Outcomes of Watchful Waiting Strategy and Predictors of Postoperative Prognosis in Asymptomatic or Equivocally Symptomatic Chronic Severe Aortic Regurgitation With Preserved Left Ventricular Function.

BACKGROUND: The optimal surgical timing for asymptomatic or equivocally symptomatic chronic severe aortic regurgitation with preserved left ventricular ejection fraction remains controversial. METHODS AND RESULTS: Two hundred ten consecutive patients (median age 65 years) with asymptomatic or equivocally symptomatic chronic severe aortic regurgitation and left ventricular ejection fraction ≥50% were registered. First, the treatment plans (aortic valve replacement or watchful waiting) after initial diagnosis were investigated. Then, 2 studies were set: Study A (n=144) investigated the prognosis of patients who were managed under the watchful waiting strategy after initial diagnosis; Study B (n=99) investigated the postoperative prognosis in patients who underwent aortic valve replacement at initial diagnosis or after watchful waiting. The primary outcomes were all-cause death in Study A and postoperative cardiovascular events in Study B. In Study A, 3 died of noncardiovascular causes during a median follow-up of 3.2 years. In Kaplan-Meier analysis, the survival curve was similar to that of an age-sex-matched general population in Japan. In Study B, 9 experienced the primary outcome during a median follow-up of 5.0 years. In Cox regression analysis, preoperative left ventricular end-systolic diameter enlargement (hazard ratio, 1.11; P=0.048) and left ventricular end-systolic diameter >45 mm (hazard ratio, 12.75; P=0.02) were significantly associated with poor postoperative prognosis. In Kaplan-Meier analysis, left ventricular end-systolic diameter >45 mm predicted a higher risk of the primary outcome (P <0.01). CONCLUSIONS: Watchful waiting was achieved safely in asymptomatic or equivocally symptomatic chronic severe aortic regurgitation with preserved left ventricular ejection fraction. Preoperative left ventricular end-systolic diameter >45 mm predicted a poor postoperative outcome and may be an optimal cut-off value for surgical indication.

A case of successful surgical treatment of left ventricular thrombus associated with acute myocardial infarction by Impella combined with extracorporeal membrane oxygenation approach.

The mortality rate in patients with heart failure complicated by cardiogenic shock following acute myocardial infarction (AMI) remains high, prompting research on mechanical circulatory support. Improved mortality rates have been reported with the early introduction of EcMELLA (Impella combined with extracorporeal membrane oxygenation, ECMO). However, clear indications for this treatment have not been established, given the associated risks and limitations related to access routes. Left ventricular thrombosis is traditionally considered a contraindication for Impella use. A 74-year-old man without specific medical history or coronary risk factors was diagnosed with Forrester IV heart failure due to cardiogenic shock complicated by AMI and left ventricular thrombosis. The patient underwent emergency coronary artery bypass surgery, intracardiac thrombus removal, and Dor surgery. Following cardiopulmonary bypass, ongoing heart failure was observed, necessitating the implementation of EcMELLA for circulatory support. Preoperative computed tomography showed that the bilateral subclavian arteries were too narrow (< 7 mm) and anatomically unsuitable for traditional access methods. Thus, we introduced a single-access EcMELLA 5.5, through which the Impella was introduced and veno-arterial-ECMO blood was delivered from a single artificial vessel anastomosed to the brachiocephalic artery. The patient was weaned off veno-arterial-ECMO and extubated on postoperative day 3. By postoperative day 14, improved cardiac function allowed for Impella removal. The patient was discharged on postoperative day 31 with improved ambulation; thereafter, the patient returned to work. Thus, the single-access EcMELLA5.5 treatment strategy combined with Dor procedure was effective in left ventricular thrombosis in patients with heart failure with cardiogenic shock complicated by AMI.

Impact of Dietary Vitamin K Intake on Anticoagulation Therapy in Patients With Left Ventricular Assist Device During the 2018 Osaka Earthquake.

Background: The 2018 Osaka earthquake caused severe damage to the National Cerebral and Cardiovascular Center, and the interruption to the delivery of hospital food in particular had a significant effect on patients with left ventricular assist devices (LVAD). Methods and Results: We retrospectively assessed 10 patients who had been provided with emergency rations on the day of earthquake and the next day for breakfast. Catered foods were provided thereafter. Vitamin K content was largely reduced due to emergency rations; the prothrombin time-international normalized ratio (PT-INR) on day 2 was significantly higher than on day 1. Conclusions: Close monitoring of PT-INR and assessing vitamin K content may be important for preventing complications in patients with a LVAD during a disaster.

Case series: successful salvage from refractory cardiogenic shock caused by COVID-19-associated myocardial injury with temporary ventricular assist devices.

Background: Coronavirus disease 2019 (COVID-19) is predominantly known to cause respiratory injury; however, the present case series highlights four instances in which the infection resulted in significant cardiac complications. Among such cases, some represent severe cardiogenic shock, which necessitates the immediate introduction of mechanical circulatory support (MCS) for salvage. Case summary: This case series involved patients with COVID-19-associated myocardial injury leading to fulminant cardiogenic shock. These patients required immediate implementation of peripheral MCS, followed by an instant upgrade to a central MCS system due to anatomical limitations and severe biventricular dysfunction. Central MCS provided effective ventricular unloading, resulting in a significant and prompt improvement in ventricular function. The treatment timeline showed rapid deterioration followed by remarkable recovery within 2 weeks of MCS initiation, demonstrating the effectiveness of aggressive and tailored MCS strategies in managing severe COVID-19-related cardiac complications. Discussion: This study provides significant insights into the cardiovascular implications of COVID-19, particularly in the context of severe myocardial injury that leads to cardiogenic shock. The report underscores the importance of early recognition and intervention in such cases, focusing on the use of MCS as a life-saving modality. The findings also revealed unique pathological features of COVID-19-associated myocardial injury, including macrophage-predominant infiltration and microthrombosis, which are distinct from the features of conventional myocarditis. These findings highlight the need for further research on the pathophysiology of COVID-19-related cardiac injuries and the development of targeted therapeutic strategies.

Efficacy and Safety of Edoxaban in Anticoagulant Therapy Early After Surgical Bioprosthetic Valve Replacement: Rationale and Design of the ENBALV Trial.

BACKGROUND AND PURPOSE: Anticoagulant therapy with vitamin K antagonists is recommended within 3 to 6 months after bioprosthetic valve replacement to prevent thromboembolic events. However, data regarding whether direct oral anticoagulants can be an alternative to warfarin in such patients are limited. The purpose of this study is to compare the efficacy and safety of edoxaban versus warfarin within 3 months after bioprosthetic valve replacement. METHODS: The ENBALV trial is an investigator-initiated, phase 3, randomized, open-label, multicenter study. It involves patients aged 18 to 85 years undergoing bioprosthetic valve replacement at the aortic and/or mitral position. They are randomized 1:1 to receive either edoxaban or warfarin. Administration of edoxaban or warfarin is to be continued for 12 weeks after surgery. The primary outcome is the occurrence rate of stroke or systemic embolism at 12 weeks after surgery. The net clinical outcome is a composite of stroke, systemic embolism, or major bleeding, which is included in the secondary outcomes. CONCLUSION: The ENBALV trial demonstrates the efficacy and safety of edoxaban compared with warfarin in patients early after bioprosthetic valve replacement, including patients with sinus rhythm, which will bring a significant benefit to patients in clinical practice. TRIAL REGISTRATION: Japan Registry of Clinical Trials (jRCT) 2051210209. 30 Mar 2022 https://jrct.niph.go.jp/latest-detail/jRCT2051210209 .

Management of aortic valve insufficiency in patients with continuous-flow left ventricular assist device: a republication of the review published in Japanese Journal of Artificial Organs.

Since 2011, implantable ventricular assist devices have been a standard treatment for severe heart failure alongside heart transplantation in Japan. However, the limited availability of donors has led to a prolonged wait for transplants, now averaging 1719 days, intensifying the issue of aortic insufficiency in patients with continuous flow ventricular assist devices. These devices limit the opening of the aortic valve, leading to sustained closure and increased shear stress, which accelerates valve degradation. Risk factors for aortic insufficiency include having a smaller body surface area, being of advanced age, and the presence of mild aortic insufficiency prior to device implantation. In patients presenting with mild or moderate aortic regurgitation at the time of ventricular assist device implantation, interventions such as aortic valve repair or bioprosthetic valve replacement are performed with the aim of halting its progression. The choice of surgical procedure should be tailored to each patient's individual condition. The management of de novo aortic insufficiency in patients with continuous flow ventricular assist devices remains challenging, with no clear consensus on when to intervene. Interventions for significant aortic insufficiency typically consider the patient's symptoms and aortic insufficiency severity. De novo aortic insufficiency progression in continuous flow ventricular assist devices patients necessitates careful monitoring and intervention based on individual patient assessments and valve condition. This review was created based on a translation of the Japanese review written in the Japanese Journal of Artificial Organs in 2023 (Vol. 52, No. 1, pp. 77-80), with some modifications.

Successful Implantation of Rapid Deployment Aortic Valve after TAVR Explantation.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has become widely used in recent years, However, there is also an increasing need for removal of TAVR valves due to prosthetic valve dysfunction (PVD) and the development of infective endocarditis. Surgical aortic valve replacement (AVR) for these patients is risky due to the original patient background and anatomic conditions. Intuity rapid deployment aortic valve (Edwards Lifesciences, Irvine, CA) replacement would be useful for such high risk patients to prevent longer cardiac arrest time and obtain good hemodynamic results. However, there are few reports which present Intuity valve replacement after TAVR explantation. Herein, We report two cases in which we have achieved good hemodynamics with shorter cardiac arrest times by using a rapid deployment valve after TAVR explantation. CASE PRESENTATION: We present 2 cases of successful implantation of the Intuity rapid deployment valve after TAVR explantation. The 84- and 88-year-old female patients had previously received TAVR for severe aortic stenosis with SAPIEN XT (Edwards Lifesciences, Irvine, CA) and developed PVD during follow-up. The TAVR valve was removed carefully, then an Intuity valve was implanted with cardiac arrest times of 69 and 41 min. Both patients had good echocardiographic results with effective orifice area of 2.0 cm2 and 1.2 cm2 and mean trans-aortic plessure gradient of 9 mmHg and 15 mmHg respectively without aortic regurgitation. They were discharged without major complications. CONCLUSIONS: Surgical AVR using a rapid deployment valve is a useful alternative to sutured AVR after TAVR valve explantation. It allows for shorter cardiac arrest times and better postoperative hemodynamics without major complication.

Anterolateral papillary muscle suction causing low flow in a COVID-19 patient without medical history: a case report of central extracorporeal life support with left ventricular apex decompression.

BACKGROUND: Left ventricular (LV) decompression is an essential strategy for improving early survival in patients with refractory cardiogenic shock. Low pump flow in patients on extracorporeal life support (ECLS) with LV apex decompression is a life-threatening issue. However, identifying the underlying causes of low flow can be challenging. CASE PRESENTATION: A 38-year-old woman with COVID-19-related fulminant myocarditis was treated with central ECLS with LV apex decompression. The pump flow in the intensive care unit (ICU) was intermittently low, and low flow alerts were frequent. The initial evaluation based on pressure monitor waveforms and transthoracic echocardiography failed to identify the underlying cause. Prompt bedside transesophageal echocardiography (TEE) revealed that the anterolateral papillary muscle was suctioned into the vent cannula of the LV apex during systole. The patient underwent a repeat sternal midline incision in the operating room, and the cannula at the LV apex was repositioned. There were no further suction events after the repositioning, and the patient was weaned from ECLS 12 days after admission to the ICU. The patient was discharged in a stable condition and without neurological deficits. CONCLUSIONS: TEE is an important diagnostic tool to identify the underlying cause of low flow flow in patients undergoing ECLS with LV apex decompression.

Predictors of late outcomes after concomitant tricuspid valve repair with left-sided valve surgery.

BACKGROUND: Concomitant tricuspid valve (TV) repair is a safe and effective procedure to protect against late moderate or greater tricuspid regurgitation (TR) after left-sided valve surgery, but studies regarding its late outcomes and recurrent TR are limited. This study aimed to reveal the late outcomes and explore the predictors of mortality and recurrent TR among patients who underwent concomitant TV repair with left-sided valve surgery. METHODS AND RESULTS: This study included 645 patients (mean age, 69.7 years; 44% male) who underwent concomitant TV repair with left-sided valve surgery (mitral valve surgery in 594 cases, aortic valve surgery in 172 cases) from 2006-2020. Preoperative TR was grade 4, 3, and less than 2 in 85, 235, and 325 patients, respectively. The median follow-up period was 4.6 (IQR 1.7-7.8) years. The in-hospital or 30-day mortality was 1.7% (n = 11). Regarding long-term outcomes after TV repair, 90.3% and 80.8% achieved 5- and 10-year survival, respectively, while 96.1% and 88.8% achieved 5- and 10-year freedom from recurrent TR, respectively. The following were independent predictors of overall mortality on multivariate analysis in patients with preoperative TR grade ≥ 3: prior pacemaker implantation, preoperative renal dysfunction, diabetes mellitus and NYHA class ≥ 3. Also, suture annuloplasty and ring type of ring annuloplasty were not independent risk factors for recurrent TR, classified as grade ≥ 3. CONCLUSIONS: Concomitant TV repair with left-sided valve surgery had acceptable outcomes in terms of survival and TR durability. In patients with preoperative TR grade ≥ 3, preoperative patient status had negative impacts on prognosis.

Mitral valve early systolic billowing induces following annular expansion and leaflet augmentation in Barlow's disease: sequential analysis using 3D echocardiography.

AIMS: Although systolic expansion of the annulus has been recognized in Barlow's disease, the mechanisms of the unique pathological movement of the annulus and its relation to the leaflet augmentation have not yet been clarified. We aimed to investigate the detailed mechanisms of the characteristic mitral apparatus dynamics in Barlow's disease by frame-by-frame sequential geometric analysis using real-time 3D transoesophageal echocardiography. METHODS AND RESULTS: Fifty-three patients with Barlow's disease and severe mitral regurgitation without torn chordae, as well as 10 controls, were included. We evaluated geometric changes in the mitral complex using 3D transoesophageal echocardiography at five points during systole. To identify early systolic billowing of leaflets, the annulo-leaflet angle was measured. We also performed a more detailed analysis in four consecutive frames just before and after leaflet free-edge prolapse above the annulus plane. The median annulo-leaflet angle of both leaflets in early systole was >0° (above annulus plane) in patients with Barlow's disease, and billowing of the leaflet body was observed from early systole. The prolapse volume of both leaflets increased markedly from early to mid-systole [1.60 (0.85-2.80) to 4.00 (2.10-6.45) mL; analysis of variance (ANOVA), P < 0.001; post hoc, P < 0.05]. With frame-by-frame analysis, dynamic augmentation of the annulus and leaflets developed between frames just before and just after leaflet free-edge prolapse (ANOVA, P < 0.01; post hoc, P < 0.05). CONCLUSION: In Barlow's disease, early systolic billowing of the mitral leaflet induces systolic annulus expansion followed by leaflet augmentation and leaflet free-edge prolapse.

Association between intraoperative blood salvage and coagulation disorder after cardiopulmonary bypass.

BACKGROUND: This study investigated whether intraoperative blood salvage was associated with coagulation disorder diagnosed by conventional coagulation tests and thromboelastography (TEG) after cardiopulmonary bypass (CPB). STUDY DESIGN AND METHODS: This was a prospective, observational study. Ninety-two patients who underwent cardiovascular surgery with CPB were enrolled. We evaluated coagulation function in patients with or without cell salvage blood transfusion at the following time points: before CPB, just after protamine administration, and 1 h after protamine administration. We evaluated platelet count, fibrinogen concentration, and TEG parameters. Patients were considered to have coagulation disorder if one or more of the following criteria were present: (1) residual heparin, (2) low platelet count, (3) low fibrinogen level, (4) low clotting factor level, and (5) hyperfibrinolysis. RESULTS: Fifty-three of 92 patients (57.6%) received intraoperative cell salvage. Coagulation disorder was observed in 56 of 92 patients (60.9%) after CPB. There was no significant difference between patients with or without intraoperative blood salvage in terms of the incidence of coagulation disorder (p = 0.542) or the total volume of blood from the drain after CPB (p = 0.437). Intraoperative blood salvage was not associated with coagulation disorder diagnosed by either TEG or conventional coagulation tests (odds ratio 1.329, 95% confidence interval: 0.549-3.213, p = 0.547). There were no significant interactions between patients with or without intraoperative blood salvage regarding coagulation parameters derived from TEG. CONCLUSIONS: The incidence of coagulation disorder and the total blood volume from the drain after CPB did not differ significantly between patients with or without intraoperative blood salvage.

18F-FDG PET/CT in left atrial undifferentiated pleomorphic sarcoma with osteosarcomatous differentiation.

Primary cardiac sarcomas are rare and sometimes difficult to discern from benign tumors and intracardiac thrombi. We describe the ultrasound, computed tomography (CT), magnetic resonance imaging (MRI), and 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET)/CT findings in a case of left atrial undifferentiated pleomorphic sarcoma with osteosarcomatous differentiation, presenting with severe mitral regurgitation and pulmonary hypertension. The tumor presented as a broad-base mass protruding into the cardiac lumen, accompanied by punctate calcification-like high attenuation on CT. 18F-FDG PET/CT revealed high 18F-FDG uptake in the mass. Severe mitral regurgitation, a rare manifestation, was caused by tumor extension to the mitral valve leaflets and subvalvular tissue, which was best visualized on transesophageal echocardiography. This case illustrates the importance of multimodal diagnostic approaches including 18F-FDG PET/CT, which can facilitate accurate diagnosis and timely initiation of curative treatment, ultimately saving the patient's life. Learning objective: Firstly, cardiac sarcomas, particularly those with calcification/ossification, are rare and may mimic benign tumors and chronic intracardiac thrombi. Multimodal imaging approach, including 18F-FDG PET/CT, may be helpful in the accurate diagnosis of malignancies. Second, left atrial undifferentiated pleomorphic sarcoma has the potential to extensively spread along the endocardium and can extend to involve the valve leaflets, resulting in mitral regurgitation and pulmonary hypertension.

Can right ventricular endomyocardial biopsy predict left ventricular fibrosis beforehand in dilated cardiomyopathy?

AIMS: Myocardial fibrosis of the left ventricle (LV) is a prognostic factor in dilated cardiomyopathy (DCM). This study aims to evaluate whether fibrosis of right ventricular (RV) endomyocardial biopsy (EMB) can predict the degree of LV fibrosis beforehand in DCM. METHODS AND RESULTS: Fibrosis extent in 70 RV-EMB specimens of DCM diagnosis was compared with that in the whole cross-sectional LV of excised hearts in the same patients (52 explanted hearts for transplant and 18 autopsied hearts). The median interval between biopsy and excision was 4.1 (0.13-19.3) years. The fibrosis area ratio of the EMBs and excised hearts were evaluated via image analysis. The distribution of cardiovascular magnetic resonance-late gadolinium enhancement (LGE) in the intraventricular septum was classified into four quartile categories. The fibrosis area ratio in RV-EMB correlated significantly with that in the short-axis cut of the LV of excised hearts (r = 0.82, P < 0.0001) and with a diffuse pattern of LGE (r = 0.71, P = 0.003). In a multivariate model, after adjusting for the interval between biopsy performance and heart excision, the fibrosis area ratio in RV-EMB was associated with that in LV-excised heart (regression coefficient, 0.82; 95% confidence interval, 0.68-0.95; P < 0.0001). CONCLUSIONS: The fibrosis observed in RV-EMB positively correlated with the extent of fibrosis in the LV of excised hearts in patients with DCM. The study findings may help predict LV fibrosis, considered a prognostic factor of DCM through relatively accessible biopsy techniques.

The outcomes of a standardized protocol for extracorporeal mechanical circulatory support selection-left ventricular challenge protocol.

There are no criteria for surgical mechanical circulatory system (MCS) selection for acute heart failure. Since 2021, we have utilized cardiopulmonary bypass system to assess patients' heart and lung condition to inform surgical MCS selection. we aimed to retrospectively analyze the outcomes of treatments administered using our protocol. We analyzed the data of 19 patients who underwent surgical MCS implantation. We compared patients' characteristics across the biventricular-assist device (BiVAD), central Y-Y extracorporeal membrane oxygenation (ECMO), central ECMO, and left VAD (LVAD) systems. Patients' diagnoses included fulminant myocarditis (47.4%), dilated cardiomyopathy (21.1%), acute myocardial infarction (15.8%), infarction from aortic dissection (5.3%), doxorubicin-related cardiomyopathy (5.3%), and tachycardia-induced myocarditis (5.3%). Eight patients (42.1%) underwent LVAD implantation, 1 (5.2%) underwent central ECMO, 4 (21.1%) underwent BiVAD implantation, and 6 (31.6%) underwent central Y-Y ECMO. 48 h after surgery, both the pulmonary arterial and right atrial pressures were effectively controlled, with median values being 19.0 mmHg and 9.0 mmHg, respectively. No patients transitioned from LVAD to BiVAD in the delayed period. Cerebrovascular events occurred in 21.1%. Successful weaning was achieved in 11 patients (57.9%), and 5 patients (26.3%) were converted to durable LVAD. Two-year cumulative survival was 84.2%. Our protocol showed good results for device selection in patients with heart failure, and device selection according to this protocol enabled good control of the pulmonary and systemic circulations.

Safety and efficacy of aortic valvuloplasty for de novo aortic insufficiency in patients with a left-ventricular assist device.

OBJECTIVES: Progression of aortic insufficiency during left-ventricular assist device (LVAD) support is a crucial topic. One treatment option is aortic valvuloplasty (AVP); however, there is controversy regarding its safety and efficacy. We investigated the safety and efficacy of AVP using the coaptation stitch method (Park's stitch) performed for de novo aortic insufficiency. METHODS: Between 2013 and 2020, 175 consecutive patients underwent LVAD implantation, of which 7 patients [men, 2 (28.6%); median age, 55 years] underwent late-stage AVP. Two patients underwent AVP within 2 weeks, and the remaining six patients underwent AVP 3, 19, 24, 28, 42, and 49 months, respectively, after LVAD implantation. RESULTS: Preoperatively, the degree of aortic insufficiency was moderate in 6 (85.7%) patients and severe in 1 (14.3%) patient. AVP was technically successful in 6 (85.7%) patients, while one case of failed plasty was subsequently treated with bioprosthetic valve replacement. A 1-year post-AVP right heart catheterization study revealed a median pulmonary artery wedge pressure of 10.0 mmHg. No deaths or heart failure admissions occurred during the follow-up (median, 38.0 months). There was no aortic insufficiency in 2 (28.6%) patients; however, trivial AI was observed in 3 (42.8%) patients, and mild AI was observed in 1 (14.3%) patient 2 years postoperatively. However, at the 3-year follow-up, two patients developed an increase in AI grade from trivial to mild. CONCLUSIONS: AVP using Park's stitch was safe. It is critical to carefully observe the aortic valve during AVP surgery to ensure that AVP is appropriate.

Single-vessel access venoarterial extracorporeal membrane oxygenation and Impella technique for acute cardiogenic shock complicated by lung congestion.

The combination of the Impella and peripheral venoarterial extracorporeal membrane oxygenation (Ecmella) is a promising treatment for critically ill patients. We report a single-access Ecmella approach using the brachiocephalic artery. A 65-year-old woman with acute myocardial infarction involving the left main coronary artery underwent intra-aortic balloon pump and peripheral venoarterial extracorporeal membrane oxygenation (VA-ECMO) placement. Given the progression of pulmonary congestion and lower limb ischaemia, and an axillary artery diameter of 4.9 mm, we decided to perform a single Ecmella approach. A Y-shaped 9-mm Dacron woven graft was anastomosed to the brachiocephalic artery through a reverse T-shaped partial sternotomy. The Impella 5.5 and arterial cannula of VA-ECMO were introduced through each graft. Six days after, VA-ECMO was removed. Sixty-two days after the surgery, the patient received durable left ventricle assist device implantation. In conclusion, haemodynamic support using a single-access Ecmella through brachiocephalic artery allows for managing patients with narrow peripheral arteries.