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displays the details of the patient disposition flow chart. Table 1 summarizes the demographics and pre-existing baseline medical conditions for the original SMART SF trial and for the subset of patients in the EP. Overall, the EP was similar to the full patient population. In the EP, the majority of participants were white (96.2%) and male (52.6%), with a median age of 64.8 ± 9.7 years. The most common preexisting medical conditions in the EP were hypertension (61.5%), atrial flutter (30.8%), and coronary artery disease (20.5%). All enrolled patients and patients in the EP experienced symptomatic AF for an average of 47.9 and 41.3 months prior to enrollment, respectively. The median duration from patients' initial AF diagnosis to enrollment was 24.0 months (all enrolled) and 19.5 months (EP). The mean follow-up duration for the 78 patients was 373.5 ± 45.38 days from index procedure. Compared with those who elected not to be included in the study extension through 12 months of follow-up (non-EP), patients in the EP (n = 78) had a slightly higher proportion of female participants (47.4% vs. 32.5%), higher mean age (64.8 vs. 60.5 years), higher proportion of patients with coronary artery disease (20.5% vs. 15.6%), and more symptomatic AF at baseline.
Source publication
PurposeThe prospective, multicenter SMART SF trial demonstrated the acute safety and effectiveness of the 56-hole porous tip irrigated contact force (CF) catheter for drug-refractory paroxysmal atrial fibrillation (PAF) ablation with a low primary adverse event rate (2.5%), leading to FDA approval of the catheter. Here, we are reporting the long-te...
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Background
Following cavotricuspid isthmus (CTI) ablation, many patients with atrial flutter (AFL) are diagnosed with atrial fibrillation (AF). The incidence, duration, pattern, and burden of AF remain undefined. These may have implications for the management of these patients.
Objective
To classify the incidence, duration, pattern, and burden of...
Citations
... Moreover, a retrospective study by Baher et al. depicted a similarity in AF recurrence rates between HPSD and LPLD ablation at a mean follow-up period of 2.5 years (42% vs. 41%, respectively, p � 0.571) [23]. It is worth noting that the STSF catheter is superior to the ST catheter in ablation efficacy [24,25], and that PVI by the STSF catheter reduces the rate of early reconnections of the left PV [26]. Likewise, there was a trend toward improved efficacy of the STSF ablation catheter compared to the ST device in the Kaplan-Meier estimation of 12-month arrhythmia-free survival (NS, p � 0.18) [27]. ...
Objectives:
To investigate the procedural efficiency, efficacy, and safety of high-power, short-term radiofrequency ablation delivered by the SmartTouch Surround Flow (STSF) catheter for paroxysmal atrial fibrillation (AF).
Methods:
We retrospectively analyzed a total of 72 patients who were admitted with paroxysmal AF, and who underwent radiofrequency catheter ablation (RFCA) for the first time. Of these patients, 36 cases underwent low-power, long-duration (LPLD, (30-35 W/20-40 s) pulmonary vein isolation (PVI) delivered by an SmartTouch (ST) catheter (control group), and the other 36 cases underwent high-power, short-duration (HPSD, (45-50 W/10-20 s) PVI delivered by a STSF catheter (study group). The baseline data, duration of PVI, procedural time, fluoroscopy time, the rate of first-pass isolation, irrigation perfusion, eschar and steam pop occurrences, intraoperative complications, and the rate of stable sinus rhythm maintenance following a blanking period of three months were analyzed between the two groups.
Results:
The isolation time of bilateral PVI and procedural time in the study group were markedly less than in controls (p < 0.01). The rate of first-pass isolation in the study group was significantly higher than in the control group (95.8% vs. 84.7%, p = 0.023), while the fluid perfusion in the study group was approximately 20% less than that in the control group (767 ± 171 vs. 966 ± 227 ml, p < 0.001). We observed no severe complications in any patients. The rate of freedom from AF recurrences following a blanking period of three months showed a tendency to be higher than in controls (93.9% vs. 87.1%, p = 0.348).
Conclusions:
The HPSD strategy delivered by the STSF catheter was superior to conventional LPLD ablation through the ST catheter with respect to efficiency, acute procedural effectiveness, short-term safety, and the risk of heart failure in patients with paroxysmal AF.
... The benefits of a CFS in these procedures allow the operator to perform ablations at an optimal CF range for effective lesion formation. The incorporation of CF feedback can potentially reduce operational time, reduce radiation dosage, improve procedural efficacy, enhance academic training, and improve safety [37][38][39][40]. ...
Introduction:
Advances in catheter design for minimally invasive surgery have brought about the incorporation of contact force (CF) sensors in catheters. Two main approaches to achieve CF sensing at the catheter end-effector consists of fiber optic or magnetic solutions. CF sensing feedback can be used to assist in ablation procedures, mapping cardiac regions, identifying tissue characteristics and enhancing robotic catheter control.
Areas covered:
This review covers the technological and clinical aspects of CFS's in catheters. Contact force and force-time integral thresholds in ablation procedures, procedural complications, and electroanatomical mapping strategies are discussed. Future applications of improving catheter control, minimizing complications and enhancing mapping techniques through CF is examined.
Expert opinion:
Fiber optic CF catheters may be more desirable compared to magnetic modalities due to the lower cost, compactness and higher accuracy. In ablation procedures, complications due to higher ablation duration, power, contact force and force time can be reduced through practical experience and informed training for catheter operators. Future prospects consist of the incorporation of CF sensors with remote catheter systems to assist in catheter control. We propose that CF can also be used in machine learning decision-making algorithms to prevent complications or improve tissue characterization.
Background:
QDOT MICRO (QDM) is a novel contact force-sensing catheter optimized for temperature-controlled radiofrequency (RF) ablation. The very high-power short-duration (vHPSD) algorithm modulates power, maintaining target temperature during 90 W ablations for ≤4 seconds.
Objectives:
This study aims to evaluate safety and 12-month effectiveness of the QDM catheter in paroxysmal atrial fibrillation (AF) ablation using the vHPSD mode combined with conventional-power temperature-controlled (CPTC) mode.
Methods:
In this prospective, multicenter, nonrandomized study, patients with drug-refractory, symptomatic paroxysmal AF underwent pulmonary vein (PV) isolation with QDM catheter with vHPSD as primary ablation mode, with optional use of the CPTC mode (25 to 50 W) for PV touch-up or non-PV ablation. The primary safety endpoint was incidence of primary adverse events within ≤7 days of ablation. The primary effectiveness endpoint was freedom from documented atrial tachyarrhythmia recurrence and acute procedural, repeat ablation, and antiarrhythmic drug failure.
Results:
Of 191 enrolled participants, 166 had the catheter inserted, received RF ablation, and met eligibility criteria. Median procedural, RF application for ablating PVs, and fluoroscopy times were 132.0, 8.0, and 9.1 minutes, respectively. The primary adverse event rate was 3.6%. Imaging conducted in a subset of participants (n = 40) at 3 months did not show moderate or severe PV stenosis. The Kaplan-Meier estimated 12-month rate for primary effectiveness success was 76.7%; freedom from atrial tachyarrhythmia recurrence was 82.1%; clinical success (freedom from symptomatic recurrence) was 86.0%; and freedom from repeat ablation was 92.1%.
Conclusions:
Temperature-controlled paroxysmal AF ablation with the novel QDM catheter in vHPSD mode (90 W, ≤4 seconds), alone or with CPTC mode (25 to 50 W), is highly efficient and effective without compromising safety. (Evaluation of QDOT MICRO Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation [Q-FFICIENCY]; NCT03775512.).
