key messages

• The bicuspid valve, the most common congenital valve anomaly, is a regular occurrence in patients undergoing TAVI
• Data on the performance of TAVI in bicuspid valves is essentially observational and based on small samples.
• The BIVOLUTX registry is an international, multi-center, and prospective registry that includes 149 consecutive bicuspid aortic valve patients scheduled for TAVI with an EVOLUT self-expanding supraannular valve
• In this registry, we observe a success rate in device implantation and satisfactory hemodynamic performance, but a high rate of neurological complications and pacemaker implantation after TAVI.
• No difference was found in the size method (annular or annular + supraannular).

introduction

Percutaneous aortic valve replacement (TAVI) is the reference treatment for severe symptomatic aortic stenosis in people 75 years and older, regardless of surgical risk. ⁽¹⁾. The bicuspid valve is a congenital valvular defect that affects approximately 2% of the general population and predisposes to the development of earlier valvular dysfunction ⁽²⁾. Approximately 0.5% of surgical aortic valve replacement cases for aortic stenosis in developed countries involve bicuspid valves ⁽³⁾. Thus, patients with a bicuspid valve had a higher risk of paravalvular leaks, pacemaker implantation, and aortic dissection with first-generation valves. ^(4.5)TAVI results appear to be comparable with the latest generation devices in tricuspid and bicuspid patients ^(6.7). Nevertheless, these data are based on observational data based on small samples.

The aim of the BIVOLUTX study was to evaluate the performance of TAVI with a self-expanding EVOLUT supraannular valve in patients with a bicuspid valve and to analyze the impact of CT sizing algorithms in this context.

Methodology and Results

The BIVOLUTX Registry is an international, multicenter, and prospective registry that includes 149 consecutive patients with bicuspid aortic valves scheduled for TAVI with a self-expanding supraannular valve EVOLUT-PRO 23, 26, or 29mm or EVOLUT-R 34mm (Medtronicâ) in 14 countries in Europe and Canada. The anatomy of the premolars was classified according to the Sievers classification. Inclusion criteria included symptomatic narrow aortic stenosis with indication for TAVI via the femoral approach with a supraannular self-expanding EVOLUT valve. The primary endpoint was valve performance at 30 days, assessed by an independent core echocardiography laboratory and defined by a mean transvalvular gradient <20 mmHg or a maximum transvalvular velocity <3 m/b and the absence of moderate or severe valve leak.

The pre-TAVI scanning method of sizing was left to the discretion of the surgeon, using two main methods: 77 patients (51.7%) had sizing based on the size of the ligament, while 72 patients (48.3%) used Die Dimensioning was based on annular and supraannular dimensions.

The baseline characteristics of the population are presented in Table 1. The mean age of the population was 78 years, 63.1% of the patients were male, and the mean STS score was 2.6%. The most common bicuspid phenotype was type I LR (72.5%), while 10.1% were type 0 and 3.3% were type 2.

To paint 1. Baseline characteristics of the study patients.

Most valve sizes used were 29 and 34 mm (49.0% and 36.9%, respectively). Pre-dilation was performed in 87.2% of cases and post-dilation in 55.7% of cases. It should be noted that there was one death related to a lead LV perforation per procedure. The successful implantation rate of the device was 91.3%. The reasons for implantation failure were as follows: TAVI-in-TAVI (3 patients, 2.0%), tamponade (4 patients, 2.7%) with conversion to open surgery in 2 patients, LV perforation (2 patients, 1.3%), mitral device damage (3 patients, 2.0%), and death per procedure (1 patient, 0.7%).

At 30 days, the cardiovascular death rate was 2.6% and the non-cardiovascular death rate was 1.3%. Seven patients (4.6%) had a stroke, 6 patients (4.0%) had serious vascular complications, and 29 patients (19.5%) had a cardiac pacemaker implantation.

At one year, the mortality rate was 11.0%. A stroke occurred in 9 patients (7.1%) and a cardiac pacemaker was implanted in 33 patients (25.6%).

The primary endpoint of valve performance was observed in 142 patients (95.3%): 74 patients (96.1%) in the ring size group vs. 68 patients (94.4%) (p=0.9) in the size group together. Valve performance results at 30 days and 1 year were comparable with both sizing methods (Figure 1).

figure 1. Main results of the study.

.

Results

The BIVOLUTX registry provides new data on the performance of TAVI with an EVOLUT self-expanding supraannular valve in bicuspid valve patients: a success rate of device implantation and satisfactory hemodynamic performance, but a rate of neurological complications and pacemaker implantation after TAVI. Finally, no difference in size method (annular or annular + supraannular) was highlighted.

references

1. Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, et al. 2021 ESC/EACTS Guidelines for the Management of Valvular Heart Disease. Eur Heart J 2021;ehab395.
2. Siu SC, Silversides CK. Bicuspid aortic valve disease. J Am Coll Cardiol 2010;55:2789-800.
3. Beyersdorf F, Bauer T, Freemantle N, Walther T, Frerker C, Herrmann E, et al. Five-year result in 18,010 patients from the German aortic valve register. Eur J Cardiothorac Surg 2021;60:1139-46.
4. Bauer T, Linke A, Sievert H, Kahlert P, Hambrecht R, Nickenig G, et al. Comparison of the effectiveness of transcatheter aortic valve implantation in patients with stenotic bicuspid and tricuspid aortic valves (from the German TAVI registry). Am J Cardiol 2014;113:518-21.
5. Mylotte D, Lefevre T, Søndergaard L, Watanabe Y, Modine T, Dvir D, et al. Transcatheter aortic valve replacement in bicuspid aortic valve disease. J Am Coll Cardiol 2014;64:2330-9.
6. Yoon SH, Kim WK, Dhoble A, Milhorini Pio S, Babaliaros V, Jilaihawi H, et al. Bicuspid aortic valve morphology and outcome after transcatheter aortic valve replacement. J Am Coll Cardiol 2020;76:1018-30.
7. Waksman R, Craig PE, Torguson R, Asch FM, Weissman G, Ruiz D, et al. Transcatheter aortic valve replacement in low-risk patients with symptomatic severe bicuspid aortic stenosis. JACC Cardiovascular Interv 2020;13:1019-27.