Fig. 7.1
(a) BAV performed with a 22 mm balloon catheter in a woman with a mean annuls diameter of 21 mm. (b) Annulus rupture through the free LV myocardial occurred after the second aggressive balloon inflation. An evident contrast extravasation (white arrow) was identified during angiography. The patient was treated by unplanned TAVI but she died during the procedure
Other important issues of BAV procedure in female patients are smaller aortic annulus and smaller vascular access [15]. It has been demonstrated that women with AS have smaller body size and consequently smaller aortic annulus and reduced ileofemoral diameters compared to men [16]. A recent multicenter study, enrolling more than 600 patients with severe AS referred for TAVI, reported that females have smaller aortic annulus and body surface area than men [17]. Smaller aortic annulus has a potential risk of annulus rupture due to the relative balloon oversizing. Annulus rupture or perforation is a rare but catastrophic complication of BAV associated with a high risk of procedural death (Fig. 7.1) [5]. Despite technical improvement, recent reports show similar rates of annulus rupture as compared with previous studies, although this complication remains infrequent [6]. Accurate measurement of the aortic root using multidetector CT or transesophageal echocardiography is crucial for appropriate device sizing allowing to avoid this drawback. Furthermore, a moderately aggressive BAV technique, meaning utilization of balloons often undersized without the pursuit of achieving excellent hemodynamic results, allows to reduce the chances of annulus damage (Fig. 7.2).
Fig. 7.2
(a) Aortic angiography view of a female with a small aortic annulus. At transthoracic echocardiography mean annulus diameter was 19 mm. (b) Moderately aggressive BAV was performed successfully with the utilization of undersized balloon (18 mm balloon catheter) to reduce the risk of annulus damage
Vascular access is also an important issue in female patients undergoing BAV. Reduced ileofemoral diameters increase the sheath to femoral artery ratio, resulting in a higher risk of vascular complications which have been shown to be associated with significant increase in mortality [18]. Recently the introduction of newer balloon catheters that allow the use of a 10-F sheath instead of a 13-F sheath may contribute to reduce the incidence of vascular complications even in patients of small body size. Moreover, the precise assessment of ileofemoral diameter and calcification with the use multidetector computer tomography, in patients screened but not eligible for TAVI and treated with BAV, let to choose the better side for a safer vascular approach.
In the TAVI setting, the limited availability of device plays a crucial role, representing a major limitation for transarterial approach, especially for women with small femoral arteries. In such selected case, when alternative TAVI approaches are not available, BAV may also be considered a palliative measure.
Acute coronary occlusion from embolic calcium is another rare potential problem during BAV. In fact, Ben-Dor et al. reported an incidence of coronary occlusion/dissection after BAV about 0.6 % [5]. The shorter distance between coronary ostia and aortic annulus in female patients with small body size could increase the risk of coronary occlusion by calcium embolization [16]. Furthermore, the more advanced aortic disease in women associated with higher trans-aortic gradients and higher degree of leaflet calcifications may contribute to a higher incidence of coronary occlusion compared with men [13].
7.4 Impact of Female Gender on BAV Outcome
Predictors of mortality in patients undergoing BAV have been previously reported (Otto 1994).
Otto et al. analyzed the largest series of nonsurgical patients treated with BAV in 24 centers in North America and identified the female gender as an independent predictor of mortality [19]. However, the impact of sex on outcome after BAV remains unclear and to be defined. Recently, Ben-Dor et al. analyzed a large cohort of patients screened but not eligible for TAVI and treated with balloon valvuloplasty and reported that women had a higher survival rates compared to men [5]. Several reports confirmed this result, demonstrating that the female sex is associated with a better outcome even among patients undergoing TAVI [13]. Furthermore, in the retrospective subanalysis of the PARTNER trial, female subjects had a lower late mortality with TAVI versus SAVR [20].
Nevertheless, female gender is actually considered a risk factor for surgical procedure, even in isolated valve operation, both in the Society of Thoracic Surgeon (STS) predicted risk of mortality score and in the EuroSCORE II. Others studies, however, questioned this finding, reporting a significant better long-term survival in women compared with men after SAVR with a bioprosthesis [21]. A randomized controlled trial conducted in female high-risk patients with AS is necessary to study differences in mortality between treatment modalities.
Conclusion
With the recent introduction of TAVI, there has been resurgence in the use of BAV, either as a bridge to TAVI in patients at high risk of periprocedural complications or as an additional selection tool whenever there are doubts about the indications to TAVI.
In this setting, the effect of gender may be relevant to understand timing and opportunity of percutaneous intervention, but none of the studies have investigated gender-specific differences in outcomes after BAV. In the future, it seems mandatory to collect more prospective data to accurately evaluate risk and strategy for patients with severe AS with regard to sex.