Wireless Telemetry Device Implantation in a Fontan Ovine Model for Continuous and Long-Term Hemodynamic Monitoring

Summary

This protocol describes the surgical methodology for implanting a large animal wireless telemetry device to enable continuous and long-term collection of hemodynamic data, including heart rate, arterial blood pressure, inferior and superior vena cava pressures, and cardiac rhythm.

Abstract

While the Fontan procedure drastically improves life expectancy for patients with single ventricle, it is well recognized that the resulting circulation causes significant disease burden long term as a consequence of chronically elevated central venous pressures and decreased cardiac output. Chronic Fontan animal models are a valuable asset to studying the late physiological outcomes associated with this operation and a necessary tool in the evaluation of future devices designed to alleviate Fontan failure. However, previous attempts at the creation of chronic Fontan models have been hindered by poor survival rates. Additionally, effective hemodynamic data collection poses a significant challenge in freely moving animals. To this end, the use of wireless implantable telemetry systems provides a novel solution for real-time and long-term monitoring of cardiovascular data. This protocol describes the methodology for surgical implantation of a wireless telemetry device in a Fontan survival ovine model, facilitating the continuous and ongoing recording of several hemodynamic parameters, including heart rate, arterial blood pressure, and localized pressures in the inferior (IVC) and superior vena cava (SVC). Telemetry devices were implanted with cannulation of either the carotid artery and internal jugular vein or femoral artery and vein, for placement of pressure-sensing catheters in the ascending aorta and SVC or abdominal aorta and IVC, respectively. The use of the wireless telemetry systems enabled close postoperative monitoring following a single-stage Fontan operation, which contributed to improved animal welfare and survival.

Introduction

The development of the Fontan procedure in 1971 led to significant improvements in outcomes for patients with single ventricle¹. The purpose of this operation is to separate systemic and pulmonary venous return to the heart, thereby increasing systemic oxygenation and relieving volume load on the systemic ventricle. Since its introduction, numerous modifications have been made to the surgical approach. Currently, total bypass of the right heart is most often achieved through staged reconstruction^2,3. Typically, the first stage is performed during the first week of life^....

Protocol

This experimental protocol was approved by the Institutional Animal Care and Use Committee of the Nationwide Children's Hospital Abigail Wexner Research Institute (AR20-00121). All procedures adhered to the guidelines outlined in the National Institute of Health's Guide for the Use and Care of Laboratory Animals. This research followed the Animal Research: Reporting of In Vivo Experiments guidelines. Dorset sheep with a weight range of 23-38 kg and an age range of 2-12 months were housed in a specific pathogen-free environment with free access to food and water for at least 1 week before surgery. The equipment and reagents used in the study are listed....

Results

Surgical outcomes
A total of 13 sheep underwent single-stage Fontan surgery involving total cavopulmonary connection with detachment of both the SVC and IVC from the right atrium, direct end-to-side anastomosis of the SVC to PA, and placement of an extracardiac conduit between the IVC and PA. Sheep underwent this procedure at a mean age of 13.3 ± 7.6 months. Of these, 3 sheep underwent wireless telemetry device implantation with placement of pressure-sensing catheters into the abdominal aorta and IVC.......

Discussion

We have developed two surgical methods for the implantation of a wireless telemetry device into an ovine model. The device was successfully implanted in 5 sheep to achieve continuous, long-term monitoring and recording of several cardiovascular parameters, including heart rate, arterial blood pressure, and localized venous pressures from the abdominal IVC and thoracic SVC. All sheep survived the surgery for device implantation without any major complications and went on to undergo a single-stage Fontan operation one mont.......

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
0.9% Sodium Chloride solution	Baxter Healthcare Corporation	Pharmacy	Intraoperative fluid resuscitation and wound rinse
16 G intravenous catheter	BD	382259	For fluid and drug administration
22 G intravascular catheter	BD	381423	For arterial  blood pressure monitoring
70% isopropyl alcohol	Aspen Vet	11795782	Topical cleaning solution
ACT cartridge	Abbot Diagnostics	03P86-25	Activated clotting time
Backhaus towel clamp	Medline	MDS1411111	To affix sterile drape
Banamine	Hospira Pharmaceuticals	Pharmacy	Postoperative pain control: concentration 50 mg/mL, dose 2.2 mg/kg
Blood pressure cuff	Royal Philips	9.89803E+11	Non-invasive blood pressure monitoring
Bupivacaine hydrochloride	Hospira Pharmaceuticals	Pharmacy	Local anesthetic: concentration 2.5 mg/mL, dose 2.5 mg/kg
Buprenorphine	Hospira Pharmaceuticals	Pharmacy	Postoperative pain control: concentration 0.3 mg/mL, dose 0.03 mg/kg
Castroviejo needle holder	Medline	MDS0750386	Needle holder when suturing blood vessels
Cautery cleaner pad	Cardinal Health	300-2SS	To clean cautery pencil tip
Cautery pencil	Medline	ESRK3002L	For dissection using electrocautery
Cefazolin	Hospira Pharmaceuticals	Pharmacy	Antibiotic prophylaxis
Cetacaine	Cetylite	220	Topical anesthetic spray for intubation
Chloraprep	BD	930825	Topical antiseptic
Debakey atraumatic forceps	Medline	MDS1130630F	For tissue handling
Diazepam	Hospira Pharmaceuticals	Pharmacy	Sedative: concentration 5 mg/mL, dose 0.5 mg/kg
ECG leads	3M	2570	ECG monitoring
Endotracheal tube, size 8-9	Covidien	86452, 86114, or 86454	To secure airway
Hartmann hemostatic forceps	Medline	MDS1221109	To clamp blood vessels and hold small sutures
Heparin	Hospira Pharmaceuticals	Pharmacy	Anticoagulant: 1,000 USP units/mL
Pressure transducer kit	Edwards Lifesciences	VSYPX12N	For arterial  blood pressure monitoring
Pulse oximeter lingual clip	Nellcor	PO736	For pulse oximetry
Isoflurane	Baxter Healthcare Corporation	Pharmacy	Anesthetic: dose 1-3%
Kantrowitz forcep (right angle)	Medline	MDS1243528	For blunt dissection around blood vessels
Ketamine	Hospira Pharmaceuticals	Pharmacy	Sedative: concentration 100 mg/mL, dose 4 mg/kg
Laparotomy drape	Medline	DYNJP3008	Sterile drape
Lubricating jelly	Medline	MDS0322273Z	Endotracheal tube lubricant
Mayo Hegar needle holder	Medline	MDS2418420F	Needle holder when suturing soft tissue
Mayo scissors	Medline	MDS0816121	To cut suture
Metzenbaum curved scissors	Medline	MDS3223226	For sharp dissection
Needles and syringes	Cardinal Health	309604	For intravenous and subcutaneous drug administration
Optixcare	Aventix	OPX-4252	Corneal lubricant
Perma-Hand silk suture	Ethicon	C016D	For blood vessel ligation and attachment of the telemetry device subcutaneously
PhysioTel Digital wireless telemetry device	Data Sciences International	L21 model	Wireless telemetry device implant
Pierce microforceps	Medline	MDG384908	Small needle handling
Plastic tourniquet and suture snare	Medtronic	79013	To facilitate hemostasis during vessel cannulation
Pressure bag	Carefusion	64-10029	For arterial blood pressure monitoring
Prolene 6-0 suture	Ethicon	8307H	Purse string stitch for vessel cannulation
Propofol	Fresenius Kabi	Pharmacy	Anesthetic: concentration 10 mg/mL, dose 20-45 mg/kg/h
Scalpel #10 blade	Medline	MDS15310	For skin incisions
Scalpel #11 blade	Medline	CISION11CS	For incision into blood vessels
Schnidt tonsil forceps	Medline	MDS5018719	For blunt dissection through subcutaneous tissue
SoftCarry stretcher	Four Flags Over Aspen	SSTR-4	For animal transportation
Sterile disposable OR towel	Medline	MDT2168201	Sterile drape
Sterile bowl	LSL Industries	5232	To hold saline solution
Sterile cotton X-ray detectable gauze sponge	Medline	NON21430LF	Fluid absorption
Orogastric tube	Jorgensen Lab, Inc.	J0348R	For stomach and rumen decompression
T-port	Medline	DYNDTN0001	Intravenous catheter tubing connector
Urine drainage bag	Covidien	3512	Connects to orogastric tube to collect gastric fluids
Veterinary trocar with stylet	Braintree Scientific, Inc.	TRO-STY 7B-12	To guide telemetry wires through subcutaneous tissue
Vicryl 2-0 suture	Ethicon	VCPB269H	Closure of subcutaneous soft tissue
Vicryl 3-0 suture	Ethicon	VCPB416H	Closure of deep dermal layer
Vicryl 4-0 suture	Ethicon	J494H	Closer of subcuticular layer
Warming blanket	Jorgensen Lab, Inc.	J1034B	To maintain animal's body temperature
Weitlander retractor	Teleflex Medical	165358	For wound retraction
Yankauer bulb tip suction	Medline	DYND50138	Sterile waste management