Assess the Outcomes of Transcatheter Aortic Valve Replacement in Bicuspid Valve with Mixed Disease versus Predominant Aortic Stenosis.

Purpose: In mixed aortic valve disease (MAVD), the results of transcatheter aortic valve replacement (TAVR) are conflicting. There is limited data on the outcomes of TAVR in patients with bicuspid aortic valve (BAV) and MAVD. The objective of this study is to compare outcomes after TAVR in BAV patients with MAVD and predominant aortic stenosis (PAS). Patients and Methods: Patients with BAV who underwent TAVR between January 2016 and April 2023 were included. The primary outcome was device success. The secondary endpoints were periprocedural mortality and other complications as defined by the Valve Academic Research Consortium-3 (VARC-3). Propensity score matching was used to minimize potential confounding. Results: A total of 262 patients were included in this study, 83 of whom had MAVD. The median age was 72 years, and 55.7% were male. The baseline comorbidity risk files were comparable between the two groups. Patients with MAVD had more mitral regurgitation, tricuspid regurgitation and pulmonary hypertension, larger annular and left ventricular outflow tract dimensions, and more severe calcification than PAS. In the unmatched population, MAVD patients had similar device success rate (69.9% vs 79.9%, P=0.075) and 30-day mortality (3.6% vs 3.4%, P=1) compared to PAS. Propensity score matching resulted in 66 patient pairs. Device success rate were still comparable in the matched population. Other clinical outcomes, including stroke, bleeding (type 2-4), major vascular complications, acute kidney injury (stage 2-4) and permanent pacemaker implantation, were comparable between the two groups. Multivariable logistic regression analysis did not show MAVD to be an independent negative predictor of device success. At one year, survival was similar between patients with MAVD and those with PAS. Conclusion: For the bicuspid valve, patients with MAVD had a more challenging anatomy. MAVD patients associated with comparable 30-day clinical outcomes after TAVR compared to PAS patients in patients with BAV.

Twenty-five years' experience with isolated bicuspid aortic valve repair: impact of commissural orientation.

OBJECTIVES: Repair of the bicuspid aortic valve (BAV) has evolved in the past 25 years. The aim of this study was to review and analyse the long-term durability of isolated BAV repair with particular focus on commissural orientation (CO). METHODS: All patients who underwent BAV repair for severe aortic regurgitation between October 1998 and December 2022 were included. The study group consists of all patients operated after 2009, i.e. since CO modification. The control group includes patients who were operated before 2009. CO was classified as symmetric, asymmetric and very asymmetric. RESULTS: Overall, 594 adult patients (93% male; mean age 42 years) were included. At 15 years, survival was 94.8% [standard deviation (SD): 2.2]; freedom from reoperation was 86.8% (SD: 2.3). Freedom from aortic insufficiency ≥II was 70.8% (SD: 4.7) at 15 years. Modification of CO by sinus plication was performed in 200 (33.7%) instances. Using competing risks analysis, the absence of effective height measurement (P = 0.018), very asymmetric CO (P = 0.028), the presence of calcification (P < 0.001), the use of pericardial patch (P < 0.001), the use of subcommissural sutures (P < 0.001) and preoperative endocarditis (P = 0.005) were identified as independent predictors for reoperation. Follow-up was 97% complete (4228 patient-years); mean follow-up was 7 years (SD: 5). CONCLUSIONS: Isolated BAV repair leads to good survival and durability in all morphologic types if cusp repair is guided by effective height, suture annuloplasty is performed, and CO is modified using sinus plication in asymmetrical valves. Very asymmetrical valves may should be treated with a lower threshold for replacement.

Three-year clinical outcomes after transcatheter aortic valve implantation in patients with bicuspid aortic disease: Comparison between self-expanding and balloon-expandable valves.

INTRODUCTION: Bicuspid aortic valve (BAV) stenosis is a complex anatomical scenario for transcatheter aortic valve implantation (TAVI). Favorable short-term clinical outcomes have been reported with TAVI in this setting, but long-term data are scarce. METHODS: We retrospectively included, in a single-center registry, patients with BAV stenosis who underwent TAVI before 2020. We compared patients treated with self-expanding valves (SEV) versus balloon-expandable valves (BEV). The primary endpoint was a composite of all-cause mortality, stroke and need for aortic valve (AV) reintervention at 3 years. Secondary endpoints included each component of the primary endpoint, cardiovascular mortality, permanent pacemaker implantation (PPI) rate, mean gradient and ≥moderate paravalvular leak (PVL) rate. RESULTS: A total of 150 consecutive patients (SEV = 83, BEV = 67) were included. No significant differences were reported between SEV and BEV groups for the primary composite endpoint (SEV 35.9% vs. BEV 32%, p = 0.66), neither for clinical secondary endpoints (all-cause mortality SEV 28.1% vs. BEV 28%, p = 0.988; cardiovascular mortality SEV 14.1% vs. BEV 20%, p = 0.399; stroke SEV 12.5% vs. BEV 6%, p = 0.342; need for AV reintervention SEV 0% vs. BEV 0%; PPI SEV 28.1% vs. BEV 24%, p = 0.620). A lower mean gradient persisted up to 3 years in the SEV group (SEV 8.8 ± 3.8 mmHg vs. BEV 10.7 ± 3.2 mmHg, p = 0.063), while no significant difference was found in the rate of ≥ moderate PVL (SEV 3/30 vs. BEV 0/25, p = 0.242). CONCLUSIONS: In this single center registry, we observed favorable 3-year clinical outcomes in nonselected BAV patients treated with different generation devices, without significant differences between patients receiving SEV or BEV.

Mechanical behaviors of a new elliptical valve stent in bicuspid aortic valve.

BACKGROUND AND OBJECTIVE: The conventional valve stents that are cylindrical in shape will become elliptical when implanted in bicuspid aortic valve, thereby reducing the durability of the artificial valve. In this study, a new design of valve stent is presented where valve stents have elliptical cross-section at the annulus and it is expected to have better expandability and circle shape during the interaction between the stent and bicuspid aortic valve, thereby extending the durability of artificial valve. METHODS: Finite element method (FEM) is used to study the mechanical behavior of the novel valve stent in the bicuspid aortic valve. The effects of three matching relationship between the ellipticity of the stents and the ellipticity of the annulus (i.e., the ellipticity of the stent is greater than, equal to and less than the annulus ellipticity, respectively) on the mechanical behavior of stent expansion are studied. In addition, the expansion mechanical behavior of the novel valve stent at different implantation depths is also compared. RESULTS: Results indicate that novel valve stent implantation with elliptical features is superior to conventional circular valve stent. When the novel valve stent ellipticity is less than the annulus ellipticity, the ellipticity of the novel valve stent after implantation is smaller than that of the conventional circular valve stent. This indicated that the novel valve stent has better expandability and post-expansion shape, making artificial valve to have better durability. The risk of paravalvular leak after implantation is lowest when the novel valve stent ellipticity is less than annulus ellipticity. When the novel valve stent ellipticity coincides with annulus ellipticity, the aortic wall is subjected to greatest stress. With the increase of implantation depth, the stress on the novel valve stent decrease. CONCLUSIONS: This study might provide insights for improving stent design for bicuspid aortic valve.

[Early to mid-term clinical outcomes of aortic valve repair in patients with bicuspid aortic insufficiency].

Objective: To examine the early to mid-term clinical outcomes of aortic valve repair in patients with bicuspid aortic insufficiency. Methods: This is a retrospective cohort study. The clinical data of 124 patients with BAV insufficiency who underwent aortic valve repair from January 2017 to June 2023 in the Department of Cardiovascular Surgery at Fuwai Hospital were analyzed retrospectively. There were 117 males and 7 females with an age of (38.1±12.7) years (range: 14 to 65 years). Depending on whether the aortic sinus was replaced or not, surgical approaches were divided into valve sparing root replacement (reimplantation, remodeling, modified remodeling) and isolated aortic valve repair (annuloplasty, isolated aortic valve leaflet repair). Perioperative and follow-up data were collected. Kaplan-Meier method was used to plot the curves of survival rate, free recurrence rate of massive aortic valve insufficiency and free re-operation rate, and Log-rank test was used for comparison between groups. Results: Among the surgeries, there were 47 cases of reimplantation, 8 cases of remodeling, 8 cases of modified remodeling, 48 cases of aortic annuloplasty (external annuloplasty in 22 cases, CV-0 annuloplasty in 26 cases), and 13 cases of isolated leaflet repair. Leaflet plication was the most used leaflet repair technique, used in 103 patients. The cardiopulmonary bypass time was (133.7±56.9) minutes (range: 48 to 461 minutes), and aortic cross-clamp time was (103.8±47.8) minutes (range: 25 to 306 minutes), with no surgical mortality. All patients underwent outpatient or telephone follow-up. The cumulative follow-up time was 340.3 person-years and the mean follow-up time was (M (IQR)) 34.0 (25.5) months (range: 3 to 76 months). The 5-year survival rate was 98.4%, the 5-year freedom from significant insufficiency rate was 93.4% and the 5-year freedom from aortic valve reoperation rate was 95.6%. The subgroup analysis revealed a significantly better freedom from the significant insufficiency rate in the aortic valve annular reduction group compared to the non-reduction group (P<0.01). Conclusions: Aortic valve repair in patients with bicuspid aortic insufficiency could obtain steady early to mid-term outcomes. Aortic annuloplasty can reduce the risk of recurrent aortic valve insufficiency in patients undergoing aortic repair.

Influence of preoperative and intraoperative factors on recovery after aortic root surgery.

OBJECTIVE: To determine the influence of intraoperative factors relative to preoperative risk factors on recovery after aortic root replacement (ARR). METHODS: Retrospective review of baseline and intraoperative characteristics was performed of 822 patients at our Aortic Center from 2005 to 2019. Inclusion criteria were all patients age 18 and older who underwent ARR at our institution from 2005 to 2019. The primary endpoint was the aggregate outcome of "failure to achieve uneventful recovery (FUR)," as previously defined. RESULTS: In total, 207 (25%) patients experienced FUR. The following preoperative and intraoperative variables were significantly associated with FUR in the multivariable analysis: cardiopulmonary bypass time (OR 1.01, 95% CI 1.01-1.02) open chest management (OR 5.67, 95% CI 2.65-12.1), ejection fraction (OR 1.03, 95% CI 1.01-1.04), chronic kidney disease > stage 3a (OR 2.37, 95% CI 1.54-3.63), bicuspid aortic valve (OR 1.54, 95% CI 1.21-1.96), and female sex (OR 1.30, 95% CI 1.06-1.61). Cardiopulmonary bypass time and open chest management were among the top three partial R2 contributors to the logistic regression model variance. CONCLUSIONS: These findings suggest efficacy in using intraoperative parameters to predict postoperative outcomes after ARR.

Valve Sparing vs Composite Valve Graft Root Replacement: Propensity Score-Matched Analysis.

BACKGROUND: Both valve-sparing root replacement and composite valve graft (CVG) are acceptable options in aortic root replacement. We compare outcomes of these 2 approaches and durability of the aortic valve. METHODS: A consecutive 1635 patients without acute dissection underwent primary aortic root replacement from 1997 to 2022; 473 (29%) underwent valve-sparing root replacement, and 1162 (71%) received CVG. Propensity score matching was used to reduce baseline differences. RESULTS: The CVG group was older (59 ± 14 years vs 49 ± 14 years; P < .001) with more comorbidities, such as hypertension (88.4% vs 66.4%; P < .001), diabetes (7% vs 1.7%; P < .001), ischemic heart disease (5.1% vs 1.3%; P = .001), pulmonary disease (6.6% vs 1.3%; P < .001), renal impairment (8.6% vs 1.3%; P < .001), class III-IV heart failure (35% vs 9.2%; P < .001), bicuspid aortic valves (44.8% vs 24.1%; P < .001), and severe aortic insufficiency (50.2% vs 13.2%; P < .001). Operative mortality was 0.4% (0% in valve sparing); incidence of major postoperative complications was 2.9% (3.6% vs 1.1%; P = .009). Ten-year survival was 93.1% (91.2% vs 97.7%; hazard ratio [HR], 1.7; 95% CI, 0.9-3.3; P = .120). Mean follow-up was 65 ± 60 months; aortic valve reoperations were similar (5.8% vs 5.7%; HR, 0.8; 95% CI, 0.4-1.4; P = .401). Recurrent moderate-severe aortic insufficiency was less prevalent in CVG (6.1% vs 11.1%; HR, 0.14; 95% CI, 0.07-0.27; P < .001). Propensity score matching identified 225 pairs. There was no difference in 10-year survival or reoperations. Recurrent moderate-severe aortic insufficiency was higher with valve sparing. CONCLUSIONS: Both valve-sparing operations and CVG provide excellent early and late outcomes out to 10 years. Valve sparing is associated with a higher risk for development of aortic insufficiency but no difference in reoperations.

Valve-Sparing Aortic Root Replacement With Reimplantation vs Remodeling: A Meta-analysis.

BACKGROUND: Long-term outcomes of valve-sparing aortic root replacement (VSARR) with reimplantation vs remodeling in patients undergoing aortic root surgery remains a controversial subject. METHODS: This study was a pooled meta-analysis of Kaplan-Meier-derived data from comparative studies published by December 31, 2022. RESULTS: Fifteen studies met our eligibility criteria, comprising 3044 patients (1991 in the reimplantation group and 2018 in the remodeling group). Patients who underwent VSARR with remodeling had a higher risk of all-cause death (hazard ratio [HR], 1.54; 95% CI, 1.16-2.03; P = .002, log-rank test P < .001). Landmark analysis (with 4 years as the landmark time point) demonstrated that survival was lower in patients who underwent VSARR with remodeling (HR, 2.15; 95% CI, 1.43-3.24; P < .001) in the first 4 years. Beyond the 4-year time point, no difference in survival was observed (HR, 1.04; 95% CI, 0.72-1.50; P = .822). The risk for need of aortic valve and/or root reintervention was higher in patients undergoing VSARR with remodeling (HR, 1.49; 95% CI, 1.07-2.07; P = .019, log-rank test P < .001). We did not find statistically significant coefficients for the covariates of age, female sex, connective tissue disorders, bicuspid aortic valve, aortic dissection, coronary bypass surgery, total arch replacement, or annular stabilization, which means that these covariates did not modulate the effects observed in our pooled analyses. CONCLUSIONS: VSARR with reimplantation is associated with better overall survival and lower risk of need for reintervention over time compared with VSARR with remodeling. Regarding overall survival, we observed a time-varying effect that favored the reimplantation technique up to 4 years of follow-up, but not beyond this time point.

Impact of Pacemaker Implantation After Transcatheter Aortic Valve Replacement on Long-Term Survival in Patients With Bicuspid Aortic Valve.

Limited data are available about the impact of permanent pacemaker (PPM) implantation on long-term survival in patients with a bicuspid aortic valve (BAV) and severe aortic stenosis (AS) treated with transcatheter aortic valve replacement (TAVR). We aimed to evaluate the long-term clinical outcomes of patients with BAV with AS who underwent periprocedural PPM implantation after TAVR with a self-expandable prosthesis. Data from patients with BAV and severe AS who underwent TAVR between April 2009 and January 2022 and followed in the framework of the One Hospital ClinicalService-CoreValve Project were collected. Patients were categorized in 2 groups according to PPM implantation after TAVR ("PPM" group) or not ("no PPM" group). The coprimary end points were all-cause death and a composite of cardiac mortality, rehospitalization because of cardiac causes, stroke, and myocardial infarction. Overall, 106 patients were considered (74 in the "no PPM" group and 32 in the "PPM" group). No statistically significant difference was found between the groups in terms of follow-up and baseline characteristics. Patients in the PPM group were more likely to show baseline conduction abnormalities (p = 0.023). Patients in the PPM group were more often treated with older generation prosthesis than those in the no PPM group (28.1% vs 5.4%, respectively, p = 0.013). At 2 years of follow-up, all-cause death in the no PPM and PPM groups occurred in 20.0% and 10.0% of patients, respectively (hazard ratio 0.37, 95% confidence interval 0.08 to 1.67). Similarly, no difference was evident for the composite end point between the 2 groups (no PPM vs PPM: 8 [14.6%] vs 6 [19.3%], hazard ratio 1.67, 95% CI 0.58 to 4.81). In conclusion, patients with severe AS and BAV treated with TAVR complicated by PPM implantation are not exposed to an increased risk of major adverse events at 2 years of follow-up.

Mid- and long-term outcomes after surgical correction of subaortic stenosis: a 27-year experience.

OBJECTIVES: We reviewed the mid- and long-term surgical outcomes of patients with subaortic stenosis (SAS). METHODS: Patients operated for SAS from April 1990 to August 2016 were reviewed retrospectively. Patients with major associations such as aortic arch obstruction were excluded. Time to reintervention and predictors of recurrence were assessed using Kaplan-Meier analysis, log-rank test and uni/multivariable Cox regression. RESULTS: 120 patients at a median age of 4.7 years (interquartile range 2.9, 8.1) underwent primary operation (median peak preoperative left ventricular outflow tract gradient 52.5 mmHg, interquartile range 40, 70) involving fibrous tissue excision (n = 120) with septal myectomy (93%; n = 112) as the procedure of choice.At median follow-up of 13 years (interquartile range 7, 18), freedom from reintervention at 1, 3, 5 and 10 years was 99% (95% confidence interval 94%, 99%), 94% (87%, 97%), 93% (86%, 96%) and 90% (82%, 94%), respectively. Recurrence occurred in 18% (n = 20) with 15 patients undergoing reinterventions, 13 of whom required radical reoperation. Multivariable analysis revealed higher preoperative peak left ventricular outflow tract gradient (hazard risk 1.06, confidence interval 1.03, 1.09, P < 0.001), and presence of bicuspid aortic valve (hazard risk 14.13, confidence interval 3.32, 60.1, P < 0.001) as predictors for reintervention. Mild/moderate aortic regurgitation occurred in 49% (n = 55) of patients at the most recent follow-up. CONCLUSIONS: Reintervention for recurrent SAS is common, predicted by higher preoperative peak left ventricular outflow tract gradient, and presence of bicuspid aortic valve, and frequently involves a radical procedure. Aortic regurgitation is a major consequence of SAS, but its severity usually remains low. CLINICAL REGISTRATION NUMBER: SCHN HREC reference number 2019/ETH02729, approved on 09 July 2019.

Clinical outcomes and the impact of valve morphology for transcatheter aortic valve replacement in bicuspid aortic valves: A systematic review and meta-analysis.

BACKGROUND: Bicuspid aortic valve (BAV) is present in approximately 0.5%-2% of the general population, causing significant aortic stenosis (AS) in 12%-37% of affected individuals. Transcatheter aortic valve replacement (TAVR) is being considered the treatment of choice in patients with symptomatic AS across all risk spectra. AIM: Aim Our study aims to compare TAVR outcomes in patients with BAV versus tricuspid aortic valves (TAV). METHODS: A comprehensive literature search was performed in PubMed, Web of Science, and Cochrane trials. Studies were included if they included BAV and TAV patients undergoing TAVR with quantitative data available for at least one of our predefined outcomes. Meta-analysis was performed by the random-effects model using Stata software. RESULTS: Fifty studies of 203,288 patients were included. BAV patients had increased 30-day all-cause mortality (odds ratio [OR] = 1.23 [1.00-1.50], p = 0.05), in-hospital stroke (OR = 1.39 [1.01-1.93], p = 0.05), in-hospital and 30-day PPI (OR = 1.13 [1.00-1.27], p = 0.04; OR = 1.16 [1.04-1.13], p = 0.01) and in-hospital, 30-day and 1-year aortic regurgitation (AR) (OR = 1.48 [1.19-1.83], p < 0.01; OR = 1.79 [1.26-2.52], p < 0.01; OR = 1.64 [1.03-2.60], p = 0.04). Subgroup analysis on new-generation valves showed a reduced 1-year all-cause mortality (OR = 0.86 [CI = 0.75-0.98], p = 0.03), despite higher in-hospital and 30-day PPI (OR = 0.1.21 [1.04-1.41], p = 0.01; OR = 1.17 [1.05-1.31], p = 0.01) and in-hospital AR (OR = 1.62 [1.14-2.31], p = 0.01) in the BAV group. The quality of included studies was moderate-to-high, and only three analyses presented high heterogeneity. CONCLUSION: TAVR is associated with comparable outcomes in patients with BAV and TAV. Careful selection of BAV cases by preprocedural assessment of valve anatomy and burden of calcification, pre- and post-procedural dilation, and implementing newer generations of valves may improve the safety and efficacy of TAVR in BAV patients.

Outcomes of valve-sparing aortic root replacement in patients with bicuspid aortic valve and tricuspid aortic valve: a systematic review and meta-analysis.

BACKGROUND: Valve-sparing aortic root replacement (VSARR) is a safe and effective surgical procedure to treat aortic root aneurysm. This meta-analysis aimed to investigate how this procedure might differ in patients with bicuspid aortic valve (BAV) and tricuspid aortic valve (TAV). DESIGN: Meta-analysis with meta-regression and systematic review. SETTING: Systematic search in the following databases: PubMed, Cochrane Central Register of Controlled Trials, and Embase. INTERVENTIONS: All observational studies of VSARR in patients with BAV or TAV were included in our study. Studies were included without any restrictions on language or publication date. A trial sequential analysis and a post-hoc meta-regression was performed on the main outcomes. RESULT: Eleven articles met the inclusion criteria. A total of 1138 patients in BAV group, and 2125 patients in TAV group. No significant differences in gender and age were observed between BAV and TAV patients. BAV and TAV patients showed no differences in in-hospital mortality rate [0.00% vs. 1.93%; RR (95% CI) 0.33 (0.09, 1.26), I2 = 0%, P = 0.11] and the rate of in-hospital reoperation [5.64% vs. 5.99%; RR (95% CI) 1.01(0.59, 1.73), I2 = 33%, P = 0.98]. The overall long-term mortality rate of BAV patients was better than that of TAV patients [1.63% vs. 8.15%; RR (95% CI) 0.34 (0.13, 0.86), I2 = 0%, P = 0.02]. During the follow-up observation period, patients in TAV group showed small but no statistic advantage in 3-year, 5-year, and over 10-year incidences of reintervention. Regarding the secondary endpoints, the two groups showed similar aortic cross-clamping time and total cardiopulmonary bypass time. CONCLUSION: The VSARR techniques yielded similar clinical outcomes in both BAV and TAV patients. Although patients with BAV might have a higher incidence of reinterventions after initial VSARR, it is still a safe and effective approach to treat aortic root dilation with or without aortic valve insufficiency. TAV patients showed small but no statistic advantage in long-term (over 10 years) reintervention rate, which means, patients with BAV may face a higher risk of reintervention in the clinic.

Outcomes of the Ross procedure in patients older versus younger than 50 years old.

OBJECTIVES: The Ross procedure is traditionally considered for young adult patients with aortic valve disease. This study compares long-term outcomes of patients undergoing the Ross procedure who are ≥50 and <50-years old. METHODS: Data were collected from 225 patients undergoing Ross procedure at a single centre from 1994 to 2019. Patients were categorized into younger (<50-years old; n = 156) and older (≥50-years old; n = 69) cohorts. Baseline demographics clinical outcomes were compared. RESULTS: The mean age was 36 ± 8.1 and 55 ± 4.2 years in the younger and older cohort, respectively. Both groups were predominantly male (58.5% vs 69.6%; P = 0.59). The younger group had a higher rate of aortic insufficiency (51% vs 26.1%; P < 0.01), and bicuspid aortic valve (81.4% vs 58.0%; P < 0.01). Aortic stenosis was more prevalent in the older cohort (25.6% vs 58.0%; P < 0.01). Operative mortality was acceptable in both groups (1.3% vs 4.3%; P = 0.15). Survival up to 10 years was not statistically different between 2 groups (96.2% vs 91.3% P = 0.16), whereas survival up to 15 years for younger patients was significantly higher (94.9% vs 85.5%; P = 0.03). After non-cardiac related deaths were excluded, survival up to 15 years (98.7% vs 91.3%; P = 0.02) was significantly lower than younger patients. In both groups, survival after the Ross procedure was similar to the age- and sex-matched US population. CONCLUSIONS: Survival up to 10 years after Ross procedure were similar, but up to 15 years was significantly higher in younger patients. The Ross procedure restored patients from both groups to expected survival. Our results suggest that at experienced centres, the Ross procedure is a safe and reasonable option for patients who are 50 years and older.

Benchmarking Outcomes of Surgical Aortic Valve Replacement in Patients With Bicuspid Aortic Valves.

BACKGROUND: The relative roles for transcatheter and surgical aortic valve replacement (SAVR) for bicuspid aortic valve (AV) stenosis are debated. This study analyzes the 5-year longitudinal outcomes of isolated SAVR in bicuspid vs tricuspid AV patients, particularly in low-risk patients. METHODS: All patients undergoing isolated index SAVR at 1146 United States hospitals in The Society of Thoracic Surgeons (STS) Adult Cardiac database between July 1, 2011, and December 31, 2018, with linkage to Medicare claims, were analyzed. RESULTS: A total of 65,687 patients were analyzed, including of 9131 bicuspid patients (13.9%). Compared with tricuspid patients, bicuspid patients were significantly younger (median 70 vs 74 years, P < .001) with lower Society of Thoracic Surgeons predicted risk of mortality scores (mean 1.6% vs 2.3%, P < .001) and lower risk profile. Risk-adjusted 30-day mortality and major morbidity were similar, but risk-adjusted 5-year mortality was significantly lower in the bicuspid patients (adjusted hazard ratio, 0.72; 95% CI, 0.66-0.77), specifically in low-risk patients (adjusted hazard ratio, 0.69; 95% CI, 0.64-0.76). Additionally, the bicuspid cohort had a lower 5-year readmission risk of heart failure, stroke, bleeding, or other cardiovascular causes (all P < .05). CONCLUSIONS: In this nationally representative study, 30-day mortality was similar, but risk-adjusted 5-year mortality was significantly lower in bicuspid patients undergoing isolated SAVR compared with tricuspid patients, specifically low-risk and normal left ventricular ejection fraction patients. This analysis provides a much-needed 5-year longitudinal national-level benchmark to better inform the discussion of transcatheter vs SAVR in bicuspid patients.

One-year outcome of transcatheter aortic valve replacement for bicuspid aortic valve stenosis: a report from the Japanese Nationwide registry (J-TVT registry).

The outcome of transcatheter aortic valve replacement (TAVR) for patients with bicuspid aortic valve (BAV) remains unclear, particularly among Asian patients that are known to have different valvular morphology and lower body habitus. This study investigated patient characteristics, procedural and 1-year outcome of TAVR for BAV within national TAVR registry in Japan. The patient-level data were extracted from the J-TVT (Japanese Transcatheter Valvular Therapy) registry between August 2013 and December 2018; overall, there were 423 patients (2.5%) with BAV and 16,802 patients with tricuspid aortic valve (TAV). At baseline, patients with BAV were younger and had less arteriosclerotic comorbidities. There was no statistically significant difference between BAV and TAV groups in conversion to surgery (0.5% vs. 1.1%, p = 0.34) and 30-day mortality (0.5% vs. 1.3%, p = 0.18). Cumulative all-cause survival and survival from major adverse events were analyzed. Cox proportional hazard regression model was used to estimate the hazard ratio. All-cause mortality and major adverse event rate at 1 year were comparable between the two groups. Relative hazard for all-cause mortality for BAV compared to TAV was 1.01 (0.70-1.45; p = 0.96), and for major adverse event was 0.94 (0.69-1.27; p = 0.67). From the Japanese nationwide TAVR registry, procedural and 1-year outcome of TAVR in BAV was as favorable as TAVR in TAV.

Transcatheter aortic valve implantation with the Evolut platform for bicuspid aortic valve stenosis: the international, multicentre, prospective BIVOLUTX registry.

BACKGROUND: Prospective data about transcatheter aortic valve implantation (TAVI) in bicuspid aortic valve (BAV) patients are limited. AIMS: We aimed to evaluate the clinical impact of the Evolut PRO and R (34 mm) self-expanding prostheses in BAV patients and explore the impact of different computed tomography (CT) sizing algorithms in a prospective registry. METHODS: A total of 149 bicuspid patients were treated in 14 countries. The primary endpoint was the intended valve performance at 30 days. Secondary endpoints were 30-day and 1-year mortality, severe patient-prosthesis mismatch (PPM) and the ellipticity index at 30 days. All study endpoints were adjudicated according to Valve Academic Research Consortium 3 criteria. RESULTS: The mean Society of Thoracic Surgeons score was 2.6% (1.7-4.2). Type I L-R BAV was observed in 72.5% of the patients. Evolut valve sizes 29 and 34 mm were utilised in 49.0% and 36.9% of the cases, respectively. The 30-day cardiac death rate was 2.6%; the 1-year cardiac death rate was 11.0%. Valve performance at 30 days was observed in 142/149 (95.3%) patients. The mean aortic valve area post-TAVI was 2.1 (1.8-2.6) cm2, and the mean aortic gradient was 7.2 (5.4-9.5) mmHg. No patient had more than moderate aortic regurgitation at 30 days. PPM was observed in 13/143 (9.1%) surviving patients and was severe in 2 patients (1.6%). Valve function was maintained at 1 year. The mean ellipticity index remained 1.3 (interquartile range 1.2-1.4). Overall, 30-day and 1-year clinical and echocardiography outcomes were similar between the two sizing strategies. CONCLUSIONS: BIVOLUTX demonstrated a favourable bioprosthetic valve performance and good clinical outcomes after TAVI with the Evolut platform in patients with bicuspid aortic stenosis. No impact from the sizing methodology could be identified.

Effect of ascending aorta replacement on the long-term outcomes of bicuspid aortic valve repair.

OBJECTIVE: The study objective was to determine the effect of sinutubular junction stabilization on long-term outcomes of bicuspid aortic valve repair. METHODS: From January 1998 to January 2020, 419 patients underwent bicuspid aortic valve repair with ascending aorta replacement and 421 without (bicuspid aortic valve repair alone). Propensity score matching (97 pairs) was used to compare outcomes. RESULTS: Before matching, prevalence of severe aortic regurgitation at 10 years was 5.4% after bicuspid aortic valve repair + ascending aorta replacement and 10% after bicuspid aortic valve repair alone; aortic valve gradient was 20 mm Hg after bicuspid aortic valve repair + ascending aorta replacement and 19 mm Hg after bicuspid aortic valve repair alone. Ten-year freedom from reoperation overall was 79% after bicuspid aortic valve repair + ascending aorta replacement and 75% after bicuspid aortic valve repair alone; freedom from late aortic regurgitation was 93% after bicuspid aortic valve repair + ascending aorta replacement and 92% after bicuspid aortic valve repair alone; and freedom from aortic stenosis was 87% after bicuspid aortic valve repair + ascending aorta replacement and 93% after bicuspid aortic valve repair alone. Ten-year survival was 95% after bicuspid aortic valve repair + ascending aorta replacement and 96% after bicuspid aortic valve repair alone. After matching, prevalence of severe aortic regurgitation at 10 years was 11% after bicuspid aortic valve repair + ascending aorta replacement and 9.1% after bicuspid aortic valve repair alone (P = .33); aortic valve gradient was 16 mm Hg after bicuspid aortic valve repair + ascending aorta replacement and 25 mm Hg after bicuspid aortic valve repair alone (P < .0001). Ten-year freedom from reoperation was 85% after bicuspid aortic valve repair + ascending aorta replacement and 72% after bicuspid aortic valve repair alone (P = .08) overall. Ten-year freedom from reoperation for late aortic regurgitation was 88% after bicuspid aortic valve repair + ascending aorta replacement and 86% after bicuspid aortic valve repair alone (P = .65). Freedom from aortic stenosis was 97% after bicuspid aortic valve repair + ascending aorta replacement and 91% after bicuspid aortic valve repair alone (P = .03). Ten-year survival was 96% after bicuspid aortic valve repair + ascending aorta replacement and 96% after bicuspid aortic valve repair alone (P = .16). CONCLUSIONS: Bicuspid aortic valve repair with or without ascending aorta replacement is associated with good short- and long-term outcomes. Bicuspid aortic valve repair + ascending aorta replacement has a minimal effect on long-term repair durability. Sinutubular junction stabilization should not be performed for the sole purpose of long-term repair durability.

Long-term outcomes of valve-sparing root versus composite valve graft replacement for acute type A aortic dissection: Meta-analysis of reconstructed time-to-event data.

OBJECTIVES: To evaluate the long-term outcomes of valve-sparing aortic root replacement (VSARR) versus composite aortic valve graft replacement (CAVGR) in the treatment of acute type A aortic dissections (ATAAD). METHODS: We performed a pooled meta-analysis of Kaplan-Meier-derived time-to-event data from studies with longer follow-up beyond the immediate postoperative period. RESULTS: Seven studies met our eligibility criteria, comprising a total of 858 patients (367 patients in the VSARR groups and 491 patients in the CAVGR group). We found no statistically significant differences in the overall survival between the groups over time (HR 0.83, 95%CI 0.63-1.10, P = 0.192), but we observed a higher risk of reoperation in the VSARR group when compared with the CAVGR group (HR 9.99, 95% CI 2.23-44.73, P = 0.003). The meta-regression revealed statistically significant positive coefficients for age (P < 0.001) in the analysis of survival, which means that this covariate has a modulating effect on this outcome. The higher the mean age, the higher the HR for overall mortality was found to be with VSARR as compared with CAVGR. Other covariates such as female sex, hypertension, diabetes, connective tissue disorders, bicuspid aortic valve, hemiarch and/or total arch replacement, concomitant coronary bypass surgery did not seem to have any effect on the outcomes. CONCLUSION: VSARR did not confer a better (or worse) survival over time in patients with ATAAD, but it was associated with higher risk of reoperations in the long run.

Latest-iteration balloon- and self-expandable transcatheter valves for severe bicuspid aortic stenosis: the TRITON study.

INTRODUCTION AND OBJECTIVES: No comparisons have been published yet regarding the newest iteration of balloon- and self-expandable transcatheter heart valves for the treatment of bicuspid aortic valve (BAV) stenosis. METHODS: Multicenter registry of consecutive patients with severe BAV stenosis treated with balloon-expandable transcatheter heart valves (Myval and SAPIEN 3 Ultra, S3U) or self-expanding Evolut PRO+(EP+). TriMatch analysis was carried out to minimize the impact of baseline differences. The primary endpoint of the study was 30-day device success, and the secondary endpoints were the composite and individual components of early safety at 30 days. RESULTS: A total of 360 patients (age 76.6±7.6 years, 71.9% males) were included: 122 Myval (33.9%), 129 S3U (35.8%), and 109 EP+(30.3%). The mean STS score was 3.6±1.9%. There were no cases of coronary artery occlusion, annulus rupture, aortic dissection, or procedural death. The primary endpoint of device success at 30 days was significantly higher in the Myval group (Myval: 100%; S3U: 87.5%; and EP+: 81.3%), mainly due to higher residual aortic gradients with S3U and greater≥moderate aortic regurgitation (AR) with EP+. No significant differences were found in the unadjusted rate of pacemaker implantation. CONCLUSIONS: In patients with BAV stenosis deemed unsuitable for surgery, Myval, S3U and EP+showed similar safety but balloon-expandable Myval had better gradients than S3U, and both balloon-expandable devices had lower residual AR than EP+, suggesting that, taking into consideration the patient-specific risks, any of these devices can be selected with optimal outcomes.