bluuebunny/crossref_metadata_2025 huggingface dataset:
Impact of the COVID-19 pandemic on emergent pacemaker implantation during lockdown and its aftermath
Authors: De Almeida Fernandes D , Cadete R , Guimaraes J , Monteiro E , Costa G , Antonio N , Goncalves L
Published: October 2021

Background

COVID-19 was first considered a pandemic on the 11th of March of 2020 by the World Health Organization. Its impact comprised not only the direct consequences of the disease but a decrease in the follow-up and interventions of patients with cardiovascular (CV) disease. In Portugal and the World, the consequences of this complex paradigm shift on emergent pacemaker implantation rates during and after this pandemic is largely unknown.

Purpose

We sought to analyse the impact of COVID-19 pandemic on emergent pacemaker implantation rate and patient profile in a tertiary hospital during the first Portuguese lockdown and subsequent post-lockdown period.

Methods

We retrospectively reviewed the clinical profile of patients who had pacemakers implanted in our hospital in an urgent/emergent setting from March 18, 2020 to May 17, 2020 (lockdown) and May 19 to July 17, 2020 (post-lockdown). This data was then directly compared to the homologous periods from the year before (H1 and H2, respectively).

Results

A total of 180 patients submitted to emergent pacemaker implantation were included.

The cohort was comprised of 29 patients who had a pacemaker implanted during lockdown, 60 post-lockdown, 38 in H1 (+31% vs lockdown) and 53 in H2. Average age and gender proportion were similar for all groups.

When comparing lockdown and post-lockdown periods, the number of cases significantly increased in the second period (+106.9%) and there was a tendency for a higher number of temporary pacemaker use (3.4% vs 16.7%; p=0.076). Patients admitted during lockdown were 7.57 times more likely to present with hypotension/shock (odds ratio (OR) 7.57; p=0.013).

Regarding lockdown and its homologous 2019 period, there was a decrease in the number of patients admitted (−23.7%). Again, there was a higher tendency for hypotension on presentation during lockdown (p=0.054).

In comparison to its homologous 2019 period, post-lockdown saw a slight increase in the number of patients (+13.2%) and more patients presented with bradycardia (16.7% vs 3.8%; p=0.026).

Also of note, no patients were admitted to the emergency department during lockdown for anomalies detected on ambulatory tests (Holter, electrocardiogram or implanted loop recorder).

Conclusion

During lockdown, clinical presentation was generally more severe, with a greater number of patients presenting with hypotension/shock. In addition, there appears to be a lockdown effect on emergent bradyarrhtmias admissions in the post-lockdown period with a profound impact: higher admission rates and more severe presentations including a higher need of temporary pacemaker. Patients with symptoms suggestive of bradyarrhythmias should be advised to present promptly regardless of the pandemic.

Funding Acknowledgement

Type of funding sources: None. Pacemakers during lockdown/post-lockdownPacemakers implanted by diagnosis
Unveiling the impact of fibrosis presence in fibrillatory electrograms
Authors: Rios-Munoz G R , Sanchez De La Nava A M , Gomez-Cid L , Grigorian-Shamagian L , Fernandez-Santos M E , Atienza F , Arenal A , Fernandez-Aviles F
Published: October 2021

Introduction

Complexity and fragmentation presence in atrial fibrillation (AF) electrograms (EGMs) has been extensively studied in the literature, with areas exhibiting complex fractionated atrial electrograms (CFAEs) postulated as responsible for AF maintenance. Computational simulations based on in silico models are widely employed to support AF initiating and maintenance theories. However, they are still limited when trying to mimic the effect of fibrosis in live cardiac cells and its impact in the clinical context, i.e., EGM morphologies in electroanatomical mapping studies. Controlled experiments on cultivated cardiomyocytes and optical mapping signals can better explain the role of fibrosis and its effect on EGM recordings.

Purpose

To study the effect of fibrosis in fibrillatory scenarios by comparing the temporal and frequency domains of EGMs and Ca2+ transient signals in cardiomyocyte cell cultures.

Methods

A total of 51 HL1 cardiomyocytes cell line monolayers experiments were cultured until confluence. Optical mapping (OM) was performed to evaluate the electrophysiological activity of the samples through Ca2+ transient quantification under the effect of Rhod2 dye. Activation frequency and calcium transient signals were acquired, and virtual EGMs were calculated from the signals virtually after post-processing the cell cultures at 16 different positions in the culture, see Figure 1A.

Results

The DF ratio between the OM and the virtual EGMs obtained for the different fibrosis levels are summarized and represented in Figure 1B. The Pearson's correlation coefficient was adjusted for all the samples and the significance level was stablished at p-value<0.01.

Conclusions

Optical mapping signal morphologies strongly correlate with EGM recordings when a clear dominant frequency (DF) dominates the complete area of the cell culture and no fibrosis is present. However, for patchy distributions of the DF, usually associated with higher concentrations of fibrosis, morphologies do not correlate for increasing fibrosis levels, and DF measurements differ with poor match between EGM-DF and OM-DF. Results on higher fibrotic experiments, i.e., 40–50% fibrosis level, show that DF correlates due to the poor and degraded cardiac activity in the EGMs and optical mapping recordings. The results reveal the importance and impact of fibrosis in the remodeling of atrial tissue and the correct interpretation of endocardial EGMs in the presence of heterogeneous tissue.

Funding Acknowledgement

Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Instituto de Salud Carlos III and Ministerio de Ciencia, Innovaciόn y Universidades
Epidemiology of subclinical atrial fibrillation in patients with cardiac implantable electronic devices: a systematic review and meta-analysis
Authors: Romiti G F , Corica B , Borgi M , Vitolo M , Miyazawa K , Healey J S , Lane D A , Boriani G , Basili S , Lip G Y H , Proietti M
Published: October 2021

Background

Sub-clinical atrial fibrillation (SCAF) and atrial high-rate episodes (AHREs), seen as high-frequency atrial tachyarrhythmias in patients with cardiac implantable electronic devices (CIEDs), have gained prominence as determinants of clinical atrial fibrillation (AF) and increased stroke risk. As a result, several studies investigating their role in predicting the onset of AF and AHRE-related outcomes have been conducted but uncertainty exists on the epidemiology of AHRE.

Purpose

To estimate the incidence of SCAF, according to presence of AHREs in patients with CIEDs, through a systematic review and meta-analysis of the available literature.

Methods

PubMed and EMBASE were searched from inception to 27th January 2021 for all studies documenting the incidence of AHREs in patients with CIEDs. We included all studies with ≥100 patients reporting data on AHREs incidence. Pooled prevalence and incidence rates were computed; we also performed meta-regressions for pooled incidence rates, according to relevant study-level characteristics. This study was registered in PROSPERO: CRD42019106994.

Results

Among the 2,515 results retrieved, we included 51 studies in the systematic review and meta-analysis, with a total of 68,414 patients. Meta-analysis of included studies showed a pooled prevalence of 28.2% (95% CI: 24.3–32.5%, I2=99%), with a pooled incidence rate (IR) of 15 new AHRE cases per 100 patient-years (95% CI: 12–19, I2=100%). Given the large heterogeneity showed in the pooled estimates we performed additional analyses. Regarding pooled prevalence, we performed several subgroup analyses, according to various studies baseline characteristics, which did not show any significant difference in any of the subgroups examined. Regarding IR, a multivariable meta-regression analysis showed that decreasing follow-up time and increasing age were the only factors significantly associated with AHRE incidence, explaining a large proportion of heterogeneity (R2=68%, p<0.001; Figure 1, Panel A and B respectively). Accordingly, the AHRE IR was highest at 1 year follow-up and in the oldest subjects. Presence of SCAF was significantly associated with older age, higher CHA2DS2-VASc score, and higher prevalence of hypertension, heart failure and history of cerebrovascular disease.

Conclusions

This systematic review and meta-regression demonstrated that SCAF is very common in patients with CIEDs, with an overall IR for AHREs of up to 15 per 100 patient-years; increasing with age and decreasing with longer follow-up time. Presence of SCAF was associated with an overall higher clinical risk profile compared to those subjects without SCAF.

Funding Acknowledgement

Type of funding sources: None. Figure 1. Meta-regression for AHRE Incidence
Diabetes is associated with atrial fibrillation phenotype, cardiac and neurological comorbidities: insights from the Swiss-AF study
Authors: Bano A , Rodondi N , Beer J , Moschovitis G , Kobza R , Aeschbacher S , Baretella O , Muka T , Stettler C , Franco O , Conte G , Sticherling C , Zuern C , Conen D , Reichlin T ,   The Swiss-AF Investigators
Published: October 2021

Background

Diabetes mellitus is a major risk factor for atrial fibrillation (AF). However, it remains unclear whether individual AF phenotype and related comorbidities differ between AF patients with and without diabetes.

Purpose

To investigate the association of diabetes with AF phenotype, cardiac and neurological comorbidities in patients with documented AF.

Methods

Participants of the multicenter Swiss-AF study with available data on diabetes and AF phenotype were eligible. The primary outcomes were parameters of AF phenotype, including AF type (paroxysmal vs non-paroxysmal), AF symptoms (yes vs no), and quality of life (assessed by EQ-5D score). The secondary outcomes were cardiac (ie, history of hypertension, myocardial infarction, heart failure) and neurological comorbidities (ie, history of stroke, cognitive impairment). The cross-sectional association of diabetes with these outcomes was assessed using logistic and linear regression. Results were adjusted for age, sex, and cardiovascular risk factors.

Results

We included 2411 AF patients (27.4% women; median age, 73.6 years). Diabetes was not associated with non-paroxysmal AF (odds ratio [OR]=1.01; 95% confidence interval [CI]=0.81 to 1.27). Patients with diabetes less often perceived AF symptoms (OR=0.73; CI=0.59 to 0.91), but had worse quality of life (predicted mean difference in EQ-5D score: β=−4.54; CI=−6.40 to −2.68) than those without diabetes. Patients with diabetes were more likely to have cardiac comorbidities [history of hypertension (OR=3.04; CI=2.19 to 4.22), myocardial infarction (OR=1.55; CI=1.18 to 2.03), heart failure (OR=1.99; CI=1.57 to 2.51)] and neurological comorbidities [history of stroke (OR=1.39; CI=1.03 to 1.87), cognitive impairment (OR=1.75; CI=1.39 to 2.21)].

Conclusions

In the Swiss-AF cohort population, patients with diabetes less often perceived AF symptoms, but had worse quality of life, more cardiac and neurological comorbidities than those without diabetes. These findings have significant clinical implications. The reduced perception of AF symptoms in patients with diabetes might result in a delayed AF diagnosis and consequently more adverse events, especially cardioembolic stroke. This raises the question whether patients with diabetes should be systematically screened for silent AF. Moreover, patients with concomitant AF and diabetes have increased likelihood of comorbidities and therefore deserve more attentive care.

Funding Acknowledgement

Type of funding sources: None.
Impact of the introduction of an integrated multi-professional pathway for atrial fibrillation on long-term outcomes
Authors: Aslam S , Vickers C , Veevers W , Farrar L , Hartley L , Viswanathan K
Published: October 2021

Background

An integrated structured approach to atrial fibrillation (AF) management is recommended by ESC.1 However, limited data is available on its “real-world” impact on anticoagulation uptake and subsequent AF-related hospitalisation and stroke rates.

Purpose

To evaluate the long-term impact of the introduction of a community-wide integrated AF service based in a secondary care hospital.

Methods

In September 2017 we implemented a new integrated pathway for patients with newly diagnosed “symptomatic” atrial arrhythmias across two regions (population 450,000) in England in collaboration with primary care. All patients were seen in a one-stop multi-professional clinic (Arrhythmia nurse and Electrophysiologist with ECG and echocardiogram) within 2 weeks. They underwent standardised screening for modifiable risk factors, counselling regarding diagnosis/ anticoagulation and received an individualised AF management plan as well as access to a nurse-led telephone helpline. We followed up the first 126 consecutive patients for a period of 12 months.

Results

Baseline characteristics are shown in Table 1, showing a high incidence of modifiable risk factors (previously un-identified in the majority). After review in clinic, 30-day AF-related readmission rates to hospital were low (1.6%, n=2) as compared to historical local data (5.8%). This was sustained at 3 months (4.7%, n=6) and at 12 months (7.9%, n=10). 99% of 83 of eligible patients (CHA2DS2-VASc score of >2 with no major contra-indications) received oral anticoagulation. Over 12 months follow-up, rates of TIA/stroke was low (n=3, 2.4%). All-cause mortality was also low (n=1, 0.8%). NHS England region-wide data showed a marked reduction in percentage of total stroke admissions with history of AF not taking anticoagulation at stroke presentation in 2018/19 as compared to 2017/18 across our two regions; this was lower than the national average and the lowest within West Yorkshire (Figure 1).

Conclusions

An integrated service for AF management implemented community-wide was associated with high uptake of oral anticoagulation among eligible patients and low rates of AF-related hospitalisations and all-cause mortality. Across the community, among stroke admissions with AF at presentation, a lower percentage of patients without anticoagulation was observed in comparison with previous years and neighbouring regions.

Funding Acknowledgement

Type of funding sources: None.
Stroke risk based on classification of atrial fibrillation: real-world vs clinical trial
Authors: Ding W.Y , Rivera-Caravaca J.M , Marin F , Roldan V , Lip G.Y.H
Published: October 2021

Background

The most widely accepted clinical classification of atrial fibrillation (AF) is according to temporal rhythm-based patterns, reflecting the notion that most patients initially suffer from transient episodes that prolong over time due to atrial substrate remodelling as the disease progresses. Therefore, it may be speculated that patients with extended episodes of “continuous” AF (persistent, long-standing persistent and permanent AF) may be at higher risk of stroke complications compared to paroxysmal AF (pAF). However, the risk of stroke according to clinical classification of AF remains poorly defined. In this study, we assessed the impact of AF type on stroke risk in patients with AF from “real-world” and “clinical trial” cohorts.

Methods

Post-hoc analysis of patient-level data from the Murcia AF Project and AMADEUS trial. All patients were anticoagulated. Patients were grouped into those with pAF and non-pAF. pAF was defined as AF that terminates spontaneously or with intervention within seven days of onset. Non-pAF was defined as AF that lasted longer than seven days, including persistent, long-standing persistent and permanent AF subtypes. Study endpoint was the incidence rate of ischaemic stroke. A modified CHA2DS2-VAS“c” score that applied one additional point for a “c” criterion of continuous AF (i.e. non-pAF) was calculated.

Results

5,917 patients were included; 1,361 (23.0%) real-world and 4,556 (77.0%) clinical trial. Real-world patients had a median age of 76 (interquartile range [IQR] 71–81) years with 51.3% females compared to a median age of 71 (IQR 64–77) years with 33.5% females among clinical trial participants. Baseline demographics were comparable in both groups in the real-world cohort but clinical trial participants with non-pAF were older, predominantly male and had more comorbidities compared to those with pAF.

Crude stroke rates were comparable between the groups in real-world patients (incidence rate ratio [IRR] 0.72 [95% CI, 0.37–1.28], p=0.259) though clinical trial participants with non-pAF (vs. pAF) had a significantly higher crude rate of stroke events (IRR 4.66 [95% CI, 2.41–9.48], p<0.001). Using multivariable cox regression analysis, AF type was not independently associated with stroke risk in the real-world (adjusted hazard ratio [HR] 1.41 [95% CI, 0.80–2.50], p=0.239) and clinical trial (adjusted HR 1.17 [95% CI, 0.62–2.20], p=0.621) cohorts, after accounting for known risk factors using the CHA2DS2-VASc score. Using receiver operating characteristic curves analysis, we found no significant improvement in the CHA2DS2-VAS“c” compared to CHA2DS2-VASc score in either cohort (p>0.05).

Conclusion

Overall, there was no association between the temporal rhythm-based patterns of AF and stroke risk among anticoagulated patients, suggesting that this should not be a consideration when assessing the need for anticoagulation in AF.

Funding Acknowledgement

Type of funding sources: None.
The impact of substrate and trigger ablation for reduction of functional mitral regurgitation in patients with persistent atrial fibrillation
Authors: Watanabe T , Yamada T , Tamaki S , Yano M , Hayashi T , Yasumura Y , Hikosou S , Sotomi Y , Morita T , Furukawa Y , Kawasaki M , Kikuchi A , Kawai T , Sakata Y , Fukunami M
Published: October 2021

Background

Functional mitral regurgitation (FMR) is not uncommon in atrial fibrillation (AF) patients. Left atrial (LA) substrate remodeling and corresponding mitral valve annulus dilation has been reported as the most possible cause of FMR. Percutaneous catheter ablation (CA) is an effective treatment for AF. Although significant FMR could be improved by sinus restoration, patients with mitral regurgitation were more likely to experience recurrent AF post ablation, especially those with significant mitral regurgitation. There is no information available on the efficacy of CA for persistent AF in patients with FMR.

Purpose

The purpose of this study is to investigate the predictors of FMR improvement by CA and to determine the efficacy of substrate and trigger CA for persistent AF in patients with FMR.

Methods

We prospectively studied 512 consecutive patients admitted for persistent AF ablation from the EARNEST-PVI (Prospective Multicenter Randomized Study of Effect of Extensive Ablation on Recurrence in Patients with Persistent Atrial Fibrillation Treated with Pulmonary Vein Isolation) trial.

On admission, enrolled patients were randomly assigned in a 1:1 ratio to pulmonary vein isolation (PVI) or PVI-plus additional ablation (linear ablation or/and CFAE ablation). Of the 512 patients, we studied 94 patients with preoperative echocardiography showing moderate or greater baseline FMR. FMR grades were classified into 5 grades (0/1/2/3/4). The FMR improvement group (FMRI(+)) was defined as a case in which the FMR was improved by two or more grades compared the preoperative echocardiography and the one year follow-up examination.

Results

Of the 94 patients, 42 were in the PVI group and 52 were in the PVI-plus additional ablation group. There were 30 cases in the FMRI(+) group and 64 cases in the FMRI(−) group. There were no significant baseline differences in age, sinus rhythm maintenance, plasma B-type natriuretic peptide (BNP) level, left ventricular diastolic dimension, or left atrium dimension between the FMRI(+) and FMRI(−) groups. AF duration was significantly shorter in the FMRI(+) group than FMRI(−) groups (5.8±9.4 months vs 12.4±15.4 months, p<0.0001). In addition, significantly more additional ablation cases were observed in the FMRI(+) group than in the FMRI(−) group (73.3% vs 46.8%, p=0.016). In multivariate analyses, only additional ablation was an independent predictor of FMRI (odds ratio 0.226 95% CI 0.081–0.626; p=0.004).

Conclusions

Catheter ablation is a valid option for the treatment of AF in patients with functional MR and additional substrate and trigger ablation were the only independent predictor of FMR improvement.

Funding Acknowledgement

Type of funding sources: None.
Long-term clinical outcomes in patients after catheter ablation for atrial fibrillation or atrioventricular node ablation: a French nationwide cohort study
Authors: Spiesser P , Bisson A , Bodin A , Herbert J , Pierre B , Clementy N , Babuty D , Fauchier L ,   Service de Cardiologie, Centre Hospitalier Universitaire Trousseau et Faculté de Médecine, Université François Rabelais, Tours, France
Published: October 2021

Background

Catheter ablation of atrial fibrillation (AF) has become a therapy of choice to treat symptomatic AF in current practice. As an alternative, atrioventricular node (AVN) ablation is an older but efficient procedure to control ventricular rate.

Purpose

To assess long-term clinical outcomes of AF ablation and AVN ablation in large cohort of patients with AF and to compare these two procedures.

Methods

This French multicentric retrospective study enrolled all patients hospitalized with a primary or secondary diagnosis of AF from 1st January 2010 to 31st December 2019, using an administrative hospital-discharge database. Clinical outcomes were analyzed in overall population and in propensity-matched samples.

Results

During follow-up (mean [SD] 2.0 [2.2], median [IQR] 1.0 [0.1–3.3] years), 2,438,015 patients were analysed (No ablation 2,360,833, AF ablation 62,490 and AVN ablation 14,692). Compared to patients treated without ablation, incidence of all-cause death was lower in patients treated with AF ablation (hazard ratio (HR) 0.272, 95% confidence interval (CI) 0.259–0.287, p<0.0001) or AVN ablation (HR 0.762, 95% CI 0.734–0.791, p<0.0001). After propensity-score matching, in patients treated with AF ablation, incidence of all-cause death (HR 0.662, 95% CI 0.557–0.788, p<0.0001), cardiovascular death (HR 0.617, 95% CI 0.471–0.807, p<0.0001) and hospitalization for heart failure (HF) (HR 0.732, 95% CI 0.620–0.865, p<0.0001) were lower compared to patients treated with AVN ablation, unlike incidence of ischemic stroke (HR 1.447, 95% CI 1.122–1.865, p<0.0001).

Conclusion

AF ablation and AVN ablation may be associated with better survival compared to non-invasive strategy. Compared to AVN ablation, AF ablation is associated with lower risk of all-cause death, cardiovascular death and hospitalization for HF, but higher incidence of ischemic stroke.

Funding Acknowledgement

Type of funding sources: None. Baseline characteristics matched cohortMain results
Digoxin treatment and long-term mortality depending on left ventricular ejection fraction and atrial fibrillation: a propensity score matched analysis
Authors: Grubler M.R , Verheyen N.D , Meinitzer A , Fiedler L , Tscharre M , Roithinger F.X , Tomaschitz A , Pilz S , Maerz W
Published: October 2021

Background/Introduction

Atrial fibrillation (AF) is a common heart rhythm disturbance, associated with an increased risk of stroke, hospital admissions and mortality, especially in patients with reduced ejection fraction. Among the oldest medications used for heart-rate control is digitalis, but largely due to observational studies showing an increased risk of death it has fallen out of favour. Recently newer clinical trials reported that the treatment with digitalis in permanent AF might be superior to beta blocker therapy in regard to functional status and symptom burden. Given this diverging results we attempt to analysis a large cohort of patients facilitating a propensity score matching algorithm.

Purpose

To assess the associations of digitalis treatment with mortality in patients with increased cardiovascular risk.

Methods

Patients were derived from a large cohort study including participants from a tertiary care centre who were referred to coronary angiography. The propensity score matching is based on a predefined list of variables, with digitalis as treatment. Matching strategy is nearest neighbour matching and to prove consistency, radius matching (radius = 0.1). For survival analysis we used a Cox proportional hazard regression comparing patients with and without digitalis for all-cause mortality. The analysis is conducted using STATA 13 MP. All patients provided written informed consent and the study was approved by the ethics committee.

Results

A total of 2457 patients (median age: 63.5 [IQR = 56.3–70.6] years, 30.1% women) referred to coronary angiography, with a median follow up of 9.9 (IQR = 8.5–10.7) years were included. The matching process and the resulting propensity score fulfilled all statistical assumptions and resulted in a balanced cohort. The risk for all-cause mortality was higher among propensity score matched participants not treated with digitalis compared to patients on treatment (n=514) HR 3.03 (95% CI 2.5 to 3.7). Total mortality in patients with AF on digitalis after a median follow-up of 9.9 years was 27.6%. At baseline, only 42.4% of patients with AF were on oral anticoagulation.

Conclusions

In the present cohort treatment with digitalis was associated with a lower risk of all-cause mortality after long-term follow-up. The patient population has a clinically significant 10-year mortality risk. The results may not apply to other cohorts but may help inform future clinical trials.

Funding Acknowledgement

Type of funding sources: None.
Same day discharge after atrial fibrillation ablation is feasible and safe. Results of a prospective study in 1015 patients
Authors: Viezelis M , Pontoppidan J , Johansen J.B , Djurhuus S.M , Dalhoj J , Asferg C , Osmanagic A , Sandgaard N.C.F
Published: October 2021

Background

Atrial fibrillation (AF) ablation is the standard treatment for symptomatic paroxysmal and persistent AF. It is a common practice for patients to stay overnight after the ablation for observation of possible complications. Thus, increasing volume of procedures places a significant strain on institutions. To tackle this issue, our institution developed a same-day discharge (SDD) protocol for AF ablation.

Purpose

To assess the feasibility and safety of the SDD protocol after at least four-hour observation in patients undergoing radiofrequency ablation (RFA) for AF.

Methods

A SDD protocol was implemented in our institution in March 2019. We conducted a prospective observational study that included all consecutive patients who underwent ablation for AF until January 2021. A detailed workflow setup provided in the figure. To compare means the Mann Whitney U test, and for categorical variables – χ2 test were used. The difference was significant when p<0.05.

Results

A total of n=1015 patients underwent RFA in the study period. Of those, same-day discharge was feasible in n=751 (74.1%) and n=264 stayed overnight. The mean age (SDD 62.5 SD 8.8 years vs overnight-stay 64.1 SD 9.2 years, p=0.105) and gender distribution (males SDD 46.8% vs overnight-stay 39.8%, p=0.265) did not differ between the two groups. In the SDD group no patients were readmitted for complications within 24 hours after the ablation. A severe complication was defined as pericardial effusion with drainage, pulmonary oedema, thromboembolic event and vascular complication needing surgical intervention. In total 3.0% of all patients experienced a severe complication. The main reasons for staying overnight were small groin hematoma without intervention (18.9%), nausea (14.4%) and logistic issues (32.2%). The 30-day hospital readmission rate was insignificantly higher in the overnight-stay group (19.4% vs 28.0%, p=0.113). The most common reasons for readmission were arrhythmias (SDD 10.1% vs overnight-stay 20.5%) and chest pain (SDD 7.6% vs overnight-stay 2.4%). One late pericardial effusion with drainage on day 10 after the ablation was noted in the SDD group.

Conclusion

Same-day discharge in patients after RFA for AF is feasible and safe with an observational period of at least four hours and immediate transthoracic echocardiography after the procedure.

Funding Acknowledgement

Type of funding sources: None.
Comparison between early versus late pulmonary vein isolation in the management of atrial fibrillation
Authors: Intan-Goey V , Scherrenberg M , Falter M , Kaihara T , Dendale P , Verwerft J
Published: October 2021

Background

Atrial fibrillation (AF) is the most common type of arrhythmia. The health burden of AF keeps increasing with the rising incidence of AF caused by the aging population and the high prevalence of unhealthy lifestyle. Pulmonary vein isolation (PVI) is the cornerstone of invasive rhythm control treatment in AF. Randomized controlled trials have shown superiority of an PVI strategy compared to conservative treatment. However, the best timing to perform a PVI to achieve the most optimal outcome is still unknown.

Purpose

To investigate whether the timing of performing PVI has consequences for the AF management in terms of medical cost, the number of repeated electrical cardioversion and hospitalisations and mortality.

Methods

In this monocentric retrospective observational study, all patients who underwent an electrical cardioversion and PVI between January 2012 and January 2020 were included using a hospital administrative data record. Follow-up data were collected up to a maximum of 67 months. Early PVI is defined as patients receiving a PVI after a first electrical cardioversion; late PVI is defined as patients receiving PVI after more than one electrical cardioversion. We compared the two groups for the mean medical cost, the number of repeated electrical cardioversions performed, any unplanned hospitalization associated with AF and mortality.

Results

A total of 407 patients were included in this analysis. Respectively, in the early versus the late PVI strategy groups, the mean age was 64.5 vs. 66.3 years (p=0.105) and the mean follow-up was 1630±843 vs. 2039±781 days (p<0.001). The mean medical cost since the first cardioversion was €8533 vs. €8987 (p=0.503), the number of additional electrical cardioversion performed was 0.4 vs 3.0 (p<0.001) and mortality rate was 2,8% vs. 0% (p=0.116). The Log-rank analysis showed a significant difference (p<0.001) between both groups in the time to first unplanned hospitalisation on cardiology ward after PVI in favor of early PVI strategy.

Conclusions

An early PVI tends to be superior to a late PVI strategy in the management of AF with less need for repeated electrical cardioversion and lower hospitalisation rate. Total medical cost and mortality rate were comparable in both approaches.

Funding Acknowledgement

Type of funding sources: None.
Thoracoscopic ablation for symptomatic atrial fibrillation improves quality of life
Authors: Vos L.M , Vos P.W.K , Nieuwkerk P.T , Vos R , Havenaar H , Hofman F.N , Boersma L.V.A , Van Putte B.P
Published: October 2021

Background

Rhythm control has become an essential part of adequate management in atrial fibrillation (AF) to reduce symptoms and ultimately to improve health related quality of life (HRQoL). Totally thoracoscopic ablation has been established over the last years as an effective and safe rhythm control strategy, especially for persistent AF, but quality of life data are lacking.

Purpose

To assess the impact of totally thoracoscopic ablation on HRQoL in patients with symptomatic AF.

Methods

Consecutive patients with symptomatic AF undergoing totally thoracoscopic ablation at a referral centre in the Netherlands (July 2016 – October 2019) were included. The primary outcome was quality of life. Short Form 36 and Atrial Fibrillation Effect on Quality-of-Life (AFEQT) health surveys were collected at baseline, 1, 3, 6 and 12 months. Clinical improvement was measured as the relative increase of the QoL-score at 1 year compared to the baseline score (in %). Multilevel regression modelling was used, coupled with fractional polynomials for adjustment of age differences and nonlinear time trends, to investigate the one-year clinical trajectories of sex differences in QoL subscales. Secondary outcomes included rhythm success (freedom from any recurrence of atrial tachyarrhythmia>30 sec), mortality and stroke.

Results

191 patients were included (63.9±8.6 years, 68% male, 22.5% paroxysmal AF, 69.6% persistent AF and 7.9% long-term persistent AF, 66.5% having at least one previous failed catheter ablation, with median Cha2ds2 Vasc score of 2 [IQR 1–3]). AFEQT sum scores (52.6 points at baseline) substantially improved after three months (49.8%; p<0.001) and remained stable up to 1-year (54.2%; p<0.001) despite adverse events. Patients with recurrent AF also showed significant improvement at 3 months which remained stable up to 1-year, but patients who remained in sinus rhythm had significantly more increase (61.3% vs 26.9%, p<.001). The SF36 physical and mental summary composite scores significantly improved after 3 months (12.3% and 11.9% respectively; p<.001) and remained stable up to 1-year (16.9% and 16.4% respectively; P<.001). Although female patients had significantly lower AFEQT and physical subscales at baseline, similar improvement in scores were observed over time compared to men, adjusted for age and sex interactions (P<.001). One-year stroke rate was 1.6 per 100 patient-years with an oral anticoagulation rate of 63%. One-year survival was 99.5%.

Conclusions

This study reveals significant improvement of HRQoL three months after thoracoscopic ablation that persisted up to 1-year, also when adjusted for sex and age differences. Despite AF recurrence or adverse events AF related QoL still improved. Trials are necessary to confirm these data.

Funding Acknowledgement

Type of funding sources: None.
Cancer incidence during follow-up in patients with new-onset atrial fibrillation treated with DOACs and its impact on bleeding risk
Authors: Angeli F , Bartoli L , Fabrizio M , Bergamaschi L , Magnani I , Paolisso P , Armillotta M , Sansonetti A , Chiti C , Stefanizzi A , Toniolo S , Foa A , Rinaldi A , Galie N , Pizzi C
Published: October 2021

Background

Cancer is increasingly recognized as strictly related to atrial fibrillation (AF). In patients with AF, the relationship between cancer and cardioembolic or bleeding risk during oral anticoagulant therapy is unknown.

Purpose

To assess the bleeding and ischaemic burden of a baseline or newly diagnosed cancer in patients treated with direct oral anticoagulants (DOACs) for non-valvular atrial fibrillation (NVAF).

Methods

All consecutive patients treated with DOACs were enrolled among those with new-onset atrial fibrillation and indication for oral anticoagulant between January 2017 and March 2019. During follow-up, bleeding events, newly diagnosed primitive or metastatic malignancy and major cardiovascular events (MACE) were evaluated. At baseline, CHA2DS2-VASc, HAS-BLED, ATRIA, and ORBIT scores were used to assess the hemorrhagic and ischaemic risk. Major bleedings (MB) were defined according to the ISTH definition. Anemia was defined as haemoglobin levels below 11 g/dL in women and 12 mg/dL in men.

Results

1258 patients constituted the study population and followed for a mean time of 21.6±9.5 months. Overall, 66 patients (5.2%) were affected by malignant neoplasia at baseline, whereas 59 (4.7%) were diagnosed with a malignancy during follow-up. Among baseline characteristics, anemia was associated with cancer at enrolment (43.9% vs 22.5%, p<0.001) but not at follow up (29.3% vs 23.4%, p=0.341). MACEs were not associated with cancer at baseline (5.3% vs 5.2%, p=1.0) and at follow up (5% vs 4.9%, p=1.0). No association was observed between major ischaemic events and cancer at enrolment or follow up (5.3% vs 4.4%, p=0.83 and 4.4% vs 5%, p=0.82). Despite no statistically significant differences in haemorrhagic risk at baseline, the overall bleeding events and MB were associated with newly diagnosed cancer (9.2% vs 3.9%, p=0.001 and 13.8% vs 4.5%, p=0.001, respectively) but not at baseline (5.2% vs 5.5%, p=0.82 and 9.2% vs 5.2%, p=0.162). At multivariate analysis adjusted for age, hypertension and renal function, anemia and a newly diagnosed cancer during follow up remained independent predictors of MB (respectively, HR 1.27, 95% CI 1.52–1.06, p=0.009 and HR 3.53, 95% CI 7.71–1.62, p=0.001).

Conclusion

Bleeding risk assessment is an ongoing challenge in patients with NVAF on DOACs. During follow-up, newly diagnosed primitive or metastatic cancer is a strong predictor of bleeding regardless of baseline haemorrhagic risk assessment. In contrast, such association is not observed with malignancy at baseline. A proper diagnosis and treatment could therefore decrease cancer-related bleeding risk. On the contrary, our study shows that cancer is not an ischaemic risk modifier, either diagnosed at baseline or follow-up.

Funding Acknowledgement

Type of funding sources: None.
Blunted heart rate reserve with dobutamine stress echocardiography predicts outcome in diabetes and/or chronic kidney disease
Authors: Bellagamba C.C.A , Quevedo N.M , Torres M
Published: October 2021

Background

A blunted heart rate reserve (HRR) during dobutamine stress echo (DSE) is an index of the altered cardiac sympathetic reserve, which is frequently present in diabetes mellitus (DM) or chronic kidney disease (CKD).

Aim

To assess the prognostic value of HRR during DSE.

Methods

We recruited 280 patients (mean age 62.9±13.1 years; 128 (45.7%) male; 28.2% on beta-blockers at the time of testing) who underwent DSE for known or suspected coronary artery disease and/or heart failure and were followed-up. Four subsets were identified: Group 1 (111 pts without DM or CKD); group 2 (37 with DM without CKD); group 3 (90 with CKD with or without DM); and group 4 (42 with CKD on dialysis). HRR was calculated by EKG as the peak/rest HR ratio.

Results

Ischemia was identified in 34/280 (12.1%) pts. During a median follow-up time of 40.3±30.5 months, 120 events occurred: 46 deaths, 15 non-fatal myocardial infarctions, 23 hospital admissions for acute decompensated heart failure, and 36 myocardial revascularizations. Multivariable comparison of HRR among the 4 groups using post hoc test showed a blunted HRR in group 3 (1.66±0.32) and 4 (1.65±0.27) when compared with group 1 (HRR 1.85±0.35), p<0.01. Group 2 (1.73±0.28) was not different from any group (p=ns). Groups 3 and 4 were not different between them (p=ns). A post hoc Tukey test for HRR separated in tercils, 1st: HRR <1.59, 2nd: 1.59 < HRR <1.86 and 3rd: HRR >1.86 (p<0.000). Kaplan-Meier curves showed blunted HRR as an independent predictor of event-free survival in the overall group - 1st: 66.08±5.9 months, 95% CI 54.3–77.7; 2nd: 69.52±6.5, 95% CI 56.6–82.3; 3rd: 90.05±5.3, 95% CI 79.5–100.5. See Figure. HRR was comparable in patients with and without inducible ischemia and off or on beta-blockers.

Conclusion

A blunted HRR during DSE is frequent in patients with DM and CKD, independent of inducible ischemia and use of beta-blockers, and is a useful non-imaging predictor of adverse events.

Funding Acknowledgement

Type of funding sources: None.
Feasibility of preprocedural LAA occluder sizing
Authors: Brenner C , Haber T , Melichercik J , Ismer B , Haas N.A
Published: October 2021

Background

Implantation of occluders in the left atrial appendage (LAA) has been established to prevent patients with atrial fibrillation (AF) from stroke and embolisation. Currently, the individual occluder sizing will be done intraprocedurally using fluoroscopy and/or transesophageal echo (TEE) imaging.

Purpose

Development of a new approach allowing preprocedural occluder sizing and its validation by conventional intraprocedural methods.

Methods

The CARTO electro-anatomical mapping system was used in 62 consecutive patients (40 m, 22 f, age: 69.8±8.4 years) to preprocedurally predict the size of Watchman (n=34) or Amplatzer Amulet (n=28) devices. During device implantation, 23 of the patients (37.1%) were in AF. LAA morphologies were Chicken Wing (40.0%), Cauliflower (31.7%), Windsock (20.0%) and Cactus (8.3%). CHA2DS2-VASc Score was 3.7±1.9 and HAS-BLED-Score was 3.6±1.3. Preprocedurally, routine cardiac CT scans were imported into the CARTO segmentation tool for segmentation of the left atrium. The resulting volume images (VI) and slice images (SI) were adjusted in their 3-dimensional orientation to fit the manufacturer's sizing recommendations. Subsequently, the match between pre- and intraprocedural sizing was compared with the actually implanted device size.

Results

In the Watchman group, preprocedural VI corresponded with 38.1% (8/21) and SI with 42.3% (11/26), while intraprocedural fluoroscopy corresponded with 29.6% (8/27) and TEE with 40.0% (12/30) of all actually implanted devices. According to clinical routine an aberration of one size is common practice. After including one additional size to the estimation, VI corresponded with 81.0% (17/21), SI with 84.6% (22/26), while fluoroscopy corresponded with 85.2% (23/27) and TEE with 80.0% (24/30) of all actually implanted occluders.

In the Amplatzer Amulet group, VI corresponded with 37.0% (10/27), SI with 57.1% (16/28) and fluoroscopy with 71.4% (20/28) of all actually implanted devices. After including one additional size to the estimation, VI corresponded with 66.7% (18/27), SI with 85.7% (24/28) and fluoroscopy with 100% (28/28) of all actually implanted occluders. The remaining were selected empirically.

Conclusion

In this study cohort of 62 patients, feasibility of a preprocedural sizing using the CARTO segmentation tool was demonstrated for Watchman occluders providing results comparable with conventional intraprocedural fluoroscopy and/or TEE based intraprocedural sizing. Possibly due to the different manufacturer measuring recommendation, 10 to 12 mm away from the LAA ostium, results for the Amplatzer Amulet system were found to be less accurate. Nevertheless, the proposed approach offers the advantage of preoperative visualisation of the individual LAA anatomy and morphology.

Funding Acknowledgement

Type of funding sources: None.
Leadless pacemaker implant with concomitant atrioventricular node ablation: experience in a single center study with longterm followup
Authors: Martinez-Sande J.L , Garcia-Seara J , Gonzalez-Melchor L , Rodriguez-Manero M , Perez-Poza M , Fernandez-Lopez X.A , Garcia-Vega D , Torrelles-Fortuny A , Gonzalez-Juanatey J.R
Published: October 2021

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 256 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 255/256 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 255 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 27.9±12 months, all patients remained alive without notable event, and electrical parameters remained unchanged (Figure 1). Actuarial survival was shown in Figure 2.

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.

Funding Acknowledgement

Type of funding sources: None. Electrical performanceSurvival
Real-world experience on the safety and effectiveness of Micra TPS in patients with pre-existing in situ CIEDs
Authors: Garweg C , Bordachar P , Boveda S , Roberts P.R , Johansen J.B , Iacopino S , Clementy N , Winter S , Anderson C , Butler K , El-Chami M.F
Published: October 2021

Background

The Micra pre-market study showed that the Micra transcatheter pacing system could be safely implanted in patients with pacing indications. Patients with pre-existing cardiac implantable electronic devices (CIED) were excluded from this clinical trial; however, this group of patients might benefit from a leadless pacemaker especially when a lead fails or after incidence of system-related infections.

Objective

To determine the outcome of patients with a pre-existing CIED or lead that remains in situ at the time of Micra implant attempt.

Methods

Patients who had a pre-existing CIED and/or lead at the time of Micra implantation attempt were identified from the Micra Post-Approval Registry and Micra Acute Performance studies. Baseline characteristics were summarized, and a Fine-Gray competing risk model was used to compare risk for major complication through 24 months for patients with and without a pre-existing CIED.

Results

Of the 2323 patients included in the analysis, 111 patients had a pre-existing CIED or lead at the time of Micra implantation attempt that remained in situ. Types of pre-existing devices included 81 pacemakers (45 single chamber, 32 dual chamber, 4 of unknown type), 10 ICDs (2 single chamber, 2 dual chamber, 6 unknown type), 10 CRT devices (6 CRT-P, 4 CRT-D), 3 generators of unknown type, and 7 patients had only leads remaining. Patients with pre-existing devices were younger and less likely to have a pacing indication of bradyarrhythmia with atrial fibrillation compared to patients without pre-existing devices (p<0.001 for both). Patients with prior devices were more likely to have a condition precluding implant of a transvenous pacemaker (67.6% vs. 21.3%, p<0.001). The presence of a pre-existing CIED did not impact the outcome of the Micra TPS implant procedure: implant success was >99% for both cohorts. Mean follow-up duration was 21.2±14.3 months (range 0–56) for pre-existing devices patients and 23.3±15.8 months (range 0–62) for other patients. The rate of major complications through 24 months was 1.8% for patients with and 3.8% for patients without prior devices (p=0.36). There were no major complications related to device malfunction or device-device interaction. There were 6 system revisions in 4 patients with preexisting devices and 52 revisions in 51 patients without preexisting devices. Pacing thresholds for patients with and without prior devices were similar at implant (0.72 and 0.63, respectively; p=0.31) and remained stable through 12 months.

Conclusion

Micra can be safely and successfully implanted in patients with a pre-existing CIED remaining in situ. It should be considered a treatment option for patients in whom CIED extraction may be deemed high risk.

Funding Acknowledgement

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