Conventional Compression vs Vessel Closure Devices - Essay Example

Conventional compression vs. vessel closure devices Cardiac catheterization has evolved over the years without any major changes in the basic procedure. If we look at other surgical procedures they have evolved into completely different procedure over the time but cardiac catheterization has not changed a lot and that shows how strong the principles of this procedure are. History shows that in 1844, Claude Bernard "passed a catheter into both the right and left ventricles of a horse's heart via a retrograde approach from the jugular vein and carotid artery. In 1929, in Eberswalde, Germany, a 25-year-old surgical trainee was the first to pass a catheter into the heart of a living person-his own. In 1947, Louis Dexter expanded the clinical use of right heart catheterization with studies in patients with congenital heart disease and identified the pulmonary capillary wedge pressure as a useful clinical measurement. By this point, the value of homodynamic measurements was being fully realized, and further developments came rapidly" (Roger, 2008). The technique and safety profile of the instruments used for bringing homodynamic stability though has been evolving over the time. Initial there used to be compression techniques to stop the vessels from bleeding which was and still is the main complication of angiography and angioplasty. Post op bleeding from the intervention site is the main reason of keeping patients in bed for a couple of hours which is very cumbersome for the patients. Cardiac catheterization can be done through different access points but the window to work in becomes an issue. Using upper extremity vessels will be a very good alternative to have a controlled bleeding because of the diameter of the vessel and their easy access but the window of access gets compromised and the choice of catheters for maximum access and manipulation becomes a problem so, the preferred access rout is still femoral arty and mainly the common femoral artery neither above non below it. "The main advantages to this method are its ease and substantial safety record. The main disadvantage is the need for an extended (2-6 h) period of bed rest after completion of the procedure. Several types of arterial closure devices now are available that provide rapid homeostasis and shorten the period of bed rest considerably. However, complication rates with these closure devices are similar to conventional manual compression". (Roger, 2008). "Reductions in sheath size, intensity and duration of anticoagulation with heparin, and procedure time were observed. Adverse outcomes of major femoral bleeding included prolonged hospital stay, and increased requirement for blood transfusion. Major femoral bleeding and blood transfusion are both associated with decreased long-term survival, driven by a significant increase in 30-day mortality" (Brendan, 2007). Manual or mechanical compression as the name itself explains it is to be done by the surgeon or any other volunteer in the surgical team to provide compression with the pressure through the pulp of three or four fingers in the downward direction without releasing it for a microsecond for at least for 10-15 minutes at the site of the intervention. (Shaffer, 2005).Vascular closure devices are a very nice and safe alternative to the mechanical compression methods in terms of vascular complication, surgeon's factors and patient's factors. In percoutaneous intervention intra vascular complication which includes "ecchymosis (37%), hematoma (20%), and oozing (15%)" are major complications. These complications occur more frequently with mechanical and device assisted compression. The main reason for these complications is the way mechanical or device assisted compression is applied and unless it is applied exactly the same way it does not fulfill the purpose. Apart from these commonly happening but comparatively less dangerous issues there is a another major complication of leg ischemia which occurs due to prolonged deprivation of blood supply. Post-operatively some patients do not regain their pulses back so only the ones that are lucky enough and establish a good collateral circulation are able to regain a good blood supply to their leg. With manual or device assisted compression these complications occur but otherwise at most of the cardiac centers this is the mode of maintaining hemostasis that is used mostly and with this mode the above vascular complications are there but bleeding is pretty much controlled successfully with less failure rate but with venous closure devices these complications occur less frequently but the fear of failure rate is high. Experience has shown that this high failure rate is there due to the fact that this technique is new, it needs further research studies to be convincing enough to be used and the surgeons will get more experience in using it if the use is encouraged with further research on it, which will reduce the complication rate. This complication mostly occurs in the early post op hours but can occur a few days later as well. These local site complications the main of which is blood vessel complications significantly prolong patient's hospital stay and it also delays ambulation profoundly. Prolonged hospital stay and delayed ambulation are the two major factors that cause morbidly mortality. A study showed that patients who had a vessel closure device had "the mean times to ambulation were 6.3 2.4 minutes and 105.2 55.3 minutes in the immediate ambulation and delayed ambulation subgroups, respectively. Complication rates were very low for both subgroups. At follow-up, no patient developed hematoma which was 4 cm; there was no ipsilateral retroperitoneal bleed, arterio-venous fistula, pseudo aneurysm, access site infection or loss of distal pulses. No patients had lower extremity ischemia nor required a blood transfusion".( Christopher, 2003). Hematoma formation larger than 4 cm requires surgical clearance and a large atriovanous fistula also needs to be corrected surgically. Infection at the local site of intervention is a factor that is comparatively more common in patients managed with venous closure device than local compression but this can be taken care of with pre-op antibiotic administration. Another drawback that can happen with the failure of these devices is that we will have to get back to the old compression technique but here that technique also turns into a safer range of intervention and when both the modalities are used together the compression time that is needed then is not so long to cause ischemia or other vessel injury so, here it will have synergistic effect with the compression technique. Patients who undergo through a long procedure of two or three vessel stent placement during percoutaneous intervention are to some extent acceptable to be kept under restriction from getting ambulated due to a number of other factors but for the ones who just have a Percoutaneous intervention for diagnostic purposes that which mostly turn out to be negative need not to be on bed rest for a significant number of hour just secondary to the procedure related complications. Surgery is the kind of management in which surgeon's comfort, experience and their performance adds a lot. For a surgery to be successful along with a number of other factors surgeon's factors are also very important. For percoutaneous intervention access if small vessels are used there will be less morbidity and mortality related to the procedure itself. There is more patient's satisfaction in terms of hospital stay, post procedure pain, early ambulation and a lot of other things but the procedure and its outcome will be getting compromised because to have enough window to manipulate things and access all the vascular lesions easily it is better to use a femoral access which is a bigger access rather but then the types of complications occur with both the procedures are different. If a larger vessel is used the chances of complication related to vessels increases but if it is radial access then the rest of complications are going to be minimal but the outcome of the procedure is not going to be that satisfactory. In order to have a good efficacy of the procedure other alternatives have been thought and implemented which have shown satisfactory results. Vessel closure devices are one of those efforts since large vessels need a good hemostatic control and these devices have promising results if used by the experienced surgeons. Initially researchers started looking for mechanical devices which were to be used for applying compression but now the trend is more towards getting started with vessel closure device for surgeons even the use of mechanical devices have shown better results than manual compression but the surgeons still feel that both the techniques will bring almost similar results with a lot of cost difference to the patient so, in order to justify their self they would obviously want something with less complications at least if the patient is paying extra money for that. Applying compression and letting it stay there for 20min and sometimes even more than that is a time consuming thing and especially for the patients who should not be exposed to the contrast for a long time or the ones that either have a back problem or an anxious personality but in such a cases if the vessel closure devices are used it will take care of the time issue as well. Patient can be ambulated within minutes with these devices unless failure occurs which is mostly a result of the professional's limited experience with the device. "In addition to the associated patient comfort issues, compression techniques are a time- and resource-intensive practice.( Fleischhauer, 2000., Shrake, 2000). The more these devices are used the more promising results are expected. Currently the use and data available on them is so limited that one can not conclude for sure whether it is good from the point of view of all the aspects or not but still it has been proven to be good at least for in aspects. Patient's who is the customer in this practice here values a lot and their perspective comes first and is taken care of with the best of our efforts. The percentage of negative angioplasties is pretty high just because it is more of a screening process. If a patient comes with a typical chest pain but the ECG finding or blood levels of cardiac enzymes are normal then the next thing comes is to have a an intervention that is diagnostic angioplasty and find out the pathology in the coronaries but most of the patients will refuse once they are explained the whole protocol of the procedure and then post procedure complications. This is all mandatory when it comes to the usual practice which is controlling hemostasis through compression whether manual or mechanical. Mechanical compression is a cumbersome thing for the patients, applying this pressure is a troublesome job for everyone whether it is the surgeon to apply it, the technicians to maintain the pressure, and for the nursing staff to removing this pressure after a specific number of hour and then mobilizing the patient with a set of protocols is a hard job. Person that suffers the most in this whole process is our client. "Numerous studies have substantiated the use of various vascular closure devices to alleviate patient discomfort and improve resource utilization without increasing complication rates". (Sola, 2001., Mehta, 2002., Gerkens, 1999). Up till now most of the studies have come up with a conclusion that the complication rate is the same with both compression techniques and the use of devices for causing hemostasis. But if patient's comfort is considered then the use of these closure devices is obviously superior. Considering the fact that is it a safer and much more comfortable procedure for the patients "Some institutions have begun routine use of closure devices in lieu of manual compression whenever feasible.( Shrake, 2000., Fleischhauer, 2000., Gerkens, 1999). This needs to be encouraged in order to have this new technique going with a most probable good outcome. "Manual compression techniques with subsequent bed rest may be associated with patient discomfort, especially for the elderly and for those patients with preexisting back and hip pain". (McCabe, 2001., Kahn, 2002). Even for very active young patients who under go through angiography/ angioplasty as a screening test must definitely be finding it hard to go throw all these restrictions of morbidity for a good 6 plus hours and the other complication over it adds even further. "Manual compression has been the standard by which recently introduced vascular hemostasis devices are judged with regard to efficacy, cost, complications and patient comfort" (Baim, 2000., Lehmann. 1999) In this new era in which research work is going on working on every aspect of life and people are coming up with advancements in every field, it is expected that these vessel closure devices will take a very important role up and percoutaneous intervention will start getting done as a day care procedure with a minimal acceptable list of complications. If this happens one of the major killer heart attacks will be controlled to a larger extent by an early detection and early intervention. This is a brighter hope to make this aspect of intervention easy and acceptable to the patients. "Manual compression has been the standard by which recently introduced vascular hemostasis devices are judged with regard to efficacy, cost, complications and patient comfort.( Bogart, 1995., Simon,1998., Kussmaul,1995., Sanborn, 1993., Shrake2000., Duffin,2001., Brachmann, 1998.). This intervention can be very useful if it is carried out with a focus on the set of complications that are very common and are the leading causes of increased mortality and morbidly. Complications that badly need to be encountered and taken care of are the ones that happen at the point of intervention like thrombosis, bleeding, aneurysms, AV fistulae and leg ischemia. These complications should be dealt with individually in research study with a focus on different solution to it including improving compression techniques or introducing vessel closure devices at every center dealing with percoutaneous interventions. Apart form these complications the advantages an the amount of satisfaction a surgeon can get out of carrying such a safe, quick and life saving procedure on day today basis with minimal morbidity and mortality is another incentive to work on this project. Patient' factors are a very important area that needs to be addressed and we should feel our self confident enough in counseling the patients with a confidence regarding these procedure. There are different types of these devices in use these days some are good for taking care of one problem and other are good for another problem but the work is still not conclusive because it is limited and needs to be elaborated further with research work. Compression techniques are well established protocols now but their establishment should be questioned and the answers should be searched in looking for even further new devices for the closure of the intervention site. The types that are currently in use and all have shown different efficacy at taking care of different aspects of the complications that need to be taken care of. References 1. Baim D, Knopf W, Hinohara T, et al. Suture-mediated closure of the femoral access site after cardiac catheterization: Results of the Suture To Ambulate aNd Discharge (STAND I and STAND II) trials. Am J Cardiol 2000;85:864-869 2. Bogart M. Time to hemostasis: A comparison of manual versus mechanical compression of the femoral artery. Am J Crit Care 1995;4:149-156. 3. Brachmann J, Ansah M, Kosinski E, Schuler, G. Improved clinical effectiveness with a collagen vascular hemostasis device for shortened immobilization time following diagnostic angiography and percutaneous transluminal angioplasty. Am J Cardiol 1998;81:1502-1505. 4. Brendan J. D., Henry, H. T., Malcolm, R. B., Ryan, J. L., Verghese, M., Mandeep, S., David, R. H. & Charanjit, S. R. (2008). Major Femoral Bleeding Complications After Percutaneous Coronary Intervention. J Am Coll Cardiol Intv, 2008; 1:202-209, doi:10.1016/j.jcin.2007.12.006 5. Christopher H. et al. (2002) Immediate Ambulation Following Diagnostic Coronary Angiography Procedures Utilizing a Vascular Closure Device (The Closer). J Invasive Cardiol 14(12):728-732, 2002. 6. Duffin D, Muhlestein J, Allison S, et al. Femoral arterial puncture management after percutaneous coronary procedures: A comparison of clinical outcomes and patient satisfaction between manual compression and two different vascular closure devices. J Invas Cardiol 2001;13:354-362. 7. Gerkens U, Cattelaens N, Lampe E, Grube E. Management of arterial puncture site after catheterization procedures: Evaluating a suture-mediated closure device. Am J Cardiol 1999;83:1658-1663 8. Fleischhauer F, Stewart J. Effectiveness of suture mediated closure of vascular access sites following diagnostic and interventional catheterizations. Cath Lab Digest 2000;(Suppl):12-14. 9. Kahn Z, Kumar M, Hollander G, Frankel R. Safety and efficacy of the Perclose suture-mediated closure device after diagnostic and interventional catheterization in a large consecutive population. Cathet Cardiovasc Intervent 2002;55:8-13. 10. Kussmaul W, Buchbinder M, Whitlow P, et al. Rapid arterial hemostasis and decreased access site complications after cardiac catheterization and angioplasty: Results of a randomized trial of a novel hemostatic device. J Am Coll Cardiol 1995;25:1685-1692 11. Lehmann K, Heath-Lange S, Ferris S. Randomized comparison of hemostasis techniques after invasive cardiovascular procedures. Am Heart J 1999;138:1118-1125 12. Mehta H, Fleisch M, Chatterjee T, et al. Novel femoral artery puncture closure device in patients undergoing interventional and diagnostic cardiac procedures. J Invas Cardiol 2002;14:9-12. 13. McCabe P, McPherson L, Lohse C, Weaver A. Evaluation of nursing care after diagnostic coronary angiography. Am J Crit Care 2001;10:330-340 14. Lehmann K, Heath-Lange S, Ferris S. Randomized comparison of hemostasis techniques after invasive cardiovascular procedures. Am Heart J 1999;138:1118-1125. 15. Roger, B. O., Arshad, M.S. & Olurotimi, J. B. (2008). Cardiac Catheterization (Left Heart). E medicine,State University of New York Downstate Medical Center. Updated: Oct 9, 2008. Available at http://emedicine.medscape.com/article/160601-overview 16. Sola R, Pastore G, Stein B. Early ambulation after diagnostic cardiac catheterization: A 4 French study. J Invas Cardiol 2001;13:75-78. 17. Shrake K. Comparison of major complication rates associated with four methods of arterial closure. Am J Cardiol 2000;85:1024-1025 18. Simon A, Burngarner B, Clark K, Israel S. Manual versus mechanical compression for femoral artery hemostasis after cardiac catheterization. Am J Crit Care 1998;7:308-313. 19. Sanborn T, Gibbs H, Brinker J, et al. A multicenter randomized trial comparing a percutaneous collagen hemostasis device with conventional manual compression after diagnostic angiography and angioplasty. J Am Coll Cardiol 1993;22:1273-1279. 20. Shaffer RB. Arterial and venous sheath removal. In: Wiegand DJ, Carlson KK, eds. AACN Procedure Manual for Critical Care. 5th ed. St Louis, MO: Elsevier Saunders; 2005:602-609 21. Shrake K. Comparison of major complication rates associated with four methods of arterial closure. Am J Cardiol 2000;85:1024-1025. Read More