Proposed LCD - Pneumatic Compression Devices (DL33829)

Feuerhake IL, Henneberg EW, Hgh A. Intermitterende pneumatisk kompressions-behandling ved underekstremitetsiskmi uden kirurgiske behandlingstilbud [The use of intermittent pneumatic compression for critical limb ischaemia without vascular surgery reconstruction]. Ugeskr Laeger. 2016;178(11): V12150982.Gardner, AMN, Fox, RH. The Return of Blood to the Heart. London: John Libbey; 1989.GRADEpro GDT: GRADEpro Guideline Development Tool [Software]. McMaster University, 2020 (developed by Evidence Prime, Inc.). Available from gradepro.org.Guarneri,G, Tiengo, A. Haemorrologic and Clotting Alterations in the Pathogenesis of the Diabetic Foot. In Faglia, E, Giuffrida, G, Oriani, G, ed. The Ischaemic Diabetic Foot. Milano, Italy: Kurtis. 1999: 17-23.Husmann M, Willenberg T, Keo HH, Spring S, Kalodiki E, Delis KT. Integrity of venoarteriolar reflex determines level of microvascular skin flow enhancement with intermittent pneumatic compression. J Vasc Surg. 2008 Dec;48(6):1509-13.Ishibashi, H, Ohta, T, Hosaka, M, Sugimoto, I, Nehei, T, Kawanishi, J. Intermittent Pneumatic Compression Therapy for Chronically Ischemic Legs. In Iwai, T, Ohta, T, Sasajima, T, Ishibashi, H, and Nishikimi, N, ed. Breakthrough in the Treatment for Critical Limb Ischemia in Japan. Japanese Society for Limb Salvage Research. 2004: 65-71.Jolissaint, J, Shah, SK, Martin, MC, Raffetto, JD, McPhee, JT. Risk Prediction of 30-day mortality after lower extremity major amputation. New England Society for Vascular Surgery. Dec 2019 70(6): 1868-1875.Labropoulos N, Watson WC, Mansour MA, Kang SS, Littooy FN, Baker WH. Acute effects of intermittent pneumatic compression on popliteal artery blood flow. Arch Surg. 1998 Oct;133(10):1072-5.Levin SR, Arinze N, Siracuse JJ. Lower extremity critical limb ischemia: A review of clinical features and management. Trends Cardiovasc Med. 2020 Apr;30(3):125-130.Liu K, Chen LE, Seaber AV, Urbaniak JR. Influences of inflation rate and duration on vasodilatory effect by intermittent pneumatic compression in distant skeletal muscle. J Orthop Res. 1999 May;17(3):415-20.Louridas, G. A Randomized, Placebo-Controlled Limb Salvage Trial Using the ArtAssist Pneumatic Compression Device. Winnipeg Vascular and Endovascular Symposium. Winnipeg, Canada; April 2006.Manfredini F, Malagoni AM, Felisatti M, Mandini S, Lamberti N, Manfredini R, Mascoli F, Basaglia N, Zamboni P. Acute oxygenation changes on ischemic foot of a novel intermittent pneumatic compression device and of an existing sequential device in severe peripheral arterial disease. BMC Cardiovasc Disord. 2014 Mar 31; 14:40.Mehta T, Venkata Subramaniam A, Chetter I, McCollum P. Assessing the validity and responsiveness of disease-specific quality of life instruments in intermittent claudication. Eur J Vasc Endovasc Surg. 2006 Jan;31(1):46-52.Mentias A, Qazi A, McCoy K, Wallace R, Vaughan-Sarrazin M, Girotra S. Trends in Hospitalization, Management, and Clinical Outcomes Among Veterans with Critical Limb Ischemia. Circ Cardiovasc Interv. 2020 Feb;13(2): e008597.Montori VM, Kavros SJ, Walsh EE, Rooke TW. Intermittent compression pump for nonhealing wounds in patients with limb ischemia. The Mayo Clinic experience (1998-2000). Int Angiol. 2002 Dec;21(4):360-6.Moran PS, Teljeur C, Harrington P, Ryan M. A systematic review of intermittent pneumatic compression for critical limb ischaemia. Vasc Med. 2015;20(1):41-50. doi:10.1177/1358863X14552096Pawlaczyk K, Gabriel M, Urbanek T, Dzieciuchowicz L, Krasinski Z, Gabriel Z, Olejniczak-Nowakowska M, Stanisic M. Effects of Intermittent Pneumatic Compression on Reduction of Postoperative Lower Extremity Edema and Normalization of Foot Microcirculation Flow in Patients Undergoing Arterial Revascularization. Med Sci Monit. 2015 Dec 21; 21:3986-92.Pfizenmaier DH 2nd, Kavros SJ, Liedl DA, Cooper LT. Use of intermittent pneumatic compression for treatment of upper extremity vascular ulcers. Angiology. 2005 Jul-Aug;56(4):417-22.Schnemann H, Brozek J, Guyatt G, Oxman A, editors. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013. The GRADE Working Group, 2013. Available from guidelinedevelopment.org/handbook.Sterne JAC, Savovic J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 2019;366: l4898. Published 2019 Aug 28. doi:10.1136/bmj. l4898Sultan S, Esan O, Fahy A. Nonoperative active management of critical limb ischemia: initial experience using a sequential compression biomechanical device for limb salvage. Vascular. 2008 May-Jun;16(3):130-9. doi: 10.2310/6670.2008.00021.Sultan S, Hamada N, Soylu E, Fahy A, Hynes N, Tawfick W. Sequential compression biomechanical device in patients with critical limb ischemia and nonreconstructible peripheral vascular disease. J Vasc Surg. 2011 Aug;54(2):440-6; discussion 446-7. doi: 10.1016/j.jvs.2011.02.057.Tawfick WA, Hamada N, Soylu E, Fahy A, Hynes N, Sultan S. Sequential compression biomechanical device versus primary amputation in patients with critical limb ischemia. Vasc Endovascular Surg. 2013 Oct;47(7):532-9.van Bemmelen PS, Mattos MA, Faught WE, Mansour MA, Barkmeier LD, Hodgson KJ, Ramsey DE, Sumner DS. Augmentation of blood flow in limbs with occlusive arterial disease by intermittent calf compression. J Vasc Surg. 1994 Jun;19(6):1052-8.van Bemmelen PS, Weiss-Olmanni J, Ricotta JJ. Rapid intermittent compression increases skin circulation in chronically ischemic legs with infra-popliteal arterial obstruction. Vasa. 2000 Feb;29(1):47-52.van Bemmelen PS, Choudry RG, Salvatore MD, Goldenberg M, Goldman BI, Blebea J. Long-term intermittent compression increases arteriographic collaterals in a rabbit model of femoral artery occlusion. Eur J Vasc Endovasc Surg. 2007 Sep;34(3):340-6.van Bemmelen P, Char D, Giron F, Ricotta JJ. Angiographic improvement after rapid intermittent compression treatment [ArtAssist] for small vessel obstruction. Ann Vasc Surg. 2003 Mar;17(2):224-8.van Bemmelen PS, Gitlitz DB, Faruqi RM, et al. Limb salvage using high-pressure intermittent compression arterial assist device in cases unsuitable for surgical revascularization. Arch Surg. 2001;136(11):1280-1286.Williams KJ, Babber A, Ravikumar R, Davies AH. Non-Invasive Management of Peripheral Arterial Disease. Adv Exp Med Biol. 2017; 906:387-406. doi:10.1007/5584_2016_129Zaki M, Elsherif M, Tawfick W, El Sharkawy M, Hynes N, Sultan S. The Role of Sequential Pneumatic Compression in Limb Salvage in Non-reconstructable Critical Limb Ischemia. Eur J Vasc Endovasc Surg. 2016 Apr;51(4):565-71. doi: 10.1016/j.ejvs.2015.12.025.Zaleska MT, Olszewski WL, Ross J. The long-term arterial assist intermittent pneumatic compression generating venous flow obstruction is responsible for improvement of arterial flow in ischemic legs. PLoS One. 2019 Dec 11;14(12): e0225950.