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Eur J Cardiothorac Surg 2003;23:996-1001
© 2003 Elsevier Science NL

Reoperation after fresh homograft replacement: 23 years’ experience with 655 patients

Department of Cardiovascular Surgery and Transplantology, Collegium Medicum, Jagiellonian University, Pradnicka 80, 31-202 Krakow, Poland

Received 25 September 2002; received in revised form 12 February 2003; accepted 19 February 2003.

^* Corresponding author. Tel.: +48-502-294250; fax: +48-12-423-3900
e-mail: cool_chris{at}interia.pl

	Abstract

Top Abstract 1. Introduction 2. Patients and methods 3. Results 4. Discussion 5. Conclusions Appendix A. Conference... References

 
Objective: Through a retrospective study on the use of fresh homografts in 655 aortic valve replacement patients over a period of 23 years, we aimed to assess the reasons for eventual reoperation and causes of valve dysfunction. Methods: Between January 1980 and December 2002, 655 patients received fresh homografts. All homografts were antibiotic sterilized and stored at 4 °C. During this time, 139 patients (116 male and 23 female) with a mean age of 46.7 years (range 18–72) required reoperation. Results: The 30-day hospital overall mortality was 2.87%. The mean durability for all homografts was 12.4±4.54 years (1 month to 23 years). The cumulative rates for freedom from reoperation for any cause were 94.09±2% at 5 years and 87.9%±4% at 10 years, 76.6 at 15 years, 49.55 at 20 years. The major cause of valve dysfunction and indication for reoperation was degeneration in 111 patients (79.8%). Predominant aortic valve insufficiency in 87 patients (62.5%) and predominant stenosis in 24 patients (17.26%). Endocarditis occurred in 21 patients (15.1%). Early endocarditis was diagnosed in five patients (3.59%), late endocarditis in 16 patients (11.5%). Additional causes for reoperation included ascending aortic aneurysm, mitral valve insufficiency and congestive cardiomyopathy. Seventeen patients (12.2%) required concomitant procedures. Coronary artery bypass grafting was performed in six cases (4.3%), mitral valve replacement in five cases (3.59%), mitral valve annuloplasty in six (4.3%). The primary reoperative procedure was artificial/mechanical aortic valve implantation. In five cases, St. Jude Medical conduit grafts were implanted due to ascending aortic aneurysms. Homograft reimplantation was performed in four cases. One patient underwent mitral valve replacement and one patient received a heart transplant. Conclusion: The results of the study suggest that reoperation in patients with aortic homografts is a low-risk procedure as compared to alternative therapies. Primary allograft aortic valve replacement can give acceptable results for up to 23 years. The major cause of valve dysfunction and indication for reoperation was degeneration. Cumulative rates for freedom from reoperation for any cause in age groups suggest careful selection and indications in homograft implantation in the younger patients. Young age is a risk factor for an early homograft structural deterioration (degeneration).

Key Words: Homograft • Homograft degeneration • Homograft reoperation

	1. Introduction

Top Abstract 1. Introduction 2. Patients and methods 3. Results 4. Discussion 5. Conclusions Appendix A. Conference... References

 
To date, there is no ideal aortic valve substitute. Since 1962, when two investigators, Sir Brian Barratt-Boyes in Auckland, New Zealand, and Mr Donald Ross in London, used allografts in the aortic position, a new chapter in Cardiac Surgery has been written [1,2]. Through their great work and the work of others, many implantation techniques [3–20], methods of homograft valve collection, and sterilization and preservation methods have been discovered [4,5,18,19]. Notwithstanding, further follow-up was needed to determine valve durability, valve-related complications and valve hemodynamic performance. The rate for freedom from perivalvular leak, endocarditis and thromboembolic events has been one of the most often asked questions of the time.

Human allograft valves offer many proven advantages, which include restoration of normal flow in the aortic root, sinuses and coronary orifices. Resistance to infection gives clear advantages in endocarditis. Human allografts are ideal for pulmonary valve replacement and right ventricular outflow reconstruction, and can be used for any age.

Homografts are well developed in Poland. To date, human allografts are the best known substitute for aortic valve replacement because of their very good hemodynamic performance, relatively easy availability in Poland, and lower costs than any prosthetic devices on the market [21,22].

Given the excellent attributes of human allograft valves, it is noteworthy that some disadvantages are evident. More complicated operative techniques, limited availability and sub-optimal durability are the most important factors leading to reoperation. The aim of this study was to assess the reasons for the reoperation and cause of valve dysfunction after fresh homograft replacement.

	2. Patients and methods

Top Abstract 1. Introduction 2. Patients and methods 3. Results 4. Discussion 5. Conclusions Appendix A. Conference... References

 
Between January 1980 and December 2002, 655 fresh homografts were used for aortic valve replacement in 655 patients (139 female, 516 male) aged from 11 to 78 years (mean 43.9±14.8 years). The indication for operation was aortic valve stenosis in 163 patients (24.8%), aortic valve insufficiency in 239 (36.4%), and mixed lesions in 212. In 85 patients (12.9%) congenital aortic valve disease was found. One hundred and twenty patients (18.3%) had ascending aorta aneurysm (including 40 dissections).

The maximum follow-up was 23 years. During this time, 139 patients (21.2%), 116 male and 23 female with a mean age of 46.7 years (range 18–72), required reoperation. There were 135 (97.1%) aortic allografts and four (2.87%) pulmonary allografts. All patients had a transthoracic echo examination before reoperation. Ninety-five percent of all patients presented a New York Heart Association (NYHA) functional classification of III or VI before reoperation. A total of four patients presenting a NYHA IV classification required emergency operation.

2.1. Allograft data
Almost all valves were taken from the homograft bank in Krakow. The valves were obtained from cadaver donors during routine autopsies, or from recipients during heart transplant procedures. The age of valve donors ranged from 21 to 50 years (mean 37.3 years), who died a maximum of 24 h before the explantation procedure. Valves were harvested under sterile conditions and kept in 4 °C at the time of implantation. The maximum storage period for all valves was 21 days (mean 14.3).

The sterilant solution is comprised of fungizone 0.25 mg/ml, neomycin 5.55 mg/ml, Ceforan (Tarcefoxym) 10 mg/ml, polymyxin-b/colistin 3333 IU/ml, carbenicillin 10 mg/ml with Parker solution. The nutrient medium consisted of diflucan 0.036 mg/ml, 1.5 ml natrium bicarbonicum 8.4%, streptomycin 0.4 mg/ml, penicillin 0.4 mg/ml, Parker solution.

The overall rate of positive cultures in the homografts harvested from routine autopsies was 4.9% and from heart transplant procedures or 2.13% from multiorgan donors with unsuitable hearts for heart transplantation. Homografts from heart transplant procedures have been taken since 1992. In the last 10 years (1992–2002) the rate of positive cultures in the homografts harvested from routine autopsies dropped from 4.9 to 2.67%.

Fresh, antibiotic-sterilized allograft valves were used in almost all cases. To date, only three cryopreserved allografts have been implanted. There were 38 pulmonary allografts and 617 aortic allografts implanted in the Department of Cardiovascular Surgery in Krakow.

Implanted homografts sizes ranged from 10 to 34 mm in diameter. The mean size of homografts was 21.08±3.56 mm. Only three patients with an aortic root diameter exceeding 31 mm received homografts. AB0 group compatibility testing data were not available for all patients.

2.2. Insertion technique
The valves were inserted as a short cylinder, homograft conduit or subcoronary graft, with a lower suture line of multiple interrupted simple stitches of 4-0 Mersilene suture (Ethicon) and a continuous upper line of 4-0 Prolene suture (Ethicon).

In the short cylinder and homograft conduit cases, an additional two holes were cut out in two sinuses of the pulmonary homograft to expose the two coronary orifices. The wall of the homograft was subsequently sutured side-by-side to the coronary ostia with a running 5-0 Prolene suture. Additional mattress sutures were then placed on the short cylinder in the noncoronary sinus to obliterate any dead space. All pulmonary allografts were inserted as a short cylinder. Unfortunately the implantation technique was not known in all cases. It was not possible to identify the description of homograft implantation techniques for specific aortic pathology. There are no data available about patient or homograft size mismatch, which could explain some of the causes for the late homograft reoperation.

	3. Results

Top Abstract 1. Introduction 2. Patients and methods 3. Results 4. Discussion 5. Conclusions Appendix A. Conference... References

 
Between January 1980 and December 2002, 655 patients received fresh homografts (38 pulmonary and 617 aortic). The number of implants ranged from 1 to 58 per year (men 28.4±3.62 per year) (Table 1).

Patients returning for reoperation (139 patients) received homografts between January 1977 and November 1997. The majority of these patients (133 patients, 95.68%) were treated in our clinic in Krakow, Poland. Three valves (2.15%) were implanted in Lodz, Poland, two (1.43%) in London and one (0.71%) in France. Unfortunately, the implantation technique was not known in all cases.

The major cause of valve dysfunction and indication for reoperation was degeneration in 111 patients (79.8%). Predominant aortic valve insufficiency was present in 87 patients (62.5%) and predominant stenosis in 24 patients (17.26%). Leaflet perforation was found in 49 cases (35.25%). In 23 patients (16.5%), all three leaflets were perforated. Left coronary leaflet was perforated in 34 patients (24.4%), right coronary leaflet in 39 (28%) and noncoronary leaflet in 32 (23%). Leaflet rupture was found in 38 patients (27.3%). In ten cases (7.19%) all leaflets were damaged. Tear was found most often at the noncoronary leaflet 22 patients (15.8%). The right coronary leaflet was ruptured in 20 patients (14.3%) and the left coronary leaflet in 21 (15.1%). Leaflet rupture and coexistence perforation occurred in 16 cases (11.5%).

Endocarditis occurred in 21 patients (15.1%). Early endocarditis was diagnosed in five patients (3.59%) and late endocarditis in 16 (11.5%). The mean time in which late endocarditis was diagnosed was 8.6 years, ranging from 1 to 17 years.

Additional causes for reoperation included ascending aortic aneurysm in five patients, severe mitral valve insufficiency in one patient, and heart transplant in one patient (Table 1).

As noted above, severe mitral valve insufficiency was observed in one case. During the intraoperative procedure, it was noted that the homograft was in an excellent condition after a period of 7 years post-implant. Ten years after implantation, one patient underwent heart transplant. Preoperative echo results were comparable to intraoperative findings.

3.1. Durability
Mean homograft durability was 12.4±4.54 years. The shortest period for reoperation was 1 month. The cause for reoperation was early endocarditis. The longest period for reoperation was 23 years.

In five cases, homograft durability exceeded 20 years. In 20 cases, homograft durability exceeded 15 years. The cumulative rates for freedom from reoperation for any cause were 94.09±2% at 5 years and 87.9±4% at 10 years, 76.6% at 15 years and 49.55% at 20 years. The rates for freedom from reoperation in groups of age were: 63.9% in the group of age 11–20 years, 70.2% for patients from 21 to 30 years old, 75% for patients from 31 to 40 years old, 81.1% for patients from 41 to 50 years old, 87.7% for patients from 51 to 60 years old, 87.76% for patients aged 61–70 years and 88.89% for the group of patients older than 71 years.

The rate for freedom from endocarditis was 97±1% at 5 years, 93±3% at 10 years, 91.5±3.5% at 15 years and 89.3±4.2% at 20 years.

3.2. Reoperative procedures
The primary reoperative procedure was artificial/mechanical aortic valve implantation. A mechanical valve was implanted inside the homograft conduit after resection of the degenerated valve in almost all cases. The whole homograft was exchanged at reoperation in only 12 cases (five conduit grafts, four homografts, two homograft wall resections with artificial/mechanical valve implantation, one heart transplant).

Many types of mechanical aortic valves were commercially available during the 20 years of study. The St. Jude Medical valve was the most often implanted device (50%) of all mechanical valves implanted. The Bjork–Shiley was implanted in 17% of cases, Carbo Medics in 14%, Sorin in 7%, Medtronic Hall in 6%, Duromedics in 3% and Jomed in 3%.

The most often implanted valve size was 23 mm in diameter (42.8%). Two valves were 19 mm, 13 were 21 mm, 29 were 25 mm, 8 were 27 mm, three were 29 mm, and one was 31 mm in diameter. In five cases, St. Jude Medical conduit grafts (three 25 and two 29 mm in diameter) were implanted due to ascending aortic aneurysms. One patient underwent mitral valve replacement due to severe mitral valve disease and one patient received a heart transplant. Only four patients received homografts again.

3.3. Concomitant procedures
Seventeen patients (12.2%) required concomitant procedures. Coronary artery bypass grafting was performed in six cases (4.3%), mitral valve replacement in five (3.59%), mitral valve annuloplasty in six (4.3%).

3.4. Mortality
Thirty-day overall hospital mortality for the total of 655 patients receiving homografts was 3.8% (25 patients), including 44 patients with endocarditis (four deaths; mortality 9%) and 40 patients with dissected aortic aneurysm (seven deaths; mortality 17.5%).

Late/post hospital mortality rate was 9.31% (61 patients) of all 655 patients who received homografts. The reasons for late deaths were: heart failure in 26 patients (42.6%), MI in ten (16.3%), sepsis in six (9.8%), gastrointestinal tract bleeding in six (9.8%), kidney insufficiency in three (4.9%) and leukemia in one patient (1.6%). The reason was not known in nine patients (14.7%).

The 30-day mortality for reoperation was 2.87% (four patients). The overall hospital mortality, including late hospital deaths (two patients), was 4.31% of the of the total 139 patients who underwent reoperation.

	4. Discussion

Top Abstract 1. Introduction 2. Patients and methods 3. Results 4. Discussion 5. Conclusions Appendix A. Conference... References

 
This analysis was conducted to define the reasons for reoperation and limitations of allografts implanted in our center in the last 23 years. It is one of the largest cohorts of homografts and contains our experience gained in the field of homograft implantation.

With a total of 655 implanted homografts, 139 (21.2%) required reoperation to date. All published studies suggest that allograft degeneration is a long-term process and usually leads to leaflet perforation, fibrosis and calcification [6,7,10–13]. The results of our study support these findings, and indicate that the degeneration process was the primary reason for reoperation. The overall hospital mortality, including late hospital deaths, was 4.31% and is comparable to numbers we can find in literature [1,6,7,12,13]. Surprisingly, the 30-day mortality for reoperation procedure was lower than for primary homograft implantation. The main drawback of allografts and of any other biologic valves is their limited durability. In the present series of more than 23-year follow-up, with a significant number of patients, the hazard of failure and constant risk was relatively low.

To further analyze historical data for homograft durability, it would be of great value to determine if there is a correlation between operative techniques and long-term patient outcomes. Unfortunately, the implantation technique was not known in all cases. However, the unique insertion technique, with simple stitches of Mersilene suture and additional mattress sutures in the noncoronary sinus to obliterate any dead space (in short cylinder), makes this data more interesting [21,22].

Homografting is well developed in our country. It is a low-risk procedure as compared to alternative therapies. In our experience human allografts are the best substitute for aortic valve replacement because of their very good hemodynamic performance, easy availability and low costs. Proven advantages, especially resistance to infection, gives us a clear choice in endocarditis. Complicated operation techniques and not easy availability can create major clinical problems and can be a limiting factor for some centers, but we have to remember that use of homografts can give some of our patients the best alternative for aortic valve replacement. We do believe in more complete regression of left ventricular hypertrophy after AVR with a homograft. Complete regression of hypertrophy is a principal factor in good left ventricle function in the long term, which may be an important determinant of long-term survival [23].

At the same time, we think young patients require extra attention regarding indications for receiving a homograft, because of a relatively low rate for freedom from reoperation in this series. Young patient age is a time-proven, known risk factor for an early homograft structural deterioration [10,24].

We recommend implanting a mechanical valve in very young patients.

The late results in homograft implantation can be improved by the use of a viable allograft and, if possible, matching patient and donor age. More liberal use of free root replacement with reimplantation of the coronary ostia rather than other operation techniques might be the best choice [23,25].

	5. Conclusions

Top Abstract 1. Introduction 2. Patients and methods 3. Results 4. Discussion 5. Conclusions Appendix A. Conference... References

 
The results of the study suggest that reoperation in patients with aortic homografts is a low-risk procedure as compared to alternative therapies. Primary allograft aortic valve replacement can give acceptable results for up to 23 years. The major cause of valve dysfunction and indication for reoperation was degeneration. The cumulative rates for freedom from reoperation for any cause in age groups suggest careful selection and indications in homograft implantation in the younger group of patients. Young age is a risk factor for an early homograft structural deterioration.

	Footnotes

 
Presented at the 16th Annual Meeting of the European Association for Cardio-thoracic Surgery, Monte Carlo, Monaco, September 22–25, 2002.

	Appendix A. Conference discussion

Top Abstract 1. Introduction 2. Patients and methods 3. Results 4. Discussion 5. Conclusions Appendix A. Conference... References

 
Dr C. Yankah (Berlin, Germany): I would like to ask a question on the durability of your homograft valves which relates to early and late calcification of the aortic wall and also the leaflets. Did the early degeneration of the homografts relate to your preservation technique and do you consider changing your technique? My second question relates to hemodynamic effect on the homograft durability. Do you have early postoperative data on the valve gradients in the patients you followed over the years? I believe that gradient related turbulence and wall stress of a suboptimal preserved homograft contribute to an early structural deterioration.

Dr Kapelak: This is data from 1980, and we started with the aortic homografts a few years ago as fresh antibiotic sterilized, but now we have changed our procedure because we have the Bank for cryopreservation in Krakow, and probably in the next year we will begin with cryopreserved homografts.

As for the second question, I think it was too short a time, but the mean gradient on the aortic homograft valves was approximately 30 or less. So in my opinion it is rather the insufficiency of the aortic valves than the stenosis. I think that may be the reason why the hemodynamic status of our patients was relatively good, because we have enough time to check the status of our patients.

	References

Top Abstract 1. Introduction 2. Patients and methods 3. Results 4. Discussion 5. Conclusions Appendix A. Conference... References

 

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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Antoni Dziatkowiak Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Sadowski, J. Articles by Dziatkowiak, A. Search for Related Content PubMed PubMed Citation Articles by Sadowski, J. Articles by Dziatkowiak, A. Related Collections Cardiac - other Valve disease