Dr. Jeffrey Moses Discusses Three Key Areas of Patient Concerns
The Protected PCI blogging team recorded our latest podcast at the Abiomed Advanced Users course in Europe, where Dr. Jeffrey Moses discussed Protected PCI and which patients to treat. An internationally recognized interventional cardiologist, Dr. Moses highlighted three areas of concern in his discussion; We don't diagnose, we don't treat, and we don't treat adequately.
Interviewer: Dr. Moses, can you describe the issues related to not evaluating patients, even for coronary artery disease and congestive heart failure?
Dr. Moses: Well, a lot of these suspicions are really garnered from my personal experience and my practice in New York where I saw many patients with advanced disease who are simply told that there is nothing that can be done for them. When we started really looking at certain registries and digging down in the data, it was very disturbing to see that so many patients with initial presentations of heart failure and left ventricular dysfunction were not even investigated for the presence of coronary artery disease. Whether it would be imaging, and only about 11% of them even had coronary angiography.
Now, when you couple that with several facts, number one is there's about a 70% prevalence of coronary disease in this population which by cost effectiveness would mean you go directly for angiography. And also the fact that these are patients with left ventricular dysfunction which make them at high risk and complex disease which puts them in a very appropriate category, dead green on our AUC. And yet, these patients who by AUC benefit with lifesaving therapy from revascularization are not getting re-vascularized, and there's no way to track them really in the system. Because we're only tracking those individuals who actually get CABG PCI.
Interviewer: Can you describe the data around patients who have coronary disease and whether they're actually getting some sort of revascularization?
Dr. Moses: Well, when we look at it at one dataset from about 75 million records and looked at people with initial heart failure, the revascularization rates were under 50%. And this sort of falls into other datasets that we've looked at. For instance, from the Action Registry which is get with the guidelines, which are well motivated hospitals. I mean, these patients are participating in national initiatives for guideline adherence. And yet even there, there are many centers with 30 to 40% of patients with non-stemi and three vessel and/or left main who are not getting re-vascularized at all.
Interviewer: Can you describe the data around the patients when you do re-vascularize?
Dr. Moses: Well, this has been something that really has been emerging over really several years. And what we do know is that when you do re-vascularize the patient residual ischemia is a key driver of their subsequent outcomes. We know this from a variety of studies. Probably the most prominent study was a nuclear sub study of Courage where residual ischemia of, say, 10% which isn't a lot, it's only moderate. It really almost tripled mortality and subsequent infarction compared to those with little or no residual ischemia.
But we see this anatomically. A very compelling analysis was done from the Courage trial where a few left one major vessel behind. We could call that a residual syntax score of eight. Your morbidity and mortality over the course of the syntax trial was increased multiple. Ironically, if you kept it below eight, even in the most complex anatomy, the high syntax scores, the outcomes were excellent. They were actually comparable to surgery. So it shows you that it's not the procedure per se, the PCI, it's how you do the PCI that drives the outcome.
Interviewer: What’s the key takeaway considering the protected PCI population and the complex high risk indicated patients?
Dr. Moses: I think it's important to recognize that these are individuals that truly benefit. They benefit in terms of quality of life, functional ability, improvement in ejection fraction. These are not just ticking off boxes of appropriateness, they have real meanings to the patient. And I think the fact that they're out there and not being treated is a disservice actually to our population. The key though is that not just focusing on identifying them, but understanding what are the proper tools for that specific patient to really maximize their best outcome.
Interviewer: To hear more Doctor interview or learn more about Protected PCI visit ProtectedPCI.com
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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.