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Selected Abstracts

Patient-controlled Analgesia in Intrathecal Therapy for Chronic Pain: Safety and Effective Operation of the Model 8831 Personal Therapy Manager with a Pre-implanted SynchroMed Infusion System

NEUROMODULATION, Issue 3 2003
Jan Maeyaert
Abstract The Model 8831 Personal Therapy Manager (PTM) offers a patient-controlled analgesia (PCA) option for the SynchroMed Infusion System (Medtronic Inc., Minneapolis, MN). The safety and effective operation of the PTM activator was evaluated in 45 patients in five European centers receiving intrathecal drug infusion for the treatment of chronic pain via a SynchroMed pump. The total volume of drug delivered intrathecally over a four-week follow-up period was calculated. Adverse events were recorded and pain levels were measured via the Visual Analog pain Scale (VAS), Brief Pain Inventory, and SF-12 Quality of Life scores. Patient satisfaction with the device and its instruction manual was also assessed by questionnaire. The expected and calculated intrathecal drug volumes (and therefore drug doses) were the same, demonstrating that the device worked as intended. There were no device-related serious adverse events. Overall, 96% of patients were satisfied with the activator. Patients appreciated being able to control their pain and considered the device and its instructions easy to use. The PTM was shown to be safe and functioning properly in the intrathecal treatment of pain. The successful addition of a PCA function to the SynchroMed system may create a new standard in intrathecal pain therapy. [source]

Left Atrial Ablation at the Anatomic Areas of Ganglionated Plexi for Paroxysmal Atrial Fibrillation

PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 10 2010
EVGENY POKUSHALOV M.D., Ph.D.
Background:,Modification of left atrial ganglionated plexi (GP) is a promising technique for the treatment of paroxysmal atrial fibrillation (AF) but its therapeutic efficacy is not established. This study aimed at evaluating the effectiveness of anatomic GP modification by means of an implantable arrhythmia monitoring device. Methods:,In 56 patients with paroxysmal AF, radiofrequency ablation at anatomic sites, where the main clusters of GP have been identified in the left atrium, was performed. In all patients, an electrocardiogram monitor (Reveal XT, Medtronic Inc., Minneapolis, MN, USA) was implanted before (n = 7) or immediately after (n = 49) AF ablation. Results:,Average duration of the procedure was 142 ± 18 min and average fluoroscopy time 20 ± 7 min. In total, 53,81 applications of RF energy were delivered (mean of 18.2 ± 3.8 at each of the four areas of GP ablation). Heart rate variability was assessed in 31 patients. Standard deviation of RR intervals over the entire analyzed period, the root mean square of differences between successive RR intervals, and high frequencies decreased, while HRmin, HRmean, and LF to HF ratio increased immediately postablation; these values returned to baseline 6 months after the procedure. At end of 12-month follow-up, 40 (71%) patients were free of arrhythmia recurrence. Ten patients had AF recurrence, two patients had left atrial flutter, and four patients had episodes of flutter as well as AF recurrence. Duration of episodes of AF after ablation gradually decreased over the follow-up period. Conclusions:,Regional ablation at the anatomic sites of the left atrial GP can be safely performed and enables maintenance of sinus rhythm in 71% of patients with paroxysmal AF for a 12-month period. (PACE 2010; 33:1231,1238) [source]

Predictors of Fracture Risk of a Small Caliber Implantable Cardioverter Defibrillator Lead

PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 4 2010
ANDREW C.T.
Introduction: The Sprint Fidelis 6949 implantable cardioverter defibrillator (ICD; Medtronic Inc., Minneapolis, MN, USA) lead has a high rate of fracture. Identification of predictors of subsequent fracture is useful in decision making about lead replacement and for future lead design. We sought to determine if there are clinical, procedural, or radiological features associated with a greater risk of subsequent lead fracture. Methods: Patients with Sprint Fidelis 6949 lead fractures (Fracture group) were identified from our institutional database. Each patient in the Fracture group was matched to two controls, immediately preceeding and succeeding Sprint Fidelis 6949 implant. Clinical and procedural characteristics were compared. Chest radiographs performed 2 weeks after ICD implant were reviewed by an observer blinded to outcomes. The following features were assessed: ICD tip location, lead slack, kinking of the lead body (,90°), and presence of lead "crimping" within the anchoring sleeve. Results: Twenty-six patients with Sprint Fidelis 6949 lead fractures were identified and were matched to 52 control patients. On univariate analysis, a higher left ventricular ejection fraction (LVEF), prior ipsilateral device implant, history of prior ICD lead fracture, and noncephalic venous access were associated with risk of lead fracture. On multivariate analysis, a higher LVEF was the only independent predictor of lead fracture (P = 0.006). Radiological features were similar between the two groups. Conclusions: In this study, a higher LVEF was associated with a greater risk of lead fracture in patients with Sprint Fidelis 6949 ICD leads. Radiographic features did not predict subsequent risk of lead fracture in our population. (PACE 2010; 437,443) [source]

Initial Experience of Pacing with a Lumenless Lead System in Patients with Congenital Heart Disease

PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 11 2009
SANTABHANU CHAKRABARTI M.D.
Background: Long-term pacing is frequently necessary in patients with congenital heart disease (CHD). Preservation of ventricular function and avoidance of venous occlusion is important in these patients. Site-selective pacing with a smaller diameter lead is achievable with the model 3830 lead (SelectSecure®, Medtronic Inc., Minneapolis, MN, USA), which was specifically designed to target these complications. We describe our initial experience with the Model 3830 lead in patients with CHD. Methods: Retrospective analysis of all patients undergoing site-selective implantation of a Model 3830 lead(s) from two congenital heart centers (Bristol, UK, and Dublin, Ireland) from October 2004 until February 2008. Results: We implanted 139 SelectSecure® leads (atrial n = 70; ventricular n = 69) in 90 patients (57 male) with CHD. Median age at implantation: 13.4 years (1.1,59.2 years), median weight: 43 kg. Sixty-nine patients (76%) were children (<18 years). Indications for lead implantation included atrioventricular block (n = 55), sinus node disease (n = 18), implantable cardiac defibrillator (n = 12), antitachycardia pacing (n = 4), and cardiac resynchronization (n = 1). Twenty-two patients underwent pre-existing lead extraction during the same procedure. All the attempted procedures resulted in successful pacing. One patient had a significantly raised threshold at implantation. There was no procedural mortality. There were two procedural complications. Three patients required lead repositioning for increasing thresholds early postprocedure (<6 weeks). Four leads (2.9%) had displaced on median follow-up of 21.8 months (0.5,42 months). Conclusions: The Model 3830 lead is safe and effective in patients with CHD. This is a technically challenging patient group yet procedural complication and lead displacement rates are acceptable. [source]

Percutaneous Permanent Pacemaker Implantation Via The Azygous Vein In A Patient With Superior Vena Cava Occlusion

PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 3 2008
M.R.C.P., RAVINDU HASMUKH KAMDAR B.Sc. (Hons)
Occlusion of the superior vena cava (SVCO) makes implantation of permanent pacemakers challenging and difficult. We describe an extended application of a Medtronic Attain (Medtronic Inc., Minneapolis, MN, USA) guide catheter (a tool designed for delivery of left ventricular pacing leads into the coronary sinus) for delivery of a right ventricular pacing lead via the azygous vein in a 72-year-old woman with SVCO secondary to long-term central venous hemodialysis catheters. This approach allowed the use of an endocardial pacing lead, implantation under local anesthesia, and conventional positioning of the pacemaker generator in the pectoral region in a patient with SVCO. [source]

Electromagnetic Interference of an Implantable Loop Recorder by Commonly Encountered Electronic Devices

PACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 10 2000
CAREL C. DE COCK
De COCK, C.C., et al.: Electromagnetic Interference of an Implantable Loop Recorder by Commonly Encountered Electronic Devices. Electromagnetic interference of pacemaker systems has been well established and can lead to an inappropriate function of these devices. Recently, an implantable loop recorder (ILR) (REVEAL, Medtronic Inc.) has been introduced to evaluate the possible arrhythmic etiology of patients with recurrent syncope. We evaluated the interference of this device in two patients with implantable ILR and in three nonimplanted ILRs with four electromagnetic sources: cellular phones (GSMs), electronic article surveillance systems (EASs), metal detector gates (MDGs), and magnetic resonance imaging (MRI). The GSM did not affect appropriate function of the ILR whereas radiofrequency (RF) EAS could interfere with normal function in implanted and nonimplanted systems. The MDG had no influence on ILR function. The magnetic field induced by the MRI resulted in an irreversible error in one nonimplanted ILR. Therefore, although interference between electromagnetic sources and ILRs appears to be rare in our study, physicians should be aware of possible malfunctioning of these devices. [source]