Women Undergoing Transcatheter Aortic Valve Research Articles

Protein and Exercise to Reverse Frailty in Older Men and Women Undergoing Transcatheter Aortic Valve Replacement: Design of the PERFORM-TAVR Trial

Despite the high procedural success of transcatheter aortic valve replacement (TAVR), 2 out of 5 older adults report poor physical performance and health-related quality of life (HRQOL) in the ensuing months, particularly those with frailty. There has yet to be a trial examining the synergistic effects of exercise and protein supplementation to counteract frailty and improve patient-centred outcomes following TAVR. The PERFORM-TAVR trial is a multicentre parallel-group randomised clinical trial that is enrolling 200 frail older adults ≥ 70 years of age undergoing TAVR. Patients will be randomly allocated to 1 of 2 treatment groups: standard-of-care lifestyle education (control group) or protein-rich oral nutritional supplement for 4 weeks before TAVR with the addition of home-based supervised exercise sessions for 12 weeks after TAVR (intervention group). The primary outcome will be physical performance as measured by a blinded observer using the Short Physical Performance Battery at 3 months. Secondary outcomes at 3, 6, and 12 months will include HRQOL, as measured by the Short-Form 36 Physical and Mental Component summary scores, and a composite safety end point. The PERFORM-TAVR trial is testing a novel frailty intervention in older adults undergoing TAVR to optimise recovery and downstream HRQOL. This represents a potential paradigm shift that highlights the value of assessing and treating patients’ frailty in parallel with their underlying heart valve disease. Clinical Trial RegistrationURL: https://www.clinicaltrials.gov. Unique identifier: NCT03522454.

Sex discrepancies in pathophysiology, presentation, treatment, and outcomes of severe aortic stenosis.

This review gives an overview of sex-based differences in aortic valve stenosis, spanning from pathophysiological mechanisms and disease progression, clinical presentation, presence of comorbidities, and diagnostic assessment, to treatment and outcomes. In particular, sex-related differences in the degree of aortic valve calcification, the response of the left ventricle to pressure overload, as well as in the referral to procedures, with women being less frequently referred for surgical aortic valve replacement and experiencing longer waiting times for transcatheter procedures, will be discussed. Sex-related differences are also particularly evident in outcomes of patients with severe aortic stenosis undergoing surgical or transcatheter procedures. The apparent sex paradox seen in women undergoing transcatheter aortic valve implantation refers to the phenomenon of women experiencing higher rates of short-term mortality and bleeding events, but demonstrating improved long-term survival as compared to men. Women who undergo surgical aortic valve replacement have generally worse outcomes as compared to men, which is reflected by the inclusion of female sex in surgical risk calculation scores. Hence, a thorough understanding of sex-related differences in aortic valve stenosis is important to provide optimal and personalized patient care.

Impact of osteoporotic risk in women undergoing transcatheter aortic valve replacement.

Low body weight and advanced age are reported to be among the best predictors of osteoporosis, and osteoporosis self-assessment tool (OST) values are calculated using a simple formula to identify postmenopausal women at increased risk of osteoporosis. In our recent study, we demonstrated an association between fractures and poor outcomes in postmenopausal women following transcatheter aortic valve replacement (TAVR). In this study, we aimed to investigate the osteoporotic risk in women with severe aortic stenosis and determined whether an OST could predict all-cause mortality following TAVR. The study population comprised 619 women who underwent TAVR. Compared to a quarter of patients with diagnosis of osteoporosis, 92.4% of participants were at high risk of osteoporosis based on OST criteria. When divided into tertiles based on OST values, patients in tertile 1 (lowest OST) displayed increased frailty, a higher incidence of multiple fractures, and greater Society of Thoracic Surgeons scores. Estimated all-cause mortality survival rates 3years post-TAVR were 84.2 ± 3.0%, 89.5 ± 2.6%, and 96.9 ± 1.7% for OST tertiles 1, 2, and 3, respectively (p = 0.001). Multivariate analysis showed that the OST tertile 3 was associated with decreased risk of all-cause mortality compared with OST tertile 1 as the referent. Notably, a history of osteoporosis was not associated with all-cause mortality. Patients with high osteoporotic risk are highly prevalent among those with aortic stenosis according to the OST criteria. OST value is a useful marker for predicting all-cause mortality in patients undergoing TAVR.

WIN Gulf TAVR Registry: Describing Sex Differences in Patient Characteristics, Prognosis, and Outcomes

<h2>Abstract</h2><h3>Background</h3> Several international registries have examined outcomes in women undergoing transcatheter aortic valve replacement (TAVR). However, none of these studies included women from the Gulf region. The Women IN Gulf Transcatheter Aortic Valve Replacement (WIN Gulf TAVR) registry aimed to examine sex-based differences in patient characteristics and outcomes in patients undergoing TAVR in the region. <h3>Methods</h3> This registry is a prespecified subanalysis of the main Gulf TAVR registry. Baseline characteristics, procedural details and success, and 1-year outcomes were recorded. The primary outcome consisted of a composite of all causes of death, myocardial infarction (MI), and rehospitalizations at 1 year. The secondary outcomes were a composite of the individual components of the primary composite. <h3>Results</h3> A total of 347 women (44% of the Gulf TAVR registry) were included in the final analysis, with a mean age of 74.1 ± 9.1 years; mean ejection fraction of 56.20% ± 10.52%; and mean Society of Thoracic Surgeons score of 5.30 ± 4.35. The composite primary end point occurred in 12.4% (95% CI, 9.3-16.2). The individual components of the primary end point were as follows: death, 4.3% (95% CI, 2.6-7.0); MI, 1.1% (95% CI, 0.4-2.9); and rehospitalization, 9.8% (95% CI, 7.1-13.3), with 7.2% (95% CI, 4.9-10.4) related to cardiac causes. <h3>Conclusions</h3> Women in the WIN Gulf TAVR registry had outcomes and baseline characteristics similar to men. Although higher rehospitalizations for cardiac causes and MI at 1 year in women were noted, the overall survival was better in women. These observations warrant a larger cohort to identify the drivers of events.

C-57 | Prevalence and Outcomes of Early Menopause in Women undergoing Transcatheter Aortic Valve Replacement: Insights from the WIN-TAVI Registry

Early menopause is associated with an increased risk of cardiovascular diseases, particularly aortic stenosis (AS). We sought to investigate the prevalence and impact of early menopause on clinical outcomes in patients undergoing transcatheter aortic valve replacement (TAVR).

Abstract 12919: Impact of Small Valve Size After Transcatheter Aortic Valve Implantation on 1-year Outcomes in Women: Results From the WIN-TAVI Registry

Introduction: Women undergoing transcatheter aortic valve implantation (TAVI) for severe aortic stenosis are more likely to have a small aortic annulus compared with men. However, there is lack of data on the prognostic relevance of bioprostheses size in women. Hypothesis: To assess the impact of a small valve size on clinical outcomes in women undergoing TAVI. Methods: The Women's INternational Transcatheter Aortic Valve Implantation (WIN-TAVI) registry was the first study to investigate the safety and efficacy of TAVI in women with aortic stenosis.Patients were stratified according to the size of aortic valve bioprosthesis, with small valve defined by a size≤23 mm and non-small valve defined by a size&gt;23 mm. The primary outcome of interests was the occurrence of Valve Academic Research Consortium (VARC)-2-efficacy endpoint, a composite of all-cause death, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure or valve-related dysfunction at 1-year follow-up. Results: Out of 934 patients, 388 (41.5%) received a small valve and had a lower body mass index, lower surgical risk scores and were less likely to suffer from atrial fibrillation as compared with patients receiving a larger valve. The latter were more likely to require post-dilation (18.6% vs. 10.4%, p&lt;0.001) and had a trend for higher rates of residual aortic regurgitation grade ≥2 (8.7% vs. 5.1%, p = 0.051). At 1 year, the risk of the VARC-2 efficacy endpoint was similar between the two groups (16.0% in small valve vs. 16.3% in non-small valve, p = 0.8808; adjusted hazard ratio 1.34, 95% confidence interval 0.90 to 2.00), Figure. No significant differences in the occurrence of the secondary endpoints were noted after multivariable adjustment. Conclusions: Among women undergoing TAVI, the valve size was associated with different baseline and procedural characteristics but was not an independent predictor of clinical outcomes.

The impact of chronic kidney disease in women undergoing transcatheter aortic valve replacement: Analysis from the Women's INternational Transcatheter Aortic Valve Implantation (WIN-TAVI) registry.

The prevalence of both chronic kidney disease (CKD) and aortic stenosis (AS) increase with age. Although baseline CKD is frequent in patients undergoing transcatheter aortic valve replacement (TAVR), its significance among women is largely unknown. Women's INternational Transcatheter Aortic Valve Implantation (WIN-TAVI) is a multinational, prospective registry of women undergoing TAVR for severe AS. We included patients with available baseline estimated glomerular filtration rate (eGFR) and completed 1-year follow-up. Patients were categorized into three groups based on their eGFR: No CKD (normal kidney function to stage 2 CKD: eGFR ≥60 ml/min/1.73 m2 ); (b) mild CKD (stage 3a CKD: eGFR = 45-59 ml/min/1.73 m2 ); and (c) moderate/severe CKD (stage ≥3b CKD: eGFR <45 ml/min/1.73 m2 ). All events were adjudicated according to the Valve Academic Research Consortium (VARC)-2 criteria. Out of 852 women undergoing TAVR, 326 (38.3%) had no CKD, 225 (26.4%) had mild CKD, and 301 (35.3%) had moderate/severe CKD. Women with higher stage of CKD at baseline were more likely to have a history of hypertension, diabetes, atrial fibrillation, anemia, chronic lung disease, hemodialysis, prior percutaneous coronary intervention, and pacemaker implantation. After multivariate adjustment, moderate/severe CKD was associated with a greater risk of 1-year VARC-2 safety endpoints [hazard ratio (HR) 1.68, 95% confidence interval (CI): 1.10-2.60], all-cause death (HR 2.00, 95% CI: 1.03-3.90), and composite of death, myocardial infarction, stroke or life-threatening bleeding (HR 1.70, 95% CI: 1.04-2.76). There were no differences in 30-day and 1-year VARC-2 efficacy and 30-day VARC-2 safety outcomes. CKD is associated with substantial and independent risk for mortality and morbidity at 1-year follow-up in women undergoing TAVR.

Edwards SAPIEN Versus Medtronic Aortic Bioprosthesis in Women Undergoing Transcatheter Aortic Valve Implantation (from the Win-TAVI Registry)

We sought to analyze outcomes of women receiving balloon-expandable valves (BEV) or self-expanding valves (SEV) in contemporary transcatheter aortic valve implantation (TAVI). WIN TAVI (Women's INternational Transcatheter Aortic Valve Implantation) is the first all-female TAVI registry to study the safety and performance of TAVI in women. We compared women treated with BEV (n = 408, 46.9%) versus those treated with SEV (n = 461, 53.1%). The primary efficacy end point was the Valve Academic Research Consortium-2 (VARC-2) composite of 1-year all-cause death, stroke, myocardial infarction, hospitalization for valve-related symptoms or heart failure or valve-related dysfunction. Women receiving SEV had higher surgical risk scores, higher rate of previous stroke and pulmonary hypertension whereas women receiving BEV were more frequently denied surgical valve replacement due to frailty. BEV patients were less likely to require post-dilation and had significantly lower rates of residual aortic regurgitation grade ≥2 (9.8% vs 4.7%, p = 0.007). At 1 year, the crude incidence and adjusted risk of the primary VARC-2 efficacy end point was similar between groups (17.1% with SEV and 14.3% with BEV, p = 0.25; hazards ratio 1.09, 95% confidence interval 0.68 to 1.75). Conversely the crude rate and adjusted risk of new pacemaker implantation was higher with SEV than BEV (15% vs 8.6%, p = 0.001; hazards ratio 1.97, 95% confidence interval 1.13 to 3.43). A subanalysis on new generation valves showed no difference in the need for pacemaker implantation between the 2 devices (10.1% vs 8.0%, p = 0.56). In conclusion, in contemporary TAVI, SEV are used more frequently in women with greater co-morbidities. While there were no differences in unadjusted and adjusted risk of 1-year primary efficacy end point between the valve types, there was a greater need for permanent pacemakers after SEV implantation.

Acute Myocardial Infarction Due to Prosthetic Valve Leaflet Thrombosis 15 Months After TAVR

An 81-year-old woman underwent transcatheter aortic valve replacement (TAVR) for aortic stenosis. Pre-procedural computed tomography revealed an aortic annulus perimeter of 68.5 mm. The mean diameter of the sinus of Valsalva was 27.3 mm. An Evolut R 26-mm device (Medtronic, Minneapolis, Minnesota

Fatal Leaflet Thrombus Following Transcatheter Aortic Valve Replacement During Temporary Anticoagulation Withdrawal

A 91-year-old woman underwent transcatheter aortic valve replacement (TAVR) due to severe aortic stenosis (23-mm Sapien 3, Edwards Lifesciences, Irvine, California). She was on apixaban (2.5 mg twice daily) as an antithrombotic therapy due to atrial fibrillation. She was admitted to our hospital

Impact of coronary artery disease and percutaneous coronary intervention in women undergoing transcatheter aortic valve replacement: From the WIN-TAVI registry.

To evaluate the impact of coronary artery disease (CAD) with or without recent (≤ 30 days) percutaneous coronary intervention (PCI) in women undergoing transcatheter aortic valve replacement (TAVR). Although women display a specific risk-profile for both PCI and TAVR, the impact of CAD and PCI in the setting of TAVR in women is unclear. The multinational Women's International Transcatheter Aortic Valve implantation registry enrolled consecutive female patients undergoing contemporary TAVR in 19 centers between 2013 and 2015. Patients with available coronary angiography or CT scan in the pre-operative assessment of TAVR were categorized as without CAD, with CAD but no recent PCI and CAD and recent PCI (≤30 days). All events were adjudicated according to the VARC-2 criteria. A total of 787 patients were included in this analysis, among whom 459 (58.3%) had no CAD, 247 (31.4%) had CAD without recent PCI and 81 (10.3%) underwent recent PCI (≤ 30 days before TAVR). After multivariable adjustment, both groups of CAD patients, without and with recent PCI, presented with higher risk of death, myocardial infarction or stroke, compared with patients without CAD (adj HR 1.56, 95%CI 1.03-2.39, P = 0.038 and adj HR 1.96, 95% CI 1.1-3.5, P = .021, respectively). Patients with recent PCI had increased risk of all-cause death (adj HR 1.89, 95% CI 1.0-3.5, P = 0.04) and stroke (adj HR 3.7, 95% CI 1.0-13.5, P = 0.046) compared with patients without CAD. The presence of CAD in women undergoing TAVR, with or without recent PCI, was associated with long-term poorer outcomes.

CT determined psoas muscle area predicts mortality in women undergoing transcatheter aortic valve implantation

ObjectivesThe aim of this study was to assess the predictive value of PMA measurement for mortality.BackgroundCurrent surgical risk stratification have limited predictive value in the transcatheter aortic valve implantation (TAVI) population. In TAVI workup, a CT scan is routinely performed but body composition is not analyzed. Psoas muscle area (PMA) reflects a patient's global muscle mass and accordingly PMA might serve as a quantifiable frailty measure.MethodsMulti‐slice computed tomography scans (between 2010 and 2016) of 583 consecutive TAVI patients were reviewed. Patients were divided into equal sex‐specific tertiles (low, mid, and high) according to an indexed PMA. Hazard ratios (HR) and their confidence intervals (CI) were determined for cardiac and all‐cause mortality after TAVI.ResultsLow iPMA was associated with cardiac and all‐cause mortality in females. One‐year adjusted cardiac mortality HR in females for mid‐iPMA and high‐iPMA were 0.14 [95%CI, 0.05–0.45] and 0.40 [95%CI, 0.15–0.97], respectively. Similar effects were observed for 30‐day and 2‐years cardiac and all‐cause mortality. In females, adding iPMA to surgical risk scores improved the predictive value for 1‐year mortality. C‐statistics changed from 0.63 [CI = 0.54–0.73] to 0.67 [CI: 0.58–0.75] for EuroSCORE II and from 0.67 [CI: 0.59–0.77] to 0.72 [CI: 0.63–0.80] for STS‐PROM.ConclusionsParticularly in females, low iPMA is independently associated with an higher all‐cause and cardiac mortality. Prospective studies should confirm whether PMA or other body composition parameters should be extracted automatically from CT‐scans to include in clinical decision making and outcome prediction for TAVI.

4284Impact of coronary artery disease and PCI on Long-term outcomes of women undergoing transcatheter aortic valve replacement: insights from the multi-center WIN-TAVI registry

4284Impact of coronary artery disease and PCI on Long-term outcomes of women undergoing transcatheter aortic valve replacement: insights from the multi-center WIN-TAVI registry

ASSOCIATIONS BETWEEN VALVE TYPE AND OUTCOMES IN WOMEN UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT: RESULTS FROM THE WIN-TAVI REGISTRY

Valve type selection in women undergoing transcatheter aortic valve replacement (TAVR) may be based on clinical, anatomical or logistical factors. We sought to compare characteristics and outcomes of women receiving balloon-expandable (BEV) or self-expanding valves (SEV) in contemporary TAVR WIN-

Patients' experiences of the transcatheter aortic valve implantation trajectory: A grounded theory study.

AimThe aim of this study was to explore how patients experienced the recovery process from transcatheter aortic valve implantation.DesignA qualitative approach where in‐depth interviews were used.MethodEleven men and eight women undergoing transcatheter aortic valve implantation were individually interviewed 6 months after transcatheter aortic valve implantation. Grounded theory was used for the analysis.ResultsThe analysis generated the core concept “A journey of balancing between life‐struggle and hope” connected to descriptive, bipolar categories. Before transcatheter aortic valve implantation patients not only felt threatened but also experienced hope. The rehabilitation phase was described as demanding or surprisingly simple. At the 6 months follow‐up patients were pleased to return to life, however, still struggling with limitations. To feel hope is essential for transcatheter aortic valve implantation patients’ well‐being, both before and during the recovery process. It is important that healthcare professionals not only support hopeful thinking but also take time to discuss and prepare patients, talk about concerns and build confidence. Individual plans for rehabilitation should be designed.

Vascular Injury Caused by Retrieval of Ruptured and Detached Balloon Valvuloplasty Catheter During Transcatheter Aortic Valve Replacement

An 88-year-old woman underwent transcatheter aortic valve implantation using a SAPIEN 3 valve (Edwards Lifesciences, Irvine, California) for symptomatic severe aortic stenosis. Pre-procedural examinations showed an aortic valve area of 0.39 cm2 and severe calcification of the leaflets. During pre-

Better midterm survival in women after transcatheter aortic valve implantation.

In previous meta-analyses demonstrating better midterm overall survival in women undergoing transcatheter aortic valve implantation (TAVI), unadjusted risk and odds ratios were combined. To determine whether female gender is independently associated with better survival after TAVI, we performed a meta-analysis pooling adjusted hazard ratios (HRs) based on multivariate Cox proportional hazard regression. MEDLINE and EMBASE were searched through September 2015 using PubMed and OVID. Studies considered for inclusion met the following criteria: the study population was patients undergoing TAVI; and main outcomes included midterm (mean or median ≥6 months) overall survival or all-cause mortality in women and men. An unadjusted and/or adjusted HR of all-cause mortality for women versus men was abstracted from each individual study. Of 1347 potentially relevant articles screened initially, 16 reports of eligible studies were identified and included. A primary meta-analysis of the 9 adjusted HRs demonstrated a significantly better midterm overall survival in women than men (N.=6891; HR=0.80; 95% confidence interval [CI]: 0.65 to 0.97; P=0.03). A secondary meta-analysis adding 5 statistically non-significant unadjusted HR also indicated better survival in women (N.=8645; HR=0.83; 95% CI: 0.72 to 0.96; P=0.01). Although statistical tests for the primary meta-analysis revealed funnel plot asymmetry in favor of women, the secondary meta-analysis produced a symmetrical funnel plot. Female gender may be independently associated with better midterm overall survival after TAVI.

Open Wide: Transient Wide-Open Mitral Regurgitation During Transcatheter Aortic Valve Implantation

An 87-year-old woman underwent transcatheter aortic valve implantation (TAVI) for severe aortic stenosis via the transfemoral approach. Pre-procedural mitral regurgitation (MR) (​(A,A, Online Video 1) was mild. During guidewire positioning across the aortic valve, the MR was unchanged (​(B,B, Online Video 2). After balloon valvuloplasty, the MR increased in severity (C and D, Online Videos 3 and ​and4).4). Subsequent continuous-wave Doppler demonstrated wide-open MR flow with a triangular-shaped spectral envelope confirming rapid pressure equalization (​(E).E). Three-dimensional echocardiography revealed noncoapting mitral valve leaflets and wire impingement (arrow) of the chordae (F and G, Online Videos 5 and ​and6).6). With guidewire removal, the severe MR resolved (​(H,H, Online Video 7). Wire impingement of the mitral valve apparatus, causing the leaflets to “open wide” with transient severe MR, can occur during any portion of the TAVI procedure and must be monitored closely for early recognition and procedural modification. LA = left atrium; LV = left ventricle. Online Video 1 Online Video 2 Online Video 3 Online Video 4 Online Video 5 Online Video 7

Comparison of Variables in Men Versus Women Undergoing Transcatheter Aortic Valve Implantation for Severe Aortic Stenosis (from Italian Multicenter CoreValve Registry)

Although transcatheter aortic valve implantation (TAVI) for severe aortic stenosis is becoming an established technique, the effect of gender-related differences is poorly described. We performed a gender-based comparison of high-risk patients undergoing TAVI with the self-expandable CoreValve Revalving System for severe aortic stenosis to evaluate early and mid-term clinical outcomes. From the Italian prospective CoreValve registry, 659 consecutive patients (55.8% women) who underwent TAVI were included in the present study. We analyzed the gender-based differences in terms of clinical, angiographic, and procedural features and the differences in the rate of early and mid-term major adverse cardiac and cerebrovascular events. The men were younger, presented more often with severe left ventricular dysfunction, and had a greater rate of previous myocardial infarction, coronary revascularization, peripheral artery disease, renal failure, and heart conduction disorders than the women. The logistic European System for Cardiac Operative Risk Evaluation score did not differ between the 2 groups. The overall unadjusted and adjusted analyses failed to show significant differences between genders in terms of major adverse cardiac and cerebrovascular events at a median follow-up of 13 months (range 8 to 18). At late follow-up (landmark analysis >12 months), a survival benefit was observed in women (hazard ratio 0.27, 95% confidence interval 0.09 to 0.84, p = 0.02). In conclusion, in this multicenter registry, the gender-based comparison of TAVI patients showed that men, despite the younger age, had more extensive atherosclerotic burden compared to women. Overall, the early and mid-term outcomes were similar between genders, although women might have a survival benefit with longer follow-up.