TIPS AND TRICKS FOR ALERT MANAGEMENT. Reveal LINQ Insertable Cardiac Monitoring System

Transcription

1 TIPS AND TRICKS FOR ALERT MANAGEMENT Reveal LINQ Insertable Cardiac Monitoring System

2 TROUBLESHOOTING CAREALERT NOTIFICATIONS Consider the below guidance when consistently reviewing non-actionable alerts Too Many Alerts No Data Available Repeated Alert False Episodes See Optimizing CareAlerts. See Device Reprogramming. CareAlert: AF If Implant date precedes Dec 14, request a manual download AF episodes < 10 min for these devices do not automatically send in daily wireless audits. CareAlert: Brady/ Pause/Tachy Request manual download An in-clinic data clear may have occurred. Wireless audits may have been missed on too many consecutive days. Max Episodes (auto or symptom) Request manual download Manual download will reset the maximum episode flag (in-clinic visit not required). Other Go to patient s overview page and ensure all reports have been opened. An unviewed report may trigger an additional alert notification. 1

3 CAREALERT NOTIFICATIONS GUIDANCE FOR REVEAL LINQ ICM PATIENTS Consider enabling the following CareAlert Notifications to receive information that may be near term or immediately actionable in your care plan for each patient. The decision to enable CareAlerts should be weighed against the work flow of your clinic to receive and analyze reports. Data collected wirelessly during the month is available on each patient s automatically generated Summary Report. CareAlert Setup To manage the amount of data from Reveal LINQ ICM patients, we recommend setting up CareAlerts by patient. Syncope AF Diagnosis Cryptogenic Stroke and Suspected AF Palpitations AF Monitoring Ablation Management Medical Management Suspected VT Reveal LINQ Wireless Device Alert Conditions Clinical Management Alerts Red Alert Yellow Alert Website-only Alert No Alert Red Alert Yellow Alert Website-only Alert No Alert Red Alert Yellow Alert Website-only Alert No Alert Red Alert Yellow Alert Website-only Alert No Alert Symptom (Patient Activated) Episode Symptom (Patient Activated) + Detected Episode Tachy Episode Pause Episode Brady Episode AF Episode AT Episode AT /AF Daily Burden > Threshold Time: Not in Use Average Ventricular Rate during AT/AF Time: Not in Use V. Rate: Not in Use Maximum Episode Count Met Maximum Symptom (Patient Activated) Count Met Low Battery Voltage Recommended Replacement Time: Electrical Reset * Only for patients with low EF or structurally abnormal hearts (higher VT risk). ** Only when implant signals have been confirmed within guidelines. 2

4 OPTIMIZING CAREALERTS Disabling Non-actionable CareAlerts Keeping CareAlerts on for all patients can significantly add unnecessary burden to a clinic work flow. A clinic should consider the following questions: Has a patient encountered a similar alert when no clinical action has been taken? Example: AF Management patient has intermittent nocturnal Brady and Brady CareAlert is still enabled. Has the patient been diagnosed? Example: Cryptogenic Stoke patient has detected AF and is put on anticoagulant medication. When new events become non-actionable, consider disabling the CareAlert. Medtronic Recommends Disabling Non-critical Alerts Symptom Episode Many patients overutilize the patient assistant for non-cardiac-related events. By enabling the Symptom + Detected Episode alert you can disable the Symptom Episode Alert in the majority of the patients. Maximum Episode Count Met and Maximum Symptom Count Met Both maximum count alerts should only be used at an individual patient level and not at a clinic level. A manual interrogation is required to clear this alert once triggered. This alert should not be used for patients with known AF or who have a history of frequent events. 3

5 TROUBLESHOOTING EPISODES Consider the below reprogramming recommendations when burdened by false episodes. Undersensing Oversensing Other Pauses Tachy AF Increase sensitivity (i.e.: 35 µv -> 25 µv) Increase Pause criteria (i.e.: 3 sec -> 4.5 sec) Brady Increase sensitivity (i.e.: 35 µv -> 25 µv) Increase Brady Detection criteria (i.e.: 4 beats -> 8 beats) Increase Tachy criteria (i.e.: 16 beats -> 32 beats) TWOS Extend Sense Threshold Decay Delay to avoid T-waves PWOS Decrease sensitivity if R-wave sensing can be maintained (i.e.: 35 µv -> 50 µv) Increase AF detection recording time (i.e.: 6 min to 10 min) Ectopy Set Ectopy Rejection: Aggressive Decrease AF sensitivity (i.e.: balanced to less) DEVICE REPROGRAMMING R-wave Amplitude Undersensing If distinct R-waves are not marked as VS, consider programming the sensitivity to a more sensitive (lower number) value (for example, from to mv). All patient and clinical data displayed on the screenshots are fictitious and for demonstration purposes only. 4

6 DEVICE REPROGRAMMING T-wave or P-wave Oversensing If distinct T-waves or P-waves are marked as VS, FS, or TS: For T-waves marked as VS, FS, or TS, consider programming a longer decay delay period. For P-waves marked as VS, FS, or TS, consider programming the sensitivity to a less sensitive (higher number) value. AF False-positive Detection Due to ectopy rhythms (i.e., sinus arrhythmia, PACs, PVCs, bigeminy, trigeminy) For false-positive detections, consider one, two, or all three options below: Consider programming Ectopy Rejection to Aggressive. 1 2 Program AT/AF ECG Recording Threshold to a longer ECG. 3 Consider programming AF Detection to Less Sensitive or Least Sensitive. 5 All patient and clinical data displayed on the screenshots are fictitious and for demonstration purposes only.

7 REVEAL LINQ MONITORING SIMPLIFIED NEW Medtronic Academy Learning Plan now available to support streamlined Reveal LINQ Patient Management START NOW! Course completion provides up to 6 CEU hours!* MedtronicAcademy.com/LINQMonitoring * Provider approved by the California Board of Registered Nursing, Provider Number 13145, for 1 contact hour per course. 6

8 Brief Statement Reveal LINQ LNQ11 Insertable Cardiac Monitor and Patient Patient Assistant Assistant The Medtronic MyCareLink Patient Monitor and the Medtronic CareLink Operation Network of are the indicated Patient Assistant for use in near the transfer sources of of patient electromagnetic data Indications from Medtronic implantable cardiac devices. These products are not a interference, substitute for such appropriate as cellular medical phones, attention computer in the monitors, event of etc., an may emergency. Data availability and alert notifications are subject to Internet adversely connectivity affect the and performance access, and service of this device. availability. The MyCareLink Reveal Patient LINQ Monitor LNQ11 must Insertable be on and Cardiac in range Monitor of the device. Alert notifications The are Reveal not intended LINQ Insertable to be used Cardiac as the Monitor sole basis is an for implantable Potential Complications making decisions about patient medical care. patient-activated and automatically activated monitoring system Potential complications include, but are not limited to, device that records subcutaneous ECG and is indicated in the rejection phenomena (including local tissue reaction), device following cases: migration, infection, and erosion through the skin. Patients with clinical syndromes or situations at increased risk of Medtronic MyCareLink cardiac arrhythmias Patient Monitor, Medtronic CareLink Network, and CareLink Patients who experience transient symptoms such as dizziness, Mobile Application palpitation, syncope, and chest pain, that may suggest a cardiac arrhythmia This device has not been tested specifically for pediatric use. Patient Assistant The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates the data management feature in the Reveal Insertable Cardiac Monitor to initiate recording of cardiac event data in the implanted device memory. Contraindications There are no known contraindications for the implant of the Reveal LINQ Insertable Cardiac Monitor. However, the patient s particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated. Warnings/Precautions Reveal LINQ LNQ11 Insertable Cardiac Monitor Patients with the Reveal LINQ Insertable Cardiac Monitor should avoid sources of diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, therapeutic ultrasound, and radio-frequency ablation to avoid electrical reset of the device, and/or inappropriate sensing as described in the Medical procedure and EMI precautions manual. MRI scans should be performed only in a specified MR environment under specified conditions as described in the Reveal LINQ MRI Technical Manual. Intended Use The Medtronic MyCareLink Patient Monitor and CareLink Network are indicated for use in the transfer of patient data from some Medtronic implantable cardiac devices based on physician instructions and as described in the product manual. The CareLink Mobile Application is intended to provide current CareLink Network customers access to CareLink Network data via a mobile device for their convenience. The CareLink Mobile Application is not replacing the full workstation, but can be used to review patient data when a physician does not have access to a workstation. These products are not a substitute for appropriate medical attention in the event of an emergency and should only be used as directed by a physician. CareLink Network availability and mobile device accessibility may be unavailable at times due to maintenance or updates, or due to coverage being unavailable in your area. Mobile device access to the Internet is required and subject to coverage availability. Standard text message rates apply. Contraindications There are no known contraindications. Warnings and Precautions The MyCareLink Patient Monitor must only be used for interrogating compatible Medtronic implantable devices. See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at and/or consult the Medtronic website at Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Medtronic 710 Medtronic Parkway Minneapolis, MN USA Tel: Fax: medtronic.com Toll-free: (24-hour technical support for physicians and medical professionals) UC a EN 2016 Medtronic. Minneapolis, MN. All Rights Reserved. Printed in USA. 07/2016