RAPID DEPLOYMENT AND SUTURELESS AORTIC PROSTHESES
Time to validate unusual or ‘off label ’ indications?
Igor Vendramin, MD1, Uberto Bortolotti,
MD1, Ugolino Livi, MD1,2
1Cardiothoracic Department, University Hospital,
Udine, Italy
2Department of Medical Area (DAME), University of
Udine
Address correspondence to: I. Vendramin, MD, Cardiothoracic Department,
P. le S.M. Misericordia 15, Udine, Italy
Tel: 39-432-552431; Fax: 39-432-552975
e-mail:vendramin.igor@gmail.com
Word count: 498
Currently available evidence supports the safety and efficacy of rapid
deployment and sutureless prostheses for aortic valve replacement (AVR)
in aortic stenosis as suggested by the International Expert Consensus in
2016 (1). Furthermore, a systematic review and meta-analysis of
recipients of Perceval sutureless (LivaNova Group, Saluggia,
Italy ), 3F Enable (Medtronic, Inc, Minneapolis, MN, USA ) or
Intuity Elite valves (Edwards Lifesciences, Irvine, CA, USA ) has
confirmed that employment of all such devices, even using a
mini-invasive approach, is associated with shorter cross-clamp and
cardiopulmonary bypass times when compared to conventional implant of
standard bioprostheses (1).
Following the increasing experience and the good results obtained in
AVR, recent reports indicate suitability of sutureless and rapid
deployment prostheses to be used in different scenarios and peculiar
surgical situations. In a recent issue of the Journal of Cardiac
Surgery , Piperata et al. have described a patient with active infective
endocarditis, complicated by an extensive aortic annulus abscess, who
was successfully treated with aortic root reconstruction using a double
pericardial patch followed by AVR with a rapid deployment prosthesis
(2). At 6-month follow‐up the echocardiographic control has shown a
normal prosthetic function without evidence of perivalvular leaks.
The use of sutureless prostheses in peculiar situations, at times as an
‘off-label ’ indication, has been reported previously
demonstrating to represent an effective solution to challenging surgical
problems. A Perceval prosthesis has been employed for AVR in failing
homografts and stentless aortic roots when standard reoperations
appeared extremely hazardous or cumbersome (3). In 2019, Martinelli and
colleagues reported a patient with severe aortic regurgitation and a
porcelain aorta in whom limited AVR was performed implanting a Perceval
bioprosthesis (4). After 2 years the patient is in NYHA class I and with
no paravalvular leaks at transthoracic echo.
We have recently described a patient in whom a Perceval bioprosthesis
was implanted after intraoperative failure of a valve-sparing procedure,
since any attempt to a further repair was considered time consuming and
with limited chances of success. Three years postoperatively, the
patient is asymptomatic with a normally functioning aortic prosthesis
(5).
The considerable experience acquired so far with rapid deployment and
sutureless valves has stimulated many surgeons to use such devices not
only for standard AVR, particularly in patients in whom limiting the
overall ischemic time is felt to be of paramount importance, but also in
different surgical scenarios. In this respect the interesting paper by
Piperata et al. shows another possible indication aimed to facilitate
complex index or redo procedures (2). Therefore, we believe the time has
come to strongly support the unusual or even ‘off label ’
employment of these devices by including them in future recommendations.
- Glauber M, Moten SC, Quaini E, et al. International expert consensus
on sutureless and rapid deployment valves in aortic valve replacement
using minimally invasive approaches. Innovations 2016; 11:165-173.
- Piperata A, Bottio T, Avesani MD, Folino G, Bellanti E, Gerosa G. Use
of rapid‐ deployment aortic valve prosthesis and patch reconstruction
in complex endocarditis. J Card Surg 2020; 35:2056–2058.
- Chiariello GA, Villa E, Messina A, et al. Perceval valve-in-valve
implant for full root xenograft failure. J Card Surg. 2017;1–4.
- Martinelli GL, Cotroneo A, Stelian E, Benea D, Diena M. A new approach
for severe aortic regurgitation in porcelain aorta with sutureless
Perceval valve: A case report. Intern J Surg Case Rep 2019; 59:
124-127.
- Vendramin I, Piani D, Sponga S, Bortolotti U, Livi U. Immediate
failure of a valve- sparing procedure: repair with a Perceval
sutureless prosthesis. J Cardiovasc Med 2020.