Skip to main content
Open access
Research Article
16 August 2023

QDOT MICRO™ versus THERMOCOOL® SMARTTOUCH™ and THERMOCOOL SMARTTOUCH® Surround Flow in radiofrequency ablation of paroxysmal atrial fibrillation

Abstract

Aim: The objective of this study was to indirectly compare QDOT MICRO™ (QDOT), Thermocool® SmartTouch™ (ST) and Thermocool® SmartTouch® Surround Flow (STSF) to treat paroxysmal atrial fibrillation. Methods: Differences in baseline characteristics between study cohorts were reduced by reweighting patients using inverse probability of treatment weighting. The primary outcome was procedure time. Secondary outcomes were fluoroscopy time, clinical success at 12 months, and rhythm monitoring-adjusted recurrence. Results: QDOT was associated with significantly faster mean procedure and fluoroscopy time, and significant improvement in the rate of recurrence compared with pooled ST/STSF. No difference was observed for clinical success at 12 months. Conclusion: QDOT was associated with greater efficiency, greater effectiveness in rhythm monitoring-adjusted recurrence and similar effectiveness in clinical success at 12 months compared with pooled ST/STSF.

Supplementary Material

File (supplementary materials.docx)

References

Papers of special note have been highlighted as: •• of considerable interest
1.
Hindricks G, Potpara T, Dagres N et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur. Heart J. 42(5), 373–498 (2021).
2.
January CT, Wann LS, Calkins H et al. 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society in Collaboration With the Society of Thoracic Surgeons. Circulation 140(2), e125–e151 (2019).
3.
Biosense Webster, Inc. Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation (Q-FFICIENCY). https://clinicaltrials.gov/ct2/show/NCT03775512 (8 April 2022).
4.
Stabile G, Solimene F, Calò L et al. Catheter-tissue contact force values do not impact mid-term clinical outcome following pulmonary vein isolation in patients with paroxysmal atrial fibrillation. J. Interv. Card. Electrophysiol. 42(1), 21–26 (2015).
5.
Reddy VY, Grimaldi M, De Potter T et al. Pulmonary Vein Isolation With Very High Power, Short Duration, Temperature-Controlled Lesions: The QDOT-FAST Trial. JACC Clin. Electrophysiol. 5(7), 778–786 (2019).
6.
Richard Tilz R, Sano M, Vogler J et al. Very high-power short-duration temperature-controlled ablation versus conventional power-controlled ablation for pulmonary vein isolation: the fast and furious - AF study. Int. J. Cardiol. Heart Vasc. 35, (2021).
7.
Osorio J, Hussein AA, Delaughter MC et al. for the Q-FFICIENCY Trial Investigators. Very high-power short-duration, temperature-controlled radiofrequency ablation in paroxysmal atrial fibrillation: the prospective multicenter Q-FFICIENCY Trial. JACC Clin. Electrophysiol. 9(4), 468–480 (2023).
•• This article presents the primary outcomes and study characteristics of the Q-FFICIENCY trial.
8.
Natale A, Reddy VY, Monir G et al. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. J. Am. Coll. Cardiol. 64(7), 647–656 (2014).
•• This article presents the primary outcomes and study characteristics of the SMART-AF trial.
9.
Chinitz LA, Melby DP, Marchlinski FE et al. Safety and efficiency of porous-tip contact-force catheter for drug-refractory symptomatic paroxysmal atrial fibrillation ablation: results from the SMART SF trial. Europace 20(Fi_3), f392–f400 (2018).
•• This article presents the primary outcomes and study characteristics of the SMART-SF trial.
10.
Li F, Morgan KL, Zaslavsky AM. Balancing covariates via propensity score weighting. J. Am. Stat. Assoc. 113(521), 390–400 (2018).
•• This article outlines recommendations on methods for balancing characteristics using propensity score weighting.
11.
Phillippo DM, Ades AE, Dias S, Palmer S, Abrams KR, Welton NJ. Methods for population-adjusted indirect comparisons in health technology appraisal. Med. Decis. Making 38(2), 200–211 (2018).
12.
Xu M, Yang Y, Zhang D, Jiang W. Meta-analysis of high power short duration in atrial fibrillation ablation – a superior efficient ablation strategy. Acta Cardiol. 77(1), 14–32 (2022).
13.
Khanra D, Hamid A, Deshpande S et al. Meta-analysis comparing outcomes of high-power short-duration and low-power long-duration radiofrequency ablation for atrial fibrillation. Anatol. J. Cardiol. 26(1), 2–14 (2022).
14.
Maan A, Bode WD, Heist EK et al. Outcome of high-power short-duration radiofrequency ablation in combination with half-normal saline irrigation for the treatment of atrial fibrillation. Pacing Clin. Electrophysiol. 45(1), 43–49 (2022).
15.
Park JW, Yang SY, Kim M et al. Efficacy and safety of high-power short-duration radiofrequency catheter ablation of atrial fibrillation. Front. Cardiovasc. Med. 8, (2021).
16.
Ferreira-Martins J, Howard J, Al-Khayatt B et al. Outcomes of paroxysmal atrial fibrillation ablation studies are affected more by study design and patient mix than ablation technique. J. Cardiovasc. Electrophysiol. 29(11), 1471–1479 (2018).
17.
Aguilar M, Macle L, Deyell MW et al. Influence of monitoring strategy on assessment of ablation success and postablation atrial fibrillation burden assessment: implications for practice and clinical trial design. Circulation 145(1), 21–30 (2022).
18.
Ziegler PD, Koehler JL, Mehra R. Comparison of continuous versus intermittent monitoring of atrial arrhythmias. Heart Rhythm 3(12), 1445–1452 (2006).
•• This article describes the association between the observed rate of postablation atrial tachyarrhythmia recurrence and arrhythmia monitoring strategy used, noting that between-trial discrepancy in outcomes may reflect different monitoring protocols.
19.
Senatore G, Stabile G, Bertaglia E et al. Role of transtelephonic electrocardiographic monitoring in detecting short-term arrhythmia recurrences after radiofrequency ablation in patients with atrial fibrillation. J. Am. Coll. Cardiol. 45(6), 873–876 (2005).
20.
Piorkowski C, Kottkamp H, Tanner H et al. Value of different follow-up strategies to assess the efficacy of circumferential pulmonary vein ablation for the curative treatment of atrial fibrillation. J. Cardiovasc. Electrophysiol. 16(12), 1286–1292 (2005).
21.
Dagres N, Kottkamp H, Piorkowski C et al. Influence of the duration of Holter monitoring on the detection of arrhythmia recurrences after catheter ablation of atrial fibrillation: implications for patient follow-up. Int. J. Cardiol. 139(3), 305–306 (2010).
22.
Faria R, Hernandez M, Manca A, Wailoo A. The use of observational data to inform estimates of treatment effectiveness in technology appraisal: methods for comparative individual patient data: NICE DSU technical support document. NICE, Sheffield, UK (2022). https://www.sheffield.ac.uk/sites/default/files/2022-02/TSD17-DSU-Observational-data-FINAL.pdf
23.
Naniwadekar A, Dukkipati SR. High-power short-duration ablation of atrial fibrillation: a contemporary review. Pacing Clin. Electrophysiol. 44(3), 528–540 (2021).
24.
Althoff TF, Mont L. Novel concepts in atrial fibrillation ablation-breaking the trade-off between efficacy and safety. J. Arrhythm 37(4), 904–911 (2021).
25.
Klein G, Lickfett L, Schreieck J et al. Comparison of ‘anatomically designed’ and ‘point-by-point’ catheter ablations for human atrial fibrillation in terms of procedure timing and costs in German hospitals. Europace 17(7), 1030–1037 (2015).
26.
Yildiz M, Yilmaz Ak H, Oksen D, Oral S. Anesthetic management in electrophysiology laboratory: a multidisciplinary review. J. Atr. Fibrillation 10(5), 1775 (2018).