CARDIOVASCULAR JOURNAL OF AFRICA • Volume 27, No 6, November/December 2016
AFRICA
399
SASCI/SCTSSA joint consensus statement and
guidelines on transcatheter aortic valve implantation
(TAVI) in South Africa
Jacques Scherman, Hellmuth Weich
The 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) and Conformité 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, transsubclavian 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 expe-
rienced in catheter-based valvular interventions and periph-
eral 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.
Previously published in
SA Heart
2016;
13
(4): 298–300.
DOI: 10.5830/CVJA-2016-092
Chris Barnard Division of Cardiothoracic Surgery,
University of Cape Town, South Africa
Jacques Scherman, MB ChB, DipOccMed, MMed, FCCardio (SA),
jacques.scherman@uct.ac.zaDivision of Cardiology, Tygerberg Hospital and
Stellenbosch University, Cape Town, South Africa
Hellmuth Weich, MB ChB, MRCP (UK), MMed (Int), Cert
Cardiology (CMSA),
hweich@sun.ac.zaConsensus Guidelines