Concept: St. Jude Medical
The purpose of this study was to determine if Optim™, a unique copolymer of silicone and polyurethane, protects Riata ST Optim and Durata implantable cardioverter-defibrillator (ICD) leads (SJM, St Jude Medical Inc., Sylmar, CA, USA) from abrasions that cause lead failure.
The aim of this study was to determine the differences in lead failure mechanisms across the major United States implantable defibrillator lead manufacturers (Boston Scientific, Medtronic, and St. Jude Medical), between all non-recalled and recalled leads, and between two recalled lead families (Medtronic Sprint Fidelis and the St. Jude Medical Riata and Riata ST).
Background -Elevated pulmonary artery (PA) pressures in patients with heart failure (HF) are associated with a high risk for hospitalization and mortality. Recent clinical trial evidence demonstrated a direct relationship between lowering remotely monitored PA pressures and HF hospitalization risk reduction using a novel implantable PA pressure monitoring system (CardioMEMS HF System, St Jude Medical). This study examines PA pressure changes in the first 2,000 US patients implanted in general practice use. Methods -De-identified data from the remote monitoring Merlin.net™ (St. Jude Medical) database were used to examine PA pressure trends from the first consecutive 2,000 patients with at least 6 months of follow-up. Changes in PA pressures were evaluated using an area under the curve (AUC) methodology to estimate the total sum increase or decrease in pressures (mmHg-day) during the follow up period relative to the baseline pressure. As a reference, the PA pressure trends were compared with the historic CHAMPION Clinical trial. The AUC results are presented as mean ± 2SE and p-values comparing the AUC of general-use cohort with outcomes in the CHAMPION Trial were computed by t-test with equal variance. Results -Patients averaged 70±12 years old, 60% male, 34% with preserved ejection fraction (EF) and were followed for an average of 333±125 days. At implant, the mean PA pressure for the general-use patients was 34.9±10.2 mmHg, compared with 31.3±10.9mmHg for CHAMPION treatment and 32.0±10.5mmHg for CHAMPION control groups. The general-use patients had an AUC of -32.8mmHg days at the 1 month time mark, -156.2mmHg days at the 3 month time mark and -434.0mmHg days after 6 months of hemodynamic guided care, which was significantly lower than the treatment group in the CHAMPION Trial. Patients consistently transmitted pressure information with a median of 1.27 days between transmissions after 6 months. Conclusions -The first 2,000 general-use patients managed with hemodynamic guided HF care had higher PA pressures at baseline and experienced greater reduction in PA pressure over time compared to the pivotal CHAMPION Clinical Trial. These data demonstrate that general-use of implantable hemodynamic technology in a non-trial setting leads to significant lowering of pulmonary artery pressures.
Cardiac resynchronization therapy (CRT) implantable cardioverter defibrillators (ICDs) deliver high burden ventricular pacing to heart failure patients, which has a significant effect on battery longevity. The aim of this study was to investigate whether battery longevity is comparable for CRT-ICDs from different manufacturers in a contemporary cohort of patients.METHODS AND RESULTS: All the CRT-ICDs implanted at our institution from 1 January 2008 to 31 December 2010 were included in this analysis. Baseline demographic and clinical data were collected on all patients using the electronic medical record. Detailed device information was collected on all patients from scanned device printouts obtained during routine follow-up. The primary endpoint was device replacement for battery reaching the elective replacement indicator (ERI). A total of 646 patients (age 69 ± 13 years), implanted with CRT-ICDs (Boston Scientific 173, Medtronic 416, and St Jude Medical 57) were included in this analysis. During 2.7 ± 1.5 years follow-up, 113 (17%) devices had reached ERI (Boston scientific 4%, Medtronic 25%, and St Jude Medical 7%, P < 0.001). The 4-year survival rate of device battery was significantly worse for Medtronic devices compared with devices from other manufacturers (94% for Boston scientific, 67% for Medtronic, and 92% for St Jude Medical, P < 0.001). The difference in battery longevity by manufacturer was independent of pacing burden, lead parameters, and burden of ICD therapy.CONCLUSION: There are significant discrepancies in CRT-ICD battery longevity by manufacturer. These data have important implications on clinical practice and patient outcomes.
-Cardiac resynchronization therapy (CRT) device implantation can be challenging, time consuming, and fluoroscopy intense. To facilitate left ventricular (LV) lead placement, a novel sensor-based electromagnetic tracking system [MediGuide (MGT), St. Jude Medical] has been developed. We report the results of the First Human Use (FHU) study evaluating the feasibility, safety, and performance of a novel CRT implantation approach using electromagnetic trackable operation equipment.
Transcatheter closure of arterial duct (AD) remains challenging in low-weight patients and using Amplatzer Duct Occluder devices is still considered off-label in infants < 6 kg. This study aimed to report a large, single-center experience of percutaneous AD closure in infants < 6 kg as well as to compare the most frequently used devices, Amplatzer Duct Occluder type I (ADO I) and Amplatzer Duct Occluder type II Additional Sizes devices (ADO II-AS) (St. Jude Medical Corp, St. Paul, MN, USA). From March 2000 to March 2017, among the 762 patients submitted to percutaneous closure of AD at our Institution, 33 were infants < 6 kg (age 4.8 ± 2.1 months; weight 5.0 ± 0.9 kg). Fourteen patients (45%) underwent ADO I (Group I) and 19 patients ADO II-AS (Group II) device implantation. AD diameter was 2.6 ± 0.8 (range 1.5-4.0) mm resulting in QP/QS of 2.6 ± 0.0.9 (range 1.1-4.5). Successful device deployment was achieved in all patients without procedural morbidity or mortality. Procedural and fluoroscopy times were not significantly different between the groups. However, total X-ray absorbed dose was significantly higher in Group I (121 ± 69 vs 29 ± 16 mGy/cm2, p < 0.01). Immediate, 24 h, and mid-term (46 ± 37 months, median 39) complete occlusion were recorded in 72.7, 90.9, and 97% of patients, respectively without significant difference between the groups. In conclusion, transcatheter closure of AD with Amplatzer Duct Occluder devices is feasible, safe, and effective also in infants less than 6 kg, without significant difference between the most commonly used devices, namely, ADO I and ADO II-AS.
Implantation of cardiac resynchronization therapy (CRT) devices can be challenging, time consuming, and associated with high-dose X-Ray exposure. We present the technique in which an electromagnetic navigation system (MediGuideTM, St. Jude Medical) and an electro-anatomical three-dimensional mapping system (EnSite NavX, St Jude Medical) are usefully combined for implanting ICD-CRT devices with strong reduction of X-ray exposure, and for targeting the most delayed regions in the activation maps avoiding scars for optimal CRT response. This article is protected by copyright. All rights reserved.
Subcutaneous implantable cardioverter defibrillators (S-ICDs) provide effective defibrillation, while also reducing the risk of long-term lead problems. However, S-ICDs do not offer bradycardia or antitachycardia pacing and therefore use has been limited. Combined implantation of an S-ICD with a leadless pacemaker (LP) has been proposed to overcome this limitation. Although a handful of combined S-ICD/LP implantations have been reported for Nanostim (St Jude Medical, St Paul, MN) as well as Micra LP (Medtronic, Minneapolis, MN) systems, none have documented delivery of appropriate shock therapies for spontaneous ventricular tachycardia. We report the first case of effective defibrillation for spontaneous ventricular tachycardia in a patient with combined Micra LP and S-ICD.
This review focuses on the manifestations of the three triggered atrial upper rate functions of St Jude Medical cardiac implantable electronic devices. The occurrence of repetitive nonreentrant ventriculoatrial synchrony (RNRVAS) is also evaluated as a basis for the development of automatic mode switching (AMS) and as a trigger for atrial tachycardia/atrial fibrillation (AT/AF) event recordings. RNRVAS is a common trigger for AMS because all the atrial events or intervals are used to calculate the filtered atrial rate interval (FARI). Once AMS is initiated, it will also effectively stop RNRVAS because entry into AMS also shortens the postventricular atrial refractory period (PVARP). Recent design developments to eliminate or minimize unusual upper rare responses include the following: (1) P waves in the PVARP are no longer counted towards the FARI if they are followed by an atrial paced event. (2) In new devices the AT/AF detection algorithm substitutes the Moving Average Interval (a relatively complex calculation) with the new FARI average. (3) Improved design of the rate-responsive PVARP with a far more aggressive response than in the past (enhanced atrial protection interval).
We present the case of a 75-year-old patient with a single-chamber St. Jude Medical internal cardioverter defibrillator (ICD; St. Jude Medical, St. Paul, MN, USA) for primary prevention, who was admitted with 39 inappropriate ICD shocks because of atrial fibrillation with rapid ventricular frequention, despite magnet placement. Review of the device manual and literature revealed that apart from different responses to magnet placement programmed for the various manufacturers, the type of magnet and the positioning can be of specific interest. In the case presented, the donut-shaped magnet should have been placed off-center instead of directly over the device.