Primary endpoint
oesophageal damage, toxicity, pain, pericardial effusion, sinus node disease, sinus node dysfunction, oesophagitis, atrial thrombus, herpes zoster infection
VENTRICULAR TACHYCARDIA, ADVERSE EVENTS, ADVERSE EVENT, EVENT, CORONARY ARTERY EMBOLISM, PERICARDIAL EFFUSION, SINUS NODE DYSFUNCTION, OESOPHAGITIS, ATRIAL THROMBUS, HERPES ZOSTER INFECTION, TORSADE DE POINTES
With a median FU time of 16 months (range 12–23), no acute toxicity more than Grade 3 surely related with irradiation was reported. All adverse events were reported in Adverse event classificationAV, atrioventricular; GI, gastrointestinal; VT, ventricular tachycardia.Five patients (27.7%) had a mild oesophagitis (Grade 1) 24 h after STAR; the symptoms resolved after 1 week using proton pump inhibitors and sucralfate. Five months after STAR, 1 patient (5.5%) had epigastric pain unresponsive to pharmacological treatment using proton inhibitors and sucralfate. The patient underwent chest CT and endoscopy not documenting oesophageal damage. After discharge, the patient developed herpes zoster infection at the site of pain symptoms.Furthermore, eight patients (44.5%) experienced an asymptomatic mild (Grade 1) pericardial effusion (max 2 mm): 2 patients after 1 month from STAR, and their pericardial effusion completely resolved in 3 months; 6 patients after 6 months from STAR, and 1 out 6 had a complete resolution, while the other 5 patients had a stable asymptomatic mild pericardial effusion at 1 year FU.Only 1 patient (5.5%) had a symptomatic (Grade 3) pericardial effusion (about 5 mm) documented after 6 months from STAR; the pericardial effusion completely resolved in 2 months using pharmacological treatment with corticosteroids. No other significant alterations were found at echocardiograms performed during the FU visits.One patient had a clinically significant acute event after STAR: after 1 h from treatment Patient 13 had a torsade de pointes treated effectively by electrical cardioversion and subsequent cardiac implantable cardioverter-defibrillator (ICD) implantation.Two adverse events were not related to STAR. In particular, one patient had a coronary artery embolism after electrical cardioversion for AF performed 4 months after STAR. The patient did not perform exams to exclude atrial thrombus because anticoagulant therapy had been taken, without interruption, for more than 3 weeks before electrical cardioversion. Moreover, 1 patient had a dual-chamber pacemaker implanted 13 months after STAR for a sinus node disease progression. An asymptomatic mild sinus node dysfunction was documented before enrolment for which beta-blocker therapy was discontinued.No significant alterations were documented on the chest CT scan performed 6 months after STAR.