Musculoskeletal Stress, Ergonomic Ease and Radiation Exposure with StandTall for Elective LRA PCI - Post Market Surveillance:
1.
StandTall (ST) Left Radial Access PCI Post Market Surveillance Evaluation.
New StandTall (ST) Left Radial Access (LRA) PCI Post Surveillance Evaluation Protocol:
May skip below to Survey if protocol understood.
Inclusion Criteria:
1. All PCI from LRA access. 2. All cases elective procedures. Do not include emergency.
3. In order for physicians to receive their estimated lifetime radiation dose and risk, each survey response requires physician name and contact info. Radiation data is not required.
Exclusion Criteria:
1. Patients over 6 ft. 3 inches tall are excluded unless 125 cm catheter system used. 2. Dialysis access in left arm or known occluded left upper extremity arterial system excluded.
Protocol:
1. 5 cases without ST. Use any set up.
If operator is competent with Left Radial Access for PCI, and will not include any case related radiation information, the physician may skip the standard left radial approach and go straight to the StandTall system.
2. 10 cases with ST 15cm (model # ST0010) or ST 11.5cm (model # ST0005) with a consistent stabilization device. See Product table recommendations below.
Radiation case specific information optional.
Specific pt. Weight and height data also optional. Patient size data requested to confirm and better define StandTall length recommendations based on patient height, weight and BMI.
3. Additional cases, up to 50 with StandTall (evaluate learning curve and behavior change).
4. More than one physician per center invited; No limits.
5. Upon completion of a post market protocol and surveys, the participating physician may receive a personalized estimated annual dose and career excess cancer risk based on a few additional questions if the physician desires. This will require some additional offline data including expected length of career and estimated annual cases combined with survey collected data for extrapolation.
Each institution will use their own protocol for LRA Patient hand positioning. For ST specific cases, the left hand is recommended to be placed in pronation as close to right inguinal region as possible, with the the elbow slightly bent and stabilized with standard support board. Please review the StandsTall "How To" video for complete StandTall System set up which is available online at www.raduxdevices.com.
Physician can wear Rad 60-R personal dosimeter on dorsum of his/her left wrist attached to wrist sweat band and a second device under sterile gown over chest on pocket.
Post procedure questionnaire completed. Radiation input, physician total dose, and patient height and weight details optional.
Pointers, possible limitations, to expect and overcome with StandTall :
A. Expect some valve leakage, back bleeding with wire in place. Will not occur without instruments or with catheter in place.
B. Expect a transition zone, lip, between StandTall adaptor transition and access sheath. Solve lip issue by advancing wire in catheter until catheter reaches transition zone. Then advance wire.
Table 1: Recommended lengths of StandTall for PCI:
Ref #
Product Name and usable length
ST recommendations for LRA PCI with standard 100 cm catheters
