Low-Profile and Long Balloons
What is the role of this technology in diabetic macroangiopathy and complex infrapopliteal interventions?
Lower limb peripheral arterial disease (PAD) in diabetic patients is a pathological condition with unique elements that differentiate it from typical atherosclerosis. However, these differences are frequently underappreciated.
Whereas atherosclerosis can be described as asymmetric inflammatory fatty plaque formation, with focal, eccentric subintimal calcification, PAD in below-the-knee (BTK) arteries in diabetes presents a degenerative, circumferential vascular involvement in substantial absence of inflammatory cells. This condition is different from typical atherosclerosis. Specifically, BTK PAD of diabetic patients is characterized by an increased amount of connective tissue, such as fibronectin, collagen, and glycoproteins, as well as an increased amount of calcium in the medial layer. The circumferential Mönckeberg’s medial calcification, typically macrophage- and lipid-free, is common in BTK PAD in diabetic patients and occurs independently from atherosclerosis, implying different etiological mechanisms, such as long duration of diabetes.1-6 This constellation of findings, known as diabetic macroangiopathy, is present in the majority of diabetic subjects with PAD, yet it has been totally ignored by the current official Atherosclerotic Lesions Classification document.7 Consequently, the lower limb PAD in patients with diabetes has always been confused with atherosclerosis and treated accordingly.
BACKGROUND OF BTK PTA THERAPY
Due to their anatomical size, analogous with the coronary arteries, the diseased tibial arteries have been approached with coronary-like devices, such as angioplasty balloons, atherectomy devices, cutting balloons, bare-metal or drug-eluting stents, and recently, drugeluting balloons.
The first devices used were small-vessel balloon catheters that were surprisingly effective and showed a very low incidence of intimal dissection when compared to similar treatment of coronary lesions (Figure 1).
To limit the incidence of intimal dissection and elastic recoil, methods similar to those used during coronary balloon dilation to lower the incidence of dissection or abrupt closure were adopted. In our institution, prolonged balloon dilation of at least 180 seconds and gradual high-pressure balloon dilation using a correct balloon size reduced the risk of dissection. Unfortunately, the use of multiple, prolonged inflations with short, coronarytype balloons in diffusely diseased tibial arteries dramatically increased the procedure length.8-17 After that time, it was clear that there was a need for a significantly longer over-the-wire balloon, tapered to 0.014 inch to fit the same size of the adopted coronary wires.
BALLOON DEVICE TECHNOLOGY
In the early 1990s, 10-cm-long balloons became available from MediTech in either a 5-F shaft tapered to 0.038 inch or small-vessel Ultra-Thin or Symmetry 4-F shaft versions (Boston Scientific Corporation, Natick, MA). The latter were tapered to 0.018 inch, but their tip profile and excessive stiffness limited their use in many BTK arteries. In the late 1990s, the Savvy balloon (Cordis Corporation, Bridgewater, NJ), which was 2 to 4 mm, 10 cm in length, tapered to 0.018 inch, was used at our institution largely due to its superior crossability. Although procedural efficiency improved, no data have demonstrated that balloon length characteristics are associated with a better acute or long-term angioplasty result for atherosclerotic lesions. In our experience, however, the benefit of long balloons first became evident in diabetics with PAD, probably due to the disease’s pathological characteristics. Long balloons were associated with fewer dissections, better remodeling, and uniform lumen gain in patients with diabetic macroangiopathy.
We made a formal request for a 120-mm-long, very low-profile, overthe- wire (OTW) balloon tapered to 0.014 inch in Brescia to the former Invatec company (Roncadelle, Italy, now part of Medtronic, Inc., Minneapolis, MN) in 2000 (Figure 2). Based on my long-term experience with the antegrade femoral approach, the requested shaft length was 120 cm to allow an easy access to foot arteries in all cases. The request for an unusually long balloon solicited several concerns from the company, which did not find favorable opinions from its consultants at the time. Among the different prototypes submitted, the final selection incorporated the device with the thinnest shaft body. I considered the stiff hydrophilic 0.014-inch wire to be the most important determinant for successful lesion crossing.
The first version (2004–2010) of the Amphirion Deep balloon (Medtronic, Inc.), was characterized by a uniformly thin shaft size and excellent crossing profile, providing an impressive improvement over other PTA balloons of that era. This improvement in BTK balloon technology led to improvement of procedural performance worldwide, promoting large interest in developing similar solutions in other companies (Figure 3).
The first successful BTK recanalization in a large series of diabetic subjects was performed using the ipsilateral antegrade femoral approach and an extensive up-to-thefoot balloon angioplasty dilation strategy.18 These results were confirmed a few years later in a methodologically identical multicenter experience in a very large population, limiting major amputation rate in this group to 1.8% to 4.0%.19 Since that time, ipsilateral antegrade femoral balloon angioplasty treatment has remained the only technique with proven efficacy for limb salvage in large series of subjects at risk of limb loss. Despite this evidence, the newly developed OTW long tibial balloons up to about 30 cm in length are unfortunately delivered in 150- and 90-cm shaft length only, with very rare exceptions.
In the author’s opinion, these new low-profile OTW balloon catheters are not well suited for the antegrade femoral approach because they are too short to reach the ankle and too long to properly accommodate the commonly available 180-cm-long, 0.014-inch coronary-type guidewires. Paradoxically, one may argue that prejudice against the antegrade femoral approach is responsible for more availability of balloons for contralateral femoral crossover or the ipsilateral pedal approach and the limited availability of balloon lengths that are ideally suited for the antegrade femoral approach (120- to 130-cm catheters). Unfortunately, a catheter’s excessive length increases the friction with the guidewire, which reduces the catheter’s pushability and crossability. The rapid exchange (RX) balloon platforms are not similarly affected, but they require the aid of a guiding catheter in many cases, even with the antegrade femoral approach.
The technological solutions adopted in the last generation of long infrapopliteal balloons have improved balloon performance dramatically, resulting in increased procedural success rates and reduced procedure length (Figures 4 and 5). With current devices, the rated burst pressure of long balloons has increased to a minimum of 14 atm. Coupled with reduced balloon compliance, these higher-pressure balloons have improved efficacy in heavily calcified arteries. Balloon deflation times continue to shorten over time and can be further improved by the use of additional dilute contrast for balloon inflation without compromising balloon visibility. Particularly impressive is the superior pushability and trackability of newer RX 200-mm-long balloons in comparison to OTW versions. The advantage of newer, low-profile long balloons is most clearly evident in cases of complex distal revascularization such as those involving the pedal arch (Figure 6). In these cases, the complicated anatomy of the diseased arch can be easily treated with a single balloon covering most of the lesion area, resulting in better arterial remodeling.
Lanfroi Graziani, MD, is Director of Interventional Cardiology, Istituto Clinico “Città di Brescia” Hospital in Brescia, Italy. He has disclosed that he has no potential conflicts of interest. Dr. Graziani may be reached at +39 030 3710262; firstname.lastname@example.org.
- Dybdahl H, Ledet T. Diabetic macroangiopathy. Quantitative histopathological studies of the extramural coronary arteries from type 2 diabetic patients. Diabetologia. 1987;30:882-886.
- Rasmussen LM, Heickendorff L. Accumulation of fibronectin in aortas from diabetic patients. A quantitative immunohistochemical and biochemical study. Lab Invest. 1989;61:440-446.
- Andresen JL, Rasmussen LM, Ledet T. Diabetic macroangiopathy and atherosclerosis. Diabetes. 1996;45(suppl 3):S91-S94.
- Lehto S, Niskanen L, Suhonen M, et al. Medial artery calcification: a neglected harbinger of cardiovascular complications in non– insulin-dependent diabetes mellitus. Arterioscler Thromb Vasc Biol. 1996;16:978-983.
- Shanahan CM, Cary NRB, Salisbury JR, et al. Medial localization of mineralization-regulating proteins in association with Mönckeberg’s sclerosis: evidence for smooth muscle cell–mediated vascular calcification. Circulation. 1999;100:2168-2176.
- Olesen P, Ledet T, Rasmussen LM. Arterial osteoprotegerin: increased amounts in diabetes and modifiable synthesis from vascular smooth muscle cells by insulin and TNF-α. Diabetologia. 2005;48:561-568.
- Stary HC, Bleakley Chandler A, Dinsmore RE, et al. A definition of advanced types of atherosclerotic lesions and a histological classification of atherosclerosis. A report from the Committee on Vascular Lesions of the Council on Arteriosclerosis, American Heart Association. Arterioscler Thromb Vasc Biol. 1995;15:1512-1531.
- Sarembock IJ, LaVeau PJ, Sigal SL, et al. Influence of inflation pressure and balloon size on the development of intimal hyperplasia after balloon angioplasty. A study in the atherosclerotic rabbit. Circulation. 1989;80:1029-1040.
- Nichols AB, Smith R, Berke AD, et al. Importance of balloon size in coronary angioplasty. J Am Coll Cardiol. 1989;13:1094-1100.
- Ilia R, Cabin H, McConnell S, et al. Coronary angioplasty with gradual versus rapid balloon inflation: initial results and complications. Cathet Cardiovasc Diagn. 1993;29:199-202.
- Ohman EM, Marquis JF, Ricci DR, et al. A randomized comparison of the effects of gradual prolonged versus standard primary balloon inflation on early and late outcome. Results of a multicenter clinical trial. Perfusion Balloon Catheter Study Group. Circulation. 1994;89:1118-1125.
- Eltchaninoff H, Cribier A, Koning R, et al. Effects of prolonged sequential balloon inflations on results of coronary angioplasty. Am J Cardiol. 1996;77:1062-1066.
- Hering D, Haude M, Caspari G, et al. Effect of high insufflation pressures on elastic recoil forces and vascular resistance after balloon dilatation. Z Kardiol. 1996;85:273-280.
- Schmitz HJ, Erbel R, Meyer J, et al. Influence of vessel dilatation on restenosis after successful percutaneous transluminal coronary angioplasty. Am Heart J. 1996;131:884-891.
- Miketic S, Carlsson J, Tebbe U. Influence of gradually increased slow balloon inflation on restenosis after coronary angioplasty. Am Heart J. 1998;135:709-713.
- Zorger N, Manke C, Lenhart M, et al. Peripheral arterial balloon angioplasty: effect of short vs. long balloon inflation times on the morphologic results. J Vasc Interv Radiol. 2002;13:355-359.
- Söder HK, Manninen HI, Räsänen HT, et al. Failure of prolonged dilation to improve long-term patency of femoropopliteal artery angioplasty: results of a prospective trial. J Vasc Interv Radiol. 2002;13:361-369.
- Faglia E, Dalla Paola L, Clerici G, et al. Peripheral angioplasty as the first-choice revascularization procedure in diabetic patients with critical limb ischemia: prospective study of 993 consecutive patients hospitalized and followed between 1999 and 2003. Eur J Vasc Endovasc Surg. 2005;29:620-627.
- Graziani L, Silvestro A. Alternative approaches in critical limb ischemia. Clin Vis. 2006;17:2-7. http://www. bresciabelowknee.com/BBK%20Advanced%20Techniques%20since%202006.pdf. Accessed May 10, 2012.
- Graziani L. Loop technique recanalization for plantar arch reconstruction. In: Dieter RS, Dieter R III, Dieter R Jr, Nanjundappa A, eds. Endovascular interventions: A case-based approach to methods and procedures. New York, NY: Springer Inc.; 2012.
TOP 5 ARTICLES FROM 2012
- Renal Artery Denervation:
A Brave New Frontier
Emerging therapies for treating patients with severe, treatment-resistant hypertension.
Compiled by Krishna J. Rocha-Singh, MD, FACC, FAHA, FSCAI, FSVM
- Endovascular Management of Common and Internal Iliac Artery Aneurysms
How iliac branch grafting may become a first-line treatment option.
By Erin H. Murphy, MD, and Edward Y. Woo, MD
- Alternative Access for Tibial Intervention
Techniques for treating challenging lesions.
By Bret N. Wiechmann, MD
- Crossing the Challenging Aortic Bifurcation
A stepwise approach to getting “up and over” for the diagnosis and treatment of peripheral vascular disease and how to choose the right guidewire, catheter, sheath, and technique.
By Kevin “Chaim” Herman, MD
- Radial Access for Peripheral Vascular Procedures
Why and how this approach is used for arterial access in peripheral endovascular procedures.
By John T. Coppola, MD, and Cezar Staniloae, MD