Patient Resources

ABBOTT MECHANICAL HEART VALVES AND REMOTE INR MONITORING WITH ACELIS CONNECTED HEALTH

Support for Patients on Anti-Coagulation.
Peace of mind for physicians.

Used together with industry-leading Abbott mechanical heart valves, Acelis Connected Health (ACH) Remote INR Monitoring services are designed to help keep clinicians promptly notified with their patients’ INR results in one of two ways. When patients report results to ACH, ACH will:

  • Fax all results to clinics or,
  • When subscribed to CoagClinic software of ACH, clinicians will have online access and the option to receive alerts if a patient’s self-test results reported to ACH are out of their physician-prescribed therapeutic range.

TWO LEADING TECHNOLOGIES. ONE SOLUTION.


ABBOTT MECHANICAL HEART VALVES

  • Leadership: Revolutionized MHV therapy with the first bi-leaflet valve design. Sponsored leading studies on anti-coagulation management.1,2
  • Experience: More than 40 years clinical experience, nearly 3M implants3, and 1,000 published papers.3


ACELIS CONNECTED HEALTH REMOTE INR MONITORING

  • Proven: A leading provider of remote INR testing and reporting with over 100,000 patients on service.
  • Efficient: ACH remote patient monitoring services are designed to help optimize clinical office efficiencies while striving to achieve a high level of TTR across a broad spectrum of age ranges.
  • Integrated: Ability to integrate data into many leading EMR systems.

 

HOW CONTINUOUS ASSURANCE WORKS

WITH ACELIS CONNECTED HEALTH REMOTE INR MONITORING
 

+Other requirements may apply based upon your Physician office preferences.
*CoagClinic is a patient management application offered to clinics by Acelis Connected Health. Not all clinics will use the CoagClinic application.
In order to receive warfarin dose adjustments instructions the clinic must use CoagClinic and the patient must use HealthCheck App with notifications turned on.

HOW CONTINUOUS ASSURANCE WORKS

WITH ACELIS CONNECTED HEALTH REMOTE INR MONITORING
 

+Other requirements may apply based upon your Physician office preferences.
*CoagClinic is a patient management application offered to clinics by Acelis Connected Health. Not all clinics will use the CoagClinic application.
In order to receive warfarin dose adjustments instructions the clinic must use CoagClinic and the patient must use HealthCheck App with notifications turned on.

REMOTE PATIENT INR MONITORING IN RANDOMIZED STUDIES HAS BEEN SHOWN TO POTENTIALLY:

  • Increase time in the therapeutic  range (TTR)4
  • Lower the risks of thromboembolic and bleeding events4
  • Reduced risk of mortality4
INCREASED TIME IN
THERAPEUTIC RANGE
REDUCED RISK
OF MORTALITY

REAL-WORLD DATA FOLLOWING ACH REMOTE INR MONITORING PATIENTS SHOWED A:5

70%

TIME IN 
THERAPEUTIC RANGE

A SEPARATE META-ANALYSIS
OF PATIENT SELF-TESTING ALSO FOUND A:6†

42%

REDUCTION IN RISK
ASSOCIATED WITH A
THROMBOEMBOLIC EVENT

† Limitations of the analysis: • Only 5 trials were considered high quality (per the analysis). • Only 2 of the 22 reviewed trials in the analysis were conducted in the United States (ref# 23, 24), and both investigated PST, not PSM. • Compared with usual care, PST with or without PSM is associated with significantly fewer deaths and thromboembolic events, without increased risk for a serious bleeding event, for a highly selected group of motivated adult patients requiring long-term anticoagulation with vitamin K antagonists. Whether this care model is cost-effective and can be implemented successfully in typical U.S. health care settings requires further study. • PST is not for every patient taking warfarin but rather only selected patients who are willing, able and reliable to do so.

Enhance Patient Satisfaction and Convenience

Give your patients the satisfaction and convenience associated with Acelis Connected Health Remote INR Monitoring Services* and the freedom from regular clinic or lab visits.

In a recent survey, nearly all current patients are extremely or very satisfied with Acelis Connected Health Remote INR Monitoring.3*

EASE OF USE/ CONVENIENCE
Overall Patient
Satisfaction

*2018 opinion survey conducted by Kalan & Associates of 307 active Acelis Connected Health customers.

MAT-2003803 v2.0 | Item approved for U.S. use only

References
  1. Koertke, Zittermann, Wagner, et al. Telemedicine-guided, very low-dose international normalized ratio self-control in patients with mechanical heart valve implants. European Heart Journal. 2014.
  2. Pruefer, Dahm, Dohmen, et al. Intensity of oral anticoagulation after implantation of St. Jude Medical mitral or multiple valve replacement: lessons learned from GELIA. European Heart Journal. 2001(3); Suppl Q.
  3. Data on file. Current users of AHM INR Monitoring services. N=307.
  4. Heneghan C, Ward A, Perera R, et al. Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. Lancet 2006;367:404-11.
  5. Internal Acelis Connected Health data on file.
  6. Bloomfield H, Krause A, Greer N, et al. Meta-analysis: Effect of patient self-testing and self-management of long-term anticoagulation on major clinical outcomes. Annals of Internal Medicine. 2011 Apr;154(7):479.
Important safety information

SJM REGENTTM MECHANICAL HEART VALVE
INDICATION FOR USE


The SJM RegentTM Mechanical Heart Valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic valve. This device may also be used to replace a previously implanted aortic prosthetic heart valve.

CONTRAINDICATIONS

The SJM RegentTM Mechanical Heart Valve is contraindicated for individuals unable to tolerate anticoagulation therapy.

WARNINGS

  • For single use only. Attempts to reuse the valve may result in valve malfunction, inadequate sterilization, or patient harm.
  • Do not use if:
    • The valve has been dropped, damaged, or mishandled in any way.
    • The expiration date has elapsed.
    • The tamper-evident container seal or inner/outer tray seals are damaged, broken or missing.
  • Remove any residual tissue that may impair valve size selection, correct seating of the valve, rotation of the valve, or leaflet motion.
  • Proper valve size selection is crucial. Do not oversize the valve. If the native annulus measurement falls between two SJM RegentTM Mechanical Heart Valve sizes, use the smaller size SJM RegentTM Mechanical Heart Valve.
  • Use only St. Jude MedicalTM mechanical heart valve sizers.
  • The outer tray is not sterile, and should not be placed in the sterile field.
  • To minimize direct handling of the valve during implantation, do not remove the holder/rotator until the valve has been seated in the annulus.
  • Do not use hard or rigid instruments to test leaflet mobility, as this may result in structural damage to the valve or thromboembolic complications. Use a St. Jude MedicalTM leaflet tester to gently test valve leaflet mobility.
  • Do not use cutting edge needles in the sewing cuff. If use of these needles is necessary, placement of sutures in the outer half of the sewing cuff is imperative.
  • Never apply force to the valve leaflets. Force may cause structural damage to the valve.
  • Use only the valve holder/rotator packaged with the SJM RegentTM Mechanical Heart Valve to perform valve rotation. Use of other instruments could result in structural damage. The valve holder/ rotator is intended for single use only and should be discarded after surgery.
  • The two retention sutures on the valve holder/ rotator must be cut and removed before the SJM RegentTM Mechanical Heart Valve can be rotated.
  • Do not pass catheters or other instruments through St. Jude MedicalTM mechanical heart valves. This could result in scratched or damaged valve components, or leaflet fracture or dislodgment.
  • Cut suture ends short, especially in the vicinity of the pivot guards, to prevent leaflet impingement.

PRECAUTIONS

  • Do not touch the prosthetic valve unnecessarily, even with gloved hands. This may cause scratches or surface imperfections that may lead to thrombus formation.
  • Be careful not to cut or tear the valve sewing cuff when removing the identification tag and the holder/rotator from the SJM RegentTM Mechanical Heart Valve.
  • Before placing sutures in the valve cuff, verify that the valve is mounted correctly on the valve holder/rotator.
  • To avoid structural damage, the valve must be rotated in the fully closed position.
  • To minimize rotational torque, verify that the valve holder/rotator is properly seated in the valve, and that the valve holder handle is perpendicular to the valve (Figures 15a and 15b).
  • Remove any loose suture or thread, which may be a source of thrombus or thromboembolism.

POTENTIAL ADVERSE EVENTS

Complications associated with replacement mechanical heart valves include, but are not limited to:

hemolysis; infections; thrombus; or thromboembolism; valve dehiscence; unacceptable hemodynamic performance; hemorrhagic complications secondary to anticoagulation therapy; prosthetic failure; and heart failure or death.

Any of these complications may require reoperation or explantation of the device.

SJMTM MASTER SERIES MECHANICAL HEART VALVE
INDICATION FOR USE


The SJM™ Masters Series Mechanical Heart Valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning mitral or aortic heart valve. This device may also be used to replace a previously implanted mitral or aortic prosthetic heart valve. The sizer model 905-15 is indicated to confrm size selection of the 15AHPJ-505 and 15MHPJ-505 valves.

CONTRAINDICATIONS

The SJM™ Masters Series Mechanical Heart Valve is contraindicated for individuals unable to tolerate anticoagulation therapy. The sizer model 905-15 is contraindicated for use with any devices other than the 15 AHPJ-505 and 15MHPJ-505 valves. Any sizer sterilization method other than steam is contraindicated.

WARNINGS

  • For single use only. Attempts to reuse the valve may result in valve malfunction, inadequate sterilization, or patient harm.
  • Use only St. Jude Medical™ mechanical heart valve sizers.
  • Do not use if:
    • The valve has been dropped, damaged, or mishandled in anyway.
    • The expiration date has elapsed.
    • The tamper-evident container seal or inner/outer tray seals are damaged, broken, or missing.
  • Remove any residual tissue that may impair valve size selection, correct seating of the valve, rotation of the valve, or leafet motion.
  • Proper valve size selection is crucial. Do not oversize the valve. If the native annulus measurement falls between two SJM™ Masters Series Mechanical Heart Valve sizes, use the smaller prosthetic valve size.
  • The outer tray is not sterile, and should not be placed in the sterile feld.
  • To minimize direct handling of the valve during implantation, do not remove the holder/rotator until the valve has been seated in the annulus.
  • Do not use hard or rigid instruments to test leafet mobility, as this may result in structural damage to the valve or thromboembolic complications. Use a St. Jude Medical™ leafet tester to gently test valve leafet mobility.
  • Place sutures in the outer half of the valve sewing cuff.
  • Never apply force to the valve leafets. Force may cause structural damage to the valve.
  • Use only SJM™ Valve Holder/Rotators to perform valve rotation. Use of other instruments could result in structural damage. The valve holder/rotator is intended for single use only and should be discarded after surgery.
  • The two retention sutures on the valve holder/rotator must be cut and removed before the valve can be rotated.
  • Do not pass catheters or other instruments through St. Jude Medical™ mechanical heart valves. This could result in scratched or damaged valve components, leafet fracture, or dislodgment.
  • Cut suture ends short, especially in the vicinity of the pivot guards, to prevent leaflt impingement.

PRECAUTIONS Valve

  • Do not touch the prosthetic valve unnecessarily, even with gloved hands. This may cause scratches or surface imperfections that may lead to thrombus formation.
  • Be careful not to cut or tear the valve sewing cuff when removing the identifcation tag and the holder/rotator from the valve.
  • Before placing sutures in the valve sewing cuff, verify that the valve is mounted correctly on the valve holder/rotator.
  • To avoid structural damage, the valve must be rotated in the fully open position.
  • To minimize rotational torque, verify that the valve holder/rotator is properly seated in the valve, and that the valve holder handle is perpendicular to the valve.
  • Remove any loose suture or thread, which may be a source of thrombus or thromboembolism.
  • Implantation of a prosthetic valve too large for the annulus may result in increased risk of damage to the conductive system, obstruction of the left ventricular outfow tract, impairment of valve mobility, damage to the left circumfex artery, and damage to surrounding tissues or cardiac structures including obstruction and/or distortion of adjacent cardiac structures.
  • NOTE: PROSPECTIVE DATA TO SUPPORT SAFETY AND EFFECTIVENESS OF THE 15-mm HP VALVE IMPLANTED IN THE AORTIC POSITION ARE NOT CURRENTLY AVAILABLE.
  • Sizer Instruments must be cleaned and sterilized prior to use.
  • Do not use cracked, deformed, discolored/rusted, or damaged instruments.
  • Improper cleaning may result in an immunological or toxic reaction.
  • Instrument sterilization temperature must not exceed 280°F (138°C).
  • Do not bend fexible instrument handles beyond a 90° angle.
  • Instruments must be sterilized in a tray or container that is permeable to steam.
  • Do not expose instruments to cleaning or rinse agents that are not compatible with polysulfone or polyphenylsulfone.

POTENTIAL ADVERSE EVENTS

Complications associated with replacement mechanical heart valves include, but are not limited to, hemolysis, infections, thrombus, or thromboembolism, valve dehiscence, unacceptable hemodynamic performance, hemorrhagic complications secondary to anticoagulation therapy, arrhythm, heart block requiring pacemaker implant, prosthetic failure, adjacent cardiac structure interference, heart failure, stroke, myocardial infarction, or death. Any of these complications may require reoperation or explantation of the device.
 

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