Sex-related characteristics and short-term outcomes of patients undergoing transcatheter tricuspid valve intervention for tricuspid regurgitation.

AIMS: The impact of sexuality in patients with significant tricuspid regurgitation (TR) undergoing transcatheter tricuspid valve intervention (TTVI) is unknown. The aim of this study was to investigate sex-specific outcomes in patients with significant TR treated with TTVI vs. medical therapy alone. METHODS AND RESULTS: The Transcatheter Tricuspid Valve Therapies (TriValve) registry collected data on patients with significant TR from 24 centres who underwent TTVI from 2016 to 2021. A control cohort was formed by medically managed patients with ≥severe isolated TR diagnosed in 2015-18. The primary endpoint was freedom from all-cause mortality. Secondary endpoints were heart failure (HF) hospitalization, New York Heart Association (NYHA) functional status, and TR severity. One-year outcomes were assessed for the TriValve cohort and compared with the control cohort with the inverse probability of treatment weighting (IPTW). A total of 556 and 2072 patients were included from the TriValve and control groups, respectively. After TTVI, there was no difference between women and men in 1-year freedom from all-cause mortality 80.9% vs. 77.9%, P = 0.56, nor in HF hospitalization (P = 0.36), NYHA Functional Classes III and IV (P = 0.17), and TR severity >2+ at last follow-up (P = 0.42). Multivariable Cox-regression weighted by IPTW showed improved 1-year survival after TTVI compared with medical therapy alone in both women (adjusted hazard ratio 0.45, 95% confidence interval 0.23-0.83, P = 0.01) and men (adjusted hazard ratio 0.42, 95% confidence interval 0.18-0.89, P = 0.03). CONCLUSION: After TTVI in high-risk patients, there were no sex-related differences in terms of survival, HF hospitalization, functional status, and TR reduction up to 1 year. The IPTW analysis shows a survival benefit of TTVI over medical therapy alone in both women and men.

Amulet or Watchman Device for Percutaneous Left Atrial Appendage Closure: Primary Results of the SWISS-APERO Randomized Clinical Trial.

BACKGROUND: No study has so far compared Amulet with the new Watchman FLX in terms of residual left atrial appendage (LAA) patency or clinical outcomes in patients undergoing percutaneous LAA closure. METHODS: In the investigator-initiated SWISS APERO trial (Comparison of Amulet Versus Watchman/FLX Device in Patients Undergoing Left Atrial Appendage Closure), patients undergoing LAA closure were randomly assigned (1:1) open label to receive Amulet or Watchman 2.5 or FLX (Watchman) across 8 European centers. The primary end point was the composite of justified crossover to a nonrandomized device during LAA closure procedure or residual LAA patency detected by cardiac computed tomography angiography (CCTA) at 45 days. The secondary end points included procedural complications, device-related thrombus, peridevice leak at transesophageal echocardiography, and clinical outcomes at 45 days. RESULTS: Between June 2018 and May 2021, 221 patients were randomly assigned to Amulet (111 [50.2%]) or Watchman (110 [49.8%]), of whom 25 (22.7%) patients included before October 2019 received Watchman 2.5, and 85 (77.3%) patients received Watchman FLX. The primary end point was assessable in 205 (92.8%) patients and occurred in 71 (67.6%) patients receiving Amulet and 70 (70.0%) patients receiving Watchman, respectively (risk ratio, 0.97 [95% CI, 0.80-1.16]; P=0.713). A single justified crossover occurred in a patient with Amulet who fulfilled LAA patency criteria at 45-day CCTA. Major procedure-related complications occurred more frequently in the Amulet group (9.0% versus 2.7%; P=0.047) because of more frequent bleeding (7.2% versus 1.8%). At 45 days, the peridevice leak rate at transesophageal echocardiography was higher with Watchman than with Amulet (27.5% versus 13.7%, P=0.020), albeit none was major (ie, >5 mm), whereas device-related thrombus was detected in 1 (0.9%) patient with Amulet and 3 (3.0%) patients with Watchman at CCTA and in 2 (2.1%) and 5 (5.5%) patients at transesophageal echocardiography, respectively. Clinical outcomes at 45 days did not differ between the groups. CONCLUSIONS: Amulet was not associated with a lower rate of the composite of crossover or residual LAA patency compared with Watchman at 45-day CCTA. Amulet, however, was associated with lower peridevice leak rates at transesophageal echocardiography, higher procedural complications, and similar clinical outcomes at 45 days compared with Watchman. The clinical relevance of CCTA-detected LAA patency requires further investigation. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03399851.

Additional value of cardiac magnetic resonance feature tracking parameters for the evaluation of the arrhythmic risk in patients with mitral valve prolapse.

OBJECTIVES: The identification of patients with mitral valve prolapse (MVP) presenting high arrhythmic risk remains challenging. Cardiovascular Magnetic Resonance (CMR) feature tracking (FT) may improve risk stratification. We analyzed the role of CMR-FT parameters in relation to the incidence of complex ventricular arrhythmias (cVA) in patients with MVP and mitral annular disjunction (MAD). METHODS: 42 patients with MVP and MAD who underwent 1.5 T CMR were classified as MAD-cVA (n = 23, 55%) in case of cVA diagnosed on a 24-h Holter monitoring and as MAD-noVA in the absence of cVA (n = 19, 45%). MAD length, late gadolinium enhancement (LGE), basal segments myocardial extracellular volume (ECV) and CMR-FT were assessed. RESULTS: LGE was more frequent in the MAD-cVA group in comparison with the MAD-noVA group (78% vs 42%, p = 0.002) while no difference was observed in terms of basal ECV. Global longitudinal strain (GLS) was reduced in MAD-cVA compared to MAD-noVA (- 18.2% ± 4.6% vs - 25.1% ± 3.1%, p = 0.004) as well as global circumferential strain (GCS) at the mid-ventricular level (- 17.5% ± 4.7% vs - 21.6% ± 3.1%, p = 0.041). Univariate analysis identified as predictors of the incidence of cVA: GCS, circumferential strain (CS) in the basal and mid infero-lateral wall, GLS, regional longitudinal strain (LS) in the basal and mid-ventricular inferolateral wall. Reduced GLS [Odd ratio (OR):1.56 (confidence interval (CI) 95%: 1.45-2.47; p < 0.001)] and regional LS in the basal inferolateral wall [OR: 1.62 (CI 95%: 1.22-2.13; p < 0.001)] remained independent prognostic factors in multivariate analysis. CONCLUSION: In patients with MVP and MAD, CMR-FT parameters are correlated with the incidence of cVA and may be of interest in arrhythmic risk stratification.

Role of genetic testing in young patients with idiopathic atrioventricular conduction disease.

AIMS: To investigate the role of genetic testing in patients with idiopathic atrioventricular conduction disease requiring pacemaker (PM) implantation before the age of 50 years. METHODS AND RESULTS: All consecutive PM implantations in Southern Switzerland between 2010 and 2019 were evaluated. Inclusion criteria were: (i) age at the time of PM implantation: < 50 years; (ii) atrioventricular block (AVB) of unknown aetiology. Study population was investigated by ajmaline challenge and echocardiographic assessment over time. Genetic testing was performed using next-generation sequencing panel, containing 174 genes associated to inherited cardiac diseases, and Sanger sequencing confirmation of suspected variants with clinical implication. Of 2510 patients who underwent PM implantation, 15 (0.6%) were young adults (median age: 44 years, male predominance) presenting with advanced AVB of unknown origin. The average incidence of idiopathic AVB computed over the 2010-2019 time window was 0.7 per 100 000 persons per year (95% CI 0.4-1.2). Most of patients (67%) presented with specific genetic findings (pathogenic variant) or variants of uncertain significance (VUS). A pathogenic variant of PKP2 gene was found in one patient (6.7%) with no overt structural cardiac abnormalities. A VUS of TRPM4, MYBPC3, SCN5A, KCNE1, LMNA, GJA5 genes was found in other nine cases (60%). Of these, three unrelated patients (20%) presented the same heterozygous missense variant c.2531G > A p.(Gly844Asp) in TRPM4 gene. Diagnostic re-assessment over time led to a diagnosis of Brugada syndrome and long-QT syndrome in two patients (13%). No cardiac events occurred during a median follow-up of 72 months. CONCLUSION: Idiopathic AVB in adults younger than 50 years is a very rare condition with an incidence of 0.7 per 100 000 persons/year. Systematic investigations, including genetic testing and ajmaline challenge, can lead to the achievement of a specific diagnosis in up to 20% of patients. Heterozygous missense variant c.2531G > A p.(Gly844Asp) in TRPM4 gene was found in an additional 20% of unrelated patients, suggesting possible association of the variant with the disease.

Association of transcatheter edge-to-edge repair with improved survival in older patients with severe, symptomatic degenerative mitral regurgitation.

BACKGROUND: Randomized clinical trials demonstrated transcatheter edge-to-edge repair (TEER) efficacy in improving outcome vs. medical management for functional mitral regurgitation, but limited randomized data are available for the treatment of degenerative mitral regurgitation (DMR). We aimed to compare the outcome of older patients treated with TEER vs. unoperated DMR. METHODS AND RESULTS: Registries including consecutive patients ≥65 years with symptomatic severe DMR treated with TEER (MitraSwiss and Minneapolis Heart Institute registries) or unoperated (MIDA registry) were analysed. Survival was compared overall and after matching for age, sex, EuroSCORE II, and ejection fraction. The study included 1187 patients (872 treated with TEER and 315 unoperated). During 24 ± 17 months of follow-up, 430 patients died, 18 ± 1% at 1 year and 50 ± 2% at 4 years. Patients undergoing TEER had similar age (82 ± 6 vs. 82 ± 7 years) and sex to unoperated patients, but higher surgical risk/comorbidity (EuroSCORE II 3.98 ± 4.28% vs. 2.77 ± 2.46%), more symptoms, and atrial fibrillation (P < 0.0001). Transcatheter edge-to-edge repair was associated with lower mortality accounting for age, sex, EuroSCORE II, New York Heart Association class, atrial fibrillation, and ejection fraction [hazard ratio (HR): 0.47, 95% confidence interval (CI): 0.37-0.58; P < 0.0001]. After propensity matching (247 pairs of patients), TEER consistently showed better survival compared with unoperated patients (49 ± 6% vs. 37 ± 3% at 4 years, P < 0.0001) even in comprehensive multivariable analysis (HR: 0.60, 95% CI: 0.40-0.91; P = 0.03). Procedural failure was infrequent but post-procedural mitral regurgitation, remaining moderate-to-severe in 66 (7.6%) patients, was associated with excess mortality vs. trivial residual regurgitation (30 ± 6% vs. 11 ± 1% at 1 year, P < 0.0001). CONCLUSION: Amongst older patients with severe symptomatic DMR at high surgical risk, mitral TEER was associated with higher survival vs. unoperated patients. Successful control of mitral regurgitation was key to survival improvement with mitral TEER, which should be actively considered in patients deemed inoperable.

Duration of antiplatelet therapy after complex percutaneous coronary intervention in patients at high bleeding risk: a MASTER DAPT trial sub-analysis.

AIM: To assess the effects of 1- or ≥3-month dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients who received biodegradable-polymer sirolimus-eluting stents for complex percutaneous coronary intervention (PCI) and/or acute coronary syndrome (ACS). METHODS AND RESULTS: In the MASTER DAPT trial, 3383 patients underwent non-complex (abbreviated DAPT, n = 1707; standard DAPT, n = 1676) and 1196 complex (abbreviated DAPT, n = 588; standard DAPT, n = 608) PCI. Co-primary outcomes at 335 days were net adverse clinical events [NACE; composite of all-cause death, myocardial infarction, stroke, and bleeding academic research consortium (BARC) 3 or 5 bleeding events]; major adverse cardiac or cerebral events (MACCE; all-cause death, myocardial infarction, and stroke); and Types 2, 3, or 5 BARC bleeding. Net adverse clinical events and MACCE did not differ with abbreviated vs. standard DAPT among patients with complex [hazard ratio (HR): 1.03, 95% confidence interval (CI): 0.69-1.52, and HR: 1.24, 95% CI: 0.79-1.92, respectively] and non-complex PCI (HR: 0.90, 95% CI: 0.71-1.15, and HR: 0.91, 95% CI: 0.69-1.21; Pinteraction = 0.60 and 0.26, respectively). BARC 2, 3, or 5 was reduced with abbreviated DAPT in patients with and without complex PCI (HR: 0.64; 95% CI: 0.42-0.98, and HR: 0.70; 95% CI: 0.55-0.89; Pinteraction = 0.72). Among the 2816 patients with complex PCI and/or ACS, NACE and MACCE did not differ and BARC 2, 3, or 5 was lower with abbreviated DAPT. CONCLUSION: In HBR patients free from recurrent ischaemic events at 1 month, DAPT discontinuation was associated with similar NACE and MACCE and lower bleeding rates compared with standard DAPT, regardless of PCI or patient complexity. CLINICAL TRIAL REGISTRATION: This trial is registered with ClinicalTrials.gov, number NCT03023020, and is closed to new participants, with follow-up completed.

Sex Differences in Epidemiology, Morphology, Mechanisms, and Treatment of Mitral Valve Regurgitation.

Sex-related disparities have been recognized in incidence, pathological findings, pathophysiological mechanisms, and diagnostic pathways of non-rheumatic mitral regurgitation. Furthermore, access to treatments and outcomes for surgical and interventional therapies among women and men appears to be different. Despite this, current European and US guidelines have identified common diagnostic and therapeutic pathways that do not consider patient sex in decision-making. The aim of this review is to summarize the current evidence on sex-related differences in non-rheumatic mitral regurgitation, particularly regarding incidence, imaging modalities, surgical-derived evidence, and outcomes of transcatheter edge-to-edge repair, with the goal of informing clinicians about sex-specific challenges to consider when making treatment decisions for patients with mitral regurgitation.

Controlled-Level EVERolimus in Acute Coronary Syndrome (CLEVER-ACS) - A phase II, randomized, double-blind, multi-center, placebo-controlled trial.

BACKGROUND: Activation of inflammatory pathways during acute myocardial infarction contributes to infarct size and left ventricular (LV) remodeling. The present prospective randomized clinical trial was designed to test the efficacy and safety of broad-spectrum anti-inflammatory therapy with a mammalian target of rapamycin (mTOR) inhibitor to reduce infarct size. DESIGN: Controlled-Level EVERolimus in Acute Coronary Syndrome (CLEVER-ACS, clinicaltrials.gov NCT01529554) is a phase II randomized, double-blind, multi-center, placebo-controlled trial on the effects of a 5-day course of oral everolimus on infarct size, LV remodeling, and inflammation in patients with acute ST-elevation myocardial infarction (STEMI). Within 5 days of successful primary percutaneous coronary intervention (pPCI), patients are randomly assigned to everolimus (first 3 days: 7.5 mg every day; days 4 and 5: 5.0 mg every day) or placebo, respectively. The primary efficacy outcome is the change from baseline (defined as 12 hours to 5 days after pPCI) to 30-day follow-up in myocardial infarct size as measured by cardiac magnetic resonance imaging (CMRI). Secondary endpoints comprise corresponding changes in cardiac and inflammatory biomarkers as well as microvascular obstruction and LV volumes assessed by CMRI. Clinical events, laboratory parameters, and blood cell counts are reported as safety endpoints at 30 days. CONCLUSION: The CLEVER-ACS trial tests the hypothesis whether mTOR inhibition using everolimus at the time of an acute STEMI affects LV infarct size following successful pPCI.

Temporal trends in cardiovascular risk factors' prevalence in patients with myocardial infarction.

INTRODUCTION AND OBJECTIVES: Little is known about changes in cardiovascular risk factors (CVRF) profile over time in patients presenting with acute myocardial infarction (AMI). METHODS: We assessed changes in age and CVRF profile in consecutive AMI patients enrolled in the Swiss nationwide AMIS Plus registry between 1 January 1997 and 31 December 2018. RESULTS: A total of 57 995 AMI patients were included in the analysis. Mean age at presentation was 71.5 ± 11.3 years for women and 63.9 ± 12.8 years for men and did not change over time. Overall, the mean (standard deviation) number of CVRF increased from 1.76 (1.07) in 1997/98 to 2.26 (1.10) in 2017/18 in men (Ptrend  < .001), while the corresponding rates in females were 1.83 (1.11) and 2.24 (1.08) (Ptrend  < .001). In terms of active smoking, no significant trend was detected for males, while there was a significant increase in females (P < .001). As a result, the gap in smoking rates between men and women presenting with AMI decreased from 19.9% (45.3% vs 25.4%) in 1997/98 to 7.9% (41.2% vs 33.3%) in 2017/18. Reassuring was the stability in terms of diabetes prevalence for both genders. Obesity was more prevalent over time in men, while the prevalence of hypertension and dyslipidemia increased in both genders. CONCLUSION: Among patients with AMI in Switzerland over two decades, age at presentation remained stable, while the mean number of CVRF increased in both men and women. Striking was the increase in the prevalence of smoking in women, leading to a reduction of the gender gap over time.

Elevated Troponin in Patients With Coronavirus Disease 2019: Possible Mechanisms.

Coronavirus disease 2019 (COVID-19) is a pandemic that has affected more than 1.8 million people worldwide, overwhelmed health care systems owing to the high proportion of critical presentations, and resulted in more than 100,000 deaths. Since the first data analyses in China, elevated cardiac troponin has been noted in a substantial proportion of patients, implicating myocardial injury as a possible pathogenic mechanism contributing to severe illness and mortality. Accordingly, high troponin levels are associated with increased mortality in patients with COVID-19. This brief review explores the available evidence regarding the association between COVID-19 and myocardial injury.

Heavy Drinking Habits Are Associated with Worse In-Hospital Outcomes in Patients with Acute Coronary Syndrome: An Insight from the AMIS Plus Registry.

BACKGROUND: The association between alcohol consumption and the occurrence of coronary heart disease is well described in the literature, while data regarding the impact of regular alcohol consumption on in-hospital outcomes in the setting of acute coronary syndrome (ACS) are lacking. We aimed to evaluate the impact of self-reported alcohol consumption on in-hospital outcomes in patients with ACS. METHODS: Data derived from patients enrolled between 2007 and 2019 in the Acute Myocardial Infarction in Switzerland (AMIS) Plus registry were retrospectively analyzed. Patients were stratified based on alcohol drinking pattern. Primary outcome was all-cause in-hospital mortality, while secondary outcomes were set as incidence of major adverse cardiac and cerebrovascular events (MACCEs). Outcome comparisons according to quantity of daily alcohol intake were also performed. RESULTS: Records concerning alcohol consumption were available in 25,707 patients; 5,298 of them (21%) fulfilled the criteria of regular alcohol consumption. Regular drinkers were predominantly male, younger, smokers, more comorbid and with a worse clinical presentation as compared with abstainers/occasional drinkers. Daily alcohol intake was reported in 4,059 (77%) of these patients (regular drinkers). Among them, 2,640 were light drinkers (≤2 drinks/day) and 1,419 heavy drinkers (>2 drinks/day). In-hospital mortality and MACCEs of heavy drinkers were significantly higher compared with those of light drinkers (5.4 vs. 3.3% and 7.0 vs. 4.4%, both p = 0.001). When tested together with Global Registry of Acute Coronary Events risk score parameters, heavy alcohol consumption was independently associated with in-hospital mortality (p = 0.004). CONCLUSIONS: Our results support that heavy alcohol consumption is an independent predictor of in-hospital mortality in patients presenting with ACS.

Five-year clinical outcomes and intracoronary imaging findings of the COMFORTABLE AMI trial: randomized comparison of biodegradable polymer-based biolimus-eluting stents with bare-metal stents in patients with acute ST-segment elevation myocardial infarction.

AIMS: The long-term outcomes of biolimus-eluting stents (BESs) with biodegradable polymer as compared with bare-metal stent (BMS) in patients with ST-segment elevation myocardial infarction (STEMI) remain unknown. METHODS AND RESULTS: We performed a 5-year clinical follow-up of 1157 patients (BES: N = 575 and BMS: N = 582) included in the randomized COMFORTABLE AMI trial. Serial intracoronary imaging of stented segments using both intravascular ultrasound (IVUS) and optical coherence tomography performed at baseline and 13 months follow-up were analysed in 103 patients. At 5 years, BES reduced the risk of major adverse cardiac events [MACE; hazard ratio (HR) 0.56, 95% confidence interval (CI): 0.39-0.79, P = 0.001], driven by lower risks for target vessel-related reinfarction (HR 0.44, 95% CI: 0.22-0.87, P = 0.02) and ischaemia-driven target lesion revascularization (HR 0.41, 95% CI: 0.25-0.66, P < 0.001). Definite stent thrombosis (ST) was recorded in 2.2% and 3.9% (HR 0.57, 95% CI: 0.28-1.16, P = 0.12) with no differences in rates of very late definite ST (1.3% vs. 1.6%, P = 0.77). Optical coherence tomography showed no difference in the frequency of malapposed stent struts at follow-up (BES 0.08% vs. BMS 0.02%, P = 0.10). Uncovered stent struts were rarely observed but more frequent in BES (2.1% vs. 0.15%, P < 0.001). In the IVUS analysis, there was no positive remodelling in either group (external elastic membrane area change BES: -0.63 mm2, 95% CI: -1.44 to 0.39 vs. BMS -1.11 mm2, 95% CI: -2.27 to 0.04, P = 0.07). CONCLUSION: Compared with BMS, the implantation of biodegradable polymer-coated BES resulted in a lower 5-year rate of MACE in patients with STEMI undergoing primary percutaneous coronary intervention. At 13 months, vascular healing in treated culprit lesions was almost complete irrespective of stent type. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Unique identifier: NCT00962416.

Post procedural risk assessment in patients undergoing trans aortic valve implantation according to the age, creatinine, and ejection fraction-7 score: Advantages of age, creatinine, and ejection fraction-7 in stratification of post-procedural outcome.

BACKGROUND: Post-procedural risk stratification based on renal function after trans aortic valve implantation (TAVI) was assessed by means of a modified age, creatinine, and ejection fraction (ACEF) score using the lowest glomerular filtration rate (GFR), obtained within 1 week after valve implantation. We refer to the score as ACEF-7 score. METHODS: The Zurich- and Cardiocentro Ticino TAVI-Cohorts comprised of 424, and 137 patients, who were not on hemodialysis and had already survived the first post-procedural week. Zurich patients were stratified into tertiles of ACEF-7 score (ACEF-7Low ≤ 2.45 (n = 138), ACEF-7Mid 2.46-4.38 (n = 142), and ACEF-7High ≥ 4.39 (n = 144) and compared for survival using KM curves. Euroscore II, Society of Thoracic Surgeons (STS), and ACEF were also calculated at baseline in all patients and assessed for prognostic significance in predicting the primary outcome of 1-year all-cause mortality using univariate and multivariate Cox regression models. Results were then confirmed in the Cardiocentro cohort. RESULTS: Six months (18.1% vs. 6.3% vs. 2.9% P < 0.001) and 1-year all-cause mortality (24.3% vs. 12.7% % vs. 5.8%, P < 0.001), as well as the composite of death or rehospitalization (35% vs. 20% vs. 11% P < 0.001) occurred significantly more frequently in the ACEF-7High compared to the other groups. Both Euroscore II and STS score were not predictors of mortality in our cohort. In a multivariate Cox regression model corrected for gender, Acute Kidney Injury, and baseline ACEF score, the ACEF-7 score was an independent predictor of 1-year all-cause mortality as a per point increment HR 1.512 [95% CI 1.227-1.862, P < 0.001] and as ACEF-7High (≥4.39); HR 5.541 [1.694-18.120]). In addition, the ACEF-7 tertiles showed a significant (P = 0.02) net reclassification improvement of 16% when compared to baseline tertiles of ACEF score, when assessing 1-year all-cause mortality. CONCLUSION: Post-procedural risk stratification using the simple ACEF-7 score significantly better predicted long-term outcome than commonly used risk-scores. Practical implications could include contrast sparing and renal protection in high-risk patients, emphasizing the importance of preventative measures.

Impact of total ischemic time on manual thrombus aspiration benefit during primary percutaneous coronary intervention.

BACKGROUND: The benefits of manual thrombus aspiration (TA) during primary percutaneous coronary intervention (pPCI) for ST-elevation myocardial infarction (STEMI) remain uncertain. We assessed the influence of total ischemic time (TIT) on clinical outcomes among STEMI patients undergoing manual TA during pPCI. METHODS AND RESULTS: We conducted a retrospective study of patients enrolled in the Acute Myocardial Infarction in Switzerland Plus registry. STEMI patients undergoing pPCI with (TA group) or without (PCI-alone group) manual TA were stratified based on short (<3 hours), intermediate (3-6 hours), and long (>6 hours) TIT. The primary endpoint was in-hospital all-cause mortality. The secondary endpoint was in-hospital major adverse cardiac events (MACE), a composite of all-cause death, myocardial reinfarction and stroke. Between 2008 and 2014, 4'154 patients (TA 48%) were included. Risk-adjusted in-hospital all-cause mortality was not different between TA and PCI-alone groups (OR 1.29; 95%CI 0.83-1.98; p=0.26), whereas there was significantly increased risk of MACE (OR 1.52; 95%CI 1.05-2.19; p=0.03) in patients treated with manual TA compared with PCI-alone. There was no significant difference between manual TA and PCI-alone with respect to risk-adjusted all-cause mortality according to TIT groups, but risk-adjusted MACE rates were significantly higher in the group of patients with long TIT treated with manual TA compared with PCI-alone (OR 2.42; 95%CI 1.16-5.04; p=0.02). CONCLUSION: In a large registry of STEMI patients, manual TA was not associated with lower risk-adjusted in-hospital all-cause mortality compared with PCI-alone regardless of TIT but was associated with significantly greater risk of MACE. In patients with prolonged TIT, manual TA was associated with higher risk-adjusted MACE rates compared with PCI-alone.

Trans-carotid access for TAVR allows safe and rapid exchange for bailout valve-in-valve procedures.

Trans-carotid access for trans-catheter aortic valve replacement is a valid alternative in patients with aortic valve dysfunction, severe peripheral vascular disease, and high-risk for surgery. However, in the event of the need for a bailout valve-in-valve procedure, the safety of this access site is uncertain. We report a patient with aortic regurgitation, previous coronary surgery, peripheral vascular disease, and impaired ventricular function who underwent a CoreValve Evolut-R (Medtronic Inc, Minneapolis, MN) implantation through the left carotid artery followed by a successful valve-in-valve procedure with a 26-mm Edwards Sapien3 valve (Edwards Lifesciences, Irvine, CA) through the same carotid access site.

Heart Team: Joint Position of the Swiss Society of Cardiology and the Swiss Society of Cardiac Surgery.

The Swiss Society of Cardiology (SSC) and the Swiss Society of Cardiac and ThoracicVascular Surgery (SSCTVS) have formulated their mutual intent of a close, patient-oriented, and expertise-based collaboration in the Heart Team Paper. The interdisciplinary dialogue between the SSC and SSCTVS reflects an attitude in decision making, which guarantees the best possible therapy for the individual patient. At the same time, it is a cornerstone of optimized process quality, placing individual interests into the background. Evaluation of the correct indication for a treatment is indeed very challenging and almost impossible to verify retrospectively. Quality in this very important health policy process can therefore only be assured by the use of mutually recognized indications, agreed upon by all involved physicians and medical specialties, whereby the capacity of those involved in the process is not important but rather their competence. These two medical societies recognize their responsibility and have incorporated international guidelines as well as specified regulations for Switzerland. Former competitors now form an integrative consulting team able to deliver a comprehensive evaluation for patients. Naturally, implementation rests with the individual caregiver. The Heart Team Paperof the SGK and SGHC, has defined guide boards within which the involved specialists maintain sufficient room to maneuver, and patients have certainty of receiving the best possible therapy they require.

Temporal trends in the treatment and outcomes of elderly patients with acute coronary syndrome.

AIMS: To determine whether treatment and outcomes of older acute coronary syndrome (ACS) patients changed over time. METHODS AND RESULTS: We analysed the use of guideline-recommended therapies and in-hospital outcomes of 13 662 ACS patients ≥70 years enrolled in the prospective Acute Myocardial Infarction in Switzerland (AMIS) cohort between 2001 and 2012 according to 4-year periods (2001-2004, 2005-2008, and 2009-2012). Between first and last 4-year period, percutaneous coronary intervention (PCI) use increased from 43.8 to 69.6% of older ACS patients ( ITALIC! P < 0.001). Use of guideline-recommended drugs as well increased. At the same time, in-hospital mortality of the overall population decreased from 11.6% in the first to 10.0% in the last 4-year period ( ITALIC! P = 0.020), and in-hospital major adverse cardiac and cerebrovascular events from 14.4 to 11.3% ( ITALIC! P < 0.001). Percutaneous coronary intervention was used in increasingly older and co-morbid patients over time (mean age of patients treated with PCI 76.2 years in 2001-2004 and 78.1 years in 2009-2012, ITALIC! P < 0.001; Charlson score ≥2 was found for 27.6% of patients treated with PCI in 2001-2004 and for 32.1% in 2009-2012, ITALIC! P = 0.003). Percutaneous coronary intervention use was associated with similar odds ratios (ORs) of in-hospital mortality over time (adjusted OR 0.29, 95% confidence interval, CI, 0.22-0.40, in 2001-2004; and, adjusted OR 0.26, 95% CI 0.20-0.35, in 2009-2012). CONCLUSION: Use of guideline-recommended therapies for ACS increased and in-hospital outcomes improved over the observed 12-year period. Though PCI was used in increasingly older and co-morbid patients, PCI use was associated with similar ORs of in-hospital mortality over time. This study suggests that increasing use of guideline-recommended therapies was appropriate. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01305785.

Long-term efficacy and safety of biodegradable-polymer biolimus-eluting stents: main results of the Basel Stent Kosten-Effektivitäts Trial-PROspective Validation Examination II (BASKET-PROVE II), a randomized, controlled noninferiority 2-year outcome trial.

BACKGROUND: Biodegradable-polymer drug-eluting stents (BP-DES) were developed to be as effective as second-generation durable-polymer drug-eluting stents (DP-DES) and as safe >1 year as bare-metal stents (BMS). Thus, very late stent thrombosis (VLST) attributable to durable polymers should no longer appear. METHODS AND RESULTS: To address these early and late aspects, 2291 patients presenting with acute or stable coronary disease needing stents ≥3.0 mm in diameter between April 2010 and May 2012 were randomly assigned to biolimus-A9-eluting BP-DES, second-generation everolimus-eluting DP-DES, or thin-strut silicon-carbide-coated BMS in 8 European centers. All patients were treated with aspirin and risk-adjusted doses of prasugrel. The primary end point was combined cardiac death, myocardial infarction, and clinically indicated target-vessel revascularization within 2 years. The combined secondary safety end point was a composite of VLST, myocardial infarction, and cardiac death. The cumulative incidence of the primary end point was 7.6% with BP-DES, 6.8% with DP-DES, and 12.7% with BMS. By intention-to-treat BP-DES were noninferior (predefined margin, 3.80%) compared with DP-DES (absolute risk difference, 0.78%; -1.93% to 3.50%; P for noninferiority 0.042; per protocol P=0.09) and superior to BMS (absolute risk difference, -5.16; -8.32 to -2.01; P=0.0011). The 3 stent groups did not differ in the combined safety end point, with no decrease in events >1 year, particularly VLST with BP-DES. CONCLUSIONS: In large vessel stenting, BP-DES appeared barely noninferior compared with DP-DES and more effective than thin-strut BMS, but without evidence for better safety nor lower VLST rates >1 year. Findings challenge the concept that durable polymers are key in VLST formation. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01166685.