DSI PhysioTel Digital User manual

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PhysioTel®Digital Device
Surgical Manual
Surgical Implantation of the PhysioTel®Digital Blood
Pressure and Biopotential Telemetry Devices

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Acknowledgments
Vetbond® and Bair Hugger® are registered trademarks of 3M.
PhysioTel®Digital Device Surgical Manual
Copyright 2012 Data Sciences International
All Rights Reserved
Printed in U.S.A.
Part Number
Rev. 01
Data Sciences International (DSI)
119 14th Street NW ● Suite 100 ● St. Paul, MN 55112
Telephone: [phone] ●1-800 262-9687
Fax: [phone]
Website: www.datasci.com

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Introduction
PhysioTel®Digital telemetry devices are surgically implanted into large laboratory animals
to acquire multiple types of physiologic measurements, process the information and
transmit the data via radio-frequency signals. The PhysioTel®Digital device can measure
pressure (such as systemic blood pressure or intra-ventricular pressure), a biopotential
(such as ECG) temperature and physical activity. This manual contains detailed procedures
for implantation of the TS-L11 and TS-L21 PhysioTel®Digital telemetry devices. The
techniques described are designed for large laboratory animals including dogs, primates
and swine but may be applicable to other, similar sized animals.
The PhysioTel®Digital Device Surgical Manual is intended for use by laboratory personnel
who will perform or assist in surgical procedures to implant PhysioTel®Digital devices. The
surgical procedures written in this manual are at a level of detail appropriate for persons
who have previous experience with surgical procedures. These devices should only be
implanted by a person who has previous surgical experience.
WARNING: The PhysioTel®Digital implantable device is not intended for use in humans. It
is a misuse of this device, and a possible violation of law, to use these devices in humans.
This Manual Contains the Following Sections:
Required Supplies for the TS-L11 and TS-L21 Surgery
Anesthesia and Analgesia Guidelines
Peri-operative Antibiotics
Device Description
Surgical Preparation
Device Handling
Device Placement
oIntra-abdominal placement
Intraperitoneal
Subperitoneal
oExtra-abdominal placement
Intramuscular
Subcutaneous
Systemic Blood Pressure Catheter Placement
oMesenteric Artery
oMedial Saphenous/Femoral Artery
oIliac Artery
oThoracic Aorta
Left Ventricular Pressure Catheter Placement

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oTrans-diaphragmatic Approach
oIntercostal Thoracotomy Approach
Solid Tip ECG Lead Placement
oInternal Jugular Vein
oExternal Jugular Vein
Traditional ECG Lead Placement
oLead II
oBase-Apex
Appendix A: Additional Device Information
Appendix B: Functional Specifications
Appendix C: Care and Use
Appendix D: Equipment and Supplies
Appendix E: Checking the Offset of a Pressure Device

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Required Supplies for the PhysioTel®Digital Surgery
EQUIPMENT
Clippers
Supplemental heating
PhysioTel®Digital device
Ponemah 5.1 data collection system
Mechanical ventilator
INSTRUMENTS
Details contained in Appendix D
SUPPLIES
Surgical scrub (Chlorhexidine or Providine-Iodine scrub)
Sterile drapes
Sterile gloves, hair bonnet and face mask
Sterile surgical gown
Sterile gauze sponges-4 inches x 4 inches (10 cm x 10 cm)
Sterile saline
Sterile basin
2% Lidocaine
Elastic vessel loops
2-0 * to 4-0 (Smaller or larger suture may be needed depending on size and species
used) non-absorbable, non swaged suture[MES1]
2-0 to 4-0 (Smaller or larger suture may be needed depending on size and species
used) non-absorbable suture swaged on a tapered needle[MES2]
2-0 or 4-0 (Smaller suture may be needed depending on size and species used)
absorbable suture material swaged on a tapered needle[MES3]
2-0 to 4-0 (Smaller suture may be needed depending on size and species used)
absorbable surgical suture swaged on a cutting needle[MES4]
14-gauge hypodermic needle *
20-gauge hypodermic needle *
Catheter introducer (i.e. vein pick)*

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Magnet *
Re-gel syringe
Vetbond®Tissue adhesive (if placing systemic blood pressure catheter in iliac artery)
Gel loading micropipette tip or insulin syringe (if placing systemic blood pressure
catheter in iliac artery)
* Contained in starter kit

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Anesthesia and Analgesia Guidelines
Proper peri-operative pain control and anesthesia are critical to humane treatment of
laboratory animals. Each institution’s staff veterinarian should be contacted for proper
analgesic and anesthetic protocols and training before survival surgery is attempted.
The use of pre- and post-surgical analgesics is strongly encouraged for all surgical
manipulations performed on laboratory animals. “The proper use of anesthetics and
analgesics in research animals is an ethical imperative…The selection of the most
appropriate analgesic or anesthetic should reflect professional judgment as to which best
meets clinical and humane requirements without compromising the scientific aspects of the
research protocol.”1Questions regarding the use of analgesics should be directed to your
staff veterinarian.
Typically, the surgical procedure for the TS-L11 will require 60 minutes of surgical
anesthesia, and the surgical procedure for the TS-L21 device will require approximately
120 minutes of surgical anesthesia. Intermittent positive pressure mechanical ventilation is
required any time the thoracic cavity is opened, such as during placement of a left
ventricular pressure catheter. Appropriate use of this technique is essential, and should be
directed by the staff veterinarian. The surgical procedures described in this manual were
developed using inhalational anesthesia consisting of Isoflurane delivered in 100% Oxygen.
These recommendations are intended as a guide only and should be modified to the
individual animal and institution’s protocol.
Anesthetized animals are predisposed to hypothermia. The use of supplemental heat
sources such as warm water re-circulating heating pads or Bair Huggers® are important to
maintain baseline body temperature. Hypothermia will prolong the recovery period and may
result in animal loss.
For additional help in determining an appropriate anesthetic protocol, the staff veterinarian
should be contacted. DSI has also prepared an Anesthesia Reference Manual as a guide
to assist in choosing an appropriate anesthetic agent for a wide variety of common
laboratory species.
1 Guide for the Care and Use of Laboratory Animals, NRC, National Academy Press, 1996 [MES5]

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Peri-operative Antibiotics and Antiarrhythmic
Medications
The use of antibiotics may be elected at the discretion of the investigator. The combination
of sterile device packaging and proper aseptic technique help increase the potential for
successful surgical outcomes. Investigators should follow the guidelines of their own
institution. Questions regarding the use of antibiotics should be directed to the institution’s
staff veterinarian.
Due to the manipulation of the heart, there is a potential to induce an arrhythmia, and the
anesthetist may wish to be prepared to deliver antiarrhythmic agents as appropriate. The
choice and dose of agents should be determined through consultation with the institution’s
veterinarian.
Device Description
It is important that you are familiar with the device and its function before you attempt
implantation (see Figure 1).
Figure 1. PhysioTel®Digital Device[MES6]
The PhysioTel®Digital device measures pressure, a biopotential signal, temperature, and
physical activity in primates, dogs and swine and is a rectangular shaped device.
The devices consist of the following major components:
Device Body - The titanium housing containing:
Pressure sensor: receives pressure fluctuations from the fluid-filled catheter
and sends the signals to the electronics module.
Reusable electronics module: translates the pressure fluctuations,
biopotential signal and temperature into digitized signals and transmits them
to a receiver. It also interprets signals received from the laboratory software
and contains a magnetically activated switch that allows the device to be
switched on or off.
Battery: provides the power supply for the electronics module.
Suture aid: allows the surgeon to suture the device securely in place at the
implant site.
Pressure Catheter(s) - Polyurethane tubing that extends (25, 35 or 40 cm) out of the
device body and contains:
Non-compressible fluid: relays pressure fluctuations to the sensor in the device
body.

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Thin-walled section: tip of the catheter farthest from the device body that senses the
dynamic portion of the pressure wave. It is designed to be completely inserted into
the vessel or space where the desired pressure can be sensed. It contains
biocompatible gel at the very tip, which prevents the non-compressible fluid from
leaving the catheter and blood from clotting in the catheter tip (see Figure2).
Tip cover: removable section of silicone tubing that protects the catheter tip until it is
actually inserted into the desired vessel. Must be removed prior to catheter insertion.
Systemic blood pressure catheter: containing a radio-opaque ring encircling the
distal end of the systemic blood pressure catheter (This is the channel 2 catheter on
the TS-L21 PhysioTel®Digital Device.)
Left ventricular pressure catheter: containing a plastic suture collar near the tip, with
only the thin-walled section protruding beyond. The white suture collar will be
inserted until the suture groove is flush with the heart wall (see Figure 3).
It is important to be familiar with the catheter and its features. See the figure below for a
detailed diagram of each catheter.
Figure 2. The PhysioTel®Digital catheter
Figure 3. The Left Ventricular Catheter Tip With Collar[MES7]

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Biopotential Leads - Two silicon coated helices of medical grade stainless steel wire
extending out of the device body. The positive (red) lead is designed to be cut to a length
suitable for the biopotential signal to be monitored. The negative (clear) lead has a solid tip
and is NOT meant to be cut (unless you require traditional lead placement). It is designed
to be introduced into the right jugular vein and fed into the cranial vena cava to collect the
ECG signal.
Silicone tubing: provides insulation from external electrical activity.
Solid tip on the negative lead: senses ECG signal within the vena cava, near the
base of the heart.

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Figure 4. [MES8]Solid Tip Biopotential Lead
Device Handling
ALWAYS handle the device with care supporting both the device body
and catheters from underneath when moving or placing the device.
Allowing the catheters to hit a solid surface can damage the pressure
sensor.
Before removing the device from its sterile package
Turn the device to the ON mode with a magnet and audibly verify proper device operation
with a DSI receiver.
1. Record the serial number of the device and ensure that the device has been identified
with the animal into which it will be implanted.
2. Measure and record the pressure offset. Refer to Appendix E for further information on
this process.
To Hydrate the Catheter
1. Open the sterile package by peeling back the white package cover from the clear plastic
tray. Do not discard the white package cover as it contains important device calibration
information. Also doDo not discard the sterile package as it can be used for eventual
return of the device to DSI.
2. Place the device and catheter into a sterile basin with sterile saline warmed to body
temperature. Do not heat the sterile saline higher than body temperature as this
can result in clotting at the catheter tip once it is placed in the animal.
3. The catheter should be hydrated for approximately 30 minutes before implantation.
Note: The catheter is very hydrophilic and, if not hydrated, will absorb water from
the blood. This can cause the gel to recede due to catheter expansion and leave a
void at the tip of the catheter, which could increase the risk of blood clot
formation.
WARNING: Do NOT use surgical electrocautery on the animal once the
device is on the surgical tableimplanted into the animal. Use of
electrocautery once the ECG leads are implanted will cause failure of the
device!

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Preoperative Patient Preparation
1. Administer the appropriate surgical anesthesia.
2. Apply Artificial Tears eye ointment to each eye.
3. Remove the body hair liberally from all intended incision sites.
4. Surgically scrub the incision sites with Chlorhexidine or Providine-iodine scrub.
a. A series of at least three scrubs after all gross debris has been removed is
recommended.
b. Begin each scrub in the center of the scrubbed area, over the planned incision
site, and scrub in a ‘bulls eye’ pattern toward the periphery, never going back to
the center with the same gauze sponge. The skin preparation should be
thorough but gentle to avoid unnecessary skin trauma.
c. The final application of scrub may be allowed to remain on the skin.
5. Once the animal and the surgeon have been prepped for surgery and a sterile field has
been established, the surgery is ready to begin.
For intra-thoracic procedures, the animal must be placed on a ventilator to maintain
respiration.

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Device Implantation
Site Selection
The PhysioTel®Digital device can be implanted either intramuscularly, subcutaneously,
intraperitoneally or subperitoneally in animals weighing at least 2.5 kilograms. Possible
locations for placement of the device body vary with the species and size of animal that is
implanted and the physiologic parameters that will be measured.
If core body temperature measurements are desired, the device must be placed in the
peritoneal cavity or subperitoneally (between the peritoneum and the abdominal muscle).
Direct placement of the device body in the abdomen of swine is not recommended due to
rare cases of engulfment and ingestion of the device by the swine’s gastrointestinal tract,.
Ttherefore subperitoneal placement is recommended in this species.
Other possible locations for placement of the device body include intramuscularly along the
animal’s flank or subcutaneously along the dorsum or the flank. Subcutaneous placement
is not generally recommended in pigs and NHPs since they are prone to picking and
rubbing the device when it is placed in this location.
For subcutaneous and intramuscular locations, the animal must be large enough to allow
the antennae to lie perpendicular to the device body to preserve signal quality and in
location that is not directly over bone since this can lead to skin necrosis and irritation. The
device must lie flat under the skin in a pocket that is large enough to accommodate the
device comfortably. However excessive pocket size predisposes to seroma formation.
Device Body
Location
Dog
NHPs
Swine
Peritoneal cavity;
sutured to the inner
abdominal wall
Acceptable location
Acceptable location
(NHP must be > 2.5
kg)
Not recommended
Peritoneal cavity;
sutured between
the peritoneum and
the abdominal wall
muscles
Acceptable location
Acceptable location
(NHP must be > 2.5
kg)
Acceptable location
Intramuscularly
along the animal’s
flank
Acceptable location
Acceptable location
Acceptable location
Subcutaneously
along the dorsum or
flank
Acceptable location
Not recommended
Not recommended

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Intra-abdominal Placement: Intraperitoneal/Subperitoneal
Intraperitoneal/subperitoneal placement is appropriate for canines and non-human primates
weighing ≥ 2.5 kg. Due to potential device engulfment by the intestines, intraperitoneal
placement is not recommended in swine; instead a modified subperitoneal approach is
favored. The intraperitoneal/subperitoneal placement is particularly useful when the trans-
diaphragmatic approach is used to access the heart for left ventricular pressure catheter
placement, since access to the peritoneal cavity will have already been established.
1. Make an incision through the skin and subcutaneous tissues between the xyphoid
process cranially and the umbilicus caudally (length will vary according to procedure, and
can be extended as needed).
2. Make a small incision in the body wall through the linea alba (tenting can prevent trauma
to underlying viscera), then insert a forceps or grooved director and use a scalpel with the
sharp edge facing externally to extend the incision. Keep The length of the incision in the
body wall should be lesssmaller than the skin incision to allow for closure (see figure 4).
Figure 5. Midline Abdominal Incision[MES9]
Subperitoneal placement
Intraperitoneal placement
3a. Make an incision into the peritoneal
lining of the abdominal wall approximately 2-
3 cm to the left animal’s left of the midline
incision (the surgeon’s right) large enough to
place the device portion of the device.
3b. Gently retract the left side of the
abdominal wall slightly to expose the internal
surface approximately 2-3 cm away from the
incision.
4a. Use a mayo scissors to create an
appropriately sized pocket using blunt
dissection. Place the device inside the
pocket with the catheters and biopotential
leads oriented cranially and the antennae
perpendicular to the device body, towards
the opposite side of the abdomen. (i.e. with
4b. Place the device inside the abdomen to
animal’s left of the midline incision (the
surgeon’s right). Orientate the catheters and
biopotential leads cranially and the antennae
perpendicular to the device body, towards
the opposite side of the abdomen. (i.e. with
device is placed on the left side of the linea

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the device is placed on the left side of the
linea alba the antennae will run along the
abdominal wall, across the abdominal
incision, towards the right side of the
abdomen.)
alba the antennae will run along the
abdominal wall, across the abdominal
incision, towards the right side of the
abdomen.)
5a. Secure the device body to the inside of
the abdominal wall by suturing the suture
aids to the inner abdominal muscle using
non-absorbable suture, it may not be
possible to place a suture through the
deepest suture tab.
5b. Secure the device body to the inside of
the abdominal wall by suturing the suture
aids to the inner abdominal muscle using
non-absorbable suture. Be sure the device
body is secured away from the incision site
so that it will not interfere with healing once
the incision is closed.
6a. Close the subperitoneal pocket using
absorbable suture material in a simple
continuous pattern.
6b. N/A
7. Do NOT secure the antennae; the antennae will be secured just prior to closing the
abdomen (see below).
8. The negative (± positive) biopotential lead(s) will now need to be exteriorized from the
peritoneal cavity by passing a 14 gauge needle from outside of the abdomen to inside, next
to the incision. The lead can then be passed into the needle which is then withdrawn.
Figure 6. Cather and Biopotential Lead Exteriorization[MES10]
9. As soon as access to the abdominal cavity is no longer needed (after catheter(s) and
biopotential leads have all been exteriorized/placed) the abdominal incision should be
closed.
10. Before closing the abdominal wall, the antenna of the device must be secured. A small
incision (~1cm) should be made in the peritoneum just next to the right of the midline
incision (surgeon’s left), across from the body of the device.

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Figure 7. PhysioTel®Digital Device Placed Intraperitoneally[MES11]
11. Next a small pocket should be tunneled in the subperitioneal space using blunt
dissection with a mayo scissors or a straight hemostat to provide a secure location for the
antenna to sit.
12. The body wall can be temporarily apposed near the antenna (without including the
antenna itself) using an interrupted suture or a towel clamp.
13. The body wall should be closed in 2-3 layers. The first layer is the muscular body wall
itself which should be closed in a simple interrupted pattern with an monofilament
absorbable suture of the appropriate size.
14. Next, the subcutaneous tissue should be closed in a simple continuous pattern using an
absorbable material, burying the knots.
15. Finally, skin should be closed in an intradermal/subcuticular pattern using an
absorbable suture material. This pattern is recommended to prevent post-operative
irritation. Tissue glue may be used to seal the incision if the surgeon chooses.
Extraperitoneal Placement: Intramuscular/Subcutaneous
Intramuscular or subcutaneous device placement is appropriate in laboratory animals
where the anatomy allows for a sufficiently sized pocket in the flank (paralumbar fossa
area) in which the device and antenna can lie flat and at 90 degrees to one another. The
device and antenna must also lie in a location that does not place either portion of the
device over bone. No implants should be placed directly underneath an incision, as this can
interfere with proper healing, but rather the overlying tissue should be undermined to create
a pocket that lies slightly distant from the incision. The intramuscular placement provides
additional soft tissue between the device body and the skin and has been noted to reduce
the incidence of rubbing or scratching in swine and non-human primates.
Figure 8. PhysioTel®Digital Device in SQ/IM Pocket with Antenna at 90 Degrees
Lateral Recumbency
1. Place a straight to curvilinear incision, slightly longer than the device body, in the
paralumbar fossa area, between the tuber ischii and the last rib. A second smaller stab
skin incision should be made at the point to which the antenna is expected to extend (as
determined by estimating approximate device location prior to surgery) at a 90 degree
angle to the device body.
Figure 9. Subcutaneous/Intramuscular Placement in Lateral Recumbency
Figure 10. Abdominal Wall Muscle Layers

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Subcutaneous
Intramuscular
2a. Using a mayo scissors bluntly dissect
under the skin to form a pocket
approximately the size of the device body.
2b. Using a gridding technique, bluntly
separate the superficial external abdominal
oblique muscle along the fibers running
craniodorsal to caudoventrally. Be cautious
not to dissect too deeply and enter the
abdominal cavity.
4a. Pass a trochar and cannula can between
the small stab incision for antenna
placement and the larger incision for device
placement.
4b. See 4a.
3a. The device body should be placed in the
pocket created using blunt dissection, and
sutured to the underlying muscle using non-
absorbable suture material through the
suture aids. The antenna should be passed
through the cannula so it lies at a 90 degree
angle to the device body.
3b. The device body should be placed in this
space created between the external and
internal abdominal oblique muscles, with
their fibers running in opposite directions.
The device should be secured to the
underlying muscle using non-absorbable
sutures through the suture aids. The
antenna should be passed through the
cannula so it lies at a 90 degree angle to the
device body.
4. The catheters and biopotential leads now need to be routed to their implantation sites.
The first step to do this requires a skin incision be made over the planned implantation site
(i.e. left jugular furrow for negative solid tip lead, medial thigh for medial saphenous artery
etc.).
5. A cannula and trochar can then be passed between the two incisions, the trochar
removed, the catheter(s) and biopotential leads passed through the cannula and the
cannula removed. If necessary to navigate difficult anatomy, an incision can be made
partway between the origin and the planned implantation site, allowing for easier navigation
of corners, angles etc. The surgeon is likely to pass the cannual and trochar multiple times
to route the catheter(s) and biopotential leads to multiple different implantation locations.
6. AFTER the catheter(s), biopotential leads and antenna have been directed to their
appropriate locations, the incision can be closed in layers.
Subcutaneous
Intramuscular
a. First the muscle can be gently
approximated in a simple continuous suture
pattern using an absorbable suture material
on a tapered point needle. Subcutaneous
tissue can also be approximated similarly.
The skin can be closed using an
intradermal/subcuticular suture pattern with
a cutting needle. The stab incision for
b. Subcutaneous tissue can also be
approximated similarly. The skin can be
closed using an intradermal/subcuticular
suture pattern with a cutting needle. The
stab incision for placement of the antenna
should also be closed using an
intradermal/subcuticular pattern.

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placement of the antenna should also be
closed using an intradermal/subcuticular
pattern.
Dorsal Recumbency
Figure 11. Subcutaneous/Intramuscular Placement in Dorsal Recumbency
Intramuscular
Subcutaneous
1a. Place a longitudinal incision just axial (to
the inside of) the fold of the flank. Make the
incision long enough to allow for insertion of
the device in whichever positioning will allow
the antenna to sit at 90 degrees to the
device body (with neither device body nor
antenna placed over any bony structure).
The incision is made through the skin and
superficial muscle layer (external abdominal
oblique), providing a natural separation
between muscle layers of the lateral body
wall.
1b. Place a longitudinal incision just abaxial
(to the outside of) the fold of the flank. Make
the incision long enough to allow for
insertion of the device in whichever
positioning will allow the antenna to sit at 90
degrees to the device body (with neither
device body nor antenna placed over any
bony structure). The incision is made
through skin only.
2a. Place a small stab incision through the
skin and external muscle layer at the level
that the antenna will extend to.
2a. Place a small stab incision through the
skin at the level that the antenna will extend
to.
3a. Blunt dissection between muscles is
used to create a pocket for the device. The
pocket should be large enough to
accommodate the device comfortably, but
not too large, as this can cause seroma
formation.
3b. Blunt dissection underneath the skin is
used to create a pocket for the device. The
pocket should be large enough to
accommodate the device comfortably, but
not too large, as this can cause seroma
formation.
Left Ventricular Pressure Catheter Placement
Trans-diaphragmatic Approach
Thoracotomy Approach*
1a. After the abdominal wall incision has
been made (see 1 and 2 in intrabdominal
and subperitoneal device placement).
Retract the abdomen wall with an
appropriately sized Belfour retractor and
elevate the xiphoid process with an army-
navy or malleable retractor to allow access
to the diaphragm.
1b. Counting backwards from the first or last
rib, locate the 5th intercostal space. Make
an incision through the skin, subcutaneous
tissue, and cutaneous trunci muscle midway
between the ribs, being careful to follow the
contour of the ribs closely from the
costovertebral junction to the sternum.
Incise the latissimus dorsi and pectinius
muscles parallel with the skin and then
incise the external abdominal oblique.
2a. Incise the diaphragm over the left apex
2b. During exhalation, cautiously make a

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of the heart. Remembering that during
dorsal recumbency the animal’s heart
shifts from its natural position so the
incision should be placed slightly
ventrally.
small nick in the intercostals muscles, being
very careful to center the incision midway
between the cranial and caudal rib; this
prevents trauma to the intercostals nerve
and blood vessels running along the caudal
aspect of the cranial rib and provides
adequate tissue for closure. Then extend
the incision using a push-cut method
dorsally to the tubercle of the rib and
ventrally past the costochondral arch to the
internal thoracic vessels (avoid cutting these
vessels).
3a. The diaphragm may be kept open by
placing stay sutures in the diaphragm on
each side of the incision using 3-0 or 4-0
suture with a taper needle. Secure the ends
of the stay suture with a hemostatic clamp
which can then be held by an assistant.
3b. Place wet laparotomy sponges or gauze
squares under the blades of a finochietto
retractor which can be used to expose the
heart and vessels.
*A rib resection may provide additional access to the thoracic cavity, especially in
swine, due to the anatomical difference of a wider rib.
Figure 12. Trans-diaphragmatic Approach to Left Ventricle[MES12]
Figure 13. Thoracotomy Approach to Left Ventricle[MES13]
1. Incise the pericardium to allow for access to the apex of the heart. Begin the incision by
tenting the pericardium over the apex and extend the incision cranially, stopping before
reaching the phrenic nerve that runs through the pericardium horizontally along the
base of the heart. Next, extend the incision to the right and left below the phrenic nerve,
exceess pericardial tissue can be excised.
2. Stay sutures using 3-0 or 4-0 suture on a tapered needle may be placed in the
pericardium on either side of the incision to improve access to the apex of the heart.
Secure the ends of the stay sutures with clamps which can be manipulated by an
assistant. Minimize cardiac retraction as it can cause poor flow into and out of the
heart, severe hypotension and arrhythmias. Monitor blood pressure and ECG
closely when manipulating the heart.
3. Identify the target area at the apex of the heart and install a purse-string suture usinig 3-
4 partial-thickness bites (avoid entering the lumen) in the myocardium (see Figure
13). This should be done using 3-0 or 4-0 non-absorbable suture with a taper needle.
Figure 13: Placement of the purse-string suture

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4. Carefully remove the tip cover from the LV catheter (Channel 1, see description above).
Removal of the tip cover should be done by alternating gentle traction and release.
Take care to prevent gel loss due to compression of the catheter or sudden
release of the tip cover. Always examine the catheter prior to implantation for gel
loss or bubbles. If there is gel loss or bubbles, the catheter will need to be re-
gelled. For help with this process, refer to the Guidelines for the Re-gel of the PA-
C40 Device on our website: www.datasci.com. A video clip of this procedure is
also available on our website.
5. Tie a piece of non-absorbable suture around the suture aid on the catheter (see Figure
14). The size of the suture should be similar to that used for the purse string suture in
the heart, and using a different may be helpful.
Figure 14: Suture around the suture aid
The process of inserting the catheter into the left ventricle is an intricate
maneuver and needs to be performed quickly and efficiently in order to
prevent damage to the heart.
6. Using a hemostat or clamp, grasp the hub of a 14-gauge needle.
7. Puncture the heart in the center of the purse-string suture and verify perforation into the
left ventricle by the presence of blood in the needle (see Figure 15).