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Alternative access routes for transcatheter aortic valve implantation (TAVI)
cor et vasa 59 (2017) e10–e16
Available online at www.sciencedirect.com
ScienceDirect journal homepage: http://www.elsevier.com/locate/crvasa
Review article – Special issue: Structural heart disease – Aortic and mitral valves
Alternative access routes for transcatheter aortic valve implantation (TAVI) Marian Branny a,*, Piotr Branny a, Miroslav Hudec a, Miroslav Bilka a, Libor Škňouřil a, Jan Chovančík a, Krystyna Kluzová a, Pavla Kufová a, Jaroslav Januška a, Jiří Jarkovský b, Milan Bláha b a
Cardiocenter Hospital Podlesi Trinec, Czech Republic Institute of Biostatistics and Analyses at the Faculty of Medicine and the Faculty of Science of the Masaryk University, Brno, Czech Republic b
article info
abstract
Article history:
The transcatheter aortic valve implantation (TAVI) is a preferred treatment option among
Received 13 January 2017
the patients with severe aortic stenosis who were considered to be non-operable or at high
Accepted 30 January 2017
surgical risk. The basic principle of the crimped valve and the catheter-based implantation
Available online 22 February 2017
to the stenotic native valve remains unchanged, but several different concepts of bioprosthesis and approaches of valve implantation have been developed. All the concepts have
Keywords:
proven their safety and efficiency, however, there are only limited data available comparing
Transcatheter valve implantation
one approach to another. The objective of this paper is to offer an overview and more
Femoral approach
detailed specification of current TAVI access techniques.
Subclavian approach
© 2017 The Czech Society of Cardiology. Published by Elsevier Sp. z o.o. All rights reserved.
Direct aortic approach Transapical approach
Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The transfemoral access (TF) . . . . . . . . . . . . . . . . . . . . . . The subclavian access (transsubclavian – TS) . . . . . . . . . Direct aortic access (DAA) . . . . . . . . . . . . . . . . . . . . . . . . The transapical access (TA) . . . . . . . . . . . . . . . . . . . . . . . The transcarotid access (common carotid access – CCA) Which access is the most advantageous? . . . . . . . . . . . . Conflict of interest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ethical statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Funding body . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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* Corresponding author at: Cardiocenter Hospital Podlesi Trinec, Konska 453, 739 61, Czech Republic. Fax: +420 558 304 407. E-mail address: [email protected] (M. Branny). http://dx.doi.org/10.1016/j.crvasa.2017.01.024 0010-8650/© 2017 The Czech Society of Cardiology. Published by Elsevier Sp. z o.o. All rights reserved.
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Introduction The transcatheter aortic valve implantation (TAVI) is a minimally invasive treatment of a severe aortic stenosis. It is indicated for the treatment of patients who are at increased risk for operative complications or death. While the basic principles of TAVI – crimped biological valve and transcatheter implantation – remain unchanged, there are several different concepts of bioprosthesis and routes of valve implantation. The retrograde transfemoral access is the most frequently used, the least invasive and the only percutaneous way of implantation. The retrograde approach is also applied in the other vascular approaches, i.e. subclavian, carotid and direct aortic accesses. These approaches, however, require a surgical cut-down of the artery, and they are commonly used, if the anatomy of the femoral and iliac artery is not suitable for a safe introduction of the catheter and valve. The antegrade approach, which was used by Cribier et al. [1] during the historically first TAVI in 2002, is used today exclusively for the transapical access. This approach also requires a surgical preparation of the site of puncture. All the above-mentioned implantation techniques proved their safety and efficiency in trials; available data, however, do not show clearly enough if any of these techniques is more advantageous as compared to the others. The objective of this paper is to give an overview of current practice of implantation techniques and access routes applied in TAVI, and also to inform about special features of each method described.
The transfemoral access (TF) The femoral access is the most often used approach in TAVI [2– 4]; it is used in 66.5–87.8% of all the implantations (Table 1). The first transfemoral valve implantations in 2005 [5] required a surgical cut-down of the femoral artery and the usage of 24 and 25 French sheaths. Large sizes of the sheath excluded many patients for this approach and led to the frequent vascular and bleeding complications [6,7]. The current generation of transcatheter femoral delivery systems, such as CoreValve Evolut R, Sapien 3, and Portico, has a size reduced to 14 and 16 French, according to the valve size. The reduction of the size of the delivery system resulted in a decreased rate of the vascular and bleeding complications from 11.9–22.9% (4.7) to 5.9–7.9% [8,9]. A smaller profile of instrumentation reduced the requirements for the minimum vessel diameter of the TAVI candidates from the previous 6–7 mm to the current 5 mm in the CoreValve Evolut R valve [10], 5.5–6 mm in the Edwards Sapien 3 valve [11], and to 6–6.5 mm in the Lotus valve [12]. Vascular complications at the femoral access site, however, still belong among the most frequent risks of the procedure. The femoral access, as compared to the subclavian, direct aortic and transapical access, is the least invasive, and it is the only approach which allows to perform the implantation truly percutaneously. The other above mentioned methods require a surgical cut-down. The transfemoral approach, due to the minimal invasion in the patient's body, allows to perform the TAVI just in local anaesthesia or deep sedation. Currently
Table 1 – Procedural characteristics TAVI patients implanted in Cardiocenter Hospital Podlesi Trinec (July 2009–December 2013). Totala N = 236 Type of native valve Tricuspid valve Bicuspid valve Unknown
210 (89.0%) 19 (8.1%) 7 (2.9%)
Type of implanted bioprosthesis, n (%) Medtronic CoreValve Medtronic Engager Edwards Sapien
228 (96.2%) 2 (0.8%) 6 (2.5%)
Access site Femoral percutaneous Femoral surgical cut down Subclavian Transapical Direct aortic
155 (65.7%) 2 (0.8%) 32 (13.6%) 8 (3.4%) 39 (16.5%)
Implantation to diseased native valve, n (%) Implantation to the diseased surgical bioprosthesis (valve-in-valve implantation), n (%)
232 (98.3%) 4 (1.7%)
Valve successfully deployed Device failure Length of hospital stay
235 (99.6%) 0 (0.0%) 8 (5;16)
a Categorical parameters were described by count and their relative count and continuous by median, supplemented by 5th and 95th percentile.
there are no convincing data available comparing the local and general anaesthesia and evidence of a superiority of any of these methods [13].
The subclavian access (transsubclavian – TS) The second least invasive arterial access is the subclavian access. This approach was first reported in 2008 [14]. The vast majority of subclavian cases are performed via left subclavian artery. The right subclavian artery is used exceptionally due to its inconvenient implantation angle [15]. The CoreValve and Evolut R are the most frequently implanted valves. The subclavian approach is rarely used for the implantation of the Edwards Sapien and Lotus valves due to a complexity of preparation of the Edwards Sapien valve [16], also a larger size and lower flexibility of the Lotus valve introduction system. The preparation of the puncture site of the subclavian artery requires surgical cut-down, placement of sutures on the vascular wall, puncture of the artery and introduction of a stiff guide wire to the left ventricle over the pig-tail diagnostic catheter and 8 French sheath (Fig. 1). Then, 18 French sheath is introduced through the subclavian artery into the ascending aorta (Fig. 2). The implantation of the valve itself does not differ from the femoral approach. In the subclavian approach, the placement of the valve is easier for the operator due to a shorter distance between the site of the puncture and the level of aortic annulus. There are a few specific conditions to be considered for subclavian approach. Among the patients with the patent LIMA/LAD graft, it is important to consider a risk of a
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cor et vasa 59 (2017) e10–e16
indicated if the femoral access is not feasible or is associated with an increased risk of vascular complications.
Direct aortic access (DAA)
Fig. 1 – Subclavian approach. Subclavian artery with inserted 8 French sheath.
The direct aortic access is another arterial approach, used in patients in whom neither femoral nor subclavian approaches are possible or a risk of peripheral vascular complication is too high. The porcelain aorta, as well as the presence of the calcified atherosclerotic plaques on the anterior wall of the ascending aorta is considered a contraindication for DAA. After the surgical preparation of the access site a stiff guide wire, followed by 18F sheath, are inserted into the left ventricle and ascending aorta respectively. Then the bioprosthesis can be implanted (Figs. 3–5). There are two surgical approaches: (1) Right anterior mini-thoracotomy (incision in the right second intercostal space); or (2) Upper ministernotomy. Right anterior mini-thoracotomy is less invasive, in addition to that gives the operator the opportunity to achieve the optimal implantation angle. However, a shortage of space for the sheath in the aorta is a disadvantage of this method. Ministernotomy enables a sufficient space for the sheath introduction into the aorta, however, it is more invasive and less favourable in terms of the achievement an optimal implantation angle. The first description of the direct aortic access was provided by Bauernschmitt in 2009 [20]. According to the VARC-2 criteria, a procedural success is achieved in 90.8–98.0% cases; 30-day mortality is 6.1–8.0% [21–23]. Direct aortic access offers an advantage due to a highly accurate transfer of the operator's manoeuvres to the delivery system, and the valve can be easily and accurately placed. A rather increased invasiveness of this method represents a disadvantage in comparison to the other vascular approaches.
The transapical access (TA) In contrast to the above-mentioned arterial approaches (femoral, subclavian and direct aortic approaches), the apical Fig. 2 – Subclavian approach. 18 French sheath inside the subclavian artery.
temporary LIMA occlusion with 18 French sheath [17,18]. If the diameter of the subclavian artery at the level of LIMA origin is more than 8 mm, and the angiography with the 18 French sheath shows a sufficient flow in the LIMA graft, the risk of ischaemia is low. In case of a limited flow in the LIMA graft, the 18 French sheath can be retracted until the distal tip not exceed the origin of the LIMA. A presence of a permanent pacemaker in the left subclavian area is not an absolute contraindication of the subclavian approach, however, it makes the surgical preparation more difficult. In some patients, the brachial plexus is located proximally and close to the subclavian artery, which increase the risk of neurological complications. The subclavian approach is safe, the shortand mid-term study results are comparable to those of the femoral approach [3,19]. The subclavian TAVI should be
Fig. 3 – Direct aortic approach. Right anterior thoracotomy with small incision in the second intercostal space.
cor et vasa 59 (2017) e10–e16
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Fig. 6 – Transapical approach. After puncture the apex 22 French sheath is inserted to the left ventricle.
Fig. 4 – Direct aortic approach. Stiff wire and 18 French sheath inserted to the ascending aorta.
the 5th or 6th left intercostal space; after the surgical preparation of the apex, puncture is performed with a needle, a prograde placement of guidewire is done through the stenotic valve into the descending aorta; after that, dedicated sheath is introduced and the bioprosthesis is implanted (Figs. 6 and 7). The apical approach is the second most widely used approach in TAVI [27,28]. The transapical access is also used for a valve in valve implantation into degenerated mitral bioprosthesis and valve in ring implantation into annuloplasty rings in patients with a severe mitral regurgitation [29–31]. In the Czech Republic, currently only one valve is available for the transapical implantation – Edwards Sapien. In comparison to the femoral access, transapical delivery system requires the
Fig. 5 – Direct aortic approach. CoreValve bioprosthesis deployment.
access means a direct invasion to the left ventricle myocardium. For this reason apical access this approach has been considered as the most invasive, and it is related to a higher complication and mortality rates [7,24,25]. An increased 30day and one year mortality is explained with patient's higher risk profile and longer learning curve. On the other hand, the apical approach offers a very good control of the delivery system, a favourable implantation angle, and no contact of the delivery system with aorta (‘‘no touch aorta principle’’) [26]. The contraindication for the transapical access may be a poor left ventricular function. The surgical access is performed in
Fig. 7 – Transapical approach. Implantation of the Edwards Sapien bioprosthesis.
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Table 2 – 30-Day outcome according to approach (in-hospital complications included) TAVI patients implanted in Cardiocenter Hospital Podlesi Trinec (July 2009 – December 2013).
Mortality Stroke/transient ischaemic attack Myocardial infarction Bleeding NACE MACE
Totala
Femorala
Transaortica
Subclaviana
N = 228
N = 157
N = 39
N = 32
6 (2.6%) 7 (3.1%) 0 (0.0%) 8 (3.5%) 20 (8.8%) 12 (5.3%)
4 (2.5%) 5 (3.2%) 0 (0.0%) 6 (3.8%) 14 (8.9%) 8 (5.1%)
2 0 0 2 4 2
(5.1%) (0.0%) (0.0%) (5.1%) (10.3%) (5.1%)
0 2 0 0 2 2
(0.0%) (6.3%) (0.0%) (0.0%) (6.3%) (6.3%)
pb
0.293 0.194 – 0.273 0.824 0.966
a Categorical parameters were described by count and their relative count and continuous by median, supplemented by 5th and 95th percentile. b statistical significance of difference between groups of patients tested by ML chi square test for categorical parameters and Kruskal–Wallis test for continuous parameters. NACE – combined endpoint consist of stroke/TIA, bleeding, MI and death. MACE – combined endpoint consist of stroke/TIA, MI and death.
usage of a larger sheath 24 and 26 French for the Sapien XT system, and 18 and 21 French for the Sapien 3 system [11,32].
The transcarotid access (common carotid access – CCA) For the first time, the access through the left carotid artery was described by French authors in 2012 [33] as an alternative method of the other vascular approaches when these were not technically viable. This is the least used approach, the advantage of which is an easy vascular access, good control over the delivery system and a short distance from the puncture site to the aortic annulus. A contact of the sheath and the delivery system with the carotid artery wall, as well as the increased risk of stroke, may be considered a disadvantage of this method. However, limited data of the French Transcarotid TAVI Registry do not support such concerns. [34].
Which access is the most advantageous? There are no prospective randomised data comparing the particular approaches, which is why it is not known if any of those methods is more advantageous than the others. Available results usually compare incomparable groups of patients. In the current medical practice, the femoral access is usually the first option. It is the least invasive, the only purely transcatheter approach, which does not require any surgical preparation, and it enables to perform the complete procedure under local anaesthesia. For this reason, it is the most widely used access for TAVI procedures. The Partner randomised trial [24], large prospective registries SOURCE [7], GARY [2], France 2 [35] and NANCY [25], and meta-analyses [36] demonstrated a lower short- and mid-term mortality when the femoral access is applied as compared to the transapical access. A rather strong invasiveness and a higher pre-implantation morbidity of patients, expressed by means of EUROScore [35], may be the cause of less favourable mortality rates of the transapical access. The Canadian registry shows a certain non-consistency of data, as it does not show any differences between the 30day mortality of the transfemoral and transapical approaches
[37]. The similar results have been achieved in the Cardiocenter Hospital Podlesi, the author's facility (Table 2). Ciucca et al. made a comparison of the safety of the transapical and subclavian TAVI approaches in 262 patients included in a prospective registry. Except bleeding (11.7% TS vs. 53.5% TA, P ≤ 0.001), no statistically significant difference was found between both methods; in 30-day follow up, a trend towards a lower mortality rate was observed in the subclavian approach (1.7% TS vs. 8.4% TA, P = 0.06) [38]. A recent meta-analysis of Irish authors made a comparison of outcomes in 193 patients with the direct aortic access and 1543 patients with the transapical access. During 30-day follow up it was found no significant difference in the procedural success rate, mortality, bleeding, stroke and permanent pacemaker implantation rate. It may be concluded that the selection of the approach is highly individual; it is influenced by capability and experience of the cardiac centre, availability of different valve types, anatomy of the patient, reimbursement policy, etc. For example, the transfemoral access will not be necessarily used in a patient with tortuous, calcified and narrow ileofemoral arteries. If the anatomy of the subclavian artery is favourable, subclavian access would be preferred. Another patient with a tortuous abdominal and thoracic aorta and calcified bicuspid aortic stenosis will be a suitable candidate for the direct aortic access and a self-expanding valve. Or, a patient with strongly angulated aortic root and small calcific valve will be indicated for the transfemoral implantation of a balloon-expandable valve. The selection of the access route and the type of valve tailor-made to the specific patient needs is, and will remain, the only correct way towards further improvement of the outcomes of the transcatheter aortic valve implantation.
Conflict of interest None declared.
Ethical statement Authors state that the research was conducted according to ethical standards.
cor et vasa 59 (2017) e10–e16
Funding body None.
references
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Available online at www.sciencedirect.com
ScienceDirect journal homepage: http://www.elsevier.com/locate/crvasa
Review article – Special issue: Structural heart disease – Aortic and mitral valves
Alternative access routes for transcatheter aortic valve implantation (TAVI) Marian Branny a,*, Piotr Branny a, Miroslav Hudec a, Miroslav Bilka a, Libor Škňouřil a, Jan Chovančík a, Krystyna Kluzová a, Pavla Kufová a, Jaroslav Januška a, Jiří Jarkovský b, Milan Bláha b a
Cardiocenter Hospital Podlesi Trinec, Czech Republic Institute of Biostatistics and Analyses at the Faculty of Medicine and the Faculty of Science of the Masaryk University, Brno, Czech Republic b
article info
abstract
Article history:
The transcatheter aortic valve implantation (TAVI) is a preferred treatment option among
Received 13 January 2017
the patients with severe aortic stenosis who were considered to be non-operable or at high
Accepted 30 January 2017
surgical risk. The basic principle of the crimped valve and the catheter-based implantation
Available online 22 February 2017
to the stenotic native valve remains unchanged, but several different concepts of bioprosthesis and approaches of valve implantation have been developed. All the concepts have
Keywords:
proven their safety and efficiency, however, there are only limited data available comparing
Transcatheter valve implantation
one approach to another. The objective of this paper is to offer an overview and more
Femoral approach
detailed specification of current TAVI access techniques.
Subclavian approach
© 2017 The Czech Society of Cardiology. Published by Elsevier Sp. z o.o. All rights reserved.
Direct aortic approach Transapical approach
Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The transfemoral access (TF) . . . . . . . . . . . . . . . . . . . . . . The subclavian access (transsubclavian – TS) . . . . . . . . . Direct aortic access (DAA) . . . . . . . . . . . . . . . . . . . . . . . . The transapical access (TA) . . . . . . . . . . . . . . . . . . . . . . . The transcarotid access (common carotid access – CCA) Which access is the most advantageous? . . . . . . . . . . . . Conflict of interest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ethical statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Funding body . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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* Corresponding author at: Cardiocenter Hospital Podlesi Trinec, Konska 453, 739 61, Czech Republic. Fax: +420 558 304 407. E-mail address: [email protected] (M. Branny). http://dx.doi.org/10.1016/j.crvasa.2017.01.024 0010-8650/© 2017 The Czech Society of Cardiology. Published by Elsevier Sp. z o.o. All rights reserved.
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Introduction The transcatheter aortic valve implantation (TAVI) is a minimally invasive treatment of a severe aortic stenosis. It is indicated for the treatment of patients who are at increased risk for operative complications or death. While the basic principles of TAVI – crimped biological valve and transcatheter implantation – remain unchanged, there are several different concepts of bioprosthesis and routes of valve implantation. The retrograde transfemoral access is the most frequently used, the least invasive and the only percutaneous way of implantation. The retrograde approach is also applied in the other vascular approaches, i.e. subclavian, carotid and direct aortic accesses. These approaches, however, require a surgical cut-down of the artery, and they are commonly used, if the anatomy of the femoral and iliac artery is not suitable for a safe introduction of the catheter and valve. The antegrade approach, which was used by Cribier et al. [1] during the historically first TAVI in 2002, is used today exclusively for the transapical access. This approach also requires a surgical preparation of the site of puncture. All the above-mentioned implantation techniques proved their safety and efficiency in trials; available data, however, do not show clearly enough if any of these techniques is more advantageous as compared to the others. The objective of this paper is to give an overview of current practice of implantation techniques and access routes applied in TAVI, and also to inform about special features of each method described.
The transfemoral access (TF) The femoral access is the most often used approach in TAVI [2– 4]; it is used in 66.5–87.8% of all the implantations (Table 1). The first transfemoral valve implantations in 2005 [5] required a surgical cut-down of the femoral artery and the usage of 24 and 25 French sheaths. Large sizes of the sheath excluded many patients for this approach and led to the frequent vascular and bleeding complications [6,7]. The current generation of transcatheter femoral delivery systems, such as CoreValve Evolut R, Sapien 3, and Portico, has a size reduced to 14 and 16 French, according to the valve size. The reduction of the size of the delivery system resulted in a decreased rate of the vascular and bleeding complications from 11.9–22.9% (4.7) to 5.9–7.9% [8,9]. A smaller profile of instrumentation reduced the requirements for the minimum vessel diameter of the TAVI candidates from the previous 6–7 mm to the current 5 mm in the CoreValve Evolut R valve [10], 5.5–6 mm in the Edwards Sapien 3 valve [11], and to 6–6.5 mm in the Lotus valve [12]. Vascular complications at the femoral access site, however, still belong among the most frequent risks of the procedure. The femoral access, as compared to the subclavian, direct aortic and transapical access, is the least invasive, and it is the only approach which allows to perform the implantation truly percutaneously. The other above mentioned methods require a surgical cut-down. The transfemoral approach, due to the minimal invasion in the patient's body, allows to perform the TAVI just in local anaesthesia or deep sedation. Currently
Table 1 – Procedural characteristics TAVI patients implanted in Cardiocenter Hospital Podlesi Trinec (July 2009–December 2013). Totala N = 236 Type of native valve Tricuspid valve Bicuspid valve Unknown
210 (89.0%) 19 (8.1%) 7 (2.9%)
Type of implanted bioprosthesis, n (%) Medtronic CoreValve Medtronic Engager Edwards Sapien
228 (96.2%) 2 (0.8%) 6 (2.5%)
Access site Femoral percutaneous Femoral surgical cut down Subclavian Transapical Direct aortic
155 (65.7%) 2 (0.8%) 32 (13.6%) 8 (3.4%) 39 (16.5%)
Implantation to diseased native valve, n (%) Implantation to the diseased surgical bioprosthesis (valve-in-valve implantation), n (%)
232 (98.3%) 4 (1.7%)
Valve successfully deployed Device failure Length of hospital stay
235 (99.6%) 0 (0.0%) 8 (5;16)
a Categorical parameters were described by count and their relative count and continuous by median, supplemented by 5th and 95th percentile.
there are no convincing data available comparing the local and general anaesthesia and evidence of a superiority of any of these methods [13].
The subclavian access (transsubclavian – TS) The second least invasive arterial access is the subclavian access. This approach was first reported in 2008 [14]. The vast majority of subclavian cases are performed via left subclavian artery. The right subclavian artery is used exceptionally due to its inconvenient implantation angle [15]. The CoreValve and Evolut R are the most frequently implanted valves. The subclavian approach is rarely used for the implantation of the Edwards Sapien and Lotus valves due to a complexity of preparation of the Edwards Sapien valve [16], also a larger size and lower flexibility of the Lotus valve introduction system. The preparation of the puncture site of the subclavian artery requires surgical cut-down, placement of sutures on the vascular wall, puncture of the artery and introduction of a stiff guide wire to the left ventricle over the pig-tail diagnostic catheter and 8 French sheath (Fig. 1). Then, 18 French sheath is introduced through the subclavian artery into the ascending aorta (Fig. 2). The implantation of the valve itself does not differ from the femoral approach. In the subclavian approach, the placement of the valve is easier for the operator due to a shorter distance between the site of the puncture and the level of aortic annulus. There are a few specific conditions to be considered for subclavian approach. Among the patients with the patent LIMA/LAD graft, it is important to consider a risk of a
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indicated if the femoral access is not feasible or is associated with an increased risk of vascular complications.
Direct aortic access (DAA)
Fig. 1 – Subclavian approach. Subclavian artery with inserted 8 French sheath.
The direct aortic access is another arterial approach, used in patients in whom neither femoral nor subclavian approaches are possible or a risk of peripheral vascular complication is too high. The porcelain aorta, as well as the presence of the calcified atherosclerotic plaques on the anterior wall of the ascending aorta is considered a contraindication for DAA. After the surgical preparation of the access site a stiff guide wire, followed by 18F sheath, are inserted into the left ventricle and ascending aorta respectively. Then the bioprosthesis can be implanted (Figs. 3–5). There are two surgical approaches: (1) Right anterior mini-thoracotomy (incision in the right second intercostal space); or (2) Upper ministernotomy. Right anterior mini-thoracotomy is less invasive, in addition to that gives the operator the opportunity to achieve the optimal implantation angle. However, a shortage of space for the sheath in the aorta is a disadvantage of this method. Ministernotomy enables a sufficient space for the sheath introduction into the aorta, however, it is more invasive and less favourable in terms of the achievement an optimal implantation angle. The first description of the direct aortic access was provided by Bauernschmitt in 2009 [20]. According to the VARC-2 criteria, a procedural success is achieved in 90.8–98.0% cases; 30-day mortality is 6.1–8.0% [21–23]. Direct aortic access offers an advantage due to a highly accurate transfer of the operator's manoeuvres to the delivery system, and the valve can be easily and accurately placed. A rather increased invasiveness of this method represents a disadvantage in comparison to the other vascular approaches.
The transapical access (TA) In contrast to the above-mentioned arterial approaches (femoral, subclavian and direct aortic approaches), the apical Fig. 2 – Subclavian approach. 18 French sheath inside the subclavian artery.
temporary LIMA occlusion with 18 French sheath [17,18]. If the diameter of the subclavian artery at the level of LIMA origin is more than 8 mm, and the angiography with the 18 French sheath shows a sufficient flow in the LIMA graft, the risk of ischaemia is low. In case of a limited flow in the LIMA graft, the 18 French sheath can be retracted until the distal tip not exceed the origin of the LIMA. A presence of a permanent pacemaker in the left subclavian area is not an absolute contraindication of the subclavian approach, however, it makes the surgical preparation more difficult. In some patients, the brachial plexus is located proximally and close to the subclavian artery, which increase the risk of neurological complications. The subclavian approach is safe, the shortand mid-term study results are comparable to those of the femoral approach [3,19]. The subclavian TAVI should be
Fig. 3 – Direct aortic approach. Right anterior thoracotomy with small incision in the second intercostal space.
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Fig. 6 – Transapical approach. After puncture the apex 22 French sheath is inserted to the left ventricle.
Fig. 4 – Direct aortic approach. Stiff wire and 18 French sheath inserted to the ascending aorta.
the 5th or 6th left intercostal space; after the surgical preparation of the apex, puncture is performed with a needle, a prograde placement of guidewire is done through the stenotic valve into the descending aorta; after that, dedicated sheath is introduced and the bioprosthesis is implanted (Figs. 6 and 7). The apical approach is the second most widely used approach in TAVI [27,28]. The transapical access is also used for a valve in valve implantation into degenerated mitral bioprosthesis and valve in ring implantation into annuloplasty rings in patients with a severe mitral regurgitation [29–31]. In the Czech Republic, currently only one valve is available for the transapical implantation – Edwards Sapien. In comparison to the femoral access, transapical delivery system requires the
Fig. 5 – Direct aortic approach. CoreValve bioprosthesis deployment.
access means a direct invasion to the left ventricle myocardium. For this reason apical access this approach has been considered as the most invasive, and it is related to a higher complication and mortality rates [7,24,25]. An increased 30day and one year mortality is explained with patient's higher risk profile and longer learning curve. On the other hand, the apical approach offers a very good control of the delivery system, a favourable implantation angle, and no contact of the delivery system with aorta (‘‘no touch aorta principle’’) [26]. The contraindication for the transapical access may be a poor left ventricular function. The surgical access is performed in
Fig. 7 – Transapical approach. Implantation of the Edwards Sapien bioprosthesis.
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Table 2 – 30-Day outcome according to approach (in-hospital complications included) TAVI patients implanted in Cardiocenter Hospital Podlesi Trinec (July 2009 – December 2013).
Mortality Stroke/transient ischaemic attack Myocardial infarction Bleeding NACE MACE
Totala
Femorala
Transaortica
Subclaviana
N = 228
N = 157
N = 39
N = 32
6 (2.6%) 7 (3.1%) 0 (0.0%) 8 (3.5%) 20 (8.8%) 12 (5.3%)
4 (2.5%) 5 (3.2%) 0 (0.0%) 6 (3.8%) 14 (8.9%) 8 (5.1%)
2 0 0 2 4 2
(5.1%) (0.0%) (0.0%) (5.1%) (10.3%) (5.1%)
0 2 0 0 2 2
(0.0%) (6.3%) (0.0%) (0.0%) (6.3%) (6.3%)
pb
0.293 0.194 – 0.273 0.824 0.966
a Categorical parameters were described by count and their relative count and continuous by median, supplemented by 5th and 95th percentile. b statistical significance of difference between groups of patients tested by ML chi square test for categorical parameters and Kruskal–Wallis test for continuous parameters. NACE – combined endpoint consist of stroke/TIA, bleeding, MI and death. MACE – combined endpoint consist of stroke/TIA, MI and death.
usage of a larger sheath 24 and 26 French for the Sapien XT system, and 18 and 21 French for the Sapien 3 system [11,32].
The transcarotid access (common carotid access – CCA) For the first time, the access through the left carotid artery was described by French authors in 2012 [33] as an alternative method of the other vascular approaches when these were not technically viable. This is the least used approach, the advantage of which is an easy vascular access, good control over the delivery system and a short distance from the puncture site to the aortic annulus. A contact of the sheath and the delivery system with the carotid artery wall, as well as the increased risk of stroke, may be considered a disadvantage of this method. However, limited data of the French Transcarotid TAVI Registry do not support such concerns. [34].
Which access is the most advantageous? There are no prospective randomised data comparing the particular approaches, which is why it is not known if any of those methods is more advantageous than the others. Available results usually compare incomparable groups of patients. In the current medical practice, the femoral access is usually the first option. It is the least invasive, the only purely transcatheter approach, which does not require any surgical preparation, and it enables to perform the complete procedure under local anaesthesia. For this reason, it is the most widely used access for TAVI procedures. The Partner randomised trial [24], large prospective registries SOURCE [7], GARY [2], France 2 [35] and NANCY [25], and meta-analyses [36] demonstrated a lower short- and mid-term mortality when the femoral access is applied as compared to the transapical access. A rather strong invasiveness and a higher pre-implantation morbidity of patients, expressed by means of EUROScore [35], may be the cause of less favourable mortality rates of the transapical access. The Canadian registry shows a certain non-consistency of data, as it does not show any differences between the 30day mortality of the transfemoral and transapical approaches
[37]. The similar results have been achieved in the Cardiocenter Hospital Podlesi, the author's facility (Table 2). Ciucca et al. made a comparison of the safety of the transapical and subclavian TAVI approaches in 262 patients included in a prospective registry. Except bleeding (11.7% TS vs. 53.5% TA, P ≤ 0.001), no statistically significant difference was found between both methods; in 30-day follow up, a trend towards a lower mortality rate was observed in the subclavian approach (1.7% TS vs. 8.4% TA, P = 0.06) [38]. A recent meta-analysis of Irish authors made a comparison of outcomes in 193 patients with the direct aortic access and 1543 patients with the transapical access. During 30-day follow up it was found no significant difference in the procedural success rate, mortality, bleeding, stroke and permanent pacemaker implantation rate. It may be concluded that the selection of the approach is highly individual; it is influenced by capability and experience of the cardiac centre, availability of different valve types, anatomy of the patient, reimbursement policy, etc. For example, the transfemoral access will not be necessarily used in a patient with tortuous, calcified and narrow ileofemoral arteries. If the anatomy of the subclavian artery is favourable, subclavian access would be preferred. Another patient with a tortuous abdominal and thoracic aorta and calcified bicuspid aortic stenosis will be a suitable candidate for the direct aortic access and a self-expanding valve. Or, a patient with strongly angulated aortic root and small calcific valve will be indicated for the transfemoral implantation of a balloon-expandable valve. The selection of the access route and the type of valve tailor-made to the specific patient needs is, and will remain, the only correct way towards further improvement of the outcomes of the transcatheter aortic valve implantation.
Conflict of interest None declared.
Ethical statement Authors state that the research was conducted according to ethical standards.
cor et vasa 59 (2017) e10–e16
Funding body None.
references
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