Mechanical Prosthetic Valve Thrombosis Research Articles

Ultraslow low-dose thrombolytic therapy in patients with acute mechanical prosthetic heart valve thrombosis – A prospective cohort study

BackgroundWhile surgery still remains the gold standard treatment for mechanical prosthetic valve thrombosis (MPVT) by many guidelines, the ultraslow low-dose thrombolytic regimen has been reported as a promising alternative. MethodsIn this prospective single-center cohort, patients with acute MPVT were treated with an ultraslow low-dose thrombolytic regimen consisting of 25 mg infusion of recombinant tissue-type plasminogen activator (rtPA) over 25 h. The regimen could be repeated in case of failure until resolution/occurrence of adverse events or a maximum cumulative dose of 150 mg. The primary outcome was the complete MPVT resolution rate; other outcomes included first-dose success rate, major bleeding, thromboembolic events, mortality, and total thrombolytic dose/duration. ResultsBetween April 2018 to January 2024, 135 episodes of acute MPVT were treated with an ultraslow low-dose thrombolytic regimen in 118 patients. In 118/135 (87.4 %) episodes, right-sided prosthetic valve was involved. Complete success was achieved in 88.1 % of cases, with 39.5 % responding after the first dose. The median total dose was 50 mg over a median of 30 h. Only one fatal intracranial hemorrhage occurred (0.7 %), with no other bleeding or thromboembolic complications. ConclusionThe ultraslow low-dose thrombolytic regimen appears to exhibit high efficacy and acceptable safety in treating acute MPVT. Further large clinical trials are essential for validating these preliminary findings.

Surgery compared to fibrinolytic therapy for symptomatic left-sided prosthetic heart valve thrombosis (SAFE-PVT): Rationale and design of a randomized controlled trial

BackgroundLeft-sided mechanical prosthetic heart valve thrombosis (PVT) occurs because of suboptimal anticoagulation and is common in low-resource settings. Urgent surgery and fibrinolytic therapy (FT) are the two treatment options available for this condition. Urgent surgery is a high-risk procedure but results in successful restoration of valve function more often and is the treatment of choice in developed countries. In low-resource countries, FT is used as the default treatment strategy, though it is associated with lower success rates and a higher rate of bleeding and embolic complications. There are no randomized trials comparing the two modalities. MethodsWe performed a single center randomized controlled trial comparing urgent surgery (valve replacement or thrombectomy) with FT (low-dose, slow infusion tissue plasminogen activator, tPA) in patients with symptomatic left-sided PVT. The primary outcome was the occurrence of a complete clinical response, defined as discharge from hospital with completely restored valve function, in the absence of stroke, major bleeding or non-CNS systemic embolism. Outcome assessment was done by investigators blinded to treatment allocation. The principal safety outcome was the occurrence of a composite of in-hospital death, non-fatal stroke, non-fatal major bleed or non-CNS systemic embolism. Outcomes will be assessed both in the intention-to-treat, and in the as-treated population. We will also report outcomes at one year of follow-up. The trial has completed recruitment. ConclusionThis is the first randomized trial to compare urgent surgery with FT for the treatment of left-sided PVT. The results will provide evidence to help clinicians make treatment choices for these patients.(Clinical trial registration: CTRI/2017/10/010159).

Systemic thrombolysis for mechanical prosthetic valve thrombosis - case report and review of literature

Prosthetic valve thrombosis is one of the life-threatening complications in patients with prosthetic heart valves. It is more common in mechanical prosthetic valves in the setting of inadequate or missing anticoagulation. Besides optimization of anticoagulation urgent surgery or thrombolytic therapy should be considered but both are associated with an increased risk for complications and mortality. We report a case of a patient with imaging data for mechanical prosthetic mitral valve thrombosis. Considering the individual patient’s characteristics and the published guidelines we decided to perform systemic thrombolysis with ultra-slow low-dose infusion of tissue-type plasminogen activator. The therapy was successful without any bleeding or thromboembolic complications. 

Diagnosis of Left-Sided Mechanical Prosthetic Valve Thrombosis: A Pictorial Review.

Although transcatheter valve therapy is rapidly evolving, surgical valve replacement is still required in many patients with severe left-side valve stenosis or regurgitation, the mechanical bi-leaflet heart valve being the standard prosthesis type in younger patients. Moreover, the prevalence of valvular heart disease is steadily increasing, especially in industrialized countries, and the problem of lifelong efficient anticoagulation of these patients remains fundamental, especially in the context where vitamin K antagonists continue to be the current standard of anticoagulation despite a level of oscillating anticoagulation. In this setting, avoiding prosthetic valve thrombosis after surgery is the number one objective for both the patient and the responsible physicians. Although rare, this complication is life threatening, with the sudden onset of acute cardiac failure such as acute pulmonary edema, cardiogenic shock, or sudden cardiac death and inadequate anticoagulation remaining the leading cause of prosthesis thrombosis, along with other risk factors. The availability of multimodal imaging techniques enables and encompasses to a full extent the diagnosis of mechanical valve thrombosis. The gold-standard diagnostic methods are transthoracic and transesophageal echocardiography. Moreover, 3D ultrasound has undoubted value in giving a more accurate description of the thrombus's extension. When transthoracic and transesophageal echocardiography are uncertain, the multidetector computer tomography examination is an important complementary imaging method. Fluoroscopy is also an excellent tool for evaluating the mobility of prosthetic discs. Each method complements the other to differentiate an acute mechanical valve thrombosis from other prosthetic valve pathologies such as pannus formation or infective endocarditis and aids the physician in accurately establishing the treatment method (surgical or pharmaceutical) and its optimal timing. The aim of this pictorial review was to discuss from an imagistic perspective the mechanical prosthetic aortic and mitral valve thrombosis and to provide an overview of the essential role of non-invasive exploration in the treatment of this severe complication.

Mechanical prosthetic mitral valve thrombosis during dabigatran treatment

Dabigatran has been approved for prevention of thromboembolic complications in non-valvular atrial fibrillation. We present a case of a mechanical prosthetic mitral valve thrombosis during anticoagulation with dabigatran, switched in the last three months after 10 years treatment with warfarin. The patient presented with acute respiratory failure and decompensated heart failure. She was initially treated with unfractioned heparin and then was sent for emergency surgery for cardiogenic shock. As emerging from contemporary evidence and as recommended by guidelines, dabigatran, as well as the other direct oral anticoagulants, should be avoided in patients with mechanical valve prosthesis. Echocardiography is indicated if dyspnoea develops in such patients.

THE CHALLENGES OF CHRONIC ANTICOAGULATION IN PATIENTS WITH PROSTHETIC HEART VALVES

The vitamin K antagonists (VKA) had been the sole option to reduce or prevent the mechanical prosthetic valve thrombosis and thromboembolic phenomena for last several decades. Their chronic usage can lead to both bleeding as well as thrombotic complications. As the therapeutic window for the drug levels is very narrow, VKA therapy needs close monitoring and periodic blood testing (PT-INR). Patients have to follow bothersome diet restrictions. Patient-education and co-operation are paramount for maintaining the INR in the prescribed safe range. The recommendation for bridging therapy when the patients with mechanical valves are subjected to any procedure or surgery is not standardized and such instructions are often confusing to patients, family members and ill-trained health professionals. The management of special populations such as the pregnant and the elderly continue to be very challenging. Anticoagulation is generally avoided in those with bioprosthetic valves unless there is atrial fibrillation. An early clinical trial with rivaroxaban in patients with bioprosthetic valves and atrial fibrillation (RIVER trial) proved it to be non-inferior to warfarin. The role of newer oral anticoagulants in patients with prosthetic valves is the current focus of research. With large number undergoing transcutaneous aortic valve implantation (TAVI) which is a bioprosthetic device, deciding what constitutes the optimal anticoagulant for them has become an emerging clinical challenge.

Clinical profile of left sided mechanical prosthetic valve thrombosis and role of fibrinolysis as the treatment in a tertiary care hospital in a suburban area of southern part of India - A retrospective study

Clinical profile of left sided mechanical prosthetic valve thrombosis and role of fibrinolysis as the treatment in a tertiary care hospital in a suburban area of southern part of India - A retrospective study

Case report: Mechanical mitral prosthetic valve thrombosis in the context of COVID-19 despite effective anticoagulation

BackgroundThe SARS-CoV2 virus has been an emerging virus since December 2019 and is the cause of a global pandemic whose clinical manifestations extend far beyond respiratory disease.Case summaryA patient with severe coronavirus disease 2019 respiratory infection, carrying a mechanical mitral valve and under anticoagulation, was admitted to our cardiology department because of a new atrial fibrillation, which turned out to be related to thrombosis of the mitral mechanical valve.ConclusionThe pro-coagulant effect of the SARS-CoV2 virus does not spare patients at risk of thrombosis, even under effective anticoagulation. In patients with mechanical valves under vitamin K antagonist treatment, there is a high risk of thrombus formation. The treatment is based on thrombolysis by therapeutic anticoagulation, fibrinolysis, or surgery depending on the size, composition of thrombus, and clinical manifestation.

Fast vs. ultraslow thrombolytic infusion regimens in patients with obstructive mechanical prosthetic valve thrombosis: a pilot randomized clinical trial.

Thrombolysis is an alternative to surgery for mechanical prosthetic valve thrombosis (MPVT). Randomized clinical trials have yet to test the safety and efficacy of a proposed ultraslow thrombolytic infusion regimen. This single-centre, open-label, pilot randomized clinical trial randomized adult patients with acute obstructive MPVT to an ultraslow thrombolytic regimen [25mg of recombinant tissue-type plasminogen activator (rtPA) infused in 25h] and a fast thrombolytic regimen (50mg of rtPA infused in 6h). If thrombolysis failed, a repeated dose of 25mg of rtPA for 6h was administered in both groups up to a cumulative dose of 150mg or the occurrence of a complication. The primary outcome was a complete MPVT resolution (>75% fall in the obstructive gradient by transthoracic echocardiography, <10° limitation in opening and closing valve motion angles by fluoroscopy, and symptom improvement). The key safety outcome was a Bleeding Academic Research Consortium type III or V major bleeding. Overall, 120 patients, including 63 (52.5%) women, at a mean age of 36.3±15.3years, were randomized. Complete thrombolysis success was achieved in 51 patients (85.0%) in the ultraslow-regimen group and 47 patients (78.3%) in the fast-regimen group [odds ratio 1.58; 95% confidence interval (CI) 0.25-1.63; P = 0.34]. One case of transient ischaemic attack and three cases of intracranial haemorrhage (absolute risk difference -6.6%; 95%CI -12% -0.3%; P = 0.07) were observed only in the fast-regimen group. The ultraslow thrombolytic regimen conferred a high thrombosis resolution rate without major complications. Such findings should be replicated in more adequately powered trials.

Thrombolysis Versus Redo-Surgery for Treatment of Mechanical Prosthetic Mitral Valve Thrombosis in Young Adult Patients

Abstract Objectives To evaluate and compare outcome of redo-surgery and thrombolysis for treatment of mitral PVT following mechanical valve replacement for rheumatic etiology in young adult patients (<50 years old). Methods and Results This retrospective study included 42 young adult patients who had PVT after mechanical valve replacement for rheumatic mitral valve disease, between January 2014 and June 2019. Eighteen patients underwent redo-surgery and 24 patients underwent thrombolysis (Streptokinase 100,000 U/h for at least 24 hours). The approach of treatment was based on proposed criteria considering hemodynamic status, NYHA functional class, and thrombus size. Complete response to thrombolysis was defined by normal clinical and echocardiographic parameters. Primary outcome included response to thrombolysis, complications, mortality, and recurrence. The median follow-up period was 24 months. The thrombus size was significantly larger in redo-surgery group (9.88±2.44 mm2 vs 5.87±1.26 mm2, P < 0.001). The response to thrombolysis was complete recovery (70.8%), partial recovery (16.7%), or failure (12.5%). There was no significant difference in the incidence of major complications. Mortality was significantly higher in redo-surgery group (27.8% vs 4.2%, P = 0.03), with cumulative survival of 72.2% for redo-surgery versus 95.8% for thrombolysis (Log-rank P-value = 0.04). The reduced cumulative survival with redo-surgery was more evident in patients with delayed presentation (> 1 week). Recurrent thrombosis occurred only with thrombolysis (8.3% vs 0%, P = 0.20). Cumulative proportions for freedom from thrombosis were 100% for surgery versus 78.1% for thrombolysis (Log-rank P-value = 0.17). Conclusions Proper patient selection may improve outcome after treatment of mitral PVT using thrombolysis or redo-surgery in young adults. Redo-surgery has advantages over thrombolysis regarding mid-term recurrence of thrombosis; however, thrombolysis has significantly lower mortality than redo-surgery. Further evaluation of the proper treatment for delayed presentation of PVT is recommended.

Mechanical Prosthetic Aortic Valve Thrombosis Treated with Low-dose Ultra Slow Infusion of Tissue-type Plasminogen Activator during Pregnancy.

Mechanical Prosthetic Aortic Valve Thrombosis Treated with Low-dose Ultra Slow Infusion of Tissue-type Plasminogen Activator during Pregnancy.

Thrombosis of Mechanical Mitral Valve Prosthesis Treated With Fibrinolysis

Mechanical prosthetic valve thrombosis is an uncommon but serious complication associated with high mortality and morbidity. Conventionally, prosthetic valve thrombosis is treated with surgical intervention, but recent literature has shown that slow-infusion of low-dose fibrinolytic therapy could be of equal efficacy.

Mechanical prosthetic valve thrombosis in current era: 5-year follow-up.

The incidence of prosthetic valve dysfunction (stuck valve) is variable and is dependent on various factors. There are studies from Indian groups that have emphasized the success of thrombolysis; however, none of them reported a follow-up. This study was designed to emphasize on the follow-up of these patients at midterm. The patients of prosthetic valve thrombosis between period of January 2013 and December 2017 were included in this retrospective observational study. Sixty-six patients were admitted with stuck valve during this period. Thrombolysis was preferred modality of treatment. Survivors were followed up with serial echocardiography, which included estimation of left ventricular and valve functions. Of a total of 66 patients, 59 were of stuck mitral valve and 7 stuck aortic valve. The event happened at a mean of 48.86 ± 48.80months after index operation of valve replacement using mechanical valve prosthesis. The median age was 40.27 ± 10.8years with 39 males and 27 females. Thrombolysis was successful in 61 patients with a mortality of 5 (7.57%). During a mean follow-up of 22.7 ± 20.9months, 42 patients were alive with 14 (22.95%) patients dead and 5 patients lost to follow-up. The average follow-up was 18.7 ± 22.7months before death. Following good early results after thrombolysis, patients of prosthetic heart valve thrombosis experience high mortality within 2years of follow-up. These patients require frequent follow-up to avoid early mortality.

Fibrinolysis in left-sided mechanical prosthetic valve thrombosis with high INR.

A significant number of patients with prosthetic valve thrombosis have a prothrombin time international normalised ratio in the therapeutic range at presentation. Surgery may not be possible in many patients and traditionally a high international normalised ratio is considered a relative contraindication for fibrinolysis. We conducted an observational study in patients with left-sided obstructive prosthetic valve thrombosis with international normalised ratio at or above the therapeutic range at presentation who received fibrinolysis. The fibrinolytic regimens, timing of initiation, success of fibrinolysis, risk of major and minor bleeding and ischaemic stroke were evaluated in the study. Of 30 patients included in the study 70% received immediate fibrinolysis and in 30% it was delayed. The majority of patients (90%) presented with New York Heart Association class III/IV symptoms. The mean international normalised ratio at fibrinolysis was 3.04 ± 0.70 in the immediate group and 2.42 ± 0.89 in the delayed group. Haemodynamically stable patients who had delayed initiation of fibrinolysis had a trend towards less bleeding without an increase in mortality. The rates of intracranial haemorrhage (0% vs. 7.7%), minor bleeding (12.5% vs. 25.1%) and ischaemic stroke (0% vs. 30.7%) were lower in patients who received low dose infusion compared to a conventional dose. Fibrinolysis can be considered in patients with prosthetic valve thrombosis with high international normalised ratio at presentation. For haemodynamically stable patients, delayed initiation of fibrinolysis is associated with a marginally lower bleeding risk without an increase in mortality. Low dose infusion may be considered over a conventional dose as it is associated with a lower incidence of ischaemic stroke and a good rate of valve function restoration with a trend towards less bleeding.

Index of deterioration of patients with mechanical prosthetic heart valve thrombosis

BackgroundMechanical prosthetic heart valves are known for their durability; however, a malfunctioning prosthesis can deteriorate rapidly to become a life-threatening complication. Our aim was to calculate a numerical index to express the rate of clinical deterioration of patients presenting with a mechanical prosthetic heart valve thrombosis (PVT), called the index of deterioration (ID), and to evaluate its usefulness in predicting hospital outcomes.ResultsThe median ID and range were (0.43, 0.03-3) NYHA class/day. A higher ID was significantly related to early development of PVT after native valve replacement, younger age, female gender, pregnancy, non-compliance to oral anticoagulation (OAC), low LVEF%, high mean pressure gradient across a mitral prosthesis, raised serum creatinine, and SGOT on admission (P < 0.05). Independent predictors were early presentation after native valve replacement, female gender, and non-compliance to OAC (P < 0.05).ID correlated positively with the need for urgent/emergency surgery, and the durations of cardiopulmonary bypass, postoperative mechanical ventilation, and positive inotropes. ID correlated negatively with the postoperative LVEF% (P < 0.05). Median ID of the 21 mortalities (0.75, 0.1-3) was > 2.1 times that of survivors (0.35: 0.03−2; P = 0.002), and the median ID of the 29 cases with postoperative complications (0.5, 0.1-1.5) was 2.5 times that of the 39 uneventful cases (0.2, 0.03-2; P = 0.011). The ID significantly predicted both mortality (odds ratio 3.87; 1.33-1.29; P = 0.013) and mortality and hospital complications (odds ratio 4.77; 1.49-15.2; P = 0.008). The respective discriminating abilities were AUC 0.734 (0.616-0.852; P = 0.002) and 0.724 (0.61-0.835; P < 0.001). EuroScore II correlated positively with ID (r = 0.571; P < 0.001) but showed better discriminative abilities.ConclusionThe simple index of deterioration was useful in monitoring deterioration and predicting hospital progression and outcomes in patients presenting with PVT.

Clinical Outcomes of Mechanical Prosthetic Valve Thrombosis.

ObjectiveTo evaluate characteristics and outcomes of patients presenting with mechanical prosthetic valve thrombosis in a tertiary cardiac center in Pakistan.MethodsThis was a prospective and interventional study conducted at Rawalpindi Institute of Cardiology over a period of two years. The clinical characteristics of patients presenting with clinical suspicion of prosthetic valve thrombosis were recorded. They were, then, subjected to streptokinase, redo surgery and heparin based on their hemodynamic stability, thrombus burden and surgical risk. The patients were then followed for the outcomes of the study.ResultsOut of 576 patients with mechanical valve replacement during the study period, 70 patients had developed prosthetic valve thrombosis. Out of 70 patients, there were 41 female (58.50%) and 29 male (41.50%) participants. The mean age of the participants was 48.40±15.00 years. The overall incidence of mechanical prosthetic valve thrombosis was 12.15%. There were 30 patients (42.80%) with a suboptimal international normalized ratio (INR) and 28 patients (40.00%) were non-compliant to warfarin therapy. The overall incidence of adverse clinical outcome was 18.00%, while the overall mortality rate was 10.00%. The mortality was higher for patients who underwent redo surgery (16.60%) as compared to patients who had received fibrinolytic therapy (9.60%).ConclusionPoor compliance with warfarin and suboptimal INR are the important factors causing mechanical prosthetic valve. Because of lower mortality rate, fibrinolysis with streptokinase is a reasonable treatment option for mechanical prosthetic valve thrombosis.

MULTIPLE PAPILLARY FIBROELASTOMAS AND MITRAL PROLAPSE WITH UNEXPECTED THROMBOTIC COMPLICATION

Papillary fibroelastoma (PFE) is a benign cardiac tumor usually unique and involving left valves. Multiple tumors including the tricuspid valve are very rare. Thrombosis of mechanical prosthetic valve is a high mortality complication that requires rapid assessment and treatment. A 42 years old

Prosthetic Valve Thrombosis: About 205 Patients

Background: The prosthetic heart valve thrombosis (PVT) is a life-threatening complication of mechanical valve prosthesis. It can be attributed more frequently to inadequate anticoagulant therapy. In the aortic and mitral position, reported incidences vary widely from 0.5% to 6% per patient-year, and are highest in the mitral position and up to 20% in tricuspid valve prosthesis. Medical therapy (Thrombolysis) has emerged as an alternative therapy in high-risk surgical patients, considering that surgical prosthetic valve replacement is related to significant operative morbidity and mortality rates. The purpose of this study is to present a single-center experience of 205 consecutive patients hospitalized between 2000 and 2016. Methods: From 2000 to 2016, 205 consecutive patients were hospitalized in our center for mechanical prosthetic valve thrombosis (PVT). The diagnosis of PVT was mainly assessed by echocardiography and/or fluoroscopy. There were 41 men and 164 women aged between 07 to 75 years. Prosthetic valve location was mitral in 191 patients, tricuspid in 05, aortic in 8 and mitro-tricuspid in one case. Predisposing causes of MVT were: poor compliance with warfarin, pregnancy or unknown. The interval from first operation to valve thrombosis was from 1 day to 38 years. Delay from first symptoms to hospitalization ranged from 1 to 4 months. The diagnosis was an incidental finding during an echocardiography, on the basis of a subacute increase in the transvalvular mean gradient seen due to thrombotic obstruction on transthoracic echocardiography and was confirmed by transesophageal echocardiography. First clinical symptoms were reported as systemic emboli, progressive exertional dyspnea (NYHA II to III–IV), muffled opening or closing sounds of the prosthetic valve, left heart failure, stroke, and cardiogenic shock. Transthoracic echocardiography is the diagnostic tool often used to evaluate a patient with valve prosthesis, when there is suspicion of PVT, and also is useful in the follow-up of patients during thrombolysis. Fluoroscopy was complementary. Anticoagulation regimen was inadequate, recently stopped or incorrectly conducted. Results: There were two groups, the first group (A) comprised of 135 patients have been operated with cardiopulmonary bypass (CPB) (prosthetic replacement or declotting and excision of pannus). It is an emergency surgery in 101 patients. In this group, we deplore 18 (13.5%). 70 patients underwent medical treatment (heparin, oral anticoagulants and aspirin) on clinical, sonographic and under strict supervision in a hospital and some external purposes for a period of 07 days at 6 months. For the non-operated group, all patients have unlocked their prothesis; we deplored 05 deaths (7.14%) (hemorrhagic stroke, left and right ventricle dysfunction). Conclusion: PVT remains a serious complication of mechanical heart valve prosthetic with high morbidity and mortality despite aggressive treatment by thrombolysis and/or surgery. Surgery treatment should be the preferred therapeutic modality for most patients with PVT. Thrombolysis, followed by heparin, warfarin, and aspirin is advised for high-risk surgical candidates without hemodynamic instability under strict echocardiographic survey. Because of the high risk of thromboembolism during thrombolysis for left sided PVT. For certain category of patients, medical therapy (thrombolysis anticoagulation++aspirin) may be offered in highrisk surgical patients, this with the consent of patients on medical and surgical rigorous monitoring and evaluating the operational risk compared to the risk of progression under medical treatment.

Management of Acute Mechanical Mitral Valve Thrombosis With Venoarterial Extracorporeal Membrane Oxygenation (ECMO)

MECHANICAL PROSTHETIC VALVE THROMBOSIS (PVT) and obstruction is a life-threatening event. Due to the associated progressive presentation of heart failure symptoms and often frequent delay in diagnosis, a high mortality rate has been described.1 In addition, surgical intervention in this setting has been associated with high perioperative risk for poor outcome that directly correlates with the degree of hemodynamic instability and a higher New York Heart Association functional class on presentation.

A global perspective on mechanical prosthetic heart valve thrombosis: Diagnostic and therapeutic challenges.

Prosthetic valve thrombosis is one of the major causes of primary valve failure, which can be life-threatening. Multimodality imaging is necessary for determination of leaflet immobilization, cause of underlying pathology (thrombus versus pannus or both), and whether thrombolytic therapy attempt in the patient would be successful or surgery is needed. Current guidelines for the management of prosthetic valve thrombosis lack definitive class I recommendations due to lack of randomized controlled trials, and usually leave the choice of treatment to the clinician’s experience. In this review, we aimed to summarize the pathogenesis, diagnosis, and management of mechanical prosthetic valve thrombosis.