“The procedure,” Dr. Hélène Eltchaninoff told Reuters Health by email, “has to be done in a medico-surgical environment with an echocardiogram available immediately if needed, a cardiothoracic surgeon if necessary and an experienced team.” However, as to limitations and disadvantages, she added, “We don’t see any.”
She and her colleagues, Dr. Eltchaninoff added, were able to “demonstrate the feasibility and safety of this ‘simplified’ strategy in more than 150 consecutive patients. We consider this ‘stent-like’ simplified strategy feasible in experienced hands and high-volume centers. Such a strategy might facilitate its expansion in the future.”
The investigators prospectively studied results from the approach in 151 high surgical risk patients with severe aortic stenosis. The transarterial femoral approach was surgical in all 78 SAPIEN procedures and a percutaneous approach was used in all but 2 of the 73 patients in the SAPIEN XT group.
The procedural success rate was 95.4% and at 30 days the combined safety-endpoint was reached in 15.9%. This included overall mortality (6.6%), major stroke (2.0%), life-threatening bleeding (7.9%), periprocedural MI (1.3%) and major vascular complication (7.9%). A repeat procedure for valve-related dysfunction was required in 2.0% and permanent pacemaker was required in 5.3%.
The researchers note that the outcomes “were comparable to other series in which most procedures were performed with general anesthesia and adjunct transesophageal echocardiography.”
The investigators conclude that “The benefit of this simplified strategy deserves further study in a larger series of patients receiving the SAPIEN XT valve.”
Dr. Augusto D. Pichard, co-author of an accompanying editorial, goes even further, telling Reuters Health by email that this pioneering work “has changed medicine for ever and has brought an effective, simple and safe treatment for patients with critical aortic stenosis.”
Dr. Pichard of Washington Hospital Center, Washington, DC added that “their ‘minimalist approach’ has provided unique perspectives on the best possible strategy to perform these procedures.”