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VOLUME 13 NUMBER 2 • DECEMBER 2016
97
SA JOURNAL OF DIABETES & VASCULAR DISEASE
CONSENSUS GUIDELINES
SASCI/SCTSSA joint consensus statement and guidelines
on transcatheter aortic valve implantation (TAVI) in South
Africa
Jacques Scherman, Hellmuth Weich
Correspondence to: Jacques Scherman
Chris Barnard Division of Cardiothoracic Surgery, University of Cape Town,
South Africa
e-mail:
jacques.scherman@uct.ac.zaHellmuth Weich
Division of Cardiology, Tygerberg Hospital and Stellenbosch University, Cape
Town, South Africa
Previously published in
S Afr J Cardiol
2016;
27
: 399–400
S Afr J Diabetes Vasc Dis
2016;
13
: 97–98
T
he South African Heart Association (SA Heart) together
with two of its special-interest groups, the South African
Society of Cardiovascular Intervention (SASCI) and the
Society of Cardiothoracic Surgeons in South Africa (SCTSSA),
represent the scientific, educational and professional interests of
South African cardiac specialists, with a combined membership
of over 200 members. These two interest groups exclusively
represent practicing cardiologists and cardiothoracic surgeons in
South Africa. SASCI and SCTSSA are dedicated to maintaining the
highest standards of specialist practice and the highest quality of
patient care. As a result, SASCI and SCTSSA seek to serve as a
knowledge resource for patients and funders in matters related
to new technology used in the cardiac interventional and surgical
disciplines.
The introduction of new technology is a constant in modern
medicine. While authorities in the United States of America (USA)
and European Union, such as the Food and Drug Administration
(FDA) andConformité Européene (CE), provide regulatory clearance
on safety and effectiveness, practicing medical practitioners
require scientific evidence on net health outcomes before offering
new procedures to their patients. In addition, to meet clinical
expectations of practicing specialists, new technology must stay
consistent with fundamental medical and surgical principles.
Transcatheter aortic valve implantation (TAVI) is considered
a feasible technique, which may be used as an alternative to
standard surgical aortic valve replacement in selected cases. The
procedure is performed on the beating heart without the need
for a sternotomy or cardiopulmonary bypass. There are currently
two devices available in South Africa that are CE-marked and
approved by the FDA. The procedure may be performed via the
transfemoral, trans-subclavian and transapical approaches or via
a mini-sternotomy (transaortic approach).
SA Heart and the respective boards of the SASCI and SCTSSA by
consensus hereby adopt the TAVI procedure for aortic stenosis in line
with the principles of evidence-based medicine after considering
the most recent published evidence and the various multinational
society position statements and guidelines concerning TAVI.
This consensus guideline considers all the literature reviewed,
including the 2014 American Heart Association/American
College of Cardiology guideline for the management of patients
with valvular heart disease, the 2012 European Society of
Cardiology/European Association for Cardiothoracic Surgery
guidelines on the management of valvular heart disease, and
the updated standardised endpoint definitions for TAVI [as per
the Valve Academic Research Consortium-2 (VARC-2) consensus
document].
1-3
Consensus guidelines on transcatheter aortic valve
implantation (TAVI)
Members of the SA Heart Association, SASCI and SCTSSA with
experience in the technique and knowledge of the TAVI literature
have agreed to the following consensus statement:
Requirements and structure of the multidisciplinary heart
team
• The performance of TAVI, ab initio, should be restricted to
a limited number of high-volume centres, which have both
cardiology and cardiac surgery departments on site, with
expertise in structural heart disease intervention and high-
risk valvular surgery. Interventional cardiologists should be
experienced in catheter-based valvular interventions and
peripheral access using large devices. Cardiac surgeons
should be experienced in valve surgery and the management
of complex cases. It is recommended that all TAVI teams aim
to perform more than 10 implants per year.
• TAVI should currently be reserved for patients who, after
evaluation by a multidisciplinary heart team (MDT) are found to
have a risk/benefit ratio favouring TAVI rather than open-heart
surgery. The heart team should at least include a cardiologist,
cardiac surgeon and imaging specialist. Its composition is
however dynamic and can also include a cardiac anaesthetist,
geriatrician and neurologist as well as other members as the
MDT sees fit.
• Patients should be screened into a TAVI programme by a MDT
(as defined above) and not by an individual specialist.
• Formal training of the implanting team should include:
o didactic theoretical training
o simulator training where available
o a visit to an experienced centre to observe TAVI cases
o support for the initial cases at any site by a proctor until the
proctor has certified the centre to be independent.
Patient selection/mandatory prerequisites
• Proof of severe symptomatic aortic valve stenosis.
• Patient evaluation by a MDT.