IMACS Users' Guide – Version 1.0 - The International Society for ...

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IMACS Users’ Guide – Version 1.0 12/21/2012 Page 34 of 56 1 Month Follow-up Adverse Events Did the patient have one or more of the following adverse events occur during this follow-up time period? Please make sure you have entered all events that have occurred during this follow-up period. o Major Bleeding o Major Infection o Neurological Dysfunction o Device Malfunction (if suspected device thrombosis, then enter as Device Malfunction) o Death o Transplant o Explant due to Transplant o Explant due to Recovery o Explant due to Exchange o Respiratory Failure o Arterial Non-CNS Thromboembolism Note: Go to section 2.10 for the definition of each Adverse Event.
IMACS Users’ Guide – Version 1.0 12/21/2012 Page 35 of 56 2.6 3 Month and 6 Month Follow-up The data on this form is collected at the following time periods: 3 months post-implant (+/- 30 days i.e., POD 60 days - 120 days) 6 months post-implant (perpetual - +/- 60 days) When doing medical chart abstraction, please use clinic visit closest to follow-up period. Check one of the following: o Inpatient (complete follow-up form) o Outpatient (complete follow-up form) o Other Facility: Yes No (complete follow-up form) o Nursing Home/Assisted Care o Hospice o Another hospital o Rehabilitation Facility o Unknown o Unable to obtain follow-up information - this will result in an incomplete follow-up (cannot complete follow-up form) State reason why you are unable to obtain follow-up information (check one): o patient didn’t come to clinic o Not able to contact patient o Not addressed by site If Inpatient, outpatient or other facility is checked then – Enter follow-up date: MM/DD/YYYY please enter the actual follow-up date post implant. Evidence of Right Heart Failure - during report interval Peripheral edema: Does patient have moderate or worse peripheral edema? Yes, No or Unknown Ascites: Yes, No or Unknown. This is in the clinicians’ best judgment, as it is sometimes difficult to tell whether abdominal protuberance is fluid or adipose tissue. Echo Findings - during report interval Evidence of elevated CVP pressure: dilated IVC, IVS with collapse, or physical exam (signs of increased jugular venous pressure? Yes, No or Unknown Mitral regurgitation: Mitral regurgitation should be recorded on a qualitative scale (if ‘trivial’ then assign as mild). Moderate-severe would be recorded as “severe”. 0 (none) 1 (mild) 2 (moderate) 3 (severe) Not Recorded or Not Documented
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