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Evolut R implantation via the brachial artery

Evolut R implantation via the brachial artery Abstract Transfemoral transcatheter aortic valve implantation is an established therapy to treat elderly patients affected by severe aortic stenosis, who are considered to be at high or extreme risk for surgical aortic valve replacement. The transfemoral approach is contraindicated in patients with severe peripheral artery disease, small vessel size or severe tortuosity. In these patients, other vascular access routes such as transapical, subclavian or direct-aortic access may be considered. We describe the first case of a Medtronic Evolut R (Medtronic, Minneapolis, MN, USA) implantation made through the brachial artery in a 75-year-old patient affected by severe aortic stenosis. Aortic stenosis , Transcatheter valve replacement , Brachial artery INTRODUCTION Transcatheter aortic valve implantation (TAVI) has become the standard of care for the management of high risk surgical patients with severe aortic stenosis. Current expert consensus strongly favours the transfemoral approach as the preferred and most commonly used access site for TAVI. However, a significant proportion of patients undergoing TAVI have concomitant peripheral arterial disease, rendering the femoral approach either unfeasible or deemed to carry a high risk of vascular complications. Therefore, alternative access routes for TAVI have proved to be viable and safe, including the transapical, the subclavian/axillary and the direct aortic access [1–3]. We describe the first case of a Medtronic Evolut R implanted through the brachial artery in a 75-year-old patient affected by severe aortic stenosis. CASE REPORT A 75-year-old female with severe aortic stenosis was admitted to our hospital for pulmonary oedema. The echocardiographic evaluation confirmed severe aortic stenosis (mean gradient 55 mmHg). The patient also had severe chronic obstructive pulmonary disease, renal failure, carotid artery disease and insulin-dependent diabetes mellitus. An electrocardiogram (ECG)-gated multislice computed tomography showed evidence of peripheral vasculopathy, and a trileaflet calcified aortic valve with annulus perimeter of 70.7 mm (27.0 mm × 16.7 mm). After evaluation by the heart team, a TAVI was preferred (EuroSCORE II: 10.6%; STS score Mortality: 10.9%). Due to peripheral calcific vasculopathy, an alternative access was considered. On the basis of a multislice computed tomography scan, the proximal brachial artery access was preferred (Fig. 1A). The procedure similar to that described by Bruschi et al. [3] was performed under local anaesthesia; the left arm of the patient was abducted and externally rotated to 90° for adequate artery exposure. The left brachial artery was exposed at the lower margin of the teres major muscle, the median nerve was displaced laterally, and the brachial artery exposed (Fig. 1B and C). Arterial cannulation was performed using the Seldinger technique through a double purse-string suture (Fig. 1D). A 14-Fr sheath was then inserted, the aortic valve was crossed, and a preshaped super-stiff guidewire was advanced in the left ventricle (LV) over a pigtail. The EnVeo R Deliver Catheter System was then inserted over the super-stiff wire (Fig. 2A), and an Evolut R 26-mm bioprosthesis was advanced through the aortic valve and slowly deployed under fluoroscopic and angiographic evaluation. The delivery system was then removed, and the 14-Fr sheath was reinserted. Final aortography revealed normal valve function with trivial paravalvular regurgitation, whereas haemodynamic evaluation revealed a mean gradient of 10 mmHg. The brachial access was closed with a linear suture, and patency was evaluated by a direct subclavian contrast injection (Fig. 2B), haemodynamic and distal oximetry measurement. The patient had an uneventful hospital course and was discharged home on the 7th postoperative day with normal left arm function and a surgical wound. Figure 1: View largeDownload slide (A) Subclavian–axillary–brachial artery size evaluation using multislice computed tomography. (B) Evaluation of the left brachial axillary artery at the lower margin of the teres major muscle. (C) Brachial artery exposure. (D) Brachial cannulation with the standard Seldinger technique. Figure 1: View largeDownload slide (A) Subclavian–axillary–brachial artery size evaluation using multislice computed tomography. (B) Evaluation of the left brachial axillary artery at the lower margin of the teres major muscle. (C) Brachial artery exposure. (D) Brachial cannulation with the standard Seldinger technique. Figure 2: View largeDownload slide (A) The EnVeo R Deliver Catheter System was inserted over the super-stiff wire and the Evolut R 26 mm advanced. (B) Final subclavian–axillary–brachial contrast injection. Figure 2: View largeDownload slide (A) The EnVeo R Deliver Catheter System was inserted over the super-stiff wire and the Evolut R 26 mm advanced. (B) Final subclavian–axillary–brachial contrast injection. Echocardiographic evaluation on the 30th day showed normal aortic valve function with a mean gradient of 7 mmHg and mild paravalvular regurgitation. COMMENT Despite the development of new generation, low profile TAVI devices, vascular complications remain one of the Achilles’ heel of transfemoral procedures. We reported the first case of a CoreValve Evolut R implantation made through the brachial artery. The system includes a 14-Fr equivalent EnVeo R Deliver Catheter System with the InLine sheath. The built-in InLine sheath allows for the whole system to be inserted into a patient without the need for a separate access sheath, reducing the overall profile of the system equivalent to the outer diameter of a 14-Fr sheath [4]. The subclavian approach is currently European Conformity (CE) mark approved for the CoreValve and Sapien device [2, 3]. Considering that the brachial artery is smaller than the subclavian and axillary arteries, this access is feasible only if the artery size is >5 mm. The risk of vascular complications is quite similar to those of axillary artery access. Access-related complications are brachial pseudoaneurysm and brachial artery thrombosis. There was no median nerve dysfunction or upper extremity limb or finger loss during this experience. Brachial access provides a closer TAVI placement and high deployment control with the advantage that the brachial artery is located superficially, closer to the skin with well-defined and readily identifiable relations with the lower margin of teres major muscle. Moreover, it is possible to directly compress the vessel, therefore enabling easier control of haemostasis and avoiding the risk of intrathoracic complications. Conflict of interest: Giuseppe Bruschi is consultant for Medtronic and St. Jude – Abbott. REFERENCES 1 Fröhlich GM , Baxter PD , Malkin CJ , Scott DJ , Moat NE , Hildick-Smith D et al. National Institute for Cardiovascular Outcomes Research . Comparative survival after transapical, direct aortic, and subclavian transcatheter aortic valve implantation (data from the UK TAVI registry) . Am J Cardiol 2015 ; 116 : 1555 – 9 . Google Scholar CrossRef Search ADS PubMed 2 Bruschi G , De Marco F , Botta L , Barosi A , Colombo P , Mauri S et al. Right anterior mini-thoracotomy direct aortic self-expanding trans-catheter aortic valve implantation: a single center experience . Int J Cardiol 2015 ; 181 : 437 – 42 . Google Scholar CrossRef Search ADS PubMed 3 Bruschi G , Colombo P , Merlanti B , Nava S , Belli O , Musca F et al. A new access for transcatheter aortic valve implantation: distal axillary artery . Int J Cardiol 2016 ; 223 : 810 – 12 . Google Scholar CrossRef Search ADS PubMed 4 Sinning JM , Werner N , Nickenig G , Grube E. Medtronic CoreValve Evolut valve . EuroIntervention 2012 ; 8 : Q94 – 6 . Google Scholar CrossRef Search ADS PubMed © The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/about_us/legal/notices) http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png European Journal of Cardio-Thoracic Surgery Oxford University Press

Evolut R implantation via the brachial artery

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Oxford University Press
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© The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
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1010-7940
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Abstract

Abstract Transfemoral transcatheter aortic valve implantation is an established therapy to treat elderly patients affected by severe aortic stenosis, who are considered to be at high or extreme risk for surgical aortic valve replacement. The transfemoral approach is contraindicated in patients with severe peripheral artery disease, small vessel size or severe tortuosity. In these patients, other vascular access routes such as transapical, subclavian or direct-aortic access may be considered. We describe the first case of a Medtronic Evolut R (Medtronic, Minneapolis, MN, USA) implantation made through the brachial artery in a 75-year-old patient affected by severe aortic stenosis. Aortic stenosis , Transcatheter valve replacement , Brachial artery INTRODUCTION Transcatheter aortic valve implantation (TAVI) has become the standard of care for the management of high risk surgical patients with severe aortic stenosis. Current expert consensus strongly favours the transfemoral approach as the preferred and most commonly used access site for TAVI. However, a significant proportion of patients undergoing TAVI have concomitant peripheral arterial disease, rendering the femoral approach either unfeasible or deemed to carry a high risk of vascular complications. Therefore, alternative access routes for TAVI have proved to be viable and safe, including the transapical, the subclavian/axillary and the direct aortic access [1–3]. We describe the first case of a Medtronic Evolut R implanted through the brachial artery in a 75-year-old patient affected by severe aortic stenosis. CASE REPORT A 75-year-old female with severe aortic stenosis was admitted to our hospital for pulmonary oedema. The echocardiographic evaluation confirmed severe aortic stenosis (mean gradient 55 mmHg). The patient also had severe chronic obstructive pulmonary disease, renal failure, carotid artery disease and insulin-dependent diabetes mellitus. An electrocardiogram (ECG)-gated multislice computed tomography showed evidence of peripheral vasculopathy, and a trileaflet calcified aortic valve with annulus perimeter of 70.7 mm (27.0 mm × 16.7 mm). After evaluation by the heart team, a TAVI was preferred (EuroSCORE II: 10.6%; STS score Mortality: 10.9%). Due to peripheral calcific vasculopathy, an alternative access was considered. On the basis of a multislice computed tomography scan, the proximal brachial artery access was preferred (Fig. 1A). The procedure similar to that described by Bruschi et al. [3] was performed under local anaesthesia; the left arm of the patient was abducted and externally rotated to 90° for adequate artery exposure. The left brachial artery was exposed at the lower margin of the teres major muscle, the median nerve was displaced laterally, and the brachial artery exposed (Fig. 1B and C). Arterial cannulation was performed using the Seldinger technique through a double purse-string suture (Fig. 1D). A 14-Fr sheath was then inserted, the aortic valve was crossed, and a preshaped super-stiff guidewire was advanced in the left ventricle (LV) over a pigtail. The EnVeo R Deliver Catheter System was then inserted over the super-stiff wire (Fig. 2A), and an Evolut R 26-mm bioprosthesis was advanced through the aortic valve and slowly deployed under fluoroscopic and angiographic evaluation. The delivery system was then removed, and the 14-Fr sheath was reinserted. Final aortography revealed normal valve function with trivial paravalvular regurgitation, whereas haemodynamic evaluation revealed a mean gradient of 10 mmHg. The brachial access was closed with a linear suture, and patency was evaluated by a direct subclavian contrast injection (Fig. 2B), haemodynamic and distal oximetry measurement. The patient had an uneventful hospital course and was discharged home on the 7th postoperative day with normal left arm function and a surgical wound. Figure 1: View largeDownload slide (A) Subclavian–axillary–brachial artery size evaluation using multislice computed tomography. (B) Evaluation of the left brachial axillary artery at the lower margin of the teres major muscle. (C) Brachial artery exposure. (D) Brachial cannulation with the standard Seldinger technique. Figure 1: View largeDownload slide (A) Subclavian–axillary–brachial artery size evaluation using multislice computed tomography. (B) Evaluation of the left brachial axillary artery at the lower margin of the teres major muscle. (C) Brachial artery exposure. (D) Brachial cannulation with the standard Seldinger technique. Figure 2: View largeDownload slide (A) The EnVeo R Deliver Catheter System was inserted over the super-stiff wire and the Evolut R 26 mm advanced. (B) Final subclavian–axillary–brachial contrast injection. Figure 2: View largeDownload slide (A) The EnVeo R Deliver Catheter System was inserted over the super-stiff wire and the Evolut R 26 mm advanced. (B) Final subclavian–axillary–brachial contrast injection. Echocardiographic evaluation on the 30th day showed normal aortic valve function with a mean gradient of 7 mmHg and mild paravalvular regurgitation. COMMENT Despite the development of new generation, low profile TAVI devices, vascular complications remain one of the Achilles’ heel of transfemoral procedures. We reported the first case of a CoreValve Evolut R implantation made through the brachial artery. The system includes a 14-Fr equivalent EnVeo R Deliver Catheter System with the InLine sheath. The built-in InLine sheath allows for the whole system to be inserted into a patient without the need for a separate access sheath, reducing the overall profile of the system equivalent to the outer diameter of a 14-Fr sheath [4]. The subclavian approach is currently European Conformity (CE) mark approved for the CoreValve and Sapien device [2, 3]. Considering that the brachial artery is smaller than the subclavian and axillary arteries, this access is feasible only if the artery size is >5 mm. The risk of vascular complications is quite similar to those of axillary artery access. Access-related complications are brachial pseudoaneurysm and brachial artery thrombosis. There was no median nerve dysfunction or upper extremity limb or finger loss during this experience. Brachial access provides a closer TAVI placement and high deployment control with the advantage that the brachial artery is located superficially, closer to the skin with well-defined and readily identifiable relations with the lower margin of teres major muscle. Moreover, it is possible to directly compress the vessel, therefore enabling easier control of haemostasis and avoiding the risk of intrathoracic complications. Conflict of interest: Giuseppe Bruschi is consultant for Medtronic and St. Jude – Abbott. REFERENCES 1 Fröhlich GM , Baxter PD , Malkin CJ , Scott DJ , Moat NE , Hildick-Smith D et al. National Institute for Cardiovascular Outcomes Research . Comparative survival after transapical, direct aortic, and subclavian transcatheter aortic valve implantation (data from the UK TAVI registry) . Am J Cardiol 2015 ; 116 : 1555 – 9 . Google Scholar CrossRef Search ADS PubMed 2 Bruschi G , De Marco F , Botta L , Barosi A , Colombo P , Mauri S et al. Right anterior mini-thoracotomy direct aortic self-expanding trans-catheter aortic valve implantation: a single center experience . Int J Cardiol 2015 ; 181 : 437 – 42 . Google Scholar CrossRef Search ADS PubMed 3 Bruschi G , Colombo P , Merlanti B , Nava S , Belli O , Musca F et al. A new access for transcatheter aortic valve implantation: distal axillary artery . Int J Cardiol 2016 ; 223 : 810 – 12 . Google Scholar CrossRef Search ADS PubMed 4 Sinning JM , Werner N , Nickenig G , Grube E. Medtronic CoreValve Evolut valve . EuroIntervention 2012 ; 8 : Q94 – 6 . Google Scholar CrossRef Search ADS PubMed © The Author(s) 2018. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/about_us/legal/notices)

Journal

European Journal of Cardio-Thoracic Surgery – Oxford University Press

Published: Jun 4, 2018

References

  • Comparative survival after transapical, direct aortic, and subclavian transcatheter aortic valve implantation (data from the UK TAVI registry)
    Fröhlich
  • Right anterior mini-thoracotomy direct aortic self-expanding trans-catheter aortic valve implantation: a single center experience
    Bruschi
  • A new access for transcatheter aortic valve implantation: distal axillary artery
    Bruschi
  • Medtronic CoreValve Evolut valve
    Sinning