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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.ResultsAmong 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.

BACKGROUND: This study aimed to compare the incidence and prognostic implications of new-onset conduction disturbances after surgical aortic valve replacement (SAVR) in patients with bicuspid aortic valve (BAV) aortic stenosis (AS) versus patients with tricuspid aortic valve (TAV) AS (ie, BAV-AS and TAV-AS, respectively). Additionally, the study included stratification of BAV patients according to subtype.

METHODS: In this cohort study, the incidence of postoperative third-degree atrioventricular (AV) block with subsequent permanent pacemaker requirement and new-onset left bundle-branch block (LBBB) was investigated in 1147 consecutive patients without preoperative conduction disorder who underwent isolated SAVR (with or without ascending aortic surgery) between January 1, 2005, and December 31, 2022. The groups were stratified by aortic valve morphology (BAV, n=589; TAV, n=558). The outcomes of interests were new-onset third-degree AV block or new-onset LBBB during the index hospitalization. The impact of new-onset postoperative conduction disturbances on survival was investigated in BAV-AS and TAV-AS patients during a median follow-up of 8.2 years. BAV morphology was further categorized according to the Sievers and Schmidtke classification system (possible in 307 BAV-AS patients) to explore association between BAV subtypes and new-onset conduction disturbances after SAVR.

RESULTS: The overall incidence of third-degree AV block and new-onset LBBB after SAVR was 4.5% and 7.8%, respectively. BAV-AS patients had a higher incidence of both new-onset third-degree AV block (6.5% versus 2.5%; P=0.001) and new-onset LBBB (9.7% versus 5.7%; P=0.013) compared with TAV-AS patients. New-onset LBBB was associated with an increased all-cause mortality during follow-up (adjusted hazard ratio, 1.60 [95% CI, 1.12-2.30]; P=0.011), whereas new-onset third-degree AV block was not associated with worse prognosis. Subgroup analysis of the BAV cohort revealed that BAV-AS patients with fusion of the right- and non-coronary cusps had the highest risk of new-onset third-degree AV block (adjusted odds ratio [aOR], 8.33 [95% CI, 3.31-20.97]; P<0.001, with TAV as reference group) and new-onset LBBB (aOR, 4.03 [95% CI, 1.84-8.82]; P<0.001, with TAV as reference group), whereas no significant association was observed for the other BAV subtypes.

CONCLUSIONS: New-onset LBBB after SAVR is associated with increased all-cause mortality during follow-up, and is more frequent complication in BAV AS patients compared with TAV-AS patients. BAV-AS patients with fusion of the right- and non-coronary cusps have an increased risk for conduction disturbances after SAVR. This should be taken into consideration when managing these patients.

Background

The role of Helicobacter pylori ( H. pylori ) screening and eradication on reducing upper gastrointestinal bleeding (UGIB) complications after acute myocardial infarction (MI) is uncertain. The HELicobacter pylori screening to prevent gastrointestinal bleeding in patients with acute MI (HELP-MI SWEDEHEART) trial aims to determine whether systematic H. pylori screening compared to usual care reduces UGIB, mortality, and cardiovascular outcomes after MI.

Methods

A cluster randomized, crossover, registry-based clinical trial using SWEDEHEART as trial platform for study population definition and source for data collection in combination with nationwide Swedish health data registries. Thirty-five Swedish hospitals, organized into 18 clusters based on percutaneous coronary intervention networks, were randomized to either routine H. pylori screening for adults with acute type-1 MI or usual care. After 1 year, a 2-month blanking period was followed by a crossover to the alternate allocation for 1 year. The trial enrolment was concluded after one additional year of registry-based follow-up. The primary endpoint is UGIB. Secondary endpoints include all-cause death, cardiovascular death, readmission for MI, stroke, or heart failure. Endpoints will be reported combined (Net Adverse Clinical Events; Major Adverse Cardiac or Cerebrovascular Events) and separately. The primary analysis will include all available follow-up time corresponding to a maximum follow-up time of 3 years and 2 months.

Conclusion

HELP-MI SWEDEHEART aims to determine the utility of routine H. pylori screening to reduce UGIB and improve cardiovascular outcomes after MI. By integrating national registry follow-up data with a pragmatic trial design, it has the potential to provide evidence for the effect of the implementation of routine H. pylori screening as part of acute MI care.

Trial Registration

ClinicalTrials.gov, NCT05024864.

Randomized controlled trials (RCTs) are the cornerstone of modern evidence-based medicine. They are considered essential to establish definitive evidence of efficacy and safety for new drugs, and whenever possible they should also be the preferred method for investigating new high-risk medical devices. Well-designed studies robustly inform clinical practice guidelines and decision-making, but administrative obstacles have made it increasingly difficult to conduct informative RCTs. The obstacles are compounded for RCTs of high-risk medical devices by extra costs related to the interventional procedure that is needed to implant the device, challenges with willingness to randomize patients throughout a trial, and difficulties in ensuring proper blinding even with sham procedures. One strategy that may help is to promote the wider use of simpler and more streamlined RCTs using data that are collected routinely during healthcare delivery. Recent large simple RCTs have successfully compared the performance of drugs and of high-risk medical devices, against alternative treatments; they enrolled many patients in a short time, limited costs, and improved efficiency, while also achieving major impact. From a task conducted within the CORE-MD project, we report from our combined experience of designing and conducting large pharmaceutical trials during the COVID-19 pandemic, and of planning and coordinating large registry-based RCTs of cardiovascular devices. We summarize the essential principles and utility of large simple RCTs, likely applicable to all interventions but especially in order to promote their wider adoption to evaluate new medical devices.

BACKGROUND Although lipoprotein(a) (Lp[a]) has been associated with acute myocardial infarction (MI), the relationship between Lp(a) and the presence of high-risk "vulnerable" coronary plaques has not been studied.

OBJECTIVES The aim of this study was to investigate whether specific lipoproteins are associated with pancoronary plaque volume and lipid deposition vs the development of non-flow-limiting high-risk vulnerable plaques.

METHODS In PROSPECT (Providing Regional Observations to Study Predictors of Events in the Coronary Tree) II, 3-vessel coronary artery imaging was performed with a combined near-infrared spectroscopy and intravascular ultrasound catheter after treatment of all flow-limiting lesions in patients with recent MI. The relationships of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (HDL-C), HDL-C, Lp(a), and triglycerides to pancoronary plaque volume, pancoronary lipid core burden index (LCBI), and the presence of focal vulnerable plaques (plaque burden >= 70% and maximum LCBI over any 4-mm segment >= 324.7) were assessed in 865 patients.

RESULTS By multivariable analysis, TC, LDL-C, and non-HDL-C (but not Lp[a]) were associated with pancoronary plaque volume and pancoronary LCBI (P < 0.01 for all), but not with the presence of vulnerable plaque. Conversely, Lp(a) (but not TC, LDL-C, or non-HDL-C) was associated with the presence of focal vulnerable plaques (P 1/4 0.01).

CONCLUSIONS In PROSPECT II, elevated TC, LDL-C, and non-HDL-C were strongly associated with pancoronary atherosclerosis and lipid deposition, whereas elevated Lp(a) was strongly associated with the presence of focal vulnerable plaques. These findings may explain the association between high Lp(a) levels and future MI and suggest a unique role for Lp(a) role in atherosclerosis progression and plaque vulnerability. (PROSPECT II & PROSPECT ABSORB-An Integrated Natural History Study and Randomized Trial; NCT02171065) (JACC. 2025;85:2011-2024) (c) 2025 by the American College of Cardiology Foundation.

Background and Aims

No-touch saphenous vein harvesting may enhance graft patency and improve clinical outcomes after coronary artery bypass grafting (CABG).

Methods

In this registry-based, randomized trial, patients undergoing CABG were randomly assigned to no-touch or conventional harvesting. The primary composite outcome was the proportion of patients with occluded/stenosed >50% vein graft on coronary computed tomography angiography, or who underwent percutaneous coronary intervention to a vein graft, or died. Secondary outcomes included clinical outcomes and leg wound complications.

Results

A total of 902 patients were enrolled with a mean total number of distal vein anastomoses of 2.0 (SD 0.87). The primary endpoint occurred in 90/454 (19.8%) of patients randomized to no-touch and in 107/446 (24.0%) of patients randomized to the conventional technique [difference, −4.3 percentage points; 95% confidence interval (CI) −10.1–1.6; P = .15] at a mean follow-up time of 3.5 (SD 0.1) years. The composite of death, myocardial infarction, or repeat revascularization at 4.4 (SD 1.3) years occurred in 57/454 (12.6%) and 44/446 (9.9%) in the no-touch and conventional groups, respectively (hazard ratio 1.3; 95% CI, 0.87–1.93). Leg wound complications were more common in patients assigned to no-touch harvesting at 3 months [107/433 (24.7%) vs. 59/427 (13.8%); difference, 10.9 percentage points; 95% CI 5.7–16.1]. At 2 years, 189/381 (49.6%) vs. 91/361 (25.2%) had remaining leg symptoms (difference, 24.4 percentage points; 95% CI 17.7–31.1).

Conclusions

No-touch vein graft harvesting for CABG was not superior to conventional open harvesting in reducing vein graft failure or clinical events after CABG but increased leg wound complications. The primary outcome requires cautious interpretation due to a lower-than-expected number of primary events.

Objectives: To establish the prevalence of clinically significant chronic obstructive pulmonary disease (COPD) and relevant characteristics in individuals with a significant smoking history who are hospitalised for acute myocardial infarction (MI).

Design: Cross-sectional study.

Setting: Hospital inpatients at 8 European centres (7 in Sweden, 1 in the UK).

Participants: 518 men or women (302 in Sweden, 216 in the UK) hospitalised for acute MI, aged 40 years or older, with a smoking history of at least 10 pack-years.

Primary and secondary outcome measures: The primary outcome was prevalence of detected significant COPD (Global Initiative for Chronic

Obstructive: Lung Disease stages 2-4), defined as a ratio of forced expiratory volume in 1 and 6 s (FEV1/FEV6) <0.7 and FEV1 <80% of the predicted value, measured using microspirometry. Secondary outcome measures were prior diagnosis of COPD, prescription of inhaled corticosteroids (ICS), symptom burden (COPD Assessment Test (CAT)) and blood eosinophil count.

Results: The prevalence of significant COPD was 91/518 (18% (95% CI 14 to 21)) with no difference between the countries. Of those with detected significant COPD, 69 (76%) had no previous COPD diagnosis. A CAT score >10 was found in 65%, and a blood eosinophil count of >= 100/mm(3) and >= 300/mm(3) was found in 76% and 20%, respectively. Inhaled corticosteroids were used by 15% of the patients.

Conclusions: In a cohort of patients hospitalised for acute MI in Sweden and the UK, one in five patients with a history of smoking was found to have significant COPD based on microspirometry. Symptom burden was high and treatment rates with ICS low. Among those diagnosed with COPD, three out of four had not been previously diagnosed with COPD.

BACKGROUND Inflammation is a driver of atherosclerosis and susceptibility to cardiovascular events.

OBJECTIVES The authors sought to evaluate whether high-sensitivity C-reactive protein (hsCRP) levels are associated with the prevalence of high-risk coronary plaques in patients with non-ST-segment elevation myocardial infarction (NSTEMI).

METHODS PROSPECT (Providing Regional Observations to Study Predictors of Events in the Coronary Tree) II was a multicenter, prospective study enrolling patients with recent myocardial infarction. Following treatment of all flow-limiting lesions, 3-vessel imaging with near-infrared spectroscopy and intravascular ultrasound was used to characterize untreated nonculprit lesions. We investigated the association between baseline hsCRP and plaque morphology (lipid content, plaque burden, lumen area) in 501 NSTEMI patients. hsCRP levels were categorized as low (<1 mg/L), intermediate (1-3 mg/L), or high (>3 mg/L).

RESULTS The percentages of patients with at least 1 highly lipidic plaque (maximum lipid core burden index for any 4-mm pullback length >= 324.7) increased from 39.4% to 57.2% to 59.3% in the low, intermediate, and high hsCRP groups, respectively (P = 0.01). The proportion of patients with at least 1 highly lipidic plaque with >= 70% burden increased with hsCRP levels from 22.7% to 27.2% to 36.7%, respectively (P = 0.01). Multivariable analyses showed that increasing hsCRP was associated with higher total coronary artery lipid core burden index and plaque volume. Higher hsCRP increased the odds of having any highly lipidic plaque and those with >= 70% plaque burden.

CONCLUSIONS Among patients with recent NSTEMI, a high baseline hsCRP level was associated with the presence of pan-coronary atherosclerosis and focal high-risk plaques. (PROSPECT II & PROSPECT ABSORB-an Integrated Natural History Study and Randomized Trial; NCT02171065) (JACC Cardiovasc Interv. 2025;18:1217-1228) (c) 2025 by the American College of Cardiology Foundation.

BACKGROUND

Randomized trials support angiographic and physiology-guided complete revascularization (CR) vs incomplete revascularization (IR) in ST-segment elevation myocardial infarction (STEMI) with multivessel disease (MVD). The implementation of these strategies in clinical practice is uncertain.

OBJECTIVES

In patients undergoing percutaneous coronary intervention for STEMI with MVD, we assessed temporal trends in the utilization of different revascularization strategies and associated outcomes.

METHODS

We included 20,131 patients from the SWEDEHEART (Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies) registry who underwent primary percutaneous coronary intervention for STEMI with MVD between 2009 and 2021. Primary outcome was a composite of all-cause mortality, myocardial infarction, or unplanned revascularization, landmarked at 90 days postindex to account for staged procedures during this time. RESULTS We observed increased adoption of CR (2009: 33% [n = 397 of 1,217]; 2015: 46% [n = 767 of 1,658]; 2021: 51% [n = 816 of 1,603]; P-trend <0.001) and physiology-guided CR (2009: 0% [n = 0 of 1,217]; 2015: 7% [n = 119 of 1,658]; 2021: 14% [n = 218 of 1,603]; P-trend < 0.001). Over a median follow-up of 4.2 years (Q1-Q3: 1.8-7.1 years), the adjusted risk of a primary event was lower with angiographic CR vs IR (adjusted HR [aHR]: 0.84, 95% CI: 0.79-0.89) and physiology-guided CR vs IR (aHR: 0.80, 95% CI: 0.69-0.93) but not physiology-guided CR vs angiographic CR (aHR: 0.94, 95% CI: 0.80-1.11).

CONCLUSIONS

In patients with STEMI and MVD, the implementation of CR and physiology-guided procedures increased over time. As of 2021, 51% of patients underwent CR and 14% physiology-guided CR. CR, whether angiographically or physiology guided, was independently associated with favorable outcomes, including mortality. (JACC Cardiovasc Interv. 2025;18:1246-1259) (c) 2025 Published by Elsevier on behalf of the American College of Cardiology Foundation.