Technical and Clinical Outcomes After Transcatheter Edge-to-Edge Repair of Mitral Regurgitation in Male and Female Patients: Is Equality Achieved?

BACKGROUND: Currently, no clear impact of sex on short- and long-term survival following transcatheter edge-to-edge mitral valve repair (TEER) is evident, although no data are available on postprocedural life expectancy. Our aim was to assess sex-specific differences in outcomes of patients with mitral regurgitation (MR) treated by TEER. METHODS AND RESULTS: Short-term and 5-year outcomes in men and women undergoing TEER between 2011 and 2018 who were included in the large, multicenter, real-world MitraSwiss registry were analyzed. Outcomes were compared stratified by sex and according to MR cause (primary versus secondary). The impact of TEER on postprocedural life expectancy was estimated by relative survival analysis. Among 1142 patients aged 60 to 89 years, 39.8% were women. They were older, with fewer cardiovascular risk factors and lower functional capacity compared with men. Thirty-day mortality was higher in men than in women (3.3% versus 1.1%; odds ratio, 3.16 [95% CI, 1.16-10.7]; P=0.020). Five-year survival was comparable in both sexes (adjusted hazard ratio for 5-year mortality in men, 1.14 [95% CI, 0.90-1.44], P=0.275). Both men and women with either primary or secondary MR showed similar clinical efficacy over time. TEER provided high relative survival estimates among all groups, and fully restored predicted life expectancy in women with primary MR (5-year relative survival estimate, 97.4% [95% CI, 85.5-107.0]). CONCLUSIONS: TEER is not associated with increased short-term mortality in women, whereas 5-year outcomes are comparable between sexes. Moreover, TEER completely restored normal life expectancy in women with primary MR. A residual excess mortality persists in secondary MR, independently of sex.

Non-Vitamin K Antagonist Versus Vitamin K Antagonist Oral Anticoagulant Agents After Transcatheter Aortic Valve Replacement.

BACKGROUND: Studies comparing long-term outcomes between non-vitamin K antagonist (VKA) oral anticoagulant agents (direct oral anticoagulant agents [DOACs]) and VKA anticoagulant agents after transcatheter aortic valve replacement (TAVR) are scarce, with conflicting results. OBJECTIVES: The aim of this study was to examine the periprocedural, short-term, and long-term safety and effectiveness of DOACs vs VKAs in patients undergoing TAVR via femoral access with concomitant indications for oral anticoagulation. METHODS: Consecutive patients undergoing transfemoral TAVR in the prospective national SwissTAVI Registry between February 2011 and June 2021 were analyzed. Net clinical benefit (a composite of all-cause mortality, myocardial infarction, stroke, and life-threatening or major bleeding) and the primary safety endpoint (a composite of life-threatening and major bleeding) were compared between the VKA and DOAC groups at 30 days, 1 year, and 5 years after TAVR. RESULTS: After 1:1 propensity score matching, 1,454 patients were available for analysis in each group. There was no significant difference in the rate of the net clinical benefit and the safety endpoints between the groups as assessed at 30 days and 1 and 5 years post-TAVR between VKAs and DOACs. VKAs were associated with significantly higher rates of 1- year (HR: 1.28; 95% CI: 1.01-1.62) and 5-year (HR: 1.25; 95% CI: 1.11-1.40) all-cause mortality. Long-term risk for disabling stroke was significantly lower in the VKA group after excluding periprocedural events (HR: 0.64; 95% CI: 0.46-0.90). CONCLUSIONS: At 5 years after TAVR, VKAs are associated with a higher risk for all-cause mortality, a lower risk for disabling stroke, and a similar rate of life-threatening or major bleeding compared with DOACs. (SwissTAVI Registry; NCT01368250).

Case report of pulmonary vein isolation in situs inversus totalis.

Background: Situs inversus totalis (SIT) is a rare condition, where all the organs in the body are mirrored. Atrial fibrillation occurs in patients with SIT. We describe the case of pulmonary vein isolation (PVI) in SIT. Case summary: A patient with atrial fibrillation was referred to our hospital due to palpitations. Diagnosis of atrial fibrillation was made by electrocardiogram. The patient reported to have a SIT that was confirmed. Meticulous preparation was done including a three-dimensional model and radiofrequency PVI was performed successfully. No recurrence of atrial fibrillation was detected until last follow-up 2 years after PVI. Discussion: Pulmonary vein isolation in SIT can be performed successfully and with excellent long-term result.

Impact of the COVID-19 Pandemic on Global TAVR Activity: The COVID-TAVI Study.

BACKGROUND: The COVID-19 pandemic adversely affected health care systems. Patients in need of transcatheter aortic valve replacement (TAVR) are especially susceptible to treatment delays. OBJECTIVES: This study sought to evaluate the impact of the COVID-19 pandemic on global TAVR activity. METHODS: This international registry reported monthly TAVR case volume in participating institutions prior to and during the COVID-19 pandemic (January 2018 to December 2021). Hospital-level information on public vs private, urban vs rural, and TAVR volume was collected, as was country-level information on socioeconomic status, COVID-19 incidence, and governmental public health responses. RESULTS: We included 130 centers from 61 countries, including 65,980 TAVR procedures. The first and second pandemic waves were associated with a significant reduction of 15% (P < 0.001) and 7% (P < 0.001) in monthly TAVR case volume, respectively, compared with the prepandemic period. The third pandemic wave was not associated with reduced TAVR activity. A greater reduction in TAVR activity was observed in Africa (-52%; P = 0.001), Central-South America (-33%; P < 0.001), and Asia (-29%; P < 0.001). Private hospitals (P = 0.005), urban areas (P = 0.011), low-volume centers (P = 0.002), countries with lower development (P < 0.001) and economic status (P < 0.001), higher COVID-19 incidence (P < 0.001), and more stringent public health restrictions (P < 0.001) experienced a greater reduction in TAVR activity. CONCLUSIONS: TAVR procedural volume declined substantially during the first and second waves of the COVID-19 pandemic, especially in Africa, Central-South America, and Asia. National socioeconomic status, COVID-19 incidence, and public health responses were associated with treatment delays. This information should inform public health policy in case of future global health crises.

Long-Term Risk of Stroke After Transcatheter Aortic Valve Replacement: Insights From the SwissTAVI Registry.

BACKGROUND: Stroke after transcatheter aortic valve replacement (TAVR) is associated with considerable morbidity and mortality. Predictors of stroke and the long-term risk after TAVR remain incompletely understood. OBJECTIVES: The authors sought to investigate the short- and long-term incidence and predictors of stroke after TAVR in the SwissTAVI Registry. METHODS: Between February 2011 and June 2021, consecutive patients undergoing TAVR were included. Standardized stroke ratios (SSRs) were calculated to compare trends in stroke of TAVR patients with an age- and sex-matched general population in Switzerland derived from the 2019 Global Burden of Disease study. RESULTS: A total of 11,957 patients (81.8 ± 6.5 years of age, 48.0% female) were included. One-third of the patients (32.3%) had a history of atrial fibrillation, and 11.8% had a history of cerebrovascular accident. The cumulative 30-day incidence rate of stroke was 3.0%, with 69% of stroke events occurring within the first 48 hours after TAVR. The incidence of stroke was 4.3% at 1 year, and 7.8% at 5 years. Compared with an age- and sex-adjusted general population, the risk of stroke was significantly higher in the TAVR population during the first 2 years after TAVR: first year: SSR 7.26 (95% CI: 6.3-8.36) and 6.82 (95% CI: 5.97-7.79) for males and females, respectively; second year: SSR 1.98 (95% CI: 1.47-2.67) and 1.48 (95% CI: 1.09-2.02) for males and females, respectively; but returned to a comparable level to that observed in the matched population thereafter. CONCLUSIONS: Compared with an age- and sex-matched population, TAVR patients experienced a higher risk of stroke for up to 2 years after the procedure, and a comparable risk thereafter. (SwissTAVI Registry; NCT01368250).

Association of chocolate consumption with neurological and cardiovascular outcomes in atrial fibrillation: data from two Swiss atrial fibrillation cohort studies (Swiss-AF and BEAT-AF).

AIM: To assess the associations of chocolate consumption with neurocognitive function, brain lesions on magnetic resonance imaging (MRI), and cardiovascular outcome in patients with atrial fibrillation (AF). METHODS: We analysed data from patients of two prospective multicentre Swiss atrial fibrillation cohort studies (Swiss-AF) and (BEAT-AF). Assessments of MRI findings and neurocognitive function were performed only in the Swiss-AF population (in 1727 of 2415 patients [71.5%] with a complete data set), as patients enrolled in BEAT-AF were not systematically evaluated for these outcomes. Otherwise, the two cohorts had an equivalent set of clinical assessments. Clinical outcome analysis was performed in 3931 patients of both cohorts. Chocolate consumption was assessed by questionnaire. Patients were categorised as no/low chocolate consumption (No/Low-Ch) ≤1 servings/week, moderate chocolate consumption (Mod-Ch) >1-6 servings/week, and high chocolate consumption (High-Ch) >6 servings/week, respectively. Brain lesions were evaluated by MRI. Assessment of cognitive function was performed by neurocognitive functional testing and included global cognition measurement with a cognitive construct score. Cerebral MRI and cognition were evaluated at baseline. Cross-sectional associations between chocolate consumption and MRI findings were analysed by multivariate logistic regression models and associations with neurocognitive function by multivariate linear regression models. Clinical outcome events during follow-up were recorded and assessed by a clinical event committee. The associations between chocolate consumption and clinical outcomes were evaluated by Cox regression models. The median follow-up time was 6 years. RESULTS: Chocolate consumption was not associated with prevalence or volume of vascular brain lesions on MRI, nor major adverse cardiac events (ischaemic stroke, myocardial infarction, cardiovascular death). However, No/Low-Ch was independently associated with a lower cognitive construct score compared to Mod-Ch (No/Low-Ch vs. Mod-Ch: coeff. -0.05, 95% CI -0.10-0), whereas other neurocognitive function tests were not independently associated with chocolate consumption categories. In addition, there was a higher risk of heart failure hospitalisation (No/Low-Ch vs. Mod-Ch: HR 1.24, 95% CI 1.01-1.52) and of all-cause mortality (No/Low-Ch vs. Mod-Ch: HR 1.29, 95% CI 1.06-1.58) in No/Low-Ch compared to Mod-Ch. No significant associations with the evaluated outcomes were observed when High-Ch was compared to Mod-Ch. CONCLUSION: While chocolate consumption was not associated with MRI findings and major adverse cardiac events in an atrial fibrillation population, No/Low-Ch was associated with a lower cognitive construct score, higher risk of heart failure hospitalisation and increased all-cause mortality compared to Mod-Ch. CLINICALTRIALS: gov Identifier: NCT02105844.

Restoration of Life Expectancy After Transcatheter Edge-to-Edge Mitral Valve Repair.

BACKGROUND: Survival data after mitral transcatheter edge-to-edge repair (TEER) are scarce, and its impact on predicted life expectancy is unknown. OBJECTIVES: The aim of this study was to estimate the impact of TEER on postprocedural life expectancy among patients enrolled in the MitraSwiss registry through a relative survival (RS) analysis. METHODS: Consecutive TEER patients 60 to 89 years of age enrolled between 2011 and 2018 (N = 1140) were evaluated. RS was defined as the ratio between post-TEER survival and expected survival in an age-, sex- and calendar period-matched group derived from the Swiss national 2011 to 2019 mortality tables. The primary aim was to assess 5-year survival and RS after TEER. The secondary aim was to assess RS according to the etiology of mitral regurgitation, age class and sustained procedural success over time. RESULTS: Overall, 5-year survival after TEER was 59.3% (95% CI: 54.9%-63.4%), whereas RS reached 80.5% (95% CI: 74.6%-86.0%). RS was 91.1% (95% CI: 82.5%-98.6%) in primary mitral regurgitation (PMR) and 71.5% (95% CI: 63.0%-79.3%) in secondary mitral regurgitation (SMR). Patients 80 to 89 years of age (n = 579) showed high 5-year RS (93.0%; 95% CI: 83.3%-101.9%). In this group, restoration of predicted life expectancy was achieved in PMR with a 5-year RS of 100% (95% CI: 87.9%-110.7%), whereas sustained procedural success increased the RS rate to 90.6% (95% CI: 71.3%-107.3%) in SMR. CONCLUSIONS: Mitral TEER in patients 80 to 89 years of age is able to restore predicted life expectancy in PMR, whereas in SMR with sustained procedural success, high RS estimates were observed. Our analysis suggests that successful, sustained mitral regurgitation reduction is key to survival improvement, particularly in patients 80 to 89 years of age.

[Update Valvular Heart Disease: Heart Team Decision-Making Based on Patient Examples]. / Update valvuläre Herzkrankheiten: Entscheidungen im interdisziplinären Herzteam anhand von Beispielen.

INTRODUCTION: In Europe, mitral regurgitation and aortic stenosis are the most common valve lesions requiring interventions. In advanced stages, these valve pathologies affect patients' quality of life and prognosis. The prevalence of mitral regurgitation and aortic stenosis is increasing with age. In view of an aging population and the comorbidities associated with age, these valve defects represent an increasing challenge to health care providers. Nowadays, surgical as well as catheter-based treatment options are available to treat affected patients. Therapeutic strategies suitable to the individual patient should be discussed in interdisciplinary heart teams. The aim of the present article is to give an overview of possible guideline-conform heart team decisions based on patient examples.

Valor pronóstico de las frecuencias cardiacas bajas en pacientes ingresados con infarto agudo de miocardio / Prognostic value of low heart rates in patients admitted with acute myocardial infarction

Introducción y objetivos: Las escalas de predicción de riesgo utilizadas en síndromes coronarios agudos (SCA) utilizan modelos incrementales para estimar mortalidad para frecuencias cardiacas (FCs)> 60 lpm. Sin embargo, estudios previos comunicaron una relación no lineal entre la FC y los eventos, lo que sugiere que la FC baja puede tener un papel pronóstico no reconocido. El objetivo fue valorar el impacto pronóstico de las FCs baja en el SCA, definida como frecuencia cardiaca de admisión <50 lpm. Métodos: El estudio analizó datos del registro AMIS Plus, una cohorte de pacientes hospitalizados con SCA entre 1999 y 2021. El criterio de valoración principal fue la mortalidad hospitalaria por todas las causas, mientras que el compuesto de mortalidad por todas las causas se estableció por eventos cardiacos/cerebrovasculares mayores como secundario. Se adoptó una metodología estadística multinivel para evaluar el papel pronóstico de la FC baja en el SCA. Resultados: Se incluyó a 51.001 pacientes. La estimación cruda mostró una distribución bimodal de las variables resultados primaria y secundaria a FCs bajas y altas. Se observó una relación no lineal entre FCs y mortalidad intrahospitalaria mediante análisis restringido de spline cúbico. Una FC entre 50-75 mostró menor mortalidad que FC <50 lpm (OR=0,67; IC95%, 0,47-0,99) solo tras el análisis primario multivariado, no confirmado tras análisis múltiples de sensibilidad. Tras la puntuación de propensión emparejada, se hizo evidente el desvanecimiento progresivo del papel pronóstico de la FC <50 lpm. Conclusiones: Las FCs baja al ingreso en SCA se asocian a una mayor tasa cruda de eventos adversos. No obstante, tras la corrección de las diferencias basales, no se confirmó el papel pronóstico de la FC baja, sino que representa más bien un marcador de morbilidad subyacente. Estos resultados pueden ser clínicamente relevantes para mejorar la precisión de las puntuaciones de riesgo en el SCA.(AU)

Introduction and objectives: The risk prediction scores adopted in acute coronary syndromes (ACS) use incremental models to estimate mortality for heart rate (HR) above 60 bpm. Nonetheless, previous studies reported a nonlinear relationship between HR and events, suggesting that low HR may have an unrecognized prognostic role. We aimed to assess the prognostic impact of low HR in ACS, defined as admission HR <50 bpm. Methods: This study analyzed data from the AMIS Plus registry, a cohort of hospitalized patients with ACS between 1999 and 2021. The primary endpoint was in-hospital all-cause mortality, while a composite of all-cause mortality, major cardiac/cerebrovascular events was set as the secondary endpoint. A multilevel statistical method was used to assess the prognostic role of low HR in ACS. Results: The study included 51 001 patients. Crude estimates showed a bimodal distribution of primary and secondary endpoints with peaks at low and high HR. A nonlinear relationship between HR and in-hospital mortality was observed on restricted cubic spline analysis. An HR of 50 to 75 bpm showed lower mortality than HR <50 bpm (OR, 0.67; 95%CI, 0.47-0.99) only after primary multivariable analysis, which was not confirmed after multiple sensitivity analyses. After propensity score matching, progressive fading of the prognostic role of HR <50 bpm was evident. Conclusions: Low admission HR in ACS is associated with a higher crude rate of adverse events. Nonetheless, after correction for baseline differences, the prognostic role of low HR was not confirmed. Therefore, low HR probably represents a marker of underlying morbidity. These results may be clinically relevant in improving the accuracy of risk scores in ACS.(AU)

Sex-specific inequalities in the use of drug-coated balloons for small coronary artery disease: a report from the BASKET-SMALL 2 trial.

BACKGROUND AND OBJECTIVES: Recent data have established non-inferiority of drug-coated balloons (DCB) compared to drug-eluting stents (DES) for treatment of small-vessel coronary artery disease. Since coronary vessels in women might have anatomical and pathophysiological particularities, the safety of the DCB strategy among women compared to men needs to be assessed in more detail. METHODS: In BASKET-SMALL 2, patients with de novo lesions in coronary vessels < 3 mm and an indication for percutaneous coronary intervention were randomly allocated (1:1) to DCB vs. DES after successful lesion preparation. The primary objective of the randomized trial was to establish non-inferiority of DCB vs. DES regarding major adverse cardiac events (MACE; i.e., cardiac death, non-fatal myocardial infarction, and target vessel revascularization) after 12 months. The aim of the current sub-analysis is to evaluate whether the DCB strategy is equally safe among women and men after 12 and 36 months. RESULTS: Among 758 randomized patients, 382 were assigned to DCB (23% women) and 376 to DES (30% women). In general, women were older, had more often diabetes mellitus and renal insufficiency, and presented more often with an acute coronary syndrome, whereas men were more often smokers, had multivessel disease and a previous history of acute myocardial infarction, and received a treatment with a statin. After 3 years, the primary clinical end point was not significantly different between groups (13% women vs. 16% men, HR 0.82; 95% CI 0.52-1.30; p = 0.40). There was no interaction between sex and coronary intervention strategy regarding MACE at 36 months (10% women vs. 16% men in DCB, 16% women vs. 15% men in DES; pinteraction = 0.31). CONCLUSION: In small native coronary artery disease, there was no statistically significant effect of sex on the difference between DCB and DES regarding MACE up to 36 months. CLINICAL TRIAL REGISTRATION: URL: http://www. CLINICALTRIALS: gov . Unique identifier: NCT01574534. CAD coronary artery disease, MACE major adverse cardiovascular events, HR Hazard ratio, DCB drug-coated balloon, DES drug-eluting stent.

Impact of chronic kidney disease and diabetes on clinical outcomes in women undergoing PCI.

BACKGROUND: For women undergoing drug-eluting stent (DES) implantation, the individual and combined impact of chronic kidney disease (CKD) and diabetes mellitus (DM) on outcomes is uncertain. AIMS: We sought to assess the impact of CKD and DM on prognosis in women after DES implantation. METHODS: We pooled patient-level data on women from 26 randomised controlled trials comparing stent types. Women receiving DES were stratified into 4 groups based on CKD (defined as creatine clearance <60 mL/min) and DM status. The primary outcome at 3 years after percutaneous coronary intervention was the composite of all-cause death or myocardial infarction (MI); secondary outcomes included cardiac death, stent thrombosis and target lesion revascularisation. RESULTS: Among 4,269 women, 1,822 (42.7%) had no CKD/DM, 978 (22.9%) had CKD alone, 981 (23.0%) had DM alone, and 488 (11.4%) had both conditions. The risk of all-cause death or MI was not increased in women with CKD alone (adjusted hazard ratio [adj. HR] 1.19, 95% confidence interval [CI]: 0.88-1.61) nor DM alone (adj. HR 1.27, 95% CI: 0.94-1.70), but was significantly higher in women with both conditions (adj. HR 2.64, 95% CI: 1.95-3.56; interaction p-value <0.001). CKD and DM in combination were associated with an increased risk of all secondary outcomes, whereas alone, each condition was only associated with all-cause death and cardiac death. CONCLUSIONS: Among women receiving DES, the combined presence of CKD and DM was associated with a higher risk of the composite of death or MI and of any secondary outcome, whereas alone, each condition was associated with an increase in all-cause and cardiac death.

Severe structural valve deterioration after TAVR with ACURATE Neo: report of two cases.

Structural valve deterioration (SVD) of transcatheter implanted aortic valve (TAVR) prostheses leading to prosthesis dysfunction is an uncommon yet increasingly described complication. Literature is scarce on specific mechanisms and clinical presentation of SVD after TAVR, notably on self-expanding valve ACURATE Neo. We report on two cases with severe bioprosthetic failure after ACURATE Neo implantation due to leaflet disruption, and we treated them with surgical aortic valve replacement. Based on the literature, we further discuss the incidence of SVD after TAVR, the durability of ACURATE NEO, and the modes of failure of biological valve prostheses.

Clinical Outcomes in High-Gradient, Classical Low-Flow, Low-Gradient, and Paradoxical Low-Flow, Low-Gradient Aortic Stenosis After Transcatheter Aortic Valve Implantation: A Report From the SwissTAVI Registry.

Background In view of the rising global burden of severe symptomatic aortic stenosis, its early recognition and treatment is key. Although patients with classical low-flow, low-gradient (C-LFLG) aortic stenosis have higher rates of death after transcatheter aortic valve implantation (TAVI) when compared with patients with high-gradient (HG) aortic stenosis, there is conflicting evidence on the death rate in patients with severe paradoxical low-flow, low-gradient (P-LFLG) aortic stenosis. Therefore, we aimed to compare outcomes in real-world patients with severe HG, C-LFLG, and P-LFLG aortic stenosis undergoing TAVI. Methods and Results Clinical outcomes up to 5 years were addressed in the 3 groups of patients enrolled in the prospective, national, multicenter SwissTAVI registry. A total of 8914 patients undergoing TAVI at 15 heart valve centers in Switzerland were analyzed for the purpose of this study. We observed a significant difference in time to death at 1 year after TAVI, with the lowest observed in HG (8.8%) aortic stenosis, followed by P-LFLG (11.5%; hazard ratio [HR], 1.35 [95% CI, 1.16-1.56]; P<0.001) and C-LFLG (19.8%; HR, 1.93 [95% CI, 1.64-2.26]; P<0.001) aortic stenosis. Cardiovascular death showed similar differences between the groups. At 5 years, the all-cause death rate was 44.4% in HG, 52.1% in P-LFLG (HR, 1.35 [95% CI, 1.23-1.48]; P<0.001), and 62.8% in C-LFLG aortic stenosis (HR, 1.7 [95% CI, 1.54-1.88]; P<0.001). Conclusions Up to 5 years after TAVI, patients with P-LFLG have higher death rates than patients with HG aortic stenosis but lower death rates than patients with C-LFLG aortic stenosis.

Impact of coronary artery disease on clinical outcomes after TAVR: Insights from the BRAVO-3 randomized trial.

OBJECTIVE: To determine the prognostic impact of coronary artery disease (CAD) in patients randomized to bivalirudin or unfractionated heparin (UFH) during transcatheter aortic valve replacement (TAVR). BACKGROUND: CAD is a common comorbidity among patients undergoing TAVR and studies provide conflicting data on its prognostic impact. METHODS: The Bivalirudin on Aortic Valve Intervention Outcomes-3 (BRAVO-3) randomized trial compared the use of bivalirudin versus UFH in 802 high-surgical risk patients undergoing transfemoral TAVR for severe symptomatic aortic stenosis. Patients were stratified according to the presence or absence of history of CAD as well as periprocedural anticoagulation. The coprimary endpoints were net adverse cardiac events (NACE; a composite of all-cause mortality, myocardial infarction, stroke, or major bleeding) and major Bleeding Academic Research Consortium (BARC) bleeding ≥3b at 30 days postprocedure. RESULTS: Among 801 patients, 437 (54.6%) had history of CAD of whom 223 (51.0%) received bivalirudin. There were no significant differences in NACE (adjusted odds ratio [OR]: 1.04; 95% confidence interval [CI]: 0.69-1.58) or BARC ≥ 3b bleeding (adjusted OR: 0.84; 95% CI: 0.51-1.39) in patients with vs without CAD at 30 days. Among CAD patients, periprocedural use of bivalirudin was associated with similar NACE (OR: 0.80; 95% CI: 0.47-1.35) and BARC ≥ 3b bleeding (OR: 0.64; 95% CI: 0.33-1.25) compared with UFH, irrespective of history of CAD (p-interaction = 0.959 for NACE; p-interaction = 0.479 for major bleeding). CONCLUSION: CAD was not associated with a higher short-term risk of NACE or major bleeding after TAVR. Periprocedural anticoagulation with bivalirudin did not show any advantage over UFH in patients with and without CAD.

Twenty-year trends in the prevalence of modifiable cardiovascular risk factors in young acute coronary syndrome patients hospitalized in Switzerland.

AIMS: Modifiable cardiovascular risk factors (RFs) play a key role in the development of coronary artery disease. We evaluated 20-year trends in RF prevalence among young adults hospitalized with acute coronary syndromes (ACS) in Switzerland. METHODS AND RESULTS: Data were analysed from the Acute Myocardial Infarction in Switzerland (AMIS) Plus registry from 2000 to 2019. Young patients were defined as those aged <50 years. Among 58 028 ACS admissions, 7073 (14.1%) were young (median 45.6 years, IQR 42.0-48.0), of which 91.6% had at least one modifiable RF and 59.0% had at least two RFs. Smoking was the most prevalent RF (71.4%), followed by dyslipidaemia (57.3%), hypertension (35.9%), obesity (21.7%), and diabetes (10.1%). Compared with older patients, young patients were more likely to be obese (21.7% vs. 17.4%, P < 0.001) and active smokers (71.4% vs. 33.9%, P < 0.001). Among young patients, between 2000 and 2019, there was a significant increase in the prevalence of hypertension from 29.0% to 51.3% and obesity from 21.2% to 27.1% (both Ptrend < 0.001) but a significant decrease in active smoking from 72.5% to 62.5% (Ptrend = 0.02). There were no significant changes in the prevalence of diabetes (Ptrend = 0.32) or dyslipidaemia (Ptrend = 0.067). CONCLUSION: Young ACS patients in Switzerland exhibit a high prevalence of RFs and are more likely than older patients to be obese and smokers. Between 2000 and 2019, RF prevalence either increased or remained stable, except for smoking which decreased but still affected approximately two-thirds of young patients in 2019. Public health initiatives targeting RFs in young adults in Switzerland are warranted.

We evaluated the prevalence of risk factors (RFs) among young patients admitted with ACS in Switzerland between 2000 and 2019. Young ACS patients in Switzerland exhibited a high prevalence of RFs. There was a significant increase in the prevalence of hypertension and obesity. Despite a significant decrease, active smoking remained the most prevalent RF. These findings strongly suggest that public health initiatives targeting RFs in young adults in Switzerland are warranted.

Impact of Insulin-Treated Compared to Non-Insulin-Treated Diabetes Mellitus on Outcome of Percutaneous Coronary Intervention with Drug-Coated Balloons versus Drug-Eluting Stents in De Novo Coronary Artery Disease: The Randomized BASKET-SMALL 2 Trial.

BACKGROUND: We evaluated the outcome of PCI of de novo stenosis with drug-coated balloons (DCB) versus drug-eluting stents (DES) in patients with insulin-treated diabetes mellitus (ITDM) versus non-insulin-treated diabetes mellitus (NITDM). METHODS: Patients were randomized in the BASKET-SMALL 2 trial to DCB or DES and followed over 3 years for MACE (cardiac death, non-fatal myocardial infarction [MI], and target vessel revascularization [TVR]). Outcome in the diabetic subgroup (n = 252) was analyzed with respect to ITDM or NITDM. RESULTS: In NITDM patients (n = 157), rates of MACE (16.7% vs. 21.9%, hazard ratio [HR] 0.68, 95% confidence interval [CI] 0.29-1.58, p = 0.37), death, non-fatal MI, and TVR (8.4% vs. 14.5%, HR 0.30, 95% CI 0.09-1.03, p = 0.057) were similar between DCB and DES. In ITDM patients (n = 95), rates of MACE (DCB 23.4% vs. DES 22.7%, HR 1.12, 95% CI 0.46-2.74, p = 0.81), death, non-fatal MI, and TVR (10.1% vs. 15.7%, HR 0.64, 95% CI 0.18-2.27, p = 0.49) were similar between DCB and DES. TVR was significantly lower with DCB versus DES in all diabetic patients (HR 0.41, 95% CI 0.18-0.95, p = 0.038). CONCLUSIONS: DCB compared to DES for treatment of de novo coronary lesions in diabetic patients was associated with similar rates of MACE and numerically lower need for TVR both for ITDM and NITDM patients.

Prognostic value of low heart rates in patients admitted with acute myocardial infarction.

INTRODUCTION AND OBJECTIVES: The risk prediction scores adopted in acute coronary syndromes (ACS) use incremental models to estimate mortality for heart rate (HR) above 60 bpm. Nonetheless, previous studies reported a nonlinear relationship between HR and events, suggesting that low HR may have an unrecognized prognostic role. We aimed to assess the prognostic impact of low HR in ACS, defined as admission HR <50 bpm. METHODS: This study analyzed data from the AMIS Plus registry, a cohort of hospitalized patients with ACS between 1999 and 2021. The primary endpoint was in-hospital all-cause mortality, while a composite of all-cause mortality, major cardiac/cerebrovascular events was set as the secondary endpoint. A multilevel statistical method was used to assess the prognostic role of low HR in ACS. RESULTS: The study included 51 001 patients. Crude estimates showed a bimodal distribution of primary and secondary endpoints with peaks at low and high HR. A nonlinear relationship between HR and in-hospital mortality was observed on restricted cubic spline analysis. An HR of 50 to 75 bpm showed lower mortality than HR <50 bpm (OR, 0.67; 95%CI, 0.47-0.99) only after primary multivariable analysis, which was not confirmed after multiple sensitivity analyses. After propensity score matching, progressive fading of the prognostic role of HR <50 bpm was evident. CONCLUSIONS: Low admission HR in ACS is associated with a higher crude rate of adverse events. Nonetheless, after correction for baseline differences, the prognostic role of low HR was not confirmed. Therefore, low HR probably represents a marker of underlying morbidity. These results may be clinically relevant in improving the accuracy of risk scores in ACS.