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.

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.

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.

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.

Electrocardiographic and Electrophysiological Characteristics of Atrial Tachycardia With Early Activation Close to the His-Bundle.

INTRODUCTION: Radiofrequency (RF) ablation of atrial tachycardia (AT) with earliest activation at the His-bundle may be associated with the risk of AV block, and detection of this AT origin using the electrocardiogram (ECG) would be helpful in planning ablation. Aim of this study was to characterize the P-wave morphology and intracardiac electrograms at the successful ablation site for this group of ATs. METHODS: All consecutive patients undergoing ablation for AT with earliest activation at the His-bundle were included. Twelve-lead ECG and intracardiac electrograms were analyzed. RESULTS: A total of 33 patients underwent successful ablation. The P-wave and the PR interval during AT (cycle length 460 ± 88, range 360-670 milliseconds) were significantly shorter compared to sinus rhythm 87 ± 18 vs. 117 ± 23 and 131 ± 37 vs. 170 ± 47 milliseconds, respectively, P < 0.01. In 28 patients (85%), the P-wave was biphasic (-/+) or triphasic (+/-/+) in the precordial leads, especially V4 -V6 , and in 25 patients (76%) it was biphasic (-/+) or triphasic (+/-/+) in the inferior leads. RF was delivered at the following locations: noncoronary aortic cusp (NCC) in 24 patients, antero-septal left atrium in 4, supero-septal right atrium in 3, left coronary cusp in 1, and between the right coronary cusp and the NCC in 1. Atrial bipolar electrograms at the successful ablation site preceded the P-wave by 38 ± 11 (range 10-60) milliseconds, and AT termination was obtained after a mean RF energy time of 10 ± 8 (range 2-31) seconds. CONCLUSION: A characteristic narrow and biphasic (-/+) or triphasic (+/-/+) P-wave in the inferior and precordial leads reliably identifies the group of AT arising from the para-Hisian region.

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

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

Isolated Disruption of the Right Coronary Artery Following a Steam Pop during Cavotricuspid Linear Ablation with a Contact Force Catheter.

A 70-year-old woman with persistent atrial fibrillation underwent pulmonary vein isolation and linear ablation with a contact sensor catheter. During cavotricuspid isthmus ablation, a steam pop resulted in cardiac tamponade, and the patient developed severe hypotension despite successful pericardial puncture and minimal residual pericardial effusion. Right coronary artery angiography revealed extravasal contrast medium accumulation posterior of the Crux Cordis. Emergent cardiac surgery confirmed isolated disruption of the artery in the absence of additional heart perforation. Although contact sensor catheters may reduce complications, steam pops can still occur and result in dramatic complications.

Incidence of ineffective safety margin testing (<10 J) and efficacy of routine subcutaneous array insertion during implantable cardioverter defibrillator implantation.

The purpose of this study was to assess (1) the incidence of safety margin testing <10 J (SMT) and (2) the efficacy/safety of routinely adding a subcutaneous array (SQA) (Medtronic 6996SQ) for these patients. Patients with SMT smaller than a 10-J safety margin from maximum output were considered to have very high readings and underwent SQA insertion. These patients were compared with the rest of the patients who had acceptable SMT (≥10 J). A total of 616 patients underwent ICD implantation during the analysis period. Of those, 16 (2.6%) had SMT <10 J. By univariate analysis, younger age, and non-ischemic cardiomyopathy, were all significant predictors of SMT <10 J (p < 0.05). In all 16 cases, other methods to improve SMT prior to array insertion were attempted but failed for all patients: reversing shock polarity (n = 15), removing the superior vena cava coil (n = 14), reprogramming shock waveform (n = 9), and repositioning right ventricular lead (n = 9). Addition of the SQA successfully increased SMT to within safety margin for all patients (32 ± 2 versus 21 ± 3 J; p < 0.001). Follow-up (mean 48.1 ± 21 months) was available for all patients with SQA, only 2 cases with inappropriate shocks due to atrial fibrillation had to be noted. None of the patients experienced complications due to SQA implantation. SMT <10 J occur in about 2.6% of patients undergoing ICD implantation. SQA insertion corrects this problem without procedural/mid-term complications.

Rationale and design of the MONITOR-ICD study: a randomized comparison of economic and clinical effects of automatic remote MONITORing versus control in patients with Implantable Cardioverter Defibrillators.

BACKGROUND AND AIMS: Implantable cardioverter defibrillator (ICD) remote follow-up and ICD remote monitoring (RM) are established means of ICD follow-up. The reduction of the number of in-office visits and the time to decision is proven, but the true clinical benefit is still unknown. Cost and cost-effectiveness of RM remain leading issues for its dissemination. The MONITOR-ICD study has been designed to assess costs, cost-effectiveness, and clinical benefits of RM versus standard-care follow-up in a prospective multicenter randomized controlled trial. METHODS AND RESULTS: Patients indicated for single- or dual-chamber ICD are eligible for the study and are implanted an RM-capable Biotronik ICD (Lumax VR-T or Lumax DR-T; Biotronik SE & Co KG, Berlin, Germany). Implantable cardioverter defibrillator programming and alert-based clinical responses in the RM group are highly standardized by protocol. As of December 2011, recruitment has been completed, and 416 patients have been enrolled. Subjects are followed-up for a minimum of 12months and a maximum of 24months, ending in January 2013. Disease-specific costs from a societal perspective have been defined as primary end point and will be compared between RM and standard-care groups. Secondary end points include ICD shocks (including appropriate and inappropriate shocks), cardiovascular hospitalizations and cardiovascular mortality, and additional health economic end points. CONCLUSIONS: The MONITOR-ICD study will be an important randomized RM study to report data on a primary economic end point in 2014. Its results on ICD shocks will add to the currently available evidence on clinical benefit of RM.

Incidence and predictors of pericardial effusion after permanent heart rhythm device implantation: prospective evaluation of 968 consecutive patients.

BACKGROUND: Pericardial effusion (PE) may complicate permanent heart rhythm device (HRD: pacemaker, implantable cardioverter-defibrillator, and cardiac resynchronization therapy) placement. Incidence of and risk factors for this complication have never been prospectively evaluated. METHODS AND RESULTS: The subjects of this prospective observational study were 968 consecutive patients undergoing HRD implantation or upgrade, and underwent echocardiographic evaluation before and 24h after the operation. PE was documented in 98 patients (10%), 14 (1.5%) of whom progressed to cardiac tamponade requiring pericardiocentesis (n=12; 86%) or surgical treatment (n=2; 14%). In 70% (10/14) of those patients a bloody effusion suggested cardiac perforation of an implanted lead; acute pericarditis was observed in the remaining 30% (4/14). At multivariate analysis, female gender (hazard ratio [HR], 2.7; 95% confidence interval [CI]: 1.4-3.5, P=0.01) was predictive in the case of any post-procedural PE, whereas intake of antiplatelet medication (HR, 3.1; 95% CI: 2.1-3.8, P=0.01) was predictive for cardiac tamponade. Previous cardiac surgery (HR, 0.70; 95% CI: 0.50-0.92, P=0.02) was a protective factor in any PE and cardiac tamponade. None of the 84 patients with small or moderate PE required pericardial drainage. After 3.1±0.5 months, a PE was no longer observed at echocardiography in 71% of those patients. CONCLUSIONS: PE is frequently seen after HRD implantation, but rarely requires any therapy. Female gender and antiplatelet therapy are risk factors, whereas previous cardiac surgery was a protective factor.

Influence of the anatomic characteristics of the pulmonary vein ostium, the learning curve, and the use of a steerable sheath on success of pulmonary vein isolation with a novel multielectrode ablation catheter.

AIMS: Anatomic variability of the pulmonary vein (PV) ostium may adversely affect isolation rates with the circular fixed-size pulmonary vein ablation catheter (PVAC). We wanted to assess the influence on PV isolation rates of anatomic characteristics of the ostium, increasing experience of four different operators, and additional use of a steerable sheath. METHODS AND RESULTS: In the first 190 patients (pts) undergoing PVAC ablation, minimum/maximum diameter, area and shape of the PV ostia, and the length of a common ostium were analysed from computed tomography 3D reconstructions of the left atrium and related to isolation rates. In addition, a comparison was drawn between pts at the beginning and after completion (isolation of all PVs in ≥ 85% of pts) of the learning curve, and the effect of a steerable sheath was assessed. Pulmonary vein isolation was achieved with the PVAC alone in 85% of pts and in 94% of veins after a median procedure and ablation time of 154 [interquartile ranges (IQR): 120, 200] and 51 (IQR: 38, 70) min. An increase in isolation rates was observed after the first 60 pts (73 vs. 90% of pts; P< 0.01; 88 vs. 96% of PVs; P< 0.001), coincident with routine use of a steerable sheath. Anatomic characteristics (larger minimum diameter and area) identified unsuccessful isolation only of the left inferior PV at the beginning of the learning curve. CONCLUSIONS: Pulmonary vein isolation rates using this catheter are high. Anatomic variability of PV ostia modestly affects PV isolation rates. Standard use of a steerable sheath plays a major role in increasing isolation rates and overcoming 'difficult' anatomies.

Long-term prognosis of adult patients with isolated congenital left ventricular aneurysm or diverticulum and abnormal electrocardiogram patterns.

BACKGROUND: Congenital left ventricular aneurysm (LVA) and diverticulum (LVD) are rare cardiac anomalies frequently associated with electrocardiogram (ECG) abnormalities. The aim of this study was to evaluate the long-term prognosis in such patients. METHODS AND RESULTS: A total of 108 patients with LVA or LVD having ECG-abnormalities were assessed. The patients were classified into 2 groups according to ECG abnormalities: a distinct ECG group (8 ECG patterns known to be frequently associated with LVA/LVD); and a control group (all other ECG abnormalities). The primary endpoint was a composite of cardiac death, rhythm disturbances, syncope, embolic events, and hospitalization for cardiovascular events. Mean patient age was 64±10 years; 45 (42%) were male; median follow-up (FU) was 50 months. The primary endpoint occurred in 12/27 patients from the distinct ECG group and in 15/81 patients in the control group (44% vs. 19%; P=0.01). Cardiac event rate per year (CER) was 1.8% vs. 0.8%, respectively. There were no cardiac deaths during FU. Symptoms (arrhythmia-related symptoms, syncope, and embolic events) at time of diagnosis increased the incidence of adverse events during FU (70% vs. 28%; P=0.05; CER 2.9% vs. 1.1%). Age ≥64 years, presence of LVD, gender, and location of the anomaly did not affect the incidence of adverse events. CONCLUSIONS: The incidence of adverse events in symptomatic patients with isolated LVA or LVD and distinct abnormal ECG patterns is increased during long-term FU. None of the present patients, however, experienced cardiac death.

Incidence and predictors of ventricular arrhythmias after ST-segment elevation myocardial infarction.

BACKGROUND: Sustained ventricular arrhythmias (VA) complicate 7% to 20% of acute myocardial infarctions. We hypothesized that primary angioplasty (percutaneous coronary intervention [PCI]) and contemporary medical treatment will result in a lower incidence of VA and shorten the time frame of their occurrence. Thus, an electrocardiographic monitoring period of 24 hours should be sufficient to detect more than 95% of all malignant VA. METHODS: We continuously monitored all patients with ST-segment elevation myocardial infarction (STEMI) for 48 hours. RESULTS: Of the 510 patients who underwent PCI for STEMI, 24 (4.7%) developed sustained VA. Sixty percent of sustained VA occurred during the first 24 hours; and 92%, during the first 48 hours. In univariate analysis, heart rate greater than 100 beats per minute, Thrombolysis in Myocardial Infarction flow grade less than 3, elevated creatinine (≥1 mg/dL), elevated C-reactive protein (≥0.8 mg/dL), higher white blood cell count (≥12 × 10(3)/µL), use of diuretics, and lower hematocrit (≤39%) were associated with an increased risk of VA. Symptom-onset-to-balloon time of 4 hours or more in patients with postprocedural Thrombolysis in Myocardial Infarction 3 flow, treatment with ß-blockers, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and statins were associated with a reduced risk of VA. After multivariate adjustment, independent predictors of sustained VA included total white blood cell count of 12 × 10(3)/µL or more, hematocrit of 39% or less, and lack of ß-blocker medication. CONCLUSIONS: In this study, we could demonstrate that primary PCI results in a lower incidence of VA compared with data from the literature but did not shorten the time frame of VA occurrence. Thus, an electrocardiographic monitoring period for VA of 48 hours should be performed in patients with STEMI.

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.

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.

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.