bluuebunny/crossref_metadata_2025 huggingface dataset:
Heart rate dynamics after pulmonary vein isolation: pulsed-field vs. radiofrequency ablation
Authors: Valeriano C , Buytaert D , De Schouwer K , Addeo L , Geelen P , De Potter T
Published: May 2024

Background

The autonomic nervous system (ANS) plays a pivotal role in the onset and maintenance of atrial fibrillation (AF). During thermal ablation, the epicardial ganglionated plexi (GP) can inadvertently be affected, as indicated by a post-ablation increase in heart rate (HR), potentially impacting post-procedural outcomes. Pulsed-field ablation (PFA) offers a safer and potentially more effective alternative, as lesion transmurality is not inversely related to safety as in thermal ablation. However, PFA's tissue selectivity may limit its effectiveness in ablating potential AF triggers like GP.

Purpose

We aimed to assess the impact of PF and RF energy on GP ablation by examining HR changes following PVI procedures.

Methods

We examined consecutive paroxysmal AF patients undergoing PVI at a single center, using either a variable-loop circular PFA catheter, as part of the inspIRE trial, or a conventional point-by-point RF catheter (1:2 ratio). ECGs were collected before and after ablation at multiple time points, including 1-hour, 1-day, 1-month, and 3-month intervals, with a 24-hour Holter ECG at 3 months. Patients without obtainable sinus rhythm ECGs at these time points were excluded. We also gathered data on post-ablation antiarrhythmic drug and beta-blocker usage. Data are reported as mean±SD, and analysis employed Student’s t-tests, paired t-tests, chi-squared tests, and multiple linear regression analysis to identify influencing factors.

Results

A total of 105 patients were included (PF = 35, RF = 70). Baseline demographics were similar (Table A). In the RF group, HR significantly increased at all measured time-points. In contrast, this trend was not observed in the PF group (Figure A and B). Following the procedure, the RF cohort exhibited a significantly higher HR compared to PF (7.3±10.3 vs. 0.8±11 at 1-day, p=0.018), and this difference persisted after 3 months (8.5±10.1 vs. 0.9±9, p<0.001, Figure C). These findings remained consistent when HR was assessed using Holter ECG data (HR at 3 months: mean 72.1±8.8 vs 65.8±9.4, min 55.2 vs 48.9; p=0.002, p=0.001, Figure D). The use of RF energy was the only predictor of HR increase after the ablation procedure (β = 7.687, p < 0.001, Table B).

Conclusion

Our findings indicates that PFA does not increase resting HR as seen with thermal RF ablation, suggesting limited effect on ANS modulation. The role of adjunctive GP ablation during PVI procedures remains a topic of debate.While PFA shows promising improvement in lesion durability, current evidence does not conclusively establish its advantage over RF. This invites contemplation about whether the addition of GP ablation in RF procedures could be a contributing factor. The absence of HR acceleration may pose issues for patients with sick sinus syndrome or pure vagally mediated AF. Further research is essential to confirm these findings and their clinical implications.Central illustrationTables
Optimization of high-power short-duration pulmonary vein isolation using QDOT catheter - the A-Q-RATE POWER trial
Authors: Gardziejczyk P , Piotrowski R , Skrzynska-Kowalczyk M , Skowronska M , Wlazlowska-Struzik E , Niedzwiedz M , Kulakowski P , Baran J
Published: May 2024

Background/Introduction

The safety and efficacy of novel ablation catheter QDOT Micro, capable of delivering high-power short-duration (HPSD) radio-frequency (RF) applications, has already been demonstrated in clinical trials. It has been shown that lesions performed with 90 Watts/4 sec (vHPSD) are shallower but wider compared to HPSD (50 Watts/4 sec) or conventional ablation settings. Thus, it may be speculated that vHPSD applications may not achieve transmurality at thick (up to 4 mm) parts of anterior aspects of pulmonary vein (PV) - left atrial (LA) wall junction.

Purpose

To compare acute completeness of PV isolation (PVI) focused on anterior wall achieved using vHSPD versus HPSD in patients undergoing ablation for atrial fibrillation (AF).

Methods

Prospective, dual-center, randomized study was conducted over a 8-month period. Patients were randomized 1:1 to vHPSD versus HPSD delivered at anterior aspects of PV. Posterior parts of PV were ablated with vHPSD in both arms. The carina region between ipsilateral PVs was ablated using 35 W and ablation index of 380. Need for additional RF applications to achieve complete PVI was the primary outcome.

Results

70 patients (mean age 63.5±11.2; 57.1% male) with paroxysmal (61.4%) or persistent AF (38.6%) were randomized to vHPSD (n=35) or HPSD (n=35). Additional RF touch-up applications at the anterior aspects of PV were significantly more frequently needed in the vHPSD group compared with the HPSD group (46% vs 19%, p<0.001) and in the right PVs (57% vs 20%, p=0.001) versus left PVs (34% vs 17%, p=0.1). Median procedure duration, LA dwell time and fluoroscopy time were similar in both groups [112 (IQR 90, 130) min vs 107 (IQR 90,125) min, p= 0.58; 95 (IQR 70,106) min vs 90 (IQR 71,100) min, p=0.55; and 28 (IQR 14,69) sec vs 46 (IQR 0,89) sec, p=0.97, respectively). In one patient in vHPSD we were not able to isolate right superior pulmonary vein (RSPV) despite additional RF touch-up applications.

Conclusions

vHPSD RF applications using the QDOT Micro catheter may not achieve transmurality in a significant proportion of anterior parts of PV. The proposed hybrid strategy consisting of HPSD delivery at anterior aspects of PV with vHPSD delivered at other parts of PV ostia is associated with significantly higher rate of first-pass PVI without extending procedural and fluoroscopy duration.
Long-term recurrence-free survival following second-generation cryoballoon ablation for persistent atrial fibrillation: role of the autonomic nervous system
Authors: Guckel D , El Hamriti M , Fink T , Sciacca V , Braun M , Khalaph M , Isgandarova K , Sommer P , Sohns C , Noelker G
Published: May 2024

Background

The cardiac autonomic nervous system (ANS) plays a pivotal role in the regulation of atrial fibrillation (AF). Cryoballon (CB)-guided pulmonary vein isolation (PVI) is an established treatment for AF.

Purpose

In our present study we evaluated the impact of vagal reactions (VRs), as a surrogate parameter for ANS modulation, on the long-term outcome of CB-ablation in patients with persistent AF (PERS AF).

Methods

Data from consecutive PERS AF patients undergoing primary CB-guided PVI for symptomatic drug refractory AF between 2013-2023 were analysed. VRs were defined as bradycardia < 40 beats/min, asystole or higher-degree atrioventricular block. Long-term follow-up data were assessed. AF-recurrence was defined as AF lasting > 30 seconds beyond a 3-month blanking period.

Results

A total of 250 consecutive patients (mean age 63.9±10.0 years, 30% female) were included. VRs were recorded in 61 patients (24%, mean age 64.2±13.0 years, 30% female). The mean follow-up duration amounted to 84±14 months. Within this observation period 101 patients (40%) developed AF-recurrence. Re-ablation procedures were performed in 61 patients (60%). Patients with PVI-associated VRs presented with a significantly higher estimated AF-free survival rate (log-rank p-value < 0.001) (Figure 1) and a significantly longer median AF-free survival time (75 months, interquartile range (IR) 63-92 months) compared to those without (69 months, IR 13-79 months) (p=0.002). Beyond that Kaplan-Meier plot analyses revealed significant gender differences (Figure 1). Multivariate cox regression analyses confirmed VRs (Confidence interval (CI) 0.294-0.838, Hazard Ratio (HR) 0.497, p=0.009) and male gender (CI 0.352-0.781, HR, 524, p=0.001) as independent predictors (IPs) for AF-free-survival.

Conclusion

CB-ablation procedure associated VRs and male gender seem to be associated with a favorable long-term outcome in PERS AF. Further studies are warranted to verify our observations.Kaplan Meier plot on long-term AF-free s
Adherence to CLOSE protocol, high-power and low baseline generator impedance predicts durable pulmonary vein isolation
Authors: Szegedi N , Boga M , Orban G , Sallo Z , Nagy V K , Osztheimer I , Perge P , Ferencz A B , Komlosi F , Toth P , Merkely B , Geller L
Published: May 2024

Background

Atrial fibrillation (AF) recurrence after pulmonary vein isolation (PVI) is predominantly attributed to pulmonary vein reconnection (PVR). Predictors of AF recurrence were widely studied. However, data are scarce on the procedural parameters that predict chronic PVR.

Aims

to study the PVR rates and the predictors of PVR after initial PVI procedure.

Methods

We included 100 consecutive patients who underwent repeated ablation due to AF recurrence after initial PVI with the CARTO system, both procedures performed between 2018 and 2023.

Results

The mean age of the patients was 60 ± 12 years, 36% were female, and 44% had persistent AF. Thirty-eight patients underwent initial CLOSE-guided, and sixty-two underwent initial non-CLOSE PVI. Repeat procedure was performed 21 ± 14 months after the initial procedure. In total, PVR was found in 192 of 373 PVs (51.5%) and all PVs were isolated in 17/100 (17%) patients. Factors associated with all PVs being isolated were adherence to the CLOSE protocol (39.5% vs. 3.5%, p < 0.0001), higher delivered mean power (37.5W vs 30W, p = 0.027), presence of first-pass isolation (88.2% vs 40.4%, p = 0.0007), and lower baseline generator impedance (127.6 vs 136.6 Ω, p = 0.0027; respectively). Baseline generator impedance >130 Ω (AUC = 0.7403, sensitivity: 77.1%, specificity: 68.8%, p = 0.0032) was associated with significantly higher probability of PVR (OR = 6.757; p < 0.0001).

Conclusions

Our findings indicate that adherence to the CLOSE protocol, higher power setting, first-pass isolation, and baseline generator impedance <130 Ω during AF ablation improves the durability of PVI and reduces the incidence of PVR.
Higher recurrence rate after ablation of persistent atrial fibrillation in patients with prolonged P-wave negativity in lead V1
Authors: Coudray E , Le Bloa M , Teres C , Herrera C , Domenichini G , Ascione C , Porretta A , Solana Munoz J , Roten L , Kuhne M , Knecht S , Sticherling C , Pascale P , Pruvot E , Luca A
Published: May 2024

Background

Several ECG P-wave parameters, such as duration, amplitude and morphology reflect the electromechanical condition of the atria. P-wave features mainly served to identify patients prone to atrial fibrillation (AF) or to predict recurrence of paroxysmal AF after ablation.

Purpose

We sought to investigate which specific features derived from the P-wave might help identify patients with persistent atrial fibrillation (peAF) unresponsive to wide circumferential pulmonary veins isolation (WPVI).

Methods

41 patients (63±10 y) with peAF (sustained duration 11±7 months) underwent a de-novo WPVI. A second WPVI was performed in patients with recurrent AF in order to provide complete PV disconnection. We defined "success" as patients who remained in sinus rhythm (SR) after one or two procedures, and "failure" otherwise. The average duration and amplitude of the P-waves on ECG lead II, and the duration and amplitude of positive and negative deflections on ECG lead V1 were extracted during SR after cardioversion at the end of the index WPVI. P-wave terminal force in V1 (PTFV1) was computed as the product of negative amplitude and duration in lead V1.

Results

Over a mean follow-up of 32±9 months, 24 patients remained free from AF (success group), while 11 patients had AF recurrence after 2 WPVIs (failure group). Six patients were lost to follow-up or declined the second WPVI. 45% (5/11) were ON antiarrhythmic drugs (AAD) during follow-up in the failure group, while 0.04% (1/24) were ON AAD in the success group (p<0.05). Other clinical characteristics (e.g. age, body mass index, left atrial volume or duration in sustained AF) were similar. The figure displays P-wave metrics of patients ON and OFF AAD during follow-up. No significant differences were found in P-wave duration (lead II; Panel A1), in PTFV1 (Panel A2), and in duration of V1 positive deflection (Panel A3). Interestingly, the failure group displayed longer duration of the negative deflection in V1 (76±17ms) than that of the success group (68±18ms, p<0.05; Panel A4). Panel B shows that the differences remained after exclusion of patients ON AAD during follow-up. No differences were found in P-wave amplitude in lead II or in amplitude of positive and negative deflections in lead V1 (data not shown).

Conclusion

Our results show that prolonged negativity in lead V1, which is indicative of left atrial electromechanical remodeling, is associated with failure to restore long-term sinus rhythm after WPVI of peAF.
Ultra-short-term deceleration capacity and heart rate variability as indicators of vagal denervation before and after pulmonary vein isolation
Authors: Zarebski L , Futyma P
Published: May 2024

Introduction

Pulmonary vein isolation (PVI) is a well-established therapy of atrial fibrillation (AF). However, subtypes of AF can differ and exact mechanisms in which patients benefit from PVI remain not fully understood. Parasympathetic activity can play important role in pathogenesis of AF. Moreover, catheter ablation can impact vagal innervation of the heart, nevertheless methods of periprocedural assessment of such impact of PVI are lacking.

Purpose

Ultra-short-term deceleration capacity (UST-DC) and ultra-short-term heart rate variability (UST-HRV) were investigated to determine their potential function as indicators of parasympathetic activity before and after PVI.

Methods

24 consecutive patients (8 females, age 54±11) with paroxysmal AF were included in the study. UST-DC and UST-HRV were calculated from 1-minute ECG recordings performed before and after PVI.

Results

There was a significant differences between UST-DC before PVI vs after PVI (7.6ms vs 2.8ms; p=0.0000018) and between UST-HRV parameters before and after PVI: standard deviation of normal-to-normal (UST-SDNN) (37.8ms vs 18.4ms; p=0.00005), root mean square of successive differences (UST-rMSSD) (25.3ms vs 12.2ms; p=0.00083) and proportion of success NN intervals differing more than 50ms divided by total number of NNs (UST-pNN50) (8.4% vs 2%; p=0.045). Heart rate (HR) increase was also statistically significant (pre-PVI vs post-PVI, 65.5bpm vs 73.7bpm; p=0.016). After 3-months patients with baseline UST-DC>7.5ms, were less likely to experience AF recurrence when compared to patients with baseline UST-DC<7.5ms (0% vs 31%, p=0.0496). In these groups difference in AF recurrences after 12-months of follow-up did not meet statistical significance (36% vs 38%, p=0.52). No correlation between UST-HRV parameters and AF recurrence during follow up was observed.

Conclusions

PVI leads to significant changes in UST-DC and UST-HRV and these parameters may serve as indicators of vagal denervation after AF ablation. Patients with more prominent baseline UST-DC are less likely to experience AF recurrence during 3-month blanking period after PVI.
Pulsed electric field, cryoballoon, and radiofrequency for paroxysmal atrial fibrillation ablation: a propensity score-matched comparison
Authors: Marcon L , Della Rocca D , Magnocavallo M , Mene' R , Pannone L , Mohanty S , Glowniak A , Sousonis V , Sorgente A , Sarkozy A , Rossi P , Boveda S , Natale A , De Asmundis C , Chierchia G B
Published: May 2024

Background and Aims

Pulmonary vein isolation (PVI) is the most effective rhythm control strategy in paroxysmal atrial fibrillation (AF). Pulsed field ablation (PFA) has emerged as a novel, non-thermal energy source to selectively ablate cardiac tissue. We report the first multicenter experience on PVI via the pentaspline FarapulseTM PFA system versus thermal-based technologies in a propensity score-matched population of paroxysmal AF patients.

Methods

Propensity score matching was adopted to compare PVI-only ablation outcomes via the FarawaveTM PFA system (Group PFA), cryoballoon ablation (Group CRYO), or focal radiofrequency (Group RF) (PFA:CRYO:RF Ratio=1:2:2).

Results

Among 1572 (mean age: 62.4±11.3 years; 42.5% females) PAF patients undergoing their first time PVI with either PFA (n=174), CRYO (n=655), or RF (n=743), propensity score matching yielded 174 PFA, 348 CRYO, and 348 RF patients. First-pass isolation was achieved in 98.8% of pulmonary veins (PVs) with PFA, 81.5% with CRYO, and 73.1% with RF (p<0.001). Procedural and dwell times were significantly shorter with PFA. Overall complication rates were 3.4% (n=6) with PFA, 8.6% (n=30) with CRYO, and 5.5% (n=19) with RF (p=0.052). The 1-year Kaplan-Meier estimated freedom from any atrial tachyarrhythmia was 79.3% with PFA, 74.7% with CRYO, and 72.4% with RF (log-rank p-value: 0.24). Among 145 repeat ablation procedures, PV reconnection rate was 19.1% after PFA, 27.5% after CRYO, and 34.8% after RF (p=0.01).

Conclusion

PFA contributed to significantly shorter procedural times. Follow-up data showed a similar arrhythmia freedom among groups, although a higher rate of PV reconnection was documented in post-CRYO and post-RF redo procedures.RecurrencePVs
Pulmonary vein isolation with additional substrate ablation for atrial fibrillation results in an increased risk for the development of atypical atrial flutter
Authors: Ferreira Neves I , Jacinto S , Portugal G , Silva Cunha P , Valente B , Lousinha A , Santos H , Monteiro A , Contins R , Cruz Ferreira R , Martins Oliveira M
Published: May 2024

Introduction

Pulmonary vein isolation (PVI) is the cornerstone of atrial fibrillation (AF) catheter ablation. Several extra pulmonary vein (PV) ablation strategies for substrate modification (PVI plus) have been employed to AF patients. It has not been proven that this approach decreases the recurrence of AF, and it could contribute to increase the risk of developing atypical atrial flutter.

Methods

Patients submitted to AF catheter ablation at our centre between 2005 and 2020 were included. Using logistic regression, we did a retrospective analysis of the association between the application of PVI plus strategies (such as ablation of the cavo tricuspid isthmus (CTI), ganglion plexus, isolation of the superior vena cava (SVC), mitral isthmus ablation and atrial roof line ablation) and the development of atypical flutter later submitted to ablation.

Results

Five hundred and seventy-five patients were included (64% males, age 57±12 years [between 14 and 81], 68.2% with paroxysmal AF) with > 1-year follow-up. Five hundred and five (87.8%) had PVI alone. From the 575 patients, 11 (1.9%) developed an atypical flutter during the follow-up, which was later submitted to ablation. The crude ODDS of a patient submitted to a PVI plus strategy developing atypical atrial flutter are 13.92 times higher than the one of those submitted to a stand-alone PVI technique, with a p value <0.001 (95% CI 3.96 – 48.87). When adjusted for age and history of heart failure, the ODDS of a patient submitted to a PVI plus strategy developing atypical atrial flutter are 16.29 times higher than the one of those submitted to a stand-alone PVI technique, with a p value <0.001 (95% CI 3.92 – 67.65).

Conclusions

Additional substrate ablation for AF significantly increases the risk of developing atypical auricular flutter.Characteristics of the study populationCharacterization of PIV plus strategies
Posterior wall isolation with pulsed field ablation or radiofrequency ablation with vein of marshall ethanol ablation for the treatment of atrial fibrillation
Authors: Mannhart D , Krisai P , Weidlich S , Knecht S , Isenegger C , Katic J , Voellmin G , Osswald S , Sticherling C , Kuehne M , Badertscher P
Published: May 2024

Background

In patients undergoing repeat catheter ablation for atrial fibrillation (AF) two ablation strategies beyond pulmonary vein isolation (PVI) have recently gained increased interest: posterior wall isolation (PWI) using pulsed field ablation (PFA) and Vein of Marshall (VoM) ethanol ablation combined with radiofrequency energy ablation (RFA). However, a direct comparison is lacking.

Purpose

To compare prospectively enrolled patients undergoing repeat catheter ablation for persistent AF using PVI and PWI with PFA (PFA group) vs. PVI and VoM ethanol ablation using RFA (VoM group) regarding procedural characteristics, safety, myocardial injury and outcomes.

Methods

Patients undergoing redo PFA-PVI with PWI and VoM ethanol ablation with RFA were included. Isolation and bidirectional block were checked using a multipolar mapping catheter. High-sensitivity cardiac troponin T (hs-cTnT) was measured after 24h of ablation.

Results

A total of 84 patients were included (age 69 [interquartile range (IQR) 63-75] years; ejection fraction 56% [IQR 48-60%]; left atrial size 42 [IQR 37-47] mm), baseline characteristics did not differ significantly between groups. Of these, 54 patients (64%) were in the PFA group and 30 (36%) in the VoM group. The procedure duration (65 [IQR 56-73] minutes vs 116 [IQR 103-142] minutes; p < .001) and fluoroscopic times (11 [IQR 8–14] minutes vs 14 [IQR 12-19] minutes; p < .001) were significantly shorter for the PFA group than for the VoM group. No major complications were observed except for a probable allergic reaction in the VoM group and a transient AV-block in the PFA group. High-sensitivity cardiac troponin levels post ablation were similar between the PFA group and the VoM group with 886 [IQR 627–1260] ng/L and 793 [IQR 543-1199] ng/L, p=0.28, respectively. During follow-up (median duration 230 [IQR 117-370] days), AF recurrence was observed in 15% in the PFA group and in 40% in the VOM group (p ≤ 0.01).

Conclusion

In patients undergoing repeat catheter ablation for AF, PVI and PWI using PFA is associated with shorter procedure and fluoroscopic times, similar high-sensitivity cardiac troponin levels and a reduced recurrence rate compared to PVI using RFA with additional VoM ethanol ablation.Central Illustration
Association of superior vena cava isolation with improved outcomes in atrial fibrillation ablation
Authors: Botis M , Doundoulakis I , Antoniou C K , Kordalis A , Deligiannis G , Tsioufis P , Gatzoulis K A , Tsioufis K , Tsiachris D
Published: May 2024

Background

Pulmonary vein isolation (PVI) is the mainstay in atrial fibrillation (AF) ablation. However, additional arrhythmogenic foci seem to contribute to AF initiation and maintenance. A great proportion of those non-PV foci have been reported to be located in the superior vena cava.

Purpose

We aimed to investigate the effectiveness of SVC isolation as an adjunctive therapy to PVI isolation.

Methods

We performed a systematic review of MEDLINE, CENTRAL, and Embase. Inclusion criteria were cohort studies with control group or randomized clinical trials, comparing patients undergoing PVI only and patients undergoing PVI with concurrent SVC isolation, in effects of freedom from atrial tachycardia, need for cardioversion, hospitalization and all-cause mortality.

Results

A total of 7 studies, incorporating 1.550 patients, were included. The combination of SVC and PVI isolation in patients undergoing AF ablation was more effective than PVI isolation alone (risk ratio = 0.689; 95% confidence interval, 0.505-0.942). In a subgroup analysis, the isolation of SVC after identifying focal potentials demonstrated effectiveness (risk ratio = 0.573; 95% confidence interval, 0.364-0.902), while the isolation of SVC when the focal potentials were induced after isoprotenerol infusion or rapid atrial pacing did not alter the clinical outcomes (risk ratio = 0.798; 95% confidence interval, 0.493, 1.292).

Conclusions

The outcomes of AF ablation are favorable when additional SVC isolation is conducted. The effect is pronounced when spontaneous SVC potentials are identified.
Effectiveness of photoplethysmography-based rhythm monitoring after atrial fibrillation ablation using a smartphone application
Authors: Gruwez H , Maris S , Dhont S , Meekers E , Bruckers L , Wouters F , Van Herendael H , Nuyens D , Rivero-Ayerza M , Vandervoort P , Haemers P , Pison L
Published: May 2024

Introduction

Recurrence of atrial fibrillation (AF) after AF ablation is frequent. Monitoring recurrence is essential for attributing patient symptoms and for assessing both AF burden and treatment effectiveness. The conventional approach relies on periodic (long-term) electrocardiograms (ECG) and is constrained by limited monitoring time, measurement dispersion, and cost. Furthermore, patients are unable to prioritize measurements based on symptoms. Photoplethysmography (PPG) emerges as a technology that could potentially transform any smartphone into a rhythm monitoring device, thereby mitigating the limitations associated with current practices. Selected applications leveraging this technology have demonstrated excellent usability and accuracy for the detection of AF. However, the effectiveness of PPG-based follow-up remains uncertain.

Purpose

To compare the effectiveness of digital follow-up utilizing a PPG-based smartphone application with conventional ECG-based follow-up for the detection of atrial arrhythmia recurrence after ablation.

Methods

Patients undergoing AF ablation were consecutively enrolled and monitored using a 24h-ECG at 3-6-12 months on top of ECGs conducted for clinical indications (conventional follow-up). Additionally, patients were instructed to perform PPG measurements twice daily or whenever symptoms were perceived, over the course of one year (digital follow-up). The primary outcome was recurrence of atrial arrhythmia.

Results

In total, 96 patients (69% male, mean age 64 [58 – 68] years) performed 39,895 PPG measurements. The compliance rate (n performed/prescribed) was 92.6% for ECG and 78.2% for PPG recordings. After one year follow-up, atrial arrhythmia recurrence was detected by conventional follow-up in 17.9% and in 38.5% of patients by digital follow-up (odds ratio, 3.4; 95% CI: 1.7-7.1). The confidence interval lower limit exceeded the predefined non-inferiority margin (p for non-inferiority > 0.001). Hence, superiority was tested (p for superiority = 0.001). The negative predictive value of digital follow-up for atrial arrhythmia detected with conventional follow-up was 98.3% (95% CI: 90.1-99.9%). Symptoms were reported in 81.1% of PPG-detected atrial arrhythmias and episodes sustained for 3.9 [1.1 – 22.7] hours.

Conclusions

Among patients with AF ablation, digital PPG-based rhythm monitoring with a smartphone, was non-inferior in the detection of atrial arrhythmia recurrence after ablation. Moreover, the detection of atrial arrhythmia was significantly increased compared to conventional ECG-based monitoring.
Atrial fibrillation ablation performed under general anesthesia is associated with significantly low arterial blood pressure and higher incidence of hypotensive events
Authors: Di Cori A , Parollo M , Fiorentini F , Pistelli L , Torre M , Cito V , Barletta V , De Lucia R , Canu A , Sbragi S , Segreti L , Zucchelli G
Published: May 2024

Introduction

Catheter ablation is a pivotal treatment for atrial fibrillation (AF). When performed under general anesthesia (GA), it may be associated to hypotensive events, with unclear prevalence and prognostic impact. Continuous non-invasive blood pressure (CNBP) measurement is a validated and reliable tool for intraprocedural beat-to-beat advanced hemodynamic monitoring.

Purpose

To assess and compare the hemodynamic impact of GA during AF ablation using a CNBP (ClearSight) system.

Methods

In an observational single large volume center study we prospectively enrolled all patients undergoing AF ablation at our institution with CNBP monitoring, as per local practice. Patients were assigned to deep sedation (DS) or general anesthesia (GA) group according to the chosen sedation regimen. The following parameters were compared between the two strategies: systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), cardiac output (CO), cardiac index (CI), stroke volume (SV), stroke volume index (SVI). Hypotension events (HE) (MAP < 65 mmHg) were counted and compared between groups.

Results

Two hundred patients were enrolled from September 2022 to August 2023. 170 patients underwent AF ablation under DS (76,7% male, mean age 56,77±15,76), while 30 patients were treated under GA (70% male, mean age 60,72±13,79).

A total of 117709 measurements were analyzed and compared, for an overall monitoring time of 39293,66 minutes. Patients treated under GA had significantly lower average SBP (104,83±21,48 mmHg vs 138,05±22,09 mmHg, p<0,001), DBP (59,59±11,89 mmHg vs 76,12±12,75 mmHg, p<0,001), MAP (74,96±15,02 mmHg vs 97,12±15,38 mmHg, p<0,001). We also observed significantly lower CO (4,40±1,47 L/min vs 5,16±1,62 L/min, p<0,001), CI (2,22±0,71 L/min/m2 vs 2,61±0,78 L/min/m2, p<0,001) SV (62,37±18,04 mL/beat vs 70,65±24,95 mL/beat, p<0,001) and SVI (31,40±8,54 mL/beat/m2 vs 35,80±12,07 mL/beat/m2, p<0,001). Patients treated under GA witnessed a higher number of per-patient HE (10,53±9,16 vs 0,61±2,07, p<0,001), and higher HE duration (4,8±6,62 min vs 2,82±3,66, p<0,001).

Conclusion

AF ablation performed under general anesthesia is associated with significantly lower systolic, diastolic, and mean arterial pressure, reduced cardiac output, stroke volume and stroke volume index when compared to deep sedation. Patients undergoing AF ablation under GA witness higher incidence and duration of hypotensive events.

CNBP is a valid tool for beat-to-beat procedural hemodynamic assessment and can help identifying and treat hypotensive events. Further studies are needed to assess the potential prognostic impact of intraprocedural hypotension during AF ablation.
Optimized workflow for pulmonary vein isolation using very high power short duration radiofrequency ablation
Authors: Gigli L
Published: May 2024

Background

Point-by-point radiofrequency ablation is the most used invasive treatment of atrial fibrillation (AF). However, single-shot technologies are largely widespread due to their proved safety and efficacy. QDOT MICRO (QDM) is a novel contact force–sensing catheter optimized for temperature-controlled radiofrequency (RF) ablation that allows to maintain target temperature during 90 W ablations for ≤4 seconds.

Purpose

This study evaluates procedural safety and effectiveness as well as long-term effects of an optimized procedural workflow using QDM catheter to perform wide atrial circumferential ablation in patients with paroxysmal AF.

Methods

Consecutive patients referred for paroxysmal AF first ablation through pulmonary vein isolation (PVI) were prospectively enrolled. Every procedure was performed in general anesthesia by using CARTO3 Electroanatomical Mapping System BiosenseWebster QDM catheter and Deflectable Sheet VIZIGO as single sheet in left atrium. VHPSD was performed to encircling the posterior wall, while conventional-power temperature-controlled (CPTC) mode was used to encircling the anterior wall. The primary safety endpoint was incidence of primary adverse events within ≤7 days of ablation. The primary effectiveness endpoint was freedom from documented atrial tachyarrhythmia recurrence and acute procedural, repeat ablation, and antiarrhythmic drug failure.

Results

120 enrolled participants (61 ± 12 years, 45% female) met eligibility criteria. Median procedural skin-to-skin time and RF application for ablating PVs were 56 and 17 minutes, respectively. Median ablation time was 22 minutes. First-pass isolation (entrance and exit block validation) was obtained in 98 % and inter-lesion distance was 4,8 ± 0,8 mm. In 100% of patients PVI was obtained without adverse events. The Kaplan-Meier estimated 12-month rate for clinical success (freedom from symptomatic recurrence of AF) was 93%, freedom from AF was 89%

Conclusions

PVI performed with point by point optimized workflow using VHPSD RF catheter in combination with steerable sheet is highly efficient and effective without compromising safety.
Baseline characteristics and risk of major bleeding in Taiwanese patients with atrial fibrillation and renal impairment receiving rivaroxaban: the prospective XARETO registry
Authors: Chao T , Chang K C , Cheng C I , Chen C P , Chen J Y , Chu P H , Chen Z C , Lin T H , Liu Y B , Tsai C T , Tsai H L , Tsao T P , Chen W J , Chen S A
Published: May 2024

Background

Data about the use of direct oral anticoagulants (DOACs) in the prospective registry of Asian atrial fibrillation (AF) patients with renal dysfunction, especially those with a creatinine clearance (CCr) between 15 to 30 ml/min, are limited. This study aimed to investigate the safety of rivaroxaban in Taiwanese AF patients with renal impairment in the daily practice.

Methods

XARETO (Xarelto for the prevention of stroke and non-central nervous systemic embolism in non-valvular atrial fibrillation with REnal impairment in Taiwanese pOpulation) is a multi-center, non-interventional, single arm prospective observational cohort study performed in Taiwan. Subjects with non-valvular AF aged >=20 years with a documented CCr of 15-50 ml/min within 6 months before the enrollment were enrolled. All subjects were prescribed rivaroxaban for stroke prevention. The major bleeding was defined as a bleeding events with fall in Hgb of >=2 g/dL or a transfusion of >= 2 units of packed red blood cells or whole blood or occurrence of bleeding at a critical site or mortality.

Results

A total of 493 patients were enrolled. The mean age was 78.3 years old and 59.6% was male. The mean CHA2DS2-VASc and HAS-BLED scores were 4.4 and 2.9, respectively. Co-morbidities were as follows: 41.0% patients had chronic heart failure, 83.2% had hypertension, 40.8% had diabetes and 14.8% had prior stroke/transient ischemic attack/systemic embolic events. The mean CCr was 35.19 ml/min, and 159 (32.3%) of them has a CCr between 15-29 ml/min.

During the follow up, there were 23 patients with 26 adjudicated major bleeding events with the incidence rate of 6.2 per 100 person-years (95% CI 3.9-9.3). Of these patients, there were 15 patients with 16 adjudicated major bleeding events considered as related to the rivaroxaban treatment with the incidence rate of 4.0 per 100 person-years (95% CI 2.2-6.6)(Figure)

Conclusions

In high-risk Taiwan AF patients (mean CHA2DS2-VASc score 4.4) with renal impairment (mean CCr 35.19 ml/min, 32.3% between 15-29 ml/min), the safety of rivaroxaban was confirmed in the prospective XARETO study.
Real-world insights on anticoagulation therapies in non-valvular atrial fibrillation: a comprehensive electronic health record-based study using natural language processing and machine learning
Authors: Cosin J , Anguita M , Suarez C , Arias-Cabrales C , Martinez-Sanchez L , Arumi D , Fernandez De Cabo S
Published: May 2024

Background

Limited evidence exists regarding real-world practices and outcomes of oral anticoagulation in patients with Non-Valvular Atrial Fibrillation (NVAF).

Purpose

To conduct a retrospective real-world data (RWD) study using Natural Language Processing (NLP) and Machine Learning (ML) on Electronic Health Records (EHRs) to evaluate the efficacy and safety of Direct Oral Anticoagulants (DOACs) and vitamin K antagonists (VKAs) in NVAF patients.

Methods

Retrospective study in 15 Spanish hospitals between 2014-2020 including adult NVAF patients treated with oral anticoagulants without anticoagulation history, recent thrombotic events, rheumatic mitral valvular heart disease, mitral valve stenosis, venous thromboembolism, nor pregnancy. We employed EHRead®, a free text analysis engine utilizing NLP and ML to extract RWD from EHRs based in SNOMED CT (standardized coding system). Free-text information was extracted and organized in an anonymized database for population-based descriptive and comparative analysis. After matching patients using propensity-score matching (PSM), we used Kaplan-Meier curves to compare VKA vs DOAC efficacy on thrombotic prevention, safety, and mortality.

Results

After evaluating 138,773,332 EHRs from 4.6 million patients, 44,292 NVAF patients were included; 35,267 (79.6%) treated with VKA and 9,025 (20.4%) with DOAC. Half of them were men (53.0%) with a mean (SD) age of 76.3 (12.7) years. VKA-treated patients tended to be older, with more cardiovascular comorbidities and higher CHA2DS2-VASc scores than DOACs-treated patients (Table 1). Using PSM, 8,930 patients were matched per subgroup with standardized mean differences below 10% for all confounders. The comparative analysis showed that DOAC-treated patients had a significant lower risk of thrombotic, minor bleeding events, and mortality than VKA-treated ones, with no significant differences in major bleeding (Figure 1).

Conclusion

The application of NLP and ML allowed us to create an extensive, plausible, and detailed database of Spanish NVAF patients from RWD in EHRs. In our cohort, we found a higher efficacy and lower mortality and minor bleeding events with DOACs over VKAs, without differences in major bleeding events.

This study was sponsored by Pfizer and Bristol Myers Squibb. JCS, MA & CS were paid consultants to Pfizer and Bristol Myers Squibb in connection with the development of this abstract. CAC & LMS are employes of the SAVANA who were paid consultants to Pfizer and Bristol Myers Squibb in connection with the development of this abstract. DA & SFC are employees of Pfizer.Table 1Figure 1
Characteristics and incidence of peri-device leaks after left atrial appendage closure in patients with prior electrical isolation of left atrial appendage during catheter ablation
Authors: Maan A , Kawamura I K , Musikantow D M , Turagam M T , Whang W W , Koruth J K , Miller M M , Dukkipati S D , Reddy V R
Published: May 2024

Background

Patients who undergo electrical isolation of left atrial appendage (eLAAi) during atrial fibrillation (AF) ablation have a higher subsequent risk of thromboembolism. In post-ablation patients with eLAAi who undergo mechanical LAA closure (LAAC), there are limited data on imaging and clinical outcomes during follow-up, particularly peri-device leaks (PDLs).

Purpose

We investigated imaging outcomes on ~1 year follow up transesophageal echocardiography (TEE) for PDL and clinical outcomes in patients who had undergone LAAc after sustaining eLAAi from catheter ablation.

Methods

We analyzed data from TEEs at ~1 year follow up in patients who had undergone LAAC with either the Watchman or Watchman-FLX device. The images were analyzed for evidence of any discernible PDL which also which also included the absence of thrombosis/obliteration of the distal LAA. "Severe" PDL was categorized as the leak size of >5 mm on follow up TEE imaging. Baseline characteristics, imaging and clinical outcomes were compared with univariate comparison using Fisher’s exact test, between the two subgroups of LAAC patients stratified according to prior h/o eLAAi.

Results

A total of 532 patients underwent LAAC at our center between 03/2015 and 10/2022, with data available on ~1 year follow-up TEE imaging. Of these, 21 (3.9%) had undergone eLAAi during AF ablation prior to LAAC. At ~1 year follow up TEE imaging, the patients with prior h/o eLAAi had a numerically higher incidence of any PDL (42.9% vs 26.5%, p = 0.09). The incidence of severe PDL was significantly higher in the subgroup of patients with prior eLAAi as compared to patients without prior eLAAi (14.3% vs 3.3%, p = 0.04; Figure). There was no statistically-significant difference in the subsequent risk of thromboembolism between the eLAAi and control subgroups (4.8% vs 6.1%, p = 1.0) over an average follow-up of 577±331 days post-LAAC.

Conclusions

A prior history of eLAAi during AF ablation was associated with a higher risk of severe PDLs (>5mm) on follow up imaging after LAAC. The finding of severe PDL in the eLAAi subgroup might be attributable to ostial fibrosis as a result of ablation which might affect the LAA endocardial surface interaction with the device fabric. The occurrence of a higher risk of severe PDL in patients with prior eLAAi after LAAC might necessitate PDL closure or resumption of anticoagulation in such patients to mitigate the risk of subsequent thromboembolism.igure showing our study schema and compa
Patient-reported outcomes in atrial fibrillation clinical trials: trends, utilisation, and implications
Authors: Lan R , Guerrero E P G , Saeed M S , Perez M V P
Published: May 2024

Background/Introduction

Atrial fibrillation (AF) is the most prevalent clinical arrhythmia, and it is associated with diverse and consequential adverse outcomes that significantly impact the quality of life (QoL) experienced by patients. The evaluation and quantification of QoL have become an important aspect of assessing AF patients, with patient-reported outcomes (PROs) increasingly used in cardiovascular clinical trials. However, there is no consensus on which PROs are most suitable to report, and there is a limited understanding of their prevalence in AF clinical trials.

Purpose

This study aims to characterise the utilisation of PROs in AF clinical trials. We distinguish between AF-specific and AF-agnostic PROs, with the goal of understanding the evolving role of PROs and emphasising the significance of precise measurement of patient QoL in AF research.

Methods

We queried the ClinicalTrials.gov database for all available clinical trials that focused on AF as the primary condition from inception to August 1, 2023. This search yielded 3,208 clinical trials, encompassing a total of 65,545,864 participants. We filtered and manually reviewed each clinical trial for their use of PROs within the "outcomes measures" field and divided the results between AF-specific and AF-agnostic PROs. We displayed these findings over time (Figure) and conducted a linear regression analysis for each PRO.

Results

Of the 3,208 AF clinical trials, 569 (17.7%) reported using at least one PRO, with 178 (5.5%) using AF-specific PROs. There was a statistically significant increase in the use of PROs between 2000 and 2023 (8 vs. 518; P < 0.001; R2= 0.959). This finding held for both AF-specific PROs between 2000 and 2023 (0 vs. 79; P < 0.001; R2=0.930) and AF-agnostic PROs between 2000 and 2023 (8 vs. 360; P < 0.001; R2=0.969). The Atrial Fibrillation Effect on Quality-of-life (AFEQT) was the most used AF-specific PRO, utilized 130 times, with its usage increasing between 2000 and 2023 (0 vs. 61; P = 0.003; R2= 0.888). The EQ-5D was the most frequently used AF-agnostic PRO, employed 131 times.

Conclusion

The study reveals a significant increase in the use of PROs in AF clinical trials over time. While most trials use AF-agnostic PROs for measuring QoL, several AF-specific PROs, especially AFEQT, have gained wide adoption. These findings underscore the importance of patient-centred outcomes and suggest the increasing emphasis on PROs in AF research. However, significant heterogeneity remains in the choice of PROs, with limited utilisation of validated, AF-specific measures. Future research should focus on understanding the distinct strengths and limitations of AF-specific PROs compared to AF-agnostic ones and promoting their appropriate integration into AF clinical trials to improve patient-centred care for AF patients.Figure
Risk of death, thrombotic and hemorrhagic events in patients with atrial fibrillation and systemic autoimmune diseases
Authors: Bucci T , Cardamone C , Triggiani M , Ames P R J , Lip G Y H
Published: May 2024

Background

Growing evidence showing that systemic autoimmune diseases (SAD) are associated with a high risk of incident atrial fibrillation (AF). However, the impact of SAD on the clinical course of AF patients is largely unknown.

Purpose

To assess the risk of all-cause death, thrombotic events, and bleeding in AF patients with SAD.

Methods

Retrospective cohort study within a global health care network (TriNetx). Using ICD codes, AF patients were categorized into two groups: 1) AF patients with SAD (M32: Systemic Lupus Erythematosus; M33: Dermato-polymyositis; M34: Systemic Sclerosis; M35: Sjogren syndrome), and 2) AF controls (without systemic autoimmune, autoinflammatory, or rheumatic diseases). The primary outcomes were the 5-year risks of 1) all-cause death, 2) thrombotic events (ischemic stroke, transient ischemic attack, peripheral arterial thromboembolism, acute myocardial infarction, deep vein thrombosis, and pulmonary embolism), and 3) hemorrhagic outcome (intracranial hemorrhage and gastrointestinal bleeding). Secondary outcomes were each component of the composite primary outcomes. Cox regression analysis before and after propensity-score-matching (PSM) was used to estimate HR and 95% confidence interval (95%CI). Sensitivity analyses were done to investigate the risk of primary outcomes associated with each systemic autoimmune disease and with different types of oral anticoagulant (OAC).

Results

We identified 22,371 AF patients with SAD (67.7±13.7 years, 72.2% females), and 1,478,693 AF controls (69.7±14.0, 42.6% females). Before PSM, AF patients with SAD were younger, more often females, and with a higher prevalence of cardiovascular risk factors; no differences were found after PSM.

After PSM, AF patients with SAD showed a higher risk of all-cause death (HR 1.21, 95% 1.17-1.25), thrombotic events (HR 1.55, 95%CI 1.49-1.61), and hemorrhagic events (HR 1.39, 95%CI 1.32-1.46) compared to AF controls (Table 1). On sensitivity analyses, we found that the risk of primary outcomes in AF patients with SAD was independent from the OAC type, but NOAC was more effective than warfarin in reducing the risk of thrombotic events.

The highest risk of all-cause death was associated with Systemic Sclerosis, while the highest risk of composite thrombotic events was associated with Systemic Lupus Erythematosus, and Dermato-polymyositis. The highest risk of stroke was associated with Sjogren syndrome; and myocardial infarction and deep vein thrombosis with Dermato-polymyositis, Systemic Lupus Erythematosus was associated with the highest risk of Intracranial hemorrhage, while Systemic Sclerosis to the highest risk of gastrointestinal bleeding (Table 2).

Conclusion

In AF patients the coexistence of SAD is associated with a high risk of all-cause death, thrombotic events, and bleeding. A personalized approach aimed to minimize the impact of SAD on the clinical course of AF patients is needed.Figure 1Figure 2
Is the conventional deployment of electrode catheters appropriate to diagnose the circuit of atypical atrioventricular nodal reentrant tachycardia? -New insights into the retrograde slow pathways-
Authors: Kawabata M , Maeda S , Kamata T , Kawashima T , Yonai R , Okishige K , Atarashi H , Hirao K
Published: May 2024

During atypical atrioventricular nodal reentrant tachycardia (AVNRT), the earliest atrial activation site following retrograde slow pathway conduction is either at the exit of the left inferior extension (LIE) in the coronary sinus (CS) or that of the right inferior extension (RIE) on the tricuspid annulus (TA). In an EP study, LIE can be detected by the CS catheter, but absence of catheters at the RIE can lead to it being missed.

Aim

To evaluate the electrophysiological characteristics of the retrograde slow pathway.

Methods

We assessed patients with atypical AVNRT using electro-anatomical 3D mapping.

Results

Among 14 patients (9 females, age 59±17), with a total of 18 atypical AVNRTs (15 fast/slow and 3 slow/slow), 4 patients had LIE, 6 had RIE, and 4 had both. The LIE exits were inside the CS, while those of RIE were on the posterior TA. During AVNRT or ventricular pacing, the local electrogram of RIE preceded that of the CS ostium and HBE by 24±12 and 34±12 ms respectively. Examination of activation times at the CS ostium and HBE showed that the nearer to the exit of RIE they were, the earlier they were excited.

Conclusion

The retrograde slow pathway of atypical AVNRT can have an exit site at the LIE or RIE, or both. Accurate identification of inferior extensions of the AV node is critical for diagnosis and treatment. We recommend placing a catheter on the posterior TA or 3D mapping the area for RIE exit detection in atypical AVNRT patients.