Original Article
Hemodynamic performance of Trifecta: Single-center experience of 400 patients
Asian Cardiovascular & Thoracic Annals 2015, Vol. 23(2) 140–145 ß The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/0218492314533684 aan.sagepub.com
Amit Modi, Mindaugas Budra, Szabolcs Miskolczi, Theodore Velissaris, Markku Kaarne, Clifford W Barlow, Steven A Livesey, Sunil K Ohri and Geoffrey M Tsang
Abstract Objective: To evaluate postoperative hemodynamic gradients and early outcomes of aortic valve replacement with the Trifecta bioprosthesis. Methods: Between 2011 and 2013, 400 patients underwent aortic valve replacement with a Trifecta bioprosthesis. Gradients were calculated by transthoracic echocardiography before discharge. Data were collected retrospectively; patients with postoperative severe left ventricular dysfunction or > mild mitral regurgitation were excluded. Results: The mean age was 75.9 8.5 years, 197 (49.25%) patients were male, and 140 (35%) were >80-years old. Concomitant procedures were performed in 207 (51.75%) patients, and 30 (7.5%) had redo procedures. Supraannular aortoplasty with bovine pericardium was necessary in 25 (6.25%) cases. Hospital mortality was 2.75% (11 patients). Postoperative peak and mean gradients were 21.7 9.3 and 11.1 4.3 mm Hg for 19-mm valves (n ¼ 29); 19.5 7 and 9.7 3.6 mm Hg for 21-mm valves (n ¼ 158); 17.3 6.6 and 8.7 3.2 mm Hg for 23-mm valves (n ¼ 134); 15.1 6.1 and 7.8 3.3 mm Hg for 25-mm valves (n ¼ 56); 13.2 3.7 and 6.9 2.6 mm Hg for 27-mm valves (n ¼ 11). Nine patients had trivial and one had mild transvalvular regurgitation. Mean follow-up was 1 0.62 years; no patient required reoperation. Kaplan-Meier survival at 1 and 2 years was 94.3% 1.3% and 93.7% 1.4%. Conclusion: Early postoperative gradients are low after Trifecta implantation. Significant transvalvular regurgitation was not observed, but the incidence of supraannular aortoplasty may be increased.
Keywords Aortic valve insufficiency, aortic valve stenosis, bioprosthesis, heart valve prosthesis implantation, treatment outcome
Introduction Aortic valve replacement (AVR) is the most effective treatment for alleviating symptoms and improving survival in patients with severe aortic valve disease. Patients with aortic valve disease present with increased left ventricular mass which is an independent predictor of adverse cardiovascular events, including death.1 It has been demonstrated that left ventricular mean wall thickness is directly related to the pressure gradient across the aortic prosthetic valve.2 The extent of left ventricular muscle mass regression has been shown to be highly dependent on the hemodynamic performance of the prosthesis used for aortic valve replacement.3–5 The St. Jude Medical Trifecta pericardial aortic valve prosthesis (St. Jude Medical, Inc., St. Paul, MN, USA) has been designed to produce less impedance to
transvalvular flow compared to other stented bioprostheses. The aim of this study was to evaluate in-vivo hemodynamic performance and early clinical outcome of patients undergoing aortic valve replacement with the recently introduced Trifecta bioprosthesis at a single center.
Wessex Cardiothoracic Centre, Southampton University Hospital, Southampton, UK Corresponding author: Amit Modi, Wessex Cardiothoracic Centre, University Hospital Southampton, Tremona Road, Southampton, SO16 6YD, UK. Email: [email protected]
Downloaded from aan.sagepub.com at Uniwersytet Warszawski on March 20, 2015
Modi et al.
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Patients and methods The St. Jude Medical Trifecta (model TF, size A) is a stented aortic bioprosthesis designed with a single sheet of bovine pericardial tissue (forming 3 cusps) attached to the exterior of a titanium stent, allowing for a greater opening (Figure 1). The stent, excluding the sewing ring, is covered with porcine pericardium to minimize wear by allowing only tissue-to-tissue contact. The polyester sewing ring has a silicone insert to conform to the shape of the native annulus. This valve is designed for supraannular placement. The leaflets undergo anti-calcification treatment with ethanolbased Linx anti-calcification technology which provides a shield against mineralization. Valve sizes are available in 2-mm increments from 19 to 29 mm. The dimensions of these valves are given in Table 1. This evaluation included consecutive patients who underwent AVR with or without concomitant procedures at a university hospital, using St. Jude Trifecta (model TF, size A) supraannular bioprostheses between March 2011 and May 2013. The institutional clinical effectiveness board approved this project. A total of
Figure 1. The Trifecta aortic bioprosthesis with the external wrap design (reproduced with permission from St. Jude Medical, Inc., St. Paul, MN, USA).
Table 1. Dimensions of various Trifecta bioprostheses (as provided by the manufacturer). Size
Tissue annulus diameter
Cuff outer diameter
Profile height
19 mm 21 mm 23 mm 25 mm 27 mm 29 mm
19 mm 21 mm 23 mm 25 mm 27 mm 29 mm
24 mm 26 mm 28 mm 31 mm 33 mm 35 mm
15 mm 16 mm 17 mm 18 mm 19 mm 20 mm
400 patients were identified. Subgroup analysis was performed for all available sizes. A median sternotomy was performed in all patients; redo sternotomy was carried out using an oscillating saw. Cardiopulmonary bypass was instituted, and myocardial protection was provided by moderate hypothermia (32 C) and intermittent cold blood cardioplegic arrest. An oblique aortotomy extending into the noncoronary sinus was employed when ascending aortic replacement was not a concomitant procedure, and the diseased valve was excised. After thorough decalcification of the annulus, the size of the implant was determined by measuring the diameter of the aortic annulus with the appropriate sizers provided by the manufacturer. Each sizer is presented with an intraannular end on one side and a supraannular end on the other side. To determine the exact size of the implant, the intra-annular end of various sizes was introduced into the aortic annulus and the size that snugly fitted into the annulus was selected after crosschecking with the supraannular side for engagement into the aortic root and positioning of the valve with regards to the coronary ostia. The correctly sized prosthesis was subsequently implanted using semi-continuous 2/0 Prolene sutures (n ¼ 335, 72.75%) or interrupted 2/0 Ethibond sutures (n ¼ 65, 27.25%), depending on the operating surgeon’s preferred technique. Supraannular aortoplasty with bovine pericardium was carried out whenever necessary. A rhomboid patch of bovine pericardium was sutured with continuous 4/0 Prolene, with one apex of the rhomboid in the noncoronary sinus and the edges of the patch stitched to the native aorta on both sides; otherwise, the aorta was closed with 4/0 Prolene continuous sutures. Concomitant procedures were performed in 51.75% (n ¼ 207) patients. All patients had a pre-discharge transthoracic echocardiogram using standard transthoracic views. The left ventricular ejection fraction was obtained by Simpson’s method. Left ventricular outflow tract gradients were assessed with pulsed-wave Doppler velocity if turbulence was observed in the left ventricular outflow tract. Trans-prosthetic peak and mean pressure gradients were obtained from the continuous-wave Doppler velocity, using the Bernoulli equation and the area under the curve trace of the continuous-wave Doppler envelope, respectively. Effective orifice area was not routinely measured. Aortic and mitral regurgitation were assessed and quantified according to the current American College of Cardiology/ American Heart Association guidelines.6 Patients with > mild postoperative mitral regurgitation and those with severe postoperative left ventricular dysfunction (left ventricular ejection fraction
Hemodynamic performance of Trifecta: Single-center experience of 400 patients
Asian Cardiovascular & Thoracic Annals 2015, Vol. 23(2) 140–145 ß The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/0218492314533684 aan.sagepub.com
Amit Modi, Mindaugas Budra, Szabolcs Miskolczi, Theodore Velissaris, Markku Kaarne, Clifford W Barlow, Steven A Livesey, Sunil K Ohri and Geoffrey M Tsang
Abstract Objective: To evaluate postoperative hemodynamic gradients and early outcomes of aortic valve replacement with the Trifecta bioprosthesis. Methods: Between 2011 and 2013, 400 patients underwent aortic valve replacement with a Trifecta bioprosthesis. Gradients were calculated by transthoracic echocardiography before discharge. Data were collected retrospectively; patients with postoperative severe left ventricular dysfunction or > mild mitral regurgitation were excluded. Results: The mean age was 75.9 8.5 years, 197 (49.25%) patients were male, and 140 (35%) were >80-years old. Concomitant procedures were performed in 207 (51.75%) patients, and 30 (7.5%) had redo procedures. Supraannular aortoplasty with bovine pericardium was necessary in 25 (6.25%) cases. Hospital mortality was 2.75% (11 patients). Postoperative peak and mean gradients were 21.7 9.3 and 11.1 4.3 mm Hg for 19-mm valves (n ¼ 29); 19.5 7 and 9.7 3.6 mm Hg for 21-mm valves (n ¼ 158); 17.3 6.6 and 8.7 3.2 mm Hg for 23-mm valves (n ¼ 134); 15.1 6.1 and 7.8 3.3 mm Hg for 25-mm valves (n ¼ 56); 13.2 3.7 and 6.9 2.6 mm Hg for 27-mm valves (n ¼ 11). Nine patients had trivial and one had mild transvalvular regurgitation. Mean follow-up was 1 0.62 years; no patient required reoperation. Kaplan-Meier survival at 1 and 2 years was 94.3% 1.3% and 93.7% 1.4%. Conclusion: Early postoperative gradients are low after Trifecta implantation. Significant transvalvular regurgitation was not observed, but the incidence of supraannular aortoplasty may be increased.
Keywords Aortic valve insufficiency, aortic valve stenosis, bioprosthesis, heart valve prosthesis implantation, treatment outcome
Introduction Aortic valve replacement (AVR) is the most effective treatment for alleviating symptoms and improving survival in patients with severe aortic valve disease. Patients with aortic valve disease present with increased left ventricular mass which is an independent predictor of adverse cardiovascular events, including death.1 It has been demonstrated that left ventricular mean wall thickness is directly related to the pressure gradient across the aortic prosthetic valve.2 The extent of left ventricular muscle mass regression has been shown to be highly dependent on the hemodynamic performance of the prosthesis used for aortic valve replacement.3–5 The St. Jude Medical Trifecta pericardial aortic valve prosthesis (St. Jude Medical, Inc., St. Paul, MN, USA) has been designed to produce less impedance to
transvalvular flow compared to other stented bioprostheses. The aim of this study was to evaluate in-vivo hemodynamic performance and early clinical outcome of patients undergoing aortic valve replacement with the recently introduced Trifecta bioprosthesis at a single center.
Wessex Cardiothoracic Centre, Southampton University Hospital, Southampton, UK Corresponding author: Amit Modi, Wessex Cardiothoracic Centre, University Hospital Southampton, Tremona Road, Southampton, SO16 6YD, UK. Email: [email protected]
Downloaded from aan.sagepub.com at Uniwersytet Warszawski on March 20, 2015
Modi et al.
141
Patients and methods The St. Jude Medical Trifecta (model TF, size A) is a stented aortic bioprosthesis designed with a single sheet of bovine pericardial tissue (forming 3 cusps) attached to the exterior of a titanium stent, allowing for a greater opening (Figure 1). The stent, excluding the sewing ring, is covered with porcine pericardium to minimize wear by allowing only tissue-to-tissue contact. The polyester sewing ring has a silicone insert to conform to the shape of the native annulus. This valve is designed for supraannular placement. The leaflets undergo anti-calcification treatment with ethanolbased Linx anti-calcification technology which provides a shield against mineralization. Valve sizes are available in 2-mm increments from 19 to 29 mm. The dimensions of these valves are given in Table 1. This evaluation included consecutive patients who underwent AVR with or without concomitant procedures at a university hospital, using St. Jude Trifecta (model TF, size A) supraannular bioprostheses between March 2011 and May 2013. The institutional clinical effectiveness board approved this project. A total of
Figure 1. The Trifecta aortic bioprosthesis with the external wrap design (reproduced with permission from St. Jude Medical, Inc., St. Paul, MN, USA).
Table 1. Dimensions of various Trifecta bioprostheses (as provided by the manufacturer). Size
Tissue annulus diameter
Cuff outer diameter
Profile height
19 mm 21 mm 23 mm 25 mm 27 mm 29 mm
19 mm 21 mm 23 mm 25 mm 27 mm 29 mm
24 mm 26 mm 28 mm 31 mm 33 mm 35 mm
15 mm 16 mm 17 mm 18 mm 19 mm 20 mm
400 patients were identified. Subgroup analysis was performed for all available sizes. A median sternotomy was performed in all patients; redo sternotomy was carried out using an oscillating saw. Cardiopulmonary bypass was instituted, and myocardial protection was provided by moderate hypothermia (32 C) and intermittent cold blood cardioplegic arrest. An oblique aortotomy extending into the noncoronary sinus was employed when ascending aortic replacement was not a concomitant procedure, and the diseased valve was excised. After thorough decalcification of the annulus, the size of the implant was determined by measuring the diameter of the aortic annulus with the appropriate sizers provided by the manufacturer. Each sizer is presented with an intraannular end on one side and a supraannular end on the other side. To determine the exact size of the implant, the intra-annular end of various sizes was introduced into the aortic annulus and the size that snugly fitted into the annulus was selected after crosschecking with the supraannular side for engagement into the aortic root and positioning of the valve with regards to the coronary ostia. The correctly sized prosthesis was subsequently implanted using semi-continuous 2/0 Prolene sutures (n ¼ 335, 72.75%) or interrupted 2/0 Ethibond sutures (n ¼ 65, 27.25%), depending on the operating surgeon’s preferred technique. Supraannular aortoplasty with bovine pericardium was carried out whenever necessary. A rhomboid patch of bovine pericardium was sutured with continuous 4/0 Prolene, with one apex of the rhomboid in the noncoronary sinus and the edges of the patch stitched to the native aorta on both sides; otherwise, the aorta was closed with 4/0 Prolene continuous sutures. Concomitant procedures were performed in 51.75% (n ¼ 207) patients. All patients had a pre-discharge transthoracic echocardiogram using standard transthoracic views. The left ventricular ejection fraction was obtained by Simpson’s method. Left ventricular outflow tract gradients were assessed with pulsed-wave Doppler velocity if turbulence was observed in the left ventricular outflow tract. Trans-prosthetic peak and mean pressure gradients were obtained from the continuous-wave Doppler velocity, using the Bernoulli equation and the area under the curve trace of the continuous-wave Doppler envelope, respectively. Effective orifice area was not routinely measured. Aortic and mitral regurgitation were assessed and quantified according to the current American College of Cardiology/ American Heart Association guidelines.6 Patients with > mild postoperative mitral regurgitation and those with severe postoperative left ventricular dysfunction (left ventricular ejection fraction
