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Ann Thorac Surg 2008;85:e14-e16. doi:10.1016/j.athoracsur.2007.12.007
© 2008 The Society of Thoracic Surgeons
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Case Reports

Forty-Year Survival With Smeloff-Cutter and Starr-Edwards Prostheses

Takanori Suezawa, MD*, Toru Morimoto, MD, Teiji Jinno, MD, Mamoru Tago, MD

Department of Cardiovascular Surgery, Kagawa Prefectural Central Hospital, Kagawa, Japan

Accepted for publication December 3, 2007.

* Address correspondence to Dr Suezawa, Department of Cardiovascular Surgery, Kagawa Prefectural Central Hospital, 5-4-16, Ban-cho, Takamatsu-shi, Kagawa, 760-8557, Japan (Email: suezawa2004{at}yahoo.co.jp).


   Abstract
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This case study describes a 40-year follow-up of a man who had a double valve replacement with Smeloff-Cutter aortic (Cutter Laboratories, Berkeley, CA) and Starr-Edwards mitral prostheses (Edwards Laboratories, Santa Ana, CA) when he was 34 years old. Double valve replacement was performed for aortic and mitral valve stenosis and insufficiency. To date, no surgical treatment has been required except a pacemaker implantation. The patient presented with a New York Heart Association functional class of I to II. Echocardiography revealed intact prostheses.


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Nearly 50 years before winning the Lasker Medical Award in 2007, Dr Starr implanted the first successful mitral valve in a patient. During the intervening years, he and his engineering partner fine-tuned the design of the Starr-Edwards prosthesis (Edwards Laboratories, Santa Ana, CA) to improve function and durability. A number of people, including 4 patients who experienced more than 40 years of survival, received the benefit. The 1965 implantation design (SE#6120), with a relatively low rate of thromboembolism, is in current use [1–3].

In 1964 Dr Smeloff introduced the first prosthetic valve with the full-flow orifice concept, which was achieved by 2 open cages of different sizes. The Smeloff-Cutter prosthesis (Cutter Laboratories, Berkeley, CA) is known for its self-washing system that helps in preventing clot formation. More than 70,000 prostheses have since been implanted, and several reports estimate the durability of the prostheses at 25 to 28 years [1, 4, 5].

The following case demonstrates the long-lasting durability of a Smeloff-Cutter (Cutter Laboratories) implanted in the aortic position and a Starr-Edwards (Edwards Laboratories) in the mitral position during a period of 40 years.

A 34-year-old man who was being conservatively managed for aortic and mitral valve stenosis and insufficiency presented with shortness of breath during exercise and at rest. He was assessed at New York Heart Association (NYHA) functional class IV. The patient was admitted to Okayama University Hospital. Double valve replacement was performed on May 18, 1967. The prostheses implanted during the operation were a Smeloff-Cutter aortic valve (A5) and a Starr-Edwards mitral valve (M4). Two months after the operation, the patient was discharged and he returned to his former occupation.

In 1972, the patient was admitted to our hospital with aortic valve thrombosis. Thrombolysis with urokinase and anticoagulant therapy with warfarin were initiated. His condition then showed improvement. After the event, continuous anticoagulation therapy was prescribed. In 1975, the patient experienced an irregular heartbeat and shortness of breath while climbing. An electrocardiogram (ECG) showed atrial fibrillation (AF), which was terminated with cardioversion. In 1976 and 1981, the patient was conservatively treated for transient ischemic attack (TIA) with AF. Pacemaker implantation was performed in 1981 for AF bradycardia.

Today, 40 years after his initial operation, the patient leads a normal life with no neurologic symptoms. With oral medications consisting of furosemide, spironolactone, losartan, and warfarin, which are carefully monitored every month, his NYHA functional classification remains at I to II.

In September 2007, the patient visited our clinic for a check-up. Cardiac auscultation revealed no murmur and normal sounds of the opening and closing clicks of the prostheses. The lungs were clear on auscultation. Laboratory studies revealed the following data: hemoglobin level, 10.3 g/dL; lactose dehydrogenase level, 294 IU/L; free hemoglobin level, 11.2 mg/dL; prothrombin time, 27%; and international normalized ratio, 2.66. The ECG showed ventricular paced rhythm.

A standard chest roentgenogram showed mild cardiomegaly (cardiothoracic ratio, 0.65), no pulmonary congestion, and the 2 implanted prostheses. The poppets of the prostheses were radiolucent; however, high-resolution image-intensification fluoroscopy detected their regular and harmonious movement. The aortic prosthesis had 2 open cages, and the mitral prosthesis had 4 thick struts joined at the apex and a heavy valve base with a "double-doughnut" configuration (Fig 1).


Figure 1
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  		Fig 1. Image intensification fluoroscopy. (A) Plane A (16° caudally tilted 18° left anterior oblique projection) shows aortic valve prosthesis. (B) Plane B (20° cranially tilted 21° right anterior oblique projection) focuses on the mitral valve prosthesis.

 
Simultaneous phonocardiography and echocardiography revealed no malfunctions of the prostheses, such as prolonged or varying intervals between the opening and closing clicks (Fig 2). Echocardiography showed trivial transvalvular leakage in the aortic position and no mitral valvular regurgitation. The mean transvalvular pressure gradient was 6.7 mm Hg in the aortic position, and the peak transvalvular pressure gradient was 23.6 mm Hg in the mitral position. No thrombotic material or cloth cover tear was found either at the prostheses or in the cardiac chambers.


Figure 2
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  		Fig 2. Phonocardiography and echocardiography. (A) One of the C.C. (a)-O.C. (m) intervals is shown in seconds. (B) The transthoracic Doppler signals were taken at the left ventricular inlet. (a = aortic prosthesis; C.C. = closing click; ECG = electrocardiogram; O.C. = opening click; Phono. = phonocardiogram; m = mitral prosthesis.)

 

   Comment
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 Abstract
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 Comment
References
 
According to previous case reports and long-term follow up studies, 28 years is the longest survival period after aortic valve replacement with Smeloff-Cutter prosthesis [5]. For the Starr-Edwards prosthesis, 37-year survival after mitral valve replacement and 41-year survival after aortic valve replacement have been previously reported [3]. Our case therefore provides useful information to people with the prosthesis and to Third World countries in which the caged-ball valve continues to be used because of its reasonable cost.

Complications of the ball valve include thromboembolism, ball variance, hemolysis, high-pressure gradient, noise, and growth of pannus. In this patient, valve thrombosis occurred 5 years after valve replacement and thrombolytic therapy took effect. After this event, no such complication occurred with therapeutic anticoagulation. Dr Smeloff reported low incidence of thromboembolic events in fully anticoagulated patients with Smeloff-Cutter prosthesis in aortic and mitral position [4]. Starr, Gometza, and their colleagues [6, 7] also reported that the prosthesis in the aortic position had markedly low rates of thromboembolism, even in patients on a regimen of antiplatelet agents only; however, those patients who received no medication had a higher incidence of embolic events. With the Starr-Edwards prosthesis, thromboembolic events were the major complications of SE#6000, and they diminished greatly after introduction of SE#6120. There is no record of the model number of the mitral prostheses implanted in our patient. However, the findings of fluoroscopy described for this patient conform to roentgenographic features of model SE#6000 [2]. Our patient is expected to continue to receive controlled anticoagulation therapy.

Examinations 9 and 11 years after valve replacement, when TIA occurred, showed no findings of thromboembolism. This may be a complication caused by AF. After implantation of the pacemaker in this patient, 26 years passed with no event.

According to the patient’s history as well as recent studies, no valve-related complication except thromboembolism occurred. Our case demonstrates that Smeloff-Cutter and Starr-Edwards ball valves are durable for at least 40 years in some patients. Anticoagulation or antiplatelet therapy appears to be a long-term solution to increase the durability of the mechanical valve.


   References
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 Abstract
 Introduction
 Comment
 References
 

  1. Gott VL, Alejo DE, Cameron DE. Mechanical heart valves: 50 years of evolution Ann Thorac Surg 2003;76:S2230-S2239.[Abstract/Free Full Text]
  2. Bonchek LI, Dobbs JL, Matar AF, Chappel P, Starr A. Roentgenographic identification of Starr-Edwards prostheses Circulation 1973;47:154-161.[Abstract/Free Full Text]
  3. Gao G, Wu Y, Grunkemeier GL, Furnary AP, Starr A. Forty-year survival with the Starr-Edwards heart valve prosthesis J Heart Valve Dis 2004;13:91-96.[Medline]
  4. Smeloff EA. Comparative study of heart valve design in the 1960s Ann Thorac Surg 1989;48:S31-S32.[Medline]
  5. Naito Y, Nakajima M, Inoue H, Hibino N, Mizutani E, Tsuchiya K. Unexpected durability of Smeloff-Cutter aortic ball valve prosthesis Ann Thorac Surg 2003;75:1633-1635.[Abstract/Free Full Text]
  6. Starr DS, Lawrie GM, Howell JF, Morris GC. Clinical experience with the Smeloff-Cutter prosthesis: 1- to 12-year follow-up Ann Thorac Surg 1980;30:448-454.[Abstract/Free Full Text]
  7. Gometza B, Duran CM. Ball valve (Smeloff-Cutter) aortic valve replacement without anticoagulation Ann Thorac Surg 1995;60:1312-1316.[Abstract/Free Full Text]



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