Temperature-controlled Radiofrequency Research Articles

Twelve-month outcomes following temperature-controlled radiofrequency treatment of the septal swell body for nasal airway obstruction.

Improved nasal airway obstruction (NAO) symptoms were reported at 3 months following temperature-controlled radiofrequency (TCRF) treatment of the septal swell body (SSB). This report provides results from assessments of the long-term safety and efficacy of TCRF treatment of SSB hypertrophy to treat NAO through 12 months posttreatment. This prospective, multicenter, long-term, open-label study was conducted in nine centers within the United States and included patients with severe/extreme NAO attributed to SSB hypertrophy. Outcome measures included assessments of Nasal Obstruction Symptom Evaluation Score (NOSE), Numeric Rating Scale (NRS) ease-of-breathing, patient satisfaction, and adverse events at 6 and 12 months. Of the 70 patients treated, 65 and 62 patients completed the 6- and 12-month follow-up assessments. Compared to baseline, there was a 67.5% decrease in adjusted mean NOSE scores at 6 months (mean change -49.6, 95% confidence interval [CI] -54.8 to -44.4; p<0.001) and a 65.4% decrease at 12 months (mean change -48.1, 95% CI -53.7 to -42.5); p<0.001), which is consistent with previously published 3-month results. A 62.0% and 62.5% improvement compared to baseline was observed in the NRS ease-of-breathing score at 6 and 12 months, respectively (p<0.001). No serious adverse were reported overall and no new device- or procedure-related adverse events were reported in the interval between 3 and 12 months posttreatment. TCRF treatment of SSB hypertrophy has a significant and durable effect on improving the symptoms of NAO and health-related quality of life in patients with symptoms of nasal obstruction and congestion through 12 months postprocedure.

Two-year outcomes of radiofrequency device treatment of the nasal valve for nasal airway obstruction.

Temperature-controlled radiofrequency (TCRF) device treatment of nasal valve dysfunction (NVD) was superior to a sham procedure control in reducing the symptoms of nasal airway obstruction (NAO) in this randomised controlled trial (RCT). Two-year outcomes for 108 patients actively treated in a prospective, multicenter, patient-blinded RCT were used to determine treatment effect durability and changes in medication/nasal dilator usage. A responder was defined as ≥ 20 reduction in NOSE score or 1 reduction in severity class. The mean (SD) age of patients was 48.5 (12.3) years; 66 (61.1%) women. Baseline NOSE score was 76.3. The 2-year responder rate was 90.4% and NOSE score treatment effect was -41.7; 54.7% improvement. Of 57 patients using medications/nasal dilators at baseline, 45 (78.9%) either stopped all use (33.3%) or stopped/decreased (45.6%) use in >=1 class at 2 years. Concurrent septal deviation, septal swell body, or turbinate enlargement did not significantly affect the odds of exhibiting a NOSE score of ≤ 25 at 2 years. TCRF device treatment of NVD resulted in significant and sustained improvements in the symptoms of NAO at 2 years, accompanied by a substantial reduction in medication/nasal dilator use.

Safety and efficacy of a temperature-controlled ablation system for ventricular tachycardia: first results from the TRAC-VT study

Abstract Background Catheter ablation using radiofrequency (RF) energy, is a well-recognized treatment option for patients with ventricular arrhythmias. However, procedural complications may be high, and efficacy is often suboptimal with high recurrence rates. Purpose The TRAC-VT study evaluated safety and efficacy of the DiamondTemp Ablation (DTA) System for the treatment of patients with ventricular arrhythmias by catheter ablation. Methods A temperature-controlled, irrigated RF catheter (with six thermocouples and an internal network of diamond coatings) was utilized to treat subjects with either sustained monomorphic ventricular tachycardia (VT) and structural heart disease or with frequent monomorphic symptomatic ventricular premature beats (VPBs) and normal hearts. Patients were enrolled at five hospital centers in five European countries and were followed for 6 months. Ablation was performed in temperature-control mode with an irrigation flow of 8 mL/min for all power deliveries. The target temperature was set to 55 or 60 °C with a power output limited to 50 Watts. RF energy was applied for a maximum of 45 seconds per target site, depending on impedance drop and electrogram abatement. Results The study enrolled 49 subjects (age 67±12 years, 80% male) in total (38 with sustained monomorphic VT and structural heart disease and 11 with symptomatic VPBs). In all cases, mapping and navigation was used with EnSite systems (Abbott). The average ablation time (defined as time from the insertion of the DTA catheter until removal from body) was 87 ± 44 minutes. During this time, RF energy was applied for an average of 28.2 ± 10.2 seconds with a power of 44.0 ± 7.0 W and a temperature of 50.9 ± 3.9 °C during 35.0 ± 23.2 applications. Acute procedural success was 100% (93%-100%), and it was defined as the elimination of VPBs or non-inducibility for sustained VT (using solely the DTA catheter). The primary safety procedure-related endpoint was an evaluation of cardiovascular-related death, stroke / TIA, cardiac tamponade/perforation, bleeding complication, myocardial infarction, thromboembolism, and pulmonary edema. In total review of the primary safety endpoint, one subject had a confirmation of a stroke / TIA event. Regarding longer term procedural efficacy, the 6-month follow-up was completed in 92% of subjects. For the whole study population chronic success from recurrence of ventricular arrhythmia (faster than 100 beats/min after 6 months) was 73.4% (58.6%-83.6%) for non-sustained ventricular arrhythmias (≥3 beats) and 87.7% (74.7%-94.3%) for sustained ventricular arrhythmias (≥30 sec). Conclusions VT/VPBs ablation using a temperature-controlled irrigated RF catheter was safe and effective with low VT recurrence at 6 months of follow-up.

Optimized workflow for pulmonary vein isolation using very high power short duration radiofrequency ablation

Abstract Background Point-by-point radiofrequency ablation is the most used invasive treatment of atrial fibrillation (AF). However, single-shot technologies are largely widespread due to their proved safety and efficacy. QDOT MICRO (QDM) is a novel contact force–sensing catheter optimized for temperature-controlled radiofrequency (RF) ablation that allows to maintain target temperature during 90 W ablations for ≤4 seconds. Purpose This study evaluates procedural safety and effectiveness as well as long-term effects of an optimized procedural workflow using QDM catheter to perform wide atrial circumferential ablation in patients with paroxysmal AF. Methods Consecutive patients referred for paroxysmal AF first ablation through pulmonary vein isolation (PVI) were prospectively enrolled. Every procedure was performed in general anesthesia by using CARTO3 Electroanatomical Mapping System BiosenseWebster QDM catheter and Deflectable Sheet VIZIGO as single sheet in left atrium. VHPSD was performed to encircling the posterior wall, while conventional-power temperature-controlled (CPTC) mode was used to encircling the anterior wall. 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 120 enrolled participants (61 ± 12 years, 45% female) met eligibility criteria. Median procedural skin-to-skin time and RF application for ablating PVs were 56 and 17 minutes, respectively. Median ablation time was 22 minutes. First-pass isolation (entrance and exit block validation) was obtained in 98 % and inter-lesion distance was 4,8 ± 0,8 mm. In 100% of patients PVI was obtained without adverse events. The Kaplan-Meier estimated 12-month rate for clinical success (freedom from symptomatic recurrence of AF) was 93%, freedom from AF was 89% Conclusions PVI performed with point by point optimized workflow using VHPSD RF catheter in combination with steerable sheet is highly efficient and effective without compromising safety.

Economic impact analysis of a minimally invasive temperature-controlled radiofrequency device versus nasal surgery for the treatment of nasal airway obstruction in the United States

Objective To determine the economic impact of a minimally invasive temperature-controlled radiofrequency (TCRF) device for treating nasal airway obstruction (NAO). Methods A budget impact model was developed for two scenarios: a reference scenario of functional rhinoplasty surgery with concomitant septoplasty and inferior turbinate reduction (ITR) performed in the hospital outpatient department where TCRF is not an available treatment option and a new scenario consisting of in-office TCRF treatment of the nasal valve and ITR. A payor perspective was adopted with a hypothetical population plan size of one million members. Costs were estimated over a time horizon of 4 years. The eligible population included patients with severe/extreme NAO and nasal valve collapse (NVC) as the primary cause or significant contributor. Data inputs were sourced from targeted literature reviews. Uncertainty within the model structure and input parameters was assessed using one-way sensitivity analysis. Results The introduction of a TCRF device resulted in population-level cost savings of $20,015,123 and per-responder average cost savings of $3531 through a 4-year time horizon due to lower procedure costs and complication rates of the device relative to the surgical comparator. Results were robust when varying parameter values in sensitivity analyses, with cost savings being most sensitive to the prevalence of NAO and estimated response rates to functional rhinoplasty and TCRF. Conclusions In patients with severe/extreme NAO, with NVC as the primary or major contributor, introducing TCRF with ITR as a treatment option demonstrates the potential for significant cost savings over functional rhinoplasty with septoplasty and ITR.

Radiofreqency device as an alternative therapy for refractory nasal valve collapse

A clinical decision report using: Silvers SL, Rosenthal JN, McDuffie CM, Yen DM, Han JK. Temperature-controlled radiofrequency device treatment of the nasal valve for nasal airway obstruction: A randomized controlled trial. Int Forum Allergy Rhinol. 2021 Dec;11(12):1676-1684. http://doi.org/10.1002/alr.22861 for a patient with nasal valve collapse.

Durable pulmonary vein isolationwith optimized high-power and very high-power short-duration temperature-controlled ablation: A step-by-step guide.

Through systematic scientific rigor, the CLOSE guided workflow was developed and has been shown to improve pulmonary vein isolation durability. However, this technique was developed at a time when using power-controlled ablation catheters with conventional power ranges was the norm. There has been increased adoption of a high-power and very high-power short-duration ablation practice propelled by the availability of the temperature-controlled radiofrequency QDOT MICRO catheter. There are fundamental differences in biophysics between very high-powered temperature guided ablation and conventional ablation strategy that may impact patient outcomes. The catheter's design and ablation modes offer flexibility in technique while accommodating the individual operator's clinical discretion and preference to deliver a durable, transmural, and contiguous lesion set. Here, we provide recommendations for 3 different workflows using the QDOT MICRO catheter in a step-by-step manner for pulmonary vein isolation based on our cumulative experience as early adopters of the technology and the data available in the scientific literature. With standardization, temperature-controlled ablation with the QDOT MICRO catheter provides operators the flexibility of implementing different ablation strategies to ensure durable contiguous pulmonary vein isolation depending on patient characteristics.

Comparison of nasal valve dysfunction treatment outcomes for temperature-controlled radiofrequency and functional rhinoplasty surgery: a systematic review and meta-analyses.

Nasal valve dysfunction (NVD) is a substantial contributor to nasal airway obstruction. Minimally-invasive temp-erature-controlled radiofrequency (TCRF) treatment of the nasal valve is available and comparison with surgical techniques is warranted. Databases: Medline (PubMed), Embase, Cochrane Library. adults with preprocedural nasal obstruction symptom evaluation (NOSE) score ≥45. Treatment effects were derived from a random effects model and reported as weighted mean difference in NOSE score between baseline; 3, 6, and 12 months postprocedure. Of 2529 initial articles, 5 studies describing TCRF treatment and 63 studies describing functional rhinoplasty were included. Pooled effect sizes for TCRF treatment and functional rhinoplasty were comparable in all analyses. TCRF treatment of the internal nasal valve for NVD was associated with sustained effects comparable to functional rhinoplasty addressing the nasal valve only, rhinoplasty without concomitant turbinate treatment, and all rhinoplasty.

Two-year outcomes of radiofrequency device treatment of the nasal valve for nasal airway obstruction

BACKGROUND: Temperature-controlled radiofrequency (TCRF) device treatment of nasal valve dysfunction (NVD) was superior to a sham procedure control in reducing the symptoms of nasal airway obstruction (NAO) in this randomised controlled trial (RCT). METHODOLOGY: Two-year outcomes for 108 patients actively treated in a prospective, multicenter, patient-blinded RCT were used to determine treatment effect durability and changes in medication/nasal dilator usage. A responder was defined as ≥20% reduction in NOSE score or ≥1 reduction in severity class. RESULTS: The mean (SD) age of patients was 48.5 (12.3) years; 66 (61.1%) women. Baseline NOSE score was 76.3. The 2-year responder rate was 90.4% and NOSE score treatment effect was −41.7; 54.7% improvement. Of 57 patients using medications/nasal dilators at baseline, 45 (78.9%) either stopped all use (33.3%) or stopped/decreased (45.6%) use in ≥1 class at 2 years. Concurrent septal deviation, septal swell body, or turbinate enlargement did not significantly affect the odds of exhibiting a NOSE score of ≤25 at 2 years. CONCLUSIONS: TCRF device treatment of NVD resulted in significant and sustained improvements in the symptoms of NAO at 2 years, accompanied by a substantial reduction in medication/nasal dilator use.

Two-Year Outcomes After Radiofrequency Neurolysis of Posterior Nasal Nerve in Chronic Rhinitis.

To assess the long-term safety and effectiveness of temperature-controlled radiofrequency (TCRF) neurolysis of the posterior nasal nerve (PNN), a minimally invasive treatment for chronic rhinitis. A prospective, single-arm study of 129 patients at 16 centers (United States, Germany) was conducted. Patient-reported outcome measures were the 24-h reflective total nasal symptom score (rTNSS) and mini rhinoconjunctivitis quality of life questionnaire (MiniRQLQ). Postnasal drip and cough symptoms were assessed using a 4-point scale. The mean pretreatment rTNSS was 7.8 (95% CI, 7.5-8.1). The significant rTNSS treatment effect at 3 months (-4.2 [95% CI, -4.6 to -3.8]; p < 0.001) was sustained through 2 years (-4.5 [95% CI, -5.0 to -3.9]; p < 0.001), a 57.7% improvement. At 2 years, the proportion of patients with a minimal clinically important difference (MCID) of ≥30% improvement in rTNSS from baseline was 80.0% (95% CI, 71.4%-86.5%). Individual postnasal drip and cough symptom scores were significantly improved from baseline through 2 years. The proportion of patients who reached the MCID for the MiniRQLQ (≥0.4-point improvement) at 2 years was 77.4% (95% CI, 68.5%-84.3%). Of 81 patients using chronic rhinitis medications at baseline, 61.7% either stopped all medication use (28.4%) or stopped or decreased (33.3%) use of ≥1 medication class at 2 years. No device/procedure-related serious adverse events were reported throughout 2 years. TCRF neurolysis of the PNN resulted in sustained improvements in chronic rhinitis symptom burden and quality of life through 2 years, accompanied by a substantial decrease in medication burden. 4 Laryngoscope, 134:2077-2084, 2024.

Paroxysmal atrial fibrillation ablation with a novel temperature-controlled CF-sensing catheter: Q-FFICIENCY clinical and healthcare utilization benefits.

The prospective, nonrandomized, multicenter Q-FFICIENCY study demonstrated the safety and 12-month efficacy of paroxysmal atrial fibrillation (AF) ablation with the novel QDOT MICRO temperature-controlled, contact force-sensing, radiofrequency (RF) catheter. Participants underwent pulmonary vein isolation with very high-power short-duration (vHPSD) mode (90 W, ≤4 s) alone or combined with conventional-power temperature-controlled (CPTC) mode (25-50 W). This study aimed to assess quality-of-life (QOL) and healthcare utilization (HCU) benefits experienced by Q-FFICIENCY study participants. Besides evaluating procedural efficiency, QOL and HCU were assessed through 12 months postablation via Atrial Fibrillation Effect on Quality-of-Life Tool (AFEQT) score, antiarrhythmic drug (AAD) use, and incidence of cardioversion and cardiovascular hospitalization. Of 191 participants enrolled, 166 were ablated with the new catheter. Compared to baseline, statistically significant, clinically meaningful improvements in composite and subcategories of AFEQT scores were observed at 3 months and sustained through 12 months (12-month increase, 29.3-44.2 points). Class I/III AAD use decreased from 97.6% (162/166) at baseline to 19.6% (31/158) during Months 6-12, representing a significant 79.9% reduction. The cardioversion rate significantly declined by 93.9% from 31.3% (12 months preablation) to 1.9% (evaluation period). One-year Kaplan-Meier estimates of freedom from all-cause and cardiovascular hospitalization were 80.9% (95% confidence interval [CI], 74.8%-86.9%) and 88.8% (95% CI, 84.0%-93.7%), respectively. Paroxysmal AF ablation with the novel temperature-controlled RF catheter in vHPSD mode, alone or with CPTC mode, led to clinically meaningful improvement in QOL and significant reduction in AAD use, cardioversion, and cardiovascular hospitalization.

Therapeutic effect of the temperature-controlled radio frequency technology in female sexual dysfunction.

To explore the therapeutic effect of the temperature-controlled radiofrequency technology in female sexual dysfunction (FSD). From July 2020 to June 2021, patients with FSD who visited the Gynecology Clinic of Peking University Shenzhen Hospital were treated with the temperature-controlled radiofrequency technology once every two weeks, for a total of five times. The therapeutic effect was objectively evaluated with pelvic floor dysfunction (PFD) indicators (FSFI score, pelvic floor muscles surface electromyography, sexual function test). The pre- and post-treatment (2 weeks)/follow-up (3 months) results were compared to evaluate the feasibility of this technology for treating FSD, as well as using PFD-related indicators in objective evaluation of FSD patients. Fifty patients completed treatment; 31 patients completed follow-up. The mean FSFI score for post-treatment/follow-up was significantly higher than pre-treatment (p < 0.05). There were no significant changes in the mean pelvic floor resting surface myoelectric potential and its variability and mean myoelectric potential of sexual function test between pre- and post-treatment/follow-up. The mean surface myoelectric potential of the patients' type I and II muscle fibers of the pelvic floor for post-treatment/follow-up was significantly higher than pre-treatment (p < 0.05). The mean peak myoelectric potential for post-treatment was significantly higher than pre-treatment (p < 0.05). Temperature-controlled radiofrequency technology has a certain therapeutic effect on FSD. Pelvic floor surface electromyography and sexual function test can be used as an objective indicator for PFD in FSD patients. Subsequent studies may involve a larger size sample and evaluate the effect over a consecutive time-point, to develop a better therapeutic approach.

Power-Controlled, Irrigated Radio-Frequency Ablation of Gastric Tissue: A Biophysical Analysis of Lesion Formation

BackgroundRadio-frequency ablation of gastric tissue is in its infancy compared to its extensive history and use in the cardiac field.AimsWe employed power-controlled, irrigated radio-frequency ablation to create lesions on the serosal surface of the stomach to examine the impact of ablation power, irrigation, temperature, and impedance on lesion formation and tissue damage.MethodsA total of 160 lesions were created in vivo in female weaner pigs (n = 5) using a combination of four power levels (10, 15, 20, 30 W) at two irrigation rates (2, 5 mL min−1) and with one temperature-controlled (65 °C) reference setting previously validated for electrophysiological intervention in the stomach.ResultsPower and irrigation rate combinations above 15 W resulted in lesions with significantly higher surface area and depth than the temperature-controlled setting. Irrigation resulted in significantly lower temperature (p < 0.001) and impedance (p < 0.001) compared to the temperature-controlled setting. No instances of perforation or tissue pop were recorded for any ablation sequence.ConclusionPower-controlled, irrigated radio-frequency ablation of gastric tissue is effective in creating larger and deeper lesions at reduced temperatures than previously investigated temperature-controlled radio-frequency ablation, highlighting a substantial improvement. These data define the biophysical impact of ablation parameters in gastric tissue, and they will guide future translation toward clinical application and in silico gastric ablation modeling.Graphical Combination of ablation settings (10–30 W power, 2–5 mL min-1 irrigation) were used to create serosal spot lesions. Histological analysis of lesions quantified localized tissue damage.

Postnasal drip and chronic cough in patients with chronic rhinitis treated with temperature-controlled radiofrequency neurolysis.

To evaluate the contribution of postnasal drip (PND) and chronic cough (CC) to symptoms of patients with chronic rhinitis treated with temperature-controlled radiofrequency (TCRF) neurolysis of the posterior nasal nerve (PNN), and correlate PND and CC scores with components of the reflective total nasal symptom score (rTNSS). Pooled data from three prospective studies: two single-arm studies and the index active treatment arm of a randomized controlled trial. Adult patients with baseline rTNSS ≥6 were treated with TCRF neurolysis at nonoverlapping regions of the PNN. PND and CC symptoms were evaluated on a 0 (none) to 3 (severe) scale. Data from 228 patients (57.9% women, 42.1% men) were included. The mean baseline rTNSS was 8.1 (95% confidence interval [CI], 7.8-8.3), which decreased to 3.2 (95% CI, 2.9-3.5) at 6 months. At baseline, 97.4% of patients had PND and 80.3% had CC. Median baseline PND and CC symptom scores were 3 (interquartile range [IQR], 2-3) and 2 (IQR, 1-2), respectively. At 6 months, this decreased to 1 (IQR, 0-2) and 0 (IQR, 0-1), respectively, showing significant improvement from baseline (both p<0.001). Spearman correlation coefficients with components of rTNSS (rhinorrhea, congestion, itching, sneezing) were 0.16 to 0.22 for CC and 0.19 to 0.46 for PND, indicating only a weak to moderate correlation. PND and CC contribute to the symptomatology of chronic rhinitis and are significantly improved after TCRF neurolysis of the PNN. The inclusion of PND and CC symptoms in a chronic rhinitis assessment instrument could provide important additional information for the characterization of the disease state and outcomes after any therapeutic treatment.

Radiofrequency Neurolysis of the Posterior Nasal Nerve: A Systematic Review and Meta-Analysis.

Temperature-controlled radiofrequency neurolysis of the posterior nasal nerve (PNN) has been approved for use since 2020. This review synthesized the published data to assess its efficacy for treatment of chronic rhinitis. Pubmed/Medline, Embase, Scopus, Web of Science. A systematic search was conducted with no restrictions on publication years in April 2023. RCTs and prospective investigations that reported the reflective Total Nasal Symptom Score (rTNSS) outcome of radiofrequency neurolysis as a single procedure in chronic rhinitis patients were included. Pooled estimates for change in rTNSS from baseline at 3 months and responder rates (≥30% reduction in baseline rTNSS) at 3 and 6 months were obtained. Other outcomes, such as postnasal drip and cough scores, quality of life (QoL) measures, and adverse events were included for qualitative review. Five studies were included in the systematic review, of which four were included in the meta-analysis. A total of 284 participants underwent treatment. The pooled change in rTNSS score at 3 months was -4.28 (95% CI, -5.10 to -3.46). The pooled responder rate at 3 months was 77.11% (95% CI, 68.21%-86.01%) and at 6 months 80.80% (95% CI, 70.85%-90.76%). Postnasal drip and cough scores and QoL also improved significantly at follow up. A total of 36 adverse events were reported in 21 (7.4%) patients. The findings from this review suggest that temperature-controlled radiofrequency neurolysis of the PNN is effective at treating chronic rhinitis symptoms and that it has an overall favorable safety profile. Laryngoscope, 134:507-516, 2024.

Two-year outcomes of temperature-controlled radiofrequency device treatment of the nasal valve for patients with nasal airway obstruction.

The objective of this study was to evaluate long-term symptom improvements in patients with nasal airway obstruction (NAO) secondary to nasal valve collapse (NVC) following minimally invasive temperature-controlled radiofrequency (TCRF) treatment. A prospective, single-arm, multicenter study in patients >18 years with NAO due to NVC. Inclusion criteria were response to nasal valve dilation (e.g., modified Cottle maneuver) and baseline Nasal Obstruction Symptom Evaluation (NOSE) Scale score ≥60. Patients were treated in the nasal valve region with a TCRF device and followed through 2 years. A responder was ≥20% reduction NOSE Scale score or ≥1 reduction in severity class. A total of 122 patients were treated and 91 reached 2 years. The mean baseline NOSE Scale score was 80.3 (95% CI, 78.1-82.6). The adjusted mean change in score at 2 years was -45.8 (95% CI, -53.5 to -38.1), p < 0.001; a 57.0% improvement. The 2-year responder rate was 90.1% (95% CI, 82.3%-94.7%). Significant and sustained symptom improvement was achieved in subpopulations based on sex, age, body mass index, baseline NAO severity, nasal surgery history, NVC mechanism, septal deviation, and other anatomic contributors of NAO. No serious adverse events with a relationship to the study device and/or procedure were reported. Minimally invasive TCRF device treatment of the internal nasal valve for NAO is well tolerated and leads to significant and sustained improvement in NAO symptom severity through 2 years, including in patients with both static and dynamic NVC, septal deviation, turbinate enlargement, or prior nasal surgery. 2b.

EE71 Budget Impact Analysis of a Non-Invasive Temperature-Controlled Radiofrequency Device for the Treatment of Nasal Airway Obstruction

Nasal airway obstruction (NAO) is a common condition that presents with congestion and feeling of fullness in the nasal cavity. Chronic NAO presents a significant economic burden and current treatments for NAO can be invasive and costly. The objective of this study is to determine the budget impact of a non-invasive temperature-controlled radiofrequency (TCRF) device for the treatment of NAO.

Cavotricuspid isthmus ablation by means of very high power short duration temperature controlled lesions: acute and mid term outcome

Abstract Funding Acknowledgements Type of funding sources: None. Background Very high-power short-duration (vHPSD) temperature-controlled radiofrequency ablation minimizes conductive heating and increase resistive heating, achieving uniform and transmural lesion while reducing the risk of collateral tissue damages. The shape of the vHPSD lesion, wider and shallower than standard radiofrequency, raises some concerns during atrial flutter ablation (AFL). Purpose We evaluated the feasibility, efficacy and safety of the vHPSD ablation of the cavotricuspid isthmus (CTI) in patients presenting with typical AFL. Methods Sixty-one consecutive patients, with typical AFL, underwent CTI ablation using the QDot Micro catheter and vHPSD (90 w for 4 s). Patients were followed-up by means of visits and ECG in the outpatient clinic 1, 6 and 12 months after the procedure and later on with telephone interviews or by 24-h Holter monitoring in case of symptoms. Results Acute CTI bidirectional block was achieved in all patients (91% of first-pass block) with a mean fluoroscopy time of 114±29 s and a mean procedure time of 37±9 min. Two steam pops were observed. Two patients had groin hematoma, no further complications were observed. During a mean follow-up of 14±7 months, two (3.2%) patient had typical AFL recurrence, and four (6.5%) patients had an atrial fibrillation recurrence. Conclusions The vHPSD ablation represents an effective and safe ablation strategy to achieve bidirectional block for the treatment of typical AFL.

Peri-procedural anesthesia and patient pain experience in pulmonary vein isolation by means of very high power short duration radiofrequency ablation

Abstract Funding Acknowledgements Type of funding sources: None. Background Very high-power short-duration (vHPSD) temperature-controlled radiofrequency ablation (vHPSD) may reduce ablation times and improve patient tolerability, permitting pulmonary vein (PV) isolation under mild conscious sedation. Purpose Evaluate the anesthetic drugs use and patients ‘pain experience during vHPSD PV isolation. Methods Thirty-three consecutive patients, with paroxysmal atrial fibrillation (AF), treated with QDot Micro catheter and vHPSD (90 w for 4 s) (vHPSD Group), were compared with the last 33 consecutive patients, with paroxysmal AF, treated with a surround flow contact force-sensing catheter guided by the ablation index (450 at anterior and superior sites at 50 W, 330 at posterior and inferior sites at 40 W) (AI Group). Anesthetic drugs (midazolam and fentanyl) use were compared as well as pain experience, measured using a 0-10 scale. Results All PVs were isolated. PV isolation ablation time in the vHPSD Group (5.9±1.4 min) was shorter than in the AI Group (25±11 min, p&amp;lt;0.001). Pain experience was significantly lower in vHPSD group (4.5±2 vs 6.6±1.8, p&amp;lt; 0.001). No patients required general anesthesia; fentanyl use was required in 4 vHPSD Group patients vs 25 AI Group patients (p&amp;lt;0.001). A lower dose of midazolam was required in vHPSD Group (2.3±1.2 mg vs 3.6±1.7 mg, p &amp;lt; 0.001). Conclusions vHPSD radiofrequency ablation for PVI can be performed under conscious sedation using only benzodiazepine in most of patients without compromising patient pain experience.

PO-01-005 GANGLIONATED PLEXI MEDIATED BRADYCARDIA RESPONSES: A PRE-CLINICAL STUDY OF DIFFERENCES BETWEEN PULSED FIELD AND RADIOFREQUENCY ABLATION IN THE LEFT ATRIUM

During left atrial catheter ablation procedures, the peri-atrial neural network of ganglionated plexi (GP) can be affected by the ablative energy. Bradycardic responses (BR) from GP stimulation have been reported during both radiofrequency (RF) and pulsed field (PF) ablation procedures. To assess differences in BR between RF and PF during canine left atrial ablation. Healthy canines (n=14) underwent transeptal access under general anesthesia. A multielectrode spherical array catheter (Globe PF System; Kardium Inc., Canada) capable of both cardiac mapping and ablation with either RF or PF was deployed in the left atrium. For each application, electroanatomic maps with ostial tags, contact maps based on blood flow detection, and animated voltage maps were created to help verify isolation. Either temperature-controlled RF ablation (63°C for 3 minutes) or PF ablation (1.7-1.8 kV) was used to circumferentially isolate two PVs/animal and create a linear and focal lesion along the posterior wall and roof of the left atrium. GP stimulation as evidenced by BR was recorded if either sinus bradycardia or AV block was noted during and/or immediately after the pulse train (Figure). A total of 11 and 3 animals underwent PF and RF ablation, respectively. All ablations were successfully delivered to all locations without adverse events. Of the animals treated with RF, none (0 of 3) displayed any evidence of GP stimulation at any locations. All animals treated with PF showed evidence of GP stimulation: all animals (11 of 11,100%) exhibited BR during ablation at the inferior common vein, with 6 of 10 (60%) animals demonstrating BR at the roof and posterior wall (Table). BR of less severity was noted during subsequent pulse trains but remained most frequent at the inferior common vein. Ganglionated plexi-mediated bradycardic responses occur with PF ablation, with evidence of some degree of stunning when repeated pulse trains are delivered. This pre-clinical model with ablation at this location will serve as a good model to further our understanding of this phenomenon. The lack of any bradycardic responses with RF either represents a lack of stimulation (perhaps because of the inability of the RF energy to reach the epicardial GPs, unlike the volumetric nature of the pulsed electrical fields) or, complete ablation without stimulation. Further work is needed to explore these differences.