Comprehensive Supporting Evidence
At St. Jude Medical, our goal is to advance the treatment of cardiac arrhythmias with innovations that improve both cost savings and clinical outcomes.
Economic impact of AF ablation first-procedure success using the TactiCath™ Quartz catheter1,2
A recent publication by Moussa Mansour et al. demonstrates that for patients undergoing repeat ablations, the cost of care increases approximately four times—to $52,821—in the first year after ablation and remained forty-six percent higher, even when excluding the cost associated with the additional ablation procedures.2
Cost of care remained 46% higher for repeat ablations, even excluding the cost associated with the additional procedures.2
Another analysis showed that the use of optimal contact force guided AF ablationa with the TactiCath™ Quartz catheter resulted in fewer post ablation clinical events, translating to a 15-percent reduction in post ablation management costs ($3,402 savings per patient) in the year after ablation, compared with patients who were treated with a non-contact force ablation catheter.1
Read the article.
Comprehensive clinical studies
Over the years, the TactiCath™ Quartz ablation catheter has been involved in the most comprehensive set of clinical studies3-6 on contact force (CF) sensing; these studies provide evidence to recommend contact force management to optimize patient outcomes.4-7
Data from studies such as TOCCATA, EFFICAS I and EFFICAS II show that CF sensing is not only safe for use in pulmonary vein isolation (PVI) but also associated with lower rates of PV reconnection and atrial fibrillation (AF) recurrence.4-7 As the cost of care has been reported to increase approximately four times in the first year after ablation for patients with repeat ablations, increased effectiveness of single ablation procedures for AF could substantially decrease health care costs for patients undergoing these procedures.8
TactiCath™ Quartz Ablation Catheter Study Highlights
Contact Force Recommendations6,7
TOCCASTAR Effectiveness: Optimal Contact Forcea Clinical Studies9
TOCCATA Clinical Trial
The purpose of the TOCCATA clinical trial was to evaluate the safety and efficacy of CF sensing during ablation procedures.4,5
- Real-time CF sensing is safe for use in RF ablation of SVT and AF.4
- There is little correlation between tactile feel and real contact force applied, resulting in high variability of forces applied between users when CF information is not available.
- High CFs may occur during catheter manipulation and not just during ablation, suggesting that measuring CF may provide additional useful information to the operator for safe catheter manipulation.
- TOCCATA was the first multicenter trial that used a direct CF catheter in human subjects.
- The TOCCATA study results were the first to show that CF > 20 g is most likely to result in durable PVI at 12 months, while CF < 10 g is associated with unsuccessful PVI.5
- Using the TactiCath ablation catheter to measure CF helps ensure successful PVI regardless of anatomical location.5
- At least 10 g of force is needed to provide sufficiently stable catheter tip contact. Intermittent contact is correlated with low CF (p < 0.001).5
- TOCCATA validated the safety and feasibility of force-sensing, while confirming the importance of contact force (CF) technology.4,5
Recurrence Rates by Average Ablation Contact Force5
EFFICAS I and II Clinical Studies
EFFICAS is a pair of studies to (I) identify and (II) validate CF recommendations to ensure pulmonary vein isolation.
- Minimum CF and minimum FTI™ values are strong predictors of PVI gap likelihood.6
- Durable PV isolation appears to be further improved when ablation lesions are created point-by-point continuously around the PV using a low Continuity Index™ (CI).7
- The EFFICAS I trial provided the CF recommendations of a target CF of 20 g, minimum CF ≥ 10 g, minimum FTI of 400 gs, targeting transmurality in a single RF application.6
- EFFICAS II provided clinical validation that following recommendations to optimize catheter contact force (target CF = 20 g, minimum CF ≥ 10 g, minimum FTI ≥ 400 gs) and creating a contiguous lesion in a single RF application (low CI < 6) can achieve successful PV isolation.7
- Optimal contact force with the TactiCath ablation catheter and contiguous lesion deployment reduces occurrence of PV gaps at 3 months.7
Read more about the EFFICAS II study.
EFFICAS I and II Clinical Study Summary6,7
EFFICAS I: PVI Success Rates by Minimum FTI6
EFFICAS II: Continuity Index7
EFFICAS I and EFFICAS II Clinical Comparison6,7
TOCCASTAR Clinical Trial9
The TOCCASTAR trial (TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation) is the only prospective, randomized, controlled, multicenter study conducted to date to evaluate the safety and effectiveness of a contact force sensing ablation catheter for the treatment of symptomatic paroxysmal AF.9
- The TOCCASTAR trial successfully met its primary safety and efficacy endpoints demonstrating the safety and effectiveness of the TactiCath™ Contact Force ablation catheter for the treatment of drug-refractory recurrent symptomatic paroxysmal atrial fibrillation.
- TactiCath ablation catheter safety results were excellent with 0.7% tamponade.9 (Previous SMART-AF results reported tamponade at 2.5%.a,10)
- Physicians who used Optimal CFb achieved 12-month clinical success in 85.5% of patients versus 67.7% when Non-optimal CFc was used.a,b,c
- This is consistent with findings from the TOCCATA and EFFICAS studies that fewer lesions at CF < 10 g correlates with increased treatment success.5-7
- Optimal CFb procedures were associated with similar or lower RF power than non-optimal CF procedures.9
- Optimal CF group had a 7.2% rate of repeat ablation as compared to 12.7% for the control group and 16.1% for the non-optimal CF group at 12 months.9
Contact Force and Control: Rate of Repeat Ablation
Read comprehensive information on these clinical studies:
TactiCath™ Quartz Ablation Catheter Clinical Compendium
Comprehensive cardiac ablation therapy and arrhythmia management
The TactiCath Quartz ablation catheter is part of our advanced ablation and mapping portfolio. As a leader in ablation and mapping technology, our vision is to transform the treatment of cardiac arrhythmias by designing outcome-driven and cost-effective technologies. Read more about the portfolio and our approach to cardiac arrhythmia management.