Background—: Bicuspid aortic valve (BAV) is regarded as a relative contraindication to transcatheter aortic valve implantation attributable to the risk of uneven expansion of the bioprosthesis. The purpose of this study was to evaluate the efficacy and safety of transcatheter aortic valve implantation in patients with BAV. Methods and Results—: Of 470 patients included in our prospective transcatheter aortic valve implantation database (October 2006–January 2012), 229 consecutive patients undergoing both echocardiography and multidetector computed tomography were analyzed. We compared clinical outcomes in patients with vs patients without BAV. In this series of 229 patients, BAV was detected by multidetector computed tomography in 21 patients (9.2%). BAV was identified by transthoracic and transoesophagal echocardiography in only 9 of these 21 patients. Patients were 83.1±6.6 years old, and European system for cardiac operative risk evaluation score was 20.0%±11.4%. The BAV group was similar to the non-BAV group except for diabetes mellitus (4.8% vs 24.0%; P =0.05). The aortic annulus diameter in BAV patients was not significantly larger by multidetector computed tomography (24.7±3.0 vs 23.7±1.9 mm; P =0.07). The CoreValve was used more frequently in the BAV group (47.6% vs 16.3%; P =0.002). There was no significant difference in device success (100% vs 92.8%; P =0.37), risk of annulus rupture (0% vs 1.4%; P =1.00), or valve migration (0% vs 1.4%; P =1.00) in BAV patients compared with non-BAV patients. Postprocedural mean gradient (10.0±3.4 vs 9.7±4.1 mm Hg; P =0.58), aortic regurgitation ≥2 of 4 (19.0% vs 14.9%; P =0.54), 30-day mortality (4.8% vs 8.2%; P =1.00), and 30-day combined safety end point (14.3% vs 13.5%; P =1.00) were also similar in both groups. Conclusions—: In selected BAV patients, transcatheter aortic valve implantation may be associated with low complication rate, efficacy, and acceptable outcomes similar to those in non-BAV patients.

The authors aimed to compare long-term data of an ultrathin cobalt-chromium stent with passive silicon carbide coating and an active biodegradable polymer that releases sirolimus (O-SES) (Orsiro, BIOTRONIK, Bülach, Switzerland) with the durable polymer-based Xience Prime everolimus-eluting stent (X-EES) (Abbott Vascular, Santa Clara, California). Biodegradable polymer stents have been developed aiming to overcome long-term detrimental effects of durable polymer stents, ultimately leaving a bare-metal stent in the vessel. This multicenter, assessor-blinded trial randomized 452 patients with 505 lesions to either O-SES or X-EES in a 2:1 fashion. Endpoints at 5 years were target lesion failure (TLF), its components, and stent thrombosis. TLF occurred in 10.4% (n = 30) of O-SES patients versus 12.7% (n = 19) of X-EES patients (p = 0.473), overall stent thrombosis occurred in 0.7% (n = 2) versus 2.8% (n = 4) (p = 0.088), and definite stent thrombosis in 0% versus 0.7% (n = 1) (p = 0.341). Post hoc analysis was performed in diabetic patients (n = 128) and vessels ≤2.75 mm (n = 259). In diabetic patients, the O-SES group had numerically more target lesion revascularizations (13.5% vs. 4.5%; p = 0.138), but fewer cardiac deaths (1.3% vs. 6.9%; p = 0.089) and stent thrombosis (0% vs. 6.9%; p = 0.039). In small vessels, the O-SES group had a significantly lower 5-year mortality (3.7% vs. 11.3%; p = 0.022). At 5 years, the biodegradable polymer O-SES demonstrated low TLF rates comparable to the durable polymer X-EES, confirming its long-term safety and performance. Particularly encouraging is the absence of definite stent thrombosis.

Transcatheter aortic valve implantation (TAVI) in patients with poor peripheral vessels still remains problematic, as the transapical approach is not always feasible and is sometimes associated with myocardial damage, bleeding, post-procedural chest pain and pleural effusion. In order to address these issues, we adopted the recently introduced transaortic (TAo) approach. The purpose of this study was to evaluate the efficacy and safety of the TAo-TAVI approach using both the Sapien XT and the CoreValve according to VARC criteria. Of 492 patients (October 2006 to February 2012), TAo-TAVI was performed in 94 consecutive patients with unfavourable peripheral access between January 2011 and February 2012. Aortic root condition, valve anatomy and annulus size were carefully assessed by multidetector computed tomography (MDCT) for possible TAo-TAVI. The aorta was exposed through an inverted ‘T’ manubriotomy. After retrograde guidewire crossing of the aortic valve, sheath insertion allowed device positioning and deployment subsequent to balloon valvuloplasty. Mean age was 84.1 ± 5.4 years (67–96) and logistic EuroSCORE 17.6 ± 10.2%. The Sapien XT was used in 88.3% and the CoreValve in 11.7% of patients. Full sternotomy allowed concomitant complete off-pump revascularization (2–4 grafts) in 11 patients. Device success rate was 92.6%. Paravalvular leak ≥2/4 was observed in 7.4%. Conversion to open chest surgery was required in 5.3% (3 aortic dissections, 1 valve migration and 1 left main occlusion). Three cerebrovascular accidents (2 transient ischaemia and 1 delayed stroke) were noted. Transfusion ≥4 units was performed in 12 patients (12.8%). Intensive care unit (ICU) and total hospital stay were 4.9 ± 5.0 and 12.2 ± 6.2 days, respectively. Thirty-day mortality and combined safety endpoint were reported in 7.4 and 16.0%, respectively. The TAo approach for both Sapien XT and CoreValve implantation can be used with satisfactory clinical outcome and an acceptable risk. This access route could prove a valid alternative to the transapical approach.