CTO PCIs Safe and Successful, Study Shows: ACC. 16

April 3, 2016

Poster 148 #2Trying again after a failed chronic total occlusion (CTO) percutaneous coronary intervention (PCI) did not significantly impact the success or safety of subsequent CTO-PCI procedures, according to a study presented at the American College of Cardiology 2016 Scientific Sessions in Chicago.

Reporting on an analysis of 1,213 patients who underwent CTO-PCI procedures between 2012 and 2015 at 12 U.S. centers, Aya J. Alame, BA, and Judit Karacsonyi, MD, said that technical and procedural success rates were similar in the two groups of patients that they and her colleagues from the VA North Texas Healthcare System and UT Southwestern Medical Center (Dallas) and from the University of Szeged (Hungary) focused on for this study.

P148 Fig 1

Ms. Alame and Dr. Karacsonyi noted that prior failed CTO-PCI was associated with longer median procedure time and fluoroscopy time than cases without a prior failed attempt. The patients who had a prior failed CTO-PCI procedure had higher Japanese Chronic Total Occlusion (J-CTO) scores. They also were more likely to have in-stent restenosis and to undergo recanalization attempts using the retrograde approach.

“This study confirms the value of the investment procedure and should help operators to feel comfortable making a second attempt,” said Dr. Karacsonyi. “There are, of course, limitations to the study, most notably that the operators whose cases are included in this multicenter study are highly experienced in CTO-PCI.”

About Impella

The Impella 2.5 system is a temporary (<6 hours) ventricular support device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 in these patients may prevent hemodynamic instability which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events.

Protected PCI and use of the Impella 2.5 is not right for every patient. Patients may not be able to be treated with Impella if they have certain pre-existing conditions, which a cardiologist can determine, such as: severe narrowing of the heart valve, severe peripheral artery disease, clots in blood vessels, or a replacement heart valve or certain heart valve deficiencies. Additionally, use of Impella has been associated with risks, including, but not limited to valvular and vascular injury, bleeding, and limb ischemia in certain patients. Learn more about the Impella devices’ approved indications for use, as well as important safety and risk information at www.protectedpci.com/hcp/information/isi.