Cryoballoon ablation for atrial fibrillation in octogenarians: a propensity score-based analysis with a younger cohort.

BACKGROUND: In terms of safety and efficacy, cryoballoon ablation (CB-A) has become a valid option for achieving pulmonary vein isolation (PVI) in patients affected by symptomatic atrial fibrillation. However, CB-A data in octogenarians are still scarce and limited to single-centre experiences. The present multicentre study aimed to compare the outcomes and complications of index CB-A in patients older than 80 years with a cohort of younger patients. METHODS AND RESULTS: We retrospectively enrolled 97 consecutive patients aged ≥80 years who underwent PVI using the second-generation CB-A. This group was compared with a younger cohort of patients using a 1:1 propensity score matching. After the matching, 70 patients from the elderly group were analysed and compared with 70 younger patients (control group). The mean age was 81.4 ±â€Š1.9 years among octogenarians and 65.2 ±â€Š10.2 years in the younger cohort. The global success rate after a median follow-up of 23 [18-32.5] months was 60.0% in the elderly group and 71.4% in the control group (P = 0.17). Phrenic nerve palsy was the most common complication occurring in a total of 11 patients (7.9%): in 6 (8.6%) patients in the elderly group and in 5 patients (7.1%) in the younger group (P = 0.51). Only two (1.4%) major complications occurred: one (1.4%) femoral artery pseudoaneurysm in the control group, which resolved with a tight groin bandage, and one (1.4%) case of urosepsis in the elderly group. Arrhythmia recurrence during the blanking period and the need for electrical cardioversion to restore sinus rhythm after PVI were found to be the only independent predictors of late arrhythmia relapses. CONCLUSIONS: The present study showed that CB-A PVI is as feasible, safe and effective among appropriately selected octogenarians as it is in younger patients.

Key characteristics for effective acute pulmonary vein isolation when using a novel cryoballoon technology: insights from the CHARISMA registry.

PURPOSE: A new cryoballoon (CB) technology (POLARx™; Boston Scientific) for pulmonary vein (PV) isolation in patients with atrial fibrillation (AF) has recently been introduced. The aim of this study was to evaluate procedural and biophysical parameters resulting in acute PV isolation when using this new CB. METHODS: We assessed the first 69 consecutive patients indicated for AF ablation who underwent PV isolation by means of a novel CB system. Procedural metrics were prospectively recorded. RESULTS: A total of 274 PVs were targeted in 69 patients. PV isolation was achieved in all patients by means of cryoablation alone. The median time to isolation (TTI) was 44 [31-68] s (median temperature at TTI = - 49 [- 53 to - 41] °C). The median duration of CB ablation was 180 [180 to 240] s. The median nadir temperature was - 56.0 [- 61 to - 52] °C, and the median thaw time to 0 °C was 18 [15-21] s. The median grade of PV occlusion was 4 [3 to 4]. On the basis of ROC analysis, we defined the following cut-off values for acute PV isolation: - 56 °C for nadir temperature (sensitivity = 73.3%, specificity = 64.6%, AUC = 0.716; positive predictive value = 88.1%), 30 s for TTT (60.2%, 53.3%, 0.578; 79.7%), thaw time > 17 s (65.3%, 70.0%, 0.709; 86.9%), and grade of PV occlusion = 4 (79.4%, 66.7%, 0.738; 88.5%). No major procedure-related adverse events were observed at 30-day post-procedure. CONCLUSIONS: The new POLARx™ CB appears to be effective and safe. A nadir temperature of - 56 °C, a thaw time to 0 °C ≥ 17 s, and complete PV occlusion were the best predictors of acute PV isolation. CLINICAL TRIAL REGISTRATION: Catheter Ablation of Arrhythmias with a High-Density Mapping System in Real-World Practice (CHARISMA). URL: http://clinicaltrials.gov/Identifier : NCT03793998. Registration date: January 4, 2019.

dST-Tiso Interval, a Novel Electrocardiographic Marker of Ventricular Arrhythmia Inducibility in Individuals With Ajmaline-Induced Brugada Type I Pattern.

The aim of this study was to investigate the reliability of a novel electrocardiographic (ECG) marker in predicting ventricular arrhythmia (VA) inducibility in individuals with drug-induced Brugada syndrome (BrS) type I pattern. Consecutive patients with drug-induced type I BrS pattern underwent programmed ventricular stimulation (PVS) and, according to their response, were divided into 2 groups. Clinical characteristics and 12-lead ECG intervals before and after ajmaline infusion were compared between the 2 groups. A novel ECG marker named dST-Tiso interval consisting in the interval between the onset of the coved ST-segment elevation and its termination at the isoelectric line was also evaluated. Our cohort included 76 individuals (median age 44 years, 75% male). Twenty-five (32.9%) had VA inducibility requiring defibrillation. As compared with not inducible subjects, those with VA inducibility were more frequently male (92% vs 65%, p = 0.013), had longer PQ interval (basal: 172 vs 152 ms, p = 0.033; after ajmaline: 216 vs 200 ms, p = 0.040), higher J peak (0.6 vs 0.5 mV, p = 0.006) and longer dST-Tiso (360 vs 240 ms, p < 0.001). The dST-Tiso showed a C-statistics of 0.90 (95% confidence interval: 0.82 to 0.99) and an adjusted odds ratio for VA of 1.03 (1.01 to 1.04, p < 0.001). A dST-Tiso interval >300 ms yielded a sensitivity of 92.0%, a specificity of 90.2%, positive and negative predictive values of 82.1% and 95.8%. In conclusion, the dST-Tiso interval is a powerful predictor of VA inducibility in drug-induced BrS type I pattern. External validation is needed, but this marker might be useful in the clinical counseling process of these individuals before invasive PVS.

Remote monitoring of cardiac implantable devices during COVID-19 outbreak: "keep people safe" and "focus only on health care needs".

BACKGROUND: The COVID-19 pandemic has challenged the ability of health care organisations to provide adequate care. We report the experience of a national tertiary electrophysiology centre in the management of patients with cardiac implantable electronic devices (CIEDs) through the use of a fully remote follow-up model. METHODS: We daily and prospectively collected remote monitoring (RM) relevant findings and following clinical actions performed from March 10th to April 3rd 2020, a period of suspension of routine ambulatory activity due to the national lockdown. RESULTS: During the study period (25 days), we received 2,215 transmissions from 2,955 devices. Among them, 129 patients reported potential clinically actionable RM observations (event rate: 12.0/1000 patient-week). In 77 patients (60%), RM events triggered a clinical action, but only 5 patients needed an urgent in-hospital access (4 urgent procedures and 1 device reprogramming). CONCLUSIONS: In the unprecedented COVID-19 pandemic, RM became an essential tool in healthcare delivery for CIED patients. We observed that RM was effective in "keep people safe" and "focus only on individuals with health care needs".

Association between clinical risk scores and mortality in atrial fibrillation: Systematic review and network meta-regression of 669,000 patients.

AIMS: Many clinical scores for risk stratification in patients with atrial fibrillation have been proposed, and some have been useful in predicting all-cause mortality. We aim to analyse the relationship between clinical risk score and all-cause death occurrence in atrial fibrillation patients. METHODS: We performed a systematic search in PubMed and Scopus from inception to 22 July 2017. We considered the following scores: ATRIA-Stroke, ATRIA-Bleeding, CHADS2, CHA2DS2-VASc, HAS-BLED, HATCH and ORBIT. Papers reporting data about scores and all-cause death rates were considered. RESULTS: Fifty studies and 71 scores groups were included in the analysis, with 669,217 patients. Data on ATRIA-Bleeding, CHADS2, CHA2DS2-VASc and HAS-BLED were available. All the scores were significantly associated with an increased risk for all-cause death. All the scores showed modest predictive ability at five years (c-indexes (95% confidence interval) CHADS2: 0.64 (0.63-0.65), CHA2DS2-VASc: 0.62 (0.61-0.64), HAS-BLED: 0.62 (0.58-0.66)). Network meta-regression found no significant differences in predictive ability. CHA2DS2-VASc score had consistently high negative predictive value (≥94%) at one, three and five years of follow-up; conversely it showed the highest probability of being the best performing score (63% at one year, 60% at three years, 68% at five years). CONCLUSION: In atrial fibrillation patients, contemporary clinical risk scores are associated with an increased risk of all-cause death. Use of these scores for death prediction in atrial fibrillation patients could be considered as part of holistic clinical assessment. The CHA2DS2-VASc score had consistently high negative predictive value during follow-up and the highest probability of being the best performing clinical score.

Radiotherapy-induced malfunctions of cardiac implantable electronic devices in cancer patients.

The number of patients with cardiac implantable electronic devices (CIEDs) requiring radiation therapy (RT) for cancer treatment is increasing. The purpose of this study is to estimate the prevalence, possible predictors, and clinical impact of RT-related CIEDs malfunctions. We retrospectively reviewed the medical records of all pacemaker (PM)/implantable cardioverter-defibrillator (ICD) patients who underwent RT in the last 14 years. One hundred and twenty-seven patients who underwent 150 separate RT courses were analysed (99 with a PM and 27 with an ICD). Of note, 21/127 (16.6%) patients were PM-dependent. Neutron-producing RT was used in 37/139 (26.6%) courses, whereas non-neutron-producing RT was used in 102/139 (73.4%) courses. The cumulative dose (Dmax) delivered to the CIED exceeded 5 Gy only in 2/132 (1.5%) cases. Device malfunctions were observed in 3/150 (2%) RT courses, but none was life-threatening or led to a major clinical event and all were resolved by CIED reprogramming. In all cases, the Dmax delivered to the CIED was < 2 Gy. Two malfunctions occurred in the 37 patients treated with neutron-producing RT (5.4%), and 1 malfunction occurred in the 102 patients treated with non-neutron-producing RT (1%) (p = 0.17). Device relocation from the RT field was performed in 2/127 (1.6%) patients. RT in patients with CIED is substantially safe if performed in an appropriately organized environment, with uncommon CIEDs malfunctions and no major clinical events. Neutron-producing energies, rather than Dmax, seem to increase the risk of malfunctions. Device interrogation on a regular basis is advised to promptly manage CIED malfunctions.

Cardiac resynchronization therapy: How did consensus guidelines from Europe and the United States evolve in the last 15 years?

Cardiac resynchronization therapy (CRT) was proposed around 20 years ago, and its clinical use rapidly moved from pioneering experiences to randomized controlled trials (RCT). Since 2002 recommendations for CRT have been included in international consensus guidelines that even in an early phase recommended CRT as an effective treatment for improving symptoms, reducing hospitalizations and mortality in well-selected patients with wide QRS, left ventricular dysfunction and moderate to severe heart failure (NYHA classes III-IV), on optimal medical therapy. Subsequently the indications were extended to mild (NYHA class II) heart failure (associated with left ventricular dysfunction and wide QRS) and more recently also to appropriately selected patients with conventional indications for pacing having a left ventricular ejection fraction of 50% or less and NYHA class I-III. While all the guidelines strongly recommend CRT in case of LBBB with QRS duration >150 ms, lower strength of recommendations, with some heterogeneity, appears when QRS duration is 130-150 ms, especially if not associated with LBBB. Of note, according to recent guidelines, CRT is not recommended in case of QRS duration <130 ms, which is now the lower limit for candidacy to CRT, differently from the 120 ms limit used before. Despite consensus guidelines, many data indicate that CRT is still underused, with great heterogeneity in its implementation, both in North America and Europe, thus requiring a more organized patient referral.