Systemic inflammatory response syndrome in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: Data on systemic inflammatory response syndrome (SIRS) after transcatheter aortic valve implantation (TAVI) are scarce and limited to small cohorts. We aimed to investigate its incidence and mid-term impact in a large cohort of TAVI patients. METHODS: From January 2018 to December 2020, 717 patients with severe aortic valve stenosis undergoing TAVI were included. SIRS was defined as fulfilling at least two of the following criteria within 48 h from the procedure: leucocyte count >12.0 or <4.0 × 109/l, respiratory rate > 20 breaths per minute or PaCO2 ≤ 4.3 kPa/32 mmHg, heart rate > 90 beats per minute and temperature > 38.0 °C or <36.0 °C. Clinical endpoints were 1-year rehospitalization for chronic heart failure (CHF) and 2-years all-cause mortality. Event rates during follow-up were calculated as Kaplan-Meier estimates. RESULTS: SIRS developed in 56.3 % (404/717) of patients after TAVI. SIRS occurred more frequently in patients with post-dilatation (SIRS 34.7 % (140/404) vs. no SIRS 23.3 % (73/313); p < 0.001) and major vascular complications (SIRS 16.1 % (65/404) vs. no SIRS 8.6 % (27/313); p = 0.004). Further, ICU days were more in patients who developed SIRS (SIRS 1.56 ± 1.50 days vs. no SIRS 1.22 ± 1.02 days; p = 0.001). At 2-years, all-cause mortality in the entire population was 23.9 %. However, there was no difference in CHF at 1-year (5.9 % vs. 4.1 %; log-rank = 0.347) nor in all-cause mortality at 2-years (22.0 % vs. 26.2 %; log-rank = 0.690) between the groups. CONCLUSIONS: SIRS is a common finding after TAVI, which may prolong hospital stay but is without effect on mortality during 2-years follow-up.

Final 3-Year Outcomes of a Randomized Trial Comparing a Self-Expanding to a Balloon-Expandable Transcatheter Aortic Valve.

BACKGROUND: In the SCOPE I trial (Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis), transcatheter aortic valve implantation with the self-expanding ACURATE neo (NEO) did not meet noninferiority compared with the balloon-expandable SAPIEN 3 (S3) device regarding a composite end point at 30 days due to higher rates of prosthetic valve regurgitation and acute kidney injury. Data on long-term durability of NEO are scarce. Here, we report whether early differences between NEO and S3 translate into differences in clinical outcomes or bioprosthetic valve failure 3 years after transcatheter aortic valve implantation. METHODS: Patients with severe aortic stenosis were randomized to transfemoral transcatheter aortic valve implantation with NEO or S3 at 20 European centers. Clinical outcomes at 3 years are compared using Cox proportional or Fine-Gray subdistribution hazard models by intention-to-treat. Bioprosthetic valve failure is reported for the valve-implant cohort. RESULTS: Among 739 patients, 84 of 372 patients (24.3%) had died in the NEO and 85 of 367 (25%) in the S3 group at 3 years. Comparing NEO with S3, the 3-year rates of all-cause death (hazard ratio, 0.98 [95% CI, 0.73-1.33]), stroke (subhazard ratio, 1.04 [95% CI, 0.56-1.92]), and hospitalization for congestive heart failure (subhazard ratio, 0.74 [95% CI, 0.51-1.07]) were similar between the groups. Aortic valve reinterventions were required in 4 NEO and 3 S3 patients (subhazard ratio, 1.32 [95% CI, 0.30-5.85]). New York Heart Association functional class ≤II was observed in 84% (NEO) and 85% (S3), respectively. Mean gradients remained lower after NEO at 3 years (8 versus 12 mm Hg; P<0.001). CONCLUSIONS: Early differences between NEO and S3 did not translate into significant differences in clinical outcomes or bioprosthetic valve failure throughout 3 years. REGISTRATION: URL: https://clinicaltrials.gov, Unique identifier: NCT03011346.

CT in Transcatheter-delivered Treatment of Valvular Heart Disease.

Minimally invasive strategies to treat valvular heart disease have emerged over the past 2 decades. The use of transcatheter aortic valve replacement in the treatment of severe aortic stenosis, for example, has recently expanded from high- to low-risk patients and became an alternative treatment for those with prohibitive surgical risk. With the increase in transcatheter strategies, multimodality imaging, including echocardiography, CT, fluoroscopy, and cardiac MRI, are used. Strategies for preprocedural imaging strategies vary depending on the targeted valve. Herein, an overview of preprocedural imaging strategies and their postprocessing approaches is provided, with a focus on CT. Transcatheter aortic valve replacement is reviewed, as well as less established minimally invasive treatments of the mitral and tricuspid valves. In addition, device-specific details and the goals of CT imaging are discussed. Future imaging developments, such as peri-procedural fusion imaging, machine learning for image processing, and mixed reality applications, are presented.

Diagonal earlobe crease and long-term survival after myocardial infarction.

BACKGROUND: The association between the presence of a diagonal earlobe crease (DEC) and coronary artery disease has been prescribed earlier. However, it is unclear whether patients with acute myocardial infarction (AMI) and DEC have a higher risk of dying. METHODS: Study participants were persons with AMI who were included in the KORA Myocardial Infarction Registry Augsburg from August 2015 to December 2016. After taking pictures of both earlobes, two employees independently assessed the severity of DEC in 4°. For analysis, the expression of the DEC was dichotomized. Information on risk factors, severity and therapy of the AMI was collected by interview and from the medical record. Vital status post AMI was obtained by population registries in 2019. The relationship between DEC and survival time was determined using Cox proportional hazards models. RESULTS: Out of 655 participants, 442 (67.5%) showed DEC grade 2/3 and 213 (32.5%) DEC grade 0/1. Median observation period was 3.06 years (5-1577 days). During this period, 26 patients (12.2%) with DEC grade 0/1 and 92 patients (20.8%) with grade 2/3 died (hazard ratio 1.91, 95% confidence interval (CI) 1.23-2.96, p = 0.0037). In the fully adjusted model, patients with DEC grade 2/3 had a 1.48-fold increased risk of death compared to the DEC grade 0/1 patient group (CI 0.94-2.34, p = 0.0897). The fully adjusted model applied for 1-year survival revealed a significant, 2.57-fold hazard ratio of death (CI 1.07-6.17, p = 0.0347) for the patients with DEC grade 2/3. CONCLUSIONS: Our results indicate that DEC is independently associated with 1-year AMI survival.

Epidemiological trends in mortality, event rates and case fatality of acute myocardial infarction from 2004 to 2015: results from the KORA MI registry.

AIM: This study examines epidemiological trends of acute myocardial infarction (AMI) in Germany from 2004-2015 across different age groups, using data of the population-based KORA myocardial infarction registry. METHODS: Annual age-standardised, age-group- and sex-specific mortality and event rates (incident and recurrent) per 100,000 population as well as 28-day case fatality were calculated from all registered cases of AMI and coronary heart disease deaths in 25-74-year-olds from 2004-2015 and 75-84-year-olds from 2009-2015. Average annual percentage changes (AAPC) were calculated by joinpoint regression. RESULTS: Mortality rates declined considerably among the elderly (75-84 years), in men by -6.0% annually, due to declines of case fatality by -3.0% and incidence rate by 3.4% and in women by -10.0%, driven by declines in incidence (-9.1%) and recurrence rate (-4.9%). Significant mortality declines also occurred in males, 65-74 years of age (AAPC -3.8%). Among the age groups 25-54 years and 55-64 years, there was no substantial decline in mortality, event rates or case fatality except for a decline of incidence rate in 55-64-year-old men (AAPC -1.8%). CONCLUSION: Inhomogeneous AMI trends across age-groups indicate progress in prevention and treatment for the population >64 years, while among <55-year-olds, we found no significant trend in AMI morbidity and mortality.KEY MESSAGESAge standardised AMI mortality continued to decline from 2009 to 2015 in the study region.Declines in AMI mortality were driven by declines in event rates (both incidence and recurrence rates) and case fatality.AMI trends were inconsistent across different age groups with the strongest declines in mortality and event rates among the elderly population (75-84 years of age).

Determinants of prehospital coronary heart disease death.

Limited data on prehospital and early in-hospital coronary heart disease (CHD) deaths is available. Aims of this study were to provide a comprehensive description on CHD cases and to analyse determinants of prehospital death. From a population-based myocardial infarction (MI) registry in Augsburg, Germany we included 12,572 CHD cases aged 25-74 years between 2003-2017 and 4754 CHD cases aged 75-84 years between 2009-2017. Multivariable logistic regression models were conducted to identify patient characteristics associated with prehospital death compared to 28-day survival. In patients aged 25-74 years, 1713 (13.6%) died prehospital, 941 (7.5%) died within the first 24 h in-hospital and 560 (4.5%) died within the 2nd and 28th day after the acute event; in patients aged 75-84 years the numbers were 1263 (26.6%), 749 (15.8%) and 329 (6.9%), respectively. In both age groups increasing age, actual smoking or nicotine abuse, previous MI, angina pectoris and previous stroke were more likely and hypertension was less likely in cases, who died prehospital compared to 28-day survivors. For example, in the 25-74 years old we revealed an adjusted odds ratio (OR) of 4.53 (95% CI 3.84-5.34) for angina pectoris and an OR of 0.69 (95% CI 0.57-0.85) for hypertension. In cases aged 25-74 years, an association of living alone (OR 1.26, 95% CI 1.06-1.49) and diabetes (OR 1.20, 95% CI 1.03-1.41) with prehospital death was found. Whereas in cases aged 75-84 years, chronic obstructive pulmonary disease (OR 2.20, 95%CI 1.69-0.2.85) was associated with prehospital death. In summary, we observed high prehospital and early in-hospital case fatality. Besides classical cardiac risk factors, the impact of living alone on prehospital death was more important in patients aged 25-74 years than in older patients.

Admission glucose level and short-term mortality in older patients with acute myocardial infarction: results from the KORA Myocardial Infarction Registry.

STUDY OBJECTIVES: To investigate the association between admission blood glucose levels and 28-day mortality as well as in-hospital complications in older patients with incident acute myocardial infarction (AMI) undergoing modern treatment. METHODS: From a German population-based regional MI registry, 5530 patients (2016 women), aged 65-84 years, hospitalised with an incident AMI between 1 January 2009 and 31 December 2016 were included in the study. Multivariable logistic regression models were used to assess the associations between admission blood glucose and 28-day mortality as well as in-hospital complications after AMI. Analyses stratified according to age, diabetes and type of infarction (ST-elevation MI (STEMI)/non-STEMI) were conducted. RESULTS: The adjusted ORs for the association between admission blood glucose and 28-day mortality in young-old (65-74 years) and old (75-84 years) patients with AMI were 1.40 (95% CI: 1.21 to 1.62) and 1.21 (95% CI: 0.98 to 1.50) per 1 SD increase in admission blood glucose, respectively. Furthermore, higher admission blood glucose was related to case fatality irrespective of the diabetes status and type of infarction only in the under-75 group. For the patients aged 75-84 years, it was only true for those without diabetes and STEMI. Admission blood glucose was also associated with major cardiac complications in both age groups. CONCLUSION: Admission blood glucose was significantly associated with 28-day case fatality in patients with AMI aged 65-74 years but not 75-84 years; furthermore, in both age groups there was an increased risk of major complications. It seems that admission glucose may play a rather minor role in terms of case fatality in higher aged patients with AMI.

Impact of COVID-19 pandemic lockdown on myocardial infarction care.

The aim of this study was to evaluate the impact of the COVID-19 pandemic lockdown on acute myocardial infarction (AMI) care, and to identify underlying stressors in the German model region for complete AMI registration. The analysis was based on data from the population-based KORA Myocardial Infarction Registry located in the region of Augsburg, Germany. All cases of AMI (n = 210) admitted to one of four hospitals in the city of Augsburg or the county of Augsburg from February 10th, 2020, to May 19, 2020, were included. Patients were divided into three groups, namely pre-lockdown, strict lockdown, and attenuated lockdown period. An additional survey was conducted asking the patients for stress and fears in the 4 weeks prior to their AMI. The AMI rate declined by 44% in the strict lockdown period; in the attenuated lockdown period the rate was 17% lower compared to the pre-lockdown period. The downward trend in AMI rates during lockdown was seen in STEMI and NSTEMI patients, and independent of sex and age. The door-to-device time decreased by 70-80% in the lockdown-periods. In the time prior to the infarction, patients felt stressed mainly due to fear of infection with Sars-CoV-2 and less because of the restrictions and consequences of the lockdown. A strict lockdown due to the Covid-19 pandemic had a marked impact on AMI care even in a non-hot-spot region with relatively few cases of COVID-19. Fear of infection with the virus is presumably the main reason for the drop in hospitalizations due to AMI.

Admission ECG changes predict short term-mortality after acute myocardial infarction less reliable in patients with diabetes.

Prior studies examined association between short-term mortality and certain changes in the admission ECG in acute myocardial infarction (AMI). Nevertheless, little is known about possible differences between patients with diabetes and without diabetes in this regard. So the aim of the study was to investigate the association between 28-day case fatality according to certain ECG changes comparing AMI cases with and without diabetes from the general population. From 2000 until 2017 a total of 9756 AMI cases was prospectively recorded in the study Area of Augsburg, Germany. Each case was assigned to one of the following groups according to admission ECG: 'ST-elevation', 'ST-depression', 'only T-negativity', 'predominantly bundle branch block', 'unspecific changes' and 'normal ECG' (the last two were put together for regression analyses). Multivariable adjusted logistic regression models were calculated to compare 28-day case-fatality between the ECG groups for the total sample and separately for diabetes and non-diabetes cases. For the non-diabetes group, the parsimonious logistic regression model revealed significantly better 28-day-outcome for the 'normal ECG / unspecific changes' group (OR: 0.47 [0.29-0.76]) compared to the reference group (STEMI). Contrary, in AMI cases with diabetes the category 'normal ECG / unspecific changes' was not significantly associated with lower short-term mortality (OR: 0.87 [0.49-1.54]). Neither of the other ECG groups was significantly associated with 28-day-mortality in the parsimonious logistic regression models. Consequently, the absence of AMI-typical changes in the admission ECG predicts favorable short-term mortality only in non-diabetic cases, but not so in patients with diabetes.

Low serum calcium is associated with higher long-term mortality in myocardial infarction patients from a population-based registry.

Calcium plays an essential role in physiology of the cardiovascular system. Aberrations from normal serum calcium levels are known to be associated with several cardiovascular diseases. Its possible role as a predictor for long-term mortality after acute myocardial infarction (AMI) is still uncertain. In this study, a total of 3732 patients (aged 25-74 years) with incident AMI surviving at least 28 days after AMI was included. The median follow-up time was 6.0 years. Admission total serum calcium levels were divided into quartiles. The Kaplan-Meier-Curve suggested a division of the follow up time in two different time periods. So, Cox regression models were calculated to assess association between admission serum calcium levels and all-cause long-term mortality with two observation periods: 28-2500 days and > 2500 days. The final model was adjusted for various comorbidities, clinical characteristics, in-hospital treatment and medication. The third quartile (normal-high Calcium levels) served as the reference group. The fully adjusted Cox-regression model shows significantly higher mortality risk for low serum calcium (quartile 1) within the timeframe 28-2500 days after the event (OR 1.53 [1.19-1.98]). The other groups did not differ significantly from each other. In the later observation period (from 2500 days until death or censoring) no more significant differences were seen between the four calcium quartiles. In summary, low serum calcium is an independent predictor of adverse outcome in the first 2500 days (about 7 years) after AMI. On later points in time this effect attenuates, so that no more significant differences can be observed.

Effort-Reward Imbalance at Work and Overcommitment in Patients with Acute Myocardial Infarction (AMI): Associations with Return to Work 6 Months After AMI.

Purpose Stress-related factors influence the adaptation to life after acute myocardial infarction (AMI), including return to work. The goal of this study was to investigate the effect of work-related stress, (expressed by the effort-reward imbalance (ERI) model) on return to work after AMI. Methods A longitudinal study with AMI patients was conducted in order to assess associations between the independent variables effort, reward, ERI and overcommitment and the outcome return to work after AMI. Return to work was inquired at 6 months follow-up. Logistic regression models were applied in the analysis. The fully-adjusted model included demographic, clinical, social, stress-related and health-related quality of life (HRQOL) covariables. Results Of the 346 enrolled patients aged 31 to 82 years, 239 (69.1%) were included in the regression analysis. In the unadjusted model ERI presented an odds ratio (OR) of 1.72 (95% confidence interval (CI) 0.86-3.42). Associations for effort and overcommitment were 0.98 (95% CI 0.83-1.15) and 1.09 (95% CI 0.99-1.18). However, reward showed a significantly inverse association with return to work with an OR of 0.90 (95% CI 0.83-0.99). In the fully adjusted model the OR of ERI decreased to 1.20 (95% CI 0.49-2.96). Effort, reward and overcommitment also showed attenuated ORs without significant results in all models. Diabetes mellitus, current smoking, low physical and low mental HRQOL presented significantly negative relations with return to work. Conclusions Work-related stress appears less important than HRQOL and resilience in terms of return to work after AMI.

Impact of COVID-19 outbreak on regional STEMI care in Germany.

AIMS: To assess the impact of the lockdown due to coronavirus disease 2019 (COVID-19) on key quality indicators for the treatment of ST-segment elevation myocardial infarction (STEMI) patients. METHODS: Data were obtained from 41 hospitals participating in the prospective Feedback Intervention and Treatment Times in ST-Elevation Myocardial Infarction (FITT-STEMI) study, including 15,800 patients treated for acute STEMI from January 2017 to the end of March 2020. RESULTS: There was a 12.6% decrease in the total number of STEMI patients treated at the peak of the pandemic in March 2020 as compared to the mean number treated in the March months of the preceding years. This was accompanied by a significant difference among the modes of admission to hospitals (p = 0.017) with a particular decline in intra-hospital infarctions and transfer patients from other hospitals, while the proportion of patients transported by emergency medical service (EMS) remained stable. In EMS-transported patients, predefined quality indicators, such as percentages of pre-hospital ECGs (both 97%, 95% CI = - 2.2-2.7, p = 0.846), direct transports from the scene to the catheterization laboratory bypassing the emergency department (68% vs. 66%, 95% CI = - 4.9-7.9, p = 0.641), and contact-to-balloon-times of less than or equal to 90 min (58.3% vs. 57.8%, 95%CI = - 6.2-7.2, p = 0.879) were not significantly altered during the COVID-19 crisis, as was in-hospital mortality (9.2% vs. 8.5%, 95% CI = - 3.2-4.5, p = 0.739). CONCLUSIONS: Clinically important indicators for STEMI management were unaffected at the peak of COVID-19, suggesting that the pre-existing logistic structure in the regional STEMI networks preserved high-quality standards even when challenged by a threatening pandemic. CLINICAL TRIAL REGISTRATION: NCT00794001.

Resilience is strongly associated with health-related quality of life but does not buffer work-related stress in employed persons 1 year after acute myocardial infarction.

PURPOSE: Resilience may facilitate the adaptation after experiencing a severe disease such as acute myocardial infarction (AMI) and attenuate the negative effects of stress on health-related quality of life (HRQOL). However, it is unclear so far whether resilience moderates a negative association between work-related stress and HRQOL in employed patients after AMI. METHODS: Patients with confirmed AMI and regular paid employment admitted to a hospital in the study region of the MONICA/KORA Myocardial Infarction Registry, Germany (04/2014-06/2017) were included and completed questionnaires during their hospital stay and 6 and 12 months after discharge. The Resilience Questionnaire (RS-11) and the Effort-Reward Imbalance (ERI) Questionnaire were used to assess trait resilience and ERI, respectively. HRQOL was measured by the Short Form 36 Health Survey (SF-36) mental and physical component summary scales. Generalized estimating equations (GEE) adjusted for relevant potential confounding variables (demographic, social, stress-related, and clinical) were used to determine the association between resilience and HRQOL in the study course. RESULTS: From the 346 patients enrolled in the study, 270 patients (78.0%) had completed all surveys. High baseline trait resilience was significantly and independently associated with high physical HRQOL (ß = 0.15, p < 0.0001) and high mental HRQOL (ß = 0.37, p < 0.0001) 1 year post AMI. No significant interaction effects between trait resilience and ERI were found in the physical HRQOL GEE model (ß = 0.05, p = 0.7241) and in the mental HRQOL model (ß = 0.05, p = 0.3478). CONCLUSIONS: The results demonstrated that trait resilience is independently and strongly related with post-AMI HRQOL but does not moderate the association between ERI and HRQOL.

Prognostic significance of emergency department bypass in stable and unstable patients with ST-segment elevation myocardial infarction.

BACKGROUND: In ST-segment elevation myocardial infarction (STEMI) patients treated with percutaneous coronary intervention, direct transport from the scene to the catheterisation laboratory bypassing the emergency department has been shown to shorten times to reperfusion. The aim of this study was to investigate the effects of emergency department bypass on mortality in both haemodynamically stable and unstable STEMI patients. METHODS: The analysis is based on a large cohort of STEMI patients prospectively included in the German multicentre Feedback Intervention and Treatment Times in ST-Elevation Myocardial Infarction (FITT-STEMI) trial. RESULTS: Out of 13,219 STEMI patients who were brought directly from the scene by emergency medical service transportation and were treated with percutaneous coronary intervention, the majority were transported directly to the catheterisation laboratory bypassing the emergency department (n=6740, 51% with emergency department bypass). These patients had a significantly lower in-hospital mortality than their counterparts with no emergency department bypass (6.2% vs. 10.0%, P<0.0001). The reduced mortality related to emergency department bypass was observed in both stable (n=11,594, 2.8% vs. 3.8%, P=0.0024) and unstable patients presenting with cardiogenic shock (n=1625, 36.3% vs. 46.2%, P<0.0001). Regression models adjusted for the Thrombolysis In Myocardial Infarction (TIMI) risk score consistently confirmed a significant and independent predictive effect of emergency department bypass on survival in the total study population (odds ratio 0.64, 95% confidence interval 0.56-0.74, P<0.0001) and in the subgroup of shock patients (OR 0.69, 95% CI 0.54-0.88, P=0.0028). CONCLUSION: In STEMI patients, emergency department bypass is associated with a significant reduction in mortality, which is most pronounced in patients presenting with cardiogenic shock. Our data encourage treatment protocols for emergency department bypass to improve the survival of both haemodynamically stable patients and, in particular, unstable patients. Clinical Trial Registration: NCT00794001 ClinicalTrials.gov: NCT00794001.