Objectives This study sought to assess the diagnostic value of optical coherence tomography (OCT) in patients with suspected spontaneous coronary artery dissection (SCAD). Background SCAD is a rare ...but challenging clinical entity. Methods Following a prospective protocol, OCT was performed in 17 consecutive patients with a clinical and angiographic suspicion of SCD from a total of 5,002 patients undergoing coronary angiography. A conservative management strategy was followed. Results OCT ruled out the diagnosis of SCAD in 6 patients with coronary artery disease (atherosclerotic plaques and/or intracoronary thrombus). In 11 patients (age 48 ± 9 years, 9 female), OCT confirmed the presence of SCAD. A double-lumen or intramural hematoma image was visualized in all cases. However, only 3 patients presented an intimal “flap” on angiography. OCT readily identified the intimal rupture site (n = 7), the thickness (348 ± 84 μm) and length (31 ± 9 mm) of the intimomedial membrane, the area of the true (1.1 ± 0.5 mm2 ) and false lumen (5.9 ± 2.1 mm2 ), the associated intramural hematoma (n = 9), and thrombi in the true or false lumens (n = 11). Most of these findings were angiographically silent. After stenting (n = 4), OCT disclosed adequate stent coverage, expansion, and apposition, but also residual intramural hematoma at the stented site (abluminal) and at the distal vessel. Conclusions OCT provides unique insights in patients with SCAD that allow an early diagnosis and adequate management. Most of these findings are undetectable by angiography.
Summary Background Absorbable scaffolds were designed to overcome the limitations of conventional, non-absorbable metal-based drug-eluting stents. So far, only polymeric absorbable scaffolds are ...commercially available. We aimed to assess the safety and performance of a novel second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) in patients with de-novo coronary artery lesions. Methods We did this prospective, multicentre, non-randomised, first-in-man trial at 13 percutaneous coronary intervention centres in Belgium, Brazil, Denmark, Germany, Singapore, Spain, Switzerland, and the Netherlands. Eligible patients had stable or unstable angina or documented silent ischaemia, and a maximum of two de-novo lesions with a reference vessel diameter between 2·2 mm and 3·7 mm. Clinical follow-up was scheduled at months 1, 6, 12, 24, and 36. Patients were scheduled for angiographic follow-up at 6 months, and a subgroup of patients was scheduled for intravascular ultrasound, optical coherence tomography, and vasomotion assessment. All patients were recommended to take dual antiplatelet treatment for at least 6 months. The primary endpoint was in-segment late lumen loss at 6 months. We did analysis by intention to treat. This trial is registered with ClinicalTrials.gov , number NCT01960504. Findings Between Oct 8, 2013, and May 22, 2015, we enrolled 123 patients with 123 coronary target lesions. At 6 months, mean in-segment late lumen loss was 0·27 mm (SD 0·37), and angiographically discernable vasomotion was documented in 20 (80%) of 25 patients. Intravascular ultrasound assessments showed a preservation of the scaffold area (mean 6·24 mm2 SD 1·15 post-procedure vs 6·21 mm2 1·22 at 6 months) with a low mean neointimal area (0·08 mm2 0·09), and optical coherence tomography did not detect any intraluminal mass. Target lesion failure occurred in four (3%) patients: one (<1%) patient died from cardiac death, one (<1%) patient had periprocedural myocardial infarction, and two (2%) patients needed clinically driven target lesion revascularisation. No definite or probable scaffold thrombosis was observed. Interpretation Our findings show that implantation of the DREAMS 2G device in de-novo coronary lesions is feasible, with favourable safety and performance outcomes at 6 months. This novel absorbable metal scaffold could be an alternative to absorbable polymeric scaffolds for treatment of obstructive coronary disease. Funding Biotronik AG.
Introduction Accuracy of intracoronary imaging to discriminate functionally significant coronary stenosis according to vessel diameter remains to be defined. Methods PubMed, Scopus, and Google ...Scholar were systematically searched for studies assessing diagnostic accuracy (area under the receiver operating characteristic curve AUC, the primary end point) and sensitivity and specificity (the secondary end points) of minimal luminal area (MLA) or of minimal luminal diameter (MLD) derived from intravascular ultrasound (IVUS) or optical coherence tomography (OCT) to detect functionally significant stenosis as determined with fractional flow reserve (FFR). Results Fifteen studies were included, 2 with 110 patients analyzing only left main (LM), 5 with 224 patients and 306 lesions using OCT, and 9 with 1532 patients and 1681 lesions with IVUS. Median MLA for the OCT studies was 1.96 mm2 (1.85-1.98 mm2 ), 2.9 mm2 (2.7-3.1 mm2 ) for MLA of all lesions assessed with IVUS, 2.8 mm2 (2.7-2.9 mm2 ) for lesions with an angiographic diameter >3 mm, 2.4 mm2 (2.4-2.5 mm2 ) for lesions <3 mm, and 5.4 mm2 (5.1-5.6 mm2 ) for LM lesions. For OCT-MLA, AUC was 0.80 (0.74-0.86), with a sensitivity of 0.81 (0.74-0.87) and specificity of 0.77 (0.71-0.83), whereas OCT-MLD had an AUC of 0.85 (0.79-0.91), sensitivity of 0.74 (0.69-0.78), and specificity of 0.70 (0.68-0.73). For IVUS-MLA, AUC was 0.78 (0.75-0.81) for all lesions, 0.78 (0.73-0.84) for vessels with a diameter >3 mm, and 0.79 (0.70-0.89) for those with a diameter <3 mm. Left main AUC was 0.97 (0.93-1). Conclusion Intravascular ultrasound and OCT had modest diagnostic accuracy for identification hemodynamically significant lesions, also with specific cutoff for different diameters. Invasive imaging for assessment of LM severity demonstrated excellent correlation with FFR. What is already known about this subject? Fractional flow reserve represents the criterion standard to evaluate the prognostic value of coronary stenosis, whereas its relationship with IVUS and OCT remains to be assessed. What does this study add? Despite improvement, IVUS and OCT do not predict functional stenosis, even with dedicated cutoff, apart from LM disease. How might this impact on clinical practice? The recent guidelines of myocardial revascularization have stressed the crucial role of FFR before performing percutaneous coronary intervention on LM, whereas intravascular imaging is often exploited to drive revascularization. The present analysis stresses the point that LM percutaneous coronary intervention may be driven only by intravascular imaging, given the high accuracy for significant ischemic lesions, whereas for other vessels, these 2 techniques mirror 2 different aspects.
Abstract Objectives The authors sought to analyze height differences within the coronary artery tree in patients in a supine position and to quantify the impact of hydrostatic pressure on ...intracoronary pressure measurements in vitro. Background Although pressure equalization of the pressure sensor and the systemic pressure at the catheter tip is mandatory in intracoronary pressure measurements, subsequent measurements may be influenced by hydrostatic pressure related to the coronary anatomy in the supine position. Outlining and quantifying this phenomenon is important to interpret routine and pullback pressure measurements within the coronary tree. Methods Coronary anatomy was analyzed in computed tomography angiographies of 70 patients to calculate height differences between the catheter tip and different coronary segments in the supine position. Using a dynamic pressure simulator, the effect of the expected hydrostatic pressure resulting from such height differences on indices stenosis severity was assessed. Results In all patients, the left anterior and right posterior descending arteries are the highest points of the coronary tree with a mean height difference of −4.9 ± 1.6 cm and −3.8 ± 1.0 cm; whereas the circumflex artery and right posterolateral branches are the lowest points, with mean height differences of 3.9 ± 0.9 cm and 2.6 ± 1.6 cm compared with the according ostium. In vitro measurements demonstrated a correlation of the absolute pressure differences with height differences (r = 0.993; p < 0.0001) and the slope was 0.77 mm Hg/cm. The Pd/Pa ratio and instantaneous wave-free ratio correlated also with the height difference (fractional flow reserve r = 0.98; p < 0.0001; instantaneous wave-free ratio r = 0.97; p < 0.0001), but both were influenced by the systemic pressure level. Conclusions Hydrostatic pressure variations resulting from normal coronary anatomy in a supine position influence intracoronary pressure measurements and may affect their interpretation during stenosis severity assessment.
Abstract Incidence, predictors and impact on prognosis of target lesion revascularization (TLR) for patients treated with second generation drug eluting stents (DESs) on unprotected left main (ULM) ...remain to be defined. The present is a multicenter study including patients treated with a second generation DES on ULM from June 2007 to January 2015. Rate of target lesion revascularization was the primary end point. All cause death, myocardial infarction, target vessel revascularization and stent thrombosis were the secondary end points. 1270 patients were enrolled: after a follow up of 650 days (230-1170) 47 (3.7%) of them underwent a re-PCI TLR on the left main, 22 during a planned angiographic follow up. Extent of CAD was similar among groups (median value of Syntax of 27±10 vs. 26±9, p 0.45), as localization of the lesion in the ULM. Of patients reporting with TLR on ULM; 56% presented with a focal re-stenosis, 33% diffuse and 10% proliferative. At multivariate analysis), insulin dependent diabetes mellitus increased risk of TLR (HR 2.0: 1.1-3.6, p 0.04), while use of IVUS resulted protective (HR 0.5: 0.3-0.9, p 0.02) At follow up, rates of cardiovascular death did not differ among the two groups (4% vs.4%, p 0.95). At multivariate analysis, TLR on LM did not increase risk of all cause death (HR 0.4: 0.1-1.6, p 0.22), while cardiogenic shock and III tertile of Syntax portended a worse prognosis (respectively HR 4.5: 2.1-10.2 p 0.01 and HR 1.4:1.1-1.6 p 0.03).. In conclusion, repeated revascularization after implantation of second generation DES on ULM represents an unfrequent event, being increased in insulin dependent patients and reduced by IVUS. Impact on prognosis remains neutral, being related to clinical presentation and extent of CAD.
Objectives This study sought to determine if adenosine administration is required for the pressure-only assessment of coronary stenoses. Background The instantaneous wave-free ratio (iFR) is a ...vasodilator-free pressure-only measure of the hemodynamic severity of a coronary stenosis comparable to fractional flow reserve (FFR) in diagnostic categorization. In this study, we used hyperemic stenosis resistance (HSR), a combined pressure-and-flow index, as an arbiter to determine when iFR and FFR disagree which index is most representative of the hemodynamic significance of the stenosis. We then test whether administering adenosine significantly improves diagnostic performance of iFR. Methods In 51 vessels, intracoronary pressure and flow velocity was measured distal to the stenosis at rest and during adenosine-mediated hyperemia. The iFR (at rest and during adenosine administration iFRa), FFR, HSR, baseline, and hyperemic microvascular resistance were calculated using automated algorithms. Results When iFR and FFR disagreed (4 cases, or 7.7% of the study population), HSR agreed with iFR in 50% of cases and with FFR in 50% of cases. Differences in magnitude of microvascular resistance did not influence diagnostic categorization; iFR, iFRa, and FFR had equally good diagnostic agreement with HSR (receiver-operating characteristic area under the curve 0.93 iFR vs. 0.94 iFRa and 0.96 FFR, p = 0.48). Conclusions iFR and FFR had equivalent agreement with classification of coronary stenosis severity by HSR. Further reduction in resistance by the administration of adenosine did not improve diagnostic categorization, indicating that iFR can be used as an adenosine-free alternative to FFR. (Classification Accuracy of Pressure-Only Ratios Against Indices Using Flow Study CLARIFY; NCT01118481 )
Impact of Platelet Reactivity on Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus and Coronary Artery Disease Dominick J. Angiolillo, Esther Bernardo, Manel Sabaté, Pilar ...Jimenez-Quevedo, Marco A. Costa, Jorge Palazuelos, Rosana Hernández-Antolin, Raul Moreno, Javier Escaned, Fernando Alfonso, Camino Bañuelos, Luis A. Guzman, Theodore A. Bass, Carlos Macaya, Antonio Fernandez-Ortiz Type 2 diabetes mellitus (T2DM) patients have increased platelet reactivity compared with nondiabetic patients. Whether high platelet reactivity (HPR) assessed in T2DM patients while in their steady-state phase of dual antiplatelet therapy is associated with an increased risk of major adverse cardiovascular events (MACE) is unknown. Platelet function analyses were performed in 173 T2DM patients on chronic dual antiplatelet therapy. At 2 years, a total of 41 MACE occurred in 19.7% of patients. High platelet reactivity was the strongest independent predictor of MACE (p = 0.001). Patients with HPR had up-regulation of multiple platelet signaling pathways, indicative of global platelet hyperreactivity. Type 2 diabetes mellitus patients with HPR may warrant more potent antithrombotic treatment.
Objectives The goal of this trial was to study the long-term effects of intravenous (IV) metoprolol administration before reperfusion on left ventricular (LV) function and clinical events. Background ...Early IV metoprolol during ST-segment elevation myocardial infarction (STEMI) has been shown to reduce infarct size when used in conjunction with primary percutaneous coronary intervention (pPCI). Methods The METOCARD-CNIC (Effect of Metoprolol in Cardioprotection During an Acute Myocardial Infarction) trial recruited 270 patients with Killip class ≤II anterior STEMI presenting early after symptom onset (<6 h) and randomized them to pre-reperfusion IV metoprolol or control group. Long-term magnetic resonance imaging (MRI) was performed on 202 patients (101 per group) 6 months after STEMI. Patients had a minimal 12-month clinical follow-up. Results Left ventricular ejection fraction (LVEF) at the 6 months MRI was higher after IV metoprolol (48.7 ± 9.9% vs. 45.0 ± 11.7% in control subjects; adjusted treatment effect 3.49%; 95% confidence interval CI: 0.44% to 6.55%; p = 0.025). The occurrence of severely depressed LVEF (≤35%) at 6 months was significantly lower in patients treated with IV metoprolol (11% vs. 27%, p = 0.006). The proportion of patients fulfilling Class I indications for an implantable cardioverter-defibrillator (ICD) was significantly lower in the IV metoprolol group (7% vs. 20%, p = 0.012). At a median follow-up of 2 years, occurrence of the pre-specified composite of death, heart failure admission, reinfarction, and malignant arrhythmias was 10.8% in the IV metoprolol group versus 18.3% in the control group, adjusted hazard ratio (HR): 0.55; 95% CI: 0.26 to 1.04; p = 0.065. Heart failure admission was significantly lower in the IV metoprolol group (HR: 0.32; 95% CI: 0.015 to 0.95; p = 0.046). Conclusions In patients with anterior Killip class ≤II STEMI undergoing pPCI, early IV metoprolol before reperfusion resulted in higher long-term LVEF, reduced incidence of severe LV systolic dysfunction and ICD indications, and fewer heart failure admissions. (Effect of METOprolol in CARDioproteCtioN During an Acute Myocardial InfarCtion. The METOCARD-CNIC Trial; NCT01311700 )
Abstract In-hospital infections (IHI) are one of the most common and serious problems following invasive procedures. Transcatheter aortic valve implantation (TAVI) is an increasingly used alternative ...to surgery in patients with severe symptomatic aortic stenosis. The aim of this study was to determine the incidence, etiology, risk factors and clinical outcomes of IHI after TAVI. A total of 303 consecutive patients with severe aortic stenosis who underwent transfemoral TAVI were included and followed during a median time of 21 months. We examined the occurrence, types, etiology and timing of infections during hospital stay as well as short and long-term clinical outcomes according to the occurrence of IHI. A total of 51 patients (17%; 62 infectious episodes) experienced IHI after TAVI. Respiratory and urinary tract infections were the most frequent type of infections (44% and 34%, respectively), followed by surgical site infection (8%) and bloodstream infection (5%). Positive cultures were obtained in 74% of the samples, of which 65% were Gram-negative bacilli. Modifiable factors such as bleeding (p=0.005) and length of coronary care unit stay (p<0.001) were independently associated with an increased infection risk. Patients with IHI had a longer hospital stay (14 versus 6 days, p<0.001), an increased mortality (HR:2.48; 95% CI:1.45-4.23) and readmission rate (HR:2.0; 95 CI:1.27-3.14) during the follow-up. In conclusion, IHI is a frequent complication following TAVI with a significant impact on short and long-term clinical outcomes. The most important risk factors associated with the development of this complication were modifiable periprocedural aspects. These results underline the importance to implement specific preventive strategies to reduce in-hospital acquired infections after TAVI.
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