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Procedure Note for EP Procedure (Implant Procedure follows) Op Date: Primary Operator: «PHYSICIAN1» Assisting Operator: «PHYSICIAN2» Referring Cardiologist: «REFERRING» Primary Care Physician: «PRIMARY_CARE_PHYS» Procedures Performed: Electrophysiology Study (Chronic Atrial Fibrillation) «PROCDATE» His Bundle Recording Right Ventricular Recording Induction of Arrhythmia with Pacing Isoproterenol Infusion 93600 93603 93618 93623 Preprocedural Diagnoses: 1. 2. 3. 4. 5. 6. 7. 8. Syncope Paroxysmal Ventricular Tachycardia Unspecified Paroxysmal Tachycardia Ischemic Dilated Cardiomyopathy Hypertrophic Cardiomyopathy Primary Dilated Cardiomyopathy Secondary Dilated Cardiomyopathy Atrial Fibrillation 780.2 427.1 427.2 414.8 425.1 425.4 425.9 427.31 Postprocedural Diagnoses: 1. 2. 3. Inducible Ventricular Tachycardia Inducible Ventricular Fibrillation Atrial Fibrillation 427.1 427.41 427.31 INDICATION FOR PROCEDURE: Unexplained Syncope / SCD Risk Assessment HISTORY: The patient is a «AGE» year old «SEX» that presents with recurrent syncope. There is a history of prior myocardial infarction and an ischemic cardiomyopathy with an estimated left ventricular ejection fraction of 40% by most recent echocardiography (xx/xx/20xx). Baseline electrocardiogram shows a left bundle branch block pattern with a QRS duration of 150 msec. The history does not suggest a vasovagal mechanism. Holter and event monitoring have not revealed a cause for syncope. Tilt table testing was without syncopal response. Medications, electrolytes and metabolic factors do not adequately explain his syncopal episodes. The patient is being referred to the electrophysiology laboratory for electrophysiology study to evaluate the etiology of syncope. The patient presents to the laboratory with persistent atrial fibrillation. Coumadin has been stopped because of the possibility of device implantation. A transesophageal echocardiogram has been performed just prior to the procedure and a preexisting intracardiac thrombus has been excluded. DESCRIPTION OF PROCEDURE: The patient gave informed, written and witnessed consent after the procedure and sedation were explained in full including indications, benefits, risks and alternatives. All questions were satisfactorily addressed. The patient was transported to the Cardiac Electrophysiology Laboratory in a fasting, unsedated state. Moderate sedation was administered according to protocol using intravenous midazolam and fentanyl. The catheter insertion sites were prepared and draped in the usual sterile fashion. Local anesthesia was achieved with a combination of subcutaneous 2% lidocaine and 2% bupivicaine. Hemostatic sheaths were placed percutaneously into the vasculature using the modified Seldinger technique. Diagnostic electrode catheters were positioned using fluroscopic guidance as follows: Insertion Site Right Femoral Vein Right Femoral Vein Sheath 6F 6F Catheter 6F CRD-2 6F CRD Electrodes 4 4 Endocardial Position His Bundle RVA/RVOT 12-lead surface ECG and intracardiac electrograms from the above positions were displayed in real time and recorded. After baseline recordings were obtained including His-Purkinje system conduction time, ventricular function was evaluated by programmed extrastimulation from the right ventricule. In order to facilitate arrhythmia induction, programmed pacing was repeated during intravenous isoproterenol infusion. At the end of the procedure, all catheters and sheaths were removed, and hemostasis of vascular sites was achieved with manual compression and sterile dressings were applied. The patient was transported to a monitored holding area in stable condition. Dr. Richard Hongo performed the electrophysiologic study, was present and personally involved in programmed stimulation, and was immediately available at all times during the procedure. FLUOROSCOPY TOTAL: 3.2 min (7 frames/sec) ESTIMATE BLOOD LOSS: <20 ml COMPLICATONS: None FINDINGS: Baseline Data (msec, [normal range]) Rhythm Atrial Fibrillation RR PR N/A [120-200] (>300 = Class IIb) QRS [80-120] QT [390-440] His-Purkinje System Function (msec, [normal]) HV [35-55] (>100 = Class IIa PPM Indication) Ventricular Function (msec, V1/V2/V3/V4) (Isuprel) 600/250 400/240 < 400/200 TI 600/250/210 400/240/200 < 400/200/200 TI 600/250/210/200 400/240/200/200 600/250 400/240 TI 600/250/200 400/240/200 TI 600/250/210/200 400/240/210/200 VERP (RVA) VERP (RVOT) VT 400/220/200/200* Sustained monomorphic ventricular tachycardia (TCL 280) was induced with programmed stimulation (*) and was terminated with ventricular burst pacing. CONCLUSIONS: 1. Chronic atrial fibrillation 2. Abnormal His-Purkinje conduction, moderately prolonged HV 3. Inducible sustained monomorphic ventricular tachycardia, successful pace termination PLAN: 1. Observe at bedrest with right leg straight for 4 hours 2. Recommend / Proceed with implantation of a single-chamber implantable cardioverter defibrillator 3. Follow-up with Dr. Hongo in the next few weeks to discuss the results of the study Physician Signature: ______________________________________ Date: ________________ Procedure Note for Implant Procedure Primary Operator: «PHYSICIAN1» Assisting Operator: «PHYSICIAN2» Referring Cardiologist: «REFERRING» Primary Care Physician: «PRIMARY_CARE_PHYS» Procedures Performed: Insertion of a Dual-Chamber ICD Op Date: «PROCDATE» Cardioverter-Defibrillator System Insertion Defibrillation Threshold Testing (post EPS) Fluoroscopy with Interpretation Venography, Interpretation Arterial Line Monitoring 33249 93641(-59) 71090-26 36005, 75820 36620 Preprocedural Diagnoses: 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. Congestive Heart Failure Ventricular Tachycardia Ischemic Dilated Cardiomyopathy Hypertrophic Cardiomyopathy Primary Dilated Cardiomyopathy Secondary Dilated Cardiomyopathy Ventricular Fibrillation Ventricular Flutter Cardiac Arrest Syncope Sinus Node Dysfunction Symptomatic Bradycardia Atrioventricular Block, Unspecified 428.0 427.1 414.8 425.1 425.4 425.9 427.41 427.42 427.5 780.2 427.81 427.89 426.10 Postprocedural Diagnoses: 1. 2. Congestive Heart Failure 428.0 INDICATION FOR PROCEDURE: Primary / Secondary Prevention of Sudden Cardiac Death HISTORY: The patient is a «AGE» year old «SEX» with severe ischemic / nonischemic dilated cardiomyopathy with a left ventricular ejection fraction 35% and New York Heart Association functional class II congestive heart failure. The patient has had a documented myocardial infarction more than 40 days prior to today, and is more than 90 days from last revascularization. The nonischemic dilated cardimyopathy has been documented to be present for more than 9 months. Sustained ventricular arrhythmia was induced during electrophysiology study. The patient has presented to the cardiac electrophysiology laboratory for insertion of an implantable cardioverter-defibrillator. The patient has had symptomatic bradycardia, exacerbated by betablocker therapy that is needed for treatment of congestive heart failure. DESCRIPTION OF PROCEDURE: The patient gave informed, written and witnessed consent after the procedure and sedation was explained in full including indications, benefits, risks and alternatives. All questions were satisfactorily addressed. The patient was transported to the cardiac electrophysiology laboratory in a fasting, unsedated state. Moderate sedation was administered according to protocol using intravenous midazolam and fentanyl. An arterial line was placed in the right femoral artery using a modified Seldinger technique for continuous blood pressure monitoring. The left upper chest was prepared and draped in the usual sterile fashion. Local anesthesia was achieved over the anticipated incision site with a combination of 2% lidocaine and 2% bupivicaine subcutaneously. Cephazolin / Vancomycin 1 gm was administered intravenously prior to skin incision. A 3-5 cm incision was made just medial and parallel to the deltopectoral groove using a #15 blade. Using blunt dissection and electrocautery, the incision was extended to the deep subcutaneous tissue, and a pocket the size of the anticipated device was created just above the pectoralis fascial layer. Bleeding was controlled with electrocautery and with 2-0 Silk ties as needed. A left upper extremity venogram was performed using 20-cc of contrast agent. The left axillary and subclavian veins were widely patent. Using the modified Seldinger approach with micropuncture technique, two J-tipped 0.036” guidewires were advanced to the right atrium from the left axillary vein. Puncture of the axillary vein was achieved with guidance from venogram and fluoroscopy. Definitive access of the venous system was confirmed by advancing the guidewire into the inferior vena cava. An introducer sheath was advanced over one guidewire, and an active fixation sensing/pacing/defibrillation lead was advanced under fluoroscopic guidance to the right ventricular apex using curved and straight stylets. Initial positioning of the lead into the pulmonary artery confirmed eventual placement of the lead in the right ventricle. Appropriate sensing and capture thresholds were obtained after successful deployment of the distal screw. The introducer sheath was removed by split sheath technique. A second introducer was advanced over the second guidewire and an active fixation sensing/pacing lead was advanced under fluoroscopic guidance to the right atrial appendage using J-curve stylets. Appropriate sensing and capture thresholds were obtained after successful deployment of the distal screw. The second introducer sheath was removed by split sheath technique. There was no diaphragmatic or phrenic nerve capture with either lead with a maximum output of 10 volts. The proximal end of each lead was secured to the underlying fascial layer using two interrupted mattress stitches of 0 Silk over a lead sleeve. Appropriate lead function was once again confirmed. Final Transvenous Lead Characteristics: Lead Position Right Atrium Sensing Amplitude (mV) 2.7 746 Impedance () Pacing Threshold (V) @ 0.5 ms 0.8 Right Ventricle 12.0 699 0.8 The leads were then connected to the implantable pulse generator and were tested for high voltage lead impedance. Defibrillation threshold was tested and was found to be appropriate. Defibrillation Threshold (DFT) Testing: Trial # 1 Shock Configuration SVC/ICD RV Sensing Threshold (mV) Least Induction Method T-Shock Rhythm VF Cycle Length (ms) 180 Drop Out 2, No Delay Therapy 1 (ICD, J) 26 Therapy 2 (ICD, J) 31 Therapy 3 (External Biphasic, J) 200 DFT (J) 26 38 Shock Impedance () 2 SVC/ICD RV Nominal T-Shock VF 190 None 31 200 31 39 The subcutaneous pocket was generously irrigated with a Bacitracin/Neomycin solution. Bleeding was controlled with electrocautery and with 2-0 Silk ties as needed and ultimately a dry field was observed. The generator was secured to the fascial layer with a loose mattress stitch using 0 Silk. The fascial and subcutaneous layers were closed with running stitches of 2-0 and 3-0 Vicryl, respectively. The skin was closed with a subcuticular stitch of 4-0 Vicryl. The arterial line was removed and hemostasis obtained with manual pressure. The patient was transported to a monitored holding area in stable condition. Dr. Richard Hongo performed the implantable cardioverter defibrillator generator insertion, the defibrillation threshold testing, arterial line insertion, venography with interpretation, fluoroscopy with interpretation, and was immediately available at all times during the procedure. CONTRAST AGENT TOTAL: 20 cc (Visipaque) FLUOROSCOPY TOTAL: 3.4 min (7 frames/sec) ESTIMATE BLOOD LOSS: <20 ml COMPLICATONS: None IMPLANTED MATERIALS: Device RA Lead RV Lead Manufacturer GDT GDT GDT Model VITALITY 2 DR, FINELINE II EZ 4469 ENDOTAK RELIANCE G 0185 Serial Number FINAL DEVICE PROGRAMMING: Ventricular Fibrillation Zone Detection 200 bpm Therapy Defib 41 J (x6) Ventricular Tachycardia Zone Detection 171 bpm Therapy ATP CV 31 J CV 41 J (x3) Bradycardia Parameters Mode DDD AMS On LRL 60 URL 120 AVI/PVI 300/350 RA Output 3.5 V @ 0.4 ms RV Output 3.5 V @ 0.4 ms RA Sens Nominal RV Sens Nominal CONCLUSIONS: 4. Successful insertion of a left-sided dual-chamber implantable cardioverter defibrillator system 5. Good sensing and pacing thresholds 6. Induction of ventricular fibrillation with appropriate sensing and demonstration of a defibrillation threshold (DFT) 26 Joules 7. Tachyarrhythmia therapy is active and programmed to detect ventricular fibrillation at a rate > 200 bpm, and ventricular tachycardia at a rate > 171 bpm 8. Bradycardia parameters are programmed to DDD mode with a long PV and AV Delay programmed in order to avoid unnecessary RV pacing 9. Widely patent left axillary and subclavian veins PLAN: 4. 5. 6. 7. 8. 9. 10. Observe on telemetry unit, pressure dressing overnight PA and lateral CXR in am to document lead position Keep wound dry for 3 days Keep left arm low for 3 weeks, use arm sling as needed Antibiotics for 5 days Wound check in 1 week Device check in 1 month