Response to Letter Regarding Article, “Percutaneous Implantation of the CoreValve Self-Expanding Valve Prosthesis in High-Risk Patients With Aortic Valve Disease: The Siegburg First-in-Man Study”
We agree with Dr Grover and colleagues that on-pump surgical aortic valve replacement is currently the gold standard for operable patients with severe aortic valve stenosis. However, the need for general anesthesia, thoracotomy, and extracorporeal circulation results in a significant risk of morbidity and mortality, particularly in patients with numerous comorbid conditions.
The 2 most widely used risk algorithms for cardiac surgery are the Society of Thoracic Surgeons model and the more recently developed, externally validated EuroSCORE.1 From the EuroSCORE, a female “high-risk patient with baseline features of left ventricular failure, concomitant coronary artery disease, prior bypass graft surgery, chronic obstructive pulmonary disease and advanced age”—a not unusual constellation of comorbidities in high-risk patients—has a predicted mortality of 53.5%. In another study restricted to elderly patients, the hospital mortality ranged between 5.7% and 19.4%.2
Results of appropriate large surgical aortic valve replacement series in high-risk patients are actually not available because these patients are typically not referred to or accepted for surgery because of the expected likelihood of an unfavorable outcome. As mentioned accurately in our article, the prospective Euro Heart Survey, a study of 5001 patients from 25 European countries, reported that almost one third (31.8%) of patients with severe single-valve disease were not referred for surgery; the figure was 33% in the group of elderly patients with severe symptomatic aortic valve stenosis.3,4
We have reported the results of a “first-in-man” experience with a new device for percutaneous aortic valve replacement.5 This early experience demonstrated a remarkable reduction of the perioperative mortality from 3 of 7 (42.9%) in the first “compassionate use” cases to 2 of 18 (11.1%) in the subsequent cases. Moreover, although this technique is in its infancy, device modifications and procedural advances are proceeding. The device profile has now been reduced to 18F, allowing insertion without cardiopulmonary support, with further outcome improvements that will be published in the next few weeks. Surgeons are also beginning to embrace a transapical approach to catheter-based aortic valve replacement6 because of the reported and expected benefits.
Thus, we respectfully disagree with the statements of Grover et al on misinterpretation of both surgical and CoreValve study data; indeed, close collaboration between the interacting specialties, more data analysis from carefully collected surgical databases in high-risk patients, and confirmation of safety and efficacy of the percutaneous technique in larger series are required to move this field forward. Only then can the complementary roles of percutaneous and surgical approaches to patients with cardiac disease be defined.
Drs Grube and Laborde are consultants for CoreValve, SA. Dr Stone owns equity options in CoreValve, SA. The remaining authors report no conflicts.
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Grube E, Laborde JC, Gerckens U, Felderhoff T, Sauren B, Buellesfeld L, Mueller R, Menichelli M, Schmidt T, Zickmann B, Iversen S, Stone GW. Percutaneous implantation of the CoreValve self-expanding prostheses in high-risk patients with aortic valve disease: the Siegburg First-in-Man Study. Circulation. 2006; 114: 1616–1624.
Lichtenstein SV, Cheung A, Ye J, Thompson CR, Carere RG, Pasupati S, Webb SG. Transapical transcatheter aortic valve implantation in humans: initial clinical experience. Circulation. 2006; 114: 591–596.