Expert Review of Medical Devices
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Alternative transarterial access for CoreValve transcatheter aortic bioprosthesis implantation Giuseppe Bruschi, Federico De Marco, Thomas Modine, Luca Botta, Paola Colombo, Silvia Mauri, Aldo Cannata, Pasquale Fratto & Silvio Klugmann To cite this article: Giuseppe Bruschi, Federico De Marco, Thomas Modine, Luca Botta, Paola Colombo, Silvia Mauri, Aldo Cannata, Pasquale Fratto & Silvio Klugmann (2015) Alternative transarterial access for CoreValve transcatheter aortic bioprosthesis implantation, Expert Review of Medical Devices, 12:3, 279-286 To link to this article: http://dx.doi.org/10.1586/17434440.2015.1005605
Published online: 11 Feb 2015.
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Alternative transarterial access for CoreValve transcatheter aortic bioprosthesis implantation Downloaded by [University of Florida] at 08:09 14 November 2015
Expert Rev. Med. Devices 12(3), 279–286 (2015)
Giuseppe Bruschi*1, Federico De Marco1, Thomas Modine2, Luca Botta1, Paola Colombo1, Silvia Mauri1, Aldo Cannata1, Pasquale Fratto1 and Silvio Klugmann1 ‘A. De Gasperis’ Cardiology and Cardiac Surgery Department, Niguarda Ca’ Granda Hospital, Piazza dell’Ospedale Maggiore 3, 20162 Milan, Italy 2 Centre Hospitalier Regional Universitaire de Lille (CHRU), Lille, France *Author for correspondence: Tel.: +39 02 644 425 65 Fax: +39 02 644 425 66 [email protected] 1
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Transcatheter aortic valve implantation (TAVI) is used to treat elderly patients with severe aortic stenosis who are considered extremely high-risk surgical candidates. The safety and effectiveness of TAVI have been demonstrated in numerous studies. The self-expanding CoreValve bioprosthesis (Medtronic Inc., Minneapolis, MN, USA) was the first transcatheter aortic valve to be granted the Conformite Europeene (CE) mark in May 2007 for retrograde transfemoral implantation. However, TAVI patients are also often affected by severe iliofemoral arteriopathy. In these patients, the retrograde transfemoral approach carries a high risk of vascular injury, making this approach unusable. Alternative arterial access sites, such as the subclavian artery, the ascending aorta, and the carotid artery, have been used for retrograde implantation of the CoreValve bioprosthesis. In the present report, we present the procedural considerations, risks, and benefits of the different types of arterial access used to implant the CoreValve bioprosthesis. KEYWORDS: aortic stenosis . catheter-based valve intervention . CoreValve . structural heart disease .
transcatheter technique
Severe aortic stenosis (AS) is the most frequent form of valvular heart disease in Western countries and is a major cause of cardiovascular morbidity and mortality in the elderly. In parallel with increasing life expectancy and a growing elderly population, symptomatic AS has become an increasing health problem, with a prevalence of 5% in patients over the age of 75 years [1,2]. Although aortic valve replacement (AVR) is the standard treatment for these patients and is a Class I recommendation in the American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines [3], one-third of patients affected by severe AS may have been denied surgery in the 1990s [4]. This was due to the fact that the mortality rate associated with AVR increases substantially if multiple comorbidities, such as significant left ventricular dysfunction, previous chest surgery or radiation, chronic obstructive pulmonary disease, liver failure or renal failure are present [5].
10.1586/17434440.2015.1005605
Transcatheter aortic valve implantation (TAVI) is designed to treat patients with severe, symptomatic AS who are deemed high risk for surgical AVR. Since the first successful human percutaneous TAVI was performed by Cribier and colleagues in 2002, more than 90,000 patients worldwide have undergone TAVI with the balloon-expandable Edwards SAPIEN prosthesis (Edwards Lifesciences, Irvine, CA, USA) or the self-expandable Medtronic CoreValve Revalving System (Medtronic, Inc., Minneapolis, MN, USA). A substantial body of data exists from observational clinical studies, post-marketing devicespecific and national registries [6–8] and randomized, controlled trials [9–11] regarding the clinical outcomes following TAVI. One study, the PARTNER I (Placement of AoRtic TraNscathet ER Valves) Trial, showed that in patients with severe AS who could not undergo surgical AVR, TAVI with a balloonexpandable device, when compared to standard medical therapy alone, improved survival [9].
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Furthermore, in high-risk AS patients who were still considered candidates for surgical AVR, TAVI, when compared to surgical AVR, was associated with a similar rate of survival at 1 year [10]. Nonetheless, TAVI was associated with a higher incidence of major stoke and major vascular events. In another study, the US CoreValve High Risk Study, which compared TAVI using a self-expanding bioprosthesis to surgical AVR in high-risk surgical patients, mortality at 1 year was lower in the TAVI group than in the surgical group, with an absolute risk reduction of 4.9% [11]. Early TAVI experience utilized the retrograde approach from the common femoral artery [12,13]. Due to the large size of current generation TAVI systems, the transfemoral approach requires favorable iliofemoral arterial anatomy. This approach is contraindicated in patients with excessive atherosclerosis, calcifications or tortuosity of the iliofemoral arteries and should be considered cautiously in patients with an aneurysm of the abdominal aorta. To treat these patients, a transapical approach with the Ascendra+ transapical catheter (Edwards Lifesciences) and the Edwards SAPIEN valve was proposed [14]. However, this approach is demanding since it requires direct surgical exposure of the left ventricular apex, which can be structurally friable in elderly patients and in cases of severe hypertrophy. Moreover, the transapical approach requires a dedicated antegrade delivery system. Since 2008, several alternative types of arterial access have been described for CoreValve implantation in patients whose iliofemoral anatomy is unsuitable for the transfemoral approach. These include the subclavian artery approach [15], the direct aortic approach [16,17] and the trans-carotid approach [18]. Here we describe the procedures, risks and benefits of each approach when performing TAVI with the CoreValve bioprosthesis. CoreValve system description
The Medtronic CoreValve System consists of three unique components: a multilevel, self-expanding, fully radiopaque, laser cut nitinol frame with a diamond cell configuration that holds a trileaflet porcine pericardial tissue valve and anchors the device in the native anatomy with three different areas of radial force; an 18 Fr catheter delivery system and a disposable loading system. Details about the design of Corevalve prosthesis have been described previously [19,20]. The CoreValve is available in four sizes (23, 26, 29 and 31 mm) to treat a broad range of annulus sizes from 18 to 29 mm; all the valves fit into the same 18-F catheter. The valve’s supra-annular design minimizes ellipticity at the valve level for more optimal leaflet coaptation and performance. The maximum support frame axial length is 55 mm for the 26 mm valve. Alternative CoreValve implantation procedures Pre-procedure evaluation
The patient screening protocol generally includes a transthoracic echocardiogram, complete left heart catheterization and coronary angiography with additional evaluation of the iliac 280
and femoral arteries and chest and aortic-iliofemoral computed tomography. We believe that a preoperative CT scan is useful in general for any TAVI in order to evaluate annulus size and the best access, but it is mandatory when alternative access sites are considered. For the subclavian/axillary approach, a CT scan is essential to evaluate subclavian vessel size, tortuosity and presence and location of calcifications; moreover, it is possible to evaluate the angle between the plane of aortic valve annulus and a horizontal plane, which should be >70 degrees in the case of left subclavian access and >30 degrees in the case of right subclavian access. For the direct aortic approach, a CT scan is essential to evaluate the presence and location of calcifications in the ascending aorta, the theoretical entry site into the ascending aorta and in re-do coronary artery bypass patients, the height of the proximal anastomosis of coronary artery grafts. For the carotid artery approach, a pre-procedural Doppler study of the carotid and vertebral arteries is essential to assess the presence of any significant arterial disease. Cerebral magnetic resonance imaging or angio-computed tomography are mandatory to study intracranial cerebral circulation and assess the patency of the circle of Willis. TAVI procedures should be performed in a hybrid operating room or in the cardiac catheterization laboratory with transesophageal echocardiographic and fluoroscopic guidance. To perform the operation, a multidisciplinary team consisting of an interventional cardiologist, a cardiac surgeon with expertise in catheterization and hybrid procedures, a vascular surgeon, an echocardiographer and an anesthesiologist is required. Common to all procedures is patient preparation. A temporary pacing lead is advanced into the right ventricle through the femoral or jugular vein in patients without a permanent pacemaker to treat possible post-TAVI atrioventricular block. The radial artery or the best femoral artery is accessed by a singlewall puncture under fluoroscopic guidance to allow hemodynamic monitoring during the procedure and landmark aortic angiography through a 6 Fr pigtail. Heparin is administered to maintain an activated clotting time of >250 s throughout the procedure. After the procedure, heparin is neutralized by protamine. Subclavian approach
The procedure should be performed with the patient under general anesthesia or under profound sedation and local anesthesia. The left subclavian artery is usually preferred to the right subclavian artery because it allows for a more favorable orientation of the CoreValve delivery system through the aortic annulus, similar to that of the femoral approach. The right subclavian approach requires attention to the right common carotid artery. The 18 Fr sheath must be positioned without impairing the right carotid flow. Generally, the sheath is pushed toward the aortic valve plane only when needed to support CoreValve positioning. Moreover, during implantation, the CoreValve bioprosthesis appears excessively vertical to the aortic plane, with a quite low position at the level of the left cusp, but a very high position to the non-coronary cusp. Also, Expert Rev. Med. Devices 12(3), (2015)
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Alternative transarterial access for CoreValve transcatheter aortic bioprosthesis implantation
deployment of the prosthesis is different because the nitinol frame starts to flare at level of the left cusp opening versus the non-coronary cusp [21–23]. The patient is placed in a supine position with arms parallel to each side. A 4–5 cm oblique skin incision is made between the deltopectoral groove and a more medial subclavicular location 1–2 cm below the clavicle. The muscle fibers of the pectoralis major are divided from the deltoid muscle into the groove, with care being taken to not injure the muscles (cautery should not be used on the muscular fibers). The pectoralis minor is then exposed and gently retracted. Sharp dissection is used to separate the axillary artery from the surrounding structures, including the accompanying vein and brachial plexus. A vessel loop is used to isolate the artery. With this technique, the muscles are divaricated but not injured by cautery, as is generally required for axillary/subclavian exposure. Two oval-shaped purse-string sutures are performed on the vessel (FIGURE 1). Using a standard needle, the vessel is punctured on the distal side of the oval purse-string suture with the Seldinger technique. A small-sized sheath is first inserted into the subclavian artery. The aortic valve is crossed retrogradely in the standard fashion, and an Amplatz super stiff 260 cm guide wire is advanced into the left ventricle. The smallsized sheath is removed, and the 18 Fr sheath is then inserted over the super stiff wire. It is possible to enlarge the entry site in the artery with an 11 blade knife to avoid artery dissection (FIGURE 2). After balloon aortic valvuloplasty, a standard retrograde CoreValve deployment is performed under echocardiographic and fluoroscopic guidance [21]. An important caveat to using the left subclavian approach for TAVI is the risk of impairing blood flow in a pre-existing left internal mammary artery (LIMA) coronary artery bypass graft during valve deployment. To reduce the duration that the 18 Fr sheath may interfere with the LIMA graft, the 18 Fr sheath should be withdrawn beyond the origin of the LIMA immediately after advancement of the CoreValve prosthesis across the aortic annulus. Since Conformite Europeene (CE) mark approval in December 2010, more than 1500 patients at 150 centers have undergone CoreValve TAVI via the subclavian approach with excellent results. In the literature, two principal papers by Petronio and colleagues have reported the results with this approach. The first, published in 2010, reported outcomes in 54 patients at 13 Italian centers. Procedural success was 100%, and no specific access site complications were reported. Thirty-day mortality was 0%, and 6-month mortality was 9.4% [22]. The second paper, published in 2012, used propensity score analysis to identify matched groups of patients from the Italian CoreValve Registry to compare outcomes of subclavian versus transfemoral TAVI. The left subclavian artery was used in 96% of subclavian patients. The two groups showed similar rates of procedural success, major vascular complications and life-threatening bleeding. Survival at 2 years was 74.0 ± 4.0% in the subclavian group and 73.7 ± 3.9% in the femoral group [23]. In the literature, more than 15 papers have been published reporting single-center experience with the subclavian approach informahealthcare.com
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Figure 1. Left subclavian/axillary artery exposure. Two ovalshaped purse-string sutures performed on the vessel.
for CoreValve implantation. The largest of these was reported by Lange and colleagues, who performed the first subclavian approach CoreValve implantation in 2008 [24]. They performed 40 CoreValve implantations via the subclavian artery in patients where the transfemoral approach was not possible. Patients who underwent TAVI via the subclavian approach experienced a lower incidence of stroke (2.5 vs 4.3%), myocardial ischemia (0 vs 2.0%) and access vessel complications (7.5 vs 10.6%) than those patients who underwent TAVI by the transfemoral approach. A Kaplan–Meier estimate of survival was similar between the two groups. Other single-center experiences support these results [21,25,26]. Outcomes following TAVI with the left subclavian approach in patients with a LIMA bypass graft, as well as comparative outcomes following TAVI with the right versus left subclavian approach, have also been reported. In the 2010 paper by Petronio and colleagues described earlier, eight patients who were
Figure 2. 18 Fr sheath is inserted in the subclavian artery to perform retrograde CoreValve implantation.
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treated via left subclavian access had a patent LIMA graft, and none of the patients experienced a fall in arterial pressure or signs of myocardial ischemia on ECG during the procedure. Other authors have similarly reported successful CoreValve implantation through the left subclavian artery in patients with a patent mammary artery graft [27]. Bedogni and co-workers reported the largest experience to date using right subclavian access in 10 patients [28]. Safety endpoints were not statistically different between the left and right subclavian approach. However, the CoreValve implantation height was higher when using the right subclavian versus the left subclavian approach (9.1 vs 7.1 mm).
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Direct aortic approach
The procedure is performed under general anesthesia. A double-lumen endotracheal tube should be used for single left lung ventilation. The procedure should be performed through a right anterior mini-thoracotomy or through an upper ministernotomy. Mini-sternotomy usually involves a J-upper sternotomy through the second or third right intercostal space or a T-sternotomy through the second intercostal space. Ministernotomy has certain advantages over a right anterior thoracotomy, such as surgeon familiarity with the procedure; the ability to keep the pleural space intact, thus avoiding complications such as pleural effusion; and the ability to rapidly convert to a full sternotomy if needed. Right anterior thoracotomy is performed more commonly through the second right intercostal space, but it can also be performed through the first right intercostal space (FIGURE 3). Right anterior thoracotomy is not a bone-cutting incision and hence has its benefits. It is the approach of choice if the patient
Figure 3. Basal aortography to evaluate a coaxial trajectory and distance from the entry site on the ascending aorta to the aortic annulus.
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has undergone a previous sternotomy, especially if the patient has patent bypass grafts. It is important to choose the right access for a given patient. Although certain clinical situations, such as patent grafts, as explained earlier, dictate the choice, in the majority of cases the decision should be based on which is technically easier. A right anterior thoracotomy approach is easier if the aorta is to the right side and not very far from the rib cage, and a mini-sternotomy is easier if the aorta is in the midline or deeper [29,30]. Basal ascending aortography using a graduated pig-tail is performed to measure the distance between the aortic annulus and the selected entry site in the ascending aorta and to evaluate a coaxial trajectory from the entry site on the ascending aorta to the aortic annulus (FIGURE 4). At the entry site, two purse-string sutures are placed in the standard fashion for direct aortic access. Ascending aortic cannulation should be performed either by directly inserting an 18 Fr sheath as for standard aortic cannulation or with the Seldinger technique through the double purse-string sutures. In this case, a 6–9 Fr sheath is first inserted into the ascending aorta, and after crossing the aortic valve, a super stiff guidewire is placed into the left ventricle and the 18 Fr sheath is advanced. At this point, a CoreValve bioprosthesis is then carefully introduced and retrogradely implanted under angiographic and fluoroscopic guidance [17,30]. A few single-center experiences have been published describing direct aortic CoreValve implantation [30,31]. The largest multicenter experience reported to date is the European Direct Aortic CoreValve Experience Registry, which comprises a total of 478 patients treated at 19 centers in nine countries in Europe and Israel [32]. Mean patient age was 81.3 ± 6.5 years, 47% were female and the mean logistic EuroSCORE was 26.6 ± 16.6. The majority of the patients (86%) were in New York Heart Association functional class III or IV and peripheral vascular disease was present in 293 (61%) patients. Coronary artery disease was present in 280 (59%) patients, and 101 (21%) patients had undergone previous coronary artery bypass surgery. The TAVI procedure was performed in 46% of cases through a right anterior mini-thoracotomy in the second intercostal space and via an upper hemi-sternotomy in 54% of cases. A 29 mm CoreValve was implanted in 200 (42%) patients. Procedural success was 98%. There were two procedural deaths, and 30-day mortality was 9%. The incidence of stroke was 1.4%, and 67 (16%) patients required a new permanent pacemaker. Median postoperative hospitalization was 10 days. Recently, Reardon and colleagues reported the 30-day outcomes of patients enrolled in the CoreValve Extreme Risk US Pivotal Trial and Continued Access Study who underwent TAVI using the direct aortic approach [33]. In the Pivotal Trial group (n = 80 direct aortic access), 13.7% had died, 6.5% had a major stoke, 3.8% had major vascular complications and 20.6% required implantation of a permanent pacemaker. In the Continued Access Group (n = 260 direct aortic approach), which consisted of patients who had been enrolled between the point of enrollment completion in the Pivotal Study and US FDA approval of the CoreValve System and who had Expert Rev. Med. Devices 12(3), (2015)
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Figure 4. View from right anterior thoracotomy after pericardial opening. (A) Ascending aorta, (B) double purse-string suture and (C) 18 Fr sheath inserted through the purse-string suture for retrograde CoreValve implantation.
‡30 days follow-up, 10.8% of the patients had died, 4.7% had a major stoke, 3.1% had major vascular complications and 16.7% required implantation of a permanent pacemaker. Trans-carotid approach
during preimplant balloon valvuloplasty and one in-hospital death due to multisystem organ failure. There were no myocardial infarctions, strokes or major bleeding. Third-degree atrioventricular block requiring pacemaker implantation occurred in three patients. No complications related to the vascular access site occurred [35].
During the procedure, cerebral perfusion is continuously monitored. The proximal common right or left carotid artery is exposed through a small incision 2 cm above the left clavicle. Expert commentary The anterior wall of the artery is carefully dissected to avoid Since its introduction by Cribier and colleagues, TAVI has injury to the vagus nerve. Progression of the wires and sheaths is been successfully adopted at hundreds of centers across the carefully monitored using fluoroscopic guidance. Progressive world, and more than 90,000 patients affected by severe AS dilation of the artery using increasing dilator diameters (e.g., 14, have been treated. The only access site used during the initial 16 and 18 Fr) is recommended. The 18 Fr sheath is then care- TAVI experience was the transfemoral approach, and significant fully inserted over a super-stiff wire (FIGURES 5A & 5B). The tip of technical and prosthetic modifications followed to solve the the sheath is positioned in the upper part of the ascending aorta, early limitations with this approach. With the CoreValve delivsimilar to the subclavian approach. Once the TAVI procedure is ery catheters decreasing in size from the initial 24 Fr to the completed, vascular clamps are briefly applied during withdrawal present 18 Fr diameter, the CoreValve TAVI procedure can of the 18 Fr sheath. The carotid arterial access site is then surgi- now be done completely percutaneously. However, considering cally repaired using 6/0 Prolene. An angiogram is then per- the known overlap of the etiology and risk factors for atherosclerotic vascular disease and AS, it is not surprising that many formed to assess artery patency. The first case of trans-carotid TAVI was reported by Modine TAVI candidates are also affected by concomitant, severe and colleagues in an 89-year-old man with symptomatic degener- peripheral vasculopathy. Because the femoral approach is ative AS [34]. In a subsequent report by the same group involving 12 consecutive A B patients who underwent TAVI via the proximal left common carotid artery under general anesthesia, prosthesis implantation was uneventful, and no vascular complications or bleeding were observed. However, one patient had an embolic transient ischemic attack contralateral to the carotid access site [18]. More recently, Azmoun and colleagues reported the outcomes of 19 patients who underwent TAVI by the carotid approach (8 right, 11 left) under local anesthesia. Accurate deployment of the device was achieved in 18 patients (4 Edwards SAPIEN XT and 14 MedFigure 5. Trans-carotid approach. (A) 18 Fr sheath inserted through the common tronic CoreValve). There was one intraocarotid artery. (B) Under fluoroscopy, 18 Fr sheath is advanced into the ascending aorta. perative death due to annulus rupture informahealthcare.com
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contraindicated in patients with excessive atherosclerosis, calcifications or tortuosity of the femoral or iliac arteries, and should be considered cautiously in patients with an aneurysm of the thoracic or abdominal aorta, alternative access sites and approaches have been devised to allow these patients to undergo TAVI. The subclavian/axillary approach was the first alternative approach to obtain the CE mark in 2010. It has the advantage in that the subclavian artery is easily accessible after surgical cutdown, and that the procedure can be performed with local anesthetic and mild sedation. However, the subclavian artery is fragile and cannot be used if it is less than 6 mm in diameter, heavily calcified, excessively tortuous or has a tight stenosis that is not amenable to percutaneous balloon angioplasty [22]. Moreover, the subclavian approach has to be considered cautiously in patients with a patent LIMA graft. The direct aortic approach received CE mark approval in November 2011. It is theoretically more invasive compared to the subclavian approach as it requires a mini-thoracotomy or upper mini-sternotomy. The advantage to this approach, however, is that there is no limitation in vessel size, and the procedure is feasible in cases where there is a severe horizontal aorta. The advantage to performing the implantation through a right anterior mini-thoracotomy is more evident in re-do patients, in whom a repeat sternotomy, even if partial, is a challenging procedure. Indeed, a right mini-thoracotomy requires only limited dissection at the entry site on the ascending aorta and is also feasible in patients with patent venous grafts whose proximal anastomosis is on the ascending aorta [36]. Importantly, this approach avoids contact with the aortic arch, as there is neither a delivery system nor wire placed in the arch that might otherwise dislodge atherosclerotic plaque during valve passage. This may translate into a lower incidence of stroke. The only contraindications to using this approach are a complete porcelain aorta, the presence of calcium at the entry zone and an inaccessible ascending aorta [29]. The more recently introduced carotid approach should be considered if no other alternative approaches are feasible. Bilateral carotid Doppler echo and cerebral MRI or angio-computed tomography is mandatory to study cerebral circulation [18]. The carotid approach offers a safe and less invasive alternative to the transapical approach in patients with a small subclavian artery, severe aortic calcifications and/or severe respiratory failure. All non-iliofemoral and proximal arterial approaches have the advantage of overcoming challenging aorto-iliofemoral vascular disease and avoid the risk of dislodging atherosclerotic plaque during valve passage through the aorta. The control of the delivery system is dramatically enhanced because any force
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is directly transmitted one-to-one without any loss of pushability or trackability compared to a transfemoral approach. A co-axial trajectory to the aortic valve plane, especially with the direct aortic approach, allows perfect alignment of the TAVI device in the aortic annulus. This undoubtedly facilitates more accurate valve deployment, which might be particularly useful in patients with complex anatomy or physiology (e.g., horizontal ascending aorta, large annulus, primary aortic regurgitation). Five-year view
Next-generation devices will have additional improvements, such as low-profile sheaths, more accurate valve deployment and the ability to either reposition or even retrieve the prosthesis, which will reduce the incidence of paravalvular leak. Medtronic has already received CE mark approval for the CoreValve Evolut R, which has several refinements to improve anatomical fit, annular sealing and durability. The introduction of the full Evolut R product family (23, 26, 29 and XL) is expected in the first quarter of 2015. The Evolut frame, which is tailored to reduce overall valve height, is approximately 10% shorter than the original CoreValve frame, although the height of the pericardial skirt is preserved (12 mm). The device is designed to be recaptured and repositioned. It will be delivered with the EnVeo R delivery system (Medtronic, Inc.). This next-generation delivery system is designed to have a stable and predictable deployment with proper implantation depth. It will also offer the ability to resheath, reposition and redeploy the valve if necessary. To help prevent vascular complications, the Evolut R system will use the new, catheter-mounted InLine sheath, which eliminates the need for an external sheath. This sheath has a lower profile with an 18 Fr outer diameter – compared to the 22 Fr outer diameter sheaths of the recent CoreValve System – and is equivalent to the 14 Fr inner diameter systems of other transcatheter heart valve manufacturers. Future studies will help determine whether these design improvements will result in improved outcomes for patients undergoing TAVI. Acknowledgement
We would like to thank Janice Hoettels, for her copyediting assistance. Financial & competing interests disclosure
G Bruschi is a consultant for Medtronic and Direct Flow; T Modine is a consultant for Medtronic; F De Marco is a consultant for Direct Flow. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. We would like to thank Janice Hoettels, PA, MBA for her copyediting assistance.
Expert Rev. Med. Devices 12(3), (2015)
Alternative transarterial access for CoreValve transcatheter aortic bioprosthesis implantation
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Key issues .
Transcatheter aortic valves have been designed to treat high risk for surgery symptomatic aortic stenosis in elderly patients; more than 90,000 patients have undergone transcatheter aortic valve implantation worldwide.
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At the beginning of the experience, the only access was the retrograde approach from the common femoral artery, but due to the large device size, the trans-femoral approach requires favorable ileo-femoral arterial anatomy; moreover, this approach is contraindicated in patients with excessive atherosclerosis, calcifications or tortuosity of ileo-femoral arteries.
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Since 2008, different alternative arterial access has been used for CoreValve implantation; in patients not suitable for peripheral femoral approach, the subclavian artery direct aortic access and a trans-carotid one.
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All non-iliofemoral and proximal arterial accesses had the advantage that the control of the delivery system is dramatically enhanced because any force is directly transmitted one-to-one without any loss of pushability and trakability compared to a trans-femoral approach. This undoubtedly facilitates more accurate valve deployment.
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To treat patients via alternative access routes, the cooperation between cardiologists, cardiac surgeons, anesthesiologists,
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echocardiographist, radiologists, nurses and all different specialists involved in transcatheter aortic valve implantation patients’ care (the so-called heart team) is crucial.
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Ruge H, Lange R, Bleiziffer S, et al. First successful aortic valve implantation with the CoreValve Revalving System via right subclavian artery access: a case report. Heart Surg Forum 2008;11:E323-4 Cioni M, Taramasso M, Giacomini A, et al. Transaxillary approach: short- and mid-term results in a single-center experience. Innovations 2011;6:361-5
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Expert Rev. Med. Devices 12(3), (2015)
ISSN: 1743-4440 (Print) 1745-2422 (Online) Journal homepage: http://www.tandfonline.com/loi/ierd20
Alternative transarterial access for CoreValve transcatheter aortic bioprosthesis implantation Giuseppe Bruschi, Federico De Marco, Thomas Modine, Luca Botta, Paola Colombo, Silvia Mauri, Aldo Cannata, Pasquale Fratto & Silvio Klugmann To cite this article: Giuseppe Bruschi, Federico De Marco, Thomas Modine, Luca Botta, Paola Colombo, Silvia Mauri, Aldo Cannata, Pasquale Fratto & Silvio Klugmann (2015) Alternative transarterial access for CoreValve transcatheter aortic bioprosthesis implantation, Expert Review of Medical Devices, 12:3, 279-286 To link to this article: http://dx.doi.org/10.1586/17434440.2015.1005605
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Alternative transarterial access for CoreValve transcatheter aortic bioprosthesis implantation Downloaded by [University of Florida] at 08:09 14 November 2015
Expert Rev. Med. Devices 12(3), 279–286 (2015)
Giuseppe Bruschi*1, Federico De Marco1, Thomas Modine2, Luca Botta1, Paola Colombo1, Silvia Mauri1, Aldo Cannata1, Pasquale Fratto1 and Silvio Klugmann1 ‘A. De Gasperis’ Cardiology and Cardiac Surgery Department, Niguarda Ca’ Granda Hospital, Piazza dell’Ospedale Maggiore 3, 20162 Milan, Italy 2 Centre Hospitalier Regional Universitaire de Lille (CHRU), Lille, France *Author for correspondence: Tel.: +39 02 644 425 65 Fax: +39 02 644 425 66 [email protected] 1
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Transcatheter aortic valve implantation (TAVI) is used to treat elderly patients with severe aortic stenosis who are considered extremely high-risk surgical candidates. The safety and effectiveness of TAVI have been demonstrated in numerous studies. The self-expanding CoreValve bioprosthesis (Medtronic Inc., Minneapolis, MN, USA) was the first transcatheter aortic valve to be granted the Conformite Europeene (CE) mark in May 2007 for retrograde transfemoral implantation. However, TAVI patients are also often affected by severe iliofemoral arteriopathy. In these patients, the retrograde transfemoral approach carries a high risk of vascular injury, making this approach unusable. Alternative arterial access sites, such as the subclavian artery, the ascending aorta, and the carotid artery, have been used for retrograde implantation of the CoreValve bioprosthesis. In the present report, we present the procedural considerations, risks, and benefits of the different types of arterial access used to implant the CoreValve bioprosthesis. KEYWORDS: aortic stenosis . catheter-based valve intervention . CoreValve . structural heart disease .
transcatheter technique
Severe aortic stenosis (AS) is the most frequent form of valvular heart disease in Western countries and is a major cause of cardiovascular morbidity and mortality in the elderly. In parallel with increasing life expectancy and a growing elderly population, symptomatic AS has become an increasing health problem, with a prevalence of 5% in patients over the age of 75 years [1,2]. Although aortic valve replacement (AVR) is the standard treatment for these patients and is a Class I recommendation in the American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines [3], one-third of patients affected by severe AS may have been denied surgery in the 1990s [4]. This was due to the fact that the mortality rate associated with AVR increases substantially if multiple comorbidities, such as significant left ventricular dysfunction, previous chest surgery or radiation, chronic obstructive pulmonary disease, liver failure or renal failure are present [5].
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Transcatheter aortic valve implantation (TAVI) is designed to treat patients with severe, symptomatic AS who are deemed high risk for surgical AVR. Since the first successful human percutaneous TAVI was performed by Cribier and colleagues in 2002, more than 90,000 patients worldwide have undergone TAVI with the balloon-expandable Edwards SAPIEN prosthesis (Edwards Lifesciences, Irvine, CA, USA) or the self-expandable Medtronic CoreValve Revalving System (Medtronic, Inc., Minneapolis, MN, USA). A substantial body of data exists from observational clinical studies, post-marketing devicespecific and national registries [6–8] and randomized, controlled trials [9–11] regarding the clinical outcomes following TAVI. One study, the PARTNER I (Placement of AoRtic TraNscathet ER Valves) Trial, showed that in patients with severe AS who could not undergo surgical AVR, TAVI with a balloonexpandable device, when compared to standard medical therapy alone, improved survival [9].
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Furthermore, in high-risk AS patients who were still considered candidates for surgical AVR, TAVI, when compared to surgical AVR, was associated with a similar rate of survival at 1 year [10]. Nonetheless, TAVI was associated with a higher incidence of major stoke and major vascular events. In another study, the US CoreValve High Risk Study, which compared TAVI using a self-expanding bioprosthesis to surgical AVR in high-risk surgical patients, mortality at 1 year was lower in the TAVI group than in the surgical group, with an absolute risk reduction of 4.9% [11]. Early TAVI experience utilized the retrograde approach from the common femoral artery [12,13]. Due to the large size of current generation TAVI systems, the transfemoral approach requires favorable iliofemoral arterial anatomy. This approach is contraindicated in patients with excessive atherosclerosis, calcifications or tortuosity of the iliofemoral arteries and should be considered cautiously in patients with an aneurysm of the abdominal aorta. To treat these patients, a transapical approach with the Ascendra+ transapical catheter (Edwards Lifesciences) and the Edwards SAPIEN valve was proposed [14]. However, this approach is demanding since it requires direct surgical exposure of the left ventricular apex, which can be structurally friable in elderly patients and in cases of severe hypertrophy. Moreover, the transapical approach requires a dedicated antegrade delivery system. Since 2008, several alternative types of arterial access have been described for CoreValve implantation in patients whose iliofemoral anatomy is unsuitable for the transfemoral approach. These include the subclavian artery approach [15], the direct aortic approach [16,17] and the trans-carotid approach [18]. Here we describe the procedures, risks and benefits of each approach when performing TAVI with the CoreValve bioprosthesis. CoreValve system description
The Medtronic CoreValve System consists of three unique components: a multilevel, self-expanding, fully radiopaque, laser cut nitinol frame with a diamond cell configuration that holds a trileaflet porcine pericardial tissue valve and anchors the device in the native anatomy with three different areas of radial force; an 18 Fr catheter delivery system and a disposable loading system. Details about the design of Corevalve prosthesis have been described previously [19,20]. The CoreValve is available in four sizes (23, 26, 29 and 31 mm) to treat a broad range of annulus sizes from 18 to 29 mm; all the valves fit into the same 18-F catheter. The valve’s supra-annular design minimizes ellipticity at the valve level for more optimal leaflet coaptation and performance. The maximum support frame axial length is 55 mm for the 26 mm valve. Alternative CoreValve implantation procedures Pre-procedure evaluation
The patient screening protocol generally includes a transthoracic echocardiogram, complete left heart catheterization and coronary angiography with additional evaluation of the iliac 280
and femoral arteries and chest and aortic-iliofemoral computed tomography. We believe that a preoperative CT scan is useful in general for any TAVI in order to evaluate annulus size and the best access, but it is mandatory when alternative access sites are considered. For the subclavian/axillary approach, a CT scan is essential to evaluate subclavian vessel size, tortuosity and presence and location of calcifications; moreover, it is possible to evaluate the angle between the plane of aortic valve annulus and a horizontal plane, which should be >70 degrees in the case of left subclavian access and >30 degrees in the case of right subclavian access. For the direct aortic approach, a CT scan is essential to evaluate the presence and location of calcifications in the ascending aorta, the theoretical entry site into the ascending aorta and in re-do coronary artery bypass patients, the height of the proximal anastomosis of coronary artery grafts. For the carotid artery approach, a pre-procedural Doppler study of the carotid and vertebral arteries is essential to assess the presence of any significant arterial disease. Cerebral magnetic resonance imaging or angio-computed tomography are mandatory to study intracranial cerebral circulation and assess the patency of the circle of Willis. TAVI procedures should be performed in a hybrid operating room or in the cardiac catheterization laboratory with transesophageal echocardiographic and fluoroscopic guidance. To perform the operation, a multidisciplinary team consisting of an interventional cardiologist, a cardiac surgeon with expertise in catheterization and hybrid procedures, a vascular surgeon, an echocardiographer and an anesthesiologist is required. Common to all procedures is patient preparation. A temporary pacing lead is advanced into the right ventricle through the femoral or jugular vein in patients without a permanent pacemaker to treat possible post-TAVI atrioventricular block. The radial artery or the best femoral artery is accessed by a singlewall puncture under fluoroscopic guidance to allow hemodynamic monitoring during the procedure and landmark aortic angiography through a 6 Fr pigtail. Heparin is administered to maintain an activated clotting time of >250 s throughout the procedure. After the procedure, heparin is neutralized by protamine. Subclavian approach
The procedure should be performed with the patient under general anesthesia or under profound sedation and local anesthesia. The left subclavian artery is usually preferred to the right subclavian artery because it allows for a more favorable orientation of the CoreValve delivery system through the aortic annulus, similar to that of the femoral approach. The right subclavian approach requires attention to the right common carotid artery. The 18 Fr sheath must be positioned without impairing the right carotid flow. Generally, the sheath is pushed toward the aortic valve plane only when needed to support CoreValve positioning. Moreover, during implantation, the CoreValve bioprosthesis appears excessively vertical to the aortic plane, with a quite low position at the level of the left cusp, but a very high position to the non-coronary cusp. Also, Expert Rev. Med. Devices 12(3), (2015)
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Alternative transarterial access for CoreValve transcatheter aortic bioprosthesis implantation
deployment of the prosthesis is different because the nitinol frame starts to flare at level of the left cusp opening versus the non-coronary cusp [21–23]. The patient is placed in a supine position with arms parallel to each side. A 4–5 cm oblique skin incision is made between the deltopectoral groove and a more medial subclavicular location 1–2 cm below the clavicle. The muscle fibers of the pectoralis major are divided from the deltoid muscle into the groove, with care being taken to not injure the muscles (cautery should not be used on the muscular fibers). The pectoralis minor is then exposed and gently retracted. Sharp dissection is used to separate the axillary artery from the surrounding structures, including the accompanying vein and brachial plexus. A vessel loop is used to isolate the artery. With this technique, the muscles are divaricated but not injured by cautery, as is generally required for axillary/subclavian exposure. Two oval-shaped purse-string sutures are performed on the vessel (FIGURE 1). Using a standard needle, the vessel is punctured on the distal side of the oval purse-string suture with the Seldinger technique. A small-sized sheath is first inserted into the subclavian artery. The aortic valve is crossed retrogradely in the standard fashion, and an Amplatz super stiff 260 cm guide wire is advanced into the left ventricle. The smallsized sheath is removed, and the 18 Fr sheath is then inserted over the super stiff wire. It is possible to enlarge the entry site in the artery with an 11 blade knife to avoid artery dissection (FIGURE 2). After balloon aortic valvuloplasty, a standard retrograde CoreValve deployment is performed under echocardiographic and fluoroscopic guidance [21]. An important caveat to using the left subclavian approach for TAVI is the risk of impairing blood flow in a pre-existing left internal mammary artery (LIMA) coronary artery bypass graft during valve deployment. To reduce the duration that the 18 Fr sheath may interfere with the LIMA graft, the 18 Fr sheath should be withdrawn beyond the origin of the LIMA immediately after advancement of the CoreValve prosthesis across the aortic annulus. Since Conformite Europeene (CE) mark approval in December 2010, more than 1500 patients at 150 centers have undergone CoreValve TAVI via the subclavian approach with excellent results. In the literature, two principal papers by Petronio and colleagues have reported the results with this approach. The first, published in 2010, reported outcomes in 54 patients at 13 Italian centers. Procedural success was 100%, and no specific access site complications were reported. Thirty-day mortality was 0%, and 6-month mortality was 9.4% [22]. The second paper, published in 2012, used propensity score analysis to identify matched groups of patients from the Italian CoreValve Registry to compare outcomes of subclavian versus transfemoral TAVI. The left subclavian artery was used in 96% of subclavian patients. The two groups showed similar rates of procedural success, major vascular complications and life-threatening bleeding. Survival at 2 years was 74.0 ± 4.0% in the subclavian group and 73.7 ± 3.9% in the femoral group [23]. In the literature, more than 15 papers have been published reporting single-center experience with the subclavian approach informahealthcare.com
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Figure 1. Left subclavian/axillary artery exposure. Two ovalshaped purse-string sutures performed on the vessel.
for CoreValve implantation. The largest of these was reported by Lange and colleagues, who performed the first subclavian approach CoreValve implantation in 2008 [24]. They performed 40 CoreValve implantations via the subclavian artery in patients where the transfemoral approach was not possible. Patients who underwent TAVI via the subclavian approach experienced a lower incidence of stroke (2.5 vs 4.3%), myocardial ischemia (0 vs 2.0%) and access vessel complications (7.5 vs 10.6%) than those patients who underwent TAVI by the transfemoral approach. A Kaplan–Meier estimate of survival was similar between the two groups. Other single-center experiences support these results [21,25,26]. Outcomes following TAVI with the left subclavian approach in patients with a LIMA bypass graft, as well as comparative outcomes following TAVI with the right versus left subclavian approach, have also been reported. In the 2010 paper by Petronio and colleagues described earlier, eight patients who were
Figure 2. 18 Fr sheath is inserted in the subclavian artery to perform retrograde CoreValve implantation.
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treated via left subclavian access had a patent LIMA graft, and none of the patients experienced a fall in arterial pressure or signs of myocardial ischemia on ECG during the procedure. Other authors have similarly reported successful CoreValve implantation through the left subclavian artery in patients with a patent mammary artery graft [27]. Bedogni and co-workers reported the largest experience to date using right subclavian access in 10 patients [28]. Safety endpoints were not statistically different between the left and right subclavian approach. However, the CoreValve implantation height was higher when using the right subclavian versus the left subclavian approach (9.1 vs 7.1 mm).
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Direct aortic approach
The procedure is performed under general anesthesia. A double-lumen endotracheal tube should be used for single left lung ventilation. The procedure should be performed through a right anterior mini-thoracotomy or through an upper ministernotomy. Mini-sternotomy usually involves a J-upper sternotomy through the second or third right intercostal space or a T-sternotomy through the second intercostal space. Ministernotomy has certain advantages over a right anterior thoracotomy, such as surgeon familiarity with the procedure; the ability to keep the pleural space intact, thus avoiding complications such as pleural effusion; and the ability to rapidly convert to a full sternotomy if needed. Right anterior thoracotomy is performed more commonly through the second right intercostal space, but it can also be performed through the first right intercostal space (FIGURE 3). Right anterior thoracotomy is not a bone-cutting incision and hence has its benefits. It is the approach of choice if the patient
Figure 3. Basal aortography to evaluate a coaxial trajectory and distance from the entry site on the ascending aorta to the aortic annulus.
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has undergone a previous sternotomy, especially if the patient has patent bypass grafts. It is important to choose the right access for a given patient. Although certain clinical situations, such as patent grafts, as explained earlier, dictate the choice, in the majority of cases the decision should be based on which is technically easier. A right anterior thoracotomy approach is easier if the aorta is to the right side and not very far from the rib cage, and a mini-sternotomy is easier if the aorta is in the midline or deeper [29,30]. Basal ascending aortography using a graduated pig-tail is performed to measure the distance between the aortic annulus and the selected entry site in the ascending aorta and to evaluate a coaxial trajectory from the entry site on the ascending aorta to the aortic annulus (FIGURE 4). At the entry site, two purse-string sutures are placed in the standard fashion for direct aortic access. Ascending aortic cannulation should be performed either by directly inserting an 18 Fr sheath as for standard aortic cannulation or with the Seldinger technique through the double purse-string sutures. In this case, a 6–9 Fr sheath is first inserted into the ascending aorta, and after crossing the aortic valve, a super stiff guidewire is placed into the left ventricle and the 18 Fr sheath is advanced. At this point, a CoreValve bioprosthesis is then carefully introduced and retrogradely implanted under angiographic and fluoroscopic guidance [17,30]. A few single-center experiences have been published describing direct aortic CoreValve implantation [30,31]. The largest multicenter experience reported to date is the European Direct Aortic CoreValve Experience Registry, which comprises a total of 478 patients treated at 19 centers in nine countries in Europe and Israel [32]. Mean patient age was 81.3 ± 6.5 years, 47% were female and the mean logistic EuroSCORE was 26.6 ± 16.6. The majority of the patients (86%) were in New York Heart Association functional class III or IV and peripheral vascular disease was present in 293 (61%) patients. Coronary artery disease was present in 280 (59%) patients, and 101 (21%) patients had undergone previous coronary artery bypass surgery. The TAVI procedure was performed in 46% of cases through a right anterior mini-thoracotomy in the second intercostal space and via an upper hemi-sternotomy in 54% of cases. A 29 mm CoreValve was implanted in 200 (42%) patients. Procedural success was 98%. There were two procedural deaths, and 30-day mortality was 9%. The incidence of stroke was 1.4%, and 67 (16%) patients required a new permanent pacemaker. Median postoperative hospitalization was 10 days. Recently, Reardon and colleagues reported the 30-day outcomes of patients enrolled in the CoreValve Extreme Risk US Pivotal Trial and Continued Access Study who underwent TAVI using the direct aortic approach [33]. In the Pivotal Trial group (n = 80 direct aortic access), 13.7% had died, 6.5% had a major stoke, 3.8% had major vascular complications and 20.6% required implantation of a permanent pacemaker. In the Continued Access Group (n = 260 direct aortic approach), which consisted of patients who had been enrolled between the point of enrollment completion in the Pivotal Study and US FDA approval of the CoreValve System and who had Expert Rev. Med. Devices 12(3), (2015)
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Figure 4. View from right anterior thoracotomy after pericardial opening. (A) Ascending aorta, (B) double purse-string suture and (C) 18 Fr sheath inserted through the purse-string suture for retrograde CoreValve implantation.
‡30 days follow-up, 10.8% of the patients had died, 4.7% had a major stoke, 3.1% had major vascular complications and 16.7% required implantation of a permanent pacemaker. Trans-carotid approach
during preimplant balloon valvuloplasty and one in-hospital death due to multisystem organ failure. There were no myocardial infarctions, strokes or major bleeding. Third-degree atrioventricular block requiring pacemaker implantation occurred in three patients. No complications related to the vascular access site occurred [35].
During the procedure, cerebral perfusion is continuously monitored. The proximal common right or left carotid artery is exposed through a small incision 2 cm above the left clavicle. Expert commentary The anterior wall of the artery is carefully dissected to avoid Since its introduction by Cribier and colleagues, TAVI has injury to the vagus nerve. Progression of the wires and sheaths is been successfully adopted at hundreds of centers across the carefully monitored using fluoroscopic guidance. Progressive world, and more than 90,000 patients affected by severe AS dilation of the artery using increasing dilator diameters (e.g., 14, have been treated. The only access site used during the initial 16 and 18 Fr) is recommended. The 18 Fr sheath is then care- TAVI experience was the transfemoral approach, and significant fully inserted over a super-stiff wire (FIGURES 5A & 5B). The tip of technical and prosthetic modifications followed to solve the the sheath is positioned in the upper part of the ascending aorta, early limitations with this approach. With the CoreValve delivsimilar to the subclavian approach. Once the TAVI procedure is ery catheters decreasing in size from the initial 24 Fr to the completed, vascular clamps are briefly applied during withdrawal present 18 Fr diameter, the CoreValve TAVI procedure can of the 18 Fr sheath. The carotid arterial access site is then surgi- now be done completely percutaneously. However, considering cally repaired using 6/0 Prolene. An angiogram is then per- the known overlap of the etiology and risk factors for atherosclerotic vascular disease and AS, it is not surprising that many formed to assess artery patency. The first case of trans-carotid TAVI was reported by Modine TAVI candidates are also affected by concomitant, severe and colleagues in an 89-year-old man with symptomatic degener- peripheral vasculopathy. Because the femoral approach is ative AS [34]. In a subsequent report by the same group involving 12 consecutive A B patients who underwent TAVI via the proximal left common carotid artery under general anesthesia, prosthesis implantation was uneventful, and no vascular complications or bleeding were observed. However, one patient had an embolic transient ischemic attack contralateral to the carotid access site [18]. More recently, Azmoun and colleagues reported the outcomes of 19 patients who underwent TAVI by the carotid approach (8 right, 11 left) under local anesthesia. Accurate deployment of the device was achieved in 18 patients (4 Edwards SAPIEN XT and 14 MedFigure 5. Trans-carotid approach. (A) 18 Fr sheath inserted through the common tronic CoreValve). There was one intraocarotid artery. (B) Under fluoroscopy, 18 Fr sheath is advanced into the ascending aorta. perative death due to annulus rupture informahealthcare.com
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contraindicated in patients with excessive atherosclerosis, calcifications or tortuosity of the femoral or iliac arteries, and should be considered cautiously in patients with an aneurysm of the thoracic or abdominal aorta, alternative access sites and approaches have been devised to allow these patients to undergo TAVI. The subclavian/axillary approach was the first alternative approach to obtain the CE mark in 2010. It has the advantage in that the subclavian artery is easily accessible after surgical cutdown, and that the procedure can be performed with local anesthetic and mild sedation. However, the subclavian artery is fragile and cannot be used if it is less than 6 mm in diameter, heavily calcified, excessively tortuous or has a tight stenosis that is not amenable to percutaneous balloon angioplasty [22]. Moreover, the subclavian approach has to be considered cautiously in patients with a patent LIMA graft. The direct aortic approach received CE mark approval in November 2011. It is theoretically more invasive compared to the subclavian approach as it requires a mini-thoracotomy or upper mini-sternotomy. The advantage to this approach, however, is that there is no limitation in vessel size, and the procedure is feasible in cases where there is a severe horizontal aorta. The advantage to performing the implantation through a right anterior mini-thoracotomy is more evident in re-do patients, in whom a repeat sternotomy, even if partial, is a challenging procedure. Indeed, a right mini-thoracotomy requires only limited dissection at the entry site on the ascending aorta and is also feasible in patients with patent venous grafts whose proximal anastomosis is on the ascending aorta [36]. Importantly, this approach avoids contact with the aortic arch, as there is neither a delivery system nor wire placed in the arch that might otherwise dislodge atherosclerotic plaque during valve passage. This may translate into a lower incidence of stroke. The only contraindications to using this approach are a complete porcelain aorta, the presence of calcium at the entry zone and an inaccessible ascending aorta [29]. The more recently introduced carotid approach should be considered if no other alternative approaches are feasible. Bilateral carotid Doppler echo and cerebral MRI or angio-computed tomography is mandatory to study cerebral circulation [18]. The carotid approach offers a safe and less invasive alternative to the transapical approach in patients with a small subclavian artery, severe aortic calcifications and/or severe respiratory failure. All non-iliofemoral and proximal arterial approaches have the advantage of overcoming challenging aorto-iliofemoral vascular disease and avoid the risk of dislodging atherosclerotic plaque during valve passage through the aorta. The control of the delivery system is dramatically enhanced because any force
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is directly transmitted one-to-one without any loss of pushability or trackability compared to a transfemoral approach. A co-axial trajectory to the aortic valve plane, especially with the direct aortic approach, allows perfect alignment of the TAVI device in the aortic annulus. This undoubtedly facilitates more accurate valve deployment, which might be particularly useful in patients with complex anatomy or physiology (e.g., horizontal ascending aorta, large annulus, primary aortic regurgitation). Five-year view
Next-generation devices will have additional improvements, such as low-profile sheaths, more accurate valve deployment and the ability to either reposition or even retrieve the prosthesis, which will reduce the incidence of paravalvular leak. Medtronic has already received CE mark approval for the CoreValve Evolut R, which has several refinements to improve anatomical fit, annular sealing and durability. The introduction of the full Evolut R product family (23, 26, 29 and XL) is expected in the first quarter of 2015. The Evolut frame, which is tailored to reduce overall valve height, is approximately 10% shorter than the original CoreValve frame, although the height of the pericardial skirt is preserved (12 mm). The device is designed to be recaptured and repositioned. It will be delivered with the EnVeo R delivery system (Medtronic, Inc.). This next-generation delivery system is designed to have a stable and predictable deployment with proper implantation depth. It will also offer the ability to resheath, reposition and redeploy the valve if necessary. To help prevent vascular complications, the Evolut R system will use the new, catheter-mounted InLine sheath, which eliminates the need for an external sheath. This sheath has a lower profile with an 18 Fr outer diameter – compared to the 22 Fr outer diameter sheaths of the recent CoreValve System – and is equivalent to the 14 Fr inner diameter systems of other transcatheter heart valve manufacturers. Future studies will help determine whether these design improvements will result in improved outcomes for patients undergoing TAVI. Acknowledgement
We would like to thank Janice Hoettels, for her copyediting assistance. Financial & competing interests disclosure
G Bruschi is a consultant for Medtronic and Direct Flow; T Modine is a consultant for Medtronic; F De Marco is a consultant for Direct Flow. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. We would like to thank Janice Hoettels, PA, MBA for her copyediting assistance.
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Key issues .
Transcatheter aortic valves have been designed to treat high risk for surgery symptomatic aortic stenosis in elderly patients; more than 90,000 patients have undergone transcatheter aortic valve implantation worldwide.
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At the beginning of the experience, the only access was the retrograde approach from the common femoral artery, but due to the large device size, the trans-femoral approach requires favorable ileo-femoral arterial anatomy; moreover, this approach is contraindicated in patients with excessive atherosclerosis, calcifications or tortuosity of ileo-femoral arteries.
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Since 2008, different alternative arterial access has been used for CoreValve implantation; in patients not suitable for peripheral femoral approach, the subclavian artery direct aortic access and a trans-carotid one.
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All non-iliofemoral and proximal arterial accesses had the advantage that the control of the delivery system is dramatically enhanced because any force is directly transmitted one-to-one without any loss of pushability and trakability compared to a trans-femoral approach. This undoubtedly facilitates more accurate valve deployment.
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To treat patients via alternative access routes, the cooperation between cardiologists, cardiac surgeons, anesthesiologists,
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echocardiographist, radiologists, nurses and all different specialists involved in transcatheter aortic valve implantation patients’ care (the so-called heart team) is crucial.
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Expert Rev. Med. Devices 12(3), (2015)
