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von Haehling, Stephan; Doehner, Wolfram; Evertz, Ruben; Garfias-Veitl, Tania; Derad, Carlotta; Diek, Monika; Karakas, Mahir; Birkemeyer, Ralf; Fillippatos, Gerasimos; Lainscak, Mitja; Butler, Javed; Ponikowski, Piotr; Böhm, Michael; Friede, Tim; Anker, Stefan D
doi: 10.1093/eurheartj/ehae479pmid: 39185895
Background and AimsEvidence is lacking that correcting iron deficiency (ID) has clinically important benefits for patients with heart failure with preserved ejection fraction (HFpEF).MethodsFAIR-HFpEF was a multicentre, randomized, double-blind trial designed to compare intravenous ferric carboxymaltose (FCM) with placebo (saline) in 200 patients with symptomatic HFpEF and ID (serum ferritin < 100 ng/mL or ferritin 100–299 ng/mL with transferrin saturation < 20%). The primary endpoint was change in 6-min walking test distance (6MWTD) from baseline to week 24. Secondary endpoints included changes in New York Heart Association class, patient global assessment, and health-related quality of life (QoL).ResultsThe trial was stopped because of slow recruitment after 39 patients had been included (median age 80 years, 62% women). The change in 6MWTD from baseline to week 24 was greater for those assigned to FCM compared to placebo [least square mean difference 49 m, 95% confidence interval (CI) 5–93; P = .029]. Changes in secondary endpoints were not significantly different between groups. The total number of adverse events (76 vs. 114) and serious adverse events (5 vs. 19; rate ratio 0.27, 95% CI 0.07–0.96; P = .043) was lower with FCM than placebo.ConclusionsIn patients with HFpEF and markers of ID, intravenous FCM improved 6MWTD and was associated with fewer serious adverse events. However, the trial lacked sufficient power to identify or refute effects on symptoms or QoL. The potential benefits of intravenous iron in HFpEF with ID should be investigated further in a larger cohort.
Kittipibul, Veraprapas; Mentz, Robert J
doi: 10.1093/eurheartj/ehae490pmid: 39185864
Graphical AbstractGraphical AbstractTreatment effects on exercise capacity and quality of life in contemporary intravenous iron therapy or heart failure with preserved ejection fraction (HFpEF) trials Estimated differences in changes from baseline to follow-up in 6-min walk test distance (6MWTD) and the Kansas City Cardiomyopathy Questionnaire (KCCQ) scores between patients receiving treatment vs. placebo from recent randomized controlled trials evaluating intravenous iron therapy or other treatments in HFpEF. The top bars of each assessment represent baseline values and the lower bars represent the estimated differences in changes from baseline. Only the trials that report both values are presented. The HEART-FID study does not report KCCQ scores.13 Patient characteristics and baseline values reflect those of the treatment group. Assessments of 6MWTD and KCCQ scores were conducted at various time points as specified. FCM, ferric carboxymaltose; HFpEF, heart failure with preserved ejection fraction; HFrEF, heart failure with reduced ejection fraction; NA, not available
Jørgensen, Troels Højsgaard; Thyregod, Hans Gustav Hørsted; Savontaus, Mikko; Willemen, Yannick; Bleie, Øyvind; Tang, Mariann; Niemela, Matti; Angerås, Oskar; Gudmundsdóttir, Ingibjörg J; Sartipy, Ulrik; Dagnegaard, Hanna; Laine, Mika; Rück, Andreas; Piuhola, Jarkko; Petursson, Petur; Christiansen, Evald H; Malmberg, Markus; Olsen, Peter Skov; Haaverstad, Rune; Sondergaard, Lars; De Backer, Ole; ,
doi: 10.1093/eurheartj/ehae331pmid: 38747246
Background and AimsTranscatheter aortic valve implantation (TAVI) has become the first choice to treat older patients with severe symptomatic aortic stenosis (AS). This study aimed to compare TAVI with surgery in low-risk patients ≤75 years of age, including both tricuspid and bicuspid AS.MethodsThe Nordic Aortic Valve Intervention (NOTION)-2 trial enrolled and 1:1 randomized low-risk patients aged ≤75 years with severe symptomatic AS to TAVI or surgery. The primary endpoint was a composite of all-cause mortality, stroke, or rehospitalization (related to the procedure, valve, or heart failure) at 12 months.ResultsA total of 370 patients were enrolled with a mean age of 71.1 years and a median Society of Thoracic Surgeons risk score of 1.1%. A total of 100 patients had bicuspid AS. The 1-year incidence of the primary endpoint was 10.2% in the TAVI group and 7.1% in the surgery group [absolute risk difference 3.1%; 95% confidence interval (CI), −2.7% to 8.8%; hazard ratio (HR) 1.4; 95% CI, 0.7–2.9; P = .3]. Patients with TAVI, when compared to surgery, had lower risk of major bleeding and new-onset atrial fibrillation and higher risk of non-disabling stroke, permanent pacemaker implantation, and moderate or greater paravalvular regurgitation. The risk of the primary composite endpoint was 8.7% and 8.3% in patients with tricuspid AS (HR 1.0; 95% CI, 0.5–2.3) and 14.3% and 3.9% in patients with bicuspid AS (HR 3.8; 95% CI, 0.8–18.5) treated with TAVI or surgery, respectively (P for interaction = .1).ConclusionsAmong low-risk patients aged ≤75 years with severe symptomatic AS, the rate of the composite of death, stroke, or rehospitalization at 1 year was similar between TAVI and surgery. Transcatheter aortic valve implantation outcomes in young bicuspid AS patients warrant caution and should be further investigated. (NOTION-2, ClinicalTrials.gov, NCT02825134).Trial Registration numberClinicalTrials.gov NCT02825134.
Schofer, Niklas; Blankenberg, Stefan
doi: 10.1093/eurheartj/ehae537pmid: 39235157
Graphical AbstractGraphical AbstractTreatment decision support in patients with severe aortic stenosis younger than 75 years of age.
Mascherbauer, Julia; Kammerlander, Andreas; Nitsche, Christian; Bax, Jeroen; Delgado, Victoria; Evangelista, Arturo; Laroche, Cecile; Maggioni, Aldo Pietro; Magne, Julien; Vahanian, Alec; Iung, Bernard
doi: 10.1093/eurheartj/ehae523pmid: 39212374
Background and AimsTo assess sex differences in disease characteristics and treatment of patients with severe native valvular heart disease (VHD) included in the VHD II EURObservational Research Programme.MethodsA total of 5219 patients were enrolled in 208 European and North African centres and followed for 6 months [41.2% aortic stenosis (AS), 5.3% aortic regurgitation (AR), 4.5% mitral stenosis (MS), 21.3% mitral regurgitation (MR), 2.7% isolated right-sided VHD, 24.9% multiple left-sided VHD]. Indications for intervention were considered concordant if corresponding to class I recommendations specified in the 2012 ESC or 2014 AHA/ACC VHD guidelines.ResultsOverall, women were older, more symptomatic, and presented with a higher EuroSCORE II. Bicuspid aortic valve and AR were more prevalent among men while mitral disease, concomitant tricuspid regurgitation (TR), and AS above age 65 were more prevalent among women. On multivariable regression analysis, concordance with recommended treatment was significantly poorer in women with MS and primary MR (both P < .001). Age, patient refusal, and decline of symptoms after conservative treatment were reported significantly more often as reasons to withhold the intervention in females. Concomitant tricuspid intervention was performed at a similar rate in both sexes although prevalence of significant TR was significantly higher in women. In-hospital and 6-month survival did not differ between sexes.Conclusions(i) Valvular heart disease subtype varied between sexes; (ii) concordance with recommended intervention for MS and primary MR was significantly lower for women; and (iii) survival of men and women was similar at 6 months.
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