Non-Vitamin K Antagonist Versus Vitamin K Antagonist Oral Anticoagulant Agents After Transcatheter Aortic Valve Replacement.

BACKGROUND: Studies comparing long-term outcomes between non-vitamin K antagonist (VKA) oral anticoagulant agents (direct oral anticoagulant agents [DOACs]) and VKA anticoagulant agents after transcatheter aortic valve replacement (TAVR) are scarce, with conflicting results. OBJECTIVES: The aim of this study was to examine the periprocedural, short-term, and long-term safety and effectiveness of DOACs vs VKAs in patients undergoing TAVR via femoral access with concomitant indications for oral anticoagulation. METHODS: Consecutive patients undergoing transfemoral TAVR in the prospective national SwissTAVI Registry between February 2011 and June 2021 were analyzed. Net clinical benefit (a composite of all-cause mortality, myocardial infarction, stroke, and life-threatening or major bleeding) and the primary safety endpoint (a composite of life-threatening and major bleeding) were compared between the VKA and DOAC groups at 30 days, 1 year, and 5 years after TAVR. RESULTS: After 1:1 propensity score matching, 1,454 patients were available for analysis in each group. There was no significant difference in the rate of the net clinical benefit and the safety endpoints between the groups as assessed at 30 days and 1 and 5 years post-TAVR between VKAs and DOACs. VKAs were associated with significantly higher rates of 1- year (HR: 1.28; 95% CI: 1.01-1.62) and 5-year (HR: 1.25; 95% CI: 1.11-1.40) all-cause mortality. Long-term risk for disabling stroke was significantly lower in the VKA group after excluding periprocedural events (HR: 0.64; 95% CI: 0.46-0.90). CONCLUSIONS: At 5 years after TAVR, VKAs are associated with a higher risk for all-cause mortality, a lower risk for disabling stroke, and a similar rate of life-threatening or major bleeding compared with DOACs. (SwissTAVI Registry; NCT01368250).

TAVR as an Alternative to SAVR for Pure Native Aortic Regurgitation.

Although transcatheter aortic valve replacement was originally fulfilling an unmet clinical need in the elderly population suffering from tricuspid aortic valve stenosis, its use has been progressively expanded to other groups of patients. In this review, we focus on pure native aortic valve regurgitation, which is in most cases a degenerative disease and therefore frequently diagnosed in elderly patients with comorbidities. Symptoms tend to appear late in the disease, when left ventricular dilation and systolic dysfunction are associated owing to excessive volume overload. It is often combined with a dilated aortic annulus and ascending aorta. Surgical aortic valve replacement remains the criterion standard treatment for severe aortic regurgitation. However, for patients at prohibitive surgical risk, transcatheter aortic valve replacement represents an attractive alternative. Various technical challenges are the absence of calcium at the level of the annulus, which means there are no anchoring points or fluoroscopic landmarks, the difficulty of valve sizing, and the increased stroke volume secondary to the aortic regurgitation, making valve deployment more unstable than in the setting of aortic stenosis. The first-generation transcatheter valves were associated with a higher mortality rate and lower procedural success related to increased risk of paravalvular leak and valve migration requiring a second valve or annular rupture than the more recent off-label or on-label transcatheter valves. Early studies with the dedicated on-label devices showed safety and promising results and will undoubtedly serve in the future a growing number of patients with native aortic regurgitation at prohibitive risk for surgery.

Degenerated Transcatheter Aortic Valve Replacement: Investigation and Management Options.

With the expansion of transcatheter aortic valve replacement (TAVR) to younger and lower-surgical-risk patients, many younger and less comorbid patients will be treated with TAVR and are expected to have a life expectancy that will exceed the durability of their transcatheter heart valve. Consequently, the number of patients requiring reintervention will undoubtedly increase in the near future. Redo-TAVR and TAVR explantation followed by surgical aortic valve replacement are the different therapeutic options in the event of bioprosthetic valve failure and the need for reintervention. Patients often anticipate being able to benefit from a redo-TAVR in the event of bioprosthetic valve failure after TAVR, despite the lack of long-term data and the risk of unfavourable anatomy. Our understanding of the feasibility of redo-TAVR is constantly improving thanks to bench test studies and growing worldwide experience. However, much remains unknown. In clinical practice, one of the heart team's objectives is to anticipate the need to reaccess the coronary arteries and implant a second or even a third valve when life expectancy may exceed the durability of the transcatheter heart valve. In this review, we address key definitions in the diagnosis of structural valve deterioration and bioprosthetic valve failure, as well as patient selection and procedural planning for redo-TAVR to reduce periprocedural risk, optimise hemodynamic performance, and maintain coronary access. We describe the bench testing and literature in the redo-TAVR and TAVR explantation fields.

Long-Term Risk of Stroke After Transcatheter Aortic Valve Replacement: Insights From the SwissTAVI Registry.

BACKGROUND: Stroke after transcatheter aortic valve replacement (TAVR) is associated with considerable morbidity and mortality. Predictors of stroke and the long-term risk after TAVR remain incompletely understood. OBJECTIVES: The authors sought to investigate the short- and long-term incidence and predictors of stroke after TAVR in the SwissTAVI Registry. METHODS: Between February 2011 and June 2021, consecutive patients undergoing TAVR were included. Standardized stroke ratios (SSRs) were calculated to compare trends in stroke of TAVR patients with an age- and sex-matched general population in Switzerland derived from the 2019 Global Burden of Disease study. RESULTS: A total of 11,957 patients (81.8 ± 6.5 years of age, 48.0% female) were included. One-third of the patients (32.3%) had a history of atrial fibrillation, and 11.8% had a history of cerebrovascular accident. The cumulative 30-day incidence rate of stroke was 3.0%, with 69% of stroke events occurring within the first 48 hours after TAVR. The incidence of stroke was 4.3% at 1 year, and 7.8% at 5 years. Compared with an age- and sex-adjusted general population, the risk of stroke was significantly higher in the TAVR population during the first 2 years after TAVR: first year: SSR 7.26 (95% CI: 6.3-8.36) and 6.82 (95% CI: 5.97-7.79) for males and females, respectively; second year: SSR 1.98 (95% CI: 1.47-2.67) and 1.48 (95% CI: 1.09-2.02) for males and females, respectively; but returned to a comparable level to that observed in the matched population thereafter. CONCLUSIONS: Compared with an age- and sex-matched population, TAVR patients experienced a higher risk of stroke for up to 2 years after the procedure, and a comparable risk thereafter. (SwissTAVI Registry; NCT01368250).

Artificial intelligence-based opportunistic detection of coronary artery stenosis on aortic computed tomography angiography in emergency department patients with acute chest pain.

Aims: To evaluate a deep-learning model (DLM) for detecting coronary stenoses in emergency room patients with acute chest pain (ACP) explored with electrocardiogram-gated aortic computed tomography angiography (CTA) to rule out aortic dissection. Methods and results: This retrospective study included 217 emergency room patients (41% female, mean age 67.2 years) presenting with ACP and evaluated by aortic CTA at our institution. Computed tomography angiography was assessed by two readers, who rated the coronary arteries as 1 (no stenosis), 2 (<50% stenosis), or 3 (≥50% stenosis). Computed tomography angiography was categorized as high quality (HQ), if all three main coronary arteries were analysable and low quality (LQ) otherwise. Curvilinear coronary images were rated by a DLM using the same system. Per-patient and per-vessel analyses were conducted. One hundred and twenty-one patients had HQ and 96 LQ CTA. Sensitivity, specificity, positive predictive value, negative predictive value (NPV), and accuracy of the DLM in patients with high-quality image for detecting ≥50% stenoses were 100, 62, 59, 100, and 75% at the patient level and 98, 79, 57, 99, and 84% at the vessel level, respectively. Sensitivity was lower (79%) for detecting ≥50% stenoses at the vessel level in patients with low-quality image. Diagnostic accuracy was 84% in both groups. All 12 patients with acute coronary syndrome (ACS) and stenoses by invasive coronary angiography (ICA) were rated 3 by the DLM. Conclusion: A DLM demonstrated high NPV for significant coronary artery stenosis in patients with ACP. All patients with ACS and stenoses by ICA were identified by the DLM.

Restoration of Life Expectancy After Transcatheter Edge-to-Edge Mitral Valve Repair.

BACKGROUND: Survival data after mitral transcatheter edge-to-edge repair (TEER) are scarce, and its impact on predicted life expectancy is unknown. OBJECTIVES: The aim of this study was to estimate the impact of TEER on postprocedural life expectancy among patients enrolled in the MitraSwiss registry through a relative survival (RS) analysis. METHODS: Consecutive TEER patients 60 to 89 years of age enrolled between 2011 and 2018 (N = 1140) were evaluated. RS was defined as the ratio between post-TEER survival and expected survival in an age-, sex- and calendar period-matched group derived from the Swiss national 2011 to 2019 mortality tables. The primary aim was to assess 5-year survival and RS after TEER. The secondary aim was to assess RS according to the etiology of mitral regurgitation, age class and sustained procedural success over time. RESULTS: Overall, 5-year survival after TEER was 59.3% (95% CI: 54.9%-63.4%), whereas RS reached 80.5% (95% CI: 74.6%-86.0%). RS was 91.1% (95% CI: 82.5%-98.6%) in primary mitral regurgitation (PMR) and 71.5% (95% CI: 63.0%-79.3%) in secondary mitral regurgitation (SMR). Patients 80 to 89 years of age (n = 579) showed high 5-year RS (93.0%; 95% CI: 83.3%-101.9%). In this group, restoration of predicted life expectancy was achieved in PMR with a 5-year RS of 100% (95% CI: 87.9%-110.7%), whereas sustained procedural success increased the RS rate to 90.6% (95% CI: 71.3%-107.3%) in SMR. CONCLUSIONS: Mitral TEER in patients 80 to 89 years of age is able to restore predicted life expectancy in PMR, whereas in SMR with sustained procedural success, high RS estimates were observed. Our analysis suggests that successful, sustained mitral regurgitation reduction is key to survival improvement, particularly in patients 80 to 89 years of age.

Clinical Outcomes in High-Gradient, Classical Low-Flow, Low-Gradient, and Paradoxical Low-Flow, Low-Gradient Aortic Stenosis After Transcatheter Aortic Valve Implantation: A Report From the SwissTAVI Registry.

Background In view of the rising global burden of severe symptomatic aortic stenosis, its early recognition and treatment is key. Although patients with classical low-flow, low-gradient (C-LFLG) aortic stenosis have higher rates of death after transcatheter aortic valve implantation (TAVI) when compared with patients with high-gradient (HG) aortic stenosis, there is conflicting evidence on the death rate in patients with severe paradoxical low-flow, low-gradient (P-LFLG) aortic stenosis. Therefore, we aimed to compare outcomes in real-world patients with severe HG, C-LFLG, and P-LFLG aortic stenosis undergoing TAVI. Methods and Results Clinical outcomes up to 5 years were addressed in the 3 groups of patients enrolled in the prospective, national, multicenter SwissTAVI registry. A total of 8914 patients undergoing TAVI at 15 heart valve centers in Switzerland were analyzed for the purpose of this study. We observed a significant difference in time to death at 1 year after TAVI, with the lowest observed in HG (8.8%) aortic stenosis, followed by P-LFLG (11.5%; hazard ratio [HR], 1.35 [95% CI, 1.16-1.56]; P<0.001) and C-LFLG (19.8%; HR, 1.93 [95% CI, 1.64-2.26]; P<0.001) aortic stenosis. Cardiovascular death showed similar differences between the groups. At 5 years, the all-cause death rate was 44.4% in HG, 52.1% in P-LFLG (HR, 1.35 [95% CI, 1.23-1.48]; P<0.001), and 62.8% in C-LFLG aortic stenosis (HR, 1.7 [95% CI, 1.54-1.88]; P<0.001). Conclusions Up to 5 years after TAVI, patients with P-LFLG have higher death rates than patients with HG aortic stenosis but lower death rates than patients with C-LFLG aortic stenosis.

[Aortic stenosis: TAVI for all patients?] / Sténose aortique : TAVI en première intention pour tous les patients ?

Over the last 21 years, the paradigm has shifted from an initial use of TAVI for inoperable aortic stenosis cases to recognition of its benefits for all categories of patients. Since 2021, the European Society of Cardiology has recommended first-line transfemoral TAVI from the age of 75 for all categories of patients with aortic stenosis (high, intermediate, low risk). However, in Switzerland, the Federal Office of Public Health currently places a restriction on the reimbursement of low-risk patients, which is expected to be reassessed in 2023. Surgery remains the best therapeutic option for patients with an unfavorable anatomy and for those whose life expectancy exceeds the potential durability of the valve. In this article we will discuss the evidence supporting TAVI, its current indications and initial complications as well as areas for improvement to potentially further expand its indications.

Au cours des deux dernières décennies, le paradigme est passé d'une utilisation initiale du TAVI pour les cas de sténose aortique inopérables à une reconnaissance de ses bénéfices pour toutes les catégories de patients. Depuis 2021, la Société européenne de cardiologie recommande le TAVI transfémoral en première intention dès 75 ans pour toutes les catégories de patients avec sténose aortique (risque élevé, intermédiaire, bas). En Suisse, l'Office fédéral de la santé publique impose une restriction pour le remboursement des patients à bas risque, avec une réévaluation prévue durant l'année 2023. Cependant, la chirurgie garde une place particulière pour les patients avec une anatomie défavorable et pour ceux dont l'espérance de vie dépasse la durabilité potentielle de la valve. Dans cet article, nous discutons des preuves, des indications actuelles, des complications initiales du TAVI et des points à améliorer pour potentiellement étendre davantage les indications.

The Impact of Left Ventricular Performance and Afterload on the Evaluation of Aortic Valve Stenosis: A 1D Mathematical Modeling Approach.

The transaortic valvular pressure gradient (TPG) plays a central role in decision-making for patients suffering from severe aortic stenosis. However, the flow-dependence nature of the TPG makes the diagnosis of aortic stenosis challenging since the markers of cardiac performance and afterload present high physiological interdependence and thus, isolated effects cannot be measured directly in vivo. We used a validated 1D mathematical model of the cardiovascular system, coupled with a model of aortic stenosis, to assess and quantify the independent effect of the main left ventricular performance parameters (end-systolic (Ees) and end-diastolic (Eed) elastance) and principal afterload indices (total vascular resistance (TVR) and total arterial compliance (TAC)) on the TPG for different levels of aortic stenosis. In patients with critical aortic stenosis (aortic valve area (AVA) ≤ 0.6 cm2), a 10% increase of Eed from the baseline value was associated with the most important effect on the TPG (-5.6 ± 0.5 mmHg, p < 0.001), followed by a similar increase of Ees (3.4 ± 0.1 mmHg, p < 0.001), in TAC (1.3 ±0.2 mmHg, p < 0.001) and TVR (-0.7 ± 0.04 mmHg, p < 0.001). The interdependence of the TPG left ventricular performance and afterload indices become stronger with increased aortic stenosis severity. Disregarding their effects may lead to an underestimation of stenosis severity and a potential delay in therapeutic intervention. Therefore, a comprehensive evaluation of left ventricular function and afterload should be performed, especially in cases of diagnostic challenge, since it may offer the pathophysiological mechanism that explains the mismatch between aortic severity and the TPG.

Establishing a priori and a posteriori predictive models to assess patients' peak skin dose in interventional cardiology. Part 2: results of the VERIDIC project.

BACKGROUND: Optimizing patient exposure in interventional cardiology is key to avoid skin injuries. PURPOSE: To establish predictive models of peak skin dose (PSD) during percutaneous coronary intervention (PCI), chronic total occlusion percutaneous coronary intervention (CTO), and transcatheter aortic valve implantation (TAVI) procedures. MATERIAL AND METHODS: A total of 534 PCI, 219 CTO, and 209 TAVI were collected from 12 hospitals in eight European countries. Independent associations between PSD and clinical and technical dose determinants were examined for those procedures using multivariate statistical analysis. A priori and a posteriori predictive models were built using stepwise multiple linear regressions. A fourfold cross-validation was performed, and models' performance was evaluated using the root mean square error (RMSE), mean absolute percentage error (MAPE), coefficient of determination (R²), and linear correlation coefficient (r). RESULTS: Multivariate analysis proved technical parameters to overweight clinical complexity indices with PSD mainly affected by fluoroscopy time, tube voltage, tube current, distance to detector, and tube angulation for PCI. For CTO, these were body mass index, tube voltage, and fluoroscopy contribution. For TAVI, these parameters were sex, fluoroscopy time, tube voltage, and cine acquisitions. When benchmarking the predictive models, the correlation coefficients were r = 0.45 for the a priori model and r = 0.89 for the a posteriori model for PCI. These were 0.44 and 0.67, respectively, for the CTO a priori and a posteriori models, and 0.58 and 0.74, respectively, for the TAVI a priori and a posteriori models. CONCLUSION: A priori predictive models can help operators estimate the PSD before performing the intervention while a posteriori models are more accurate estimates and can be useful in the absence of skin dose mapping solutions.