Changes in demographics, treatment and outcomes in a consecutive cohort who underwent transcatheter aortic valve implantation between 2005 and 2020.

INTRODUCTION: Transcatheter aortic valve implantation (TAVI) has matured to the treatment of choice for most patients with aortic stenosis (AS). We sought to identify trends in patient and procedural characteristics, and clinical outcomes in all patients who underwent TAVI between 2005 and 2020. METHODS: A single-centre analysis was performed on 1500 consecutive patients who underwent TAVI, divided into three tertiles (T) of 500 patients treated between November 2005 and December 2014 (T1), January 2015 and May 2018 (T2) and June 2018 and April 2020 (T3). RESULTS: Over time, mean age and gender did not change (T1 to T3: 80, 80 and 79 years and 53%, 55% and 52% men, respectively), while the Society of Thoracic Surgeons risk score declined (T1: 4.5% to T3: 2.7%, p < 0.001). Use of general anaesthesia also declined over time (100%, 24% and 1% from T1 to T3) and transfemoral TAVI remained the default approach (87%, 94% and 92%). Median procedure time and contrast volume decreased significantly (186, 114 and 56 min and 120, 100 and 80 ml, respectively). Thirty-day mortality (7%, 4% and 2%), stroke (7%, 3% and 3%), need for a pacemaker (19%, 22% and 8%) and delirium (17%, 12% and 8%) improved significantly, while major bleeding/vascular complications did not change (both approximately 9%, 6% and 6%). One-year survival was 80%, 88% and 92%, respectively. CONCLUSION: Over our 15 years' experience, patient age remained unchanged but the patient risk profile became more favourable. Simplification of the TAVI procedure occurred in parallel with major improvement in outcomes and survival. Bleeding/vascular complications and the need for pacemaker implantation remain the Achilles' heel of TAVI.

Reclassification of aortic stenosis by fusion of echocardiography and computed tomography in low-gradient aortic stenosis.

BACKGROUND: The integration of computed tomography (CT)-derived left ventricular outflow tract area into the echocardiography-derived continuity equation results in the reclassification of a significant proportion of patients with severe aortic stenosis (AS) into moderate AS based on aortic valve area indexed to body surface area determined by fusion imaging (fusion AVAi). The aim of this study was to evaluate AS severity by a fusion imaging technique in patients with low-gradient AS and to compare the clinical impact of reclassified moderate AS versus severe AS. METHODS: We included 359 consecutive patients who underwent transcatheter aortic valve implantation for low-gradient, severe AS at two academic institutions and created a joint database. The primary endpoint was a composite of all-cause mortality and rehospitalisations for heart failure at 1 year. RESULTS: Overall, 35% of the population (n = 126) were reclassified to moderate AS [median fusion AVAi 0.70 (interquartile range, IQR 0.65-0.80) cm2/m2] and severe AS was retained as the classification in 65% [median fusion AVAi 0.49 (IQR 0.43-0.54) cm2/m2]. Lower body mass index, higher logistic EuroSCORE and larger aortic dimensions characterised patients reclassified to moderate AS. Overall, 57% of patients had a left ventricular ejection fraction (LVEF) <50%. Clinical outcome was similar in patients with reclassified moderate or severe AS. Among patients reclassified to moderate AS, non-cardiac mortality was higher in those with LVEF <50% than in those with LVEF ≥50% (log-rank p = 0.029). CONCLUSIONS: The integration of CT and transthoracic echocardiography to obtain fusion AVAi led to the reclassification of one third of patients with low-gradient AS to moderate AS. Reclassification did not affect clinical outcome, although patients reclassified to moderate AS with a LVEF <50% had worse outcomes owing to excess non-cardiac mortality.

Clinical consequences of consecutive self-expanding transcatheter heart valve iterations.

OBJECTIVE: To compare early clinical outcomes after transcatheter aortic valve implantation (TAVI) with three consecutive generations of self-expanding valves (SEVs). METHODS: Clinical endpoints of consecutive patients who underwent TAVI with CoreValve, Evolut R or Evolut PRO were included in a prospective database. RESULTS: TAVI was performed with CoreValve (n = 116), Evolut R (n = 160) or Evolut PRO (n = 92). Evolut R and Evolut PRO showed a tendency towards lower permanent pacemaker implantation (PPI) rates compared to CoreValve (CoreValve 27% vs Evolut R 16% vs Evolut PRO 18%, p = 0.091). By multivariable regression analysis CoreValve had a significantly higher risk for PPI (odds ratio (OR) 2.79, 95% confidence interval (CI) 1.31-5.94, p = 0.008) compared to Evolut R, while Evolut R and PRO were similar. Severe paravalvular leakage (PVL) occurred only with CoreValve, but no significant difference was observed in moderate PVL (10% vs 8% vs 6%, p = 0.49). CoreValve had a tendency towards a higher risk for more-than-mild PVL as compared with the Evolut platform (R + PRO) (OR 2.46, 95% CI 0.98-6.16, p = 0.055). No significant differences in all-cause mortality (7% vs 4% vs 1%, p = 0.10), stroke (6% vs 3% vs 2%, p = 0.21) or major vascular complications (10% vs 12% vs 4%, p = 0.14) were observed. CONCLUSIONS: TAVI with self-expanding valves was safe, and device iterations may result in a lower need for PPI. More-than-mild PVL seemed to occur less often with repositionable technology.

Transcatheter mitral valve repair in proportionate and disproportionate functional mitral regurgitation-insights from a small cohort study.

BACKGROUND: Functional mitral regurgitation (FMR) can be subclassified based on its proportionality relative to left ventricular function and end-diastolic volume. FMR proportionality could help identify responders to transcatheter edge-to-edge mitral valve repair (MitraClip) in terms of residual FMR and/or clinical improvement. METHODS: This single-centre retrospective cohort study evaluated the feasibility of determining FMR proportionality in symptomatic heart failure patients with reduced left ventricular function who were treated with MitraClip for ≥ moderate-to-severe FMR. Baseline proportionate (pFMR) and disproportionate FMR (dFMR) were distinguished. Patient characteristics and MitraClip procedural outcomes were described. RESULTS: From an overall cohort of 81 eligible FMR patients, 23/81 (28%) had to be excluded due to missing transthoracic echocardiogram parameters, 22/81 were excluded based on FMR severity. The remaining cohort, of 36/81 patients (44%), could be classified into dFMR (n = 26) or pFMR (n = 10). Conduction disorders were numerically increased in dFMR. All cases requiring > 2 clips were in the dFMR group and absence of FMR reduction occurred more frequently with dFMR. POINT OF VIEW/CONCLUSION: Important limitations in terms of imaging acquisition affect the translation of the FMR proportionality concept to a real-world data set. We did observe different demographic and FMR response patterns in patients with proportionate and disproportionate FMR that warrant further investigation.

Treatment decision for transcatheter aortic valve implantation: the role of the heart team : Position statement paper of the Dutch Working Group of Transcatheter Heart Interventions.

The current paper presents a position statement of the Dutch Working Group of Transcatheter Heart Valve Interventions that describes which patients with aortic stenosis should be considered for transcatheter aortic valve implantation and how this treatment proposal/decision should be made. Given the complexity of the disease and the assessment of its severity, in particular in combination with the continuous emergence of new clinical insights and evidence from physiological and randomised clinical studies plus the introduction of novel innovative treatment modalities, the gatekeeper of the treatment proposal/decision and, thus, of qualification for cost reimbursement is the heart team, which consists of dedicated professionals working in specialised centres.

An update on the use of anticoagulant therapy in ST-segment elevation myocardial infarction.

INTRODUCTION: Together with antiplatelet therapy, anticoagulants are vital to improve outcomes in patients presenting with ST-segment elevation myocardial infarction. Challenges lie in finding the optimal balance between the risk of bleeding and preventing thrombotic complications such as reinfarction or stent thrombosis. During the last decade, bivalirudin was introduced as a valid alternative to heparin for patients undergoing primary percutaneous coronary intervention. Several trials have been conducted to identify the agent with the best antithrombotic results at the lowest bleeding complication rate. In a rapidly evolving field with changes in vascular access, available P2Y12 inhibitors, and indications for glycoprotein IIb/IIIa inhibitor administration, conflicting evidence became available. AREAS COVERED: This paper mainly focuses on the evidence above and gives brief discussion to the recent literature on anticoagulation in fibrinolytic therapy and advances in antiplatelet therapy. EXPERT OPINION: To date, no robust evidence is available challenging unfractionated heparin as the primary choice for anticoagulation in patients presenting with ST-segment elevation myocardial infarction. Further research should include efforts to refine anticoagulation strategies on an individual patient level. For patients undergoing primary percutaneous coronary intervention, bivalirudin could be used as an alternative to unfractionated heparin, while enoxaparin or fondaparinux is an alternative agent for patients treated with fibrinolytic therapy.

Patient-specific computer modelling - its role in the planning of transcatheter aortic valve implantation.

Transcatheter aortic valve implantation is increasingly used to treat patients with severe aortic stenosis who are at increased risk for surgical aortic valve replacement and is projected to be the preferred treatment modality. As patient selection and operator experience have improved, it is hypothesised that device-host interactions will play a more dominant role in outcome. This, in combination with the increasing number of valve types and sizes, confronts the physician with the dilemma to choose the valve that best fits the individual patient. This necessitates the availability of pre-procedural computer simulation that is based upon the integration of the patient-specific anatomy, the physical and (bio)mechanical properties of the valve and recipient anatomy derived from in-vitro experiments. The objective of this paper is to present such a model and illustrate its potential clinical utility via a few case studies.

Are BVS suitable for ACS patients? Support from a large single center real live registry.

OBJECTIVES: To investigate one-year outcomes after implantation of a bioresorbable vascular scaffold (BVS) in patients presenting with acute coronary syndrome (ACS) compared to stable angina patients. BACKGROUND: Robust data on the outcome of BVS in the setting of ACS is still scarce. METHODS: Two investigator initiated, single-center, single-arm BVS registries have been pooled for the purpose of this study, namely the BVS Expand and BVS STEMI registries. RESULTS: From September 2012-October 2014, 351 patients with a total of 428 lesions were enrolled. 255 (72.6%) were ACS patients and 99 (27.4%) presented with stable angina/silent ischemia. Mean number of scaffold/patient was 1.55±0.91 in ACS group versus 1.91±1.11 in non-ACS group (P=0.11). Pre- and post-dilatation were performed less frequent in ACS patients, 75.7% and 41.3% versus 89.0% and 62.0% respectively (P=0.05 and P=0.001). Interestingly, post-procedural acute lumen gain and percentage diameter stenosis were superior in ACS patients, 1.62±0.65mm (versus 1.22±0.49mm, P<0.001) and 15.51±8.47% (versus 18.46±9.54%, P=0.04). Major adverse cardiac events (MACE) rate at 12months was 5.5% in the ACS group (versus 5.3% in stable group, P=0.90). One-year definite scaffold thrombosis rate was comparable: 2.0% for ACS population versus 2.1% for stable population (P=0.94), however, early scaffold thromboses occurred only in ACS patients. CONCLUSIONS: One-year clinical outcomes in ACS patients treated with BVS were similar to non-ACS patients. Acute angiographic outcomes were better in ACS than in non-ACS, yet the early thrombotic events require attention and further research.

Predictors of paravalvular aortic regurgitation following self-expanding Medtronic CoreValve implantation: the role of annulus size, degree of calcification, and balloon size during pre-implantation valvuloplasty and implant depth.

OBJECTIVES: We sought to investigate the role of balloon size during pre-implantation valvuloplasty in predicting AR and optimal Medtronic CoreValve (MCS) implantation depth. BACKGROUND: Paravalvular aortic regurgitation (AR) is common following MCS implantation. A number of anatomical and procedural variables have been proposed as determinants of AR including degree of valve calcification, valve undersizing and implantation depth. METHODS: We conducted a multicenter retrospective analysis of 282 patients who had undergone MCS implantation with prior cardiac CT annular sizing between 2007 and 2011. Native valve minimum (Dmin), maximum (Dmax) and arithmetic mean (Dmean) annulus diameters as well as agatston calcium score were recorded. Nominal and achieved balloon size was also recorded. AR was assessed using contrast angiography at the end of each procedure. Implant depth was measured as the mean distance from the nadir of the non- and left coronary sinuses to the distal valve frame angiographically. RESULTS: 29 mm and 26 mm MCS were implanted in 60% and 39% of patients respectively. The majority of patients (N=165) developed AR <2 following MCS implantation. AR ≥3 was observed in 16% of the study population. High agatston calcium score and Dmean were found to be independent predictors of AR ≥3 in multivariate analysis (P<0.0001). Nominal balloon diameter and the number of balloon inflations did not influence AR. However a small achieved balloon diameter-to-Dmean ratio (≤0.85) showed modest correlation with AR ≥3 (P=0.04). This observation was made irrespective of the degree of valve calcification. A small MCS size-to-Dmean ratio is also associated with AR ≥3 (P=0.001). A mean implantation depth of ≥8+2mm was also associated with AR ≥3. Implantation depth of ≥12 mm was associated with small MCS diameter-to-Dmean ratio and increased 30-day mortality. CONCLUSION: CT measured aortic annulus diameter and agatston calcium score remain important predictors of significant AR. Other procedural predictors include valve undersizing and low implantation depth. A small achieved balloon diameter-to-Dmean ratio might also predict AR ≥3. Our findings confirm that a small achieved balloon size during pre-implantation valvuloplasty predicts moderate-severe AR in addition to previously documented factors.