Safety and Efficacy of Minimal- versus Zero-fluoroscopy Radiofrequency Catheter Ablation for Atrial Fibrillation: A Multicenter, Prospective Study

Zei, Paul C.; Quadros, Kenneth; Clopton, Paul; Thosani, Amit J.; Ferguson, John; Brodt, Chad; O’Riordan, Geraldine; Ramsis, Mattheus; Mitra, Raman; Baykaner, Tina

doi:10.19102/icrm.2020.111105

Cited by 31 publications

(53 citation statements)

References 31 publications

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“…In total, 28 patients from ZF (1.26%) crossed over to CF/LF. Acute procedural success rates were reported in 14 studies 3–9,11,12,17,19–22 . Recurrence‐free survival rates were reported in 12 studies 3,5,6,8,10–12,17–22 .…”

Section: Resultsmentioning

confidence: 99%

Zero fluoroscopy approach versus fluoroscopy approach for cardiac arrhythmia ablations: A systematic review and meta‐analysis

Kanitsoraphan

Techorueangwiwat

Rattanawong

et al. 2021

Cardiovasc electrophysiol

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Background Radiofrequency catheter ablation for cardiac arrhythmias has traditionally been guided by fluoroscopy. Fluoroscopy exposes the patient, operator, and staff to ionizing radiation which has no safe dose void of stochastic and deterministic biologic risks. Zero fluoroscopy (ZF) approaches for catheter ablation have been advocated to eliminate these risks. We conducted a meta‐analysis comparing acute procedure success, recurrence‐free survival, complications, and procedure times between the approaches. Methods We conducted a literature search from inception through December 2020 in the databases of EMBASE and MEDLINE. We included randomized controlled trials and cohorts that compared the outcomes of interest in ZF and conventional/low fluoroscopy (CF/LF) approaches. The outcomes sought were acute procedure success, recurrence‐free survival, complications, and procedure times. Effect estimates were combined, using the random‐effects, generic inverse variance method of DerSimonian and Laird. Results Sixteen studies from 2013 to 2020, including 6052 patients (2219 ZF, 3833 CF/LF) were included. There were no significant differences in acute procedure success rate (odds ratio [OR]: 1.10, 95% confidence interval [CI]: 0.75–1.59), recurrence‐free survival (OR: 1.08, 95% CI: 0.78–1.49), periprocedural complication rate (OR: 0.72, 95% CI: 0.45–1.16), or total procedure time (weighted mean difference 2.32 min, 95% CI: −2.85–7.50) between ZF and CF/LF approaches, respectively. Overall, only 1.26% of patients crossed over from ZF to CF/LF arm. Conclusions Periprocedural and postprocedural outcomes with a ZF approach compared favorably with traditional fluoroscopic guidance without increasing procedural times. As comfort with ZF grows, coupled with evolving mapping technologies, this method has potential to become the standard approach for catheter ablation.

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Section: Resultsmentioning

confidence: 99%

Zero fluoroscopy approach versus fluoroscopy approach for cardiac arrhythmia ablations: A systematic review and meta‐analysis

Kanitsoraphan

Techorueangwiwat

Rattanawong

et al. 2021

Cardiovasc electrophysiol

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“…The most unique feature of Real-AF is the inclusion of a low fluoroscopy approach to ablations. Safety and efficacy using low fluoro techniques have been reported previously [15,18]. In the Get with the Guidelines, the median fluoroscopy time was 16 min, and the 25th percentile was only 8 min [24].…”

Section: Discussionmentioning

confidence: 98%

“…For radiofrequency (RF) ablation, the advent of contact force sensing catheters [4][5][6][7], improvements in catheter irrigation design [8], development of High Power Short Duration (HPSD) techniques [9,10], and the use of algorithms to predict adequate lesion formation [11][12][13], among other advancements, have resulted in a more efficacious and safe procedure [14][15][16][17]. A low fluoroscopy ablation approach is now employed by an increasing number of operators utilizing advances in intra-cardiac echocardiography (ICE) and electroanatomic mapping (EAM), which has demonstrated comparable outcomes to traditional ablation while reducing or eliminating risks of ionizing radiation to patients, operators, and staff [18,19].…”

Section: Introductionmentioning

confidence: 99%

A prospective multi-site registry of real-world experience of catheter ablation for treatment of symptomatic paroxysmal and persistent atrial fibrillation (Real-AF): design and objectives

Varley

Kreidieh

Godfrey

et al. 2021

J Interv Card Electrophysiol

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Purpose Catheter ablation has become a mainstay therapy for atrial fibrillation (AF) with rapid innovation over the past decade. Variability in ablation techniques may impact efficiency, safety, and efficacy; and the ideal strategy is unknown. Real-world evidence assessing the impact of procedural variations across multiple operators may provide insight into these questions. The Real-world Experience of Catheter Ablation for the Treatment of Symptomatic Paroxysmal (PAF) and Persistent (PsAF) Atrial Fibrillation registry (Real-AF) is a multicenter prospective registry that will enroll patients at high volume centers, including academic institutions and private practices, with operators performing ablations primarily with low fluoroscopy when possible. The study will also evaluate the contribution of advent in technologies and workflows to real-world clinical outcomes. Methods Patients presenting at participating centers are screened for enrollment. Data are collected at the time of procedure, 10-12 weeks, and 12 months post procedure and include patient and detailed procedural characteristics, with short and long-term outcomes. Arrhythmia recurrences are monitored through standard of care practice which includes continuous rhythm monitoring at 6 and 12 months, event monitors as needed for routine care or symptoms suggestive of recurrence, EKG performed at every visit, and interrogation of implanted device or ILR when applicable. Results Enrollment began in January 2018 with a single site. Additional sites began enrollment in October 2019. Through May 2021, 1,243 patients underwent 1,269 procedures at 13 institutions. Our goal is to enroll 4000 patients. Discussion Real-AF's multiple data sources and detailed procedural information, emphasis on high volume operators, inclusion of low fluoroscopy operators, and use of rigorous standardized follow-up methodology allow systematic documentation of clinical outcomes associated with changes in ablation workflow and technologies over time. Timely data sharing may enable real-time quality improvements in patient care and delivery. Trial registration Clinicaltrials.gov: NCT04088071

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“…For the treatment of deep hyperplastic tissues and tumors (e.g., breast cancer and liver tumors), ultrasound thermal therapy is a highly precise, highly accurate cardiac catheterization and treatment. The basic procedure of the fully developed radiofrequency treatment involves puncturing the peripheral artery of the hand or leg (usually the artery of the wrist or groin) under local anesthesia, and then inserting a tailored slender catheter into the blood stream along a large blood vessel to examine and treat it [ 1 , 2 ]. The catheter allows specially made equipment such as balloons and stents to enter the body and reopen blocked blood vessels (e.g., through balloon dilatation or stenting).…”

Section: Introductionmentioning

confidence: 99%

Investigation of Cylindrical Piezoelectric and Specific Multi-Channel Circular MEMS-Transducer Array Resonator of Ultrasonic Ablation

2021

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Background: A cylindrical piezoelectric element and a specific multi-channel circular microelectromechanical systems (MEMS)-transducer array of ultrasonic system were used for ultrasonic energy generation and ablation. A relatively long time is required for the heat to be conducted to the target position. Ultrasound thermal therapy has great potential for treating deep hyperplastic tissues and tumors, such as breast cancer and liver tumors. Methods: Ultrasound ablation technology produces thermal energy by heating the surface of a target, and the heat gradually penetrates to the target’s interior. Beamforming was performed to observe energy distribution. A resonance method was used to generate ablation energy for verification. Energy was generated according to the coordinates of geometric graph positions to reach the ablation temperature. Results: The mean resonance frequency of Channels 1–8 was 2.5 MHz, and the cylindrical piezoelectric ultrasonic element of Channel A was 4.2546 Ω at 5.7946 MHz. High-intensity ultrasound has gradually been applied in clinical treatment. Widely adopted, ultrasonic hyperthermia involves the use of high-intensity ultrasound to heat tissues at 42–45 °C for 30–60 minutes. Conclusion: In the ultrasonic energy method, when the target position reaches a temperature that significantly reduces the cell viability (46.9 °C), protein surface modification occurs on the surface of the target.

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Safety and Efficacy of Minimal- versus Zero-fluoroscopy Radiofrequency Catheter Ablation for Atrial Fibrillation: A Multicenter, Prospective Study

Cited by 31 publications

References 31 publications

Zero fluoroscopy approach versus fluoroscopy approach for cardiac arrhythmia ablations: A systematic review and meta‐analysis

Zero fluoroscopy approach versus fluoroscopy approach for cardiac arrhythmia ablations: A systematic review and meta‐analysis

A prospective multi-site registry of real-world experience of catheter ablation for treatment of symptomatic paroxysmal and persistent atrial fibrillation (Real-AF): design and objectives

Investigation of Cylindrical Piezoelectric and Specific Multi-Channel Circular MEMS-Transducer Array Resonator of Ultrasonic Ablation

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