Rilascio dei biomarkers di danno miocardico dopo iniezione diretta per via percutanea di cellule staminali e terapia genica

Aims: We aimed to quantify the release of bio-markers of myocardial damage in relation to direct intramyocardial injections of genes and stem cells in patients with severe coronary artery disease. Methods and Results: We studied 71 patients with “no-option” coronary artery disease. Patients had, via the percutaneous transluminal route, a total of 11±1 (mean ± SD) intramyocardial injections of vascular endothelial growth factor genes (n=56) or mesenchymal stromal cells (n=15). Injections were guided to an ischemic area by electromechanical mapping, using the NOGA™/Myostar™ catheter system. ECG was monitored continuously until discharge. Plasma CKMB (upper normal laboratory limit=5 μg/l) was 2 μg/l (2-3) at baseline; increased to 6 (5-9) after 8 hours (p < 0.0001) and normalized to 4 (3-5) after 24 hours. A total of 8 patients (17%), receiving a volume of 0.3 ml per injection, had CKMB rises exceeding 3 times the upper limit, whereas no patient in the group receiving 0.2 ml had a more than two fold CKMB increase. No patient developed new ECG changes. There were no clinically important ventricular arrhythmias and no death. Conclusion: Direct Intramyocardial injections of stem cells or genes lead to measurable release of cardiac bio-markers, which was related to the injected volume.

Fibrinolysis Versus Primary Pci In Stemi Patients Enrolled In The International Survey Of Acute Coronary Syndromes In Transitional Countries

Primary angioplasty has been shown to be more effective than fibrinolysis in terms of mortality and adverse outcomes. More recent data, however, suggests that timely reperfusion with fibrinolysis is comparable to primary angioplasty. The current study gathered data from the International Survey of Acute Coronary Syndromes in Transitional Countries registry. Among 7406 ST-elevation myocardial infarction patients presenting within 12 hours from symptom onset, 6315 underwent primary percutaneous coronary intervention and 1091 were treated with fibrinolysis. The primary outcome was 30-day mortality, while the secondary outcome was a composite of 30-day incidence of death, severe left ventricular dysfunction, stroke or reinfarction. Patients who underwent primary angioplasty tended to have a greater cardiovascular risk profile and were slightly older. On the other hand, patients treated with fibrinolysis received less anti-platelet medications yet were more often prescribed beta blockers in the acute phase. Among those who received fibrinolysis, 43% underwent coronary angiography while 32.3% were treated with a subsequent angioplasty. Total ischemic time was lower in patients undergoing fibrinolysis (185 minutes) than in those treated with primary angioplasty (258 minutes). Rates of primary and secondary combined endpoints were higher in patients receiving fibrinolysis compared to those receiving primary angioplasty (7.8% vs. 4.1%; p<0.0001; OR 1.97, 95% CI, 1.38-2.81; and 14.8% vs. 10.1%, p<0.0001; OR 1.43, 95% CI, 1.12-1.81). When considering only patients receiving reperfusion within 3 hours, regardless of reperfusion strategy, differences in mortality (6.3% vs. 4%, p=0.094, for fibrinolysis or primary angioplasty, respectively; OR 0.87, 95% CI, 0.35-2.16) and in the combined secondary endpoint were no longer observed (12.9% vs 10.8%, p=0.33; OR 0.98, 95% CI, 0.58-1.64), and female sex was no longer a significant predictor of adverse outcomes. When performed 3 hours from symptom onset, fibrinolysis is safe and feasible, in terms of mortality and adverse outcomes, compared to primary angioplasty.

Balloon pulmonary angioplasty in chronic thromboembolic pulmonary hypertension: experience of four years in a single centre

Background: Balloon pulmonary angioplasty (BPA) has recently been developed as an alternative and less- invasive treatment strategy for chronic thromboembolic pulmonary hypertension (CTEPH), but therapeutic efficacy and technical safety of the technique have to be established. Aim: effects of BPA on patients with inoperable disease or residual pulmonary hypertension (PH) after pulmonary endarterectomy (PEA). Methods: From June 2015 to September 2019 we enrolled symptomatic (NYHA ≥ II) inoperable CTEPH patients and patients with residual PH after PEA. At baseline, immediately before the first BPA session and 3-6 months after last BPA session all patients underwent clinical evaluation, six-minute walking distance and right heart catheterization. For comparisons Friedman test (with Bonferroni post-hoc pairwise analysis) was used. Survival curves were done with Kaplan Meier method. Results: Forty-seven patients [male 45%, median age 68 (51-74) years, 40 inoperable and 7 with residual PH after PEA] were treated for a total of 136 sessions (median number of sessions for each patient: 2); during each session we treated 2 (2-3) vessels; BPA significantly improved symptoms (NYHA III-IV from 85 to 42%), exercise capacity (from 425 to 446 m) and hemodynamic profile (reduction of mean pulmonary arterial pressure from 41 to 35 mmHg and of pulmonary vascular resistance from 7.1 to 4.7 WU). Five pulmonary artery dissection and 2 hemoptysis with clinical impairment were documented; 33 patients had lung injury (radiographic opacity with/without hemoptysis and/or hypoxemia), 7 patients had access site complications. Five patients died during follow-up (none within 30 days from the procedure) because of sepsis (1), heart failure (1), cancer (1), arrhythmic storm (1) and sudden death in a patient with severe coronary atherosclerosis (1). Conclusions: BPA is a safe and effective treatment able to improve symptoms and hemodynamic profile in inoperable CTEPH patients and in patients with residual PH after PEA.