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How do you build new privileges for new procedures offered by the device manufacturers?

Basudhaa Dasgupta, CEO, has worked with multiple healthcare systems and helped develop new privilege sets based on 21st century Fellowship training in various specialties and/or any new FDA approved devices.

Below is an example of building a new privilege set for clinicians trained on Watchman.

Over 1/3 of people with AFib feel trapped between the fear of having a stroke and fear of the risks associated with blood thinners. In fact, more than 4 in 5 people with AFib taking a blood thinner (83%) say they would be willing to try a different treatment to help reduce their risk of stroke.

As a permanent implant, WATCHMAN doesn’t come with the same bleeding risks associated with the long-term use of blood thinners. This makes it an important option for people with a history or risk of serious bleeding on blood thinners.

Who can perform this procedure – Qualifications and requirements in the Privilege Request Form?

The procedure must be performed by an interventional cardiologist(s), electrophysiologst(s) or cardiovascular surgeon (s) that meet the following criteria:

  • Has received training prescribed by the manufacturer on the safe and effective use of the device prior to performing LAAC; and

  • Has performed ≥ 25 interventional cardiac procedures that involve transeptal puncture through an intact septum; and

  • Continues to perform ≥ 25 interventional cardiac procedures that involve transeptal puncture through an intact septum, of which at least 12 are LAAC, over a two-year period.

Background information submitted to Credentials Committee for review, evaluation and feasibility prior to offering these privileges within their healthcare organizations. This information was taken from different sources and is not the full report submitted to Credentials committee and MEC at different healthcare systems.

The WATCHMAN physician training program involves multiple phases including didactic training, imaging training, training in patient selection, device selection, complication management, and optional physician proctoring

  • Individual physicians and/or the collective physician-team must be proficient in transseptal skills prior to entering the WATCHMAN Training Program

  • Implantation of the WATCHMAN FLX Device should only be performed by interventional cardiologists and/ or electrophysiologists who are trained in percutaneous and transseptal procedures and who have completed the WATCHMAN FLX Physician Training program.

  • Device selection should be based on accurate LAA measurements obtained using echocardiographic imaging guidance in multiple views (TEE recommended in multiple angles [e.g., 0°, 45°, 90°, 135°]) to avoid improper Closure Device sizing.

  • Potential for Closure Device embolization exists with cardioversion < 30 days following Closure Device implantation; verify Closure Device position after cardioversion during this period.

  • Appropriate post-procedure drug therapy should be followed.

Data listed below is presented to the committee to help determine under what criteria should a clinician be allowed to request this privilege and what guardrails should the healthcare organization implement to manage patient safety.

  • This device has not been studied in pregnant or breastfeeding women. Careful consideration should be given to use of the Closure Device in pregnant and/ or breastfeeding women due to the risk of significant exposure to x-rays and the use of anticoagulation medication.

  • The safety and effectiveness (and benefit-risk profile) of the WATCHMAN FLX Device has not been established in patients for whom long-term anticoagulation is determined to be contraindicated.

  • The LAA is a thin-walled structure. Use caution when accessing the LAA, and deploying, recapturing, and repositioning the Closure Device.

  • Use caution when introducing a WATCHMAN Access System to prevent damage to cardiac structures.

  • Use caution when introducing the Delivery System to prevent damage to cardiac structures.

  • To prevent damage to the Delivery Catheter or Closure Device, do not allow the WATCHMAN FLX Device to protrude beyond the distal tip of the Delivery Catheter when inserting the Delivery System into the Access Sheath.

First three-year data from NCDR-LAAO Registry

The NCDR-LAAO Registry analysis is a review of the first three years and over 38,000 WATCHMAN implants. This analysis, The NCDR Left Atrial Appendage Occlusion (LAAO) RegistryTM: Review of the First 3 Years, presented by Dr. James Freeman on March 29, 2020 at the ACC 2.0/WCC Virtual Experience. This analysis demonstrates that major in-hospital adverse event rates were in-line with those reported in the pivotal WATCHMAN device trials.

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