A randomized comparison of the treatment sequence of percutaneous coronary intervention and transcatheter aortic valve implantation: Rationale and design of the TAVI PCI trial.

BACKGROUND: About half of patients with severe aortic stenosis present with concomitant coronary artery disease. The optimal timing of percutaneous coronary intervention (PCI) and transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis and concomitant coronary artery disease remains unknown. STUDY DESIGN: The TAVI PCI trial is a prospective, international, multicenter, randomized, 2-arm, open-label study planning to enroll a total of 986 patients. It is designed to investigate whether the strategy "angiography-guided complete revascularization after (within 1-45 days) TAVI" is noninferior to the strategy "angiography-guided complete revascularization before (within 1-45 days) TAVI" using the Edwards SAPIEN 3 or 3 Ultra Transcatheter Heart Valve in patients with severe aortic stenosis and concomitant coronary artery disease. Patients are randomized in a 1:1 ratio to one of the 2 treatment strategies. The primary end point is a composite of all-cause death, nonfatal myocardial infarction, ischemia-driven revascularization, rehospitalization (valve- or procedure-related including heart failure), or life-threatening/disabling or major bleeding at 1 year. CONCLUSIONS: The TAVI PCI trial tests the hypothesis that the strategy "PCI after TAVI" is noninferior to the strategy "PCI before TAVI" in patients with severe aortic stenosis and concomitant coronary artery disease.

Quality of Life Measures in Aortic Stenosis Research: A Narrative Review.

BACKGROUND: Elderly patients with aortic stenosis (AS) not only have a reduced life expectancy but also a reduced quality of life (QoL). The benefits of an AS intervention may be considered a balance between a good QoL and a reasonably extended life. However, the different questionnaires being used to determine the QoL were generally not developed for the specific situation of patients with AS and come with strengths and considerable weaknesses. The objective of this article was to provide an overview of the available QoL instruments in AS research, describe their strengths and weaknesses, and provide our assessment of the utility of the available scoring instruments for QoL measurements in AS. SUMMARY: We identified and reviewed the following instruments that are used in AS research: Short Form Health Survey (SF-36/SF-12), EuroQol-5D (EQ-5D), the Illness Intrusiveness Rating Scale (IIRS), the HeartQoL, the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Minnesota Living with Heart Failure Questionnaire (MLHF), the MacNew Questionnaire, and the Toronto Aortic Stenosis Quality of Life Questionnaire (TASQ). KEY MESSAGES: There is no standardized assessment of QoL in patients with AS. Many different questionnaires are being used, but they are rarely specific for AS. There is a need for AS-specific research into the QoL of patients as life prolongation may compete for an improved QoL in this elderly patient group.

Association of N-terminal pro-B-type natriuretic peptide with mortality in elderly (≥80 years) patients undergoing percutaneous coronary intervention.

OBJECTIVES: The aim of this study was to determine the role of N-terminal pro-B-type natriuretic peptide (NT-proBNP) in the prognostication of patients ≥80 years of age undergoing percutaneous coronary intervention (PCI). BACKGROUND: Elderly patients with coronary artery disease in need of PCI represent a growing patient population. Advanced risk prediction in this frail and comorbid patient population is important. METHODS: A total of 460 consecutive patients ≥80 years of age undergoing PCI for acute (ACS) or chronic coronary syndromes (CCS) at the University Hospital Zurich, Switzerland, between January 2016 and December 2018 and with available baseline NT-proBNP levels were included in the analysis. Patients were stratified according to baseline NT-proBNP levels. The primary endpoint was all-cause mortality at a median follow-up of 33 (interquartile range: 3-392) days. RESULTS: Median baseline NT-proBNP levels were 1411 (457-3984) ng/L. All-cause mortality was 7.8% in the lowest and 27.8% in the highest NT-proBNP quartile group (p < 0.001). In patients with ACS, all-cause mortality was 4.8% and 30.4% in the lowest and the highest NT-proBNP quartile (p < 0.001), and corresponding rates in patients with CCS were 11.1% and 22.2% (p = 0.38). In multivariable Cox regression analysis, baseline NT-proBNP levels were independently associated with an increased risk of all-cause mortality (adjusted hazard ratio: 1.00, 95% confidence interval: 1.00-1.00, p = 0.04). CONCLUSIONS: Baseline NT-proBNP levels were identified as independent predictor of mortality in elderly (≥80 years) patients undergoing PCI. Hence, baseline NT-proBNP allows for the identification of a high-risk elderly patient subset.

[Personalized Therapeutic Concepts in Chronic Coronary Syndromes]. / Personalisierte Therapie des chronischen Koronarsyndroms.

Personalized Therapeutic Concepts in Chronic Coronary Syndromes Abstract. Chronic coronary syndromes (CCS) are related to substantial morbidity and mortality. Myocardial ischemia in CCS is caused by either obstructive or non-obstructive alterations of the coronary arteries, including both morphological and functional changes of epicardial vessels and the coronary microvasculature. Diagnostic algorithms of patients with suspected CCS include non-invasive and invasive imaging and functional testing. Therapeutic management comprises lifestyle changes, optimal medical therapy, and coronary revascularization when indicated. This review summarizes the contemporary management of patients with CCS, focusing on the role of invasive assessment and treatment.

Prediction of risk for bleeding, myocardial infarction and mortality after percutaneous coronary intervention in patients with acute coronary syndromes.

BACKGROUND: Whether bleeding and myocardial infarction (MI) improve the performance of risk prediction models for mortality in patients with acute coronary syndromes (ACS) treated with percutaneous coronary intervention (PCI) remains unknown. METHODS: This study included 3377 patients with ACS who underwent PCI in the setting of the ISAR-REACT 5 trial. Patients with bleeding, MI or those dying at 1 year after PCI were characterized in terms of baseline characteristics, risk estimates and C-statistic of the risk prediction models for these outcomes. RESULTS: Major bleeding (Bleeding Academic Research Consortium types 3-5), MI and mortality occurred in 195 patients (5.8%), 143 patients (4.3%) and 143 patients (4.3%), respectively. After adjustment, bleeding [hazard ratio = 5.08; 95% confidence interval (CI), 3.03-8.53; P < 0.001] and MI [hazard ratio = 5.90; 95% CI, (3.00-11.65); P < 0.001) remained independently associated with the risk for 1-year mortality. The C-statistic (with 95% CI) of the model for bleeding, MI and mortality was, 0.755 (0.722-0.786), 0.752 (0.717-0.789) and 0.868 (0.837-0.896), respectively. The inclusion of bleeding [C-statistic: 0.892 (0.867-0.913); delta C-statistic 0.024 (-0.014 to 0.065); P = 0.200] or MI [C-statistic: 0.878 (0.851-0.903); delta C-statistic 0.011 (-0.030 to 0.053); P = 0.635] in the risk prediction models for mortality alongside baseline demographical and clinical variables did not improve prediction for mortality. CONCLUSIONS: In patients with ACS treated with PCI, mortality is the most accurately predicted outcome. Bleeding and MI did not improve risk discrimination for mortality when added in the risk prediction models for mortality suggesting that these outcomes do not provide incremental prognostic information on top of baseline demographical and clinical data.

Extracellular Volume Quantification With Cardiac Late Enhancement Scanning Using Dual-Source Photon-Counting Detector CT.

OBJECTIVES: The aim of this study was to evaluate the feasibility and accuracy of cardiac late enhancement (LE) scanning for extracellular volume (ECV) quantification with dual-source photon-counting detector computed tomography (PCD-CT). MATERIALS AND METHODS: In this institutional review board-approved study, 30 patients (mean age, 79 years; 12 women; mean body mass index, 28 kg/m2) with severe aortic stenosis undergoing PCD-CT as part of their preprocedural workup for transcatheter aortic valve replacement were included. The scan protocol consisted of a nonenhanced calcium-scoring scan, coronary CT angiography (CTA) followed by CTA of the thoracoabdominal aorta, and a low-dose LE scan 5 minutes after the administration of 100 mL contrast media (all scans electrocardiogram-gated). Virtual monoenergetic (65 keV) and dual-energy (DE) iodine images were reconstructed from the LE scan. Extracellular volume was calculated using the iodine ratios of myocardium and blood-pool of the LE scan, and additionally based on single-energy (SE) subtraction of the nonenhanced scan from the LE scan. Three-dimensional analysis was performed automatically for the whole-heart myocardial volume by matching a heart model generated from the respective coronary CTA data. Bland-Altman and correlation analysis were used to compare the ECV values determined by both methods. RESULTS: The median dose length product for the LE scan was 84 mGy·cm (interquartile range, 69; 125 mGy·cm). Extracellular volume quantification was feasible in all patients. The median ECV value was 30.5% (interquartile range, 28.4%-33.6%). Two focal ECV elevations matched known prior myocardial infarction. The DE- and SE-based ECV quantification correlated well (r = 0.87, P < 0.001). Bland-Altman analysis showed small mean errors between DE- and SE-based ECV quantification (0.9%; 95% confidence interval, 0.1%-1.6%) with narrow limits of agreement (-3.3% to 5.0%). CONCLUSIONS: Dual-source PCD-CT enables accurate ECV quantification using an LE cardiac DE scan at low radiation dose. Extracellular volume calculation from iodine ratios of the LE scan obviates the need for acquisition of a true nonenhanced scan and is not affected by potential misregistration between 2 separate scans.

Postprocedural Troponin Elevation and Mortality After Transcatheter Aortic Valve Implantation.

Background This study sought to investigate the role of postprocedural troponin elevations in mortality prediction after transcatheter aortic valve implantation and to define the threshold at which clinically relevant postprocedure myocardial injury determines mortality. Methods and Results A total of 1333 consecutive patients with transcatheter aortic valve implantation with available postprocedural high-sensitivity cardiac troponin T measurements were included in the analysis. The threshold at which postprocedure myocardial injury determines long-term mortality was identified using restricted cubic spline analysis. A >18.3-fold increase of troponin above the upper reference limit was identified as threshold for relevant postprocedure myocardial injury. Associations remained significant in a landmark analysis between 30 days and 2 years (hazard ratio [HR], 1.61, [95% CI, 1.13-2.28]; P=0.01), after adjusting for known confounders (adjusted HR, 1.90 [95% CI, 1.40-2.57]; P<0001), and in subgroups of patients with coronary artery disease (adjusted HR, 2.17 [95% CI, 1.44-3.29]; P<0.001), renal dysfunction (adjusted HR, 1.88 [95% CI, 1.35-2.62]; P<0.001), and intermediate/high surgical risk (adjusted HR, 2.70 [95% CI, 1.40-5.22]; P=0.003). Conclusions This study determined a troponin threshold for the identification of patients at increased mortality risk after transcatheter aortic valve implantation. The proposed definition of postprocedure myocardial injury advances risk stratification in patients with transcatheter aortic valve implantation and may assist in postprocedural patient management.

[The Role of Percutaneous Coronary Revascularization in Chronic Coronary Syndromes]. / Perkutane koronare Revaskularisation beim chronischen Koronarsyndrom: wann sinnvoll, wann nicht?

The Role of Percutaneous Coronary Revascularization in Chronic Coronary Syndromes Abstract. Coronary heart disease represents the leading cause of morbidity and mortality worldwide. Optimal management of these patients is therefore crucial and includes lifestyle changes, optimal medical therapy, and coronary revascularization. This review summarizes diagnostic and therapeutic strategies of patients with chronic coronary syndromes, focusing on the 2019 European Society of Cardiology (ESC) guidelines for the diagnosis and management of chronic coronary syndromes. In particular, the role of invasive assessment and coronary revascularization in chronic coronary syndromes is discussed.

[TAVI - New Frontiers]. / TAVI ­ Neue Grenzen.

TAVI - New Frontiers Abstract. In this overview, the current major challenges in the field of TAVI are discussed with available supporting data. Valve-in-valve procedures have become routine with reliable evidence to optimise outcomes and minimise the risk of patient prosthesis mismatch. Treating bicuspid aortic valve anatomy remains a challenge with no imminent sign of randomised data to assist treatment decisions; however, it seems clear that improving transcatheter technology and operator experience can lead to excellent results in selected patients. Despite the lingering risk of valve leaflet thrombosis, dual-antiplatelet therapy after TAVI appears to do more harm than good in comparison to single antiplatelet therapy. Whether oral anticoagulation may yet tip the scales toward net clinical benefit remains to be determined. Finally, with TAVI firmly established as the preferred treatment for patients with high and intermediate surgical risk, and as a suitable alternative to surgery in some low risk patients, increasing attention is being turned to the timing of valve intervention. In particular, there is a clear trend away from the traditional symptomatology and strict haemodynamic parameter-driven strategies that have dictated treatment algorithms until now, toward investigating and treating aortic stenosis before the occurrence of deleterious extra-valvular effects.