Temporal trends in treatment strategies and clinical outcomes among patients with advanced chronic kidney disease and ST-elevation myocardial infarctions: results from the Bremen STEMI registry.

BACKGROUND: Although the detrimental effects of advanced chronic kidney disease (CKD) on prognosis in coronary artery disease is known, there are few data on the efficacy and safety of modern interventional therapies and medications in patients with advanced CKD, because this special patient cohort is often excluded or underrepresented in randomized trials. METHODS: In the present study all patients admitted with ST-elevation myocardial infarctions (STEMI) from the region of Bremen/Germany treated between 2006 and 2019 were analyzed. Advanced CKD was defined as glomerular filtration rate < 45 ml/min. RESULTS: Of 9605 STEMI-patients, 1018 (10.6%) had advanced CKD with a serum creatinine of 2.22 ± 4.2 mg/dl at admission and with lower rates of primary percutaneous coronary intervention (pPCI) (84.1 vs. 94.1%, p < 0.01) and higher all-cause-mortality (44.4 vs. 3.6%, p < 0.01). Over time, advanced CKD-patients were more likely to be treated with pPCI (2015-2019: 90.3% vs. 2006-2010:75.8%, p < 0.01) and with ticagrelor/prasugrel (59.6% vs. 1.7%, p < 0.01) and drug eluting stents (90.7% vs. 1.3%, p < 0.01). During the study period a decline in adverse ischemic events (OR 0.3, 95% CI 0.1-0.7) and an increase in bleedings (OR 2.2, 95% CI 1.3-3.8) within 1 year after the index event could be observed in patients with advanced CKD while 1-year-mortality (OR 1.0, 95% CI 0.7-1.4) and rates of acute kidney injury (OR 1.2, 95% CI 0.8-1.7) did not change in a multivariate model. Both, ticagrelor/prasugrel (OR 0.48, 95% CI 0.2-0.98) and DES (OR 0.38, 95% CI 0.2-0.8) were associated with a decrease in ischemic events at 1 year. CONCLUSIONS: During the observed time period STEMI-patients with advanced CKD were more likely to be treated with primary PCI, ticagrelor or prasugrel and DE-stents. These changes probably have contributed to the decline in ischemic events and the increase in bleedings within 1 year after STEMI while overall mortality at 1-year remained unchanged for this high-risk patient group.

General Versus Local Anesthesia With Conscious Sedation in Transcatheter Aortic Valve Implantation: The Randomized SOLVE-TAVI Trial.

BACKGROUND: In clinical practice, local anesthesia with conscious sedation (CS) is performed in roughly 50% of patients undergoing transcatheter aortic valve replacement. However, no randomized data assessing the safety and efficacy of CS versus general anesthesia (GA) are available. METHODS: The SOLVE-TAVI (Comparison of Second-Generation Self-Expandable Versus Balloon-Expandable Valves and General Versus Local Anesthesia in Transcatheter Aortic Valve Implantation) trial is a multicenter, open-label, 2×2 factorial, randomized trial of 447 patients with aortic stenosis undergoing transfemoral transcatheter aortic valve replacement comparing CS versus GA. The primary efficacy end point was powered for equivalence (equivalence margin 10% with significance level 0.05) and consisted of the composite of all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, and acute kidney injury at 30 days. RESULTS: The primary composite end point occurred in 27.2% of CS and 26.4% of GA patients (rate difference, 0.8 [90% CI, -6.2 to 7.8]; Pequivalence=0.015). Event rates for the individual components were as follows: all-cause mortality, 3.2% versus 2.3% (rate difference, 1.0 [90% CI, -2.9 to 4.8]; Pequivalence<0.001); stroke, 2.4% versus 2.8% (rate difference, -0.4 [90% CI, -3.8 to 3.8]; Pequivalence<0.001); myocardial infarction, 0.5% versus 0.0% (rate difference, 0.5 [90% CI, -3.0 to 3.9]; Pequivalence<0.001), infection requiring antibiotics 21.1% versus 22.0% (rate difference, -0.9 [90% CI, -7.5 to 5.7]; Pequivalence=0.011); acute kidney injury, 9.0% versus 9.2% (rate difference, -0.2 [90% CI, -5.2 to 4.8]; Pequivalence=0.0005). There was a lower need for inotropes or vasopressors with CS (62.8%) versus GA (97.3%; rate difference, -34.4 [90% CI, -41.0 to -27.8]). CONCLUSIONS: Among patients with aortic stenosis undergoing transfemoral transcatheter aortic valve replacement, use of CS compared with GA resulted in similar outcomes for the primary efficacy end point. These findings suggest that CS can be safely applied for transcatheter aortic valve replacement. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02737150.

One-Year Outcomes after PCI Strategies in Cardiogenic Shock.

BACKGROUND: Among patients with acute myocardial infarction, cardiogenic shock, and multivessel coronary artery disease, the risk of a composite of death from any cause or severe renal failure leading to renal-replacement therapy at 30 days was found to be lower with percutaneous coronary intervention (PCI) of the culprit lesion only than with immediate multivessel PCI. We evaluated clinical outcomes at 1 year. METHODS: We randomly assigned 706 patients to either culprit-lesion-only PCI or immediate multivessel PCI. The results for the primary end point of death or renal-replacement therapy at 30 days have been reported previously. Prespecified secondary end points at 1 year included death from any cause, recurrent myocardial infarction, repeat revascularization, rehospitalization for congestive heart failure, the composite of death or recurrent infarction, and the composite of death, recurrent infarction, or rehospitalization for heart failure. RESULTS: As reported previously, at 30 days, the primary end point had occurred in 45.9% of the patients in the culprit-lesion-only PCI group and in 55.4% in the multivessel PCI group (P=0.01). At 1 year, death had occurred in 172 of 344 patients (50.0%) in the culprit-lesion-only PCI group and in 194 of 341 patients (56.9%) in the multivessel PCI group (relative risk, 0.88; 95% confidence interval [CI], 0.76 to 1.01). The rate of recurrent infarction was 1.7% with culprit-lesion-only PCI and 2.1% with multivessel PCI (relative risk, 0.85; 95% CI, 0.29 to 2.50), and the rate of a composite of death or recurrent infarction was 50.9% and 58.4%, respectively (relative risk, 0.87; 95% CI, 0.76 to 1.00). Repeat revascularization occurred more frequently with culprit-lesion-only PCI than with multivessel PCI (in 32.3% of the patients vs. 9.4%; relative risk, 3.44; 95% CI, 2.39 to 4.95), as did rehospitalization for heart failure (5.2% vs. 1.2%; relative risk, 4.46; 95% CI, 1.53 to 13.04). CONCLUSIONS: Among patients with acute myocardial infarction and cardiogenic shock, the risk of death or renal-replacement therapy at 30 days was lower with culprit-lesion-only PCI than with immediate multivessel PCI, and mortality did not differ significantly between the two groups at 1 year of follow-up. (Funded by the European Union Seventh Framework Program and others; CULPRIT-SHOCK ClinicalTrials.gov number, NCT01927549 .).

Prognostic Impact of the Pulmonary Artery Pulsatility Index in Patients with Chronic Heart Failure and Severe Mitral Regurgitation Undergoing Percutaneous Edge-to-Edge Repair.

BACKGROUND: Pulmonary artery (PA) pulsatility index (PAPi), calculated as (PA systolic pressure - PA diastolic pressure)/right atrial pressure, emerged as a novel predictor of right ventricular failure in patients with acute inferior myocardial infarction, advanced heart failure, and severe pulmonary hypertension. However, the prognostic utility of PAPi in transcatheter mitral valve repair (TMVR) using the MitraClip® system has never been tested. OBJECTIVE: To assess the prognostic impact of PAPi in patients with severe functional mitral regurgitation (MR) and chronic heart failure (CHF) undergoing TMVR. METHODS: Consecutive patients with severe functional MR (grade 3+ or 4+) and CHF who underwent successful TMVR (MR ≤2+ at discharge) were enrolled and divided into 3 groups according to PAPi (A: low PAPi ≤2.2; B: intermediate PAPi 2.21-3.99; C: high PAPi ≥4.0). The primary endpoint was a composite of all-cause mortality and rehospitalization due to CHF during a mean follow-up period of 16 ± 4 months. The impact of PAPi on prognosis was assessed by a receiver-operating characteristic (ROC) analysis and a multivariable Cox proportional hazard regression analysis investigating independent predictors for outcome. RESULTS: 78 patients (A: n = 27, B: n = 28, C: n = 23) at high operative risk (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation] 18.8 vs. 21.5 vs. 20.6%; nonsignificant) were enrolled. Mean PAPi was 1.6 ± 0.41 vs. 2.9 ± 0.53 vs. 6.8 ± 3.5; p < 0.001). Patients with low PAPi showed significantly higher rates of early rehospitalization for heart failure at the 30-day follow-up (14.9 vs. 7.1 vs. 4.3%; p = 0.04). In the long term, a significantly lower event-free survival for the combined primary endpoint was observed in the low PAPi group (44.4 vs. 25.0 vs. 20.3%; log-rank p = 0.016). ROC curve analysis revealed that optimal sensitivity and specificity were achieved using a PAPi cutoff of 2.46 (sensitivity 83%, specificity 78.3%, area under the curve 0.82 [0.64-0.99]; p = 0.01). In Cox regression analysis, PAPi ≤2.46 was an independent predictor for the combined primary endpoint (hazard ratio 2.85; 95% confidence interval 1.15-7.04; p = 0.023). CONCLUSIONS: PAPi is strongly associated with clinical outcome among patients with CHF and functional MR undergoing TMVR. A PAPi value ≤2.46 predicts a worse prognosis independent of other important clinical, echocardiographic, and hemodynamic factors. Therefore, PAPi may serve as a new parameter to improve patient selection for TMVR.

Comparison of newer generation self-expandable vs. balloon-expandable valves in transcatheter aortic valve implantation: the randomized SOLVE-TAVI trial.

AIMS: Transcatheter aortic valve implantation (TAVI) has emerged as established treatment option in patients with symptomatic aortic stenosis. Technical developments in valve design have addressed previous limitations such as suboptimal deployment, conduction disturbances, and paravalvular leakage. However, there are only limited data available for the comparison of newer generation self-expandable valve (SEV) and balloon-expandable valve (BEV). METHODS AND RESULTS: SOLVE-TAVI is a multicentre, open-label, 2 × 2 factorial, randomized trial of 447 patients with aortic stenosis undergoing transfemoral TAVI comparing SEV (Evolut R, Medtronic Inc., Minneapolis, MN, USA) with BEV (Sapien 3, Edwards Lifesciences, Irvine, CA, USA). The primary efficacy composite endpoint of all-cause mortality, stroke, moderate/severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30 days was powered for equivalence (equivalence margin 10% with significance level 0.05). The primary composite endpoint occurred in 28.4% of SEV patients and 26.1% of BEV patients meeting the prespecified criteria of equivalence [rate difference -2.39 (90% confidence interval, CI -9.45 to 4.66); Pequivalence = 0.04]. Event rates for the individual components were as follows: all-cause mortality 3.2% vs. 2.3% [rate difference -0.93 (90% CI -4.78 to 2.92); Pequivalence < 0.001], stroke 0.5% vs. 4.7% [rate difference 4.20 (90% CI 0.12 to 8.27); Pequivalence = 0.003], moderate/severe paravalvular leak 3.4% vs. 1.5% [rate difference -1.89 (90% CI -5.86 to 2.08); Pequivalence = 0.0001], and permanent pacemaker implantation 23.0% vs. 19.2% [rate difference -3.85 (90% CI -10.41 to 2.72) in SEV vs. BEV patients; Pequivalence = 0.06]. CONCLUSION: In patients with aortic stenosis undergoing transfemoral TAVI, newer generation SEV and BEV are equivalent for the primary valve-related efficacy endpoint. These findings support the safe application of these newer generation percutaneous valves in the majority of patients with some specific preferences based on individual valve anatomy.

PCI Strategies in Patients with Acute Myocardial Infarction and Cardiogenic Shock.

BACKGROUND: In patients who have acute myocardial infarction with cardiogenic shock, early revascularization of the culprit artery by means of percutaneous coronary intervention (PCI) improves outcomes. However, the majority of patients with cardiogenic shock have multivessel disease, and whether PCI should be performed immediately for stenoses in nonculprit arteries is controversial. METHODS: In this multicenter trial, we randomly assigned 706 patients who had multivessel disease, acute myocardial infarction, and cardiogenic shock to one of two initial revascularization strategies: either PCI of the culprit lesion only, with the option of staged revascularization of nonculprit lesions, or immediate multivessel PCI. The primary end point was a composite of death or severe renal failure leading to renal-replacement therapy within 30 days after randomization. Safety end points included bleeding and stroke. RESULTS: At 30 days, the composite primary end point of death or renal-replacement therapy had occurred in 158 of the 344 patients (45.9%) in the culprit-lesion-only PCI group and in 189 of the 341 patients (55.4%) in the multivessel PCI group (relative risk, 0.83; 95% confidence interval [CI], 0.71 to 0.96; P=0.01). The relative risk of death in the culprit-lesion-only PCI group as compared with the multivessel PCI group was 0.84 (95% CI, 0.72 to 0.98; P=0.03), and the relative risk of renal-replacement therapy was 0.71 (95% CI, 0.49 to 1.03; P=0.07). The time to hemodynamic stabilization, the risk of catecholamine therapy and the duration of such therapy, the levels of troponin T and creatine kinase, and the rates of bleeding and stroke did not differ significantly between the two groups. CONCLUSIONS: Among patients who had multivessel coronary artery disease and acute myocardial infarction with cardiogenic shock, the 30-day risk of a composite of death or severe renal failure leading to renal-replacement therapy was lower among those who initially underwent PCI of the culprit lesion only than among those who underwent immediate multivessel PCI. (Funded by the European Union 7th Framework Program and others; CULPRIT-SHOCK ClinicalTrials.gov number, NCT01927549 .).

Effectiveness, efficacy, and safety of wearable cardioverter-defibrillators in the treatment of sudden cardiac arrest - Results from a health technology assessment.

OBJECTIVES: To assess the effectiveness, efficacy, and safety of a wearable cardioverter-defibrillator (WCD) in adult persons with high risk for sudden cardiac arrest and for which an implantable cardioverter is currently not applicable. METHODS: We performed a systematic literature search in Medline, Embase, Cochrane Library, and CRD-databases. Study selection was performed by two reviewers independently. Data were presented quantitatively; due to heterogeneity of studies no meta-analysis was performed. RESULTS: One randomized-controlled trial (RCT), one non-randomized comparative trial, and forty-four non-comparative trials were included. The RCT reported an overall mortality of 3.1 percent in the WCD group versus 4.9 percent in controls (relative risk [RR]: .64; 95 percent confidence interval [CI], .43-.98, p = .04), but no significant effect on arrhythmia-related mortality. The RR for arrhythmia-related mortality amounted to .67 (95 percent CI, .37-1.21, p = .18) as assessed in the RCT. Appropriate shocks were observed in 1.3 percent of patients in both comparative studies, and inappropriate shocks in .6 percent of patients in the RCT. Termination of ventricular tachycardia (VT) or ventricular fibrillation (VF) was successful in 75 to 100 percent of appropriate shocks in all studies. Adverse events assessed in the RCT showed a lower incidence of shortness of breath (38.8 percent vs. 45.3 percent; p = .004), higher incidence of rash at any location (15.3 percent vs. 7.1 percent; p < .001), and higher incidence of itching at any location (17.2 percent vs. 6.4 percent; p < .001) for WCD. CONCLUSIONS: Available evidence demonstrates that the WCD detects and terminates VT/VF events reliably and shows a high rate of appropriate shocks in mixed patient populations. Data of large registries confirm that the WCD is a safe intervention.

Randomized trial of ticagrelor vs. aspirin in patients after coronary artery bypass grafting: the TiCAB trial.

AIMS: The antiplatelet treatment strategy providing optimal balance between thrombotic and bleeding risks in patients undergoing coronary artery bypass grafting (CABG) is unclear. We prospectively compared the efficacy of ticagrelor and aspirin after CABG. METHODS AND RESULTS: We randomly assigned in double-blind fashion patients scheduled for CABG to either ticagrelor 90 mg twice daily or 100 mg aspirin (1:1) once daily. The primary outcome was the composite of cardiovascular death, myocardial infarction (MI), repeat revascularization, and stroke 12 months after CABG. The main safety endpoint was based on the Bleeding Academic Research Consortium classification, defined as BARC ≥4 for periprocedural and hospital stay-related bleedings and BARC ≥3 for post-discharge bleedings. The study was prematurely halted after recruitment of 1859 out of 3850 planned patients. Twelve months after CABG, the primary endpoint occurred in 86 out of 931 patients (9.7%) in the ticagrelor group and in 73 out of 928 patients (8.2%) in the aspirin group [hazard ratio 1.19; 95% confidence interval (CI) 0.87-1.62; P = 0.28]. All-cause mortality (ticagrelor 2.5% vs. aspirin 2.6%, hazard ratio 0.96, CI 0.53-1.72; P = 0.89), cardiovascular death (ticagrelor 1.2% vs. aspirin 1.4%, hazard ratio 0.85, CI 0.38-1.89; P = 0.68), MI (ticagrelor 2.1% vs. aspirin 3.4%, hazard ratio 0.63, CI 0.36-1.12, P = 0.12), and stroke (ticagrelor 3.1% vs. 2.6%, hazard ratio 1.21, CI 0.70-2.08; P = 0.49), showed no significant difference between the ticagrelor and aspirin group. The main safety endpoint was also not significantly different (ticagrelor 3.7% vs. aspirin 3.2%, hazard ratio 1.17, CI 0.71-1.92; P = 0.53). CONCLUSION: In this prematurely terminated and thus underpowered randomized trial of ticagrelor vs. aspirin in patients after CABG no significant differences in major cardiovascular events or major bleeding could be demonstrated. CLINICALTRIALS.GOV IDENTIFIER: NCT01755520.

Impact of right heart function on outcome in patients with functional mitral regurgitation and chronic heart failure undergoing percutaneous edge-to-edge-repair.

AIMS: To evaluate the impact of right ventricular dysfunction (RVD) on outcome after transcatheter mitral valve repair (TMVR) in patients with chronic heart failure (CHF) and severe functional mitral regurgitation (FMR). METHODS AND RESULTS: One hundred thirty patients (median age 72.7 ± 10.7 years; 63.8% male) at high operative risk (LogEuroSCORE 23.8 ± 13.9%) with FMR and CHF (left ventricular ejection fraction 32 ± 7%) were enrolled and separated into two groups according to the RVD. RVD was assessed by the tricuspid annular plane systolic excursion (TAPSE) method (A: TAPSE ≤ 16 mm, n = 58; B: TAPSE > 16 mm, n = 72). The rate of successful reduction of mitral regurgitation (MR ≤2+) by TMVR was similar in both groups (94.6% vs 91.2%; P: n.s.) with low in-hospital major adverse event rates. During a median follow-up period of 10.5 ± 4 months, the Kaplan-Meier analysis revealed a significantly higher all-cause mortality in group A (43.1% vs 23.6%; log-rank P = 0.039) and a significantly higher rate of hospital readmission due to congestive heart failure (56.9% vs 26.4%; log-rank P < 0.001). At long-term follow-up, 25% of patients in group A remained in NYHA functional class IV (none in group B). Preexisting RVD as assessed by TAPSE and Doppler tissue imaging (DTI-S') was an independent predictor of all-cause mortality after TMVR (hazard ratio 2.84; 95% confidence interval 1.15-7.65; P = 0.039; hazard ratio 4.70; 95% confidence interval 1.14-20.21; P = 0.044, respectively). CONCLUSIONS: Patients with CHF and RVD were with regard to functional capacity less often responder and showed an unfavorable long-term outcome. Thus, patients with CHF and RVD seem to benefit less frequently from TMVR.

Bivalirudin versus heparin and provisional GP IIb/IIIa inhibitors in patients treated for ST-segment elevation myocardial infarctions: Comparison of outcomes in a "real-world" setting.

INTRODUCTION: The beneficial effects of bivalirudin during primary PCIs are controversially discussed, data on unselected patients are rare. It was the aim of the study to compare bivalirudin versus heparin and provisional glycoprotein IIb/IIIa inhibitors (GPIs) in a "real-world" study. METHODS: From 05/2013 until 11/2014, the STEMI-patients in the Bremen STEMI registry were treated with periinterventional bivalirudin; before and after this period the standard anticoagulative treatment was heparin and provisional GPIs. RESULTS: In 714 patients bivalirudin was used for PCI, this cohort was compared to 683 patients with heparin and provisional GPIs. In patients with bivalirudin a significantly lower rate of hospital bleedings was observed compared to patients with heparin (4.6% vs 8.1%, P < 0.01, multivariate HR 0.57, 95%CI 0.35-0.93), in an exclusive analysis of severe bleedings a trend toward less bleedings was found in patients with bivalirudin (2.0% vs 3.5%, P = 0.07, multivariate HR 0.66, 95%CI 0.30-1.42). The rate of stent thromboses reinfarctions and mortality was not different between the bivalirudin and the heparin group. During 1-year follow-up bivalirudin was associated with a lower rate of bleedings and no significant differences in stent thromboses, reinfarctions, and mortality. Bivalirudin was not associated with an excess of bleedings or stent thromboses in subgroups that are regularly underrepresented in randomized trials (older patients, women, cardiogenic shock). CONCLUSIONS: In this "real-world" cohort of patients with STEMI bivalirudin compared to heparin and GPIs was associated with less bleedings and no significant differences in stent thromboses, reinfarctions, and mortality during hospital and long-term course.

Long-term risk factor management and adverse events in patients with early-onset myocardial infarction-a "real-world" study.

BACKGROUND: International guidelines emphasize the importance of preventive efforts after early-onset myocardial infarction (EOMI); however, data on "real-world" long-term risk factor management and adverse event rates in this special patient group is scarce. METHODS: In this German registry study, 301 patients with MI aged ≤ 45 years were investigated. Risk factor control was assessed at the time of index MI and after 1 year. Major adverse cardiac and cerebrovascular events (MACCE) and its predictors were analyzed during long-term follow-up (median duration 49 months). RESULTS: A majority of patients with EOMI presented with insufficient risk factor control, even during 1-year follow-up. After 1-year 42% of patients were persistent smokers; 74% were physically inactive. The rate of obesity increased significantly from index MI (41%) to 1-year follow-up (46%, p = 0.03) as well as the rate of dysglycemia (index MI: 40%; 1-year follow-up: 51%, p < 0.01) and diabetes mellitus (index MI: 20%; 1-year follow-up: 24%, p < 0.01). 66% of the patients with diabetes mellitus had unsatisfactory HbA1c after 1 year; 69% of the patients did not attain guideline-recommended lipid targets. The rate of MACCE during long-term follow-up was 20% (incidence rate 0.05 per person-year). In a multivariable analysis smoking (HR 2.2, HR 1.3-3.7, p < 0.01) and physical inactivity (HR 2.8, HR 1.2-6.7, p = 0.02) were significant predictors for the occurrence of MACCE. CONCLUSION: Insufficient long-term risk factor control was common in patients with EOMI and was associated with an elevated rate of MACCE. The study reveals that better strategies for prevention in young patients are crucially needed.

Impact of educational attainment on preventive efforts after myocardial infarction: results of the IPP and NET-IPP trials.

AIMS: Educational attainment might impact secondary prevention after myocardial infarction (MI). The purpose of the present study was to compare the rate of risk factors and the efficacy of an intensive prevention program (IPP), performed by prevention assistants and supervised by physicians, in patients with MI and different levels of education. METHODS: In this post hoc analysis of the multicenter IPP and NET-IPP trials, patients with MI were stratified into two groups according to educational attainment: no "Abitur" (no A) vs. "Abitur" or university degree (AUD). The groups were compared at the time of index MI and after 12-month IPP vs. usual care. RESULTS: Out of n = 462 patients with MI, 76.0% had no A and 24.0% had AUD. At the time of index, MI rates of obesity (OR 2.4; 95%CI 1.4-4.0), smoking (OR 2.2, 95%CI 1.4-3.6), and physical inactivity (OR 1.6; 95%CI 1.0-2.5) were significantly elevated in patients with no A. At 12 months after index MI, larger improvements of the risk factors smoking and physical inactivity were observed in patients with IPP and no A than in patients with IPP and AUD or with usual care. LDL cholesterol levels were reduced by IPP compared to usual care, with no difference between no A vs. AUD. A matched-pair analysis revealed that high baseline risk was an important reason for the large risk factor reductions in patients with IPP and no A. CONCLUSION: The study demonstrates that patients with MI and lower educational level have an increased rate of lifestyle-related risk factors and a 12-month IPP, which is primarily performed by non-physician prevention assistants, is effective to improve prevention in this high-risk cohort.

Right Ventricular Cardiac Power Index Predicts 1 Year Outcome After Transcatheter Edge-to-Edge-Repair for Severe Tricuspid Valve Regurgitation.

Tricuspid transcatheter edge-to-edge repair (T-TEER) for severe tricuspid regurgitation (TR) emerged as a novel treatment option for patients not amenable to surgery. However, knowledge regarding independent risk factors for a worse prognosis is rarely available. The study sought to investigate the impact of right ventricular cardiac power index (RVCPi) on 1-year outcomes in patients with severe symptomatic TR who underwent T-TEER. Consecutive patients with severe TR who underwent T-TEER from August 2020 to March 2022 were included and followed prospectively. Baseline clinical and invasive hemodynamic variables, changes in echocardiographic parameters and New York Heart Association functional class, and periprocedural and in-hospital major adverse events were assessed. Primary end point was defined as a composite of all-cause mortality and heart failure hospitalization at 1 year after T-TEER. A multivariable Cox proportional-hazards regression analysis was performed to identify independent risk factors for combined primary end point. RVCPi was calculated as: (cardiac index × mean pulmonary pressure) × K (conversion factor 2.22 × 10-3) = W/m². Receiver operator characteristic analysis was used to determine discriminative capacity of RVCPi. The prognostic value of RVCPi threshold was tested using Kaplan-Meier analysis. In total, 102 patients (mean age 81 ± 6 years, 51% women) at high operative risk underwent T-TEER for severe TR. Primary end point occurred in 30 patients (32%). Receiver operator characteristic curve analysis demonstrated that RVCPi was associated with an area under the curve of 0.69 (95% confidence interval 0.56 to 0.82; p = 0.003). With a RVCPi threshold of 0.17 W/m² (maximally selected rank statistics), the event-free survival was significantly higher in the RVCPi <0.17 W/m² group compared with those with RVCPi ≥0.17 W/m² (71% vs 35%, log-rank p <0.001). In the multivariable Cox regression analysis, RVCPi was an independent predictor for the combined primary end point (hazard ratio 2.6, 95% confidence interval 1.4 to 5.1, p = 0.003). In conclusion, RVCPi is associated with outcome in patients who underwent T-TEER for severe TR and this hemodynamic predictor is useful in risk stratification of T-TEER candidates.

Sudden cardiac death while waiting: do we need the wearable cardioverter-defibrillator?

Sudden cardiac death (SCD) is the most frequent cause of cardiovascular death in industrialized nations. Patients with cardiomyopathy are at increased risk for SCD and may benefit from an implantable cardioverter-defibrillator (ICD). The risk of SCD is highest in the first months after myocardial infarction or first diagnosis of severe non-ischemic cardiomyopathy. On the other hand, left ventricular function may improve in a subset of patients to such an extent that an ICD might no longer be needed. To offer protection from a transient risk of SCD, the wearable cardioverter-defibrillator (WCD) is available. Results of the first randomized clinical trial investigating the role of the WCD after myocardial infarction were recently published. This review is intended to provide insight into data from the VEST trial, and to put these into perspective with studies and clinical experience. As a non-invasive, temporary therapy, the WCD may offer advantages over early ICD implantation. However, recent data demonstrate that patient compliance and education play a crucial role in this new concept of preventing SCD.

Lifestyle and metabolic risk factors in patients with early-onset myocardial infarction: a case-control study.

AIMS: Family history is a known risk factor for early-onset myocardial infarction (EOMI). However, the role of modifiable lifestyle and metabolic factors in EOMI risk is unclear and may differ from that of older adults. METHODS: This case-control study included myocardial infarction (MI) patients aged ≤45 years from the Bremen ST-elevation MI Registry and matched controls randomly selected from the general population (German National Cohort) at the same geographical region. Multiple logistic regression was used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for the individual and combined associations of lifestyle and metabolic factors with EOMI risk, overall and according to family history for premature MI. RESULTS: A total of 522 cases and 1191 controls were included. Hypertension, current smoking, elevated waist-to-hip ratio, and diabetes mellitus were strongly associated with the occurrence of EOMI. By contrast, higher frequency of alcohol consumption was associated with decreased EOMI risk. In a combined analysis of the risk factors hypertension, current smoking, body mass index ≥25.0 kg/sqm, and diabetes mellitus, participants having one (OR = 5.4, 95%CI = 2.9-10.1) and two or more risk factors (OR = 42.3, 95%CI = 22.3-80.4) had substantially higher odds of EOMI compared to those with none of these risk factors, regardless of their family history. CONCLUSION: This study demonstrates a strong association of smoking and metabolic risk factors with the occurrence of EOMI. The data suggest that the risk of EOMI goes beyond family history and underlines the importance of primary prevention efforts to reduce smoking and metabolic syndrome in young persons.

Impact of moderate or severe left ventricular outflow tract calcification on clinical outcomes of patients with severe aortic stenosis undergoing transcatheter aortic valve implantation with self- and balloon-expandable valves: a post hoc analysis from the SOLVE-TAVI trial.

BACKGROUND: Left ventricular outflow tract (LVOT) calcification has been associated with worse outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) and may influence the selection of prosthetic valve type. AIMS: We aimed to evaluate the impact of LVOT calcification on outcomes after TAVI with a self-expanding valve (SEV) versus a balloon-expandable valve (BEV). METHODS: Patients of the SOLVE-TAVI trial, randomised to Edwards SAPIEN 3 or Medtronic Evolut R, were divided according to LVOT calcification into no/mild (≤1 calcium nodule extending <5 mm and covering <10% of the LVOT perimeter) and moderate/severe LVOT calcification groups. The primary endpoint was a composite of death, stroke, moderate/severe paravalvular regurgitation, permanent pacemaker implantation and annulus rupture at 30 days. Additional endpoints included all-cause and cardiovascular mortality at 1 year. RESULTS: Out of 416 eligible patients, moderate/severe LVOT calcification was present in 143 (34.4%). Moderate/severe LVOT calcification was associated with significantly longer fluoroscopy time and higher rates of pre- and post-dilation. Regardless of the LVOT calcification group, there was no significant difference in the primary endpoint associated with the valve type (no/mild LVOT calcification group: SEV 25.0% vs BEV 27.0%; hazard ratio [HR] 1.10, 95% confidence interval [95% CI]: 0.68-1.73; p=0.73 and moderate/severe LVOT calcification group: SEV 25.0% vs BEV 19.4%; HR 0.76, 95% CI: 0.38-1.61; p=0.49), no significant interaction between LVOT calcification and valve type (pint=0.29) and no differences between SEV vs BEV within LVOT calcification groups regarding 1-year all-cause and cardiovascular mortality. CONCLUSIONS: Moderate/severe LVOT calcification was associated with longer fluoroscopy time and an increased need for pre- and post-dilation, but not with a higher incidence of early and mid-term adverse clinical outcomes, regardless of valve type. (ClinicalTrials.gov: NCT02737150).

Prognostic impact of secondary prevention after coronary artery bypass grafting-insights from the TiCAB trial.

OBJECTIVES: There are disparities in the adherence to guideline-recommended therapies after coronary artery bypass graft (CABG). We therefore sought to evaluate the effect of guideline-adherent medical secondary prevention on 1-year outcome after CABG. METHODS: Data were taken from the randomized 'Ticagrelor in CABG' trial. From April 2013 until April 2017, patients who underwent CABG were included. For the present analysis, we compared patients who were treated with optimal medical secondary prevention with those where 1 or more of the recommended medications were missing. RESULTS: Follow-up data at 12 months were available in 1807 patients. About half (54%) of them were treated with optimal secondary prevention. All-cause mortality [0.5% vs 3.5%, hazard ratio (HR) 0.14 (0.05-0.37), P < 0.01], cardiovascular mortality [0.1% vs 1.7%, HR 0.06 (0.01-0.46), P = 0.007] and major adverse events [6.5% vs 11.5%, HR 0.54 (0.39-0.74), P < 0.01] were significantly lower in the group with optimal secondary prevention. The multivariable model for the primary end point based on binary concordance to guideline recommended therapy identified 3 independent factors: adherence to guideline recommended therapy [HR 0.55 (0.39-0.78), P < 0.001]; normal renal function [HR 0.99 (0.98-0.99), P = 0.040]; and off-pump surgery [HR 2.06 (1.02-4.18), P = 0.045]. CONCLUSIONS: Only every second patient receives optimal secondary prevention after CABG. Guideline adherent secondary prevention therapy is associated with lower mid-term mortality and less adverse cardiovascular events after 12 months.

Prevalence and clinical characteristics of prediabetes and diabetes mellitus in young patients with ST-segment elevation myocardial infarction.

BACKGROUND: Only few data on the prevalence of DM in young patients with ST-elevation myocardial infarction (STEMI) exist. Aim of the present study was to analyse this prevalence, its association to other cardiovascular risk factors and its impact on severity of CAD. In a substudy, consecutive HbA1c measurements in each patient were evaluated. METHODS: All patients ≤ 45 years old, admitted with STEMI to an overregional German Heart Centre and treated with primary coronary intervention between 2006 and 2019, entered analysis. Since 2015 HbA1c measurements were performed to detect unknown dysglycaemia. RESULTS: Out of 776 young patients of the total cohort, 88 patients (11.4%) had a DM, while 688 (88.6%) did not. Diabetics were more likely to be obese (BMI ≥ 30 kg/m2, OR 2.4, 95%CI 1.4-4.0, p < 0.01) and very obese (BMI ≥ 40 kg/m2, OR 5.1, 95%CI 2.1-12.2, p < 0.01). In diabetics, a higher likelihood of subacute STEMI (OR 2.2, 95% CI 1.1-4.5, p < 0.05) and more advanced CAD (OR 1.6, 95% CI 1.0-2.6, p < 0.05) compared to non-diabetics was observed. 208 patients were included in the substudy with HbA1c measurements. Out of those, 26 patients (12%) had known DM, while 17 patients (8%) had newly diagnosed DM and 49 patients (24%) preDM. The combined prevalence of any type of dysglycaemia was 44%. CONCLUSION: DM in young patients with STEMI was associated with (severe) obesity, a higher likelihood of subacute STEMI and more advanced CAD compared to non-diabetics. Measurement of HbA1c in every consecutive STEMI-patient increased the rate of detected dysglycaemias more than three times higher than in general population.

Efficacy of Drug-Eluting Stents in Diabetic Patients Admitted with ST-Elevation Myocardial Infarctions Treated with Primary Percutaneous Coronary Intervention.

BACKGROUND: Diabetic patients show higher adverse ischemic event rates and mortality when undergoing percutaneous coronary intervention (PCI) in acute myocardial infarctions. Therefore, diabetic patients might benefit even more from modern-generation drug-eluting stents (DES). The aim of the present study was to compare adverse ischemic events and mortality rates between bare-metal stents (BMS) and DES in diabetic patients admitted with ST-elevation-myocardial infarction (STEMI) with non-diabetic patients as the control group. METHODS: All STEMI patients undergoing emergency PCI and stent implantation documented between 2006 and 2019 in the Bremen STEMI registry entered the analysis. Efficacy was defined as a combination of in-stent thrombosis, myocardial re-infarction or additional target lesion revascularization at one year. RESULTS: Of 8356 patients which entered analysis, 1554 (19%) were diabetics, while 6802 (81%) were not. 879 (57%) of the diabetics received a DES. In a multivariate model, DES implantation in diabetics compared to BMS was associated with lower rates of in-stent thrombosis (OR 0.16, 95% CI 0.05-0.6), myocardial re-infarctions (OR 0.35, 95%CI, 0.2-0.7, p < 0.01) and of the combined endpoint at 1 year ((ST + MI + TLR): OR 0.31, 95% CI 0.2-0.6, p < 0.01), with a trend towards lower 5-year mortality (OR 0.56, 95% CI 0.3-1.0, p = 0.058). When comparing diabetic to non-diabetic patients, an elevation in event rates for diabetics was only detectable in BMS (OR 1.78, 95% CI 0.5-0.7, p < 0.01); however, this did not persist when treated with a DES (OR 1.03 95% CI 0.7-1.6, p = 0.9). CONCLUSIONS: In STEMI patients with diabetes, the use of DES significantly reduced ischemic event rates and, unlike with BMS, adverse ischemic event rates became similar to non-diabetic patients.

Impact of COVID-19 Pandemic on Presentation and Outcome of Consecutive Patients Admitted to Hospital Due to ST-Elevation Myocardial Infarction.

Impact of COVID-19 pandemic and pandemic-related social restrictions on clinical course of patients treated for acute ST-elevation myocardial infarction (STEMI) is unclear. In the present study presentation and outcome of patients with STEMI in the year 2020 were compared with the years before in a German registry that includes all patients hospitalized for acute STEMI in a region with approximately 1 million inhabitants. In the year 2020 726 patients with STEMI were registered compared with 10.226 patients in the years 2006 to 2019 (730 ± 57 patients per year). No significant differences were observed between the groups regarding age, gender and medical history of patients. However, in the year 2020 a significantly higher rate of patients admitted with cardiogenic shock (21.9% vs 14.2%, p <0.01) and out-of-hospital cardiac arrest (OHCA) (14.3% vs 11.1%, p <0.01) was observed. The rate of patients with subacute myocardial infarction (14.3% vs 11.6%, p <0.05) was elevated in 2020. Hospital mortality increased by 52% from the years 2006 to 2019 (8.4%) to the year 2020 (12.8%, p <0.01). Only 4 patients (0.6%) with STEMI in the year 2020 had SARS-CoV-2 infection, none of those died in-hospital. In conclusion, in the year 2020 a highly significant increase of STEMI-patients admitted to hospital with advanced infarction and poor prognosis was observed. As the structure of the emergency network to treat patients with STEMI was unchanged during the study period, the most obvious reason for these changes was COVID-19 pandemic-related lockdown and the fear of many people to contact medical staff during the pandemic.