Roma Verona Study: Complete Revascularization Associated with Significant Improvement in LVEF and Long-Term Survival

Amin Medjamia, MD, interviews Francesco Burzotta, MD, and Carlo Trani, MD, from the Institute of Cardiology, Catholic University of the Sacred Heart in Rome. The cardiologists discuss their most recent manuscript, "Long-Term Outcomes of Extent of Revascularization in Complex High Risk and Indicated Patients Undergoing Impella-Protected Percutaneous Coronary Intervention: Report from the Roma-Verona Registry," published in the Journal of Interventional Cardiology in April 2019.

This study was a retrospective study at 2 centers in Rome and Verona, Italy using a prospectively maintained registry database. The objective of the study was to investigate the effect of extent of revascularization on LVEF and survival in complex high risk indicated patients (CHIP) undergoing Protected PCI. The study included 86 patients supported with the Impella 2.5® or Impella CP® heart pump between April 2007 and December 2016. Patients were followed for an average of 14 months.

Dr. Burzotta notes that the patient population was older (72±10) with significant comorbidities such as CABG, heart failure, and renal failure. Patients were in stable condition at the time of interventions. While patients with cardiogenic shock were excluded from the study, many patients had acute coronary syndromes and the mean SYNTAX score was 31±10 and BCIS-JS was 10±2. In addition, the vast majority (78%) of patients had LVEF ≤35.

Dr. Trani discusses the procedural characteristics, noting that all patients had 3-vessel disease and had been turned down for surgery. More than 75% of patients (66 of 86) were treated with radial approach for PCI with significant PCI on bifurcation (60%) and Rotablator™ was used in 15% of patients. By the end of the procedure, post-PCI SYNTAX scores were 12±8.7 and BCIS-JS dropped to 3±3, indicating extensive revascularization. Regarding hemostasis technique, Dr. Trani emphasizes that 75% of the patients were treated with preclosure and particular care was taken with vascular access and closure, often using ultrasound puncture and performing angiographic follow up on all access sites.

Study results revealed a very low complication rate with no life-threatening bleeding and no major vascular complications. Minor vascular complication occurred in 2% of patients and total rate of bleeding complications (Types I, II, and III) was 14%. Dr. Trani states that these results were quite notable for this type of study.

Dr. Burzotta discusses other key results from this study. He notes that the study revealed excellent long-term outcomes in these patients with a very low mortality rate of 10% at 14 months and low MACCE (24%). In addition, reassessment of LV function after 6 months demonstrated a 3-fold increase in the number of patients with EF≥35% (67% of patients had EF≥35% at 6 month follow up compared to 22% at baseline). Results also revealed that complete revascularization was associated with significant improvement in LVEF and significant improvement in long-term survival.

This study adds to more than 12 years of real-world data and FDA studies demonstrating the safety and efficacy of Impella 2.5 and Impella CP used prophylactically in high-risk complex patients undergoing non-emergent PCI.