Patients with bicuspid aortic valves (BAVs) are considered a relative contraindication to transcatheter aortic valve implantation (TAVI). One of the main reasons is the presumed risk for residual aortic regurgitation (AR). However, case reports and small case series have suggested that TAVI can be successfully performed with acceptable clinical outcomes in high-risk patients with BAV. Within the large German TAVI Registry, we sought to evaluate TAVI in older high-risk patients with BAV. From January 2009 to June 2010, a total of 1,424 patients with severe aortic stenosis undergoing TAVI were prospectively enrolled into the German TAVI Registry. For the present analysis, patients with valve-in-valve procedures were excluded and those with BAV (n = 38, 3%) were compared with those with tricuspid aortic valve (TAV; n = 1357, 97%). Patient characteristics did not markedly differ and procedural success was very high in both groups. There was a higher rate of relevant AR (≥II) after TAVI among patients with BAV (25 vs 15%, p = 0.05), whereas pacemakers were more often implanted in patients with TAV (17% vs 35%, p = 0.02). Thirty-day mortality rate was similar in both cohorts (11% vs 11%). In a Cox proportional regression analysis, BAV was not associated with higher 1-year mortality rate (hazard ratio 0.64, 95% confidence interval 0.29 to 1.41). In selected patients with BAV, TAVI can be performed with a satisfactory clinical result. Although the risk for relevant AR seems to be greater among patients with BAV, 30-day and 1-year mortality rates were not elevated compared with patients with TAV.
Bicuspid aortic valves (BAVs) are the most common congenital valvular abnormality, occurring in 1% to 2% of the general population and a male preponderance ratio of 2:1. BAVs are associated with increased mechanical stress, which predisposes to calcification and development of aortic stenosis (AS). Transcatheter aortic valve implantation (TAVI) is used to treat older high-risk patients with severe AS. Despite previous assumptions, the frequency of BAV seems to be quite high even among octogenarians with symptomatic AS. BAV has been considered a relative contraindication to TAVI. One of the main reasons is the presumed risk for relevant aortic regurgitation (AR). However, case reports and small case series have suggested that TAVI can be successfully performed with acceptable clinical outcomes in high-risk patients with BAV. Within the German TAVI Registry, which prospectively enrolled unselected patients from 2009 until 2010, we compared patients with BAV with those with tricuspid aortic valves (TAVs) treated with TAVI.
Methods
The German TAVI Registry is a multicenter prospective registry. It has already been described in detail. In brief, the aim was to monitor the use and outcome of transcatheter aortic valve interventions, including TAVI and balloon valvuloplasty alone, in daily clinical practice and evaluate safety, effectiveness, and health-economical data. Both publication and project were supported by unrestricted grants from foundation Stiftung Institut für Herzinfarktforschung. From January 2009 until June 2010, all participating hospitals committed to include all consecutive patients with severe symptomatic AS treated with either balloon valvuloplasty alone or TAVI. Proposed inclusion criteria for treatment were the following: severe symptomatic AS with a valve area ≤1 cm 2 , with or without aortic valve regurgitation and (1) age ≥80 years and a logistic EuroSCORE ≥20% or (2) logistic EuroSCORE <20% and at least 1 of the following criteria: cirrhosis of liver, pulmonary insufficiency (FEV1 ≤1 L), or porcelain aorta. Furthermore, technical feasibility such as a feasible arterial access and a fitting aortic annulus diameter according to the available prostheses sizes should have been given. All patients gave written informed consent before the procedure and for processing of their anonymous data. The registry was open to all available prostheses. However, 2 prostheses were predominately used: the Medtronic CoreValve (Irvine, California) and the Edwards SAPIEN (Edwards Lifesciences LLC, Irvine, California) prostheses. For the present study, patients with valve-in-valve procedures (n = 29) were excluded. Patients with BAV (n = 38, 2.7%) were compared with those with TAV (n = 1,357, 97.3%). However, diagnosis of BAV was not fixed before and left to the treating physician. Procedural success was defined as deployment of the valve as intended, without need for conversion to immediate surgery. The degree of postprocedural AR was angiographically evaluated at the end of the TAVI procedure after final device deployment and removal of the catheter and guidewire. Qualitative angiographic assessment of the severity of AR was performed by visual estimation of the concentration of the contrast medium in the left ventricle, using the method by Sellers et al Categorical data are presented as absolute numbers and percentages, metrical data as mean ± SD or medians and quartiles. The frequencies of categorical variables in 2 populations were compared by Pearson chi-square test, the distributions of metrical variables by Mann-Whitney-Wilcoxon test. Descriptive statistics were calculated from the available cases. Furthermore, Cox proportional regression analysis was performed to determine the impact of BAV on 1-year mortality. The multivariate analysis included as explanatory variables age, female gender, low gradient AS, myocardial infarction, pulmonary hypertension, 3-vessel disease, peripheral arterial disease, chronic obstructive lung disease, previous cardiac surgery, diabetes mellitus, shock/decompensation, ejection fraction ≤30%, mitral insufficiency II+, renal insufficiency, previous balloon valvuloplasty, New York Heart Association class IV, and transapical/transaortic TAVI. p Values ≤0.05 were considered significant. All p values are results of 2-tailed tests. The analysis was performed with the SAS system, release 9.2, on a personal computer (SAS Institute Inc., Cary, North Carolina).
Results
From January 2009 to June 2010, a total of 1,424 patients with severe AS undergoing TAVI were prospectively enrolled into the German TAVI Registry. For the present analysis, patients with valve-in-valve procedures (n = 29) were excluded and those with BAV (n = 38, 3%) were compared with those with TAV (n = 1,357, 97%). The baseline characteristics of the patients are listed in Table 1 . There were no major differences between the 2 groups. Frailty was much more often an indication for TAVI among those with TAV ( Table 2 ). Procedural success was very high in both patient collectives; however the risk of residual AR ≥II was elevated in patients with BAV. Pacemakers were more often implanted in patients with TAV ( Table 2 ). During hospital stay, 1 patient with BAV underwent reoperation for an aortic dissection. Among those with TAV, 16 patients underwent reoperation and 33 reintervention. The reasons were cardiac tamponade (35%), prosthesis failure (19%), bleeding (17%), aortic dissection (10%), coronary obstruction (6%), low cardiac output (6%), and others (18%). Thirty-day mortality rate was similar in both cohorts, but there was a tendency toward a lower death rate after 1 year in the BAV group ( Figure 1 ). In the univariate analysis (hazard ratio 0.55, 95% CI 0.26 to 1.18) and the Cox regression analysis (hazard ratio 0.64, 95% CI 0.29 to 1.41), BAV was not associated with higher 1-year mortality rate. The rate of nonfatal adverse events was low in both groups. In the BAV group, 1-year mortality rate was markedly elevated among those with residual AR ≥II (22% vs 7%). Because of the small number of patients, the level of significance was missed (p = 0.61).
| Variable | BAV (n = 38) | TAV (n = 1,357) | p Value |
|---|---|---|---|
| Age (yrs) | 80.7 ± 6.6 | 81.8 ± 6.2 | NS ∗ |
| Women | 55 | 58 | NS |
| BMI (kg/m²) | 26 ± 5 | 27 ± 8 | NS ∗ |
| Previous percutaneous coronary intervention | 34 | 35 | NS |
| Previous coronary bypass | 13 | 18 | NS |
| Previous valve surgery | 3 | 2 | NS |
| Previous balloon valvuloplasty | 18 | 12 | NS |
| Previous pacer/ICD implantation | 11 | 14 | NS |
| Previous stroke | 13 | 8 | NS |
| Diabetes mellitus | 37 | 34 | NS |
| Chronic renal insufficiency | 58 | 61 | NS |
| Chronic obstructive lung disease | 21 | 24 | NS |
| Peripheral arterial disease | 11 | 22 | NS |
| Malignancy | 11 | 5 | NS |
| Preinterventional findings | |||
| NYHA III/IV | 84 | 89 | NS |
| Shock/decompensation | 21 | 24 | NS |
| ASA III–V | 87 | 70 | NS |
| Logistic EuroSCORE (%) | 18 ± 10 | 20 ± 13 | NS ∗ |
| Aortic valve area (cm 2 ) | 0.68 ± 0.22 | 0.68 ± 0.43 | NS ∗ |
| Delta P peak mean (mm Hg) | 47.1 ± 19.6 | 49.6 ± 19.1 | NS ∗ |
| Ejection fraction (%) | 50 ± 16 | 53 ± 15 | NS ∗ |
| Low-gradient AS | 11 | 11 | NS |
| Aortic insufficiency II+ | 29 | 20 | NS |
| Mitral insufficiency II+ | 37 | 33 | NS |
| Aortic annulus (mm) | 21 ± 7 | 23 ± 3 | NS ∗ |
| Severely calcified valve | 58 | 67 | NS |
| Porcelain aorta | 3 | 11 | NS |
| No coronary artery disease | 32 | 40 | NS |
| Multivessel disease | 53 | 38 | NS |
| Left main disease | 11 | 6 | NS |
| Pulmonary hypertension | 58 | 66 | NS |
| Variable | BAV (n = 38) | TAV (n = 1,357) | p Value |
|---|---|---|---|
| Indication for intervention | |||
| High surgical risk (EuroSCORE >20%) | 63 | 73 | NS |
| Age | 45 | 58 | NS |
| Frailty | 5 | 18 | 0.05 |
| Limiting concomitant malignancy | 11 | 5 | NS |
| Patients’ decision | 16 | 19 | NS |
| Urgency of intervention | |||
| Elective | 95 | 83 | NS |
| Urgent | 5 | 16 | NS |
| Emergency | 0 | 1 | NS |
| Type of access | |||
| Transapical | 16 | 9 | NS |
| Transaortic | 3 | 1 | NS |
| Transfemoral | 82 | 88 | NS |
| Transaxillary | 0 | 3 | NS |
| Type of valve | |||
| CoreValve | 68 | 82 | 0.04 |
| Edwards SAPIEN | 32 | 18 | 0.04 |
| Procedural characteristics | |||
| Intervention time (min) | 106 ± 84 | 90 ± 48 | NS ∗ |
| Fluoroscopy time (min) | 16:3 ± 7:3 | 15:4 ± 7:4 | NS ∗ |
| Amount of contrast dye used (ml) | 184 ± 87 | 164 ± 71 | NS ∗ |
| Interventional closure of puncture site | 97 | 91 | NS |
| Surgical closure of puncture site | 3 | 9 | NS |
| Concomitant PCI | 5 | 4 | NS |
| Procedural results | |||
| Procedural success | 100 | 97 | NS |
| Conversion to open heart surgery | 0 | 1 | NS |
| Unsuccessful termination of the procedure | 0 | 1 | NS |
| Gradient after the procedure (mm Hg) | 5.5 ± 7.1 | 5.9 ± 6.8 | NS |
| Residual aortic insufficiency II+ | 25 | 15 | 0.05 |
| Clinical course | |||
| Pacemaker implantation | 17 | 35 | 0.02 |
| Stroke | 0 | 3 | NS |
| Groin problems | 25 | 22 | NS |
| Myocardial infarction | 0 | 1 | NS |
| Time at intensive care unit (days) | 3.4 ± 2.9 | 3.2 ± 3.0 | NS |
| Reoperation/intervention | 3 | 4 | NS |
| Low cardiac output | 14 | 7 | NS |
| Pulmonary embolism | 0 | 2 | NS |
| In-hospital death | 11 | 8 | NS |
| 30-Day death | 11 | 11 | NS |
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