and 4 [IQR, 2-7] vs 11.5 cm2 [IQR, 8-16.5]; P = .001). CONCLUSIONS: The ZAQ score identifies LVZs and may be useful for planning the ablation strategy ahead of time.

Phantom shocks in implantable cardioverter-defibrillator recipients: impact of education level, anxiety, and depression.

BACKGROUND: Implantable cardioverter defibrillators (ICDs) are designed to deliver shocks in the event of ventricular arrhythmias. Some ICD recipients experience the sensation of ICD discharge in the absence of an actual discharge (phantom shock, PS). OBJECTIVES: The aim of this study was to evaluate the incidence, predictors, and consequences of PS in ICD recipients. MATERIALS AND METHODS: Consecutive ICD recipients were examined during a routine outpatient follow-up (FU) visit. Subjects completed a written survey; their level of depression and anxiety was assessed with the hospital anxiety and depression scale (HADS). Quality of life (QOL) was assessed using the Minnesota living with heart failure questionnaire. RESULTS: Of 434 patients invited to the study, 423 (97.5%) ICD recipients agreed to and completed the survey; 349 (83%) had a primary prevention indication and 339 (80%) ischemic cardiomyopathy. A total of 27 patients (6.4%) reported a PS during a mean FU of 64 ± 44 months (5.4% in the primary prevention group and 10.8% in the secondary prevention group; p = 0.11). PS were related to higher education (≥bachelor's degree 41% versus 20%; p = 0.03), and more frequent in patients receiving adequate shocks during FU (34% versus 0.5%; p < 0.001). HADS score levels were higher following PS (15 ± 6 versus 8.8 ± 7.4; p < 0.001). The majority of patients reporting PS felt that the information provided to them prior to ICD placement was insufficient (22.2% versus 5.0%), that they needed psychological support after ICD implantation (26% versus 3%), and considered ICD deactivation in near end-of-life situations (59% versus 29%; p < 0.001 for all). CONCLUSIONS: PS occur in 6.4% of all ICD recipients and are related to higher education and to patients that experienced adequate shocks during FU.

Pocket related complications following cardiac electronic device implantation in patients receiving anticoagulation and/or dual antiplatelet therapy: prospective evaluation of different preventive strategies.

PURPOSE: We sought to assess the safety and effectiveness of three different devices: (1) vacuum drainage system, (2) hemostatic gelatin sponge (Stypro®), and (3) compression device (Premofix®) compared to standard of care (control) in patients undergoing cardiac implantable electronic device (CIED) implantation receiving anticoagulation and/or dual antiplatelet therapy (DAPT). METHODS: We enrolled all consecutive patients admitted for first permanent CIED implantation receiving anticoagulation and/or DAPT into a prospective registry. The primary endpoint (1°EP) was a composite of hematoma grade > 1 and pocket infection. RESULTS: We included 406 patients (median age 73 years, 71% male) of whom 103 (25%) received a vacuum drainage system, 99 (24%) received Stypro®, 103 (25%) received Premofix®, and 101 (25%) were in the control group. One hundred eighty patients (44%) were treated with anticoagulation (median INR 2.0), 176 (43%) received DAPT, and 50 (12%) both. The occurrence of the 1°EP was reduced by Stypro® (hazard ratio (HR) 0.38 (95% confidence interval (CI) 0.16-0.94) and Premofix® (HR: 0.37 (95% CI 0.15-0.90)) compared to controls (p < 0.05 for both). The incidence of hematoma grade 2 or 3 was exclusively lowered by Premofix® compared to control (6% versus 15%; p < 0.05) and was not affected by the type of CIED, INR (≥ 2.5 versus < 2.5), body mass index (≥ 30 versus < 30), or CIED implantation under anticoagulation plus DAPT. The vacuum drainage system did not affect the 1°EP or the incidence of hematoma. CONCLUSIONS: In patients receiving anticoagulation and/or DAPT undergoing CIED implantation, the use of Premofix® and Stypro® significantly lowered the 1°EP occurrence compared to control. Premofix® additionally lowered the frequency of pocket hematomas >grade 1.

Left atrial appendage electrical isolation for persistent atrial fibrillation.

Left atrial appendage (LAA) may be the source for initiation and maintenance of atrial fibrillation (AF). This report shows restoration of sinus rhythm in the atria during radiofrequency wide-area LAA electrical isolation, whereas AF persists in the LAA.

Effect of intraoperative local application of 3% hydrogen peroxide on pocket infections following cardiac implantable electronic device implantation: An observational study.

AIMS: The aim of this study was to analyze whether local application of 3% hydrogen peroxide (H2O2) additionally to standard antibiotic prophylaxis following implantation of cardiac implantable electronic devices (CIED) reduces the incidence of pocket infections (PI). METHODS: In this observational case-control study every patient from the group additionally treated with H2O2 was matched with two patients out of the control group for age, male-gender, body-mass-index and operation time. The incidence of PI within 365 days after device implantation was compared. RESULTS: During the 5-year study period, 429 consecutive patients were additionally treated with H2O2 and matched with 858 patients undergoing standard treatment (mean age 69 ±â€¯12 years, 876 males (67.4%), body-mass-index 28 ±â€¯4.0 kg/m2 and operation time 45 ±â€¯23 min). Except for a more frequent use of dual-platelet-inhibition in the H2O2-group, clinical characteristics were otherwise similar. A total of 23 (1.78%) PIs occurred, most of them (14/23; 61%) during the first 45 days after implantation procedure. The use of H2O2 was associated with a significant reduction (3/429 = 0.69% versus 20/858 = 2.33%; p = 0.04), although patients of the H2O2 treated group received more complex procedures increasing the risk of PI. CONCLUSION: Intraoperative local application of 3% H2O2 seems to be associated with a significant reduced incidence of PI following implantation of CIED. Because of its non-randomized character this trial should be considered as a hypothesis generating study.

Critical analysis of ineffective post implantation implantable cardioverter-defibrillator-testing.

AIM: To test of the implantable-cardioverter-defibrillator is done at the time of implantation. We investigate if any testing should be performed. METHODS: All consecutive patients between January 2006 and December 2008 undergoing implantable cardioverter-defibrillator (ICD) implantation/replacement (a total of 634 patients) were included in the retrospective study. RESULTS: Sixteen patients (2.5%) were not tested (9 with LA/LV-thrombus, 7 due to operator's decision). Analyzed were 618 patients [76% men, 66.4 + 11 years, 24% secondary prevention (SP), 46% with left ventricular ejection fraction (LVEF) < 20%, 56% had coronary artery disease (CAD)] undergoing defibrillation safety testing (SMT) with an energy of 21 + 2.3 J. In 22/618 patients (3.6%) induced ventricular fibrillation (VF) could not be terminated with maximum energy of the ICD. Six of those (27%) had successful SMT after system modification or shock lead repositioning, 14 patients (64%) received a subcutaneous electrode array. Younger age (P = 0.0003), non-CAD (P = 0.007) and VF as index event for SP (P = 0.05) were associated with a higher incidence of ineffective SMT. LVEF < 20% and incomplete revascularisation in patients with CAD had no impact on SMT. CONCLUSION: Defibrillation testing is well-tolerated. An ineffective SMT occurred in 4% and two third of those needed implantation of a subcutaneous electrode array to pass a SMT > 10 J.

Catheter ablation of ventricular ectopy with para-hisian origin: importance of mapping both sides of the interventricular septum and understanding when to stop ablating.

Catheter ablation of para-Hisian premature ventricular contractions (PVCs) still represents a challenge and is a compromise between success and inadvertent AV block. We describe a possible strategy to address PVCs from this location with high-amplitude His-bundle potentials at the site of earliest activation.