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It was reported that post ablation procedure the patient presented with several syncopal episodes and sinus bradycardia was confirmed.There were no complications reported at the time of the cryo ablation procedure.An electrophysiology (ep) procedure was done and ventricular tachycardia (vt) and ventricular fibrillation (vf) were inducible.There was discussion about the patient receiving an implantable cardioverter defibrillator (icd) for the arrhythmia's versus an implantable pulse generator (ipg) for the bradycardia, but neither was ultimately done due to physician preference.After the ep study, an echocardiogram was done which showed a small pericardial effusion and at this time the patient still had bradycardia but was otherwise hemodynamically stable.The patient reported nausea about an hour post procedure and was given medication for the nausea that did not resolve the symptom.A repeat echocardiogram was done with no change to the amount of effusion previously observed.The patient then became profoundly bradycardiac with a heart rate of fifteen beats per minute, then eventually had no heart rate; cardiopulmonary resuscitation (cpr) was started and return of spontaneous circulation (rosc) was confirmed.After the patient was resuscitated, a temporary pacemaker was placed transvenously in the angiography suite.Upon placement of the temporary pacemaker, the patient's blood pressure began decreasing and the patient required intravenous medications to stabilize the blood pressure.Bleeding was suspected due to hemodynamic instability and a computerized tomography (ct) scan was done showing bleeding which appeared to originate from a liver injury and fractured ribs with a pneumothorax and/or a hemothorax, which were thought to have occurred as a result of cpr.An attempt to perform angiography to identify and control bleeding was unsuccessful due to the massive intra-abdominal bleeding; therefore, the patient was taken to the operating room (or) to have an open thoracotomy procedure.The thoracotomy confirmed massive bleeding in the abdominal cavity from liver injury with bleeding.Hemostasis was not possible, even with blood transfusions.The patient was then taken to the intensive care unit (icu) where the patient passed away.An autopsy was done which confirmed the cause of death was severe blood loss due to liver and lung injury as a result of cpr.
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Additional information was received from a physician employed at the facility where the patient had the cryo ablation procedure.The patient was a (b)(6) male, with a past medical history of hyper-igm syndrome and was taking oral steroids.In addition, the patient's past surgical history included splenectomy and laparotomy due to inguinal hernia on the right side.The patient underwent laparotomy due to strangulated ileus in (b)(6) 2015 and was having follow-up hospital visits afterwards.The patient had been aware of skipped heart beats for a few years and was diagnosed with paroxysmal atrial fibrillation (paf) by a local doctor.The patient was referred for catheter ablation to treat the paf that could not be managed by anti-arrhythmic medication as it had led to bradycardia.In addition, the patient had previously had detailed examinations for syncopal attack, which had been occurring a few times for the past few years.On (b)(6) 2015, the patient was admitted to the hospital for catheter ablation to treat the paf and also for electrophysiological studies (evaluation to rule out sick sinus syndrome and provocative testing for ventricular arrhythmia).Upon the hospital admission, echocardiogram (ecg) showed a heart rate of 49 bpm and a right bundle branch block was confirmed, and neither supraventricular premature contraction nor ventricular premature contraction was confirmed.On (b)(6) 2015, pulmonary vein isolation (pvi) was conducted using the cryo balloon catheter.Ablation of the cavotricuspid isthmus (cti) was conducted with radiofrequency ablation, with a competitor product, in order to avoid atrial flutter.Sinus bradycardia with the rate of forty beats per minute was confirmed in the patient upon the arrival to the catheterization laboratory; however, neither hemodynamically significant bradycardia nor hypotension was confirmed during the ablation procedure.Isolation of all the pulmonary veins and blocking of the cti were successfully performed and the procedure was completed.The time taken for the catheter ablation procedure was two hours and thirty eight minutes.An electrophysiology procedure was performed with competitor products following the cryo ablation procedure.It was reported that ventricular fibrillation (vf) was induced but sinus node dysfunction was not confirmed from the ep study.The patient exhibited some hemodynamic changes with induction of vf but when direct current defibrillation was used, hemodynamics improved instantly per the reported information.Post procedure after the patient was taken back to the recovery unit, the patient reported nausea and cardiac ultrasonography (echocardiogram) was performed again in the ward.There was no change in the ventricular contractile function or in the level of the pericardial effusion, compared with that of the immediate postoperative period which remained stable at three millimeters in the four-chamber view on the echo.There was no change in vital signs from those of the pre-procedure and all vitals were stable.A short time later, bleeding from the inguinal area was reported, however neither obvious bleeding nor hematoma in the punctured site was confirmed.The area was immobilized and pressure was applied as there was the possibility that the patient had moved lower legs.Later in the day, the primary doctor was called due to the patient having a decreased level of consciousness.At the same time, an emergency call for the entire hospital was made and cardio pulmonary resuscitation (cpr) was conducted by the emergency physicians.The ecg monitor showed a gradual degrease in the patient's blood pressure over a five minute period.Ventricular arrhythmia was not confirmed.Lowered respiratory rate in parallel with decreased level of consciousness was confirmed, and therefore intubation and artificial respiration were started.The heartbeat was restarted by cpr, however, the decreased level of consciousness remained and anisocoria was confirmed.A head ct scan was therefore performed, which showed no indication of hypoxic encephalopathy or obvious bleeding.An entire body ct scan revealed pneumothorax in the both lungs and multiple fractures of the ribs were confirmed.An external pacemaker was deployed as sinus bradycardia was observed post resuscitation.Afterwards, the systolic blood pressure decreased and medication was used to stabilize, however the response was minimal.Therefore, a contrast enhanced ct test was again conducted.The ct result showed pneumothorax in the both lungs, and the possibility of bleeding from the gastro-epiglotic artery (gea) was suspected.Therefore, angiography for identification of the bleeding site and embolization were performed.As for the pneumothorax, chest drainage was used for both lungs.The source of bleeding could not be identified with angiography and blood pressure fell further.Therefore, a laparotomy was conducted in order to identify the bleeding source and then to stop bleeding.Liver damage and bleeding as a result of it were confirmed during the procedure.Hemostasis was attempted, however it was difficult.Bleeding from the small intestine and was also confirmed.Bleeding was out of control and it was considered disseminated intravascular coagulation (dic).Multiple blood products were transfused, and again medications were used to attempt to stabilize the patient hemodynamically; however, blood pressure did not rise and resulted in temporary cardiac arrest.The patient was taken back to the intensive care unit where the patient was pronounced dead.An autopsy was performed which demonstrated that frostbite scars were confirmed in the pulmonary vein, however no abnormality such as perforation or bleeding were confirmed.A defect hole as a result of the atrial septal puncture was confirmed as well as abnormal change in the color of the cti, however, perforation was not confirmed.There was no abnormality in the cardiac muscle.There were eighty milliliters of pericardial effusion confirmed.According to the thoracic observation, multiple fractures of the ribs (under the fifth and the sixth rib) were confirmed to both sides of the ribs.There was two-hundred milliliter of intrathoracic bleeding and crepitus on the front chest observed.According to the abdominal observation, nine-hundred and thirty grams of bleeding (the weight including that of gauze) and liver damage was confirmed.Phrenic injury was not confirmed, and large bleeding source was not confirmed in the intestine though dot hemorrhage was observed.According to the arterial observation, only mild atherosclerosis of the aorta was confirmed, and no obvious perforation in either the gea or the coeliac artery was confirmed.The cause of death was confirmed to be caused by blood loss, possibly due to intraperitoneal bleeding.However the ct scan did not clearly show any damage in the coeliac artery or the gea that had been suspected, indicating no clear source of bleeding.According to the fact that there was dot hemorrhage, dic was possible.
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