Peper, Joyce

Abstract Background Incorporation of CT-derived fractional flow reserve (CT-FFR) enhances the precision of Coronary CT Angiography (CCTA) to detect hemodynamically significant coronary artery disease (CAD). However, the financial consequences remain unclear. Purpose Our objective is to assess the economic implications of CT-FFR in the Dutch Healthcare system. Methods This retrospective, single-center cost effectiveness analysis includes patient data of a previously published study assessing the impact of routine CT-FFR availability on clinical management. We collected medical resource use for both diagnostic and therapeutic cardiovascular care with a follow-up duration of 1 year. Costs of CT-FFR analysis were set at €1000, its current price for Dutch hospitals. Median total costs at were compared using the Wilcoxon rank sum test, including a sensitivity analysis in which cost estimations (without registered maximum tariffs) were increased or decreased with 10%. Results A total of 360 patients, classified as having low to intermediate risk of CAD, were enrolled in the study – 224 in the CCTA group and 136 in the CT-FFR group. In addition to undergoing more (invasive) diagnostic testing and revascularization procedures over the studied period, patients in the CCTA-group had more outpatient clinic consultations (p<0.001), presented more frequently to the emergency department (p=0.035) and spend more nights in the hospital (p=0.11). Median costs were €3.347 (IQR €1.066 – €4.862) in the CCTA-group and €1.436 (IQR €1.362 - €3.943) in the CT-FFR group (p=0.091). Increasing cost estimation with 10% revealed a median of €3.431 in the CCTA-group versus €1.479 in the CT-FFR group (p=0.078), decreasing with 10% showed median costs of €3.263 in the CCTA-group and €1.392 in the CT-FFR group (p=0.118). In our sample, CT-FFR guided care would have been significantly cheaper than CCTA-guided care at or below a market price of €770. Conclusion Despite the significant reduction in additional diagnostic testing and hospital visits in the CT-FFR group, CT-FFR guided care was not cheaper than CCTA-guided care at its current market price of €1.000. Economic cost-effectiveness would have occurred from a price of €770 per analysis. The large difference between medians suggests that the lack of significance might partially be attributed to insufficient power in this relatively small sample size. Additionally, this study did not account for costs associated with loss of productivity and quality of life. However, less additional diagnostic testing, less revascularization procedures and less hospital consultations and admissions leads to reduction in hospital resource consumption and patient burden, which is an important advantage of CT-FFR as the number of referred patients increases yearly.

Abstract Objectives To perform a systematic review and meta-analysis on diagnostic accuracy and other outcomes of coronary computed tomography angiography (CCTA) and CT-derived fractional flow reserve (CT-FFR) in candidates for trans-catheter aortic valve implantation (TAVI). Background Screening for obstructive coronary artery disease (CAD) with CCTA during TAVI work-up could prevent unnecessary invasive coronary angiography (ICA). This becomes increasingly relevant as the TAVI-population grows. CT-FFR improves CCTA accuracy in chest pain patients, but its reliability is unknown in the TAVI-population. Methods Pubmed, Embase and Web of Science were searched for studies regarding CCTA and/or CT-FFR in TAVI-candidates. Primary endpoint was correct identification and rule-out of obstructive CAD. Results were pooled in a meta-analysis. Results Twenty-four of the 29 included articles were part of the meta-analysis, reporting results for CCTA and CT-FFR in 3.494 and 797 patients respectively. Reference standard was anatomical severity of CAD in most studies. At patient-level, pooled CCTA sensitivity was 94.3% and specificity 74.8%. CT-FFR sensitivity was 91.5% and specificity 60.3% with strong variation between studies. CCTA correctly ruled out CAD in 52% of all patients, but 42% of positive CCTAs were false positives. CT-FFR correctly ruled out CAD in 47% of all patients included in this meta-analysis, but showed better accuracy than CCTA in studies that compared both. In these studies, sensitivity of CCTA versus CT-FFR was 70.7% versus 79.0% and specificity was 64.4% versus 92.9%. Conclusions Negative CCTA effectively rules-out CAD in the TAVI-population. Adding CCTA to TAVI work-up could lead to significant reduction in pre-TAVI ICA procedures, but the proportion of false-positives remains high. In studies performing a direct comparison, CT-FFR performed better than CCTA. This is not reflected in the CT-FFR meta-analysis. Therefore, diagnostic accuracy of CT-FFR and added value over CCTA in the TAVI-population remains unclear. Further research regarding validation and reliability is warranted.Meta-analysis of CCTA and CT-FFR

ImportancePatients with atrial fibrillation (AF) who have ischemic stroke despite taking oral anticoagulation therapy (OAT) have a very high risk of recurrence. Left atrial appendage occlusion (LAAO) is a mechanical stroke prevention strategy that may provide additional protection in patients with thromboembolic events under OAT.ObjectiveTo compare percutaneous LAAO with continuing OAT alone regarding stroke prevention in patients with AF who had a thromboembolic event despite taking OAT.Design, Setting, and ParticipantsThis cohort study was a propensity score–matched comparison of the STR-OAC LAAO cohort, an international collaboration of 21 sites combining patients from multiple prospective registries of patients who underwent LAAO between 2010 and 2022. STR-OAC LAAO cohort patients who had follow-up longer than 3 months were propensity score–matched to a previously published control cohort comprising patients from an established international collaboration of investigator-initiated prospective studies. This control cohort included patients with nonvalvular AF, recent ischemic stroke or transient ischemic attack, and follow-up longer than 3 months who were taking OAT before the index event. Analyses were adjusted for imbalances in gender, age, hypertension, diabetes, and CHA2 DS2-VASc score.ExposureLeft atrial appendage occlusion vs continuation of oral anticoagulation therapy alone (control group).Main Outcomes and MeasuresThe primary outcome was time to first ischemic stroke.ResultsFour hundred thirty-three patients from the STR-OAC LAAO cohort (mean [SD] age, 72 [9] years; 171 [39%] females and 262 [61%] males; mean [SD] CHA2 DS2-VASc score, 5.0 [1.6]) were matched to 433 of 1140 patients (38%) from the control group. During 2-year follow-up, 50 patients experienced ischemic stroke: an annualized event rate of 2.8% per patient-year in the STR-OAC LAAO group vs 8.9% per patient-year in the control group. Left atrial appendage occlusion was associated with a lower risk of ischemic stroke (hazard ratio, 0.33; 95% CI, 0.19-0.58; P < .001) compared with the control group. After LAAO, OAT was discontinued in 290 patients (67%), and the remaining 143 patients (33%) continued OAT after LAAO as an adjunctive therapy.Conclusions and RelevanceIn patients with nonvalvular AF and a prior thromboembolic event despite taking OAT, LAAO was associated with a lower risk of ischemic stroke compared with continued OAT alone. Randomized clinical trial data are needed to confirm that LAAO may be a promising treatment option for this population with a very high risk of stroke.

Abstract Objectives The addition of CT-derived fractional flow reserve (FFR-CT) increases the diagnostic accuracy of Coronary CT Angiography (CCTA). We assessed the impact of FFR-CT in routine clinical practice on clinical decision-making and patient prognosis in patients suspected of stable coronary artery disease (CAD). Methods This retrospective, single-center study compared a cohort that received CCTA with FFR-CT to a historical cohort that received CCTA before FFR-CT was available. We assessed the clinical management decisions after FFR-CT and CCTA and the rate of major adverse cardiac events (MACE) during the one-year follow-up using chi-square tests for independence. Kaplan-Meier curves were used to visualize the occurrence of safety outcomes over time. Results 360 patients at low to intermediate risk of CAD were included, 224 in the CCTA only group and 136 in the FFR-CT group. During follow-up, 13 MACE occurred in 12 patients, 9 (4.0%) in the CCTA-group and three (2.2%) in the FFR-CT group. Clinical management decisions differed significantly between both groups. After CCTA, 60 patients (26.5%) received optimal medical therapy (OMT) only, 115 (51.3%) invasive coronary angiography (ICA) and 49 (21.9%) single positron emission CT (SPECT). After FFR-CT, 106 patients (77.9%) received OMT only, 27 (19.9%) ICA and three (2.2%) SPECT (p<0.001 for all three options). The revascularization rate after ICA was similar between groups (p=0.15). However, patients in the CCTA-group more often underwent revascularization (p=0.007). Conclusion Addition of FFR-CT to CCTA led to a reduction in (invasive) diagnostic testing and less revascularizations without observed difference in outcomes after one year.Clinical decisions and follow upSignificant LAD lesion, negative FFRCT

Abstract Objectives To assess the diagnostic performance of CT-FFR for the diagnosis of CAD in the work-up for TAVI. Background Work-up for transcatheter aortic valve implantation (TAVI) currently utilizes computed tomography (CT) to evaluate annulus diameter and peripheral vascular access, plus invasive coronary angiography (ICA) to assess significant coronary artery disease (CAD). ICA might partially be redundant with the use of Coronary CT Angiography (CCTA). Prior studies found improvement of the diagnostic accuracy of CCTA by use of CT derived fractional flow reserve (CT-FFR). Methods Consecutive patients with severe symptomatic aortic valve stenosis who underwent TAVI work-up between 2015–2019 were included in this cross-sectional study. All patients underwent CCTA and ICA within 3 months and diagnostic performance of both CCTA and CT-FFR were assessed using ICA as reference. Results Seventy-six of the 338 patients included in the analysis had ≥1 significant coronary stenosis at ICA. The sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy per-patient were 76.9%, 64.5%, 34.0%, 92.1% and 66.9% for CCTA and 84.6%, 88.3%, 63.2%, 96.0% and 87.6% for CT-FFR. The area under the receiver-operating characteristic-curve significantly differ between CCTA and CT-FFR (0.84 versus 0.90 p=0.02). A CT-FFR guided approach could avoid ICA in 57.1% versus 43.6% using CCTA. Conclusions CT-FFR significantly improves the diagnostic accuracy of CCTA without additional testing and increases the proportion of patients in whom ICA could have been safely avoided It has the potential to be integrated in the current clinical work-up for TAVI for diagnosing stable CAD requiring treatment. Funding Acknowledgement Type of funding sources: None.