**7. Equipment and personnel**

The care of a patient with severe aortic stenosis should be collaboratively under a Heart Team that consists of a primary cardiologist, an interventional cardiologist, cardiothoracic surgeon, radiologist, and anesthetist. We discussed the meticulous workup and pre-screening measures necessary prior to fully committing to a transcatheter approach. Depending on the comorbidities of the patient, additional specialists may be invited to help fine-tune and optimize patients prior to undergoing TAVR. This multidisciplinary team is needed even post-procedurally to ensure proper follow-up and care should any complications arise.

Centers who wish to pursue TAVR are recommended to have an active valvular heart disease program with at least two surgeons experienced in valvular surgery.

A heart catheterization laboratory, high quality radiology and imaging department should also available. Access to multiple echocardiographic modalities is also necessary. A hybrid operating room is preferred but not mandatory.

The American College of Cardiology, along with partnering societies (AATS, SCAI, STS, ACCF) clearly delineate the components needed for centers to establish and maintain a TAVR program. Quality is the primary endpoint. These are assessed with several various metrics. Due to the learning curves associated with the procedure, having adequate volume of patients is necessary. It has been shown that roughly 30–45 cases are needed for operators to plateau in their procedure times and success rates [41, 42]. The slope for major post-procedural outcomes however remains steep for roughly the first 100 cases [43]. Thus, proceduralists are expected to have documented involvement with 100 cases with half (50) requiring them to be the primary operator. **Table 1** summarizes current requirements to establish TAVR programs.

#### **ACC requirements for new TAVR programs [45]**

There should be documentation of a multidisciplinary approach and of patient access to all forms of therapy for aortic valve disease (TAVR, SAVR, and palliative and medical care) using an SDM process.

	- Completion of an evaluation by both a cardiac surgeon and a cardiologist with knowledge and experience in both TAVR and SAVR
	- Education of patients regarding the treatment recommendations and options by the multidisciplinary team
	- Use of an SDM process incorporating patient preference
	- For this requirement to fulfill CMS coverage criteria, the NCD should be updated as it currently recommends evaluation by surgeons for all patients having TAVR

The proposed TAVR proceduralist for a new TAVR program should document the following:


The TAVR sites must have:


The proposed TAVR surgeon for a new TAVR program should document the following:

• 100 lifetime SAVRs or 25 per prior year or 50 over 2 years and ≥20 SAVRs in the year prior to TAVR program initiation Board eligible or certified by the American Board of Thoracic Surgery or equivalent

The institution should document the following prior to expanding into alternative-access TAVR (e.g., transapical, direct aortic, brachiocephalic arteries, transcaval):

• Completion of 80 TAVRs using transfemoral access with an STS/ACC TVT Registry 30-day riskadjusted TAVR all-cause mortality "as expected" or "better than expected"

The institution should document the following concerning its SAVR program:


#### **ACC requirements for new TAVR programs [45]**


The institution should document the following resources and experience:

• PCI

	- Physicians experienced and competent in vascular arterial interventions
	- Experienced and competent physicians for temporary and permanent pacemaker placement and management
	- On-site services should be available 24 hours/day and 7 days/week to handle conduction disturbances as a result of TAVR

Quality assessment/quality improvement program requirements:

	- Registry submission of all cases using FDA-approved TAVR/SAVR technology, including off-label uses
	- Registry documentation that data submissions meet performance metrics for completeness and accuracy as defined by each registry
	- Review of institutional reports for TAVR (quarterly) and SAVR (semi-annually) from the STS/ACC TVT Registry and STS National Database or an alternative approved registry
	- Assessment and proposed actions if site performance for TAVR and SAVR is suboptimal relative to volume and quality requirements, including national benchmarking of performance metrics
	- Presentation of selected TAVR/SAVR cases at quarterly mortality/morbidity conferences

#### **Table 1.**

*TAVR program recommendations and requirements in the United States as of 2018 per official statement by ACC and its partnering societies. Obtained from Bavaria et al. (obtained from Ref. [44]).*
