Search

Introduction: Deep Brain Stimulation (DBS) has been shown to be an effective method in managing motor complications associated with moderate to severe Parkinson's disease (PD). However, individual outcomes and adverse effects following DBS can vary depending on the volume of tissue activated. Historically, DBS systems have used ring-shaped electrodes that produce stimulation fields with limited control over the shape of the field, thereby limiting the extent and shape of the volume of tissue activated. A pilot study of 7 PD subjects reported that a novel, directional DBS system, combining an eight-contact directional lead and an implantable pulse generator (IPG) capable of multiple independent current control (MICC), can feasibly accomplish directional current steering using permanently implanted electrodes, thereby enabling modulation of the adverse effect and efficiency thresholds (to facilitate enhanced individualization of neurostimulation) and in turn an increase in the therapeutic window (current difference between efficacy and adverse event threshold)¹. In this report, we present real-world clinical outcomes of subjects implanted with a directional lead for the management of Parkinson's disease as part of a larger, on-going registry study. Methods: The Vercise DBS Registry is a prospective, onlabel, multi-center, international registry sponsored by Boston Scientific Corporation. The Vercise PC system is a CE-marked, multiple-source constant-current system with a rechargeable battery (Boston Scientific). Subjects in this specific cohort were implanted with a directional lead (Cartesia, Boston Scientific) included as part of a directional Vercise PC system for bilateral STN-DBS. Subjects will be followed up to 3, 6, 12 months and up to 3 years post-implantation where their overall improvement in quality of life and PD motor symptoms will be evaluated. Clinical endpoints will be evaluated at baseline and during study follow up that include Unified Parkinson's disease Rating Scale (UPDRS), MDS-UPDRS, Parkinson's disease Questionnaire (PDQ-39), and Global Impression of Change. Adverse events are also collected. Results: Subjects at several European Centers implanted with a directional lead were included in the Vercise DBS Registry. The accompanying report provides the study design, demographics, programming parameters, and other preliminary data from this directional lead cohort. Discussion: The Vercise DBS Registry represents a comprehensive, large scale collection of real-world outcomes and includes evaluation of the safety and effectiveness of the Vercise DBS System. Data from this cohort will provide insight on the use of current steering with a directional lead as part of the directional Vercise PC system, and its implications in the treatment of patients. [ABSTRACT FROM AUTHOR]

Objective: A DBS device that enables current fractionalization using a multiple-source mode of delivery can permit the application of a well-defined, shaped electrical field. Thus, we postulated that a multiple-source, constant-current device that permits a well-defined distribution of current would lead to motor improvement in patients with Parkinson's disease (PD). Previously, results from the VANTAGE clinical study demonstrated highly significant improved motor function (p < 0.0001) as assessed by UPDRS III "meds off" at 6 months post-first lead implant as compared with Baseline "meds off," thereby successfully achieving the study primary endpoint. Here we present the four year, long-term follow up results of patients in the VANTAGE clinical study that employed multiple independent current control (MICC) Deep Brain Stimulation (DBS) in the management of motor symptoms of Parkinson's disease. Methods: VANTAGE is a prospective, multi-center, non-randomized, open-label study sponsored by Boston Scientific Corporation. Forty subjects with idiopathic PD were implanted bilaterally with a DBS system (Vercise, Boston Scientific) targeting the subthalamic nucleus and followed up to three years post-lead placement. Assessments measured up to 3 years post-lead placement included the following: Levodopa Equivalent Dose (LED), Parkinson's Disease Questionnaire (PDQ-39), Global Impression of Change (GIC), and Modified Schwab and England (SE) scores. Results: Data from three years post-lead placement has been collected and analyzed. Anti-parkinsonian medications were found to have remained stable (average of 1399 mg at baseline versus average of 699 mg at 3 years follow up). PDQ-39 summary index scores demonstrate continued improvement (versus baseline values) in quality of life based on assessments of bodily discomfort, activity of daily living, mobility, emotional well-being, and stability of cognition. Further, a high proportion of GIC responses were characterized as "improved" (Clinician: 88.2%; Subject: 82.4%), and modified Schwab and England scores remained stable. Results from 4 years post-lead placement to be presented. Conclusion: The collected outcomes from the VANTAGE clinical study will inform clinicians on the use of this system, and its flexibility to manage the motor symptoms of idiopathic PD. [ABSTRACT FROM AUTHOR]

Introduction: Historically, DBS systems have delivered stimulation using cylindrical electrodes, which stimulate neurons around the entire circumference of the lead. In this study, we will test a directional DBS lead, which includes radially segmented electrodes designed for selective stimulation in directions orthogonal to the lead trajectory, in addition to standard cylindrical electrodes. Bilateral directional DBS leads will be connected to the Boston Scientific Vercise PC pulse generator, which provides an independent current source for each of its 16 contacts. This system, therefore, is capable of current steering to shape stimulation in the plane orthogonal to the long axis of the lead (directional stimulation), as well as providing Ring Mode (omnidirectional) stimulation equivalent to historical leads. We aim to characterize the effects of directional stimulation in subjects implanted with this system. Methods: Direct Dbs is a prospective, randomized, multicenter, double-blind study employing a crossover design. Subjects (N = 10 to 12, adaptive) will be enrolled per center standard of care and implanted with a directional lead (Cartesia, Boston Scientific) included as part of a directional Vercise PC system for bilateral STN-DBS. Study visits occur in 3 major periods- during implant, at 3 months, and at 1 year. Programming is restricted during the first 3 months post-implant to Ring Mode. At 3 months, multiple single-day programming visits will be undertaken to optimize directional programming. Patients are then randomized to one of two arms (4 weeks per arm) for a double-blind crossover comparison between Ring Mode and unrestricted (e.g. directional) programming. After the crossover phase, subjects enter an open-label phase of the study, with follow-up at 1 year. Results: This exploratory study will have no prospective statistical hypothesis, but will collect data such as side effect threshold, therapeutic window, UPDRS scores, and quantitative accelerometer- based measures of bradykinesia and tremor. Discussion: DIRECT DBS is an exploratory study which will investigate the effects of subthalamic deep brain stimulation (DBS) using directional DBS leads with current steering in patients with Parkinson's disease. The DIRECT DBS trial will compare the effects of directional stimulation and omnidirectional stimulation over the first year post-implant. Results will inform future studies. [ABSTRACT FROM AUTHOR]

Introduction: The effectiveness and safety of the use of Deep Brain Stimulation (DBS) to reduce motor complications of subjects with Parkinson's disease (PD) has been substantiated by several randomized controlled trials (Deuschl et al., 2006, Weaver et al., 2009, Okun et al., 2012, Scheupbach et al., 2013). Motor improvement following DBS is sustained for up to 10 years as reported by Castrioto et al. An in-depth evaluation of real-world outcomes following DBS will add to the existing database of knowledge and prove to be a useful tool for physicians. We present the outcomes of a large scale clinical registry that compiles the effectiveness and safety-related real-world outcomes of a multiplesource, constant-current DBS System in the treatment of levodoparesponsive PD. Methods: The Vercise DBS Registry is a prospective, onlabel, multi-center, international registry sponsored by Boston Scientific Corporation. The Vercise DBS system (Boston Scientific) is a CE-marked, multiple-source, constant-current system with a rechargeable battery. Subjects will be followed up at 3, 6.12 months and up to 3 years post-implantation where their overall improvement in quality of life and PD motor symptoms will be evaluated. Clinical endpoints will be evaluated at baseline and during study follow up that include Unified Parkinson's Disease Rating Scale (UPDRS), MDS-UPDRS, Parkinson's disease Questionnaire (PDQ-39), and Global Impression of Change. The registry also utilizes the newly developed MDS UPDRS for the evaluation of motor symptoms and includes the evaluation of non-motor symptoms of PD (Non-Motor Symptom Assessment Scale) following DBS. Adverse events are also collected. Results: This report will provide the safety and effectiveness outcomes of the first cohort of subjects implanted with the Vercise DBS System analyzed at 6 months post-implantation as compared with baseline. Discussion: The Vercise DBS registry study represents the first comprehensive, large scale collection of real-world outcomes and evaluation of the safety and effectiveness of the Vercise DBS System. This report will provide such data from the first cohort of subjects analyzed at 6 months post-implantation as compared with baseline. [ABSTRACT FROM AUTHOR]

Background: We report the 5-year results of the SYNTAX trial, which compared coronary artery bypass graft surgery (CABG) with percutaneous coronary intervention (PCI) for the treatment of patients with left main coronary disease or three-vessel disease, to confirm findings at 1 and 3 years., Methods: The randomised, clinical SYNTAX trial with nested registries took place in 85 centres in the USA and Europe. A cardiac surgeon and interventional cardiologist at each centre assessed consecutive patients with de-novo three-vessel disease or left main coronary disease to determine suitability for study treatments. Eligible patients suitable for either treatment were randomly assigned (1:1) by an interactive voice response system to either PCI with a first-generation paclitaxel-eluting stent or to CABG. Patients suitable for only one treatment option were entered into either the PCI-only or CABG-only registries. We analysed a composite rate of major adverse cardiac and cerebrovascular events (MACCE) at 5-year follow-up by Kaplan-Meier analysis on an intention-to-treat basis. This study is registered with ClinicalTrials.gov, number NCT00114972., Findings: 1800 patients were randomly assigned to CABG (n=897) or PCI (n=903). More patients who were assigned to CABG withdrew consent than did those assigned to PCI (50 vs 11). After 5 years' follow-up, Kaplan-Meier estimates of MACCE were 26·9% in the CABG group and 37·3% in the PCI group (p<0·0001). Estimates of myocardial infarction (3·8% in the CABG group vs 9·7% in the PCI group; p<0·0001) and repeat revascularisation (13·7%vs 25·9%; p<0·0001) were significantly increased with PCI versus CABG. All-cause death (11·4% in the CABG group vs 13·9% in the PCI group; p=0·10) and stroke (3·7%vs 2·4%; p=0·09) were not significantly different between groups. 28·6% of patients in the CABG group with low SYNTAX scores had MACCE versus 32·1% of patients in the PCI group (p=0·43) and 31·0% in the CABG group with left main coronary disease had MACCE versus 36·9% in the PCI group (p=0·12); however, in patients with intermediate or high SYNTAX scores, MACCE was significantly increased with PCI (intermediate score, 25·8% of the CABG group vs 36·0% of the PCI group; p=0·008; high score, 26·8%vs 44·0%; p<0·0001)., Interpretation: CABG should remain the standard of care for patients with complex lesions (high or intermediate SYNTAX scores). For patients with less complex disease (low SYNTAX scores) or left main coronary disease (low or intermediate SYNTAX scores), PCI is an acceptable alternative. All patients with complex multivessel coronary artery disease should be reviewed and discussed by both a cardiac surgeon and interventional cardiologist to reach consensus on optimum treatment., Funding: Boston Scientific., (Copyright © 2013 Elsevier Ltd. All rights reserved.)