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J Am Coll Cardiol, 2007; 50:69-76, doi:10.1016/j.jacc.2007.04.047 (Published online 5 June 2007).
© 2007 by the American College of Cardiology Foundation
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EXPEDITED REVIEW

Percutaneous Aortic Valve Replacement for Severe Aortic Stenosis in High-Risk Patients Using the Second- and Current Third-Generation Self-Expanding CoreValve Prosthesis

Device Success and 30-Day Clinical Outcome

Eberhard Grube, MD, FACC*,1,*, Gerhard Schuler, MD, FACC{dagger}, Lutz Buellesfeld, MD*, Ulrich Gerckens, MD*, Axel Linke, MD{dagger}, Peter Wenaweser, MD*, Barthel Sauren, MD*, Friedrich-Wilhelm Mohr, MD{dagger}, Thomas Walther, MD{dagger}, Bernfried Zickmann, MD*, Stein Iversen, MD*, Thomas Felderhoff, MD*, Raymond Cartier, MD{ddagger} and Raoul Bonan, MD, FACC{ddagger},1

* HELIOS Heart Center Siegburg, Siegburg, Germany
{dagger} Heart Center Leipzig, Leipzig, Germany
{ddagger} Institut de Cardiologie de Montreal, Montreal, Canada.

Manuscript received February 20, 2007; revised manuscript received April 10, 2007, accepted April 16, 2007.

* Reprint requests and correspondence: Dr. Eberhard Grube, Department of Cardiology/Angiology, HELIOS Heart Center Siegburg, Ringstrasse 49, 53721 Siegburg, Germany. (Email: GrubeE{at}aol.com).

Objectives: We sought to determine both the procedural performance and safety of percutaneous implantation of the second (21-French [F])- and third (18-F)-generation CoreValve aortic valve prosthesis (CoreValve Inc., Irvine, California).

Background: Percutaneous aortic valve replacement represents an emerging alternative therapy for high-risk and inoperable patients with severe symptomatic aortic valve stenosis.

Methods: Patients with: 1) symptomatic, severe aortic valve stenosis (area <1 cm2); 2) age ≥80 years with a logistic EuroSCORE ≥20% (21-F group) or age ≥75 years with a logistic EuroSCORE ≥15% (18-F group); or 3) age ≥65 years plus additional prespecified risk factors were included. Introduction of the 18-F device enabled the transition from a multidisciplinary approach involving general anesthesia, surgical cut-down, and cardiopulmonary bypass to a truly percutaneous approach under local anesthesia without hemodynamic support.

Results: A total of 86 patients (21-F, n = 50; 18-F, n = 36) with a mean valve area of 0.66 ± 0.19 cm2 (21-F) and 0.54 ± 0.15 cm2 (18-F), a mean age of 81.3 ± 5.2 years (21-F) and 83.4 ± 6.7 years (18-F), and a mean logistic EuroSCORE of 23.4 ± 13.5% (21-F) and 19.1 ± 11.1% (18-F) were recruited. Acute device success was 88%. Successful device implantation resulted in a marked reduction of aortic transvalvular gradients (mean pre 43.7 mm Hg vs. post 9.0 mm Hg, p < 0.001) with aortic regurgitation grade remaining unchanged. Acute procedural success rate was 74% (21-F: 78%; 18-F: 69%). Procedural mortality was 6%. Overall 30-day mortality rate was 12%; the combined rate of death, stroke, and myocardial infarction was 22%.

Conclusions: Treatment of severe aortic valve stenosis in high-risk patients with percutaneous implantation of the CoreValve prosthesis is feasible and associated with a lower mortality rate than predicted by risk algorithms.

Abbreviations and Acronyms
  AS = aortic stenosis
  F = French
  MACCE = major adverse cardiovascular and cerebral event
  MI = myocardial infarction




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S. W. Grant, M. P. Devbhandari, A. D. Grayson, I. Dimarakis, I. Kadir, D. M. T. Saravanan, R. D. Levy, S. G. Ray, and B. Bridgewater
What is the impact of providing a transcatheter aortic valve implantation service on conventional aortic valve surgical activity: patient risk factors and outcomes in the first 2 years
Heart, October 15, 2010; 96(20): 1633 - 1637.
[Abstract] [Full Text] [PDF]

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 J. Thorac. Cardiovasc. Surg.Home page
H. Treede, T. Tubler, H. Reichenspurner, E. Grube, A. Pascotto, O. Franzen, R. Mueller, R. Low, S. F. Bolling, T. Meinertz, et al.
Six-month results of a repositionable and retrievable pericardial valve for transcatheter aortic valve replacement: The Direct Flow Medical aortic valve
J. Thorac. Cardiovasc. Surg., October 1, 2010; 140(4): 897 - 903.
[Abstract] [Full Text] [PDF]

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 J. Thorac. Cardiovasc. Surg.Home page
T. Modine, G. Lemesle, R. Azzaoui, and A. Sudre
Aortic valve implantation with the CoreValve ReValving System via left carotid artery access: First case report
J. Thorac. Cardiovasc. Surg., October 1, 2010; 140(4): 928 - 929.
[Full Text] [PDF]

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 ANN INTERN MEDHome page
R. R. Coeytaux, J. W. Williams Jr., R. N. Gray, and A. Wang
Percutaneous Heart Valve Replacement for Aortic Stenosis: State of the Evidence
Ann Intern Med, September 7, 2010; 153(5): 314 - 324.
[Abstract] [Full Text] [PDF]

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 Eur Heart JHome page
R. del Valle-Fernandez, V. Jelnin, G. Panagopoulos, Y. Dudiy, L. Schneider, P. T. de Jaegere, C. Schultz, P. W. Serruys, E. Grube, and C. E. Ruiz
A method for standardized computed tomography angiography-based measurement of aortic valvar structures
Eur. Heart J., September 1, 2010; 31(17): 2170 - 2178.
[Abstract] [Full Text] [PDF]

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 Eur Heart J SupplHome page
N. Piazza, N. van Mieghem, A. Tzikas, R. Lange, P. de Jaegere, and P. W. Serruys
Interpreting the current data on transcatheter aortic valve implantation: a difficult task
Eur. Heart J. Suppl., September 1, 2010; 12(suppl_E): E41 - E45.
[Full Text] [PDF]

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 J Am Coll CardiolHome page
M. Pasic, A. Unbehaun, S. Dreysse, T. Drews, S. Buz, M. Kukucka, A. Mladenow, T. Gromann, and R. Hetzer
Transapical Aortic Valve Implantation in 175 Consecutive Patients: Excellent Outcome in Very High-Risk Patients
J. Am. Coll. Cardiol., August 31, 2010; 56(10): 813 - 820.
[Abstract] [Full Text] [PDF]

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 J Am Coll Cardiol IntvHome page
H. Jilaihawi, R. Bonan, A. Asgar, R. Ibrahim, T. Spyt, D. Chin, and J. Kovac
Anatomic Suitability for Present and Next Generation Transcatheter Aortic Valve Prostheses: Evidence for a Complementary Multidevice Approach to Treatment
J. Am. Coll. Cardiol. Intv., August 1, 2010; 3(8): 859 - 866.
[Abstract] [Full Text] [PDF]

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 J Am Coll Cardiol IntvHome page
P. Wenaweser and S. Windecker
Anatomical Suitability for Transcatheter Aortic Valve Implantation With Complementary Roles for 2 Rivals
J. Am. Coll. Cardiol. Intv., August 1, 2010; 3(8): 867 - 869.
[Full Text] [PDF]

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 J Am Coll Cardiol IntvHome page
A. Kumar, J. Wojciuk, K. P. Morgan, S. Khan, R. S. More, F. Sogliani, R. W. Bury, and D. H. Roberts
Contained Aortic Rupture as a Late Complication of Transcutaneous Aortic Valve Implantation
J. Am. Coll. Cardiol. Intv., August 1, 2010; 3(8): 878 - 879.
[Full Text] [PDF]

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 Circ Cardiovasc IntervHome page
A. S. Petronio, M. De Carlo, F. Bedogni, A. Marzocchi, S. Klugmann, F. Maisano, A. Ramondo, G. P. Ussia, F. Ettori, A. Poli, et al.
Safety and Efficacy of the Subclavian Approach for Transcatheter Aortic Valve Implantation With the CoreValve Revalving System
Circ Cardiovasc Interv, August 1, 2010; 3(4): 359 - 366.
[Abstract] [Full Text] [PDF]

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 Interact CardioVasc Thorac SurgHome page
A. N. Azadani, N. Jaussaud, P. B. Matthews, L. Ge, T. A. M. Chuter, and E. E. Tseng
Transcatheter aortic valves inadequately relieve stenosis in small degenerated bioprostheses
Interact CardioVasc Thorac Surg, July 1, 2010; 11(1): 70 - 77.
[Abstract] [Full Text] [PDF]

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 HeartHome page
M. Gotzmann, T. Hehen, A. Germing, M. Lindstaedt, A. Yazar, A. Laczkovics, A. Mumme, A. Mugge, and W. Bojara
Short-term effects of transcatheter aortic valve implantation on neurohormonal activation, quality of life and 6-minute walk test in severe and symptomatic aortic stenosis
Heart, July 1, 2010; 96(14): 1102 - 1106.
[Abstract] [Full Text] [PDF]

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 Eur Heart J Cardiovasc ImagingHome page
F. Guarracino, L. Cabrini, R. Baldassarri, C. Cariello, R. D. Covello, G. Landoni, S. Petronio, and N. Ambrosino
Non-invasive ventilation-aided transoesophageal echocardiography in high-risk patients: a pilot study
Eur Heart J Cardiovasc Imaging, July 1, 2010; 11(6): 554 - 556.
[Abstract] [Full Text] [PDF]

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 Ann. Thorac. Surg.Home page
J. Kempfert, A. Van Linden, A. Linke, M. A. Borger, A. Rastan, C. Mukherjee, J. Ender, G. Schuler, F. W. Mohr, and T. Walther
Transapical Off-Pump Valve-in-Valve Implantation in Patients With Degenerated Aortic Xenografts
Ann. Thorac. Surg., June 1, 2010; 89(6): 1934 - 1941.
[Abstract] [Full Text] [PDF]

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 J. Thorac. Cardiovasc. Surg.Home page
T. D. Yan, C. Cao, J. Martens-Nielsen, R. Padang, M. Ng, M. P. Vallely, and P. G. Bannon
Transcatheter aortic valve implantation for high-risk patients with severe aortic stenosis: A systematic review
J. Thorac. Cardiovasc. Surg., June 1, 2010; 139(6): 1519 - 1528.
[Abstract] [Full Text] [PDF]

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 Eur J Cardiothorac SurgHome page
I. Florath, A. Albert, A. Boening, I. C. Ennker, and J. Ennker
Aortic valve replacement in octogenarians: identification of high-risk patients
Eur J Cardiothorac Surg, June 1, 2010; 37(6): 1304 - 1310.
[Abstract] [Full Text] [PDF]

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 Anesth. Analg.Home page
A. Vegas and M. Meineri
Core Review: Three-Dimensional Transesophageal Echocardiography Is a Major Advance for Intraoperative Clinical Management of Patients Undergoing Cardiac Surgery: A Core Review
Anesth. Analg., June 1, 2010; 110(6): 1548 - 1573.
[Abstract] [Full Text] [PDF]

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 CMAJHome page
M. W. A. Chu, M. A. Borger, F. W. Mohr, and T. Walther
Transcatheter heart-valve replacement: update
Can. Med. Assoc. J., May 18, 2010; 182(8): 791 - 795.
[Full Text] [PDF]

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 J Am Coll Cardiol IntvHome page
S. Bleiziffer, H. Ruge, J. Horer, A. Hutter, S. Geisbusch, G. Brockmann, D. Mazzitelli, R. Bauernschmitt, and R. Lange
Predictors for New-Onset Complete Heart Block After Transcatheter Aortic Valve Implantation
J. Am. Coll. Cardiol. Intv., May 1, 2010; 3(5): 524 - 530.
[Abstract] [Full Text] [PDF]

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 J Am Coll CardiolHome page
A. Ghanem, A. Muller, C. P. Nahle, J. Kocurek, N. Werner, C. Hammerstingl, H. H. Schild, J. O. Schwab, F. Mellert, R. Fimmers, et al.
Risk and Fate of Cerebral Embolism After Transfemoral Aortic Valve Implantation: A Prospective Pilot Study With Diffusion-Weighted Magnetic Resonance Imaging
J. Am. Coll. Cardiol., April 6, 2010; 55(14): 1427 - 1432.
[Abstract] [Full Text] [PDF]

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 Eur Heart JHome page
L. Buellesfeld, P. Wenaweser, U. Gerckens, R. Mueller, B. Sauren, G. Latsios, B. Zickmann, G. Hellige, S. Windecker, and E. Grube
Transcatheter aortic valve implantation: predictors of procedural success--the Siegburg-Bern experience
Eur. Heart J., April 2, 2010; 31(8): 984 - 991.
[Abstract] [Full Text] [PDF]

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 Eur Heart JHome page
H. Jilaihawi, D. Chin, T. Spyt, M. Jeilan, M. Vasa-Nicotera, J. Bence, E. Logtens, and J. Kovac
Prosthesis-patient mismatch after transcatheter aortic valve implantation with the Medtronic-Corevalve bioprosthesis
Eur. Heart J., April 1, 2010; 31(7): 857 - 864.
[Abstract] [Full Text] [PDF]

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 J Am Coll CardiolHome page
J. Rodes-Cabau, J. G. Webb, A. Cheung, J. Ye, E. Dumont, C. M. Feindel, M. Osten, M. K. Natarajan, J. L. Velianou, G. Martucci, et al.
Transcatheter Aortic Valve Implantation for the Treatment of Severe Symptomatic Aortic Stenosis in Patients at Very High or Prohibitive Surgical Risk: Acute and Late Outcomes of the Multicenter Canadian Experience
J. Am. Coll. Cardiol., March 16, 2010; 55(11): 1080 - 1090.
[Abstract] [Full Text] [PDF]

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 Ann. Thorac. Surg.Home page
T. M. Dewey, D. L. Brown, M. A. Herbert, D. Culica, C. R. Smith, M. B. Leon, L. G. Svensson, M. Tuzcu, J. G. Webb, A. Cribier, et al.
Effect of Concomitant Coronary Artery Disease on Procedural and Late Outcomes of Transcatheter Aortic Valve Implantation
Ann. Thorac. Surg., March 1, 2010; 89(3): 758 - 767.
[Abstract] [Full Text] [PDF]

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 Ann. Thorac. Surg.Home page
A. Parolari, L. L. Pesce, M. Trezzi, L. Cavallotti, S. Kassem, C. Loardi, D. Pacini, E. Tremoli, and F. Alamanni
EuroSCORE Performance in Valve Surgery: A Meta-Analysis
Ann. Thorac. Surg., March 1, 2010; 89(3): 787 - 793.
[Abstract] [Full Text] [PDF]

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 CirculationHome page
P. Kahlert, S. C. Knipp, M. Schlamann, M. Thielmann, F. Al-Rashid, M. Weber, U. Johansson, D. Wendt, H. G. Jakob, M. Forsting, et al.
Silent and Apparent Cerebral Ischemia After Percutaneous Transfemoral Aortic Valve Implantation: A Diffusion-Weighted Magnetic Resonance Imaging Study
Circulation, February 23, 2010; 121(7): 870 - 878.
[Abstract] [Full Text] [PDF]

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 J Am Coll Cardiol IntvHome page
D. John, L. Buellesfeld, S. Yuecel, R. Mueller, G. Latsios, H. Beucher, U. Gerckens, and E. Grube
Correlation of Device Landing Zone Calcification and Acute Procedural Success in Patients Undergoing Transcatheter Aortic Valve Implantations With the Self-Expanding CoreValve Prosthesis
J. Am. Coll. Cardiol. Intv., February 1, 2010; 3(2): 233 - 243.
[Abstract] [Full Text] [PDF]

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 J Am Coll Cardiol IntvHome page
U. Gerckens, G. Latsios, R. Mueller, L. Buellesfeld, D. John, S. Yuecel, B. Sauren, T. Felderhof, S. Iversen, and E. Grube
Procedural and Mid-Term Results in Patients With Aortic Stenosis Treated With Implantation of 2 (In-Series) CoreValve Prostheses in 1 Procedure
J. Am. Coll. Cardiol. Intv., February 1, 2010; 3(2): 244 - 250.
[Abstract] [Full Text] [PDF]

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 Eur J Cardiothorac SurgHome page
G. Di Giammarco, R. Rabozzi, B. Chiappini, and G. Tamagnini
Absolute and relative risk prediction in patients candidate to isolated aortic valve replacement: should we change our mind?
Eur J Cardiothorac Surg, February 1, 2010; 37(2): 255 - 260.
[Abstract] [Full Text] [PDF]

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 Eur J Cardiothorac SurgHome page
H. G. Thyregod, J. T. Lund, T. Engstrom, and D. A. Steinbruchel
Transcatheter aortic valve prosthesis surgically replaced 4 months after implantation
Eur J Cardiothorac Surg, February 1, 2010; 37(2): 494 - 496.
[Abstract] [Full Text] [PDF]

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 J Am Coll CardiolHome page
M. Z. Khawaja, P. Haworth, A. Ghuran, L. Lee, A. de Belder, N. Hutchinson, U. Trivedi, J.-C. Laborde, and D. Hildick-Smith
Transcatheter Aortic Valve Implantation for Stenosed and Regurgitant Aortic Valve Bioprostheses: CoreValve for Failed Bioprosthetic Aortic Valve Replacements
J. Am. Coll. Cardiol., January 12, 2010; 55(2): 97 - 101.
[Abstract] [Full Text] [PDF]

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 J Am Coll Cardiol IntvHome page
V. C. Babaliaros, Z. Junagadhwalla, S. Lerakis, V. Thourani, D. Liff, E. Chen, T. Vassiliades, C. Chappell, N. Gross, A. Patel, et al.
Use of Balloon Aortic Valvuloplasty to Size the Aortic Annulus Before Implantation of a Balloon-Expandable Transcatheter Heart Valve
J. Am. Coll. Cardiol. Intv., January 1, 2010; 3(1): 114 - 118.
[Abstract] [Full Text] [PDF]

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 J Am Coll Cardiol IntvHome page
A. Latib, I. Michev, J.-C. Laborde, M. Montorfano, and A. Colombo
Post-Implantation Repositioning of the CoreValve Percutaneous Aortic Valve
J. Am. Coll. Cardiol. Intv., January 1, 2010; 3(1): 119 - 121.
[Full Text] [PDF]


 
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