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.

Effect of Diabetes Mellitus on Outcomes in Patients With Left Ventricular Assist Device　- Analysis of Data From a Japanese National Database.

BACKGROUND: The objective of this study is to investigate the effect of preoperative diabetes on all-cause mortality and major postoperative complications among patients with continuous-flow left ventricular assist device (LVAD) by using data from a national database.Methods and Results: The 545 study patients who underwent primary HeartMateII implantation between 2013 and 2019 were divided into 2 groups according to their diabetes mellitus (DM) status; patients with DM (n=116) and patients without DM (n=429). First, the on-device survival and incidence of adverse events were evaluated. Second, after adjusting for patients' backgrounds, the change of laboratory data in the 2 groups were compared. Overall, on-device survival at 1, 2, and 3 years was almost equivalent between the 2 groups; it was 95%, 94%, and 91% in patients without DM, and 93%, 91%m and 91% in patients with DM (P=0.468) The incidence of adverse events was similar between 2 groups of patients, except for driveline exit site infection in the adjusted cohort. Cox proportional hazards regression analysis revealed younger age (HR: 0.98 (95% confidence interval (CI): 0.97-0.99, P=0.001) and presence of DM (HR: 1.83 (95% CI: 1.14-2.88), P=0.016) as significant predictors of driveline infection. Laboratory findings revealed no differences between groups throughout the periods. CONCLUSIONS: The clinical results after LVAD implantation in DM patients were comparable with those in non-DM patients, except for the driveline exit site infection.

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.

Large interventricular membranous septal aneurysm renders the anatomy unsuitable for transcatheter aortic valve replacement.

An interventricular membranous septal aneurysm, though rare, can coexist with aortic valve stenosis. In this report, we present an unsuitable anatomy for transcatheter aortic valve replacement (TAVR) due to large interventricular membranous septal aneurysm. This case suggests that the feasibility of TAVR would depend on the location and size of the aneurysm and its relationship with the aortic root.

Multidisciplinary surgical approach for renal cell carcinoma with inferior vena cava tumor thrombus.

PURPOSES: The optimal surgical management of renal cell carcinoma with tumor thrombus within the inferior vena cava (IVC) remains to be clarified. METHODS: Sixteen consecutive cases were reviewed. Incision, the IVC clamping position, and the venous drainage procedure were modified according to the tumor thrombus extension level: level I or II (below the hepatic vein, n = 8), level III (above the hepatic vein but below the right atrium, n = 5), and level IV (extending into the right atrium, n = 3). RESULTS: For level I or II, resection could be simply achieved by clamping the IVC below the hepatic vein, without hemodynamic collapse. For level III, clamping the IVC above the hepatic vein and the hepatoduodenal ligament was required. Venous drainage from the lower body (cannulation to distal IVC) and portal system (cannulation to ileocolic vein) were applied. When opening the IVC, the significant backflow was controlled using cardiopulmonary bypass with drop-in suckers. For level IV, median sternotomy, exposure of the right atrium, and cardiopulmonary bypass were mandatory. With the combination of these approaches, the perioperative mortality rate was 0% and the 5-year overall survival rate was 52%. CONCLUSIONS: A multidisciplinary surgical approach is essential, especially for level III and IV cases.

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.

Therapeutic effect of allogeneic bone marrow-derived mesenchymal stromal cells on aortic aneurysms.

We previously reported the effectiveness of autologous mesenchymal stromal cells (MSCs) for the treatment of aortic aneurysm (AA), mediated mainly by these cells' anti-inflammatory properties. In this study, we investigate whether the therapeutic effects of allogeneic MSCs on AA are the same as those of autologous MSCs. To examine the immune response to allogeneic MSCs, C57BL/6 lymphocytes were co-cultured with BALB/c MSCs for 5 days in vitro. Apolipoprotein E-deficient C57BL/6 mice with AA induced by angiotensin II were randomly divided into three groups defined by the following intravenous injections: (i) 0.2 ml of saline (n = 10, group S) as a control, (ii) 1 × 106 autologous MSCs (isolated from C57BL/6, n = 10, group Au) and (iii) 1 × 106 allogeneic MSCs (isolated from BALB/c, n = 10, group Al). Two weeks after injection, aortic diameters were measured, along with enzymatic activities of MMP-2 and MMP-9 and cytokine concentrations in AAs. Neither allogenic (BALB/c) MSCs nor autologous (C57BL/6) MSCs accelerated the proliferation of lymphocytes obtained from C57BL/6. Compared with group S, groups Au and Al had significantly shorter aortic diameters (group S vs Au vs Al; 2.29 vs 1.40 vs 1.36 mm, respectively, p < 0.01), reduced MMP-2 and MMP-9 activities, downregulated IL-6 and MCP-1 and upregulated expression of IGF-1 and TIMP-2. There were no differences in these results between groups Au and Al. Thus, our study suggests that treatment with allogeneic MSCs improves chronic inflammation and reduced aortic dilatation. These effects were equivalent to those of autologous MSCs in established mouse models of AA.

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.

Regression of Electrocardiographic Left Ventricular Hypertrophy After Transcatheter Aortic Valve Implantation for Aortic Stenosis.

BACKGROUND: The changes in electrocardiographic left ventricular hypertrophy (ECG-LVH) after transcatheter aortic valve implantation (TAVI) are not fully elucidated.Methods and Results:The study group included 64 patients who underwent TAVI for aortic stenosis. Their 12-lead ECGs before and at 2 days and 1, 6 and 12 months after TAVI were analyzed, and ECG-LVH was evaluated using various definitions. Values and prevalence of each ECG-LVH parameter significantly decreased between 1 and 6 months after TAVI. Values of ECG-LVH parameters decreased especially in patients with ECG-LVH at baseline. CONCLUSIONS: Regression of ECG-LVH was observed between 1 and 6 months after TAVI.

Worsening renal function after transcatheter aortic valve replacement and surgical aortic valve replacement.

Several prior reports have investigated worsening renal function around transcatheter aortic valve replacement (TAVR) procedures. However, in clinical practice, it seems more important to evaluate changes associated with TAVR-related procedures, including preoperative enhanced computed tomography (CT), as well as the TAVR procedure itself, as CT assessment is considered essential for safe TAVR. This study evaluated worsening renal function during the TAVR perioperative period, from the preoperative enhanced CT to 1 month after TAVR, and then compared the incidence with that in patients undergoing surgical aortic valve replacement (SAVR). This retrospective single-center study investigated 123 TAVR patients and 130 SAVR patients. We evaluated baseline renal function before enhanced CT in TAVR patients and before operation in SAVR patients, and again at 1 month post-operatively. We defined worsening renal function at 1 month according to three definitions: (1) an increase in serum creatinine ≥ 0.3 mg/dL or ≥ 1.5-fold from baseline or initiation of dialysis, (2) a decline in eGFR at 1 month ≥ 20% from baseline or initiation of dialysis, (3) a decline in eGFR at 1 month ≥ 30% from baseline or initiation of dialysis. TAVR patients were significantly older and had higher surgical risk scores than SAVR patients. In TAVR patients, serum creatinine levels were 1.00 ± 0.32 mg/dL at baseline and 1.01 ± 0.40 mg/dL at 1 month post-operatively (p = 0.58), while in SAVR patients, these levels were 0.99 ± 0.51 mg/dL and 0.98 ± 0.49 mg/dL, respectively (p = 0.59). In TAVR patients, 7 (5.7%), 14 (11.4%), and 3 (2.4%) patients experienced worsening renal function according to the three definitions, respectively, but there were no significant differences from those in SAVR patients, for any definition. Worsening renal function after TAVR was uncommon, and the incidence rate was comparable to that in SAVR patients, even though TAVR patients had worse baseline characteristics.

Incidental findings on computed tomography for preoperative assessment before transcatheter aortic valve implantation in Japanese patients.

Extra-cardiovascular incidental findings (IFs) on preoperative computed tomography (CT) are frequently observed in transcatheter aortic valve implantation (TAVI) candidates. However, the backgrounds of TAVI candidates and comorbidities differ based on the race and/or country, and data on IFs in a specific population are not always applicable to another. The aim of this study was to assess the prevalence, type, and clinical impact of IFs in Japanese TAVI candidates. This was a retrospective, single-center, observational study. CT reports of 257 TAVI candidates were reviewed, and IFs were classified as (a) insignificant: findings that did not require further investigation, treatment, or follow-up; (b) intermediate: findings that needed to be followed up or were considered for further investigation but did not affect the planning of TAVI; and (c) significant: findings that required further investigation immediately or affected the planning of TAVI. At least one IF was found in 254 patients (98.8%). Insignificant, intermediate, and significant IFs were found in 253 (98.4%), 153 (59.5%), and 34 (13.2%) patients, respectively. Newly indicated significant IFs were found in 19 patients (7.4%). In 2 patients (0.8%), TAVI was canceled because of significant IFs. In patients who consequently underwent TAVI, the presence of significant IFs was not associated with the duration from CT performance to TAVI [28 (19-40) days vs. 27 (19-43) days, p = 0.74] and all-cause mortality during the median follow-up period of 413 (223-805) days (p = 0.44). Almost all Japanese TAVI candidates had at least one IF, and the prevalence of significant IFs was not negligible. Although the presence of significant IFs was not associated with mid-term mortality, appropriate management of IFs was considered important.

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.

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.

Contemporary Outcomes of Surgical Aortic Valve Replacement in Japan.

BACKGROUND: Given the rapid expansion in the use of transcatheter aortic valve implantation (TAVI), recent outcomes of surgical aortic valve replacement (SAVR) should be re-evaluated.Methods and Results:Using the data from the Japan Cardiovascular Surgery Database of 160 enrolled hospitals, trends in elective isolated SAVR were evaluated until the introduction of TAVI in Japan. Trend analyses were performed over 4 periods: period 1, 2008-2009 (4,415 cases); period 2, 2010-2011 (4,861 cases); period 3, 2012-2013 (5,674 cases); and period 4, 2014-2015 (5,563 cases). Baseline risk, evaluated on JapanSCORE, increased significantly over the 4 periods, from a median of 1.56 (IQR, 0.99-2.61) in period 1 to 2.08 (IQR, 1.33-3.96) in period 4 (P<0.001, trend test). Despite the increased risk, the composite major complication and operative mortality rate decreased significantly (10.7% in period 1 to 9.2% in period 4, P=0.01). Using a risk-adjusted model, the OR of operative mortality was 1.61 (95% CI: 1.29-2.02) in period 1 (P<0.0001) compared with period 4. An increase in the use of bioprostheses was also observed, from 60.4% to 76.8% (P<0.001) over the 4 periods. CONCLUSIONS: Even in a short 8-year period, SAVR outcomes improved in Japan. This should be taken into account when discussing the indications for aortic valve intervention.

Correction to: Extracorporeal membrane oxygenation support for postcardiotomy cardiogenic shock in adult patients: predictors of in­hospital mortality and failure to be weaned from extracorporeal membrane oxygenation.

In the original publication of the article, author group affiliation was published incorrectly.