Impact of Prosthesis-Patient Mismatch After Transcatheter Aortic Valve Replacement.

BACKGROUND: Data on the long-term impact of prosthesis-patient mismatch (PPM) on outcomes after transcatheter aortic valve replacement (TAVR) remain sparse. We therefore aimed to investigate the incidence, predictive factors, and long-term prognostic impact of PPM on bioprosthesis durability and mortality. METHODS: This was a single-centre retrospective study including 2117 patients who underwent TAVR for aortic stenosis from 2002 to 2022. Moderate PPM was defined by indexed effective orifice area (iEOA) > 0.65 and ≤ 0.85 cm2/m2 (> 0.55 and ≤ 0.70 cm2/m2 if BMI ≥ 30 kg/m2) and severe PPM by an iEOA ≤ 0.65 cm2/m2 (≤ 0.55 cm2/m2 If BMI ≥ 30 kg/m2). RESULTS: There were 351 patients (16.6%) with PPM, including 39 patients (1.8%) with severe PPM and 312 patients (14.7%) with moderate PPM. The mean follow-up duration was 31.2 ± 26.5 months. Factors independently associated with the occurrence of PPM were body surface area (odds ratio [OR] 3.32, 95% confidence interval [CI] 1.32-8.35; P = 0.01), valve-in-valve TAVR (OR 6.12, 95% CI 2.29-16.08; P < 0.001), small annulus (OR 2.42, 95% CI 1.41-4.07; P = 0.001), and the use of a balloon-expandable valve (OR 4.17, 95% CI 2.17-8.33; P < 0.001). PPM was associated with increased risk of mortality (hazard ratio [HR] 1.3, 95% CI 1.1-1.5, P = 0.004) and valve thrombosis (HR 4.2, 95% CI 1.4-12.6, P = 0.01), and a trend towards increased risk of structural valve deterioration (HR 1.7, 95% CI 0.9-2.9; P = 0.08). CONCLUSIONS: The results of this study suggest that PPM has a negative long-term impact on outcomes after TAVR. These findings emphasise the importance of preventing PPM.

Safety and efficacy of NOAC vs. VKA in patients treated by PCI: a retrospective study of the FRANCE PCI registry.

Introduction: Dual antithrombotic therapy (DAT) combining oral anticoagulation (OAC), preferentially Non-vitamin K antagonist OAC (NOAC) and single antiplatelet therapy (SAPT) for a period of 6-12 months is recommended after percutaneous coronary intervention (PCI) in patients with an indication for OAC. Objective: To compare outcomes between vitamin K antagonist (VKA) and NOAC-treated patients in the nation-wide France PCI registry. Methods: All consecutive patients from the France PCI registry treated by PCI and discharged with OAC between 2014 and 2020 were included and followed one-year. Major bleeding was defined as Bleeding Academic Research Consortium (BARC) classification ≥3 and major adverse cardiac events (MACE) as the composite of all-cause mortality, myocardial infarction (MI), and ischemic stroke. A propensity-score analysis was used. Results: Of the 7,277 eligible participants, 2,432 (33.4%) were discharged on VKA and 4,845 (66.6%) on NOAC. After propensity-score adjustment, one-year major bleeding was less frequent in NOAC vs. VKA-treated participants [3.1% vs. 5.2%, -2.1% (-3.6% to -0.6%), p = 0.005 as well as the rate of MACE [9.2% vs. 11.9%, -2.7% (-5.0% to -0.4%), p = 0.02]. One-year mortality was also significantly decreased in NOAC vs. VKA-treated participants [7.4% vs. 9.9%, -2.6% (-4.7% to -0.5%), p = 0.02]. The area under ROC curves of the anticoagulant treatment propensity score was estimated at 0.93, suggesting potential indication bias. Conclusions: NOAC seems to have a better efficacy and safety profile than VKA. However, potential indication bias were found.

Subtotal Nephrectomy Associated with a High-Phosphate Diet in Rats Mimics the Development of Calcified Aortic Valve Disease Associated with Chronic Renal Failure.

Introduction. This study addressed the hypothesis that subtotal nephrectomy associated with a high-phosphorus diet (5/6Nx + P) in rats represents a suitable animal model to mimic the cardiovascular consequences of chronic kidney disease (CKD) including calcified aortic valve disease (CAVD). Indeed, the latter contributes to the high morbidity and mortality of CKD patients and sorely lacks preclinical models for pathophysiological and pharmacological studies. Methods. Renal and cardiovascular function and structure were compared between sham-operated and 5/6 Nx rats + P 10 to 12 weeks after surgery. Results. As expected, 11 weeks after surgery, 5/6Nx + P rats developed CKD as demonstrated by their increase in plasma creatinine and urea nitrogen and decrease in glomerular filtration rate, estimated by using fluorescein-isothiocyanate-labelled sinistrin, anemia, polyuria, and polydipsia compared to sham-operated animals on a normal-phosphorus diet. At the vascular level, 5/6Nx + P rats had an increase in the calcium content of the aorta; a decrease in mesenteric artery dilatation in response to a stepwise increase in flow, illustrating the vascular dysfunction; and an increase in blood pressure. Moreover, immunohistology showed a marked deposition of hydroxyapatite crystals in the aortic valve of 5/6Nx + P rats. Echocardiography demonstrated that this was associated with a decrease in aortic valve cusp separation and an increase in aortic valve mean pressure gradient and in peak aortic valve velocity. Left-ventricular diastolic and systolic dysfunction as well as fibrosis were also present in 5/6Nx + P rats. Conclusion. This study demonstrates that 5/6Nx + P recapitulates the cardiovascular consequences observed in humans with CKD. In particular, the initiation of CAVD was shown, highlighting the interest of this animal model to study the mechanisms involved in the development of aortic stenosis and test new therapeutic strategies at an early stage of the disease.

Transcatheter aortic valve implantation: The road to a minimalist "stent-like" procedure.

BACKGROUND: Since the first-in-man implantation of a transcatheter aortic stented valve in April 2002 in Rouen, the procedure has expanded worldwide. In our centre, all transfemoral procedures have been performed using local anaesthesia without transoesophageal echocardiographic monitoring. AIM: To report our experience of transfemoral arterial transcatheter aortic valve implantation (TAVI) over the last 2 decades, following the evolution of devices, practices and indications. METHODS: Between 2002 and 2021, 2097 consecutive patients had a TAVI procedure in our centre. Among them, 1780 underwent transfemoral arterial aortic valve implantation, and were subdivided into three groups according to the time period: before 2009; 2009-2014; and 2014-2021. RESULTS: Median age was 85 years, and remained unchanged over time. The mean logistic EuroSCORE gradually decreased over time (28% before 2009 vs 15% for 2009-2014 vs 11% since 2014; P<0.001). Predilatation was performed almost systematically before 2009 (93%), but was rarely performed in the last period (14%; P<0.001). Thirty-day all-cause mortality decreased over time, and was only 1.4% in 2021. Length of stay decreased considerably, with a median duration of only 2 days after the procedure, and>70% of patients were discharged home within 72hours. Similarly, procedural duration, X-ray time and contrast volume decreased over time. CONCLUSION: Transfemoral aortic valve implantation, performed as a minimalist "stent-like" procedure using only local anaesthesia, is feasible in the vast majority of patients, with excellent outcomes.

Impact of the Lubrizol factory fire in Rouen on coronary events: A retrospective study from the France PCI registry.

BACKGROUND: On 26 September 2019, an industrial fire occurred in the Lubrizol factory in Rouen (France), exposing the population to the inhalation of many volatile toxic agents secondary to combustion. AIM: To assess the impact of the Lubrizol factory fire on the incidence of coronary artery events. METHODS: All coronary angiograms performed in Rouen (exposed) and Le Havre (unexposed) from May 2019 to December 2019 were extracted from the prospective France Percutaneous Coronary Intervention (France PCI) registry. To study the impact of the fire on coronary events, an interrupted time series analysis was performed in Rouen, with adjustment on Le Havre in an autoregressive moving average (ARMA)(1,1) model with the precision of 1 week. The primary outcome was the incidence of acute coronary syndrome, and the secondary outcome was the incidence of ST-segment elevation myocardial infarction. RESULTS: The mean number of acute coronary syndromes per week in the exposed zone (Rouen) increased non-significantly from 37.5±9.4 before the fire to 43.2±6.2 after the fire, for an estimated effect of +5.5 (95% confidence interval -0.7 to 11.8; P=0.09) events per week. In municipalities exposed to the plume of smoke (subgroup of Rouen), the mean number of acute coronary syndromes increased non-significantly from 7.3±2.8 before the fire to 8.7±3.6 after the fire, for an estimated effect of +1.0 (95% confidence interval -2.0 to 4.0; P=0.51) events per week. The results were similar when taking into account only ST-segment elevation myocardial infarctions or all coronary events. CONCLUSIONS: Our study did not find a significant effect of the Lubrizol factory fire on the incidence of acute coronary syndrome. Further studies are needed to investigate the impact of industrial accidents on air pollution and coronary events.

Incidence, Predictive Factors, and Prognostic Impact of Right Ventricular Dysfunction Before Transcatheter Aortic Valve Implantation.

Right ventricular dysfunction (RVD) is considered to be a late marker of aortic stenosis. However, there is a lack of consensus regarding the incidence, prognostic impact, and evolution of RVD in patients treated with transcatheter aortic valve implantation (TAVI). All patients treated with TAVI for severe aortic stenosis were included in a prospective single-center database. Patients who had a quantitative assessment of right ventricular (RV) function including tricuspid annular plane systolic excursion (TAPSE) and/or Doppler tissue imaging-derived tricuspid lateral annular systolic velocity (S' wave) measurements were eligible for this study. RVD was defined as TAPSE <17 mm or S' <9.5 cm/s if TAPSE was not available. Between 2014 and 2019, 503 patients with RV function assessment were included. The incidence of RVD before TAVI was 18.7%. Predictors of RVD were diabetes (p = 0.03), atrial fibrillation (p = 0.001), impaired left ventricular ejection fraction (p <0.0001), left ventricular dilatation (p = 0.007), and previous cardiac surgery (p = 0.002). Long-term survival was worse in patients with RVD before TAVI compared with those without RVD (hazard ratio 1.97, 95% confidence interval 1.1 to 3.4, p = 0.01). One year after TAVI, 58.7% of patients with baseline RVD had normal RV function and had similar outcomes as compared with those without RVD at baseline. In contrast, patients with persistent RVD had the worst prognosis. In conclusion, RVD is not rare and has a deleterious prognostic impact in patients treated with TAVI. Recovery of normal RV function is frequent after TAVI, whereas persistence of RVD is associated with poor outcomes.

Standardized Measurement of Femoral Artery Depth by Computed Tomography to Predict Vascular Complications After Transcatheter Aortic Valve Implantation.

Vascular complications (VCs) are difficult to predict and remain an important issue after transfemoral (TF) transcatheter aortic valve implantation (TAVI) although their incidence has decreased with size reduction of introducers. We aimed to evaluate a standardized measurement of femoral artery depth (FAD) using computed tomography (CT) to predict VCs after TAVI. We performed a retrospective study of 679 TF TAVI patients. We evaluated a standardized CT method to measure FAD immediately above the bifurcation. Sheath-to-femoral-artery ratio (SFAR), calcification, and tortuosity were also evaluated. VCs were defined by the Valve Academic Research Consortium (VARC)-2. Receiver operating characteristic (ROC) curves were used to predict major VCs and the need for a stent-graft. The median values of FAD and SFAR were 49.0 (36.2 to 66.7) mm and 0.95 (0.81 to 1.18), respectively. Major VCs occurred in 37 (5.4%) patients and a stent-graft was required in 49 (7.1%) patients. FAD predicted the need for a stent-graft [0.61 (0.51 to 0.70), p = 0.04] but not major VCs [0.52 (0.40 to 0.63), p = 0.76]. In contrast, SFAR did not predict the need for a stent-graft [0.53 (0.43 to 0.62), p = 0.61] but predicted major VCs [0.70 (0.58 to 0.81), p = 0.001]. Calcification and tortuosity predicted neither major VCs nor the need for a stent-graft. In conclusion, the results of our study suggest that CT measurements of FAD and SFAR provide additional information to predict major VCs and the need for a femoral stent-graft after TF TAVI.