Sutureless aortic valve replacement as an alternative treatment for
patients belonging to the ‘‘gray zone’’ between transcatheter aortic
valve
... [Show More] implantation and conventional surgery: A propensity-matched,
multicenter analysis
Augusto D’Onofrio, MD,a Antonio Messina, MD,b Roberto Lorusso, MD,c Ottavio R. Alfieri, MD,d
Melissa Fusari, MD,e
Paolo Rubino, MD,f Mauro Rinaldi, MD,g Roberto Di Bartolomeo, MD,h
Mattia Glauber, MD,i Giovanni Troise, MD,b
and Gino Gerosa, MDa
Objective: The aim of this propensity-matched, multicenter study was to compare early clinical and echocardiographic outcomes of patients undergoing transapical aortic valve implantation (TA-TAVI) versus
patients undergoing sutureless aortic valve replacement (SU-AVR) for severe symptomatic aortic valve
stenosis.
Methods: We reviewed 468 TA-TAVIs performed in 20 centers from April 2008 to May 2011, and 51 SUAVRs performed in 3 centers from March to September 2011. Based on a propensity score analysis, 2
groups with 38 matched pairs were created. Variables used in the propensity analysis were age, sex,
body surface area, New York Heart Association class, logistic EuroSCORE, peripheral vascular disease,
chronic obstructive pulmonary disease, aortic valve area, mitral regurgitation, and left ventricular ejection
fraction.
Results: Preoperative characteristics of the 2 groups were comparable. Hospital mortality was 5.3% and 0% in
the TA-TAVI and SU-AVR groups, respectively (P ¼ .49). We did not observe stroke or acute myocardial infarction in the 2 groups. Permanent pacemaker implantation was needed in 2 patients of each group (5.3%,
P ¼ 1.0). Dialysis was required in 2 patients (5.3%) in the SU-AVR group and in 1 patient (2.7%) in the
TA-TAVI group (P ¼ 1.0). Predischarge echocardiographic data showed that the incidence of paravalvular
leak (at least mild) was greater in the TA-TAVI group (44.7% vs 15.8%, P ¼ .001), but there were no differences
in terms of mean transprosthetic gradient (10.3 5 mm Hg vs 11 3.7 mm Hg, P ¼ .59).
Conclusions: This preliminary experience showed that, in patients at high risk for conventional surgery, SUAVR is as safe and effective as TA-TAVI and that it is associated with a lower rate of postprocedural paravalvular
leak. (J Thorac Cardiovasc Surg 2012;144:1010-8)
Surgical aortic valve replacement (SAVR) is the treatment
of choice in patients with severe symptomatic aortic valve
stenosis (SSAVS) because it provides excellent early and
long-term clinical outcomes as well as good results in terms
of hemodynamics, valve durability, and freedom from
valve-related complications.1
Transcatheter aortic valve implantation (TAVI) has shown excellent early and mid-term
clinical and hemodynamic results in inoperable or highrisk patients with SSAVS.2,3 In particular, TAVI with
balloon-expandable bioprostheses has demonstrated better
results than medical therapy alone in inoperable patients4
as well as noninferiority to SAVR in high-risk elderly patients.5
TAVI using balloon-expandable valves can be accomplished with either an antegrade transapical access or
with a retrograde approach. The latter is usually performed
via a transfemoral access, but recently a transaortic approach has been described6,7; the transsubclavian access
is used less frequently. The transfemoral access is
generally considered the first choice because it is less
invasive and there is no need for general anesthesia and
tracheal intubation. However, transapical TAVI (TATAVI) provides good results with a low incidence of
From the Division of Cardiac Surgery,a University of Padova, Padova, Italy; the
Division of Cardiac Surgery,b
Poliambulanza Hospital, Brescia, Italy; the Division
of Cardiac Surgery,c Community Hospital, Brescia, Italy; the Department of Cardiac Surgery,d
San Raffaele University Hospital, Milan, Italy; Department of Cardiovascular Sciences,e Centro Cardiologico Monzino, IRCCS, University of Milan,
Milan, Italy; the Invasive Cardiology Laboratory,f Cardiology Division, Montevergine Clinic, Mercogliano, Italy; the Division of Cardiac Surgery,g University of
Turin, Turin, Italy; the Division of Cardiac Surgery,h University of Bologna, Bologna, Italy; and Department of Adult Cardiac Surgery,i G. Pasquinucci Heart Hospital, Massa, Italy.
Disclosures: Authors have nothing to disclose with regard to commercial support.
Read at the 92nd Annual Meeting of The American Association for Thoracic Surgery, San Francisco, California, April 28-May 2, 2012.
A.O. and A.M. contributed equally to this manuscript.
Received for publication April 15, 2012; revisions received May 25, 2012; accepted
for publication July 25, 2012; available ahead of print Sept 12, 2012.
Address for reprints: Augusto D’Onofrio, MD, Division of Cardiac Surgery, University of Padova, Centro Gallucci, Via Giustiniani 2, 35128 Padova, Italy (E-mail:
[email protected]).
0022-5223/$36.00
Copyright 2012 by The American Association for Thoracic Surgery
http://dx.doi.org/10.1016/j.jtcvs.2012.07.040
1010 The Journal of Thoracic and Cardiovascular Surgery c November 2012
ACQUIRED CARDIOVASCULAR DISEASE
ACD
access-related complications, even in patients with severe
peripheral vascular disease.8 Recently, sutureless aortic
valve replacement (SU-AVR) has been proposed as additional therapeutic option for the treatment of high-risk patients with SSAVS because it provides good early clinical
and hemodynamic outcomes.9,10 Potential advantages of
SU-AVR over SAVR are related mainly to the removal of
the native aortic valve, to the shortening of aortic crossclamp time, and to the possibility of performing easier, minimally invasive access. Therefore, potential candidates for
SU-AVR are high-risk, operable patients who could benefit
from a shorter crossclamp time and/or from a minimally invasive procedure. In other words, they belong to a ‘‘gray
zone’’ that includes patients who are at high risk for
SAVR but who are not really inoperable. Because TAVI
and SU-AVR are both aimed at the therapy of high-risk patients with SSAVS, the objective of this propensity-matched
multicenter study is to compare clinical and echocardiographic outcomes at hospital discharge of patients undergoing TA-TAVI versus patients undergoing SU-AVR.
PATIENTS AND METHODS
This study was approved by the ethics committees, and patient informed
consent was collected.
Transapical Transcatheter Aortic Valve Implantation
We reviewed data from 566 patients enrolled in the Italian Registry of
Trans-Apical Aortic Valve Implantation (I-TA) from April 2008 through
May 2011. The I-TA is an independent, prospective, multicenter registry
that includes the majority of patients who have undergone TA-TAVI in Italy
with the Edwards Sapien/Sapien XT pericardial bioprosthesis (Edwards
Lifesciences, Irvine, Calif) since this procedure became available in April
2008. Details about the I-TA, participating centers and investigators, indications for TA-TAVI, device characteristics, sizing and surgical technique,
postoperative medications, and data collection and analysis have been described previously.11 To avoid potential selection bias, we excluded from
the current analysis 98 inoperable patients who underwent TA-TAVI for
porcelain aorta. Consequently, we took into consideration the data from
468 patients in the I-TA who represent the unmatched TA-TAVI cohort
of this study.
Sutureless Valve
We collected and analyzed data prospectively of 51 patients who underwent SU-AVR with the Perceval S bioprosthesis (Sorin Biomedica Cardio,
Saluggia, Italy) at 3 Italian centers from March to September 2011. These
patients represent the entire experience of the 3 participating institutions.
Sutureless valve data were collected using the same data set of the I-TA
to obtain homogeneous, comparable, and, most important, reliable data.
The Perceval S is made of 3 bovine pericardium leaflets mounted on
a self-expandable metallic stent. SU-AVR was performed with either full
sternotomy, mini sternotomy or mini thoracotomy, according to the type
of intervention, the associated procedures, and, ultimately, the surgeon’s
preferences. In particular, full sternotomy, mini sternotomy, and mini right
thoracotomy in the second intercostal space12 were performed in 36
(70.6%), 4 (7.8%), and 11 (21.6%) patients, respectively. All SU-AVR procedures were performed under moderately hypothermic (32C) cardiopulmonary bypass with aortic crossclamping and cardioplegic arrest of the
heart. A transverse aortotomy was performed around 3 to 3.5 cm above
the aortic annulus, the native valve was removed, and annular decalcification was performed. Annular decalcification is not as extensive as for conventional surgery, but it is aimed at removing bulky calcifications to obtain
a homogeneous, round-shaped annulus for sutureless valve implantation.
After decalcification, the aortic annulus was sized and the correct prosthesis
was selected. Prosthesis size ‘‘small’’ was selected, with an annulus diameter between 19 mm and 21 mm. Size ‘‘medium’’ was selected, with an annulus diameter between 21 mm and 23 mm. During the study period, size
‘‘large’’ was still not available. Three 4-0 prolene guiding sutures are passed
through the aortic annulus at the nadir of each sinus. The delivery system
was guided in its correct position using these sutures and the valve was
deployed. After deployment, the delivery system and sutures were removed,
and a balloon wasinserted inthe valve and expanded for 30 seconds at a pressure of 3 atm. The ascending aorta was then closed according to the usual
technique (Figure 1). Further details about Perceval S implantation technique have been described previously.9,13 Indications for SU-AVR were
as follows: SSAVS defined by a valve area less than 0.8 cm2
and mean transaortic gradient more th [Show Less]