Martijn S. van Mourik

An up-to-date overview of the most recent transcatheter implantable aortic valve prostheses

Over the past decade transcatheter aortic valve implantation (TAVI) has evolved towards the routine therapy for high-risk patients with severe aortic valve stenosis. Technical refinements in TAVI are rapidly evolving with a simultaneous expansion of the number of available devices. This review will present an overview of the current status of development of TAVI-prostheses; describes the technical features and applicability of each device and the clinical data available.

Procedural Outcome and Midterm Survival of Lower Risk Transfemoral Transcatheter Aortic Valve Implantation Patients Treated With the SAPIEN XT or SAPIEN 3 Device

Over the years increasing experience and technical device improvements in transcatheter aortic valve implantation (TAVI) have led to treatment of patients with lower surgical risks. Specifically for this population, device performance and longer term outcome are of great importance. In this single center, we performed a retrospective analysis of 515 consecutive patients with low- to intermediate surgical risk (STS-PROM ≤8), who underwent transfemoral TAVI between January 2009 and February 2017 with the SXT and ES3 prostheses, and we assessed procedural outcome and procedural and 3-year survival. Mean age (82 years in both groups, p = 0.344) and STS-PROM risk score (3.862 vs 3.992, p = 0.154) did not differ between the ES3 and SXT group. ES3-treated patients showed favorable procedural outcomes, with significantly higher device success (90% vs 73%, p <0.0001) and less paravalvular leakage (7% vs 13%, p <0.0001). Procedural mortality (0.87% vs 1.45%, p = 0.245) and the very low rate of permanent pacemaker implantations (7.4% vs 6.1%, p = 0.234) did not differ significantly. Three-year survival was 87% in the ES3 vs 80% in the SXT group (log-rank p = 0.385). In conclusion, we showed excellent survival and procedural outcomes in patients receiving a transfemoral TAVI with either the SAPIEN 3 or the SAPIEN XT device. The newer SAPIEN 3 even outperforms the SAPIEN XT in terms of less major bleeding complications, substantially higher device success rates, and less paravalvular leakage, with the permanent pacemaker implantation rate being very low in both groups. Survival curves show a nonsignificant trend toward better midterm survival in the ES3 group.

Predicting hospitalisation duration after transcatheter aortic valve implantation

Objective Transcatheter aortic valve implantation (TAVI) is widely used as an alternative to conventional surgical aortic valve replacement. The aim of this study was to identify preprocedural predictors of duration of length of stay (LoS) after transfemoral TAVI (TF-TAVI). Methods We included all consecutive patients who underwent TF-TAVI at our centre between November 2010 and June 2013. Preprocedural, periprocedural and postprocedural variables were collected and evaluated to LoS. Linear regression was performed to find preprocedural predictors for total LoS. Results The population consisted of 114 patients (mean age: 79.6±8.7, 32.5% male). The median total LoS was 6.5 days (5–9 days). Multivariate analysis showed that the Metabolic Equivalent score (METs) (β=−0.084, p=0.011) and diastolic blood pressure (β=−0.011, p=0.016) independently contributed to the log-transformed LoS. Conclusion Multivariate linear regression showed that lower METs and lower diastolic blood pressure were associated with prolonged LoS. Understanding patients’ physical functionality can improve logistical planning of hospital stay and selecting patients eligible for early discharge.

PREVENTION OF CONTRAST-INDUCED NEPHROPATHY FOR COMPUTED TOMOGRAPHY (CT)-SCANNING IN TAVR WORK-UP: ONE-HOUR HYDRATION WITH SODIUM BICARBONATE IS NOT INFERIOR TO 24-HOUR SALINE HYDRATION

Background: Computed tomography-angiography (CTA) is required in work-up for Transcatheter Aortic Valve Replacement (TAVR). In patients with impaired renal function CTA can cause contrast-induced nephropathy (CIN). The standard protocol for prevention of CIN in patients with heart failure is iv

Impact of Potentially Malignant Incidental Findings by Computed Tomographic Angiography on Long-Term Survival After Transcatheter Aortic Valve Implantation

Computed tomography angiography (CTA) in workup for transcatheter aortic valve implantation (TAVI) frequently reveals potentially malignant incidental findings. Most incidental findings provoke discussions on their influence. We aimed to analyze if these findings were a predictor of long-term survival after TAVI. In a single-center retrospective analysis, all consecutive patients with pre-TAVI CTA were included (years 2009 to 2014). Patients were divided by presence or absence of incidental findings. We analyzed up to 5 years of all-cause, non-cardiovascular and cardiovascular mortality for all 553 patients who underwent TAVI; 113 had a potentially malignant incidental finding (20.4%). At 5 years, all-cause mortality risk was 64.5% in patients with versus 49.1% in patients without a finding (hazard ratio [HR] 1.70, 95% confidence interval [CI] 1.25 to 2.31). After adjustment, the findings remained an independent predictor of all-cause (adjusted HR 1.46, 95% CI 1.07 to 1.99) and non-cardiovascular mortality (adjusted subdistribution HR 1.84, 95% CI 1.06 to 3.20), but not of cardiovascular mortality. In conclusion, the presence of potentially malignant incidental findings on CTA is an independent predictor of long-term all-cause and noncardiovascular mortality but not of cardiovascular mortality.

Guideline-defined futility or patient-reported outcomes to assess treatment success after TAVI: what to use? Results from a prospective cohort study with long-term follow-up

Objective Transcatheter aortic valve implantation (TAVI) provides a significant symptom relief and mortality reduction in most patients; however, a substantial group of patients does not experience the same beneficial results according to physician-determined outcomes. Methods Single-centre prospective design; the population comprises all consecutive patients undergoing TAVI in 2012–2017. TAVI futility was defined as the combined endpoint of either no symptomatic improvement or mortality at 1 year. We actively gathered telephone follow-up using a predefined questionnaire. Results Guideline defined TAVI futility was present in 212/741 patients. Multivariate regression showed lower albumin and non-transfemoral approach to be predictive for futility. In addition to these, chronic obstructive pulmonary disease, lower estimated glomerular filtration rate, atrial fibrillation, low-flow–low-gradient aortic stenosis and lower Body Mass Index were predictive for 1-year mortality. Patients who showed symptomatic benefit estimated the percentage in which their symptoms were remedied higher than patients who did not (80% vs 60%, p<0.001). Guideline-defined TAVI futility occurs frequently, contrasting with patient-reported outcome measures (PROMs). The vast majority in both groups would again choose for TAVI treatment. Conclusion Lower albumin and non-transfemoral access route were predictors for guideline-defined TAVI futility, defined as mortality within 1 year or no objective symptomatic improvement in New York Heart Association class. Futility according to this definition occurred frequently in this study, contrasting with much more positive PROMs. The majority of patients would undergo a TAVI again, underlining the patients’ experienced value of TAVI and putting the definition of TAVI futility further on debate. In the near future, less-strict criteria for TAVI futility, that is, using a shorter warranted life expectancy and incorporating patients’ perceived outcomes, should be used.

Infective Endocarditis After Melody Valve Implantation in the Pulmonary Position: A Systematic Review

Background Infective endocarditis (IE) after transcatheter pulmonary valve implantation (TPVI) in dysfunctioning right ventricular outflow tract conduits has evoked growing concerns. We aimed to investigate the incidence and the natural history of IE after TPVI with the Melody valve through a systematic review of published data. Methods and Results PubMed, EMBASE, and Web of Science databases were systematically searched for articles published until March 2017, reporting on IE after TPVI with the Melody valve. Nine studies (including 851 patients and 2060 patient‐years of follow‐up) were included in the analysis of the incidence of IE. The cumulative incidence of IE ranged from 3.2% to 25.0%, whereas the annualized incidence rate ranged from 1.3% to 9.1% per patient‐year. The median (interquartile range) time from TPVI to the onset of IE was 18.0 (9.0–30.4) months (range, 1.0–72.0 months). The most common findings were positive blood culture (93%), fever (89%), and new, significant, and/or progressive right ventricular outflow tract obstruction (79%); vegetations were detectable on echocardiography in only 34% of cases. Of 69 patients with IE after TPVI, 6 (8.7%) died and 35 (52%) underwent surgical and/or transcatheter reintervention. Death or reintervention was more common in patients with new/significant right ventricular outflow tract obstruction (69% versus 33%; P=0.042) and in patients with non‐streptococcal IE (73% versus 30%; P=0.001). Conclusions The incidence of IE after implantation of a Melody valve is significant, at least over the first 3 years after TPVI, and varies considerably between the studies. Although surgical/percutaneous reintervention is a common consequence, some patients can be managed medically, especially those with streptococcal infection and no right ventricular outflow tract obstruction.

Remote Monitoring of Patients Undergoing Transcatheter Aortic Valve Replacement: A Framework for Postprocedural Telemonitoring

Background The postprocedural trajectory of patients undergoing transcatheter aortic valve replacement (TAVR) involves in-hospital monitoring of potential cardiac rhythm or conduction disorders and other complications. Recent advances in telemonitoring technologies create opportunities to monitor electrocardiogram (ECG) and vital signs remotely, facilitating redesign of follow-up trajectories. Objective This study aimed to outline a potential set-up of telemonitoring after TAVR. Methods A multidisciplinary team systematically framed the envisioned telemonitoring scenario according to the intentions, People, Activities, Context, Technology (iPACT) and Functionality, Interaction, Content, Services (FICS) methods and identified corresponding technical requirements. Results In this scenario, a wearable sensor system is used to continuously transmit ECG and contextual data to a central monitoring unit, allowing remote follow-up of ECG abnormalities and physical deteriorations. Telemonitoring is suggested as an alternative or supplement to current in-hospital monitoring after TAVR, enabling early hospital dismissal in eligible patients and accessible follow-up prolongation. Together, this approach aims to improve rehabilitation, enhance patient comfort, optimize hospital capacity usage, and reduce overall costs. Required technical components include continuous data acquisition, real-time data transfer, privacy-ensured storage, automatic event detection, and user-friendly interfaces. Conclusions The suggested telemonitoring set-up involves a new approach to patient follow-up that could bring durable solutions for the growing scarcities in health care and for improving health care quality. To further explore the potential and feasibility of post-TAVR telemonitoring, we recommend evaluation of the overall impact on patient outcomes and of the safety, social, ethical, legal, organizational, and financial factors.

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

The aim of this study was to assess the predictive value of PMA measurement for mortality.

Incidence, Predictors, and Impact of Vascular Complications After Transfemoral Transcatheter Aortic Valve Implantation With the SAPIEN 3 Prosthesis

Vascular complications (VCs) after transfemoral transcatheter aortic valve implantation (TAVI) have always been reported to occur frequently. Studies addressing VCs have been conducted with older-generation prostheses. We aimed to evaluate the incidence, predictors, and impact of VCs after transfemoral TAVI with the balloon-expandable SAPIEN 3. We report a single-center retrospective analysis of 400 consecutive patients of a prospectively acquired cohort. All patients underwent transfemoral TAVI with SAPIEN 3 between January 2014 and December 2016. VC was defined according to the Valve Academic Research Consortium. In this cohort 83 patients had VCs (20.8%), 5.8% major and 15.0% minor. Sheath-to-iliofemoral artery ratio was the only predictor of major VCs (odds ratio 7.51, 95% confidence interval 1.61 to 34.95, p = 0.010). The area under the receiver-operator characteristic curve for sheath-to-iliofemoral artery ratio was 0.63 (poor accuracy). Thirty-day mortality rates were 17.4%, 1.7%, and 0.6% for major, minor, and no VCs, respectively (log-rank p ≤0.001). After adjustment, only major VCs were associated with 30-day mortality (adjusted hazard ratio 48.31, 95% confidence interval 7.80 to 299.24). Mortality from 30 days until 1 year did not differ between patients with and without VCs (log-rank p = 0.61). In conclusion we report that VCs remain an issue of transfemoral TAVI with the SAPIEN 3, and their prediction continues to be difficult, albeit the low-incidence, major VCs were associated with higher 30-day mortality. However, after these first 30 days, they were not of influence on survival anymore.