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Transcatheter Aortic Valve Implantation Chapter | 41 457
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however, the short working distance to the native aortic valve is a possible benefit. Additionally, the transaortic access
could be combined with off-pump coronary artery bypass grafting in patients with concomitant coronary artery disease, using the same incision [26]. High procedural success and low procedural complication and mortality rates have
been reported in a multicenter international trial [25].
Transaxillary [27], transcarotid [28], and transcaval [29] approaches are additionally described techniques for selected
patients. However, none of these are performed routinely.
Besides native aortic valve stenosis, TAVI can also be performed in degenerated biological aortic valve prosthesis.
These valve-in-valve procedures are performed in degenerated prosthesis with predominant stenosis, regurgitation, or
a combination of both. In 2013, Medtronic CoreValve and CoreValve Evolut were the first devices receiving CE mark
approval for valve-in-valve procedures in Europe [30]. Since then, other devices received CE mark approval for this
indication, as well.
PROSTHESIS
Since the first CE market approval in 2007, the valve prostheses have permanently been developed and improved, especially in regard to paravalvular leakage, bleeding and vascular complications, as these are the major complications [31,32].
Currently, there are 10 prostheses commercially available for TAVI (Fig. 41.1). All prostheses are biological valves made of
bovine or porcine pericardium or porcine full root mounted on a stent. The valves can be divided into balloon-expandable
and self-expandable frames.
The system consists of a valve prosthesis and a delivery system. The majority of valves need to be crimped or loaded
onto the delivery system before implantation or are already precrimped and inserted into a sheath. One major improvement of newer generation valves is the reduction of the valve’s profile, allowing smaller sheaths and less traumatic access
site manipulation. Some valves, for example, the CoreValve Evolut R, Boston’s Lotus, and the Direct Flow Medical, are
repositionable devices that allow improvement of malpositioned prostheses. The implantation manner differs between all
valve prostheses.
The prostheses differ in structural and technical features. These differences and the results of the clinical evaluation
studies are listed in Table 41.1 for the new-generation valves. All prostheses are licensed for severe aortic stenosis. Only the
JenaValve prosthesis (JenaValve Technology GmbH, Germany) is available for aortic valve regurgitation since 2013, as well.
FIGURE 41.1 Commercially available TAVI prostheses with time of CE market approval and the name of postmarket trial in brackets (see Further Reading).
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Edwards
Sapien 3 [46]
Bovine
CoreValve
Evolut R [45]
Porcine
Bovine
Lotus
(n = 120)
[42,43] Engager [44]
Bovine
pericardium
29
pericardium
pericardium
pericardium
23, 25, 27 23, 26 23, 26, 29 20, 23, 26,
transapical
Balloon-
expandable
Self-
expanding
Self-
expanding
Self-
expanding
Direct Flow
Medical
(n = 100) [41]
[40]
b
ACURATE
neo
[39]
a
JenaValve
for AR
(n = 30) [38] Portico
JenaValve
(n = 180) [37]
Bovine
pericardium
Porcine
pericardium
Bovine
pericardium
Porcine aor-
tic valve
valve
29
S, M, L 23, 25, 27,
29
23, 25, 27 23, 25, 27 23, 25, 27,
Self-
expanding
Self-
expanding
Self-
expanding
Self-
expanding
expanding
95.0% 96.7% – 93.3% 93.0% 100.0% 100.0% – –
0.6% 0 1.9% 0 1.0% 3.4% 0.9% – 0.5%
1.1% 3.3% 2.9% 0 5.0% 1.7% 1.7% 0 0.9%
10.6% 0 3.9% 6.7% 9.0% 5.0% 6.5% 5.0% 6.3%
8.3% 0 5.8% – 2.0% 2.5% – 8.3% 5.0%
14.4% 3.3% 9.7% 0 17.0% 28.6% 28.5% 11.7% 13.0%
11.1% 10.0% 2.9% 0 1.0% 4.2% 8.1% 0 2.2%
TABLE 41.1 Technical Aspects and Results of the Clinical Evaluation Studies of the New-Generation Valves
Valve material Porcine aortic
Valve sizes
(mm)
Access site Transapical Transapical Transfemoral Transfemoral Transfemoral Transfemoral Transapical Transfemoral Transfemoral,
Implantation Self-
30-day results
Device
success
Periprocedural
MI (<72 h)
Disabling/
major stroke
Life-
threatening
bleeding
Major
vascular
complications
Permanent
pacemaker
30-day
mortality
PVR
None/trace 82.4% 84.6% 26.7% 50.0% 80.2% 83.6% 95.8% 32.8% 55.0%
Mild 16.9% 15.4% 69.3% 50.0% 18.5% 15.6% 4.2% 63.8% 41.3%
Moderate 0.7% 0 4.0% 0 1.2% 0.8% 0 3.4% 3.7%
Transcatheter Aortic Valve Implantation Chapter | 41 459
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14.1 ± 5.6 11.4 ± 3.7 8.8 7.6 12.6 ± 5.8 11.45 ± 5.20 13.1 8.1 11.3
Severe 0 0 0 0 0 0 0 0 0
Mean aortic
gradient
(mmHg)
1-year results
22.8% 23.1% 8.7% – 10.0% 10.9% – 6.7% 14.4%
1-year
mortality
1.1% – 3.9% – 8.0% 3.4% – 3.4% 2.4%
11.7% – 3.9% – 10.0% 5.9% – 10.2% –
Disabling/
major stroke
Life-
19.4% – 10.7% – 21.0% 31.9% – 15.2% –
threatening
bleeding
Permanent
pacemaker
PVR – –
14.8 ± 6.4 11.8 ± 1.7 9.7 – 12.2 ± 6.6 12.6 ± 5.7 – 7.5 –
Symetis SA, Switzerland.
None/trivial 77.8% 23.5% – 68.2% 88.6% 61.7% –
Mild 19.0% 64.7% 31.8% 21.4% 34.0% –
Moderate 3.2% 8.8% 0 0 4.3% 3.2%
Severe 0 2.9% 0 0 0 0
Mean aortic
gradient
St. Jude Medical, USA.
(mmHg)
MI, myocardial infarction; PVR, paravalvular leak.
a
b
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Moderate/Severe PVL [%]
II [48]
II [48]
[49]
Risk [50]
[51]
II [42]
[41]
[37]
REPRISE
II [38]
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COMPLICATIONS
There are several possible complications associated with TAVI. To determine the important clinical endpoints,
the first Valve Academic Research Consortium (VARC-1) consensus manuscript was published in 2011 [33] and
novated with the VARC-2 criteria in 2012 [34]. These defined clinical endpoints reflect device-, procedure-, and
patient-related effectiveness and safety, and every clinical trial reporting outcomes after TAVI should refer to
these endpoints.
Myocardial infarction during the initial 72 h after procedure, determined as a combination of significant rise in
cardiac biomarkers and clinical symptoms, is one of the defined clinical endpoints. Stroke, bleeding, and vascular
complications are the main problems after TAVI [35,36]. Additional endpoints are acute kidney injury, conductive
disturbance, and arrhythmias. The pacemaker rates after TAVI differ between valve types and generation and are
reported with 3%–29% [36–46].
Mortality is defined as immediate procedural mortality (intraprocedural death and death ≤72 h postoperative) and 30-day
mortality and differentiated as all-cause, cardiovascular, and noncardiovascular mortality.
The different valve types are associated with different complication rates, summarized in Table 41.1.
UPDATES AND FUTURE DEVELOPMENTS
One of the remaining problems after TAVI is paravalvular leakage. Moderate or severe paravalvular aortic regurgitation is reported in up to 11.7% of patients undergoing TAVI with an increased mortality at 30 days and 1 year [47].
To reduce this incidence, newer prostheses have been developed. The Edwards Sapien 3 prosthesis has an outer skirt
to minimize paravalvular leak. The Direct Flow Medical device (Direct Flow Medical, USA) is a fully repositionable
and retrievable prosthesis, which allows hemodynamic assessment before final detachment and reduces paravalvular
leak by sealing the annulus. The Lotus (Boston Scientific, USA) has an adaptive seal as well, is repositionable and
retrievable, and has high radial forces. The new-generation valves have already proofed lower rates of paravalvular
leak after 30 days (Fig. 41.2).
Periprocedural stroke, as it is reported in 4%–5% of patients after TAVI, is another important complication [8,9]. There
are different devices available to reduce this complication, for example, the Embrella Embolic Deflector System or the
TriGuard HDH Embolic Deflection Device (Keystone Heart Ltd., Caesarea, IL, USA), a mesh filter positioned across all
three cerebral vessels during TAVI. Initial studies could demonstrate lower rates of ischemic brain lesions and neurologic
deficits after protected TAVI [48].
To decrease complication rates, further developments are to be expected in terms of valve types, delivery or closure
systems.
FIGURE 41.2 Paravalvular leak after 30 days postinterventional according to the valve evolution. PVL, paravalvular leak.
30
20
10
24.2
SAPIEN XT
PARTNER
16.9
SAPIEN
PARTNER
14.2
CoreValve
ADVANCE
Reduction of PVL in the course of newer devices
11.4
CoreValve
Extreme
9.0
CoreValve
High Risk
4.0
Portico CE
study [35]
3.7
SAPIEN 3
PARTNER
3.4
Evolut R
CE study
1.2
Direct Flow
DISCOVER
0.8
Lotus
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[25] Bapat V, Aiello M, Baumbach H, Bonaros N, Bramlage P, Chocron S, et al. Transcatheter aortic valve implantation using transaortic access – experi-
ence from the multicenter, multinational, prospective ROUTE registry. JACC Cardiovasc Interv 2016. [ahead of print].
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[27] Muensterer A, Mazzitelli D, Ruge H, Wagner A, Hettich I, Piazza N, et al. Safety and efficacy of the subclavian access route for TAVI in cases of
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[28] Modine T, Sudre A, Delhaye C, Fayad G, Lemesle G, Collet F, et al. Transcutaneous aortic valve implantation using the left carotid access: feasibil-
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[29] Greenbaum AB, O’Neill WW, Paone G, Guerrero ME, Wyman JF, Cooper RL, et al. Caval-aortic access to allow transcatheter aortic valve replace-
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[30] Medtronic News Release 05/23/2013 http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=1823561&highlight.
[31] Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, et al. Registry of transcatheter aortic-valve implantation in high-risk
patients. N Engl J Med 2012;366(18):1705–15.
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bleeding according to VARC-2 criteria on 1-year clinical outcomes in patients after transcatheter aortic valve implantation. Int Heart J
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[41] Lefèvre T, Colombo A, Tchétché D, Latib A, Klugmann S, Fajadet J, et al. Prospective multicenter evaluation of the direct Flow medical transcath-
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patients with severe aortic stenosis (DISCOVER) study. JACC Cardiovasc Interv 2016;9(1):68–75.
[42] Meredith Am IT, Walters DL, Dumonteil N, Worthley SG, Tchétché D, Manoharan G, et al. Transcatheter aortic valve replacement for severe
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[43] Meredith Am IT, Walters DL, Dumonteil N, Worthley SG, Tchétché D, Manoharan G, et al. 1-Year outcomes with the fully repositionable and
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study. JACC Cardiovasc Interv 2016;9(4):376–84.
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transapical transcatheter aortic valve implantation with a self-expanding prosthesis. In: Engager CE Pivotal Trail data presented at EuroPCR. May
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[46] Kodali S. clinical and echocardiographic outcomes at 30 days with the SAPIEN 3 TAVR system in inoperable, high-risk and intermediate-risk AS
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[47] Athappan G, Patvardhan E, Tuzcu EM, Svensson LG, Lemos PA, Fraccaro C, et al. Incidence, predictors, and outcomes of aortic regurgitation after
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FURTHER READING
[1] Webb JG, Doshi D, Mack MJ, Makkar R, Smith CR, Pichard AD, et al. A randomized evaluation of the SAPIEN XT transcatheter heart valve system
in patients with aortic stenosis who are not candidates for surgery. JACC Cardiovasc Interv 2015;8(14):1797–806.
[2] Linke A, Gerckens U, Wenaweser P, Tamburino C, Bosmans J, Brecker S, et al. Treatment of high risk aortic stenosis patients with transcatheter
Medtronic CoreValve implantation: results from the international multi-center ADVANCE study. J Am Coll Cardiol 2012;59(13s1). E:8–E8.
[3] Popma JJ, Adams DH, Reardon MJ, Yakubov SJ, Kleiman NS, Heimansohn D, et al. Transcatheter aortic valve replacement using a self-expanding
bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol 2014;63(19):1972–81.
[4] Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, et al. Transcatheter aortic-valve replacement with a self-expanding prosthesis.
N Engl J Med 2014;370(19):1790–8.
Chapter 42
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Transcatheter Aortic Valve Implantation in
Aortic Valve Regurgitation
Daniel Wendt, Konstantinos Tsagakis, Mohamad El Gabry, Heinz Jakob, Matthias Thielmann
University Hospital Essen, Essen, Germany
Chapter Outline
Introduction 463
Current Valves in Use 463
CoreValve 465
JenaValve 465
J-valve 466
INTRODUCTION
Symetis ACURATE 467
Lotus 467
Discussion 467
Conclusion 468
References 468
Transcatheter aortic valve implantation (TAVI) has been well established in the treatment of high-risk patients presenting with aortic valve stenosis and has meanwhile changed the paradigms in the treatment of aortic valve stenosis [1,2].
Originally, the concept of this technique was based in principle on implanting an oversized balloon- or self-expandable
transcatheter heart valve into the calcified native aortic annulus [3]. As a result, aortic calcification is presumably essential
for stable fixation of the stent frame. This follows from the fact that, pure, severe aortic regurgitation has been considered
a relative contraindication to TAVI because of the absence of aortic calcification. This is currently also reflected by the
instructions for use of all commercial TAVI systems. However, in the past, there has been an, although low, unmet clinical
need as sometimes high-risk patients present with a combined aortic valve disease with predominant regurgitation without
a reasonable amount of calcium or even pure aortic regurgitation without any calcium. In general, such patients could be
treated only by conventional aortic valve replacement in the past. Although in the past the overall numbers of real high-risk
patients presenting with aortic regurgitation have been quite low, there is still a reasonable number of patients presenting
with an, so far, unmet clinical need of alternative approaches.
Therefore, the concept of TAVI was considered to be also applied to patients presenting with pure or predominant aortic valve regurgitation. As those patients present with very low or even no calcification of the aortic valve,
only self-expandable valve systems seem to be suitable to be used in such cases. The first published cases have been
treated with the CoreValve (Medtronic, Minneapolis, Minnesota, USA) system. Meanwhile, the only approved valve
systems to be used in pure aortic regurgitation is the JenaValve prosthesis (JenaValve Technology GmbH, Munich,
Germany). The J-valve system (JC Medical, Inc., Burlingame, CA, USA, and Suzhou, China), a recently introduced
new, also self-expandable TAVI-system, has also been used in pure aortic regurgitation. Another concept using a
self-expandable valve, the Symetis ACURATE TA device (Symetis S.A., Ecublens, Switzerland) system has been
introduced by us, being the largest single-center study published. More recently, also the Lotus (Boston Scientific,
USA) valve system has been used to treat pure aortic regurgitation. In the following, the different concepts and valve
designs were described.
CURRENT VALVES IN USE
CoreValve. The CoreValve device consists of a self-expandable Nitinol stent, incorporating a trileaflet bioprosthetic
porcine pericardial tissue valve. The prosthetic stent is manufactured by laser cutting of a nitinol metal tube. The
lower portion of the prosthesis has a high radial force to expand and exclude the calcified leaflets and to avoid recoil;
New Approaches to Aortic Diseases from Valve to Abdominal Bifurcation. http://dx.doi.org/10.1016/B978-0-12-809979-7.00042-0
Copyright © 2018 Elsevier Inc. All rights reserved.
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the middle portion carries the valve and is constrained to avoid the coronary arteries; and the upper portion is flared
to fixate the stent in the ascending aorta and to provide longitudinal stability. The valve is made of single-layer pericardial elements sewn together and sewn to the frame. It is constructed of six individual pieces (three skirt elements
and three leaflet elements) of porcine pericardium treated with standard tissue fixation and sterilization techniques.
Meanwhile the valve is available in four sizes of 23, 26, 29, and 31 mm to serve a range of annulus sizes (from 18 to
29 mm), and all the valve sizes fit into a 18F catheter system. The valve is depicted in Fig. 42.1.
JenaValve. The JenaValve device, also made from Nitinol, comes with a unique clip fixation mechanism of the
native aortic valve leaflets that may even offer a secure anchorage even in the absence of calcifications. The JenaValve
concept results in a subcoronary valve position with an anatomically correct valve rotation relying on axial in addition
to radial fixation by the three Nitinol “feelers” embracing the native valve leaflets. The valve is available in three sizes
of 23, 25, and 27 mm. The valve is shown in Fig. 42.2.
J-valve. The J-valve (JC Medical, Inc., Burlingame, CA, USA, and Suzhou, China) bioprosthesis consists of a selfexpandable Nitinol stent, available in four sizes of 21, 23, 25, and 27 mm, and meanwhile, the company offers six different
valve sizes to cover a broad range of aortic annuli. The concept of implantation is that the valve should automatically slide
FIGURE 42.1 CoreValve prosthesis.
FIGURE 42.2 JenaValve prosthesis.
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into the correct place within the aortic annulus place, also providing tactile feedback to the operator to achieve optimal
positioning. The device currently has no US Food and Drug Administration approval and is under investigation. The valve
is shown in Fig. 42.3.
Symetis ACURATE. The ACURATE TA device (Symetis S.A., Ecublens, Switzerland) consists of a self-expandable
Nitinol stent, available in three sizes of 23, 25, and 27 mm (equal to S, M, and L), covering an aortic annulus diameter of
between 21 and 27 mm. This self-expandable Nitinol stent acts as an anchoring structure within the native aortic annulus,
consisting of an upper and lower crown, enabling correct valve fixation in a subcoronary and supra-annular position. Three
additional stabilization arches within the outflow tract are used to orientate the bioprosthesis in the ascending aorta during
deployment. This unique implantation method facilitates the self-positioning of the device within the aortic annulus. A threeleaflet porcine valve, composed of three independent porcine noncoronary leaflets is fixed within the lower part of the Nitinol
stent. A double PET-skirt (polyethylene terephthalate) covers the inner and outer surface of the stent body and lower crown to
reinforce the biological porcine valve, thereby avoiding any direct contact between the biological tissue and the metallic stent
struts. The valve is depicted in Fig. 42.4. This additional PET-skirt seals the cells of the Nitinol stent frame and guarantees
impermeability of the stent at the aortic annular level to prevent leakage. The whole system enables a sheathless implantation
(28F equivalent) via the apex of the left ventricle. The valve prosthesis is contained within the distal section of the delivery
device. The valve is released by an “unsheathing” process, initiated by rotating a knob on the proximal end of the delivery
system. Meanwhile, the ACURATE neodevice, also for the transfemoral approach, has been launched.
Lotus. The Lotus device represents a second-generation TAVI device, which consists of a preloaded, stent-mounted
tissue valve prosthesis and catheter delivery system. The idea of this concept was that this new device offers the possibility to reposition or retrieve the device if it is not perfectly placed. The valve is illustrated in Fig. 42.5.
In the following, the so far published results of the above-described valves were presented.
CoreValve
Roy et al. presented their results of a voluntary multiinstitutional registry using the self-expandable CoreValve prosthesis
in a total of 43 patients suffering from aortic regurgitation. In this series, final implantation was performed in 42 patients
(one conversion to open heart surgery) with a VARC-defined procedure success for TAVI of 74.4% when grade II or higher
aortic regurgitation and the need for a second valve were taken into account. In their series, a total of 8 (18.6%) patients
required a second valve during the index procedure because of residual aortic regurgitation. The authors reported at 30 days
a major stroke incidence of 4.7%, and an all-cause mortality rate of 9.3%. Moreover, at 12 months, the all-cause mortality
rate was 21.4% (6 of 28 patients) [4].
JenaValve
The JenaValve represents the only percutaneous valve, which obtained CE mark approval for the treatment of aortic regurgitation. All other so far used transcatheter aortic valves have been used totally off-label. Initially, the JenaValve was used
FIGURE 42.3 J-valve prosthesis.
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FIGURE 42.4 Symetis ACURATE prosthesis.
in a small series of five patients presenting with pure aortic regurgitation and the authors reported no major complications
[5]. Thereafter, the initial overall outcomes in Germany with this second-generation TAVI prosthesis were published in a
multicentre evaluation. They reported the implantation of the JenaValve in a total of 31 patients, with a successful implantation in 30 patients, with one acute valve dislocation. The all-cause mortality was reported to be as high as 12.9% and 19.3%
at 30 days and 6 months, respectively [6].
J-valve
Most recently, Wei et al. presented their results of six patients (mean age: 75.5 ± 8.1 years) presenting with native
aortic valve regurgitation without any valve calcification, who were treated by transapical implantation of the J-valve
prosthesis. The mean logistic EuroSCORE was 29.3 ± 7.7%. All implantations were successful in the patients. The
FIGURE 42.5 Lotus prosthesis.
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