Canadian Journal of Cardiology 30 (2014) 1461.e9e1461.e11 www.onlinecjc.ca
Case Report
First Direct Aortic Retrievable Transcatheter Aortic Valve Implantation in Humans Jaya Chandrasekhar, MD, FRACP,a Chris Glover, MD,a Marino Labinaz, MD,a and Marc Ruel, MDb a b
Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada
Division of Cardiac Surgery, University of Ottawa Heart Institute, Ottawa, Ontario, Canada
ABSTRACT
RESUM E
We describe 2 cases in which transcatheter aortic valve implantation was performed with a Portico prosthesis (St Jude Medical, St Paul, MN) through a direct aortic approach. In 1 of the cases, prosthesis retrieval was needed during the procedure and was essential to the successful outcome. This is the first report, to our knowledge, of direct aortic Portico prosthesis implantation, and it highlights the significance of the retrievable nature of this device.
crivons 2 cas d’implantation par cathe te risme de la prothèse Nous de valvulaire aortique Portico (St Jude Medical, St Paul, MN) selon une approche par voie aortique directe. Dans l’un (1) des cas, la cupe ration de la prothèse a e te ne cessaire durant l’intervention et re ussite. À notre connaissance, il s’agit du premier cas essentielle à sa re d’implantation de la prothèse Portico par voie aortique rapporte galement en e vidence l’importance de la capacite à directe, qui met e cupe rer ce dispositif. re
The Portico (St Jude Medical, St Paul, MN) self-expanding prosthesis provides the advantage of being the first clinically approved, retrievable, and repositionable transcatheter aortic valve; it is available in 4 sizes. We discuss 2 clinical cases that highlight the feasibility of direct aortic Portico transcatheter aortic valve implantation (TAVI) and the role of the retrievable nature of this device.
aortic angle of 60 and a nearly vertical aortic annular plane (Fig. 1). CT also showed an annulus diameter of 20 24 mm, a perimeter of 74 mm, and an area of 365 mm2. Because of the horizontal position of the aorta, a decision was made for transaortic 25-mm Portico prosthesis implantation (see Supplementary Material). Valvuloplasty was performed with an 18-mm balloon followed by implantation of the 25-mm Portico prosthesis without complications (Fig. 1; Videos 1-3 , view video online). The patient recovered well and was discharged after 10 days. She remained well at 6-month follow-up.
Case 1 An 83-year-old woman with a remote history of coronary bypass surgery presented with New York Heart Association class III dyspnea and severe aortic stenosis. The grafts to the right and circumflex arteries were occluded, and the left internal mammary artery was atretic because of competitive native left anterior descending artery filling. Transthoracic echocardiography (TTE) showed an aortic valve mean gradient of 55 mm Hg, a valve area of 0.60 cm2, and normal biventricular systolic function. The calculated Society of Thoracic Surgeons (STS) score was 9.2% and the logistic euroSCORE was 23.5%. Aortography and computed tomography (CT) showed a horizontal ascending aorta with an Received for publication June 4, 2014. Accepted July 17, 2014. Corresponding author: Dr Marc Ruel, 40 Ruskin Street, University of Ottawa Heart Institute, Ottawa, Ontario K1Y 1J7, Canada. Tel.: þ1-613761-4893; fax: þ1-613-761-5367. E-mail: [email protected] See page 1461.e11 for disclosure information.
Case 2 An 88-year-old woman with previous coronary bypass surgery (saphenous vein grafts to diagonal and obtuse marginal arteries) was admitted with heart failure and experienced pulseless electrical activity from which she was successfully resuscitated. She was found to have severe global left ventricular (LV) systolic dysfunction with thrombus in the left ventricle and severe aortic stenosis. CT showed bilateral pulmonary emboli, deep vein lower limb thrombosis, and distal descending aortic atherothrombosis. She required permanent pacemaker insertion during the admission, and after 4 weeks of anticoagulation, a decision was made for TAVI. The calculated STS score was 18.5% and the logistic euroSCORE was 48.6%. On CT, the aortic annulus measured 25.2 19.3 mm, with a perimeter of 71 mm and an area of 353 mm2. TTE showed an aortic valve mean gradient of 60 mm Hg,
http://dx.doi.org/10.1016/j.cjca.2014.07.017 0828-282X/Ó 2014 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.
1461.e10
Canadian Journal of Cardiology Volume 30 2014
Figure 1. Deployment of Portico device in a horizontal aorta. (A) Aortic angle; (B) arrows indicate the transaortic sheath and eccentric device position across the annulus; (C) fully deployed device.
aortic valve area of 0.34 cm2, pulmonary pressure of 60 mmHg and severe biventricular dysfunction. Because of the patient’s poor clinical status, a decision was made for Portico prosthesis implantation. A transaortic approach was deemed most suitable because of the abdominal aortic thrombus, severe LV dysfunction, and presence of small femoral and subclavian arteries (Supplementary Material). With a right minithoracotomy, an aortic incision was made 7 cm above the annulus, and a Cook sheath (Cook Medical, Bloomington, IN) was placed. The valve was crossed easily with the guide wire, but predilation balloons ruptured during valvuloplasty. The 25-mm Portico valve would not expand initially. The device was retrieved and repeated balloon valvuloplasty was performed. A new 25-mm Portico valve was then deployed, followed with a 22-mm NuCLEUS balloon (NuMed, Cornwall, ON) after dilation, which also ruptured after full inflation. The final result was excellent, without significant aortic , view videos oninsufficiency (AI) (Fig. 2; Videos 4-7 line). The patient remained well at 3-month follow-up.
favorable outcomes, mainly through transfemoral access, with a low incidence of AI3,4 (for further details regarding clinical rationale, see Supplementary Material). The retrievable nature of the Portico device is advantageous, allowing operators greater precision with device delivery. With extremely horizontal aortas, device manufacturers recommend a nontransfemoral approach to reduce bias and a very low or eccentric LV implantation.5 Additionally, selfexpanding valves are preferred in this context because of the lower risk of device embolization. The Portico self-expanding valve also allows for better conformability to the device landing zone, because of larger stent cell size, and consequently confers a reduced likelihood of paravalvular AI. In patients with LV dysfunction, who are less likely to tolerate significant postimplantation AI, this may be a more appropriate device choice. Finally, the shorter implantation height of the Portico device reduces the risk of deep LV implantation and the subsequent need for a permanent pacemaker.
Discussion Observational data exist for successful transaortic TAVI with both of the mainstay nonretrievable devices currently available.1,2 Early data with 2 other retrievable devices suggest
Conclusions This report documents the first and third cases of transaortic transcatheter aortic valve implantation performed worldwide using the retrievable Portico prosthesis. This
Chandrasekhar et al. First Direct Aortic Retrievable TAVI
1461.e11
Figure 2. (A-D) Device positioning (arrows indicate the transaortic sheath and device across the annulus), release, dilation after implantation, and final result.
improvement in TAVI technology renders an advantage in clinically unstable patients and in patients with a highly horizontal aorta, and preliminary data outlined in this report suggest that the procedure can be safely performed using a transaortic approach. Disclosures The authors have no conflicts to disclose. References 1. Hayashida K, Romano M, Lefevre T, et al. The transaortic approach for transcatheter aortic valve implantation: a valid alternative to the transapical access in patients with no peripheral vascular option. A single center experience. Eur J Cardiothorac Surg 2013;44:692-700. 2. Dahle G, Rein KA. Direct aorta ascending approach in transcatheter aortic valve implantation. Innovations (Phila) 2014;9:1-9.
3. Meredith IT, Worthley SG, Whitbourn RJ, et al. Transfemoral aortic valve replacement with the repositionable Lotus Valve System in high surgical risk patients: the REPRISE I study. EuroIntervention 2014;9: 1264-70. 4. Schofer J, Colombo A, Klugmann S, et al. Prospective multicenter evaluation of the direct flow medical transcatheter aortic valve. J Am Coll Cardiol 2014;63:763-8. 5. Chan PH, Alegria-Barrero E, Di Mario C. Difficulties with horizontal aortic root in transcatheter aortic valve implantation. Catheter Cardiovasc Interv 2013;81:630-5.
Supplementary Material To access the supplementary material accompanying this article, visit the online version of the Canadian Journal of Cardiology at www.onlinecjc.ca and at http://dx.doi.org/10. 1016/j.cjca.2014.07.017.
Case Report
First Direct Aortic Retrievable Transcatheter Aortic Valve Implantation in Humans Jaya Chandrasekhar, MD, FRACP,a Chris Glover, MD,a Marino Labinaz, MD,a and Marc Ruel, MDb a b
Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada
Division of Cardiac Surgery, University of Ottawa Heart Institute, Ottawa, Ontario, Canada
ABSTRACT
RESUM E
We describe 2 cases in which transcatheter aortic valve implantation was performed with a Portico prosthesis (St Jude Medical, St Paul, MN) through a direct aortic approach. In 1 of the cases, prosthesis retrieval was needed during the procedure and was essential to the successful outcome. This is the first report, to our knowledge, of direct aortic Portico prosthesis implantation, and it highlights the significance of the retrievable nature of this device.
crivons 2 cas d’implantation par cathe te risme de la prothèse Nous de valvulaire aortique Portico (St Jude Medical, St Paul, MN) selon une approche par voie aortique directe. Dans l’un (1) des cas, la cupe ration de la prothèse a e te ne cessaire durant l’intervention et re ussite. À notre connaissance, il s’agit du premier cas essentielle à sa re d’implantation de la prothèse Portico par voie aortique rapporte galement en e vidence l’importance de la capacite à directe, qui met e cupe rer ce dispositif. re
The Portico (St Jude Medical, St Paul, MN) self-expanding prosthesis provides the advantage of being the first clinically approved, retrievable, and repositionable transcatheter aortic valve; it is available in 4 sizes. We discuss 2 clinical cases that highlight the feasibility of direct aortic Portico transcatheter aortic valve implantation (TAVI) and the role of the retrievable nature of this device.
aortic angle of 60 and a nearly vertical aortic annular plane (Fig. 1). CT also showed an annulus diameter of 20 24 mm, a perimeter of 74 mm, and an area of 365 mm2. Because of the horizontal position of the aorta, a decision was made for transaortic 25-mm Portico prosthesis implantation (see Supplementary Material). Valvuloplasty was performed with an 18-mm balloon followed by implantation of the 25-mm Portico prosthesis without complications (Fig. 1; Videos 1-3 , view video online). The patient recovered well and was discharged after 10 days. She remained well at 6-month follow-up.
Case 1 An 83-year-old woman with a remote history of coronary bypass surgery presented with New York Heart Association class III dyspnea and severe aortic stenosis. The grafts to the right and circumflex arteries were occluded, and the left internal mammary artery was atretic because of competitive native left anterior descending artery filling. Transthoracic echocardiography (TTE) showed an aortic valve mean gradient of 55 mm Hg, a valve area of 0.60 cm2, and normal biventricular systolic function. The calculated Society of Thoracic Surgeons (STS) score was 9.2% and the logistic euroSCORE was 23.5%. Aortography and computed tomography (CT) showed a horizontal ascending aorta with an Received for publication June 4, 2014. Accepted July 17, 2014. Corresponding author: Dr Marc Ruel, 40 Ruskin Street, University of Ottawa Heart Institute, Ottawa, Ontario K1Y 1J7, Canada. Tel.: þ1-613761-4893; fax: þ1-613-761-5367. E-mail: [email protected] See page 1461.e11 for disclosure information.
Case 2 An 88-year-old woman with previous coronary bypass surgery (saphenous vein grafts to diagonal and obtuse marginal arteries) was admitted with heart failure and experienced pulseless electrical activity from which she was successfully resuscitated. She was found to have severe global left ventricular (LV) systolic dysfunction with thrombus in the left ventricle and severe aortic stenosis. CT showed bilateral pulmonary emboli, deep vein lower limb thrombosis, and distal descending aortic atherothrombosis. She required permanent pacemaker insertion during the admission, and after 4 weeks of anticoagulation, a decision was made for TAVI. The calculated STS score was 18.5% and the logistic euroSCORE was 48.6%. On CT, the aortic annulus measured 25.2 19.3 mm, with a perimeter of 71 mm and an area of 353 mm2. TTE showed an aortic valve mean gradient of 60 mm Hg,
http://dx.doi.org/10.1016/j.cjca.2014.07.017 0828-282X/Ó 2014 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.
1461.e10
Canadian Journal of Cardiology Volume 30 2014
Figure 1. Deployment of Portico device in a horizontal aorta. (A) Aortic angle; (B) arrows indicate the transaortic sheath and eccentric device position across the annulus; (C) fully deployed device.
aortic valve area of 0.34 cm2, pulmonary pressure of 60 mmHg and severe biventricular dysfunction. Because of the patient’s poor clinical status, a decision was made for Portico prosthesis implantation. A transaortic approach was deemed most suitable because of the abdominal aortic thrombus, severe LV dysfunction, and presence of small femoral and subclavian arteries (Supplementary Material). With a right minithoracotomy, an aortic incision was made 7 cm above the annulus, and a Cook sheath (Cook Medical, Bloomington, IN) was placed. The valve was crossed easily with the guide wire, but predilation balloons ruptured during valvuloplasty. The 25-mm Portico valve would not expand initially. The device was retrieved and repeated balloon valvuloplasty was performed. A new 25-mm Portico valve was then deployed, followed with a 22-mm NuCLEUS balloon (NuMed, Cornwall, ON) after dilation, which also ruptured after full inflation. The final result was excellent, without significant aortic , view videos oninsufficiency (AI) (Fig. 2; Videos 4-7 line). The patient remained well at 3-month follow-up.
favorable outcomes, mainly through transfemoral access, with a low incidence of AI3,4 (for further details regarding clinical rationale, see Supplementary Material). The retrievable nature of the Portico device is advantageous, allowing operators greater precision with device delivery. With extremely horizontal aortas, device manufacturers recommend a nontransfemoral approach to reduce bias and a very low or eccentric LV implantation.5 Additionally, selfexpanding valves are preferred in this context because of the lower risk of device embolization. The Portico self-expanding valve also allows for better conformability to the device landing zone, because of larger stent cell size, and consequently confers a reduced likelihood of paravalvular AI. In patients with LV dysfunction, who are less likely to tolerate significant postimplantation AI, this may be a more appropriate device choice. Finally, the shorter implantation height of the Portico device reduces the risk of deep LV implantation and the subsequent need for a permanent pacemaker.
Discussion Observational data exist for successful transaortic TAVI with both of the mainstay nonretrievable devices currently available.1,2 Early data with 2 other retrievable devices suggest
Conclusions This report documents the first and third cases of transaortic transcatheter aortic valve implantation performed worldwide using the retrievable Portico prosthesis. This
Chandrasekhar et al. First Direct Aortic Retrievable TAVI
1461.e11
Figure 2. (A-D) Device positioning (arrows indicate the transaortic sheath and device across the annulus), release, dilation after implantation, and final result.
improvement in TAVI technology renders an advantage in clinically unstable patients and in patients with a highly horizontal aorta, and preliminary data outlined in this report suggest that the procedure can be safely performed using a transaortic approach. Disclosures The authors have no conflicts to disclose. References 1. Hayashida K, Romano M, Lefevre T, et al. The transaortic approach for transcatheter aortic valve implantation: a valid alternative to the transapical access in patients with no peripheral vascular option. A single center experience. Eur J Cardiothorac Surg 2013;44:692-700. 2. Dahle G, Rein KA. Direct aorta ascending approach in transcatheter aortic valve implantation. Innovations (Phila) 2014;9:1-9.
3. Meredith IT, Worthley SG, Whitbourn RJ, et al. Transfemoral aortic valve replacement with the repositionable Lotus Valve System in high surgical risk patients: the REPRISE I study. EuroIntervention 2014;9: 1264-70. 4. Schofer J, Colombo A, Klugmann S, et al. Prospective multicenter evaluation of the direct flow medical transcatheter aortic valve. J Am Coll Cardiol 2014;63:763-8. 5. Chan PH, Alegria-Barrero E, Di Mario C. Difficulties with horizontal aortic root in transcatheter aortic valve implantation. Catheter Cardiovasc Interv 2013;81:630-5.
Supplementary Material To access the supplementary material accompanying this article, visit the online version of the Canadian Journal of Cardiology at www.onlinecjc.ca and at http://dx.doi.org/10. 1016/j.cjca.2014.07.017.
