3-Year Outcomes From the Evolut Low Risk TAVR Bicuspid Study.

BACKGROUND: Outcomes from transcatheter aortic valve replacement (TAVR) in low-surgical risk patients with bicuspid aortic stenosis beyond 2 years are limited. OBJECTIVES: This study aimed to evaluate 3-year clinical and echocardiographic outcomes from the Evolut Low Risk Bicuspid Study. METHODS: The Evolut Low Risk Bicuspid Study is a prospective, multicenter, single-arm study conducted in 25 U.S. CENTERS: Patients with severe aortic stenosis at low surgical risk with bicuspid aortic valve anatomy (all subtypes) underwent TAVR with a self-expanding, supra-annular Evolut R or PRO (Medtronic) bioprosthesis. An independent clinical events committee adjudicated all deaths and endpoint-related adverse events, and a central echocardiographic core laboratory assessed hemodynamic endpoints. RESULTS: An attempted implant was performed in 150 patients from December 2018 to October 2019. The mean age was 70.3 ± 5.5 years, 48% (72/150) of the patients were women, and the mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 1.3% (Q1-Q3: 0.9%-1.7%). Sievers type 1 was the dominant bicuspid morphology (90.7%, 136/150). The Kaplan-Meier rates of all-cause mortality or disabling stroke were 1.3% (95% CI: 0.3%-5.3%) at 1 year, 3.4% (95% CI: 1.4%-8.1%) at 2 years, and 4.1% (95% CI: 1.6%-10.7%) at 3 years. The incidence of new permanent pacemaker implantation was 19.4% (95% CI: 12.4%-29.6%) at 3 years. There were no instances of moderate or severe paravalvular aortic regurgitation at 2 and 3 years after TAVR. CONCLUSIONS: The 3-year results from the Evolut Low Risk Bicuspid Study demonstrate low rates of all-cause mortality or disabling stroke and favorable hemodynamic performance.

Association Between Aortic Wall Thrombus and Thromboembolic Events After Transfemoral Transcatheter Aortic Valve Replacement.

BACKGROUND: Thromboembolic events, particularly strokes, remain a major complication of transcatheter aortic valve replacement (TAVR). Embolic protection devices have failed to show significant clinical benefit in large randomized clinical trials. Aortic wall thrombus (AWT) is often observed on multidetector computed tomography during TAVR work-up, but its prognostic significance is uncertain. OBJECTIVES: This study sought to evaluate the association between the presence of AWT and the incidence of thromboembolic outcomes in patients undergoing transfemoral (TF) TAVR for severe aortic stenosis. METHODS: This was a prospective cohort study of consecutive patients who underwent TF TAVR for severe aortic stenosis between January 2011 and April 2022. A dedicated scale (range: 0-10) was qualitatively used to assess AWT. The primary outcome was a composite of procedural thromboembolic events defined as ischemic stroke, blue toe syndrome, bowel ischemia, or other solid organ infarction. The secondary endpoints were ischemic strokes and procedural death. RESULTS: Of the 641 patients included, severe AWT (score ≥8) was identified in 73 (11.4%). The presence of severe AWT was strongly associated with an increase in the primary outcome (OR: 8.48; 95% CI: 3.36-21.40; P < 0.001). This relationship persisted following multivariable analysis, which adjusted for comorbidities and procedural characteristics. The presence of severe AWT was also found to be associated with an increased incidence of stroke and procedural death (OR: 5.66; 95% CI: 2.00-15.30; P = 0.002 and OR: 4.66; 95% CI: 1.80-11.30; P = 0.002, respectively). CONCLUSIONS: The presence of severe AWT on preprocedural multidetector computed tomography is strongly associated with thromboembolic complications including stroke and mortality after TF TAVR.

Sex-specific aspects on prognosis after aortic valve replacement for aortic stenosis: a SWEDEHEART registry study.

OBJECTIVE: To compare long-term cardiovascular (CV) outcomes between men and women with aortic stenosis (AS) undergoing aortic valve replacement (AVR) by the type of valve implant. METHODS: The study population consisted of 14 123 non-selected patients with AS undergoing first-time AVR and included in the Swedish Web system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART) registry during 2008-2016. Comparisons were made between men and women and type of valve implant (ie, surgical implantation with a mechanical (mSAVR) (n=1 966) or biological valve (bioSAVR) (n=9 801)) or by a transcatheter approach (TAVR) (n=2 356). Outcomes included all-cause mortality, ischaemic stroke, major bleeding, thromboembolic events, heart failure and myocardial infarction, continuously adjusted for significant comorbidities and medical treatment. RESULTS: In the mSAVR cohort, there were no significant sex differences in any CV events. In the bioSAVR cohort, a higher risk of death (HR: 1.14; 95% CI: 1.04 to 1.26, p=0.007) and major bleeding (HR: 1.41; 95% CI: 1.18 to 1.69, p<0.001) was observed in men. In the TAVR cohort, men suffered a higher risk of death (HR: 1.24; 95% CI: 1.07 to 1.45, p=0.005), major bleeding (HR: 1.35; 95% CI: 1.00 to 1.82, p=0.022) and thromboembolism (HR: 1.35, 95% CI: 1.00 to 1.82, p=0.047). CONCLUSION: No significant long-term difference in CV events was noted between men and women undergoing AVR with a mechanical aortic valve. In both the bioSAVR and TAVR cohort, mortality was higher in men who also had an increased incidence of several other CV events.

Comparative Analysis of PCI Strategies in Aortic Stenosis Patients Undergoing TAVI: A Systematic Review and Network Meta-Analysis.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has been increasingly used in patients with severe aortic stenosis (AS). Since coronary artery disease (CAD) is common among these patients, it is crucial to choose the best method and timing of revascularization. This study aims to compare different timing strategies of percutaneous coronary intervention (PCI) in patients with severe AS undergoing TAVI to clarify whether PCI timing affects the patients' outcomes or not. METHODS: A frequentist network meta-analysis was conducted comparing three different revascularization strategies in patients with CAD undergoing TAVI. The 30-day all-cause mortality, in-hospital mortality, all-cause mortality at 1 year, 30-day rates of myocardial infarction (MI), stroke, and major bleeding, and the need for pacemaker implantation at 6 months were analyzed in this study. RESULTS: Our meta-analysis revealed that PCI during TAVI had higher 30-day mortality (RR = 2.46, 95% CI = 1.40-4.32) and in-hospital mortality (RR = 1.70, 95% CI = [1.08-2.69]) compared to no PCI. Post-TAVI PCI was associated with higher 1-year mortality compared to other strategies. While no significant differences in major bleeding or stroke were observed, PCI during TAVI versus no PCI (RR = 3.63, 95% CI = 1.27-10.43) showed a higher rate of 30-day MI. CONCLUSION: Our findings suggest that among patients with severe AS and CAD undergoing TAVI, PCI concomitantly with TAVI seems to be associated with worse 30-day outcomes compared with no PCI. PCI after TAVI demonstrated an increased risk of 1-year mortality compared to alternative strategies. Choosing a timing strategy should be individualized based on patient characteristics and procedural considerations.

Cerebrovascular Disease Detected on Preprocedural Computed Tomography in Patients With Severe Aortic Stenosis Undergoing Aortic Valve Replacement.

BACKGROUND: There is a scarcity of data on the prevalence and clinical impact of cerebrovascular disease detected on preprocedural computed tomography (CT) before aortic valve replacement (AVR) in patients with severe aortic stenosis. METHODS AND RESULTS: Among patients with severe aortic stenosis undergoing AVR, the authors compared clinical outcomes between patients with and without cerebrovascular disease detected on preprocedural CT, which was defined as chronic brain infarction or hemorrhage. The primary outcome measure in this study was a composite of all-cause death or stroke. Among 567 study patients, 200 patients (35.3%) had cerebrovascular disease on preprocedural CT. Among 200 patients with cerebrovascular disease on preprocedural CT, only 28.5% of patients had a clinical history of symptomatic stroke. The cumulative 3-year incidence of death or stroke was higher in patients with cerebrovascular disease on preprocedural CT than in those without cerebrovascular disease on preprocedural CT (40.7% versus 24.1%, log-rank P<0.001). After adjusting for confounders, the higher risk of patients with cerebrovascular disease on preprocedural CT relative to those without remained significant for death or stroke (hazard ratio [HR], 1.42 [95% CI, 1.02-1.98]; P=0.04). Among 200 patients with cerebrovascular disease on preprocedural CT, patients with prior symptomatic stroke compared with those without were not associated with higher adjusted risk for death or stroke (HR, 1.18 [95% CI, 0.72-1.94]; P=0.52). CONCLUSIONS: Among patients with severe aortic stenosis undergoing AVR, a substantial proportion had cerebrovascular disease on preprocedural CT, with a clinical history of symptomatic stroke in one-fourth of patients. Regardless of history of symptomatic stroke, patients with cerebrovascular disease on preprocedural CT had worse clinical outcomes compared with those without cerebrovascular disease on preprocedural CT.

Impact on Outcome of Different Mechanisms, Baseline Degree and Changes of Mitral Regurgitation in Patients With Aortic Stenosis Who Underwent Transcatheter Aortic Valve Replacement.

BACKGROUND: Mitral regurgitation (MR) is frequent in patients with aortic stenosis (AS). Although primary MR is an established negative prognostic factor, whether different mechanisms of MR have different effects on outcome is currently unknown. The aim of this study was to evaluate the impact of the MR mechanism in patients undergoing transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: This is a retrospective observational study of patients who underwent TAVR for severe aortic stenosis in a high-volume tertiary care center. Echocardiographic comprehensive MR assessment was performed at baseline and within 3 months post TAVR. The study population was divided into 4 groups according to MR mechanism: Group I: fibro-calcific leaflet degeneration; Group II: prolapse/flail; Group III: ventricular secondary MR (functional MR); and Group IV: atrial functional MR. The study end point was a combination of death from cardiovascular cause and heart failure-related hospitalization. The study population included 427 patients (mean age 81.7±6.5 years; 71% primary MR; 62% ≥moderate MR). At 3-year follow-up, survival free from the composite end point significantly differs according to MR mechanism: it was higher in group IV (atrial functional MR, 96.6%) compared with group I (80.4%, P=0.002) and group II patients (60.7%, P=0.001), and group III (84.8%, P=0.037); patients with MR due to leaflet prolapse showed poorer prognosis compared with patients with functional MR (group III, P=0.023 and group IV, P=0.001) and with group I (P=0.040). Overall, severe MR after TAVR identified patients with poorer prognosis and was significantly more frequent in group II (46.4%, P=0.001). CONCLUSIONS: In patients undergoing TAVR, preprocedural identification of MR mechanism and mechanism provides prognostic insights.

Outcomes of Transcatheter Aortic Valve Implantation in Patients with and without Diabetes Mellitus.

INTRODUCTION: Diabetes mellitus (DM) in patients undergoing cardiac transcatheter or surgical interventions usually is correlated with poor outcomes. Transcatheter aortic valve implantation (TAVI) has been developed as a therapy choice for inoperable, high-, or intermediate-risk surgical patients with severe aortic stenosis (AS). OBJECTIVE: To evaluate the impact of DM and hemoglobin A1c (HbA1c) on outcomes and survival after TAVI. METHODS: Five hundred and fifty-two symptomatic severe AS patients who underwent TAVI, of whom 164 (29.7%) had DM, were included in this retrospective study. Follow-up was performed after 30 days, six months, and annually. RESULTS: The device success and risks of procedural-related complications were similar between patients with and without DM, except for acute kidney injury, which was more frequent in the DM group (2.4% vs. 0%, P=0.021). In-hospital and first-year mortality were similar between the groups (4.9% vs. 3.6%, P=0.490 and 15.0% vs. 11.2%, P=0.282, respectively). There was a statistical difference between HbA1c ≥ 6.5 and HbA1c ≤ 6.49 groups in total mortality (34.4% vs. 15.8%, P<0.001, respectively). The only independent predictors were Society of Thoracic Surgeons score (hazard ratio [HR] 1.28, 95% confidence interval [CI] 1.09-1.51; P=0.003) and HbA1c level ≥ 6.5 (HR 10.78, 95% CI 2.58-21.50; P=0.003) in multivariable logistic regression analysis. CONCLUSION: In this study, we conclude that DM was not correlated with an increased mortality risk or complication rates after TAVI. Also, it was shown that mortality was higher in patients with HbA1c ≥ 6.5, and it was an independent predictor for long-term mortality.

Sutureless Aortic Valve Replacement vs. Transcatheter Aortic Valve Implantation in Patients with Small Aortic Annulus: Clinical and Hemodynamic Outcomes from a Multi-Institutional Study.

OBJECTIVE: This study aimed to compare hemodynamic performances and clinical outcomes of patients with small aortic annulus (SAA) who underwent aortic valve replacement by means of sutureless aortic valve replacement (SUAVR) or transcatheter aortic valve implantation (TAVI). METHODS: From 2015 to 2020, 622 consecutive patients with SAA underwent either SUAVR or TAVI. Through a 1:1 propensity score matching analysis, two homogeneous groups of 146 patients were formed. Primary endpoint: all cause-death at 36 months. Secondary endpoints: incidence of moderate to severe patient-prosthesis mismatch (PPM) and incidence of major adverse cardiovascular and cerebrovascular events (MACCEs). RESULTS: All-cause death at three years was higher in the TAVI group (SUAVR 12.2% vs. TAVI 21.0%, P=0.058). Perioperatively, comparable hemodynamic performances were recorded in terms of indexed effective orifice area (SUAVR 1.12 ± 0.23 cm2/m2 vs. TAVI 1.17 ± 0.28 cm2/m2, P=0.265), mean transvalvular gradients (SUAVR 12.9 ± 5.3 mmHg vs. TAVI 12.2 ± 6.2 mmHg, P=0.332), and moderate-to-severe PPM (SUAVR 4.1% vs. TAVI 8.9%, P=0.096). TAVI group showed a higher cumulative incidence of MACCEs at 36 months (SUAVR 18.1% vs. TAVI 32.6%, P<0.001). Pacemaker implantation (PMI) and perivalvular leak ≥ 2 were significantly higher in TAVI group and identified as independent predictors of mortality (PMI: hazard ratio [HR] 3.05, 95% confidence interval [CI] 1.34-6.94, P=0.008; PPM: HR 2.72, 95% CI 1.25-5.94, P=0.012). CONCLUSION: In patients with SAA, SUAVR and TAVI showed comparable hemodynamic performances. Moreover, all-cause death and incidence of MACCEs at follow-up were significantly higher in TAVI group.

Impact of Neighborhood Social Deprivation on Delays to Access for Transcatheter Aortic Valve Replacement: Wait-Times and Clinical Consequences.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has become the standard of care for severe aortic stenosis treatment. Exponential growth in demand has led to prolonged wait times and adverse patient outcomes. Social marginalization may contribute to adverse outcomes. Our objective was to examine the association between different measures of neighborhood-level marginalization and patient outcomes while on the TAVR waiting list. A secondary objective was to understand if sex modifies this relationship. METHODS AND RESULTS: We conducted a population-based retrospective cohort study of 11 077 patients in Ontario, Canada, referred to TAVR from April 1, 2018, to March 31, 2022. Primary outcomes were death or hospitalization while on the TAVR wait-list. Using cause-specific Cox proportional hazards models, we evaluated the relationship between neighborhood-level measures of dependency, residential instability, material deprivation, and ethnic and racial concentration with primary outcomes as well as the interaction with sex. After multivariable adjustment, we found a significant relationship between individuals living in the most ethnically and racially concentrated areas (quintile 4 and 5) and mortality (hazard ratio [HR], 0.64 [95% CI, 0.47-0.88] and HR, 0.73 [95% CI, 0.53-1.00], respectively). There was no significant association between material deprivation, dependency, or residential instability with mortality. Women in the highest ethnic or racial concentration quintiles (4 and 5) had significantly lower risks for mortality (HR values of 0.52 and 0.56, respectively) compared with quintile 1. CONCLUSIONS: Higher neighborhood ethnic or racial concentration was associated with decreased risk for mortality, particular for women on the TAVR waiting list. Further research is needed to understand the drivers of this relationship.

Prevalence, Characteristics, and Impact on Prognosis of Aortic Stenosis in Patients With Cardiac Amyloidosis.

BACKGROUND: Cardiac amyloidosis (CA) is frequently found in older patients with aortic stenosis (AS). However, the prevalence of AS among patients with CA is unknown. The objective was to study the prevalence and prognostic impact of AS among patients with CA. METHODS AND RESULTS: We conducted a retrospective analysis of a prospective registry comprising 976 patients with native aortic valves who were confirmed with wild type transthyretin amyloid (ATTRwt), hereditary variant transthyretin amyloid (ATTRv), or immunoglobulin light-chain (AL) CA. CA patients' echocardiograms were re-analyzed focusing on the aortic valve. Multivariable Cox regression analysis was performed to assess the mortality risk associated with moderate or greater AS in ATTRwt CA. The crude prevalence of AS among patients with CA was 26% in ATTRwt, 8% in ATTRv, and 5% in AL. Compared with population-based controls, all types of CA had higher age- and sex-standardized rate ratios (SRRs) of having any degree of AS (AL: SRR, 2.62; 95% Confidence Interval (CI) [1.09-3.64]; ATTRv: SRR, 3.41; 95%CI [1.64-4.60]; ATTRwt: SRR, 10.8; 95%CI [5.25-14.53]). Compared with hospital controls, only ATTRwt had a higher SRR of having any degree of AS (AL: SRR, 0.97, 95%CI [0.56-1.14]; ATTRv: SRR, 1.27; 95%CI [0.85-1.44]; ATTRwt: SRR, 4.01; 95%CI [2.71-4.54]). Among patients with ATTRwt, moderate or greater AS was not associated with increased all-cause death after multivariable adjustment (hazard ratio, 0.71; 95%CI [0.42-1.19]; P=0.19). CONCLUSIONS: Among patients with CA, ATTRwt but not ATTRv or AL is associated with a higher prevalence of patients with AS compared with hospital controls without CA, even after adjusting for age and sex. In our population, having moderate or greater AS was not associated with a worse outcome in patients with ATTRwt.

The evolution of TAVI performance overtime: an overview of systematic reviews.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a well-established treatment for high and intermediate-risk patients with severe aortic stenosis (AS). Recent studies have demonstrated non-inferiority of TAVI compared to surgery in low-risk patients. In the past decade, numerous literature reviews (SLRs) have assessed the use of TAVI in different risk groups. This is the first attempt to provide an overview of SRs (OoSRs) focusing on secondary studies reporting clinical outcomes/process indicators. This research aims to summarize the findings of extant literature on the performance of TAVI over time. METHODS: A literature search took place from inception to April 2024. We searched MEDLINE and the Cochrane Library for SLRs. SLRs reporting at least one review of clinical indicators were included. Subsequently, a two-step inclusion process was conducted: [1] screening based on title and abstracts and [2] screening based on full-text papers. Relevant data were extracted and the quality of the reviews was assessed. RESULTS: We included 33 SLRs with different risks assessed via the Society of Thoracic Surgeons (STS) score. Mortality rates were comparable between TAVI and Surgical Aortic Valve Replacement (SAVR) groups. TAVI is associated with lower rates of major bleeding, acute kidney injury (AKI) incidence, and new-onset atrial fibrillation. Vascular complications, pacemaker implantation, and residual aortic regurgitation were more frequent in TAVI patients. CONCLUSION: This study summarizes TAVI performance findings over a decade, revealing a shift to include both high and low-risk patients since 2020. Overall, TAVI continues to evolve, emphasizing improved outcomes, broader indications, and addressing challenges.

Mitral regurgitation carries greater prognostic significance than mitral stenosis in patients undergoing transcatheter aortic valve replacement.

AIMS: This study assessed the outcomes of concomitant mitral valve disease and severe aortic stenosis in patients undergoing transcatheter aortic valve replacement (TAVR). METHODS: Echocardiographic data of 813 patients with severe aortic stenosis undergoing transfemoral TAVR were collected, and clinical outcomes were analyzed for individuals with mitral stenosis and mitral regurgitation. RESULTS: The final cohort includes 788 patients with severe calcific aortic stenosis. Among single parameters of mitral stenosis, a smaller baseline mitral valve area (MVA) by the continuity equation and higher postprocedural mean mitral gradients (MMG) were associated with an increased risk of death at 1 year (P-values 0.02 and <0.01, respectively), but no correlation with outcomes was demonstrated after multivariate adjustment for major prognosticators. Mitral stenosis (based on MVA + MMG) was not associated with complications or mortality. Mitral regurgitation was present in 94.6% of the population at baseline and regressed by at least one grade post-TAVR in 28% of the patients. The improvement in mitral regurgitation was associated with a greater prosthetic effective orifice area (P-value 0.03). Significant (at least moderate) residual mitral regurgitation was correlated with short-term complications and shown to be an independent predictor of 1-year mortality (P-value 0.02, odds ratio (OR) 5.37, confidence interval 1.34-21.5). CONCLUSION: Mitral regurgitation has a greater impact on TAVR patients than mitral stenosis as assessed by functional methods.

Cardiac fibrosis as a predictor for sudden cardiac death after transcatheter aortic valve implantation.

BACKGROUND: Cardiac fibrosis plays a major pathophysiological role in any form of chronic heart disease, and high levels are associated with poor outcome. Diffuse and focal cardiac fibrosis are different subtypes, which have different pathomechanisms and prognostic implications. The total fibrosis burden in endomyocardial biopsy tissue was recently proved to play an independent prognostic role in aortic stenosis patients after transcatheter aortic valve implantation (TAVI). AIMS: Here, for the first time, we aim to assess the specific impact of different fibrosis subtypes on sudden cardiac death (SCD) as a primary reason for cardiovascular mortality after TAVI. METHODS: The fibrosis pattern was assessed histologically in the left ventricular biopsies obtained during TAVI interventions in 161 patients, who received a structured follow-up thereafter. RESULTS: Receiver operating characteristic analyses, performed 6, 12, 24 and 48 months after TAVI, showed diffuse, but not focal, fibrosis as a significant predictor for SCD at all timepoints, with the highest area under the curve at the first time point and a decrease in its SCD predictivity over time. In both multivariate Cox proportional hazards and Fine-Gray competing risk models, including both fibrosis subtypes, as well as age, sex and ejection fraction, high diffuse fibrosis remained statistically significant. Accordingly, it represents an independent SCD predictor, most importantly for the occurrence of early events. CONCLUSIONS: The burden of diffuse cardiac fibrosis plays an important and independent prognostic role regarding SCD early after TAVI. Therefore, the histological evaluation of fibrosis topography has value as a prognostic tool for TAVI patients and may help to tailor individualised approaches to optimise their postinterventional management.

Predictors and 5-Year Clinical Outcomes of Pacemaker After TAVR: Analysis From the PARTNER 2 SAPIEN 3 Registries.

BACKGROUND: Conduction disturbances requiring a permanent pacemaker (PPM) are a frequent complication of transcatheter aortic valve replacement (TAVR) with few reports of rates, predictors, and long-term clinical outcomes following implantation of the third-generation, balloon-expandable SAPIEN 3 (S3) transcatheter heart valve (THV). OBJECTIVES: The aim of this study was to investigate the rates, predictors, and long-term clinical outcomes of PPM implantation following TAVR with the S3 THV. METHODS: The current study included 857 patients in the PARTNER 2 S3 registries with intermediate and high surgical risk without prior PPM, and investigated predictors and 5-year clinical outcomes of new PPM implanted within 30 days of TAVR. RESULTS: Among 857 patients, 107 patients (12.5%) received a new PPM within 30 days after TAVR. By multivariable analysis, predictors of PPM included increased age, pre-existing right bundle branch block, larger THV size, greater THV oversizing, moderate or severe annulus calcification, and implantation depth >6 mm. At 5 years (median follow-up 1,682.0 days [min 2.0 days, max 2,283.0 days]), new PPM was not associated with increased rates of all-cause mortality (Adj HR: 1.20; 95% CI: 0.85-1.70; P = 0.30) or repeat hospitalization (Adj HR: 1.22; 95% CI: 0.67-2.21; P = 0.52). Patients with new PPM had a decline in left ventricular ejection fraction at 1 year that persisted at 5 years (55.1 ± 2.55 vs 60.4 ± 0.65; P = 0.02). CONCLUSIONS: PPM was required in 12.5% of patients without prior PPM who underwent TAVR with a SAPIEN 3 valve in the PARTNER 2 S3 registries and was not associated with worse clinical outcomes, including mortality, at 5 years. Modifiable factors that may reduce the PPM rate include bioprosthetic valve oversizing, prosthesis size, and implantation depth.

Selection for transcatheter versus surgical aortic valve replacement and mid-term survival: results of the AUTHEARTVISIT study.

OBJECTIVES: Limited data are available from randomized trials comparing outcomes between transcatheter aortic valve replacement (TAVR) and surgery in patients with different risks and with follow-up of at least 4 years or longer. In this large, population-based cohort study, long-term mortality and morbidity were investigated in patients undergoing aortic valve replacement (AVR) for severe aortic stenosis using a surgically implanted bioprosthesis (surgical/biological aortic valve replacement; sB-AVR) or TAVR. METHODS: Individual data from the Austrian Insurance Funds from 2010 through 2020 were analysed. The primary outcome was all-cause mortality, assessed in the overall and propensity score-matched populations. Secondary outcomes included reoperation and cardiovascular events. RESULTS: From January 2010 through December 2020, a total of 18 882 patients underwent sB-AVR (n = 11 749; 62.2%) or TAVR (n = 7133; 37.8%); median follow-up was 5.8 (95% CI 5.7-5.9) years (maximum 12.3 years). The risk of all-cause mortality was higher with TAVR compared with sB-AVR: hazard ratio 1.552, 95% confidence interval (CI) 1.469-1.640, P < 0.001; propensity score-matched hazard ratio 1.510, 1.403-1.625, P < 0.001. Estimated median survival was 8.8 years (95% CI 8.6-9.1) with sB-AVR versus 5 years (4.9-5.2) with TAVR. Estimated 5-year survival probability was 0.664 (0.664-0.686) with sB-AVR versus 0.409 (0.378-0.444) with TAVR overall, and 0.690 (0.674-0.707) and 0.560 (0.540-0.582), respectively, with propensity score matching. Separate subgroup analyses for patients aged 65-75 years and >75 years indicated a significant survival benefit in patients selected for sB-AVR in both groups. Other predictors of mortality were age, sex, previous heart failure, diabetes and chronic kidney disease. CONCLUSIONS: In this retrospective national population-based study, selection for TAVR was significantly associated with higher all-cause mortality compared with sB-AVR in patients ≥65 years with severe, symptomatic aortic stenosis in the >2-year follow-up.

Sex-Specific Differences in Upstream Cardiac Damage in Patients With Aortic Stenosis Undergoing TAVR.

BACKGROUND: Cardiac damage caused by aortic stenosis (AS) can be categorized into stages, which are associated with a progressively increasing risk of death after transcatheter aortic valve replacement (TAVR). OBJECTIVES: The authors investigated sex-related differences in cardiac damage among patients with symptomatic AS and the prognostic value of cardiac damage classification in women and men undergoing TAVR. METHODS: In a prospective registry, pre-TAVR echocardiograms were used to categorize patients into 5 stages of cardiac damage caused by AS. Differences in the extent of cardiac damage were compared according to sex, and its implications on clinical outcomes after TAVR were explored. RESULTS: Among 2,026 patients undergoing TAVR between August 2007 and June 2022 (995 [49.1%] women and 1,031 [50.9%] men), we observed sex-specific differences in the pattern of cardiac damage (women vs men; stage 0: 2.6% vs 3.1%, stage 1: 13.4% vs 10.1%, stage 2: 37.1% vs 39.5%, stage 3: 27.5% vs 15.6%, and stage 4: 19.4% vs 31.7%). There was a stepwise increase in 5-year all-cause mortality according to stage in women (HRadjusted: 1.43; 95% CI: 1.28-1.60, for linear trend) and men (HRadjusted: 1.26; 95% CI: 1.14-1.38, for linear trend). Female sex was associated with a lower 5-year mortality in early stages (stage 0, 1, or 2) but not in advanced stages (stage 3 or 4). CONCLUSIONS: The pattern of cardiac damage secondary to AS differed by sex. In early stages of cardiac damage, women had a lower 5-year mortality than men, whereas in more advanced stages, mortality was comparable between sexes. (SwissTAVI Registry; NCT01368250).

Impact of Elevated Gradients After Transcatheter Aortic Valve Implantation for Degenerated Surgical Aortic Valve Bioprostheses.

BACKGROUND: Elevated aortic valve gradients are common after transcatheter aortic valve implantation for degenerated surgical aortic valve replacement bioprostheses, but their clinical impact is uncertain. METHODS: A total of 12 122 patients who underwent transcatheter aortic valve implantation-in-surgical aortic valve replacement from November 2011 to December 2019 in the Society of Thoracic Surgery/American College of Cardiology Transvalvular Therapeutics Registry were included. The primary outcome was a composite of 1-year all-cause mortality, stroke, myocardial infarction, or valve reintervention. Secondary outcomes included 1-year all-cause mortality, readmission, and change from baseline 12-question self-administered Kansas City Cardiomyopathy Questionnaire-Overall Summary Score. Due to nonlinearity observed with restricted cubic splines analysis, a Cox regression analysis with aortic valve mean gradient modeled as a spline-continuous variable (with 20 mm Hg as a cutoff) was used to study the 1-year composite outcome and mortality. RESULTS: The composite outcome occurred most frequently in patients with aortic valve mean gradient ≥30 and <10 mm Hg, as compared with those with 10 to 20 and 20 to 30 mm Hg ranges (unadjusted rates, 13.9%, 12.1%, 7.5%, and 6.5%, respectively; P=0.002). When the mean aortic valve gradient was ≥20 mm Hg, higher gradients were associated with greater risk of the 1-year composite outcome (adjusted hazard ratio, 1.02 [1.02-1.03] per mm Hg; P<0.001) and 1-year mortality (adjusted hazard ratio, 1.02 [1.00-1.03] per mm Hg; P=0.007). Whereas when the mean aortic valve gradient was <20 mm Hg, higher gradients were not significantly associated with the composite outcome (adjusted hazard ratio, 0.99 [0.98-1.003] per mm Hg; P=0.12) but were associated with lower 1-year mortality (adjusted hazard ratio, 0.98 [0.97-0.99] per mm Hg; P=0.007). CONCLUSIONS: The relationship between postprocedural aortic valve mean gradient after transcatheter aortic valve implantation-in-surgical aortic valve replacement and clinical outcomes is complex and nonlinear, with relatively greater adverse events occurring at low and high gradient extremes. Further study of factors mediating the relationship between postprocedural gradients and clinical outcomes, including low-flow states, is necessary.

Incidence, Predictors, and Outcomes of Paravalvular Regurgitation After TAVR in Sievers Type 1 Bicuspid Aortic Valves.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BAV) stenosis is technically challenging and is burdened by an increased risk of paravalvular regurgitation (PVR). OBJECTIVES: The aim of this study was to identify the incidence, predictors, and clinical outcomes of PVR after TAVR in Sievers type 1 BAV stenosis. METHODS: Consecutive patients with Sievers type 1 BAV stenosis undergoing TAVR with current-generation transcatheter heart valves (THVs) in 24 international centers were enrolled. PVR was graded as none/trace, mild, moderate, and severe according to echocardiographic criteria. The endpoint of major adverse events (MAEs), defined as a composite of all-cause death, stroke, or hospitalization for heart failure, was assessed at the last available follow-up. RESULTS: A total of 946 patients were enrolled. PVR occurred in 423 patients (44.7%)-mild, moderate, and severe in 387 (40.9%), 32 (3.4%), and 4 (0.4%) patients, respectively. Independent predictors of moderate or severe PVR were a larger virtual raphe ring perimeter (adjusted OR: 1.07; 95% CI: 1.02-1.13), severe annular or left ventricular outflow tract calcification (adjusted OR: 5.21; 95% CI: 1.45-18.77), a self-expanding valve (adjusted OR: 9.01; 95% CI: 2.09-38.86), and intentional supra-annular THV positioning (adjusted OR: 3.31; 95% CI: 1.04-10.54). At a median follow-up of 1.3 years (Q1-Q3: 0.5-2.4 years), moderate or severe PVR was associated with an increased risk of MAEs (adjusted HR: 2.52; 95% CI: 1.24-5.09). CONCLUSIONS: After TAVR with current-generation THVs in Sievers type 1 BAV stenosis, moderate or severe PVR occurred in about 4% of cases and was associated with an increased risk of MAEs during follow-up.

Stroke risk after transcatheter aortic valve replacement in patients with carotid stenosis: A systematic review and meta-analysis.

BACKGROUND: Stroke is a feared complication of transcatheter aortic valve replacement (TAVR). Patients undergoing TAVR typically have multiple comorbidities, such as carotid artery stenosis (CAS). We conducted the present meta-analysis to determine the risk of stroke and mortality following TAVR in patients with CAS. METHODS: We searched PubMed/Medline, Scopus, ScienceDirect, and Cochrane Clinical Trials databases for clinical studies that compared CAS ≥50% and CAS ≥70% versus non-CAS TAVR population. The endpoints included the 30-day incidence of stroke or transient ischemic attack (TIA) and 30-day all-cause of mortality. RESULTS: We identified seven studies that included 12,418 patients in the CAS group and 102,316 in the control group. CAS ≥50% was not associated with an increased risk of 30-day stroke or TIA after TAVR [risk ratio (RR): 1.38; 95% confidence interval (95% CI): 0.95-2.02; p = 0.09]. However, patients with CAS ≥70% had an increased risk of stroke or TIA (RR: 1.43; 95% CI: 1.02-2.01; p = 0.04). No difference in 30-day all-cause mortality was observed between CAS ≥50% or CAS ≥70% and control groups (RR: 1.09; 95% CI: 0.79-1.52; p = 0.59 and RR: 1.11; 95% CI: 0.85-1.45; p = 0.43, respectively). CONCLUSIONS: CAS ≥70% was associated with an increased risk of stroke or TIA following TAVR compared with patients without CAS.

Systematic review and meta-analysis of the impact of sex on outcomes after aortic valve replacement.

AIMS: In recent years, extensive literature has been produced demonstrating inferior outcomes for women when compared with men undergoing heart valve interventions. Herein, we seek to analyze the literature comparing outcomes between men and women undergoing surgical aortic valve replacement (SAVR). METHODS: A systematic literature search of PubMed, MEDLINE, and Embase was conducted for articles comparing differences in outcomes between adult men and women undergoing SAVR. One thousand nine hundred and ninety titles were screened, of which 75 full texts were reviewed, and a total of 19 manuscripts met the inclusion criteria and were included in this review. RESULTS: Pooled estimates of mortality demonstrated that women tended to have lower rates of survival within the first 30 days post-SAVR, although mid-term and long-term mortality did not differ significantly up to 10 years postoperatively. Pooled estimates of postoperative data indicated no difference in the rates of stroke and postoperative bleeding. Rates of aortic valve reoperation and acute kidney injury favored women. CONCLUSION: Despite the inferior outcomes for women post-SAVR that have been reported in recent years, the results of this meta-analysis demonstrate comparable results between the sexes with comparable mid- to long-term mortality in data pooled from the literature. Although mortality favored men in the short term, rates of aortic valve reoperation and acute kidney injury favored women. Future investigation into this field should focus on identifying discrepancies in diagnosis and initial surgical management in order to address any potential factors contributing to discrepant short-term outcomes. GRAPHICAL ABSTRACT: http://links.lww.com/JCM/A651.