Transcript PPT - Knowledge Center

FemoStop™ Gold
How to Use
Content





2
FemoStop Gold
Femoral anatomy
How to Use
Compression Time Example
Clinical Highlight: Rapid Ambulation
Fully Integrated Compression Offers
Precise, Efficient Hemostasis.
The FemoStop™ Gold compression assist device includes an integrated
digital manometer and transparent, inflatable dome that offer precise, handsfree femoral artery compression. Compared to manual compression,
FemoStop Gold has been shown1 to help achieve hemostasis quicker and
more comfortably, while helping to improve staff efficiency.
3
1.
Sridhar K, Fischman D, Goldberg S, et al. Peripheral vascular complications
after intracoronary stent placement: prevention by use of a pneumatic vascular
compression device.Cathet Cardiovasc Diagn. 1996;39(3):224-229.
Femoral Anatomy and Arterial Puncture Site
ASIS
(anterior superior iliac spine)
Inguinal ligament
External iliac artery
Femoral head
Common femoral artery
Pubic tubercle
Deep femoral artery
(profunda)
Femoral bifurcation
Superficial femoral artery
Figure: Right thigh
4
Arterial Puncture Site
The arterial puncture is usually made in the common
femoral artery, below the inguinal ligament and above the
bifurcation.
How to Use – Step 1 & 2
For Compression of the Femoral Artery or Vein after Vessel Cannulation
1. Activate pump
Prior to activating the pump loosen the control
knob to enable pulling the red battery release.
Pull the red battery release in the direction of
the arrow.
2. Position belt and check pedal pulse
Position belt in line with puncture site(s), equal
on both sides. Check pedal pulse to determine
what is a normal pedal pulse for the patient.
How to Use – Step 3
3. Remove lid
Peel back lid, keeping the dome sterile.
How to Use – Step 4
Correct
4. Position dome
Center dome over arterial puncture (superior
and medial to skin incision).
Keep sheath hubs clear of dome rim.
Wrong
One of the most important things to remember
when applying FemoStop apply pressure to the
arterial puncture and not in the skin incision.
How to Use – Step 5
5. Attach belt
Attach belt to arch and tighten firmly. Ensure
arch is level and square across the groin area.
Adjust by pulling on appropriate corner of belt
to make arch perpendicular to femoral
compression site.
How to Use – Step 6
6. Remove sheaths
Inflate dome to 20–30 mmHg: remove
venous sheath (if applicable).*
Further inflate to 60–80 mmHg and remove
arterial sheath (if applicable).
Then quickly increase pressure in dome to be
+10–20 mmHg greater than systolic BP or
higher a necessary to maintain initial
hemostasis.
Once the device has reached the desired
pressure you may close the pinch clamp on
the tubing to ensure pressure maintenance.
*
To minimize the risk of AV-fistula formation, venous hemostasis should be
achieved prior to the removal of the arterial sheath.
How to Use – Step 7
7. Compression time
After a maximum of 3 minutes, lower to a
maintenance pressure until limb perfusion is
restored to baseline and hemostasis is
maintained. Check pedal pulse periodically to
confirm that flow remains in vessel.
If flow is absent, slowly lower the pressure
until palpable pedal pulse.
After appropriate duration as defined by
hospital guidelines; lower by 10–20 mmHg
every 2-3 minutes until you reach zero.
Leave in place at low pressure if appropriate.
Remove carefully. Dress wound. Discard
entire device.
Compression Time Example*
* Found in the FemoStop Instructions for Use.
** After max three minutes: lower to mean arterial pressure. Check pedal pulse.
*** The length of compression depends on factors which vary, such as sheath size
and anticoagulation status.
Clinical Highlight: Rapid Ambulation
Rapid Ambulation after Coronary Angiography via Femoral Artery Access:
A Prospective Study of 1,000 Patients*
OBJECTIVE
The aim of this study was to assess the safety and efficacy of a 90-minute bed rest protocol for
patient undergoing elective 6 F coronary angiography via the right femoral artery.
BACKGROUND
Following cardiac catheterization, reducing the period of immobilization has been shown to
have beneficial effects on patient comfort. Previously, immobilization times of up to two hours
has been shown to be safe.
METHODS
One thousand consecutive patients undergoing elective daytime coronary angiography were
studied. A novel protocol with a commercially available compression device to mobilize patients
after 90 minutes of bed rest (Figure 1) was used.
RESULTS
Of 1,000 patients, one had a minor bleed that was successfully treated with manual
compression followed by a pressure dressing. Two patients developed pseudoaneurysms, one
of whom required a transfusion and surgery. No other patients required a transfusion or
experienced hemodynamic instability. Thirteen patients had delayed discharge, most
commonly due to a delay in obtaining ultrasound scans to exclude pseudoaneurysm.
CONCLUSION
Results demonstrate that early mobilization (90 minutes) is feasible and safe for patients
undergoing elective coronary angiography performed via the right femoral artery.
12
* Scott Gall, MD, Aamir Tarique, MD, Arun Natarajan, MD, Azfar Zaman, MD, Cardiology Department,
Freeman Hospital, Newcaste-upon-Tyne, United Kingdom and Leicester Royal Infirmary, United
Kingdom, Journal of Invasive Cardiology 2006;18:106-108.
Practical Tips
Snug belt fit
For successful compression, the system must be snug and secure around the patient’s hips before pressure is applied.
Do not over-tighten the belt.
Correctly positioned throughout the procedure
For successful compression, the system must be correctly positioned throughout the procedure so that pressure is
applied to the point intended.
Obese Patients
On very obese patients, it may be necessary to tighten the belt slightly more to enhance downward compression.
Placement of the system may not be suitable on large patients, or patients with very wide hips as the belt may be too
short. An abdominal strap/tape may be used to pull excessive adipose tissue away from dome.
Careful monitoring
Careful monitoring of the dome pressure during the initial period of use is recommended, as the elastic material of the
dome may stretch slightly during the first few minutes. You may notice a slight drop in pressure on the manometer. If this
occurs, reinflate to initial pressure.
Pinch clamp open when increasing or decreasing
Ensure that the pinch clamp is open when increasing or decreasing the pressure.
13
Rx Only
Please review the Instructions for Use prior to using these devices for a
complete listing of indications, contraindications, warnings,
precautions, potential adverse events and directions for use.
Product referenced is approved for CE Mark. FemoStop is designed,
developed and manufactured by St. Jude Medical Systems AB.
FemoStop, RADI, ST. JUDE MEDICAL, the nine-squares symbol and
MORE CONTROL. LESS RISK. are registered and unregistered
trademarks and service marks of St. Jude Medical, Inc. and its related
companies.
©2011 St. Jude Medical, Inc. All rights reserved.
IPN 1742-11
14