CardioVascular Radiology

Transcription

1 Cardiovasc. Radiol. 2: 3-7, 1979 CardioVascular Radiology Percutaneous Transluminal Angioplasty (PTA) with the Griintzig Balloon Catheter: Technical Problems Encountered in the First Forty Patients B.T. Katzen 1 and J. Chang 2 1 Department of Radiology, The Alexandria Hospital, Alexandria, Virginia, USA, and 2 St. Vincent's Hospital and Medical Center of New York, New York, New York, USA Abstract. Forty patients have undergone percutaneous transluminal angioplasty (PTA) of the iliac or femoral-popliteal system with the Grtintzig balloon catheter. Technical problems have included experience with difficult antegrade puncture, production of intimal flaps, and loss of collateral vessels, as well as the need to develop an approach for recanalization of obstructions and for use of the balloon. Since problems in these areas may jeopardize the success of the procedure, they have been elucidated with some discussion of prevention. Preliminary results on the success of the procedure are included. Key words: Percutaneous transluminal angioplasty - Griintzig balloon catheter - Catheter, dilatation - Vascular disease, peripheral. Since the original description of percutaneous transluminal angioplasty (PTA) in 1964 [1], this procedure has gained relatively limited acceptance despite reports from large centers in both this country [2] and Europe [3-7]. Criticism has included the lack of adequate long-term follow-up and prospective control in the studies that have been performed. In addition, a competitive attitude may exist among surgical colleagues. Since development of a new dilatation catheter* with unique catheter construction (Fig. 1), a prospective study was initiated to evaluate the effectiveness of PTA in the treatment of peripheral vascular disease. Correlation is to be made with length of obstruction, presence of calcium, smoking, and status of run- Address reprint requests to: Barry T. Katzen, M.D., Department of Radiology, Alexandria Hospital, 4320 Seminary Road, Alexandria, VA 22314, USA * Available from Schneider Medintag, Witikonerstrage 253, CH-8053 Ziirich, Switzerland off vessels, in addition to other risk parameters. Limb salvage procedures will be tabulated as a separate study. Patients are being followed by pulse volume recording and Doppler pressure measurements in the clinical vascular laboratory and by arteriography at two and three years when possible. The purpose of this paper is to report technical problems encountered during the first forty procedures performed with the Griintzig balloon catheter. Problems and Techniques Antegrade Puncture Antegrade puncture of the common femoral artery may often be the greatest obstacle to a successful superficial femoral or popliteal angioplasty. To avoid this potential problem, fluoroscopy is used to provide precise localization of the needle tip. If extensive adipose tissue is present, this is secured out of the field. To obtain optimal puncture of the common femoral artery, the skin incision site must often be quite cephalad, becoming more exaggerated with increasing abdominal girth. Even with these precautions, the puncture site may still be at the origin of, or directly into, the profunda femoral artery. Large hematomas may result from attempts to manipulate the needle tip or "catheterize" the superficial femoral artery (SFA), jeopardizing the entire procedure. For this reason, if it is apparent that the catheter is placed in the profunda femoral artery, attempts are made to redirect the needle under fluoroscopy with contrast. However, if this is unsuccessful within a short period of time or if a hematoma begins to develop, the needle is withdrawn, compression is applied, and another puncture is made, more cephalad in position. Repeat attempts at repositioning are not recommended /79/ $ Springer-Verlag New York Inc.

2 4 B.T. Katzen and J. Chang: Percutaneous Transluminal Angioplasty mm GRONTZlG DILITATION CATHETER OUTER DIAMETER OF DILATING SEGMENTS WITH 12.0cm length) INCREASli~IG PRESSURE Temp. 36.8~ s 2nd USE 1st USE Fig. 1A and B. Percutaneous transluminal angioplasty catheters. A Femoral dilatation catheter balloon inflated (above), iliac dilatation catheter balloon inflated (middle), dilatation catheter in the uninflated state (below). B Physical characteristic of the iliac dilatation catheter. Note relatively constant outer diameter (between 6 and 8 ram) while ballon pressure is increased up to 4.5 atmospheres. These characteristics are lost after sterilization, and second use is, therefore, not recommended [6]. E -, 10 I- uj 5 < 8 I]: uj I- :) 6 0 B ILIAC CATHETER--BALLOON LENGTH OUTER DIAMETER ~ -~ ~ ~ s PRESSURE (ATM) 8 mm Following successful placement of the wire in the SFA, a 5 F straight or multipurpose catheter is placed to perform a control arteriogram and pressure measurements; A J wire has been most helpful and least traumatic, although if there is a tight stenosis in the proximal SFA, a straight wire may be necessary. personal experience has shown that continuing the manipulation, once an intimal flap has occurred, may result in occlusion. The presence of a flap, however, does not preclude a successful procedure, as these intimal irregularities have been shown to persist without significance in patients up to 2.5 years (i.e., to date) (Fig. 2). While the final result is often not as radiographically desirable as one would like, this does not represent a serious problem since intraarterial pressure gradients rather than morphologic determinations are generally used as the end point. Steps taken to avoid intimal tear include the use of a 5 F catheter from the contralateral side to obtain pressure gradients above an iliac stenosis. Earlier, this had been done via a single catheter, but use of two catheters reduces the amount of manipulation across the stenosis. Another technique in superficial femoral artery dilatation is to leave the J wire across the stenosis while the dilatation proceeds, thus reducing manipulation across the stenosis. By using a Y adapter, contrast may be injected through the catheter while the wire remains in place. lntimal Flaps Occasionally, especially in iliac stenoses, intimal flaps or "cracks" have developed during dilatation. Earlier Negotiating Obstructions- Recanalization Indications for recanalization of long complete obstructions have been limited to limb salvage and cases of rest pain.

3 B.T. Katzen and J. Chang: Percutaneous Transluminal Angioplasty 5 Fig. 2A and B. Intimal flap in a 50-year-old registered nurse with one-half-block claudication. A Subtraction arteriogram demonstrating high-grade iliac stenoses with a 50 mm pressure gradient. Irregularity in the distal aorta is also noted. B Arteriogram following PTA demonstrating lumen approximating contralateral side with intimal flap extending to a level just distal to previous stenosis. Loss of right L4 lumbar artery is also noted. Pulse volume recording and clinical evaluation reveal patency to date (23 months). In dealing with complete obstruction of the superficial femoral-popliteal artery, an intial attempt to pass through the occluded segment with a straight wire is made. The wire will generally pass through the proximal part of the occlusion; however, a straight wire of larger size (up to G) may be needed to traverse the distal portion of the obstruction. Use of the straight wire may be associated with small perforations of the vessel wall, and one may occasionally note a minimal extravasation and/or an occasional mild arteriovenous shunting. These have occurred infrequently, primarily with obstructions, and have been of no clinical significance. All have disappeared by the end of the procedure. A stiffening cannula is provided by the manufacturer; however, its use has not been necessary in our experience. Loss of Collateral Vessels In the process of balloon dilatation, plaque adjacent to the orifice of a collateral vessel may be compressed, producing occlusion. This is noted frequently with superficial femoral artery dilatations and occasionally with iliac dilatations (Fig. 3). Although this loss of collateral vessels has been clinically insignificant, there is potential for a net decrease in flow to the extremity if the PTA is unsuccessful. The collateral branches of the SFA generally are of less significance than the profunda branches. The geniculate branches are important to popliteal collateral flow and there is, therefore, some risk in distal dilatation procedures. Although loss of only one internal iliac artery has occurred in our series, one would expect potential problems with impotence if one internal iliac artery were occluded in a patient with poor flow from the contralateral side or in the case of bilateral occlusions, Balloon Techniques Inflation of the balloon has been done by hand, using a 3 ml syringe with 30% contrast solution. The balloon is generally inflated for seconds with maximal hand pressure. A mechanical device that is available for this function can provide higher and more consistent pressures. Once the balloon dilatation is started, the procedure is continued as expeditiously as possible. The dilatation is performed segmentally with fluoroscopic monitoring. When the procedure is completed, a large syringe is attached to the balloon inflation port. Maximum aspiration is applied while the balloon is removed from the femoral artery, to reduce further puncture site trauma. Due to physical

4 6 B.T. Katzen and J. Chang: Percutaneous Transluminal Angioplasty Fig. 3A-C. Occlusion of collateral vessels in a 53-year-old professional golfer with severe left claudication. A Crosstable oblique lateral pelvic arteriogram demonstrating high-grade stenoses of the common and external iliac arteries, including the orifice of the left hypogastric artery with a 64 mm pressure gradient. B Dilatation balloon inflated with 30% contrast solution. C Arteriogram eight months after PTA demonstrating no pressure gradient; however, occlusion of the left hypogastric artery and intimal irregularity are still present. Clinical maintenance of pressure in the common femoral artery has been documented in this patient 13 months to date. characteristics of the catheter (Fig. 1 B) resulting in greater distensibility of the balloon after sterilization, the catheters are not reused. Anticoagulation When possible, 10 grains of salicylates are administered twice a day for two days before PTA. All patients are given 2500 units of heparin intraarterially after the diagnostic arteriogram and 2500 units before removal of the catheter, with systemic heparinization continued for three days. The patients are discharged on 10 grains of salicylates twice a day. No anticoagulation complications have occurred. Complications In forty patients (41 procedures) three complications occurred, two necessitating surgical intervention (4.9%). One large groin hematoma (not requiring transfusions) developed during our first antegrade puncture attempt. This resulted in a one-week deferment in the procedure, which was eventually successful. In a second patient, immediately after left iliac PTA, the left femoral pulse was diminished. Subse-

5 B.T. Katzen and J. Chang: Percutaneous Transluminal Angioplasty 7 quently, ischemic symptoms developed in the left leg and the foot became cold one hour after the procedure. Surgical exploration of the left common femoral artery showed the lumen to be intact. However, an intramural clot was noted, indicating a dissection originating from a more proximal location in the iliac vessels. The dissection most likely originated from the stenotic site, as a result of guide wire manipulation. Following removal of the intramural clot, there was a good flow from above, and the patient did well. Although discharge was delayed for seven days because of the complication, PTA was successful, and patency has been documented at fifteen months to date. A third patient developed distal embolization of atheroma following successful angioplasty. The embolus was removed by popliteal exploration, and discharge took place seven days after the angioplasty. Discussion In the rapidly expanding area of interventional radiology, percutaneous transluminal angioplasty has proven to be of great value in selected patients. However, questions still exist regarding patient selection and long-term patency. This latter factor is somewhat more complicated to evaluate than the surgical equivalent, since there are many characteristics of a stenotic or obstructed segment that may directly influence success. In our study patients are advised before undergoing PTA that they are part of an ongoing research project. Because of the establishment of good initial patient rapport and the use of a noninvasive method of post-procedure follow-up, the overall followup has been satisfactory. Since these patients are part of a projected long-term study, results are only preliminary; however, our overall initial success rate has been 90%, with a one-year patency rate of 93% when initial failures are excluded. The longest documented patency to date is 2.5 years. The procedure has been performed on four patients with gangrene, longstanding obstructions, and poor runoff vessels. Amputation was avoided in all patients. In one patient who was scheduled for an above-knee amputation, the surgical procedure was changed to a minimal autoamputation of the great toe, with local treatment. Of the technical problems mentioned above, the two most potentially hazardous are the antegrade puncture in SFA angioplasty and creation of flaps at any site. We would emphasize that when problems arise during antegrade puncture the best choice is to terminate the attempted puncture, compress, and start again. It is possible to do some manipulation if the superficial femoral artery is visualized during contrast injection, but continued manipulation is not recommended. Intimal flaps have been created during the dilatation, possibly due to "cracking" of a hard atherosclerotic segment. Once this occurs, continued manipulation is not recommended. If the flap has occurred due to cracking, the therapeutic result (a diminished pressure gradient) is generally achieved. If the flap is a result of subintimal dissection of the guide wire, the wire will continue to pass preferentially into the subintimal space. Use of a J wire to traverse stenoses has been helpful in avoiding subintimal dissection. The stenosis should be traversed slowly while attempting to "feel" with the end of the J wire. The technical problems discussed above are presented to assist others in the performance of percutaneous transluminal angioplasty, a procedure which we believe to be of considerable value in the treatment of specific forms of peripheral vascular disease. Recognition of these problems has resulted in continually increasing initial success rates, which will be reflected in further reports. References 1. Dotter, C.T., Judkins, M.P. : Transluminal treatment of arteriosclerotic obstruction. Circulation 30: , Dotter, C.T., R6sch, J., Judkins, M.P.: Transluminal dilatation of atherosclerotic stenosis. Surg. Gynecol. Obstet. 127: , [ Andel, G.J.: Percutaneous transluminal angioplasty. Amsterdam-Oxford, Excerpta Medica, Wierny, L., Plass, R., Porstmann, W. : Long-term results in 100 consecutive patients treated by transluminal angioplasty. Radiology 112: , Zeitler, E., Schoop, W., Zahnow, W. : The Treatment of Occlusive Arterial Disease by Transluminal Catheter Angioplasty. Radiology 99 : 19-26, Grtintzig, A., Bollinger, A., Brunner, U., Schlumpf, M., Wellaure, J.: Perkutane Rakanalisation chronischer arterieller Verschl/isse nach Dotter. Eine nicht-operative Kathetertechnik. Schweiz. Med. Wochenschr. 103 : 825, Zeitler, E., Griintzig, A., Schoop, W. : Percutaneous vascular recanalization. Technique, application, clinical results. Berlin- Heidelberg-New York, Springer, 1978