Cryoplasty therapy for limb salvage in patients with critical limb ischemia.
OBJECTIVE
To report the 6-month outcomes from a prospective multicenter study investigating the use of cryoplasty (cold balloon angioplasty) to treat below-knee occlusive disease in patients with critical limb ischemia (CLI).


METHODS
Between August 2004 and October 2005, 108 patients (77 men; mean age 73+/-12 years, range 41-101) with CLI involving 111 limbs were enrolled in a prospective multicenter trial (Below-the-Knee Chill Study), which was conducted at 16 institutions. The primary study endpoints were acute technical success, defined as the ability to achieve < or =50% residual stenosis and continuous inline flow to the foot, and absence of major (above or below-knee) amputation of the target limb 180 days post procedure.


RESULTS
Acute technical success was achieved in 108 (97.3%) of the 111 limbs treated, with only 1 (0.9%) clinically significant dissection (> or =type C) and 2 residual stenoses >50%. During the 180-day follow-up, 15 (13.9%) of the initial 108 patients either withdrew or were lost to follow-up. Five (4.6%) deaths occurred, leaving 88 (81.5%) patients with 91 (82.0%) treated limbs available for 180-day assessment. The rate of freedom from major amputation at 180 days was 93.4%. Amputation-free survival was 89.3% at 180 days (5 deaths, 6 major amputations). Stratifying data by diabetics (n=71) versus non-diabetics (n=34), the 180-day death and amputation rates were 4.9% and 10.0%, respectively, for diabetics versus 6.7% and 0.0%, respectively, for non-diabetics.


CONCLUSIONS
Cryoplasty therapy is a safe and effective method of treating infrapopliteal disease, providing excellent acute outcomes and a high rate of limb salvage in patients with CLI. Study outcomes support the use of cryoplasty therapy as a primary treatment option for patients with CLI secondary to below- knee disease.
Cardiology & Interventional Vascular Associates, Presbyterian Heart Institute, Dallas, TX 75231, USA. Tdas@civadallas.com
Tony
T
Das
Thomas
T
McNamara
Bruce
B
Gray
Gino J
GJ
Sedillo
Brian R
BR
Turley
Kenneth
K
Kollmeyer
Michael
M
Rogoff
John E
JE
Aruny
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000671:Amputation, Surgical / Q000706:statistics & numerical data; D000800:Angioplasty, Balloon / Q000009:adverse effects; D001157:Arterial Occlusive Diseases / Q000150:complications* / Q000401:mortality / Q000628:therapy; D016638:Critical Illness; D017679:Cryotherapy / Q000009:adverse effects; D048909:Diabetes Complications / Q000401:mortality / Q000628:therapy*; D005260:Female; D006801:Humans; D007511:Ischemia / Q000209:etiology / Q000401:mortality / Q000628:therapy*; D007866:Leg / Q000098:blood supply*; D023821:Limb Salvage; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology