I prefer the MitraClip in these cases: the 5-year COAPT data.

The COAPT 5-year data demonstrate that compared with medical treatment transcatheter edge-to-edge repair (TEER) with the MitraClip in symptomatic patients with Grade 3+/Grade 4+ secondary mitral regurgitation (SMR) reduced by nearly half the annualized hospitalization risk (33 vs. 57%), by almost 30% the death rate (57 vs. 67%) and achieved significant and durable SMR reduction in 95% of patients. Control patients who crossed over to TEER at 2 years had better prognosis, but nearly half of them died before reaching crossover eligibility. Death or hospitalization for heart failure (HHF) occurred in 73.6% of TEER patients and 91.5% of controls within 5 years, pointing to a need for further study to address left ventricle (LV) dysfunction, the underlying cause of patient's disease. MTRA-FR targeted SMR using the same device and did not improve the composite endpoint of all-cause mortality or HHF at 12 months. Possible reasons for the discrepancy include enrolment of patients with more severe MR and less-advanced LV disease (dilation/dysfunction), less-procedural complications, and higher success in reducing MR in COAPT compared with MITRA-FR. Thus, the ideal patient for MitraClip treatment would be one with severe MR, but with no too severe LV dilation/dysfunction, which is what differentiates COAPT patients from those in MITRA-FR.

OCT-Guided versus Angiography-Guided Coronary Stent Implantation in Complex Lesions: An ILUMIEN IV Substudy.

BACKGROUND: ILUMIEN IV was the first large-scale, multicenter, randomized trial comparing optical coherence tomography (OCT)-guided versus angiography-guided stent implantation in patients with high-risk clinical characteristics and/or complex angiographic lesions. OBJECTIVE: Here, we aimed to specifically examine outcomes in the complex angiographic lesions subgroup. METHODS: From the original trial population (n=2487), high-risk patients without complex angiographic lesions were excluded (n=514). Complex angiographic lesion characteristics included 1) long or multiple lesions with intended total stent length ≥28 mm; 2) bifurcation lesion with intended two-stent strategy; 3) severely calcified lesion; 4) chronic total occlusion; or 5) in-stent restenosis. The study endpoints were 1) final minimal stent area (MSA); 2) 2-year composite of serious major adverse cardiovascular events (MACE; cardiac death, target-vessel myocardial infarction (MI), or stent thrombosis); and 3) 2-year effectiveness, defined as target-vessel failure (TVF), a composite of cardiac death, target-vessel MI, or ischemia-driven target-vessel revascularization. RESULTS: The post-PCI MSA was larger in the OCT- (n=992) versus angiography-guided (n=981) group (5.56±1.95 versus 5.26±1.81mm2; difference, 0.30; 95% confidence interval [CI], 0.14-0.47; P<0.001). Compared with angiography-guided PCI, OCT-guided PCI resulted in a lower risk of serious MACE (3.1% versus 4.9%; hazard ratio [HR], 0.63; 95% CI, 0.40-0.99; P=0.04). TVF was not significantly different between groups (7.3% versus 8.8%; HR, 0.82; 95% CI, 0.59-1.12; P=0.20). CONCLUSIONS: In complex angiographic lesions, OCT-guided PCI led to a larger MSA and reduced the serious MACE composite of cardiac death, target-vessel MI, or stent thrombosis compared with angiography-guided PCI at 2 years, but did not significantly improve TVF.

Outcomes of Transcatheter Aortic Valve Replacement Patients With Different Transvalvular Flow-Gradient Patterns.

Low-flow low-gradient (LF-LG) aortic stenosis (AS) may occur with preserved or depressed left ventricular ejection fraction (LVEF). Both situations represent the most challenging subset of patients to manage and generally have a poor prognosis. Few and controversial data exist on the outcomes of these patients compared with normal flow-high gradient (NF-HG) AS after transcatheter aortic valve replacement (TAVR). We sought to characterize different transvalvular flow-gradient patterns and to examine their prognostic value after TAVR. We enrolled 1,208 patients with severe AS and categorized as follow: 976 patients NF-HG (mean aortic pressure gradient [MPG] ≥40 mm Hg), 107 paradoxical LF-LG (pLF-LG, MPG <40 mm Hg, LVEF ≥50%, stroke volume index <35 ml/m2), and 125 classical LF-LG (cLF-LG) (MPG <40 mm Hg, LVEF <50%, stroke volume index <35 ml/m2). When compared with NF-HG and pLF-LG, cLF-LG had a worse symptomatic status (New York Heart Association III to IV 86% vs 62% and 67%, p <0.001), a higher prevalence of eccentric hypertrophy and a higher level of LV global afterload reflected by a higher valvuloarterial impedance. Valvular function after TAVR was excellent over time in all patients. While 30-day mortality (p = 0.911) did not differ significantly among groups, cLF-LG had a lower 5-year survival rate (LF-LG 50% vs pLF-LG 62% and NF-HG 68%, p <0.05). cLF-LG was associated with a hazard ratio for mortality of 2.41 (95% confidence interval 1.65 to 3.52, p <0.001). In conclusion, TAVR is an effective procedure regardless of transvalvular flow-gradient patterns. However, special care should be given to characterized hemodynamic of AS, as patients with pLF-LG had similar survival rates than patients with NF-HG, whereas cLF-LG is associated with a twofold increased risk of mortality at 5-year follow-up.

Optical Coherence Tomography-Guided versus Angiography-Guided PCI.

BACKGROUND: Data regarding clinical outcomes after optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) as compared with angiography-guided PCI are limited. METHODS: In this prospective, randomized, single-blind trial, we randomly assigned patients with medication-treated diabetes or complex coronary-artery lesions to undergo OCT-guided PCI or angiography-guided PCI. A final blinded OCT procedure was performed in patients in the angiography group. The two primary efficacy end points were the minimum stent area after PCI as assessed with OCT and target-vessel failure at 2 years, defined as a composite of death from cardiac causes, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization. Safety was also assessed. RESULTS: The trial was conducted at 80 sites in 18 countries. A total of 2487 patients underwent randomization: 1233 patients were assigned to undergo OCT-guided PCI, and 1254 to undergo angiography-guided PCI. The minimum stent area after PCI was 5.72±2.04 mm2 in the OCT group and 5.36±1.87 mm2 in the angiography group (mean difference, 0.36 mm2; 95% confidence interval [CI], 0.21 to 0.51; P<0.001). Target-vessel failure within 2 years occurred in 88 patients in the OCT group and in 99 patients in the angiography group (Kaplan-Meier estimates, 7.4% and 8.2%, respectively; hazard ratio, 0.90; 95% CI, 0.67 to 1.19; P = 0.45). OCT-related adverse events occurred in 1 patient in the OCT group and in 2 patients in the angiography group. Stent thrombosis within 2 years occurred in 6 patients (0.5%) in the OCT group and in 17 patients (1.4%) in the angiography group. CONCLUSIONS: Among patients undergoing PCI, OCT guidance resulted in a larger minimum stent area than angiography guidance, but there was no apparent between-group difference in the percentage of patients with target-vessel failure at 2 years. (Funded by Abbott; ILUMIEN IV: OPTIMAL PCI ClinicalTrials.gov number, NCT03507777.).

Noblestitch® system for PFO closure: A novel but judicious alternative to traditional devices-A case report.

Background: Percutaneous suture-mediated patent foramen ovale (PFO) closure has recently been used with the aim of avoiding double-disc nitinol device implantation. This novel technique has been carried out successfully in several centers offering PFO closure with an effective closure rate comparable to conventional double-disc devices. Case summary: A 50-year-old man, a pentathlon athlete, suffering from a previous left-sided ischemic stroke, underwent percutaneous closure of a permanent right-to-left shunt via PFO with a large fenestrated septum primum aneurysm at another institution. The NobleStitch® system was successfully implanted using local anesthesia and under angiographic-fluoroscopic monitoring. He was discharged home on aspirin 100 mg daily with a moderate residual shunt on contrast transthoracic echocardiography (cTTE) that persisted unaltered at subsequent controls. After 7 months, unable to resume sporting activity because of physical discomfort and dyspnea on exertion, the patient asked for a second opinion at our Heart and Brain clinic. Two-dimensional (2D) TTE showed septum primum laceration next to a radiopaque polypropylene knot with a moderate bidirectional shunt located at the fenestrated septum primum far from the PFO site. A catheter-based closure of the septal defect was therefore planned under local anesthesia and rotational intracardiac echo monitoring. An equally sized discs 28.5 mm × 28.5 mm Flex II UNI occluder (Occlutech GmbH, Jena, Germany) was successfully implanted across the atrial septal defect without complications. The patient was discharged in good clinical conditions; dual antiplatelet therapy (aspirin 100 mg/daily and clopidogrel 75 mg/daily) was recommended for 2 months and then single antiplatelet therapy (aspirin100 mg/daily) up to 6 months. Abolition of the residual shunt was confirmed at 1- and 6-month follow-up by contrast transcranial Doppler and 2D color Doppler cTTE. Discussion: Closing a PFO with a suture-base system, without leaving a device implant behind, may be a cutting-edge technology and potential alternative to traditional devices. Nevertheless, meticulous selection of the PFO anatomies by 2D TEE is key to a successful closure procedure in order to avoid complications that must be managed again with a second percutaneous procedure or by surgery.

Comparison between different approaches to evaluate fibrous cap thickness in sequential optical coherence tomography studies.

BACKGROUND: In this in-vivo human study we tested the reproducibility for optical coherence tomography (OCT) assessment of lumen area (LA) and plaque components measurements, such as lipid arc extension and fibrous cap thickness (FCt). METHODS: We tested the variability of LA, lipid arc and FCt assessments in two repeated OCT pullbacks from the same diseased coronary segment matched using fiduciary anatomical landmarks. In particular, for the reliability of minimal FCt measurement we compared four different approaches based on continuous (longitudinal) or segmental (spot) individuation of smaller thickness: 1) comparison of single minimal FCt individuated alongside all plaque extension in the two pullbacks (Longitudinal (L)-spot minimal FCt value); 2) comparison of the mean FCt values of the plaque in the two pullbacks (L-plot mean FCt value); 3) comparison between the single minimal FCt value obtained in the first pullback and the single FCt obtained in the matched CS of second pullback (L-spot CS matched FCt value); 4) comparison of measurements obtained by visual selection of CS with minimal FCt s in the two pullbacks (single-spot minimal FCt value). RESULTS: From the paired analyses of 20 non culprit lesions (accounting for a total of 387 matched CS), we found a suboptimal in-segment correlation for LA (Intra-Class Coefficient [ICC] 0.731), but a good in-segment correlation for lipid arc (ICC 0.963). Regarding FCt measurement, a high reproducibility was obtained applying continuous assessment; in particular, the best correlation was observed with L-spot minimal FCt value and the L-plot mean FCt (ICC 0.893 and 0.952, respectively) with small inter-pullback differences (confidence intervals less than 0.04 mm). CONCLUSIONS: In this methodological study we observed a good reproducibility for quantitative plaque measurements with OCT confirming its reliability for serial assessment. In particular, longitudinal measurement in multiple adjacent frames seems to be the more accurate and reproducible approach for sequential FCt assessment.

Optical coherence tomography-derived lipid core burden index and clinical outcomes: results from the CLIMA registry.

AIMS: The aim of this study was to assess the morphological characteristics and prognostic implications of the optical coherence tomography (OCT)-derived lipid core burden index (LCBI). METHODS AND RESULTS: OCT-LCBI was assessed in 1003 patients with 1-year follow-up from the CLIMA multicentre registry using a validated software able to automatically obtain a maximum OCT-LCBI in 4 mm (maxOCT-LCBI4mm). Primary composite clinical endpoint included cardiac death, myocardial infarction, and target-vessel revascularization. A secondary analysis using clinical outcomes of CLIMA study was performed. Patients with a maxOCT-LCBI4mm ≥ 400 showed higher prevalence of fibrous cap thickness (FCT) <75 µm [odds ratio (OR) 1.43, 95% confidence interval (CI) 1.03-1.99; P = 0.034], lipid pool arc >180° (OR 3.93, 95%CI 2.97-5.21; P < 0.001), minimum lumen area <3.5 mm2 (OR 1.5, 95%CI 1.16-1.94; P = 0.002), macrophage infiltration (OR 2.38, 95%CI 1.81-3.13; P < 0.001), and intra-plaque intimal vasculature (OR 1.34, 95%CI 1.05-1.72; P = 0.021). A maxOCT-LCBI4mm ≥400 predicted the primary endpoint [adjusted hazard ratio (HR) 1.86, 95%CI 1.1-3.2; P = 0.019] as well as the CLIMA endpoint (HR 2.56, 95%CI 1.24-5.29; P = 0.011). Patients with high lipid content and thin FCT < 75 µm were at higher risk for adverse events (HR 4.88, 95%CI 2.44-9.72; P < 0.001). CONCLUSIONS: A high maxOCT-LCBI4mm was related to poor outcome and vulnerable plaque features. This study represents a step further in the automated assessment of the coronary plaque risk profile.

Transcatheter mitral valve replacement: there is still work to be done.

Transcatheter mitral valve replacement (TMVR) is a novel therapeutic option for patients with severe mitral regurgitation (MR) at high or prohibitive surgical risk. Most TMVR technologies under investigation use either a trans-apical or a trans-septal approach via dedicated multistep anchoring systems. Transcatheter mitral valve replacement offers several potential advantages over transcatheter repair, notably a greater and more sustained MR reduction. At the same time, significant engineering challenges and potential disadvantages must be acknowledged. Preclinical and clinical studies have shown promising results, demonstrating TMVR feasibility. Nevertheless, further development, testing, and trials are needed before considering TMVR as a definitive therapeutic option for MR in a wide range of anatomical scenarios.

Conduction disorders after transcatheter aortic valve implantation: A comparison between SAPIEN 3 and SAPIEN 3 Ultra balloon-expandable valves.

Background: Conduction disorders (CD) are the most common complications after Transcatheter Aortic Valve Implantation (TAVI). The last generation of Edwards balloon expandable valves, the SAPIEN 3 Ultra (S3U), is provided with an external sealing skirt that aims to further reduce paravalvular leakage (PVL) compared to SAPIEN 3 (S3) and could potentially lead to higher CD rate. We sought to investigate the rate of new-onset CD in patients undergoing TAVI with the S3 or S3U valve. Methods: We included 582 consecutive patients undergoing TAVI in a single high-volume Center. Patients with previously implanted pacemaker and Valve in valve procedures were excluded. CD rate was evaluated early after implantation and at discharge. Results: No significant difference in the overall CD rate was found between S3 and S3U patients both immediately after the procedure (S3 45.5% vs. S3U 41.8%, p = 0.575) and at discharge (S3 30.4% vs. S3U 35.6%, p = 0.348) with low rate of permanent pacemaker implantation (S3 6.3% vs. S3U 5.5%, p = 0.749). No significant differences were found also in patients with pre-existing atrial fibrillation (S3 8.2% vs. S3U 5%, p = 0.648). A significantly lower rate of PVL was found with S3U compared to S3 (S3 42% vs. S3U 26%, p = 0.007). According to the manufacturer's guidelines we confirmed that S3U were implanted in a significantly higher position compared to S3 (S3 4.89 ± 1.57 mm vs. S3U 4.47 ± 1.36 mm, p = 0.001). Conclusion: No significant difference in the rate of CD, including the need for PPM implantation, was found in patients undergoing TAVI with the S3 compared to S3U. Moreover, S3U significantly reduced the PVL rate.

Management of Iatrogenic Aortic Dissections During Percutaneous Right Coronary Artery Interventions.

Iatrogenic acute aortic dissections during percutaneous coronary interventions are an extremely rare but potentially life-threatening complication, occurring in less than 0.02% of transcatheter procedures. We report three patients with different characteristics suffering from iatrogenic aortic dissection during percutaneous coronary intervention successfully treated with an emergency open-heart surgery. A conservative strategy should be pursuit only in small, localized lesions.

Management of Iatrogenic Aortic Dissections During Percutaneous Right Coronary Artery Interventions

ABSTRACT Iatrogenic acute aortic dissections during percutaneous coronary interventions are an extremely rare but potentially life-threatening complication, occurring in less than 0.02% of transcatheter procedures. We report three patients with different characteristics suffering from iatrogenic aortic dissection during percutaneous coronary intervention successfully treated with an emergency open-heart surgery. A conservative strategy should be pursuit only in small, localized lesions.

Polymer-Based Versus Polymer-Free Stents in High Bleeding Risk Patients: Final 2-Year Results From Onyx ONE.

BACKGROUND: Resolute Onyx polymer-based zotarolimus-eluting stents (ZES) were noninferior in safety and effectiveness to BioFreedom polymer-free biolimus A9-coated stents (DCS) in high-bleeding-risk (HBR) patients treated with 1-month dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT) at 1 year. OBJECTIVES: This study reports the final 2-year results of the randomized Onyx ONE trial. METHODS: The Onyx ONE (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients) trial randomly assigned HBR patients to treatment with ZES or DCS. Following 1-month DAPT, event-free patients received SAPT (either aspirin or a P2Y12 inhibitor at physician discretion). The primary safety endpoint, a composite of cardiac death, myocardial infarction, or stent thrombosis at 1 year, was determined at 1 year. Rates of primary and secondary endpoints were calculated after final follow-up at 2 years. RESULTS: A total of 1,003 patients were randomly allocated to ZES and 993 patients to DCS. Follow-up was complete in 980 (97.7%) ZES patients and 962 (96.9%) DCS patients at 2 years. The primary safety endpoint occurred in 208 (21.2%) patients in the ZES group and 199 (20.7%) patients in the DCS group (risk difference: 0.5%; 95% CI: -3.1% to 4.2%; P = 0.78) at 2 years without significant differences in individual components of the composite endpoint. The secondary effectiveness endpoint occurred in 217 (22.1%) patients in the ZES group and 202 (21.0%) patients in the DCS group (risk difference: 1.1%; 95% CI: -2.5% to 4.8%; P = 0.54). CONCLUSIONS: Among patients at HBR treated with 1-month DAPT followed by SAPT, the Resolute Onyx polymer-based ZES had similar 2-year outcomes for the primary safety and secondary effectiveness endpoint compared with the BioFreedom polymer-free DCS. (A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy [DAPT] for High-Bleeding Risk Patients [Onyx ONE]; NCT03344653).

The Role of the Association Between Serum C-Reactive Protein Levels and Coronary Plaque Macrophage Accumulation in Predicting Clinical Events - Results from the CLIMA Registry.

The present investigation aims to study the interaction between systemic and intra-plaque inflammation in predicting cardiac events. We investigated C-reactive protein (CRP) levels as well as plaque inflammation with optical coherence tomography (OCT)-detected macrophages in the CLIMA study. 689 patients had admission CRP serum values reported, and high CRP values were defined as ≥ 2 mg/dl. The main study endpoint was a composite of cardiac death, myocardial infarction, and/or target vessel revascularization at 1-year follow-up. At multivariate Cox regression analysis, a large (hazard ratio [HR] 2.27, 95% confidence interval [CI] 1.2-4.3; p = 0.013) and superficial (HR 2.78, 95%CI 1.5-5.1; p = 0.001) macrophage arc was predicted of the main composite endpoint in patients with high CRP levels. Patients with large/superficial macrophage accumulation and low CRP levels were not at higher risk of adverse events. The presence of high CRP levels and large/superficial macrophage accumulation at OCT analysis identified patients at higher risk of clinical events.

Intravascular Lithotripsy in Calcified Coronary Lesions: A Single-Center Experience in "Real-World" Patients.

Objectives: This study aims to describe the outcome of intravascular lithotripsy (IVL) when used with different indications and to assess the short- and long-term outcomes of IVL-facilitated percutaneous coronary intervention (PCI). Background: Intravascular lithotripsy can improve the results of PCI of calcified coronary lesions with a low rate of periprocedural complications. Methods: A total of 105 consecutive patients with 110 calcified lesions underwent IVL. A total of 87 de novo lesions were treated by IVL with the following indications: 25 before attempting other balloon-based devices (primary IVL), 51 after the failure of non-compliant balloon dilatation (secondary IVL), and 11 after stent implantation because of stent under expansion (bailout IVL). In 23 lesions, IVL was used for the treatment of in-stent restenosis (ISR). Effectiveness (angiographic success) and safety [major adverse cardiovascular events (MACEs) and IVL-related procedural complications] endpoints were assessed. Results: Angiographic success was achieved in 84.6% of lesions. Early MACEs were periprocedural MI only, ranging from 6.7 to 20% depending on MI definition. The flow-limiting dissections rate was 2.7%. A total of five (4.5%) IVL balloons ruptured during treatment with subsequent vessel perforation in 1 case. MACEs at 12 months were 13.3%, with TLR occurring in 8 lesions (12% primary IVL, 0% secondary IVL, 0% bailout IVL, and 21.7% IVL for ISR, p = 0.002). Conclusion: Treatment of calcified coronary lesions with IVL in a "real-world" setting can be performed with high success, low rate of procedural complications, and an acceptable MACEs rate. Target lesion failure may be more frequent when IVL is performed for the treatment of ISR due to calcium-mediated stent under expansion.

Polymer-free biolimus-A9-eluting stent performance according to renal impairment: insights from the RUDI-FREE registry.

AIMS: Patients with chronic kidney disease (CKD) are at increased risk of cardiovascular disease and have a worse prognosis after percutaneous coronary interventions (PCI). The BioFreedom polymer-free biolimus-A9-eluting stent (PF-BES) has shown promising results in patients at high bleeding risk; however, its performance in CKD patients has yet to be analyzed. METHODS: The all-comers RUDI-FREE registry documented patients undergoing PCI with PF-BES in routine clinical practice. Patients were stratified into three groups according to their estimated glomerular filtration rate (eGFR): preserved renal function, mild renal insufficiency (RI), and with moderate to severe RI (eGFR ≥ 90, between 90 and 45, and <45 ml/min/1.73 m2, respectively). The primary safety end point was a patient-oriented composite end point of cardiovascular death, myocardial infarction (MI), and definite or probable stent thrombosis (ST). The primary efficacy end point was target lesion revascularization (TLR). RESULTS: The registry documented 1,104 consecutive patients treated with PF-BES: 258 (23.4%) with preserved renal function, whereas 712 (64.7%) and 131 (11.9%) had mild and moderate to severe RI, respectively. At 1 year, the primary safety end point was significantly higher in patients with moderate to severe RI (3.5% vs. 2.8% vs. 11.5%; P < 0.001). Conversely, TLR proved similar among groups (0.4% vs. 1.8% vs. 0.8%; P = 0.235). CONCLUSIONS: Patients with worse renal function had increased risk of the composite of cardiovascular deaths, MI, and definite or probable ST. However, the PF-BES showed similar efficacy despite differences in renal function. These findings need to be confirmed in large-scale randomized trials.

Polymer-Free Biolimus-Eluting Stents or Polymer-Based Zotarolimus-Eluting Stents for Coronary Bifurcation Lesions.

BACKGROUND: A polymer-free biolimus-eluting stent (PF-BES) and a zotarolimus-eluting stent (ZES) recently showed similar clinical profiles and appear to be competing options in specific clinical settings of patients undergoing percutaneous coronary intervention (PCI). Whether they perform similarly also in complex procedural settings as coronary bifurcation lesions remains unaddressed. METHODS: All consecutive patients undergoing coronary bifurcation PCI with PF-BES or the new iteration of the ZES from three large multicenter real-world registries were included. The primary outcome was major adverse cardiovascular events (MACE), a composite of all-cause death, myocardial infarction (MI), target lesion revascularization (TLR) and stent thrombosis (ST). Multiple analyses to adjust for baseline differences were carried out including propensity-score matching, propensity-score stratification and inverse-probability-weighting. Outcomes are reported according to Cox proportional hazard models censored at 400-day follow-up. RESULTS: 1169 patients treated with PF-BES (n = 440) or ZES (n = 729) on the main branch of a coronary bifurcation lesion were included (mean age 69 ± 11 years, 75.4% male, 53.8% acute coronary syndrome at presentation, 26.6% left main bifurcation, median dual antiplatelet therapy duration 12 [range 12-12] months). MACE, all-cause death, TLR and ST tended towards non-statistically higher rates with the PF-BES as compared to the ZES. Higher MI and target vessel revascularization occurrence was observed with PF-BES. CONCLUSIONS: In this large contemporary cohort of patients undergoing coronary bifurcation PCI, the occurrence of MACE was non-statistically different with the use of PF-BES and ZES devices. However, differences favoring the ZES device that may entail clinical relevance were observed. Further studies are needed to confirm these findings and explore whether they remain valid when a short dual antiplatelet therapy is adopted.

Relationship betweeen the amount and location of macrophages and clinical outcome: subanalysis of the CLIMA-study.

BACKGROUND: The ability of optical coherence tomography (OCT) to recognize intraplaque macrophage infiltration is now well acknowledged. This post-hoc analysis of the CLIMA study aimed to address the clinical impact of the circumferential extension of OCT-defined macrophages and their location at one year follow-up. METHODS: The multicentre CLIMA study enrolled 1003 patients undergoing OCT evaluation of the untreated proximal left anterior descending (LAD) coronary artery. Measurements of circumferential extension of macrophages and measurements of the distance from intima-lumen contour to macrophages string were performed at the plaque cross-section judged as containing the greatest amount of macrophages. The main study endpoint was a composite of cardiac death, myocardial infarction (MI) and/or target vessel revascularization (TVR). RESULTS: Patients with large macrophage arc (p = 0.001) and superficial macrophage arc (p < 0.001) showed a higher one-year incidence of the main one-year composite endpoint. Consistently hypertension (p = 0.018), family history of CAD (p = 0.046), diabetes mellitus (p = 0.036), lower ejection fraction (p = 0.009) and chronic kidney disease (p = 0.019) were more frequently found in patients experiencing the main composite endpoint. At multivariate Cox regression analysis, fibrous cap thickness < 75 µm (HR 2.51, 95% 1.46-4.32), presence of large (HR 1.97, 95%CI 1.16-3.35, p = 0.012) and superficial (HR 1.72, 95%CI 1.02-2.90; p = 0.040) macrophage arc remained independent predictors of the main composite endpoint. Large macrophage arc was associated with target LAD related MI. CONCLUSION: The present post-hoc analysis of the CLIMA showed that the circumferential extension of macrophages and their location are related to a composite endpoint of cardiac death, MI and/or TVR.

Clinical outcomes of suboptimal stent deployment as assessed by optical coherence tomography: long-term results of the CLI-OPCI registry.

BACKGROUND: Intraprocedural optical coherence tomography (OCT) is a valuable tool for guidance of percutaneous coronary intervention, but long-term follow-up data are lacking. AIMS: The aim of this study was to address the long-term (7.5 years) clinical impact of quantitative OCT metrics of suboptimal stent implantation. METHODS: This retrospective study includes 391 patients with long-term follow-up (mean 2,737 days; interquartile range 1,301-3,143 days) from the multicentre Centro per la Lotta contro l'Infarto - Optimisation of Percutaneous Coronary Intervention (CLI-OPCI) registry. OCT-assessed suboptimal stent deployment required the presence of at least one of the following pre-defined OCT findings: in-stent MLA <4.5 mm2, proximal or distal reference lumen narrowing with lumen area <4.5 mm2, significant proximal or distal edge dissection width ≥200 µm. RESULTS: One hundred and two patients (26.1%) with 138 stented lesions (27.7%) experienced a device-oriented cardiovascular event (DOCE). In-stent MLA <4.5 mm2 (38.1% vs 19.8%, p<0.001), in-stent lumen expansion <70% (29.5% vs 20.3%, p=0.032), proximal reference lumen narrowing <4.5 mm2 (6.5% vs 1.4%, p=0.004), and distal reference lumen narrowing <4.5 mm2 (12.9% vs 3.6%, p=0.001) were significantly more common in the DOCE vs non-DOCE group. OCT-assessed suboptimal stent deployment was an independent predictor of long-term DOCE (HR 2.17, p<0.001), together with bare metal stent implantation (HR 1.73, p=0.003) and prior revascularisation (HR 1.53, p=0.017). CONCLUSIONS: The presence of OCT-assessed suboptimal criteria for stent implantation was related to a worse clinical outcome at very long-term follow-up. This information further supports an OCT-guided strategy of stent deployment.

Adoption of a new automated optical coherence tomography software to obtain a lipid plaque spread-out plot.

PURPOSE: Near infrared spectroscopy-Intravascular ultrasound (NIRS-IVUS) provide a fully automated Lipid Core Burden Index (LCBI). Optical coherence tomography (OCT) is potentially capable of measuring lipid longitudinal extension in a dedicated two-dimensional LCBI spread-out plot. The present study has been designed to validate an automated approach to assess OCT images, able of providing a dedicated LCBI spread-out plot. METHODS: We compared results obtained with conventional (manual) OCT, with those obtained with a novel automated OCT algorithm and with NIRS-IVUS in consecutive 40 patients. Our goal was to calculate the lipid core longitudinal extension in a dedicated two-dimensional LCBI spread-out plot. Three groups were identified according to the studied lesions: (1) culprit lesions in ACS patients (n = 16), (2) non-culprit lesions in ACS patients (n = 12) and (3) lesions in stable patients (n = 12). OCT (either manual and automated) and NIRS-IVUS assessment showed for culprit ACS plaques a more complex anatomy. RESULTS: A strong trend for increased LCBI was found in the culprit ACS group, regardless of the adopted imaging modality (either NIRS-IVUS or automated OCT). A fair correlation was obtained for the maximum 4 mm LCBI measured by NIRS-IVUS and automated OCT (r = 0.75). The sensitivity and specificity of automated OCT to detect significant LCBI (> 400) were 90.5 and 84.2 respectively. CONCLUSION: We developed an OCT automated approach that can provide a dedicated lipid plaque spread-out plot to address plaque vulnerability. The automated OCT software can promote and improve OCT clinical applications for the identification of patients at risk of hard events.

Predicting Long-Term Mortality in TAVI Patients Using Machine Learning Techniques.

BACKGROUND: Whereas transcatheter aortic valve implantation (TAVI) has become the gold standard for aortic valve stenosis treatment in high-risk patients, it has recently been extended to include intermediate risk patients. However, the mortality rate at 5 years is still elevated. The aim of the present study was to develop a novel machine learning (ML) approach able to identify the best predictors of 5-year mortality after TAVI among several clinical and echocardiographic variables, which may improve the long-term prognosis. METHODS: We retrospectively enrolled 471 patients undergoing TAVI. More than 80 pre-TAVI variables were collected and analyzed through different feature selection processes, which allowed for the identification of several variables with the highest predictive value of mortality. Different ML models were compared. RESULTS: Multilayer perceptron resulted in the best performance in predicting mortality at 5 years after TAVI, with an area under the curve, positive predictive value, and sensitivity of 0.79, 0.73, and 0.71, respectively. CONCLUSIONS: We presented an ML approach for the assessment of risk factors for long-term mortality after TAVI to improve clinical prognosis. Fourteen potential predictors were identified with the organic mitral regurgitation (myxomatous or calcific degeneration of the leaflets and/or annulus) which showed the highest impact on 5 years mortality.