bluuebunny/crossref_metadata_2025_split huggingface dataset:
Intravenous vagal stimulation catheter, JOHAKU, rapidly decreases heart rate and myocardial oxygen consumption without worsening hemodynamics
Authors: Yokota S , Kakuuchi M , Yokoi A , Kawada T , Uemura K , Ishida E , Sakamoto K , Todaka K , Saku K 
Published: October 2022

Abstract

Background
Rapid reduction of heart rate (HR) is the most evident physiological response of vagal nerve stimulation (VNS). Since HR reduction is the most potent factor to decrease myocardial oxygen consumption rate (MVO2), the appropriate VNS can exert cardio-protective effects. It is also known that VNS reduces inflammation, oxidative stress, and sympathetic overload. In addition, the VNS during ischemia-reperfusion is known to attenuate myocardial damage by studies in various animal species. Despite the presence of preclinical evidence of VNS benefits, the lack of the device has limited the translation of this technology to clinical practice. We have recently developed an intravenous VNS catheter (JOHAKU, Neuroceuticals Inc.) that can stimulate the right vagal nerve via superior vena cava (SVC) (Figure 1) on temporary basis.

Purpose
We aimed to confirm the feasibility of JOHAKU as a device to modulate heart rate and MVO2 rapidly by a canine experiment.

Methods
In eight beagle dogs, JOHAKU was inserted from the right femoral vein and placed at the SVC level. The stimulation intensity was adjusted to 10–20 V (20 Hz). We simultaneously recorded electrocardiogram and intraarterial blood pressure (BP). In three of eight dogs, we measured the left anterior descending coronary artery flow and oxygen saturations of arterial and coronary sinus blood to calculate MVO2. We compared HR, BP, and MVO2 during JOHAKU stimulation to ones at baseline.

Results
As shown in Figure 2, JOHAKU attenuated HR immediately after stimulation. Compared with baseline, JOHAKU significantly reduced HR (baseline: 135±13 vs. 5 min on stimulation: 107±13 bpm, p&lt;0.05), and did not affect mean BP significantly (96.2±22.8 vs. 89.4±26.6 mmHg, P=0.59). HR promptly recovered to baseline level after JOHAKU stopped. JOHAKU also reduced MVO2 (0.57±0.43 vs. 0.48±0.38 ml/min, p&lt;0.05).

Conclusion
JOHAKU rapidly attenuated cardiac metabolism burden via the rapid HR reduction. The controllability of HR by JOHAKU without affecting BP enables us to apply the VNS even for patients with hemodynamic instability, such as heart failure and acute myocardial infarction.

Funding Acknowledgement
Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Japan Agency for Medical and Research Development
Holistic approach of ablation versus antiarrhythmic drugs for efficacy, safety, and quality of life improvement in rhythm control of atrial fibrillation: a meta-analysis of randomized trials
Authors: Prana Jagannatha G , Putra Swi Antara I M , Surya Pradnyana I W A , Kamardi S 
Published: October 2022

Abstract

Background/Introduction
Recent studies have shown that catheter ablation (CA) is more superior compared to the usage of the antiarrhythmic drug (AAD) regarding its efficacy in decreasing the incidence of persistent and chronic atrial fibrillation (AF). However, choosing the right rhythm control strategy to provide holistic care for the patients should be individualized on each patients condition.

Purpose
In this meta-analysis, the author will compare both CA and AAD regarding their efficacy, safety, and their effect on the quality of life of AF patients.

Methods
The authors systematically searched the relevant journals throughout PubMed, Medline, and the Cochrane Library, with a range of publications from 2010 to 2021. The primary outcomes were AF recurrence, quality of life score, and adverse events. Secondary outcomes were the rehospitalization rate and all-cause mortality. Analysis was performed using a random-effects model with the Mantel-Haenszel method, and results are presented as 95% CIs.

Results
A total of 23 RCTs consisted of 10,316 patients were included. Although some adverse events (pericarditis, pleural effusions, and cardiac tamponade) were found in 2.8% population of the CA group (RR: 4.15; 95% CI: 1.65, 10.41; p=0.002), the CA group was found superior in suppressing the rate of AF recurrence (RR: 0.56; 95% CI: 0.48, 0.65; p&lt;0.00001). Regarding the SF-36 Mental (p&lt;0.00001) and Physical Assessment (p&lt;0.0001), both CA and AAD showed increased quality of life post treatment compared with baseline level (pre-treatment) for each therapy. Following the interventions, the CA group significantly showed a lower rehospitalization rate (RR: 0.82; 95% CI: 0.70,0.97; p=0.02) and also showed a lessened mortality trend (6.84%) compared to the AAD group (9.01%) even though not statistically significant.

Conclusion(s)
Statistically, there is no difference for both groups in their capability of reducing the mortality rate. However, CA was found to be more superior in efficacy and reducing the number of rehospitalizations. Quality of life also significantly improve same as AAD, which further might be provide a holistic outcome of rhytm control.

Funding Acknowledgement
Type of funding sources: None.
Impact of high-power and very high-power short-duration radiofrequency ablation on procedure characteristics and first-pass isolation during pulmonary vein isolation
Authors: Sallo Z , Perge P , Orban G , Piros K , Herczeg S Z , Nagy K V , Abraham P , Osztheimer I , Merkely B , Geller L , Szegedi N 
Published: October 2022

Abstract

Introduction
High-power short-duration (HPSD) radiofrequency ablation has been proposed as a method for producing rapid and effective lesions for pulmonary vein isolation (PVI). We aimed to evaluate the procedural characteristics and the first-pass isolation (FPI) rate of HPSD and very high-power short-duration (vHPSD) ablation compared to low-power long-duration (LPLD) ablation technique.

Methods
156 patients with atrial fibrillation (AF) were enrolled and assigned to LPLD, HPSD, or vHPSD PVI. The energy setting was 30W, 50W, and 90W in the LPLD, HPSD, and vHPSD groups, respectively.

Results
Bilateral PVI was achieved in all cases. The procedure time was 85 [75–101] min, 79 [65–91] min, and 70 [53–83] min in the LPLD, HPSD, and vHPSD groups, respectively (p&lt;0.0001). Left atrial (LA) dwelling times were also decreased significantly with the increase of RF energy (61 [55–70] min, 53 [41–56] min, and 45 [34–52] min, in the LPLD, HPSD, and vHPSD groups, respectively, p&lt;0.0001). The total RF ablation time was 1567 [1366–1761] sec, 1398 [1021–1711] sec, and 336 [247–386] sec in the LPLD, HPSD, and vHPSD group, respectively (p&lt;0.0001). The bilateral FPI rate was 57%, 78%, and 80% in the LPLD, HPSD, and vHPSD groups, respectively (p=0.0097). On the left side, FPI was achieved in 66% in the LPLD, 92% in the HPSD, and 85% in the vHPSD ablation group (p=0.0015). FPI on the right side was achieved in 72% in the LPLD, 88% in the HPSD, and 88% in the vHPSD ablation group (p=0.0188). The univariate analysis revealed that the use of HPSD (both sides: OR=2.72, 95% CI 1.15–6.44, p=0.023; right side: OR=2.90, 95% CI 1.02–8.20, p=0.045; left side: OR=5.91, 95% CI 1.84–19.04, p=0.003) and vHPSD (both sides: OR=2.90, 95% CI 1.24–6.44, p=0.014; right side: OR=3.09, 95% CI 1.09–8.74, p=0.045; left side: OR=2.89, 95% CI 1.13–7.43, p=0.027) ablation techniques were associated with a higher probability of FPI. The mid-term arrhythmia-free survival was similarly high in all three groups.

Conclusion
Our prospective, observational cohort study showed that both HPSD and vHPSD RF ablation is effective, as it shortens procedure time and RF time and results in a higher rate of FPI compared to LPLD ablation. Moreover, the mid-term arrhythmia-free survival was similarly high in all three groups. In our study, no safety concerns were raised for HPSD or vHPSD ablation.

Funding Acknowledgement
Type of funding sources: None.
P-wave beat-to-beat analysis to predict atrial fibrillation recurrence after catheter ablation
Authors: Tachmatzidis D , Mouselimis D , Tsarouchas A , Filos D , Antoniadis A P , Lysitsas D N , Mezilis N , Sakellaropoulou A , Giannopoulos G , Bakogiannis C , Triantafyllou K , Fragakis N , Efremidis M , Chouvarda I , Vassilikos V P 
Published: October 2022

Abstract

Introduction
Identification of patients prone to atrial fibrillation (AF) relapse after catheter ablation is essential for better patient selection and risk stratification.

Purpose
The current prospective cohort study aims to validate a novel P-wave index based on beat-to-beat (B2B) P-wave morphological and wavelet analysis designed to detect patients with low burden AF, as a predictor of AF recurrence within a year after successful catheter ablation.

Methods
12-lead ECG and 10-minute vectorcardiogram (VCG) recordings were obtained from 138 consecutive patients scheduled for AF ablation. Pre-ablation B2B P-wave index, along with standard P-wave indices, clinical scores and patients history and physical examination parameters were evaluated as AF recurrence predictors.

Results
Univariate analysis revealed that patients with higher B2B P-wave index had a two-fold risk for AF recurrence (HR: 2.35, 95% CI: 1.24–4.44, p: 0.010). Prolonged P-wave, interatrial block, early AF recurrence, female gender, heart failure history, previous stroke, and CHA2DS2-VASc score ≥2 were also found to be related to higher recurrence rate. Multivariate analysis of predictors that can be assessed before ablation revealed that B2B P-wave index, along with heart failure history and history of previous stroke or transient ischemic attack are independent predicting factors of AF relapse.

Conclusion
B2B P-wave morphology and wavelet analysis, is a promising, non-invasive technique, able to identify patients prone to AF recurrence after pulmonary veins ablation. Further studies are needed to assess the predictive value of B2B index with greater accuracy and evaluate a possible relationship with atrial substrate analysis.

Funding Acknowledgement
Type of funding sources: Public Institution(s). Main funding source(s): Hellenic Society of Cardiology
Safety and effectiveness of near-zero fluoroscopy paroxysmal AF radiofrequency ablation with a temperature-controlled, contact force-sensing catheter: a Q-FFICIENCY study sub-analysis
Authors: Hussein A , Delaughter M C , Monir G , Natale A , Dukkipati S , Oza S , Daoud E , Di Biase L , Mansour M , Fishel R , Valderrabano M , Ellenbogen K , Osorio J 
Published: October 2022

Abstract

Background/Introduction
Q-FFICIENCY evaluated 12-month (M) safety and efficacy of temperature-controlled paroxysmal atrial fibrillation ablation with a novel contact force-sensing, radiofrequency catheter with 3 microelectrodes and 6 thermocouples. Patients underwent pulmonary vein isolation with very high-power short-duration (vHPSD; 90 W/ up to 4 s) mode in combination with conventional-power temperature-controlled (CPTC; 25–50 W) mode.

Purpose
To assess procedural efficiency, safety, and 12M outcomes of participants ablated under near-zero fluoroscopy guidance compared to procedures performed with standard fluoroscopy.

Methods
In this US multi-centre (22 sites), non-randomised investigational study, patients underwent pulmonary vein isolation with vHPSD as primary ablation mode; CPTC was used for PV touch-up or non-PV ablation. Primary safety endpoint was incidence of primary adverse events ≤7 days post-procedure. Primary effectiveness was freedom from documented atrial tachyarrhythmia recurrence and additional pre-defined failure modes (acute failure, repeat ablation, new/higher dose anti-arrhythmic drug). Participants were followed-up through 12M post-ablation (3M blanking & 9M evaluation) to assess safety, effectiveness, and healthcare utilisation.

Results
Of 191 participants enrolled (63.5±10.7 years, CHA2DS2-VASc 2.4±1.5, 60.7% men), 166 were ablated with the investigational catheter, and 165 had fluoroscopy data available for inclusion in this analysis. Forty-four participants received ≤1 minute of fluoroscopy. Compared to the &gt;1-minute of fluoroscopy cohort, the ≤1-minute group showed improved efficiencies in all procedural parameters (Table). Primary adverse event rates were similar among groups (≤1-minute, 4.5%; &gt;1-minute, 3.3%). Kaplan-Meier estimated 12M clinical success rates (i.e., freedom from documented symptomatic recurrence) were similar regardless of fluoroscopy exposure (≤1-minute, 85.4%; &gt;1-minute, 86.0%). Freedom from cardiovascular hospitalisation 12M post-ablation was comparable among groups (90.8% vs 88.0%).

Conclusion
Near-zero fluoroscopy paroxysmal atrial fibrillation ablation with the novel temperature-controlled catheter in vHPSD mode, alone or combined with CPTC, led to enhanced procedural efficiencies with good effectiveness and clinical success without comprising safety.

Funding Acknowledgement
Type of funding sources: Private company. Main funding source(s): Biosense Webster, Inc.
Catheter ablation of persistent atrial fibrillation with heart failure improves hemodynamic status without deteriorating renal function in the elderly
Authors: Okahara A , Kawai S , Tokutome M , Matsuura H , Noma A , Hara A , Nakashima H , Watanabe T , Sakemi T , Okabe K , Matsukawa R , Masuda S , Mukai Y 
Published: October 2022

Abstract

Background/Introduction
Atrial fibrillation (AF) and heart failure (HF) frequently coexist in the elderly people, leading to worse clinical outcomes. HF with preserved ejection fraction (HFpEF) is the most common form of HF in the elderly, particularly in women, associated with AF. Ablation of AF in younger patients with HF with reduced EF (HFrEF) has become an established treatment option. However, clinical impact of ablation for persistent AF accompanying with HF in the elderly remains unclear.

Purpose
This study aimed to evaluate the effect of catheter ablation of persistent AF with heart failure in the elderly.

Methods
Consecutive 70 patients who underwent catheter ablation of persistent AF accompanying with HF (NYHA class&gt; II, mean LVEF 51.7%) in our institution were retrospectively analyzed with regards to their 1-year clinical outcomes, HF markers such as BNP, renal function and transthoracic echocardiographic findings. Patients were dichotomized by age of 75-year-old (31 elderly vs 39 younger subjects) and separately analyzed.

Results
Mean age of the studied population was 70.5 year-old; 79.6±3.8 in the elderly group and 63.2±8.5 in the younger group. The elderly patients were more frequently females (45% vs 21%). Longstanding persistent AF was observed in 32% in the elderly and 28% in the younger group. Circumferential pulmonary vein isolation (PVI) was performed in all patients, with additional ablations of liner lesions and/or non-PV foci as needed. PVI alone was observed in 54.8% in the elderly and 41% in the younger group. There were no serious complications associated with the procedure. During 1 year after ablation, recurrence of AF was observed in 15 patients [6/31 (19%) in the elderly, 9/39 (23%) in the younger]. Readmission due to HF was observed in only 1 patient in the elderly and 2 patients in the younger group (3% vs. 5%, respectively). Cardiovascular events were observed in 3 patients [2/31 (6%) in the elderly, 1/39 (3%) in the younger], but there was no death. The BNP level as well as the NYHA class significantly decreased at 1-year follow-up compared to baseline in the both groups (Figure A and B). There was no change in serum creatinine level in the both groups (Figure C). The left atrial dimension and the LA volume index decreased at 1-year follow-up in the both groups (Figure D and E). The LVEF improved only in the younger group (Figure F).

Conclusions
Ablation of persistent AF in the elderly with HF (mostly with preserved EF) was associated with hemodynamic and functional improvements without deteriorating renal function in a mid-term, which was mostly comparable to the results in the younger.

Funding Acknowledgement
Type of funding sources: None.
Paroxysmal atrial fibrillation ablation with a novel flexible tip radiofrequency catheter incorporating contact force sensing: acute results of the TactiFlex AF IDE trial
Authors: Nair D , Martinek M R , Colley J , Sundaram S , Hariharan R , Morales G , Sommer P , Healy S , Siddiqui U , Williams C , Sarver A , Lo M 
Published: October 2022

Abstract

Background
Catheter ablation is an established therapy for paroxysmal atrial fibrillation (PAF). The TactiFlex™ Ablation Catheter, Sensor-Enabled™ (TactiFlex SE) is a next-generation radiofrequency ablation catheter incorporating highly accurate fiber optics-based contact force sensing technology with a flexible, laser-cut tip.

Purpose
To demonstrate that ablation with TactiFlex SE is safe and effective for the treatment of drug refractory, symptomatic PAF.

Methods
The TactiFlex AF IDE is a prospective, non-randomized, multi-center clinical study which enrolled 355 subjects worldwide. Enrollment in the main study began on June 26, 2020 and completed on June 18, 2021. Subjects underwent de novo Pulmonary Vein Isolation (PVI) and, if indicated, a Cavotricuspid Isthmus ablation (CTI line) for CTI-dependent atrial flutter.

Results
Subjects were divided into two as treated subgroups: High Standard Power (HSP, n=189), defined as subjects with 100% of left atrial lesions ablated at ≥40 W, and Low Standard Power (LSP, n=119), defined as subjects with at least one left atrial lesion ablated at &lt;40W. First pass success, defined as isolation of all pulmonary veins (PVs) confirmed after a minimum 20 min waiting period was achieved in 93.5% (175/186) and 84.5% (98/116) of HSP and LSP subjects, respectively (p=0.0104). Significant decreases in the HSP versus LSP procedures were also seen in total procedure time (112.0 min [89.0, 139.5] and 149.0 [115.0, 182.0], respectively [p&lt;0.001]), total RF time for PV ablation (14.0 min [11.0, 19.0] and 29.0 [19.0, 41.0], respectively [p&lt;0.0001]), total fluoroscopy time (4.0 min [0.0, 11.0] and 8.0 [3.0, 17.0], respectively [p&lt;0.0001]) and irrigation fluid volume (378.0 mL [310.0, 466.0] and 636.0 [476.0, 829.0], respectively [p&lt;0.0001]) (values given as Median [Q1, Q3]), see Figure 1. Both HSP and LSP subjects had a low rate of repeat procedures (1.6% [3/182] and 4.3% [5/115], respectively [p=0.2684]) and primary safety endpoint events (4.8% [9/189] and 4.2% [5/119], respectively [p=0.8182]) through 90 days post-index procedure.

Conclusion
The acute data on the TactiFlex SE catheter demonstrates safe and effective treatment of PAF using either a HSP or LSP ablation strategy. Ablation procedures performed using a HSP strategy were shorter and required less irrigation fluid and fluoroscopy. It is anticipated these results will be reflected in the 12-month safety and effectiveness primary endpoints.

Funding Acknowledgement
Type of funding sources: Private company. Main funding source(s): Abbott
Low voltage area as a predictor of recurrence after a single pulmonary vein isolation procedure: results of the WAVE-MAP AF study
Authors: Starek Z , Di Cori A , Betts T , Clerici G , Gras D , Lyan E , Della Bella P , Li J , Hack B , Zitella Verbick L , Sommer P 
Published: October 2022

Abstract

Background/Introduction
Pulmonary vein isolation (PVI) is a recommended approach for atrial fibrillation (AF) ablation procedures. Substrate modification beyond PVI has mixed results but identifying and ablating low voltage zones and ablating those targets in addition to PVI may be beneficial. Electroanatomic mapping is critical to identify subjects that may require further substrate modification. Low voltage area may be predictive of optimal treatment approach.

Purpose
This was a prospective, multicenter, interventional study of a high-density grid-style mapping catheter (HD Grid) to characterize left atrial low voltage substrate during sinus rhythm (SR) and AF and identify associations with 12 month recurrence rates after a single de novo radiofrequency (RF) ablation using a PVI only approach.

Methods
This study (NCT03882021) enrolled 300 subjects at 18 centers in Europe and Israel. Subjects underwent de novo RF ablation for paroxysmal AF (PAF) (N=113), early persistent AF (PsAF; AF sustained 7 days to 3 months) (N=86) or non-early PsAF (AF sustained &gt;3 months to 12 months) (N=101). High density voltage maps were collected with HD Grid. Two pre-ablation maps, in SR and AF, were created for each subject (N=196) followed by PVI only ablation. Low voltage area (using cutoffs of 0.1 mV to 1.5 mV) was investigated in SR and AF. Follow up visits were at 3, 6 and 12 months post-ablation, with a 24-hour Holter monitor at 12 months. A Cox proportional hazards model was used to identify associations between mapping data and 12 month AF/atrial flutter (AFL)/atrial tachycardia (AT) recurrence after a single PVI procedure.

Results
At 12 months, 75.5% of subjects were free from AF/AFL/AT recurrence. On average, PsAF subjects had more low voltage area than PAF subjects in SR and AF. However, while univariate analysis found no correlation between recurrence and PAF or PsAF diagnosis (p=0.1261), those with recurrence had a significantly larger percent left atrial low voltage area under 0.5 mV with simultaneous orthogonal bipole wave configuration (HDW) in both AF (p=0.0011) and SR (p=0.0210) than those without recurrence. Using HDW, low voltage area (identified as &lt;0.5 mV) greater than 28% of the left atrium in SR (HR: 4.82, 95% CI: 2.08–11.18, p=0.0003) and greater than 72% in AF (HR: 5.66, 95% CI: 2.34–13.69, p=0.0001) were associated with a higher risk of AF/AFL/AT recurrence at one year.

Conclusion(s)
Using a standard cutoff of 0.5 mV, a larger percent low voltage area was associated with increased risk of recurrence in both SR and AF. Future analyses will explore optimal low voltage cutoffs and thresholds predictive of recurrence that may necessitate additional substrate modification beyond PVI.

Funding Acknowledgement
Type of funding sources: Private company. Main funding source(s): Abbott
Safety of same day discharge after atrial fibrillation ablation
Authors: Ijaz H , Al-Sadawi M , Aslam F , Aleem S , Jacob R , Cao K , Santore L , Almasry I , Singh A , Fan R , Rashba E 
Published: October 2022

Abstract

Background
Atrial fibrillation (AF) ablation is an outpatient procedure with traditionally an overnight hospital observation (OHO). Recently, there has been a trend towards same day discharge (SDD).

Purpose
Compare AF ablation procedure safety outcomes with SDD vs. OHO.

Methods
We reviewed consecutive AF procedures performed from January 2013 to June 2021 at a single academic center. Patients underwent OHO until June 2020, after which patients had SDD whenever feasible. Adverse events were assessed at three months, which included pericardial effusion, pericarditis, post-procedure hypotension, embolic events, and vascular complications. We also assessed emergency department (ED) visits and procedure-related hospital admissions.

Results
There were 1254 patients who underwent 1575 AF ablations. 1440 patients underwent OHO and 135 had SDD. Mean age was 62.2 years, BMI 33 kg/m2, 65% were male, and 27.6% had persistent AF, without significant differences in baseline characteristics between OHO and SDD. We found that SDD was not associated with increased complications (OHO 0.20% v. SDD 0.49%; p&gt;0.05), ED visits, or hospital admissions (2% v. 5%; p&gt;0.05) (Figure 1, 2). There were no gender or age-related disparities in all outcomes (p&gt;0.05).

Conclusion
SDD protocol after AF ablation is feasible and not associated with higher incidence of complications, ED visits, and procedure-related hospitalizations.

Funding Acknowledgement
Type of funding sources: None.