Patient-Centric Innovation: Superior Vena Cava Approach in Zero-Fluoroscopy

Patient-Centric Innovation: Superior Vena Cava Approach in Zero-Fluoroscopy Radiofrequency Catheter Ablation for Atrioventricular Nodal Reentrant Tachycardia

This study aims to evaluate the viability and therapeutic efficacy of zero-fluoroscopy radiofrequency catheter ablation (RFCA) using the superior vena cava (SVC) approach in patients with atrioventricular nodal reentrant tachycardia (AVNRT). The study compares outcomes between the SVC approach and the conventional inferior vena cava (IVC) approach. Patients diagnosed with AVNRT who underwent RFCA between June 2022 and October 2022 were retrospectively analyzed. The primary outcome measure is the non-inducibility of AVNRT, while secondary outcomes include postoperative recovery time and complication rates. The study seeks to provide a safer and more efficient RFCA method, enhancing patient recovery by minimizing radiation exposure and optimizing catheter access routes.

Study Overview

• Status: Completed
• Conditions: Atrioventricular Nodal Reentrant Tachycardia
• Intervention / Treatment: Procedure: Zero-Fluoroscopy Radiofrequency Catheter Ablation

Detailed Description

This retrospective study investigates the feasibility and therapeutic efficacy of zero-fluoroscopy radiofrequency catheter ablation (RFCA) using the superior vena cava (SVC) approach in patients diagnosed with atrioventricular nodal reentrant tachycardia (AVNRT). The study was conducted at our institution between June 2022 and October 2022, including adult patients (age >18 years) who underwent RFCA during this period. Patients were divided into two groups based on the catheter access site: the SVC approach group and the inferior vena cava (IVC) approach group.

The primary objective of the study is to assess the success rate of AVNRT ablation using the SVC approach compared to the conventional IVC approach, under zero-fluoroscopy conditions. Secondary objectives include evaluating the postoperative recovery time, incidence of complications, and overall patient outcomes.

Inclusion criteria required that patients experienced at least one episode of AVNRT during transesophageal atrial pacing (TEAP) and programmed stimulation. Exclusion criteria included cases where AVNRT was attributed to reversible causes such as acute myocarditis, cardiac surgery, or other types of tachycardias (e.g., atrial tachycardia, Wolff-Parkinson-White syndrome, ventricular tachycardia).

The electrophysiologic study involved TEAP and programmed stimulation to screen for AVNRT and exclude other arrhythmias. The catheterization procedure was performed under conscious sedation and local infiltration anesthesia, with continuous monitoring of vital signs. Catheter access sites for the SVC group included the median cubital vein and the basilic vein, while the femoral vein was used for the IVC group. The ablation procedure utilized a large-tip electrode catheter for mapping and ablation, guided by the EnSite NavX system.

Ablation endpoints were determined by the non-inducibility of AVNRT after programmed stimulation. Follow-up evaluations included monitoring for recurrence of atrial arrhythmias or the occurrence of iatrogenic atrioventricular block (AVB). Statistical analysis was performed using R 4.4.0 software, with continuous variables expressed as mean ± SD or median (interquartile range) and categorical variables as counts or percentages. An unpaired t-test or nonparametric test was used to compare the SVC and IVC approach groups, with a p-value of <0.05 considered statistically significant.

This study aims to demonstrate that the SVC approach for zero-fluoroscopy RFCA is a viable and effective alternative to the conventional IVC approach, potentially offering advantages such as reduced postoperative vascular events and elimination of bed rest requirements. The findings could broaden treatment options and enhance patient safety in RFCA procedures. Further research is encouraged to validate these findings across diverse populations and optimize procedural techniques for improved long-term efficacy and minimized risks.

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population includes adults (age >18 years) diagnosed with AVNRT who underwent RFCA at our institution between June and October 2022. Patients were divided into two groups based on catheter access site: the SVC approach group (median cubital or basilic vein) and the IVC approach group (femoral vein). Inclusion required at least one AVNRT episode during TEAP and programmed stimulation. Exclusion criteria were reversible causes of AVNRT, other tachycardias, severe comorbidities, or contraindications for conscious sedation or local anesthesia. This setup allows comparative analysis of SVC and IVC approaches focusing on success, complications, and recovery.

Description

Inclusion Criteria:

• Adults aged >18 years.
• Diagnosed with atrioventricular nodal reentrant tachycardia (AVNRT).
• Underwent radiofrequency catheter ablation (RFCA) at our institution between June 2022 and October 2022.
• Experienced at least one episode of AVNRT during transesophageal atrial pacing (TEAP) and programmed stimulation.
• Provided informed consent for the procedure and data collection.

Exclusion Criteria:

• AVNRT attributed to reversible causes, such as acute myocarditis or recent cardiac surgery.
• Presence of other types of tachycardias (e.g., atrial tachycardia, Wolff-Parkinson-White syndrome, ventricular tachycardia).
• Inability to abstain from pharmacological interventions for at least five half-lives of the medication prior to TEAP.
• Contraindications for the use of conscious sedation or local anesthesia.
• Severe comorbidities that would interfere with study participation or follow-up.
• Patients who are pregnant or lactating.
• Previous RFCA procedures for AVNRT within the past six months.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SVC Approach Group; This group includes patients who underwent zero-fluoroscopy radiofrequency catheter ablation (RFCA) for atrioventricular nodal reentrant tachycardia (AVNRT) using the superior vena cava (SVC) approach. The catheter was inserted through the median cubital vein or basilic vein, navigating through the axillary vein, subclavian vein, and brachiocephalic vein to reach the SVC. The ablation procedure was performed under conscious sedation and local infiltration anesthesia, with a large-tip electrode catheter used for mapping and ablation guided by the EnSite NavX system. The ablation parameters were set at 40 W power and 50°C temperature.	Procedure: Zero-Fluoroscopy Radiofrequency Catheter Ablation; Patients undergo zero-fluoroscopy RFCA for atrioventricular nodal reentrant tachycardia (AVNRT) using the superior vena cava (SVC) or inferior vena cava (IVC) approach. The procedure is performed under conscious sedation and local infiltration anesthesia. A large-tip electrode catheter is used for mapping and ablation, guided by the EnSite NavX system, with ablation parameters set at 40 W power and 50°C temperature.
IVC Approach Group; This group includes patients who underwent zero-fluoroscopy radiofrequency catheter ablation (RFCA) for atrioventricular nodal reentrant tachycardia (AVNRT) using the inferior vena cava (IVC) approach. The catheter was inserted through the femoral vein, extending through the iliac vein to the IVC. The ablation procedure was performed under conscious sedation and local infiltration anesthesia, with a large-tip electrode catheter used for mapping and ablation guided by the EnSite NavX system. The ablation parameters were set at 40 W power and 50°C temperature.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-inducibility of Atrioventricular Nodal Reentrant Tachycardia (AVNRT)	This is determined during the procedure by performing programmed stimulation to test for the presence of AVNRT. Non-inducibility is confirmed if AVNRT cannot be induced following the ablation, indicating a successful therapeutic intervention.	During the procedure
Recurrence of supraventricular tachycardia	It is defined as any documented episode of supraventricular tachycardia, such as AVNRT, atrial fibrillation, or atrial flutter, confirmed by electrocardiographic evidence.	Within 1 year post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Recovery Time	It is defined as the duration from the completion of the RFCA procedure to the patient's ability to walk unassisted.	Within 24 hours post-procedure
Complication Rate	It is defined as any documented episode of SVT, including AVNRT, confirmed by electrocardiographic evidence.	Within 1 year post-procedure

Collaborators and Investigators

• Sponsor: Ning Zhou

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): June 20, 2024

Study Registration Dates

• First Submitted: July 2, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Radiofrequency Catheter Ablation; Zero-Fluoroscopy; Superior Vena Cava (SVC) Approach
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia, Reciprocating; Tachycardia; Tachycardia, Atrioventricular Nodal Reentry
• Other Study ID Numbers: m202276475

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No