Medtronic plc is an American Irish-domiciled medical device company that generates the majority of its sales and profits from the U.S. healthcare system but is headquartered in the Republic of Ireland for tax purposes. Medtronic has an operational and executive headquarters in Fridley, Minnesota in the U.S. In 2015, Medtronic acquired Irish–tax registered Covidien (a U.S. tax inversion to Ireland from 2007), in the largest U.S. corporate tax inversion in history, which enabled Medtronic to move its legal registration from the U.S. to Ireland. Medtronic operates in 140 countries and employs over 100,000 people.
AIMS:Radiofrequency (RF) renal denervation (RDN) safely lowers office and 24-h blood pressure (BP). This meta-analysis examined the long-term durability of RF RDN based on randomized trials and observational studies. METHODS AND RESULTS:Patients with uncontrolled hypertension undergoing RF RDN using the Symplicity Flex™ or Spyral™ device and a minimum follow-up of 3 years were included. Key outcomes included office and 24-h BP change from baseline as well as changes in anti-hypertensive drugs. A random effects meta-analysis was conducted over 3 years, or the last reported follow-up beyond 3 years. A total of 2212 patients identified among 18 reports were evaluated for BP. The mean duration of follow-up was 4.4 years (range 3-9.4). The long-term reduction in office systolic BP from baseline in 15 reports (n = 2040) was -23.0 mmHg (95% confidence interval: -26.8 to -19.1, P < 0.05) for the random effects model and -20.5 (-21.6 to -19.4) for the fixed effect model. Twenty-four-hour ambulatory systolic BP was available in 11 reports (n = 1018) and decreased significantly by -13.6 mmHg (-16.5 to -10.8, P < 0.05). Fixed effect model results were similar. Diastolic office and 24-h BP paralleled these findings in both models. Nighttime systolic BP also decreased significantly by -14.2 mmHg (-27.6 to -0.8, P < 0.05). The number of prescribed anti-hypertensive drugs and eGFR also decreased. Heart rate remained unchanged through the final follow-up in both models. Safety events were rare, with a mean rate of renal artery complications of 0.14% (0.08-0.20%). CONCLUSION:This meta-analysis comprising 18 studies demonstrated sustained and significant office and ambulatory BP reductions following Symplicity RDN through at least 3 years without an increase in anti-hypertensive medication.
Background:Atrial fibrillation (AF) prevalence has increased with Japan's aging population. Data on cryoballoon ablation (CBA) for persistent AF (PsAF) in Japan is limited. This study reports CBA clinical outcomes in PsAF patients in Japan from the prospective Cryo Global Registry. Methods:Data was analyzed from 60 Japanese centers with 1226 PsAF patients that underwent CBA. The primary endpoints were serious adverse events and freedom from atrial arrhythmia (AA) recurrence, at 12 months. The effect of ablation strategy (pulmonary vein isolation [PVI] or PVI with additional ablations [PVI+]) was evaluated. Quality-of-life (QoL) was measured by EQ-5D-3L questionnaire. Results:The patient mean age was 68 ± 10 years and 29.0% were female. The overall 12-months Kaplan-Meier (KM) estimate for freedom from AA recurrence was 84.4% (95% CI: 82.2%-86.3%). Among PVI+ patients, 33.0% received cavotricuspid isthmus (CTI) and 34.6% received non-CTI ablation (majority being left-atrial roofline [27.2%]). The 12-months KM estimate for freedom from AA recurrence was higher for PVI+ subgroup (86.6% [CI: 83.6%-89.1%]) than PVI subgroup (82.0% [CI: 78.6%-84.9%]) (HR adj = 1.40, p = 0.025). Twenty-two serious adverse events were reported in 1.6% patients. At 12 months, compared to baseline, QoL improved with a mean summary-index score difference of 0.03 ± 0.16 (p < 0.001) and a mean EQ visual analogue scale score difference of 7.9 ± 18.5 (p < 0.001). Conclusion:This study showed CBA is safe and effective for PsAF treatment in real-world use in Japan. Trial Registration:Cryo Global Registry, ClinicalTrials.gov ID NCT02752737.
Background In 2024, the UK National Institute of Health and Care Excellence (NICE) recommended TriageHF alerts as an option for remote monitoring of patients with heart failure (HF) and a compatible cardiac implantable electronic device (CIED). Data on the cost-effectiveness of this approach has not been published. This research evaluates the cost-effectiveness of TriageHF Plus in public hospital settings, using data from the TriageHF Plus multicentre study (758 participants, NCT04177199 ). Methods An economic model was developed to capture the lifetime cost and benefits of TriageHF Plus versus usual care, based on a site of 300 eligible patients. Analysis on individual patient-level data informed model efficacy and resource use parameters. EuroQol five-dimensional questionnaire data and unit costs were obtained from published, peer-reviewed literature and national databases respectively. Costs and benefits were discounted at 3.5% per annum to adjust future costs and benefits to present value. Results In a site size of 300, TriageHF Plus was predicted to prevent 384 (363–405) hospitalisations over 5 years. In total, TriageHF Plus saved £3989 (£1812–£5563) per person-lifetime versus usual care and was more effective and cost-saving in 99.4% of simulations. Results were robust to changes in key input parameters. Modelling showed that to avoid one hospitalisation, 1.7 people would need lifetime access to TriageHF Plus. Conclusion The TriageHF Plus pathway is cost-effective for the remote monitoring of HF in patients with CIEDs. Trial registration number NCT04177199 .
BACKGROUND:Antitachycardia pacing (ATP) can prevent defibrillator shocks and associated adverse outcomes. Opportunities to enhance ATP performance exist, particularly for rapid monomorphic ventricular tachycardia (MVT). Intrinsic ATP (iATP) is the first closed-loop algorithm that designs and auto-adjusts ATP therapy in real time. OBJECTIVE:This study aimed to evaluate iATP performance in a large, real-world cohort. METHODS:This global, prospective, observational study enrolled patients with an iATP-enabled implantable cardioverter-defibrillator or cardiac resynchronization therapy-defibrillator device. The primary objective, to demonstrate iATP could effectively terminate >60% of MVT episodes in the fast ventricular tachycardia (VT) zone, was analyzed using the generalized estimating equations (GEE) method. Additional analyses included overall effectiveness and the rate of MVT acceleration resulting in shock. A post hoc analysis used GEE models to compare iATP data with standard ATP from a retrospective cohort. RESULTS:In total, 1875 enrolled patients were followed for a total of 3200 patient-years, yielding 2575 iATP-treated MVT episodes. Of 265 iATP-treated episodes in the fast VT zone (73 patients), the GEE-estimated success rate was 89.7% (95% confidence interval [CI] 83.6-93.7), exceeding the primary objective. The GEE-estimated rate of iATP-associated MVT acceleration resulting in shock was 2.3%. Compared with standard ATP, iATP almost doubled the odds of VT termination (adjusted odds ratio 1.87; 95% CI 1.32-2.66; P = .0005) and halved the odds of acceleration resulting in shock (adjusted odds ratio 0.43; 95% CI 0.25-0.74; P = .0026). CONCLUSION:In routine practice, iATP was highly effective and safe across all VT rates. Although exploratory, iATP had overall superior termination rates and a lower chance of acceleration resulting in shock than standard ATP.
Abstract Background/Introduction Tissue contact is critical for effective energy delivery and durable lesion creation with pulsed field ablation (PFA). Currently operators rely on fluoroscopy and intracardiac echocardiography (ICE) to evaluate catheter-tissue contact with the fixed loop multielectrode PFA catheter. However, these visualization modalities are limited in their ability to clearly display contact across the entire catheter array. Purpose This prospective, first-in-human study evaluated the performance of a new impedance-based tissue proximity indicator that measures and displays real-time impedance changes at each catheter electrode on the circular multielectrode PFA system. Methods This analysis included data from 11 patients indicated for atrial fibrillation (AF) that were enrolled September - October 2025 at a single center. All patients underwent pulmonary vein isolation (PVI) using a circular multielectrode PFA system (PulseSelect) and investigational proximity adaptor. Impedance-based tissue proximity indication on the generator screen was confirmed against ICE images and electrogram recordings. In 5 patients, data were recorded, but proximity feedback was not used to inform catheter positioning. The next 6 patients utilized feedback from the proximity indicator to optimize catheter positioning during the normal case workflow. The number of electrodes in contact with tissue immediately before energy delivery based on proximity indication was evaluated across cases. Results A total of 11 patients (64.2±10.0 years, 73% male, 82% paroxysmal AF) received de novo AF ablation. All procedures were performed using general anesthesia. Mean total procedure time was 116.5±18.7 minutes, with an average "first-to-last" energy application time of 33.7±11.0 minutes and mean fluoroscopy time of 16.2±3.5 minutes. Acute PVI was achieved in 100% of subjects. No serious adverse events (AEs) occurred. The mean number of electrodes indicating tissue proximity immediately prior to energy delivery increased from 63% without proximity feedback to 75% when proximity feedback was used to optimize catheter positioning (Figure 1). Conclusion This analysis demonstrates the clinical performance of local impedance recordings for assessing catheter-tissue contact with the circular multielectrode PFA catheter. Visual feedback from the proximity indicator increased the number of electrodes in close proximity to tissue during energy delivery.
