Tavr Procedure Room Requirements

A specific requirement for the initiation of a new tavr site is a full time board eligible or certified in interventional cardiology or cardiothoracic surgery primary tavr operator.

Tavr procedure room requirements.

Laboratories will be evaluated on an individual case by case basis. Tavr treats the stenotic heart valve by displacing and functionally replacing the native aortic valve with a bioprosthetic valve delivered on a catheter via a percutaneous transarterial approach through a peripheral artery e g the femoral artery. Blood products are to be available in room during procedure pre procedure hydration to prevent kidney injury chg bath completed. Beginning in their third year existing tavr programs will be expected to meet a higher bar for demonstrating competency in terms of volumes and outcomes to continue performing.

The first in man studies were performed in 2002 and as such tavr is a relatively new procedure. Complete requirements for new tavr programs are available on pages 60 62 of the expert consensus document. Specifically the updated policy includes new volume requirements for reimbursable tavr programs. As more tavr programs have emerged it s become even harder for new players to meet these volume requirements particularly the current ncd s requirement for 50 surgical aortic valve replacement savr procedures a year as these procedures are often shifting to tavr sites.

Since tavr is so new there are no specific guidelines on how many procedures are needed before a clinical center operator becomes proficient in tavr. Aortic valve replacement tavr procedures in cardiac catheterization laboratories cardiothoracic surgery room specifications are required. Transcatheter aortic valve replacement tavr is a minimally invasive procedure to replace the aortic valve in people with aortic valve stenosis. For hospitals without tavr experience cms will require the tavr program to have performed at least 50 open heart surgeries and 20 or more aortic valve related procedures in the two years preceding tavr program initiative.

The primary tavr operator should be a member of the mdt at the designated new institution where he she spends at least 50 of his her active practice time. Mep and electrical requirements shall be pursuant to the nec and ahj 4. However since this is a highly complex procedure tavr should be performed only in centers that currently and routinely perform large volumes of surgical aortic valve operations see table 1. In developing today s decision cms met with numerous stakeholders including medical professional societies who recommended requirements for hospitals and physicians to perform a certain volume of heart procedures.

Aortic valve stenosis or aortic stenosis occurs when the heart s aortic valve thickens and calcifies preventing the valve from opening fully which limits blood flow from your heart to the.