Long-Term Mortality After TAVI for Bicuspid vs. Tricuspid Aortic Stenosis: A Propensity-Matched Multicentre Cohort Study.
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ABSTRACT: Objectives
Patients with bicuspid aortic valve (BAV) stenosis were excluded from the pivotal trials of transcatheter aortic valve implantation (TAVI). We compared the in-hospital and long-term outcomes between patients undergoing TAVI for bicuspid and tricuspid aortic valve (TAV) stenosis.Methods
We performed a retrospective registry-based analysis on patients who underwent TAVI for BAV and TAV at five different centers between January 2009 and August 2017. The primary outcome was long-term all-cause mortality. Secondary outcomes were in-hospital mortality, procedural complications, and valve performance.Results
Of 1,451 consecutive patients who underwent TAVI, two propensity-matched cohorts consisting of 130 patients with BAV and 390 patients with TAV were analyzed. All-cause mortality was comparable in both groups up to 10 years following TAVI (HR 1.09, 95% CI: 0.77-1.51). Device success and in-hospital mortality were comparable between the groups (96 vs. 95%, p = 0.554 and 2.3 vs. 2.1%, p = 0.863, respectively). Incidence of procedural complications was similar in both groups, with a trend toward a higher rate of stroke in patients with BAV (5 vs. 2%, p = 0.078). Incidence of moderate or severe paravalvular leak (PVL) at discharge was comparable in both groups (2 vs. 2%, p = 0.846). Among patients with BAV, all-cause mortality was similar in self-expanding and balloon-expandable prostheses (HR 1.02, 95% CI: 0.52-1.99) and lower in new-generation devices compared to old-generation valves (HR 0.27, 95% CI 0.12-0.62).Conclusion
Patients who had undergone TAVI for BAV had comparable mortality to patients with TAV up to 10 years after the procedure. The device success, in-hospital mortality, procedural complications, and PVL rate were comparable between the groups. The high rate of neurological complications (5%) in patients with BAV warrants further investigation.
SUBMITTER: Gasecka A
PROVIDER: S-EPMC9253589 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectiveTo compare 1-year outcomes in patients at low surgical risk with bicuspid aortic valve stenosis (AS) following transcatheter aortic valve replacement (TAVR) and low-risk patients with tricuspid AS following surgical aortic valve replacement (SAVR).BackgroundThe pivotal randomized, prospective, multicenter TAVR trials compared TAVR vs SAVR in patients with tricuspid AS. No such trials exist for bicuspid AS.MethodsThe Low Risk Bicuspid Study is a prospective, single-arm, TAVR trial that enrolled 150 patients from 25 sites in the United States. A screening committee confirmed bicuspid anatomy and valve classification based on computed tomography using the Sievers classification. Annular measurements guided valve sizing. These patients were propensity-matched to the SAVR patients in the randomized Evolut Low Risk Trial using 1:1 5-to-1-digit Greedy method, resulting in 144 matched pairs. For both trials, an independent clinical events committee adjudicated all serious adverse events, and the same independent core laboratory assessed all echocardiograms.ResultsThe 1-year composite of death, disabling stroke, or aortic valve-related rehospitalization for bicuspid TAVR vs tricuspid SAVR was 6 (4.2%) vs 6 (4.2%) (P = .99). The effective orifice area (2.2 ± 0.7 cm2 vs 2.0 ± 0.6 cm2) was larger and the valve gradient was lower (8.7 ± 3.9 mm Hg vs 11.2 ± 4.7 mm Hg) in the TAVR group at 1 year (both P < .001). Moderate/severe aortic regurgitation was present in 1 TAVR and 2 SAVR patients (0.8% vs 1.6%; P > .99).ConclusionsIn this select group of low-risk bicuspid patients, in the short-term follow-up, TAVR appears to have similar outcomes to those seen in comparable low-risk tricuspid patients undergoing SAVR.
| S-EPMC11307701 | biostudies-literature
Project description:ImportanceTranscatheter aortic valve replacement (TAVR) indications are expanding, leading to an increasing number of patients with bicuspid aortic stenosis undergoing TAVR. Pivotal randomized trials conducted to obtain US Food and Drug Administration approval excluded bicuspid anatomy.ObjectiveTo compare the outcomes of TAVR with a balloon-expandable valve for bicuspid vs tricuspid aortic stenosis.Design, setting, and participantsRegistry-based prospective cohort study of patients undergoing TAVR at 552 US centers. Participants were enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapies Registry from June 2015 to November 2018.ExposuresTAVR for bicuspid vs tricuspid aortic stenosis.Main outcomes and measuresPrimary outcomes were 30-day and 1-year mortality and stroke. Secondary outcomes included procedural complications, valve hemodynamics, and quality of life assessment.ResultsOf 81 822 consecutive patients with aortic stenosis (2726 bicuspid; 79 096 tricuspid), 2691 propensity-score matched pairs of bicuspid and tricuspid aortic stenosis were analyzed (median age, 74 years [interquartile range {IQR}, 66-81 years]; 39.1%, women; mean [SD] STS-predicted risk of mortality, 4.9% [4.0%] and 5.1% [4.2%], respectively). All-cause mortality was not significantly different between patients with bicuspid and tricuspid aortic stenosis at 30 days (2.6% vs 2.5%; hazard ratio [HR], 1.04, [95% CI, 0.74-1.47]) and 1 year (10.5% vs 12.0%; HR, 0.90 [95% CI, 0.73-1.10]). The 30-day stroke rate was significantly higher for bicuspid vs tricuspid aortic stenosis (2.5% vs 1.6%; HR, 1.57 [95% CI, 1.06-2.33]). The risk of procedural complications requiring open heart surgery was significantly higher in the bicuspid vs tricuspid cohort (0.9% vs 0.4%, respectively; absolute risk difference [RD], 0.5% [95% CI, 0%-0.9%]). There were no significant differences in valve hemodynamics. There were no significant differences in moderate or severe paravalvular leak at 30 days (2.0% vs 2.4%; absolute RD, 0.3% [95% CI, -1.3% to 0.7%]) and 1 year (3.2% vs 2.5%; absolute RD, 0.7% [95% CI, -1.3% to 2.7%]). At 1 year there was no significant difference in improvement in quality of life between the groups (difference in improvement in the Kansas City Cardiomyopathy Questionnaire overall summary score, -2.4 [95% CI, -5.1 to 0.3]; P = .08).Conclusions and relevanceIn this preliminary, registry-based study of propensity-matched patients who had undergone transcatheter aortic valve replacement for aortic stenosis, patients with bicuspid vs tricuspid aortic stenosis had no significant difference in 30-day or 1-year mortality but had increased 30-day risk for stroke. Because of the potential for selection bias and the absence of a control group treated surgically for bicuspid stenosis, randomized trials are needed to adequately assess the efficacy and safety of transcatheter aortic valve replacement for bicuspid aortic stenosis.
| S-EPMC6563564 | biostudies-literature
Project description:OBJECTIVES:To compare aortic size and stiffness parameters on MRI between bicuspid aortic valve (BAV) and tricuspid aortic valve (TAV) patients with aortic stenosis (AS). METHODS:MRI was performed in 174 patients with asymptomatic moderate-severe AS (mean AVAI 0.57?±?0.14 cm2/m2) and 23 controls on 3T scanners. Valve morphology was available/analysable in 169 patients: 63 BAV (41 type-I, 22 type-II) and 106 TAV. Aortic cross-sectional areas were measured at the level of the pulmonary artery bifurcation. The ascending and descending aorta (AA, DA) distensibility, and pulse wave velocity (PWV) around the aortic arch were calculated. RESULTS:The AA and DA areas were lower in the controls, with no difference in DA distensibility or PWV, but slightly lower AA distensibility than in the patient group. With increasing age, there was a decrease in distensibility and an increase in PWV. After correcting for age, the AA maximum cross-sectional area was higher in bicuspid vs. tricuspid patients (12.97 [11.10, 15.59] vs. 10.06 [8.57, 12.04] cm2, p?<?0.001), but there were no significant differences in AA distensibility (p?=?0.099), DA distensibility (p?=?0.498) or PWV (p?=?0.235). Patients with BAV type-II valves demonstrated a significantly higher AA distensibility and lower PWV compared to type-I, despite a trend towards higher AA area. CONCLUSIONS:In patients with significant AS, BAV patients do not have increased aortic stiffness compared to those with TAV despite increased ascending aortic dimensions. Those with type-II BAV have less aortic stiffness despite greater dimensions. These results demonstrate a dissociation between aortic dilatation and stiffness and suggest that altered flow patterns may play a role. KEY POINTS:• Both cellular abnormalities secondary to genetic differences and abnormal flow patterns have been implicated in the pathophysiology of aortic dilatation and increased vascular complications associated with bicuspid aortic valves (BAV). • We demonstrate an increased ascending aortic size in patients with BAV and moderate to severe AS compared to TAV and controls, but no difference in aortic stiffness parameters, therefore suggesting a dissociation between dilatation and stiffness. • Sub-group analysis showed greater aortic size but lower stiffness parameters in those with BAV type-II AS compared to BAV type-I.
| S-EPMC6443917 | biostudies-literature
Project description:Background: Subclinical leaflet thrombosis (SLT) is an important sequela that compromises the durability of the bioprosthetic valve. Objectives: To better determine the effect of SLT in bicuspid aortic valve (BAV), we performed a retrospective assessment of CT-defined SLT in BAV and tricuspid aortic valve (TAV) stenotic patients. Methods: We consecutively collected patients undergoing the TAVR between August 2015 and March 2020 in our center. A total of 170 BAV and 201 TAV cases were enrolled. Multidetector computed tomography was performed within 30 days and at 1-year. Results: Twenty cases in the BAV group and 19 cases in the TAV group had hypoattenuated leaflet thickening (HALT) in 30 days (12.5 vs. 9.9%, p = 0.449), and 52 cases in BAV and 61 cases in TAV had the HALT (34.9 vs. 36.7%, p = 0.733) at 1-year follow-up. The mean aortic gradient (MAG) and effective orifice areas (EOA) values were comparable between the two groups at 30 days (HALT vs. no HALT; 10.8 ± 4.8 vs. 11.3 ± 6.0, p = 0.638; 1.6 ± 0.4 vs. 1.6 ± 0.3, p = 0.724), and still, no difference was observed in the MAG at 1-year (11.5 ± 5.6 vs. 10.6 ± 5.1, p = 0.164). However, the EOA at 1-year was statistically different between the two groups (1.5 ± 0.3 vs. 1.6 ± 0.4, p = 0.004). The multivariate logistic regression analysis demonstrated the anticoagulation and age as independent predictors both in the BAV and TAV groups at 1-year. There was no difference in clinical events between the HALT and no HALT group in relevant to BAV or TAV at 1-year follow-up. Conclusions: The presence of subclinical leaflet thrombosis defined by the CT was comparable between the BAV and TAV in the first year after the TAVR procedure. Age and anticoagulation were the independent predictors of the subclinical leaflet thrombosis at 1 year after the TAVR. There was no difference in relevant clinical events between the BAV and TAV groups at 1-year follow-up.
| S-EPMC8727537 | biostudies-literature
Project description:BackgroundTranscatheter aortic valve replacement (TAVR) is the preferred option for high-risk patients with severe aortic stenosis. The preferred access for TAVR is transfemoral (TF). Alternatives include the transapical (TA), trans-subclavian (TS), and direct aortic (TAo) approaches.HypothesisThe TF approach is associated with lower in-hospital outcomes as well as shorter length of stay and lower cost of hospitalization.MethodsThe National Inpatient Sample database from 2012 through 2014 was used to obtain the TAVR study population. International Classification of Diseases, 9th Revision, Clinical Modification procedure codes were utilized to identify the 2 groups. In-hospital outcomes were compared in propensity-score-matched (1:3) cohorts, in which we took TA-TAVR as a control.ResultsA total of 8210 (weighted N = 41 050) patients were identified. Of these, 1622 (weighted N = 8110) patients underwent TA-TAVR and 6588 (weighted N = 32 940) patients underwent TF-TAVR. In-hospital mortality was lower with TF-TAVR (4% vs 5.4%; P = 0.0355), along with a shorter length of stay (7.7 vs 9.7 days; P < 0.0001) and lower median hospitalization cost ($64 216 vs $74 735; P < 0.0001). Secondary outcomes of acute renal failure, transfusion, cardiogenic shock, and composite of all complications were lower with TF-TAVR.ConclusionsTF-TAVR is safer and associated with lower in-hospital outcomes compared with TA-TAVR and should be the preferred approach. As TAVR is gaining popularity in intermediate- and low-risk patients, we must not lose sight of the serious mortality and secondary outcomes associated with TA-TAVR access.
| S-EPMC6490061 | biostudies-literature
Project description:BackgroundTo explore why bicuspid aortic stenosis has certain clinical differences from the tricuspid morphology, we evaluated the metabolomics profile involved in bicuspid aortic valve (BAV) aortic stenosis prior to and after transcatheter aortic valve replacement (TAVR) in comparison with tricuspid aortic valve (TAV).MethodsIn this TAVR cohort with prospectively collected data, blood samples were obtained before TAVR valve deployment and at the 7th day after TAVR, which were then sent for liquid and gas chromatography-mass spectrometry detection. Besides comparisons between BAV and TAV, BAV patients were also divided in subgroups according to baseline hemodynamics (i.e. maximal transaortic velocity, Vmax) and post-procedural reverse left ventricular (LV) remodeling (i.e. the change in LV mass index from baseline, ∆LVMI) for further analysis. Metabolic differences between groups were identified by integrating univariate test, multivariate analysis and weighted correlation network analysis algorithm.ResultsA total of 57 patients were enrolled including 33 BAV patients. The BAV group showed lower arginine and proline metabolism both before and post TAVR than TAV represented by decreased expression of L-Glutamine. In BAV subgroup analysis, patients with baseline Vmax > 5 m/s (n = 11) or the 4th quartile of change in ∆LVMI at one-year follow-up (i.e. poorly-recovered LV, n = 8) showed elevated arachidonic acid metabolism compared with Vmax < 4.5 m/s (n = 12) or the 1st quartile of ∆LVMI (i.e. well-recovered LV, n = 8) respectively.ConclusionsDifference in arginine and proline metabolism was identified between BAV and TAV in TAVR recipients. Elevated arachidonic acid metabolism may reflect more severe baseline hemodynamics and worse LV reserve remodeling after TAVR in BAV.
| S-EPMC7236099 | biostudies-literature
Project description:ObjectiveTo identify the effects of preprocedural significant mitral regurgitation (MR) and change in MR severity upon mortality after transcatheter aortic valve implantation (TAVI) using the Edwards SAPIEN system.MethodsA retrospective analysis of 316 consecutive patients undergoing TAVI for aortic stenosis at a single centre in the UK between March 2008 and January 2013. Patients were stratified into two groups according to severity of MR: ≥grade 3 were classed as significant and ≤grade 2 were non-significant. Change in MR severity was assessed by comparison of baseline and 30-day echocardiograms.Results60 patients had significant MR prior to TAVI (19.0%). These patients were of higher perioperative risk (logistic EuroScore 28.7±16.6% vs 20.3±10.7%, p=0.004) and were more dyspnoeic (New York Heart Association class IV 20.0% vs 7.4%, p=0.014). Patients with significant preprocedural MR displayed greater 12-month and cumulative mortality (28.3% vs 20.2%, log-rank p=0.024). Significant MR was independently associated with mortality (HR 4.94 (95% CI 2.07 to 11.8), p<0.001). Of the 60 patients with significant MR only 47.1% had grade 3-4 MR at 30 days (p<0.001). Patients in whom MR improved had lower mortality than those in whom it deteriorated (log-rank p=0.05).ConclusionsSignificant MR is frequently seen in patients undergoing TAVI and is independently associated with increased all-cause mortality. Yet almost half also exhibit significant improvements in MR severity. Those who improve have better outcomes, and future work could focus upon identifying factors independently associated with such an improvement.
| S-EPMC4215343 | biostudies-literature
Project description:OBJECTIVE:To determine whether the leaflets of bicuspid aortic valve (BAV) experience increased strain when compared to tricuspid aortic valve (TAV) leaflets. BACKGROUND:The population at highest risk of aortic valve calcification (AVC) are individuals with BAVs. Currently, efforts to medically treat AVC are hampered by a limited understanding of the biomechanical forces involved in the molecular pathogenesis of AVC. METHODS:Surgically created BAVs and control TAVs were placed into a left heart simulator. Strains were calculated by comparing the distances between points on the aortic valve (AoV) leaflet during various time points during a simulated cardiac cycle. RESULTS:The fused leaflets of BAVs experience significantly more strain during systole when compared to TAVs. Specifically, BAVs experience 24% strain (P < .0001) in the radial direction, parallel to the direction of blood flow, as compared to TAVs. There was peak difference of 4% (P < .001) in the circumferential direction. DISCUSSION:Based upon the data presented here, we are in the process of identifying how increased strain activates calcification-associated pathways in AoV cells. Future studies will examine whether these stretch responsive pathways can be blocked to inhibit calcification of BAVs.
| S-EPMC6261454 | biostudies-other
Project description:AimsTo compare the progression of aortic stenosis (AS) in patients with bicuspid aortic valve (BAV) or tricuspid aortic valve (TAV).Methods and resultsOne hundred and forty-one patients with mild-to-moderate AS, recruited prospectively in the PROGRESSA study, were included in this sub-analysis. Baseline clinical, Doppler echocardiography and multidetector computed tomography characteristics were compared between BAV (n = 32) and TAV (n = 109) patients. The 2-year haemodynamic [i.e. peak aortic jet velocity (Vpeak) and mean transvalvular gradient (MG)] and anatomic [i.e. aortic valve calcification density (AVCd) and aortic valve calcification density ratio (AVCd ratio)] progression of AS were compared between the two valve phenotypes. The 2-year progression rate of Vpeak was: 16 (-0 to 40) vs. 17 (3-35) cm/s, P = 0.95; of MG was: 1.8 (-0.7 to 5.8) vs. 2.6 (0.4-4.8) mmHg, P = 0.56; of AVCd was 32 (2-109) vs. 52 (25-85) AU/cm2, P = 0.15; and of AVCd ratio was: 0.08 (0.01-0.23) vs. 0.12 (0.06-0.18), P = 0.16 in patients with BAV vs. TAV. In univariable analyses, BAV was not associated with AS progression (all, P ≥ 0.26). However, with further adjustment for age, AS baseline severity, and several risk factors (i.e. sex, history of hypertension, creatinine level, diabetes, metabolic syndrome), BAV was independently associated with faster haemodynamic (Vpeak: β = 0.31, P = 0.02) and anatomic (AVCd: β = 0.26, P = 0.03 and AVCd ratio: β = 0.26, P = 0.03) progression of AS.ConclusionIn patients with mild-to-moderate AS, patients with BAV have faster haemodynamic and anatomic progression of AS when compared to TAV patients with similar age and risk profile. This study highlights the importance and necessity to closely monitor patients with BAV and to adequately control and treat their risk factors.Clinical trial registrationhttps://clinicaltrials.gov Unique identifier: NCT01679431.
| S-EPMC7306858 | biostudies-literature
Project description:ObjectiveGuidelines for repair of bicuspid aortic valve-associated ascending thoracic aortic aneurysms have been changing, most recently to the same criteria as tricuspid aortic valve-ascending thoracic aortic aneurysms. Rupture/dissection occurs when wall stress exceeds wall strength. Recent studies suggest similar strength of bicuspid aortic valve versus tricuspid aortic valve-ascending thoracic aortic aneurysms; thus, comparative wall stress may better predict dissection in bicuspid aortic valve versus tricuspid aortic valve-ascending thoracic aortic aneurysms. Our aim was to determine whether bicuspid aortic valve-ascending thoracic aortic aneurysms had higher wall stresses than their tricuspid aortic valve counterparts.MethodsPatients with bicuspid aortic valve- and tricuspid aortic valve-ascending thoracic aortic aneurysms (bicuspid aortic valve = 17, tricuspid aortic valve = 19) greater than 4.5 cm underwent electrocardiogram-gated computed tomography angiography. Patient-specific 3-dimensional geometry was reconstructed and loaded to systemic pressure after accounting for prestress geometry. Finite element analyses were performed using the LS-DYNA solver (LSTC Inc, Livermore, Calif) with user-defined fiber-embedded material model to determine ascending thoracic aortic aneurysm wall stress.ResultsBicuspid aortic valve-ascending thoracic aortic aneurysms 99th-percentile longitudinal stresses were 280 kPa versus 242 kPa (P = .028) for tricuspid aortic valve-ascending thoracic aortic aneurysms in systole. These stresses did not correlate to diameter for bicuspid aortic valve-ascending thoracic aortic aneurysms (r = -0.004) but had better correlation to tricuspid aortic valve-ascending thoracic aortic aneurysms diameter (r = 0.677). Longitudinal stresses on sinotubular junction were significantly higher in bicuspid aortic valve-ascending thoracic aortic aneurysms than in tricuspid aortic valve-ascending thoracic aortic aneurysms (405 vs 329 kPa, P = .023). Bicuspid aortic valve-ascending thoracic aortic aneurysm 99th-percentile circumferential stresses were 548 kPa versus 462 kPa (P = .033) for tricuspid aortic valve-ascending thoracic aortic aneurysms, which also did not correlate to bicuspid aortic valve-ascending thoracic aortic aneurysm diameter (r = 0.007).ConclusionsCircumferential and longitudinal stresses were greater in bicuspid aortic valve- than tricuspid aortic valve-ascending thoracic aortic aneurysms and were more pronounced in the sinotubular junction. Peak wall stress did not correlate with bicuspid aortic valve-ascending thoracic aortic aneurysm diameter, suggesting diameter alone in this population may be a poor predictor of dissection risk. Our results highlight the need for patient-specific aneurysm wall stress analysis for accurate dissection risk prediction.
| S-EPMC8447844 | biostudies-literature