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.

Percutaneous Coronary Intervention Pre-TAVR: Current State of the Evidence.

PURPOSE OF REVIEW: This review intends to give an up-to-date overview of the current state of evidence in the treatment of coronary artery disease (CAD) in patients undergoing transcatheter aortic valve replacement (TAVR), focusing on percutaneous coronary interventions (PCI) pre-TAVR. RECENT FINDINGS: The recently published ACTIVATION trial is the 1st randomized trial comparing coronary revascularization (PCI) versus medical treatment in patients with significant CAD undergoing TAVR. With the caveat of several major limitations of the trial, the results of this study raised the question about the appropriateness of the common practice to routinely revascularize coronary stenosis before TAVR. Aortic valve stenosis is the most common valvular heart disease among the elderly and it often co-occurs with CAD. TAVR is increasingly considered an alternative to surgical aortic valve replacement not only in the elderly population but also in younger and lower-risk patients. The impact of co-existing CAD on clinical outcomes as well as the optimal timing of PCI in TAVR candidates is still unclear and the subject of ongoing randomized trials. Meanwhile, it is common practice in many centers to routinely perform invasive coronary angiography and PCI for significant coronary disease as part of the TAVR workup. While computed tomography angiography has emerged as a possible alternative to the invasive coronary angiography in patients with low pre-test probability for CAD, the value of functional invasive assessment of coronary lesions in the pre-TAVR setting has still to be clarified. Also, there is an increasing interest in the clinical relevance and optimal management of the potentially challenging coronary access post-TAVR, requiring further research.

Continued non-vitamin K antagonist oral anticoagulants versus vitamin K antagonists during transcatheter aortic valve implantation.

BACKGROUND: One-third of patients undergoing transcatheter aortic valve implantation (TAVI) have an indication for long-term oral anticoagulation (OAC). AIMS: We aimed to investigate whether continued non-vitamin K antagonist oral anticoagulant (NOAC) therapy compared with continued vitamin K antagonist (VKA) therapy during TAVI is equally safe and effective.  Methods: Consecutive patients on OAC with either NOAC or VKA undergoing transfemoral TAVI at five European centres were enrolled. The primary outcome measure was a composite of major/life-threatening bleeding, stroke, and all-cause mortality at 30 days. RESULTS: In total, 584 patients underwent TAVI under continued OAC with 294 (50.3%) patients receiving VKA and 290 (49.7%) patients receiving NOAC. At 30 days, the composite primary outcome had occurred in 51 (17.3%) versus 36 (12.4%) patients with continued VKA and with continued NOAC, respectively (odds ratio [OR] 0.68, 95% confidence interval [CI]: 0.43-1.07; p=0.092). Rates of major/life-threatening bleeding (OR 0.87, 95% CI: 0.52-1.47; p=0.606) and stroke (OR 1.02, 95% CI: 0.29-3.59; p=0.974) were not different between groups. In a multivariate Cox regression analysis, continued NOAC, compared with continued VKA, was associated with a lower risk for all-cause 1-year mortality (hazard ratio [HR] 0.61, 95% CI: 0.37-0.98; p=0.043). The analysis of the propensity score-matched cohort revealed similar results. CONCLUSIONS: Continued NOAC compared with continued VKA during TAVI led to comparable outcomes with regard to the composite outcome measure indicating that continued OAC with both drugs is feasible. These hypothesis-generating results need to be confirmed by a dedicated randomised controlled trial.

Syncope in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement.

BACKGROUND: No data exist on the clinical and prognostic significance of syncope in patients undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis. METHODS: A total of 1705 consecutive patients with severe aortic stenosis undergoing TAVR in a tertiary university centre between 2007 and 2021 were included and classified according to the presence of syncope before the TAVR procedure. Baseline, procedural, and follow-up data were collected prospectively in a dedicated database. RESULTS: A total of 115 patients (7%) presented with syncope before the TAVR procedure. Of these, 15 patients (13%) showed arrhythmic episodes as the probable cause of the syncope, and all of them had pacemakers implanted at a median of 13 (6 to 53) days before the TAVR procedure. Patients with syncope were older (82 ± 8 years vs 80 ± 8 years, P = 0.001) and had a higher rate of pacemaker implantation before the TAVR procedure (27% vs 14%, P < 0.001), with no differences between groups regarding the severity of aortic stenosis (transvalvular gradient, valve area). There were no differences between groups in 30-day (adjusted hazard ratio [HR], 1.28; 95% confidence interval [CI], 0.46-3.60) and 1-year (adjusted HR, 0.71; 95% CI, 0.0.35-1.45) mortality following TAVR. CONCLUSIONS: Syncope was not associated with a more advanced valvular disease and had no significant prognostic impact on patients undergoing TAVR. However, arrhythmias and conduction-system disturbances were more common in patients with previous syncope and might play a relevant role in the pathogenesis of syncope in patients with aortic stenosis.

Angina in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement.

INTRODUCTION AND OBJECTIVES: To evaluate the prevalence, clinical characteristics, and outcomes of patients with angina undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis. METHODS: A total of 1687 consecutive patients with severe aortic stenosis undergoing TAVR at our center were included and classified according to patient-reported angina symptoms prior to the TAVR procedure. Baseline, procedural and follow-up data were collected in a dedicated database. RESULTS: A total of 497 patients (29%) had angina prior to the TAVR procedure. Patients with angina at baseline showed a worse New York Heart Association (NYHA) functional class (NYHA class> II: 69% vs 63%; P=.017), a higher rate of coronary artery disease (74% vs 56%; P <.001), and a lower rate of complete revascularization (70% vs 79%; P <.001). Angina at baseline had no impact on all-cause mortality (HR, 1.02; 95%CI, 0.71-1.48; P=.898) and cardiovascular mortality (HR, 1.2; 95%CI, 0.69-2.11; P=.517) at 1 year. However, persistent angina at 30 days post-TAVR was associated with increased all-cause mortality (HR, 4.86; 95%CI, 1.71-13.8; P=.003) and cardiovascular mortality (HR, 20.7; 95%CI, 3.50-122.6; P=.001) at 1-year follow-up. CONCLUSIONS: More than one-fourth of patients with severe aortic stenosis undergoing TAVR had angina prior to the procedure. Angina at baseline did not appear to be a sign of a more advanced valvular disease and had no prognostic impact; however, persistent angina at 30 days post-TAVR was associated with worse clinical outcomes.

Depressive symptoms in patients after primary and secondary prophylactic ICD implantation.

OBJECTIVE: Implantable cardioverter defibrillators (ICD) are successfully used to treat life-threatening arrhythmias and prevent sudden cardiac death. However, they are also known to have a major psychological impact leading to higher prevalence of depression and anxiety in a substantial proportion of patients. The aim of this study was to assess the prevalence of depressive symptoms in a large cohort of ICD carriers with a different clinical background and to compare prevalence and risk factors between patients with primary and secondary prophylactic indication for ICD implantation. METHODS: 315 out of 622 patients (50.6%), who regularly attended ICD assessments at the University Hospital Zurich completed the Beck Depression Inventory (BDI I-II) to estimate current depressive symptoms. RESULTS: Overall, depressive symptoms were common in ICD patients, with 20.3% of the patients showing clinically relevant depression (12.4% mild depressive symptoms, 6.0% moderate, 1.9% severe). Moderate to severe depressive symptoms seem to be more likely in patients with secondary prophylactic indication of the ICD as compared to a group of patients with primary prophylactic implantation. Patients that received more than 5 ICD shocks since implantation reveal more depressive symptoms than those with less events. Mean BDI Score in total (n = 315) was at 8.44 ± 7.56 without a statistically significant difference between the primary (M = 8.04 ± 7.10, n = 153) and secondary (M = 8.81 ± 7.98, n = 162) preventive group (p value = 0.362), even after adjustment for various clinical characteristics. ICD patients should therefore be well supported and advised concerning the psychological impact of their device and particular aspects of daily life concerns (e.g. physical activity), with a special focus on patients, who have received multiple shocks.

Safety and Efficacy of Transcatheter Aortic Valve Replacement With Continuation of Vitamin K Antagonists or Direct Oral Anticoagulants.

OBJECTIVES: This study investigated whether transcatheter aortic valve replacement (TAVR) with peri-procedural continuation of oral anticoagulation is equally safe and efficacious as TAVR with peri-procedural interruption of anticoagulation. BACKGROUND: A significant proportion of patients undergoing TAVR have an indication for long-term oral anticoagulation. The optimal peri-procedural management of such patients is unknown. METHODS: Consecutive patients on oral anticoagulation who underwent transfemoral TAVR at 5 European centers were enrolled. Oral anticoagulation was either stopped 2 to 4 days before TAVR or continued throughout the procedure. Primary safety outcome was major bleeding. Secondary efficacy endpoints included vascular complications, stroke, and mortality. RESULTS: Of 4,459 patients, 584 patients were treated with continuation of anticoagulation and 733 with interruption of anticoagulation. At 30 days, major or life-threatening bleedings occurred in 66 (11.3%) versus 105 (14.3%; odds ratio [OR]: 0.86; 95% confidence interval [CI]: 0.61 to 1.21; p = 0.39) and major vascular complications in 64 (11.0%) versus 90 (12.3%; OR: 0.89; CI: 0.62 to 1.27; p = 0.52) of patients with continuation and with interruption of anticoagulation, respectively. Transfusion of packed red blood cells was less often required in patients with continuation of anticoagulation (80 [13.7%] vs. 130 [17.7%]; OR: 0.59; 95% CI: 0.42 to 0.81; p = 0.001). Kaplan-Meier estimates of survival at 12 months were 85.3% in patients with continuation of anticoagulation and 84.0% in patients with interruption of anticoagulation (hazard ratio: 0.90; 95% CI: 0.73 to 1.12; p = 0.36). CONCLUSIONS: Continuation of oral anticoagulation throughout TAVR did not increase bleeding or vascular complication rates. Moreover, packed red blood cell transfusions were less often required in patients with continuation of oral anticoagulation.

Diagnostic performance of angiography-based quantitative flow ratio for the identification of myocardial ischemia as assessed by 13N-ammonia myocardial perfusion imaging positron emission tomography.

BACKGROUND: Quantitative flow ratio (QFR) is a novel, adenosine-free method for functional lesion interrogation based on 3-dimensional quantitative coronary angiography and computational algorithms. We sought to investigate the diagnostic performance of QFR versus myocardial perfusion imaging positron emission tomography (MPI-PET), which yields the highest accuracy for detection of myocardial ischemia. METHODS: Diagnostic performance of QFR versus MPI-PET was assessed in consecutive patients undergoing both clinically indicated coronary angiography and 13N-ammonia MPI-PET within a six-month period. RESULTS: Out of 176 patients (439 coronary arteries), 19.3% were women. Percent area stenosis was 45 [32-58] %. Myocardial ischemia on 13N-ammonia MPI-PET was detected in 106 (24.1%) vessel territories and hemodynamic significance defined as contrast-flow vessel QFR ≤ 0.80 was observed in 83 (18.9%) vessels. Diagnostic accuracy, sensitivity, and specificity of contrast-flow vessel QFR for the prediction of myocardial ischemia on 13N-ammonia MPI-PET were 92.5 (95% CI 89.6-94.7) %, 73.6 (95% CI 64.1-81.7) %, and 98.5 (95% CI 96.5-99.5) %, respectively. The AUCs for contrast-flow vessel QFR, percent diameter stenosis, and percent area stenosis were 0.85 (95% CI 0.81-0.88, p < 0.001), 0.76 (95% CI 0.71-0.79, p < 0.001) and 0.75 (95% CI 0.70-0.79, p < 0.001), respectively. CONCLUSIONS: QFR, a novel diagnostic tool for functional coronary lesion assessment, provides good diagnostic agreement with MPI-PET and superior diagnostic accuracy for the detection of myocardial ischemia as compared to anatomic indices. Future studies will have to determine the non-inferiority of QFR to fractional flow reserve with respect to clinical outcomes.

Third-Generation Balloon and Self-Expandable Valves for Aortic Stenosis in Large and Extra-Large Aortic Annuli From the TAVR-LARGE Registry.

BACKGROUND: Currently, 2 third-generation transcatheter valves, 29-mm Sapien-3 and 34-mm Evolut-R (ER), are indicated for large sized aortic annuli. We analyzed short and 1-year performance of these valves in patients with large (area ≥575 mm2 or perimeter ≥85 mm) and extra-large (≥683 mm2 or ≥94.2 mm) aortic annuli undergoing transcatheter aortic valve replacement. METHODS: A total of 833 patients across 12 centers with symptomatic aortic stenosis and large aortic annuli underwent transcatheter aortic valve replacement with 29-mm Sapien-3 (n=640) or 34-mm ER (n=193). Clinical, anatomic, and procedural characteristics were collected, and Valve Academic Research Consortium-2 outcomes were reported. RESULTS: Median aortic annulus area and perimeter were 617 mm2 (591-657) and 89.1 mm (87.0-92.1), respectively (704 mm2 [689-743] and 96.0 mm [94.5-97.9] in the subgroup of 124 patients with extra-large annuli). Overall device success was 94.3% (Sapien-3, 95.8% and ER, 89.3%; P=0.001), with a higher rate of significant paravalvular leak (P=0.004), second valve implantation (P=0.013), and valve embolization (P=0.009) in the ER group. Thirty-day and 1-year mortality was 2.4% and 9.2%, respectively, without differences between groups. Valve hemodynamics were excellent (mean gradient, 8.8±3.6 mm Hg; 3.3% rate of moderate-severe paravalvular leak) in the extra-large annulus, without differences compared with the large annulus group. CONCLUSIONS: In patients with large and extra-large aortic annuli, transcatheter aortic valve replacement using 29-mm Sapien-3 and 34-mm ER is safe and feasible. Observed differences in clinical outcomes and hemodynamic performance may guide valve choice in this cohort of patients undergoing transcatheter aortic valve replacement.

Baseline Predictors of Renal Failure in Transcatheter Aortic Valve Implantation.

BACKGROUND: Acute kidney injury (AKI) post transcatheter aortic valve implantation (TAVI) is associated with worsened short- and long-term outcomes. We sought to identify significant baseline predictors of AKI and establish a high-risk group within patients enrolled in the multicenter SWISS-TAVI cohort. METHODS AND RESULTS: A total of 526 patients who underwent TAVI were included in our analysis. Patients on hemodialysis were excluded. Within the first week after valve implantation, fifty patients (9.5%) developed AKI. There was a significantly higher prevalence of diabetes mellitus in the AKI group (45% vs 28%; P=.02). The odds ratio (OR) for patients suffering from diabetes mellitus who developed AKI was 1.9 after multivariable binary regression analysis (95% confidence interval, 1.018-3.553; P=.04). Chronic kidney disease (CKD) stage ≥4 was more prevalent in the AKI group (26% vs 14%; P=.04). Every 1 mg/dL creatinine above normal level at baseline increased AKI risk by a factor of 1.6 (OR, 1.605; 95% CI, 1.111-2.319; P=.01). Age, gender, body mass index, history of dyslipidemia, and history of hypertension were similar between the groups. In the diabetic population of 155 patients (29.5%), AKI developed in 22 patients (14.2%), compared with the non-diabetic population of 370 patients (70.5%), where AKI developed in 27 patients (7.3%). In the diabetic population, an elevation by 1 mg/dL in baseline creatinine was an independent predictor of developing kidney injury (OR, 2.061; 95% CI, 1.154-3.683; P=.02, while in non-diabetic patients, neither baseline glomerular filtration rate, CKD grade, STS score, EuroScore II, ACEF score, nor procedural contrast usage were predictors of AKI. CONCLUSION: Diabetics with CKD stage ≥4 (as defined by the Kidney Disease: Improving Global Outcomes criteria) constitute a high-risk group for developing AKI after TAVI. In this high-risk subgroup, baseline creatinine in combination with amount of contrast agent used were strong risk factors for developing AKI. AKI in non-diabetics was less predictable by baseline characteristics.