The CLI Continuum of Care Model : A Multidisciplinary Approach to Improve Outcomes

, TM November 2014 Welcome to the Critical Limb Ischemia Compendium, or CLIC, which was born out of the need to provide more information to health care providers treating patients with critical limb ischemia (CLI), who are often left with minimal to no options for care. It is time to turn the key that opens the door to CLI therapy and just treat CLI. The time has come for vascular specialists to create a movement in the implementation of therapeutic plans for CLI patients that includes promising alternatives to amputation. The time has come to ask for more resources, tools, data, medications, and systems of care for the sick CLI patient. The spectrum of presentation of CLI has changed and therefore it is time for CLI therapy goals to change. CLI used to be the disease of elderly and debilitated patients. This is no longer true. CLI is claiming younger patients every day and is reaching epidemic proportions. Given the predicted morbidity and mortality associated with CLI, vascular specialists, family physicians, podiatrists, and wound care specialists have to turn the key by using each of their educational backgrounds and clinical experience to provide the level and spectrum of appropriate care these patients need. As the impact of this disease continues to broaden, so do the skills, tools, and medicines available to counter the progressive stages of the disease. Each member of the team with his or her unique and varied skill set has something to contribute to the therapeutic algorithm of the CLI patient. So let’s put our hands together, unify directed efforts and “Just treat it!” Turning the Key to Critical Limb Ischemia Therapy

[1]  F. Vermassen,et al.  Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12-month results from the IN.PACT DEEP randomized trial. , 2014, Journal of the American College of Cardiology.

[2]  C. St. Hilaire,et al.  Medial vascular calcification revisited: review and perspectives. , 2014, European heart journal.

[3]  D. Scheinert,et al.  The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. , 2014, JACC. Cardiovascular interventions.

[4]  R. Engelberger,et al.  Clinically-Driven Need for Secondary Interventions After Endovascular Revascularization of Tibial Arteries in Patients With Critical Limb Ischemia , 2013, Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists.

[5]  I. Porto,et al.  Drug-Eluting Balloon in Peripheral Intervention for Below the Knee Angioplasty Evaluation (DEBATE-BTK): A Randomized Trial in Diabetic Patients With Critical Limb Ischemia , 2013, Circulation.

[6]  M. Dake,et al.  Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: 2-year follow-up from the Zilver PTX randomized and single-arm clinical studies. , 2013, Journal of the American College of Cardiology.

[7]  M. Makaroun,et al.  Predictors and outcomes of restenosis following tibial artery endovascular interventions for critical limb ischemia. , 2013, Journal of vascular surgery.

[8]  G. Knapp,et al.  Drug-eluting balloon angioplasty for in-stent restenosis: a systematic review and meta-analysis of randomised controlled trials , 2013, Heart.

[9]  T. Albrecht,et al.  Drug-coated balloons and their place in treating peripheral arterial disease , 2013, Expert review of medical devices.

[10]  Adnan Kastrati,et al.  Five‐year clinical outcomes of a polymer‐free sirolimus‐eluting stent versus a permanent polymer paclitaxel‐eluting stent: Final results of the intracoronary stenting and angiographic restenosis – test equivalence between two drug‐eluting stents (ISAR‐TEST) trial , 2013, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[11]  D. Scheinert,et al.  A prospective randomized multicenter comparison of balloon angioplasty and infrapopliteal stenting with the sirolimus-eluting stent in patients with ischemic peripheral arterial disease: 1-year results from the ACHILLES trial. , 2012, Journal of the American College of Cardiology.

[12]  T. Albrecht,et al.  Paclitaxel-Coated Balloons Reduce Restenosis After Femoro-Popliteal Angioplasty: Evidence From the Randomized PACIFIER Trial , 2012, Circulation. Cardiovascular interventions.

[13]  A. Cannavale,et al.  Lower Limb Multilevel Treatment With Drug-Eluting Balloons: 6-Month Results From the DEBELLUM Randomized Trial , 2012, Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists.

[14]  J. Granada,et al.  Evaluation of efficacy and dose response of different paclitaxel-coated balloon formulations in a novel swine model of iliofemoral in-stent restenosis. , 2012, JACC. Cardiovascular interventions.

[15]  F. Castriota,et al.  Clinical evaluation of a paclitaxel-eluting balloon for treatment of femoropopliteal arterial disease: 12-month results from a multicenter Italian registry. , 2012, JACC. Cardiovascular interventions.

[16]  D. Scheinert,et al.  Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease. , 2012, Journal of vascular surgery.

[17]  M. Joner,et al.  Vascular effects of paclitaxel following drug-eluting balloon angioplasty in a porcine coronary model: the importance of excipients. , 2011, EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.

[18]  D. Scheinert,et al.  First experience with drug-eluting balloons in infrapopliteal arteries: restenosis rate and clinical outcome. , 2011, Journal of the American College of Cardiology.

[19]  G. Hubermont,et al.  A Reliable Approach to Diabetic Neuroischemic Foot Wounds: Below-the-Knee Angiosome-Oriented Angioplasty , 2011, Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists.

[20]  Dirk Mahnkopf,et al.  Dose Response to Paclitaxel-Coated Balloon Catheters in the Porcine Coronary Overstretch and Stent Implantation Model , 2011, Investigative radiology.

[21]  D. Scheinert,et al.  PERIPHERAL VASCULAR DISEASE Original Studies Angiographic Patency and Clinical Outcome After Balloon-Angioplasty for Extensive Infrapopliteal Arterial Disease , 2010 .

[22]  B. Cremers,et al.  Paclitaxel-coated balloons - Survey of preclinical data. , 2010, Minerva cardioangiologica.

[23]  G. Sangiorgi,et al.  Optimization of drug‐eluting balloon use for safety and efficacy: Evaluation of the 2nd generation paclitaxel‐eluting DIOR‐balloon in porcine coronary arteries , 2010, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[24]  S. Nanto,et al.  Importance of the angiosome concept for endovascular therapy in patients with critical limb ischemia , 2010, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[25]  E. Jude,et al.  Peripheral arterial disease in diabetes—a review , 2010, Diabetic medicine : a journal of the British Diabetic Association.

[26]  T. Zeller,et al.  Recanalization of chronic occlusions of the superficial femoral artery using the outback™ re‐entry catheter: A single centre experience , 2009, Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.

[27]  K. Yamashita,et al.  The stent-eluting drugs sirolimus and paclitaxel suppress healing of the endothelium by induction of autophagy. , 2009, The American journal of pathology.

[28]  R. Pakala,et al.  Drug-eluting balloon: the comeback kid? , 2009, Circulation. Cardiovascular interventions.

[29]  S. Nanto,et al.  Long-term results of endovascular therapy with nitinol stent implantation for TASC II A/B femoro-popliteal artery lesions: 4 years' experience. , 2009, Circulation journal : official journal of the Japanese Circulation Society.

[30]  B. Hamm,et al.  Inhibition of Restenosis in Femoropopliteal Arteries: Paclitaxel-Coated Versus Uncoated Balloon: Femoral Paclitaxel Randomized Pilot Trial , 2008, Circulation.

[31]  M. Gyöngyösi,et al.  Attainment of local drug delivery with paclitaxel-eluting balloon in porcine coronary arteries , 2008, Coronary artery disease.

[32]  M. Romiti,et al.  Meta-analysis of infrapopliteal angioplasty for chronic critical limb ischemia. , 2008, Journal of vascular surgery.

[33]  C. Claussen,et al.  Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. , 2008, The New England journal of medicine.

[34]  K. Ouriel,et al.  Angiography Underestimates Peripheral Atherosclerosis: Lumenography Revisited , 2008, Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists.

[35]  L. Norgren,et al.  Inter-society consensus for the management of peripheral arterial disease. , 2007, International angiology : a journal of the International Union of Angiology.

[36]  D. Desilvey Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. , 2007, The American journal of geriatric cardiology.

[37]  L. Norgren,et al.  Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). , 2007, Journal of vascular surgery.

[38]  Johannes Lammer,et al.  Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. , 2006, The New England journal of medicine.

[39]  Christopher Piorkowski,et al.  Prevalence and clinical impact of stent fractures after femoropopliteal stenting. , 2005, Journal of the American College of Cardiology.

[40]  M. Böhm,et al.  Paclitaxel Balloon Coating, a Novel Method for Prevention and Therapy of Restenosis , 2004, Circulation.

[41]  W. Fan Possible mechanisms of paclitaxel-induced apoptosis. , 1999, Biochemical pharmacology.

[42]  P. Heller Paclitaxel and arterial smooth muscle cell proliferation. , 1998, Circulation.

[43]  A. Küttner,et al.  Paclitaxel inhibits arterial smooth muscle cell proliferation and migration in vitro and in vivo using local drug delivery. , 1997, Circulation.

[44]  K. Johnston Femoral and popliteal arteries: reanalysis of results of balloon angioplasty. , 1992, Radiology.

[45]  Second European Consensus Document on chronic critical leg ischemia. , 1992, European journal of vascular surgery.