Patient management important for long-term support beyond 5 years in the BTT: republication of the article published in the Japanese Journal of Artificial Organs.

Heart transplantation is considered to be the best treatment for severe heart failure refractory to medical therapy, improving patients' survival and quality of life (QOL). However, the number of donors is smaller than the number of registered applicants for heart transplantation, which increases every year, and the waiting period for heart transplantation has been extended to more than 1700 days by 2022. Since 2011, reimbursement for the implantable left ventricular assist device (iLVAD) was established. The numbers of the iLVAD patients have been increasing year by year. Patients are managed at home with an iLVAD and can live with their families and even return to work, depending on the situation. On the other hand, self-management at home, including caregivers, is important for a safe life. Home management beyond 5 years is becoming more common due to long waiting time for transplant. This article outlines the important aspects of patient management for long-term support. 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. 62-66), with some modifications.

Usefulness of bicarbonate-based Impella purge solution in a patient with heparin-induced thrombocytopenia: the first case report of long-term management in Japan.

Percutaneous mechanical circulatory support utilizing micro-axial flow pumps, such as the Impella group of devices, has become a life-saving technique in the treatment of refractory cardiogenic shock, with ever-increasing success rates. A 30-year-old man presented with acute decompensated heart failure and a severely reduced left ventricular ejection fraction (17%). Despite initial treatment with inotropic drugs and intra-aortic balloon pump support, his hemodynamic status remained unstable. Transition to Impella CP mechanical circulatory support was made on day 6 owing to persistently low systolic blood pressure. A significant decline in platelet count prompted suspicion of heparin-induced thrombocytopenia (HIT), later confirmed by positive platelet-activated anti-platelet factor 4/heparin antibody and a 4Ts score of 6 points. Argatroban was initially used as the purge solution, but owing to complications, a switch to Impella 5.0 and a bicarbonate-based purge solution (BBPS) was performed. Despite additional veno-arterial extracorporeal membrane oxygenation support on day 24, the patient, aiming for ventricular assist device treatment and heart transplantation, died from infection and multiple organ failure. Remarkably, the Impella CP continued functioning normally until the patient's demise, indicating stable Impella pump performance using BBPS. This case highlights the usefulness of BBPS as an alternative to conventional Impella heparin purge solution when HIT occurs.

Impact of Early Ambulation on the Prognosis of Coronary Artery Bypass Grafting Patients.

BACKGROUND: The effect of delayed ambulation on the outcome of coronary artery bypass grafting (CABG) remains to be clarified.Methods and Results: The long-term and in-hospital outcomes of 887 patients who underwent isolated CABG (455 off-pump cases, 135 urgent cases) were evaluated, with a focus on the timing of first ambulation. In-hospital mortality cases were excluded. Early ambulation (first ambulation within 3 days after operation) was achieved in 339 (38%) patients. In the multivariable logistic regression analysis, longer operation time and urgent case, EuroSCORE II, re-thoracotomy, and respiratory time were associated with delayed (≥4 days) ambulation. Delayed ambulation was associated with a high incidence of postoperative complications, such as pneumonia, and stroke (P<0.01). Following discharge, 22.2% of patients experienced major cardiac events and 13.8% died during the follow-up period (median follow-up 60 months). Cox hazards analysis revealed that delayed ambulation was associated with long-term adverse events (hazard ratio 1.04 per day, P<0.001). With adjustment for preoperative factors, the estimated future risk of adverse events was found to be increased day-by-day during the delay until initial ambulation. CONCLUSIONS: In isolated CABG patients, delayed ambulation was associated with poor outcomes, even in the long-term period. The results support the current guideline recommending early ambulation protocol after cardiac surgery.

Impact of an improved driveline management for HeartMate II and HeartMate 3 left ventricular assist devices.

BACKGROUND: We evaluated the impact of a standardized driveline care strategy, including a subfascial-tunneling method and dressing protocol, on the incidence of driveline infection (DLI). METHODS: DLI data from all HeartMate II (HMII) and HeartMate 3 (HM3) patients (including exchange devices) were retrospectively collected between 2013 and 2021. The driveline subfascial-tunneling method was altered in three steps (A: right direct; B: left triple, C: right triple), and the shower protocol was changed in two steps (A: with/without cover, B: with cover). Disinfection was individually tailored after changing the shower protocol. Complications associated with morbidity and mortality were evaluated for each modification. RESULTS: During the study period, 80 devices were implanted (HMII, n = 54; HM3, n = 26). The 8-year incidence of DLI was 15% (n = 8) in HMII patients and 0% in HM3 patients (p = 0.039). DLI was not associated with hospital mortality. The modified dressing protocol and tunneling method was associated with a significantly better DLI incidence rate in comparison to the previous one: Protocol-A (n = 17), Protocol-B (n = 63), 35% vs 3% (p = 0.0009), Method-A (n = 13), Method-B (n = 42), Method-C (n = 25), 46% vs 5% vs 0% (p = 0.0001). The rete of freedom form DLI at 1, 2, and 3 years had also significant difference between groups: Protocol-A and Protocol-B, 80%, 54%, 54% vs 96%, 96%, 96%, respectively (p < 0.0001), Method-A, Method-B and Method-C, 76%, 44%, 44%, vs 94%, 94%, 94% vs 100%, 100%, respectively (p < 0.0001). CONCLUSIONS: A standardized triple driveline tunneling strategy and waterproof dressing protocol reduced driveline infection in HM3 patients to 0%.

Increased risk of purge system malfunction after Impella 5.0 replacement: a case series.

The Impella 5.0 is an axial-flow percutaneous ventricular assist device used in patients with cardiogenic shock. Although the recommended period of use is 10 days or less, weaning can be delayed because of ongoing hemodynamic instability. In clinical practice, this device sometimes malfunctions during long-term management with heparin and must be replaced; however, the relationship between the duration of support with the initial and replacement Impella 5.0 and the changes in value of the purge system has not been fully elucidated. From July 2018 to May 2021, Impella 5.0 was implanted and used for more than 10 days in 11 patients at our institution. Four patients required Impella replacement because of device malfunction and the second Impella had purge system malfunction in all cases. The second Impella was used for a significantly shorter time than the first Impella (p = 0016). We calculated the ratio of purge pressure to purge flow rate and found that the ratio exceeded 50 mm Hg/mL/h in all cases with purge system malfunction. In conclusion, it is important to construct a treatment strategy considering the duration of use, because the risk of purge system malfunction is high after replaced Impella 5.0.

[Perioperative Management of Coagulation After the Weaning of Cardiopulmonary Bypass in Cardiac Surgery].

During cardiopulmonary bypass, the major disturbances in coagulation systems were affected by perioperative hemo-dilutional changes. Dilutional coagulopathy which is usually followed by hemorrhage is often refractory at the end of cardiopulmonary bypass. Thus, perioperative monitoring of coagulation markers might be necessary to estimate the differential diagnosis of hemorrhage and decrease thrombotic complications. It is very important to understand the timely coagulation and hemolysis pattern after the weaning of cardiopulmonary bypass. There is a limitation of central laboratory test to get a real time perioperative hemostatic management. Point-of-care devices are increasingly applied in clinical practice as we used in our practice. The data from these devices are useful to establish optimal hemostatic strategies.

Methods for confirming the safety of radiation therapy in patients with left ventricular assist device: a case of extranodal NK/T-cell lymphoma, nasal type.

A left ventricular assist device (LVAD) is a treatment option for patients with end-stage heart failure; however, a certain number of patients on durable LVADs are diagnosed with malignancy. Radiation therapy (RT) for patients with durable LVADs has safety concerns, because RT may interfere with the device. Herein, we report a case of RT during durable LVAD management. A 48-year-old man with a durable LVAD was diagnosed with sinusitis. As his symptoms were resistant to drug therapy, endoscopic sinus surgery was performed, and extranodal NK/T-cell lymphoma, nasal type (ENKL) was pathologically detected. Since RT was the first-line treatment for ENKL, we conducted two types of irradiation experiments to determine whether RT can be safely performed in patients with durable LVADs as follows: (1) assessing the extent of the radiation levels at each site and evaluating device malfunction by irradiating the lesion sites in the patient model with the same protocol as planned, and (2) evaluating device malfunction by directly irradiating the durable LVAD equipment once at the scheduled total dose. The radiation doses at the pump, driveline, system controller, power cable, and power module of the durable LVAD reached 7.86 cGy, 6.34 cGy, 0.66 cGy, 0.38 cGy, and 0.14 cGy, respectively. In both experiments, durable LVAD malfunction or any type of alarm was not observed. We concluded that RT could be safely performed with chemotherapy in this patient and our irradiation experiments can be applied to RT for other malignancies.

Effectiveness of the scheduled transfusion strategy for factor V deficiency with platelet dysfunction during coronary artery surgery.

BACKGROUND: Factor V deficiency is a rare disease, with an incidence of one in a million. Symptoms are mostly scant, and it is often diagnosed by the presence of an abnormality on PT-INR or APTT. In addition, no established therapy exists and platelet dysfunction is seldom found to be concomitant with this disease CASE PRESENTATION: A 64-year-old man who had both factor V deficiency and platelet dysfunction had angina in the past year. Coronary surgery was required, and we successfully performed coronary artery bypass grafting under strategic planned platelet transfusion with additional adequate cryoprecipitates transfusion. No perioperative problems nor any postoperative major bleeding issues were observed. The postoperative course was also uneventful. CONCLUSION: Strategic planned platelet transfusion with the additional transfusion of an adequate amount of cryoprecipitates is thus considered to be feasible for cases presenting with factor V deficiency and platelet dysfunction.

Impella5.0 "ILIPELLA" Approach for a Fulminant Myocarditis Patient With a Small Peripheral Artery.

Cardiogenic shock with fulminant myocarditis is a life-threatening diagnosis. Extracorporeal membrane oxygenation (ECMO) with an Impella for left ventricle unloading is often required to maintain the haemodynamics. However, the small peripheral vascularity in small-bodied patients interrupts the upgrade from ECMO to Impella5.0, which usually requires grafting to a femoral artery or subclavian artery of at least 7 mm in size. This report outlines the external iliac artery approach, named the "ILIPELLA" technique, which uses a reconstructed external iliac artery to introduce Impella5.0 in patients with small peripheral vascularity.

[Traumatic Thoracic Aortic Injury].

Traumatic thoracic aortic injury is a life-threatening event and needs emergency treatment. Blunt aortic injury( BAI) is one of the major traumatic aortic injuries and is the second most common cause of death due to non-penetrating trauma. Most of the BAI patients die before reaching the hospital. Patients who survive until hospital arrival might be salvageable, however, multiple injuries can progress to lethal aortic rupture without definitive treatment. We present 4 cases of BAI, who successfully treated by stent graft repair in 2 cases and open surgical repair in 2 cases. We highlighted the key point of BAI including the diagnosis, timing of the surgery, types of surgery and risk scoring.

Midterm Outcomes of Zone 0 Antegrade Endograft Implantation During Type I Hybrid Aortic Arch Repair.

OBJECTIVE: Type I hybrid arch repair has become popular as a procedure that is less invasive than total arch replacement. The major advantage of this technique is that antegrade endograft implantation can be performed during the procedure, thereby avoiding the complications of introducing the endograft from the groin. The aim of this study was to assess the midterm outcomes of type I hybrid aortic arch repair with antegrade endograft implantation. METHODS: Thirty consecutive patients who underwent type I hybrid repair with antegrade endograft implantation from 2009 to 2015 were reviewed retrospectively. Patient demographics, and peri-operative and late results were collected from a prospective database and analysed. RESULTS: Four patients (13%) were female and the median age was 78 years. Median aneurysm size was 64 mm. Six patients (20%) developed stroke, and the 30 day mortality rate was 3%. Two patients suffered aortic dissection at the site of debranching anastomosis. The median follow up was 5.2 years. All aneurysms remained stable or had decreased in size at three years, and 82% were stable at five years. Overall survival was 79% at three years and 71% at five years. The rates of freedom from aorta related death were 86% at three and five years, respectively. During the follow up period, three additional left subclavian artery embolisations and one endograft relining due to type IIIb endoleak were required. CONCLUSION: Midterm outcomes of type I hybrid aortic arch repair with antegrade endograft implantation for aortic arch aneurysms are reported. Although the incidence of peri-operative stroke was high, late sac behaviour was acceptable.

Beating-heart total arch replacement for an octogenarian patient with severe heart failure.

Surgical outcomes of total arch replacement (TAR) have improved dramatically over the last decades. However, patients of advanced age and with a severely reduced cardiac function and an extended aortic arch aneurysm may not be candidates for conventional TAR. Endovascular and hybrid treatment for extended aortic aneurysm have demonstrated lower mortality and morbidity, and considered for the advanced age and high-risk patients. But endovascular with total de-branching technique remains challenging with the slightly dilated ascending aorta. Reducing the operation time, cardiac arrest time, and circulatory arrest time should be needed to resolve the problem for the conventional TAR with an advanced age and a severely reduced cardiac function. We herein introduce our surgical technique for the case of an 84-year-old man with a severely reduced cardiac function, who was successfully treated with beating heart TAR with minimization of the operation time, cardiac arrest time, and circulatory arrest time.

Cor triatriatum in adulthood with mitral valve regurgitation and atrial fibrillation.

Cor triatriatum is a rare congenital heart disease. A 57-year-old woman had cor triatriatum with severe mitral valve regurgitation (MR) and atrial fibrillation (AF). We performed mitral valve repair, left atrial appendage resection, and maze procedure by resection of the anomalous septum in the left atrium. As a result, MR was controllable and AF disappeared after the operation. Although there is no established maze procedure with cor triatriatum, removing the septum was effective to complete it.

Efficacy of Plasma free Hemoglobin for detecting centrifugal pump thrombosis.

INTRODUCTION: Lactate dehydrogenase (LDH) is widely used as an indicator of pump thrombosis in a centrifugal pump. However, due to the low specificity of LDH, pump thrombosis is difficult to detect in the clinical environment. We measured plasma free hemoglobin (pfHb) with the portable device in ICU. The goal of this investigation is to evaluate its diagnostic ability for pump thrombosis. METHODS: We enrolled 31 consecutive patients who needed Extracorporeal Membrane Oxygenation (ECMO) therapy and pfHb was determined with HemoCue® plasma/Low Hb photometer. Pump thrombosis was analyzed macroscopically at the timing of pump explantation or exchange. Also, we divided the pump thrombosis into a grading scale by the place of thrombosis. RESULTS: The median of peak pfHb was significantly lower in the none thrombus group (0.03 g/dL) than that of in the thrombus group (0.05g/dL) (p = 0.01). In our grading criteria, pfHb was significantly higher when the thrombus is existing near the shaft (p = 0.015). Contrary, no significant difference was found for LDH.The ROC analysis of pfHb revealed an AUC of 0.77 for detecting pump thrombosis with the best statistical cutoff value at 0.05 g/dL (specificity, 78%; sensitivity, 77%). Also, ROC analysis of LDH was performed (AUC, 0.44; cutoff value, 1200 IU/L; specificity, 59%; sensitivity, 54%) and compared with pfHb. AUC was significantly higher in pfHb (p = 0.04). CONCLUSION: Our results showed the efficacy of pfHb for detecting centrifugal pump thrombosis.

"Double Cuff" Technique for Modified Bentall Procedure.

The combination of interrupted and running sutures was initially introduced as a tandem suture line to improve haemostasis in the modified Bentall procedure. These techniques basically consist of two suturing techniques. This paper reports the "Double Cuff" technique, which uses only one interrupted suture with a double-folded layer between the aortic remnant wall of Valsalva and the aortic ring and a double-folded layer on the composite graft side to ensure absolute proximal annular haemostasis. The proximal side of the composite graft is made by fashioning a double layer, in which the graft is everted inside and sutured with the prosthetic valve. The "Double Cuff" technique is a simple, reproducible and durable method for ensuring haemostasis and should be considered as a supplementary procedure for proximal anastomosis.

"Millefeuille Technique" by Using Excised Intimal Layers in Repair of Type A Aortic Dissection.

Surgical outcomes for acute Type A aortic dissection (AAD) have dramatically improved in recent years due to prompt diagnosis, improved surgical technique and perioperative management. A single needle hole can become a new entry point in AAD cases with such a fragile wall, so a mixed technique using minimal surgical stitches and glue is required for a good outcome. The 'Millefeuille' technique involves multiple layers with a prosthetic graft, intimal layer, additionally inserted surplus intimal layer with BioGlue, adventitial layer, and felt. This technique may help to prevent needle hole re-entry.

Is Hybrid Repair for an Entire Shaggy Aorta Feasible?

OBJECTIVE: This paper reviewed clinical experiences to evaluate the feasibility of a surgical strategy for an entire shaggy aorta. METHODS: Fifty-two (52) surgeries (47 men, average age 72±7 years) were performed for an entire shaggy aorta at the current institution from 2002-2017. Open surgery was performed in 30 cases, including total arch replacement in 12, extended aortic arch replacement via L-shaped thoracotomy in 10 and median sternotomy combined with left thoracotomy in two, and thoracoabdominal aortic replacement in six. Hybrid procedures were performed in 22 cases: type I hybrid arch repair in six, type II hybrid arch repair in seven and type III hybrid arch repair in nine. RESULTS: Hospital mortality was significantly higher with a hybrid repair: surgical, one case (3%); hybrid, six cases (27%), (p=0.0125). Stroke occurred at relatively high rates in both groups: surgical, seven cases (23%); hybrid, six cases (27%) (p=0.75). Spinal cord injury was significantly higher in hybrid repair: surgical, one case (3%); hybrid, seven cases (32%), (p=0.004). Open surgery revealed a better long-term survival rate than the hybrid procedure at 5 and 10 years: surgical, 82%, 65.7%; hybrid, 53%, 35.1%, respectively (p=0.0452). The rate of freedom from aortic events was significantly better with open surgery than a hybrid procedure at 5 and 10 years: surgical, 96%, 85%; hybrid, 83%, 41.3%, respectively (p=0.0082). CONCLUSIONS: Surgery for an entire shaggy aorta was frequently associated with embolic complications such as stroke, paraplegia, renal failure, and bowel necrosis. However, open surgical repair may produce better early and late outcomes and freedom from aortic events compared with hybrid repair.

Aortic insufficiency associated with Impella that required surgical intervention upon implantation of the durable left ventricular assist device.

The Impella is an axial-flow percutaneous ventricular assist device for cardiogenic shock. In this report, we describe two patients who developed aortic insufficiency (AI) associated with Impella and required surgical intervention upon implantation of the durable left ventricular assist device (LVAD). Both patients presented with cardiogenic shock and underwent insertion of Impella 5.0 as a bridge to decision. The cardiac function in these patients did not improve and obtaining approval for heart transplantation required time. They were managed with Impella for 91 and 98 days, respectively. In both cases, moderate AI that was not present before Impella insertion was observed when the Impella was removed. Therefore, we performed aortic valve closure to control the AI during durable LVAD implantation. In patients with durable LVAD implantation, AI may occur and progress after the operation in several cases. Aortic valve surgery is often performed to prevent deterioration of AI, especially in patients with AI before the surgery. Hence, AI is an important complication following Impella device implantation as a bridge to decision. Careful observation of AI is essential when the Impella is removed as the evaluation of AI by echocardiogram during Impella management is cumbersome because of device-generated artifacts.

Spinal cord injury following aortic arch replacement.

PURPOSE: Postoperative spinal cord injury is a devastating complication after aortic arch replacement. The purpose of this study was to determine the predictors of this complication. METHODS: A group of 254 consecutive patients undergoing aortic arch replacement via median sternotomy, with (n = 78) or without (n = 176) extended replacement of the upper descending aorta, were included in a risk analysis. The frozen elephant trunk technique was used in 46 patients. The patients' atherothrombotic lesions (extensive intimal thickening of > 4 mm) were identified from computed tomography images. RESULTS: Complete paraplegia (n = 7) and incomplete paraparesis (n = 4) occurred immediately after the operation (permanent spinal cord injury rate, 1.97%; transient spinal cord injury rate, 2.36%). A multivariable logistic regression analysis identified the use of the frozen elephant trunk technique (odds ratio 36.3), previous repair of thoracoabdominal aorta or descending aorta (odds ratio 29.4), proximal atherothrombotic aorta (odds ratio 9.6), chronic obstructive lung disease (odds ratio 7.1) and old age (odds ratio 1.1) as predictors of spinal cord injury (p < 0.0001, area under curve 0.93). CONCLUSIONS: Spinal cord injury occurs with a non-negligible incidence following aortic arch replacement. The full objective assessment of the morphology of the whole aorta and the recognition of the risk factors are mandatory.

Exclusion Technique for Entire Shaggy Aorta Followed by One-Stage Repair of the Aortic Arch and Descending Aorta.

OBJECTIVE: A shaggy aorta is defined as a very extensive atheromatous disease with diffuse ulcers in combination with fragile and mobile debris, and actual thrombus. Multiple embolisation - resulting in permanent neurological deficits, paraplegia and a large area of mesenteric embolisation - attributed to cholesterol atheromatic mobile plaque caused by shaggy aorta needs to be prevented. METHODS: Complete exclusion of the shaggy aorta from the distal aortic arch to the end of the descending aorta was presented in two cases: a 71-year-old male and a 51-year-old male. Successful one-stage repair of the extended aortic arch and descending aorta was performed using an isolated selective cerebral perfusion technique via sternotomy and left anterior thoracotomy. RESULTS: There were no neurological or embolic events in the present cases. Contrast-enhanced computed tomography showed good reconstruction of the aortic arch and descending aorta. The patients are still being followed up in the outpatient clinic and have shown no atheromatic embolisation for the past 6 years. CONCLUSIONS: The exclusion technique for an entire shaggy aorta followed by one-stage repair of the aortic arch and descending aorta is a durable and feasible operation for preventing atheromatous embolisation.