The Association of ACGME Milestones With Performance on American Board of Surgery Assessments: A National Investigation of Surgical Trainees.

OBJECTIVE: To determine the relationship between, and predictive utility of, milestone ratings and subsequent American Board of Surgery (ABS) vascular surgery in-training examination (VSITE), vascular qualifying examination (VQE), and vascular certifying examination (VCE) performance in a national cohort of vascular surgery trainees. BACKGROUND: Specialty board certification is an important indicator of physician competence. However, predicting future board certification examination performance during training continues to be challenging. METHODS: This is a national longitudinal cohort study examining relational and predictive associations between Accreditation Council for Graduate Medical Education (ACGME) Milestone ratings and performance on VSITE, VQE, and VCE for all vascular surgery trainees from 2015 to 2021. Predictive associations between milestone ratings and VSITE were conducted using cross-classified random-effects regression. Cross-classified random-effects logistic regression was used to identify predictive associations between milestone ratings and VQE and VCE. RESULTS: Milestone ratings were obtained for all residents and fellows(n=1,118) from 164 programs during the study period (from July 2015 to June 2021), including 145,959 total trainee assessments. Medical knowledge (MK) and patient care (PC) milestone ratings were strongly predictive of VSITE performance across all postgraduate years (PGYs) of training, with MK ratings demonstrating a slightly stronger predictive association overall (MK coefficient 17.26 to 35.76, ß = 0.15 to 0.23). All core competency ratings were predictive of VSITE performance in PGYs 4 and 5. PGY 5 MK was highly predictive of VQE performance [OR 4.73, (95% CI, 3.87-5.78), P <0.001]. PC subcompetencies were also highly predictive of VQE performance in the final year of training [OR 4.14, (95% CI, 3.17-5.41), P <0.001]. All other competencies were also significantly predictive of first-attempt VQE pass with ORs of 1.53 and higher. PGY 4 ICS ratings [OR 4.0, (95% CI, 3.06-5.21), P <0.001] emerged as the strongest predictor of VCE first-attempt pass. Again, all subcompetency ratings remained significant predictors of first-attempt pass on CE with ORs of 1.48 and higher. CONCLUSIONS: ACGME Milestone ratings are highly predictive of future VSITE performance, and first-attempt pass achievement on VQE and VCE in a national cohort of surgical trainees.

The Association of Subspecialty and Sex with Industry Payments to Internal Medicine Physicians Who Recently Completed Training.

BACKGROUND: Financial relationships with drug and medical device companies may impact quality of care and academic research. However, little is known when and how these financial relationships develop among newly independent physicians who recently completed from residency or fellowship programs in internal medicine (IM). OBJECTIVE: To compare patterns of industry payments among IM graduates. DESIGN: Retrospective, observational cohort study. SUBJECTS: IM graduates from residency or fellowship programs between January 2015 and December 2019. MAIN MEASURES: We analyzed Open Payments reports made between July 2015 and June 2021 to recent graduates of U.S. Accreditation Council for Graduate Medical Education (ACGME)-accredited residency and fellowship programs in IM. The primary outcome was general payments accepted by these physicians, stratified by procedural (i.e., critical care medicine/pulmonary medicine, cardiac/cardiovascular disease, and gastroenterology) and non-procedural (i.e., infectious disease, general internal medicine, and other specialties) subspecialties. The secondary outcomes included general payments stratified by sex and age at residency or fellowship training completion. KEY RESULTS: There were 41,669 IM physicians with a median age of 33.0 years. In the first 3 years after completion, the proportion of physicians accepting any general payments was 72.6%, 91.9%, and 86.8% in Critical Care Medicine/Pulmonary Medicine, Cardiac/Cardiovascular Disease, and Gastroenterology, compared to 56.1%, 52.6%, and 52.3% in Infectious Disease, General Internal Medicine, and Other Specialties (p<0.0001). After adjusting for confounding variables, the procedural group showed an increased hazard ratio (HR) for accepting any general payments and at least $5000 of general payments compared to the non-procedural group. The HRs of accepting any general payments in the procedural subspecialty were 2.26 (95% CI, 2.11-2.42) and 2.83 (95% CI, 2.70-2.97) in female and male physicians, respectively (p-value < 0.0001). CONCLUSION: Industry financial relationships among newly independent physicians in IM exist immediately after completion of training and are influenced by subspecialty, sex, and age.

Supersaturation dependent nucleation of methane + propane mixed-gas hydrate.

Before hydrates can be widely used in industry, we should better understand the problematic issues of hydrate nucleation, particularly its stochastic nature. Here, we report on measurements of the nucleation probability of mixed-gas hydrates in which the guest molecules are a mixture of methane and propane. For the pure cases, at a supersaturation near 1.0, we had previously measured an induction time for the methane hydrate of about 1 h, whereas for the propane hydrate, it was over one day. Using the same experimental setup, we examine here the nucleation probability for a mixture of 90% methane and 10% propane as the guest gas for a range of supersaturations. For the experiments, the temperature was 274 ± 0.5 K and the stirring rate was about 300 rpm. The experiments were repeated at least ten times under the same condition, exchanging the sample water every time. We define the nucleation probability at a given time as the fraction of trials that nucleated by that time and then determine the nucleation probability distribution. The resulting nucleation frequency is found to have a power-law relation to supersaturation. Then, we examine how the nucleation frequency is affected by the existence of ultrafine bubbles in the initial water. We find that the ultrafine bubbles increase the nucleation frequency but much less than that of typical changes in supersaturation.

Detailed tracking of antigen and antibody levels during coronavirus disease 2019 treatment in an immunosuppressed patient with anti-neutrophil cytoplasmic autoantibody-associated vasculitis.

A 67-year-old woman with anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis was not vaccinated against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and was on multiple immunosuppressive drugs. She was hospitalized because of interstitial shadowing in the lungs and diagnosed with persistent coronavirus disease 2019 (COVID-19). Despite treatment with a recombinant monoclonal antibody and antivirals, her symptoms persisted and she lacked a specific antibody response. She tested negative for SARS-CoV-2 antigen after the second antiviral treatment, and a subsequent chest radiograph showed improvement. However, the antibody levels did not change. This case highlights the importance of careful monitoring of the SARS-CoV-2 antigen and antibody levels during COVID-19 treatment in patients with immunosuppression.

The Use of Learning Analytics to Enable Detection of Underperforming Trainees: An Analysis of National Vascular Surgery Trainee ACGME Milestones Assessment Data.

OBJECTIVE: This study aims to investigate at-risk scores of semiannual Accreditation Council for Graduate Medical Education (ACGME) Milestone ratings for vascular surgical trainees' final achievement of competency targets. SUMMARY BACKGROUND DATA: ACGME Milestones assessments have been collected since 2015 for Vascular Surgery. It is unclear whether milestone ratings throughout training predict achievement of recommended performance targets upon graduation. METHODS: National ACGME Milestones data were utilized for analyses. All trainees completing 2-year vascular surgery fellowships in June 2018 and 5-year integrated vascular surgery residencies in June 2019 were included. A generalized estimating equations model was used to obtain at-risk scores for each of the 31 subcompetencies by semiannual review periods, to estimate the probability of trainees achieving the recommended graduation target based on their previous ratings. RESULTS: A total of 122 vascular surgery fellows (VSFs) (95.3%) and 52 integrated vascular surgery residents (IVSRs) (100%) were included. VSFs and IVSRs did not achieve level 4.0 competency targets at a rate of 1.6% to 25.4% across subcompetencies, which was not significantly different between the 2 groups for any of the subcompetencies ( P = 0.161-0.999). Trainees were found to be at greater risk of not achieving competency targets when lower milestone ratings were assigned, and at later time-points in training. At a milestone rating of 2.5, with 1 year remaining before graduation, the at-risk score for not achieving the target level 4.0 milestone ranged from 2.9% to 77.9% for VSFs and 33.3% to 75.0% for IVSRs. CONCLUSION: The ACGME Milestones provide early diagnostic and predictive information for vascular surgery trainees' achievement of competence at completion of training.

[A Case of pagetoid Carcinoma of the Breast with Pathological Complete Response by Neoadjuvant Chemotherapy].

We herein report a 63-year-old woman who presented with about 20 mm-sized mass in the right breast and the right nipple with erosion. Preoperative examinations revealed a diagnosis of HER2-type pagetoid carcinoma with axillary lymph node metastasis. After neoadjuvant chemotherapy(pertuzumab, trastuzumab, and docetaxel, followed by adriamycin and cyclophosphamide), a pathological complete response was achieved. The patient was treated with anti-HER2 therapy without recurrence.

[A Case of Long-Term Survival Achieved by Multimodal Treatments for Postoperative Lung Metastasis and Mediastinal Lymph Node Metastasis after Surgery for Ascending Colon Cancer].

A 52-year-old male patient with Stage Ⅲc ascending colon cancer underwent laparoscopic right hemicolectomy with D3 lymph node dissection. Adjuvant chemotherapy was administered for 6 months, and no recurrence was observed during the follow-up period. Left lung metastasis was detected and surgically removed 7 years after the initial surgery. He underwent open partial small bowel resection with lymph node dissection when mesenteric lymph node metastasis was identified 2 years later. Although chemotherapy was conducted on the identification of mediastinal lymph node metastasis 2 years later, the mediastinal lymph nodes increased. Although attempted, lymph node dissection was impossible because of the strong adhesion to the trachea. Subsequently, chemotherapy and radiation therapy were administered. However, an infiltration of the mediastinal lymph nodes into the trachea was observed. The patient underwent bronchoscopic laser tumor ablation. The patient died 4 months after the resumption of chemotherapy(18 years after the initial surgery). Mediastinal lymph node recurrence after curative resection for colon cancer is a rare clinical condition. Nevertheless, long-term survival could be achieved by multimodal treatments in such patients.

Expert consensus on the conceptual alignment of Accreditation Council for Graduate Medical Education competencies with patient outcomes after common vascular surgical procedures.

BACKGROUND: The quality and effectiveness of vascular surgery education should be evaluated based on patient care outcomes. To investigate predictive associations between trainee performance and subsequent patient outcomes, a critical first step is to determine the conceptual alignment of educational competencies with clinical outcomes in practice. We sought to generate expert consensus on the conceptual alignment of the Accreditation Council for Graduate Medical Education (ACGME) Vascular Surgery subcompetencies with patient care outcomes across different Vascular Quality Initiative (VQI) registries. METHODS: A national panel of vascular surgeons with expertise in both clinical care and education were recruited to participate in a modified Delphi expert consensus building process to map ACGME Vascular Surgery subcompetencies (educational markers of resident performance) to VQI clinical modules (patient outcomes). A master list of items for rating was created, including the 31 ACGME Vascular Surgery subcompetencies and 8 VQI clinical registries (endovascular abdominal aortic aneurysm repair, open abdominal aortic aneurysm, thoracic endovascular aortic repair, carotid endarterectomy, carotid artery stent, infrainguinal, suprainguinal, and peripheral vascular intervention). These items were entered into an iterative Delphi process. Positive consensus was reached when 75% or more of the participants ranked an item as mandatory. Intraclass correlations (ICCs) were used to evaluate consistency between experts for each Delphi round. RESULTS: A total of 13 experts who contributed to the development of the Vascular Surgery Milestones participated; 12 experts (92%) participated in both rounds of the Delphi process. Two rounds of Delphi were conducted, as suggested by excellent expert agreement (round 1, ICC = 0.79 [95% confidence interval, 0.74-0.84]; round 2, ICC = 0.97 [95% confidence interval, 0.960-.98]). Using the predetermined consensus cutoff threshold, the Delphi process reduced the number of subcompetencies mapped to patient care outcomes from 31 to a range of 9 to 15 across the 8 VQI clinical registries. Practice-based learning and improvement, and professionalism subcompetencies were identified as less relevant to patient outcome variables captured by the VQI registries after the final round, and the only the systems-based practice subcompetency that was identified as relevant was radiation safety in two of the endovascular registries. CONCLUSIONS: A national panel of vascular surgeon experts reported a high degree of agreement on the relevance of ACGME subcompetencies to patient care outcomes as captured in the VQI clinical registry. Systems-based practice, practice-based learning and improvement, and professionalism competencies were identified as less relevant to patient outcomes after specific surgical procedures.

Efficacy of polyglycolic acid sheeting with fibrin glue for perforations related to gastrointestinal endoscopic procedures: a multicenter retrospective cohort study.

OBJECTIVES: Gastrointestinal (GI) perforations are one of the major adverse events of endoscopic procedures. Polyglycolic acid (PGA) sheets with fibrin glue have been reported to close GI perforations. However, its clinical outcome has not yet been fully investigated; thus, we conducted a multicenter retrospective observational study to assess the efficacy of PGA sheeting for GI perforation. METHODS: The medical records of patients who underwent PGA sheeting for endoscopic GI perforations between April 2013 and March 2018 in 18 Japanese institutions were retrospectively analyzed. PGA sheeting was applied when the clip closure was challenging or failed to use. Perforations were filled with one or several pieces of PGA sheets followed by fibrin glue application through an endoscopic catheter. Nasal or percutaneous drainage and endoscopic clipping were applied as appropriate. Clinical outcomes after PGA sheeting for intraoperative or delayed perforations were separately evaluated. RESULTS: There were 66 intraoperative and 24 delayed perforation cases. In intraoperative cases, successful closure was attained in 60 cases (91%). The median period from the first sheeting to diet resumption was 6 days (interquartile range [IQR], 4-8.8 days). Large perforation size (≥ 10 mm) and duodenal location showed marginal significant relationship to higher closure failure of intraoperative perforations. In delayed perforation cases, all cases had successful closure. The median period from the first sheeting to diet resumption was 10 days (IQR, 6-37.8 days). No adverse events related to PGA sheeting occurred. CONCLUSION: Endoscopic PGA sheeting could be a therapeutic option for GI perforations related to GI endoscopic procedures.

[Successful Surgical Correction of Partial Atrioventricular Septal Defect in an Elderly Patient:Report of a Case].

There are only few reports on surgery for partial atrioventricular septal defect( pAVSD) in patients aged over 70 years. This report is about successful surgical correction of pAVSD in a 79-year-old women. Echocardiography showed left-sided atrioventricular valve regurgitation with cleft and ostium primum atrial septal defect, but without ventricular septal defect. Accordingly, she was diagnosed with pAVSD. Treatment plan included direct cleft closure, patch closure for the ostium primum atrial septal defect, and right atrioventricular annuloplasty. The postoperative course was uneventful. She was followed up without complications for four years. To the best of our knowledge, our patient is the oldest to undergo such surgical techniques in Japan to date.

[A Case of Locally Advanced Rectal Cancer Treated Successfully with TNT].

Local control is important in the treatment of locally advanced rectal cancer(LARC). In Western countries, the standard therapy for LARC is preoperative chemoradiotherapy(CRT)followed by total mesorectal excision. Recently, addition of intensive chemotherapy to CRT known as total neoadjuvant therapy(TNT)is increasing. We herein report a 69-year-old woman who developed LARC(cT3N3M0, cStage Ⅲc). She was diagnosed as clinical complete response after TNT, and she chose"watch and wait". She did not have a recurrence for 16 months.

[A Case of Rectal Cancer with Bladder Invasion Performed with Robot-Assisted Low Anterior Resection after TNT].

A 73-year-old woman was admitted with a chief complaint of weight loss. Colonoscopy revealed rectal cancer. After the placement of a colonic stent, the patient was referred to our department. Computed tomography, magnetic resonance imaging, and cystoscopy indicated extensive invasion of the bladder. Since total pelvic exenteration was necessary at the first diagnosis, total neoadjuvant therapy(TNT)was conducted. The diagnosis after TNT was ycT4bycN0ycM0. Low anterior resection with partial resection of the bladder and a diverting ileostomy were performed. The patient was discharged on the 16th day post-surgery with a good postoperative course. The pathological examination revealed a complete response, ypT0ypN0.

Correlations between Accreditation Council for Graduate Medical Education Obstetrics and Gynecology Milestones and American Board of Obstetrics and Gynecology qualifying examination scores: an initial validity study.

BACKGROUND: Since the launch of the Outcome Project in 2001, the graduate medical education community has been working to implement the 6 general competencies. In 2014, all Obstetrics and Gynecology residency programs implemented specialty-specific milestones to advance competency-based assessment. Each clinical competency committee of the Obstetrics and Gynecology program assesses all residents twice a year on the milestones. These data are reported to the Accreditation Council for Graduate Medical Education as part of a continuous quality improvement effort in graduate medical education. OBJECTIVE: This study aimed to evaluate the correlation between the Accreditation Council for Graduate Medical Education Obstetrics and Gynecology Milestones and residency program graduates' performance on the American Board of Obstetrics and Gynecology qualifying (written) examination. STUDY DESIGN: We conducted a validity study of all graduating (postgraduate year 4) Obstetrics and Gynecology residents in 2017 within Accreditation Council for Graduate Medical Education-accredited United States training programs (1260 residents from 242 programs). This cohort of residents began receiving milestone assessments during their postgraduate year 2 in 2014; the first-year milestones were implemented for all Accreditation Council for Graduate Medical Education-accredited Obstetrics and Gynecology programs. This cohort completed their sixth and final milestone assessment at graduation in June 2017 for a total of 6 periods of milestone assessments. Data regarding each resident's milestone ratings in each of the 28 Accreditation Council for Graduate Medical Education subcompetencies for Obstetrics and Gynecology were assessed for their association with candidates' American Board of Obstetrics and Gynecology qualifying examination scores using a generalized estimating equation regression model. RESULTS: Data were available and analyzed from 1184 residents from 240 programs, representing 94% of the total academic year 2017 graduates of Obstetrics and Gynecology residency training programs. There was a substantial association between most milestone ratings at the 6 assessment points and candidates' performance on the American Board of Obstetrics and Gynecology qualifying examination. The strongest associations with the American Board of Obstetrics and Gynecology were within all 7 of the subcompetencies of Medical Knowledge (range of slope correlation coefficients at final milestone ratings 3.84-5.17; slope coefficients can be interpreted as the gain in qualifying examination points per unit increase in milestone level). At the final milestone assessment, but more modest associations with the American Board of Obstetrics and Gynecology qualifying examination scores were also seen with 9 of the 11 Patient Care and Procedural Skills subcompetencies, the 2 of 2 Practice-Based Learning and Improvement subcompetencies, the 2 of 2 Systems-Based Practice subcompetencies, and 2 of the 3 Professionalism subcompetencies. Only 1 of the 3 Interpersonal and Communication Skills subcompetencies was associated with American Board of Obstetrics and Gynecology qualifying examination scores. CONCLUSION: The pattern of associations between the qualifying examination scores and milestone ratings for the 2017 graduating cohort of Obstetrics and Gynecology residents followed a logical pattern, with the strongest associations seen in Medical Knowledge, and lower to no associations in subcompetencies not as effectively assessed on multiple-choice examinations. Although some positive associations were noted for non-Medical Knowledge milestones, these associations could be caused by correlational rating errors with further study needed to better understand these patterns.

Evaluation of cardiac beat synchronization control for a rotary blood pump on valvular regurgitation with a mathematical model.

We have studied the cardiac beat synchronization (CBS) control for a rotary blood pump (RBP) and revealed that it can promote pulsatility and reduce cardiac load. Besides, patients with LVAD support sometimes suffer from aortic and mitral regurgitation (AR and MR). A control method for the RBP should be validated in wider range of conditions to clarify its benefits and pitfalls prior to clinical application. In this study, we evaluated pulsatility and cardiac load reduction obtained with the CBS control on valvular failure conditions with a mathematical model. Diastolic assist could reduce cardiac load on the left ventricle by decreasing external work of the ventricle even in MR cases while it was not so effective in AR cases. Systolic assist can still promote pulsatility in AR and MR cases; however, aortic valve function should be carefully confirmed since pulse pressure can be wider not due to systolic assist but to AR.

Using Learning Analytics to Examine Achievement of Graduation Targets for Systems-Based Practice and Practice-Based Learning and Improvement: A National Cohort of Vascular Surgery Fellows.

BACKGROUND: Surgeons provide patient care in complex health care systems and must be able to participate in improving both personal performance and the performance of the system. The Accreditation Council for Graduate Medical Education (ACGME) Vascular Surgery Milestones are utilized to assess vascular surgery fellows' (VSF) achievement of graduation targets in the competencies of Systems Based Practice (SBP) and Practice Based Learning and Improvement (PBLI). We investigate the predictive value of semiannual milestones ratings for final achievement within these competencies at the time of graduation. METHODS: National ACGME milestones data were utilized for analysis. All trainees entering the 2-year vascular surgery fellowship programs in July 2016 were included in the analysis (n = 122). Predictive probability values (PPVs) were obtained for each SBP and PBLI sub-competencies by biannual review periods, to estimate the probability of VSFs not reaching the recommended graduation target based on their previous milestones ratings. RESULTS: The rate of nonachievement of the graduation target level 4.0 on the SBP and PBLI sub-competencies at the time of graduation for VSFs was 13.1-25.4%. At the first time point of assessment, 6 months into the fellowship program, the PPV of the SBP and PBLI milestones for nonachievement of level 4.0 upon graduation ranged from 16.3-60.2%. Six months prior to graduation, the PPVs across the 6 sub-competencies ranged from 14.6-82.9%. CONCLUSIONS: A significant percentage of VSFs do not achieve the ACGME Vascular Surgery Milestone targets for graduation in the competencies of SBP and PBLI, suggesting a need to improve curricula and assessment strategies in these domains across vascular surgery fellowship programs. Reported milestones levels across all time point are predictive of ultimate achievement upon graduation and should be utilized to provide targeted feedback and individualized learning plans to ensure graduates are prepared to engage in personal and health care system improvement once in unsupervised practice.

[A Case of Esophagogastric Junction Cancer Treated Successfully with Conversion Surgery after Complete Response to Nivolumab Treatment].

As shown in the ATTRACTION-2 trial, nivolumab is effective as third-line chemotherapy for advanced or recurrent gastric cancer and esophagogastric junction cancer. We report a patient with esophagogastric junction cancer who underwent conversion surgery after third-line chemotherapy with nivolumab. The patient was a 72-year-old woman. Upper gastrointestinal endoscopy revealed advanced esophagogastric junction cancer of Siewert type Ⅱ, and computed tomography revealed multiple hepatic and pulmonary metastases. The esophagogastric junction cancer was diagnosed as cT3N1M1, cStage Ⅳb, and she was administered SP as first-line and nab-PTX/RAM as second-line treatment, but progressive disease remained. Nivolumab as a third-line treatment remarkably reduced the hepatic and pulmonary metastases after its administration was initiated, and conversion surgery was performed after 28 courses. The pathological diagnosis was ypT1b2(SM2), ypN0. After discharge from the hospital, postoperative chemotherapy with nivolumab was continued in the outpatient clinic, and there has been no evidence of disease progression.

[A Case of Advanced Rectal Cancer with Left Hydronephrosis Treated with Left Ureter-Sparing Laparoscopic High Anterior Resection after Chemotherapy].

A 47-year-old woman with a complaint of weight loss for the past 5 months was referred to our hospital. Colonoscopy revealed advanced rectal cancer 20 cm from the anal verge. The patient had left hydronephrosis caused by ureteral invasion. Firstly, we performed transverse colostomy and left nephrostomy. After 8 courses of capecitabine, oxaliplatin plus bevacizumab( CAPOX plus Bmab)therapy, colonoscopy and computed tomography revealed shrinkage of both the primary and metastatic lesions. Laparoscopic high anterior resection was performed, and the left ureter was successfully preserved. The patient received chemotherapy after surgery. Neither local recurrence nor enlargement of metastases has been observed 8 months after surgery.

[A Case of Synchronous Multiple Colorectal Cancer with Rectal Neuroendocrine Tumor and Ascending Colon Cancer].

A 43-year-old man who had no previous medical history or family history had positive fecal occult blood test in a local physician. Colonoscopy revealed a type 2 tumor of the ascending colon and a 10 mm submucosal tumor(SMT)of the lower rectum. Biopsy indicated moderately-differentiated adenocarcinoma of the ascending colon and neuroendocrine tumor (NET)of the lower rectum. No metastasis was detected by computed tomography. Therefore, the rectal SMT was resected first by endoscopic submucosal resection. Histopathologically, the lesion was localized in the submucosa and no lymphovascular invasion was found. Vertical margin was also negative. We decided not to perform additional intestinal resection for rectal NET. Thereafter, the patient underwent laparoscopic right hemicolectomy for ascending colon cancer. The histopathological findings were pT3, pN1, pM0, pStage Ⅲb. The patient received adjuvant chemotherapy. No relapse was found 18 months after surgery. We reported a rare case of a lower rectal NET with concomitant ascending colon cancer.

Bridge-to-Bridge Left Ventricular Assist Device Implantation Strategy vs. Primary Left Ventricular Assist Device Implantation Strategy.

BACKGROUND: The bridge-to-bridge (BTB) strategy, a conversion to durable left ventricular assist device (LVAD) after stabilization using surgical temporary mechanical circulatory supports for a couple of months, is not uncommon in Japan. However, its effect on clinical outcomes in comparison with a primary durable LVAD implantation strategy remains unknown.Methods and Results:Data of 837 consecutive patients (median age 45, 73% males) who underwent durable LVAD implantation as BTB (n=168) or primary implant (n=669) between April 2011 and April 2019 were retrospectively reviewed from the prospective multicenter Japanese mechanically assisted circulatory support registry. The BTB group was younger and had comparable end-organ function, better hemodynamic profile, and longer operative time compared with the primary implant group at baseline. The 3-year survival was 80% vs. 87% (P=0.007) for the BTB and primary implant groups respectively, with greater observed rates of stroke and infection as the predominant causes of death. The BTB strategy was independently associated with increased 3-year mortality (hazard ratio 2.69 [1.43-5.07], P=0.002) in addition to other significant risk factors. CONCLUSIONS: The BTB cohort had comparable baseline characteristics to the primary implant cohort at the time of durable LVAD conversion, but had lower 3-year survival. Detailed analysis clarifying the causality of this finding should improve outcomes with the BTB strategy.

Hemocompatibility-related Adverse Events Following HeartMate II Left Ventricular Assist Device Implantation between Japan and United States.

Background: Left ventricular assist device (LVAD) therapy has improved the clinical outcomes in advanced heart failure patients, however, this may differ between countries. We aimed to compare outcomes between Japanese and US LVAD cohorts. Methods: For 416 consecutive LVAD patients who received HeartMate II LVAD implantation and completed a one-year follow-up, age-matched Japanese patients (the Japanese registry for mechanically assisted circulatory support (J-MACS) group) and the US patients were compared for their clinical outcomes. Results: 154 J-MACS patients and 77 US patients were compared. Survival, free from hemocompatibility-related adverse events (HRAEs) in the J-MACS was statistically comparable with the US (75% vs. 63%, p = 0.79). J-MACS had more disabling strokes than the US (0.221 vs. 0.052/patient-year, p = 0.005), whereas there was less nonsurgical bleeding (0.045 vs. 0.117/patient-year, p = 0.024). The net hemocompatibility score was statistically comparable between the groups (1.54 vs. 1.19 points/patient, p = 0.99). Post-LVAD prothrombin time with international normalized ratio (INR) <1.5 (odds ratio 4.07) was a risk factor for HRAEs in J-MACS, whereas INR >3.0 (odds ratio 5.71) was a risk factor in the US (p < 0.05 for both). Conclusion: In the age-matched cohorts, the J-MACS group experienced more strokes, while the US group had more bleedings. "Tailor-made" therapeutic strategy might be required for each country, given the unique variation of HRAE incidence among each country.