The Ross Procedure

The Ross Procedure was developed by a British surgeon, Dr. Donald Ross, and first performed in humans in 1967. The procedure was initially considered controversial by some because of its complexity and because some believe that it transforms a one-valve procedure into a two-valve procedure.¹ However, despite these concerns, over the next several decades studies continued to show excellent long-term results for patients undergoing the Ross Procedure.²

What is the
Ross Procedure?

The Ross Procedure (Pulmonary Autograft)

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The Ross Procedure is a surgical technique that uses your own healthy pulmonary valve (pulmonary autograft), which is a mirror image of a normal aortic valve, to replace your damaged aortic valve. A donated human pulmonary valve (pulmonary homograft/allograft) is used to replace your pulmonary valve.

Advantages of the
Ross Procedure

The Ross Procedure is the only surgical technique to replace the aortic valve with living autologous tissue, resulting in the advantages stated below. Importantly, the Ross Procedure is the only operation that has been consistently shown to restore long-term life expectancy (survival) of patients, compared to the general population.³

Advantages of the Ross Procedure Include:

No need for lifelong anticoagulation medicine (blood thinner)³
Excellent hemodynamic performance (blood flow) at rest and during exercise^4,5
Only operation shown to restore life expectancy similar to that of the general population³
Quality of life similar to those who have not undergone aortic valve replacement³
Low risk of thromboembolism (blood clots)³

The Science Behind the Ross Procedure

The aortic root is a living structure with complex functions, such as excellent hemodynamics (blood flow), low thrombogenicity (clot formation), and resistance to infections. The more “natural” these functions are after aortic valve replacement, the lower the risk of complications related to the implanted valve and the better the patient’s quality of life.^3,6
The aortic valve sees a lot of force and pressure as all the oxygenated blood that is pumped throughout your body via the left ventricle and through the aorta passes through the aortic valve.⁷
Your pulmonary valve is the mirror image of your aortic valve.⁶ It is a living structure, and it is your own valve, meaning that your body is highly likely to accept it in the aortic position.^1,3,6
Just like a high performance car needs to be as aerodynamic as possible, your heart valves need to have optimal hemodynamics for you to live a normal life. Since your pulmonary valve (pulmonary autograft) is the mirror image of your aortic valve,⁶ it retains natural hemodynamics, so your exercise capacity and quality of life after a Ross Procedure is very similar to “normal”.^1,3-6
In contrast to the Ross Procedure, conventional replacement valves (mechanical and bioprosthetic) are made of prosthetic (artificial) material. Not only are they unable to replicate the heart’s “natural” hemodynamics,^1,4,5,8 thus increasing stress on the heart muscle, but the risk of blood clot formation,^1,6,8-11 accelerated wear-and-tear,^8,9,12,13 and infection is significantly higher than with the Ross Procedure.^9,14,15

Candidate
Selection

Who is a Candidate for the Ross Procedure?

The ideal Ross Procedure patient is:

An adult less than 60 years old, with aortic valve disease that requires surgical replacement.
Someone with no chronic condition that may affect long-term survival such as chronic renal disease or severe coronary artery disease.
Women contemplating pregnancy.
Individuals who have active lifestyles.
Certain pediatric patients stand to benefit the most from this operation.^8,9

Who May Not be a Candidate for the Ross Procedure?

A patient may not be a candidate for the Ross Procedure if they have the following conditions:

Connective tissue disorders (e.g., Marfan syndrome, Loeys-Dietz syndrome)¹⁵
Some autoimmune diseases (e.g., rheumatoid arthritis, lupus erythematosus)¹⁵
Pulmonary valve disease¹⁵
Multi-vessel coronary artery disease¹⁵

This list is not exhaustive and does not apply to all patients. Please consult your physician for further evaluation.

Survival and
Reoperation Data

The Reality of Survival

The Ross Procedure is the only option for aortic valve replacement that has resulted in survival, or life expectancy, similar to that of matched general population and those who have not undergone aortic valve replacement.⁹

Numerous studies across various countries, totaling over 3,500 patients (at a mean age of 38 years at the time of surgery) have shown a survival rate of over 90% at 15 years after surgery. This means that 15 years after undergoing the Ross Procedure, 90% of these patients are still alive.^1-3,14,16-19
In a group of 1,501 young patients who underwent a Ross Procedure or prosthetic (mechanical or tissue) aortic valve replacement between 2000 and 2012 in the United Kingdom, it was found that the Ross Procedure was superior to mechanical valves and tissue valves in clinical outcomes.¹³

The Reality of Reoperation

A common misconception is that the Ross Procedure takes a one-valve disease and turns it into a two-valve disease and can result in early reoperation of the autograft (the new aortic valve) or the homograft (the human donor valve in the pulmonary position). However, the data paints a different picture.

Fifteen (15) years after surgery, almost 9 out of 10 patients continue to live without requiring a second intervention of either the pulmonary autograft or the homograft.^1-3,14,16-19 In addition, with today’s technology, most re-interventions on the homograft in the pulmonary position can be done using catheter-based approaches.^20,21 An important point to remember is that long-term durability of the Ross Procedure is largely dependent on the expertise of the surgeon. It is therefore important to seek high-volume centers of expertise with aortic surgery, and specifically with the Ross Procedure.²²

Which Line do You Want to be on When it Comes to the Reality of Reoperation?

Figure C - Comparison of Long-Term Outcomes among the Ross Procedure, Mechanical Aortic Valve Replacement, and Bioprosthesis for Young Adults¹³

Pulmonary Homograft

SynerGraft Pulmonary Valve

CryoValve^® SynerGraft Pulmonary Human Heart Valve is the First and Only Decellularized Human Heart Valve to Receive 510(k) Clearance From the US Food and Drug Administration.

*Compared to Standard Cryopreserved Allograft.

SynerGraft is CryoLife’s patented process that virtually eliminates the presence of donor cells while maintaining the functionality and shape of the biological matrix.^26,27 The SynerGraft process allows the donated pulmonary valve to be free of the donor’s cells without damaging the valve itself. The SynerGraft process removes over 99% of donor cells from the elements of the tissue matrix (see Figure 1).²⁸

Figure 1

CryoValve^® Leaflet Without SynerGraft Processing

CryoValve SG Leaflet After SynerGraft Processing

CryoValve^®SG Pulmonary Human Heart Valve has not been approved for use as a medical device by Health Canada, and nothing on this website is intended to promote its use in Canada.

References:

1. Mazine A et al., Circulation 2016;134(8):576-85.
2. David T et al., J Thorac Cardiovasc Surg 2014;147(1):85-94.
3. El Hamamsy I et al., The Lancet 2010;376(9740):524-31.
4. Pibarot P et al., Am J Cardiol 2000;86(9):982-8.
5. Laforest I et al., Circulation 2002;106:I-57-62.
6. El-Hamamsy I et al., Can J Cardiol 2013;29:1569-76.
7. https://www.nhlbi.nih.gov/node/3717. Accessed July 5, 2018.
8. El Hamamsy I et al., Ann Transl Med 2017;5(6):142.
9. Ouzounian M et al., J Thorac Cardiovasc Surg 2017;154:778-82.
10. Kvidal P et al., JACC 2000;35(3):747-56.
11. Bouhout I et al., JTCVS 2014;148(4):1341-46.e1.
12. Bourguignon T et al., Ann Thorac Surg 2015;99(3):831-37.
13. Sharabiani M et al. J Am Coll Cardiol 2016;67:2858–70.
14. Kalfa D, et al. Eur J Cardiothorac Surg 2015;47:159–67.
15. Cook S et al. Progress in Ped Cardiol 2003;16:133-140.
16. Sievers H et al., Euro J Cardio-Thorac Surg 2016;49:212-18.
17. Skillington P et al., Ann Thorac Surg 2013;96:823–9.
18. Andreas M et al., Ann Thorac Surg 2014;97:182–8.
19. Martin E et al., JACC 2017;70(15):1890-99.
20. Ghobrial J et al. Curr Cariol Rep 2016;18(4):33.
21. Cheatham J et al. Circulation 2015;131:1960-70.
22. Bouhout I et al., Interact CardioVasc Thorac Surg 2017;24:41-7.
23. Ruzmetov M, et al. J Thorac Cardiovasc Surg 2012; 143:543-9.
24. Brown JW, et al. J Thorac Cardiovasc Surg 2009; 139:339-348.
25. Bibevski S, et al. Ann Thorac Surg 2017; 103:869-875.
26. Elkins R, et al. Decellularized Human Valve Allografts. Ann Thorac Surg 2001; 71: S428-32.
27. Gerson C, et al. Circulation 2011; 64:33-42.
28. CryoLife, Inc. data on file, including interim data collected from the CryoValve SG Post Clearance study through 12.31.2012.