Ten-year experience with the On-X prosthetic heart valve

Tossios, Paschalis; Reber, Daniela; Wahle, Tina; Reichert, Josef; Fritz, Markus; Laczkovics, Axel

doi:10.1055/s-2007-967712

Cited by 5 publications

(11 citation statements)

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“…At 10-year follow-up for aortic and mitral valve replacement, Bryan and coworkers [31 ] reported a freedom from valve-related mortality of 95% in patients receiving a CarboMedics prosthesis and 93% for patients receiving a St. Jude Medical prosthesis. Similar rates of freedom from valve-related mortality were found with the ATS Medical valve [32] and the On-X valve [33,34].…”

Section: Long-term Outcomessupporting

confidence: 55%

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Are all bileaflet mechanical valves equal?

Halkos

Puskas

2009

Current Opinion in Cardiology

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Bileaflet mechanical valves are a valuable option for patients undergoing valve replacement surgery. All of the bileaflet designs provide good hemodynamic performance with long-term durability. However, some designs may provide better hemodynamic profiles in smaller valve sizes. Furthermore, newer models may have a more favorable thromboembolic profile. Nonetheless, the risk of anticoagulant-related complications with mechanical valves must be weighed against the risks of structural deterioration and reoperation of bioprostheses. Ultimately, the choice of prosthesis should be made after careful discussion with the patient, referring cardiologist, and cardiac surgeon.

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Section: Long-term Outcomessupporting

confidence: 55%

“…In a prospectively randomized comparison between the St. Jude Medical valve and the CarboMedics valve, the linearized bleeding event rates were 3.2 and 2.3% per patient-year, respectively [31 ]. The On-X and ATS Medical prostheses have shown similar rates of bleeding events [32][33][34].…”

Section: Long-term Outcomesmentioning

confidence: 99%

Are all bileaflet mechanical valves equal?

Halkos

Puskas

2009

Current Opinion in Cardiology

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“…15 Patients in this study were comparable in age to those of other studies describing outcomes after mechanical valve replacement. [3][4][5][6][7][8][9][10][11][12][13] Overall, 6% (38/682) of patients had preoperative left ventricular ejection fraction of less than 35%, whereas concomitant CABG was performed in 13% (80/682) of patients. Not surprisingly, patients with major thromboembolism tended to have a subtherapeutic INR, whereas patients with hemorrhagic events tended to have a supratherapeutic INR.…”

Section: Discussionmentioning

confidence: 99%

“…These are similar to previously reported rates for valve-related reoperation and valverelated mortality. [3][4][5]7,16,18,[20][21][22][23]…”

Section: Discussionmentioning

confidence: 99%

Influence of the On-X mechanical prosthesis on intermediate-term major thromboembolism and hemorrhage: A prospective multicenter study

Chan

Jamieson

Lam

et al. 2010

The Journal of Thoracic and Cardiovascular Surgery

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Objectives: Long-term thromboembolic and hemorrhagic outcomes after mechanical valve replacement have been well described; however, few studies have described these outcomes after valve replacement with the On-X mechanical prosthesis (On-X Life Technologies, Inc, Austin, Tex). Methods: Between 2003 and 2008, 737 patients underwent either aortic valve replacement (n ¼ 400), mitral valve replacement (n ¼ 282), or double-valve replacement (n ¼ 55). Longitudinal performance, freedom evaluation, and risk analysis were assessed with regard to major thromboembolism and hemorrhage. Risk modeling was performed with 16 variables inclusive of age, atrial fibrillation, concomitant coronary artery bypass grafting, New York Heart Association class, and ventricular dysfunction. Results: Early mortality was 2.5% (n ¼ 10) for aortic valve replacement and 3.2% (n ¼ 9) for mitral valve replacement. Late mortality for aortic valve replacement was 4.8% per patient-year and 6.0% per patient-year for mitral valve replacement. Five-year freedom from major thromboembolism was 96.5% AE 1.2% for aortic valve replacement and 97.7% AE 0.9% for mitral valve replacement. Five-year freedom from hemorrhage was 93.6% AE 1.8% for aortic valve replacement and 95.7% AE 1.5% for mitral valve replacement. Concomitant coronary artery bypass grafting was predictive of major thromboembolism after aortic valve replacement (hazard ratio, 5.3; P ¼ .02) and antithrombotic hemorrhage after mitral valve replacement (hazard ratio, 4.7; P ¼ .03). No other independent predictors of major thromboembolism or hemorrhage were identified. One thrombosed mitral prosthesis was observed after deliberate discontinuation of anticoagulation. The major thromboembolic events occurred with variation of international normalized ratio levels inclusive of subtherapeutic levels. The majority of hemorrhagic events occurred with high international normalized ratio levels. Conclusions: The On-X mechanical prosthesis provides favorable intermediate-term results with regard to major thromboembolism and hemorrhage.

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“…This pyrolytic carbon bileaflet valve has been reported to achieve excellent in vitro and in vivo [33][34][35] hemodynamics along with low adverse clinical event rates at long-term follow-up (mean follow-up 5.2 years) [36,37]. Anticoagulation therapy for On-X valves follows the general recommended INR targets yet mid-term thromboembolic event rates in a poorly anticoagulated cohort of patients in South Africa were acceptable [38].…”

Section: Modified Anticoagulation Strategiesmentioning

confidence: 99%

Review of anticoagulation options for mechanical valve prosthesis

Toeg

Boodhwani

2015

Interventional Cardiology

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Clinical guidelines recommend lifelong oral anticoagulation (OAC) with warfarin in all patients with mechanical valves with variance in the target INR for patient associated risk factors, type of mechanical valve or implant position of the valve. Recent randomized controlled trials have demonstrated that clinicians may consider a lower OAC strategy (INR: 1.5-2.5) in low (thrombogenic) risk patients undergoing bileaflet mechanical valve replacement thereby achieving similar thromboprophylaxis yet minimizing bleeding events. Likewise, physicians may also consider a lowered OAC option in high (thrombogenic) risk patients undergoing bileaflet mechanical valve replacement yielding similar efficacy (avoidance of thromboembolic events) and improving safety (bleeding events). Finally, while advancement of novel oral anticoagulants (NOACs) has been swift in the realm of atrial fibrillation anticoagulation management, NOACs for mechanical valves are currently contraindicated due to evidence of increased thromboembolic and bleeding risk. Future studies comparing NOACs and warfarin along with newer mechanical valve construction are eagerly being awaited. a significant increased risk of major bleeding [16]. At mid-term follow-up, contemporary (2005+) incidence of thromboembolic events has been relatively low ranging from 0 to 3.6% [17,18]. With the advent of newer generation mechanical valves, there is potential for achieving even lower rates of thromboembolic and bleeding events with either less intense OAC, antiplatelet therapy alone or potentially novel OACs (NOAC). Therefore, this review is aimed at discussing current practice trends, novel strategies and future endeavors for postoperative t hromboprophylaxis for mechanical valves. Current practice for anticoagulationCurrent international guidelines generally recommend the following: low dose aspirin (74-100 mg) for all patients, OAC in mechanical aortic valves with target INR 2.0-3.0 at low-risk for thromboembolic events and OAC with target INR 2.5-3.5 in mechanical mitral valves and high-risk aortic valve patients (Table 1) [12][13][19][20]. High-risk patients are considered to be those with concomitant atrial fibrillation, previous thromboembolism, hypercoagulable state or depressed left ventricular function [21,22]. These recommendations have been partially based on older studies using more thrombogenic mechanical valves (i.e., StarrEdwards ball and cage, Bjork-Shiley tilting disc) [23][24][25] along with a landmark meta-analysis by Cannegieter and colleagues [20]. Moreover, based on Massel and Little's meta-analysis, the European guidelines advise caution with the addition of an antiplatelet medication due to the increased risk of bleeding with an odds ratio of 1.58 (95% CI: 1.14-2.18) [16,26]. Several groups have demonstrated similar effectiveness with reduced OAC therapy (compared with historically target INR of 3.0-4.5 in patients with bileaflet St. Jude Medical [St. Jude Medical, Inc., Saint Paul, MN, USA]) mechanical valves, mostly in the aortic position [21,27]...

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Ten-year experience with the On-X prosthetic heart valve

Cited by 5 publications

References 0 publications

Are all bileaflet mechanical valves equal?

Are all bileaflet mechanical valves equal?

Influence of the On-X mechanical prosthesis on intermediate-term major thromboembolism and hemorrhage: A prospective multicenter study

Review of anticoagulation options for mechanical valve prosthesis

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