Long-term effect of biodegradable vs durable polymer everolimus-eluting stents on neoatherosclerosis in ST-segment elevation myocardial infarction: the CONNECT trial.

BACKGROUND AND AIMS: Neoatherosclerosis is a leading cause of late (>1 year) stent failure following drug-eluting stent implantation. The role of biodegradable (BP) versus durable polymer (DP) drug-eluting stents on long-term occurrence of neoatherosclerosis remains unclear. Superiority of biodegradable against durable polymer current generation thin-strut everolimus-eluting stent (EES) was tested by assessing the frequency of neoatherosclerosis 3 years after primary percutaneous coronary intervention (pPCI) among patients with ST-segment elevation myocardial infarction (STEMI). METHODS: The randomized controlled, multicentre (Japan and Switzerland) CONNECT trial (NCT03440801) randomly (1:1) assigned 239 STEMI patients to pPCI with BP-EES or DP-EES. The primary endpoint was the frequency of neoatherosclerosis assessed by optical coherence tomography (OCT) at 3 years. Neoatherosclerosis was defined as fibroatheroma or fibrocalcific plaque or macrophage accumulation within the neointima. RESULTS: Among 239 STEMI patients randomized, 236 received pPCI with stent implantation (119 BP-EES; 117 DP-EES). A total of 178 patients (75%; 88 in the BP-EES group and 90 in the DP-EES group) underwent OCT assessment at 3 years. Neoatherosclerosis did not differ between the BP-EES (11.4%) and DP-EES (13.3%; odds ratio 0.83, 95% confidence interval 0.33-2.04, p=0.69). There were no differences in the frequency of fibroatheroma (BP-EES 9.1% vs DP-EES 11.1%, p=0.66) or macrophage accumulation (BP-EES 4.5% vs DP-EES 3.3%, p=0.68), and no fibrocalcific neoatherosclerosis was observed. Rates of target lesion failure did not differ between groups (BP-EES 5.9% vs DP-EES 6.0%, p=0.97). CONCLUSIONS: Use of BP-EES for primary PCI in patients presenting with STEMI was not superior to DP-EES regarding frequency of neoatherosclerosis at 3 years.

Multi-modality artificial intelligence-based transthyretin amyloid cardiomyopathy detection in patients with severe aortic stenosis.

PURPOSE: Transthyretin amyloid cardiomyopathy (ATTR-CM) is a frequent concomitant condition in patients with severe aortic stenosis (AS), yet it often remains undetected. This study aims to comprehensively evaluate artificial intelligence-based models developed based on preprocedural and routinely collected data to detect ATTR-CM in patients with severe AS planned for transcatheter aortic valve implantation (TAVI). METHODS: In this prospective, single-center study, consecutive patients with AS were screened with [99mTc]-3,3-diphosphono-1,2-propanodicarboxylic acid ([99mTc]-DPD) for the presence of ATTR-CM. Clinical, laboratory, electrocardiogram, echocardiography, invasive measurements, 4-dimensional cardiac CT (4D-CCT) strain data, and CT-radiomic features were used for machine learning modeling of ATTR-CM detection and for outcome prediction. Feature selection and classifier algorithms were applied in single- and multi-modality classification scenarios. We split the dataset into training (70%) and testing (30%) samples. Performance was assessed using various metrics across 100 random seeds. RESULTS: Out of 263 patients with severe AS (57% males, age 83 ± 4.6years) enrolled, ATTR-CM was confirmed in 27 (10.3%). The lowest performances for detection of concomitant ATTR-CM were observed in invasive measurements and ECG data with area under the curve (AUC) < 0.68. Individual clinical, laboratory, interventional imaging, and CT-radiomics-based features showed moderate performances (AUC 0.70-0.76, sensitivity 0.79-0.82, specificity 0.63-0.72), echocardiography demonstrated good performance (AUC 0.79, sensitivity 0.80, specificity 0.78), and 4D-CT-strain showed the highest performance (AUC 0.85, sensitivity 0.90, specificity 0.74). The multi-modality model (AUC 0.84, sensitivity 0.87, specificity 0.76) did not outperform the model performance based on 4D-CT-strain only data (p-value > 0.05). The multi-modality model adequately discriminated low and high-risk individuals for all-cause mortality at a mean follow-up of 13 months. CONCLUSION: Artificial intelligence-based models using collected pre-TAVI evaluation data can effectively detect ATTR-CM in patients with severe AS, offering an alternative diagnostic strategy to scintigraphy and myocardial biopsy.

Routine 4D Cardiac CT to Identify Concomitant Transthyretin Amyloid Cardiomyopathy in Older Adults with Severe Aortic Stenosis.

Background Transthyretin amyloid cardiomyopathy (ATTR-CM) often coexists with severe aortic stenosis (AS). Although strain analysis from cardiac MRI and echocardiography was demonstrated to predict coexisting ATTR-CM, comparable data from four-dimensional (4D) cardiac CT are lacking despite wide availability. Purpose To evaluate the diagnostic performance of 4D cardiac CT-derived parameters in identifying ATTR-CM in older adults considered for transcatheter aortic valve implantation (TAVI). Materials and Methods This prospective single-center screening study for ATTR-CM included consecutive patients with severe AS considered for TAVI who underwent 4D cardiac CT between August 2019 and August 2021 approximately 1 day before technetium 99m (99mTc) 3,3-diphosphono-1,2-propanodicarboxylic-acid (DPD) scintigraphy. The diagnostic performance of CT-based left ventricular (LV), right ventricular, and left atrial dimensions, ejection fraction (EF), and myocardial strain were evaluated against 99mTc-DPD scintigraphy as the reference standard to identify ATTR-CM. Predictors and an unweighted cardiac CT score were validated with internal bootstrapping. The assignment of variables to the score was based on cutoff values achieving the highest Youden index J. Results Among 263 participants (mean age, 83 years ± 4.6 [SD]; 149 male and 114 female participants), 99mTc-DPD scintigraphy (Perugini grade 2 or 3) confirmed coexisting ATTR-CM in 27 (10.3%). CT-derived LV mass index, LV and LA global longitudinal strain (GLS), and relative apical longitudinal strain each predicted the presence of ATTR-CM with an area under the curve (AUC) of at least 0.70. Implementing these parameters with cutoff values of 81 g/m2 or higher, -14.9% or higher, less than 11.5%, and 1.7 or higher in the CT score, respectively, yielded high diagnostic performance (AUC = 0.89; 95% CI: 0.81, 0.94; P < .001) robust to internal bootstrapping validation (AUC = 0.88; 95% CI: 0.82, 0.94). If two criteria were fulfilled, the sensitivity and specificity in the detection of ATTR-CM were 96.3% (95% CI: 81.0, 99.9) and 58.9% (95% CI: 52.3, 65.2), respectively. Conclusion When compared against 99mTc-DPD scintigraphy as the reference standard, routine 4D cardiac CT in older adults considered for TAVI provided high diagnostic performance in the detection of concomitant ATTR-CM by assessing LV and left atrial GLS, relative apical longitudinal strain, and LV mass index. ClinicalTrials.gov registration no.: NCT04061213 © RSNA, 2023 Supplemental material is available for this article. See also the editorial by Tavakoli and Onder in this issue.

Aortic annulus ellipticity and outcomes after transcatheter aortic valve implantation.

BACKGROUND: Elliptical shape of the aortic annulus has been associated with an increased risk of device failure after transcatheter aortic valve implantation (TAVI) compared with a circular annular shape. AIMS: To assess the impact of annulus ellipticity on procedural outcomes and device performance in patients undergoing TAVI. METHODS: In a prospective TAVI registry, aortic annulus ellipticity was assessed by preprocedural multidetector computed tomography. The annulus ratios, defined by the ratio of minimum and maximum annulus diameters measured in a transverse double oblique plane, were split into tertiles for comparisons between groups. RESULTS: A total of 1732 patients undergoing TAVI between August 2007 and June 2020 were included in the present analysis. Patients in the tertile with the most elliptical shape of the annulus were more likely to be female (59.7% vs. 47.9%; p < 0.001) and had a higher Society of Thoracic Surgeons Predicted Risk of Mortality (5.4 ± 3.8 vs. 4.8 ± 3.5; p = 0.002). There were no significant differences in the rate of technical success (95.3% vs. 96.5%; p = 0.235), device success (83.6% vs. 86.5%; p = 0.118) and intended valve performance (90.7% vs. 91.7; p = 0.503) between patients in the most elliptical tertile and the rest. However, valve dislocation/embolization occurred more frequently in patients with elliptical as compared to circular annular shape (2.6% vs. 1.2%; p = 0.046). CONCLUSIONS: Ellipticity of the aortic annulus does not affect procedural and device outcomes in patients undergoing TAVI irrespective of transcatheter heart valve design and generation. https:www.//clinicaltrials.gov. NCT01368250.

Sinus of Valsalva Dimension and Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Implantation.

BACKGROUND: Ascending aortic root anatomy is routinely evaluated on pre-procedural multi-detector computed tomography (MDCT). However, its clinical significance has not been adequately studied. We aimed to investigate the impact of the sinus of Valsalva (SOV) dimension on clinical outcomes in patients undergoing transcatheter aortic valve implantation (TAVI). METHODS: In a prospective TAVI registry, we retrospectively assessed SOV dimensions by pre-procedural MDCT. Patients were stratified according to tertiles of SOV diameter indexed to body surface area (SOVi). The primary endpoint was all-cause mortality at 1 year. RESULTS: Among 2066 consecutive patients undergoing TAVI between August 2007 and June 2018, 1554 patients were eligible for the present analysis. Patients in the large SOVi group were older (83 ± 6 vs 82 ± 6 vs 81 ± 6; P < .001) and had a higher Society of Thoracic Surgeons Predicted Risk of Mortality (6.3 ± 3.8 vs 5.1 ± 3.1 vs 4.9 ± 3.5; P < .001) than those in the other groups. Patients in the large SOVi group had a higher incidence of moderate or severe paravalvular regurgitation (11.9% vs 4.5% vs 3.5%; P < .001). At 1 year, a large SOVi was independently associated with an increased risk of mortality (HR: 1.62; 95% CI: 1.19-2.21; P = .002) and major or life-threatening bleeding (HR: 1.30; 95% CI: 1.02-1.65; P = .035). CONCLUSIONS: Dilatation of the aortic root at the SOV was associated with adverse outcomes after TAVI. The assessment of the aortic root should be integrated into the risk stratification system in patients undergoing TAVI.

Cardiovascular outcomes in patients with left atrial enlargement undergoing transcatheter aortic valve implantation.

BACKGROUND: Increased left ventricular afterload resulting from severe aortic stenosis (AS) leads to progressive cardiac remodeling. Left atrial enlargement (LAE) is an early manifestation in a series of maladaptive changes and may affect clinical outcomes after valvular replacement therapy. The aim of this study is to determine the impact of LAE on clinical outcomes in symptomatic patients with severe AS undergoing transcatheter aortic valve implantation (TAVI). METHODS: In a prospective single-center TAVI registry, we analyzed LA dimensions measured by echocardiography before intervention. Patients with atrial fibrillation or concomitant mitral valve disease were excluded. LAE was defined as indexed LA volume >34 ml/m2 . The primary endpoint was cardiovascular death (CVD) at 1 year. RESULTS: Among 1663 patients undergoing TAVI between August 2007 and December 2016, 768 (46.2%) were eligible for the present analysis and 486 patients had LAE. The prevalence of LAE was higher in males (68.3%) as compared to females (58.8%). Patients with LAE were older (82.3 ± 6.7 years vs. 80.0 ± 6.4 years) and had a higher STS-PROM score (6.1 ± 4.7% vs. 4.7 ± 2.9%). After adjustment, patients with LAE had an increased risk of CVD at 1-year compared to patients with normal LA dimensions (49 [10.4%] vs. 8 [2.9%]; HRadj , 3.52; 95% CI, 1.66-7.44)]. In multivariable analysis, LAE was independently associated with an increased risk of CVD at 1-year (HRadj , 3.52; 95% CI, 1.66-7.44). CONCLUSIONS: LAE secondary to AS was documented in a significant proportion of patients undergoing TAVI and was associated with a more than threefold increased risk of CVD at 1-year.

Diagnostic performance of quantitative coronary artery disease assessment using computed tomography in patients with aortic stenosis undergoing transcatheter aortic-valve implantation.

BACKGROUND: Computed tomography angiography (CTA) is a cornerstone in the pre- transcatheter aortic valve replacement (TAVI) assessment. We evaluated the diagnostic performance of CTA and coronary artery calcium score (CACS) for CAD evaluation compared to invasive coronary angiography in a cohort of TAVI patients. METHODS: In consecutive TAVI patients without prior coronary revascularization and device implants, CAD was assessment by quantitative analysis in CTA. (a) Patients with non-evaluable segments were classified as obstructive CAD. (b) In patients with non-evaluable segments a CACS cut-off of 100 was applied for obstructive CAD. The reference standard was quantitative invasive coronary angiography (QCA, i.e. ≥ 50% stenosis). RESULTS: 100 consecutive patients were retrospectively included, age was 82.3 ± 6.5 years and 30% of patients had CAD. In 16% of the patients, adequate visualization of the entire coronary tree (all 16 segments) was possible with CTA, while 84% had at least one segment which was not evaluable for CAD analysis due to impaired image quality. On a per-patient analysis, where patients with low image quality were classified as CAD, CTA showed a sensitivity of 100% (95% CI 88.4-100.0), specificity of 11.4% (95% CI 5.1-21.3), PPV of 32.6% (95% CI 30.8-34.5), NPV of 100% and diagnostic accuracy of 38% (95% CI 28.5-48.3) for obstructive CAD. When applying a combined approach of CTA (in patients with good image quality) and CACS (in patients with low image quality), the sensitivity and NPV remained at 100% and obstructive CAD could be ruled out in 20% of the TAVI patients, versus 8% using CTA alone. CONCLUSION: In routinely acquired pre-TAVI CTA, the image quality was insufficient in a high proportion of patients for the assessment of the entire coronary artery tree. However, when adding CACS in patients with low image quality to quantitative CTA assessment in patients with good image quality, obstructive CAD could be ruled-out in 1/5 of the patients and may therefore constitute a strategy to streamline pre-procedural workup, and reduce risk, radiation and costs in selected TAVI patients without prior coronary revascularization or device implants.

Heart valve sizing and clinical outcomes in patients undergoing transcatheter aortic valve implantation.

OBJECTIVES: To investigate the impact of transcatheter heart valve (THV) sizing on procedural results and clinical outcomes following transcatheter aortic valve implantation (TAVI). BACKGROUND: The impact of individual THV sizing for patients with borderline aortic annulus anatomy remains unclear. METHODS: In the prospective BernTAVI registry, THV sizing conditions were retrospectively evaluated, and patients were categorized into three groups based on the recommendations and the sizing chart of the manufacturers: optimal sizing, borderline sizing (THV size located within 5% to each border of the optimal sizing recommendation), and suboptimal sizing (THV size outside the recommended range). The latter two groups were further subcategorized into THV-oversizing and THV-undersizing. The primary endpoint was a composite of all-cause death and unplanned repeat intervention at 1 year. RESULTS: Out of a total of 1,638 patients who underwent TAVI, 9.5 and 15.6% of patients were categorized into the borderline and suboptimal sizing group, respectively. Device success was achieved in 87.4, 88.9, and 83.6% of patients with optimal, borderline, and suboptimal sizing, respectively. The primary endpoint occurred in 12.3% of patients with optimal sizing, 14.9% of patients with borderline sizing (HRadj 1.35, 95%CI 0.87-2.09), and in 17.4% of patients with suboptimal sizing (HRadj 1.42, 95%CI 1.01-1.99). Within the suboptimal sizing cohort, unfavorable outcomes were mainly associated with THV undersizing (device success: 76.4%, primary endpoint: 23.9%, HRadj 1.98, 95%CI 1.36-2.87). CONCLUSION: Suboptimal TAVI prosthesis sizing is associated with an increased risk of all-cause death and unplanned repeat intervention within 1 year largely attributable to undersized THV prostheses.

Validation of high bleeding risk criteria and definition as proposed by the academic research consortium for high bleeding risk.

AIMS: To validate the set of clinical and biochemical criteria proposed by consensus by the Academic Research Consortium (ARC) for High Bleeding Risk (HBR) for the identification of HBR patients. These criteria were categorized into major and minor, if expected to carry in isolation, respectively, ≥4% and <4% Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding risk within 1-year after percutaneous coronary intervention (PCI). High bleeding risk patients are those meeting at least 1 major or 2 minor criteria. METHODS AND RESULTS: All patients undergoing PCI at Bern University Hospital, between February 2009 and September 2018 were prospectively entered into the Bern PCI Registry (NCT02241291). Age, haemoglobin, platelet count, creatinine, and use of oral anticoagulation were prospectively collected, while the remaining HBR criteria except for planned surgery were retrospectively adjudicated. A total of 16 580 participants with complete ARC-HBR criteria were included. After assigning 1 point to each major and 0.5 point to each minor criterion, we observed for every 0.5 score increase a step-wise augmentation of BARC 3 or 5 bleeding rates at 1 year ranging from 1.90% among patients fulfilling no criterion, through 4.01%, 5.98%, 7.42%, 8.60%, 12.21%, 12.29%, and 17.64%. All major and five out of six minor criteria, conferred in isolation a risk for BARC 3 or 5 bleeding at 1 year exceeding 4% at the upper limit of the 95% confidence intervals. CONCLUSION: All major and the majority of minor ARC-HBR criteria identify in isolation patients at HBR.

Safety and efficacy of a self-expanding versus a balloon-expandable bioprosthesis for transcatheter aortic valve replacement in patients with symptomatic severe aortic stenosis: a randomised non-inferiority trial.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is the preferred treatment option for older patients with symptomatic severe aortic stenosis. Differences in the properties of available TAVR systems can affect clinical outcomes. Among patients undergoing TAVR, we compared the self-expanding ACURATE neo TAVR system with the balloon-expandable SAPIEN 3 TAVR system with regard to early safety and efficacy. METHODS: In this randomised non-inferiority trial, patients (aged ≥75 years) undergoing transfemoral TAVR for treatment of symptomatic severe aortic stenosis, and who were deemed to be at increased surgical risk, were recruited at 20 tertiary heart valve centres in Germany, the Netherlands, Switzerland, and the UK. Participants were randomly assigned (1:1) to receive treatment with the ACURATE neo or the SAPIEN 3 with a computer-based randomly permuted block scheme, stratified by study centre and Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) category. The primary composite safety and efficacy endpoint comprised all-cause death, any stroke, life-threatening or disabling bleeding, major vascular complications, coronary artery obstruction requiring intervention, acute kidney injury (stage 2 or 3), rehospitalisation for valve-related symptoms or congestive heart failure, valve-related dysfunction requiring repeat procedure, moderate or severe prosthetic valve regurgitation, or prosthetic valve stenosis within 30 days of the procedure. Endpoint assessors were masked to treatment allocation. Non-inferiority of ACURATE neo compared with SAPIEN 3 was assessed in the intention-to-treat population on the basis of a risk-difference margin of 7·7% for the primary composite endpoint, with a one-sided α of 0·05. This trial is registered with ClinicalTrials.gov (number NCT03011346) and is ongoing but not recruiting. FINDINGS: Between Feb 8, 2017, and Feb 2, 2019, up to 5132 patients were screened and 739 (mean age 82·8 years [SD 4·1]; median STS-PROM score 3·5% [IQR 2·6-5·0]) were enrolled. 30-day follow-up was available for 367 (99%) of 372 patients allocated to the ACURATE neo group, and 364 (99%) of 367 allocated to the SAPIEN 3 group. Within 30 days, the primary endpoint occurred in 87 (24%) patients in the ACURATE neo and in 60 (16%) in the SAPIEN 3 group; thus, non-inferiority of the ACURATE neo was not met (absolute risk difference 7·1% [upper 95% confidence limit 12·0%], p=0·42). Secondary analysis of the primary endpoint suggested superiority of the SAPIEN 3 device over the ACURATE neo device (95% CI for risk difference -1·3 to -12·9, p=0·0156). The ACURATE neo and SAPIEN 3 groups did not differ in incidence of all-cause death (nine patients [2%] vs three [1%]) and stroke (seven [2%] vs 11 [3%]); whereas acute kidney injury (11 [3%] vs three [1%]) and moderate or severe prosthetic aortic regurgitation (34 [9%] vs ten [3%]) were more common in the ACURATE neo group. INTERPRETATION: TAVR with the self-expanding ACURATE neo did not meet non-inferiority compared to the balloon-expandable SAPIEN 3 device in terms of early safety and clinical efficacy outcomes. An early composite safety and efficacy endpoint was useful in discriminating the performance of different TAVR systems. FUNDING: Boston Scientific (USA).

ACURATE neo: How Is This TAVR Valve Doing to Fit into an Increasingly Crowded Field?

PURPOSE OF REVIEW: Critical appraisal of the available evidence on the self-expanding ACURATE neo transcatheter heart valve (THV) for the treatment of aortic valve disease. RECENT FINDINGS: In an investigator-initiated, multicenter, randomized non-inferiority trial with broad inclusion criteria, ACURATE neo failed to meet non-inferiority compared with SAPIEN 3 with regard to a primary composite safety and efficacy endpoint at 30 days. The difference was driven by higher rates of moderate or severe paravalvular regurgitation and higher rates of acute kidney injury. In turn, registry data suggest that the safety and efficacy profile of the ACURATE neo is comparable to that of other commercially available devices. Randomized evidence indicated favorable hemodynamic results with large effective orifice areas and low residual gradients. The self-expanding ACURATE neo THV is associated with higher rates of residual aortic regurgitation compared to the balloon-expandable SAPIEN 3 THV. The supra-annular design with low residual gradients may be advantageous in patients with small anatomy and mild degree of calcification.

Transcatheter aortic valve replacement in patients with concomitant mitral stenosis.

AIMS: Multivalvular disease is of increasing concern in elderly patients undergoing transcatheter aortic valve replacement (TAVR). The objective of the present analysis was to investigate the impact of concomitant mitral stenosis (MS) on clinical outcomes in patients undergoing TAVR for severe, symptomatic aortic stenosis (AS). METHODS AND RESULTS: Among 1339 patients undergoing TAVR between August 2007 and December 2015, adequate echocardiographic data for the assessment of severity and aetiology of MS was available in 971 (72.5%) patients. Patients were stratified according to degree and aetiology of concomitant MS. Mitral stenosis was documented in 176 (18.1%) TAVR patients (mean mitral valve area 1.9 ± 0.4 cm2) and considered degenerative in 110 (62.5%) and rheumatic in 66 (37.5%) patients, respectively. Mitral stenosis was categorized as moderate/severe in 28 patients (2.9%). Baseline characteristics were comparable between patients with vs. without MS. At 1 year, patients with MS were at increased risk of cardiovascular death [36 (21.4%) vs. 66 (8.7%); adjusted hazard ratio (HRadj) 3.64, 95% confidence interval (CI) 2.38-5.56] and disabling stroke [12 (7.1%) vs. 23 (3.0%); HRadj 2.98, 95% CI 1.46-6.09] as compared to patients without MS. Differences in cardiovascular death and disabling stroke emerged within 30 days of the index procedure and were largely driven by a difference in patients with rheumatic MS [cardiovascular death: 7 (10.6%) vs. 24 (3.2%), HRadj 4.80, 95% CI 1.98-11.6; disabling stroke: 4 (6.1%) vs. 16 (2.0%), HRadj 4.18, 95% CI 1.34-13.0]. CONCLUSION: Concomitant MS was documented in approximately one-fifth of patients undergoing TAVR for severe, symptomatic AS and associated with a three-fold increased risk of cardiovascular adverse events at 1 year. The difference emerged early and was largely driven by patients with rheumatic MS.

Early Detection of Subclinical Myocardial Damage in Chronic Aortic Regurgitation and Strategies for Timely Treatment of Asymptomatic Patients.

A series of hemodynamic and pathological responses occur in chronic aortic regurgitation, which eventually result in myocardial fibrosis and irreversible left ventricular dysfunction. According to guidelines, valvular surgery is recommended with the development of symptoms, left ventricular systolic dysfunction, or left ventricular dilatation. The optimal timing of surgical intervention has recently been questioned with documentation of irreversible myocardial damage resulting in incomplete left ventricular recovery and adverse clinical outcomes after surgery. Recognizing the shortcomings of the guidelines, we performed a comprehensive review on the novel diagnostic methods that have been shown to improve the detection of subclinical ventricular dysfunction in chronic aortic regurgitation and to improve prediction of outcomes.

The impact of functional vs degenerative mitral regurgitation on clinical outcomes among patients undergoing transcatheter aortic valve implantation.

BACKGROUND: Among patients undergoing transcatheter aortic valve implantation (TAVI), concomitant mitral regurgitation (MR) has been associated with adverse prognosis. We aimed to assess long-term clinical outcomes according to MR etiology. METHODS: In a single-center registry of consecutive patients undergoing TAVI, we investigated the impact of functional (FMR) vs degenerative (DMR) MR on cardiovascular (CV) mortality throughout 2years of follow-up. RESULTS: Among 603 patients (mean age 82.4±5.7years, 55% female) undergoing TAVI, 149 patients had moderate or severe MR (24.7%). Functional MR and DMR were documented in 53 (36%) and 96 (64%) patients, respectively. At 2years, patients with FMR and DMR had higher rates of CV mortality (30.2% vs 32.4%) as compared with patients with no MR (14.6%; FMR vs no MR: hazard ratio [HR] 2.32, 95% CI 1.34-4.02, P=.003; DMR vs no MR: HR 2.56, 95% CI 1.66-3.96, P<.001). In adjusted analyses, DMR was associated with an increased risk of CV mortality throughout the 2-year follow-up (adjusted HR 2.21, 95% CI 1.4-3.49, P=.001) as compared with FMR (adjusted HR 1.13, 95% CI 0.59-2.18, P=.707). Relevant MR was postprocedurally significantly reduced in both the DMR and FMR groups, whereas improvement of a decreased left ventricular ejection fraction was predominantly seen in the FMR group as compared with baseline. CONCLUSION: Patients with severe, symptomatic aortic stenosis undergoing TAVI complicated by moderate or severe MR portend impaired prognosis. Particularly, patients with DMR are at increased risk for CV mortality during long-term follow-up.

Stroke in Adults With Congenital Heart Disease: Incidence, Cumulative Risk, and Predictors.

BACKGROUND: Stroke is an important cause of morbidity and mortality, although there is a lack of comprehensive data on its incidence, cumulative risk, and predictors in patients with adult congenital heart disease. METHODS AND RESULTS: This retrospective study of 29 638 Quebec patients with adult congenital heart disease aged 18 to 64 years between 1998 and 2010 was based on province-wide administrative data. The cumulative risk of ischemic stroke estimated up to age 64 years was 6.1% (95% confidence interval [CI], 5.0-7.0%) in women and 7.7% (95% CI, 6.4-8.8%) in men; the risk of hemorrhagic stroke was 0.8% (95% CI, 0.4-1.2%) and 1.3% (95% CI, 0.8-1.8%), respectively. Compared with rates reported for the general Quebec population, age-sex standardized incidence rates of ischemic stroke were 9 to 12 times higher below age 55 years and 2 to 4 times higher in the age group 55 to 64 years; hemorrhagic stroke rates were 5 to 6 times (age <55 years) and 2 to 3 times higher. Using a combination of stepwise model selection and Bayesian model averaging, the strongest predictors of ischemic stroke were heart failure (odds ratio for age group 18-49 years, 5.94 [95% CI, 3.49-10.14], odds ratio for age group 50-64 years, 1.68 [95% CI, 1.06-2.66]), diabetes mellitus (odds ratio, 2.33 [95% CI, 1.66-3.28]), and recent myocardial infarction (odds ratio, 8.38 [95% CI, 1.77-39.58]). CONCLUSIONS: Among patients with adult congenital heart disease, 1 in 11 men and 1 in 15 women experienced a stroke between ages 18 and 64 years. Stroke incidence was considerably higher than in the general population, especially at a younger age. The most important predictors of ischemic stroke were heart failure, diabetes mellitus, and recent myocardial infarction. Additional research is required to see whether advances in the management of adult congenital heart disease may reduce this substantial stroke rate.

Total Muscle Area and Visceral Adipose Tissue Measurements for Frailty Assessment in TAVR Patients.

Background: Transcatheter aortic valve replacement (TAVR) is a treatment option for severe aortic valve stenosis. Pre-TAVR assessments, extending beyond anatomy, include evaluating frailty. Potential frailty parameters in pre-TAVR computed tomography (CT) scans are not fully explored but could contribute to a comprehensive frailty assessment. The primary objective was to investigate the impact of total muscle area (TMA) and visceral adipose tissue (VAT) as frailty parameters on 5-year all-cause mortality in patients undergoing TAVR. Methods: Between 01/2017 and 12/2018, consecutive TAVR patients undergoing CT scans enabling TMA and VAT measurements were included. Results: A total of 500 patients qualified for combined TMA and VAT analysis. Age was not associated with a higher risk of 5-year mortality (HR 1.02, 95% CI: 0.998-1.049; p = 0.069). Body surface area normalized TMA (nTMA) was significantly associated with 5-year, all-cause mortality (HR 0.927, 95% CI: 0.927-0.997; p = 0.033), while VAT had no effect (HR 1.002, 95% CI: 0.99-1.015; p = 0.7). The effect of nTMA on 5-year, all-cause mortality was gender dependent: the protective effect of higher nTMA was found in male patients (pinteraction: sex × nTMA = 0.007). Conclusions: Normalized total muscle area derived from a routine CT scan before transcatheter aortic valve replacement complements frailty assessment in patients undergoing TAVR.

Long-Term Impact of Cardiac Damage Following Transcatheter Aortic Valve Replacement.

BACKGROUND: Extravalvular cardiac damage caused by aortic stenosis affects prognosis after transcatheter aortic valve replacement (TAVR). The long-term impact of changes in cardiac damage in response to relief from mechanical obstruction has not been fully investigated. OBJECTIVES: The authors aimed to investigate changes in cardiac damage early after TAVR and the prognostic impact of the cardiac damage classification after TAVR. METHODS: In this single-center observational study, patients undergoing transfemoral TAVR were retrospectively evaluated for cardiac damage before and after TAVR and classified into 5 stages of cardiac damage (0-4). RESULTS: Among 1,863 patients undergoing TAVR between January 2007 and June 2022, 56 patients (3.0%) were classified as stage 0, 225 (12.1%) as stage 1, 729 (39.1%) as stage 2, 388 (20.8%) as stage 3, and 465 (25.0%) as stage 4. Cardiac stage changed in 47.7% of patients (improved: 30.1% in stages 1-4 and deteriorated: 24.7% in stages 0-3) early after TAVR. Five-year all-cause mortality was associated with cardiac damage both at baseline (HRadjusted: 1.34; 95% CI: 1.24-1.44; P < 0.001 for linear trend) and after TAVR (HRadjusted: 1.40; 95% CI: 1.30-1.51; P < 0.001 for linear trend). Five-year all-cause mortality was stratified by changes in cardiac damage (improved, unchanged, or worsened) in patients with cardiac stage 2, 3, and 4 (log-rank P < 0.001 for stage 2, 0.005 for stage 3, and <0.001 for stage 4). CONCLUSIONS: The extent of extra-aortic valve cardiac damage before and after TAVR and changes in cardiac stage early after TAVR have important prognostic implications during long-term follow-up. (SwissTAVI Registry; NCT01368250).