A study published ahead of print in the Journal of American College of Cardiology: Cardiovascular Interventions supports a minimalist transfemoral approach to transcatheter aortic valve implantation (TAVI) for the treatment of high-risk and inoperable patients with aortic stenosis. Data from the study show that the minimalist approach is associated with shorter length of stay and a lower initial hospital cost with similar safety and efficacy to the standard approach in the hybrid operating room.
The study compared the safety, efficacy and cost of transfemoral TAVI performed in a catheterisation laboratory without general anaesthesia or transoesophageal echocardiography (minimalist approach) with the current standard transfemoral approach performed in a hybrid operating room.
Vasilis Babaliarous (Structural Heart and Valve Centre, Division of Cardiology, Emory University School of Medicine, Atlanta, Georgia, USA) and colleagues reviewed 142 patients with aortic stenosis who underwent transfemoral TAVI at their centre from November 2010 to September 2013 using the Sapien valve (Edwards Lifesciences).
The minimalist approach was performed in 70 patients and the standard approach in the hybrid operating room was performed in 72 patients; with both groups having a mean patient age older than 80 years and mean Society of Thoracic Surgeons mortality risk score of >10%. All patients were classified as high risk or inoperable for surgical aortic valve replacement by the structural heart team.
Babaliarous et al report that all patients in the minimalist approach group had a successful procedure, with one patient requiring intubation and intra-aortic balloon pump support due to wire entanglement of the papillary muscles causing severe mitral regurgitation (haemodynamics normalised after the wire was removed). In the standard approach group, the authors add, three patients had procedure-related deaths (one patient with massive aortic insufficiency despite a second valve placement and two patients with major vascular complications).
“There was a trend toward more frequent TAVI post-dilation in the minimalist approach group. Fluoroscopy time (28±10min vs. 32±11min; p=0.01), procedural time (93±32min vs. 125±46min; pË‚0.0001), and room time (150±48min vs. 218±56min; pË‚0.0001) were significantly less in the minimalist approach group,” they write.
The study showed that rates of stroke, bleeding complications and new pacemaker implantation were low and similar between groups. Patients in the minimalist approach group had reduced intensive care unit (ICU) stay and length of hospital stay. There was no in-hospital mortality with the minimalist approach group, whereas there was 4.2% mortality in the standard approach group (p=0.24). Mortality at 30 days was not significantly different between the two groups (0% in minimalist approach group vs. 6% in the standard approach group; p=0.12).
Furthermore, the authors found that cost (US$45,485±14,397 vs. US$55,377±22,587, pË‚0.001) was significantly less in the minimalist approach group.
“Our data support a minimalist approach strategy for the treatment of high-risk and inoperable patients with aortic stenosis. The advantage of the minimalist approach compared with the standard approach includes a shorter length of stay and a lower initial hospital cost without compromising safety or efficacy. Our data suggest that TAVI programmes that have a similar, considerable experience with the standard approach as our centre can safely perform the minimalist approach. We believe that the cost savings realised with the minimalist approach strategy will become even greater with the approval of newer generation, low-profile TAVI systems,” the authors conclude.