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Background: Management of severe aortic stenosis (AS) has evolved over the past decade, driven by the widespread adoption of transcatheter aortic valve implantation (TAVI). This study aims to assess trends in procedural volumes, patient characteristics, and outcomes for patients undergoing TAVI or surgical aortic valve replacement (SAVR) in Sweden.

Methods: This was a descriptive, non-comparative, nationwide cohort study using the SWEDEHEART registry. We included 21,383 patients who underwent TAVI or SAVR between 2013 and 2023 (11,366 TAVI and 10,017 SAVR). Trends in patient characteristics, preoperative risk, complications and mortality were examined.

Findings: TAVI procedures increased from 307 (26.1%, n = 307/1174) in 2013 to 1851 (71.2%, n = 1851/2601) in 2023, while SAVR volumes declined from ∼1000 annually before 2018 to roughly 750 procedures annually. Median age of TAVI patients were 81 (IQR 77, 85) years and 71 (IQR 65, 76) years for SAVR patients. The median EuroSCORE II for TAVI decreased from 5.6 (IQR 3.3, 10.2) to 2.7 (IQR 1.7, 4.6) (p = 0.002), and STS-PROM from 3.3 (IQR 1.9, 4.1) to 1.6 (IQR 1.1, 2.8) (p = 0.0021). Among SAVR patients, EuroSCORE II decreased from 1.5 (IQR 1.0, 2.3) to 1.3 (IQR 0.9, 2.1) (p = 0.022) and STS-PROM from 1.8 (IQR 1.2, 3.0) to 1.6 (IQR 1.1, 2.6) (p = 0.0082). Any in-hospital complications declined significantly for TAVI (29.2%, n = 210/719 to 13.2%, n = 244/1851), while SAVR complication rates increased slightly (18.4%, n = 354/1921 to 18.7%, n = 140/750). In-hospital mortality for TAVI declined from 3.6% (n = 26/719) to 1.0% (n = 18/1851), and 1-year mortality from 11.1% to 6.9% (p = 0.019). SAVR in-hospital all-cause death decreased from 1.6% to 0.4% (n = 3/750) and 5.0% to 2.2% for 1-year mortality (p = 0.013).

Interpretation: TAVI has become the predominant treatment strategy for AS in Sweden expanding access within the treated cohort. Despite this, current 2023 SAVR results demonstrate similar in-hospital complication rates compared to TAVI (18.7% vs 13.2%), but lower in-hospital (0.4% vs 1.0%) and 1-year mortality rates (2.2% vs 6.9%). Funding: This study was supported by ALF and national research funding bodies.

Background: Transcatheter aortic valve replacement (TAVR) is increasingly used in patients with bicuspid aortic valve (BAV) stenosis, but there is limited comparative data on balloon-expandable (BEV) versus self-expanding valves (SEV) in this population.

Aim: To compare clinical and hemodynamic outcomes between BEVs and SEVs in patients with BAV stenosis.

Methods: This observational cohort included all patients who underwent TAVR in Sweden between 2016 and 2022. Exclusion criteria included procedures for pure aortic insufficiency and valve-in-valve interventions. The analysis focused on Evolut, Sapien, Acurate, and Portico/Navitor valve families. A doubly robust approach was applied combining inverse probability of treatment weighting and multivariable regression. Sensitivity analyses were also conducted.

Results: Of 577 patients, 274 (47.5%) received a BEV. The majority in the SEV group received an Evolut valve (62%). The mean EUROSCORE II-predicted mortality risk was 4.1% for BEV and 3.6% for SEV. BEVs were used more in patients with reduced ejection fraction (EF ≤ 40%) and larger aortic annuli. There were no significant differences between groups in periprocedural mortality, all-cause mortality at a median follow-up of 675 days, or device success. However, SEVs had higher technical success (aOR: 2.21, p = 0.006), lower postprocedural gradients (adjusted coefficient: −3.72, p < 0.001), and reduced risk of prosthesis-patient mismatch (aOR: 0.10, p = 0.02). SEVs, though, had a higher incidence of paravalvular leakage (aOR: 7.5, p < 0.01).

Conclusion: Both BEVs and SEVs were feasible with similar clinical outcomes in BAV stenosis. SEVs had better hemodynamic outcomes but more paravalvular leakage. Randomized trials are needed to determine the optimal valve choice.

Background: Limited data exist on transcatheter aortic valve replacement (TAVR) outcomes in patients with bicuspid aortic valve (BAV) stenosis. This study compared TAVR outcomes in BAV versus tricuspid aortic stenosis.

Methods: This observational study included all patients who underwent TAVR in Sweden from 2016 to 2022, excluding those with pure aortic insufficiency and valve-in-valve procedures. Only Evolut-, SAPIEN-, ACURATE-, and Portico/Navitor-family devices were included. A doubly robust method was used, combining propensity score estimation and multivariable regression.

Results: Among 7,095 patients, 577 (8.1 %) had BAV stenosis. The mean EUROSCORE II-predicted mortality risk was 3.8 % for BAV and 4.5 % for TAV. BAV patients were younger, predominantly male, and had fewer comorbidities but higher baseline aortic valve gradients, larger annulus diameters, and more reduced ejection fraction.

After matching, 30-day mortality and all-cause mortality (median follow-up: 690 days) were similar between BAV and TAV patients (p = 0.8 for both). While BAVs had numerically lower technical success per VARC-3 criteria, this was not statistically significant (p = 0.08). However, BAV patients had lower device success (aOR = 0.8, p = 0.04) and a higher incidence of post-TAVR pacemaker implantation (aOR = 1.76, 95 % CI: 1.14–2.58, p = 0.007). No significant differences were observed in prosthesis-patient mismatch (p = 0.3), paravalvular leakage (p = 0.6), stroke (p = 0.3), or post-TAVR gradients (p > 0.9).

Conclusion: TAVR in BAV patients yields similar mortality and hemodynamic outcomes as in TAV patients. However, BAVs are associated with lower device success and higher pacemaker rates. While TAVR is a viable alternative to SAVR, treatment should be individualized, especially in younger BAV patients, considering lifetime management and coronary access.

Aims: Low Carbohydrate High Fat (LCHF) diets are popular for weight loss or glucose control. The main source of energy in such diets is fat but the composition of nutrients varies. This study aims to investigate dietary variations in a real-world LCHF population and its associations with cardiovascular risk factors.

Methods: We recruited 100 volunteers who considered themselves adherent to a LCHF diet. Their last 14 days of dietary intake was assessed using diet history interviews. Validation of energy intake against expenditure was made using activity monitors. Predictive variables for the linear regression models were selected using stepwise bidirectional assessment of Akaike information criterion (AIC).

Results: Energy intake (E%) from carbohydrates was low, 8.7 E%, and fat was the main replacement. Dietary cholesterol was associated with higher total cholesterol, low-density lipoprotein (LDL), and high-density lipoprotein (HDL). Dietary sodium intake was associated with higher blood pressure. Protein intake was associated with lower diastolic blood pressure but also with lower HDL. The intake of dietary fibre was associated with lower LDL and total cholesterol but with higher hemoglobin A1c (HbA1c). The intake of carbohydrates and saturated fatty acids (SFA) was not associated with any of the outcome variables.

Conclusion: In this LCHF population, variations in intake of carbohydrates and saturated fatty acids could not predict any aspects of the cardiovascular risk profile. Lower fibre intake and higher cholesterol and sodium intake predicted a less favorable cardiovascular risk profile.

Aims: Diet is a determinant of cardiovascular diseases (CVD) with coronary disease as predominant cause of pre-mature death. To analyse how diet was associated with coronary atherosclerosis, including plaque features.

Methods and results: The cross-sectional population-based study using data from the Swedish CArdioPulmonary BioImage Study (SCAPIS) included 24 079 adults aged 50-64 years, recruited in 2013 to 2018 who were free of clinical cardiovascular disease. The recruitment and comprehensive examinations were conducted at six locations in Sweden. A dietary index (DI) based on a previously published anti-inflammatory DI including high proportion of plant-based foods, and low in red or processed meat and sugar-sweetened beverages was constructed. The reference group was within lowest DI tertile. Coronary atherosclerosis assessed by coronary computed tomography angiography, including any-, significant-, and adverse or high-risk coronary plaque, which is non-calcified with a significant stenosis ≥50%. Lowest, compared to highest DI tertile was associated with younger age, more often men (62.2% vs. 32.9%), higher high-sensitive C-reactive protein, more cardiometabolic risk and smokers, higher alcohol-, and higher energy-intake. In the highest and lowest tertile, coronary plaques were present in 36.3% and 44.3%, respectively, stenosis ≥ 50% in 3.7% and 6.0%. Non-calcified coronary plaques with stenosis ≥50% were present in 0.9% and 1.5% in highest and lowest tertiles. In multivariable analyses, the lowest tertile of DI was associated with high-risk plaque features after adjusting for age, sex, smoking, with waist circumference, triglycerides (TGs), and hypertension as possible mediators.

Conclusion: A low-fibre diet with high red meat content was associated with high-risk plaques features, increased coronary calcification and significant stenosis. Waist circumference, TGs, and hypertension emerged as potential mediators of these associations, underscoring the role of metabolic and hemodynamic factors in the dietary impact on coronary atherosclerosis. Our findings strengthen the importance of cardioprotective dietary recommendations.

Introduction: Data are lacking about the risk for death and major adverse cardiovascular events (MACE) after transcatheter aortic valve implantation (TAVI), compared to the general population. Therefore, we assessed the risk for all-cause death and MACE after TAVI in patients aged 65 years and older, in comparison to an age- and sex-matched control population.

Methods and results: In total, 5924 TAVI patients and 10 928 matched controls [mean age 82.1, standard deviation (SD) 6.0, and 81.9, SD 6.1, respectively] were included from 2014 to 2020. The SWEDEHEART registry and four mandatory national registers were used to collect data. Cox regression models were used to assess the association with all-cause mortality and MACE risk. In total, 1410 (23.8%) of the TAVI patients and 2115 (19.4%) controls died during the follow-up period. Median follow-up was 1.9 years (inter quartile range 0.9–3.3) respectively. The crude mortality and MACE risks were higher in TAVI patients than in controls {hazard ratios 1.27 [95% Confidence interval (CI): 1.19–1.36] and HR 1.44 (95% CI: 1.35–1.53), respectively}. After adjustment, there was a lower risk for both mortality and MACE in TAVI patients [adjusted hazard ratio (aHR) 0.77 (95% CI: 0.71–0.84) and aHR 0.90 (95% CI: 0.83–0.98), respectively].

Conclusion: After adjustments for comorbidities, the mortality risk was lower in TAVI patients, compared with an age- and sex-matched control population. These findings suggest that the high burden of comorbidities in TAVI patients has a strong impact on the risk for mortality and MACE after TAVI.

Background: Small aortic annulus is associated with poorer hemodynamic outcomes in transcatheter aortic valve replacement (TAVR). In these cases, supra-annular (SA) self-expandable valves (SEVs) may offer better results than intra-annular SEVs (IA SEVs). This study evaluated clinical and hemodynamic outcomes for SA SEVs (Evolut valves, Acurate valves) and IA SEVs (Portico/Navitor valves).

Methods: We analyzed data from patients who underwent TAVR in Sweden between 2013 and 2022 with an annular diameter ≤23 mm, using inverse probability of treatment weighting. Endpoints included mortality, device, and technical success as per Valve Academic Research Consortium 3 definitions. Other endpoints were the incidence of post-TAVR mean or peak gradients over 20 and 40 mmHg, respectively, significant paravalvular leakage, new pacemaker implantation, and postprocedural aortic valve gradients.

Results: The study included 1068 patients, with a median age of 81.2 years, and 88% were women. After inverse probability of treatment weighting adjustment, no differences were observed in the outcomes apart from a marginally lower risk of postprocedural mortality in the Portico/Navitor valves compared to the Evolut valves (adjusted odds ratio: 0.99; p ​= ​0.05; 95% CI: 0.98-1.00). Hemodynamically, the Evolut valves showed the lowest mean gradients, followed by the Portico/Navitor valves and the Acurate valves (7.97 vs 9.02 mmHg vs. 0.84 mmHg, respectively, p ​< ​0.001; 95% CI: 0.35-1.00).

Conclusions: SA and IA SEVs show comparable clinical outcomes and excellent hemodynamic performance in patients with small aortic annuli. Further studies, including randomized trials, are needed to provide clearer guidance on valve selection.

Background: Transcatheter aortic valve implantation (TAVI) has become a safe procedure. However, complications occur, including uncommon complications such as valve malposition, which requires the implantation of an additional rescue valve (rescue-AV). The aim was to study the occurrence and outcomes of rescue-AV in a nationwide registry.

Methods: The Swedish national TAVI registry was used as the primary data source, where all 6706 TAVI procedures from 2016 to 2021 were retrieved. Nontransfemoral access and planned valve-in-valve were excluded. In total, 79 patients were identified as having had a rescue-AV, and additional detailed data were collected for these patients. This dataset was analyzed for any characteristics that could predispose patients to a rescue-AV. The outcome of patients receiving rescue-AV also was studied.

Results: Of the 5948 patients in the study, 1.3% had a rescue-AV. There were few differences between patients receiving 1 valve and rescue-AV patients. For patients receiving a rescue-AV, the 30-day mortality was 15.2% compared to 1.6% in the control group. A poor outcome after rescue-AV was often associated with a second complication; for example, stroke, need for emergency surgery, or heart failure. Among the patients with rescue-AV who survived at least 30 days, landmark analyses showed similar survival rates compared to the control group.

Conclusions: Among TAVI patients in a nationwide register, rescue-AV occurred in 1.3% of patients. The 30-day mortality in patients receiving rescue-AV was high, but long-term outcome among 30-day survivors was similar to the control group.

Background: Transcatheter aortic valve replacement (TAVR) is the most common treatment in patients with symptomatic severe aortic stenosis (AS). As concomitant coronary artery disease is common in AS patients, access to the coronary arteries following TAVR is of increasing importance.

Objectives: This study evaluated the incidence and risk factors for unplanned coronary angiography following TAVR and, using fluoroscopic time as a surrogate, analyzed the complexity of coronary artery cannulation.

Methods: All patients who underwent TAVR in Sweden between 2008 and 2022 were identified using the SWEDEHEART registry. The cumulative incidence of coronary angiography after TAVR was analyzed with mortality as a competing risk. Angiography and PCI complexity were analyzed using fluoroscopic time and compared across different transcatheter heart valve designs.

Results: Out of 9806 patients, 566 subsequently required coronary angiography. The incidence was highest for three-vessel and/or left main disease. Younger age, the extent of prior coronary artery disease, and peripheral vascular disease were associated with an increased risk of coronary angiography. Fluoroscopy time was increased in TAVR patients compared to the control group with the longest fluoroscopy times observed in cases involving supra-annular and self-expanding valves.

Conclusions: The incidence of coronary angiography following TAVR is still low. Younger patients and patients with concomitant coronary artery disease have a higher risk. Procedural time is longer in patients with a previous THV replacement. As TAVR is emerging as the first-line treatment in patients with longer life expectancy, facilitating coronary access is an important factor when considering which THV device to implant.

Background: Transcatheter aortic valve implantation (TAVI) has shown similar or improved clinical outcomes compared with surgical aortic valve replacement (SAVR) in patients with symptomatic severe aortic stenosis at low risk for surgical mortality. This cost-utility analysis compared TAVI with SAPIEN 3 versus SAVR in symptomatic severe aortic stenosis patients at low risk of surgical mortality from the perspective of the Swedish healthcare system.

Methods: A published, two-stage, Markov-based cost-utility model that captured clinical outcomes from the Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated according to Recommended Therapies (SWEDEHEART) registry (2018-2020) was adapted from the perspective of the Swedish healthcare system using local general population mortality, utility and costs data. The model had a lifetime horizon. Model outputs included changes in direct healthcare costs and health-related quality of life from using TAVI as compared with SAVR.

Results: TAVI with SAPIEN 3 resulted in lifetime costs per patient of 940,541 Swedish krona (SEK) and lifetime quality-adjusted life years (QALYs) per patient of 7.16, whilst SAVR resulted in lifetime costs and QALYs per patient of 821,380 SEK and 6.81 QALYs, respectively. Compared with SAVR, TAVI offered an incremental improvement of +0.35 QALY per patient at an increased cost of +119,161 SEK per patient over a lifetime horizon, resulting in an incremental cost-effectiveness ratio of 343,918 SEK per QALY gained.

Conclusion: TAVI with SAPIEN 3 is a cost-effective option versus SAVR for patients with symptomatic severe aortic stenosis at low risk for surgical mortality treated in the Swedish healthcare setting. These findings may inform policy decisions in Sweden for the management of this patient group.