Thromboaspiration (TA) has been proposed as an adjunct to primary percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction (STEMI) to reduce thrombus burden. However, its effect on microvascular perfusion remains uncertain, and concerns have been raised about its potential to aggravate microvascular injury. This study aimed to evaluate the impact of TA on microvascular obstruction (MVO) using cardiac magnetic resonance imaging in a large cohort of STEMI patients. We prospectively enrolled 460 STEMI patients treated with primary PCI within 12 hours of symptom onset. TA was performed in 193 patients (42%). Cardiac magnetic resonance was performed at day 6 and 3 months to assess infarct size and MVO. A propensity score-based average treatment effect analysis was used to adjust for baseline differences. Subgroup analyses were conducted according to symptom-to-treatment time, thrombus burden (thrombolysis in myocardial infarction thrombus score), and sex. TA was independently associated with higher MVO incidence (odds ratios [OR] 1.52; 95% confidence intervals [CI]: 1.16 to 1.98; p = 0.0024) and greater MVO extent (standardized mean differences 0.42; 95% CI: 0.02 to 0.72; p = 0.041). The association was particularly significant in patients reperfused beyond 6 hours (OR 3.46; 95% CI: 1.92 to 6.23; p < 0.0001) and those with nonocclusive thrombus (thrombolysis in myocardial infarction thrombus score "1 to 4") (OR 2.23; 95% CI: 1.29 to 3.85; p = 0.004). Sex-stratified analysis showed increased MVO risk in men (OR 1.52; 95% CI: 1.14 to 2.05; p = 0.005) but not in women. TA during primary PCI was associated with increased occurrence and extent of MVO, particularly in patients with delayed reperfusion or nonocclusive thrombus. These findings reinforce current ESC guidelines against routine TA use and suggest that its application should be restricted to carefully selected patients.
OBJECTIVES:Transfemoral transcatheter aortic valve implantation (TAVI) has become the preferred approach for treating aortic stenosis in patients over 70 years. Despite advancements in technology and operator experience, major vascular complications (MVCs) remain a concern, potentially affecting outcomes. This study aimed to assess the incidence, risk factors, and clinical impact of MVCs following transfemoral TAVI using propensity score matching. METHODS:We retrospectively analysed patients who underwent transfemoral TAVI. Patients were divided into 2 groups: patients who developed MVCs (MVC group) and those who did not present the complication (No-MVC group). The primary end-point was the 30-day mortality. A 1:1 propensity score matching was performed, and clinical outcomes were compared at 30 days and up to 2 years. RESULTS:Between 2012 to 2023, a total of 2296 underwent a percutaneous-transfemoral approach. Major vascular complications occurred in 6.6% (n = 151) and were associated with increased transfusion requirement, major bleeding, reinterventions, and longer hospital stays. Female sex, obesity, higher STS score, use of the Manta closure device, and post-implantation balloon valvuloplasty were independently associated with MVCs. The 30-day mortality was similar between groups (P = .723). The long-term survival was lower in the MVC group (P = .016). Two-year survival after propensity score matching did not differ between groups (P = .08). CONCLUSIONS:Major vascular complications after transfemoral transcatheter valve implantation are associated with worse clinical outcomes and reduced long-term survival despite similar at 30-day mortality. Recognizing high-risk patients, optimizing procedural planning, and considering alternative access routes may help reduce vascular complications.
BACKGROUND:Management of degenerated aortic bioprostheses through valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) or redo surgical aortic valve replacement (Re-SAVR) shows similar short-term safety and efficacy. However, long-term survival and haemodynamic performance data are limited. AIM:To compare clinical characteristics, haemodynamics and outcomes at 3 years between ViV-TAVR and Re-SAVR techniques. METHODS:This retrospective two-centre study included 266 patients treated for isolated aortic bioprosthesis degeneration (130 Re-SAVR, 136ViV-TAVR) from 2009 to 2018, with up to 3 years of follow-up. RESULTS:The ViV-TAVR group was older (83 vs. 77 years; P=0.005) with higher surgical risk (Logistic EuroSCORE 22% vs. 13%; P=0.005). At 3 years, univariate analysis showed no significant difference in all-cause deaths (22.1% vs. 17.7%; P=0.37). ViV-TAVR was associated with fewer first-month complications, including major bleeding (11.0% vs. 52.3%; P=0.007) and acute renal failure grade 2/3 (5.1% vs. 14.6%; P=0.053). Inverse probability of treatment weighting analysis revealed no difference in all-cause deaths at 1 year (hazard ratio [HR] 0.78, 95% confidence interval [CI] 0.36-1.67; P=0.52) or between 1 and 3 years (HR 1.56, 95% CI 0.82-2.99; P=0.17). Composite events were similar at 1 year (HR 0.80, 95% CI 0.44-1.44; P=0.45) and between 1 and 3 years (HR 1.41, 95% CI 0.83-2.38; P=0.21). Mean gradients at 3 years were similar (16.1±11.4 vs. 13.2±5.3mmHg; P=0.17). In patients with small bioprostheses (true internal diameter≤20mm [n=151]), death rates at 3 years were similar (21.1% vs. 20.0%; P=0.86), as was haemodynamic performance (mean gradient 19.2±14.0mmHg for ViV-TAVR vs. 13.7±4.12mmHg for Re-SAVR [P=0.38]). Compared to balloon-expandable, self-expandable valves showed better 1-year mean gradients (16.4±10.5 vs. 13.7±4.12mmHg; P=0.012). CONCLUSIONS:ViV-TAVR and Re-SAVR had similar mortality and haemodynamic outcomes at 3 years, including in patients with small bioprostheses where self-expandable valves yielded the best results.
article: Transversus abdominis plane block for transcatheter aortic valve implantation under intravenous sedation: a retrospective single-center study - Minerva Anestesiologica 2022 March;88(3):201-3 - Minerva Medica - Journals
OBJECTIVES Using French transcatheter aortic valve replacement (TAVR) registries linked with the nationwide administrative databases, the study compared the rates of long-term mortality, bleeding, and ischemic events after TAVR in patients requiring oral anticoagulation with direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs). BACKGROUND The choice of optimal drug for anticoagulation after TAVR remains debated. METHODS Data from the France-TAVI and FRANCE-2 registries were linked to the French national health single-payer claims database, from 2010 to 2017. Propensity score matching was used to reduce treatment-selection bias. Two pri-mary endpoints were death from any cause (efficacy) and major bleeding (safety). RESULTS A total of 24,581 patients who underwent TAVR were included and 8,962 (36.4%) were treated with OAC. Among anticoagulated patients, 2,180 (24.3%) were on DOACs. After propensity matching, at 3 years, mortality (hazard ratio [HR]: 1.37; 95% confidence interval [CI]: 1.12-1.67; P < 0.005) and major bleeding including hemorrhagic stroke (HR: 1.64; 95% CI: 1.17-2.29; P < 0.005) were lower in patients on DOACs compared with those on VKAs. The rates of ischemic stroke (HR: 1.32; 95% CI: 0.81-2.15; P = 0.27) and acute coronary syndrome (HR: 1.17; 95% CI: 0.68-1.99; P = 0.57) did not differ among groups. CONCLUSIONS In these large multicenter French TAVR registries with an exhaustive clinical follow-up, the long-term mortality and major bleeding were lower with DOACs than VKAs at discharge. The present study supports preferential use of DOACs rather than VKAs in patients requiring oral anticoagulation therapy after TAVR. (J Am Coll Cardiol Intv 2021;14:1704-13) (c) 2021 Published by Elsevier on behalf of the American College of Cardiology Foundation.
Background. Abciximab (ABX) is used for acute coronary syndrome and unstable angina. Thrombocytopenia is a frequent adverse effect described as occurring in the first 24 hours. The aim of this study was to evaluate, in a context of pharmacovigilance survey, the occurrence of delayed thrombocytopenia following ABX infusion in pharmacovigilance database reports and in the literature. Methods. Individual case safety reports (ICSRs) of delayed thrombocytopenia between 3 and 30 days - with ABX presented as a single suspect were selected in VigiBase, the WHO global database of ICSRs. The French cases were then extracted from the French national pharmacovigilance database. In addition, a literature review of published cases was performed using PubMed. Results. Among the 84 ICSRs selected from VigiBasec', 43 were also reported in the FPVD. Mean age was 60.1 +12.3 years with a majority of male patients (77.4%). The average time to onset (TTO) was 8.9 5.2 days. Thrombocytopenia regressed in 5.1 2.7 days. Haemorrhagic complications were reported in 15% of ICSRs. In the French cases, the median nadir of platelet count was 28 \ 109/L (range 1-110) with a majority of grade 4 thrombocytopenia (39.5%). The literature review identified 42 cases and provided additional information on administered therapies, which include platelet units, corticosteroids, and IV immunoglobulins. GPIlb/111a-ABX complex antibodies were described in 26 published cases. Conclusion. Delayed thrombocytopenia, probably due to immune reaction, is a possible life threatening adverse effect of ABX with a mean TTO of 9 days, supporting the recommendation of a platelet count monitoring during at least two weeks. This recommendation was added to the abcximab SmPC in 2019. (C) 2021 Societe francaise de pharmacologie et de therapeutique. Published by Elsevier Masson SAS. All rights reserved.
article: Successful recovery from severe inverted Takotsubo cardiomyopathy after liver transplantation: the efficacy of extracorporeal membrane oxygenation (ECMO) - Minerva Anestesiologica 2022 March;88(3):199-201 - Minerva Medica - Journals
Background: The FRANCE-2 registry (French Aortic National Corevalve and Edwards) previously reported good early- and medium-term clinical and echocardiographic efficacy for transcatheter aortic valve replacement. We here report 5-year follow-up results from the registry. Methods: The registry includes all consecutive patients undergoing transcatheter aortic valve replacement for severe aortic stenosis in France. Follow-up is scheduled at 30 days, 6 months, then annually from 1 to 5 years. Clinical events were defined according to the Valve Academic Research Consortium criteria, and hemodynamic structural valve deterioration (SVD) was defined according to the consensus statement by the European Association of Percutaneous Cardiovascular Interventions. Results: Between January 2010 and January 2012, 4201 patients were enrolled in 34 centers. Five-year vital status was available for 95.5% of patients; 88.1% had clinical evaluation or died. Overall, at 5 years, all-cause mortality was 60.8% (n=2478; 95% CI, 59.3% to 62.3%). The majority of cardiovascular events occurred in the first month after valve implantation, and incidence remained low thereafter, at <2% per year up to 5 years, except for heart failure. The rate of heart failure was 14.3% at 1 year, then decreased over time to <5% per year. In cumulative incidence function, the rates of severe SVD and moderate/severe SVD at 5 years were 2.5% and 13.3%, respectively. Mortality did not differ between patients with or without severe SVD (hazard ratio, 0.71; 95% CI, 0.47–1.07; P =0.1). Finally, in the population of patients with severe SVD, 1 patient (1.7%) experienced a stroke, and 8 patients presented ≥1 heart failure event (13.3%). Conclusions: The 5-year follow-up results of the FRANCE-2 registry represent the largest long-term data set available in a high-risk population. In surviving patients, the low rate of clinical events and the low level of SVD after 1 year support the long-term efficacy of transcatheter aortic valve replacement in both types of transcatheter prosthesis featuring in the registry.
A 76-year-old woman with degenerative mitral valve disease was referred for refractory heart failure. An echocardiogram showed the presence of a massive mitral annular calcification with severe stenosis (mitral valve area, 1.0 cm2; mean gradient, 11 mm Hg) and a small left ventricular cavity with a
TAVI offers an attractive option for patients with failed bioprosthesis and high operative risk (valve-in-valve concept). The objective of this study was to analyze outcomes of patients with failed aortic bioprosthesis undergoing transcatheter aortic valve-in-valve implantation. From January 2012 to January 2015, 15 patients with degenerated aortic valve bioprosthesis underwent transcatheter aortic valve-in-valve implantation in our institution. Mean patient age was 82±6 years. Mean logistic Euroscore was 36±16% and mean STS score was 16±14%. The mean follow-up was 260±316 days. The failing bioprosthesis were Cryolife O’brien in 5 patients, Carpentier Edwards in 5 patients, Medtronic mosaic in 4 patients and Mitroflow in 1 patient. Bioprosthesis mode of failure was stenosis (n=6), regurgitation (n=5), or combined stenosis and regurgitation (n=4). The mean degenerative time was 11.15±6.1 years. Implanted devices included Medtronic CoreValve (n=6) and Edwards SAPIEN (n=9). Successful implantation of a transcatheter aortic valve-in-valve with the patient leaving the catheterization laboratory alive was achieved in all patients. Adverse procedural outcomes included initial device malposition in 3 cases requiring a second valve, retroperitoneal hematoma in 1 patient, permanent pacemaker in 1 patient, Stroke in 1 patient and acute renal failure in 1 patient. The mean transvalvular gradient passed from 48.7±17.63 to 18.32±9.3mmHg in stenotic degenerated bioprosthesis. No significant aortic regurgitation was observed post-implantation. During hospitalization, 1 patient developed myocardial infarction. The medium inhospital stay was 13.4±7.7 days. During later follow-up, there was no death, no myocardial infarction and no stroke or TIA. 2 patients were hospitalized for heart failure. Transcatheter aortic valve-in-valve implantation seems to be feasible and safe in both stenotic and regurgitant degenerative bioprosthesis.
BACKGROUND:Benefit of β-blockers (BB) and angiotensin-converting-enzyme inhibitors (ACEI) on mortality following acute myocardial infarction (MI) is well demonstrated. This study assessed the impact of BB and ACEI doses administered following ST-elevation MI on mortality and outcome up to 1 year. METHODS AND RESULTS: The French prospective observational cohort "RIMA" included 1,461 MI patients. Dosing of BB and ACEI given at 24 h and at time of discharge was assessed as follows: no treatment; <50% of target dose; or ≥50% of target dose. For in-hospital mortality, after MI, the use of BB in the first 24 h, but not ACEI, was associated with significantly lower event rate on multivariate analysis (OR, 5.78; 95% CI: 2.62-12.76, P<0.001). In contrast at 1 year, use of higher doses of ACEI, but not BB, was associated with significantly lower CV mortality, readmission for heart failure and the composite of CV mortality and readmission for heart failure (HR, 2.65; 95% CI: 1.32-5.31, P=0.006 for absence of ACEI at discharge).CONCLUSIONS:Prescription of BB in the first 24 h was independently associated with a lower in-hospital mortality following MI. There appeared to be a significant dose effect on outcome with regard to <50% vs. ≥50% of target dose, which requires confirmation in further large-scale clinical studies.
Local ischemic postconditioning (IPost) and remote ischemic perconditioning (RIPer) are promising cardioprotective therapies in ST-elevation myocardial infarction (STEMI). We aimed: (1) to investigate whether RIPer initiated at the catheterization laboratory would reduce infarct size, as measured using serum creatine kinase-MB isoenzyme (CK-MB) release as a surrogate marker; (2) to assess if the combination of RIPer and IPost would provide an additional reduction. Patients (n = 151) were randomly allocated to one of the following groups: (1) control group, percutaneous transluminal coronary angioplasty (PTCA) alone; (2) RIPer group, PTCA combined with RIPer, consisting of three cycles of 5-min inflation and 5-min deflation of an upper-arm blood-pressure cuff initiated before reperfusion; (3) RIPer+IPost group, PTCA combined with RIPer and IPost, consisting of four cycles of 1-min inflation and 1-min deflation of the angioplasty balloon. The CK-MB area under the curve (AUC) over 72 h was reduced in RIPer, and RIPer+IPost groups, by 31 and 29 %, respectively, compared to the Control group; however, CK-MB AUC differences between the three groups were not statistically significant (p = 0.06). Peak CK-MB, CK-MB AUC to area at risk (AAR) ratio, and peak CK-MB level to AAR ratio were all significantly reduced in the RIPer and RIPer+IPost groups, compared to the Control group. On the contrary, none of these parameters was significantly different between RIPer+IPost and RIPer groups. To conclude, starting RIPer therapy immediately prior to revascularization was shown to reduce infarct size in STEMI patients, yet combining this therapy with an IPost strategy did not lead to further decrease in infarct size.
Background Preclinical studies and pilot clinical trials have shown that high-dose erythropoietin (EPO) reduces infarct size in acute myocardial infarction. We investigated whether a single high-dose of EPO administered immediately after reperfusion in patients with ST-segment elevation myocardial infarction (STEMI) would limit infarct size.Methods A total of 110 patients undergoing successful primary coronary intervention for a first STEMI was randomized to receive standard care either alone (n = 57) or combined with intravenous administration of 1,000 U/kg of epoetin beta immediately after reperfusion (n = 53). The primary end point was infarct size assessed by gadolinium-enhanced cardiac magnetic resonance after 3 months. Secondary end points included left ventricular (LV) volume and function at 5-day and 3-month follow-up, incidence of microvascular obstruction (MVO), and safety.Results Erythropoietin significantly decreased the incidence of MVO (43.4% vs 65.3% in the control group, P = .03) and reduced LV volume, mass, and function impairment at 5-day follow-up (all P < .05). After 3 months, median infarct size (interquartile range) was 17.5 g (7.6-26.1 g) in the EPO group and 16.0 g (9.4-28.2 g) in the control group (P = .64); LV mass, volume, and function were not significantly different between the 2 groups. The same number of major adverse cardiac events occurred in both groups.Conclusions Single high-dose EPO administered immediately after successful reperfusion in patients with STEMI did not reduce infarct size at 3-month follow-up. However, this regimen decreased the incidence of MVO and was associated with transient favorable effects on LV volume and function. (Am Heart J 2012;163:200-207.e1.)
To determine the prognostic significance of systolic wall stress (SWS) after reperfused acute myocardial infarction (AMI) using MRI.
Right ventricular (RV) dysfunction is a predictor of poor outcome in patients with heart disease. Conventional imaging modalities fail to assess RV volumes accurately. We sought to assess the accuracy and reproducibility of routine breath-hold gradient echo magnetic resonance imaging (MRI)-derived RV mass, volumes and function. We assessed (1) The accuracy of in vivo MRI-derived RV mass in comparison to the RV weight in 9 minipigs. (2) Intra- and inter-observer reproducibility of RV mass, end-diastolic (EDV) and end-systolic (ESV) volumes and ejection fraction (EF) in 15 normal volunteers and 10 patients with heart disease. (3) Inter-study reproducibility of the former parameters in 25 coronary artery disease patients. (4) The correlation between right and left ventricular stroke volumes in the total population. Strong statistically significant correlations were found between: (1) MRI-derived RV mass and RV weight (r = 0.98, bias = 2.5 g), (2) Intra-observer measurements of RV mass (r = 0.96, bias = 0.5 g), EDV (r = 0.99, bias = -1.5 ml), ESV (r = 0.98, bias = 0.1 ml) and EF (r = 0.92, bias = -1.4%), (3) Inter-observer measurements of RV mass (r = 0.95, bias = 1.1 g), EDV (r = 0.98, bias = -1.1 ml), ESV (r = 0.98, bias = 1.2 ml) and EF (r = 0.87, bias = -1.9%), (4) Inter-study measurements of RV mass (r = 0.91, bias = -0.1 g), EDV (r = 0.96, bias = 3.8 ml), ESV (r = 0.98, bias = 0.3 ml) and EF (r = 0.90, bias = 0.9%), (5) MRI-derived right and left ventricular stroke volumes (r = 0.87). The assessment of the RV mass, volumes and function by routine breath-hold gradient echo MRI is accurate and highly reproducible. The correlation between left and RV MRI-derived stroke volumes indicates excellent coherence of simultaneous bi-ventricular volume measurements.