Rate Of Device-related Adverse Events Research Articles

Sacral and Implantable Tibial Neuromodulation for the Management of Overactive Bladder: A Systematic Review and Meta-analysis.

Implantable tibial neuromodulation (iTNM) systems have recently become commercially available in the US, and offer a new method of neurostimulation for the treatment of overactive bladder (OAB). In the absence of head-to-head studies, the aim of this meta-analysis was to indirectly compare the efficacy and safety of sacral neuromodulation (SNM) and implantable tibial neuromodulation (iTNM) for the treatment of OAB. A comprehensive search was performed using terms for OAB and neuromodulation. Primary efficacy measures included a≥50% reduction in urgency urinary incontinence (UUI) episodes, urinary frequency, and/or OAB symptoms. Primary safety measures included the rate of device-related adverse events (AEs). A total of 20 studies met selection criteria, encompassing 1416 patients treated with SNM and 350 patients treated with iTNM. No comparative or placebo-controlled studies for SNM and iTNM were identified, and therefore the analysis was completed using single-arm results. Weighted averages showed that the UUI responder rate was similar for both SNM and iTNM (71.8% and 71.3%, respectively). Similarly, weighted averages of OAB responder rates were 73.9% for SNM and 79.4% for iTNM. Similar rates of device-related AEs were also observed. This meta-analysis found similar efficacy and safety of SNM and iTNM for the treatment of OAB and UUI, including UUI and OAB symptom response rates, reduction in UUI episodes, significant improvements in quality-of-life (QoL), and low rates of procedure and device-related adverse events. Notably, this comparable efficacy was seen without the use of a trial phase of neuromodulation in the iTNM studies versus SNM studies.

Large Single-Center Experience with Short-Term Follow-up of Neqstent-Assisted Coiling.

Endovascular treatment of wide-neck bifurcation aneurysms has historically proved difficult with variable outcomes. Different endovascular techniques such as balloon-assisted coiling, stent-assisted coiling, or intrasaccular devices provide a varied range of efficacy and safety. Neqstent-assisted coiling is a new device and technique that aim to provide a maximum of both. We analyzed the early clinical and radiologic outcomes after the use of this new technique and device in our practice. This study was a retrospective analysis of ruptured and unruptured intracranial aneurysms treated with the Neqstent. The primary radiologic outcomes were quantified on DSA, CTA, or MRA using the modified Raymond-Roy criteria. The outcomes were defined as immediate complete occlusion (modified Raymond-Roy criteria 1) and complete (modified Raymond-Roy criteria 1) and adequate occlusion (modified Raymond-Roy criteria 1 and modified Raymond-Roy criteria 2) at 6 months posttreatment. The primary safety outcome was the rate of device-related adverse events. Secondary safety outcomes included time to discharge and change in the mRS score at 6-month follow-up. Twenty patients were treated with the Neqstent from November 2020 to January 2023. Nine had unruptured aneurysms, and 11 were patients with subarachnoid haemorrhage due to ruptured aneurysms. Eighteen of 20 aneurysms (90%) treated demonstrated complete occlusion (modified Raymond-Roy criteria 1) on immediate postembolization angiograms. Sixteen of 17 aneurysms treated (94.1%) remained adequately occluded on 6-month follow-up (modified Raymond-Roy criteria 1 and modified Raymond-Roy criteria 2). Immediate postoperative complications occurred in 2 patients; only 1 patient had residual neurologic deficits at 6 months (mRS = 2). Management of large, wide-neck aneurysms remains difficult, with high rates of recurrence and complications. The use of the Neqstent shows promising short-term results for the treatment of complex wide-neck aneurysms. Initial complication rates for our cohort were relatively high. However, this result is likely related to the initial learning experience of device deployment and the use of antiplatelets.

Remote electrical neuromodulation (REN) in the acute treatment of migraine: a comparison with usual care and acute migraine medications

BackgroundThere is a significant unmet need for new, effective and well tolerated acute migraine treatments. A recent study has demonstrated that a novel remote electrical neuromodulation (REN) treatment provides superior clinically meaningful pain relief with a low rate of device-related adverse events. The results reported herein compare the efficacy of REN with current standard of care in the acute treatments of migraine.MethodsWe performed a post-hoc analysis on a subgroup of participants with migraine from a randomized, double-blind, parallel-group, sham-controlled, multicenter study on acute care. The original study included a 2–4 weeks run-in phase, in which migraine attacks were treated according to patient preference (i.e., usual care) and reported in an electronic diary; next, participants entered a double-blind treatment phase in which they treated the attacks with an active or sham device. The efficacy of REN was compared to the efficacy of usual care or pharmacological treatments in the run-in phase in a within-subject design that included participants who treated at least one attack with the active REN device and reported pain intensity at 2 h post-treatment.ResultsOf the 252 patients randomized, there were 99 participants available for analysis. At 2 h post-treatment, pain relief was achieved in 66.7% of the participants using REN versus 52.5% participants with usual care (p < 0.05). Pain relief at 2 h in at least one of two attacks was achieved by 84.4% of participants versus 68.9% in usual care (p < 0.05). REN and usual care were similarly effective for pain-free status at 2 h. The results also demonstrate the non-inferiority of REN compared with acute pharmacological treatments and its non-dependency on preventive medication use.ConclusionREN is an effective acute treatment for migraine with non-inferior efficacy compared to current acute migraine therapies. Together with a very favorable safety profile, these findings suggest that REN may offer a promising alternative for the acute treatment of migraine and could be considered first line treatment in some patients.Trial registrationClinicalTrials.gov NCT03361423. Registered 18 November 2017.

Abstract No. 570 - Does timely removal of retrievable inferior vena cava filters improve the rate of device-related adverse events?

Abstract No. 570<Comp: Insert SIR Foundation logo> - Does timely removal of retrievable inferior vena cava filters improve the rate of device-related adverse events?

Improved Outcome with Preventive Cardiac Resynchronization Therapy in the Elderly: A MADIT‐CRT Substudy

Elderly patients comprise a large portion of patients with heart failure (HF). Limited data exist on the effectiveness of cardiac resynchronization therapy with defibrillator (CRT-D) in patients with mild HF symptoms in this population. The benefit of CRT-D compared with ICD-only therapy in reducing HF or death was assessed by age categories (prespecified as <60 [n = 548], 60-74 [n = 941], and ≥75 [n = 331] years) among 1,820 patients in MADIT-CRT. In patients with ICD-only, there was a graded age-related increase in the Kaplan-Meier cumulative probability of HF or death at 3-year follow-up (19%, 33%, and 36%, in patients aged <60, 60-74, and ≥75 years, respectively, P = 0.003). Multivariate analysis demonstrated that CRT-D therapy was associated with a significant reduction in the risks of HF or death in patients aged 60-74, and ≥75 years (HR = 0.57, P = <0.001 and HR = 0.59, P = 0.017, respectively), and no significant benefit in patients aged <60 years (HR = 0.81, P = 0.3; P-value for all treatment-by-age interactions >0.10). There was no significant difference in the rate of device-related adverse events within 90 days following CRT-D implantation among age-subgroups (16.7%, 15.7%, and 11.7%, in patients <60, 60-74, and ≥75 years, respectively, P = 0.42). CRT-D was associated with a significant clinical benefit in older patients (≥60 years) during an average 2.4-year follow-up. These effects were preserved for the elderly patients ≥75 years of age but attenuated in patients <60 years. Elderly patients had no increase in device-related adverse events compared with younger patients.