Primary Operator: - EPreward, Inc.



Procedure Note for EP Procedure (Implant Procedure follows)

|Primary Operator: |«PHYSICIAN1» |Op Date: |«PROCDATE» |

|Assisting Operator: |«PHYSICIAN2» |

|Referring Cardiologist: |«REFERRING» |

|Primary Care Physician: |«PRIMARY_CARE_PHYS» |

|Procedures Performed: |Electrophysiology Study (Chronic Atrial Fibrillation) |

| |His Bundle Recording 93600 |

| |Right Ventricular Recording 93603 |

| |Induction of Arrhythmia with Pacing 93618 |

| |Isoproterenol Infusion 93623 |

|Preprocedural Diagnoses: |Syncope 780.2 |

| |Paroxysmal Ventricular Tachycardia 427.1 |

| |Unspecified Paroxysmal Tachycardia 427.2 |

| |Ischemic Dilated Cardiomyopathy 414.8 |

| |Hypertrophic Cardiomyopathy 425.1 |

| |Primary Dilated Cardiomyopathy 425.4 |

| |Secondary Dilated Cardiomyopathy 425.9 |

| |Atrial Fibrillation 427.31 |

|Postprocedural Diagnoses: |Inducible Ventricular Tachycardia 427.1 |

| |Inducible Ventricular Fibrillation 427.41 |

| |Atrial Fibrillation 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 |

|Sheath |

|Catheter |

|Electrodes |

|Endocardial Position |

| |

|Right Femoral Vein |

|6F |

|6F CRD-2 |

|4 |

|His Bundle |

| |

|Right Femoral Vein |

|6F |

|6F CRD |

|4 |

|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: 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) |

|VERP (RVA) | |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 | |400/220/200/200* |

|VERP (RVOT) | |600/250 | |400/240 |

|TI | |600/250/200 | |400/240/200 |

|TI | |600/250/210/200 | |400/240/210/200 |

|VT |Sustained monomorphic ventricular tachycardia (TCL 280) was induced with programmed stimulation (*) and |

| |was terminated with ventricular burst pacing. |

|CONCLUSIONS: |Chronic atrial fibrillation |

| |Abnormal His-Purkinje conduction, moderately prolonged HV |

| |Inducible sustained monomorphic ventricular tachycardia, successful pace termination |

|PLAN: |Observe at bedrest with right leg straight for 4 hours |

| |Recommend / Proceed with implantation of a single-chamber implantable cardioverter defibrillator |

| |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» |Op Date: |«PROCDATE» |

|Assisting Operator: |«PHYSICIAN2» |

|Referring Cardiologist: |«REFERRING» |

|Primary Care Physician: |«PRIMARY_CARE_PHYS» |

|Procedures Performed: |Insertion of a Dual-Chamber ICD |

| |Cardioverter-Defibrillator System Insertion 33249 |

| |Defibrillation Threshold Testing (post EPS) 93641(-59) |

| |Fluoroscopy with Interpretation 71090-26 |

| |Venography, Interpretation 36005, 75820 |

| |Arterial Line Monitoring 36620 |

|Preprocedural Diagnoses: |Congestive Heart Failure 428.0 |

| |Ventricular Tachycardia 427.1 |

| |Ischemic Dilated Cardiomyopathy 414.8 |

| |Hypertrophic Cardiomyopathy 425.1 |

| |Primary Dilated Cardiomyopathy 425.4 |

| |Secondary Dilated Cardiomyopathy 425.9 |

| |Ventricular Fibrillation 427.41 |

| |Ventricular Flutter 427.42 |

| |Cardiac Arrest 427.5 |

| |Syncope 780.2 |

| |Sinus Node Dysfunction 427.81 |

| |Symptomatic Bradycardia 427.89 |

| |Atrioventricular Block, Unspecified 426.10 |

|Postprocedural Diagnoses: |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 |

|Right Ventricle |

| |

|Sensing Amplitude (mV) |

|2.7 |

|12.0 |

| |

|Impedance (() |

|746 |

|699 |

| |

|Pacing Threshold (V) @ 0.5 ms |

|0.8 |

|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 |

|2 |

| |

|Shock Configuration |

|SVC/ICD ( RV |

|SVC/ICD ( RV |

| |

|Sensing Threshold (mV) |

|Least |

|Nominal |

| |

|Induction Method |

|T-Shock |

|T-Shock |

| |

|Rhythm |

|VF |

|VF |

| |

|Cycle Length (ms) |

|180 |

|190 |

| |

|Drop Out |

|2, No Delay |

|None |

| |

|Therapy 1 (ICD, J) |

|26 |

|31 |

| |

|Therapy 2 (ICD, J) |

|31 |

| |

| |

|Therapy 3 (External Biphasic, J) |

|200 |

|200 |

| |

|DFT (J) |

|( 26 |

|( 31 |

| |

|Shock Impedance (() |

|38 |

|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: 200 bpm, and ventricular |

| |tachycardia at a rate > 171 bpm |

| |Bradycardia parameters are programmed to DDD mode with a long PV and AV Delay programmed in order to avoid unnecessary RV|

| |pacing |

| |Widely patent left axillary and subclavian veins |

|PLAN: |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 |

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