Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest X-ray abnormal, Condition aggravated, Coronary artery disease, Myelopathy, Venogram
Clinical narrative: This 62-year-old male subject was enrolled in an open label study. The subject received the 2nd dose of Zoster VZV-gE-AS01B (intramuscular) .5 ml on 19th April 2017. The subject's past medical history included myocardial infarction (Unk/Unk/2006), myocardial infarction (Unk/Unk/2005), coronary stent placement (LAD-Unk/Unk/2005) and coronary stent placement (LAD-Unk/Unk/2003). Concurrent medical conditions included hyperlipidemia, coronary artery disease and bradycardia (Symptomatic). On 9th August 2017, 112 days after receiving Zoster VZV-gE-AS01B, the subject developed severe - grade 3 coronary artery disease aggravated. Serious criteria included hospitalization. Additional event(s) included severe - grade 3 complete heart block on 25th August 2017 with serious criteria of hospitalization and GSK medically significant. The subject was treated with LIPITOR. The outcome of coronary artery disease aggravated was recovered/resolved on 25th August 2017. The outcome(s) of the additional event(s) included complete heart block (recovered/resolved on 26th August 2017). The investigator considered that there was no reasonable possibility that the coronary artery disease aggravated may have been caused by Zoster VZV-gE-AS01B. The investigator considered that there was a reasonable possibility that the complete heart block may have been caused by Zoster VZV-gE-AS01B. Relevant Tests: 08/25/2017 - XR Chest Post Procedure: Technique - XR chest SP procedure CXR. Findings: Left-Sided pacer has been placed in the interval. Pacer leads project in the region of the right atrium and right ventricle. No pneumothorax is evident post pacer insertion. Heart size is enlarged. Pulmonary vascular redistribution is evident. Sternal Wires are again seen with fractures involving at least the upper 2 sternal wires. Impression: Left-sided pacer placement without pneumothorax seen. 08/26/2017 - XR Chest 2 View PA and Lateral: Technique: XR Chest 2 view PA and Lateral. Findings: The cardiac pacemaker remains in place. Sternotomy wires are noted. Heart size, mediastinum, and pulmonary vessels are stable. Mild atelectasis is present in the lung bases. No pleural effusion or pneumothorax is identified. Moderate spinal degenerative changes are present. Impression: Pacemaker remains in place. Previous Median Sternotomy. Mild atelectasis in the bilateral lung bases. Moderate spinal degenerative changes. Diagnostic results (unless otherwise stated, normal values were not provided): On 25th August 2017, Blood glucose result was 305 mg/dL and Chest X-ray result was see text. On 26th August 2017, Chest X-ray result was see text. Investigator text: 09 August 2017 Right coronary artery stent, this procedure took place at Hospital. MR Pending. Will resubmit request 09Jan2018. Discharge Diagnoses: CHB (Complete Heart Block), Second Degree Heart Block. Operative Procedures Performed: Pacemaker Dual New BSC STAT. Presenting Problem/History of Present Illness: Symptomatic Bradycardia. Hospital Course: Patient presented for planned pacemaker placement on 08/25/2017. Name of Procedure: Venogram of Subclavian Vein, Placement of dual chamber pacemaker, Moderate Sedation. Sedation was moderate and was accomplished with fentanyl and VERSED administration. The independent trained observed was nurse. Sedation start time was 1459. Sedation end time was 1539. Vitals were continuously observed during sedation. The patient tolerated sedation without complications. Patient observed overnight. CXR with stable lead positions and no complications. Tele with proper function. Got post op antibiotics. Exam ok today with no hematoma. Description of Procedure: The left peripheral IV was used to obtain a venogram using 10cc of contrast that demonstrated a patent subclavian vein. Systemic sedation was obtained with fentanyl and VERSED. Lidocaine 1% was used as a local anesthetic. An incision was made with scalpel and Bovie electrocautery was used to dissect down to the fascia and create a pocket along the fascia. Micropuncture needle was used with modified Seldinger technique to obtain extrathoracic venous access x2 with 6French short sheaths. Using a curved stylet and fluoroscopy guidance the RV lead was advanced through the tricuspid valve to the RVOT, then off stylet positioned down onto the septum. The location was verified with RAO and LAO views and actively fixed in place. Testing of the lead was adequate. The atrial lead was then advanced to the RA and actively fixed into the appendage. The lead dislodged to the ventricle and was redeployed just lateral. Initial sensing was slow in this position but injury current and thresholds were excellent so we gave the lead some time to mature and sensing improved. The leads were sutured into the fascia. The leads were then placed into the generator, and the pacemaker generator was placed into the pocket. The pocket was irrigated with antibiotic solution. Hemostasis was adequate. The pocket was closed with interrupted sutures and running 3-0 and 4-0 suture. Steristrips were placed over the incision along with a dressing. The patient tolerated the procedure very well. Pacemaker Generator: Boston Scientific Accolade MRI L331. Right Ventricular Lead: Boston Scientific Ingevity MRI. Right Atrial Lead: Boston Scientific Ingevity MRI. RV Threshold: 0.4V at 0.4ms. RV sensing: 25.0mV. RV impedance: 830ohms. RA Threshold: 0.5V and 0.4ms. RS sensing: 2.3mV. RA impedance: 636ohms. Information provided in medical records is very limited. Labs are included and have been added with only out of range values included in this report. Medications provided during hospital course were pulled from procedure description. Full table of medications administered not included in report. Additional details: Investigator reported SAE as Worsening of Coronary Artery Disease. Case US2018000727 has been updated as duplicate of US2017134967. All the future information will be captured in case US2017134967.