- Email: [email protected]
Bioprostheses “Thrombosis” After Transcatheter Aortic Valve Replacement
Correspondence
JACC Vol. 61, No. 7, 2013 February 19, 2013:787–91
*EMO-GVM Centro Cuore Columbus Via Buonarroti 48 20145 Milan Italy E-mail: [email protected]
789
Himbert is a proctor for Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Latib and Messika-Zeitoun contributed equally to this manuscript and are joint first authors. REFERENCES
http://dx.doi.org/10.1016/j.jacc.2012.10.016
†Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy; ‡Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy; §Department of Cardiology and University Paris 7, Bichat Hospital, Paris, France; and the 储Department of Cardiothoracic Surgery, San Raffaele Scientific Institute, Milan, Italy. Please note: Dr. Latib is a member of the Medtronic advisory board, and has consulted to Edwards Lifesciences. Dr. Messika-Zeitoun is a consultant to, and has received lecture fees from, Edwards Lifesciences, Valtech, and Symetis. Dr. Maisano is a consultant to Valtechcardio, Medtronic, and St. Jude Medical. Dr.
1. Vahanian A, Alfieri O, Andreotti F, et al. Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J 2012;33:2451–96. 2. Ong SH, Mueller R, Iversen S. Early calcific degeneration of a CoreValve transcatheter aortic bioprosthesis. Eur Heart J 2011;33:586. 3. Hammerstingl C, Nickenig G, Grube E. Treatment of a degenerative stenosed CoreValve(®) aortic bioprosthesis by transcatheter valve-invalve insertion. Catheter Cardiovasc Interv 2012;79:748 –55. 4. Kefer J, Astarci P, Renkin J, et al. Thrombotic aortic restenosis after transapical Sapien valve implantation. Circ Cardiovasc Interv 2010;3:289 –92.
CORRESPONDENCE Research Correspondence
Bioprostheses “Thrombosis” After Transcatheter Aortic Valve Replacement To the Editor: Surgical replacement of the aortic valve reduces symptoms and improves survival in patients with symptomatic and severe aortic stenosis (1). Transcatheter aortic valve replacement (TAVR) provides a safe and efficient alternative for inoperable and high-risk surgical patients (2– 4). Available guidelines recommend aspirin for all patients with biological prosthetic heart valves and for those with no risk factors for thromboembolism. After TAVR, it is common practice to prescribe antiplatelet therapy only. No cases of valve thrombosis were reported after TAVR in 1 randomized trial and in large-scale registries (4 – 6). In the PARTNER EU (Randomized Placement of Aortic Transcatheter Valves Trial European) Study (7), only 1 case of valve thrombosis was reported. This patient required explant on day 257. We report here on 3 cases of bioprostheses dysfunction due to leaflet thrombosis after TAVR. Case 1 was an 80-year-old woman with severe aortic valve stenosis who underwent TAVR (23-mm Sapien XT, Edwards Lifesciences Inc., Irvine, California). The patient was discharged home as asymptomatic on day 5 on dual antiplatelet therapy (DAPT). At discharge, transthoracic echocardiography (TTE) showed normal function of the aortic prosthesis, with a mean pressure gradient (MPG) of 10 mm Hg. At 1-month follow-up, a MPG of 12 mm Hg was observed. At 10 months, the patient was symptomatic for dyspnea (New York Heart Association [NYHA] functional class III), and TTE showed severe aortic restenosis with a MPG of 54 mm Hg (Vmax 510 cm/s). Transesophageal echocardiography (TEE) showed fusion of 2 leaflets with suspicion of “thrombotic apposition” (Figs. 1A and 1B). Screening tests for thrombophilia, allergy to valve components, and systemic inflammation activation were all negative. Oral anticoagulation therapy (OAT) was prescribed. After 3 months, TEE (Figs. 1C and 1D) showed restored bioprostheses
function (MPG 13 mm Hg), and the patient was asymptomatic. Two months after discontinuing OAT, the patient is still asymptomatic, and the aortic bioprostheses is functioning properly. Case 2 is a 81-year-old man with severe dysfunction of the aortic valve bioprostheses (25-mm Carpentier Edwards, Edwards Lifesciences) who underwent TAVR (23-mm Sapien XT, Edwards Lifesciences). The patient was discharged home as asymptomatic on day 5. At discharge, TTE showed normal function of the aortic prosthesis (MPG 15 mm Hg). At 1-month follow-up, a MPG of 14 mm Hg was observed. At 4 months, the patient was symptomatic for dyspnea (NHYA functional class III), and TTE showed severe aortic restenosis with a MPG of 51 mm Hg (Vmax 4.24 cm/s). TEE showed fusion of 2 leaflets with a suspicion of thrombotic apposition. OAT was prescribed. After 2 months, TEE showed restored bioprostheses function (MPG 9 mm Hg), and the patient was asymptomatic. Case 3 involved a 74-year-old woman with severe aortic valve stenosis who underwent TAVR (26-mm Sapien XT, Edwards Lifesciences). The patient was discharged home as asymptomatic on day 4 on DAPT. At discharge, TTE showed normal function of the aortic bioprostheses (MPG 7 mm Hg). At 1-month follow-up, a MPG of 8 mm Hg was observed. At 2 months, the patient was symptomatic for dyspnea (NHYA functional class II), and TTE showed severe aortic restenosis with a MPG of 34 mm Hg (Vmax 328 cm/s). TEE showed a suspicion of thrombotic apposition blocking the movement of a bioprostheses leaflet. OAT was prescribed. After 2 months, the patient was asymptomatic, and TEE showed restored bioprostheses function (MPG 9 mm Hg). Edwards SAPIEN aortic valve stents (Edwards Lifesciences) are manufactured in the same way as conventional aortic bioprostheses, and they should have the similar thrombogenicity. For this
790
Figure 1
Correspondence
JACC Vol. 61, No. 7, 2013 February 19, 2013:787–91
Echocardiography of Aortic Valve Bioprostheses 3 Months After Percutaneous Implantation
Transesophageal (short axis) identified thrombus (red arrows) on the bioprostheses leaflet (A, diastole), which limited mobility (B, systole) and determined an elevated peak aortic flow velocity (Vmax 510 cm/s) (C). After 3 months of oral anticoagulation therapy, thrombus resolved (D, diastole), the leaflet was moving properly (E, systole), and peak aortic velocity was reduced (Vmax 253 cm/s) (F).
reason, after TAVR, it is common practice to prescribe antiplatelet therapy and no oral anticoagulation. In all 3 reported cases, valve thrombosis was resolved with OAT, and the patients did not require open-heart surgery. We believe that this report can be hypothesis-generating to design a trial aimed at identifying the proper antiplatelet or anticoagulation therapy after TAVR and to identify therapy for bioprostheses thrombosis. Linda Cota, MD† *Eugenio Stabile, MD, PhD† Marco Agrusta, MD‡ Giovanni Sorropago, MD† Armando Pucciarelli, MD† Vittorio Ambrosini, MD†
Gaetano Mottola, MD‡§ Giovanni Esposito, MD, PhD¶ Paolo Rubino, MD† *Cardiac Catheterization Laboratories Division of Cardiology Clinica Montevergine Via Mario Malzoni 1 Mercogliano AV 83013 Italy E-mail: [email protected] http://dx.doi.org/10.1016/j.jacc.2012.11.042
From the †Laboratory of Invasive Cardiology, Clinica Montevergine, Mercogliano, Italy; ‡Coronary Care Unit, Clinica
JACC Vol. 61, No. 7, 2013 February 19, 2013:787–91
Montevergine, Mercogliano, Italy; §Division of Cardiology, Clinica Montevergine, Mercogliano, Italy; and the ¶Cattedra di Cardiologia, Facoltà di Medicina e Chirurgia, Università degli Studi di Napoli “Federico II”, Napoli, Italy.
REFERENCES
1. Bonow RO, Carabello BA, Chatterjee, K et al. 2008 focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease). Endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol 2008;52:e1–142.
Correspondence
791
2. Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363:1597– 607. 3. Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011;364: 2187–98. 4. Thomas M, Schymik G, Walther T, et al. One-year outcomes of cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry: the European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation 2011;124:425–33. 5. Kodali SK, Williams MR, Smith CR, et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med 2012;366: 1686–95. 6. Gilard M, Eltchaninoff H, Iung B et al. FRANCE 2 Investigators registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med 2012;366:1705–15. 7. Trepels T, Martens S, Doss M, Fichtlscherer S, Schachinger V. Thrombotic restenosis after minimally invasive implantation of aortic valve stent. Circulation 2009;120:e23– 4.
JACC Vol. 61, No. 7, 2013 February 19, 2013:787–91
*EMO-GVM Centro Cuore Columbus Via Buonarroti 48 20145 Milan Italy E-mail: [email protected]
789
Himbert is a proctor for Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Latib and Messika-Zeitoun contributed equally to this manuscript and are joint first authors. REFERENCES
http://dx.doi.org/10.1016/j.jacc.2012.10.016
†Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy; ‡Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy; §Department of Cardiology and University Paris 7, Bichat Hospital, Paris, France; and the 储Department of Cardiothoracic Surgery, San Raffaele Scientific Institute, Milan, Italy. Please note: Dr. Latib is a member of the Medtronic advisory board, and has consulted to Edwards Lifesciences. Dr. Messika-Zeitoun is a consultant to, and has received lecture fees from, Edwards Lifesciences, Valtech, and Symetis. Dr. Maisano is a consultant to Valtechcardio, Medtronic, and St. Jude Medical. Dr.
1. Vahanian A, Alfieri O, Andreotti F, et al. Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J 2012;33:2451–96. 2. Ong SH, Mueller R, Iversen S. Early calcific degeneration of a CoreValve transcatheter aortic bioprosthesis. Eur Heart J 2011;33:586. 3. Hammerstingl C, Nickenig G, Grube E. Treatment of a degenerative stenosed CoreValve(®) aortic bioprosthesis by transcatheter valve-invalve insertion. Catheter Cardiovasc Interv 2012;79:748 –55. 4. Kefer J, Astarci P, Renkin J, et al. Thrombotic aortic restenosis after transapical Sapien valve implantation. Circ Cardiovasc Interv 2010;3:289 –92.
CORRESPONDENCE Research Correspondence
Bioprostheses “Thrombosis” After Transcatheter Aortic Valve Replacement To the Editor: Surgical replacement of the aortic valve reduces symptoms and improves survival in patients with symptomatic and severe aortic stenosis (1). Transcatheter aortic valve replacement (TAVR) provides a safe and efficient alternative for inoperable and high-risk surgical patients (2– 4). Available guidelines recommend aspirin for all patients with biological prosthetic heart valves and for those with no risk factors for thromboembolism. After TAVR, it is common practice to prescribe antiplatelet therapy only. No cases of valve thrombosis were reported after TAVR in 1 randomized trial and in large-scale registries (4 – 6). In the PARTNER EU (Randomized Placement of Aortic Transcatheter Valves Trial European) Study (7), only 1 case of valve thrombosis was reported. This patient required explant on day 257. We report here on 3 cases of bioprostheses dysfunction due to leaflet thrombosis after TAVR. Case 1 was an 80-year-old woman with severe aortic valve stenosis who underwent TAVR (23-mm Sapien XT, Edwards Lifesciences Inc., Irvine, California). The patient was discharged home as asymptomatic on day 5 on dual antiplatelet therapy (DAPT). At discharge, transthoracic echocardiography (TTE) showed normal function of the aortic prosthesis, with a mean pressure gradient (MPG) of 10 mm Hg. At 1-month follow-up, a MPG of 12 mm Hg was observed. At 10 months, the patient was symptomatic for dyspnea (New York Heart Association [NYHA] functional class III), and TTE showed severe aortic restenosis with a MPG of 54 mm Hg (Vmax 510 cm/s). Transesophageal echocardiography (TEE) showed fusion of 2 leaflets with suspicion of “thrombotic apposition” (Figs. 1A and 1B). Screening tests for thrombophilia, allergy to valve components, and systemic inflammation activation were all negative. Oral anticoagulation therapy (OAT) was prescribed. After 3 months, TEE (Figs. 1C and 1D) showed restored bioprostheses
function (MPG 13 mm Hg), and the patient was asymptomatic. Two months after discontinuing OAT, the patient is still asymptomatic, and the aortic bioprostheses is functioning properly. Case 2 is a 81-year-old man with severe dysfunction of the aortic valve bioprostheses (25-mm Carpentier Edwards, Edwards Lifesciences) who underwent TAVR (23-mm Sapien XT, Edwards Lifesciences). The patient was discharged home as asymptomatic on day 5. At discharge, TTE showed normal function of the aortic prosthesis (MPG 15 mm Hg). At 1-month follow-up, a MPG of 14 mm Hg was observed. At 4 months, the patient was symptomatic for dyspnea (NHYA functional class III), and TTE showed severe aortic restenosis with a MPG of 51 mm Hg (Vmax 4.24 cm/s). TEE showed fusion of 2 leaflets with a suspicion of thrombotic apposition. OAT was prescribed. After 2 months, TEE showed restored bioprostheses function (MPG 9 mm Hg), and the patient was asymptomatic. Case 3 involved a 74-year-old woman with severe aortic valve stenosis who underwent TAVR (26-mm Sapien XT, Edwards Lifesciences). The patient was discharged home as asymptomatic on day 4 on DAPT. At discharge, TTE showed normal function of the aortic bioprostheses (MPG 7 mm Hg). At 1-month follow-up, a MPG of 8 mm Hg was observed. At 2 months, the patient was symptomatic for dyspnea (NHYA functional class II), and TTE showed severe aortic restenosis with a MPG of 34 mm Hg (Vmax 328 cm/s). TEE showed a suspicion of thrombotic apposition blocking the movement of a bioprostheses leaflet. OAT was prescribed. After 2 months, the patient was asymptomatic, and TEE showed restored bioprostheses function (MPG 9 mm Hg). Edwards SAPIEN aortic valve stents (Edwards Lifesciences) are manufactured in the same way as conventional aortic bioprostheses, and they should have the similar thrombogenicity. For this
790
Figure 1
Correspondence
JACC Vol. 61, No. 7, 2013 February 19, 2013:787–91
Echocardiography of Aortic Valve Bioprostheses 3 Months After Percutaneous Implantation
Transesophageal (short axis) identified thrombus (red arrows) on the bioprostheses leaflet (A, diastole), which limited mobility (B, systole) and determined an elevated peak aortic flow velocity (Vmax 510 cm/s) (C). After 3 months of oral anticoagulation therapy, thrombus resolved (D, diastole), the leaflet was moving properly (E, systole), and peak aortic velocity was reduced (Vmax 253 cm/s) (F).
reason, after TAVR, it is common practice to prescribe antiplatelet therapy and no oral anticoagulation. In all 3 reported cases, valve thrombosis was resolved with OAT, and the patients did not require open-heart surgery. We believe that this report can be hypothesis-generating to design a trial aimed at identifying the proper antiplatelet or anticoagulation therapy after TAVR and to identify therapy for bioprostheses thrombosis. Linda Cota, MD† *Eugenio Stabile, MD, PhD† Marco Agrusta, MD‡ Giovanni Sorropago, MD† Armando Pucciarelli, MD† Vittorio Ambrosini, MD†
Gaetano Mottola, MD‡§ Giovanni Esposito, MD, PhD¶ Paolo Rubino, MD† *Cardiac Catheterization Laboratories Division of Cardiology Clinica Montevergine Via Mario Malzoni 1 Mercogliano AV 83013 Italy E-mail: [email protected] http://dx.doi.org/10.1016/j.jacc.2012.11.042
From the †Laboratory of Invasive Cardiology, Clinica Montevergine, Mercogliano, Italy; ‡Coronary Care Unit, Clinica
JACC Vol. 61, No. 7, 2013 February 19, 2013:787–91
Montevergine, Mercogliano, Italy; §Division of Cardiology, Clinica Montevergine, Mercogliano, Italy; and the ¶Cattedra di Cardiologia, Facoltà di Medicina e Chirurgia, Università degli Studi di Napoli “Federico II”, Napoli, Italy.
REFERENCES
1. Bonow RO, Carabello BA, Chatterjee, K et al. 2008 focused update incorporated into the ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease). Endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol 2008;52:e1–142.
Correspondence
791
2. Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363:1597– 607. 3. Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011;364: 2187–98. 4. Thomas M, Schymik G, Walther T, et al. One-year outcomes of cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry: the European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation 2011;124:425–33. 5. Kodali SK, Williams MR, Smith CR, et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med 2012;366: 1686–95. 6. Gilard M, Eltchaninoff H, Iung B et al. FRANCE 2 Investigators registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med 2012;366:1705–15. 7. Trepels T, Martens S, Doss M, Fichtlscherer S, Schachinger V. Thrombotic restenosis after minimally invasive implantation of aortic valve stent. Circulation 2009;120:e23– 4.