Porcine Xenograft ValvesLong-term (60-89-month) Follow-up
JEFFREY B. LAKIER, M.D., FAREED KHAJA, M.D., DONALD J. MAGILLIGAN, JR., M.D.,
AND SIDNEY GOLDSTEIN, M.D.
SUMMARY An analysis of 211 patients who had porcine xenograft valve replacements at Henry FordHospital between October 1971 and March 1974, was accomplished, with 100% follow-up. The follow-upperiod extended from 60-89 months after implantation. One hundred sixty-seven patients with 192 valves sur-vived the perioperative period and were subjected to life table analysis. Hemodynamically significant porcinexenograft degeneration that required reoperation occurred in 18 patients, two of whom had infective endocar-ditis. Only four valves failed within 48 months of surgery. Ten of 42 (23.8%) patients with isolated aortic valvereplacement and eight of 102 patients (7.8%) patients with isolated mitral valve replacement required reopera-tion (p < 0.01). In patients under 25 years of age, six of nine surviving patients had repeat operations. Ourdata indicate that porcine xenograft degeneration is related to the duration of implantation and the age of thepatient at the time implantation was performed. In addition, porcine xenograft valves in the aortic position aremore likely to degenerate than are those in the mitral position.
THE GLUTERALDEHYDE-prepared porcine xeno-graft is one of the most encouraging valve substitutesavailable. The initial highly satisfactory resultsreported with this prosthesis have resulted in its usefor replacement of diseased aortic, mitral andtricuspid valves.' Although the porcine xenograftvalve has good hemodynamic features and a lowthromboembolic rate," 3' 4it has the same potentialfor late degeneration as other bioprosthetic valves.6Recent reports have suggested a low incidence ofdegeneration in adult patients7 and a higher rate inchildren.8 We recently described the echocardio-graphic characteristics of degenerated porcine xeno-grafts.9 Because of these observations we analyzed thefirst 211 patients in whom a gluteraldehyde porcinexenograft was implanted at this institution. Thisenabled us to obtain a minimum 5-year follow-up inorder to assess the long-term durability of the valve.
Two hundred eleven patients received 252 porcinevalve xenografts between October 1971 and March1974. All deaths during the initial hospitalization andup to I month postoperatively were considered peri-operative deaths, and accounted for 44 patients. Therewere 167 surviving patients with 192 valves 1 monthafter surgery. Information on all these was obtainedregarding cardiac status, hospital admissions aftervalve replacement, evidence of thromboembolicepisodes and current medication. A further 42 patientsdied during the follow-up period, leaving 125 patientsalive at the end of the study (March 1979). Of these,112 patients were evaluated at Henry Ford Hospital
From the Divisions of Cardiovascular Medicine and Cardiac andThoracic Surgery, Henry Ford Hospital, Detroit, Michigan.
Address for correspondence: Jeffrey B. Lakier, M.D., HenryFord Hospital, 2799 West Grand Boulevard, Detroit, Michigan48202.
Received July 19, 1979; revision accepted January 8, 1980.Circulation 62, No. 2, 1980.
during a closing period (January through March1979). The remaining 13 patients were unable toreturn for follow-up examination, but 12 were con-tacted by telephone and one by letter. If any symp-toms were reported the patient's physician was con-tacted.
Xenograft valve failure was diagnosed if there wasdisruption or distortion of the valve mechanism result-ing in a hemodynamic lesion necessitating xenograftreplacement. All patients included under this defini-tion of xenograft dysfunction thus had the valvesreplaced.
In this paper we assess the long-term durability ofthe porcine xenograft. Hence, the I-month mortalityor perioperative mortality is not included in long-termsurvival statistics. Several reports3' and our currentexperience indicate that there is no difference inperioperative mortality when using xenografts com-pared with other valve prostheses. Patients who de-veloped infective endocarditis and died during thecourse of therapy and in whom the cause of death wasnot due primarily to valve failure are not included inthe definition of valve dysfunction. Also, patients whodied without a necropsy being performed are not in-cluded as valve failures. Both of these groups are in-cluded in the overall mortality. Systemic thromboem-bolism was diagnosed if a persistent neurologic deficitoccurred postoperatively or if absent or diminishedperipheral pulses were noted. Bland systemic embolito other viscera were not noted in this series.
Patients with large left atria and those with atrialfibrillation were anticoagulated and were maintainedindefinitely on warfarin unless bleeding complicationsoccurred.
Statistical analysis comparing the rate of reopera-tion in the mitral and aortic groups was done using thechi-square method for cumulative actuarial analysis,based on a generalized Kruskal-Wallis test.'0 Statis-tical analysis comparing valve degeneration betweenthe younger patients (younger than 25 years) and olderpatients (older than 25 years) was done using standardchi-square testing.
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VOL 62, No 2, AUGUST 1980
There were 192 porcine xenograft valve insertions inthe 167 patients who survived longer than 1 month.One hundred two patients had mitral valvereplacements, 42 aortic, 13 mitral and aortic, eightmitral and tricuspid and two mitral, aortic andtricuspid. Thus, 125 mitral, 57 aortic and 10 tricuspidporcine xenograft valves were followed long-term. Theage range of the patients was 8-77 years (mean age 50years). Nine patients were under 25 years. One hun-dred seventeen patients were female. At the end of thefollow-up period, 84 patients with mitral, 27 with aor-tic, eight with aortic and mitral, one with mitral, aor-tic and tricuspid and five with mitral and tricuspidporcine xenografts (total 125 patients) were alive.
Actuarial survival curves for the group as a wholeand for subsets of valve replacements are shown infigures 1-3. Figure 1 shows overall mortality for the167 patients alive 1 month after surgery. A progressiveand almost linear mortality is seen, with an 89-monthcumulative survival of 72%. The timing of patients
requiring reoperation as a result of valve failure isshown in figure 2. The cumulative valve failure rate at48 months was only 4%; however, in the next 30months this figure almost tripled, with an additional11% valve failures.During the period of follow-up, 18 of the 167 had
reoperation for replacement of the porcine xenograftvalve (fig. 2, table 1). In 15, this was necessary becauseof spontaneous dysfunction of the xenograft. Therewas no evidence of infective endocarditis either beforesurgery or on histologic examination of the removedvalve. Two patients had had preoperative evidence ofinfective endocarditis (one aortic and one mitral) andone patient had a thickened aortic porcine valvereplaced at a second operation to repair paravalvarleaks. The aortic valve was replaced in 10 of the 18patients and the mitral valve in the remaining eight.Ten of the 42 patients (23.8%) with isolated aortic andeight of the 102 patients (7.8%) with isolated mitralporcine xenografts required reoperation. Using thelife-table curves at 89 months (fig. 3), the differencebetween the cumulative reoperation rates for mitral
FIGURE 1. Actuarial survival curve for allpatients starting at 1 month after valvereplacement. A 72% survival appears at 89months.
Time in Months
--rl E4n3~ 33
FIGURE 2. Time of reoperation for valvefailure starting 1 month after first valvereplacement. The cumulative valve failurerate was 4% at 48 months and 15% at 89months. Note that the valve failure ratealmost tripled from 48 to 89 months.
0 . 0. 2 4 60.
O 0 12.0 24.0 36.0 48.0 60.0
Time in Months
0.000..0 12.0 24.0 36.0 48.0 60.0 72.0 84.0 90.0
.2 0.30COm L 0.40
a) O 0.50.> CLX z 060D3 O~ 0.70
1.UV 1 .72.0 84.0 90.0
E3 E3 E3 E3
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PORCINE XENOGRAFT VALVES/Lakier et al.
FIGURE 3. The disparity in failure ratesfor aortic vs mitral valve xenografts start-ing at I month after first valve replacement.Note that the incidence of valve failure inthe aortic position (23.8%) was significantlyhigher than in the mitral position (7.8%)(p < 0.002). MVR = mitral valve replace-ment; A VR = aortic valve replacement.
0.0 12.0 24.0 36.0 48.0 60.0 72.0 84.0 90.0
Time in Months
(0.88 0.04 (SEM]) and aortic (0.61 0.10) porcinexenografts is statistically significant (p < 0.01).
In the nine patients younger than 25 years of age inwhom the initial porcine xenograft valve implantationwas carried out, six required reoperation, five ofwhomshowed spontaneous degeneration (55.5%), comparedwith 12 of 158 patients over the age of 25, 1 1 of whomshowed spontaneous valve degeneration (7%) (p