Impact of coronary calcium morphology on intravascular lithotripsy.

BACKGROUND: Coronary calcification negatively impacts optimal stenting. Intravascular lithotripsy (IVL) is a new calcium modification technique. AIMS: We aimed to assess the impact of different calcium morphologies on IVL efficacy. METHODS: This was a prospective, multicentre study (13 tertiary referral centres). Optical coherence tomography (OCT) was performed before and after IVL, and after stenting. OCT-defined calcium morphologies were concentric (mean calcium arc >180°) and eccentric (mean calcium arc ≤180°). The primary outcomes were angiographic success (residual stenosis <20%) and the presence of fracture by OCT in concentric versus eccentric lesions. RESULTS: Ninety patients were included with a total of 95 lesions: 47 concentric and 48 eccentric. The median number of pulses was 60 (p=1.00). Following IVL, the presence of fracture was not statistically different between groups (79.0% vs 66.0% for concentric vs eccentric; p=0.165). The number of fractures/lesion (4.2±4.4 vs 2.3±2.8; p=0.018) and ≥3 fractures/lesion (57.1% vs 34.0%; p=0.029) were more common in concentric lesions. Angiographic success was numerically but not statistically higher in the concentric group (87.0% vs 76.6%; p=0.196). By OCT, no differences were noted in final minimum lumen area (5.9±2.2 mm2 vs 6.2±2.1 mm2; p=0.570), minimum stent area (5.9±2.2 mm² vs 6.25±2.4 mm2; p=0.483), minimum stent expansion (80.9±16.7% vs 78.2±19.8%), or stent expansion at the maximum calcium site (100.6±24.2% vs 95.8±27.3%) (p>0.05 for all comparisons of concentric vs eccentric, respectively). Calcified nodules were found in 29.5% of lesions; these were predominantly non-eruptive (57%). At the nodule site, dissection was more common than fracture with stent expansion of 103.6±27.2%. CONCLUSIONS: In this prospective, multicentre study, the effectiveness of IVL followed by stenting was not significantly affected by coronary calcium morphology.

Study design for the "effect of METOprolol in CARDioproteCtioN during an acute myocardial InfarCtion" (METOCARD-CNIC): a randomized, controlled parallel-group, observer-blinded clinical trial of early pre-reperfusion metoprolol administration in ST-segment elevation myocardial infarction.

BACKGROUND: Infarct size predicts post-infarction mortality. Oral ß-blockade within 24 hours of a ST-segment elevation acute myocardial infarction (STEMI) is a class-IA indication, however early intravenous (IV) ß-blockers initiation is not encouraged. In recent magnetic resonance imaging (MRI)-based experimental studies, the ß(1)-blocker metoprolol has been shown to reduce infarct size only when administered before coronary reperfusion. To date, there is not a single trial comparing the pre- vs. post-reperfusion ß-blocker initiation in STEMI. OBJECTIVE: The METOCARD-CNIC trial is testing whether the early initiation of IV metoprolol before primary percutaneous coronary intervention (pPCI) could reduce infarct size and improve outcomes when compared to oral post-pPCI metoprolol initiation. DESIGN: The METOCARD-CNIC trial is a randomized parallel-group single-blind (to outcome evaluators) clinical effectiveness trial conducted in 5 Counties across Spain that will enroll 220 participants. Eligible are 18- to 80-year-old patients with anterior STEMI revascularized by pPCI ≤6 hours from symptom onset. Exclusion criteria are Killip-class ≥III, atrioventricular block or active treatment with ß-blockers/bronchodilators. Primary end point is infarct size evaluated by MRI 5 to 7 days post-STEMI. Prespecified major secondary end points are salvage-index, left ventricular ejection fraction recovery (day 5-7 to 6 months), the composite of (death/malignant ventricular arrhythmias/reinfarction/admission due to heart failure), and myocardial perfusion. CONCLUSIONS: The METOCARD-CNIC trial is testing the hypothesis that the early initiation of IV metoprolol pre-reperfusion reduces infarct size in comparison to initiation of oral metoprolol post-reperfusion. Given the implications of infarct size reduction in STEMI, if positive, this trial might evidence that a refined use of an approved inexpensive drug can improve outcomes of patients with STEMI.

Less iodine injected for the same diagnostic performances: comparison of two low-osmolar contrast agents (iobitridol 350 and iopamidol 370) in coronary angiography and ventriculography: a randomized double-blind clinical study.

OBJECTIVE: Mild reductions in iodine concentration could reduce acute side effects after intraarterial contrast media administration without affecting the quality of coronary artery images. This study was designed to show the equivalence in terms of image quality of two nonionic low-osmolar monomers, iobitridol 350 and iopamidol 370, and to compare their clinical safety in coronary angiography and ventriculography. METHODS AND RESULTS: In this multicentre, double-blind clinical trial, 98 adult patients were randomized to receive either iobitridol 350 or iopamidol 370. The image quality (primary evaluation criterion) of the whole examination was assessed using a 5-point scale (poor, fair, moderate, good, excellent). Secondary endpoints were the image quality per territory, diagnostic efficacy, practical comfort (5-point scale: impossible to evaluate, not practical, moderately practical, practical, very practical to use) and clinical safety (adverse events and vital signs). The proportions of examinations presenting with good or excellent global image quality was similar with both contrast media: 87.8% with iobitridol 350 vs. 89.8% with iopamidol 370. Similar results were observed when considering the image quality specifically for each major coronary artery and left ventricle. No difference between groups was found with respect to other secondary criteria. Adverse events occurred in 7 patients with iobitridol 350 (14.3%) and in 10 patients with iopamidol 370 (20.4%). CONCLUSIONS: This study showed that, with regard to image quality and diagnostic efficacy and using a lower iodine concentration, iobitridol 350 was comparable to iopamidol 370 in adult patients requiring coronary angiography and ventriculography for diagnostic indications.

Scaling Echocardiographic Cardiac Dimensions to Body Size: A Bayesian Analysis in Healthy Men and Women.

BACKGROUND: Proper scaling of cardiac dimensions is of paramount importance in making correct decisions in clinical cardiology. The usual normalization of cardiac dimensions to overall body size assumes an isometric relationship. We sought to investigate these relationships to obtain the best allometric coefficient (AC) for scaling. METHODS: Ninety-seven healthy volunteers were included. The dimensions to be scaled were the left atrial volume, the end-diastolic and end-systolic left ventricular volumes, and the diameter of the tricuspid annulus. A Bayesian statistical analysis was applied with isometric coefficients as priors. RESULTS: The linear correlations between cardiac dimensions and body size were modest, ranging from 0.12 (-0.10-0.32) for the left atrial volume and height to 0.70 (0.58-0.80) for the end-diastolic volume and height. The ACs varied across the different cardiac dimensions and body size measurements. For the best linear relationships, the isometric coefficients were outside the 95% highest density interval of the posterior distribution for the left atrial volume-weight (AC: 0.7; 0.4-0.9) and end-diastolic volume-height (AC: 2.3; 1.7-2.9), whereas they were different from 1 for the left atrial volume-weight, end-diastolic volume, and diameter of the tricuspid annulus-body surface area (AC: 0.6; 0.3-0.8). Not scaling the cardiac dimensions to their corresponding ACs can lead to important errors in size estimations of cardiac structure. CONCLUSIONS: The ACs found in this study are somewhat different from the corresponding isometric coefficients and often different from 1. This finding should be considered when normalizing cardiac structures to body size when making clinical decisions.

Comparison of Transfemoral Versus Transradial Secondary Access in Transcatheter Aortic Valve Replacement.

BACKGROUND: Transfemoral approach has been commonly used as secondary access in transcatheter aortic valve replacement (TAVR). Scarce data exist on the use and potential clinical benefits of the transradial approach as secondary access during TAVR procedures. The objective of the study is to determine the occurrence of vascular complications (VC) and clinical outcomes according to secondary access (transfemoral versus transradial) in patients undergoing TAVR. METHODS: This was a multicenter study including 4949 patients who underwent TAVR (mean age, 81±8 years, mean Society of Thoracic Surgeons score, 4.9 [3.3-7.5]). Transfemoral and transradial approaches were used as secondary access in 4016 (81.1%) and 933 (18.9%) patients, respectively. The 30-day clinical events (vascular and bleeding complications, stroke, acute kidney injury, and mortality) were evaluated and defined according to Valve Academic Research Consortium-2 criteria. Clinical outcomes were analyzed according to the secondary access (transfemoral versus transradial) in the overall population and in a propensity score-matched population involving 2978 transfemoral and 928 transradial patients. RESULTS: Related-access VC occurred in 834 (16.9%) patients (major VC, 5.7%) and were related to the secondary access in 172 (3.5%) patients (major VC, 1.3%). The rate of VC related to the secondary access was higher in the transfemoral group (VC, 4.1% versus 0.9%, P<0.001; major VC, 1.6% versus 0%, P<0.001). In the propensity score-matched population, VC related to the secondary access remained higher in the transfemoral group (4.7% versus 0.9%, P<0.001; major VC, 1.8% versus 0%, P<0.001), which also exhibited a higher rate of major/life-threatening bleeding events (1.0% versus 0%, P<0.001). Significant differences between secondary access groups were observed regarding the rates of 30-day stroke (transfemoral: 3.1%, transradial: 1.6%; P=0.043), acute kidney injury (transfemoral: 9.9%, transradial: 5.7%; P<0.001), and mortality (transfemoral: 4.0%, transradial: 2.4%, P=0.047). CONCLUSIONS: The use of transradial approach as secondary access in TAVR procedures was associated with a significant reduction in vascular and bleeding complications and improved 30-day outcomes. Future randomized studies are warranted.

Use and Outcomes of Triple Antithrombotic Therapy with Non-Vitamin K Antagonists in Patients with Atrial Fibrillation Undergoing Percutaneous Coronary Intervention.

BACKGROUND: Triple antithrombotic therapy (TT) is recommended for patients with nonvalvular atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI). However, there is a lack of comparative data in a real-world clinical setting between non-vitamin K antagonist oral anticoagulants (NOAC) and vitamin K antagonists (VKA). The aim of this study was to compare the safety and efficacy of TT with NOAC or VKA after PCI in patients with AF at 1-year of follow-up. MATERIALS AND METHODS: This was an observational retrospective study in 2 tertiary care hospitals during 2013-2016. Patients with indication for anticoagulation due to AF from an initial registry of 5,269 patients undergoing PCI were identified. Safety primary endpoint was the occurrence of major bleeding events as defined by Bleeding Academic Consortium (BARC ≥ 3). The primary efficacy endpoint was defined as major adverse cardiovascular events (MACE). RESULTS: A total of 187 consecutive patients on TT were identified: 45.4% of were discharged on NOAC and 54.6% on VKA. Patients who received VKA presented more comorbidities and had a higher bleeding risk than those who received NOACs. Major bleeding events occurred in 17 patients (9%), with a higher rate in the VKA group (3.5% vs. 13% confidence interval, 0.19-0.86, P = 0.02). There were no differences in the rates of major adverse cardiovascular events, stroke or net clinical benefit. CONCLUSIONS: In this real-world study, patients with AF undergoing PCI treated on NOAC-based TT showed lower bleeding rates than those on VKA, with a lower rate of major bleeding events, while efficacy was similar between groups.

Arrhythmic Burden as Determined by Ambulatory Continuous Cardiac Monitoring in Patients With New-Onset Persistent Left Bundle Branch Block Following Transcatheter Aortic Valve Replacement: The MARE Study.

OBJECTIVES: The authors sought to determine: 1) the global arrhythmic burden; 2) the rate of arrhythmias leading to a treatment change; and 3) the incidence of high-degree atrioventricular block (HAVB) at 12-month follow-up in patients with new-onset persistent left bundle branch block (LBBB) following transcatheter aortic valve replacement (TAVR). BACKGROUND: Controversial data exist on the occurrence of significant arrhythmias in patients with LBBB post-TAVR. METHODS: This was a multicenter prospective study including 103 consecutive patients with new-onset persistent LBBB post-TAVR with the balloon-expandable SAPIEN XT/3 valve (n = 53), or the self-expanding CoreValve/Evolut R system (n = 50). An implantable cardiac monitor (Reveal XT, Reveal Linq) was implanted at 4 (3 to 6) days post-TAVR, and patients had continuous electrocardiogram monitoring for 12 months. All arrhythmic events were adjudicated in a central electrocardiography core lab. Primary endpoints were the incidence of arrhythmias leading to a treatment change, and the incidence of HAVB at 12-month follow-up. RESULTS: A total of 1,553 new arrhythmic events were detected in 44 patients (1,443 episodes of tachyarrhythmia in 26 patients [atrial fibrillation/flutter/atrial tachycardia: 1,427, ventricular tachycardia 16]; 110 episodes of bradyarrhythmia in 21 patients [HAVB 54, severe bradycardia 56]). All arrhythmic events were silent in 34 patients (77%), the arrhythmic event led to a treatment change in 19 patients (18%), and 11 patients (11%) required pacemaker or implantable cardioverter-defibrillator implantation (due to HAVB, severe bradycardia, or ventricular tachycardia episodes in 9, 1, and 1 patient, respectively). A total of 12 patients died at 1-year follow-up, 1 from sudden death. CONCLUSIONS: A high incidence of arrhythmic events was observed at 1-year follow-up in close to one-half of the patients with LBBB post-TAVR. Significant bradyarrhythmias occurred in one-fifth of the patients, and PPM was required in nearly one-half of them. These data support the use of a cardiac monitoring device for close follow-up and expediting the initiation of treatment in this challenging group of patients. (Ambulatory Electrocardiographic Monitoring for the Detection of High-Degree Atrio-Ventricular Block in Patients With New-onset PeRsistent LEft Bundle Branch Block After Transcatheter Aortic Valve Implantation [MARE study]: NCT02153307).

One-year results of unprotected left main disease treatment with paclitaxel-eluting stents: results of a multicenter registry.

BACKGROUND: Preliminary data suggest that drug-eluting stents might have a role in selected cases of unprotected left main stenosis (ULMS). The purpose of this study was to determine the rates of death, myocardial infarction, and repeated revascularization in a multicenter, prospective series of patients with ULMS treated with paclitaxel-eluting stents. METHODS: A prospective registry was initiated in March 2003 through December 2004 in five tertiary centers including all patients with a significant (>50%) stenosis in ULMS treated with at least one paclitaxel-eluting stent. There were no clinical or angiographic exclusion criteria. Clinical follow-up was obtained at 6 and 12 months. RESULTS: A total of 100 patients were included. Mean age was 67.6 +/- 11.4 years and 36% were diabetics. Distal left main was affected in 53% of patients. Implantation of two stents was required in only 15%. Angiographic success was achieved in all cases. Significant periprocedural CK-MB elevation occurred in 5 patients and there was 1 intraprocedural death. At a median 9 months follow-up, cardiac death occurred in 7%, the majority of which (4%) in patients with ST-elevation myocardial infarction and cardiogenic shock before stent implantation. Only 3 patients (3%) required repeated target-vessel revascularization, all repeated angioplasty procedures. CONCLUSION: Percutaneous treatment of unprotected left main lesions with paclitaxel-eluting stents is associated with acceptable mid-term results in selected patients, with very low rates of repeated revascularization.