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Eur J Cardiothorac Surg 2002;21:698-702
© 2002 Elsevier Science NL

Aortic valve replacement with the Toronto SPV: long-term clinical and hemodynamic results

Göran Dellgrena,b, Christopher M. Feindela,b*, Joanne Bosa,b, Joan Ivanova,b, Tirone E. Davida,b

a Division of Cardiovascular Surgery, The Toronto General Hospital, 200 Elizabeth Street, EN 14-222, Toronto, Ontario, Canada M5N 2C4
b University of Toronto, Toronto, Ontario, Canada

Received 12 October 2001; received in revised form 20 December 2001; accepted 3 January 2002.

* Corresponding author. Tel.: +1-416-340-5909; fax: +1-416-340-3803
e-mail: chris.feindel{at}uhn.on.ca


   Abstract
Top
 Abstract
1. Introduction
 2. Material and methods
 3. Results
 4. Discussion
 5. Limitations of the...
 References
 
Objective: Long-term durability and hemodynamics of stentless valves are unknown. Therefore, this study was undertaken to evaluate long-term clinical and echocardiographic outcome after aortic valve replacement with the Toronto stentless porcine valve (SPV) bioprosthesis at our institution. Methods: Between 1991 and 1998, the Toronto SPV was implanted in 255 patients (mean age, 63±11 years, range 22–83 years, 181 males and 74 females). Preoperative diagnoses were aortic stenosis (76%), aortic insufficiency (12%) and mixed lesion (12%). New York Heart Association class III and IV were present in 49% (126/255) of the patients preoperatively. Mean valve size implanted was 26.5±2.1 mm and in addition 34% (86/255) of the patients had coronary artery bypass surgery. Results: Early mortality was 0.8% (2/255). Actuarial survival at 7 years was 90±3%. At 7 years, the freedom from cardiac death was 98±2%; from valve-related death, 99±1%; from valve reoperation, 97±2%; from structural valve degeneration, 97±2%; from thromboembolism, 95±2%; and from endocarditis, 99±1%. At 7 years of follow-up, the transvalvular peak and mean pressure differences across the aortic valve measured with Doppler echocardiography was 9.6±5.1 and 3.6±2.0 mmHg, respectively. Conclusions: The Toronto SPV has provided excellent clinical and hemodynamic results up until 7 years of follow-up.

Key Words: Aortic bioprostheses • Aortic stentless valves • Follow-up • Aortic valve hemodynamics


   1. Introduction
Top
 Abstract
 1. Introduction
2. Material and methods
 3. Results
 4. Discussion
 5. Limitations of the...
 References
 
The Toronto stentless porcine valve (SPV) bioprosthesis has been in clinical use for aortic valve replacement (AVR) in our institution since 1991 [1]. The long-term clinical results are unknown. Therefore, this study has been undertaken to review our clinical experience and also examine the hemodynamic performance of the Toronto SPV.


   2. Material and methods
Top
 Abstract
 1. Introduction
 2. Material and methods
3. Results
 4. Discussion
 5. Limitations of the...
 References
 
2.1. Patients
From July 1991 to December 1998, the Toronto SPV bioprosthesis (St. Jude, St. Paul, MN) was used for AVR in 255 patients at the Toronto General Hospital in Toronto, Ontario, Canada. The clinical profile and the operative data of these patients are summarized in Tables 1 and 2, respectively.


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  		Table 1. Clinical characteristics

 

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  		Table 2. Operative data

 
The Toronto SPV is an excised porcine aortic valve fixed in glutaraldehyde under low pressure and subsequently covered with a single layer of fine Dacron polyester fabric [2]. The Toronto SPV was implanted with a subcoronary technique that has been previously described [2].

Operative survivors were followed prospectively at our hospital between February 1999 and February 2000. The follow-up was 100% complete. The mean follow-up was 53±24 months (range, 2–101 months) and 1097 patient-years of follow-up were available for analysis.

2.2. Doppler echocardiography
Transthoracic echocardiography with continuous-wave (CW), pulsed-wave (PW) and color flow Doppler studies were performed using an Hewlett Packard 1000, 1500, 2500 or 5500 Ultrasonoscope equipped with a 2.5 MHz transducer. Imaging was performed in a prospective protocol before discharge in the early postoperative period, 6 months and annually thereafter in the first 174 consecutive patients. Imaging included two-dimensional imaging in the parasternal long- and short-axis views. PW Doppler was used to assess flow in the left ventricular outflow tract (LVOT).

The peak and mean systolic flow velocity across the aortic valve was recorded with CW Doppler, and proximal to the AV using PW Doppler in the LVOT. Peak and mean pressure differences were calculated using the modified Bernoulli equation [3]. The effective orifice area (EOA) was calculated with the continuity equation [3]. Aortic insufficiency (AI) was assessed using color flow Doppler, CW and PW Doppler in any view and graded as follows: 0=none; 1=trace; 2=mild; 3=moderate; and 4=severe.

2.3. Definitions and statistics
This report is based on the guidelines for reporting morbidity and mortality after cardiac valvular operations [4]. Survival and time-related event analysis was performed with the Kaplan–Meier method. Differences were tested for statistical significance with one-way analysis of variance (ANOVA) for repeated measurements. When the F-test revealed a significant difference, each pair of means was compared using Scheffe's test. A P<0.05 was considered statistically significant.


   3. Results
Top
 Abstract
 1. Introduction
 2. Material and methods
 3. Results
4. Discussion
 5. Limitations of the...
 References
 
3.1. Patient survival
There were two (0.8%) operative and 21 (8%) late deaths. The operative morbidity and mortality and the late mortality are shown in Table 3. The actuarial survival is shown in Fig. 1 .


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  		Table 3. Operative morbidity and mortality and late mortality

 


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  		Fig. 1. Actuarial survival rates.

 
3.2. Valve- and cardiac-related mortality and morbidity
The actuarial freedom from valve-related deaths at 5 and 7 years was 99±1% and 99±1%, respectively. The actuarial freedom from valve-related mortality and morbidity (including thromboembolism, endocarditis and reoperation as well as any death related to these) is shown in Fig. 2 . The actuarial freedom from cardiac deaths at 5 and 7 years was 98±1% and 98±1%, respectively.



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  		Fig. 2. Actuarial freedom from valve-related mortality and morbidity (VRMM).

 
3.3. Thromboembolism
Thromboembolic events were observed in 14 patients, seven suffered from a stroke and seven had experienced a transient ischemic attack (TIA). The actuarial freedomient from thromboembolism is shown in Fig. 3 . At the last follow-up, 12 (12/226, 5%) patients were taking warfarin sodium and 166 (166/226, 73%) patients were taking aspirin daily.



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  		Fig. 3. Actuarial freedom from thromboembolism (TE).

 
3.4. Structural valve deterioration
Structural valve deterioration (SVD) occurred in two patients after 74 and 86 months, respectively. Both patients were younger than 50 years of age when originally operated on and both survived the reoperation uneventfully. The actuarial freedom from SVD at 5 and 7 years was 100 and 97±2%, respectively.

3.5. Bioprosthetic valve endocarditis
Two patients had bioprosthetic valve endocarditis after 1 and 3 months, respectively. Both were treated medically and one patient died. The actuarial freedom from bioprosthetic valve endocarditis at 5 and 7 years was 99±1% and 99±1%, respectively.

3.6. Reoperations
Reoperations were performed in two patients after 74 and 86 months of follow-up, respectively. The actuarial freedom from reoperation at 5 and 7 years was 100% and 97±2%, respectively. The indication for reoperation in both patients was SVD.

3.7. Other complications
One patient needed late pacemaker implantation. No patient had experienced a late acute myocardial infarction or an anticoagulant-related hemorrhage.

3.8. Late functional classification
At late follow-up, New York Heart Association (NYHA) functional classification was determined in 225 survivors: 195 (87%) patients were in NYHA class I, 29 (12.5%) were in class II, 1 (0.5%) in class III and no patient was in class IV.

3.9. Echocardiography
Peak and mean systolic gradients across the aortic valve were both significantly decreased at 1 year compared to that at discharge. There was no further significant change in these hemodynamic parameters (Table 4). Doppler-derived data at 7 years showed peak and mean pressure differences across the aortic valve of 9.6±5.1 and 3.6±2.0 mmHg, respectively. The EOA had increased significantly during the follow-up period (Table 4). Fourteen patients (14/173, 8%) developed AI of more than grade 1 during the follow-up period. AI slowly progressed over time in a small number of patients but most patients remained stable without any signs of AI (Table 4). However, leaflet motion and opening/closure were normal in most patients over time.


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  		Table 4. Hemodynamic dataa

 

   4. Discussion
Top
 Abstract
 1. Introduction
 2. Material and methods
 3. Results
 4. Discussion
5. Limitations of the...
 References
 
Aortic valve replacement with the Toronto SPV continues to show excellent results [5,6]. Despite the fact that implantation of the Toronto SPV takes longer cross-clamp time, compared to stented alternatives, it has not been associated with higher operative mortality and morbidity rates. The patient population in this study does not seem to be very different from what is generally seen in a regular practice with varying degree of coronary artery disease in about 40% of the cases. However, the population was selected to a certain extent since patients with an expected survival of less than 2 years as well as those with renal insufficiency were excluded from having this valve implanted. In a previous study, we adjusted for some of these factors in a retrospective case-match comparison of stentless and stented porcine valves [7]. This study showed a significant reduction in cardiac mortality rates and valve-related morbidity when the Toronto SPV was compared with a stented porcine valve. Furthermore, Westaby et al. also showed an enhanced survival in patients receiving the Freestyle stentless valve when compared to a stented pericardial bioprosthesis [8]. Although it is possible that confounding factors may have influenced the outcome of these case-control studies, it suggested that stentless valves enhance survival.

Stentless valves are technically more challenging to implant compared to stented valves. Since surgeons who are comfortable with stentless valves tend to do a high volume of valve operations, the excellent results of the SPV valve in this series may in part simply be a reflection of their experience. However, long-term results with the Toronto SPV also seem to be characterized by a very low valve-related mortality and morbidity and well in line if not superior with results from stented alternatives published elsewhere [9]. Although not studied in a prospective randomized study, there clearly seems to be very few postoperative valve-related events with the Toronto SPV. However, in the near future we expect to see the first cases of degeneration since the porcine valve tissue still is immunogenic and slowly will calcify secondary to rejection. Furthermore, as described earlier by our institution, a small number of patients seem to develop a slowly progressing AI secondary to dilatation of the sinotubular junction [10].

In numerous studies, the hemodynamics of stentless valves has been shown to be better than stented alternatives, and are almost identical to aortic valve homografts [11] and resemble the normal aortic valve [12]. Serial echocardiographic studies in patients who underwent AVR with the Toronto SPV demonstrated a progressive reduction in the mean transvalvular gradient and an increase in the effective valve orifice area during the first postoperative year [6,13,14]. Moreover, as shown in a study from our institution, these changes remain constant during the first 5 postoperative years [6]. At 5 years postoperatively, the mean transvalvular gradient was 4 mmHg and remained unchanged up to 7 years. There are several studies showing that patients with AVR with stented valves still have significant left ventricular hypertrophy after several years of follow-up [15]. Moreover, regression of left ventricular hypertrophy postoperatively has been shown to be more enhanced in patients with stentless valves compared to a conventional stented bioprosthesis [16]. Left ventricular hypertrophy regresses rapidly during the first postoperative year in patients with the Toronto SPV [6,13]. Residual hypertrophy is rarely seen, and after the initial postoperative regression of left ventricular mass index, patients with the Toronto SPV bioprosthesis have a normal left ventricular mass index at 5 years of follow-up [6]. The rapid reduction in left ventricular hypertrophy seen with stentless valves may contribute to the reduction in cardiac-related mortality seen in the above-mentioned case-control study from our institution [7]. However, we have previously also shown that the regression of left ventricular hypertrophy is multifactorial and may be influenced by genetics as well as gender and other yet unknown factors [6,17]. These may influence the clinical or hemodynamic outcome of patients undergoing AVR.

In conclusion, the Toronto SPV has provided excellent clinical and hemodynamic results up until 7 years of follow-up. The patients' survival is exceptionally high by comparison with other series of bioprosthetic aortic valves in adults.


   5. Limitations of the study
Top
 Abstract
 1. Introduction
 2. Material and methods
 3. Results
 4. Discussion
 5. Limitations of the...
References
 
This study is a prospective study and therefore the likelihood of underestimating the valve-related complication rates are minimized since follow-up was obtained annually for this population. The follow-up was 100% complete and reliable when it comes to survival and all the clinical data. However, echocardiography data was only obtained in the first 174 patients and therefore has to be interpreted with caution. Furthermore, the number of small valves inserted was few and could influence the clinical and hemodynamic outcome in a positive direction.


   Acknowledgments
 
We would like to thank Sue Armstrong for assistance with the follow-up data and Sue Collins for data base support. We would also like to thank the Karolinska Institutet and the Swedish Institute for financial support to G.D.


   References
Top
 Abstract
 1. Introduction
 2. Material and methods
 3. Results
 4. Discussion
 5. Limitations of the...
 References
 

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  2. David T.E., Ropchan G.C., Butany J.W. Aortic valve replacement with stentless porcine bioprosthesis. J Cardiac Surg 1998;3:501-505.
  3. Feigenbaum H. Hemodynamic information derived from echocardiography. In: Feigenbaum H., ed. Echocardiography, 5th ed Philadelphia, PA: Lea and Febiger, 1994:181-215.
  4. Edmunds L.H., Clark R.E., Cohn L.H., Grunkemeier G.L., Miller D.C., Weisel R.D. Guidelines for reporting morbidity and mortality after cardiac valvular operations. Eur J Cardiothorac Surg 1996;10(9):812-816.[Abstract]
  5. David T.E., Feindel C.M., Scully H.E., Bos J., Rakowski H. Aortic valve replacement with stentless porcine aortic valves: a ten-year experience. J Heart Valve Dis 1998;7:250-254.[Medline]
  6. Dellgren G., David T.E., Raanani E., Bos J., Ivanov J., Rakowski H. The Toronto SPV: hemodynamic data at 1 and 5 years post-implantation. Semin Thorac Cardiovasc Surg 1999;11(Suppl 1):107-113.[Medline]
  7. David T.E., Puschman R., Ivanov J., Bos J., Armstrong S., Feindel C.M., Scully H.E. Aortic valve replacement with stentless and stented porcine valves: a case-match study. J Thorac Cardiovasc Surg 1998;116:236-241.[Abstract/Free Full Text]
  8. Westaby S., Horton M., Jin X.Y., Katsumata T., Ahmed O., Saito S., Li H.H., Grunkemeier G.L. Survival advantage of stentless aortic bioprostheses. Ann Thorac Surg 2000;70(3):785-790.[Abstract/Free Full Text]
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  10. David T.E., Ivanov J., Eriksson M.J., Bos J., Feindel C.M., Rakowski H. Dilatation of the sinotubular junction causes aortic insufficiency after aortic valve replacement with the Toronto SPV bioprosthesis. J Thorac Cardiovasc Surg 2001;122(5):929-934.[Abstract/Free Full Text]
  11. Jin X.U., Gibson D.G., Yacoub M.H., Pepper J.R. Perioperative assessment of aortic homograft. Toronto stentless valve, and stented valve in the aortic position. Ann Thorac Surg 1995;60:S395-S401.
  12. Walther T., Falk V., Autschbach R., Scheidt A., Baryalei M., Schindewolf K., Dalichau H., Mohr F.W. Hemodynamic assessment of the stentless Toronto SPV bioprosthesis by echocardiography. J Heart Valve Dis 1994;3:657-665.[Medline]
  13. Jin X.U., Zhang Z.M., Gibson D.G., Yacoub M.H., Pepper J.R. Effects of valve substitute on changes in left ventricular function and hypertrophy after aortic valve replacement. Ann Thorac Surg 1996;62:683-690.[Abstract/Free Full Text]
  14. Del Rizzo D.F., Goldman B.S., Christakis G.T., David T.E. Hemodynamic benefits of the Toronto stentless valve. J Thorac Cardiovasc Surg 1994;112(6):1431-1445.[Abstract/Free Full Text]
  15. De Paulis R., Sommariva L., De Matteis G.M., Caprara E., Tomai F., Penta de Peppo A., Polisca P., Bassano C., Chiariello L. Extent and pattern regression of left ventricular hypertrophy in patients with small size CarboMedic aortic valves. J Thorac Cardiovasc Surg 1996;113:901-909.[Abstract/Free Full Text]
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  17. Dellgren G., Eriksson M., Blange I., Brodin L.., Rdegran K., Sylvén C. Angiotensin converting enzyme gene polymorphism influences degree of left ventricular hypertrophy in aortic stenosis. J Am Cardiol 1999;84:909-913.



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