The Beginning of Balloon Conception and Application in
Peripheral Arterial Disease

When German-born Andreas Roland Grüntzig arrived in 1969 in Zurich, Switzerland, and joined the Angiology Division of the University Hospital, founded some years before, he stated: “I have dedicated my life to the vascular diseases”.¹ First, he proved his dedication by showing that the relaxation time of the Achilles tendon reflex is significantly prolonged in intermittent claudication during calf muscle pain (Figure 1).² He also contributed to the evaluation of the recently-introduced continuous wave Doppler ultrasound for the measurement of systolic ankle pressure and for the diagnosis of deep venous thrombosis.³
Soon, he realized that the spectrum of therapeutic possibilities in patients with peripheral arterial occlusive disease was still poor, with the exceptions of walking exercise, endarterectomy and bypass surgery, which were then just gaining importance. The frequent necessity for leg amputation in incipient gangrene was a major concern for him. Inspired by Charles Dotter’s article in Circulation,⁴ he became interested in the percutaneous technique of reopening occluded arteries by coaxial catheters. He visited the Aggertalclinic in Engelskirchen near Köln, a center specialized in rehabilitation and therapy for vascular patients. There he learned the Dotter procedure from Eberhard Zeitler,⁵ who was the first practitioner worldwide to treat large patient groups. Back in Zurich, Andreas performed the Dotter procedure on 50 patients in the angiology division.⁶ In the United States, Charles Dotter was forced to abandon the procedure because of the opposition of prominent vascular surgeons.
One day, Andreas came up with the idea of an inflatable balloon that would assume a stable sausage shape. Fogarty's pioneer catheter for embolectomy⁷ was too weak for dilatations at high balloon pressures; Porstmann’s caged balloon⁸ had an inadequate oval form and ridges potentially harmful for the arterial wall. By achieving more adequate dilatation diameters than possible with Dotter's superposed catheters, Andreas wanted to improve peripheral angioplasty (PTA) and reduce the incidence of complications. The most significant problems encountered were insufficient dilatation of the stenosis, peripheral embolization and postinterventional bleeding. Therefore, the inflated balloon needed to equal the lumen width of the vessel to be treated, and the introduction catheter had to be as small as possible to minimize the size of the puncture holes. After many experiments, including animal studies with a drilling device, Andreas found a suitable material for the manufacture of balloon catheters: polyvinyl chloride, recommended to him by Professor Hopff, a teacher at Zurich Technical High School.⁹ Together with his wife Michaela, Maria and Walter Schlumpf, Andreas built prototypes on the kitchen table of his apartment. The balloons were fixed on conventional angiographic catheters, immersed in boiling water, had to resist pressures of 5 atmospheres and, once inflated, had to look like sausages.

On February 12,1974, Andreas used his first handmade catheter in a patient with femoral artery stenosis causing severe intermittent claudication. The patient was recruited by the angiology division and had given his informed consent. Moreover, the application of the new catheter treatment had been approved at a staff meeting with the participation of vascular surgeons.^1,9,10 The therapy was successful and soon applied to other patients including some who suffered from rest pain, ischemic ulcers or incipient gangrene.^11,12 In the early patients with iliac artery obstruction, the result of therapy was not only documented by arteriography, but also by determination of pressure gradients across the stenosis and by measurements of calf blood flow (venous occlusion plethysmography) at rest and after circulatory arrest (Figure 2).¹¹ A double-lumen catheter was designed, built and introduced on January 23, 1975. It rendered catheter therapy much easier. During the first two years, each balloon catheter was made by hand on the kitchen table. Using a centimeter, Andreas measured length and width of the obstruction on the arteriographic images of each patient. According to the values obtained, the individual catheter was manufactured. A good deal of time elapsed before he was able to convince the Cook and Schneider companies to produce the instruments by industrial means.

The prospective follow up of all 242 patients with iliac or femoro-popliteal artery obstructions treated by Andreas Grüntzig himself was performed by Maria Schlumpf (clinical history and findings, pulse wave recordings at thigh, lower leg and big toe, arm and ankle systolic pressures) (Figure 3). No deaths occurred during hospitalization for PTA.^11,12 Despite the relatively small catheter diameters, aneurysmal spurium formation remained a problem. Urs Brunner took care of these and other rarer complications requiring vascular surgery. At that time, PTA was already a primary success in more than 90% of patients. Recurrent occlusions, however, were frequently observed in femoro-popliteal cases, and much less so in iliac artery disease. Aspirin was given for secondary prevention. The patency rates at 15 years (Figure 4)¹ were 82% in patients with iliac (52% still alive) and 46% in those with femoral lesions (20% still alive). At the time of PTA, the mean age of the iliac group was 56 years, and 67 years in the femoral group, which probably explains the better survival duration of patients with proximal disease.
PTA was performed in Zurich by a team including angiologists, radiologists and surgeons, supervised by vascular pathologist Hans Jörg Leu. In angiology, Felix Mahler, who later performed the first renal angioplasty,¹³ succeeded Andreas Grüntzig. At that time, the latter changed to the cardiology division, headed by Wilhelm Rutishauser, and began to modify the balloon catheters for use in coronary artery disease. Later, Ernst Schneider followed Felix Mahler,¹⁴ whereas Gregorios Pouliadis participated on the PTA team as chief resident of radiology. All had been trained by Andreas.
Without the proof that Grüntzig’s balloon catheter was a valuable tool for the treatment of patients with peripheral artery disease, the move to the heart and to the carotid arteries would not have been possible.

References

1. Bollinger A, Schlumpf M. Andreas Grüntzig’s balloon catheter for angioplasty of peripheral arteries (PTA) is 25 years old. Vasa 1999;28:58–64.
2. Grüntzig A, Schlumpf M, Bollinger A. The reliability of true half-relaxation time (TRT) and maximal contraction force (Tmax) of the calf muscles in intermittent claudication. Angiology 1972;23:377–391.
3. Grüntzig A, Bollinger A, Zehender O. Möglichkeiten und grenzen der qualitativen venendiagnostik mit Doppler-ultraschall (ergebnisse einer blindstudie). Klin Wschr 1971;49:245–251.
4. 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.
5. Zeitler E, Schoop W, Zahnow W. The treatment of occlusive arterial disease by transluminal catheter angioplasty. Radiology 1971;99:19–26.
6. Grüntzig A, Bollinger A, Brunner U, et al. Perkutane rekanalisation chronischer arterieller verschlüsse nach Dotter-eine nicht-operative kathetertechnik. Schweiz Med Wschr 1973;103:825–831.
7. Fogarty T, Cranley JJ, Krause RJ, et al. A method for extraction of arterial emboli and thrombi. Surg Gynecol Obst 1963;116:241–244.
8. Porstmann W. Ein neuer korsett-ballon-katheter zur transluminalen rekanalisation nach Dotter unter besonderer berücksichtigung von obliterationen an den beckenarterien. Radiol Diagn 1973;14:239–244.
9. Grüntzig A, Hopff H. Perkutane rekanalisation chronischer arterieller verschlüsse mit einem neuen dilatationskatheter. Dtsch med Wschr 1974;99:2502–2505.
10. Grüntzig A. Die Perkutane Transluminale Rekanalisation Chronischer Arterienverschlüsse mit einer Neuen Dilatationstechnik. Baden-Baden, Köln, New York: Witzstrock, 1977.
11. Zeitler E, Grüntzig A, Schoop W (eds). Percutaneous Vascular Recanalization. Berlin: Springer, 1978.
12. Grüntzig AR, Kumpe DA. Techniques of percutaneous transluminal angioplasty with the Grüntzig balloon catheter. Amer J Radiol 1979;132:547–552.
13. Mahler F, Krneta A, Haertel M. Treatment of renovascular hypertension by transluminal renal artery dilatation. Ann Int Med 1979;90:56–57.
14. Schneider E, Grüntzig A, Bollinger A. Langzeitergebnisse nach perkutaner transluminaler Angioplastie bei 882 konsekutiven Patienten mit iliakalen und femoro-poplitealen obstruktionen. Vasa 1982;11:322–326.