Thrombosis of two St. Jude Medical prostheses in one patient after triple valve replacement. Case report and review of the literature

Reports of experience with the St. Jude Medical (SJM) valve state that thrombosis of the prosthesis is a rare complication. In a 57-year-old woman, reoperation was necessary 12 months after triple valve replacement using SJM prostheses because of thrombosis of the valves in the tricuspid and aortic positions. Dysfunction of both mechanical valves was detected clinically by changing heart sounds and the appearance of murmurs. Echocardiography and cinefluoroscopy confirmed at least one fixed leaflet of the tricuspid prosthesis, but abnormalities of the aortic prosthesis could not be detected. At reoperation, the SJM prosthesis in the tricuspid position was almost completely thrombosed and was replaced by an Ionescu-Shiley bioprosthesis. A thrombotic formation at the hinge point of the SJM aortic prosthesis was removed. To our knowledge, this is the first report of a thrombotic complication of two SJM prostheses after triple valve replacement in one patient.     

Nonsurgical correction for thrombosis of a St. Jude Medical tricuspid prosthesis: Report of a case

A 43-year-old woman with rheumatic heart disease underwent replacement of the aortic, mitral, and tricuspid valves using three SJM prostheses. Despite adequate warfarin therapy, routine cineradiography performed on the 40th postoperative day showed one of the leaflets of the tricuspid prosthesis to be “stuck” in the semiclosing position. A thrombosis of the tricuspid prosthesis was successfully treated with a urokinase infusion and mechanical thrombolysis using a pacemaker, following which normal valve function was restored.     

Valve thrombosis of St. Jude Medical prosthesis; report of three cases

Three cases with valve thrombosis of St. Jude Medical prosthesis (SJM valve) are reported. Incidence of valve thrombosis of SJM valve was 0.15%/patient-year. Cineradiography was useful to make the diagnosis. SJM valves were implanted with the hinges anatomically oriented in mitral position, and in both aortic and tricuspid positions with the leaflet opening parallel to the ventricular septum. Therefore, we recommend that SJM valve should be placed with the hinge antianatomically oriented in mitral position, and in both aortic and tricuspid positions with the leaflet opening to be perpendicular to the interventricular septum, respectively.     

Operative results of tricuspid valve replacement with St. Jude Medical prosthesis

Since 1974, 14 patients underwent tricuspid valve replacement (TVR) with prosthetic heart valves. Hardy's operation was undergone in 2 patients with Ebstein's anomaly and mitral valve surgery or multiple valve surgery were undergone in 9 patients with rheumatic valvular disease, concomitantly. Four types of prosthetic heart valves were used in the tricuspid position, i.e. 2 Starr-Edwards prostheses, 1 Hancock xenograft, 1 Bj?rk-Shiley prosthesis and 12 st. Jude Medical prostheses. The operative mortality rate was 14.3% (2/14) and 2 hospital deaths were due to low cardiac output syndrome. Twelve survivors have been followed with a maximum follow-up of 13 years and the mean of 4.7 years. There were 3 late deaths due to congestive heart failure and prosthetic valve endocarditis (PVE) of the aortic Bj?rk-Shiley prosthesis. There was 1 PVE of the tricuspid Starr-Edwards prosthesis and 1 thrombosis of the tricuspid Bj?rk-Shiley prosthesis, but no thrombosis and no other valve-related complications of SJM prostheses in the tricuspid position. The post-operative NYHA function class improved satisfactorily in 9 survivors. Judging from our relatively satisfactory post-operative results in TVR cases using SJM prostheses, SJM prosthesis in the tricuspid position is one of advisable prosthesis to get satisfactory hemodynamic improvement post-operatively.     

Intermittent opening of a mechanical mitral valve prosthesis due to pannus formation; report of a case

A 76-year-old woman with a history of severe mitral valve stenosis had undergone mitral valve replacement with a 27 mm St. Jude Medical (SJM) valve in 1991. Follow-up transthoracic echocardiography revealed an increase in the pressure gradient across the mitral prosthesis 16 years after the surgery. Prosthetic valve dysfunction was suspected, but transesophageal echocardiography and cineradiography failed to show mechanical valve dysfunction. Two years later, she presented with dyspnea on exertion and leg edema. Cineradiography revealed intermittent restriction of the opening of the mechanical valve leaflet approximately every 10 beats. Thus, we diagnosed intermittent prosthetic valve dysfunction and performed a reoperation. On inspection of the prosthesis, we observed semicircular pannus formation around the posterior leaflet in the ventricular side. It was considered that the pannus tissue had interfered with 1 leaflet opening of the mitral valve prosthesis, resulting in intermittent valve dysfunction. We replaced the prosthesis with a new 25 mm SJM valve. The patient was discharged after confirmation of normal prosthetic function.     

Preexisting mitral valve prosthesis in patients undergoing left ventricular assist device implantation

Experience with patients undergoing left ventricular assist device (LVAD) implantation with preexisting mitral valve prostheses is limited. Patients with mechanical heart valves might have an increased risk of thromboembolism; in patients with biologic valves, there might be a risk of structural deterioration of the leaflets. Out of 597 patients supported with a LVAD system between 2000 and 2009, 18 patients had mitral valve surgery prior to implantation. We excluded all patients below 18 years of age, those with postcardiotomy failure, and patients who had had mitral valve reconstruction. Only 1% of the studied patient population (n= 6) had mitral valve replacement. The mitral valve implantation has been performed 7.4 ± 9.4 years prior to LVAD insertion. None of the valves (one biologic, five mechanical) were exchanged or explanted. LVAD implantation was done either with left lateral thoracotomy (n= 5) or with midline resternotomy (n= 1). Temporary right ventricular assist device support was necessary in one case (16.6%); 30-day mortality was 16.6% (n= 1). Median support time was 14 ± 15 months. Two patients received heart transplantation after 6 and 26 months on the device; four patients died on mechanical circulatory support after 1, 2, 5, and 40 months. No valve or pump thrombosis or other clinically relevant thromboembolic events were observed. Only a small number of patients (1%) had a preexisting mitral valve prosthesis prior to LVAD implantation. No severe adverse events were observed when the prosthesis was left in place. Attention should be paid to the anticoagulation regime.     

Surgical treatment of early acute thrombosis of mechanical mitral prosthesis

Prosthetic valve thrombosis is a rare but life threatening complication of mechanical heart valve prosthesis. A 44-year-old woman diagnosed with rheumatic heart disease with severe mitral valve stenosis, moderate tricuspid valve insufficiency, and atrial fibrillation underwent transseptal mitral valve replacement and tricuspid valvuloplasty in our department. Heparin and warfarin were routinely used postoperatively. Although the international normalized ratio (INR), activated partial thromboplastin time ratio, and platelet count were satisfactory, the patient presented with severe dyspnea suddenly 10 days after discharge; echocardiogram showed that the prosthetic posterior leaflet was immobile. The patient suffered cardiac arrest suddenly during the examination and cardiopulmonary resuscitation was carried out successfully. Emergent surgery was performed, confirming the prosthetic valve thrombosis. The prosthetic valve was replaced with another mechanical prosthesis. The patient recovered smoothly and was discharged 14 days later with atrial fibrillation. During the 12-months follow-up period, her prosthetic valve and heart function were normal with INR around 3.0. This case highlights the need for awareness among clinicians for the possibility of valve thrombosis in the early postoperative period.     

Case report of a malfunctioning SJM 19 A aortic valve prosthesis requiring reoperation

The patient was a 56-year-old female diagnosed with poor lung function who had undergone an aortic valve replacement 10 years ago, receiving an SJM 19 A prosthetic valve. She suffered from dyspnea and chest pain with postural change. Her anticoagulation level was maintained therapeutic. A cinefluoroscopy showed that one of the leaflets in the prosthetic valve was not moving. The aortic peak pressure gradient was calculated to be 68 mmHg using Doppler echocardiography. The patient's clinical condition improved after thrombolytic therapy with urokinase, but a complete normalization of her prosthetic discs was not obtained, so the patient was treated surgically. After an aortotomy, a pannus formation covering the entire SJM 19 A valve was observed. The aortic annulus was estimated to be 16 mm in diameter after the excision of the SJM 19 A valve and required before a larger prosthesis could be inserted. A SJM 19 HP valve was then anchored to the enlarged annulus. Her postoperative course was uneventful. We report a case requiring reoperation after a small aortic mechanical valve prosthesis implanted 10 years previously was damaged by thrombosis and pannus. Pannus formation on small aortic prosthesis easily caused hemodynamic obstructions and mechanical failure. Intensive evaluation with Doppler echocardiography and cinefluoroscopy is required for such patients.     

Tricuspid valve replacement with the St. Jude Medical valve

A study was conducted on 20 patients who underwent tricuspid valve replacement (TVR) with the St. Jude Medical (SJM) valve. Isolated TVR was performed on 9 patients, and additional mitral, or mitral and aortic valve replacements were performed on 11 patients. Four patients (20%) died in the early postoperative period, but there were no deaths related to the SJM valve in the tricuspid position. The mean follow-up period of the 16 survivors was 74.4 months, and there have been no deaths during the follow-up period. The postoperative actuarial survival rate was 80%, 10 years after surgery. Three patients, representing 0.25%/patient-months, developed valve thrombosis, the valve thrombosis-free rate being 72.8%, 10 years after surgery, while entrapment of a leaflet by endothelial pannus was found in one patient, representing 0.08%/patient-months. Thus, the incidence of all prosthetic valve-related complications was 0.34%/patient-months, and the postoperative complication-free rate was 65.3%, 10 years after surgery. The medium-term follow-up study of TVR with the SJM valve revealed no prosthetic valve-related deaths and a relatively low incidence of prosthetic valve-related complications. However, as with other mechanical valves, valve thrombosis was a major risk posed by the SJM valve in the tricuspid position.     

Selection of a prosthetic valve for mitral valve replacement

The early and the late results of mitral valve replacement were retrospectively evaluated to delineate the concept of selection of the prosthetic valve for the mitral position. The mitral valve was replaced with porcine bioprosthesis (P-B) in 102 patients and with St. Jude Medical prosthesis (SJM) in 341 patients between 1975 and 1987. Operative mortality was 5.3% for the SJM and 8.8% for the P-B group (N.S.). Cumulative duration of follow up was 1479.8 patient-years for the SJM and 888.9 patient-years for the P-B group. Actuarial survival rate was 90% for the SJM at 9 years and 81%, 76% for the P-B group at 10 and 13 years (N.S.). Freedom from valve-related death was 94% for the SJM at 9 years and 94% for the P-B at 13 years (N.S.). Thrombo-embolic complications occurred at an incidence of 0.47%/patient-years (p-y) for the SJM and 0.67%/p-y for the P-B group (N.S.). Freedom from prosthetic valve dysfunction due to primary tissue failure (PTE) lowered rapidly after the seventh postoperative year from 88% to 35% in the P-B group. Prosthetic valve dysfunction free rate was significantly lower in the P-B group compared with the SJM between the seventh post operative year and ninth postoperative year (p less than 0.01). From this analysis, we believe that the SJM prosthesis is suitable cardiac valve prosthesis to the mitral position.     

The St. Jude "Silzone" valve: midterm results in treatment of active endocarditis

BACKGROUND: The Silzone-coated St. Jude Medical valve (SJM "Silzone" valve), developed to reduce prosthetic valve endocarditis (PVE), was recalled by SJM due to a higher rate of paravalvular leaks. The aim of this study was to determine the efficacy of the SJM "Silzone" valve in avoiding PVE and to evaluate the frequency of paravalvular leaks, when the valve was used exclusively for active bacterial endocarditis. METHODS: From January 1998 to December 1999, the SJM "Silzone" valve was implanted in 40 consecutive patients with active endocarditis (20 aortic, 14 mitral, and 6 both valves). Late transesophageal echocardiography was performed in 87% of survivors, and transthoracic echocardiography in the remaining 13%. Follow-up was 100%. RESULTS: Hospital mortality was 17.5%. Early PVE occurred in 2 of 40 patients (5%). There were two late deaths without signs of recurrent PVE. A hemodynamic relevant paravalvular leak necessitating reoperation was seen in 2 patients within 6 months after operation. The rate of a minor paravalvular leak was 13% (4 of 31 patients). CONCLUSIONS: The SJM "Silzone" valve when implanted for active bacterial endocarditis does not give better results than other mechanical prostheses with regard to early recurrence of endocarditis. The rate of a hemodynamic relevant paravalvular leak requiring reoperation seems rather high during the early postoperative period, whereas the occurrence of minor paravalvular leaks is comparable with that of other mechanical prostheses. Routine observation, recommended for all patients with mechanical heart valves, is also sufficient for patients with the SJM "Silzone" valve.     

Thromboembolic and bleeding complications in patients treated with oral anticoagulant therapy after mechanical heart valve prostheses implantation

Thromboembolic and bleeding events are major cause of morbidity and mortality in patients with mechanical heart valves. Ninety-three patients had been received anticoagulant (warfarin with bucolome 300 mg) for mechanical prosthetic valves, and the regulation of anticoagulation was performed within a prothrombin time international normalized ratio (PT-INR) about 2.0 of normal. The mean duration of follow-up was 64.1 months, and the total duration of follow-up was 496.8 patient-years (py). The valve related complications occurred in 10 cases (2.0 per 100 py). Anticoagulant related hemorrhagic events occurred in 7 cases, and valve thrombosis in 3 cases. All three cases of valve thrombosis were in cases with Bj?rk-Shiley valve at the mitral position. An artificial valve in mitral position increased the valve related risk compared with the aortic position (3.1%/py vs 0.0%/py). Bileaflet valve showed a lower incidence of thromboembolism than tilting disc valve (2.3%/py vs 0.0%/py). The risk of valve related complication varied with the type and the position of the prosthesis, it is desirable that the intensity of anticoagulation would be changed according to the prosthetic valve type and its position. These results suggest that the intensity of anticoagulation is optimal when the PT-INR is 1.8-2.0 for patients with bileaflet valve in the mitral position, and is 1.6-1.8 in the aortic position. Tilting disc valve needs more intensity of anticoagulation, and needs additional antiplatelet agent in the mitral position.     

Bileaflet mechanical prostheses performance in mitral position

Objective: The experience with the Carbomedics (CM) and the St. Jude Medical (SJM) bileaflet mechanical prostheses was evaluated to determine thromboembolic and hemorrhagic complications and predictive risk factors. Methods: From 1989 to 1994, a total of 625 patients had mitral valve replacement (CM, 240; SJM, 385); 32.5% (203), concomitant procedures and 32.8% (205), previous cardiac surgery, primarily valve replacement procedures. Results: The pre-operative variables did not distinguish the populations, except for previous surgery CM 37.9% and SJM 29.6% (P<0.05). The pre-operative variables (type of prostheses, cardiac rhythm, coronary artery bypass, NYHA III/IV, advancing age, gender, urgency status and previous surgery) were not predictive of overall thromboembolism (TE), major TE, minor TE, prosthesis thrombosis and hemorrhage (P not significant; P=NS). The linearized rate of total TE events for overall MVR was 5.0%/patient-year (CM 4.4; SJM 5.4). The ≤30 day major crude rate was 0.44%, while the >30 day late major event rate was 2.0%/patient-year. Of the total TE events 91% of ≤30 days and 75%, >30 days had an INR <2.5 at or immediately prior to the event. The thrombosis rate (included in TE events) was 0.63%/patient-year (ten events, four managed successfully with thrombolysis, five successfully with reoperation, and one fatality identified at autopsy). The freedom, at 5 years, from major/fatal TE, thrombosis and hemorrhage from anticoagulation was 88.2%, and 89.5% exclusive of early events. Conclusions: This non-randomized prospective observational evaluation of the CarboMedics and St. Jude Medical prostheses has not revealed any differentiation in performance of the prostheses. The study serves as a single institution experience with the potential for future comparative evaluation.     

An unusual cause of acute mitral regurgitation in TTK Chitra heart valve prosthesis

Structural failure of mechanical heart valve was a known feature when it was evolving in the 1960s and 1970s. With the advent of pyrolytic carbon and a better design, it is a rare entity with present valves. We report a case of disc fracture leading to acute mitral regurgitation in TTK Chitra heart valve prosthesis (CHVP) (TTK Healthcare Limited, India) heart valve, 6 years after its implantation in mitral position.     

A successful surgical repair of acute postinfarction mitral papillary muscle rupture]

We reviewed a case who underwent early operation for acute postinfarction papillary muscle rupture. The patient was a 75-year-old male who was admitted to our hospital with cardiogenic shock required endotracheal intubation and intraaortic balloon support. The period to operation was 6 days from the onset of inferior myocardial infarction, and 2 days from the onset of postinfarction papillary muscle rupture. The posterior papillary muscle of mitral valve was totally ruptured and the mitral valve was replaced with a mechanical prosthesis (SJM 27 mm). Postoperative clinical course was not smooth, but the patient was going well. We believe to get good results for early operations of postinfarction papillary muscle rupture unless operative chances were lost.     

Use of an inverted On-X mitral valve in the aortic position in a resource limited setting

Implanting an inverted aortic valve prosthesis in the mitral position has shown to be a viable solution for a small mitral annulus. We describe a case of implanting an inverted in the mitral prosthesis in the aortic position in a patient with an excessively large aortic annulus. A 46-year-old male with severe aortic insufficiency underwent aortic valve replacement during a surgical outreach program in Tegucigalpa, Honduras. Aortic valve annulus measured 30 mm on preoperative echocardiogram. An inverted On-X mechanical mitral heart valve with Conform-X sewing ring 25/33 mm was implanted with an excellent hemodynamic result and no paravalvular leak. To the best of our knowledge, this case demonstrates the first inverted mitral prosthesis implanted in the aortic valve position.     

A case of thrombosed St. Jude Medical valve 16 years after initial mitral valve replacement]

We report successful surgery for a thrombosed St. Jude Medical (SJM) valve 16 years after the initial mitral valve replacement even under conditions of satisfactory anticoagulation therapy. A 61-year-old-female had intermittent claudication and was admitted to our hospital for examination. The prosthetic valve sounds were normal to auscultation and the left ankle-pressure index was decreased to 0.6. Transthoracic echocardiography revealed no mitral regurgitation and a mean mitral valve gradient of 6-7 mmHg. Furthermore, transesophageal echocardiography revealed that one of the leaflets of the prosthetic valve was entirely immobilized at the closing position and a mobile soft tissue mass, 5 mm in diameter, was detected at the atrial side of the obstructed leaflet. Although 96,0000 IU of urokinase was administered intravenously for a week, we could not confirm any change in leaflet mobility. At the time of surgery, the posterior leaflet of the SJM valve, which was implanted at an anatomical orientation, was obstructed at the closing position with old and fresh thrombi. We decided upon replacement with a CarboMedics 29 M prosthetic valve. Postoperative medication consisted of warfarin plus low-dose aspirin. Generally, valve thrombosis occurs within 5 years after valve replacement. However, valve thrombosis is possible even in a reliable SJM valve and as long as 16 years after replacement. Therefore, the implantation of an SJM valve at an anti-anatomical orientation might lower the incidence of valve thrombosis in addition to life-long anticoagulation therapy.     

Disruption of the silver and non-silver coated sewing cuff of a new generation bileaflet valve prosthesis during aortic valve replacement: report on four cases.

OBJECTIVES: New generation bileaflet valve prostheses with a silver-coated sewing cuff like the St Jude Medical (SJM((R)) Regent) model are designed to offer a larger valvular orifice as well as a better resistance to postoperative prosthetic endocarditis, at the expense of a smaller sewing cuff. METHODS AND RESULTS: We report on four cases of aortic valve replacement where during the implantation procedure the fixation cuff disrupted, leading to the exchange of all four valve prostheses. This happened three times with silver- coated sewing cuffs and after withdrawal of the silver- coated cuff prostheses from the market, once with a non silver- coated sewing cuff. This was due to the arbitrary cutting of the cuff fixation suture at the ventricular side of the prosthesis, although the implantation was performed according to the recommendations of the company. This problem didn't occur previously, using other models of the same manufacturer, although the sewing cuff had been fixed in the same technique. CONCLUSION: Fixation of smaller sewing cuffs of mechanical valve prostheses with a critically exposed fixation suture at the ventricular side of the prosthesis represents a significant risk for disruption during the implantation process through cut off by chance. We recommend meticulous inspection of the sewing cuff for signs of disruption before seating the valve into position. During follow-up particular attention should be paid to valve dislodgement and leakage. The company was informed and advised by us to modify the fixation of the prosthetic annulus of the SJM((R)) Regent valve, which has led to an alternative cuff design, called the SJM Flex cuff.     

Five-year clinical evaluation of the St. Jude Medical valve prosthesis in 136 patients

One hundred and thirty-six patients (June 1979, through May 1984) underwent mitral, aortic or double valve replacement and apico-aortic bypass with the St. Jude Medical (SJM) prosthesis, at Ryukyu University Hospital, Okinawa. Operative mortality for the entire group was 4.4 per cent. Late mortality from 1979-1984 was 6.1 per cent. There were no deaths related to mechanical failure. Warfarin anticoagulation was recommended for all patients. The incidence of thromboembolism was 0.76/100 patient years. Post operative catheterization studies in 21 patients one year after operation showed a satisfactory recovery of cardiac function. The SJM valve seems to be the satisfactory artificial valve in present use.     

A comparative study of the St. Jude Medical and Bj?rk-Shiley convexo-concave prostheses in isolated valve replacement

This is a study of 199 consecutive patients who survived isolated mitral or aortic valve replacement with a Bj?rk-Shiley (B-S) or St. Jude Medical (SJM) prostheses. Mean follow-up was 36 months. Preoperative status was similar for both groups (B-S or SMJ). Five year survival rates for mitral valve replacement (MVR) were 91% for B-S and SJM, and for aortic valve replacement (AVR) 96% vs 91% for SJM (p less than 0.06). Linearized incidence of thromboembolism in MVR was 5.62% patient year for BS and 5.23% patient year for SJM (p = NS). Classical risk factors for thromboembolism were evaluated on a univariate analysis: no single risk factor was identified. Only the association of two or more was possibly significant. The presence of inadequate anticoagulation (prothrombin index greater than 50%) was the main risk factor for thromboembolism, as the incidence rate was 19% per patient year when poorly anticoagulated versus 4.6% per patient year incidence in the whole series (p less than 0.01).