Boston Scientific (United States)

Fast-acting subperception therapy in spinal cord stimulation (FAST-SCS) uses low-frequency, subthreshold stimulation to engage the dorsal column-mediated surround inhibition mechanism and thereby relieve pain. Our study was performed to better characterize the multidimensional long-term clinical outcomes of FAST-SCS therapy in patients with chronic low back and/or leg pain. Our prospective, multicenter, single-arm, open-label trial, conducted at 12 pain management centers across the USA, included male and female patients with chronic low back pain with/without leg pain refractory to conservative therapy. All eligible patients received an SCS implant. Outcomes evaluated included pain relief, disability, mobility, health-related quality of life, sleep quality, depression, pain catastrophizing, and global impression of change. Fifty-six patients received a permanent SCS implant and 55 were activated with FAST-SCS therapy. At 12months, 89% and 59% of patients achieved ≥ 50% and ≥ 80% pain relief, respectively (p < 0.0001), and pain intensity (verbal numerical rating scale) decreased by 4.9 ± 2.2 points (p < 0.0001). Significant improvements were observed in disability (Oswestry Disability Index - 24 ± 16 points, p < 0.0001) and endurance (6-Minute Walk Test + 73 ± 96m, p < 0.0001), while mobility and balance improved without reaching statistical significance (Timed Up-and-Go test - 7.5 ± 37.5s, p = 0.17). All psychosocial measures improved significantly at 12months compared to baseline, with an increase in the EQ5D-5L index (+ 0.200 ± 0.182, p < 0.0001) and decreases in the Pittsburgh Sleep Quality index (- 3.96 ± 4.31, p < 0.0001), Pain Catastrophizing Score (- 13.3 ± 11.4, p < 0.0001), and Beck Depression Index (- 7.9 ± 10.0, p < 0.0001). At 12months, 87% of patients reported being "much" or "very much" improved. Responses to FAST-SCS were at or above the minimal clinically important differences across all measured clinical dimensions. This prospective study demonstrated that FAST-SCS provided statistically significant, multidimensional benefits across pain, disability, mobility, and psychosocial outcomes over 12months in patients with chronic low back and/or leg pain. These findings support the use of FAST-SCS in this patient population. ClinicalTrials.gov (NCT04618471). https://www. gov/study/NCT04618471 .

For patients with atrial fibrillation, the use of oral anticoagulant therapy to prevent stroke is limited by the risk of bleeding. Left atrial appendage closure is considered for patients who are unsuitable candidates for long-term anticoagulation, but its role in patients who are eligible for anticoagulants has not been established. In this ongoing, prospective, international, randomized trial involving patients with atrial fibrillation who were suitable candidates for anticoagulation, we randomly assigned patients in a 1:1 ratio to receive either device-based left atrial appendage closure (device group) or non-vitamin K antagonist oral anticoagulant (NOAC) therapy (anticoagulation group). The primary efficacy end point - a composite of death from cardiovascular causes, stroke, or systemic embolism - was tested for noninferiority (noninferiority margin, 4.8 percentage points) after 3 years of follow-up. The primary safety end point, non-procedure-relatedbleeding, was tested for superiority. Of the 3000 patients who underwent randomization, 1499 were assigned to the device group and 1501 to the anticoagulation group. The mean (±SD) age of the patients was 71.7±7.5 years, 31.9% of the patients were women, and the mean CHA2DS2-VASc score was 3.5±1.3. At 3 years, a primary efficacy end-point event had occurred in 81 patients (Kaplan-Meier estimate, 5.7%) in the device group and in 65 patients (Kaplan-Meier estimate, 4.8%) in the anticoagulation group (difference, 0.9 percentage points; 95% confidence interval [CI], -0.8 to 2.6; P<0.001 for noninferiority). Non-procedure-related bleeding occurred in 154 patients (Kaplan-Meier estimate, 10.9%) in the device group and in 260 patients (Kaplan-Meier estimate, 19.0%) in the anticoagulation group (hazard ratio, 0.55; 95% CI, 0.45 to 0.67; P<0.001 for superiority). Among patients with atrial fibrillation who were candidates for anticoagulation, device-based left atrial appendage closure was noninferior to NOAC therapy with respect to a composite of death from cardiovascular causes, stroke, or systemic embolism and was superior to NOAC therapy for non-procedure-related bleeding at 3 years. (Funded by Boston Scientific; CHAMPION-AF ClinicalTrials.gov number, NCT04394546.).

Despite the rise of pulsed-field ablation (PFA), predicting and titrating lesion geometry remains challenging. This study aimed to find modifiable parameters that can accurately and repeatedly predict focal PFA lesions across a range of dimensions and to develop a model to predict lesion geometry. An in vivo study was performed in 9 swine using an investigational dual-energy contact-force focal catheter with local impedance. Ablations were performed endocardially in the right and left ventricles using settings specifically selected to provide a wide range of lesion dimensions. Predefined PFA applications (1, 2, or 4) were delivered while maintaining different contact-force values (5-45 g). Four different voltages were used (1.0, 1.4, 2.0, and 2.2 kV). Following a 1-week survival period, the animals were euthanized for histopathologic examination. In the study characterization data set, a total of 78 PFA lesions were analyzed. Lesion depth ranged from 1.4 mm to 12.3 mm, while lesion width ranged from 3.3 mm to 21.2 mm. All 3 tested parameters-contact force, number of applications, and voltage-demonstrated a positive linear correlation with lesion depth (P<0.01). The proposed formula (Focal FARAPULSE Index Model) showed a strong positive correlation with lesion depth (R=0.83; P<0.0001) and lesion width (R=0.76; P<0.0001). A perpendicular catheter orientation was correlated with deeper lesions than a parallel orientation. No ST-segment elevations or sustained ventricular arrhythmias were observed. Our findings demonstrate that PFA can be effectively titrated and predicted using the Focal FARAPULSE Index Model to create lesions of varying depths (1-12 mm), with these results being specific to the proprietary waveform and catheter used.

Abstract Background The procedural synergy of PVI and LAAC in a single session is increasingly adopted in clinical workflows. However, the acute tissue response to PFA may influence LAAC device sizing and LAA complete seal. This preclinical study investigated healing dynamics, residual flow mechanisms, and structural device integrity using serial contrast CT and post-mortem micro-CT following combined PFA or RFA with WATCHMAN FLX Pro implantation. Methods Nine healthy canines underwent PVI using either PFA (n=6) or RFA (n=3), followed by LAAC in the same setting. Serial TEE and contrast-enhanced CT scans were acquired at baseline, post-procedure, and on days 7, 14, 28, and 45. All animals received DAPT for the duration of follow-up. Hypoattenuated Thickening (HAT) was evaluated to characterize healing and potential thrombus formation. Residual contrast patency was classified by source (e.g., uncovered trabeculations vs. trans-fabric flow). At terminal sacrifice, micro-CT imaging was performed with 35μm resolution and 1120×1120 pixel image size. CTvox software enabled 3D rendering of the devices, which were evaluated for grossly visible structural abnormalities, including fractures, disconnections, tangles, or other surface defects. Results All animals achieved successful LAAC with no acute complications. No device dislodgement was observed on imaging. At day 45, 5 animals (3 PFA, 2 RF) exhibited residual contrast patency. In 3 of these (1 PFA, 2 RF), the source was trans-fabric flow, suggesting incomplete endothelialization of the device fabric. The remaining 2 cases (both PFA) showed contrast patency due to small PDLs (&amp;lt;5mm) (Tables 1a and 1b). HAT was frequently observed early, with HAT noted in 5 animals by day 7 (4 PFA, 1 RFA) 2 of which were protruding – 1 in the PFA and one in the RFA group. Pedunculated HAT was not observed in any of the animals. All HATs evolved toward either a flat sessile phenotype or sub-fabric by day 45, with no evidence of protruding phenotype on final imaging. There were no major differences noted between the treatment groups. Micro-CT confirmed intact structural integrity in all devices despite extreme "deformation" to fit different LAAs 3D geometries, with no evidence of strut fractures, tangling, disconnection or device surface integrity breach (Figure 1). Conclusion In this preclinical model, concomitant PFA or RF ablation followed by WATCHMAN FLX Pro LAAC was procedurally feasible and safe, with no device dislodgment or thrombus formation. Residual contrast patency at day 45 occurred in 5 animals, with trans-fabric flow identified as the source in 3 and minor PDLs in 2 in the PFA group, pointing to a probable localized delay in endothelialization. Micro-CT imaging demonstrated structural device integrity despite deformation across various LAA morphologies.Figure 1 Tables 1a and 1b

An artificial urinary sphincter (AUS) is a gold standard treatment for moderate to severe male stress urinary incontinence (SUI). The objective of this study was to evaluate whether self-reported toileting behaviors are associated with quality of life (QOL) following AUS implantation. Artificial Urinary Sphincter Clinical Outcomes (AUSCO) is a prospective, multicenter study evaluating the AMS 800 AUS in men with primary SUI. A total of 115 participants were implanted at 17 sites, with follow-up at 3, 6, and 12 mo. Patients with predominant overactive bladder symptoms were preoperatively excluded from participation. Participants reported on incontinence events (voiding diaries), toileting habits, device use, and satisfaction. QOL was assessed via questionnaires such as the Incontinence Quality of Life (I-QOL), Incontinence Impact Questionnaire (IIQ-7), and EQ-5D-5L. Of the participants, 94% achieved ≥50% reduction in pad weight and 92% reported satisfaction at 12mo. Significant improvements were observed in I-QOL, IIQ-7, and EQ-5D-5L scores (p<0.001). Reduction in pad weight and ease of device use were strong predictors of both satisfaction and QOL improvement. Voiding diary-based stress and urgency incontinence events declined significantly, but changes in toileting habits (eg, sitting vs standing and urinal vs stall use) were minimal and not associated with satisfaction. Postvoid dribbling persisted in 68% of patients at 12mo, despite an improvement from baseline (p=0.02). Functional limitations in self-care and mobility predicted more difficulty in using the device. AUS implantation results in high satisfaction and substantial improvements in continence and QOL at 1yr. Ease of use and effectiveness are key drivers of satisfaction, while toileting behaviors appear largely unchanged following implant. These findings offer valuable insights to guide preoperative counseling and patient selection.