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.

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.

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.

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.

Safety and efficacy of a self-expanding versus a balloon-expandable bioprosthesis for transcatheter aortic valve replacement in patients with symptomatic severe aortic stenosis: a randomised non-inferiority trial.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is the preferred treatment option for older patients with symptomatic severe aortic stenosis. Differences in the properties of available TAVR systems can affect clinical outcomes. Among patients undergoing TAVR, we compared the self-expanding ACURATE neo TAVR system with the balloon-expandable SAPIEN 3 TAVR system with regard to early safety and efficacy. METHODS: In this randomised non-inferiority trial, patients (aged ≥75 years) undergoing transfemoral TAVR for treatment of symptomatic severe aortic stenosis, and who were deemed to be at increased surgical risk, were recruited at 20 tertiary heart valve centres in Germany, the Netherlands, Switzerland, and the UK. Participants were randomly assigned (1:1) to receive treatment with the ACURATE neo or the SAPIEN 3 with a computer-based randomly permuted block scheme, stratified by study centre and Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) category. The primary composite safety and efficacy endpoint comprised all-cause death, any stroke, life-threatening or disabling bleeding, major vascular complications, coronary artery obstruction requiring intervention, acute kidney injury (stage 2 or 3), rehospitalisation for valve-related symptoms or congestive heart failure, valve-related dysfunction requiring repeat procedure, moderate or severe prosthetic valve regurgitation, or prosthetic valve stenosis within 30 days of the procedure. Endpoint assessors were masked to treatment allocation. Non-inferiority of ACURATE neo compared with SAPIEN 3 was assessed in the intention-to-treat population on the basis of a risk-difference margin of 7·7% for the primary composite endpoint, with a one-sided α of 0·05. This trial is registered with ClinicalTrials.gov (number NCT03011346) and is ongoing but not recruiting. FINDINGS: Between Feb 8, 2017, and Feb 2, 2019, up to 5132 patients were screened and 739 (mean age 82·8 years [SD 4·1]; median STS-PROM score 3·5% [IQR 2·6-5·0]) were enrolled. 30-day follow-up was available for 367 (99%) of 372 patients allocated to the ACURATE neo group, and 364 (99%) of 367 allocated to the SAPIEN 3 group. Within 30 days, the primary endpoint occurred in 87 (24%) patients in the ACURATE neo and in 60 (16%) in the SAPIEN 3 group; thus, non-inferiority of the ACURATE neo was not met (absolute risk difference 7·1% [upper 95% confidence limit 12·0%], p=0·42). Secondary analysis of the primary endpoint suggested superiority of the SAPIEN 3 device over the ACURATE neo device (95% CI for risk difference -1·3 to -12·9, p=0·0156). The ACURATE neo and SAPIEN 3 groups did not differ in incidence of all-cause death (nine patients [2%] vs three [1%]) and stroke (seven [2%] vs 11 [3%]); whereas acute kidney injury (11 [3%] vs three [1%]) and moderate or severe prosthetic aortic regurgitation (34 [9%] vs ten [3%]) were more common in the ACURATE neo group. INTERPRETATION: TAVR with the self-expanding ACURATE neo did not meet non-inferiority compared to the balloon-expandable SAPIEN 3 device in terms of early safety and clinical efficacy outcomes. An early composite safety and efficacy endpoint was useful in discriminating the performance of different TAVR systems. FUNDING: Boston Scientific (USA).

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.

Incidence and outcome of peri-procedural transcatheter heart valve embolization and migration: the TRAVEL registry (TranscatheteR HeArt Valve EmboLization and Migration).

AIMS: Peri-procedural transcatheter valve embolization and migration (TVEM) is a rare but potentially devastating complication of transcatheter aortic valve implantation (TAVI). We sought to assess the incidence, causes, and outcome of TVEM in a large multicentre cohort. METHODS AND RESULTS: We recorded cases of peri-procedural TVEM in patients undergoing TAVI between January 2010 and December 2017 from 26 international sites. Peri-procedural TVEM occurred in 273/29 636 (0.92%) TAVI cases (age 80.8 ± 7.3 years; 53.8% female), of which 217 were to the ascending aorta and 56 to the left ventricle. The use of self-expanding or first-generation prostheses and presence of a bicuspid aortic valve were independent predictors of TVEM. Bail-out measures included repositioning attempts using snares or miscellaneous tools (41.0%), multiple valve implantations (83.2%), and conversion to surgery (19.0%). Using 1:4-propensity matching, we identified a cohort of 235 patients with TVEM (TVEMPS) and 932 patients without TVEM (non-TVEMPS). In the matched cohort, all-cause mortality was higher in TVEMPS than in non-TVEMPS at 30 days (18.6% vs. 4.9%; P < 0.001) and after 1 year (30.5% vs. 16.6%; P < 0.001). Major stroke was more frequent in TVEMPS at 30 days (10.6% vs. 2.8%; P < 0.001), but not at 1 year (4.6% vs. 1.9%; P = 0.17). The need for emergent cardiopulmonary support, major stroke at 30 days, and acute kidney injury Stages 2 and 3 increased the risk of 1-year mortality, whereas a better renal function at baseline was protective. CONCLUSION: Transcatheter valve embolization and migration occurred in approximately 1% and was associated with increased morbidity and mortality.

Association of sleep disturbances within 4 weeks prior to incident acute myocardial infarction and long-term survival in male and female patients: an observational study from the MONICA/KORA Myocardial Infarction Registry.

BACKGROUND: Sleep-related investigations in acute myocardial infarction (AMI) patients are rare. The aim of this study was to examine sex-specific associations of patient-reported sleep disturbances within 4 weeks before AMI and long-term survival. METHODS: From a German population-based, regional AMI registry, 2511 men and 828 women, aged 28-74 years, hospitalized with a first-time AMI between 2000 and 2008 and still alive after 28 days, were included in the study (end of follow-up: 12/2011). Frequency of any sleep disturbances within 4 weeks before AMI was inquired by a 6-categorical item summarized to 'never', 'sometimes' and 'nightly'. Cox regression models were calculated. RESULTS: Over the median follow-up time of 6.1 years (IQR: 4.1) sleep disturbances were reported by 32.3% of male and 48.4% of female patients. During the observation period, 318 men (12.7%) and 131 women (15.8%) died. Men who 'sometimes' had sleep disturbances showed a 56% increased mortality risk compared to those without complaints in an age-adjusted model (HR 1.56; 95%-CI 1.21-2.00). Additional adjustment for confounding variables attenuated the effect to 1.40 (95%-CI 1.08-1.81). Corresponding HRs among women were 0.97 (95%-CI 0.65-1.44) and 0.99 (95%-CI 0.66-1.49). HRs for patients with nightly sleep disturbances did not suggest any association for both sexes. CONCLUSIONS: Our study found that nightly sleep disturbances have no influence on long-term survival in male and female AMI patients. Contrary to women, men who reported sometimes sleep disturbances had a higher mortality. Further investigations on this topic taking into account the role of obstructive sleep apnoea are needed.

Association between admission anemia and long-term mortality in patients with acute myocardial infarction: results from the MONICA/KORA myocardial infarction registry.

BACKGROUND: Previous studies have shown that the presence of anemia is associated with increased short- and long-term outcomes in patients with acute myocardial infarction (AMI). This study aims at examining the impact of admission anemia on long-term, all-cause mortality following AMI in patients recruited from a population-based registry. Contrary to most prior studies, we distinguished between patients with mild and moderate to severe anemia. METHODS: This prospective study was conducted in 2011 patients consecutively hospitalized for AMI that occurred between January 2005 and December 2008. Patients who survived more than 28 days after AMI were followed up until December 2011. Hemoglobin (Hb) concentration was measured at hospital admission and classified according to the World Health Organization (WHO). Mild anemia was defined as Hb concentration of 11 to < 12 g/dL in women and 11 to < 13 g/dL in men; moderate to severe anemia as Hb concentration of < 11 g/dL. Adjusted Cox regression models were calculated to compare survival in patients with and without anemia. RESULTS: Mild anemia and moderate to severe anemia was found in 183 (9.1%) and 100 (5%) patients, respectively. All-cause mortality after a median follow-up time of 4.2 years was 11.9%. The Cox regression analysis showed significantly increased mortality risks in both patients with mild (HR 1.74, 95% CI 1.23-2.45) and moderate to severe anemia (HR 2.05, 95% CI 1.37-3.05) compared to patients without anemia. CONCLUSION: This study shows that anemia adversely affects long-term survival following AMI. However, further studies are needed to confirm that anemia can solely explain worse long-term outcomes after AMI.

Admission serum potassium concentration and long-term mortality in patients with acute myocardial infarction: results from the MONICA/KORA myocardial infarction registry.

BACKGROUND: Conflicting with clinical practice guidelines, recent studies demonstrated that serum potassium concentrations (SPC) of ≥4.5 mEq/l were associated with increased mortality in patients with acute myocardial infarction (AMI). This study examined the association between SPC and long-term mortality following AMI in patients recruited from a population-based registry. METHODS: Included in the study were 3347 patients with AMI aged 28-74 years consecutively hospitalized between 1 January 2000 and 31 December 2008 and followed up until 31 December 2011. Patients were categorized into five SPC groups (<3.5, 3.5 to <4.0, 4.0 to <4.5, 4.5 to <5.0, and ≥5.0 mEq/l). The outcome of the study was all-cause mortality. Cox regression models adjusted for risk factors, co-morbidities and in-hospital treatment were constructed. RESULTS: In our study population, 249 patients (7.4%) had a low SPC (<3.5 mEq/l) and 134 (4.0%) patients had a high SPC (≥5.0 mEq/l). Patients with SPC of ≥5.0 mEq/l had the highest long-term mortality (29.9%) and in the adjusted model, their risk of dying was significantly increased (HR 1.46, 95% CI 1.03 to 2.07) compared to patients with SPC between 4.0 and <4.5 mEq/l. Analyses of increasing observation periods showed a trend towards a higher risk of dying in patients with SPC between 4.5 and <5.0 mEq/l. CONCLUSION: An admission SPC of ≥5.0 mEq/l might be associated with an increased mortality risk in patients with AMI. Patients with an admission SPC between 4.5 and <5.0 mEq/l might have an increased mortality risk in the first few years following AMI.

Factors Associated With Emergency Services Use by Patients With Recurrent Myocardial Infarction: From the Monitoring Trends and Determinants in Cardiovascular Disease/Cooperative Health Research in the Region of Augsburg Myocardial Infarction Registry.

BACKGROUND: Although emergency medical services (EMS) use is the recommended mode of transport in case of acute coronary symptoms, many people fail to use this service. OBJECTIVE: The objective of this study was to determine factors associated with EMS use in a population-based sample of German patients with recurrent acute myocardial infarction (AMI). METHODS: The sample consisted of 998 persons with a first and recurrent AMI, recruited from 1985 to 2011. Logistic regression modeling adjusted for sociodemographic, situational, and clinical variables, previous diseases, and presenting AMI symptoms was applied. RESULTS: Emergency medical services was used by 48.8% of the patients at first, and 62.6% at recurrent AMI. In first AMI, higher age, history of hyperlipidemia, ST-segment elevation AMI, more than 4 presenting symptoms, symptom onset in daytime, and later year of AMI were significantly related with EMS use. Pain in the upper abdomen and pain between the shoulder blades were significantly less common in EMS users. In recurrent AMI, EMS use at first AMI, presence of any other symptom except chest pain, ST-segment elevation myocardial infarction, and later year of AMI were significantly related with EMS use. Significant predictors of EMS use in recurrent AMI in patients who failed to use EMS at first AMI were unmarried, experience of any symptom except chest symptoms at reinfarction, bundle branch block (first AMI), any in-hospital complication (first AMI), longer duration between first and recurrent AMI, and later year of reinfarction. CONCLUSIONS: Patients with AMI and their significant others may profit by education about the benefits of EMS use.

Variables associated with disability in male and female long-term survivors from acute myocardial infarction. Results from the MONICA/KORA Myocardial Infarction Registry.

Increasing attention is paid on functional limitations and disability among people with chronic diseases. However, only few studies have explored disability in persons with acute myocardial infarction (AMI). The objective of this study was to provide a description of disability and to identify determinants of disability in a population-based sample of long-term AMI survivors. The sample consisted of 1943 persons (35-85years) with AMI from the German population-based MONICA/KORA Myocardial Infarction Registry, who responded to a postal follow-up survey in 2011. Disability was assessed with the 12-item version of the World Health Organization Disability Schedule (WHODAS). Multivariate linear regression models were established in order to identify socioeconomic and clinical factors, risk factors and comorbidities which are associated with disability. The mean WHODAS score for the total sample was 7.86±9.38. The regression model includes 26 variables that explained 37.2% of the WHODAS variance. Most of the explained variance could be attributed to the presence of depression, female sex, joint disorders, digestive disorders, and stroke. Depression was the most important determinant of disability in both sexes. Replacement of single comorbidities by the total number of comorbidities resulted in a model with 15 variables explaining 31.9% of the WHODAS variance. Most of the variance was explained by the number of comorbidities. Further significant determinants of disability were female sex, low education level, angina pectoris, and no revascularization therapy. In AMI patients, the number of comorbidities and particularly the presence of depression are important determinants of disability and should be considered in post-AMI health care.

Predictors of non-invasive therapy and 28-day-case fatality in elderly compared to younger patients with acute myocardial infarction: an observational study from the MONICA/KORA Myocardial Infarction Registry.

BACKGROUND: A substantial proportion of patients with acute myocardial infarction (AMI) did not receive invasive therapy, defined as percutaneous coronary intervention and/or coronary artery bypass grafting. Aims of this study were to evaluate predictors of non-invasive therapy in elderly compared to younger AMI patients and to assess the association between invasive therapy and 28-day-case fatality. METHODS: From the German population-based registry, 3475 persons, consecutively hospitalized with an AMI between 2009 and 2012 were included. Data were collected by standardized interviews and chart review. All-cause mortality was assessed on a regular basis. Multivariable logistic regression analyses were conducted. RESULTS: The sample consisted of 1329 patients aged 28-65 years (age category [AC] 1), 1083 aged 65-74 years (AC 2), and 1063 aged 75-84 years (AC 3). The proportion of patients receiving non-invasive therapy was 10.7, 17.7, and 35.8 % in AC 1, 2, and 3, respectively. Predictors of non-invasive therapy in all ACs were non-ST segment elevation MI, bundle branch block, reduced left ventricular ejection fraction, prior stroke, absence of hyperlipidemia, and low creatine kinase. Elderly women (≥65 years) were less likely to receive invasive therapy. Stratifying the models by type of AMI revealed fewer predictors in patients with ST segment elevation MI. Regarding 28-day-case fatality, strong inverse relations with invasive therapy were seen in all AC: odds ratio of 0.35 (95 % confidence interval [CI] 0.15-0.84), 0.45 (95 % CI 0.22-0.92), and 0.39 (95 % CI 0.24-0.63) in AC 1, 2 and 3, respectively. CONCLUSION: In today's real-life patient care we found that predictors of non-invasive therapy were predominantly the same in all age groups, but differed particularly by type of AMI. Further research is necessary to investigate the real reasons for non-invasive therapy, especially among elderly women. Moreover, we confirmed that receiving invasive therapy was inversely associated with 28-day-case fatality independent of age.

Computer-aided stenosis detection at coronary CT angiography: effect on performance of readers with different experience levels.

OBJECTIVES: To evaluate the effect of a computer-aided detection (CAD) algorithm for coronary CT angiography (cCTA) on the performance of readers with different experience levels. METHODS: We studied 50 patients (18 women, 58 ± 11 years) who had undergone cCTA and quantitative coronary angiography (QCA). Eight observers with varying experience levels evaluated all studies for ≥50 % coronary artery stenosis. After 3 months, the same observers re-evaluated all studies, this time guided by a CAD system. Their performance with and without the CAD system (sensitivity, specificity, positive predictive value and negative predictive value) was assessed using the Likelihood Ratio Χ(2) test both at the per-patient and per-vessel levels. RESULTS: The sensitivity of the CAD system alone for stenosis detection was 71 % per-vessel and 100 % per-patient. There were 54 false positive (FP) findings within 199 analyzed vessels, most of them associated with non-obstructive (<50 %) lesions. With CAD, one (out of three, 33 %) inexperienced reader's per-patient sensitivity and negative predictive value significantly improved from 79 % to 100 % (P = 0.046) and from 90 % to 100 % (P = 0.034), respectively. Other readers' performance indices showed no statistically significant change. CONCLUSIONS: Our results suggest that CAD can improve some inexperienced readers' sensitivity for diagnosing coronary artery stenosis at cCTA.

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.

Acute pulmonary embolism in patients with obstructive sleep apnoea: does it affect the severity of sleep-disordered breathing?

BACKGROUND: Acute pulmonary embolism (PE) may result in an increase in central venous pressure, which may contribute to pharyngeal narrowing by fluid accumulation in nuchal and peripharyngeal soft tissues and therefore affect obstructive sleep apnoea (OSA). PURPOSE: This study aimed to clarify the impact of acute PE on the severity of sleep-disordered breathing in OSA patients. METHODS: Polysomnography (PSG) was performed in 15 OSA patients shortly after acute PE and again after 3 months of sufficient anticoagulation therapy. OSA remained untreated meanwhile. RESULTS: Acute PE did not significantly affect the apnoea-hypopnoea index (AHI). CONCLUSION: The diagnosis of OSA is representative in acute PE, as the transient increase of central venous pressure seems not to affect the AHI once the patients are clinical stable for PSG.