Six months follow-up of protected high-risk percutaneous coronary intervention with the microaxial Impella pump: results from the German Impella registry.

BACKGROUND: Percutaneous coronary intervention (PCI) represents an important alternative to coronary bypass surgery for the treatment of patients with complex coronary artery disease and high perioperative risk. Protected percutaneous coronary intervention applies temporary percutaneous ventricular assist devices to mitigate potential hemodynamic compromise in high-risk patients. The Impella system is currently the most commonly used device for protected percutaneous coronary intervention and showed improved hemodynamic parameters in earlier trials. METHODS: This study was designed as a retrospective, observational multi-center registry conducted in ten hospitals in Germany. We included consecutive patients undergoing protected high-risk percutaneous coronary intervention with Impella support. The primary endpoint was defined as the occurrence of a major adverse cardiac event defined as all-cause mortality, ST-elevation myocardial infarction, or stroke during a postprocedural 180-day follow-up period. RESULTS: In total, 157 patients (80.3% male; mean age 71.8 ± 10.8 years) were included in the present study, and 180-day follow-up was complete for 149 patients (94.9%). At baseline, the patients had a median left ventricular ejection fraction of 39.0% (interquartile range, 25.0-50.0%). The median SYNergy between PCI with TAXUS and Cardiac Surgery-Score I was 33.0 (interquartile range, 24.0-40.5) and the median EuroSCORE II was 7.2% (interquartile range, 3.2-17.1%). During postprocedural follow-up, 34 patients (22.8%) suffered a major adverse cardiac event. All-cause mortality was 18.1% (27 patients). Nine patients (6.0%) sustained a ST-elevation myocardial infarction, while 4 patients (2.7%) had a stroke. CONCLUSIONS: Patients undergoing protected high-risk percutaneous coronary intervention with Impella support showed an acceptable 180-day clinical outcome regarding major adverse cardiac event and mortality.

One-year clinical outcome of angiography, fractional flow reserve and instantaneous wave-free ratio guided percutaneous coronary intervention: A PRISMA-compliant meta-analysis.

The present study aimed to compare the clinical outcome of patients with coronary artery disease (CAD) who underwent a revascularization using conventional coronary angiography or a physiologically guided revascularization with Fractional Flow Reserve (FFR). Furthermore, outcomes in FFR guided percutaneous coronary intervention (PCI) and instantaneous wave-free ratio (iFR) guided PCI were compared. The analysis was performed for reported outcomes at a 1-year follow-up. After searching PubMed, EMBASE, and Web of Science for suitable publications, a total of 15,880 subjects were included. Comparing angiography guided and FFR guided PCI showed no significant difference in major adverse cardiac events [odds ratio (OR), 0.78; 95% confidence interval (CI), 0.59-1.04; P=0.09; I2=73%], death from any cause (OR, 0.74; 95% CI, 0.46-1.18; P=0.20; I2=74%), myocardial infarction (OR, 0.93; 95% CI, 0.81-1.07; P=0.31; I2=0%) or unplanned revascularization (OR, 0.71; 95% CI, 0.41-1.23; P=0.22; I2=79%). In addition, no significant difference could be found between iFR and FFR guided PCI for major adverse cardiac events (OR, 0.97; 95% CI; 0.76-1.23; P=0.81; I2=0%), death from any cause (OR, 0.66; 95% CI, 0.40-1.11; P=0.12; I2=0%), myocardial infarction (OR, 0.83; 95% CI, 0.56-1.24; P=0.37) or unplanned revascularization (OR, 1.16; 95% CI, 0.85-1.58; P=0.34; I2=16%). Overall, there was a tendency towards better outcomes of FFR in all four clinical endpoints compared with angiography guiding of PCI, and furthermore iFR showed no significant inferiority when compared to FFR in said clinical endpoints. When conducting a network meta-analysis, the results confirmed a non-inferiority of iFR compared to angiography guided revascularization.

Comparison of peri and post-procedural complications in patients undergoing revascularisation of coronary artery multivessel disease by coronary artery bypass grafting or protected percutaneous coronary intervention with the Impella 2.5 device.

BACKGROUND: While coronary artery bypass grafting remains the standard treatment of complex multivessel coronary artery disease, the advent of peripheral ventricular assist devices has enhanced the safety of percutaneous coronary intervention. We therefore evaluated the safety in terms of inhospital outcome comparing protected high-risk percutaneous coronary intervention with the Impella 2.5 device and coronary artery bypass grafting in patients with complex multivessel coronary artery disease. METHODS: This retrospective study included patients with complex multivessel coronary artery disease (SYNTAX score >22) undergoing either coronary artery bypass grafting before the implementation of a protected percutaneous coronary intervention programme with a peripheral ventricular assist device or protected percutaneous coronary intervention with the Impella 2.5 device following the start of the programme. The primary endpoint consisted of inhospital major adverse cardiac and cerebrovascular events. The combined secondary endpoint included peri and post-procedural adverse events. RESULTS: A total of 54 patients (mean age 70.1±9.9 years, 92.6% men) were enrolled in the study with a mean SYNTAX score of 34.5±9.8. Twenty-six (48.1%) patients underwent protected percutaneous coronary intervention while 28 (51.9%) patients received coronary artery bypass grafting. The major adverse cardiac and cerebrovascular event rate was numerically higher in the coronary artery bypass grafting group (17.9 vs. 7.7%; P=0.43) but was not statistically significant. The combined secondary endpoint was not different between the groups; however, patients undergoing coronary artery bypass grafting experienced significantly more peri-procedural adverse events (28.6 vs. 3.8%; P<0.05). CONCLUSION: Patients with complex multivessel coronary artery disease undergoing protected percutaneous coronary intervention with the Impella 2.5 device experience similar intrahospital major adverse cardiac and cerebrovascular event rates when compared to coronary artery bypass grafting. Protected percutaneous coronary intervention represents a safe alternative to coronary artery bypass grafting in terms of inhospital adverse events.

Unprotected versus protected high-risk percutaneous coronary intervention with the Impella 2.5 in patients with multivessel disease and severely reduced left ventricular function.

Selecting a revascularization strategy in patients with multivessel disease (MVD) and severely reduced left ventricular ejection fraction (LVEF) remains a challenge. PCI with Impella 2.5 may facilitate high-risk PCI, however long-term results comparing unprotected versus protected PCI are currently unknown. We sought to evaluate the outcome of patients undergoing protected compared to unprotected percutaneous coronary intervention (PCI) in the setting of MVD and severely reduced LVEF.We included patients with MVD and severely reduced LVEF (≤35%) in this retrospective, single-centre study. Patients that underwent unprotected PCI before the start of a dedicated protected PCI program with Impella 2.5 were compared to patients that were treated with protected PCI after the start of the program. The primary endpoint was defined as major adverse cardiac and cerebrovascular events (MACCE) during a 1-year follow-up. The secondary endpoints consisted of in-hospital MACCE and adverse events.A total of 61 patients (mean age 70.7 ±â€Š10.9 years, 83.6% male) were included in our study, of which 28 (45.9%) underwent protected PCI. The primary endpoint was reached by 26.7% and did not differ between groups (P = .90). In-hospital MACCE (P = 1.00) and in-hospital adverse events (P = .12) also demonstrated no significant differences. Multivariate logistic regression identified procedural success defined as complete revascularization and absence of in-hospital major clinical complications as protective parameter for MACCE (OR 0.17, 95% CI 0.04-0.70, P = .02).Patients with MVD and severely depressed LVEF undergoing protected PCI with Impella 2.5 demonstrate similar in-hospital and one-year outcomes compared to unprotected PCI.