What is an Accredited Heart Team?
A Heart Team is defined as a multi-disciplinary team of professionals who are charged with the governance of, and accountability for, the decision making and outcomes of the TAVI program within an institution. It consists of a formal multi-disciplinary collaboration between a broad range of health care professionals with expertise in the assessment and management of patients with valvular heart disease, including during the periprocedural period.
The core members of a Heart team are an interventional cardiologist and a cardiac surgeon supported by a TAVI nurse case manager/coordinator. The Heart Team should include a broad range of health professionals providing all the necessary skills and expertise to adequately assess patients who are potential TAVI candidates, provide balanced judgment about the most appropriate procedure in patients deemed appropriate for an aortic valve intervention, guide and perform a TAVI if indicated and support the patient peri-procedurally.
Typically, a Heart Team could include, but is not limited to, the following:
- Interventional Cardiologist(s)
- Cardiothoracic Surgeon(s)
- Imaging Cardiologist (CT, TTE, TOE) / Radiologist
- TAVI Nurse Case Manager
- Co-ordinator General Cardiologist(s)
- Cardiac Anaesthetist
- Intensive Care Physician
- Geriatrician / General Physician
- Vascular Surgeon
What is an Accredited Institution?
TAVI requirements should be established in high volume cardiac surgical centres where on-site valve surgery is performed.
The following activity levels for institutions undertaking TAVI programs are suggested:
- Institutional interventional program
- 1000 catheter studies / 400 PCI per year
- Institutional surgical program
- 50 Total AVR per year if which at least 10 aortic valve replacement (AVR) should be high risk (STS score>_ 6)
- Minimum of 2 institutionally cardiac-based surgeons in the program
The facilities should include but are not limited to:
- Cardiac catheterisation laboratory or hybrid operating room (OR) equipped with a fixed radiographic imaging system with high-resolution fluoroscopy and facility for cineangiography and haemodynamic monitoring.
- Non-invasive imaging
- Echocardiographic laboratory with transthoracic and transoesophageal echocardiographic capabilities. Sonographers and echocardiographers experienced in valvular heart disease.
- Access to a vascular laboratory (non-invasive) with vascular specialists capable of performing and interpreting vascular studies.
- Access to a CT angiography laboratory with CT technologists and specialists who can acquire and interpret cardiac CT studies.
- A sterile environment that meets, at minimum, or standards necessary for pacemaker/ICD implantation.
- Sufficient space to accommodate the necessary equipment for implantations, including space for anaesthesia, echocardiography, and cardiopulmonary bypass equipment and personnel.
- Appropriate equipment for the procedure and for dealing with possible complications including complete heart block, large vessel rupture, pericardial tamponade, and haemodynamic collapse.
- A post-procedure intensive care facility, HDU, or CCU experienced in managing complex cardiac patients, including patients following conventional cardiac surgery.
The following are desirable, but may not be available in most current interventional cardiology suites:
- Circulating heating, ventilation, and air conditioning laminar flow diffusers
- High-output surgical lighting.
- Facilities for running cardiopulmonary bypass or extracorporeal membrane oxygenators (ECMO).
Volume and Outcome Monitoring Requirements
The following minimum volume and outcomes requirements are recommended for approved TAVI programs:
- Program volume of 20 TAVI per year or 40 per 2 years
- 30-day all-cause mortality < 10%
- 30-day all-cause neurologic events including transient ischemic attack (TIAs) < 10%
- Major vascular complication rate< 10%
- >90% institutional follow-up
- 80% 1-year survival rate for patients after the program has been running for 2 years (2-year average)
- All cases should be submitted to a prospective national database registry