“Magic” Bioabsorbable Metal Stents: The Role of the “Houdini stent” in the disappearance of CLI
- Volume 2 - Issue 4 - July/August 2005
- Posted on: 9/5/08
- 0 Comments
- 5216 reads
David E. Allie, MD
In 1892, Ehrich Weiss (aka Harry Houdini) with his brother, and later his beloved wife, Bess, burst upon the vaudeville scene by performing the first of over 11,000 performances of their famous disappearing act “Metamorphosis.” Harry was tied up, shackled with irons and locks, and put in a locked trunk in full view of the audience. A small curtain was placed over the trunk by Bess, who immediately stepped out behind one side of the curtain while Harry stepped from the other side. The curtain was immediately raised and the trunk opened, only to find Bess tied and locked within the trunk, all within 10 seconds, completely mystifying the audience. Harry Houdini went on to become the world's greatest magician and escape artist, and I could not help but to think of him when I read this report on the Magic (Biotronik Inc., Berlin, Germany) absorbable metal stent (AMS). Is this technology “hocus-pocus,” or the real thing, as we are certainly in great need of weapons to fight the war against critical limb ischemia (CLI).
CLI is rapidly becoming a “global epidemic” and is responsible for an estimated 220,000-240,000 major and minor amputations yearly in the United States and Europe.1-2 The incidence of CLI and diabetes is increasing yearly and one out of four diabetics will experience CLI in their lifetime, with a 7-40 times greater risk for an amputation than the non-diabetic.3 The clinical costs of CLI and amputations are high, with the 30-day perioperative mortality and morbidity ranging from 4-30% and 20-37%, respectively, in the highest risk patient populations, and overall less than 50% of amputees achieving full mobility.1-3 The 2- to 5-year survival for the amputee significantly decreases versus the non-amputee, and those patients who achieved limb salvage in a recent report by Kalra et al were found to have a 60% 5-year survival rate after revascularization versus only a 26% survival rate after an amputation.4
The economic costs to the patient, family and our health care system have likewise been found to be extremely high, with the estimated total U.S. costs of treating CLI between $10-20 billion yearly. There is an estimated annual cost of $49,000 to maintain one amputee at home and between $70,000-$100,000 for the 15-20% of amputees who will now require permanent nursing home placement and professional nursing care.2,4-5 Clearly, the clinical and economic costs of CLI are staggering, and any new “metamorphosis” or treatment strategy, such as a “disappearing stent,” that could facilitate a “great escape” from the crippling grip of CLI would be as revolutionary or “disruptive” as the balloon of the 1970’s and the bare metal stent (BMS) of the 1980’s.
BMS were revolutionary as an excellent solution for elastic vessel recoil and dissections after balloon angioplasty, and have become a primary platform for the treatment of most cardiovascular diseases. BMS, however, have unfortunately created their own “diseases,” including intimal hyperplasia, subacute thrombosis, toxicity, inflammation, and stent fracture. Many of these “diseases” are being creatively treated, but certainly a safe and effective short-term nonpermanent BMS solution (<30-90 days) to recoil and dissection would be very appealing, especially if positive remodeling of the vessel wall was a resulting longer-term effect, thereby avoiding the long-term negative effects of a BMS.
Stent fractures have been reported in almost every vascular territory, including coronary artery stents.6-7 Several recent reports have identified nitinol stent fractures in infrainguinal arteries to be common and associated with adverse clinical outcomes.8-9 Scheinert et al analyzed 261 SFA stents in 121 legs and reported a 37.2% incidence of stent fractures in the treated legs and 64 of 261 stents (24.5%) with a significant decrease in 12-month stent patency in those patients suffering stent fractures (41.1% vs. 84.3%, p < 0.001).9
One may theorize that the incidence of stent fractures in infrapopliteal vessels should be less than in the SFA, but much is still left to be learned regarding the incidence and mechanisms of stent crush and fracture. I suspect the report by Sianos et al of several drug-eluting coronary stent fractures all presenting with thrombosis should alert us to the potential for infrapopliteal stent fractures.7 Clearly, many clinicians have lowered their threshold for utilizing recent novel non-stent plaque debulking technologies, such as excimer laser atherectomy (Spectranetics Corporation, Colorado Springs, CO), plaque excision atherectomy (SilverHawk, FoxHollow Technologies, Inc., Redwood City, CA) and non-stent cryoplasty (Polarcath, Boston Scientific Corporation, Maple Grove, MA) when treating CLI, indicating a potential interest in a non-BMS or a bioabsorbable stent in this clinical scenario.
These authors report a first-in-man or near first-in-man report using the Magic AMS in 20 CLI patients with 12-month Kaplan Meier clinical results for mortality, primary patency, secondary patency, and limb salvage of 85.0%, 73.3%, 78.9%, and 94.7%, respectively, in Rutherford class 4 and 5 patients. Immediate technical success was high, utilizing intravascular ultrasound (IVUS)-directed stent deployment with clinical follow-up being provided by duplex ultrasound (DU). This safety and efficacy study was somewhat limited to short lesions (<15 mm length) in vessels ? 3.0 mm diameter, but 2 stents (30mm length) were allowed. Other limitations would include the small sample size, lack of angiographic follow-up, and the Kaplan Meier methodology. Despite these limitations, the authors and Biotronik are to be commended for this body of work. However, much is still left to be accomplished and randomized trials should be a goal.
1. Yost, ML. Peripheral Arterial Disease: A Report by The Sage Group. 2004; Vol. II.
2. Allie DE, Hebert CJ, Lirtzman, MD, et al. Critical limb ischemia: a global epidemic. A critical analysis of current treatment unmasks the clinical and economic costs of CLI. Eur Interv May 2005: 1, 1: 75-84.
3. Akbari, CM. Diabetes and critical limb ischemia. Endovasc Today February 2004; 3, 2:66-69.
4. Kalra M, et al. Limb salvage after successful pedal bypass grafting is associated with improved long-term survival. J Vasc Surg 2001: 33: 6-16.
5. Paaske WP, Lausten J. Femorodistal bypass grafting: quality of life and socioeconomic aspects. Eur J Vasc Endovasc Surg 1995;10:226-230.
6. MDA section of the Medicines and Healthcare products regulatory agency. MDA DA 2002 (10), August 2002.
7. Sianos G, Hofma S, Ligthart JMR, et al. Stent fracture and restenosis in the drug-eluting stent era. Cath and Cardiovasc Interv 2004; 61, 1:111-116.
8. Allie DE, Hebert CJ, Walker CM, et al. Nitinol Stent Fractures in the SFA: The biomechanical forces exerted on the SFA provide a ‘stiff’ challenge to endovascular stenting. Endovasc Today, July/August 2004; 1-8.
9. Scheinert D, Scheinert S, Sax J, et al. Prevalance and Clinical Impact of Stent Fractures After Femoropopliteal Stenting. JACC 2005; 45, 2:312-315.