bluuebunny/crossref_metadata_2025 huggingface dataset:
Left atrial wall stress and the outcome of catheter ablation for atrial fibrillation: artificial intelligence-based prediction of clinical outcome
Authors: Lee J , Kwon OS , Lee JS , Yu HT , Kim TH , Uhm JS , Joung BY , Lee MH , Pak HN
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Background/Introduction: Left atrial (LA) wall stress (LAW-str) may contribute to the mechanism of atrial fibrillation (AF).

Purpose

We explored the clinical characteristics and the rhythm outcome of AF depending on LAW-str among the patients who underwent AF catheter ablation (AFCA). We also tested whether artificial intelligence (AI) properly estimate LAW-str without invasive parameters.

Methods

We included 2223 patients (72.8% male, 59.0 [52.0–67.0] years old, 28.7% with persistent AF [PeAF]) who underwent radiofrequency catheter ablation (RFCA). LAW-str was calculated by the Law of Laplace using LA diameter (echocardiogram), peak LA pressure, and mean LA wall thickness (computed tomography) measured by customized software. Based on the quartile (Q1–4) or AI-estimated values of LAW-str, we compared clinical characteristics and rhythm outcome.

Results

LAW-str was independently associated with PeAF (p < 0.001), diabetes (p = 0.012) and vascular disease (p = 0.002), body mass index (p < 0.001), E/Em (p < 0.001), and mean LA voltage (p < 0.001). During 26.0 (12.0–52.0) months follow-up, clinical recurrence of AF was significantly higher in the Q4 of LAW-str group (log rank p = 0.001). LAW-str was independently associated with clinical recurrence after AFCA (HR 1.001 [1.000–1.002], p = 0.013). AI-based model using non-invasive parameters predicted Q4 of LAW-str with area under the curve (AUC) 0.734, which was similar to logistic regression based predictive model using all data including invasive parameters (AUC 0.726). Patients in Q4 of LAW-str showed consistently worse rhythm outcome regardless of the type of AF, sex, or AI-based prediction (p = 0.039).

Conclusions

The LAW-str seems to be associated with rhythm outcome of AFCA and AI can predict this complex parameter with moderate accuracy. TableMultivariateβ (95% CI)PPersistent AF31.08 (21.77-40.39)<0.001Diabetes mellitus15.36 (3.35-27.38)0.012Vascular disease22.27 (8.4-36.14)0.002Body mass index2.91 (1.53-4.29)<0.001E/Em4.95 (3.87-6.02)<0.001Mean LA voltage-22.24 (-27.96–16.52)<0.001Linear regression analysis for clinical variables predictive of LA wall stress (10^3 dyn/cm2).Abstract Figure. AF recurrence by LAW-str, AI-prediction
Usefulness of different screening questionnaires and scoring systems for obstructive sleep apnea in patients with atrial fibrillation
Authors: Delesie M , Knaepen L , Wouters A , De Cauwer A , De Roy A , Verbraecken J , Weytjens K , Dendale P , Heidbuchel H , Desteghe L
Published: May 2021

Funding Acknowledgements

Type of funding sources: Public Institution(s). Main funding source(s): This study is part of Limburg Clinical Research Center, supported by the foundation Limburg Sterk Merk, province of Limburg, Flemish government, Hasselt University, Ziekenhuis Oost-Limburg and Jessa Hospital.

OnBehalf

Research Group Cardiovascular Diseases, University of Antwerp

Background

Obstructive sleep apnea (OSA) influences the progression of atrial fibrillation (AF) but is underdiagnosed in this population. Studies have shown that its treatment can help to reduce AF recurrences and improve symptoms. Polysomnography (PSG) is currently the gold standard for diagnosing OSA but being expensive and requiring overnight examination it is therefore not the ideal screening method. Different OSA screening tools such as questionnaires and scoring systems already exist but their value in AF patients remains unclear.

Purpose

The aim of this study was to examine the performance of different screening questionnaires and scoring systems for diagnosing OSA in an AF cohort, compared with PSG as gold standard.

Methods

Prospective study of the predictive performance of seven screening questionnaires and scoring systems (the Epworth Sleepiness Scale (ESS), the Berlin Questionnaire (BQ), Sleep Apnea Clinical Score (SACS), OSA50, STOP-BANG, NoSAS, MOODS) in consecutive AF patients referred to two sleep clinics.

Results

A total of 100 AF patients presenting for PSG were included (64.0 ± 8.6 years, 73% male, 87% non-permanent AF, mean Body Mass Index 30.6 ± 5.9 kg/m2, mean CHA2DS2-VASc score 2.4 ± 1.7, mEHRA≥2 in 64%; mean AF history 5.4 ± 5.6 years).  Forty-two percent of patients were referred to the sleep clinic by cardiologists. PSG diagnosed ≥mild OSA in 90% of patients, ≥moderate in 69%, and severe OSA in 33%. In screening for mild OSA, NoSAS, STOP-BANG and MOODS screening questionnaires had a fair area under the curve (AUC) of 0.773, 0.710 and 0.709 respectively. For at least moderate OSA, only the SACS and the NoSAS questionnaires had an AUC of 0.704 and 0.712 respectively (Figure 1). None of the seven screening questionnaires/scoring systems were performant enough (i.e. a fair AUC > 0.7) to detect severe OSA.

Conclusions

Our analysis shows that screening questionnaires and scoring systems such as ESS, BQ, SACS, NoSAS, OSA50, STOP-BANG and MOODS are not very useful to predict clinically relevant OSA (i.e. at least moderate OSA) in AF patients. Therefore, other screening modalities for OSA in AF patients should be investigated and validated. Abstract Figure 1
Stabilization of unstable reentrant atrial tachycardias via fractionated continuous electrical activity ablation (CHAOS study)
Authors: Franco E , Lozano-Granero C , Matia R , Hernandez-Madrid A , Sanchez-Perez I , Zamorano JL , Moreno J
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Background. Unstable reentrant atrial tachycardias (ATs) (i.e. those with frequent circuit modification or conversion to atrial fibrillation) are challenging to ablate. 

Purpose. We have tested a strategy to convert unstable reentrant ATs into mappable stable ATs based on the detection and ablation of rotors.

Methods. From May 2017 to December 2019, we included all consecutive patients scheduled for ablation of reentrant AT, excluding CTI-dependent atrial flutter, in which the tachycardia circuit was unstable. Operators subjectively identified rotors as sites with fractionated continuous (or quasi-continuous) electrical signals on 1-2 adjacent bipoles of conventional high-density mapping catheters, without dedicated software (Figure, A). Focal ablation of these sites was performed in order to stabilize the AT or convert it into sinus rhythm. In patients without rotors or failed rotor ablation, sites with spatiotemporal dispersion (i.e. all the cycle length comprised within the mapping catheter) plus non-continuous fractionation on single bipoles were targeted (Figure, B). Procedural success was defined as the successful ablation of all inducible ATs, without need of cardioversion, final sinus rhythm and non-inducibility. Follow-up included visits with ECG and 24h Holter-ECG at 3, 6 and 12 months.

Results. From May 2017 to December 2019, 97 patients were scheduled for reentrant AT ablation, excluding CTI-dependent atrial flutter. Of these, 18 patients (18.6%; 72.1 ± 8.9 years of age, 9 females) presented unstable circuits and were included. 9 patients (50%) had structural cardiomyopathy, 11 patients (61%) prior atrial arrhythmias ablations, and 4 patients (22%) previous cardiac surgery. 13 patients (72%) had detectable rotors (26 rotors; median 2 [1–3] rotors per patient); focal ablation achieved conversion into stable AT or sinus rhythm in 12 (92%). In the other patient, and the 5 patients without detectable rotors, 17 sites with spatiotemporal dispersion were detected and focally ablated, with success to achieve arrhythmia stabilization in 5 patients (83%). Globally, and excluding one patient with spontaneous AT stabilization, ablation success to stabilize the AT was achieved in 16/17 patients (94.1%). Procedural success was achieved in 16/18 patients (88.9%). Rate of one-year freedom from atrial arrhythmias was 66.7%. In the 9 patients with stable ATs ablated during the same period, procedural success (92.4%) and one-year freedom from atrial arrhythmias (65.8%) were similar (Figure, C).

Conclusion. Most unstable reentrant ATs show detectable rotors, identified as sites with single-bipole fractionated quasi-continuous signals, or spatiotemporal dispersion plus non-continuous fractionation. Ablation of these sites is highly effective to stabilize the AT or convert it into sinus rhythm. Abstract FIGURE
Radiofrequency catheter denervation of sinus node: a randomized comparison of right and left atrial approach for the cardioneuroablation
Authors: Wichterle D , Jansova H , Stiavnicky P , Peichl P , Stojadinovic P , Cihak R , Kautzner J
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Background

Radiofrequency catheter ablation of superior paraseptal ganglionic plexus is an important step to eliminate the vagal modulation of sinus node for the treatment of neurally-mediated syncope. The reasonable effect can be achieved by targeting this plexus from the endocardial aspect of both right (RA) and left (LA) atria.

Purpose

We investigated the efficacy of RA and LA ablation in terms of sinus nodal denervation.

Methods

The study included 24 patients (age: 42 ± 13 years, 50% males) who underwent cardioneuroablation for recurrent cardioinhibitory syncope in general anesthesia. Right atrial semicircular lesion at the posteroseptal quadrant of superior vena cava ostium was composed of 5-6 equidistantly distributed ablation sites (30 W, 30 s, 20 ml/min).  Left atrial lesion of comparable size was placed strictly contralaterally across the interatrial septum in the anterior vestibulum of a right superior pulmonary vein. Patients were randomly (1:1) assigned to RA-to-LA or LA-to-RA ablation. Sinus rate and the response to extracardiac right vagal nerve high-frequency stimulation (50 Hz, 0.05 ms, 1 V/kg [<70V], 5 s) were recorded at baseline and after each ablation cluster.

Results

Study protocol ablations overall resulted in sinus acceleration (81 ± 13 vs. 59 ± 12 bpm, P <0.0001) and attenuation of inducible sinus arrests (maximum pause: 1.2 ± 1.4 vs. 5.5 ± 3.0 s, P <0.0001). Temporal development of outcome measures with the progression of ablation is shown in the Figure. There was no significant difference between study groups. Irrespective of ablation order, the first ablation cluster on average generated 77% of the final effect on sinus rate and 68% of the final effect on suppression of vagally-induced sinus pauses.  

Conclusions

 Neither RA nor LA approach is preferable for targeting the superior paraseptal ganglionic plexus. Both ablation clusters convey complementary and, in part, mutually independent effects. Biatrial cardioneuroablation seems essential for efficacious sinus nodal denervation. Abstract Figure.
New biochemical predictor of the ventricular tachyarrhythmias in patients with ischemic cardiomyopathy
Authors: Atabekov T , Batalov R , Sazonova S , Gusakova S , Krivolapov S , Khlynin M , Popov S
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Introduction. The cardioverter-defibrillator (ICD) implantation is the most effective method for the sudden cardiac death (SCD) prevention. However, about 25% patients did not receive an ICD therapy during the first 5-years follow-up. At the same time ICD does not register ventricular tachyarrhythmias (VTA) events in patients with ICD implanted for the primary prevention of SCD. So, it’s necessary to find out new prognostic markers of the VTA incidence, which will help to optimize the selection of patients who really need an ICD implantation. Currently, ST-2 and galectin-3 are actively studied in patients with coronary artery disease (CAD) and chronic heart failure due to their high potential prognostic value. Moreover, their role in the development of life-threatening arrhythmias is still poorly understood. In this regard, the study of the level of biomarkers of inflammation and myocardial fibrosis is relevant.

Aim. To evaluate the prognostic value of the ST-2 and galectin-3 in VTA predicting in patients with coronary artery disease and left ventricular ejection fraction less than 35 %.

Material and methods. The study included 40 patients (males – 36, median age – 64,5 [57,5; 68,5] years) with CAD, II and III functional class of chronic heart failure, left ventricle ejection fraction less than 35 % and ICD implantation indications (primary prevention of the SCD). ST-2 and galectin-3 blood concentration were determined before ICD implantation. All patients were followed-up during 18 months. There were assessed arrhythmological events recorded in ICD memory and ICD-lead parameters.

Results. The 1st group consisted of 10 (25,0 %) patients with VTA events terminated with ICD antitachycardia pacing or shock, the 2nd group – 30 (75,0 %) patients without VTA events. The univariate ROC-analysis showed that the high values of the ST-2 (p = 0,003) and galectin-3 (p = 0,045) were associated with frequent VTA events. Kaplan-Meier analysis showed that the ST-2 > 22,48 ng/ml (p = 0,02) and galectin-3 > 10,95 ng/ml (p = 0,009) significantly increase the risk of the VTA events. The multivariate ROC-analysis showed that only ST-2 increase (OR = 1,1053; CI 95 %: 1,0134-1,2056; р = 0,023) leaded to frequent VTA events. Conclusion. An increase of ST-2 more than 22,48 ng/ml and galectin-3 more than 10,95 ng/ml has predictive value in VTA assessing risk in patients with ischemic cardiomyopathy. In multivariate analysis, an independent predictor of VTA is the ST-2 increase more than 22,48 ng/ml.
Investigate clinical characteristics and genetic mutations of CPVT patients in Taiwan and risk stratification
Authors: Hsu CY , Wu MH , Chiu SN , Lin MT , Lai LP , Chen WJ , Lin TT , Juang JM
Published: May 2021

Funding Acknowledgements

Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Ministry of Science and Technology

Background

Catecholaminergic polymorphic ventricular tachycardia (CPVT) is a rare and lethal arrhythmia in children and young adults. RYR2 mutation accounts for 60% of CPVT patients. While many articles about CPVT are published in the Caucasian population, only a few studies are based on Asian ethnicity. A CPVT scorecard proposed using Caucasian patients is proven effective in reducing the burden of variants of uncertain significance (VUS) of RYR2 mutations is not yet tested in the Asian population.

Purpose

Identify mutations among Taiwanese CPVT patients and compare genetic and clinical results with other ethnicities. We also tested the efficacy of the CPVT scorecard in Taiwanese CPVT patients.

Methods

40 clinically diagnosed CPVT patients and their family members were consecutively enrolled from multi-centers. We compared clinical characteristics and genetic results with other ethnicities, and applied the Caucasian CPVT scorecard to test whether it is applicable in Taiwanese CPVT patients.

Results

This is the first nationwide CPVT cohort in Taiwan. Among the 29 patients with CPVT-related gene mutation, 12 RYR2 variants was identified in our cohort with 5 of them unreported in previous studies. The RYR2 yield rate was 55%, similar to other ethnicities. Exercise-induced symptoms including syncope and cardiac arrest were more severe in Taiwanese CPVT cohort, compared to Japanese and Caucasian cohorts. The CPVT scorecard also successfully reduced the VUS rate for the Taiwanese cohort.

Conclusions

Our study demonstrated genetic difference in CPVT patients across ethnicities, suggesting the importance of genetic testing in Taiwan. The CPVT scorecard is applicable to Taiwanese CPVT patients and is a helpful tool in interpreting genetic test results in clinical practice. Clinical characteristics of the cohort Gender (male, %) 15 (52%) Mean age of onset (years) 18 ± 15 Exercise-related syncope or cardiac arrest (n, %) 23 (79%) Exercise-related cardiac arrest (n, %) 14 (48%) Family history of unexplained sudden cardiac death (n, %) 5 (17%) Heart rate (bpm) 73 ± 16 Exercise stress test or Holter positive (n, %) 14 (48%) Ventricular arrhythmia (n, %) 23 (79%) Beta-blockers only (n, %) 10 (35%) Intracardiac defibrillator implantation (n, %) 15 (52%) CPVT score 6 ± 3
Concealed cardiomyopathy as a frequent cause of idiopathic ventricular fibrillation in a representative Czech cohort of survivors of sudden cardiac arrest (SCA)
Authors: Krebsova A , Votypka P , Peldova P , Haskova J , Tavacova T , Peichl P , Segetova M , Roubicek T , Vancura V , Kubus P , Sramko M , Macek Jr M , Zoubkova V , Janousek J , Kautzner J
Published: May 2021

Funding Acknowledgements

Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Ministry of Health of the Czech Republic

Introduction

The complex diagnostic work up in SCA survivors often does not yield a concrete cardiological diagnosis. Moreover, there is conflicting evidence whether genetic testing could support or guide clinical diagnostics.

Purpose

To assess the molecular architecture of idiopathic ventricular fibrillation in cases without apparent evidence of specific structural or arrhythmic cardiac disease at initial diagnostic work up in a representative Czech cohort.

Patients and Methods

Between 2013 - 2020 we have ascertained 100 SCA survivors (54 M / 46 F; age range at cardiac arrest 5-69 years). Genetic counselling was followed by massively parallel DNA sequencing using custom-made panels comprising 100 cardiac conditions-related genes. Subsequently, thorough cardiological screening examinations in first degree relatives were carried out. Presence of pathogenic variants was validated by Sanger DNA sequencing and through family segregation analyses.

Results

Highly likely or certain molecular aetiology (i.e. based on the presence of Class 4 or 5 variants) was disclosed in 20/100 (20%) in PKP2 (3x), SCN5A (4x), RYR2 (3x), TTN (2x), PLN, FLNC, PRKAG2, KCNH2, KCNQ1, SLC4A, TNNT2, and DSP. Interestingly, the KCNE1 p.Asp85Asn (LQT 5 lite) variant, was detected in further 3/100 cases, representing a recognized risk factor for ventricular arrhythmias.

Conclusions

Genetic testing facilitates stratification of the cause of arrhythmia in a substantial portion of SCA survivors. The utility of positive outcomes of genetic testing was substantiated in 10/20 gene positive patients, where the genetic stratification led to diagnosis of concealed arrhythmogenic cardiomyopathy, whose extent of morphological changes was under the diagnostic sensibility of imaging modalities or ECG. Our results enable individualized care in SCA survivors and assure targeted preventive approaches in their relatives.
Management of Nanostim leadless pacemaker early-life battery failures. A single center experience
Authors: Oosterwerff F , Salavati A , Adiyaman A , Ghani A , Smit JJJ , Ramdat Misier A , Delnoy PPHM , Elvan A
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Background/introduction Early studies of the Nanostim leadless pacemaker demonstrated technical feasibility effective pacing performance at the short-term. However, recently the Nanostim proved to be susceptible to early-life battery failures.

Purpose In this study, we addressed the following research questions:

1) What percentage of Nanostim LPs experience early-life battery failure?

2) Is Nanostim extraction and subsequent pacemaker reimplantation safe and effective?

3) Is three monthly follow-up under the Nanostim advisory effective at preventing Nanostim LP related in-between hospitalizations?

Methods In a retrospective study, we collected data of 49 Nanostim implanted patients with a mean follow up of 3 (±1.5) years at our tertiary hospital.

Results Nanostim early-life battery failure in our population was 37% (18/49). Extraction of 14 Nanostim pacemakers (device age 1040  ± 467 days) in an older population (80 ± 7 years) was safe (0 complications) and effective (80% extraction success, 100% reimplantation success). All known cases of early-life battery failure were identified during the three monthly follow-up consultations.

Conclusions Nanostim LP early-life battery failure is substantially higher than previously reported.

In case of dysfunction Nanostim extraction in an older population is safe and effective. Three monthly follow-up is effective at preventing in-between Nanostim related hospitalization. Abstract Figure. Management of Nanostim battery failure
Non-selective and selective His bundle pacing both preserve left ventricular activation time and pattern
Authors: Arnold A , Shun-Shin MJ , Keene D , Howard JP , Chow J , Miyazawa AA , Qureshi N , Lefroy DC , Koa-Wing M , Linton NWF , Lim PB , Peters NS , Kanagaratnam P , Francis DP , Whinnett ZI
Published: May 2021

Funding Acknowledgements

Type of funding sources: Public Institution(s). Main funding source(s): British Heart Foundation

Background: His bundle pacing can be achieved in two ways

selective His bundle pacing, where the His bundle is captured alone, and non-selective His bundle pacing, where local myocardium is also captured resulting a pre-excited ECG appearance. We assessed the impact of this ventricular pre-excitation on left and right ventricular dys-synchrony.

Methods

We recruited patients who displayed both selective and non-selective His bundle pacing. We performed non-invasive epicardial electrical mapping to determine left and right ventricular activation times and patterns.

Results

In the primary analysis (n = 20, all patients), non-selective His bundle pacing did not prolong LVAT compared to select His bundle pacing by a pre-specified non-inferiority margin of 10ms (LVAT prolongation: -5.5ms, 95% confidence interval (CI): -0.6 to -10.4, non-inferiority p < 0.0001). Non-selective His bundle pacing did not prolong right ventricular activation time (4.3ms, 95%CI: -4.0 to 12.8, p = 0.296) but did prolong QRS duration (22.1ms, 95%CI: 11.8 to 32.4, p = 0.0003).

In patients with narrow intrinsic QRS (n = 6), non-selective His bundle pacing preserved left ventricular activation time (-2.9ms, 95%CI: -9.7 to 4.0, p = 0.331) but prolonged QRS duration (31.4ms, 95%CI: 22.0 to 40.7, p = 0.0003) and mean right ventricular activation time (16.8ms, 95%CI: -5.3 to 38.9, p = 0.108) compared to selective His bundle pacing.

Activation pattern of the left ventricular surface was unchanged between selective and non-selective His bundle pacing. Non-selective His bundle pacing produced early basal right ventricular activation, which was not observed with selective His bundle pacing.

Conclusions

Compared to selective His bundle pacing, local myocardial capture during non-selective His bundle pacing produces right ventricular pre-excitation resulting in prolongation of QRS duration. However, non-selective His bundle pacing preserves the left ventricular activation time and pattern of selective His bundle pacing. When choosing between selective and non-selective His bundle pacing, left ventricular dyssynchrony is not an important factor. Abstract Figure: Selective vs Non-Selective HBP
Clinical outcomes with ventricular pacing or dual-chamber pacing for sinus-node dysfunction: a nationwide matched control study
Authors: Fauchier L , Bodin A , Bisson A , Herbert J , Ah-Fat V , Spiesser P , Pierre B , Clementy N , Babuty D
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Introduction.Evidence from randomized trials suggests that, in patients with sinus-node dysfunction (SND), physiologic pacing (dual-chamber, DDD) may be superior to single-chamber (ventricular, VVI) pacing because it is associated with lower risks of atrial fibrillation and stroke, better exercise capacity and lower risk of pacemaker syndrome. However, benefits on mortality and risk of heart failure have not been demonstrated and these issues have not been fully evaluated in large "real life" analyses.

Objective.The aim of our study was to assess and compare clinical outcomes within the first 30 days and during a longer-term follow-up with the two types of pacing at a nationwide level for patients with SND.

Methods and results.Using the administrative hospital database in France 2010-2020, 52,974 patients with SND were included in the analysis: 4,069 patients had VVI pacing and 48,905 had DDD pacing. Patients with leadless VVI pacemakers were excluded of the analysis. After propensity score matching 2,213 patients with VVI pacemaker were matched 1:1 with 2,213 patients treated with DDD pacemaker. In the matched analysis, patients with DDD pacemakers had a lower rate of all-cause (hazard ratio HR 0.711, 95%CI 0.61-0.828) and cardiovascular death (HR 0.628, 95%CI 0.48-0.818) within the 30 days after implantation. There were no significant differences for incidence of tamponade (HR 0.666, 95%CI 0.11-3.992), pneumothorax (HR 1.000, 95%CI 0.32-3.105), hemothorax (HR 0.800, 95%CI 0.21-2.982), major bleeding (HR 0.824, 95%CI 0.68-1.005) and transfusion (HR 1.016, 95%CI 0.83-1.243). During subsequent follow-up (mean: 3.0 ± 2.8 years), risk of all-cause death in the matched population was significantly lower in the DDD group than in the VVI pacemaker group (HR 0.683, 95%CI 0.60-0.784). Patients with SND treated DDD pacemakers also had a lower risk of cardiovascular death (HR 0.569, 95%CI 0.44-0.732), new-onset atrial fibrillation (HR 0.638, 95%CI 0.58-0.706), ischemic stroke (HR 0.685, 95%CI 0.53-0.887) and hospitalization for heart failure (HR 0.758, 95%CI 0.68-0.850) than those treated VVI pacemakers, whilst risk of endocarditis was not significantly different (HR 0.986, 95%CI 0.50-1.951). 

Conclusion.Patients with SND treated with DDD pacemakers had better clinical outcomes compared to those treated with VVI pacemakers. DDD pacing was associated with lower risks of death, cardiovascular death, new-onset atrial fibrillation, ischemic stroke, hospitalization for heart failure. DDD pacing was neither associated with a higher risk of complication on the short-term nor of endocarditis on the longer-term.
Conduction disturbances after TAVR: rates of pacemaker implantation, burden of ventricular pacing and prognostic significance
Authors: Bricoli S , Benatti G , Vignali L , Tadonio I , Notarangelo MF , Crocamo A , Gonzi G , Placci A , Bottoni N , Biagi A , Rossi L , Guiducci V , Losi L , Zardini M
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

BACKGROUND

The occurrence of conduction disturbances remains frequent after TAVR. However, the effect of PM on mortality is controversial and many patients may recover spontaneous AV conduction during follow-up. 

PURPOSE

To evaluate the incidence of PM implantation after TAVR, PM dependency and  burden of ventricular pacing during follow-up and their influence on mortality. 

METHODS AND RESULTS

We performed a retrospective analysis of all consecutive 293 patients who underwent TAVR from 2015 to 2019 at our hospital, regional hub for this procedure. Patients were classified into 3 groups: patients without PM (no-PM), patients with a PM implanted prior to TAVR (pre-PM) and patients requiring a PM following TAVR (post-PM) and their clinical and procedural characteristics are listed in Table 1. 

The rate of PM implantation after TAVR was 20,8%, at a median of 3.6 days after the procedure. The most common indication was complete AV block. A VVIR pacemaker was implanted in 28 patients, a DDD/DDDR PM in 27 patients and 2 patients received a CRT device. Among post-PPM patients, only 16% were PM-dependent at 2-month and 1-year follow-up. All of them received a PM for complete AV block (AVB). At 1-year follow-up, RV pacing burden was 60% among AVB patients and 23% in patients with a PM implanted for other reasons. PM implantation after TAVR was not associated with a mortality difference at 30-day, 1-year and long-term follow-up. Pre-PPM patients showed a higher mortality rate at long-term follow-up although not statistically significant.

CONCLUSIONS

Our data suggest that a single chamber device should be preferred in patients implanted for reasons other than complete AVB; in patients with AVB, the use of dual chamber device with an algorithm to minimize RV pacing should be the most suitable choice. Overall (293)No PPM (216)Pre-PPM (19)Post-PPM (57)p-valueAge, median(IQR)82(80-86)82(80-86)82(79-87)82(80-86)0,53Female, n(%)160(55)129(59)6(32)25(44)0,40NYHA III-IV, n(%)191(65)147(68)15(79)29(51)0,06Logistic Euroscore, mean (IQR)7,53(3,5-8,3)7(3,5-8)9,83(3,6-12)6(3,5-7,4)0,51Right bundle-branch block, n(%)21(7)13(6)na8(14)0,04AVA, mean ± SD0,69 ± 0,190,7 ± 0,190,7 ± 0,160,66 ± 0,180,23Self-expandable valve, n(%)181(62)123(57)12(63)46(81)0,001Balloon-expandable valve, n(%)102(35)86(40)7(37)8(14)0,0003Implant depth, mean ± SD6,87 ± 2,96,32 ± 2,65,71 ± 39,12 ± 30,0001Abstract Figure. Kaplan-Meier survival curve
Leadless pacemaker implant with concomitant atrioventricular node ablation: a single center study with longterm followup
Authors: Martinez Sande JL , Garcia-Seara J , Gonzalez-Melchor L , Rodriguez-Manero M , Torrelles-Fortuny A , Perez-Poza M , Abou-Jokh C , Gonzalez-Ferrero T , Garcia-Vega D , Fernandez-Lopez XA , Gonzalez-Juanatey JR
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Introduction

Feasibility of concomitant leadless-pacemaker(LP) implantation plus atrioventricular node ablation(AVNA) is unknown. Moreover, safety issues in the long run are also undetermined. It seems theoretically attractive since it could avoid one additional procedure and catheter could be introduced through the same sheath employed for the LP. On the contrary, risk of dislocation/electrical variations could represent a shortcoming .

Objective

We aim to report 1) feasibility of concomitant AVNA after a LP implantation and 2) long-term outcomes. 

Methods

Single center, prospective and observational study of 243 consecutive patients with an indication for single-chamber pacemaker placement. The implantation procedure was carried out using a femoral approach and conventional technique. Successful implantation was accomplished in 242/243 patients referred for leadless implantation. In one patient, a complete obstruction of the inferior vena cava was documented, and a conventional unicameral pacemaker was implanted.

Results

33 out of  242 patients underwent immediate AV ablation. Mean age was 75.2 ± 8.3 years. Were predominantly females: 25(75.7%) and indication was fast conduction atrial fibrillation(n = 25), atypical flutter or atrial tachycardia (n = 8). Mean acute "R wave" was 11.3mV, threshold of 0.55Vx0.24ms and impedance of 833Ω. Uneventful AV node ablation was performed in all of them immediately after LP implantation. Additional mean fluoroscopic time was 3.0 minutes.

There were no vascular or arrhythmic complications after the implantation. After a mean follow-up of  19.9± 12 months, all patients remained alive without notable event, and electrical parameters remained unchanged.(Figure 1)

Conclusions

Conconmitant AVN ablation after LP implantation seems feasible without remarkable complications in the long run.  In our  experience, this approach appears more comfortable for the patients and less time-consuming than conventional pacemaker implantation with sequential AV node ablation. There were no device macrodislodgements or unexpected device malfunctions in the follow-up period. Abstract Figure. Electrical performance
Pacemaker therapy in the elderly and very elderly: survival and prognostic factors
Authors: Del Castillo-Carnevali HA , Marschall A , Torres-Lopez M , Basabe-Velasco E , Gomez-Sanchez I , Fraile-Sanz C , Goncalves-Sanchez F , Rodriguez-Torres D , Rueda-Linares A , Coto-Morales B , Dejuan-Bitria C , Cinza-Rey R , Marti-Sanchez D , Alvarez-Anton S
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Background

The number of elderly patients undergoing pacemaker (PM) implantation is constantly growing. However, information on survival and prognostic factors of this particular patient group is scarce.

Objective

The objective of this study was to determine the survival of elderly and very elderly patients undergoing PM implantation, as well as to investigate prognostic factors of mortality.

Methods

This is a retrospective observational study of a single centre. Patients ≥ 80 years of age, that underwent PM implantation between January 2017 and December 2018 in our centre, were included for chart review. Very elderly patients were defined as those with ≥ 90 years of age.

Results

A total of 269 patients were included in the study with a mean age of 85 (±4.1) years. 53 patients were ≥ 90 years of age. 52% of the patients were male. 24.5% of the elderly patients and 41.5% of the very elderly patients received a single chamber PM. Median follow-up time was 28 (14-30) months, with no significant differences between the two groups of patients. The mortality rate for elderly patients was 15.7% for the elderly and 32.1% for the very elderly (p = 0.002). Generating multivariate Cox regression models, the following parameters showed to be significant predictors of all-cause mortality: Age (1.37 (1.02-1.29), p = 0.005), chronic kidney disease (5.57 (2.47-12.56), p < 0.001), COPD (3.74 (1.19-11.55), p = 0.023) and cancer (3.57 (1.02-12.51), p = 0.046). In the group of the very elderly only age (1.58 (1.10-2.27), p = 0.014) and cancer (3.76 (2.38-4.18), p = 0.003) significantly predicted mortality.

Conclusions

Our study shows a good life expectancy of elderly and very elderly patients, that underwent PM implantation, with a survival rate that is comparable to the general population. The primary prognostic factors were non-cardiological and co-morbidities, such as chronic kidney disease, cancer and COPD, had a stronger association with mortality than age.
A leadless pacemaker in the real-world setting: Patient profile and performance over time
Authors: Garweg C , Clementy N , Mondoloy P , Winter S , Bordachar P , Sharman D , Jung W , Eschalier R , Theis C , Defaye P , Anderson C , Pol A , Roberts PR
Published: May 2021

Funding Acknowledgements

Type of funding sources: Private company. Main funding source(s): Medtronic, Inc.

OnBehalf

Micra Acute Performance EMEA Investigators

Background

The first in-man implant of the Micra leadless pacemaker occurred in December 2013. While prior trials demonstrated a high implant success rate and favorable safety and efficacy results; whether the patient population and outcomes have changed over time is not well studied.

Purpose

To characterize the evolution of patient profile and outcomes for patients receiving a leadless pacemaker through the pre-market and post-market environment.

Methods

Patients undergoing a Micra leadless pacemaker implant attempt from the initial Micra Investigational Device Exemption [IDE] and current Micra studies (Micra post-approval registry [PAR], Micra acute performance [MAP] study) were analyzed. Patient characteristics and pericardial effusions regardless of severity were summarized.

Results

The 3466 patients included in the analysis underwent a Micra implant attempt and were enrolled during consecutive timeframes: patients from the Micra IDE study (n = 726) underwent a Micra implant attempt from 2013-2015, patients from the PAR (n = 1814) from 2015-2018, and patients from Micra MAP cohort (n = 926) from 2018 – 2020.  Implant success was >99.0% in all 3 studies. Median age ranged from 78 – 79 years among the 3 studies without significant difference. There were more patients requiring dialysis in the MAP cohort compared to the PAR or IDE cohorts (10.3%, 7.9%, and 3.9%, respectively; P < 0.001), but fewer patients with congestive heart failure (8.3%, 13.1%, and 18.0%; P < 0.001). Pacing indication was significantly different between the studies, with fewer patients in MAP having an indication of bradyarrhythmia associated with atrial fibrillation (AF) and more having an indication associated with atrioventricular block without AF (P < 0.001). The number of patients considered to be precluded for a transvenous pacemaker implant increased significantly from the initial IDE study to the PAR and MAP studies (6.2%, 23.9%, and 44.1%, respectively, P < 0.001).  Implant site placement was mostly apical for the IDE but shifted to mostly septal placement in the PAR and MAP (septal placement: 33.3%, 64.0%, and 79.5%, respectively). The rate of pericardial effusion regardless of severity was 1.79% (n = 13) in the IDE, 0.83% (n = 15) in the PAR, and 0.97% (n = 9) in MAP (figure). Mean pacing thresholds among MAP EMEA patients were low (0.61 ± 0.40V) at implant and remained stable through 12 months (0.62 +/- 0.41V).

Conclusion

Despite patient differences over time, the Micra leadless pacemaker was implanted with a high success rate and a low perforation rate, in-line with prior reports. Abstract Figure. Pericardial effusion rate by study
How good is operator opinion at predicting high ventricular pacing burden among patients receiving device therapy for bradycardia?
Authors: Chattopadhyay R , Chousou P , Thomas R , Hayes J , O"brien J , Pierres F , Vassiliou V , Pugh PJ
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Introduction

Current guidelines indicate that pacing methods that maintain physiologic ventricular activation (biventricular pacing or His-bundle pacing) should be chosen over right ventricular pacing (Vp) among patients with EF 36-50% who are expected to Vp >40% of the time. There are no guidelines to help predict which patients will receive a high burden of Vp and this is left to operator

opinion. We sought to ascertain whether operator opinion is an accurate predictor of high burden of Vp.

Methods

This was a single-centre single-blinded observational study of patients who received pacemaker implant for treatment of bradycardia between April 2015 and 2019 and had at least 12 month follow-up data on record. Patients’ demographic, clinical, electrocardiographic and echocardiographic data were reviewed in a blinded fashion by a senior implanting physician, who estimated whether the Vp at 12 months would exceed 40%. The Vp at approximately 12 months was obtained from the pacing records and compared with the prediction.

Results

Some 982 patients underwent pacemaker implantation during the study period, 698 for conduction system disease (CSD), 267 for sinus node disease (SND) and 17 for other conditions. Overall, 856 had valid follow-up data. Of these, 543 (63.4%) were predicted to Vp >40% , and 527(61.6%) were documented as having Vp >40%. The sensitivity and specificity of operator prediction were 93.2% and 84.2%, with positive and negative predictive values of 90.4% and 88.5%. Table 1 illustrates analyses of different populations by clinical parameter. In sub-group analysis, complete heart block and PR > 300ms were significant factors for accurate prediction of Vp > 40%, however clinical features, such as syncope, were poor discriminators.

Conclusion

In this single-centre study, among patients receiving pacemaker implant for treatment of bradycardia, operator prediction of the burden of Vp >40% has an acceptable degree of accuracy. Sub-group analysis suggests that certain clinical parameters could make this prediction easier. Table 1. Comparison of operator opinion SND CSD CHB SND+PR < 160 PR > 300 Syncope Non-syncope n 698 267 216 84 60 409 344 Sensitivity 44.4% 97.7% 100% 6.3% 100% 86.4% 87.9% Specificity 98.3% 62.0% 45.2% 97.1% 0%* 89.9% 79.6% PPV 87.0% 90.6% 91.6% 33.3% 98.3% 94.2% 92.2% NPV 87.9% 87.9% 100% 81.5% - 77.6% 70.5% * only 1 patient did not RV pace >40% - this was not predicted. SND – sinus node disease; CSD – conduction system disease; CHB – complete heart block, PPV – positive predictive value; NPV – negative predictive value
Safety of omitting defibrillation efficacy testing with subcutaneous defibrillators: a propensity matched case-control study
Authors: Bianchi V , Bisignani G , Russo V , Migliore F , Tola G , Viani S , Rossi P , Biffi M , Palmisano P , Checchi L , Licciardello G , Francia P , Leidi C , Ospizio R , D"onofrio A
Published: May 2021

Funding Acknowledgements

Type of funding sources: None.

Background

Defibrillation efficacy testing (DT) is recommended at implantation of subcutaneous implantable cardioverter–defibrillators (S-ICD). However, prior works found that adherence to this recommendation is declining in clinical practice.

Purpose

To compare survival from all-cause death and first ineffective shock (primary endpoint) and the composite of all-cause death, ineffective shock, inappropriate shock and device-related complication (secondary endpoint) between patients who underwent DT and those with omitted DT.

Methods

We analyzed 1652 consecutive patients who underwent S-ICD implantation in 60 Italian centers from 2013 to 2019.

Results

DT was not performed in 325 (20%) patients (no-DT patients). As compared with the DT group, these patients were older (51 ± 16 vs. 48 ± 15 years; p < 0.01) and had lower ejection fraction (37 ± 16% vs. 46 ± 16%; p < 0.01). The 325 no-DT patients were propensity matched with 325 patients of the DT group. During a median follow up of 19 months, 27 (4.2%) patients died for any-cause. During follow-up, 34 (5.2%) patients received appropriate shocks to treat discrete episodes of VT/VF. The first shock was effective in 30 out of 34 patients (88%), whereas a second shock was required to terminate VT/VF in 3 patients and a third shock in the last one. The primary endpoint occurred in 31 (4.8%) patients, and the risk was not significantly increased in the no-DT cohort (HR = 1.26, 95%CI:0.62-2.55, p = 0.522). Inappropriate shocks were reported in 36 (5.5%) patients and device-related complications in 25 (3.8%) patients during follow-up. Survival from the composite secondary endpoint was comparable between groups (HR = 0.86, 95%CI:0.57-1.32, p = 0.500).

Conclusions

Our data confirmed that DT is frequently omitted in current clinical practice, especially in older patients with worse systolic function. A strategy that omits DT did not appear to compromise the effectiveness of the S-ICD and no additional risk seems associated with DT omission at a mid-term follow-up. These data suggest that routine DT at S-ICD implant might not be necessary. Randomized trials are needed to confirm this finding.
New onset depression and anxiety in patients with an implantable cardioverter defibrillator during 24 months of follow-up
Authors: Pedersen SS , Nielsen JC , Wehberg S , Jorgensen OD , Riahi S , Haarbo J , Philbert BT , Johansen JB
Published: May 2021

Funding Acknowledgements

Type of funding sources: Foundation. Main funding source(s): Danish Heart Foundation

OnBehalf

DEFIB-WOMEN study group

Background

Patients adjust well to living with an implantable cardioverter defibrillator (ICD), but 20% develop anxiety and depression that may compromise their quality of life (QoL) and increase risk of ventricular tachyarrhythmias and mortality.

Purpose

We examined the incidence and correlates of new onset anxiety and depression during 24 months of follow-up in ICD patients without depression and anxiety.

Methods

Patients with a first-time ICD (n = 1040) enrolled in the national, multi-centre prospective observational DEFIB-WOMEN study completed questionnaires on anxiety, depression and physical QoL at baseline, 3-, 6-, 12-, and 24 months. Information on demographic and clinical data was obtained from the Danish Pacemaker and ICD Register.

Results

During 24 months of follow-up, 46-57 (4%-5%) patients developed new onset anxiety and 42-47 (4%-5%) new onset depression. The incidence of new onset comorbid anxiety and depression was higher with 69-80 (7%-8%). Age [HR:0.54; 95%CI:0.36-0.80], marital status [HR:1.66; 95%CI:1.01-2.73], secondary prevention indication [HR:1.43; 95%CI:1.00-2.04], Type D personality [HR:2.50; 95%CI:1.62-3.86], and lower self-reported physical functioning [HR:1.48; 95%CI:1.00-2.17] were associated with new onset anxiety during follow-up. Age [HR:0.57; 95%CI:0.37-0.89], higher self-reported physical functioning [HR:0.46; 95%CI:0.25-0.85], smoking [HR:2.13; 95%CI:1.33-3.40], Type D personality [HR:2.53; 95%CI: 1.57-4.05], and lower self-reported physical functioning [HR:1.64; 95%CI:1.08-2.48] were associated with new onset depression.

Conclusion

Between 4%-8% of patients with a first-time ICD with no anxiety or depression at baseline are at risk of new onset anxiety, depression, or comorbid anxiety and depression up to 24 months post implant, suggesting that safeguarding their QoL and prognosis warrants that we screen patients not only at baseline.
Endocardial pacing is not haemodynamically superior to trans-coronary sinus epicardial pacing in cardiac resynchronization therapy: the Endo-Epi CRT study
Authors: Okafor O , Zegard A , Stegemann B , Arif S , De Bono J , Marshall H , Leyva F
Published: May 2021

Funding Acknowledgements

Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Medtronic

Background

Cardiac resynchronization therapy (CRT) conventionally involves trans-coronary sinus, epicardial left ventricular (LV) pacing. Some studies have suggested that endocardial LV pacing may be superior to epicardial LV pacing.

Objectives

To compare the acute haemodynamic effects of CRT when delivered from endocardial (Endo-CRT) and epicardial LV stimulation sites (Epi-CRT).

Methods and results

Sixteen CRT recipients (aged 70.4 ± 10.1 years [mean ± SD], 62.5% male, QRS: 156.5 ± 16.1 ms, LBBB in 13 [81.3%]) in sinus rhythm underwent intra-procedural measurements of the rate of rise of LV pressure (dP/dtmax) during Endo- and Epi-CRT (RADI pressure wire). Epi-CRT was delivered in basal, mid and apical positions. The Endo-CRT pacing site was chosen using iterative, biplane fluoroscopic views, to target the same position as the Epi-CRT site on the endocardium (see Figure A). Compared to AAI pacing (10 beats per minute above intrinsic rate), both Endo-CRT and Epi-CRT led to an increase in LV dP/dtmax (6.52 ± 8.90% and 6.15 ± 7.97% respectively, both p < 0.001). There were no significant differences in the change in LV dP/dtmax (ΔLV dP/dtmax) between Endo-CRT and Epi-CRT at basal (p = 0.54), mid (p = 0.78) or apical LV stimulation sites (p = 0.12) [Figure B].

Conclusions

Endo-CRT is not haemodynamically superior to Epi-CRT. Abstract Figure.