Background ST-segment-elevation myocardial infarction complicated with no reflow after primary percutaneous coronary intervention is associated with adverse outcomes. Although several hyperemic drugs ...have been shown to improve the Thrombolysis in Myocardial Infarction flow, optimal treatment of no reflow remains unsettled. Saline infusion at 20 mL/min via a dedicated microcatheter causes (flow-mediated) hyperemia. The objective is to compare the efficacy of pharmacologic versus flow-mediated hyperemia in patients with ST-segment-elevation myocardial infarction complicated with no reflow. Methods and Results In the RAIN-FLOW (Treatment of Slow-Flow After Primary Percutaneous Coronary Intervention With Flow-Mediated Hyperemia) study, 67 patients with ST-segment-elevation myocardial infarction and no reflow were randomized to receive either pharmacologic-mediated hyperemia with intracoronary adenosine or nitroprusside (n=30) versus flow-mediated hyperemia (n=37). The angiographic corrected Thrombolysis in Myocardial Infarction frame count and the minimal microcirculatory resistance, as assessed with intracoronary pressure-thermistor wire, dedicated microcatheter, and thermodilution techniques, were compared after study interventions. Both Thrombolysis in Myocardial Infarction frame count(40.2±23.1 versus 39.2±20.7;
=0.858) and minimal microcirculatory resistance (753.6±661.5 versus 993.3±740.8 Wood units;
=0.174) were similar between groups. Thrombolysis in Myocardial Infarction 3 flow was observed in 26.7% versus 27.0% (
=0.899). Flow-mediated hyperemia showed 2 different thermodilution patterns during saline infusion indicative of the severity of the no reflow phenomenon. In-hospital death and nonfatal heart failure were observed in 10.4% and 26.9%, respectively. Conclusions Both treatments showed similar (and limited) efficacy restoring coronary flow. Flow-mediated hyperemia with thermodilution pattern assessment allowed the simultaneous characterization of the no reflow degree and response to hyperemia. No reflow was associated with a high rate of adverse outcomes. Further research is warranted to prevent and to treat no reflow in patients with ST-segment-elevation myocardial infarction. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT04685941.
Background Early generation drug-eluting stents (DESs) showed a high grade of coronary endothelial dysfunction that was attributed to lack of stent reendothelialization. Endothelium-dependent ...vasomotor response of current DESs and bioresorbable scaffolds (BRSs) remains unknown. This study sought to assess the device-related endothelial function of current devices and to correlate neointima healing with endothelial function. Methods and Results A total of 206 patients from 4 randomized trials treated with the durable-polymer everolimus-eluting Xience (n=44), bioresorbable-polymer sirolimus-eluting Orsiro (n=35), polymer-free biolimus-eluting Biofreedom (n=24), bioactive endothelial-progenitor cell-capturing sirolimus-eluting Combo DES (n=25), polymer-based everolimus-eluting Absorb (n=44), and Mg-based sirolimus-eluting Magmaris BRS (n=34) underwent endothelium-dependent vasomotor tests and optical coherence tomography imaging, as per protocol, at follow-up. Crude vasomotor responses of distal segments to low-dose acetylcholine (10
mol/L) were different between groups: bioresorbablepolymer DEShad the worst (-8.4%±12.6%) and durable-polymer DES had the most physiologic (-0.4%±11.8%;
=0.014). High-dose acetylcholine (10
mol/L) showed similar responses between groups (ranging from -10.8%±11.6% to -18.1%±15.4%;
=0.229). Device healing was different between devices. Uncovered struts ranged from 6.3%±7.1% (bioresorbable-polymer DES) to 2.5%±4.5% (bioactive DES;
=0.056). In multivariate models, endothelium-dependent vasomotor response was associated with age, bioresorbable-polymer DES, and angiographic lumen loss, but not with strut coverage nor plaque type. Endothelial dysfunction (defined as ≥4% vasoconstriction) was observed in 46.6% of patients with low-dose and 68.9% with high-dose acetylcholine, without differences between groups. Conclusions At follow-up, endothelial dysfunction was frequently observed in distal segments treated with current stents without remarkable differences between devices. Although neointima healing was different between devices, poor healing was not associated with endothelial dysfunction.
Aim
Use of a Bioresorbable Scaffolds (BRS) either in clinical practice or in the setting of an acute myocardial infarction (MI) is controversial. Despite an overall high rate of thrombosis, vascular ...healing response following BRS implantation tend to superiority as compared to metallic drug‐eluting stent in ST‐segment elevation myocardial infarction (STEMI) patients.
We sought to compare the in‐stent/scaffold vasomotion between metallic BRS and sirolimus eluting stent (SES) at 12‐month angiographic follow‐up in the setting of patients with STEMI treated by primary PCI.
Study design
This is an investigator‐driven, prospective, multicenter, randomized, single blind, two‐arm, controlled trial (ClinicalTrials.gov number: NCT03234348). This trial will randomize ~148 patients 1:1 to SES or BRS. Primary end‐point is the in‐stent/scaffold change in mean lumen diameter after nitroglycerin administration at 12‐month angiographic follow‐up. Besides, patient‐oriented combined endpoint of all‐cause death, any MI, and any revascularization, together with scaffold/stent thrombosis rate and device‐oriented endpoint of cardiac death, target vessel (TV)‐MI and TVR at 1 year will be also evaluated. Clinical follow‐up will be scheduled yearly up to 5 years.
Conclusion
This trial will shed light on the vascular vasomotion following BRS implantation in the complex scenario of STEMI.
Blood pressure indices like fractional flow reserve (FFR) and the instantaneous wave-free ratio (iFR) measure the distal-to-aortic pressure ratio of a lesion in a similar way using a pressure ...guidewire. FFR requires the induction of maximal hyperemia while the iFR is an index based on the assessment of pressure curves at rest. There is solid confirmation of the validity and efficacy of such indices from multiple studies while their use is widely backed by the clinical practice guidelines.1 However, the efficacy of blood pressure indices is based on 2 fundamental objectives. The first one is to prove that they are useful to indicate the revascularization of a lesion when the resulting value is below the cut-off point (≤ 0.80 for the FFR, and ≤ 0.89 for the iFR). The second one is to demonstrate that lesions with values above the cut-off point (> 0.80 or > 0.89, respectively) have a low risk of requiring revascularization, and lack of ischemic events at follow-up. Conceptually, the first indication is clear: a lesion with pathological values is an obstructive lesion that causes ischemia now. Therefore, if clinically indicated (and technically feasible) the best thing to do is to revascularize such a lesion. The second...
Background
This study sought to evaluate the clinical outcomes of patients treated with magnesium‐based bioresorbable scaffolds (MgBRS) in the context of acute coronary syndromes (ACS) at long‐term ...follow‐up (24 months). The study also aims to investigate the MgBRS performance by angiography and the healing and bioresorption pattern by optical coherence tomography (OCT) at 18 months.
Methods
Between December 2016 and December 2018, a total of 90 patients admitted for ACS and treated with MgBRS (Magmaris, Biotronik AG, Bülach, Switzerland) were enrolled in a multicenter prospective study. Clinical follow‐up was performed in all patients at 24 months and angiographic and OCT follow‐up in 51.5% of patients at 18 months. Serial OCT was available in 33 patients (36.7%).
Results
At a 2‐year follow‐up, 88.8% were free of symptoms, no cardiac death was reported, and the device‐oriented composite event (DOCE): consisting of cardiac death, target vessel myocardial infarction, and target lesion revascularization (TLR) was 13.3%. Stent thrombosis and TLR were observed in 2.2 and 11.1%, respectively. Binary restenosis was observed in 21.7% of cases and in‐stent late lumen loss was 0.61 ± 0.75 mm. By serial OCT imaging, the minimal lumen area was significantly reduced greater than 40% (from 6.12 ± 1.59 to 3.5 ± 1.55 mm2, p < .001). At follow‐up, area stenosis was 44.33 ± 23.07% and half of the patients presented indiscernible struts. The principal observed mechanism of restenosis was scaffold collapse.
Conclusions
At long‐term follow‐up, MgBRS implantation in ACS patients showed a high rate of DOCE, mainly caused by clinically driven TLR. MgBRS restenosis was caused by scaffold collapse in most of the cases.
Background
Thrombocytopenia after transcatheter aortic valve implantation (TAVI) is common and has been related to higher mortality and major complications. No comparison between balloon‐expandable ...(BEV) and self‐expanding valves (SEV) regarding drop platelet count (DPC) has been reported to date. The objectives of this study were to analyze the differences in DPC between BEVs or SEVs and their prognostic implications in clinical outcomes.
Methods
We retrospectively analyzed patients undergoing TAVI. Platelet counts after TAVI were collected. Two groups were created: DPC ≤ 30% and DPC > 30%. VARC‐2 criteria were used to define outcomes.
Results
Study population was composed of 195 patients (age 77.5 ± 6.7, 57.4% males). All of them but one experienced DPC (mean DPC 31.9 ± 15.3%). DPC was significantly higher among the patients treated with BEV compared to those treated with SEV (36.3 ± 15.1% vs 27.7 ± 14.4, P < 0.001). After multivariate analysis, the use of BEV was independently associated with a higher rate of DPC > 30% (67.4% vs 36.0%; OR 3.4; 95% CI, 1.42‐8.16). At 30 days, the DPC > 30% was associated with a higher rate of life‐threatening/major bleeding, major vascular complications, in‐hospital sepsis and mortality. At one year, there were no statistically significant differences in the mortality rate between groups (6.35% vs 10.0%, HR 1.54; 95% CI, 0.56–4.25).
Conclusions
In this study, the use of BEV was associated with a higher risk of DPC after TAVI. A DPC rate > 30% was associated with an increased risk of major complications at 30 days.
Patients presenting with the coronavirus-2019 disease (COVID-19) may have a high risk of cardiovascular adverse events, including death from cardiovascular causes. The long-term cardiovascular ...outcomes of these patients are entirely unknown. We aim to perform a registry of patients who have undergone a diagnostic nasopharyngeal swab for SARS-CoV-2 and to determine their long-term cardiovascular outcomes.
This is a multicenter, observational, retrospective registry to be conducted at 17 centers in Spain and Italy (ClinicalTrials.gov number: NCT04359927). Consecutive patients older than 18 years, who underwent a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) for SARS-CoV2 in the participating institutions, will be included since March 2020, to August 2020. Patients will be classified into two groups, according to the results of the RT-PCR: COVID-19 positive or negative. The primary outcome will be cardiovascular mortality at 1 year. The secondary outcomes will be acute myocardial infarction, stroke, heart failure hospitalization, pulmonary embolism, and serious cardiac arrhythmias, at 1 year. Outcomes will be compared between the two groups. Events will be adjudicated by an independent clinical event committee.
The results of this registry will contribute to a better understanding of the long-term cardiovascular implications of the COVID19.
Aims
This study aimed to assess, in patients with cardiogenic shock secondary to unprotected left main coronary artery‐related myocardial infarction (ULMCA‐related AMICS), the incidence and ...predictors of no recovery of left ventricular function during the admission.
Methods and results
This was an observational study conducted at two tertiary care centres (2012–20). The main outcome measured was death or requirement for heart transplantation (HT) or left ventricular assist devices (LVAD) during the admission. A total of 70 patients were included. Percutaneous coronary intervention (PCI) was successful in 53/70 patients (75.7%). The combined endpoint of death or requirement of HT or LVAD during the admission occurred in 41/70 patients (58.6%). The highest incidence of the primary endpoint was observed among patients with profound shock and occluded left main coronary artery (LMCA) (20/23, 87%, P < 0.001). Although a successful PCI reduced the incidence of the event in the whole cohort (51.9% vs. 82.4% in failed PCI, P = 0.026), this association was not observed among this last group of complex patients (86.7% vs. 87.5% in failed PCI, P = 0.731). The predictive model included left ventricular ejection fraction, baseline ULMCA Thrombolysis In Myocardial Infarction flow, and severity of shock and showed an optimal ability for predicting death or requirements for HT or LVAD during the admission (area under the curve 0.865, P < 0.001).
Conclusions
ULMCA‐related AMICS was associated with a high in‐hospital mortality or need for HT or LVAD. Prognosis was especially poor among patients with profound shock and baseline occluded LMCA, with a low probability of recovery regardless of successful PCI.
ABSTRACT Coronary vasoreactivity testing is a key diagnostic procedure in patients with suspected coronary spasm and research procedures intended to assess the coronary endothelial function. We ...should mention that coronary spasm has been observed in > 40% of the patients with angina and non-obstructive coronary stenosis. Also, that its dedicated treatment has proven to reduce ischemic symptoms and improve these patients' quality of life. This technical report elaborated by the Working Group on Intracoronary Diagnostic Techniques of the Interventional Cardiology Association of the Spanish Society of Cardiology (ACI-SEC) summarizes the indications, preparation, performance, and interpretation of the vasoreactivity testing performed by intracoronary infusion of acetylcholine.
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