Bicaval TricValve Implantation in Patients With Severe Symptomatic Tricuspid Regurgitation: 1-Year Follow-Up Outcomes.

BACKGROUND: Several orthotopic transcatheter strategies have been developed to treat severe tricuspid regurgitation (TR); however, many patients are deemed unsuitable. Caval valve implantation with the TricValve system addresses this unmet need. OBJECTIVES: This study sought to determine the impact of TricValve on systemic congestion and quality of life (QOL) at 1 year. METHODS: The TRICUS (Safety and Efficacy of the TricValve® Transcatheter Bicaval Valves System in the Superior and Inferior Vena Cava in Patients With Severe Tricuspid Regurgitation) and TRICUS EURO studies were prospective, nonblinded, nonrandomized, single-arm trials representing the early-in-man experience of the TricValve system in NYHA functional class III or IV severe TR patients, optimally medicated and ineligible for open heart surgery, with significant caval backflow. The primary endpoint was QOL metrics and functional status. The 1-year results of the combined cohort are described here. RESULTS: Forty-four patients were included. Mean age was 76.2 ± 7.5 years, 81.0% were women, and the TRISCORE (risk score model for isolated tricuspid valve surgery) was 5.3 ± 1.3. Clinical improvement at 1 year was achieved in 42 (95.5%) patients, measured by (at least 1 of) an increase in ≥15 points from baseline in 12-item Kansas City Cardiomyopathy Questionnaire score, improvement to NYHA functional class to I or II, or an increase ≥40 m in the 6-minute walk test. There were 3 (6.8%) deaths at 1-year follow-up (1 cardiovascular), and the heart failure rehospitalization rate was 29.5%. Stent fracture, conduction system disturbances, or clinically significant leaflet thrombosis were not detected. Abolished hepatic vein backflow was achieved and persisted in 63.8% of the patients, contributing towards a reduction in congestive symptoms, N-terminal pro-B-type natriuretic peptide levels (P = 0.032), and diuretic treatment. CONCLUSIONS: Caval valve implantation with the TricValve system associated with meaningful 1-year clinical improvements in terms of QOL along with relatively low mortality rates. (TRICUS Study - Safety and Efficacy of the TricValve® Device; NCT03723239).

Effect of Austrian COVID-19 lockdowns on acute myocardial infarction frequency and long-term mortality: a multicentre observational study.

OBJECTIVES: The aim of this study was to find out if the decrease in acute myocardial infarction (AMI) admissions during the first COVID-19 lockdowns (LD), which was described by previous studies, occurred equally in all LD periods (LD1, LD2, LD2021), which had identical restrictions. Further, we wanted to analyse if the decrease of AMI admission had any association with the 1-year mortality rate. DESIGN AND SETTING: This study is a prospective observational study of two centres that are participating in the Vienna ST-elevation myocardial infarction network. PARTICIPANTS: A total of 1732 patients who presented with AMI according to the 4th universal definition of myocardial infarction in 2019, 2020 and the LD period of 2021 were included in our study. Patients with myocardial infarction with non-obstructive coronary arteries were excluded from our study. MAIN OUTCOME MEASURES: The primary outcome of this study was the frequency of AMI during the LD periods and the all-cause and cardiac-cause 1-year mortality rate of 2019 (pre-COVID-19) and 2020. RESULTS: Out of 1732 patients, 70% (n=1205) were male and median age was 64 years. There was a decrease in AMI admissions of 55% in LD1, 28% in LD2 and 17% in LD2021 compared with 2019.There were no differences in all-cause 1-year mortality between the year 2019 (11%; n=110) and 2020 (11%; n=79; p=0.92) or death by cardiac causes [10% (n=97) 2019 vs 10% (n=71) 2020; p=0.983]. CONCLUSION: All LDs showed a decrease in AMI admissions, though not to the same extent, even though the regulatory measures were equal. Admission in an LD period was not associated with cardiac or all-cause 1-year mortality rate in AMI patients in our study.

Frailty as a predictor of mortality and readmission rate in secondary mitral regurgitation.

INTRODUCTION: Selection in patients with functional mitral regurgitation (MR) to identify responders to interventions is challenging. In these patients, frailty might be used as a multidimensional parameter to summarize the resilience to stressors. Our objective was to evaluate frailty as a predictor of outcome in patients with moderate to severe secondary MR. METHODS: We conducted a single-center retrospective observational cohort study and included 239 patients with moderate to severe secondary MR aged 65 years or older between 2014 and 2020. Echocardiography was performed at baseline; frailty was evaluated using the clinical frailty scale (CFS). The combined primary endpoint was hospitalization for heart failure and all-cause mortality. RESULTS: A total of 53% (127) of all patients were classified as CFS 4 (living with mild frailty) or higher. Frail patients had a higher risk for the combined endpoint (hazard ratio, HR 3.70, 95% confidence interval, CI 2.12-6.47; p < 0.001), 1­year mortality (HR 5.94, 95% CI 1.76-20.08; p < 0.001) even after adjustment for EuroSCORE2. The CFS was predictive for the combined endpoint (AUC 0.69, 95% CI 0.62-0.75) and outperformed EuroSCORE2 (AUC 0.54, 95% CI 0.46-0.62; p = 0.01). In sensitivity analyses, we found that frailty was associated with adverse outcomes at least in trend in all subgroups. CONCLUSION: For older, medically treated patients with moderate to severe secondary mitral regurgitation, frailty is an independent predictor for the occurrence of death and heart failure-related readmission within 1 year and outperformed the EuroSCORE2. Frailty should be assessed routinely in patients with heart failure to guide clinical decision making for mitral valve interventions or conservative treatment.

Not to Rush-Laboratory Parameters and Procedural Complications in Patients Undergoing Left Atrial Appendage Closure.

Background: As a preventive procedure, minimizing periprocedural risk is crucially important during left atrial appendage closure (LAAC). Methods: We included consecutive patients receiving LAAC at nine centres and assessed the relationship between baseline characteristics and the acute procedural outcome. Major procedural complications were defined as all complications requiring immediate invasive intervention or causing irreversible damage. Logistic regression was performed and included age and left-ventricular function. Furthermore, the association between acute complications and long-term outcomes was evaluated. Results: A total of 405 consecutive patients with a median age of 75 years (37% female) were included. 47% had a history of stroke. Median CHA2DS2-VASc score was 4 (interquartile range, 3−5) and the median HAS-BLED score was 3 (2−4). Major procedural complications occurred in 7% of cases. Low haemoglobin (OR 0.8, 95% CI 0.65−0.99 per g/dL, p = 0.040) and end-stage kidney disease (OR 13.0, CI 2.5−68.5, p = 0.002) remained significant in multivariate analysis. Anaemia (haemoglobin < 12 and < 13 g/dL in female and male patients) increased the risk of complications 2.2-fold. Conclusions: The major complication rate was low in this high-risk patient population undergoing LAAC. End-stage kidney disease and low baseline haemoglobin were independently associated with a higher major complication rate.

6-Month Outcomes of the TricValve System in Patients With Tricuspid Regurgitation: The TRICUS EURO Study.

BACKGROUND: Severe tricuspid regurgitation (TR) is frequently associated with significant morbidity and mortality; such patients are often deemed to be at high surgical risk. Heterotopic bicaval stenting is an emerging, attractive transcatheter solution for these patients. OBJECTIVES: The aim of this study was to evaluate the 30-day safety and 6-month efficacy outcomes of specifically designed bioprosthetic valves for the superior and inferior vena cava. METHODS: TRICUS EURO (Safety and Efficacy of the TricValve® Transcatheter Bicaval Valves System in the Superior and Inferior Vena Cava in Patients With Severe Tricuspid Regurgitation) is a nonblinded, nonrandomized, single-arm, multicenter, prospective trial that enrolled patients from 12 European centers between December 2019 and February 2021. High-risk individuals with severe symptomatic TR despite optimal medical therapy were included. The primary endpoint was quality-of-life (QOL) improvement measured by Kansas City Cardiomyopathy Questionnaire score and New York Heart Association (NYHA) functional class improvement at 6-month follow-up. RESULTS: Thirty-five patients (mean age 76 ± 6.8 years, 83% women) were treated using the TricValve system. All patients at baseline were in NYHA functional class III or IV. At 30 days, procedural success was 94%, with no procedural deaths or conversions to surgery. A significant increase in QOL at 6 months follow-up was observed (baseline and 6-month Kansas City Cardiomyopathy Questionnaire scores 42.01 ± 22.3 and 59.7 ± 23.6, respectively; P = 0.004), correlating with a significant improvement in NYHA functional class, with 79.4% of patients noted to be in functional class I or II at 6 months (P = 0.0006). The rates of 6-month all-cause mortality and heart failure hospitalization were 8.5% and 20%, respectively. CONCLUSIONS: The dedicated bicaval system for treating severe symptomatic TR was associated with a high procedural success rate and significant improvements in both QOL and functional classification at 6 months follow-up.

Identifying Patients without a Survival Benefit following Transfemoral and Transapical Transcatheter Aortic Valve Replacement.

Transcatheter aortic valve replacement (TAVR) offers a novel treatment option for patients with severe symptomatic aortic valve stenosis, particularly for patients who are unsuitable candidates for surgical intervention. However, high therapeutical costs, socio-economic considerations, and numerous comorbidities make it necessary to target and allocate available resources efficiently. In the present study, we aimed to identify risk factors associated with futile treatment following transfemoral (TF) and transapical (TA) TAVR. Five hundred and thirty-two consecutive patients (82 ± 9 years, female 63%) who underwent TAVR between June 2009 and December 2016 at the Vienna Heart Center Hietzing were retrospectively analyzed to identify predictors of futility, defined as all-cause mortality at one year following the procedure for the overall patient cohort, as well as the TF and TA cohort. Out of 532 patients, 91 (17%) did not survive the first year after TAVR. A multivariate logistic model identified cerebrovascular disease, home oxygen dependency, wheelchair dependency, periinterventional myocardial infarction, and postinterventional renal replacement therapy as the factors independently associated with an increased one-year mortality. Our findings underscore the significance of a precise preinterventional evaluation, as well as illustrating the subtle differences in baseline characteristics in the TF and TA cohort and their impact on one-year mortality.

A Sneak-Peek into the Physician's Brain: A Retrospective Machine Learning-Driven Investigation of Decision-Making in TAVR versus SAVR for Young High-Risk Patients with Severe Symptomatic Aortic Stenosis.

Transcatheter aortic valve replacement (TAVR) has rapidly become a viable alternative to the conventional isolated surgical aortic valve replacement (iSAVR) for treating severe symptomatic aortic stenosis. However, data on younger patients is scarce and a gap exists between data-based recommendations and the clinical use of TAVR. In our study, we utilized a machine learning (ML) driven approach to model the complex decision-making process of Heart Teams when treating young patients with severe symptomatic aortic stenosis with either TAVR or iSAVR and to identify the relevant considerations. Out of the considered factors, the variables most prominently featured in our ML model were congestive heart failure, established risk assessment scores, previous cardiac surgeries, a reduced left ventricular ejection fraction and peripheral vascular disease. Our study demonstrates a viable application of ML-based approaches for studying and understanding complex clinical decision-making processes.

Transcatheter versus Isolated Surgical Aortic Valve Replacement in Young High-Risk Patients: A Propensity Score-Matched Analysis.

BACKGROUND: Younger patients with severe symptomatic aortic stenosis are a particularly challenging collective with regard to the choice of intervention. High-risk patients younger than 75 years of age are often eligible for both the transcatheter aortic valve replacement (TAVR) and the isolated surgical aortic valve replacement (iSAVR). Data on the outcomes of both interventions in this set of patients are scarce. METHODS: One hundred and forty-four propensity score-matched patients aged 75 years or less who underwent TAVR or iSAVR at the Hietzing Heart Center in Vienna, Austria, were included in the study. The mean age was 68.9 years (TAVR 68.7 vs. SAVR 67.6 years; p = 0.190) and the average EuroSCORE II was 5.4% (TAVR 4.3 [3.2%] vs. iSAVR 6.4 (4.3%); p = 0.194). RESULTS: Postprocedural adverse event data showed higher rates of newly acquired atrial fibrillation (6.9% vs. 19.4%; p = 0.049), prolonged ventilation (2.8% vs. 25.0%; p < 0.001) and multi-organ failure (0% vs. 6.9%) in the surgical cohort. The in-hospital and 30-day mortality was significantly higher for iSAVR (1.4% vs. 13.9%; p = 0.012; 12.5% vs. 2.8%; p = 0.009, respectively). The long-term survival (median follow-up 5.0 years (2.2-14.1 years)) of patients treated with the surgical approach was superior to that of patients undergoing TAVR (p < 0.001). CONCLUSION: Although the survival analysis revealed a higher in-hospital and 30-day survival rate for high-risk patients aged ≤75 years who underwent TAVR, iSAVR was associated with a significantly higher long-term survival rate.

The impact of antiplatelet and antithrombotic regimen after TAVI: Data from the VIenna CardioThOracic Aortic Valve RegistrY (VICTORY).

BACKGROUND: We compared the outcomes and adverse events of TAVI patients based on the discharge and long-term antiplatelet or anticoagulant treatment regimens (single antiplatelet [SAPT] vs. dual antiplatelet [DAPT] vs. anticoagulation [OAC] vs. no treatment [NT]). METHODS: The outcome of 532 consecutive patients treated with TAVI was evaluated. As the main study endpoint, the 1-year all-cause mortality was chosen to compare the different discharge treatment regimens and the 3-year all-cause mortality to compare the different long-term treatment regimens. The secondary endpoints were adverse events as defined by the Valve Academic Research Consortium-II. RESULTS: One-year survival after TAVI was highest amongst patients treated with DAPT compared to SAPT (P < .001) and OAC (P = .003), and patients under OAC demonstrated improved 1-year survival over patients treated with SAPT (P = .006). Furthermore, there was a strong trend towards improved 3-year survival for patients in the OAC cohort treated with non-vitamin K antagonists compared to vitamin K antagonists (N-VKAs vs. VKA; log-rank P = .056). CONCLUSION: The lower all-cause mortality for DAPT within the first year and N-VKAs over VKA within the first 3 years warrant considerable attention in further recommendations of antithrombotic and anticoagulation regimens after TAVI.

The use of semi-compliant versus non-compliant balloon systems for predilatation during the implantation of self-expandable transcatheter aortic valves: Data from the VIenna CardioThOracic Aortic Valve RegistrY (VICTORY).

BACKGROUND: This study aimed to evaluate the differences in outcome arising from the use of semi-compliant (SCB) versus non-compliant balloon (NCB) systems for predilatation during self-expanding transcatheter aortic valve replacement (TAVR). METHODS: 251 TAVR procedures with the implantation of self-expanding valves after predilatation were analyzed. SCB systems were used in 166 and NCB systems in 85 patients. The primary endpoint was defined as device success, a composite endpoint comprising the absence of procedural mortality, correct valve positioning, adequate valve performance and the absence of more than a mild paravalvular leak. The secondary endpoints were chosen in accordance with the valve academic research consortium (VARC-2) endpoint definitions. RESULTS: No significant differences were observed with regard to procedural device success between the SCB- and NCB cohort (SCB: 142 [85.5%%] vs. NCB: 77 [90.6%]; P = .257). There was a notable difference between the rates of conversion to open surgery and the postdilatation rate, both of which were higher for the NCB group (SCB: 1 [0.6%] vs. NCB: 4 [5.1%]; P = .042; SCB: 30 [18.1%] vs. NCB: 34 [40%]; P < .001). In a multivariate logistic regression analysis, the use of semi-compliant balloon systems for predilatation was associated with a lower risk for postdilatation (OR: 0.296; 95% CI: 0.149-0.588) and conversion to open surgery (OR: 0.205; 95% CI: 0.085-0.493; P = .001) but not for device success. CONCLUSION: While the balloon compliance did not affect the procedural mortality, device success or the rate of paravalvular leakage, the use of semi-compliant balloons for predilatation during TAVR should be investigated in larger randomized trials in the light of the lower rates of postdilatation and conversion to open surgery compared to their non-compliant counterparts.

2020 update of the Austrian Society of Cardiology (ÖKG) and the Austrian Society of Cardiac Surgery (ÖGHTG) on the position statement of the ÖKG and ÖGHTG for transcatheter aortic valve implantation 2011.

This position statement is an update to the 2011 consensus statement of the Austrian Society of Cardiology (ÖKG) and the Austrian Society of Cardiac Surgery (ÖGTHG) for transfemoral transcatheter aortic valve implantation.Due to a number of recently published studies, broadening of indications and recommendations of medical societies and our own national developments, the ÖKG and the ÖGHTG wish to combine the 2017 ESC/EACTS guidelines for the management of valvular heart disease with a national position paper and to focus on certain details for the application in Austria. Thus, this position statement serves as a supplement and further interpretation of the international guidelines.

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.

The Iliofemoral tortuosity score predicts access and bleeding complications during transfemoral transcatheter aortic valve replacement: DataData from the VIenna Cardio Thoracic aOrtic valve registrY (VICTORY).

BACKGROUND: Arterial tortuosity is linked to a higher risk of adverse clinical events after transfemoral transcatheter aortic valve replacement (TF-TAVR). Currently, there are no assessment tools that can quantify this variable in three-dimensional space. This study investigated the impact of novel scoring methods of iliofemoral tortuosity on access and bleeding complications after TF-TAVR. METHODS: The main access vessel was assessed between the aortoiliacal and femoral bifurcation in preoperative multislice computed tomography scans of 240 consecutive patients undergoing TF-TAVR. Tortuosity was assessed by three methods: largest single angle, sum of all angles, and iliofemoral tortuosity (IFT) score [((true vessel length/ideal vessel length)-1)*100]. The primary study endpoint was a composite of access and bleeding complications. The secondary study endpoints were 30-day mortality and long-term survival. RESULTS: Among 240 patients, only the IFT score demonstrated a good positive correlation with the composite primary endpoint of access and bleeding complications (P = 0.031). A higher incidence of access and bleeding complications was found in patients with a higher IFT score (56 [36.8%] vs 17 [19.3%]; P = 0.003). In a multivariate logistic regression analysis, only the IFT score was a significant predictor of the primary endpoint (OR: 2.11; 95% CI: 1.09-4.05; P = 0.026). CONCLUSION: Vascular tortuosity is an underestimated risk factor during TF-TAVR. The IFT score is a valuable tool in risk stratification before TF-TAVR, predicting periprocedural access and bleeding complications.

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.

Plasma MMP-9 and TIMP-1 levels on ICU admission are associated with 30-day survival.

BACKGROUND: Matrix metalloproteinases (MMPs) are involved in systemic inflammatory responses and organ failure. The aim of this study was to evaluate early circulating plasma levels of MMP­2, MMP­9 and their inhibitors TIMP­1 and TIMP­2 and their prognostic significance in critically ill patients on admission to the intensive care unit (ICU). METHODS: In a single center prospective study 120 consecutive patients (72.5% male, mean age 66.8 ± 13.3 years, mean simplified acute physiology score [SAPS II] score 52.9 ± 21.9) were enrolled on transfer to the ICU of a cardiology department. The most common underlying conditions were cardiac diseases (n = 42.5%), respiratory failure (n = 10.8%) and sepsis (n = 6.7%). Blood samples were taken within 12 h of ICU admission. The MMP­2, MMP­9, TIMP­1 and TIMP­2 levels in plasma were evaluated in terms of 30-day survival, underlying condition and clinical score. RESULTS: On ICU admission 30-day survivors had significantly lower plasma MMP­9 (odds ratio, OR 1.67 per 1 SD; 95% confidence interval, CI 1.10-2.53; p = 0.016) and TIMP­1 (OR 2.15 per 1 SD; 95% CI 1.27-3.64; p = 0.004) levels than non-survivors; furthermore, MMP­9 and TIMP­1 correlated well with SAPS II (both p < 0.01). In patients with underlying cardiac diseases, MMP­9 (p = 0.002) and TIMP­1 (p = 0.01) were independent predictors of survival (Cox regression). No significant correlation was found between MMP­2 and TIMP­2 levels, MMP/TIMP ratios and 30-day mortality. CONCLUSION: The MMP­9 and TIMP­1 levels are significantly elevated in acute critical care settings with increased short-term mortality risk, especially in patients with underlying heart disease. These findings support the value of MMPs and TIMPs as prognostic markers and potential therapeutic targets in conditions leading to systemic inflammation and acute organ failure.

Evaluating the Association between Contrast Medium Dosage and Acute Kidney Injury in Transcatheter Aortic Valve Replacement Using Different Predictive Models.

Recent studies have suggested that contrast medium (CM) volume is associated with acute kidney injury (AKI) after transcatheter aortic valve replacement (TAVR). However, in a high-risk elderly TAVR population, the prognostic value and ideal threshold of CM dosage for AKI is unclear. Data of 532 successive TAVR patients (age 81.1 ± 6.8 years, EuroSCORE II 4.8% ± 6.0%) were therefore retrospectively analyzed. Based on a recently published formula, the renal function (preprocedural serum creatinine: SCr) corrected ratio of CM and body weight (CM*SCr/BW) was calculated to determine the risk of postprocedural contrast-associated AKI. AKI occurred in 94 patients (18.3%) and significantly increased 1-year all-cause mortality (23.4% vs. 13.1%; p = 0.001). A significant correlation between AKI and 30-day as well as 1-year all-cause mortality was observed (p = 0.001; p = 0.007). However, no association between CM dosage or the CM*SCr/BW ratio with the occurrence of AKI was seen (p = 0.968; p = 0.442). In our all-comers, all-access cohort, we found no relationship between CM dosage, or the established risk ratio model and the occurrence of postprocedural AKI. Further research needs to be directed towards different pathophysiological causes and preventive measures as AKI impairs short- and long-term survival.

Fitness-Tracker Assisted Frailty-Assessment Before Transcatheter Aortic Valve Implantation: Proof-of-Concept Study.

BACKGROUND: While transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of aortic valve stenosis, wearable health-monitoring devices are gradually transforming digital patient care. OBJECTIVE: The aim of this study was to develop a simple, efficient, and economical method for preprocedural frailty assessment based on parameters measured by a wearable health-monitoring device. METHODS: In this prospective study, we analyzed data of 50 consecutive patients with mean (SD) age of 77.5 (5.1) years and a median (IQR) European system for cardiac operative risk evaluation (EuroSCORE) II of 3.3 (4.1) undergoing either transfemoral or transapical TAVR between 2017 and 2018. Every patient was fitted with a wrist-worn health-monitoring device (Garmin Vivosmart 3) for 1 week prior to the procedure. Twenty different parameters were measured, and threshold levels for the 3 most predictive categories (ie, step count, heart rate, and preprocedural stress) were calculated. Patients were assigned 1 point per category for exceeding the cut-off value and were then classified into 4 stages (no, borderline, moderate, and severe frailty). Furthermore, the FItness-tracker assisted Frailty-Assessment Score (FIFA score) was compared with the scores of the preprocedural gait speed category derived from the 6-minute walk test (GSC-6MWT) and the Edmonton Frail Scale classification (EFS-C). The primary study endpoint was hospital mortality. RESULTS: The overall preprocedural stress level (P=.02), minutes of high stress per day (P=.02), minutes of rest per day (P=.045), and daily heart rate maximum (P=.048) as single parameters were the strongest predictors of hospital mortality. When comparing the different frailty scores, the FIFA score demonstrated the greatest predictive power for hospital mortality (FIFA area under the curve [AUC] 0.844, CI 0.656-1.000; P=.048; GSC-6MWT AUC 0.671, CI 0.487-0.855; P=.42; EFS-C AUC 0.636, CI 0.254-1.000; P=.44). CONCLUSIONS: This proof-of-concept study demonstrates the strong predictive performance of the FIFA score compared to that of the conventional frailty assessments.

Effect of the COVID-19 Pandemic on Treatment Delays in Patients with ST-Segment Elevation Myocardial Infarction.

Coronavirus disease 19 (COVID-19) and its associated restrictions could affect ischemic times in patients with ST-segment elevation myocardial infarction (STEMI). The objective of this study was to investigate the influence of the COVID-19 outbreak on ischemic times in consecutive all-comer STEMI patients. We included consecutive STEMI patients (n = 163, median age: 61 years, 27% women) who were referred to seven tertiary care hospitals across Austria for primary percutaneous coronary intervention between 24 February 2020 (calendar week 9) and 5 April 2020 (calendar week 14). The number of patients, total ischemic times and door-to-balloon times in temporal relation to COVID-19-related restrictions and infection rates were analyzed. While rates of STEMI admissions decreased (calendar week 9/10 (n = 69, 42%); calendar week 11/12 (n = 51, 31%); calendar week 13/14 (n = 43, 26%)), total ischemic times increased from 164 (interquartile range (IQR): 107-281) min (calendar week 9/10) to 237 (IQR: 141-560) min (calendar week 11/12) and to 275 (IQR: 170-590) min (calendar week 13/14) (p = 0.006). Door-to-balloon times were constant (p = 0.60). There was a significant difference in post-interventional Thrombolysis in myocardial infarction (TIMI) flow grade 3 in patients treated during calendar week 9/10 (97%), 11/12 (84%) and 13/14 (81%; p = 0.02). Rates of in-hospital death and re-infarction were similar between groups (p = 0.48). Results were comparable when dichotomizing data on 10 March and 16 March 2020, when official restrictions were executed. In this cohort of all-comer STEMI patients, we observed a 1.7-fold increase in ischemic time during the outbreak of COVID-19 in Austria. Patient-related factors likely explain most of this increase. Counteractive steps are needed to prevent further cardiac collateral damage during the ongoing COVID-19 pandemic.

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.