Sleep duration and architecture during ASV for central sleep apnoea in systolic heart failure.

BACKGROUND: Adaptive servoventilation (ASV) effectively treats nocturnal respiratory events in patients with heart failure and reduced ejection fraction (HFrEF) and central sleep apnoea (CSA), but increased mortality has been reported. This study investigated changes in sleep architecture during ASV treatment in HFrEF patients. METHODS: A retrospective analysis of polysomnographic datasets for 30 ASV-treated patients with stable HFrEF and moderate-to-severe CSA was performed, including blinded analyses of total sleep time (TST), and percentage of REM and non-REM sleep (stages N1-N3). RESULTS: Follow-up was 109 ±â€¯32 days; mean device usage was 6.0 ±â€¯1.1 h/day. During ASV there was reduction of N1 (34 ±â€¯20%/TST to 13 ±â€¯5%/TST, p < 0.001) and N3 sleep (4 ±â€¯6%/TST to 1 ±â€¯4%/TST, p = 0.020), and increase of N2 (44 ±â€¯14%/TST to 62 ±â€¯7%/TST, p < 0.001) and REM-sleep (18 ±â€¯8%/TST to 24 ±â€¯6%/TST, p = 0.002). CONCLUSIONS: Disturbances of sympatho-vagal balance during ASV might help explain increased mortality during ASV. Since sympathetic tone is highest in REM-sleep and vagal predominance occurs during N3 sleep, these findings generate new hypotheses for the increased mortality seen in SERVE-HF.

Long-term development of radiation exposure, fluoroscopy time and contrast media use in daily routine in cryoballoon ablations after implementation of intracardiac echocardiography and other radioprotective measures: experiences from a large single-centre cohort.

PURPOSE: The concern of higher radiation exposure during cryoballoon ablation (CBA) compared with radiofrequency ablation for atrial fibrillation (AF) was raised before. Previously, we compared CBA plus intracardiac echocardiography (ICE) to our former standard approach without ICE. A substantial reduction of radiation exposure without compromising safety or outcome was observed. We now investigate if at all and possibly to which amount radiation reduction can be achieved with growing experience. METHODS: We retrospectively analysed procedure time, dose area product (DAP), fluoroscopy time (FT) and contrast media (CM) use for all patients receiving CBA between 2013 and 2017 for AF. RESULTS: In 1131 procedures, procedure time decreased significantly between 2013 and 2017 (2013 111 ± 26 min, 2017 99 ± 25 min, p = 0.005). DAP halved between 2013 and 2014 without further significant decline (2013 1428 ± 1276 cGycm2, 2014 725 ± 551 cGycm2, p < 0.001). FT demonstrated a constant decrease from 2013 to 2017 (2013 11.7 ± 5.5 min, 2017 5.1 ± 3.5 min, p < 0.001). CM use did not show a significant reduction comparing 2013 to 2017 (2013 62 ± 19 ml, 2017 59 ± 18 ml, 2013/2017 p = 0.584). CONCLUSION: Given the imminent negative effects of radiation, every effort should be undertaken for its reduction. Feasible protocols can be kept simple by technical changes as reducing frame rates and basic radiation reduction strategies such as collimation, but ICE might add additional benefit. With growing experience and awareness of radioprotection, DAP and FT as low as or lower than in radiofrequency ablations seem possible.

Pulmonary vein isolation and beyond: Predictive value of vagal reactions in second-generation cryoballoon ablation for the outcome of persistent atrial fibrillation.

BACKGROUND: Cryoballoon ablation (CBA) is gaining increasing acceptance in the treatment of persistent (per) atrial fibrillation (AF). The cardiac autonomic nervous system plays a pivotal role in the regulation of AF. OBJECTIVE: We evaluated the impact of vagal reactions (VRs), as a surrogate marker for autonomic nervous system modulation, on the outcome of CBA in patients (pts) with perAF. METHODS: A total of 250 consecutive pts (mean age 63.9 ± 10.0 years; 175 pts, 70% male) undergoing primary second-generation CBA for perAF were studied. VRs were defined as bradycardia <40 beats/min, asystole, or higher-degree atrioventricular block. Follow-up visits at 3, 6, and 12 months included 7-day Holter electrocardiograms. RESULTS: VRs were recorded in 61 pts (24%). These pts showed a significantly reduced recurrence rate of AF (5%) than did those without VRs (log-rank, P < .01). Univariate Cox regression analyses confirmed VRs as a strong predictor of AF-free survival (hazard ratio [HR] 0.10; P < .01). Female sex (HR 1.71; P = .02), preprocedural tachycardia (HR 1.01; P = .01), and AF (HR 1.75; P = .01) before CBA at admission were revealed as predictors of AF recurrence. Multivariate regression model calculation solely identified VRs (HR 0.11; 95% confidence interval 0.03-0.34; P < .01) and male sex (HR 0.57; 95% confidence interval 0.36-0.89; P = .01) as independent predictors of AF-free survival. CONCLUSION: VR is an independent predictor of AF-free survival after CBA for perAF.

Transcatheter Aortic Valve Implantation in Patients With Pre-Existing Mechanical Mitral Valve Prostheses.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) has become standard therapy for aortic stenosis patients with intermediate or high operative risk. Treatment of patients with pre-existing mechanical mitral valve replacement (MVR) is challenging due to possible interference between the TAVI prosthesis and MVR. We present our single-center experience with this special patient cohort. METHODS: A total of 1960 patients underwent TAVI at our institution between 2009 and March 2018; of these, 16 patients had pre-existing mechanical MVR. Device success and adverse events were analyzed according to the Valve Academic Research Consortium (VARC)-2 criteria. Patients were followed for at least 12 months. RESULTS: Mean patient age was 81.5 ± 4.4 years. The patients had a mean logistic EuroScore of 37.1 ± 13.5% and STS score of 7.1 ± 3.2%. Successful valve deployment was achieved in all patients, peri-interventional stroke rate was 0.0%, and permanent pacemaker was implanted in 2 patients (12.5%). Two patients experienced major complications, with blockage of the MVR disc in 1 patient and annulus rupture in 1 patient. Hence, 30-day mortality was 12.5% and 1-year mortality was 25.0%. CONCLUSION: TAVI in patients with mechanical MVR is challenging and requires careful preparation and choice of TAVI device. Repositionable and retrievable devices seem to be a safer option.

Effect of impaired cardiac conduction after alcohol septal ablation on clinical outcomes: insights from the Euro-ASA registry.

AIMS: We analysed the impact of bundle branch block (BBB) and pacemaker (PM) implantation on symptoms and survival after alcohol septal ablation (ASA) in patients with hypertrophic cardiomyopathy (HCM). METHODS AND RESULTS: Among 1416 HCM patients from the Euro-ASA registry, 58 (4%) patients had a PM and 64 (5%) patients had an implantable cardioverter-defibrillator (ICD) before ASA. At latest follow-up (5.0 ± 4.0 years) after ASA, 118 (8%) patients had an ICD and 229 (16%) patients had a PM. In patients without an implantable device prior to ASA 13% had a PM and 5% had an ICD implanted following ASA. New onset BBB was present in 44% (right BBB in 31%) of patients without previous BBB. At latest follow-up, we found no associations between BBB and New York Heart Association (NYHA) Class 3-4 [odds ratio (OR) 0.98, 95% confidence interval (CI) 0.63-1.51; P = 0.91] or Canadian Cardiovascular Society (CCS) Class 3-4 (OR 1.5, CI 0.32-6.7; P = 0.62), respectively, and no associations between PM and NYHA Class 3-4 (OR 1.2, CI 0.70-2.0; P = 0.52) or CCS 3-4 (OR 1.3, CI 0.24-6.6; P = 0.79), respectively. The survival after ASA was not reduced in patients with BBB [hazard ratio (HR) 0.73, CI 0.53-1.01; P = 0.06] or PM (HR 0.78, CI 0.52-1.17; P = 0.24). CONCLUSIONS: Development of BBB or need for a PM after ASA in patients with obstructive HCM was not associated with inferior symptomatic outcome or reduced survival, thus concerns for the negative impact of impaired cardiac conduction on the clinical outcome after ASA were not confirmed.

Hemoptysis as a side effect of cryoballoon pulmonary vein isolation in atrial fibrillation: a retrospective case-control study.

PURPOSE: Hemoptysis and pulmonary hemorrhage are rarely described as complications of cryoballoon ablation for pulmonary vein isolation (CB PVI). This study evaluated a large cohort to determine the frequency and risk factors for manifestation of these complications and assess the clinical relevance of hemoptysis after CB PVI. METHODS: Seven hundred fifteen consecutive patients (351 female) from a single-center database were evaluated to identify those who developed hemoptysis after CB PVI. RESULTS: A total of 31 patients with hemoptysis (4.3%; 2 female, age 60.5 ± 11.5 years) were matched with a control group (n = 31). Hemoptysis developed within 72 h after CB PVI. Cases versus controls had significantly lower ablation temperatures in the right inferior pulmonary vein (PV) (- 56.2 ± 26.6 vs - 49.1 ± 13.2 °C; p = 0.004) and left inferior PV (- 56.4 ± 11.9 vs - 47.2 ± 7.6 °C; p = 0.001). A trend to lower temperatures not reaching the level of significance was also found for the superior PV. All other procedural parameters were not significantly different between cases and controls. Although pre-procedural hemoglobin levels were comparable, post-procedural hemoglobin was lower in cases versus controls (12.9 ± 1.6 vs 13.7 ± 1.5 g/dL; p < 0.05). Twenty-six patients presenting with hemoptysis underwent chest CT scan, which showed perivenous infiltration at either the right (n = 23) or left inferior PV (n = 2) or no infiltrate (n = 1). No negative long-term effects were reported after 3, 6, and 12 months' follow-up. CONCLUSIONS: Post-procedural hemoptysis after CB PVI is a relatively frequent finding and was associated with low freezing temperatures and pulmonary tissue infiltration predominantly located at the right inferior PV. Hemoptysis resolved without long-term sequelae.

Physiological left ventricular segmental myocardial mechanics: Multiparametric polar mapping to determine intraventricular gradients of myocardial dynamics.

OBJECTIVE: We investigated physiological systolic left ventricular (LV) myocardial mechanics and gradients to provide a database for later studies of diseased hearts. METHODS: The analyses were performed in 131 heart-healthy individuals and included seven parameters of myocardial mechanics using speckle tracking echocardiography (STE). RESULTS: Basal to apical and circumferentially significant physiological intraventricular parameter gradients of myocardial activity were determined. Global mean values and segmental ranges were peak systolic longitudinal strain -21.2 ± 3.3%, 95% confidence interval [CI] -21.8% to -20.6%), gradient (basal to apical) -16.0% to -26.7%; peak systolic longitudinal strain rate -1.24 ± 0.31%/s, 95% CI -1.29% to -1.19%/s, gradient (basal to apical) -0.91% to -1.61%/s; post-systolic index 2.6 ± 3.2%, 95% CI 3.15%-2.05%, gradient (basal/medial/apical) 7.0/1.2/2.4%; pre-systolic stretch index 1.3 ± 2.7%, 95% CI 1.77%-0.83%, gradient (basal/medial/apical) 6.5/0.2/1.3%; peak longitudinal displacement 12.2 ± 2.6 mm, 95% CI 12.6-11.8 mm, gradient (basal to apical) 21.0-3.4 mm; time-to-peak longitudinal strain 370 ± 43 ms, 95% CI 377-363 ms, gradient (basal to apical) 396-361 ms; and time-to-peak longitudinal strain rate 180 ± 47 ms, 95% CI 188-172 ms, gradient (basal to apical) 150-200 ms. CONCLUSION: This study generated a database of seven STE-derived parameters of physiological segmental and global myocardial LV mechanics. The resulting sets of three-dimensional intraventricular mappings of the entire LV provide physiological parameter gradients in baso-apical and circumferential direction by applying the 17-segment polar model. This will facilitate comparison of systolic myocardial activity of the healthy LV with diseased or otherwise altered (eg, sports) hearts.

Characteristics and circadian distribution of cardiac arrhythmias in patients with heart failure and sleep-disordered breathing.

BACKGROUND: Cardiac arrhythmias and sleep-disordered breathing (SDB) are common comorbidities in heart failure with reduced ejection fraction (HFrEF). However, understanding of the association between arrhythmias and SDB is poor. This study assessed the occurrence and circadian distribution of ventricular arrhythmias in HFrEF patients with and without SDB. METHODS: This retrospective analysis included HFrEF patients admitted for unattended overnight cardiorespiratory polygraphy and 24-h Holter-ECG recording. Holter-ECG data (events/h) were categorized by time of day: morning, 06:00-13:59; afternoon, 14:00-21:59; nighttime, 22:00-05:59. Respiratory events were expressed using the apnea-hypopnea index (AHI) and an AHI ≥ 15/h was categorized as moderate to severe SDB. RESULTS: 167 patients were included (82% male, age 65 ± 10.4 years, left ventricular ejection fraction 30.9 ± 7.9%); SDB was predominantly central sleep apnea (CSA) in 45.5%, obstructive sleep apnea (OSA) in 23.9% or none/mild (nmSDB) in 17.4%. Morning premature ventricular contractions (PVCs) were detected significantly more frequently in CSA versus nmSDB patients (44.4/h versus 1.8/h; p = 0.02). Non-sustained VT was more frequent in patients with CSA versus versus OSA or nmSDB (17.9 versus 3.2 or 3.2%/h; p = 0.003 and p = 0.005, respectively). There was no significant variation in VT occurrence by time of day in HFrEF patients with CSA (p = 0.3). CSA was an independent predictor of VT occurrence in HFrEF in multivariate logistic regression analysis (odds ratio 4.1, 95% confidence interval 1.5-11.4, p = 0.007). CONCLUSION: CSA was associated with VT occurrence irrespective of sleep/wake status in HFrEF patients, and independently predicted the occurrence of VT. This association may contribute to chances by which CSA increases sudden death risk in HFrEF patients.

Adaptive servo-ventilation to treat central sleep apnea in heart failure with reduced ejection fraction: the Bad Oeynhausen prospective ASV registry.

BACKGROUND: Central sleep apnea (CSA) is highly prevalent in heart failure patients with reduced left ventricular ejection fraction (HF-REF). The Bad Oeynhausen Adaptive Servo-ventilation (ASV) registry (NCT01657188) was designed to investigate whether treatment of CSA with ASV improved survival in HF-REF patients; the effects of ASV on symptoms and cardiopulmonary performance were also investigated. METHODS AND RESULTS: From January 2004 to October 2013, the registry prospectively enrolled HF-REF patients [NYHA class ≥ II, left ventricular ejection fraction (LVEF) ≤ 45%] with moderate to severe predominant CSA [apnea-hypopnea index (AHI) ≥ 15/h]. ASV-treated patients were followed up at 3, 6, 12 and 24 months, including natriuretic peptide concentrations, blood gas analyses, echocardiography, 6-min walk distance (6MWD), and cardiopulmonary exercise (CPX) testing. 550 patients were included [age 67.7 ± 10 years, 90% male, 52% in NYHA class ≥ III, LVEF 29.9 ± 8%, AHI 35.4 ± 13.6/h, and time with nocturnal oxygen saturation < 90% (T < 90%) 58 ± 73 min]; ASV was prescribed to 224 patients. Over a median follow-up of 6.6 years, 109 (48.7%) ASV-treated patients and 191 (58.6%) controls died (adjusted Cox modelling hazard ratio of 0.95, 95% confidence interval 0.68-1.24; p = 0.740); older age, lower LVEF, impaired renal function, low sodium concentration, and nocturnal hypoxemia were significant predictors of mortality. Patient reported NYHA functional class improved in the ASV group, but LVEF, CPX, 6MWD, natriuretic peptides and blood gases remained unchanged. CONCLUSIONS: Long-term ASV treatment of predominant CSA in HF-REF patients included in our registry had no statistically significant effect on survival. ASV improved HF symptoms, but had no significant effects on exercise capacity, LVEF, natriuretic peptide concentrations or blood gases during follow-up as compared to control patients.

Cycle length identifies obstructive sleep apnea and central sleep apnea in heart failure with reduced ejection fraction.

AIM: To clarify whether unmasking of central sleep apnea during continuous positive airway pressure (CPAP) initiation can be identified from initial diagnostic polysomnography (PSG) in patients with heart failure with reduced ejection fraction (HFREF) and obstructive sleep apnea (OSA) MATERIALS AND METHODS: Forty-three consecutive patients with obstructive sleep apnea and central sleep apnea (OSA/CSA) in HFREF were matched with 43 HFREF patients with OSA and successful CPAP initiation. Obstructive apneas during diagnostic PSG were then analyzed for cycle length (CL), ventilation length (VL), apnea length (AL), time to peak ventilation (TTPV), and circulatory delay (CD). We calculated duty ratio (DR) as the ratio of VL/CL and mathematic loop gain (LG). RESULTS: While AL was similar, CL, VL, TTPV, CD, and DR was significantly longer in patients with OSA/CSA compared to those with OSA, and LG was significantly higher. Receiver operator curves identified optimal cutoff values of 50.2 s for CL (area under the curve (AUC) 0.85, 29.2 s for VL (AUC 0.92), 11.5 s for TTPV (AUC 0.82), 26.4 s for CD (AUC 0.79), and 3.96 (AUC 0.78)) respectively for LG to identify OSA/CSA. CONCLUSION: OSA/CSA in HFREF can be identified by longer CL, VL, TTPV, and CD from obstructive events in initial diagnostic PSG. The underlying mechanisms seem to be the presence of an increased LG.

Valve-in-valve transcatheter aortic valve implantation with CoreValve/Evolut R© for degenerated small versus bigger bioprostheses.

OBJECTIVES: We present our single center experience with Medtronic CoreValve and Evolut R regarding procedural outcome and 3 years follow-up in patients with degenerated bioprostheses. METHODS: From 1645 patients who underwent transfemoral TAVI at our institution between February 2009 and December 2016, 37 patients with degenerated bioprosthesis were treated with Medtronic CoreValve/Evolut R. All data concerning baseline characteristic, procedural outcomes and follow-up were entered into a dedicated database. RESULTS: Mean age was 83.9 ± 4.4 years and patients showed an average logistic EuroSCORE of 33.2 ± 16.7%. Successful ViV deployment was achieved in all cases, a permanent pacemaker was implanted in 16.2%, no periinterventional stroke and no coronary obstruction occurred. Mortality at 30 days was 2.7%, at 1-year follow-up 5.7% and at three years 13.5%. Depending on bioprosthesis size <23 mm versus ≥23 mm echocardiographic mean gradients post implantation were significantly higher in the smaller bioprostheses, 22.8 mmHg ± 9.4 mmHg versus 15.1 ± 7.1, P = 0.013. CONCLUSION: ViV-TAVI with CoreValve/R is demonstrated to be safe and effective in terms of no coronary obstruction and very low mortality up to 3 years despite slightly higher mean transprosthetic gradients especially in very small bioprostheses.

Risk marker profiles in patients treated with percutaneous septal ablation for symptomatic hypertrophic obstructive cardiomyopathy.

BACKGROUND AND STUDY OBJECTIVE: Different studies have shown a good long-term survival with improvement of symptoms and hemodynamics after percutaneous septal ablation (PTSMA), similar to myectomy considered to be the therapeutic "gold standard" for symptomatic hypertrophic obstructive cardiomyopathy (HOCM). Furthermore, desobliteration of left ventricular (LV) outflow may modify features of the disease considered to be risk-relevant, such as magnitude of LV hypertrophy, outflow gradient, and left atrial (LA) size. The aim oft this study was to examine predictors of long-term mortality in a large cohort of patients with HOCM treated with PTSMA. METHODS AND RESULTS: 497 consecutive patients with symptomatic HOCM (mean age 55.4 ± 14.4 years, NYHA class: 2.9 ± 0.4) who underwent PTSMA between 1996 and 2014 were studied. Periprocedural mortality was 1% (five patients). During a follow-up time of 64.5 ± 53.2 months (range 0.1-207), 51 patients died, of these 25 due to cardiovascular problems, while 26 deaths were attributed to non-cardiac causes. Overall survival rates were 89.4% (± 1.7) after 5 and 80.6% (± 2.7) after 10 years. Among the baseline variables, advanced age, recurrent syncope, and magnitude of LV thickening were risk markers correlated to long-term post-procedural survival. The only mortality predictor that could be identified during follow-up was post-procedural NYHA class. Neither the other classical HCM risk markers nor other clinical or echocardiographic parameters predicted cardiac or all-cause mortality in this cohort. CONCLUSIONS: Our findings suggest that the risk profile after septal ablation may differ from that of HOCM patients without an outflow desobliteration.

Impact of procedure-related conduction disturbances after transcatheter aortic valve implantation on myocardial performance and survival evaluated by conventional and speckle tracking echocardiography.

OBJECTIVES: Although procedure-related new cardiac conduction disturbances (CCDs) remain an important issue in transcatheter aortic valve implantation (TAVI), their effect on myocardial function and overall patient outcome remains unclear. The goal of this study was to analyze the influence of procedure-related CCDs on systolic and diastolic LV performance and on patient survival after TAVI. METHODS AND RESULTS: Ninety-five patients who underwent TAVI for severe symptomatic aortic stenosis (AS) and had a complete follow-up were evaluated with respect to procedure-related CCDs. Left ventricular (LV) performance was measured using standard echocardiographic parameters and speckle tracking analysis. Survival was assessed during longer-term follow-up (mean: 29.1 ± 16.9 months). After TAVI, the improvement of global LV function expressed as ejection fraction (LVEF; from 45.5 ± 10.0 to 47.8 ± 13.9%, P = .13) was not significant. New CCDs were found in 35.7% of TAVI recipients. A comparison between patients with and without new CCDs showed that LV systolic function improved in those without CCDs, while it tended to deteriorate in patients with CCDs (change in LVEF: 5.5 ± 12.3% vs -4.9% ± 11.5%, P = .001; change in global longitudinal strain (GLS): -1.1 ± 4.6% vs 1.2 ± 4.5%, P = .01). Changes in diastolic function did not differ significantly between the groups (changes in transmitral E/A-ratio: -0.3 ± 0.6 vs -0.5 ± 0.5, P = .1). Kaplan-Meier survival analysis revealed no significant differences between the two cohorts (P = .795). CONCLUSION: Procedure-related conduction abnormalities after TAVI lead to an LBBB-related dyssynchrony with impairment of LV performance but not of overall survival.

Noninvasive pulse contour analysis for determination of cardiac output in patients with chronic heart failure.

BACKGROUND: Determination of cardiac output (CO) is essential in diagnosis and management of heart failure (HF). The gold standard to obtain CO is invasive assessment via thermodilution (TD). Noninvasive pulse contour analysis (NPCA) is supposed as a new method of CO determination. However, a validation of this method in HF is pending and performed in the present study. METHODS: Patients with chronic-stable HF and reduced left ventricular ejection fraction (LVEF ≤ 45%; HF-REF) underwent right heart catheterization including TD. NPCA using the CNAP Monitor (V5.2.14, CNSystems Medizintechnik AG) was performed simultaneously. Three standardized TD measurements were compared with simultaneous auto-calibrated NPCA CO measurements. RESULTS: In total, 84 consecutive HF-REF patients were enrolled prospectively in this study. In 4 patients (5%), TD was not successful and for 22 patients (26%, 18 with left ventricular assist device), no NPCA signal could be obtained. For the remaining 58 patients, Bland-Altman analysis revealed a mean bias of + 1.92 L/min (limits of agreement ± 2.28 L/min, percentage error 47.4%) for CO. With decreasing cardiac index, as determined by the gold standard of TD, there was an increasing gap between CO values obtained by TD and NPCA (r = - 0.75, p < 0.001), resulting in a systematic overestimation of CO in more severe HF. TD-CI classified 52 (90%) patients to have a reduced CI (< 2.5 L/min/m2), while NPCA documented a reduced CI in 18 patients (31%) only. CONCLUSIONS: In HF-REF patients, auto-calibrated NPCA systematically overestimates CO with decrease in cardiac function. Therefore, to date, NPCA cannot be recommended in this cohort.

Second generation cryoballoon ablation for persistent atrial fibrillation: an updated meta-analysis.

BACKGROUND: Catheter ablation is an established treatment option for patients with symptomatic atrial fibrillation (AF). The cornerstone of AF ablation is pulmonary vein isolation (PVI). The second-generation cryoballoon (2G-CB) has shown non-inferiority to radiofrequency (RF) ablation in paroxysmal AF in several trials. Growing evidence suggests that 2G-CB is also effective in patients with persistent AF (perAF). The aim of this study was to summarize and analyze available data on safety and mid-term (≥ 12 months) efficacy of PVI using 2G-CB in patients with perAF. METHODS: We did a search in PubMed, Web of Science, Cochrane Library, and clinicaltrials.gov in December 2016 for studies of 2G-CB ablation for perAF. Studies reporting clinical success rates at a follow-up (FU) of ≥ 12 months were included. Success was defined as freedom from any atrial arrhythmia lasting > 30 s after an initial blanking period of 3 months. Acute success and complication rates were also assessed. Data were analyzed applying random-effects model. RESULTS: A total of 917 patients from 11 studies meeting study inclusion criteria were analyzed. After a mean FU of 16.7 ± 3.0 months, 68.9% were free from recurrences [95% confidence interval (CI) 63.4-74.7%]. Overall acute success rate was 99.7% (95% CI 99.2-100%). Complications occurred in 5.5% (95% CI 2.4-9.6%). Vascular access complications were the most frequent 3.3% (95% CI 1.5-5.6%). The rate of phrenic nerve palsy/injury was 2.09% (95% CI 0.8-3.9%). No death, stroke or myocardial infarction was reported. CONCLUSION: The 2G-CB seems to be safe and effective in the treatment of perAF in the mid-term.

Characteristics of sleep-disordered breathing in patients with atrial fibrillation and preserved left ventricular ejection fraction.

BACKGROUND: Sleep-disordered breathing (SDB) represents a common and highly relevant co-morbidity in patients with atrial fibrillation (Afib). Obstructive sleep apnea (OSA) has been identified as an independent risk factor for developing Afib and for Afib recurrence after treatment, but the role of central sleep apnea (CSA) is less clear. This study investigated characteristics of SDB in Afib patients with preserved left ventricular ejection fraction (PEF). METHODS AND RESULTS: Consecutive patients (07/2007 to 03/2016) with documented Afib at hospital admission and PEF undergoing 6-channel cardiorespiratory polygraphy (PG) screening were retrospectively analyzed. A total of 211 patients were included (146 men; age 68.7 ± 8.5 years). Only 6.6% of patients had no SDB (apnea-hypopnea index [AHI] < 5/h). When moderate-to-severe SDB (AHI ≥ 15/h) was classified based on the predominant type of apneas and hypopneas, OSA (≥ 80% obstructive events) was found in 15% of patients, CSA (≥ 80% central events) in 10%, and 36% had mixed sleep apnea. For patients with Cheyne-Stokes respiration (CSR; 34%), time spent in CSR increased significantly as total AHI increased (p < 0.001); total CSR duration was 20, 50, and 117 min, respectively, in patients with mild, moderate, and severe SDB. CONCLUSIONS: SDB was highly prevalent in this cohort of patients with Afib and PEF. The proportion of patients with moderate-to-severe OSA, for whom treatment is recommended by current guidelines, was about 15%. With 36% of patients presenting with moderate-to-severe mixed sleep apnea and almost 10% of patients having CSA, treatment guidelines for these types of SDB in the setting of Afib are needed.

Validation of the HCM Risk-SCD model in patients with hypertrophic cardiomyopathy following alcohol septal ablation.

Aims: The HCM Risk-SCD model for prediction of sudden cardiac death (SCD) in hypertrophic cardiomyopathy recommended by the 2014 European Society of Cardiology (ESC) guidelines has not been validated after septal reduction therapy. The aim of this study was to validate the HCM Risk-SCD model in patients undergoing alcohol septal ablation (ASA) and to compare its performance to previous models. Methods and result: A total of 844 ASA patients without prior SCD event were included. The primary endpoint was a composite of SCD and appropriate implantable cardioverter defibrillator (ICD) therapy, identical to the HCM Risk-SCD endpoint. A distinction between periprocedural (≤30 days) and long-term (>30 days) SCD was made to discern procedure-related adverse arrhythmic events caused by the ASA-induced myocardial infarction from long-term SCD risk. Twenty patients reached the SCD endpoint within the first 30 days. During a follow-up of 6.5 ± 4.2 years, another 46 patients reached the SCD endpoint. The predicted 5-year SCD risk according to the HCM Risk-SCD model was 5.1%, and the observed 5-year SCD risk was 4.0%. The C-statistics for the use of the HCM Risk-SCD model was 0.61 (P = 0.02), the C-statistics for the use of the 2003 American College of Cardiology/ESC guidelines was 0.59 (P = 0.051), and the C-statistic for the use of the 2011 American College of Cardiology Foundation/American Heart Association guidelines was 0.58 (P = 0.054). Maximal left ventricular wall thickness, syncope after ASA, and fulfilling the 2014 ESC recommendations for primary ICD implantation according to the HCM Risk-SCD model, respectively, predicted SCD during long-term follow-up. Conclusion: The HCM Risk-SCD model can be used for SCD prediction in patients undergoing ASA.

Effect of Institutional Experience on Outcomes of Alcohol Septal Ablation for Hypertrophic Obstructive Cardiomyopathy.

BACKGROUND: The current American College of Cardiology Foundation/American Heart Association guidelines on hypertrophic cardiomyopathy state that institutional experience is a key determinant of successful outcomes and lower complication rates of alcohol septal ablation (ASA). The aim of this study was to evaluate the safety and efficacy of ASA according to institutional experience with the procedure. METHODS: We retrospectively evaluated 1310 patients with symptomatic obstructive hypertrophic cardiomyopathy who underwent ASA and were divided into 2 groups. The first-50 group consisted of the first consecutive 50 patients treated at each centre, and the over-50 group consisted of patients treated thereafter (patients 51 and above). RESULTS: In the 30-day follow-up, there was a significant difference in the occurrence of major cardiovascular adverse events (21% in the first-50 group vs 12% in the over-50 group; P < 0.01), which was driven by the occurrence of cardiovascular deaths (2.1% vs 0.4%; P = 0.01) and implanted pacemakers (15% vs 9%; P < 0.01). In the long-term follow-up (5.5 ± 4.1 years), the first-50 group was associated with a significantly higher occurrence of major adverse events (P < 0.01) and higher cardiovascular mortality (P < 0.01). Also, patients in the first-50 group were more likely to self-report dyspnea of New York Heart Association class III/IV (16% vs 10%), to have a left ventricular outflow gradient > 30 mm Hg (16% vs 10%) at the last clinical check-up (P < 0.01 for both), and a probability of repeated septal reduction therapy (P = 0.03). CONCLUSIONS: An institutional experience of > 50 ASA procedures was associated with a lower occurrence of ASA complications, better cardiovascular survival, better hemodynamic and clinical effect, and less need for repeated septal reduction therapy.