Oxidative Stress in Structural Valve Deterioration : A Longitudinal Clinical Study

The cause of structural valve deterioration (SVD) is unclear. Therefore, we investigated oxidative stress markers in sera from patients with bioprosthetic heart valves (BHVs) and their association with SVD. Blood samples were taken from SVD (Phase A) and BHV patients during the first 24 (Phase B1) and >48 months (Phase B2) after BHV implantation to assess total antioxidant capacity (TAC), malondialdehyde (MDA), and nitrotyrosine (NT). The results show that MDA levels increased significantly 1 month after surgery in all groups but were higher at 6 months only in incipient SVD patients. NT levels increased gradually for the first 24 months after implantation in the BHV group. Patients with transcatheter aortic valve implantation (TAVI) showed even higher levels of stress markers. After >48 months, MDA and NT continued to increase in BHV patients with a further elevation after 60-72 months; however, these levels were significantly lower in the incipient and established SVD groups. In conclusion, oxidative stress may play a significant role in SVD, increasing early after BHV implantation, especially in TAVI cases, and also after 48 months' follow-up, but decreasing when SVD develops. Oxidative stress potentially represents a target of therapeutic intervention and a biomarker of BHV dysfunctio

Structural valve deterioration of bioprosthetic heart valves

Avec une prévalence de plus de 2% des patients âgés de plus de 65 ans, la maladie valvulaire aortique est la principale maladie valvulaire de l’adulte, avec plus de 200000 remplacements valvulaires réalisés chaque année dans le monde. La détérioration valvulaire aortique (SVD) reste le problème majeur des bioprothèses implantées. Cependant, en raison d’une méthodologie inadaptée, son incidence peut parfois être sousestimée. Ainsi, la prothèse SORIN Mitroflow® (modèles LX/12A) semble poser problèmes avec plusieurs cas décrits de SVD précoces. Son incidence reste cependant incertaine. Nous avons cherché ici à estimer son incidence réelle, les facteurs de risque de SVD, et l’impact de la SVD sur la survie des patients. Nous avons tout d’abord utilisé un modèle de Cox étendue, modèle le plus souvent utilisé dans la littérature, et nous avons reporté une incidence anormale de SVD qui était retrouvé comme un facteur important de mortalité. Le Mismatch Patient-Prothèse restant débattu dans la littérature comme facteur de risque potentiel de SVD, un modèle original utilisant les scores de propension au sein d’un modèle multi-état, a été proposé pour confirmer ou non cette hypothèse. Enfin, après une extension du suivi, nous proposons une analyse multivariée au sein d’un modèle multi-états de type illness-death pour une estimation moins biaisée de l’incidence et de l’impact de la SVD dans notre cohorte.With a prevalence of 2% of patients older than 65 years old, the aortic valve stenosis is the main valvular heart disease with more than 200000 aortic valve replacement worldwide. The structural valve deterioration (SVD) remains the major flaw of implanted bioprostheses. However, due to methodological pitfalls observed in the current literature, its incidence may be underestimated. As an example, a true concern appeared lately concerning the Mitroflow® valve (SORIN group, Model LX/12A), with very early SVD observed in serval centers. Indeed, the true incidence of SVD for this valve remained unclear in the literature. We sought here to assess precisely the SVD incidence, the associated risk factors, and its impact on the patient survival. First, we used a extended Cox model, as the more frequent model used in published studies, and we reported an unusual and early SVD rate. Secondly, the Patient-Prosthesis Mismatch is still debated as a risk factor of SVD and we carried out an original model using propensity scores (IPW: Inverse probability weighting) in a multistate model to answer this question. At last, with an updated follow-up, we handled the intervalcensoring and competing risk through a multivariable illness-death model for interval censored data in order to get a better estimation of the true incidence of SVD and its impact in our cohort

Structural Valve Deterioration of Bioprosthetic Aortic Valves: An Underestimated Complication

International audienceOBJECTIVES: Structural valve deterioration (SVD) remains a major bioprosthesis-related complication, as recently described for the Mitroflow~valve (models LX and 12A) (LivaNova, London, United Kingdom). The real incidence of the SVD risk remains unclear, often due to methodologic pitfalls by systematically using the Kaplan-Meier estimator and/or the Cox model. In this report, we propose for the first time a precise statistical modeling of this issue. METHODS: Five hundred sixty-one patients who underwent aortic valve replacement with the aortic Mitroflow valve between 2002 and 2007 were included. We used an illness-death model for interval-censored data. Median follow-up was 6.6~years; 103 cases of SVD were diagnosed. RESULTS: The 4-year and 7-year SVD cumulative incidences after the first anniversary of surgery were 15.2% (95% confidence interval, 11.9-19.1) and 31.0% (95% confidence interval, 25.8-37.2), respectively. Female gender, dyslipidemia, chronic obstructive pulmonary disease, and severe patient-prosthesis mismatch were significant risk factors of SVD. The occurrence of SVD was associated with a 2-fold increase in the risk of death. CONCLUSIONS: Appropriate statistical models should be used to avoid underestimating the SVD complication associated with worse long-term survival

Romiplostim as a Transfusion Saving Strategy in 20 Patients after Heart or Lung Transplantation: A Single Centre before-after Pilot Study

International audienceBACKGROUND: Thrombocytopenia is a common disorder after heart or lung transplantation. Platelet transfusion is often required to maintain haemostasis but represents a specific cause of morbidity and mortality in this setting including alloimmunisation and graft rejection. STUDY DESIGN AND METHODS: As part of a health-care quality improvement project, in a single-centre before-after pilot study, the relevance of a platelet transfusion saving strategy based on romiplostim administration after transplantation was assessed in patients with platelet count <100\,\texttimes\,109/L. Transfusions on days 28 and 90 were compared using propensity matched score for adjustment of demographic characteristics at baseline. The primary outcome was platelet transfusion until day 28 after transplantation. RESULTS: Ninety-three patients were analysed (73 before vs. 20 after). The median [interquartile range] number of platelet concentrate was 1 [0;4.0] before versus 0.5 [0;2.0] in the after period, mean difference 0.5 confidence interval 95% [-0.7 to 1.7], p\,=\,0.39. On day 28, median [interquartile range] red blood cell transfusion was significantly higher in the before versus the after period, 7 [2.0;13.5] versus 6 [1.5;8.5], mean difference 3.2 CI 95% [0.4-6.0], p\,=\,0.02. At 6\,months, the rate of patients with de novo anti-human leukocyte antigen alloimmunisation was 45% before versus 53% in the after period (p\,=\,0.56). Deep venous thrombosis was detected in nine patients (12%) before versus seven patients (35%) in the after period (p\,=\,0.04). CONCLUSION: Romiplostim did not significantly reduce platelet transfusion after heart or lung transplantation. Its relevance and safety in a global transfusion strategy remains to be studied in this setting in a large randomised study

High-Flow Therapy by Nasal Cannulae Versus High-Flow Face Mask in Severe Hypoxemia After Cardiac Surgery: A Single-Center Randomized Controlled Study-The HEART FLOW Study

International audienceOBJECTIVE: To determine whether high-flow oxygen therapy by nasal cannulae (HFNC) is more effective than a high-flow face mask (HFFM) in severe hypoxemia. DESIGN: Randomized, single-center, open-labeled, controlled trial. SETTING: University Hospital of Nantes, France. PARTICIPANTS: Cardiac surgery patients presenting oxygen saturation <96% with Venturi mask 50%. INTERVENTION: Oxygenation by HFNC (45 L/min, FIO2 100%) or Hudson RCI non-rebreather face mask with a reservoir bag (15 L/min). MEASUREMENTS AND MAIN RESULTS: The co-primary outcomes were the PaO2/FIO2 ratio at 1 and 24 hours. In the intent-to-treat analysis (90 patients), the mean (standard deviation) PaO2/FIO2 ratios were: after 1 hour, 113.4 (50.2) in HFFM versus 137.8 (57.0) in HFNC (mean difference 24.4, CI 97.5% [2.9-45.9], p = 0.03), and after 24 hours, 106.9 (62.6) in HFFM versus 129.9 (54.0) in HFNC (mean difference 23.0, CI 97.5% [1.5-44.6], p = 0.04). After adjustment on baseline PaO2/FIO2, this difference persisted at 24 hours (p = 0.04). For secondary outcomes, the PaO2/FIO2 ratio after 6 hours was 108.7 (47.9) in HFFM versus 136.0 (45.2) in HFNC (p = 0.01), without difference after 48 hours (p = 0.95). Refractory hypoxemia requiring noninvasive ventilation occurred in 13 (28%) patients in HFNC versus 24 (56%) patients in HFFM (p = 0.007). The HFNC improved satisfaction (p = 0.0002) and reduced mucus dryness (p = 0.003) compared with HFFM. CONCLUSION: In patients with severe hypoxemia after cardiac surgery, PaO2/FIO2 at 1 and 24 hours were higher and the use of noninvasive ventilation was reduced in HFNC compared with HFFM

Success of Thrombectomy in Management of Ischemic Stroke in Two Patients with SynCardia Total Artificial Heart in Bridge-to-Transplantation

Introduction: Circulatory assistance from a SynCardia Total Artificial Heart (SynCardia-TAH) is a reliable bridge-to-transplant solution for patients with end-stage biventricular heart failure. Ischemic strokes affect about 10% of patients with a SynCardia-TAH. We report for the first time in the literature two successful thrombectomies to treat the acute phase of ischemic stroke in two patients treated with a SynCardia-TAH in the bridge-to-transplant (BTT). Case report: We follow two patients with circulatory support from a SynCardia-TAH in the bridge-to-transplant for terminal biventricular cardiac failure with ischemic stroke during the support period. An early in-hospital diagnosis enables the completion of a mechanical thrombectomy within the first 6 h of the onset of symptoms. There was no intracranial hemorrhagic complication during or after the procedure and the patients fully recovered from neurological deficits, allowing a successful heart transplant. Conclusion: This case report describes the possibility of treating ischemic strokes under a SynCardia-TAH by mechanical thrombectomy following the same recommendations as for the general population with excellent results and without any hemorrhagic complication during or after the procedure

Carotid versus femoral access for transcatheter aortic valve replacement: comparable results in the current era

International audienceAbstract OBJECTIVES The carotid approach for transcatheter aortic valve replacement (TAVR) has been shown to be feasible and safe. The goal of this study was to compare the 30-day outcomes of trans-carotid (TC) and transfemoral (TF) TAVR. METHODS This retrospective study enrolled 500 consecutive patients treated by TC-TAVR (n = 100) or TF-TAVR (n = 400) with percutaneous closure between January 2018 and January 2020 at the Nantes University Hospital. The primary end-point was the occurrence of cardiovascular death and cerebrovascular events at 30 days. RESULTS The mean age was 79.9 ± 8.1 in the TC group and 81.3 ± 6.9 (P = 0.069) in the TF group. The TC group had more men (69% vs 50.5%; P = 0.001) and more patients with peripheral vascular disease (86% vs 14.8%; P &lt; 0.0001). Cardiac characteristics were similar between the groups, and the EuroSCORE II was 3.8 ± 2.6% vs 4.6 ± 6.0%, respectively (P = 0.443). The 30-day mortality was 2% in the TC group versus 1% in the TF group (P = 0.345). TC-TAVR was not associated with an increased risk of stroke (2% vs 2.5%; P = 0.999) or major vascular complications (2% vs 4%; P = 0.548). More permanent pacemakers were implanted in the TF group (14.9% vs 5.6%; P = 0.015), and no moderate or severe aortic regurgitation was observed in the TC group (0 vs 3.3%; P = 0.08). TC-TAVR was not associated with an increased risk of mortality or stroke at 30 days (odds ratio 1.32; 95% confidence interval 0.42–4.21; P = 0.63) in the multivariable analysis. CONCLUSIONS No statistically significant differences between TC-TAVR and TF-TAVR were observed; therefore, TC-TAVR should be the first alternative in patients with anatomical contraindications to the femoral route

AORTLANTIC: French registry of aortic valve-sparing root replacement, preliminary multicenter results from Western France

International audienceOBJECTIVES: Aortic root aneurysms often affect younger patients in whom valve-sparing surgery is challenging. Amongst current techniques, aortic valve-sparing root replacement described by Tirone David has shown encouraging results. The AORTLANTIC registry was instituted for a multicentre long-term evaluation of this procedure. The current initial study evaluates the hospital outcomes of the procedure. MATERIAL AND METHOD: This is a retrospective study of patients operated between January 01, 2004, and December 31, 2020, in 6 hospitals in western France. All study data were recorded in the national digital database of the French Society of Cardiac Surgery: EPICARD. RESULTS: 524 consecutive patients with a mean age of 53(15.1) years underwent surgery. 13% (n = 68) patients presented with acute aortic dissection, 16.5% (n = 86) had associated connective tissue pathology and 7.3% (n = 37) had bicuspid aortic valves. Preoperative aortic regurgitation ≥ 2/4 was present in 65.3% (n = 341) of patients. Aortic valvuloplasty was required in 18.6% (n = 95) patients. At discharge, 92.8% (n = 461) patients had no or 1/4 aortic regurgitation. The stroke rate was 1.9% (n = 10). Intra-hospital mortality was 1.9% (n = 10). CONCLUSION: The AORTLANTIC registry includes 6 centers in western France with more than 500 patients. Despite numerous complex cases (acute aortic dissections, bicuspid aortic valves, preoperative aortic regurgitation), aortic valve-sparing root replacement has a low intra-hospital mortality. The initial encouraging results of this multicentre study warrant further long-term evaluation by future studies. CLINICAL REGISTRATION NUMBER: Nov 2021: This registry was approved by an ethics committee mandated by the CNIL (Commission Nationale de l’Informatique et des Libertés) to approve scientific projects of the Nantes Hospital Centre

Oxidative Stress in Structural Valve Deterioration: A Longitudinal Clinical Study

International audienceThe cause of structural valve deterioration (SVD) is unclear. Therefore, we investigated oxidative stress markers in sera from patients with bioprosthetic heart valves (BHVs) and their association with SVD. Blood samples were taken from SVD (Phase A) and BHV patients during the first 24 (Phase B1) and >48 months (Phase B2) after BHV implantation to assess total antioxidant capacity (TAC), malondialdehyde (MDA), and nitrotyrosine (NT). The results show that MDA levels increased significantly 1 month after surgery in all groups but were higher at 6 months only in incipient SVD patients. NT levels increased gradually for the first 24 months after implantation in the BHV group. Patients with transcatheter aortic valve implantation (TAVI) showed even higher levels of stress markers. After >48 months, MDA and NT continued to increase in BHV patients with a further elevation after 60–72 months; however, these levels were significantly lower in the incipient and established SVD groups. In conclusion, oxidative stress may play a significant role in SVD, increasing early after BHV implantation, especially in TAVI cases, and also after 48 months’ follow-up, but decreasing when SVD develops. Oxidative stress potentially represents a target of therapeutic intervention and a biomarker of BHV dysfunction