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- Karason, Kristjan, 1962, et al.
(författare)
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Randomized trial of a left ventricular assist device as destination therapy versus guideline-directed medical therapy in patients with advanced heart failure. Rationale and design of the SWEdish evaluation of left Ventricular Assist Device (SweVAD) trial
- 2020
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Ingår i: European Journal of Heart Failure. - : Wiley. - 1388-9842 .- 1879-0844. ; 22:2, s. 739-50
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Tidskriftsartikel (refereegranskat)abstract
- Aims Patients with advanced heart failure (AdHF) who are ineligible for heart transplantation (HTx) can become candidates for treatment with a left ventricular assist device (LVAD) in some countries, but not others. This reflects the lack of a systematic analysis of the usefulness of LVAD systems in this context, and of their benefits, limitations and cost-effectiveness. The SWEdish evaluation of left Ventricular Assist Device (SweVAD) study is a Phase IV, prospective, 1:1 randomized, non-blinded, multicentre trial that will examine the impact of assignment to mechanical circulatory support with guideline-directed LVAD destination therapy (GD-LVAD-DT) using the HeartMate 3 (HM3) continuous flow pump vs. guideline-directed medical therapy (GDMT) on survival in a population of AdHF patients ineligible for HTx. Methods A total of 80 patients will be recruited to SweVAD at the seven university hospitals in Sweden. The study population will comprise patients with AdHF (New York Heart Association class IIIB-IV, INTERMACS profile 2-6) who display signs of poor prognosis despite GDMT and who are not considered eligible for HTx. Participants will be followed for 2 years or until death occurs. Other endpoints will be determined by blinded adjudication. Patients who remain on study-assigned interventions beyond 2 years will be asked to continue follow-up for outcomes and adverse events for up to 5 years. Conclusion The SweVAD study will compare survival, medium-term benefits, costs and potential hazards between GD-LVAD-DT and GDMT and will provide a valuable reference point to guide destination therapy strategies for patients with AdHF ineligible for HTx.
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| 3. |
- Olofsson, Mona, et al.
(författare)
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A description of characteristics of very elderly patients newly diagnosed with heart failure : a retrospective population-based cohort study in Sweden
- 2017
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Ingår i: European Journal of Heart Failure. - : European Society of Cardiology. - 1388-9842 .- 1879-0844. ; 19:S1, s. 362-362
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Tidskriftsartikel (refereegranskat)abstract
- Background and purpose: Over a quarter of patients with heart failure (HF) in Sweden are very elderly (defined as aged ≥85 years). Evidence on the demographic and clinical characteristics of these patients, and on the diagnostic procedures they receive in clinical practice, is scarce.Methods: Patients with HF were identified via electronic medical records from primary and/or secondary care in Västerbotten, linked via unique identifiers to data from the National Patient Register and Swedish Prescribed Drug Register. Local echocardiography data were used to identify patients with HF with preserved (HFpEF, ≥50%) and reduced (HFrEF, <50%) ejection fraction. Patients aged ≥18 years with ≥2 diagnoses of HF between 01/01/2010 and 31/03/2015 and an ICD-10 diagnostic code of I50 (inclusive of all granular codes), I42.0, I42.6, I42.7, I42.9, I110, I130 or I132 in any position were included. The date of the first diagnosis was the index date. ICD-10 codes were also used to identify comorbidities. A 10-year look-back period was used to exclude prevalent HF cases. Patient characteristics were assessed at index, except comorbidities (in the 5 years before index) and pre-diagnosis comedications (in the first year before index).Results: In total, 8702 patients with HF were identified; 27.7% were aged ≥85 years. Compared with patients <85 years, more patients ≥85 years were female (60.2% vs 40.6%) and fewer were overweight (BMI >25 kg/m2, 42.3% vs 63.5%). In both groups, HF was more commonly diagnosed in secondary than in primary care, but patients ≥85 years were more often diagnosed in primary care than those <85 years (31.2% vs 20.9%). Fewer patients ≥85 years than those <85 years received an echocardiogram at diagnosis (19.3% vs 42.9%); of those who did, more patients ≥85 years than <85 years had HFpEF (46.8% vs 33.4%). Patients ≥85 years had a comorbidity burden similar to those <85 years (mean number of comorbidities/patient, 2.4 vs 2.3); prevalence of atrial fibrillation (32.0% vs 30.4%), hypertension (53.2% vs 53.0%) and ischaemic heart disease (20.5% vs 22.5%) were also similar in both age groups. N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels and systolic blood pressure (BP) increased with age, and diastolic BP and estimated glomerular filtration rate decreased. Potassium and sodium levels did not differ between age groups (Table). The most common pre-diagnosis comedications were ?-blockers, antithrombotic agents and diuretics; ?-blockers were less frequently prescribed in patients ≥85 years (59.6% vs 64.4%), and antithrombotic agents and diuretics were more frequently prescribed in those ≥85 years (antithrombotic agents, 57.0% vs 54.3%; diuretics, 50.1% vs 43.1%).Conclusions: Very elderly patients with HF in Sweden are clinically different from younger patients, with a higher prevalence of HFpEF and higher NT-proBNP levels (as expected). Most importantly, very elderly patients seldom receive an echocardiogram at diagnosis.
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| 6. |
- Wikstrom, G., et al.
(författare)
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Drug treatment patterns in patients newly diagnosed with heart failure : a retrospective population-based cohort study in Sweden
- 2017
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Ingår i: European Journal of Heart Failure. - : European Society of Cardiology. - 1388-9842 .- 1879-0844. ; 19:S1, s. 55-55
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Tidskriftsartikel (refereegranskat)abstract
- Background and purpose: Limited data are available on longitudinal drug treatment patterns in newly diagnosed patients with heart failure (HF) with preserved (HFpEF), reduced (HFrEF) and unknown ejection fraction (EF) in Sweden. We evaluated drug treatment patterns in these patients based on ESC 2012 guidelines, which recommend treatment with angiotensin-converting enzyme inhibitors (ACEis), angiotensin II receptor blockers (ARBs), ?-blockers (BBs) and mineralocorticoid receptor antagonists (MRAs) for HFrEF (ESC does not make recommendations for HFpEF or unknown EF).Methods: Patients were identified via electronic medical records from primary and/or secondary care in Västerbotten, linked via unique identifiers to the National Patient Register and Swedish Prescribed Drug Register. Local echocardiography data identified HFrEF (<50%) and HFpEF (≥50%). Patients aged ≥18 years with ≥2 diagnoses of HF between 01/01/2010 and 31/03/2015 and an ICD-10 diagnostic code of I50 (inclusive of all granular codes), I42.0, I42.6, I42.7, I42.9, I110, I130 or I132 in any position were included. The date of the first diagnosis was defined as the index date. A 10-year look-back period was used to exclude prevalent HF cases. ATC codes were identified from drug prescriptions. Patients with a 4-year look-back and 2 years of follow-up were included.Results: Overall, 4357 patients were included (mean± SD age, 76.6± 12.6 years; 27.7% aged ≥85 years; HFrEF, 24.6%; HFpEF, 12.9%; unknown EF, 62.5%). At the index date, 63.0% of patients were treated with an ACEi or an ARB, 62.3% with a BB and 16.0% with an MRA; 18.5% were not receiving treatment. The most common treatment groups (monotherapy or combinations) were: ACEi + BB (HFrEF, 20.5%; HFpEF, 21.0%; unknown EF, 23.5%); BB monotherapy (HFrEF, 12.1%; HFpEF, 14.0%; unknown EF, 15.6%); and ARB + BB (HFrEF, 8.5%; HFpEF, 12.3%; unknown EF, 12.3%) (Figure). The majority of patients receiving an ACEi or ARB at the index date continued to do so for the following 2 years (ACEi, 63.6%; ARB, 60.9%); most of these were receiving doses lower than those recommended by the ESC (70.8% and 88.9%, respectively). A small proportion of patients receiving an ACEi at the index date switched to an ARB over the 2-year period (4.1%) and vice versa (2.6%). Most patients were not receiving the recommended ESC dose before switching (ACEi, 81.8%; ARB, 77.8%). Similarly, most patients who discontinued an ACEi (37.3%) or ARB (39.1%) were not receiving the recommended dose before discontinuation (ACEi, 64.8%; ARB, 87.4%).Conclusions: A large proportion of patients with HF in Sweden do not receive drug combinations recommended by the ESC. Furthermore, few patients are prescribed ESC-recommended doses of HF drugs and few undergo up-titration of treatment before switching. These findings are remarkable for HFrEF, for which guidelines are established. These findings may be partly reflective of the high proportion of elderly patients studied.
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