Usability of Fantom Encore® scaffold in non-complex bifurcations-Analysis in bench models.

OBJECTIVE: Present bench study aimed to evaluate whether technical characteristics of Fantom Encore® bioresorbable scaffold (BRS) allow to perform proximal optimization/side branch dilation/proximal optimization (POT-SB-POT) technique, as an adequate solution for bifurcation percutaneous coronary intervention. METHODS: Two Fantom Encore® BRS platforms (small with 3.0 mm nominal diameter, n = 7; and large with 3.5 mm nominal diameter, n = 7) were evaluated in bench models, which were designed according to Finet-law and fitted to nominal scaffold diameter in the distal main branch (MB) and fitted to indicated maximal expansion capacity in the proximal main branch (MB). Results were evaluated by (a) fluoroscopy, (b) optical coherence tomography (OCT) and (c) micro-computed tomography (µCT). RESULTS: All procedures were performed according to the protocol. Careful review of the fluoroscopic loops by an independent operator did not reveal any strut fracture or major deformation. By OCT the overall rate of perfectly apposed struts in the bifurcation area was 15 ± 6% after SB opening, that increased significantly but remained low with 22 ± 9% after final POT (p = .001). Compared to SB ballooning alone, significant benefit of final POT was found in rate of perfect apposition in the proximal MB (15 ± 12% vs. 26 ± 15%, respectively; p = .017) and at the abostial side of polygon of confluence (7 ± 9% vs. 16 ± 13%, respectively; p = .005). µCT analysis revealed a single strut fracture in one case with the small platform, while four cases showed single or multiple strut fractures with the large platform. CONCLUSION: The mechanical characteristics of the device are not suitable for use of Conventional techniques for bifurcation PCI such as POT-SB-POT. The use of Fantom Encore® BRS for bifurcation PCI with relevant SB should not be encouraged.

Influence of fractional flow reserve on grafts patency: Systematic review and patient-level meta-analysis.

OBJECTIVE: To investigate the impact of invasive functional guidance for coronary artery bypass graft surgery (CABG) on graft failure. BACKGROUND: Data on the impact of fractional flow reserve (FFR) in guiding CABG are still limited. METHODS: Systematic review and individual patient data meta-analysis were performed. Primary objective was the risk of graft failure, stratified by FFR. Risk estimates are reported as odds ratios (ORs) derived from the aggregated data using random-effects models. Individual patient data were analyzed using mixed effect model to assess relationship between FFR and graft failure. This meta-analysis is registered in PROSPERO (CRD42020180444). RESULTS: Four prospective studies comprising 503 patients referred for CABG, with 1471 coronaries, assessed by FFR were included. Graft status was available for 1039 conduits at median of 12.0 [IQR 6.6; 12.0] months. Risk of graft failure was higher in vessels with preserved FFR (OR 5.74, 95% CI 1.71-19.29). Every 0.10 FFR units decrease in the coronaries was associated with 56% risk reduction of graft failure (OR 0.44, 95% CI 0.34 to 0.59). FFR cut-off to predict graft failure was 0.79. CONCLUSION: Surgical grafting of coronaries with functionally nonsignificant stenoses was associated with higher risk of graft failure.

Validation of the all-comers design: Results of the TARGET-AC substudy.

BACKGROUND: Results of clinical trials are often criticized by low inclusion rate and potential sampling bias in patient recruitment. The aim of this validation registry is to evaluate how far an all-comers design in the context of clinical research can ensure the representation of the true all-comers population. METHODS: This validation registry is a prospective international multicentre registry, conducted at 10 out of the total 21 centers, participating in TARGET-AC (registered under NCT02520180). During a predefined four-week period data were recorded prospectively on all PCIs performed in the participating centers, whether or not patients were enrolled in TARGET-AC. Data were collected on patient demographics, angiographic lesion- and procedural characteristics. For patients who were not enrolled in the study, operators were asked to declare the reason for not enrolling the patient, using a single-choice questionnaire. RESULTS: A total of 131 patients were enrolled in the TARGET-AC study during the investigated period (ER group), standing as 20% (range 4% and 54%) of all eligible cases per protocol. In the ER group more patients presented with stable angina (61% vs. 43%, respectively; P < .001). Whereas ST-elevation infarction was less common (5% vs. 26%, respectively; P < .001), there was no difference in non-ST elevation acute coronary syndrome (32% vs. 27%, respectively; P = .248). Risk factors and comorbidities did not show any difference between the ER and the non-enrolled (NER) groups, except for greater rate of significant valvular disease in the NER group (12% vs 19%, respectively; P = .037). The NER group presented more thrombotic stenoses than the ER group (20% vs 12%, respectively; P = .040). No difference was found in any other investigated angiographic parameters, like target vessels, bifurcation lesion, severe calcification or chronic total occlusions. Admission during regular working hours and availability of study nurse were associated with markedly higher recruitment rate. CONCLUSION: Results suggest that TARGET AC was outbalanced for stable patients over primary PCIs as compared to real world. However in terms of risk factors and comorbidities the trial managed to represent the collective of real world clinical practice. Fairly representative cases were included at an average inclusion-to-eligible rate of 20%.

Revascularization decisions in patients with chronic coronary syndromes: Results of the second International Survey on Interventional Strategy (ISIS-2).

BACKGROUND: In chronic coronary syndromes, guidelines mandate invasive functional guidance of revascularization whenever non-invasive proof of ischemia is missing. ISIS-2 survey aimed to evaluate how the adoption of guideline recommendation on ischemia-guided revascularization has evolved over the last 5-7 years. METHODS: In ISIS-2 participants assessed five complete angiograms, presenting only intermediate stenoses without information on non-invasive pre-testing. Fractional flow reserve was known for each stenosis, but remained undisclosed. Participants could determine stenosis significance either by angiography or by requesting an adjunctive invasive diagnostic method (intravascular imaging or functional tests). Primary endpoint was the rate of requesting adjunctive functional assessment. Secondary endpoints were the rate of concordance between angiography-based decisions and know functional severity. ISIS-2 utilized the same web-based platform as ISIS-1 in 2013. (NCT04001452). RESULTS: 334 participants performed 2059 lesion evaluations: 1202 (59%) decisions were based solely on angiography without expressed need for further evaluation. These decisions were discordant with known functional significance in 39%, mainly with potential of overtreatment. Participants requested invasive functional assessment in 643 (31%) and intravascular imaging in 214 (10%) cases. Compared to ISIS-1 the rate of purely angiography-based decisions has decreased (59% vs 66%; p < 0.001), while invasive functional tests were more frequently requested (31% vs 25%; p < 0.001). CONCLUSIONS: ISIS-2 suggests an evolving pattern in the intention to integrate invasive coronary physiology into the revascularization decisions. However, the disconnect between recommendations and current thinking is still dominant.

Resorbable Magnesium Scaffold in Coronary Bifurcations - Report of in Vitro Experiments.

OBJECTIVES: The aim of this work is to evaluate in an in vitro setting the behavior of resorbable magnesium scaffolds (RMS) in bifurcations. BACKGROUND: As coronary bifurcations represent an important portion of all PCIs, it is crucial to understand whether RMS is applicable in these complex lesions. METHODS: Performance of RMS was evaluated with focus on bifurcations. In bifurcations RMS was tested for (1) main branch stenting with side branch opening and proximal optimization; for (2) main branch stenting with final kissing and proximal optimization; for (3) T-and-protrusion technique; for (4) string technique, which is a minimalistic version of conventional culotte technique. All tests were performed using 3.50 × 25 mm RMS. Results were evaluated by fluoroscopy, optical coherence tomography (OCT) and micro-computed tomography (µCT), for scaffold conformability, strut apposition, structural deformation and strut fracture. RESULTS: All planned procedural steps were performed successfully with good result according to fluoroscopy. By OCT the overall malapposition rate in bifurcation cases was 4.3%, occurring predominantly in the carinal area. No malapposition was seen at the proximal main branch confirming proper conformability of RMS. µCT analysis has shown that final kissing dilation resulted in fully stretched struts in cases, where performed with 3.5 and 3.0 mm balloons. In one case a broken connector (T-and-protrusion) and in another case, a broken strut (String technique) were identified. CONCLUSIONS: RMS can structurally cope with bifurcations. Still, for cases and techniques where overexpansion beyond the recommended limit is needed, RMS might not be the proper device due to risk of strut fracture.

Sniff of coke breaks the heart: cocaine-induced coronary vasospasm aggravated by therapeutic hypothermia and vasopressors after aborted sudden cardiac death: a case report.

INTRODUCTION: Coronary vasospasm and sudden cardiac death are a frequently reported complication of cocaine abuse. We present a case with uniquely severe clinical and angiographic presentation. CASE PRESENTATION: A 39-year-old patient was presented to the cath lab after out-of-hospital cardiac arrest. Coronary angiography revealed focal coronary vasospasm in the proximal LCx, well responsive for intracoronary nitrates. Accordingly, no coronary intervention was performed and the patient was transferred to the cardiac intensive care unit. There, after systematically cooling sudden haemodynamic deterioration and massive ST-elevation was observed. Repeated coronary angiography revealed subocclusive LAD and LCx vasospasm, which again recovered after intracoronary injection of nitric oxide. DISCUSSION: Coronary-spastic effect of cocaine and its potentially dreadful clinical consequences are well-described phenomena. As novelty this case emphasizes that standard of care, including systematic hypothermia and vasopressor administration after out-of-hospital cardiac arrest can potentiate cocaine-induced coronary spasm with dramatic outcomes.

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.