Effectiveness of Nutritional Guidance Focusing on Leucine Intake During Cardiac Rehabilitation Maintenance.

Objective: Due to the lack of information on the effects of nutritional guidance focused on leucine intake in patients undergoing maintenance cardiac rehabilitation, this study investigated on plasma leucine concentrations, lean body mass, and muscle strength. Methods: Nutritional guidance, focused on leucine (intervention group) or general nutritional guidance (control group), was provided for six months to patients participating in cardiac rehabilitation. Body composition, grip strength, hematological test results, and diet of both groups were compared before and after the intervention. Results: Seven patients in the intervention group (53.2 ±â€…18.2 years) and 7 patients in the control group (58.6 ±â€…15.3 years) were included. Dietary survey results showed that the six-month intervention significantly (p < 0.05) increased protein intake and estimated leucine intake only in the intervention group. There was no significant difference in the rate of change in plasma leucine concentration between the two groups. The rate of change in lean body mass was significantly higher in the intervention group compared to the control group (p = 0.035). The rate of change in plasma leucine concentration and that in lean body mass was positively correlated only in the intervention group (r = 0.777, p = 0.040), and the rate of change in plasma leucine concentration was also positively correlated with the rate of change in grip strength (ρ = 0.857, p = 0.014). Conclusions: In the patients undergoing maintenance cardiac rehabilitation, increased plasma leucine concentration by nutritional guidance focused on leucine increased lean body mass without any increasing the training load.

Relationship between prehabilitation responsiveness and postoperative physical functional recovery in cardiovascular surgery.

BACKGROUND: The purpose of this study was to examine the relationship between responsiveness to prehabilitation and postoperative recovery of physical function in cardiac surgery patients. METHODS: Ninety-three cardiac surgery patients (mean age: 76.4 years) were included in this retrospective cohort study. Preoperative physical function was measured using the Short Physical Performance Battery (SPPB), and a prehabilitation exercise program was implemented for the SPPB domains with low scores. Among the patients, those whose SPPB score was over 11 from the start of prehabilitation and remained over 11 on the day before surgery were defined as the high-functioning group, and those whose SPPB score improved by 2 points or more from the start of prehabilitation and exceeded 11 points were defined as the responder group. Those whose SPPB score did not exceed 11 immediately before surgery were classified as non-responders. The characteristics of each group and postoperative recovery of physical function were investigated. RESULTS: There were no serious adverse events during prehabilitation. Mean days of prehabilitation was 5.4 days. The responder group showed faster improvement in postoperative physical function and shorter time to ambulatory independence than the non-responder group. The non-responder group had lower preoperative skeletal muscle index, more severe preoperative New York Heart Association classification, and a history of musculoskeletal disease or stroke. CONCLUSION: There were responders and non-responders to prehabilitation among cardiac surgery patients. Cardiac surgery patients who respond to prehabilitation had faster recovery of physical function. Further research is needed to determine what type of prehabilitation is more effective in postoperative recovery of physical function in cardiac surgery patients.

Long-term follow-up of repair-like replacement of mitral valve using autologous pericardium.

Objectives: The present study assessed the late results of the operation, which consisted of the construction of a stentless mitral valve using autologous pericardium and valve implantation. Methods: Between 2011 and 2018, among 1617 consecutive patients who underwent mitral valve operation at our institution, 15 adult patients (0.9%) with unrepairable mitral valves who wished to avoid conventional mitral valve replacement underwent this operation. Ten patients (67%) had a history of valve repair. After discharge, patients were prospectively followed-up with a echocardiographic evaluation up to the end point. The mean follow-up term was 70.8 ± 42.5 months. Results: There were no hospital deaths or thromboembolic events and only 1 late noncardiac death. Intraoperative transesophageal echocardiography of all patients revealed no or trivial mitral regurgitation. Eight patients (53.3%) underwent redo valve replacement within 12 years. Except 1 late death, the postoperative course was divided into 3 groups depending on the occurrence of redo surgery, as follows: an early reoperation group (reoperation within 4 years; n = 4), a late reoperation group (reoperation after 4 years; n = 4), and a free from reoperation group (n = 6). The latest transthoracic echocardiographic examination performed 7.2 ± 2.9 years after the operation revealed the grade of mitral regurgitation to be none in 2 patients, mild in 2 patients, mild to moderate in 1 patients, and moderate in 1 patient in the free from reoperation group. Conclusions: Despite the high incidence of reoperation, Normo operation can be a viable option during valve replacement, especially for young patients.

Cool-Shot Technique to Protect Spinal Cord during Thoracoabdominal Aortic Replacement.

Deep hypothermia helps protect the spinal cord, but is invasive. Here, we present a method to avoid reperfusion injury by selectively circulating cold blood under high pressure to the intercostal artery during reperfusion after intercostal artery reconstruction. Of the 23 patients who underwent thoracoabdominal aortic aneurysm open repair, one died. The motor evoked potential disappeared during aortic clamping in nine patients. Six patients recovered completely from aortic clamping release, two showed recovery >50% and one achieved full recovery 3 months later. Permanent motor impairment did not occur. This method could prevent reperfusion injury and paraplegia following thoracoabdominal aortic aneurysm surgery.

Long-Term Outcomes of Coronary Artery Bypass Grafting Using an Internal Thoracic Artery versus a Radial Artery as a Second Arterial Graft.

PURPOSE: To compare the outcomes of left circumflex artery (LCx) revascularization using an internal thoracic artery (ITA) or radial artery (RA) as the second arterial graft. METHODS: Patients who underwent primary isolated coronary artery bypass grafting with left anterior descending artery revascularization using an ITA and LCx revascularization using another bilateral ITA (BITA group) or an RA (ITA-RA group) were included. All-cause mortality (primary endpoint), cardiac death, major adverse cardiac events, in-hospital death, and deep sternal wound infection (secondary endpoints) were evaluated. RESULTS: Among 790 patients (BITA, n = 548 (69%); ITA-RA, n = 242 (31%)), no significant difference in all-cause mortality between the groups was observed (hazard ratio (HR): 0.87; 95% confidence interval (CI): 0.67-1.12; p = 0.27) during follow-up (mean, 10 years). Multivariate analysis revealed that the BITA group exhibited significantly lower rates of long-term all-cause mortality (HR: 0.63; 95% CI: 0.48-0.84; p = 0.01). In the propensity-matched cohort (n = 480, 240 pairs), significantly fewer all-cause deaths occurred in the BITA group (HR: 0.66; 95% CI 0.47-0.93; p = 0.02). There were no significant differences in secondary outcomes. CONCLUSIONS: When used as second grafts for LCx revascularization, ITA grafts may surpass RA grafts in reducing all-cause mortality 10 years postoperatively.

Long-term prognostic value of the H2FPEF score in patients undergoing transcatheter aortic valve implantation.

AIMS: A considerable proportion of candidates for transcatheter aortic valve implantation (TAVI) have underlying heart failure (HF) with preserved ejection fraction (HFpEF), which can be challenging for diagnosis because significant valvular heart disease should be excluded before diagnosing HFpEF. This study investigated the long-term prognostic value of the pre-procedural H2FPEF score in patients with preserved ejection fraction (EF) undergoing TAVI. METHODS AND RESULTS: Patients who underwent TAVI between October 2013 and May 2017 were enrolled from the Optimized CathEter vAlvular iNtervention-Transcatheter Aortic Valve Implantation Japanese multicentre registry. After excluding 914 patients, 1674 patients with preserved EF ≥ 50% (median age: 85 years, 72% female) were selected for calculation of the H2FPEF score and were dichotomized into two groups: the low H2FPEF score [0-5 points; n = 1399 (83.6%)] group and the high H2FPEF score [6-9 points; n = 275 (16.4%)] group. Patients with high H2FPEF scores were associated with a higher prevalence of New York Heart Association Functional Class III/IV (59.3% vs. 43.7%, P < 0.001), diabetes (24.4% vs. 18.5%, P = 0.03), and paradoxical low-flow, low-gradient aortic stenosis (15.9% vs. 6.2%, P < 0.001). These patients showed worse prognoses than those with low H2FPEF scores regarding the cumulative 2 year all-cause mortality (26.3% vs. 15.5%, log-rank P < 0.001), cardiovascular mortality (10.5% vs. 5.4%, log-rank P < 0.001), HF hospitalization (16.2% vs. 6.7%, log-rank P < 0.001), and the composite endpoint of cardiovascular mortality and HF hospitalization (23.8% vs. 10.8%, log-rank P < 0.001). After adjustment for several confounders, the high H2FPEF scores were independently associated with increased risk for all-cause mortality [adjusted hazard ratio (HR), 1.48; 95% confidence interval (CI), 1.09-2.00; P = 0.011] and for the composite endpoint of cardiovascular mortality and HF hospitalization (adjusted HR, 1.95; 95% CI, 1.38-2.74; P < 0.001). Subgroup analysis confirmed the excess risk of high H2FPEF scores relative to low H2FPEF scores for the composite endpoint of cardiovascular mortality and HF hospitalization increased with a lower Society of Thoracic Surgeons (STS) score (STS score <8%: adjusted HR, 2.40; 95% CI, 1.50-3.85; P < 0.001; STS score ≥8%: adjusted HR, 1.34; 95% CI, 0.79-2.28; P = 0.28; Pinteraction = 0.030). CONCLUSIONS: The H2FPEF score is useful for predicting long-term adverse outcomes after TAVI, including all-cause mortality, cardiovascular mortality, and HF hospitalization for patients with preserved EF. More aggressive interventions targeting HFpEF in addition to the TAVI procedure might be relevant in patients with high H2FPEF scores, particularly in those with a lower surgical risk.

Midterm outcomes of transcatheter aortic valve replacement in patients with active cancer.

OBJECTIVES: The clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with aortic stenosis (AS) and concomitant active cancer remain insufficiently explored. This study aimed to assess the midterm outcomes of TAVR in patients diagnosed with AS and active cancer. METHODS: Data from the OCEAN-TAVI, a prospective Japanese registry of TAVR procedures, was analysed to compare prognoses and clinical outcomes in patients with and without active cancer at the time of TAVR. RESULTS: Of the 2336 patients who underwent TAVR from October 2013 to July 2017, 89 patients (3.8%) had active cancer, whereas 2247 did not. Among patients with active cancer, 49 had limited-stage cancer (stage 1 or 2). The prevalent cancers identified before TAVR were colon (21%), prostate (18%), lung (15%), liver (11%) and breast (9%). Although the periprocedural complications and 30-day mortality rates were comparable between the groups, the 3-year survival rate after TAVR was notably lower in patients with active cancer (64.7%) than in those without active cancer (74.7%; p=0.016). Nevertheless, the 3-year survival rate of patients with limited-stage cancer (stage 1 or 2) did not significantly differ from those without cancer (70.6% vs 74.7%, p=0.50). CONCLUSIONS: The patients with active cancer exhibited significantly reduced midterm survival rates. However, no distinct disparity existed in those with limited-stage cancer (stage 1 or 2). Although TAVR is a viable treatment in patients with AS with active cancer, the type and stage of cancer and prognosis should be carefully weighed in the decision-making process.

Surgical treatment in the chronic phase for uncomplicated Stanford type B aortic dissection.

BACKGROUND: The most appropriate surgical method for patients with uncomplicated type B aortic dissection (UTBAD) in the chronic phase remains controversial. This study evaluated the outcomes of patients with UTBAD who needed aortic treatment as well as the impact of the treatment method or indication criteria on their prognosis. METHODS: This retrospective review of 106 consecutive patients with aortic events in the chronic phase who underwent initial treatment for UTBAD between 2004 and 2021 comprised three groups: 19 patients who underwent endovascular repair (TEVAR), 38 who underwent open aortic repair and the medication group that included 49 patients. Aortic events were defined as a late operation or indication for operation for dissected aorta, aortic diameter (AD) ≥ 55 mm, rapid aortic enlargement (≥5 mm/6 months), and saccular aneurysmal change. The endpoint was all-cause death. We assessed the association between treatment methods or surgical indication criteria and mortality using a Cox regression analysis. RESULTS: The 5-year actuarial mortality rates were 27.1% in the TEVAR group, 19.6% in the open aortic repair group, and 38.4% in the medication group (p = 0.86). Moreover, the 5-year actuarial mortality rates in patients who had AD ≥ 55 mm were significantly higher than those patients with other surgical indication criteria (41.2% vs. 18.7%, p < 0.01). Multivariable analysis revealed a significant difference in AD ≥ 55 mm (hazard ratio [HR]: 2.88, 95% confidence interval [CI] 1.38-6.02, p < 0.01) and age (HR: 1.09, 95% CI 1.05-1.13, p < 0.01). CONCLUSIONS: Under the existing surgical indication criteria, there was no difference in mortality rates among patients with UTBAD based on their surgical treatment.

Feasibility of Nurse-Led Advance Care Planning Before Pre-cardiac Procedures: A Descriptive Study.

Background Shared decision-making is important for deciding whether to perform surgery, especially high-risk surgery, or end-of-life care in cases of serious complications after the surgery. In shared decision-making, surgeons should be aware of patients' values. Therefore, advance care planning (ACP) before the surgery is important. In Japan, the feasibility of ACP, particularly preoperative nurse-led ACP, is yet to be evaluated. Methodology This retrospective, single-center, descriptive study included all adult candidates for open-heart or thoracic aortic surgery and transcutaneous aortic valve implantation (TAVI) referred by their surgeon for a nurse-led preoperative ACP between April 1, 2020 and December 31, 2021. The nurse conducted semi-structured interviews with patients regarding goals of care, unacceptable conditions, undesired procedures, advance directives, and their surrogates and documented them. The content of these interviews and their influence on decision-making were retrospectively investigated. Results Sixty-four patients (median age, 82 years; Society of Thoracic Surgeons (STS) score, 7.9; EuroSCORE II, 4.2; JapanSCORE, 7.0) were included (open-heart or thoracic aortic surgery 24, TAVI 40). Among them, 63 (98.4%), 56 (87.5%), and 13 (20.3%) patients articulated their goals of care, unacceptable conditions, and undesired procedures. Only one (1.6%) had a written advance directive. Although all of the patients could designated their surrogate, only 11 (17.2%) had shared their values disclosed in the pre-procedure ACP communication with their surrogates. Two patients who planned to undergo open-heart surgery disclosed their wish not to undergo the surgery only to the nurses but could not tell their surgeon; thereafter, the surgery was canceled. Three patients died after the procedure; however, the patients' value disclosed in ACP was not used for the end-of-life decision. Conclusion Nurse-led ACP can be implemented before high-risk cardiac procedures. It may have an impact on the decision-making of surgery although the ACP content may not be utilized for the end-of-life discussion after the procedures between surgeons and the family member.

Acute endocarditis complicated by left ventricular pseudoaneurysm with acute bloody pericardial effusion: A case report.

RATIONALE: Delay in seeking medical attention for high fever and inadequate diagnosis can lead to rapid progression of inflammation and spread to surrounding tissues and organs. Staphylococcus aureus is a common cause of systemic infections, and infectious endocarditis can swiftly become severe; therefore, careful management is required. PATIENT CONCERNS: A 54-year-old woman was admitted to our hospital with high fever and progressive loss of consciousness. Meningitis was suspected, and antibiotic treatment was initiated. Blood culture revealed methicillin-sensitive Staphylococcus aureus. Subsequently, the patient developed hypotension, bradycardia, and cardiac arrest and underwent emergency cardiopulmonary resuscitation. DIAGNOSES: Transesophageal echocardiography performed during the procedure revealed significant vegetation at the posterior leaflet of the mitral valve, an abscess at the valve annulus, and a pseudoaneurysm of the left ventricular posterior wall. INTERVENTIONS: The patient underwent emergency small incision pericardiotomy drainage, and her blood pressure and heart rate stabilized. After pericardial drainage, acute renal failure, fulminant hepatitis, and disruption of coagulation function were observed, and she was treated with plasma exchange therapy and intravenous immunoglobulin. Resection of the huge vegetation, debridement, patch closure of the ventricular perforation, and mitral valve replacement were performed. OUTCOMES: Surgical findings showed massive vegetation in the posterior leaflet of the mitral valve, an annular abscess in the posterior leaflet of the mitral valve connected to the left ventricular posterior wall, and a pseudoaneurysm. Postoperatively, her pseudoaneurysm resolved and her cardiac function stabilized, while circulatory failure due to bacteremia progressed, and she gradually developed acidosis and unstable blood pressure. Plasma exchange and continuous hemodiafiltration were continued; however, she died of progressive multiorgan failure. LESSON: Staphylococcus aureus bacteremia can cause fatal complications. Even when symptoms of meningitis are suspected, it is essential to examine the patient for endocarditis. Delayed diagnosis can lead to fatal endocarditis-related complications.

Immune-Mediated Non-Infectious Periaortitis After Aortic Graft Replacement Surgery: A Case Report Highlighting the Need for Immunosuppressive Therapy.

BACKGROUND A non-infectious inflammatory reaction against replaced aortic graft for aortic dissection often manifests as fever, malaise, and peri-graft effusion. It usually lasts less than 1 month and subsides spontaneously without immunosuppressive treatment. CASE REPORT A 49-year-old man underwent ascending aorta and total arch replacement for acute thoracic aortic dissection. He had fever, malaise, nausea, and elevated serum C-reactive protein for 1 month postoperatively. Pathological examination of the aorta revealed no aortitis, and repeated blood cultures were negative. We also noted periaortic graft fluid collection, and a small amount of pleural and pericardial effusions. We suspected post-pericardiotomy syndrome. Colchicine and prednisolone were administered, with an excellent clinical response. Three weeks after discontinuation of a 7-week prednisolone treatment, the same symptoms recurred and gradually worsened. Prednisolone was restarted 6 months after the first surgery, with good clinical response. Thereafter, he developed left-sided weakness and dysarthria, being diagnosed as ischemic stroke. Contrast-enhanced computed tomography revealed fluid collection with contrast leak around the aortic grafts, suggesting peel dehiscence, and thrombus formation in anastomotic pseudoaneurysm. He underwent surgical repair. He was diagnosed with non-infectious periaortitis, likely due to an immune reaction to the grafts, based on an excellent clinical response to immunosuppressive therapy. CONCLUSIONS We report a case of non-infectious periaortitis around a thoracic aortic graft, probably with an immune-mediated mechanism, requiring immunosuppressive treatment. When fever persists after aortic graft replacement surgery, non-infectious periaortitis should be considered and immunosuppressive treatment should be considered to prevent critical complications of anastomotic pseudoaneurysm and graft dehiscence.

Sternal closure with sandwiched three-piece bioresorbable mesh reduces postoperative hemorrhage: a retrospective study.

BACKGROUND: Median sternotomy is the most performed procedure in cardiac surgery; however, sternal displacement and bleeding remains a problem. This study aimed to investigate whether sternal reconstruction using a sandwiched three-piece bioresorbable mesh plate can prevent postoperative sternal displacement and bleeding more than a bioresorbable pin. METHODS: Patients (n = 218) who underwent median sternotomy were classified according to whether a sandwiched three-piece bioresorbable mesh plate and wire cerclage (group M, n = 109) or a bioresorbable pin and wire cerclage (group P, n = 109) were used during sternal reconstruction. The causes of postoperative sternal displacement and bleeding with computed tomography data were analyzed and compared between the groups. RESULTS: The preoperative patient characteristics did not significantly differ between the groups. However, the evaluation of sternal and substernal hematoma on postoperative day 5 using computed tomography showed sternal displacement in 4 (4%) and 22 (20%) patients, and substernal hematoma in 17 (16%) and 41 (38%) patients in groups M and P, respectively; this difference was significant. Furthermore, the amount of bleeding at 6 h postoperatively was lower in group M than in group P (235 ± 147 vs. 284 ± 175 mL, p = 0.0275). Chest reopening, intubation time, and length of intensive care unit and hospital stays did not differ between the groups. The evaluation of substernal hematoma based on computed tomography yielded a significantly lower for group M than for group P, revealing that the mesh plate was an independent predictor of substernal hematoma prevention. CONCLUSION: Sternal fixation with a three-piece bioresorbable mesh plate could prevent postoperative sternal displacement, bleeding, and substernal hematoma more than sternal fixation with a pin.

Repairable ex vivo model of functional and degenerative mitral regurgitation.

OBJECTIVES: Transcatheter mitral valve repair is an emerging alternative to the surgical repair. This technology requires preclinical studies to assess efficacy in mitigating mitral regurgitation (MR). However, ex vivo MR models are not established. We developed 2 novel repairable models, functional and degenerative, which can quantitatively assess regurgitation and effect of intervention. METHODS: We used porcine mitral valves and a pulsatile flow circulation system. In the functional MR model, the annulus was immersed in 0.1% collagenase solution and dilated using 3D-printed dilators. To control the regurgitation grade, the sizes of the dilator and silicone sheet in which the valve was sutured to were adjusted. Chordae of P2 were severed in the degenerative model, and the number of severed chordae was adjusted to control the regurgitation grade. Models were repaired using the edge-to-edge or artificial chordae technique. RESULTS: The mean regurgitant fraction of the moderate-severe functional and degenerative models were 47.9% [standard deviation (SD): 2.2%] and 58.5% (SD: 8.0%), which were significantly reduced to 28.7% (SD: 4.4%) (P < 0.001) and 26.0% (SD: 4.4%) (P < 0.001) after the valve repair procedures. Severe functional model had a mean regurgitant fraction of 59.4% (SD: 6.0%). CONCLUSIONS: Both functional and degenerative models could produce sufficient MR levels that meet the interventional indication criteria. The repairable models are valuable in evaluating the efficacy of valve repair procedures and devices. The ability to control the amount of regurgitation enhances the versatility and reliability of these models. These reproducible models could expedite the development of novel devices.

Validation study of EuroSCORE II for dialysis patients: A single-center study in Japan.

BACKGROUND: The European System for Cardiac Operative Risk Evaluation (EuroSCORE) II is a predictive model for in-hospital mortality after cardiac surgery. Although it has good performance among the general population undergoing cardiac surgery, it has not been validated among dialysis patients, who have a higher rate of mortality after cardiac surgery. This study aimed to evaluate the performance of the model in predicting in-hospital mortality in maintenance dialysis patients undergoing cardiac surgery. METHODS: This retrospective, single-center study included adult patients on maintenance dialysis who underwent open cardiac surgery at our institution. Calibration performance of EuroSCORE II for in-hospital death was determined based on the comparison between expected and observed mortalities for low- (EuroSCORE II <4 %), intermediate- (4-8 %), and high-risk (>8 %) groups. The area under receiver operating characteristic curve (AUROC) was investigated to determine the model's discrimination performance. RESULTS: A total of 163 patients (male, 73.6 %; median age, 70 years; median dialysis vintage, 9 years; median EuroSCORE II, 3.3 %) were included. The mortality rate was 9.2 %. The observed mortality rates (vs. mean expected mortality) rates were 2.1 % (vs. 2.4 %), 7.5 % (vs. 5.5 %), and 34.5 % (vs. 21.1 %) in the low-, intermediate-, and high-risk groups, respectively. Its AUROC was 0.825 (95 % confidence interval, 0.711-0.940). CONCLUSIONS: Although EuroSCORE II model adequately estimated in-hospital mortality in the low-and intermediate-risk groups (EuroSCORE II <8 %), it underestimated in-hospital mortality in the high-risk group (EuroSCORE II >8 %) among maintenance dialysis patients. The discrimination performance of the model for in-hospital death was good among maintenance dialysis patients.

Rationale and design of Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation (NAPT) Trial.

BACKGROUND: Despite the wide implementation of transcatheter aortic valve implantation (TAVI), the optimal antithrombotic therapy after TAVI has not been established yet. Owing to the accumulating evidence supporting the efficacy and safety of single antiplatelet therapy (SAPT) over dual antiplatelet therapy, the latest guideline recommends life-long SAPT. However, there is scarce evidence supporting SAPT compared with non-antithrombotic therapy. Given the vulnerability of patients undergoing TAVI in terms of high bleeding risk, the benefit of SAPT may be canceled out by its potential increased bleeding risk. STUDY DESIGN AND OBJECTIVES: Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation (NAPT) Trial is a prospective, randomized controlled, open-label blinded endpoint multicenter trial conducted in Japan, testing the non-inferiority of non-antithrombotic therapy compared with aspirin monotherapy in patients who underwent TAVI and had no indications for long-term oral anticoagulation therapy (OAC). Patients who successfully underwent trans-femoral TAVI for severe aortic stenosis with either balloon-expandable or self-expandable valves are eligible for inclusion. Key exclusion criteria are (i) occurrence of perioperative complications (ii) indications of taking antithrombotic drugs for other reasons; (iii) eGFR <30 ml/min/1.73 m2 or hemodialysis or peritoneal dialysis. A total of 360 patients will be randomized (1:1) to aspirin monotherapy vs. non-antithrombotic therapy. The primary outcome is a composite of all-cause mortality, myocardial infarction, stroke, and bleeding. All bleeding events based on the Valve Academic Research Consortium 3 are included as a component of the primary outcome. CONCLUSION: The NAPT trial will determine the non-inferiority of a non-antithrombotic therapy compared with aspirin monotherapy after TAVI.

Safety and Feasibility of Tele-Cardiac Rehabilitation Using Remote Biological Signal Monitoring System: A Pilot Study.

Background: Cardiac rehabilitation (CR) is categorized as a class I recommendation in the guidelines for the management of patients with cardiovascular disease (CVD). However, the penetration rate of outpatient CR is low in Japan. We designed a pilot study to evaluate the safety and feasibility of tele-CR using a remote biological signal monitoring system. Methods: A total of nine patients (median aged 70.0 (66.0 - 76.0) years (male = 6) with CVD who participated in phase II CR for 1 month under the exercise prescription using the cardiopulmonary exercise test (CPET) were analyzed. They participated in the tele-CR program with a remote biological signal monitoring system (Nipro HeartLineTM, Osaka, Japan, and Duranta, Miyagi, Japan) in the CR room and were instructed by the CR staff from a separate room in the hospital. We evaluated the occurrence and degree of remote biological signal monitoring defects as safety evaluation items, i.e., whether the patients could set the remote biological signal monitoring equipment, as a feasibility evaluation item during a 3-month period. We also performed CPET at the baseline and follow-up. Following the 3-month tele-CR program, a total of 122 remote CR programs were performed using the remote biological signal monitoring system. Results: No patient experienced a lack of remote biological signal monitoring during exercise therapy. Significant improvement was noted in the exercise capacity, as assessed using the cardiopulmonary test (from 19.5 (16.7 - 20.2) mL/kg/min to 21.1 (17.3 - 22.8) mL/kg/min, P = 0.01, age ratio from 86% (75-96%) to 99% (78-104%), P = 0.01). One patient required support using the remote biological signal monitoring system, including information technology literacy. Conclusions: This study suggests the safety and feasibility of tele-CR using the remote biological signal monitoring system. However, further investigations are required to explore the suitability, effects, and cost-effectiveness of tele-CR as an alternative to center-based CR in the future.

Prognostic Value of Electrocardiographic Left Ventricular Hypertrophy After Transcatheter Aortic Valve Implantation: Insights from the OCEAN-TAVI Registry.

Electrocardiogram (ECG) left ventricular hypertrophy (LVH) is associated with the prognosis of patients with aortic stenosis. However, the impact of the presence or absence of ECG-LVH on the clinical outcomes after transcatheter aortic valve implantation (TAVI) is limited. This study aimed to assess the prognostic value of ECG-LVH among patients with aortic stenosis treated by TAVI. A total of 1,667 patients who underwent TAVI were prospectively enrolled into the OCEAN-TAVI (Optimized CathEter vAlvular iNtervention-Transcatheter Aortic Valve Implantation) registry. A total of 1,446 patients (mean age 84 years; 29.9% men) were analyzed. The Sokolow-Lyon index was used to determine the presence of ECG-LVH. LVH was also assessed using transthoracic echocardiography (TTE). We investigated the association between ECG-LVH and all-cause and cardiovascular mortality. This study identified ECG-LVH and TTE-LVH in 743 (51.5%) and 1,242 patients (86.0%), respectively. The Kaplan-Meier analysis revealed that all-cause mortality was significantly higher among patients without ECG-LVH than among those with ECG-LVH (log-rank p <0.001). In the multivariable analysis, the absence of ECG-LVH was independently associated with all-cause mortality (hazard ratio 1.98, 95% confidence interval 1.39 to 2.82, p <0.001), regardless of the presence or absence of TTE-LVH. Furthermore, the presence of TTE-LVH with the absence of ECG-LVH was observed in 575 patients (40%), which was associated with cardiovascular mortality (hazard ratio 2.84, 95% confidence interval 1.56 to 5.17, p <0.001). In conclusion, the absence of ECG-LVH was independently associated with an increased risk of all-cause mortality after TAVI. Risk stratification using both ECG-LVH and TTE-LVH is a useful predictor of adverse clinical outcomes after TAVI.

Temporary venovenous extracorporeal membrane oxygenation after cardiopulmonary bypass in minimally invasive cardiac surgery via right minithoracotomy.

Objectives: In minimally invasive cardiac surgery, it can be difficult at times to maintain adequate oxygenation with single-lung ventilation after weaning from cardiopulmonary bypass (CPB), and intermittent double-lung ventilation is required during hemostasis. Venovenous extracorporeal membrane oxygenation (VV-ECMO) after weaning from CPB eliminates the necessity of overinflation of the left lung and intermittent double-lung ventilation and enables secure and fast hemostasis. We investigated the effectiveness and safety of temporary VV-ECMO in MICS. Methods: Between May 2018 and March 2021, 149 patients underwent temporary VV-ECMO during minimally invasive cardiac surgery in our institutions. After weaning from CPB, the arterial circuit was reconnected to the right internal jugular venous cannula, the femoral venous cannula was pulled down by 20 cm, and VV-ECMO was established using the CPB machine and cannulas. After starting VV-ECMO, we administered protamine and performed hemostasis. Operative data and outcomes were retrospectively reviewed. Results: The mean VV-ECMO time and flow were 26 ± 13 minutes and 2.38 ± 0.40 L/m2, respectively. There was no thrombus in the CPB circuit, including the oxygenator. The trans-oxygenator pressure gradient index at the end of VV-ECMO significantly correlated with that at the start of VV-ECMO (r = 0.88; 95% CI, 0.79-0.94; P = .01). The 30-day mortality rate was 2.0%. The incidences of unilateral pulmonary edema, prolonged ventilation, and re-exploration for bleeding were 2.7%, 5.4%, and 2.0%, respectively. Conclusions: Temporary VV-ECMO is safe and useful to maintain single-lung ventilation without overinflation after weaning from CPB for secure and fast hemostasis in minimally invasive cardiac surgery. No thrombotic event was found during temporary VV-ECMO without heparinization.