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Protocol of the RADIO-STAR trial: a phase 1 safety and dose finding study of hypofractionated radiotherapy to the stellate ganglia for the treatment of ventricular arrhythmia

Por: Bussmann · B. M. · George · B. · Robinson · M. · Grist · J. · Sukumar · P. · Chinherende · E. · Sheerin · F. · Enzhil · V. · Rider · O. · Jones · B. · Sabharwal · A. · Herring · N.
Introduction

Sympathetic activation is the hallmark of cardiac disease, driving disease progression and triggering ventricular arrhythmia (VA). Despite optimal medical therapy, many patients experience recurrent VAs refractory to medical therapy, leading to repetitive implantable cardioverter defibrillator (ICD) therapy, worse quality of life and adverse outcomes. Cardiac sympathetic denervation (CSD) through surgical removal of the stellate ganglia is an effective treatment for refractory VAs but carries a high complication rate. We hypothesise that high precision image guided radiotherapy can be used to target the stellate ganglia to achieve CSD non-invasively.

Methods and analysis

RADIO-STAR (hypofractionated radiotherapy to the stellate ganglia for ventricular arrhythmia) is a first-in-human, phase 1 safety and dose finding study of radiotherapy to the stellate ganglia in patients with recurrent VAs. Patients with structural heart disease requiring recurrent ICD therapy for VAs are invited to undergo radiotherapy bilaterally to their stellate ganglia with a predetermined sample size of n=13. Radiotherapy dose will be determined by a prespecified dose escalation protocol. The primary outcome is safety defined as any treatment-related grade 3–5 toxicity occurring within 6 months of radiotherapy treatment, as defined by the Common Terminology Criteria for Adverse Events or any treatment-related side effects detected on patient symptom questionnaires and clinical examination during study visits. Secondary outcome measures to evaluate feasibility and efficacy include ability to safely deliver radiotherapy and consequent changes in circulating catecholamines and neuropeptide-Y, heart rate variability, structural changes in the stellate ganglia on MRI imaging and ICD therapy burden.

Ethics and dissemination

This study has received ethical approval by the South Central—Oxford B Research Ethics Committee (REC/SC/0005). Study findings will be submitted for publication in peer-reviewed scientific journals and presented at national and/or international scientific conferences.

Trial registration number

ISRCTN49861434.

Are we getting better over time? Clinical and patient-reported outcomes for reverse shoulder arthroplasty: a National Joint Registry cohort study

Por: OMalley · O. · Davies · A. · Taghavi Azar Sharabiani · M. · Rangan · A. · Sabharwal · S. · Reilly · P.
Objectives

This study aims to review whether both clinical and Patient Reported Outcome Measures (PROMs) of Reverse Shoulder Arthroplasty have improved over time using the National Joint Registry (NJR).

Design

This study is a population-based cohort study using the NJR and Hospital Episode Statistics for England.

Setting

Publicly funded hospitals and procedures in England from 1 January 2013 to 31 December 2021.

Participants

All patients that received a reverse shoulder arthroplasty (RSA) in the specified time period. Patients were excluded if they had less than 1 year of follow-up.

Main outcome measures

Primary outcome was revision at one year. Secondary outcomes were non-revision re-operation and mortality at one year, length of stay (LOS) and mean change in Oxford Shoulder Score (OSS) from pre-operatively to 6 months post-operatively.

Results

There were 24 411 RSA cases available for analysis. There was no significant improvement in revision rates over time; however, there was a significant reduction in non-revision re-operations (OR 0.93 (0.86–0.99) p=0.03) and mortality (0.96 (0.92–1.00) p=0.04). LOS over time improved with an average reduction of 0.24 days per year, ranging from a mean of 3.94 days in 2013 to 2.44 days in 2021 (p

Conclusion

Over the 9-year period recorded in the NJR, revision rates were low and remained similar. There has, however, been an improvement in other clinical outcomes such as non-revision reoperation and mortality as well as functional outcomes and reduced LOS, which demonstrates progress in the quality of care provided to shoulder replacement patients and is suggestive of advancements in surgical techniques, perioperative management and rehabilitation strategies.

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