Abstract
Percutaneous coronary intervention has transformed the management of ST-elevation myocardial infarction (STEMI) due to a reduction in early mortality and need for repeat revascularization. However, the conventional revascularization strategy, combined with state-of-the-art anti-thrombotic and antiplatelet therapies, can still be associated with poor clinical outcome in some patients, because of reperfusion injury and microvascular obstruction contributing to the infarct size. To address this important therapeutic need, a broad-range of device-based treatments have been introduced. This is an overview of the pressure-controlled intermittent coronary sinus occlusion (PiCSO) device (Miracor Medical SA) which has been proposed for STEMI patients. PiCSO therapy could lead to an improved perfusion, decrease microvascular dysfunction, and thus potentially reduce infarct size.
Papers of special note have been highlighted as: • of interest; •• of considerable interest
References
- 1. . Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomized trials. Lancet 361(9351), 13–20 (2003).
- 2. CADILLAC trial. Impact of ST-segment resolution after primary angioplasty on outcomes after myocardial infarction in elderly patients: an analysis from the CADILLAC trial. Am. Heart J. 147(4), 669–675 (2004).
- 3. Relationship of TIMI myocardial perfusion grade to mortality after administration of thrombolytic drugs. Circulation 101(2), 125–130 (2000).
- 4. Prognostic value of microvascular obstruction and infarct size, as measured by CMR in STEMI patients. JACC Cardiovasc. Imaging 7(9), 930–939 (2014).
- 5. Relationship between microvascular obstruction and adverse events following primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: an individual patient data pooled analysis from seven randomized trials. Eur. Heart J. 38(47), 3502–3510 (2017). • This study showed the extent of microvascular obstruction (MVO) measured by cardiovascular magnetic resonance (CMR) is associated with mortality and heart failure (HF) hospitalization at 1 year.
- 6. . Event-free survival following successful percutaneous intervention in acute myocardial infarction depends on microvascular perfusion. Circ. Cardiovasc. Imaging 13(6), e010091 (2020).
- 7. Heart failure after myocardial infarction: incidence and predictors. ESC. Heart Fail. 8(1), 222–237 (2021).
- 8. Door-to-balloon time and mortality among patients undergoing primary PCI. NEJM 369(10), 901–909 (2013).
- 9. . The potential use of the index of microcirculatory resistance to guide stratification of patients for adjunctive therapy in acute myocardial infarction. JACC Cardiovasc. Interv. 12(10), 951–966 (2019).
- 10. Novel device-based therapies to improve outcome in ST-segment elevation myocardial infarction. Eur. Heart J. Acute Cardiovasc. Care 10(6), 687–697 (2021).
- 11. Transcatheter coronary sinus interventions. JACC Cardiovasc. Interv. 15(14), 1397–1412 (2022).
- 12. Coronary venous reperfusion: an old concept, a new approach. J. Appl. Physiol. 104(5), 1266–1272 (2008).
- 13. . Coronary venous anatomy and anomalies. J. Cardiovasc. Comput. Tomogr. 14(1), 80–86 (2022).
- 14. . Anatomical barriers in the right atrium to thecoronary sinus cannulation. PeerJ 3, e1548 (2016).
- 15. . Coronary sinus anatomy: Ajmer Working Group Classification. J. Invasive Cardiol. 26(2), 71–74 (2014).
- 16. . The nutrition of the heart through the vessels of Thebesius and the coronary veins. Am. J. Physiol. 1(1), 86–103 (1898).
- 17. Revascularization of heart by graft of systemic artery into coronary sinus. J. Am. Med. Assoc. 137(5), 436–442 (1948).
- 18. Preliminary experience with synchronized coronary sinus retroperfusion in humans. Circulation 74(2), 381–388 (1986).
- 19. Clinical applications of coronary sinus retroperfusion during high-risk percutaneous transluminal coronary angioplasty. J. Am. Coll. Cardiol. 22(1), 127–134 (1993).
- 20. Synchronized coronary venous retroperfusion for support and salvage of ischemic myocardium during elective and failed angioplasty. J. Am. Coll. Cardiol. 18(1), 271–282 (1991).
- 21. Coronary sinus reducer stent for the treatment of chronic refractory angina pectoris: a prospective, open-label, multicenter, safety feasibility first-in-man study. J. Am. Coll. Cardiol. 49(17), 1783–1789 (2007).
- 22. Efficacy of a device to narrow the coronary sinus in refractory angina. NEJM 372(6), 519–527 (2015).
- 23. . Clinical evaluation of pressure-controlled intermittent coronary sinus occlusion: randomized trial during coronary artery surgery. Ann. Thorac. Surg. 46(2), 192–201 (1988).
- 24. . PICSO: from myocardial salvage to tissue regeneration. Cardiovasc. Revasc. Med. 16(1), 36–46 (2015).
- 25. . Signs and signals limiting myocardial damage using PICSO: a scoping review decoding paradigm shifts toward a new encounter. Front. Cardiovasc. Med. 9(10), 1030842 (2023).
- 26. . Pressure-controlled intermittent coronary sinus occlusion: a novel approach to improve microvascular flow and reduce infarct size in STEMI. Cardiovasc. Revasc. Med. 28,
S1553-8389(22)00678-9 (2022). - 27. . Cardioprotected percutaneous coronary intervention - a case study in a stable angina patient. J. Interv. Cardiol. 6(2), 186–189 (2011).
- 28. Intracoronary hemodynamic effects of pressure-controlled intermittent coronary sinus occlusion (PICSO): results from the First-In-Man Prepare PICSO Study. J. Interv. Cardiol. 25(6), 549–556 (2012).
- 29. Pressure-controlled intermittent coronary sinus occlusion (PICSO) in acute ST-segment elevation myocardial infarction: results of the Prepare RAMSES safety and feasibility study. EuroIntervention 11(1), 37–44 (2015). •• This study of small group of patients presenting with anterior ST-elevation myocardial infarction (STEMI) showed pressure-controlled intermittent coronary sinus occlusion (PiCSO) therapy is safe in the setting of anterior STEMI.
- 30. Index of microcirculatory resistance-guided therapy with pressure-controlled intermittent coronary sinus occlusion improves coronary microvascular function and reduces infarct size in patients with ST-elevation myocardial infarction: the Oxford Acute Myocardial Infarction - Pressure-controlled Intermittent Coronary Sinus Occlusion study (OxAMI-PICSO study). EuroIntervention 814(3), e352–e359 (2018). •• This was an index of microcirculatory resistance (IMR) guided study of PiCSO therapy compared with historic control group which showed reduction in infarct size and IMR in those treated with PiCSO.
- 31. Effect of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) on infarct size in anterior STEMI: PiCSO in ACS study. Int. J. Cardiol. Heart Vasc. 28, 100526 (2020). •• This is another study of a small group of patients with anterior STEMI who underwent PiCSO treatment, and assessment of infarct size by myocardial infarction (MI) in PiCSO group.
- 32. Oxford Acute Myocardial Infarction (OxAMI) Study. Pressure-controlled intermittent coronary sinus occlusion improves the vasodilatory microvascular capacity and reduces myocardial injury in patients with STEMI. Catheter Cardiovasc. Interv. 99(2), 329–339 (2022). •• This study showed improvement is infarct size and IMR in both anterior and inferior STEMI in small group of patients treated with PiCSO compared with matched control group.
- 33. Prognostic value of the index of microcirculatory resistance measured after primary percutaneous coronary intervention. Circulation 127(24), 2436–2441 (2013). • This study demonstrated that an elevated IMR at the time of primary percutaneous coronary intervention (pPCI) is indicative of poor long-term outcomes.
- 34. Angiography-derived index of microcirculatory resistance (IMRangio) as a novel pressure-wire-free tool to assess coronary microvascular dysfunction in acute coronary syndromes and stable coronary artery disease. Int. J. Cardiovasc. Imaging 37(6), 1801–1813 (2021).
- 35. . High-risk left main percutaneous coronary intervention supported by pressure-controlled intermittent coronary sinus occlusion. EuroIntervention 12(11), e1437 (2016).
- 36. Coronary microvascular dysfunction across the spectrum of cardiovascular diseases: JACC state-of-the-art review. J. Am. Coll. Cardiol. 78(13), 1352–1371 (2021).
- 37. First in man prolonged pressure-controlled intermittent coronary sinus occlusion to treat refractory left ventricular dysfunction and ischemia with patent epicardial coronary arteries. Int. J. Cardiol. 241, 138–141 (2017).