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Spontaneous disruption of Ionescu-Shiley bovine pericardial xenograft in the mitral position
J
THoRAc CARDIOV ASC SURG
86:784-790, 1983
Brief communications Spontaneous disruption of Ionescu-Shiley bovine pericardial xenograft in the mitral position Suresh C. Ghosh, M.B.B.S., FA.C.S., F.C.C.P., F.I.C.S., Alberto J. Larrieu, M.D., Sarie! G. G. Ablaza, M.D ., and Vicente P. Grana, M.D., Philadelphia. Pa. From the Section of Thoracic and Cardi ovascular Surgery, The Medical College of Pennsylvania and Hospital, and the Albert Einstein Medical Center, Northern Division. Philadelphia. Pa.
We report a case of spontaneous disruption of the lonescuShiley pericardial xenograft in the mitral position at 3 years and its successful management.
Malfunction of a cardiac valve prosthesis continues to be a catastrophic complication.I' Such malfunctions have been reported in most types of frequently used prosthetic valves.!' To our knowledge, however, there has been only one reported occurrence of valve failure by an Ionescu-Shiley bovine pericardial bioprosthesis in the literature.' We document here the successful management of a case of spontaneous failure of an IonescuShiley bioprosthesis. Case report. A 45-year-old woman with severe mitral stenosis and moderate mitral regurgitation had the mitral valve replaced with an IBM (25 mm) Lillehei-Kaster valve on Oct. 19, 1978. The postoperative period was uneventful. On a examination almost 2 months postoperativeroutine fol~ow-up ly, severe signs and symptoms of recurrent mitral stenosis were noticed. Further investigations revealed pulmonary edema. An echocardiogram showed marked enlargement of the left atrium and a normally functioning Lillehei-Kaster mitral prosthesis. Repeat cardiac catheterization revealed a 20 mm Hg gradient across the mitral prosthesis. The patient was reoperated upon on Dec. 16, 1978, and the Lillehei-Kaster mit~al pro~thesi~ was replaced by a 27 mm Ionescu-Shiley bovme pericardial xenograft. The postoperative period was again unremarkable and she was discharged on Jan. 14, 1979, on the following program : digoxin 0.25 mg daily, quinidine 200 .mg f?ur times a day, .quinidine gluconate 300 mg at bedtime, Iron and furosemide 40 mg twice a week, and warfarin sodium. Because of bleeding problems, warfarin had to be discontinued in 1979. The patient otherwise remained in good health and active in New York Heart Association Class I. On Aug. 21, 1981, she again was admitted to another
784
Fig. I. Probe points to the disrupted leaflet torn from the stent and from a portion of the sewing ring. hospital with severe pulmonary edema and promptly had a cardiac arrest. The patient was successfully resuscitated and transferred to our institution for further evaluation and treatment. Upon arrival, she had acute pulmonary edema, congestive heart failure, and a Grade 5/6 systolic murmur at the apex. Emergency card iac catheterization showed the following pressures (in mm Hg) : right atrial 2, right ventricular 50/4, pulmonary arterial 40/20, and mean pulmonary wedge 14. There was no gradient across the aortic valve and t~e left. ventriculogram showed 4+ mitral regurgitatio~. A diagnosis of acute prosthetic mitral valve failure was made and the patient was reoperated upon on Aug. 22, 1981, almost 3 years . after the i~sertion of the original Ionescu-Shiley prosthesis. At operation. one cusp of the prosthesis was tom from th~ stent and ~ew .ing ring, so that there was a wide-open acute mitral regurgitation. There was no evidence of infection trauma, or thrombi, and there was minimal tissue ingrowth: The val~e ~as repla~ with another 27 mm Ionescu-Shiley pr~thesls wltho~t any mt~aoperative or postoperative cornpli~tlO~ . The patient was discharged on September 7 receiving dIgOXIn 0.125 mg daily, dipyridamole 75 mg three times a day an~ furosemide 40 mg twice a week. At I year's follow-up, th~ patient was asymptomatic and had no evidence of failure or murmur. She remained in NYHA Class I.
Discussion. According to Shiley Laboratories , 26,706
Volume 86 Number 5 November, 1983
glutaraldehyde-stabilized Ionescu-Shiley pericardial xenografts have been used clinically for cardiac valve replacements since 1971. Clinical experience with this prosthesis has documented its durability, excellent hydraulic characteristics, and low embolic rate without anticoagulants.v' Our own clinical experience with this prosthesis began in 1978, and since then we have inserted over 50 of these prostheses with similar good results. Gabbay and associates' have recently reported sudden death due to cuspal dehiscence of this IonescuShiley valve in the mitral position. Recent communication with Shiley Laboratories reveals that up to early 1982 there have been only seven instances of noncalcitied valve dysfunction occurring between 13 months and 7 years following valve implantation. In most of these cases, there has been a lack of tissue ingrowth possibly because of long-term anticoagulation. Similarly, in our case there was almost no tissue ingrowth even though the patient had been off warfarin therapy for about 2 years prior to the valve failure. This particular complication should be kept in mind by all who are using this prosthesis, and these patients should continue to be followed up carefully.
2 3
4 5
REFERENCES Tyers GFO, Williams EH, Pierce WS, Waldhausen JA: Present status of cardiac valve replacement. Curr Probl Surg 14:1-80, 1977 Lefrak EA, Starr A: Cardiac valve prostheses Gabbay S, Factor SM, Strom J, Becker R, Frater RWM: Sudden death due to cuspal dehiscence of the lonescuShiley valve in the mitral position. J THoRAc CARDIOVASC SURG 84:313-314, 1982 Ott D, Coelho A, Cooley D, Reul G: Clinical experience with the lonescu-Shiley pericardiaI xenograft valve. Cardiovasc Div, Bull Texas Heart Inst 7:137-148,1980 Cooley D: Implantation of an Ionescu-Shiley valve, Cardiovasc Div, Bull Texas Heart Inst 8:216-220, 1981
Pericardial injury by antib.acterial irrigants John M. Kratz, M.D., John S. Metcalf, M.D., and Robert M. Sade, M.D., Charleston. S. C. From the Division of Cardiothoracic Surgery and Department of Pathology, Medical University of South Carolina, Charleston, S. C.
We injected antibacterial solutions into rabbit pericardium to investigatetissue injury. Povidone-iodine was the only irrigant found to cause substantial damage. These data lend experi-
Reprints not available from the authors.
Brief communications 7 8 5
mental support to recent clinical observations that suggest a causal relation between pericardial irrigation with povidoneiodine and the later development of constrictive pericarditis.
Mediastinal infection after cardiac operations is lifethreatening. Irrigation of the surgical wound with antibacterial solution has been reported to be useful in prevention of wound infection. Several studies have demonstrated the prevention of infection in contaminated wounds of animals.'? Furthermore, in general surgery, wound infection in both clean and contaminated wounds has been shown to be significantly decreased by the use of surgical antibacterial irrigating solutions.t" Certain antibacterial irrigants, however, may cause tissue injury; hexachlorophene and povidoneiodine scrub have been shown to injure the cartilage of the rabbit knee joint.' Therefore, we studied the gross and microscopic changes in the pericardial sac of rabbits after the instillation of several commonly used antibacterial irrigating solutions and one inappropriate solution that could be used accidentally (povidone-iodine scrub). Method. Several antibacterial substances in concentrations that might be used in clinical practice were chosen for this study (Table I). Each of 27 standard New Zealand white rabbits weighing 2 to 5 kg was anesthetized with a combination of xylazine 5 mgjkg and ketamine 45 mgjkg. Through a left lateral thoracotomy, 1 rn1 of antibacterial solution was injected into the pericardial sac through a 27 gauge needle, avoiding injury to the underlying structures. After 1 week, a lethal dose of intravenous thiopental sodium was administered. The chest was opened through a median sternotomy, and pericardial tissue distant from the area of previous injection was excised. The pericardium and the pericardiaI sac were examined grossly and microscopically. Results. Except for specimens irrigated with povidone-iodine and neomycin, the gross and microscopic appearance of the pericardium after irrigation with all antibacterial solutions was identical to the control specimens (Fig. 1). Pericardial sacs injected with neomycin were not grossly different on inspection from those of normal rabbits; however, mild microscopic changes were present. Both concentrations of neomycin caused thickening of the fibrous stroma. The more concentrated solution also caused mild hyperplasia of the mesothelial layer. These findings suggest a mild injury by neomycin solutions (Fig. 2). Gross examination of pericardium exposed to the more concentrated solution of povidone-iodine revealed
THoRAc CARDIOV ASC SURG
86:784-790, 1983
Brief communications Spontaneous disruption of Ionescu-Shiley bovine pericardial xenograft in the mitral position Suresh C. Ghosh, M.B.B.S., FA.C.S., F.C.C.P., F.I.C.S., Alberto J. Larrieu, M.D., Sarie! G. G. Ablaza, M.D ., and Vicente P. Grana, M.D., Philadelphia. Pa. From the Section of Thoracic and Cardi ovascular Surgery, The Medical College of Pennsylvania and Hospital, and the Albert Einstein Medical Center, Northern Division. Philadelphia. Pa.
We report a case of spontaneous disruption of the lonescuShiley pericardial xenograft in the mitral position at 3 years and its successful management.
Malfunction of a cardiac valve prosthesis continues to be a catastrophic complication.I' Such malfunctions have been reported in most types of frequently used prosthetic valves.!' To our knowledge, however, there has been only one reported occurrence of valve failure by an Ionescu-Shiley bovine pericardial bioprosthesis in the literature.' We document here the successful management of a case of spontaneous failure of an IonescuShiley bioprosthesis. Case report. A 45-year-old woman with severe mitral stenosis and moderate mitral regurgitation had the mitral valve replaced with an IBM (25 mm) Lillehei-Kaster valve on Oct. 19, 1978. The postoperative period was uneventful. On a examination almost 2 months postoperativeroutine fol~ow-up ly, severe signs and symptoms of recurrent mitral stenosis were noticed. Further investigations revealed pulmonary edema. An echocardiogram showed marked enlargement of the left atrium and a normally functioning Lillehei-Kaster mitral prosthesis. Repeat cardiac catheterization revealed a 20 mm Hg gradient across the mitral prosthesis. The patient was reoperated upon on Dec. 16, 1978, and the Lillehei-Kaster mit~al pro~thesi~ was replaced by a 27 mm Ionescu-Shiley bovme pericardial xenograft. The postoperative period was again unremarkable and she was discharged on Jan. 14, 1979, on the following program : digoxin 0.25 mg daily, quinidine 200 .mg f?ur times a day, .quinidine gluconate 300 mg at bedtime, Iron and furosemide 40 mg twice a week, and warfarin sodium. Because of bleeding problems, warfarin had to be discontinued in 1979. The patient otherwise remained in good health and active in New York Heart Association Class I. On Aug. 21, 1981, she again was admitted to another
784
Fig. I. Probe points to the disrupted leaflet torn from the stent and from a portion of the sewing ring. hospital with severe pulmonary edema and promptly had a cardiac arrest. The patient was successfully resuscitated and transferred to our institution for further evaluation and treatment. Upon arrival, she had acute pulmonary edema, congestive heart failure, and a Grade 5/6 systolic murmur at the apex. Emergency card iac catheterization showed the following pressures (in mm Hg) : right atrial 2, right ventricular 50/4, pulmonary arterial 40/20, and mean pulmonary wedge 14. There was no gradient across the aortic valve and t~e left. ventriculogram showed 4+ mitral regurgitatio~. A diagnosis of acute prosthetic mitral valve failure was made and the patient was reoperated upon on Aug. 22, 1981, almost 3 years . after the i~sertion of the original Ionescu-Shiley prosthesis. At operation. one cusp of the prosthesis was tom from th~ stent and ~ew .ing ring, so that there was a wide-open acute mitral regurgitation. There was no evidence of infection trauma, or thrombi, and there was minimal tissue ingrowth: The val~e ~as repla~ with another 27 mm Ionescu-Shiley pr~thesls wltho~t any mt~aoperative or postoperative cornpli~tlO~ . The patient was discharged on September 7 receiving dIgOXIn 0.125 mg daily, dipyridamole 75 mg three times a day an~ furosemide 40 mg twice a week. At I year's follow-up, th~ patient was asymptomatic and had no evidence of failure or murmur. She remained in NYHA Class I.
Discussion. According to Shiley Laboratories , 26,706
Volume 86 Number 5 November, 1983
glutaraldehyde-stabilized Ionescu-Shiley pericardial xenografts have been used clinically for cardiac valve replacements since 1971. Clinical experience with this prosthesis has documented its durability, excellent hydraulic characteristics, and low embolic rate without anticoagulants.v' Our own clinical experience with this prosthesis began in 1978, and since then we have inserted over 50 of these prostheses with similar good results. Gabbay and associates' have recently reported sudden death due to cuspal dehiscence of this IonescuShiley valve in the mitral position. Recent communication with Shiley Laboratories reveals that up to early 1982 there have been only seven instances of noncalcitied valve dysfunction occurring between 13 months and 7 years following valve implantation. In most of these cases, there has been a lack of tissue ingrowth possibly because of long-term anticoagulation. Similarly, in our case there was almost no tissue ingrowth even though the patient had been off warfarin therapy for about 2 years prior to the valve failure. This particular complication should be kept in mind by all who are using this prosthesis, and these patients should continue to be followed up carefully.
2 3
4 5
REFERENCES Tyers GFO, Williams EH, Pierce WS, Waldhausen JA: Present status of cardiac valve replacement. Curr Probl Surg 14:1-80, 1977 Lefrak EA, Starr A: Cardiac valve prostheses Gabbay S, Factor SM, Strom J, Becker R, Frater RWM: Sudden death due to cuspal dehiscence of the lonescuShiley valve in the mitral position. J THoRAc CARDIOVASC SURG 84:313-314, 1982 Ott D, Coelho A, Cooley D, Reul G: Clinical experience with the lonescu-Shiley pericardiaI xenograft valve. Cardiovasc Div, Bull Texas Heart Inst 7:137-148,1980 Cooley D: Implantation of an Ionescu-Shiley valve, Cardiovasc Div, Bull Texas Heart Inst 8:216-220, 1981
Pericardial injury by antib.acterial irrigants John M. Kratz, M.D., John S. Metcalf, M.D., and Robert M. Sade, M.D., Charleston. S. C. From the Division of Cardiothoracic Surgery and Department of Pathology, Medical University of South Carolina, Charleston, S. C.
We injected antibacterial solutions into rabbit pericardium to investigatetissue injury. Povidone-iodine was the only irrigant found to cause substantial damage. These data lend experi-
Reprints not available from the authors.
Brief communications 7 8 5
mental support to recent clinical observations that suggest a causal relation between pericardial irrigation with povidoneiodine and the later development of constrictive pericarditis.
Mediastinal infection after cardiac operations is lifethreatening. Irrigation of the surgical wound with antibacterial solution has been reported to be useful in prevention of wound infection. Several studies have demonstrated the prevention of infection in contaminated wounds of animals.'? Furthermore, in general surgery, wound infection in both clean and contaminated wounds has been shown to be significantly decreased by the use of surgical antibacterial irrigating solutions.t" Certain antibacterial irrigants, however, may cause tissue injury; hexachlorophene and povidoneiodine scrub have been shown to injure the cartilage of the rabbit knee joint.' Therefore, we studied the gross and microscopic changes in the pericardial sac of rabbits after the instillation of several commonly used antibacterial irrigating solutions and one inappropriate solution that could be used accidentally (povidone-iodine scrub). Method. Several antibacterial substances in concentrations that might be used in clinical practice were chosen for this study (Table I). Each of 27 standard New Zealand white rabbits weighing 2 to 5 kg was anesthetized with a combination of xylazine 5 mgjkg and ketamine 45 mgjkg. Through a left lateral thoracotomy, 1 rn1 of antibacterial solution was injected into the pericardial sac through a 27 gauge needle, avoiding injury to the underlying structures. After 1 week, a lethal dose of intravenous thiopental sodium was administered. The chest was opened through a median sternotomy, and pericardial tissue distant from the area of previous injection was excised. The pericardium and the pericardiaI sac were examined grossly and microscopically. Results. Except for specimens irrigated with povidone-iodine and neomycin, the gross and microscopic appearance of the pericardium after irrigation with all antibacterial solutions was identical to the control specimens (Fig. 1). Pericardial sacs injected with neomycin were not grossly different on inspection from those of normal rabbits; however, mild microscopic changes were present. Both concentrations of neomycin caused thickening of the fibrous stroma. The more concentrated solution also caused mild hyperplasia of the mesothelial layer. These findings suggest a mild injury by neomycin solutions (Fig. 2). Gross examination of pericardium exposed to the more concentrated solution of povidone-iodine revealed