Complicaciones tromboembólicas y hemorrágicas en pacientes portadores de prótesis valvulares del corazón en un centro de tercer nivel. ¿Qué hemos aprendido? / Thromboembolic and hemorrhagic complications in patients with prosthetic heart valves at third level care center. What have we learned?

Resumen Antecedentes: El reemplazo valvular por prótesis mecánicas o biológicas implica riesgo de tromboembolismo y complicaciones hemorrágicas. Objetivo: Determinar las complicaciones relacionadas con la terapia de anticoagulación complementaria y la probabilidad de riesgo en pacientes portadores de prótesis valvulares del corazón. Métodos: Se estudiaron 163 pacientes entre 2002 y 2016, portadores de prótesis mecánicas y biológicas, quienes recibieron antagonistas de la vitamina K posterior al egreso hospitalario. La terapia de anticoagulación se categorizó en óptima y no óptima conforme a los valores de INR previos a las complicaciones. Fueron excluidos los pacientes con comorbilidades y otros factores de riesgo de trombosis y/o sangrado. Resultados: a 68.7 % de los pacientes se les colocó prótesis mecánica y a 31.3 %, biológica (p ≤ 0.001); 25.2 % presentó las complicaciones motivo de estudio (p ≤ 0.001), hemorrágicas en 48.8 %, tromboembólicas en 26.8 % y de ambos tipos en 24.4 % (riesgo relativo = 4.229); a 95.1 % de los pacientes con complicaciones se les colocó prótesis mecánica y a 4.9 %, biológica (p = 0.005); 49.7 % presentó INR no óptimo (p ≤ 0.001). Conclusiones: Ante riesgo alto de complicaciones tromboembólicas y hemorrágicas, la elección de las prótesis valvulares, la prevención y el seguimiento son prioridades, principalmente en quienes requieren terapia de anticoagulación.

Abstract Background: Heart valve replacement surgery with mechanical or biological prostheses entails a risk of thromboembolism and bleeding complications. Objective: To determine the complications related to complementary anticoagulation therapy and the probability of risk. Methods: One-hundred and sixty-three patients who underwent heart valve replacement between 2002 and 2016 with either mechanical or biological prostheses, and who received vitamin K antagonists after hospital discharge, were studied. Anticoagulation therapy was categorized into optimal and non-optimal according to INR values prior to the development of complications. Patients with comorbidities and other risk factors for thrombosis and/or bleeding were excluded. Results: In total, 68.7 % of patients received mechanical prostheses, and 31.3 %, biological prostheses (p ≤ 0.001); 25.2 % experienced the complications that motivated the study (p ≤ 0.001), which were hemorrhagic in 48.8 %, thromboembolic in 26.8 %, and of both types in 24.4 % (relative risk = 4.229). Among the patients with complications, 95.1 % received mechanical prostheses, and 4.9 %, biological (p = 0.005); non-optimal INR was identified in 49.7 % (p ≤ 0.001). Conclusions: Given the high risk of thromboembolic and hemorrhagic complications, valve prostheses must be carefully chosen, and care priorities should include prevention and follow-up, especially in those patients who require anticoagulation therapy.

Implications of five-year outcomes of PERIGON trial for bioprosthetic aortic valve replacement / 中国胸心血管外科临床杂志

@#For patients with aortic valve disease who require replacement of their native valve, surgical aortic valve replacement (SAVR) has been the standard of care. Due to the hemorrhage and thromboembolic risks of long-term anticoagulation therapy for mechanical prosthesis, bioprosthetic aortic valve replacement (AVR) has a trend to be used in younger patients, which raising the concern for the durability of bioprosthetic valves. The newly published 5-year outcomes of PERIGON trial, with no structural valve deterioration, again demonstrated the favorable durability of the new generation bioprosthetic valves, further providing the evidence of using bioprosthetic AVR in younger patients. At the meantime, the rapid progress of transcatheter aortic valve implantation (TAVI) has brought a new treatment option. For younger patients with low risks, choosing SAVR or TAVI becomes a critical decision. This paper reviews the outcomes of PERIGON trial and its implications to the clinical practice and research of bioprosthetic AVR.

A Case of Mechanical Hemolytic Anemia due to Aortic Regurgitation Jet Collision with the Mitral Valve Stent-Post / 日本心臓血管外科学会雑誌

The 76-year-old woman underwent double bioprosthetic valve replacement for aortic and mitral valve regurgitation without any postoperative complication. About 33 months later, the patient complained of sudden dyspnea and was diagnosed with mechanical hemolytic anemia, severe aortic regurgitant jet collision with stent post (SP) at mitral position and acute heart failure. The cause of mechanical hemolysis was suspected to be a collision of the regurgitant jet due to structural valve deterioration (SVD) with the SP because of the absence of any paravalvular leak (PVL). The externally-mounted bioprosthetic aortic valve was replaced and the inadequate projection of the SP in left ventricular outflow tract was recognized simultaneously. The patient fully recovered from heart failure and hemolytic anemia after surgery. Early SVD of externally-mounted bioprosthetic valves has often been reported, and the eccentric regurgitant jet due to SVD may collide with any sub-valvular structures. We report a rare case of hemolytic anemia due to SVD.

Implications of five-year outcomes of COMMENCE (SAVR) trial for aortic valve surgery in China / 中国胸心血管外科临床杂志

@#The advent of transcatheter aortic valve replacement (TAVR) has brought up a new treatment option for patients with severe aortic valve disease. However, with the continuous expansion of surgical indications, problems such as structural valve deterioration caused by biological prosthesis have become increasingly prominent. In the newly announced 5-year follow-up results of COMMENCE (SAVR) trial, the aortic bioprosthesis using the new RESILIA biotissue material demonstrated extraordinary clinical safety, efficacy and durability with zero structural valve deterioration and excellent hemodynamic evaluation results. As a result, patients with valvular heart disease have more diverse therapeutic options. However, the choice between surgical aortic valve replacement (SAVR) and TAVR, biological prosthesis and mechanical prosthesis, etc, has become more and more prominent, which brings more difficulties to clinicians. This paper reviews the research background, 5-year follow-up results of COMMENCE trial and the implications for aortic valve surgery in China.

Comparison of Implantability, Early Post-Operative Valve Function and Structural Valve Deterioration between the Carpentier-Edward Perimount Magna Valve and St. Jude Medical Trifecta Valve / 日本心臓血管外科学会雑誌

Purpose : Easy and safe implantability, good post-operative valve function and good long-term durability are required for any bioprosthetic valve implanted in aortic position. The Carpentier Edwards Perimount Magna valve (Magna) was introduced in 2009 and the St. Jude Medical Trifecta valve (Trifecta) was introduced in 2012 to our institution. In this study, we compared implantability, early post-operative valve function and structural valve deterioration (SVD) between these two valves. Patients and Methods : Between January 2009 and December 2019, Magna or Trifecta were electively implanted for 254 patients (Magna 151 patients and Trifecta 103 patients) and these patients were included in this study. Implantability was evaluated by occurrence of intraoperative valve dysfunction. Early post-operative valve function was evaluated by mean pressure gradient (m-PG) and indexed aortic valve area (AVAI) by ultrasonography performed 10 days after surgery. The relationship between indexed bioprosthetic valve orifice area calculated from internal diameter (GOAI) and AVAI was evaluated. If there was a significant relationship between GOAI and AVAI, maximum body surface area (BSA) to obtain AVAI≥0.85 cm2/m2 was estimated from 99% reliable interval of regression line. Results : Age, gender, and BSA did not differ between the two groups. There was no intraoperative valve dysfunction in Magna ; however we experienced one patient with severe aortic regurgitation due to stent distortion by the aortic wall during surgery with the 25 mm Trifecta valve. For this patient, Trifecta was replaced with Magna intra-operatively. In the 19 mm valve, AVAI was significantly larger (1.12±0.27 cm2/m2 vs. 0.88±0.21 cm2/m2, p<0.001) and m-PG was significantly lower (8.7±2.7 mmHg vs. 17.2±6.3 mmHg, p<0.001) in Trifecta. The frequency of AVAI<0.85 cm2/m2 (24% vs. 49%, p=0.036) and the frequency of m-PG≥20 mmHg (0% vs. 26%, p=0.006) were significantly less in Trifecta. There was significant relationship between GOAI and AVAI in both valves. Maximum BSA to obtain AVAI ≥0.85 cm2/m2 was estimated as 1.35 m2 in Magna and 1.50 m2 in Trifecta. In the 21 mm valve, AVAI was significantly larger (1.14±0.23 cm2/m2 vs. 0.92±0.22 cm2/m2, p<0.001) and m-PG was significantly lower (7.8±3.2 mmHg vs. 14.6±4.7 mmHg, p<0.001) in Trifecta. The frequency of AVAI<0.85 cm2/m2 was significantly less in Trifecta (11% vs. 42%, p=0.002) ; however, the frequency of m-PG≥20 mmHg did not differ significantly. There was a significant relationship between GOAI and AVAI in Magna and Trifecta. Maximum BSA to obtain AVAI ≥0.85 cm2/m2 was estimated as 1.49 m2 in Magna and 1.70 m2 in Trifecta. In the 23 and 25 mm valves, AVAI was significantly larger and m-PG was significantly lower in Trifecta. However neither the frequency of AVAI<0.85 cm2/m2 nor m-PG≥20 mmHg differed between the two valves. There was one early (27 months after surgery) SVD due to leaflet tear in Trifecta and two SVDs due to leaflet calcification more than 10 years after surgery in Magna. Conclusion : For Trifecta implantation, valve size selection seemed to be important and larger valves should be avoided with narrow ST junctions. Selection of 19 and 21 mm Magna valves should be limited for the patient with a BSA less than 1.35 and 1.49 m2 respectively. In Trifecta, early SVD might occur and careful follow-up is necessary.

A Case of Minimally Structural Deterioration in Starr-Edwards Caged-Disk Valve 39 Years after Implantation / 日本心臓血管外科学会雑誌

<p>The durability of the Starr-Edwards (SE) mitral caged-disk valve, model 6520, is not clearly known. We reported that SE mitral caged-disk valves implanted ＞20 years previously should be carefully followed up, and that SE caged-disk valves implanted ＞30 years previously should be electively replaced with modern prosthetic valves in our experience. We found the removed valve 39 years after implantation, which seemed minimal structural deterioration. The patient was discharged on the 10th postoperative day without any complications.</p>

Aortic Insufficiency Caused by a Leaflet Tearing of the Medtronic Freestyle Stentless Aortic Bioprosthesis Complicated by Rheumatic Multivalvular Heart Disease / 日本心臓血管外科学会雑誌

<p>We report a case of an 85-year-old woman with severe aortic insufficiency caused by structural valve deterioration (SVD) of Medtronic Freestyle stentless aortic bioprosthesis (Freestyle valve) complicated by rheumatic multivalvular heart disease. The patient received an aortic valve replacement by using the modified sub-coronary method with a 21 mm Freestyle stentless porcine valve (Medtronic Inc., Minneapolis, MN, USA), for severe aortic valve stenosis at of the age of 71. The patient developed severe heart failure 14.5 years after the surgery. She was admitted for severe aortic insufficiency caused by a leaflet injury (tear) of the Freestyle valve. She also had had rheumatic mitral stenosis and secondary tricuspid insufficiency with severe pulmonary hypertension. Therefore, treating her heart failure was difficult, but surgery was performed. The leaflets of the stentless bioprosthesis were resected. The insertion of the needle suture into the annulus of the stentless valve was difficult because of calcification of the tissue. An aortic root enlargement procedure was performed using a bovine pericardial patch, enabling the insertion of the needle suture into the Dacron cloth at the bottom of the stentless valve, with 2-0 Ethibond threads and single sutures. We successfully performed an aortic valve re-replacement using an Open Pivot Mechanical Heart Valve (OPHV) 16 mm AP (Medtronic, Minneapolis, MN, USA), which was implanted by using the partial valve-in-valve technique. Simultaneously, mitral valve commissurotomy and tricuspid annuloplasty were performed. The patient had an uneventful postoperative recovery.</p>

Hemolytic Anemia after Mitral Valve Surgery / 日本心臓血管外科学会雑誌

<b>Objective</b> : The aim of this study is to describe a series of patients undergoing reoperation due to hemolytic anemia after mitral valve surgery and assess the mechanisms and surgical outcomes. <b>Methods</b> : Between 2009 and 2014, we performed redo mitral valve surgery in 11 patients who had refractory hemolytic anemia after mitral valve surgery at Kyoto University Hospital. The mean age of the patients was 72.2±6.8 years old, and there were 5 men. <b>Results</b> : Preoperative echocardiography demonstrated that only 3 patients had ≥ grade 3 mitral regurgitation (MR), the rest of the patients had only mild to moderate MR. The mechanisms of severe hemolysis included paravalvular leakage (PVL) after mitral valve replacement (MVR) in 8 patients, structural valve deterioration (SVD) after MVR using a bioprosthesis in one, and residual/recurrent mitral regurgitation after mitral valve plasty (MVP) in two. All the patients except one (re-MVP) underwent MVR. The mean interval between previous operation and current operation was 14.1±9.4 years in post-MVR cases, and 2.0±1.9 years in post-MVP cases. There were three late deaths, one of which was due to cardiac death (exacerbation of heart failure due to pneumonia). There was one patient who required re-MVR for recurrent hemolysis due to PVL after MVR. <b>Conclusion</b> : Although hemolytic anemia after mitral valve surgery is rare, it often requires reoperation regardless of the degree of MR at late follow-up period. Thus, patients after mitral valve surgery should be carefully followed-up.

Emergent Redo-Mitral Valve Replacement during Pregnancy at 23 Weeks and 4 Days of Gestation due to Bioprosthetic Valve Deterioration / 日本心臓血管外科学会雑誌

We report a case of emergent redo-mitral valve replacement during pregnancy at 23 week and 4 days of gestation. A 23-year-old woman, who underwent mitral valve replacement with a bioprosthetic valve (Carpentier-Edwards Perimount^® 27 mm) for infective endocarditis 5 years ago, was transferred to our hospital due to severe congestive heart failure. Echocardiography revealed structural valve deterioration of the mitral prosthesis and severe mitral stenosis. Emergent redo-mitral valve replacement with a bioprosthetic valve was performed to save the patient with top priority. Cardiopulmonary bypass was operated under normothermic, high flow, high pressure and pulsatile fashion. Fetal heart rate was continuously monitored during the operation. Although her baby was delivered vaginally just after operation weighing only 520 g, she was treated by the neonatologists successfully.

Early Structural Valve Deterioration of Third-Generation Porcine Bioprosthesis in Patients / 日本心臓血管外科学会雑誌

A 78-year-old woman underwent mitral valve replacement (MVR) with bioprosthesis in 1984. By 1997 the valve had become dysfunctional and was replaced with a Mosaic valve. Dyspnea on exertion occurred in 2005 and a systolic murmur was detected at that time. Echocardiography revealed severe mitral regurgitation (MR). The mitral valve was replaced for the third time. The explanted valve showed commissural dehiscence at the stent position and calcified leaflets. The mitral valve of a 70-year-old man was replaced with a bioprosthesis in 1986, and again with a Mosaic valve in 1997 because the original bioprosthesis had become dysfunctional. Seven years later, a systolic murmur appeared and echocardiography revealed severe MR. The valve was replaced for the third time. A leaflet tear was found in the removed valve. The Mosaic valve is a third generation porcine bioprosthesis that reportedly has excellent long-term durability. However, in these cases, the Mosaic valves deteriorated prematurely, and no obvious causes of this early structural deterioration could be identified. Continued long-term follow up is necessary, and the possibility of premature deterioration should be considered when selecting bioprostheses.