the RVAD from the provided drop down boxes. Please refer to Appendix K (Device Brand Table available at for reference purposes). Durable Devices Temporary Devices (include only in conjunction LVAD, BiVAD, TAH with a durable device listed above) HeartMate II LVAS Abiomed AB5000 HeartMate 3 Abiomed BVS 5000 HeartMate IP Biomedicus HeartMate VE Thoratec Centrimag (Levitronix) HeartMate XVE Sorin Revolution HeartWare HVAD TandemHeart Micromed DeBakey VAD – Child Abiomed Impella 2.5 Novacor PC Abiomed Impella 5.0 Novacor PCq Abiomed Impella CP Thoratec IVAD Abiomed Impella RP Thoratec PVAD Other, Specify Abiocor TAH Syncardia Cardiowest TAH – 70cc Berlin Heart EXCOR (paracorporeal) Other, Specify Exclusion: Any exclusion will disqualify the patient for entry into STS Intermacs®: If patient meets ANY exclusion criteria then check any of the appropriate exclusion reasons below: Select all that apply: Patient receives a durable (MCSD) which is not FDA approved Yes or No Patient is incarcerated (prisoner) Yes or No If the patient meets all of the STS Intermacs criteria and none of the exclusion criteria then this patient is enrolled in STS Intermacs® and you will be directed to the Patient Demographics Form. If Patient is EXCLUDED, please complete STS Intermacs® required screening information below: Implant date: Enter the patient’s implant date in MMDDYYYY format. Device Type: Enter the appropriate device side for this implant
Aortic Valve Surgery - Replacement – Biological Aortic Valve Surgery - Replacement – Mechanical Mitral Valve Surgery – Repair Mitral Valve Surgery - Replacement – Biological Mitral Valve Surgery - Replacement – Mechanical Tricuspid Valve Surgery - Repair – DeVega Tricuspid Valve Surgery - Repair – Ring Tricuspid Valve Surgery - Repair – Other Tricuspid Valve Surgery – Replacement - Biological Tricuspid Valve Surgery – Replacement - Mechanical Pulmonary Valve Surgery - Repair Pulmonary Valve Surgery – Replacement - Biological Pulmonary Valve Surgery – Replacement - Mechanical Other Cardiac Surgical Procedure - textbox Cardiac Surgical Procedure – Unknown Other Procedures: Reintubation due to Respiratory Failure Dialysis Bronchoscopy Other, specify - textbox PUMP CHANGE - Please answer all questions regarding pump status considering all time since previous visit and current follow-up date. Was there a pump exchange of a para- or extra- corporeal pump? Example: PVAD, Berlin Heart. Yes, No, or Unknown If yes, Please select the Pump Exchange Reason: Thrombus NOT associated with hemolysis Change in hemodynamics Clinical status Device parameters (please enter Device Malfunction Form) Upsizing device because of patient growth status All other reasons would categorize the pump change as a Device Malfunction. If selected, please fill out the Device Malfunction Form. Was there a console change? For TAH or Berlin Heart Consoles. Yes, No, or Unknown If Yes please complete the following: Date of console change: Enter date in MMDDYYYY format. ST= Unknown Original console name: Text. New console name: Text. Major Outcomes and Adverse Events
c. Visiting family or friends out of your home⁯ Severely limited Limited quite a bit Moderately limited Slightly limited Did not limit at all Does not apply or did not do for other reasons Unknown Developed by John Spertus et al., Mid America Heart Institute, Saint Luke’s Hospital, Kansas City, MO. 2.15 Neurocognitive Function Test The Trail-Making Sample B and Part B are provided in Appendix G. The Trail-Making Sample B and Part B instruments can be printed from Neurocognitive function is to be measured by the Trail-Making Part B test. Trail-Making Part B is to be administered pre-implant and post-implant (3 months, 6 months, and every 6 months thereafter). After the subject completes Part B, take the test sheet and record the time in seconds. Errors contribute to the evaluation of the performance principally by increasing the total performance time. If the patient completes the test, but the test is considered invalid, select “completed but invalid (score not entered)”. Do not allow patient to retake the test. Administering the test 1. Let patient practice with Sample B Script: "On this page are some numbers and letters. Begin at 1 (point) and draw a line from 1 to A" (point to A) "A to 2,"(point to 2), “2 to B” (point to B), “B to 3” (point to 3), “3 to C” (point to C), “and so on, in order, until you reach the end” (point to the circle marked "end"). Then say: “Remember, first you have a number” (point to 1), “then a letter” (point to A), “then a number” (point to 2), “then a letter” (point to B), “and so on. Draw the lines as fast as you can. Ready--- Begin!” If the subject completes the sample B correctly say: "Good! Let’s try the next one." Proceed immediately to Part B. If the subject makes a mistake on sample B, point out the error and explain why it is incorrect. The following explanations of mistakes serve as illustrations: “You started with the wrong circle. This is where you start (point to 2).“You skipped this circle” (point to the circle the subject omitted). “You should go from 1” (point to 1)