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.

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.

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.

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.

Differences in the presentation and management of patients with severe aortic stenosis in different European centres.

BACKGROUND: An investigation into differences in the management and treatment of severe aortic stenosis (AS) between Germany, France and the UK may allow benchmarking of the different healthcare systems and identification of levers for improvement. METHODS: Patients with a diagnosis of severe AS under management at centres within the IMPULSE and IMPULSE enhanced registries were eligible. RESULTS: Data were collected from 2052 patients (795 Germany; 542 France; 715 UK). Patients in Germany were older (79.8 years), often symptomatic (89.5%) and female (49.8%) and had a lower EF (53.8%) than patients in France and UK. Comorbidities were more common and they had a higher mean Euroscore II.Aortic valve replacement (AVR) was planned within 3 months in 70.2%. This was higher (p<0.001) in Germany than France/ UK. Of those with planned AVR, 82.3% received it within 3 months with a gradual decline (Germany>France> UK; p<0.001). In 253 patients, AVR was not performed, despite planned. Germany had a strong transcatheter aortic valve implantation (TAVI) preference (83.2%) versus France/ UK (p<0.001). Waiting time for TAVI was shorter in Germany (24.9 days) and France (19.5 days) than UK (40.3 days).Symptomatic patients were scheduled for an AVR in 79.4% (Germany> France> UK; p<0.001) and performed in 83.6% with a TAVI preference (73.1%). 20.4% of the asymptomatic patients were intervened. CONCLUSION: Patients in Germany had more advanced disease. The rate of intervention within 3 months after diagnosis was startlingly low in the UK. Asymptomatic patients without a formal indication often underwent an intervention in Germany and France.

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.

Prespecified Risk Criteria Facilitate Adequate Discharge and Long-Term Outcomes After Transfemoral Transcatheter Aortic Valve Implantation.

Background Despite the availability of guidelines for the performance of transcatheter aortic valve implantation (TAVI), current treatment pathways vary between countries and institutions, which impact on the mean duration of postprocedure hospitalization. Methods and Results This was a prospective, multicenter registry of 502 patients to validate the appropriateness of discharge timing after transfemoral TAVI, using prespecified risk criteria from FAST-TAVI (Feasibility and Safety of Early Discharge After Transfemoral [TF] Transcatheter Aortic Valve Implantation), based on hospital events within 1-year after discharge. The end point-a composite of all-cause mortality, vascular access-related complications, permanent pacemaker implantation, stroke, cardiac rehospitalization, kidney failure, and major bleeding-was reached in 27.0% of patients (95% CI, 23.3-31.2) within 1 year after intervention; 7.5% (95% CI, 5.5-10.2) had in-hospital complications before discharge and 19.6% (95% CI, 16.3-23.4) within 1 year after discharge. Overall mortality within 1 year after discharge was 7.3% and rates of cardiac rehospitalization 13.5%, permanent pacemaker implantation 4.2%, any stroke 1.8%, vascular-access-related complications 0.7%, life-threatening bleeding 0.7%, and kidney failure 0.4%. Composite events within 1 year after discharge were observed in 18.8% and 24.3% of patients with low risk of complications/early (≤3 days) discharge and high risk and discharged late (>3 days) (concordant discharge), respectively. Event rate in patients with discordant discharge was 14.3% with low risk but discharged late and increased to 50.0% in patients with high risk but discharged in ≤3 days. Conclusions The FAST-TAVI risk assessment provides a tool for appropriate, risk-based discharge that was validated with the 1-year event rate after transfemoral TAVI. Registration URL: https://www.ClinicalTrials.gov; Unique identifier: NCT02404467.

Impact of selected comorbidities on the presentation and management of aortic stenosis.

BACKGROUND: Contemporary data regarding the impact of comorbidities on the clinical presentation and management of patients with severe aortic stenosis (AS) are scarce. METHODS: Prospective registry of severe patients with AS across 23 centres in nine European countries. RESULTS: Of the 2171 patients, chronic kidney disease (CKD 27.3%), left ventricular ejection fraction (LVEF) <50% (22.0%), atrial fibrillation (15.9%) and chronic obstructive pulmonary disease (11.4%) were the most prevalent comorbidities (49.3% none, 33.9% one and 16.8% ≥2 of these). The decision to perform aortic valve replacement (AVR) was taken in a comparable proportion (67%, 72% and 69%, in patients with 0, 1 and ≥2 comorbidities; p=0.186). However, the decision for TAVI was more common with more comorbidities (35.4%, 54.0% and 57.0% for no, 1 and ≥2; p<0.001), while the decision for surgical AVR (SAVR) was decreased with increasing comorbidity burden (31.9%, 17.4% and 12.3%; p<0.001). The proportion of patients with planned AVRs that were performed within 3 months was significantly higher in patients with 1 or ≥2 comorbidities than in those without (8.7%, 10.0% and 15.7%; p<0.001). Furthermore, the mean time to AVR was significantly shorter in patients with one (30.5 days) or ≥2 comorbidities (30.8 days) than in those without (35.7 days; p=0.012). Patients with reduced LVEF tended to be offered an AVR more frequently and with a shorter delay while patients with CKD were less frequently treated. CONCLUSIONS: Comorbidities in severe patients with AS affect the presentation and management of patients with severe AS. TAVI was offered more often than SAVR and performed within a shorter time period.

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.

Treatment of Severe TRIcuspid Regurgitation in Patients with Advanced Heart Failure with CAval Vein Implantation of the Edwards Sapien XT VALve (TRICAVAL): a randomised controlled trial.

AIMS: The aim of our study was to compare the impact of implantation of a balloon-expandable transcatheter valve into the inferior vena cava (CAVI) on exercise capacity with optimal medical therapy (OMT) in patients with severe tricuspid regurgitation (TR) and high surgical risk. METHODS AND RESULTS: Twenty-eight patients were randomised to OMT (n=14) or CAVI (n=14). The primary endpoint was maximal oxygen uptake at the three-month follow-up. Secondary endpoints included six-minute walk test, NYHA class, NT-proBNP levels, right heart function, unscheduled heart failure hospitalisation, and quality of life as assessed by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Patients underwent follow-up examinations one, three, six, and twelve months after randomisation. Maximal oxygen uptake did not change significantly in either group after three months and there was no difference between the OMT and CAVI groups (-0.1±1.8 ml∙kg-1∙min-1 vs -1.0±1.6 ml∙kg-1∙min-1, p=0.4995). Compared to baseline, CAVI improved NYHA class, dyspnoea, and quality of life after three months. However, there were no statistically significant differences in the secondary endpoints between the groups. Four periprocedural complications occurred after CAVI, resulting in open heart surgery. Four patients in the OMT group and eight patients (including four after conversion to surgery) in the CAVI group died from right heart failure, sepsis or haemorrhage. CONCLUSIONS: CAVI did not result in a superior functional outcome compared to OMT. Due to an unexpectedly high rate of valve dislocations, the study was stopped for safety reasons.

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.

Balloon-expandable transfemoral transcatheter aortic valve implantation with or without predilation: findings from the prospective EASE-IT TF multicentre registry.

Background: Predilation of the native valve has long been deemed necessary in transfemoral transcatheter aortic valve implantation (TF-TAVI), despite little trial evidence to support its clinical use. As most evidence is derived from retrospective analyses of observational studies, we conducted a two-armed, prospective multicentre registry. Methods: Patients undergoing TF-TAVI with the Edwards SAPIEN 3 valve, with or without balloon aortic valvuloplasty (BAV), were included and their procedural characteristics, short-term safety and short-term efficacy outcomes compared. We hypothesised that BAV may be safely omitted in many patients and omission could be associated with procedural benefits. Results: Overall, 196 consecutive patients underwent TF-TAVI, 56 with BAV and 140 without. The mean age was 81.2±6.2 years, and the mean logistic EuroSCORE I was 17.1±13.6. Device success according to Valve Academic Research Consortium-2 (VARC-2) was achieved in 96.4%. The median procedural duration was shorter without BAV (56 min vs 90 min; p=0.001), as was fluoroscopy time (10 min vs 13 min; p=0.001). The need for balloon postdilation was less frequent in patients without BAV (15.7% vs 30.4%, p=0.029). There was no difference in the proportion of patients meeting the VARC-2 defined composite safety endpoint at 30 days (9.3% without vs 8.9% with BAV; adjusted OR (adjOR) 2.55; 95% CI 0.56 to 18.84) and at 6 months (15.2% without vs 16.4% with BAV; adjOR 1.66; 95% CI 0.49 to 6.55). Conclusions: In the majority of patients, BAV can be safely omitted from the TAVI procedure without adverse effects. The omission of BAV is associated with shorter procedural duration and could be advantageous for the majority of patients. Trial registration number: NCT02760771.

Facilitated Data Relay and Effects on Treatment of Severe Aortic Stenosis in Europe.

Background Many patients with severe aortic stenosis are referred late with advanced symptoms or inappropriately denied intervention. The objective was to investigate whether a structured communication to referring physicians (facilitated data relay) might improve the rate and timeliness of intervention. Methods and Results A prospective registry of consecutive patients with severe aortic stenosis at 23 centers in 9 European countries with transcatheter as well as surgical aortic valve replacement being available was performed. The study included a 3-month documentation of the status quo (phase A), a 6-month intervention phase (implementing facilitated data relay), and a 3-month documentation of a legacy effect (phase-B). Two thousand one hundred seventy-one patients with severe aortic stenoses were enrolled (phase A: 759; intervention: 905; phase-B: 507). Mean age was 77.9±10.0 years, and 80% were symptomatic, including 52% with severe symptoms. During phase A, intervention was planned in 464/696 (67%), 138 (20%) were assigned to watchful waiting, 8 (1%) to balloon aortic valvuloplasty, 60 (9%) were listed as not for active treatment, and in 26 (4%), no decision was made. Three hundred sixty-three of 464 (78%) patients received the planned intervention within 3 months. Timeliness of the intervention improved as shown by the higher number of aortic valve replacements performed within 3 months (59% versus 51%, P=0.002) and a significant decrease in the time to intervention (36±38 versus 30±33 days, P=0.002). Conclusions A simple, low-cost, facilitated data relay improves timeliness of treatment for patients diagnosed with severe aortic stenosis, resulting in a shorter time to transcatheter aortic valve replacement. This effect was mainly driven by a significant improvement in timeliness of intervention in transcatheter aortic valve replacement but not surgical aortic valve replacement. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02241447.

Caseload management and outcome of patients with aortic stenosis in primary/secondary versus tertiary care settings-design of the IMPULSE enhanced registry.

Background: Severe aortic stenosis (AS) is one of the most common and most serious valve diseases. Without timely intervention with surgical aortic valve replacement or transcatheter aortic valve replacement, patients have an estimated survival of 2-3 years. Guidelines for the treatment of AS have been developed, but studies suggest that as many as 42% of patients with AS are not treated according to these recommendations.The aims of this registry are to delineate the caseload of patients with AS, outline the management of these patients and determine appropriateness of treatments in participating centres with and without onsite access to surgery and percutaneous treatments. Methods/design: The IMPULSE enhanced registry is an international, multicentre, prospective, observational cohort registry conducted at four central full access centres (tertiary care hospitals) and at least two satellite centres per hub (primary/secondary care hospitals). An estimated 800 patients will be enrolled in the registry and patient follow-up will last for 12 months. Discussion: In addition to the primary aims determining the caseload management and outcome of patients with AS in primary, secondary and tertiary care settings, the registry will also determine a time course for the transition from asymptomatic to symptomatic status and the diagnostic steps, treatment decisions and the identification of decision-makers in tertiary versus primary/secondary care hospitals. The last patient will be enrolled in the registry in 2018 and results of the registry are anticipated in 2019. Registration number: NCT03112629.

Value of a comprehensive geriatric assessment for predicting one-year outcomes in patients undergoing transcatheter aortic valve implantation: results from the CGA-TAVI multicentre registry.

BACKGROUND: In a three-month report from the CGA-TAVI registry, we found the Multidimensional Prognostic Index (MPI) and Short Physical Performance Battery (SPPB) to be of value for predicting short-term outcomes in elderly patients undergoing transcatheter aortic valve implantation (TAVI). In the present analysis, we examined the association of these tools with outcomes up to one year post-TAVI. METHODS: CGA-TAVI is an international, observational registry of geriatric patients undergoing TAVI. Patients were assessed using the MPI and SPPB. Efficacy of baseline values and any postoperative change for predicting outcome were established using logistic regression. Kaplan-Meier analysis was carried out for each comprehensive geriatric assessment tool, with survival stratified by risk category. RESULTS: One year after TAVI, 14.1% of patients deceased, while 17.4% met the combined endpoint of death and/or non-fatal stroke, and 37.7% the combined endpoint of death and/or hospitalisation and/or non-fatal stroke. A high-risk MPI score was associated with an increased risk of all-cause mortality (aOR = 36.13, 95% CI: 2.77-470.78, P = 0.006) and death and/or non-fatal stroke (aOR = 10.10, 95% CI: 1.48-68.75, P = 0.018). No significant associations were found between a high-risk SPPB score and mortality or two main combined endpoints. In contrast to a worsening SPPB, an aggravating MPI score at three months post-TAVI was associated with an increased risk of death and/or non-fatal stoke at one year (aOR = 95.16, 95% CI: 3.41-2657.01). CONCLUSIONS: The MPI showed value for predicting the likelihood of death and a combination of death and/or non-fatal stroke by one year after TAVI in elderly patients.