Abstract
Background: Pulsed field ablation (PFA) is a non-thermal energy source with promising safety and efficacy advantages. We aimed to develop a convenient, safe, effective and fast method of pulmonary vein isolation (PVI) utilizing a penta-spline PFA catheter via a single femoral vein and a venous closure system.
Methods and Results: Consecutive patients (n=50; mean age: 63.6±10.7 years, 38% female) presenting with AF (paroxysmal AF: 56%) underwent first-time PVI via PFA. A single ultrasound-guided femoral vein puncture and a single transseptal puncture were used. After PVI using the penta-spline PFA catheter, extra pulse trains were added to the posterior wall for wide antral circumferential ablation. A venous closure system was used and a Donati suture was performed. The pressure bandage was removed after 1 h. A total of 196 PVs were identified and isolated with PFA only. The mean procedural time was 27.4±6.6 min, and the mean dwelling time was 14.4±5.5 min. Time to ambulation was 3.3±3.1 h. No severe complications occurred. During a mean follow-up of 6.5±2.1 months, 41/50 patients (82%) remained in sinus rhythm.
Conclusions: The combination of a single venous puncture, single transseptal puncture approach using PFA and vascular closure device resulted in a 100% rate of acute PVI and an extraordinarily fast procedure and time to ambulation. The rate of periprocedural complications was low.
Catheter ablation (CA) of atrial fibrillation (AF) by pulmonary vein isolation (PVI) is an established treatment option,1 but venous access complications following AF ablation are by far the most common. Ultrasound-guided vascular access reduces the number of vascular access complications, and moreover, use of venous closure devices results in earlier ambulation.2 Application of thermal energy by cryothermal, laser or radiofrequency (RF) energy is currently the standard approach for lesion formation, but because thermal energy is non-selective there is a risk of collateral damage, including esophageal thermal injury and injury of nervous tissue.3–5 Recently, irreversible electroporation by pulsed field ablation (PFA) has been introduced as a novel source for lesion formation. Its advantages are a tissue-specific irreversible electroporation of cardiomyocytes with sparing of surrounding tissue, which promises safety advantages.6–8 Additionally, PFA creates lesions very quickly, possible leading to shorter procedures times and therefore higher efficacy and efficiency of CA procedures. In the present study, our aim was to develop a tailored simplified approach by combining (1) single venous ultrasound-guided puncture of the femoral vein, (2) single transseptal puncture (TSP), (3) single-catheter PVI procedure using a penta-spline PFA catheter and (4) venous closure system to achieve a high level of patient convenience, safety, efficacy, and efficiency with a shorter time to ambulation.
Methods
Patient Population
Between February 2022 and September 2022, consecutive patients with symptomatic AF undergoing PFA (Boston Scientific, Farawave) were prospectively enrolled. The study was approved by the local ethical review board (Lübeck ablation registry ethical review board no. WF-028/15) and all participants provided written informed consent. All investigations were performed in compliance with the ethical standards of the 1964 Declaration of Helsinki and its later amendments. The primary endpoint was acute success for PVI. Secondary endpoints were periprocedural characteristics including periprocedural complications.
Study Aim
The primary study aim was to assess a novel, simplified approach for PFA-based PVI, which we termed the “Fast and Furious PFA approach” combining (1)–(4) above. Procedural efficacy, periprocedural data as indicated by acute PVI, procedure duration, left atrial (LA) dwelling time, fluoroscopy time and dose, and time to ambulation were assessed. Furthermore, the incidence of periprocedural complications, such as bleeding events (defined as bleedings requiring medical action), pericardial effusion and/or pericardial tamponade, cerebral stroke, ST-elevation myocardial infarction, phrenic nerve injury (PNI) or air embolism, were analyzed. The Fast and Furious PFA approach is depicted in Figure 1.
Periprocedural complications were defined according to the latest guidelines. Only adverse events adjudicated as possible, probable, or definitely related to the ablation procedure are mentioned as safety events. An adverse event was considered serious if it resulted in permanent injury or death, required an intervention for treatment, or required hospitalization for >24 h.9 The procedure time was defined as time from femoral vein puncture to removal of the sheath out of the femoral vein. The LA dwelling time was defined as time from transseptal puncture to removal of the FARADRIVE sheath from the LA. The time to ambulation was defined as time from deployment of the pressure bandage to the first time the patient stood up from the hospital bed.
Periprocedural Management
All patients underwent preprocedural investigation as per the center’s standard of care. In brief, intracardiac thrombi were ruled out via transesophageal echocardiography. For patients on vitamin K antagonists the procedure was performed under therapeutic international normalized ratio values of 2–3. In patients on direct oral anticoagulants (DOAC) the morning dose was omitted on the procedure day. All ablations were performed under intravenous sedation using propofol, midazolam and fentanyl following the recommendations of a position paper from the German Cardiac Society.10 A single ultrasound-guided femoral vein puncture was performed (1×8F) and a venous closure system (Perclose Proglide or Perclose Prostyle, Abbott Vascular) was prepared.2 A coronary sinus catheter was not used in this population. A single TSP was performed under fluoroscopic guidance using a modified Brockenbrough technique via a SL1 sheath. After the TSP, heparin boluses were administered targeting an activated clotting time >300 s. Angiography of the pulmonary veins was performed with a contrast medium directly via the Sl1 sheath or via a multipurpose catheter (7F). Prior to the first pulse delivery, 1 mg atropine was given intravenously to avoid vagal reactions such as sinus arrest or intermittent atrioventricular block. No phrenic nerve pacing or CMAP monitoring were performed to monitor phrenic nerve function during the procedure.
Ablation Protocol
A detailed description of the optimized PFA procedure has been given previously.11 In brief, 8 pulse trains (2 kV/2.5 s, bipolar, biphasic, 4×basket/flower configuration each) were delivered to each PV starting with the left-sided veins. Two extra pulse trains per PV in a flower configuration and more anterior and posterior angulation were added for very wide antral circumferential ablation (WACA) as per the center’s specific protocol.
Postprocedural Management
A vascular closure device (Proglide or Prostyle), a Donati’s suture and a pressure bandage were used to prevent femoral bleeding. After 1 h the pressure bandage was removed and the patient was mobilized. The suture was removed the following day. Following ablation, all patients underwent transthoracic echocardiography immediately, after 1–2 h, and at day 1 post-ablation to rule out pericardial effusion. Oral anticoagulants were reinitiated 6 h after the procedure and continued for at least 3 months and thereafter according to the CHA2DS2-VASc-score. Antiarrhythmic drugs were prescribed for 3 months post-ablation to prevent early AF recurrence during the blanking period.
Rhythm follow-up was based on 24-hour Holter ECG recorded directly after the procedure as well as after 3, 6 and 12 months. At 6 months, rhythm outcome was assessed on telephone follow-up. Additional outpatient clinic visits were immediately initiated in cases of symptoms suggestive of arrhythmia recurrence.
Statistical Analysis
All analyses were performed using STATA software version 14.0 (STATA Corp., TX, USA). Distributions of continuous variables were tested for normality using the Shapiro Wilk test. Continuous variables are expressed as mean±standard deviation. Categorical variables are reported as counts (percentage). All reported P values are two-sided and P<0.05 was considered statistically significant.
Results
Patients’ Characteristics
We enrolled 50 consecutive patients with predominantly clinical symptomatic paroxysmal AF, a normal left ventricular ejection fraction and a low burden of comorbidities. The mean age was 63.6±10.7 years. The majority of patients (56%) presented with paroxysmal AF. Detailed baseline characteristics are shown in Table 1.
Table 1. Baseline Characteristics of the Study Patients
| No. of patients |
50 |
| Age, years |
63.6±10.7 |
| BMI, kg/m2 |
25.8±6.4 |
| Left atrial diameter, mL/m2 |
40±7.4 |
| Persistent AF, n (%) |
22 (44) |
| Female sex, n (%) |
19 (38) |
| Arterial hypertension, n (%) |
33 (66) |
| Congestive heart failure, n (%) |
9 (18) |
| Diabetes mellitus type II, n (%) |
5 (10) |
| Prior TIA/stroke, n (%) |
3 (6) |
| CHA2DS2-VASc score |
1.7±1.4 |
Data expressed as n (%); mean±standard deviation. Categorical data are presented as N (%). AF, atrial fibrillation; BMI, body mass index; TIA, transient ischemic attack.
All PFA procedures were performed by 2 experienced EP operators with >10 years of training in invasive interventions (R.R.T., C.-H.H.). Using the Fast and Furious PFA approach, a single (ultrasound-guided) venous puncture, single-catheter approach without using a coronary sinus catheter was deployed (Figure 2). A single TSP was performed under fluoroscopic guidance only using a modified Brockenbrough technique via a SL1 sheath. All PVs were successfully isolated using only PFA (196/196, 100%). No touch-up ablations were needed. A mean of 40±0.6 pulse trains per patient were applied for ostial and WACA-PFA. The mean procedural time was 27.4±6.6 min, the mean catheter dwell time was 14.4±5.5 min and the mean fluoroscopy time and dose were 6.0±2.0 min and 308±147 cGy respectively. Procedural data are depicted in Table 2. The Proglide venous closure system was used in 45/50 (90%) of patients and the Prostyle venous closure system was used in 5/50 (10%) patients. Time to ambulation was 3.3±3.1 h. During a mean follow-up of 6.5±2.1 months a total of 41/50 patients (82%) showed stable sinus rhythm. A total of 10/41 (24.4%) patients were off antiarrhythmic medication.
Table 2. Procedural Data
| No. of patients |
50 |
| No. of pulmonary veins |
196 |
| RF ablation touch-up, n (%) |
0 (0) |
| Isolated pulmonary veins, n (%) |
196/196 (100) |
| WACA-PVI, n (%) |
50 (100) |
| Single access, n (%) |
50 (100) |
| PFA applications/patient, n (%) |
40±0.6 |
| Procedure duration, min |
27.4±6.6 |
| Fluoroscopy time, min |
6.0±2.0 |
| Dose-area product, cGy*cm2 |
308±147 |
| LA dwelling time, min |
14.4±5.5 |
| Contrast medium, mL |
42.3±11.6 |
Data expressed as n (%), mean±standard deviation. LA, left atrium; PFA, pulsed field ablation; PVI, pulmonary vein isolation; RF, radiofrequency; WACA, wide antral circumferential ablation.
One patient (2%) experienced a transient phrenic nerve palsy during application in the basket position to the RIPV. However, it had recovered by the end of the procedure and all PVs were isolated using PFA only. Two patients (4%) experienced superficial bleeding of the puncture site requiring pressure bandage for 8–12 h, without surgical or other intervention. These minor complications did not lead to further treatment or prolonged hospital stay. No severe ST changes, hematoma, blood transfusions or interventions occurred, nor did pericardial effusion or tamponade (Table 3).
Table 3. Periprocedural Complications
| No. of patients |
50 |
| Serious adverse events, n (%) |
0 (0) |
| Minor complications, n (%) |
3 (6) |
| Death from any cause, n (%) |
0 (0) |
| Pericardial tamponade, n (%) |
0 (0) |
| Pericardial effusion without intervention, n (%) |
0 (0) |
| Atrioesophageal fistula, n (%) |
0 (0) |
| PNI, n (%) |
1 (2) |
| PNI recovered by end of procedure, n (%) |
1 (2) |
| PNI persistent until discharge, n (%) |
0 (0) |
| Stroke, n (%) |
0 (0) |
| Transient ischemic attack, n (%) |
0 (0) |
| Severe bleeding at puncture site, n (%) |
0 (0) |
| Minor bleeding at puncture site, n (%) |
2 (4) |
| Groin aneurysm with conservative treatment, n (%) |
0 (0) |
| Arteriovenous fistula, n (%) |
0 (0) |
| Air embolism, n (%) |
0 (0) |
Data expressed as n (%), mean±standard deviation. Only events adjudicated as possible, probable, or definitely related to the ablation procedure are noted. An adverse event was considered serious if it resulted in permanent injury or death, required an intervention for treatment, or required hospitalization for >24 h. PNI, phrenic nerve injury.
Discussion
The present Fast and Furious PFA study aimed to assess a simplified and tailored PFA-based PVI approach to simplify the procedure, reduce vascular access complications and shorten time to ambulation, with the overall aim of increasing patients’ satisfaction. The main findings were: (1) very high acute efficacy, (2) remarkably short procedure time, (3) low rate of periprocedural complications and (4) short time to ambulation.
Irreversible electroporation by PFA is a novel modality for CA of cardiac tissue to treat cardiac arrhythmias. The first studies and registry focusing on PFA showed promising results in terms of efficacy and safety advantages compared with standard ablation modalities such as RF and cryothermal energy.12–15 Those findings were mainly driven by the unique myocardial tissue specificity and fast energy delivery.11 Early preclinical and clinical data report sharp and homogeneous delineated lesions with improved acute and chronic PVI rates between ≤84% and 100%.16–18
Consistent with these unique findings, the multinational MANIFEST-PF registry reported the first clinical data from real-world performance of PFA in unselected AF patients and there were high rates of efficacy and saftey.6 To date, no case of atrio-esophageal fistula after a PFA procedure has been reported.5
The safety and short procedure time, as well as the high rate of efficacy of PFA procedures waive the question of further optimizing and simplifying preexisting approaches to improving efficacy and safety as well as efficiency and patient convenience. The 5S strategy aimed to tailor PVI procedures, and with a mean procedure time of 38 min, 100% rate of acute PVI and a low incidence of periprocedural complications, a very high rate of efficacy and safety was achieved.7 To further reduce the complexity of cardiac CA and to improve efficiency, we developed a novel simplified and tailored approach. With our Fast and Furious PFA approach we aimed for a tailored simplified approach by combining a single venous ultrasound-guided puncture of the femoral vein, a single TSP, single catheter-based PVI procedure using a penta-spline PFA catheter and a venous closure system to achieve a high level of safety, efficacy and efficiency.
In the 5S study 2 femoral vein punctures, a decapolar diagnostic catheter and a multipurpose catheter were used, whereas with the Fast and Furious PFA approach the number of femoral vein punctures is reduced to 1. Furthermore, the decapolar diagnostic catheter and multipurpose catheter are omitted. Additionally, an ultrasound-guided femoral vein puncture and a venous closure system are used in the Fast and Furious PFA approach. These differences to the 5S strategy possible resulted in a faster procedure time.
With a 100% success rate of PVI, a mean procedure time <30 min and a mean LA dwelling time of 14.4 min, efficacy was remarkably high. Additionally, a very low rate of periprocedural complications was observed.
Because vascular complications remain the most frequent complication during CA procedures the aim of the Fast and Furious PFA study was to further reduce their incidence.19,20 Ultrasound-guided venous puncture has shown high efficacy in limiting vascular complications without increasing the procedure time and seems an ideal method for vascular access. In terms of introducing same-day discharge for CA procedures, ultrasound-guided venous puncture in combination with a vascular closure system appear crucial for this purpose.2
Study Limitations
The presented data were obtained from a single-center registry experience and encompass only a small number of patients with limited comorbidities. No randomization or comparison to other ablation energy sources was performed.
Conclusions
In the prospective Fast and Furious PFA study, a simplified and tailored PFA-based PVI approach was used. Very high efficacy and safety were observed when using this approach, suggesting it to be safe, feasible, effective and efficient for PVI. It is suggested as an ideal approach for same-day discharge after CA procedures through prompt ambulation of patients.
Conflict of Interest Disclosures
B.K. received travel and congress sponsoring from Biotronik, Abbott, Impulse Dynamics, and Pfizer, and speaker honoraria from Biotronik, Impulse Dynamics, C.T.I. GmbH and Doctrina Med. C.-H.H. received travel grants and research grants from Boston Scientific, Liftech, Biosense Webster and Cardiofocus, and speaker honoraria from Boston Scientific, Biosense Webster, Cardiofocus and C.T.I. GmbH and Doctrina Med. J.V. received speaker honoraria from Abbott, Boston Scientific, Impulse Dynamics, Pfizer and Doctrina Med. H.-L.P. received travel grants from Cardiofocus and C.T.I., and educational grants from Biosense Webster, all outside the submitted work. S.S.P. received travel and congress sponsoring from LifeTech outside the submitted work. R.R.T. is a consultant for Abbott, Boston Scientific, Biotronik and Biosense Webster, and received speaker honoraria from Biosense Webster, Medtronic, Boston Scientific and Abbot Medical. K.-H.K. reports grants and personal fees from Abbott Vascular, Medtronic, and Biosense Webster outside the submitted work. All other authors have no relevant disclosures.
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