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valve in place with the delivery system, and toconfirm the seating position of the valve onto
the annulus. The commissure posts should correspond to the remnants of the native valve
commissures so as not to obstruct the coronary ostia. Maintaining proper seating of the valve
is recommended to prevent valve displacement. After we must secure the valve by snares
compressed with hemostats over the sewing ring, ensuring that the snares are placed directly
on the sewing ring, not on the valve holder legs as this may result in loose sutures or
difficulty in removing the holder/delivery system once the holder sutures are cut. After
securing the snares, appropriate valve seating should be confirmed by direct visual inspection.
In particular, the valve must be firmly seated in the non-coronary sinus and no gaps should
exist between the sewing cuff and native annulus. If adjustment is necessary, the snares may
be loosened and the valve repositioned. After that we must verify that the coronary ostia are
not obstructed, the commissure posts do not interfere with the aortic wall at the sinotubular
junction and there is good apposition between the sewing ring and the annulus (Figure 13).
Figure 11. Hockey-stick aortotomy crossing the sinotubular junction into the noncoronary sinus.
Reprinted from Step-by-Step Aortic Valve Replacement With a New Rapid Deployment Valve. Accola
KD, Chitwood WR Jr, Mumtaz MA, Barnhart GR. Ann Thorac Surg. 2018;105(3):966-971.
Figure 12. Edwards Intuity Valve System – Placing sutures. (A) Location of sutures correspond to
markers on sizer to ensure proper valve seating. (B) Placement of guiding suture at the nadir of the
right, left, and noncoronary cusps with exit site well away from annulus (inset). Reprinted from Stepby-Step Aortic Valve Replacement With a New Rapid Deployment Valve. Accola KD, Chitwood WR
Jr, Mumtaz MA, Barnhart GR. Ann Thorac Surg. 2018;105(3):966-971.
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Figure 13. Valve delivery.
Figure 14. Edwards INTUITY Aortic Valve. A. Valve before deployment B. Valve after deployment.
Reprinted from TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY
Valve System for Aortic Valve Replacement) US clinical trial: Performance of a rapid deployment
aortic valve. Barnhart GR, Accola KD, Grossi EA, et al. J Thorac Cardiovasc Surg. 2017;
153(2):241-251.e2.
Then we fill the inflation device with sterile physiological saline and remove any air to a
final volume of 25 cc . The balloon catheter is advanced distally until the catheter snaps into
place and an audible “click” is heard. We must be sure to stabilize the handle while advancing
the balloon catheter and that the distal portion of the delivery system is perpendicular to the
plane of the valve and apply gentle pressure in a distal direction to maintan proper valve
seating during balloon inflation. During balloon inflation pressure must be maintained for 10
seconds to ensure proper frame expansion. The delivery system must be held in position
during balloon inflation to ensure that the valve remains seated in the annulus. Inflation of the
sealing frame should be performed up to the recommended pressure in a slow and controlled
fashion; this slow expansion against the septum may reduce the risk of heart block. Overinflation may cause excessive frame expansion and may result in annular damage, conduction
interference/arrhythmia, or sub-annular tissue damage. Under-inflation may cause insufficient
expansion of the frame and may result in paravalvular leak, thrombosis, and/or
thromboembolism. If the inflation pressure is not achieved is recommended to completely
deflate the balloon by fully retracting the syringe plunger, remove the valve and delivery
system beginning with the removal of the snares and sutures and then to use a new valve and
delivery system. We must to take attention to not retract the balloon catheter through the
valve holder when removing the whole system to avoid possible valve displacement. Once the
inflation pressure is achieved and maintained for 10 seconds, we deflate the balloon by
unlocking the inflation device, fully retracting the plunger, and locking the plunger in the
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retracted position. We remove the delivery system and valve holder as a single unit. To tie the
sutures first we remove one snare while maintaining valve seating position by applying
downward pressure on the sewing ring and then we tie the suture (we repeat the process for
the other two or three snares) (Figure 14). The aortotomy is closed using standard surgical
techniques. Minimal manipulation of the heart after valve implant is recommended to avoid
valve displacement.
Sizing
The sizing is crucial for the good results of the implant of an edwards Intuity
bioprosthesis. The final decision to use the EDWARDS INTUITY Elite valve system should
be made after the native aortic valve is excised and the annulus is debrided, or decalcified. An
assessment of the potential interaction between the EDWARDS INTUITY Elite valve system
and surrounding cardiac structures, such as, the aortic annulus, anterior leaflet of the mitral
valve, and coronary ostia, should be conducted. Severely calcified LVOT that is not properly
debrided may result in balloon rupture during inflation. When choosing a valve, the size, age,
and physical condition of the patient in relation to the size of the prosthesis must be taken into
consideration to minimize the possibility of obtaining a suboptimal hemodynamic result. A
combined intra- and supra-annular sizing technique is recommended for this valve. The
practice of using only a supra-annular sizing technique is not recommended, due to the intraannular and sub-annular aspects of the EDWARDS INTUITY Elite valve.
Intra-annular sizing: is recommanded to insert the sizer barrel end through the
aortotomy and place it into the aortic root and annulus. If a transverse aortotomy is
used and the sinotubular junction diameter is estimated to be equal or smaller than
the annulus diameter, it is recommended to extend the aortotomy into the non-
coronary sinus to facilitate sizer and implant insertion. If extension of the aortotomy
is not possible, it is not recommended to use the product as parachuting the valve
through a narrow sinotubular junction may result in increased difficulty of valve
implant and/or aortic injury. It is suggested to sized the valve choosing the largest
diameter barrel end that is a comfortable fit in the annulus. It is important to ensure
that the lip of the barrel does not pass through the annulus. The lip of the barrel
represents the sewing cuff of the valve, therefore it is intended to rest on the annulus
and not go through it. We do not have to implant a valve larger than the size
indicated by the barrel end of the sizer as it may result in annular or aortic damage.
We do not have to select a valve size based on the sizer that will fit through the
sinotubular junction as it may result in paravalvular leak due to the use of an
undersized valve.
Supra-annular sizing : the replica end of the same sizer may be used to verify
adequate fit and orientation of the supra-annular section of the valve in the aortic
root. Adequate fit includes good seating on the aortic annulus and no interference of
the commissure posts of the valve with the aortic wall at the sinotubular junction or
with the coronary ostia. We can also use three black orientation markers on the
replica end to assess guiding suture placement in the annulus.
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Figure 15. SIZING: (A) Incorrect sizing: Loose fit with flange protruding through the annulus. (B)
Correct sizing: Sizer barrel seen intraannular with flange sitting on annulus. (C) Sizer replica end
placed in a supra-annular position. Reprinted from Step-by-Step Aortic Valve Replacement With a New
Rapid Deployment Valve. Accola KD, Chitwood WR Jr, Mumtaz MA, Barnhart GR. Ann Thorac Surg.
2018;105(3):966-971.
When using either sizer, a barrel sizer that falls through the annulus is too small, and one
that requires significant force to push it through the annulus is too big. When using the sizer,
the correct size will not allow the flange to comfortably pass into the LVOT. In cases of “inbetween” sizes, the smaller size should be chosen without concern for perivalvular leak and
with the confidence of improved hemodynamics. The expanded frame width is 2.5 mm larger
in diameter than the nominal size of each valve. Oversizing may lead to tearing of the aorta,
failure to completely seat the valve within the LVOT, or increased risk of conduction
disturbance. If oversizing is clinically required, EIE should not be used (Figure 15).
Intra-operative trans-esophageal echocardiography (TEE) is required to assess
bioprosthetic valve function. While trace of paravalvular leak is acceptable, mild or greater
paravalvular leak should be addressed in the operating room. Because of stainless steel in its
sealing frame, the Intuity valve will have an appearance on TEE similar to that following
transcatheter aortic valve replacement. First, the sealing frame will be seen in the LVOT
extending on the aorta-mitral curtain. Second, the sealing frame casts an acoustic shadow
which can obscure the contralateral side of the valve on mid-esophageal and long-axis views.
Therefore, to completely assess for paravalvular regurgitation, two additional TEE views
should be performed: mid-esophageal, short-axis and deep trans- gastric.
The indications for anticoagulat/antiplatelets terapy management are the same for any
other aortic bioprosthetic valve: some medical professional societies recommend
anticoagulant therapy, unless contraindicated, during the first 3 months after bioprosthetic
aortic valve implantation. Long-term anticoagulant therapy, unless contraindicated, is
recommended for patients who have risk factors for thromboembolism. Long-term low dose
aspirin, unless contraindicated, is recommended for all patients.
Results
Edwards Intuity valve system combines the long term proven Magna Ease Perimount
aortic valve platform with the stent-based technology. First published article by Borger et al.
[23] presented the Edwards Intuity valve as an exciting device that may further change the
landscape of aortic valve intervention expecially for the possibility to facilitate the
performance of minimally invasive aortic valve surgery and for the possibility to reduced
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implantation times in higher risk patients or in those requiring concomitant procedures. An
impportant advantage connected to facilitating surgical implant of Intuity valve bioprosthesis
is the reduction in crossclamp and cardiopulmonary bypass (CPB) times. The CADENCEMIS trial [24], a prospective, multicentre, randomized trial, that compares outcomes in
patients undergoing minimally invasive AVR using the EDWARDS INTUITY Valve System
with those undergoing conventional full sternotomy with a commercially available
bioprosthetic valve, focusing on early and mid-term outcomes particularly on haemodynamic
data, showed a highly significant reduction in myocardial ischemic time (54.0 min and
41.3min, respectively), favoring the Intuity valve despite the more challenging minimally
invasive surgical access. These findings were confirmed in two articoles that reported the
European (TRITON) and the American (TRANSFORM) trials. Kocher [25] presents the 1year clinical outcomes and device efficacy of the first 146 subjects receiving an EDWARDS
INTUITY Valve in a prospective, multicenter study (Surgical Treatment of Aortic Stenosis
With a Next Generation Surgical Aortic Valve [TRITON]). Barnhart and collegues [26] show
the one year primary and effectiveness endpoints of 839 underwent AVR using an
EDWARDS INTUITY Valve in a prospective, nonrandomized, multicenter (n = 29), singlearm trial (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System
for Aortic Valve Replacement [TRANSFORM]). In both TRITON and TRANSFORM trials
was documented a remarkable reduction in crossclamp and cardiopulmonary bypass (CPB)
times for both isolated full sternotomic approaches and minimally invasive RDAVR
operations when compared with Society of Thoracic Surgeons (STS) National Database
values. Even more important, these times were reduced significantly in combined cardiac
procedures. Both trials involved the surgeon implanting the Intuity valve for the first time.
Thus, without the learning curve effect, crossclamp and CPB times might have been even
shorter. These benefits are impressive and suggest a positive impact on hard clinical end
points (eg. 30-day mortality). The 30-day mortality in the TRITON and TRANSFORM
studies was 1.7% and 0.9%, respectively. This appears to be noticeably low, considering the
risk profiles of patients in both studies (mean age, 75/73 years; only 55/62% isolated
RDAVR; mean STS score, 3.5/2.5, respectively). The data collected through the clinical trial
were confirmed by short-term outcomes of the Assessing Standard oF Care and Clinical
Outcomes UsiNg the EDWARDS INTUITY VAlve SysTem in a European multI-center,
Active, pOst-market surveillaNce Study (FOUNDATION) registry, representing the largest
series of patients receiving the EDWARDS INTUITY valve system in a registry setting. The
FOUNDATION registry was a prospective, multicenter, single-arm, postmarket 2-year study
designed to determine the safety and effeciveness of the EDWARDS INTUITY rapiddeployment valve system in a broad registry setting across Europe. In this registry we
observed a valve-related mortality of 1.4% early and 1.4%/patient-year beyond 30 days,
within the range of those reported with this valve in TRITON, CADENCE and
TRANSFORM. The Intuity valve system design not only enables quicker and easier aortic
valve implantation but also promises improved hemodynamic performance.
With the use of in vitro testing, Capelli and colleagues [27] demonstrated that pledget-
armed sutures adversely affect the hemodynamic performance of biologic aortic valves when
compared with the stent-based anchoring system of the Intuity system. Moreover low
transvalvular gradients of this valve is also related to the shape of expanded stent frame. The
stent skirt frame is seated below the annulus in a flared configuration within the left
ventricular outflow tract. The stent may limit active constriction of the LVOT during systole
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which may lead to more laminar blood flow across the prosthesis. In addition, the lack of
pledgeted sutures may contribute to more laminar flow across the LVOT/aortic annulus. Both
TRITON and TRANSFORM trials confirm these previously postulated advantages with a 1year mean gradients of 9.0 ± 3.5mm Hg and 10.3 ± 3.8mm Hg and effective orifice areas of
1.7 ± 0.2cm2 and 1.7 ± 0.2cm2, respectively. A noteworthy hemodynamics also was observed
on FOUNDATION registry confirming smaller reports with a mean EOA at 1 year of 1.88 +/-
0.6 cm2 and the mean and peak valve gradients of 9.6 +/- 4.6 mm Hg and 17.7+/- 7.3 mm Hg
at 1 year. In the TRITON trial, optimal hemodynamic performance was shown for the Intuity
valve by the low rate of severe patient–prosthesis mismatch (PPM) from discharge to 3 years
(2.4%-3.9%). In FOUNDATION registry was unexpectly observed a 9.76% severe PPM at 1
year, especially given this registry’s 43% proportion of small 19- and 21-mm valves. Device
sizing is critical; in this series, standard sizing criteria were used, but there was also a
deliberate tendency not to oversize. Maybe the high incidence of small valves in this registry
reflects the cohort rather than undersizing. In routine clinical practice, PPM is a concern,
especially in patients with small valve sizes. Theron and colleagues [28] focused on the small
aortic root (only 19-mm and 21-mm Intuity valves) and reported a severe PPM rate as low as
15% in this subset. This is remarkable because severe PPM rates with conventional
bioprosthesis SAVR have been approximately 20% according to a meta-analysis by Takagi
and colleagues [29]. The anchoring mechanism design of the Intuity valve is based on balloon
inflation of a subvalvular stent frame with radial pressure apposition throughout the distal
subvalvular outflow tract.
A highly debated aspect is the new early permanent pacemaker implantations (PPI) rate.
Theoretically, any pressure below the leaflet attachment zone induces the risk of a cardiac
restricted to the leaflet attachment zone and immediately below where the sutures are placed.
In both TRITON and TRANSFORM trials, AVR was performed in patients with the higherrisk profile of a combined cardiac operation in 45.9% and 37.5%, respectively. Thus, a higher
likelihood for new conduction disturbances existed preoperatively, but the PMI rates reported
tend to have increased compared to conventional prostheses. Although European TRITON
data showed an early PPI rate of 6.9%, the US TRANSFORM trial revealed a higher early
PPI rate (14.0% overall and 6.0% without previous conduction abnormalities). These
observed differences in PPIs have to be interpreted with caution: First, the implant technique,
although the valve is fixed at the nadir in all 3 sinuses, allows variability as to how deep the
valve descends in the outflow tract. If commissural suspension sutures are used for better
exposure and traction is exerted during introduction of the valve, the stent frame can be
deployed deeper into the conduction sensitive area in the right nonsubcommissural triangle,
promoting a higher risk of new conduction disturbances. Second, sizing is critical. Surgeons
in the “learning phase” of implantation may tend to oversize the valve to avoid paravalvular
leak, which can result in increased radial stress along the subvalvular rim. Third, with this
valve, approximately 30% of new conduction disturbances revert within 1 week
postoperatively. Generally, in the United States an earlier patient discharge strategy is present
than in European centers. Thus, in TRANSFORM more patients may have had pacemakers
implanted early to ensure safety at discharge. A watchful waiting strategy should allow more
patients to recover from transitory rhythm disturbances and result in a lower PPI rate. As
shown by Romano M. A. and collegues [30] patient factors associated with PPI after RDAVR
were RBBB, AVB, female gender and larger valve size. In FOUNDATION registry was
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experienced a pacemaker rate of 6.1%. An interesting observation was conducted by
Mogilansky et al. [31] who studied 183 patients undergoing RDAVR. Out of these 38.1% had
new left bundle branch block, 2.5% of patients had new right bundle branch block and 9.6%
had atrioventricular block III requiring either a pacemaker or defibrillator. Another quality of
this valve is a remarkable resistance to prosthetic valve endocarditis (PVE). In the TRITON
trial, the early incidence was 0.2% (late 0.2%/per patient-year), and in TRANSFORM there
were no early cases or throughout late follow-up. This advatage could be releated to a low
paravalvular leak rates that could been associated with subsequent PVE (the exceptionally
low PVE rates may be explained by the covered stent smooth surface, which reduces surface
roughness that is present with multiple pledgets in the outflow tract). Moreover, the valve can
be implanted with almost no contact between the surgeon’s gloves and the prosthesis,
especially if a knot pusher is used to tie the guiding sutures. Valve thrombosis in TRITON
and TRANSFORM patients (n = 1126) was absent at both early and late clinical follow-ups.
Underreporting of early subclinical bioprosthesis valve thrombosis (BPVT) in TRITON and
TRANSFORM cannot be excluded because subclinical valve thrombosis often is associated
with absent or minimal gradient increases. However, in the TRITON trial, the lack of BPVT
evidence on high-quality, core laboratory–adjudicated TTE images (N=1126 patients) at 1
year and 5 years and gradient stability suggest that it is unlikely. Nevertheless, a prospective
study using 4-dimensional volume-rendered computed tomography scans with different
antithrombotic strategies would add valuable information. A very important benefit related to
this valve is representing by the possibility to increase minimally invasive AVR as shows in
CADENCE-MIS (24% reduction in XCT). Minimally invasive AVR has been shown to
improve operative mortality, with a risk ratio of 0.74 for mini-AVR versus full sternotomy
[32]. Moreover in all types of cardiac surgery, resternotomy is associated with increased
mortality. However, resternotomy after a minimally invasive approach approaches is
straightforward because the right ventricle is not adherent to the posterior table of the
sternum.
In the past few years, the proportion of patients receiving tissue valves as opposed to
mechanical valves has been recently increasing, especially in younger patients in whom the
prospect of lifelong anticoagulation therapy is unappealing and fraught with risks. Therefore,
it can be expected that there will be an increase in revision aortic valve procedures in the
future. If this bioprosthesis facilitates an increase in minimally invasive approaches, then it
can be expected that the mortality of repeat surgery may be significantly reduced when the
Edwards Intuity valve implantation is used through a minimally invasive approach. One of
the main drawbacks, like that seen with transcatheter heart valve systems, is the complication
of paravalvular leaks (PVL). The association of PVL with mortality and poor long‐term
outcomes make a search for standardized treatment options essential. Currently, there is no
universally agreed single treatment option. Various transcatheter methods for treating with
PVL, such as the use of coils and plugs, have been tried. The ease of access and superior
forward flow valve hemodynamics seen with balloon expandable valves used during RDAVR
make balloon valvuloplasty a promising treatment option in cases complicated by PVL as
shown by Grant J. K. et al. [33] in a case report that explained a case of a patient that received
an Edwards Intuity valve and developed a PVL 6 moins after the procedure. In this patient a
balloon valvuloplasty with a 25 mm True Balloon was performed with resolution of the PVL
that remained stable also at 1 year follow up. The costs of this bioprosthesis is higher
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compared with standard prostheses, but general economic outcome end points have been
documented to be equal or even superior as shown by Moore et al. [34].
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