Focus on Vascular Access: The Introducer Sheath Revisited

Editorial

Submitted on Wed, 01/14/2009 - 12:09
Author: Frank J. Criado, MD Author Affiliations: From Union Memorial Hospital/MedStar Health, Baltimore, Maryland. Correspondence: Frank J. Criado, MD, Union Memorial Hospital/MedStar Health, 3333 N. Calvert St., Suite 570, Baltimore, MD 21218. E-mail: frank.criado@medstar.net. Dr. Criado has disclosed that he is a paid consultant to Terumo Medical. _________________________________ The Seldinger technique (first published in 1953) stands alone as a development so singularly important that it changed…everything! Nothing would have been possible without it: not modern diagnostic angiography or cardiac and vascular intervention as we know them today. It was a simple idea: one of those “why-didn’t-I-think-of-it” moments that tend to be commonplace in medical breakthroughs — if not in life in general! Central to the procedure, of course, is the arterial puncture itself: where and how and its management following the removal of the sheath. Many interventionalists probably assume that introducer sheath usage has always been part of this technique and that no one would dare dispute its value… Not true. The reality is that it was only in the previous decade that the routine use of a sheath became accepted — almost universally — for performance of all diagnostic and interventional cardiovascular procedures. Happily, we need not make this argument ever again! Puncture-site management has received a great deal of attention in the recent past. This has been mainly propelled by the development of vessel-closure technologies that have brought considerable (and appropriate) focus to the issues surrounding hemostasis. However, we still do not hear much about certain important aspects of vascular access, such as the technique of vessel entry and the introducer sheath. After all, together with anatomic level, the size and characteristics of the puncture hole itself are what largely determine the likelihood of complications and the possible difficulties with hemostasis. It is my intention in this short, editorial-style article to make a plea to all interventional specialists to refocus their attention — if only this one time — in the direction of the arterial puncture and the introducer sheath, and away from “damage-control” (vessel closure), which has been the dominating consideration for too long. Vessel closure technologies are an important advancement, no doubt, but their use is (at best) hard to justify in many cases, and they carry additional risks and cost. Introducer sheath design and features have received little, if any, attention over the last several years; I would like to change this. Recently, I have had experience with 120 consecutive diagnostic and interventional procedures where the new Terumo Pinnacle TIF Tip (Somerset, New Jersey) sheath was used exclusively. The cases involved femoral artery access (n = 106) as well as brachial artery punctures (n = 14). Of the procedures, 30% involved the use of a 5 Fr introducer, and the rest were 6 Fr or 7 Fr. The TIF sheath incorporates important refinements that result in superior atraumatic tissue penetration and the smoothest possible transitions at the guidewire-tip and dilator-sheath interfaces (Figures 1 and 2). Its ability to traverse some of the most densely scarred areas and multiply punctured vessels has been impressive. None of the patients had vessel closure, and there were no complications related to the puncture site. More than 90% of these patients were discharged home at an average of 4.5 hours after sheath-pull. While more detailed information will be reported when the “TIF Study” is published in 2009, it seemed appropriate to provide these initial impressions and early procedural experience. The performance of the sheath and the level of satisfaction have been optimal and most reassuring in every way. Admittedly, it is going to be difficult — if not impossible — to design and conduct a clinical study that would produce the kind of high-level scientific evidence that could be offered as “proof” of its superior qualities. Nonetheless, there is the growing distinct impression that the new sheath’s alleged advantages (Table 1) may well translate into real clinical and economic benefit. Despite the many impressive advances in the whole of the interventional field, vascular access retains its crucial importance and potential for complications — even catastrophe. It is where every intervention begins and ends. “Success” or “failure” can be determined in large part by the events occurring (or not occurring) at the vascular access site, with hemorrhagic complications (and others) continuing to account for a large portion of the morbidity related to all such procedures. How (and where) we create the puncture and the quality of the introducer sheath inserted through it are critical technical aspects that require refocused attention. Use of the new TIF sheath as described in this article has resulted in impressive performance during a relatively small and early clinical experience. Analysis and reporting of a larger number of procedures will hopefully confirm these initial impressions.