Clinical Utility of 3 French Infrapopliteal Intervention in the Setting of Critical Limb Ischemia

ABSTRACT: Objectives. To evaluate the clinical utility of 3 Fr infrapopliteal intervention in critical limb ischemia (CLI) patients with isolated infrapopliteal artery disease (IPD). Background. There is considerable scope for the miniaturization of infrapopliteal intervention in the clinical field. Methods. In this study, 3 Fr infrapopliteal intervention was performed in a total of 11 consecutive patients and limbs, selected by operator judgment on the basis of the clinical and angiographical conditions of the patients. The 3 Fr sheath was removed immediately after the completion of the procedure in the cath lab. After manual compression for 5 minutes (min), a compressive dressing was applied for 30 min. Results. Among the subjects, a poor general condition was observed in 3 patients, while end-stage renal disease was observed in 9. Technical success was achieved in all cases except for 1 case in which the limb of the patient required 4 Fr sheath for coronary stenting for the flow-limiting tibial dissection. In all the patients undergoing 3 Fr intervention, complete hemostasis was achieved simply without any complication. Skin perfusion pressure of the foot significantly increased at both the dorsum and plantar. Further, clinical success was achieved in all patients. Conclusions. This study showed that 3 Fr infrapopliteal intervention is safe and feasible for selected CLI patients with isolated IPD. In particular, the benefits offered by this miniaturized intervention from the aspect of the comfort of patients can be potentially of considerable value in the setting of CLI; however, this intervention requires further validation. J INVASIVE CARDIOL 2009;21:383–385 In the field of coronary intervention, the downsizing of catheter equipments can contribute to a decrease in the vascular complications and a decrease in the discomfort experienced by patients.1–3 A variety of vascular interventions has benefited from the miniaturization of endovascular equipment despite the availability of small amounts of data. Recently, considerable attention has been paid to infrapopliteal intervention for limb salvage in patients with critical limb ischemia (CLI). However, this latest frontier remains underdeveloped. In particular, the severity of discomfort that would be experienced during puncture site hemostasis is one of major concerns of CLI patients with a variety of serious comorbidities. The present study describes the clinical utility of 3 French (Fr) intervention for CLI patients with isolated infrapopliteal artery disease (IPD). Methods Population. This study included patients who were undergoing 3 Fr intervention in our hospital between October 2008 and December 2008. A 3 Fr intervention was performed for CLI patients with isolated IPD on the judgment of a single operator (OK) pertaining to the clinical comorbidity of the patient and the condition of an approaching lesion. The angiographical indication for revascularization was significant IPD (50% and greater stenosis) without straight-line flow to the foot. Complex lesions including chronic total occlusion or severe calcification were excluded from the study. Further, extensive diffuse disease affecting the entire tibial artery was also excluded. Technical and clinical successes were assessed. Moreover, the time taken for the procedure, the time taken for fluoroscopy, the quantity of contrast dye used and any complications encountered were recorded. Interventional procedure. Written informed consent was obtained from all the patients. Following the administration of superficial local anesthesia, the ipsilateral common femoral artery or proximal superficial femoral artery was punctured, and a 3 Fr sheath (Super Sheath Medikit Co., Ltd., Tokyo, Japan) was inserted. Diagnostic angiography was performed using a 3 Fr multipurpose catheter (Fukuda Denshi Co., Ltd., Tokyo, Japan) placed at the femoro-popliteal segment. Stenotic lesions were crossed with 0.014 inch guidewires (Regalia XS 1.0, Asahi Intecc Co., Ltd., Nagoya, Japan; Ruby Soft, Kaneka Medix Corp., Osaka, Japan; and Runthrough Peripheral, Terumo Corp., Tokyo, Japan) with the assistance of the 3 Fr multipurpose catheter. An Ikazuchi PAD monorail balloon (Kaneka Medix Corp., Osaka, Japan) for peripheral use in Japan, with a diameter up to 4 mm and a length up to 40 mm, developed by the coronary balloon technology, was employed. The balloon size was selected as follows: 4 mm for the popliteal artery, 2.5–3.0 mm for the tibial or peroneal artery, 1.5–2.5 mm for the dorsalis pedis or plantar artery, and 3.0 mm for distal bypass. The sheath was removed immediately after the completion of the procedure in the catheterization laboratory. After manual compression for 5 minutes (min), a compressive dressing was applied for 30 min, and vascular access site complications including hematoma, bleeding or false aneurysm were judged on the basis of an examination performed following the removal of the compressive dressing. Technical success was defined as the attainment of revascularization with Results A total of 27 consecutive patients underwent 43 catheter interventions for IPD presenting CLI at our institute during the time of our study. Among them, 11 patients (8 males, 3 females) and limbs underwent 3 Fr intervention for infrapopliteal artery. Target limbs included 4 with de novo stenosis, 6 with restenosis and, 1 with distal bypass stenosis. Table 1 presents the clinical and angiographical characteristics of these patients and limbs. The average age of the subjects was 64 ± 11 (46–77) years. With respect to the clinical conditions, poor general conditions including bleeding tendency due to pancytopenia was observed in 3 patients and long standing end-stage renal disease upon undergoing chronic hemodialysis in 9. The number of target vessels that underwent breakdown was as follows: 1 in the popliteal artery, 7 in the anterior tibial artery, 2 in the dorsalis pedis artery, 2 in the posterior tibial artery, 1 in the plantar artery, 1 in the tibioperoneal trunk, 3 in the peroneal artery, and 1 in the distal bypass (Figures 1–3). Technical success was achieved in all cases except in the case of 1 patient whose limb required 4 Fr sheath for coronary stenting for the flow-limiting tibial dissection. No vessel rupture, perforation, or distal embolization was observed during the procedure. Moreover, no acute or subacute thrombosis of treated vessels was observed. The procedure time was 41 ± 13 (23–70) min, the fluoroscopy time was 13 ± 4 (8–23) min, and the total volume of contrast dye used was 87 ± 19 (52–115) ml. In all the patients undergoing 3 Fr intervention, complete hemostasis was achieved simply without any complication. Out of these patients, 4 underwent outpatient interventions. Skin perfusion pressure of the foot significantly increased from 34 ± 10 to 69 ± 20 mmHg (p = 0.001) at the dorsum and from 33 ± 14 to 62 ± 15 mmHg (p = 0.008) at the plantar, respectively; this suggests the high likelihood of wound healing,4 though the ankle-brachial index did not show a significant increase (prior to the procedure, 0.81 ± 0.20; following the procedure, 0.93 ± 0.15; p = 0.185). Further, clinical success was achieved in all cases except for the fact that assistance of scheduled intensive debridement, minor amputation, or appropriate intravenous antibiotic treatment was required in the case of 5 limbs. Discussion The infrapopliteal artery is the smallest and the straightest vessel that can be treated in the body; further, it can be simply approached via the ipsilateral femoral artery. Moreover, fortunately, balloon angioplasty is the mainstay of infrapopliteal intervention for the treatment of CLI even under the current situation, as previous studies reported an acceptable outcome involving acute procedural success rates of 78–98% and limb salvage rates of 77–91%.5–11 Judging from our experience, both restenosis and distal bypass stenosis can be treated with relative ease by means of balloon angioplasty. Taking these findings into consideration, 3 Fr infrapopliteal intervention can be applied in the field of infrapopliteal artery. Therefore, the present study focuses on 3 Fr intervention for the treatment of isolated IPD under the setting of CLI. Catheter-based treatment of lower limb arterial disease has progressed with the downsizing of endovascular equipment over the past 4 decades. Dotter and Judkins first reported a case of successful limb salvage by infrapopliteal angioplasty using 8 and 12 Fr coaxial Teflon catheters in 1964.12 Thereafter, Gruntzig and Hopff contrived 6 and 7 Fr balloon catheters.13 The advancement of endovascular technology has enabled the realization of the performance of current balloon procedures in lower limb intervention with 4 Fr balloon catheters. The most striking finding of this study is that 3 Fr intervention can achieve infrapopliteal revascularization leading to limb salvage with little discomfort following the procedure. Taking into consideration the fact that the area of the puncture site clearly decreases by using the 3 Fr sheath (3.14 mm2) in comparison with the 4 Fr (5.56 mm2), 5 Fr (8.76 mm2), and 6 Fr (12.56 mm2), there appears to be a definitive advantage of 3 Fr intervention over larger-sized interventions from the viewpoint of simple hemostasis and prevention of access site complication following the removal of the sheath. The use of 4 Fr and the oversized sheath compels CLI patients to take bed rest for a minimum of several hours. On the contrary, the present study showed that half an hour was a time-period that was sufficient to achieve complete hemostasis without any complications. This suggests that this mini-invasive procedure can contribute to minimal discomfort following 3 Fr intervention in CLI patients. The puncture site stenosis, probably due to the thickening of the tunica intima resulting from repeated sheath insertion injuries, can be associated with the potential risk of limb ischemia in the territory of the lower limb artery. However, the employment of the 3 Fr sheath is less likely to cause thickening of the tunica intima even though the sheath is inserted repeatedly. Furthermore, in the present study, 3 Fr intervention showed significant improvement in foot circulation with acceptable procedure time, fluoroscopy time, and contrast volume. We emphasize that the benefits offered by the negligible amount of discomfort associated with the use of the 3 Fr sheath is a great boon to CLI patients with serious comorbidities. The present study has certain limitations that need to be taken into consideration. Firstly, the performance of 3 Fr infrapopliteal intervention requires the ipsilateral antegrade femoral approach that is associated with a learning curve. Secondly, complex lesions involving total occlusions, long lesions, and severe calcification are common in infrapopliteal atherosclerosis; therefore, the use of 3 Fr catheters will be limited in treating these lesions, at least in its current state. Finally, the 3 Fr sheath does not allow the stent implantation even in cases of a flow-limiting dissection and severe residual stenosis following balloon angioplasty, and the employment of aspiration catheter for distal embolization. With the considerable advancement of endovascular technology, this mini-invasive intervention might overcome these limitations to gain a wider acceptance. In conclusion, to the best of our knowledge, the present study is the first to describe the safety and efficacy of 3 Fr infrapopliteal intervention. From the clinical perspective, this miniaturized intervention can enhance the comfort of patients in the setting of CLI, though further validation is required. From the Department of Cardiology, Kishiwada Tokushukai Hospital, Osaka, Japan. The author reports no conflicts of interest regarding the content herein. Manuscript submitted February 9, 2009, provisional acceptance given March 26, 2009, final version accepted April 13, 2009. Address for correspondence: Osami Kawarada, MD, FSCAI, Division of Cardiovascular Medicine, Stanford University Medical Center, 300 Pasteur Drive, Room H3554, Stanford, CA 94305-5637. E-mail: kawarada@stanford.edu

1. Metz D, Meyer P, Touati C, et al. Comparison of 6F with 7F and 8F guiding catheters for elective coronary angioplasty: Results of a prospective, multicenter, randomized trial. Am Heart J 1997; 134:131–137.

2. Dahm JB, Vogelgesang D, et al. A randomized trial of 5 vs. 6 French transradial percutaneous coronary interventions. Catheter Cardiovasc Interv 2002;57: 172–176.

3. Gwon HC, Doh JH, Choi JH, et al. A 5Fr catheter approach reduces patient discomfort during transradial coronary intervention compared with a 6Fr approach: A prospective randomized study. J Interv Cardiol 2006;19:141–147.

4. Castronuovo JJ Jr, Adera HM, Smiell JM, et al. Skin perfusion pressure measurement is valuable in the diagnosis of critical limb ischemia. J Vasc Surg 1997; 26:629–637.

5. Varty K, Bolia A, Naylor AR, et al. Infrapopliteal percutaneous transluminal angioplasty: A safe and successful procedure. Eur J Vasc Endovasc Surg 1995;9: 341–345.

6. Bakal CW, Cynaman J, Sprayregen S. Infrapopliteal percutaneous transluminal angioplasty: What we know. Radiology 1996;200:36–43.

7. Nydahl S, Hartshorne T, Bell PR, et al. Subintimal angioplasty of infrapopliteal occlusions in critically ischaemic limbs. Eur J Vasc Endovasc Surg 1997;14:212–216.

8. Söder HK, Manninen HI, Jaakkola P, et al. Prospective trial of infrapopliteal artery balloon angioplasty for critical limb ischemia: Angiographic and clinical results. J Vasc Interv Radiol 2000;11:1021–1031.

9. Boyer L, Therre T, Garcier JM, et al. Infrapopliteal percutaneous transluminal angioplasty for limb salvage. Acta Radiol 2000;41:73–77.

10. Vraux H, Bertoncello N. Subintimal angioplasty of tibial vessel occlusions in critical limb ischaemia: A good opportunity? Eur J Vasc Endovasc Surg 2006;32: 663–667.

11. Dorros G, Jaff MR, Dorros AM, et al. Tibioperoneal (outflow lesions) angioplasty can be used as primary treatment in 235 patients with critical limb ischemia: Five-year follow-up. Circulation 2001;104:2057–2062.

12. Dotter CT, Judkins MP. Transluminal treatment of arteriosclerotic obstruction: Description of a new technique and a preliminary report of its application. Circulation 1964;30:654–670.

13. Grüntzig A, Hopff H. Percutaneous recanalization after chronic arterial occlusion with a new dilator-catheter (modification of Dotter technique). Dtsch Med Wochenschr 1974;99:2502–2510.