Study design
We retrospectively included 40 consecutive patients who underwent PCI and AFCA in a single procedure between Jan 2020 and Ju 2021. The data were collected from the Cardiovascular Center of Beijing Friendship Hospital Data Bank (CBD bank). Included were patients with: (1) age > = 18 years, symptomatic AF, and nonresponse or intolerance to at least one antiarrhythmic drug (AAD); (2) definitive diagnosis of CAD requiring single-vessel PCI treatment. Excluded were those with: (1) structural heart disease (valvular and congenital heart diseases and dilated or hypertrophic cardiomyopathy); (2) transient AF due to reversible causes (e.g., cardiac surgery, pulmonary embolism, and untreated thyroid disease); (3) coronary artery bypass grafting six months before; (4) myocardial infarction two months before; (5) thromboembolism six months before; (6) coagulation dysfunction; (7) life expectancy less than 12 months; (8) multi-vessel PCI.
This study complied with the Declaration of Helsinki and was approved by our institutional review board. Written informed consent was waived.
Covid-19-related Interventions
Interventions to ensure the safety of patients and healthcare workers included the following pre-hospital screenings: (1) COVID-19 nucleic acid test within 72 hours, (2) chest CT within one week, (3) blood routine and C-reaction protein within one week, and no visitation.
Pci Procedure
The procedure started with PCI, followed by AFCA. First, the radial artery was punctured under local anesthesia. Then coronary angiography was performed to determine single-vessel or multi-vessel CAD. Multi-vessel CAD was defined as angiographically significant stenosis ( > = 50%) in at least two major epicardial coronary arteries or their branches, with or without involvement in the left main artery [24, 25]. Single- or multi-vessel PCI was selected based on each patient’s clinical status at the operator's discretion. For the patients undergoing single-vessel PCI, AFCA was followed immediately. For patients undergoing multi-vessel PCI, AFCA was performed at a time point after discharge to ensure their safety. All procedures were performed following the guidelines. All patients had drug-eluting stents placed. A successful procedure was defined as angiographically residual stenosis ≤ 30% with thrombosis in myocardial infarction (TIMI) grade 3 flow [24]. After PCI, the radial artery compressor was retained for six hours to stop bleeding.
Catheter Description And Ca Procedure
All patients underwent radiofrequency CA. All ablations were performed using the new THERMOCOOL SMARTTOUCH SF catheter (Biosense-Webster, Diamond Bar, CA, USA), which contains a 56-hole porous tip. This porous tip is an improved irrigation system that strengthens the cooling effect with less fluid delivery compared with the traditional 6-hole irrigation system [26, 27].
CA was performed under conscious sedation (fentanyl). The strategy of CA for AF in our center has been described before [28]. In brief, after a single transseptal puncture, the ablation catheter was advanced to the left atrium (LA) to reconstruct the LA electroanatomic map under the guidance of the 3D mapping system (CARTO 3; Biosense-Webster, Diamond Bar, CA, USA). Ablation was guided by ablation index (AI) targets: 450 at the roof and anterior walls and 380 at the posterior and inferior walls (Fig. 1). Ablation power was set at 45 W. A contact force of 10–20 g was targeted at each site. Pulmonary vein isolation (PVI) was achieved in all PAF patients. Additional linear ablation was performed in PsAF patients. It was limited to the LA roof line, mitral valve isthmus line, LA posterior line, and cavotricuspid isthmus line. Cardioversion was performed if the sinus rhythm did not appear after the ablation. Cautious catheter manipulations were emphasized to avoid complications. After the procedure, sheaths were removed, and the venous access site was manually compressed for 3–5 min or until no bleeding was observed.
Post-procedure Anticoagulation And Follow-up
Triple therapy (rivaroxaban [15 mg, QD] + aspirin + clopidogrel) lasted for one month following the combined procedure [29, 30]. Dual therapy (rivaroxaban [15 mg, QD] + clopidogrel) followed for up to 12 months, and then life-long aspirin was prescribed if AF did not recur. In order to prevent post-procedure gastrointestinal bleeding and atrioesophageal fistula, a proton pump inhibitor (PPI) was used for one month. Type I or III AAD was prescribed for all patients for three months, followed by a β-blocker. The patients were seen in the outpatient clinic 1, 3, 6, and 12 months after the procedure or whenever symptoms developed. Electrocardiography and 24 h Holter were obtained. Patients who reported episodes of angina pectoris were readmitted for coronary angiography. AF recurrence was defined as any atrial fibrillation lasting at least 30 seconds after a 3-month blanking period.
Outcomes
The primary safety outcome in this analysis was evaluated according to the adverse events (AEs) related to the procedure and post-procedure anticoagulant therapy. The AEs were reported from vascular access to 90 d after the index procedure. AEs included cardiac tamponade, cerebrovascular accident/stroke, TIA, thromboembolism, myocardial infarction, vascular access site complications (hematoma, pseudoaneurysm, and arteriovenous fistula), and major/minor bleeding during the follow-up period. Major bleeding was defined as bleeding requiring invasive treatment or blood transfusion. The primary efficacy outcome was evaluated according to 12-month AF recurrence and in-stent restenosis (ISR).
Staistical Analysis
Descriptive statistics were used to report patient characteristics. Continuous variables were presented as mean ± SD. Categoric variables were presented as a percentage. In addition, a Kaplan-Meier analysis was conducted on the efficacy endpoint. All statistical analyses were performed in the STATA software.