Risk factors for permanent pacemaker implantation in patients receiving a balloon-expandable transcatheter aortic valve prosthesis.

Permanent pacemaker implantation (PPI) is a widely recognized complication associated with TAVI (incidence up to 20%). Smaller registries have identified several variables associated with PPI. The objective was to validate patient- and transcatheter aortic valve implantation (TAVI)-related procedural variables associated with PPI. We performed a retrospective analysis of patients from six European centers undergoing TAVI with the Edwards SAPIEN 3 prosthesis. Baseline variables and pre-procedural ECG characteristics and CT-scans were taken into account. Data for 1745 patients were collected; 191 (10.9%) required PPI after TAVI. The baseline variables pulmonary hypertension (OR 1.64; 95% CI 1.01-2.59), QRS duration > 117 ms (OR 2.58; 95% CI 1.73-3.84), right bundle branch block (RBBB; OR 5.14; 95% CI 3.39-7.72), left anterior hemi block (OR 1.92; 95% CI 1.19-3.02) and first-degree atrioventricular block (AVB, OR 1.63; 95%CI 1.05-2.46) were significantly associated with PPI. RBBB (OR 8.11; 95% CI 3.19-21.86) and first-degree AVB (OR 2.39; 95% CI 1.18-4.66) remained significantly associated in a multivariate analysis. Procedure-related variables included access site (TF; OR 1.97; 95% CI 1.07-4.05), implanted valve size (29 mm; OR 1.88; 95% CI 1.35-2.59), mean TAVI valve implantation depth below the annulus > 30% (OR 3.75; 95% CI 2.01-6.98). Patients receiving PPI had longer ICU stays and later discharges. Acute kidney injury stage 2/3 was more common in patients with PPI until discharge (15.2 vs. 3.1%; p = 0.007), but was not statistically significant thereafter. Further differences in outcomes at 30 days did not reach significance. The data will aid pre- and post-procedural patient management and prevent adverse long-term outcomes.Clinical Trial: NCT03497611.

Transcatheter heart valve interventions: where are we? Where are we going?

Transcatheter heart valve interventions have transformed the outcomes of patients with valvular heart disease (VHD) who are unfavourable candidates for surgery. Technological advances have allowed extension of these interventions to younger or lower risk patients and those with other forms of VHD and may in the future permit earlier treatment of VHD in less symptomatic patients or those with moderate disease. The balance of risks and benefits is likely to differ between lower and higher risk patients, and more evidence is needed to evaluate the net benefit of transcatheter technology in these groups. As academic researchers, clinicians, industry, and patient stakeholders collaborate to research these broader indications for transcatheter valve interventions, it is essential to address (i) device durability and deliverability, (ii) specific anatomical needs (e.g. bicuspid aortic valves, aortic regurgitation, mitral and tricuspid valve disease), (iii) operator training, and (iv) the reinforced importance of the multidisciplinary Heart Team.

Aortic valve stenosis awareness in Austria-results of a nationwide survey in 1001 subjects.

Despite the prognostic significance of severe aortic valve stenosis, knowledge is limited in the general population. To document the status quo for Austria, knowledge about valvular heart disease/aortic valve stenosis was documented in 1001 participants >60 years of age. 6.7% of respondents were knowledgeable of aortic valve stenosis, with 1.6% being concerned about the condition (24.1% cancer, 18.8% Alzheimer's disease, 15.1% stroke). 29.5% were familiar with valvular heart disease (76.7% heart attack, 36.9% stroke). Only 1/3 reported auscultation by their general practitioner (GP) at least every third visit. Typical symptoms of aortic valve stenosis were likely to be reported by 50%. After exposure to further information on aortic valve stenosis, only 20% reported to be more concerned and ready to obtain more disease-related information. Awareness of surgical and catheter-based treatment options was claimed by 77% of respondents. Awareness campaigns on valvular heart disease are warranted to improve patient care in Austria.

Degree of valve calcification in patients undergoing transfemoral transcatheter aortic valve implantation with and without balloon aortic valvuloplasty: Findings from the multicenter EASE-IT TF registry.

AIMS: We aimed to assess whether the level of aortic root calcification is associated with BAV performance/omission during transcatheter aortic valve implantation (TAVI), and to explore related outcomes. METHODS AND RESULTS: EASE-IT TF was a prospective, observational, multicenter registry of patients undergoing TF-TAVI with the Edwards SAPIEN 3, with or without BAV predilation. Valvular calcification was quantified from pre-procedural multi-slice computed tomography images and compared between BAV and no BAV patients. Data for 178 patients (55 BAV; 123 no BAV) were analyzed. There were no significant differences between groups in terms of regional/leaflet sector calcification volumes, maximum asymmetry between the different leaflet sectors, or total calcification scores. Overall, a greater-than-average leaflet calcification volume was independently predictive of ≥mild PVL (OR: 5.116; 95% CI: 1.042-38.35) and the need for post-dilation (OR: 3.592; 95% CI: 1.173-12.14). The latter effect was abated in patients with BAV (OR: 1.837; 95% CI: 0.223-18.00) and intensified in those without BAV (OR: 5.575; 95% CI: 1.114-38.74). No other BAV-dependent effects of calcification on outcomes were observed. CONCLUSIONS: In the majority of transfemoral valve implantations, calcification does not appear to be the main driving factor in the decision to perform/omit BAV. Predilation may be valuable for reducing post-dilation requirements in patients only with a greater degree of leaflet calcification.

Balloon-expandable transcatheter aortic valve implantation with or without pre-dilation - results of a meta-analysis of 3 multicenter registries.

BACKGROUND: To evaluate the outcomes of transcatheter aortic valve implantation (TAVI) without balloon aortic valvuloplasty (BAV) in a real-world setting through a patient-level meta-analysis. METHODS: The meta-analysis included patients of three European multicenter, prospective, observational registry studies that compared outcomes after Edwards SAPIEN 3 or XT TAVI with (n = 339) or without (n = 355) BAV. Unadjusted and adjusted pooled odds ratios (with 95% confidence intervals) were calculated for procedural and 30-day outcomes. RESULTS: Median procedural time was shorter in the non-BAV group than in the BAV group (73 versus 93 min, p = 0.001), as was median fluoroscopy time (7 versus 11 min, p = 0.001). Post-delivery balloon dilation (15.5% versus 22.4%, p = 0.02) and catecholamine use (9.0% vs. 17.9%; p = 0.016) was required less often in the non-BAV group than in the BAV group with the difference becoming insignificant after multiple adjustment. There was a reduced risk for periprocedural atrioventricular block during the intervention (1.4% versus 4.1%, p = 0.035) which was non-significant after adjustment. The rate of moderate/severe paravalvular regurgitation post-TAVI was 0.6% in the no-BAV group versus 2.7% in the BAV group. There were no between-group differences in the risk of death, stroke or other adverse clinical outcomes at day 30. CONCLUSIONS: This patient-level meta-analysis of real-world data indicates that TAVI performed without BAV is advantageous as it has an adequate device success rate, reduced procedure time and no adverse effects on short-term clinical outcomes.

Comprehensive geriatric assessment in patients undergoing transcatheter aortic valve implantation - results from the CGA-TAVI multicentre registry.

BACKGROUND: In older patients with aortic stenosis (AS) undergoing TAVI, the potential role of prior CGA is not well established. To explore the value of comprehensive geriatric assessment (CGA) for predicting mortality and/or hospitalisation within the first 3 months after transcatheter aortic valve implantation (TAVI). METHODS: An international, multi-centre, prospective registry (CGA-TAVI) was established to gather data on CGA results and medium-term outcomes in geriatric patients undergoing TAVI. Logistic regression was used to evaluate the predictive value of a multidimensional prognostic index (MPI); a short physical performance battery (SPPB); and the Silver Code, which was based on administrative data, for predicting death and/or hospitalisation in the first 3 months after TAVI (primary endpoint). RESULTS: A total of 71 TAVI patients (mean age 85.4 years; mean log EuroSCORE I 22.5%) were enrolled. Device success according to VARC criteria was 100%. After adjustment for selected baseline characteristics, a higher (poorer) MPI score (OR: 3.34; 95% CI: 1.39-8.02; p = 0.0068) and a lower (poorer) SPPB score (OR: 1.15; 95% CI: 1.01-1.54; p = 0.0380) were found to be associated with an increased likelihood of the primary endpoint. The Silver Code did not show any predictive ability in this population. CONCLUSIONS: Several aspects of the CGA have shown promise for being of use to physicians when predicting TAVI outcomes. While the MPI may be useful in clinical practice, the SPPB may be of particular value, being simple and quick to perform. Validation of these findings in a larger sample is warranted. TRIAL REGISTRATION: The trial was registered in ClinicalTrials.gov on November 7, 2013 ( NCT01991444 ).

How to adapt the implantation technique for the new SAPIEN 3 transcatheter heart valve design.

The new balloon-expandable Edwards SAPIEN 3 THV has significant design improvements requiring adjustments in the implantation technique as compared to the previous generation SAPIEN XT. Basically, the new valve requires less oversizing due to the outer skirt, which, if positioned underneath the annulus, can reduce the occurrence and severity of paravalvular leak (PVL). As with any transcatheter vale, a thorough assessment of the device-landing-zone, the surrounding structures, and the distribution of calcifications is of vast importance. Once the SAPIEN 3 valve is positioned with the initial orientation of the middle balloon marker at the level of the leaflet hinge points, the outer skirt will remain under the annulus, despite the foreshortening of the lower inflow portion of the valve. If there is an incomplete apposition, the outer skirt can conform to the anatomy, close the gaps, and reduce the risk of PVL. When calcifications are located on the edges of the annulus, PVL is common with the SAPIEN XT THV but dramatically reduced with the SAPIEN 3 THV. If the calcification extends from the annulus into the entire LVOT, there is always an incomplete apposition of the either valve frame; however, the resulting PVL is reduced by the outer skirt of the SAPIEN 3. In 165 consecutive SAPIEN 3 patients, 89.7% (n = 145) had none or a trace PVL and there were no patients with moderate or severe PVL. The new generation SAPIEN 3 valve allows more challenging anatomies to be treated, requires less oversizing, and can reduce PVL.

The investigation of systolic and diastolic leaflet kinematics of bioprostheses with a new in-vitro test method.

OBJECTIVES: We aimed to investigate leaflet kinematics of bioprostheses with a novel high-speed imaging method. MATERIAL AND METHODS: High-speed-imaging (1000 Hz) was used to evaluate leaflet kinematics of the Carpentier-Edwards Perimount Magna (PM) and Magna Ease (PME) aortic bioprostheses. Both prostheses (diameter 23 mm) were placed inside a model aorta under pulsatile flow conditions. Frequencies (F) and different stroke volumes (S) were simulated. Maximum aortic valve area (AVA), total ejection time (TET), rapid valve opening time (RVOT) and rapid valve closing time (RVCT) as well as opening (OS) and closing (CS) speeds were evaluated. RESULTS: Both bioprostheses showed different results dependent on flow conditions. The test setup was capable of identifying small AVA-differences between both valves (235 vs. 202 mm², F60/S60; 272 vs. 207 mm²; F70/S80), as well as differences in OS and CS (2.36 vs. 1.62 mm²/ms; 2.97 vs. 2.44 mm²/ms, F80/S60). TET was comparable (638 vs. 645 ms F60/S60; 341 vs. 343 ms, F90/S60), while results for RVOT and RVCT were equal, and dependent on frequency and stroke volume. CONCLUSIONS: The novel evaluation method is sensitive to detect differences between valves, although differences were found to be small. PM has a larger visible AVA associated with higher opening and closing speeds in contrast to PME.

[Atrial fibrillation in Germany--epidemiology, diagnosis, treatment and costs]. / Vorhofflimmern in Deutschland-- Epidemiologie, Diagnostik, Therapie und Kosten.

Atrial fibrillation is the most common cardiac arrhythmia. It is an independent risk factor for cardiovascular complications and stroke. The treatment options for atrial fibrillation have changed significantly in recent years by new drugs and ablative procedures. It is based on the principal strategies of anticoagulation, rhythm and rate control. Goal is to reduce symptoms and subsequent events. Although the costs of about 700 to pound 800 per patient per year are rather high, new treatment options might be associated with a reduction in event rates and an increase in quality adjusted life years (QALYs). The aim of this review is to give a practical overview of the epidemiology, diagnosis, treatment and costs to pharmacists who have a key role in the implementation of pharmacotherapy of atrial fibrillation.

Severe aortic stenosis management in heart valve centres compared with primary/secondary care centres.

OBJECTIVE: Current guidelines recommend use of heart valve centres (HVCs) to deliver optimal quality of care for patients with valve disease but there is no evidence to support this. The hypothesis of this study is that patient care with severe aortic stenosis (AS) will differ in HVCs compared with satellite centres. We aimed to compare the treatment of patients with AS at HVCs (tertiary care hospitals with full access to AS interventions) to satellites (hospitals without such access). METHODS: IMPULSE enhanced is a European, observational, prospective registry enrolling consecutive patients with newly diagnosed severe AS at four HVCs and 10 satellites. Clinical characteristics, interventions performed and outcomes up to 1 year by site-type were examined. RESULTS: Among 790 patients, 594 were recruited in HVCs and 196 in satellites. At baseline, patients in HVCs had more severe valve disease (higher peak aortic velocity (4.3 vs 4.1 m/s; p=0.008)) and greater comorbidity (coronary artery disease (CAD) (44% vs 27%; p<0.001) prior myocardial infarction (MI) (11% vs 5.1%; p=0.011) and chronic pulmonary disease (17% vs 8.9%; p=0.007)) than those presenting in satellites. An aortic valve replacement was performed more often by month 3 in HVCs than satellites in the overall population (52.6% of vs 31.3%; p<0.001) and in symptomatic patients (66.7% vs 43.2%, p<0.001). One-year survival rate was higher for patients in HVCs than satellites (HR2.19; 95% CI 1.28 to 3.73 total population and 2.89 (95%CI 1.64 to 5.11) for symptomatic patients. CONCLUSIONS: Our data support the implementation of referral pathways that direct patients to HVCs performing both surgery and transcatheter interventions. TRIAL REGISTRATION NUMBER: NCT03112629.

The COORDINATE Pilot Study: Impact of a Transcatheter Aortic Valve Coordinator Program on Hospital and Patient Outcomes.

The transcatheter aortic valve implantation (TAVI) treatment pathway is complex, leading to procedure-related delays. Dedicated TAVI coordinators can improve pathway efficiency. COORDINATE was a pilot observational prospective registry at three German centers that enrolled consecutive elective patients with severe aortic stenosis undergoing TAVI to investigate the impact a TAVI coordinator program. Pathway parameters and clinical outcomes were assessed before (control group) and after TAVI coordinator program implementation (intervention phase). The number of repeated diagnostics remained unchanged after implementation. Patients with separate hospitalizations for screening and TAVI had long delays, which increased after implementation (65 days pre- vs. 103 days post-implementation); hospitalizations combining these were more efficient. The mean time between TAVI and hospital discharge remained constant. Nurse (p = 0.001) and medical technician (p = 0.008) working hours decreased. Patient satisfaction increased, and more consistent/intensive contact between patients and staff was reported. TAVI coordinators provided more post-TAVI support, including discharge management. No adverse effects on post-procedure or 30-day outcomes were seen. This pilot suggests that TAVI coordinator programs may improve aspects of the TAVI pathway, including post-TAVI care and patient satisfaction, without compromising safety. These findings will be further investigated in the BENCHMARK registry.

Community-based aortic stenosis detection: clinical and echocardiographic screening during influenza vaccination.

BACKGROUND: Degenerative aortic stenosis (AS), the most common valvular heart disease in the Western world, is often diagnosed late when the mortality risk becomes substantial. We determined the feasibility of AS screening during influenza vaccination at general practitioner (GP) surgeries in the UK. METHODS: Consecutive subjects aged >65 years presenting to a GP for influenza vaccination underwent heart auscultation and 2D echocardiography (V-scan). Based on these findings, a patient management strategy was determined (referral to cardiologist, review within own practice or no follow-up measures) and status at 3 months was determined. RESULTS: 167 patients were enrolled with a mean age of 75 years. On auscultation, a heart murmur was detected in 30 of 167 (18%) patients (6 subjects with an AS-specific and 24 with a non-specific murmur). 75.2% of those with no murmur had a negative V-scan finding. Conversely, 16 of 30 (53%) patients with any murmur had an abnormal V-scan finding that was largely related to the aortic valve. Using clinical auscultation and V-scan screening, a decision not to pursue follow-up measures was taken in 147 (88%) cases, whereas 18 (10.8%) subjects were referred onward; with 5 of 18 (27.8%) and 3 of 18 (16.7%) being diagnosed with mild and moderate AS. CONCLUSIONS: Our pilot study confirms feasibility of valvular heart disease screening in the elderly in a primary care setting. Using simple and inexpensive diagnostic measures and 7.3 million UK inhabitants undergoing influenza vaccination, nationwide screening could potentially identify 130 000 patients with moderate AS and a significant number of patients with severe AS.

Narrative review of the role of artificial intelligence to improve aortic valve disease management.

Valvular heart disease (VHD) is a chronic progressive condition with an increasing prevalence in the Western world due to aging populations. VHD is often diagnosed at a late stage when patients are symptomatic and the outcomes of therapy, including valve replacement, may be sub-optimal due the development of secondary complications, including left ventricular (LV) dysfunction. The clinical application of artificial intelligence (AI), including machine learning (ML), has promise in supporting not only early and more timely diagnosis, but also hastening patient referral and ensuring optimal treatment of VHD. As physician auscultation lacks accuracy in diagnosis of significant VHD, computer-aided auscultation (CAA) with the help of a commercially available digital stethoscopes improves the detection and classification of heart murmurs. Although used little in current clinical practice, CAA can screen large populations at low cost with high accuracy for VHD and faciliate appropriate patient referral. Echocardiography remains the next step in assessment and planning management and AI is delivering major changes in speeding training, improving image quality by pattern recognition and image sorting, as well as automated measurement of multiple variables, thereby improving accuracy. Furthermore, AI then has the potential to hasten patient disposal, by automated alerts for red-flag findings, as well as decision support in dealing with results. In management, there is great potential in ML-enabled tools to support comprehensive disease monitoring and individualized treatment decisions. Using data from multiple sources, including demographic and clinical risk data to image variables and electronic reports from electronic medical records, specific patient phenotypes may be identified that are associated with greater risk or modeled to the estimate trajectory of VHD progression. Finally, AI algorithms are of proven value in planning intervention, facilitating transcatheter valve replacement by automated measurements of anatomical dimensions derived from imaging data to improve valve selection, valve size and method of delivery.

IMPULSE: the impact of gender on the presentation and management of aortic stenosis across Europe.

AIMS: There is an increasing awareness of gender-related differences in patients with severe aortic stenosis and their outcomes after surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI). METHODS: Data from the IMPULSE registry were analysed. Patients with severe aortic stenosis (AS) were enrolled between March 2015 and April 2017 and stratified by gender. A subgroup analysis was performed to assess the impact of age. RESULTS: Overall, 2171 patients were enrolled, and 48.0% were female. Women were characterised by a higher rate of renal impairment (31.7 vs 23.3%; p<0.001), were at higher surgical risk (EuroSCORE II: 4.5 vs 3.6%; p=0.001) and more often in a critical preoperative state (7.0vs 4.2%; p=0.003). Men had an increased rate of previous cardiac surgery (9.4 vs 4.7%; p<0.001) and a reduced left ventricular ejection fraction (4.9 vs 1.3%; p<0.001). Concomitant mitral and tricuspid valve disease was substantially more common among women. Symptoms were highly prevalent in both women and men (83.6 vs 77.3%; p<0.001). AVR was planned in 1379 cases. Women were more frequently scheduled to undergo TAVI (49.3 vs 41.0%; p<0.001) and less frequently for SAVR (20.3 vs 27.5%; p<0.001). CONCLUSIONS: The present data show that female patients with severe AS have a distinct patient profile and are managed in a different way to males. Gender-based differences in the management of patients with severe AS need to be taken into account more systematically to improve outcomes, especially for women.

Management of patients with severe aortic stenosis in the TAVI-era: how recent recommendations are translated into clinical practice.

OBJECTIVE: Approximately 3.4% of adults aged >75 years suffer from aortic stenosis (AS). Guideline indications for aortic valve replacement (AVR) distinguish between patients with symptomatic and asymptomatic severe AS. The present analysis aims to assess contemporary practice in the treatment of severe AS across Europe and identify characteristics associated with treatment decisions, namely denial of AVR in symptomatic patients and assignment of asymptomatic patients to AVR. METHODS: Participants of the prospective, multinational IMPULSE database of patients with severe AS were grouped according to AS symptoms, and stratified into subgroups based on assignment to/denial of AVR. RESULTS: Of 1608 symptomatic patients, 23.8% did not undergo AVR and underwent medical treatment. Denial was independently associated with multiple factors, including severe frailty (p=0.024); mitral (p=0.002) or tricuspid (p=0.004) regurgitation grade III/IV, and the presence of renal impairment (p=0.017). Of 392 asymptomatic patients, 86.5% had no prespecified indication for AVR. Regardless, 36.3% were assigned to valve replacement. Those with an indexed aortic valve area (AVA; p=0.045) or left ventricular ejection fraction (LVEF; p<0.001) below the study median; or with a left ventricular end systolic diameter above the study median (p=0.007) were more likely to be assigned to AVR. CONCLUSIONS: There may be considerable discrepancies between guideline-based recommendations and clinical practice decision-making in the treatment of AS. It appears that guidelines may not fully capture the complete clinical spectrum of patients with AS. Thus, there is a need to find ways to increase their acceptance and the rate of adoption.

Quality of life after transcatheter or surgical aortic valve replacement using the Toronto Aortic Stenosis Quality of Life Questionnaire.

BACKGROUND: The Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ) is a validated instrument for assessing quality of life (QoL) in patients with severe aortic stenosis (AS). In this study, we evaluated health status outcomes, based on the TASQ, in patients with severe AS undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). METHODS: The TASQ registry was a prospective observational registry. Patients with severe AS from nine centres in Europe and one in Canada underwent either SAVR or transfemoral TAVR. Patients completed the TASQ, Kansas City Cardiomyopathy Questionnaire and Short Form-12 V.2 prior to the intervention, predischarge, and at 30-day and 3-month follow-ups. Primary end point was the TASQ score. RESULTS: In both the TAVR (n=137) and SAVR (n=137) cohorts, significant increases were observed in all three scores. The overall TASQ score improved as did all but one of the individual domains at 3 months after the intervention (p<0.001). TASQ health expectations were the only domain which worsened (p<0.001). Across TASQ subscores, significant changes were evident from the time of discharge in the TAVR and 30-day follow-up in the SAVR cohort. In a categorical analysis of the TASQ, 39.7% of the TAVR group and 35.0% of the SAVR group had a substantially improved health status at 3 months compared with baseline. CONCLUSIONS: The TASQ captured changes in QoL among patients with severe AS who were treated with TAVR or SAVR. QoL improved substantially after either intervention, as indicated by changes in the TASQ overall score at 3 months. TRIAL REGISTRATION NUMBER: NCT03186339.

Aortic valve replacement: validation of the Toronto Aortic Stenosis Quality of Life Questionnaire.

AIMS: There is no quality of life tool specifically developed for patients with severe aortic stenosis (AS) to assess how this chronic condition and its treatment affect patients. The Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ) has been developed to overcome this gap. The results of the validation of the TASQ in patients undergoing treatment for severe AS are presented. METHODS AND RESULTS: Prospective study at 10 centres in Europe and Canada, which enrolled 274 patients with severe symptomatic AS undergoing surgical or transcatheter aortic valve replacement. Mean TASQ score at baseline was 71.2 points and increased to 88.9 three months after aortic valve implantation (P < 0.001). Increases were seen for the emotional impact (32.0 to 39.0; P < 0.001), physical limitations (14.8 to 22.0; P < 0.001), and physical symptoms (8.5 vs. 11.0; P < 0.001) domains. Internal consistency was good/excellent for overall TASQ score (α = 0.891) and for the physical limitation, emotional impact, and social limitation domains (α = 0.815-0.950). Test-retest reliability was excellent or strong for the overall TASQ (intraclass correlation coefficient of 0.883) and for the physical symptoms, physical limitation, emotional impact, and social limitation domains (intraclass correlation coefficient of 0.791-0.895). Responsiveness was medium overall (Cohen's d = 0.637) and medium/large for physical symptoms, emotional impact, and physical limitations (0.661-0.812). Sensitivity to change was significant for physical symptoms, physical limitations (both P < 0.001), emotional impact (P = 0.003), and social limitations (P = 0.038). CONCLUSIONS: The TASQ is a new, brief, self-administered, and clinically relevant health-specific tool to measure changes in quality of life in patients with AS undergoing an intervention.

Effect of irbesartan and enalapril in non-ST elevation acute coronary syndrome: results of the randomized, double-blind ARCHIPELAGO study.

AIMS: This study investigated the effects of irbesartan vs. enalapril, with early vs. late treatment, on markers of inflammation and ischaemic heart disease in patients with non-ST-segment elevation acute coronary syndrome (NSTEACS). METHODS AND RESULTS: Patients hospitalized with ischaemic symptoms and evidence of NSTEACS were randomized to early (at hospitalization) or late (at hospital discharge) treatment with irbesartan 150 mg/day followed by 300 mg/day on day 15 (n = 212) or enalapril 10 mg/day followed by 20 mg/day on day 15 (n = 217) to day 60. The primary endpoint was the change from baseline in high-sensitivity C-reactive protein (hs-C-reactive protein) at day 60; secondary endpoints included changes in troponin I, B-type natriuretic peptide, microalbuminuria, interleukin 6, myeloperoxidase, secretory non-pancreatic type II phospholipase A2, ischaemia-modified albumin, soluble CD40 ligand, matrix metalloproteinase-9, aldosterone, and blood pressure. High-sensitivity C-reactive protein levels were comparable in both the irbesartan and enalapril treatment arms. There were no treatment-related differences in any of the biomarkers measured. Changes in inflammatory markers were unaffected by the timing of treatment initiation. Both treatments were well tolerated, with no differences in major adverse cardiac events. CONCLUSION: In patients with NSTEACS, inflammatory markers decreased over time in both treatment arms, with no differences between irbesartan and enalapril.

Atrial fibrillation and heart rate independently correlate to microalbuminuria in hypertensive patients.

AIMS: To investigate the relationship between microalbuminuria (MAU) and atrial fibrillation (AF) and to further evaluate whether the heart rate dependency of MAU in patients without AF is maintained in patients with a history of AF. METHODS AND RESULTS: The International Survey Evaluating Microalbuminuria Routinely by Cardiologists in patients with Hypertension (I-SEARCH) included 18,900 patients without and 1705 patients with a history of AF suffering from hypertension and other risk factors for cardiovascular disease in 26 countries worldwide from September 2005 to March 2006. Heart rate, blood pressure, urinary albumin excretion, and an estimated glomerular filtration rate were determined among other parameters. The prevalence of MAU was higher at higher heart rate in both patients with and without a history of AF. Prevalence of MAU was about 10% higher in patients with a history of AF (P < 0.001). Male gender, the presence of diabetes mellitus, a higher heart rate, and a higher diastolic blood pressure were independently associated with increased odds for MAU in patients without and with a history of AF. CONCLUSION: The prevalence of MAU in hypertensive patients with cardiovascular risk factors is related to heart rate and significantly higher in patients with a history of AF.

Gender differences in aortic valve replacement: is surgical aortic valve replacement riskier and transcatheter aortic valve replacement safer in women than in men?

Aortic stenosis (AS) is a progressive and degenerative disease that necessitates valve replacement through either surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). Various studies have shown that, unlike for TAVR, SAVR is associated with an elevated risk for women as compared to men. The aim of this review is to better understand the risks and their possible causes, associated with the use of both TAVR and SAVR in female patients. Our systematic review included studies published between 2012 and 2020, identified through specific searches of PubMed. Compatibility of publications, determined by the use of pre-defined inclusion/exclusion criteria, resulted in 15 articles being used in our review. Overall, more men than women undergo SAVR, but our findings confirmed that SAVR is associated with worse outcomes in women in the short-term. Reasons for a higher 30-day mortality post-SAVR in women include an increased age, higher in-hospital mortality and, possibly baseline comorbidities and anatomical differences. There was no difference observed in 30-day mortality between men and women undergoing TAVR. Female patients appear to have a better longer-term survival post-TAVR than their male counterparts. Understanding the reasons why women have worse outcomes post-SAVR is essential for ensuring appropriate treatment selection for patients with AS, as well as for achieving the best possible long-term and safety outcomes for these patients.