Balloon Angioplasty for Aortic Recoarctation: Results of Valvuloplasty and Angioplasty of Congenital Anomalies Registry William E. Hellenbrand, MD, Hugh D. Allen, MD, Richard J. Golinko, MD, Donald J. Hagler, MD, William Lutin, MD, PhD, and Jean Kan, MD

8alloon an-sty was performed in 200 patients with recoarctation of the aorta in a muttkenter prospective study. The average age at the time of the procedure was 7.0 years (range 1 month to 26 years). Systotk pressure (mean f standard deviation) in the ascending aorta decreased from 134.5 f 23.4 to 127.4 f 22.0 mm Hg. The descending aortic systdic pressure rose from 92.7 f 18.2 to 114.1 f 21.6 mm Hg. Peak systotic pressure differencesdecreasedfrom 41.9 f 19.6 to 13.3 f 12.1 mm Hg. The diameter of the recurrent coarctation site increased from 52 f 2.9 to 8.9 f 3.4 mm. After angioptasty residual pressure differences of I20 mm Hg were found in 79.4% of the patients. Five patknts dii of comptications related to the procedure (2.5%). Two deaths were directty retatedtothetechniealaspectsoftheprecedureand3 patients dted because of tke severity of the undertying disease. One addt6onal patient had a cerebrovascular accident. Femoral artery complications occurred in 17 patients (8.5%) and 8 patients required surgical thrombectomy. Baltoon angioptasty offers a satisfactory atternative to surgery for recurrent coarctatkm; both results and compfiitions compare favorabty with surgical therapy. (AmJCardiol1999#6:793-797)

From the Valvuloplasty and Angioplasty of Congenital Anomalies Registry; Division of Pediatric Cardiology, Yale University School of Medicine, New Haven, Connecticut; University of Arizona, Tucson, Arizona; Mt. Sinai Medical Center, New York, New York; Mayo Clinic, Rochester, Minnesota; and Johns Hopkins Hospital, Baltimore, Maryland. Manuscript received November 22, 1989, and accepted November 28. Address for reprints: William E. Hellenbrand, MD, Division of Pediatric Cardiology, Yale University School of Medicine, 333 Cedar Street, New Haven, Connecticut 06510.

surgical repair of coarctation of the aorta improved the prognosis for patients with malformation, the long-term results after coarctation repair may not be completely satisfactory. A significant percentage of patients will encounter persistent or recurrent aortic obstruction at or near the previous surgical site and many will require reoperation.1-9 Published reports suggest that such reoperations may carry significant risk, mortality rates in various series range from 0 to 33%.‘J”-I3 With the advent of balloon angioplasty techniques, a nonsurgical method to relieve residual aortic obstruction became available. Previous studies evaluating the effectiveness of balloon angioplasty for recoarctation have been limited by small patient numbers.14-l7 In this multicenter prospective study of balloon angioplasty for recurrent or residual coarctation of the aorta, we address the questions of efficacy and safety of this transcatheter technique for the relief of aortic obstruction in 200 patients. METHODS Stssdy patientr: A prospective study of 200 consecutive patients with recurrent or residual aortic coarctation followed in 26 institutions enrolled in the Valvuloplasty and Angioplasty of Congenital Anomalies (VACA) Registry was performed. Hospital records, operative reports, catheterization data and angiograms were reviewed. Individual institutions recorded historical data including type of previous surgery as reported in the hospital record and catheterization data including aortic pressure proximal and distal to the residual coarctation, both before and after balloon angioplasty. Angiographic data included measurements of the aorta immediately proximal to, distal to and at the coarctation site both before and after angioplasty. Institutions reported catheter size, balloon diameter and length and balloon inflation pressure in psi or atmospheres. The incidence of balloon rupture and whether this was circumferential or longitudinal and other complications were reported for each patient. Each institution applied its own indications and catheter selection criteria for angioplasty. Statistical auatysis: Statistical significance was assessedwith the t test for paired observations and analysis of variance. All variables evaluated by t test were first shown to be normally distributed by the Kolmogorov Smirnoff test. Values are expressed as mean and standard deviation. Variables were correlated against outcome using the Spearman rank correlation or PearTHE AMERICAN

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son’s correlation coefficient. Evaluation of ages in the 3 outcome groups was performed with the Kruskal-Wallis nonparametric multiple comparisons test because of high asymmetry observed in the distribution of ages. RESULTS Clinical profile: Age at the time of initial operation varied from 1 day to 15 years (mean 1.9 years) (Table I). Ninety-three of the 200 patients were under 1 year of age (73 under 2 months of age). At the time of angioplasty the patients’ ages varied from 1 month to 26 years (mean 7.0 years). Forty-six underwent angioplasty under 1 year of age, 43 between 1 and 5 years, 109 between 5 and 26 years of age and the age was unknown in 2 patients. The interval between initial surgery and angioplasty varied from 45 days to 20 years (mean 5.4 years). Eighty-four patients had undergone an end-to-end aortic anastomosis as their initial surgical technique. Forty-eight patients had had an initial subclavian artery

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flap angioplasty, 40 patients had undergone synthetic patch angioplasty, 12 patients had previously undergone stage I Norwood procedures and 4 had had tubular conduit interpositions. The initial form of surgery was unknown in the 12 remaining patients. Response to therapy: Pressure data before and after angioplasty were available for 190 patients (Table II). Peak systolic blood pressure in the ascending aorta was 134.5 f 23.4 mm Hg and decreased to 127.4 f 22.0 mm Hg (p