Background: Fractional flow reserve (FFR) is the current gold standard to determine hemodynamic severity of angiographically intermediate coronary lesions. Much less is known about the prognostic effects of FFR measured directly after percutaneous coronary intervention (PCI). The aims of this study were to evaluate post-PCI FFR values, identify predictors for a low post-PCI FFR, and to investigate whether a relationship between postprocedural FFR and outcome during 30-day follow-up exists. Methods and Results: The FFR-SEARCH (Fractional Flow Reserve—Stent Evaluated at Rotterdam Cardiology Hospital) is a prospective registry in which FFR measurements were performed after PCI in 1000 consecutive patients. All FFR measurements were performed under maximum hyperemia with intravenous adenosine with the Navvus RXi system (ACIST Medical Systems, Eden Prairie, MN). The clinical end point was defined as a composite of death, target vessel revascularization, or nonfatal myocardial infarction at 30-day follow-up. Measurement of post-PCI FFR was successful in 959 patients (96%), and a total of 1165 lesions were assessed. There were no complications related to the microcatheter. A total of 322 ST-segment–elevation myocardial infarction patients with 371 measured lesions were excluded leaving 637 patients with 794 measured lesions for the final analysis. Overall post-PCI FFR was 0.90±0.07. In 396 lesions (50%), post-PCI FFR was >0.90. A total of 357 patients (56%) had ≥1 lesion(s) with a post-PCI FFR ≤0.90, and 73 patients (11%) had ≥1 lesion(s) with a post-PCI FFR ≤0.80 with post-PCI FFR ≤0.80 in 78 lesions (9.8%). Complex lesion characteristics, use of multiple stents and smaller reference vessel diameter was associated with post-PCI FFR ≤0.90. During follow-up, 11 patients (1.8%) reached the clinical end point. There was no significant relationship between post-PCI FFR and the clinical end point at 30-day follow-up ( P =0.636). Conclusions: Routine measurement of post-PCI FFR using a monorail microcatheter is safe and feasible. Several lesion and patient characteristics were associated with a low post-PCI FFR. Post-PCI FFR did not correlate with clinical events at 30 days.
Background: Instantaneous wave–free ratio (iFR) offers a reliable non–hyperemic assessment of coronary physiology but requires dedicated proprietary software with a fully automated algorithm. We hypothesized that dPR (diastolic pressure ratio), calculated with novel universal software, has a strong correlation with iFR, similar diagnostic accuracy relative to resting distal coronary artery pressure/aortic pressure and fractional flow reserve (FFR). Methods and Results: The dPR study is an observational, retrospective, single-center cohort study including patients who underwent iFR or FFR. Dedicated software was used to calculate the dPR from Digital Imaging and Communications in Medicine (DICOM) pressure waveforms. The flat period on the pressure difference between sample (dP) to the time difference between the same sample points (dt) signal was used to detect automatically the period, where the resistance is low and constant, and to calculate the dPR, which is an average over 5 consecutive heartbeats. The software was validated by correlating iFR results with dPR. Software validation was done by comparing 78 iFR measurements in 44 patients who underwent iFR. Mean iFR and dPR were 0.91±0.10 and 0.92±0.10, respectively, with a significant linear correlation ( R =0.997; P <0.001). Diagnostic accuracy was tested in 100 patients who underwent FFR. Mean FFR, resting distal coronary artery pressure/aortic pressure, and dPR were 0.85±0.09, 0.94±0.05, and 0.93±0.07, respectively. There was a significant linear correlation between dPR and FFR ( R =0.77; P <0.001). Both distal coronary artery pressure/aortic pressure and dPR had good diagnostic accuracy in the identification of lesions with an FFR ≤0.80 (area under the curve, 0.84; 95% CI, 0.76–0.92 and 0.86; 95% CI, 0.78–0.93, respectively). Conclusions: dPR, calculated by a novel validated software tool, showed a strong linear correlation with iFR. dPR correlated well with FFR with a good diagnostic accuracy to identify positive FFR.
Objectives: To assess the performance of the commercially available Magmaris sirolimuseluting bioresorbable scaffold (BRS) with invasive imaging at different time points.Background: Coronary BRS with a magnesium backbone have been recently studied as an alternative to polymeric scaffolds, providing enhanced vessel support and a faster resorption rate. We aimed to assess the performance of the commercially available Magmaris sirolimus-eluting BRS at different time points.Methods: A prospective, single-center, nonrandomized study was performed at the Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands. Six patients with stable de novo coronary artery lesions underwent single-vessel revascularization with the Magmaris sirolimus-eluting BRS. Invasive follow-up including intravascular imaging using optical coherence tomography (OCT) was performed at different time points.Results: At a median of 8 months (range 4-12 months) target lesion failure occurred in one patient. Angiography revealed a late lumen loss of 0.59 ± 0.39 mm, a percentage diameter stenosis of 39.65 ± 15.81%, and a binary restenosis rate of 33.3%. OCT showed a significant reduction in both minimal lumen area (MLA) and scaffold area at the site of the MLA by 43.44 ± 28.62 and 38.20 ± 25.74%, respectively. A fast and heterogeneous scaffold degradation process was found with a significant reduction of patent struts at 4-5 months.Conclusions: Our findings show that the latest iteration of magnesium BRS suffers from premature dismantling, resulting in a higher than expected decrease in MLA. K E Y W O R D S bioresorbable scaffolds, constrictive remodeling, Magmaris sirolimus-eluting bioresorbable scaffold, scaffold bioresorption, scaffold collapse, scaffold recoil Abbreviations: AMS, absorbable magnesium scaffolds; BRS, bioresorbable scaffold; DAPT, dual antiplatelet therapy; DES, drug-eluting stent; DS, diameter stenosis; LA, lumen area; LLL, late lumen loss; MLA, minimal lumen area; MSA, minimal scaffold area; NC, noncompliant; OCT, optical coherence tomography; post-PCI, post-percutaneous coronary intervention; pre-PCI, prepercutaneous coronary intervention; QCA, quantitative coronary analysis; RVD, reference vessel diameter; SA, scaffold area; SE-MEA, scaffold expansion according to manufacturer's expected area; SE-RVA, scaffold expansion according to reference vessel area.
Quantitative MRA of patients treated with RDN revealed no significant change in renal artery dimensions up to 12-month follow-up. The lack of a change in renal artery luminal dimensions was irrespective of the arterial response to the individual devices used.
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