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Transcutaneous Aortic Valve Replacement With the Edwards SAPIEN XT and Medtronic CoreValve Prosthesis Under Fluoroscopic Guidance and Local Anaesthesia Only
Study Questions:
Is transcatheter aortic valve replacement (TAVR) with fluoroscopic guidance and local anesthesia feasible?
Methods:
This study evaluated 461 patients with severe aortic stenosis treated with TAVR using only local anesthesia and fluoroscopic guidance, and utilizing either the Medtronic CoreValve (n = 302) or the Edwards SAPIEN (n = 159) valve. Patients were treated with lidocaine for local anesthesia, piritramide as an analgesic, and metoclopramide and dimenhydrinate to prevent nausea. No echocardiography was used during the procedure, and aortic regurgitation was assessed angiographically.
Results:
TAVR was performed successfully in 459/461 cases. Conversion to general anesthesia was needed in four patients who required cardiopulmonary resuscitation, and conversion to conscious sedation was required in seven patients for agitation or hypotension. Aortic regurgitation grade ≥3 was observed in 3.3% of patients as measured by aortography. The rates of adverse outcomes were 5.0% (23/461) for 30-day mortality, 2.1% (10/461) for cerebral complications, and 7.1% (33/461) for vascular complications. The overall combined safety endpoint by VARC was 12.6% overall (12% in the Medtronic CoreValve group, and 9% in the Edwards SAPIEN group).
Conclusions:
The authors concluded that TAVR performed with local anesthesia and fluoroscopic guidance is feasible and had an overall low rate of conversion to general anesthesia or conscious sedation.
Perspective:
This study provides the experience of a single center that has used local anesthesia and fluoroscopic guidance throughout its entire TAVR experience, and reports a high success rate with a low rate of conversion to conscious sedation or general anesthesia. The advantages of this approach include the lack of the risks associated with general anesthesia and conscious sedation. Nevertheless, the lack of transesophageal echocardiography presents challenges in accurately assessing valve position, valve function, and aortic regurgitation. Aortography has clear limitations in grading aortic regurgitation, and it is unfortunate that the study does not report the results of post-procedural transthoracic echocardiography, as it is possible that the aortic regurgitation may be underestimated. Further, it is curious that the study did not utilize transthoracic echocardiography during TAVR to provide additional information regarding valve function. Finally, there was no control group in this study, so the relative safety and efficacy of this approach is not clear, and further study is needed.
Keywords: Nausea, Conscious Sedation, Cardiopulmonary Resuscitation, Hypotension, Heart Valve Prosthesis Implantation, Bioprosthesis, Lidocaine, Echocardiography, Transesophageal
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