Author + information
- Francesco Giannini1,
- Luca Baldetti2,
- Alfonso Ielasi3,
- Neil Ruparelia4,
- Francesco Ponticelli5,
- Azeem Latib1,
- Satoru Mitomo6,
- Antonio Esposito7,
- Anna Palmisano7,
- Alaide Chieffo1 and
- Antonio Colombo8
- 1Interventional Cardiology Institute San Raffaele Hospital, Milan, Milan, Italy
- 2IRCCS San Raffaele Hospital, Milan, Milan, Italy
- 3Ospedale Bolognini, Seriate, Bergamo, Italy
- 4Hammersmith Hospital, London, United Kingdom
- 5IRCCS San Raffaele Hospital, 20100, Milan, Italy
- 6IRCCS San Raffaele Scientific Institute, Milan, Milan, Italy
- 7Experimental Imaging Center, Department of Radiology, San Raffaele Scientific Institute, Milan, Milan, Italy
- 8Interventional Cardiology Institute San Raffaele Hospital - Stamford Hospital - Columbia University - Centro Cuore Columbus, Milan, Milan, Italy
Refractory angina following angiographically successful PCI is common and microvascular dysfunction (CMD) seems the underlying mechanism. As no data are available on Reducer performance in these patients, we tried to address this issue.
Between 2015 and 2016, 8 patients underwent coronary angiography due to refractory angina and non-invasive evidence of ischemia. All had previously undergone at least one PCI. All had non-obstructed epicardial coronary arteries (absence of plaques, <50% narrowing, or a negative FFR test in case of intermediate lesions) and underwent compassionate Reducer implantation for microvascular angina.
Population age was 61.5 (50-68) years. 4 (50%) were women. All were on OMT (median number of anti-ischemic drugs was 3, range: 2-4). Median LVEF was 58.0 (55.0-61.5)%. No cases of death, coronary angiography/PCI or hospitalization for angina were noted at follow-up. CCS class improved from 3 (3-4) to 1.5 (1-3); p=0.014. At 1 year, this benefit was maintained for 3 of the 5 patients assessed. Discontinuation of at least one drug was possible in 3 (37.5%) patients. An improvement at the SAQ (Seattle Angina Questionnaire) scores was observed: physical limitation 46.0 (IQR 40.5-53.3) to 64.0 (IQR 53.0-80.0), p=0.028; angina stability 40.0 (21.3-43.0) to 80.0 (58.0-100.0), p=0.028; angina frequency 47.0 (33.0-58.0) to 66.0 (56.0-80.0), p=0.028; treatment satisfaction 40.0 (26.8-73.3) to 75.0 (66.0-82.0), p=0.063; quality of life 26.5 (17.8-39.0) to 56.0 (53.0-60.0), p=0.018. At the six-minute walk test, the distance walked increased from 266 (238.5-372.8) to 360 (341-420) metres, p=0.018; and the Borg scale scores reduced from 4.0 (3.0-5.0) to 0.0 (0.0-2.5), p=0.042. 3 patients underwent stress cardiac magnetic resonance with myocardial perfusion reserve index (MPRI) calculation. MPRI of the ischemic segments increased after Reducer implantation from 1 to 2.06 in patient 1 (p=0,023), 1.08 to 1.38 in patient 4 (p=0,004) and 1 to 2.85 in patient 5 (p=0,052). LV MPRI showed an increase from 2.25 to 3.08 in patient 1 (p=0,028), 1.25 to 1.51 in patient 4 (p=0,004) and 1.33 to 2.20 in patient 5 (p<0,001).
This preliminary experience suggests that Reducer is safe and may have a role in the management of patients presenting with refractory angina in spite of complete epicardial revascularization with PCI and OMT.
OTHER: Pre-Clinical/First In-Human Studies