Dynamic Coronary Roadmap versus standard angiography for percutaneous coronary intervention: the randomised, multicentre DCR4Contrast trial.

BACKGROUND: Decreasing the amount of iodinated contrast is an important safety aspect of percutaneous coronary interventions (PCI), particularly in patients with a high risk of contrast-induced acute kidney injury (CI-AKI). Dynamic Coronary Roadmap (DCR) is a PCI navigation support tool projecting a motion-compensated virtual coronary roadmap overlay on fluoroscopy, potentially limiting the need for contrast during PCI. AIMS: This study investigates the contrast-sparing potential of DCR in PCI, compared to standard angiographic guidance. METHODS: The Dynamic Coronary Roadmap for Contrast Reduction (DCR4Contrast) trial is a multicentre, international, prospective, unblinded, stratified 1:1 randomised controlled trial. Patients were randomised to either DCR-guided PCI or to conventional angiography-guided PCI. The primary endpoint was the total volume of iodinated contrast administered, and the secondary endpoint was the number of cineangiography runs during PCI. RESULTS: The study population included 356 randomised patients (179 in DCR and 177 in control groups, respectively). There were no differences in patient demographics, angiographic characteristics or estimated glomerular filtration rate (eGFR) between the two groups. The total contrast volume used during PCI was significantly lower with DCR guidance compared with conventional angiographic guidance (64.6±44.4 ml vs 90.8±55.4 ml, respectively; p<0.001). The total number of cineangiography runs was also significantly reduced in the DCR group (8.7±4.7 vs 11.7±7.6 in the control group; p<0.001). CONCLUSIONS: Compared to conventional angiography-guided PCI, DCR guidance was associated with a significant reduction in both contrast volume and the number of cineangiography runs during PCI. (ClinicalTrials.gov: NCT04085614).

Rationale and design of the Dynamic Coronary Roadmap for Contrast Reduction (DCR4Contrast) in PCI randomized controlled trial.

BACKGROUND: The clinical and anatomic complexity of patients undergoing percutaneous coronary interventions (PCI) has increased significantly over the past 2 decades. Contrast induced nephropathy (CIN) significantly impacts prognosis after PCI, therefore minimizing the risk of CIN is important in improving clinical outcomes. Dynamic Coronary Roadmap (DCR) is a PCI navigation support tool which may decrease CIN by projecting a motion-compensated virtual coronary roadmap overlay on fluoroscopy, potentially reducing iodinated contrast volume during PCI. STUDY DESIGN AND OBJECTIVES: The Dynamic Coronary Roadmap for Contrast Reduction trial (DCR4Contrast) is a multi-center, prospective, unblinded, stratified 1:1 randomized controlled trial investigating if DCR use reduces the total contrast volume administered during PCI compared to PCI performed without DCR guidance. DCR4Contrast aims to recruit 394 patients undergoing PCI. The primary end point is the total undiluted iodinated contrast volume administered during the PCI, performed with or without DCR. As of November 14, 2022, 346 subjects have been enrolled. CONCLUSIONS: The DCR4Contrast study will investigate the potential contrast-sparing effect of the DCR navigation support tool in patients undergoing PCI. By reducing iodinated contrast administration, DCR has the potential to contribute to reduced risk of CIN and thus increase PCI safety. CLINICAL TRIAL REGISTRATION URL: https://clinicaltrials.gov/ct2/show/NCT04085614.

The evolution of the CTO-PCI landscape in Belgium and Luxembourg: a four-year appraisal.

BACKGROUND: To chart the evolution of the CTO-PCI landscape in Belgium and Luxembourg, the Belgian Working Group on Chronic Total Occlusions (BWGCTO) was established in 2016. METHODS: Between May 2016 and December 2019, patients undergoing a CTO-PCI treatment were prospectively and consecutively enrolled. Twenty-one centres in Belgium and one in Luxembourg participated. Individual operators had mixed levels of expertise in treating CTO lesions. Demographic, angiographic, procedural parameters and incidence of major adverse cardiac and cerebrovascular events (MACCE) were systematically registered. RESULTS: Over a four-year enrolment period, 1832 procedures were performed in 1733 patients achieving technical success in 1474 cases (80%), with an in-hospital MACCE rate of 2.3%. Fifty-nine (3%) cases were re-attempt procedures of which 41 (69%) were successful. High-volume centres treated more complex lesions (mean J-CTO score: 2.15 ± 1.21) as compared to intermediate (mean J-CTO score: 1.72 ± 1.23; p < 0.001) and low-volume centres (mean J-CTO score: 0.99 ± 1.21; p = 0.002). Despite this, success rates did not differ between centres (p = 0.461). Overall success rates did not differ over time (p = 0.810). High-volume centres progressively tackled more complex CTOs while keeping success rates stable. In all centres, the most applied strategy was antegrade wire escalation (83%). High-volume centres more often successfully applied antegrade dissection and re-entry and retrograde techniques in lesions with higher complexity. CONCLUSION: With variable experience levels, operators treated CTOs with high success and relatively few complications. Although AWE remains the most used technique, it is paramount for operators to be skilled in all contemporary techniques in order to be successful in more complex CTOs.

Assessing the landscape of percutaneous coronary chronic total occlusion treatment in Belgium and Luxembourg: the Belgian Working Group on Chronic Total Occlusions (BWGCTO) registry.

Background: Important developments in materials, devices, and techniques have improved outcomes of chronic total occlusion (CTO) percutaneous coronary intervention (PCI), and resulted in a growing interest in CTO-PCI. The Belgian Working Group on Chronic Total Occlusions (BWGCTO) working group aims to assess the evolution within the CTO-PCI landscape over the next years. Methods: From May 2016 onwards, patients undergoing CTO-PCI were included in the BWGCTO registry by 15 centres in Belgium and Luxemburg. Baseline, angiographic, and procedural data were collected. Here, we report on the one-year in-hospital outcomes. Results: Over the course of one year, 411 procedures in 388 patients were included with a mean age of 64 ± 11 years. The majority were male (81%). Relatively complex CTOs were treated (Japanese CTO score =2.2 ± 1.2) with a high procedure success rate (82%). Patient- and lesion-wise success rates were 83 and 85%, respectively. Major adverse in-hospital events were acceptably low (3.4%). Antegrade wire escalation technique was applied most frequently (82%). On the other hand, antegrade dissection and re-entry and retrograde strategies were more frequently applied in higher volume centres and successful for lesions with higher complexity. Conclusion: Satisfactory procedural outcomes and a low rate of adverse events were obtained in a complex CTO population, treated by operators with variable experience levels. Antegrade wire escalation was the preferred strategy, regardless of operator volume.

In-stent fractional flow reserve variations and related optical coherence tomography findings: the FFR-OCT co-registration study.

We sought to assess in-stent variations in fractional flow reserve (FFR) in patients with previous percutaneous coronary intervention (PCI) and to associate any drop in FFR with findings by optical coherence tomography (OCT) imaging. Suboptimal post-PCI FFR values were previously associated with poor outcomes. It is not known to which extent in-stent pressure loss contributes to reduced FFR. In this single-arm observational study, 26 patients who previously underwent PCI with drug-eluting stent or scaffold implantation were enrolled. Motorized FFR pullback during continuous intravenous adenosine infusion and OCT assessments was performed. Post-PCI FFR < 0.94 was defined as suboptimal. At a median of 63 days after PCI (interquartile range: 59-64 days), 18 out of 26 patients (72%) had suboptimal FFR. The in-stent drop in FFR was significantly higher in patients with suboptimal FFR vs. patients with optimal FFR (0.08 ± 0.07 vs. 0.01 ± 0.02, p < 0.001). Receiver operating characteristic curve analysis showed that an in-stent FFR variation of > 0.03 was associated with suboptimal FFR. In patients with suboptimal FFR, the OCT analyses revealed higher mean neointimal area (respectively: 1.06 ± 0.80 vs. 0.51 ± 0.23 mm2; p = 0.018) and higher neointimal thickness of covered struts (respectively 0.11 ± 0.07 vs. 0.06 ± 0.01 mm; p = 0.021). Suboptimal FFR values following stent-implantation are mainly caused by significant in-stent pressure loss during hyperemia. This finding is associated to a larger neointimal proliferation.

Single String Technique for Coronary Bifurcation Stenting: Detailed Technical Evaluation and Feasibility Analysis.

OBJECTIVES: The study aimed to evaluate the adequacy and feasibility of the single string bifurcation stenting technique. BACKGROUND: Double-stent techniques may be required for complex bifurcations. Currently applied methods all have their morphological or structural limitations with respect to wall coverage, multiple strut layers, and apposition rate. METHODS: Single string is a novel method in which, first, the side branch (SB) stent is deployed with a single stent cell protruding into the main branch (MB). Second, the MB stent is deployed across this protruding stent cell. The procedure is completed by final kissing balloon dilation. The single string technique was first tested in vitro (n = 20) and next applied in patients (n = 11) with complex bifurcation stenoses. RESULTS: All procedures were performed successfully, crossing a single stent cell in 100%. Procedure duration was 23.0 ± 7.9 min, and the fluoroscopy time was 9.4 ± 3.5 min. The results were evaluated by optical coherence tomography, showing fully apposed struts in 83.0 ± 9.2% in the bifurcation area. Residual area obstruction in the MB was 6.4 ± 5.6% and 25.0 ± 16.9% in the SB, as evaluated by micro computed tomography. All the human cases were performed successfully with excellent angiographic results: the residual area stenosis was 27 ± 8% and 29 ± 10% in the MB and in the SB, respectively, by 3-dimensional quantitative coronary angiography. No relevant periprocedural enzyme increase was observed. During follow-up (6 ± 4 months), no adverse clinical events (death, myocardial infarction, target vessel revascularization) were noted. CONCLUSIONS: The single string technique for complex bifurcation dilation was shown to be adequate in vitro and feasible in humans, with favorable results in terms of stent overlap, malapposition rate, and low residual obstruction in both the MB and SB.

Revascularization decisions in patients with stable angina and intermediate lesions: results of the international survey on interventional strategy.

BACKGROUND: Fractional flow reserve (FFR) measurement of intermediate coronary stenoses is recommended by guidelines when demonstration of ischemia by noninvasive testing is unavailable. The study aims to evaluate the penetration of this recommendation into current thinking about revascularization strategies for stable coronary artery disease. METHODS AND RESULTS: International Survey on Interventional Strategy was conducted via a web-based platform. First, participants' experiences in interventional cardiology were queried. Second, 5 complete angiograms were provided, presenting only focal intermediate stenoses. FFR and quantitative coronary angiography values were known; however, remained undisclosed. Determination of stenosis significance was asked for each lesion. In cases of uncertainty, the most appropriate adjunctive invasive diagnostic method among quantitative coronary angiography, intravascular ultrasound, optical coherence tomography, or FFR needed to be selected. International Survey on Interventional Strategy was taken by 495 participants who provided 4421 lesion evaluations. In 3158 (71%) decisions, participants relied solely on angiographic appearance that was discordant in 47% with the known FFR, using 0.80 as cutoff value. The use of FFR and imaging modalities was requested in 21% and 8%, respectively. Comparing 4 groups of participants according to the experience in FFR, angiogram-based decisions were less frequent with increasing experience (77% versus 72% versus 69% versus 67%, respectively; P<0.001). As a result, requests for FFR were more frequent (14% versus 19% versus 24% versus 28%, respectively; P<0.001) and rates of discordant decisions decreased (51% versus 49% versus 47% versus 43%, respectively; P<0.022). CONCLUSIONS: The findings confirm that, even when all potential external constraints are virtually eliminated, visual estimation continues to dominate the treatment decisions for intermediate stenoses, indicative of a worrisome disconnect between recommendations and current practice.

Evolving concepts of angiogram: fractional flow reserve discordances in 4000 coronary stenoses.

AIMS: The present analysis addresses the potential clinical and physiologic significance of discordance in severity of coronary artery disease between the angiogram and fractional flow reserve (FFR) in a large and unselected patient population. METHODS AND RESULTS: Between September 1999 and December 2011, FFR and percent diameter stenosis (DS) as assessed by quantitative coronary angiography were obtained in 2986 patients (n = 4086 coronary stenoses), in whom at least one stenosis was of intermediate angiographic severity. Fractional flow reserve correlated slightly but significantly with DS [-0.38 (95% CI: -0.41; -0.36); P < 0.001]. The sensitivity, specificity, and diagnostic accuracy of a ≥ 50% DS for predicting FFR ≤ 0.80 were 61% (95% CI: 59; 63), 67% (95% CI: 65; 69), and 0.64 (95% CI: 0.56; 0.72), respectively. In different anatomical settings, sensitivity and specificity showed marked variations between 35 to 74% and 58 to 76%, respectively, resulting in a discordance in 35% of all cases for these thresholds. For an angiographic threshold of 70% DS, the diagnostic performance by the Youden's index decreased from 0.28 to 0.11 for the overall population. CONCLUSION: The data confirm that one-third of a large patient population shows discordance between angiogram ≥ 50%DS and FFR ≤ 0.8 thresholds of stenosis severity. Left main stenoses are often underestimated by the classical 50% DS cut-off compared with FFR. This discordance offers physiologic insights for future trials. It is hypothesized that the discordance between angiography and FFR is related to technical limitations, such as imprecise luminal border detection by angiography, as well as to physiologic factors, such as variable minimal microvascular resistance.

ACEF and clinical SYNTAX score in the risk stratification of patients with heavily calcified coronary stenosis undergoing rotational atherectomy with stent implantation.

AIM: To assess ACEF (age, creatinine, and ejection fraction) and Clinical SYNTAX (CSS) score in the risk stratification of patients with heavily calcified stenosis undergoing rotational atherectomy with stent implantation (rota-stenting). METHODS AND RESULTS: ACEF and CSS were calculated in 221 consecutive patients with stable angina undergoing rota-stenting. Mean age of the patients was 74 ± 10 years, left ventricular ejection fraction was 61 ± 18%, and final burr size 1.78 ± 0.24 mm, with 2.6 ± 0.9 burrs used for each patient. Primary end-point was MACE at one-year defined as the composite of cardiac death, myocardial infarction, and target vessel revascularization. Post-hoc analysis was performed by stratifying the clinical outcome according to ACEF and CSS tertiles. At 1 year there was a significantly higher MACE rate in the high tertile of ACEF (24% for ACEFHigh vs. 13% for ACEFMid vs. 9% for ACEFLow; P = 0.017) and CSS (25% for CSSHigh vs. 12% for CSSMid vs. 8% for CSSLow; P = 0.008). The predictive accuracy for both ACEF and CSS was moderate (c-statistics, 0.629 and 0.638, respectively). CONCLUSION: Both ACEF and CSS predict with moderate accuracy MACE at 1-year in patients with heavily calcified coronary stenosis undergoing rotational atherectomy with stent implantation.

Quantitative angiography and optical coherence tomography for the functional assessment of nonobstructive coronary stenoses: comparison with fractional flow reserve.

BACKGROUND: The purpose was to compare 3-dimensional quantitative coronary angiography (3D-QCA) with optical coherence tomography (OCT) for the functional assessment of nonobstructive coronary stenoses, as evaluated by fractional flow reserve (FFR). METHODS: Fifty-five nonobstructive coronary stenoses (30%-50% diameter stenosis by visual estimation) were assessed in 36 patients using FFR, 2-dimensional QCA (2D-QCA), 3D-QCA, and OCT. RESULTS: Angiographic stenosis severity by 2D-QCA was 34% ± 13% diameter stenosis, and minimal lumen diameter (MLD) was 1.77 ± 0.58 mm. Fractional flow reserve values were 0.85 ± 0.10. Correlation coefficients between FFR and MLD or minimal lumen area (MLA) were highly significant for both 2D- and 3D-QCA (all P < .001), but higher R(2) values were observed for 3D-QCA measurements. Although significant, correlation coefficients between OCT and FFR data were weak (R(2) = 0.28, P = .001 for MLD and R(2) = 0.23, P = .003 for MLA). Correlation coefficients with FFR were significantly higher for 3D-QCA than for OCT (P values for MLD and MLA = .043 and .042, respectively). Nonobstructive stenoses with MLD >1.53 mm or MLA >2.43 mm(2) are unlikely to be hemodynamically significant. CONCLUSIONS: In nonobstructive coronary stenoses, anatomical parameters derived from 3D-QCA can best identify lesions with preserved FFR values.

Fractional flow reserve-guided versus angiography-guided coronary artery bypass graft surgery.

BACKGROUND: Fractional flow reserve (FFR) is well established for patients undergoing percutaneous coronary intervention, yet little is known about candidates for coronary artery bypass graft surgery. METHODS AND RESULTS: From 2006 to 2010, we retrospectively included in this registry 627 consecutive patients treated by coronary artery bypass graft surgery having at least 1 angiographically intermediate stenosis. In 429 patients, coronary artery bypass graft surgery was based solely on angiography (angiography-guided group). In 198 patients, at least 1 intermediate stenosis was grafted with an FFR ≤0.80 or deferred with an FFR >0.80 (FFR-guided group). The end point was major adverse cardiovascular events at 3 years, defined as the composite of overall death, myocardial infarction, and target vessel revascularization. The rate of angiographic multivessel disease was similar in the angiography-guided and FFR-guided groups (404 [94.2%] versus 186 [93.9%]; P=0.722). In the FFR-guided group, this was significantly downgraded after FFR measurements to 86.4% (P<0.001 versus before FFR) and was associated with a smaller number of anastomoses (3 [2-3] versus 3 [2-4]; P<0.001) and rate of on-pump surgery (49% versus 69%; P<0.001). At 3 years, major adverse cardiovascular events were not different between the angiography-guided and FFR-guided groups (12% versus 11%; hazard ratio, 1.030; 95% confidence interval, 0.627-1.692; P=0.908). However, the FFR-guided group compared with the angiography-guided group presented a significantly lower rate of angina (Canadian Cardiovascular Society class II-IV, 31% versus 47%; P<0.001). CONCLUSIONS: FFR-guided coronary artery bypass graft surgery was associated with a lower number of graft anastomoses and a lower rate of on-pump surgery compared with angiography-guided coronary artery bypass graft surgery. This did not result in a higher event rate during up to 36 months of follow-up and was associated with a lower rate of angina.

Synergistic effect of thrombus aspiration and abciximab in primary percutaneous coronary intervention.

BACKGROUND: Previous studies failed to assess the individual prognostic role of thrombus aspiration (TA) or abciximab in primary percutaneous coronary intervention (pPCI), due their prevalent combined use. METHODS AND RESULTS: A total of 644 consecutive ST-segment elevation myocardial infarction patients treated with pPCI were included in this retrospective registry from January 2006 to December 2008. Patients were divided in: (a) Group 1, with conventional pPCI; (b) Group 2, with pPCI and abciximab; (c) Group 3, with pPCI and TA; (d) Group 4, with pPCI and abciximab plus TA. Primary end point was the composite of major adverse cardiovascular events (MACEs, defined as overall mortality, myocardial infarction, target vessel revascularization, and major bleedings) at 1 year. Baseline clinical and angiographic characteristics were not different among the groups, with the exception of a younger age in group 4. The two groups of patients treated with TA (group 3 and 4) received more frequently direct stenting (P < 0.001 vs. group 1 for both), presented higher rate of end-procedural TIMI flow grade 3 (P < 0.001 vs. group 1 for both), and lower rate of no-reflow (P = 0.016 and P < 0.001 vs. group 1, respectively). Patients of group 2 presented a borderline nonsignificant trend toward higher rate of end-procedural TIMI flow grade 3 (P = 0.083 vs. group 1). MACEs at 1 year were 43 (29%) in group 1 versus 25 (22%) in group 2 versus 24 (19%) in group 3 versus 32 (13%) in group 4 (log-rank P = 0.001). At the multivariate Cox regression analysis, combined TA plus abciximab in group 4 [hazard ratio (HR): 0.48, confidence interval (CI) 95% 0.28-0.84, P = 0.01] and a higher left ventricular ejection fraction (HR: 0.97, CI 95% 0.95-0.98, P < 0.001) were significantly associated with lower MACE rate. CONCLUSIONS: The combination of pharmacologic and mechanic antithrombotic treatment during pPCI was associated with better 1-year clinical outcome.

Contrast-induced nephropathy in patients undergoing primary percutaneous coronary intervention without acute left ventricular ejection fraction impairment.

The prognostic relevance of direct contrast toxicity in patients treated with primary percutaneous coronary intervention remains unclear, owing to the confounding hemodynamic effect of acute left ventricular ejection fraction (LVEF) impairment on kidney function estimation. In the present study, 644 consecutive patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention were prospectively enrolled. Contrast-induced nephropathy (CIN) was defined as an increase in serum creatinine >25% or a decrease in the estimated glomerular filtration rate (eGFR) <25% from baseline in the first 72 hours. The primary end point of the study was major adverse cardiovascular events at 1 year (composite of death, myocardial infarction, target lesion revascularization, and bleeding). Among the global population, the interaction between the LVEF and eGFR at admission to define CIN was statistically significant (p <0.001). When only the 385 patients without acute LVEF impairment (i.e., those with LVEF ≥40%) were considered, 27 (7%) developed postprocedural CIN that was associated with increased major adverse cardiovascular events rate at 1 year of clinical follow-up (38% vs 9%; p <0.001). On adjusted Cox multivariate analysis, CIN was an independent predictor of worse outcomes, both when defined according to creatinine (hazard ratio 3.81, 95% confidence interval 1.71 to 8.48, p = 0.001) or eGFR (hazard ratio 3.77, 95% confidence interval 1.53 to 9.28, p = 0.004) variations. In conclusion, in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention, LVEF has a significant interaction with eGFR. When only patients without acute LVEF impairment were considered, CIN confirmed its negative prognostic effect on the 1-year clinical outcomes.

"Valve in valve" percutaneous aortic valve implantation for severe mixed bioprosthetic aortic valve disease.

Transcatheter aortic valve implantation (TAVI) is an effective treatment for patients with severe aortic stenosis at high risk for surgical valve replacement. We present a case of successful, off-label transfemoral valve-in-valve implantation of the self-expandable Medtronic-CoreValve prosthesis in an inoperable elderly patient with structural deterioration of an existing bioprosthesis in the aortic position. This case illustrates that TAVI for a deteriorated aortic bioprosthesis is feasible in a patient who was not suitable for reoperation.