Search

Background: Women present specific risks for transcatheter aortic valve replacement (TAVI) but there are scarce sex-based analysis. The aim of this study was to explore the risk of vascular/bleeding complications in females vs. males that underwent TAVI and the impact of red blood cell (RBC) transfusion., Methods: TRITAVI-Women is a retrospective analysis in 13 European institutions. Propensity score based on pairs of different sex was performed and global outcomes, vascular/bleeding risk factors were determined. Afterwards, the female population of the study was divided into two groups according to the need of RBC transfusion and the risk for mortality, AKI, MI, stroke at 30-days and at 1-year were compared as a combined endpoint (primary endpoint) and separately (secondary endpoints)., Results: The global study population included 5837 patients. Females presented more advanced NYHA class, chronic kidney disease, and baseline anemia. Vascular/bleeding complications and RBC transfusion were more common in women. However, 1-year mortality was lower for women in the matched cohort (8.1% vs.10.3%, p = 0.028). The need for RBC transfusion was an independent predictor of higher incidence of the primary endpoint at 30-day and 1-year. The main predictor of RBC transfusion in women was the presence of baseline anemia., Conclusions: Women present lower risk of mortality than men at 1-year follow up, but not at 30-day due to higher rates of vascular/bleeding complications. RBC transfusion was also more often required in women and was an independent predictor or poorer outcomes. The treatment of pre-existing anemia before TAVI might improve the short-term results in women., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Background: The impact of patient-prosthesis mismatch (PPM) on long-term outcome after surgical aortic valve replacement (SAVR) is controversial. We sought to investigate the incidence of PPM and its impact on survival and reinterventions in a Finnish nationwide cohort., Methods: In the context of the nationwide FinnValve registry, we identified 4097 patients who underwent SAVR with a stented bioprosthesis with or without myocardial revascularization. The indexed effective orifice areas (EOAs) of surgical bioprostheses were calculated using literature-derived EOAs. PPM was graded as moderate (EOA 0.65-0.85 cm 2 /m 2 ) or severe (EOA ≤0.65 cm 2 /m 2 )., Results: The incidence of PPM was 46.0%. PPM was moderate in 38.8% (n = 1579) patients and severe in 7.2% (n = 297) patients. Time-trend analysis showed that the proportion of PPM decreased significantly from 74% in 2009 to 18% in 2017 (P < .01). Severe PPM was associated with increased 5-year all-cause mortality (adjusted hazard ratio [HR], 1.72; 95% confidence interval [CI], 1.07-2.76; P = .02). Severe PPM was not associated with an increased risk of repeat AVR (adjusted HR, 5.90; 95% CI, 0.95-36.5; P = .06). In a subanalysis of patients greater than or equal to 70 years of age, in comparison with no PPM, any PPM (adjusted HR, 1.23; 95% CI, 1.05-1.45; P = .01) and severe PPM (HR, 1.53; 95% CI, 1.17-2.00; P < 0.01) were associated with increased risk of 5-year mortality., Conclusions: Severe PPM after SAVR had a negative impact on survival. This study demonstrated that the effects of PPM should not be overlooked in elderly undergoing SAVR., (Copyright © 2021 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: The data on acute kidney injury (AKI) in patients without chronic kidney disease (CKD) after transcatheter aortic valve replacement (TAVR) are limited. The study sought to compare the incidence of AKI and its impact on 5-year mortality after TAVR and surgical aortic valve replacement (SAVR) in patients without CKD., Methods: This registry included data from 6463 consecutive patients who underwent TAVR or SAVR. CKD was defined as estimated glomerular filtration rate <60 mL/min/1.73 m 2 . AKI was defined according to the Kidney Disease Improving Global Outcomes criteria. For sensitivity analysis, propensity-score matching between TAVR and SAVR was performed., Results: The study included 4555 consecutive patients (TAVR, n = 1215 and SAVR, n = 3340) without CKD. Propensity-score matching identified 542 pairs. Patients who underwent TAVR had a significantly lower incidence of AKI in comparison to those who underwent SAVR (unmatched 4.7% vs 16.4%, P < 0.001, multivariable analysis: odds ratio, 0.29, 95% confidence interval [CI], 0.20-0.41; matched 5.9% vs 19.0%, P < 0.001). Patients with AKI had significantly increased 5-year mortality compared with those without AKI (unmatched 36.0% vs 19.1%, log-rank P < 0.001; matched 36.3% vs 24.0%, log-rank P < 0.001). The adjusted hazard ratios for 5-year mortality were 1.58 (95% CI, 1.20-2.08) for AKI grade 1, 3.27 (95% CI, 2.09-5.06) for grade 2, and 4.82 (95% CI, 2.93-8.04) for grade 3., Conclusions: TAVR in patients without CKD was associated with a significantly less frequent incidence of AKI compared with SAVR. AKI significantly increased the risk of 5-year mortality after either TAVR or SAVR, and increasing severity of AKI was incrementally associated with 5-year mortality., (Copyright © 2020 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Aim: The aim of this study was to assess the outcome of transcatheter aortic valve replacement (TAVR) in patients with cancer., Methods: This is a retrospective study from the nationwide FinnValve registry on 2130 consecutive patients who underwent TAVR for severe AS from January 2008 to October 2017., Results: In this cohort, 417 patients (19.6%) had history of cancer and 113 (5.3%) had an active malignancy at the time of TAVR. Patients with any malignancy had similar late mortality than patients without any malignancy (at 7 years, 65.1% vs. 59.3%, adjusted HR 1.105, 95%CI 0.892-1.369). At 7 years, cancer-related mortality was 22.5% among patients with preoperative cancer, and 11.0% in those without preoperative cancer (p < 0.0001). Among cancer patients, 18 died of the same disease (at 7 years, mortality 12.5%). Active malignancy was not associated with increased risk of all-cause mortality (adjusted HR 1.100, 95%CI 0.757-1.599). However, patients with blood malignancies had a significantly increased risk of mortality (at 4-year, 53.5% vs. 35.4%, adjusted HR 2.029, 95%CI 1.328-3.098)., Conclusions: This analysis showed that, when properly selected by the heart team and oncologists, most cancer patients undergoing TAVR can achieve a good survival and eventually die of other diseases. Blood malignancies seem to carry a poor prognosis in these patients., Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT03385915; https://clinicaltrials.gov/ct2/show/NCT03385915., Competing Interests: Declaration of competing interest Dr. Mikko Savontaus is proctor for Medtronic, the relationship is significant; Dr. Mika Laine is proctor for Boston Scientific, the relationship is significant. The other coauthors do not have any significant conflict of interest related to this study., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background: Recent surgical bovine pericardial prostheses are widely used despite limited data on their long-term durability., Methods: This is a comparative analysis of the outcome of the Trifecta (Abbott, Abbott Park, IL) and Perimount Magna Ease (Edwards, Lifesciences Corp, Irvine, CA) bioprostheses from the FinnValve registry, a Finnish nationwide database including patients with aortic stenosis who underwent transcatheter or surgical aortic valve replacement with a bioprosthesis between 2008 and 2017., Results: Overall 2216 patients (mean age, 74.1 ± 6.7 years; age <65 years, 8.9%; mean follow-up, 3.8 ± 2.1 years) received the Trifecta (851 patients) or the Perimount Magna Ease (1365 patients) bioprostheses. The rates of late mortality and prosthetic valve endocarditis were comparable in the study cohorts. At 7 years the Trifecta cohort had a significantly higher risk of repeat aortic valve replacement for structural valve failure (3.3% vs 0%; adjusted subdistribution hazard ratio, 2.224; 95% confidence interval, 1.044-4.737), repeat aortic valve replacement for any cause (3.6% vs 0.4%; adjusted subdistribution hazard ratio, 3.210; 95% confidence interval, 1.286-8.013), and repeat aortic valve replacement and/or prosthetic valve endocarditis (4.1% vs 0.9%; adjusted subdistribution hazard ratio, 3.210; 95% confidence interval, 1.286-8.013) compared with the Perimount Magna Ease cohort. Among 772 propensity score-matched pairs, at 7 years the Trifecta cohort had a higher risk of repeat aortic valve replacement for structural valve failure (5.7% vs 0%, P = .009)., Conclusions: The Trifecta aortic bioprosthesis is associated with a higher occurrence of repeat aortic valve replacement for structural valve failure compared with the Perimount Magna Ease bioprosthesis. Further comparative studies with echocardiographic data on structural valve deterioration and longer follow-up are needed to confirm these findings., (Copyright © 2020 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Patients with severe aortic stenosis and heart failure have poor prognosis, and their outcomes may be suboptimal even after transcatheter (TAVR) and surgical aortic valve replacement (SAVR)., Methods: This is an analysis of the nationwide FinnValve registry, which included patients who underwent primary TAVR or SAVR with a bioprothesis for aortic stenosis. We evaluated the outcome of patients with acute heart failure (AHF) within 60 days prior to TAVR or SAVR., Results: The prevalence of recent AHF was 11.4% (484 of 4241 patients) in the SAVR cohort and 11.3% (210 of 1855 patients) in the TAVR cohort. In the SAVR cohort, AHF was associated with lower 30-day survival (91.3% vs 97.0%; adjusted odds ratio 1.801, 95% confidence interval [CI] 1.125-2.882) and 5-year survival (64.0% vs 81.2%; adjusted hazard ratio 1.482, 95% CI 1.207-1.821). SAVR patients with AHF had higher risk of major bleeding, need of mechanical circulatory support, acute kidney injury, prolonged hospital stay, and composite end-point (30-day mortality, stroke and/or acute kidney injury). Patients with AHF had a trend toward lower 30-day survival (crude rates 95.2% vs 97.9%; adjusted odds ratio 2.028, 95% CI 0.908-4.529) as well as significantly lower 5-year survival (crude rates 45.3% vs 58.5%; adjusted hazard ratio 1.530, 95% CI 1.185-1.976) also after TAVR. AHF increased the risk of acute kidney injury, prolonged hospital stay, and composite end-point after TAVR., Conclusions: Recent AHF is associated with increased risk of mortality and morbidity after SAVR and TAVR. These findings suggest that aortic stenosis patients should be referred for invasive treatment before the development of clinically evident heart failure., (Copyright © 2020 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Coronary artery bypass grafting (CABG) is the standard treatment for revascularisation in patients with left main coronary artery disease, but use of percutaneous coronary intervention (PCI) for this indication is increasing. We aimed to compare PCI and CABG for treatment of left main coronary artery disease., Methods: In this prospective, randomised, open-label, non-inferiority trial, patients with left main coronary artery disease were enrolled in 36 centres in northern Europe and randomised 1:1 to treatment with PCI or CABG. Eligible patients had stable angina pectoris, unstable angina pectoris, or non-ST-elevation myocardial infarction. Exclusion criteria were ST-elevation myocardial infarction within 24 h, being considered too high risk for CABG or PCI, or expected survival of less than 1 year. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCE), a composite of all-cause mortality, non-procedural myocardial infarction, any repeat coronary revascularisation, and stroke. Non-inferiority of PCI to CABG required the lower end of the 95% CI not to exceed a hazard ratio (HR) of 1·35 after up to 5 years of follow-up. The intention-to-treat principle was used in the analysis if not specified otherwise. This trial is registered with ClinicalTrials.gov identifier, number NCT01496651., Findings: Between Dec 9, 2008, and Jan 21, 2015, 1201 patients were randomly assigned, 598 to PCI and 603 to CABG, and 592 in each group entered analysis by intention to treat. Kaplan-Meier 5 year estimates of MACCE were 29% for PCI (121 events) and 19% for CABG (81 events), HR 1·48 (95% CI 1·11-1·96), exceeding the limit for non-inferiority, and CABG was significantly better than PCI (p=0·0066). As-treated estimates were 28% versus 19% (1·55, 1·18-2·04, p=0·0015). Comparing PCI with CABG, 5 year estimates were 12% versus 9% (1·07, 0·67-1·72, p=0·77) for all-cause mortality, 7% versus 2% (2·88, 1·40-5·90, p=0·0040) for non-procedural myocardial infarction, 16% versus 10% (1·50, 1·04-2·17, p=0·032) for any revascularisation, and 5% versus 2% (2·25, 0·93-5·48, p=0·073) for stroke., Interpretation: The findings of this study suggest that CABG might be better than PCI for treatment of left main stem coronary artery disease., Funding: Biosensors, Aarhus University Hospital, and participating sites., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Background: Transcatheter aortic valve replacement (TAVR) has become an established therapeutic option for patients with symptomatic, severe aortic valve stenosis (AS) who are ineligible or at high risk for conventional valvular surgery. In Northwestern Europe, the TAVR technology is also increasingly used to treat patients with an intermediate risk profile., Methods and Results: The study was designed as an independent Nordic multicenter registry of intermediate risk patients treated with the Lotus Valve System (Boston Scientific, MA, USA; N=154). Valve Academic Research Consortium (VARC)-defined device success was obtained in 97.4%. A Lotus Valve was successfully implanted in all patients. There was no valve migration, embolization, ectopic valve deployment, or TAV-in-TAV deployment. The VARC-defined combined safety rate at 30days was 92.2%, with a mortality rate of 1.9% and stroke rate of 3.2%. The clinical efficacy rate after 30days was 91.6% - only one patient had moderate aortic regurgitation. When considering only those patients in the late experience group (N=79), the combined safety and clinical efficacy rates were 93.7% and 92.4%, respectively. The pacemaker implantation rate was 27.9% - this rate was 12.8% in case of a combined implantation depth <4mm and a device/annulus ratio<1.05., Conclusions: The present study demonstrates the efficacy and safety of the repositionable, retrievable Lotus Valve System in intermediate risk patients with AS. The VARC-defined device success rate was 97.4% with a 30-day patient safety and clinical efficacy rate of more than 90%. Less than moderate aortic regurgitation was obtained in 99.4% of patients., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Objective: Young patients undergoing percutaneous coronary intervention (PCI) are generally considered at low procedural risk, but the potentially aggressive nature of coronary artery disease and long expectancy of life expose them to a high risk of recurrent coronary events. The extent and determinants of disease progression in this patient subset remain largely unknown. The aim of the present study was to evaluate general risk factors for late outcomes among patients ≤50 years old who underwent PCI., Methods: Coronary aRtery diseAse in younG adults (CRAGS) is a multicenter European retrospective registry that enrolled 1617 patients (age ≤50 years) who underwent PCI over the years 2002-2012. The median follow-up was 3.0 years., Results: The majority of patients were smokers who were nevertheless prescribed adequate secondary prevention medication, including statins, aspirin, beta blockers and/or ACE inhibitors/AT blockers. At 5 years, survival was 97.8%, while freedom from major adverse cardiac and cerebrovascular events was 74.1%, from repeat revascularization 77.8% and from myocardial infarction 89.9%. Altogether 13.5% of patients exhibited disease progression that indicated a need for repeat revascularization. Other indications for repeat revascularization were restenosis (7.1%) and stent thrombosis (2.1%) at the 5-year follow-up. Independent post-PCI predictors of disease progression were multivessel disease, diabetes and hypertension., Conclusion: PCI is associated with excellent survival in patients ≤50 years old. Nevertheless, despite guideline-adherent medication, every eighth patient underwent repeat revascularization due to disease progression diagnosed at the median follow-up of three years, underscoring the need for more effective secondary prevention than currently available., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Aims: The prevalence of eight different ventricular conduction blocks and their association with risk factors and major cardiovascular diseases were studied in a major Finnish population study., Methods: Data, including 12-lead electrocardiograms, were collected from 6315 subjects. The prevalence of left bundle branch block (LBBB), right bundle branch block (RBBB), non-specific ventricular block, incomplete LBBB, incomplete RBBB, R-R'-pattern, left anterior hemiblock (LAHB), and left posterior hemiblock (LPHB) was calculated for both genders in three age groups. Their association with risk factors and cardiovascular diseases was studied., Results: R-R'-pattern was the most common ventricular conduction block in all age groups (3.9%, p<0.001 for comparison between groups), but it showed no association with cardiovascular diseases. Males had more RBBB (1.5% vs. 0.7%, p<0.001), incomplete LBBB (1.8 vs. 0.4, p<0.001) and non-specific ventricular block (1.1% vs. 0.1%, p<0.001). With increasing age (<45 years vs. >55 years) LBBB, RBBB and LAHB (0 vs. 2.2%, 0.3 vs. 2.2%, 0.2 vs. 1.9% respectively, p-values<0.001) became more prevalent. LBBB, RBBB and non-specific ventricular conduction block were associated with coronary heart disease (angina pectoris in 28.3, 20.3 and 22.9%, respectively) and heart failure (25.0, 10.1 and 11.4%, respectively). LBBB and RBBB were also associated with peripheral vascular disease (8.8%)., Conclusions: Ventricular conduction blocks differ in prevalence between sexes and age groups. They also show disparate association with cardiovascular diseases. These differences need to be taken into consideration in everyday clinical practice., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)