Author + information
- Klaudija Bijuklic, MD∗ ( and )
- Joachim Schofer, MD, PhD
- ↵∗Hamburg University Cardiovascular Center, Woerdemansweg 25-27, Hamburg 20037, Germany
We thank Dr. Philip and colleagues for their interest in our study (1) and appreciate their comments.
In our study comparing transcatheter aortic valve implantation replacement (TAVR) with versus without balloon aortic valvuloplasty (BAV) in patients receiving a balloon-expandable aortic valve, we found a significantly shorter procedural duration and contrast volume, but a significantly higher total volume of cerebral ischemic lesions in patient without prior BAV (1).
Dr. Philip and colleagues hypothesized that a difference in procedural variables, not mentioned in our paper, may explain the difference in the observed findings.
The procedure variables were as follows:
In all patients, the aortic valve was crossed only 1 time, and the prosthesis was implanted using a routine 2-step slow-inflation technique. In the TAVR group with prior BAV, only 1 balloon inflation was performed.
In all patients, heparin was administered after insertion of the sheath, and an activated clotting time >250 s was maintained throughout the procedure.
In our study, post-dilation, which has been shown to be a significant predictor for stroke in TAVR (1), was only considered when a paravalvular leak more than mild was observed. Of 87 patients, 5 required post-dilation (5.7%): 1 patient in the BAV group (3.1%) and 4 patients in the group without BAV (7.3%). When patients with post-dilation were excluded from the analysis, the difference in the mean volume of ischemic lesions between the 2 groups remained statistically significant (243.4 ± 334.9 mm3 for 55 patients without BAV and 79.7 ± 117.4 mm3 for patients with BAV; p = 0.006).
Sizing was performed by transesophageal echocardiography or computed tomography. We therefore cannot provide data on the degree of oversizing. However, the use of the 3 available sizes (23, 26, and 29 mm) did not differ between the 2 groups (p = 0.79). In addition (as shown under Results) the echocardiographic baseline characteristics including mean gradient, effective orifice area, and annulus diameter were comparable between both groups (1).
We agree with Dr. Philip and colleagues that the aortic and aortic valve calcification may impact our magnetic resonance imaging findings. We do not have data on the degree of aortic/valve calcification.
However, as mentioned in the Results section, in patients considered for an Edwards SAPIEN 3 (Edwards Lifesciences, Irvine, California) TAVR without BAV, in those with severe asymmetric valve calcification or aortic valve effective orifice area ≤0.5 cm2—as measured by intraprocedural transesophageal echocardiography—BAV was performed (1). Although a higher embolic burden might have been expected in these patients, we observed a lower total volume of cerebral lesions in the patient cohort with BAV.
In summary, it is very unlikely that procedure variables can explain our findings.
Please note: The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- 2016 American College of Cardiology Foundation