Search

This study retrospectively evaluated the mid-term outcomes of surgical aortic valve replacement (SAVR) using a stented porcine aortic valve bioprosthesis (Mosaic; Medtronic Inc., Minneapolis, MN, USA) with concomitant mitral valve (MV) repair. From 1999 to 2014, 157 patients (median [interquartile range] age, 75 [70–79] years; 47% women) underwent SAVR with concomitant MV repair (SAVR + MV repair), and 1045 patients (median [interquartile range] age, 76 [70–80] years; 54% women) underwent SAVR only at 10 centers in Japan as part of the long-term multicenter Japan Mosaic valve (J-MOVE) study. The 5-year overall survival rate was 81.5% ± 4.1% in the SAVR + MV repair group and 85.1% ± 1.4% in the SAVR only group, and the 8-year overall survival rates were 75.2% ± 5.7% and 78.1% ± 2.1%, respectively. Cox proportional hazards analysis showed no significant difference in the survival rates between the two groups (hazard ratio, 0.87; 95% confidence interval, 0.54–1.40; P = 0.576). Among women with mild or moderate mitral regurgitation who were not receiving dialysis, those who underwent SAVR + MV repair, were aged > 75 years, and had a preoperative left ventricular ejection fraction of 30–75% tended to have a lower mortality risk. In conclusion, this subgroup analysis of the J-MOVE cohort showed relevant mid-term outcomes after SAVR + MV repair. [ABSTRACT FROM AUTHOR]

Objectives: This study analyzed the long-term survival of dialysis patients undergoing AVR using the Japanese National Clinical Database with additional survival data., Methods: De-novo AVR for dialysis-dependent patients between 2010 and 2012 who were registered in the Japan Cardiovascular Surgery Database were included. Concomitant aortic surgery and transcatheter aortic valve replacement were excluded. An additional questionnaire was sent to each hospital regarding the underlying kidney disease, the duration of dialysis initiation to the surgery, and clinical outcomes. The Kaplan-Meier survival curve was descriptively shown for all cohorts and each renal pathology. Furthermore, we compared the incidence of bioprosthetic valve failure in patients who were < 65 years old (group Y) and ≧65 years old (group O)., Results: Of these 1529 patients, diabetic nephropathy was 517, chronic glomerulonephritis was 437, and renal sclerosis was 210, regarding renal pathology. 1, 3, and 5-year survival in each pathology was 78.4%, 58.6%, 45.9% in diabetic nephritis, 78.8%, 68.4%, 58.2% in chronic glomerulonephritis, 79.0%, 67.8%, 52.1% in renal sclerosis, and 74.4%, 62.6%, 49.2% in others. Active infectious endocarditis was more prevalent in group Y (O 2.7% vs. Y 9.6%). The incidence of bioprosthetic valve failure requiring re-hospitalization was too small to analyze. 1, 3, and 5-year survival was 76.0%, 63.4%, 49.2% in group O and 74.3%, 64.2%, and 47.7% in group Y., Conclusions: Long-term survival of AVR for dialysis-dependent was higher in patients with chronic glomerulonephritis and lower in patients with diabetic nephritis than in other pathologies., (© 2024. The Author(s).)

Objectives: New versions of balloon-expandable and self-expandable valves for transcatheter aortic valve replacement (TAVR) have been developed, but few studies have examined the outcomes associated with these devices using national-level data. This study aimed to elucidate the clinical and economic outcomes of TAVR for aortic stenosis in Japan through an analysis of real-world data.Methods: This retrospective cohort study was performed using data from patients with aortic stenosis who had undergone transfemoral TAVR with Edwards SAPIEN 3, Medtronic CoreValve, or Medtronic Evolut R valves throughout Japan from April 2016 to March 2018. Pacemaker implantation, mortality, and health expenditure were examined for each valve type during hospitalization and at 1 month, 3 months, 6 months, and 1 year. Generalized linear regression models and Cox proportional hazards models were used to examine the associations between the valve types and outcomes.Results: We analyzed 7244 TAVR cases (SAPIEN 3: 5276, CoreValve: 418, and Evolut R: 1550) across 145 hospitals. The adjusted 1-year expenditures for SAPIEN 3, CoreValve, and Evolut R were $79 402, $76 125, and $75 527, respectively; SAPIEN 3 was significantly more expensive than the other valves (P < .05). The pacemaker implantation hazard ratios (95% confidence intervals) for CoreValve and Evolut R were significantly higher (P < .001) than SAPIEN 3 at 2.61 (2.07-3.27) and 1.80 (1.53-2.12), respectively. The mortality hazard ratios (95% confidence intervals) for CoreValve and Evolut R were not significant at 1.11 (0.84-1.46) and 1.22 (0.97-1.54), respectively.Conclusions: SAPIEN 3 users had generally lower pacemaker implantation and mortality but higher expenditures than CoreValve and Evolut R users. [ABSTRACT FROM AUTHOR]

Objective: Reports on long-term outcomes of surgical aortic valve replacement (AVR) for patients aged < 60 years are scarce in Japan. Hence, we aimed to evaluate these outcomes in patients aged < 60 years., Methods: Between March 2000 and December 2020, 1477 patients underwent aortic valve replacement. In total, 170 patients aged < 60 years who underwent aortic valve replacement were recruited. Patients aged < 18 years were excluded. Patient data collected from the operative records and follow-up assessments were reviewed., Results: The mean age was 49 ± 9 years, and 64.1% of patients were male. One-hundred-and-fifty-two patients (89.4%) underwent aortic valve replacement with a mechanical valve and 18 (10.6%) with a bioprosthetic valve. The mean follow-up period was 8.1 ± 5.5 years. No operative mortality occurred, and in-hospital mortality occurred in one patient (0.6%). Ten late deaths occurred, with seven cardiac-related deaths. The overall survival rate was 95.4 ± 1.7%, 93.9 ± 2.3%, 90.6 ± 3.9%, and 73.2 ± 11.8% at 5, 10, 15, and 20 years, respectively. Freedom from major bleeding was 96.4 ± 1.6% at 5, 10, and 15 years, and 89.0 ± 7.3% at 20 years. Freedom from thromboembolic events was 98.7 ± 1.3%, 97.3 ± 1.9%, 90.5 ± 4.5%, and 79.0 ± 11.3% at 5, 10, 15, and 20 years, respectively. Freedom from valve-related reoperation was 99.4 ± 0.6% at 5 years, 97.8 ± 1.7% at 10 and 15 years, and 63.9 ± 14.5% at 20 years., Conclusions: Patients aged < 60 years undergoing aortic valve replacement with a high mechanical valve implantation rate had favorable long-term outcomes., (© 2024. The Author(s).)

The INSPIRIS RESILIA aortic bioprosthesis (Edwards Lifesciences LLC, Irvine, USA) was fixed in novel tissue preservation technology to ensure long-term durability. Hemodynamic performance after aortic valve replacement (AVR) for severe aortic stenosis (AS) has not been published in the Japanese cohort. Twenty-nine patients underwent AVR with INSPIRIS RESILIA bioprosthesis for severe AS between November 1, 2018 and December 31, 2020. The mean age was 75.1 ± 4.5 years with 19 female patients. Body surface area was 1.58 ± 0.19 m 2 and New York Heart Association functional class was 2.2 ± 0.5. Hemodynamic performance was assessed using follow-up transthoracic echocardiographic data collected at 3-6 months, 1 year and 2 years. The mean follow-up time was 19.2 ± 7.2 months, with a 100% follow-up rate. One patient died of postoperative heart failure. The preoperative mean and peak transvalvular pressure gradients (PGs) were 51.9 ± 18.4 mmHg and 89.3 ± 34.9 mmHg, respectively, and effective orifice area 0.72 ± 0.26 cm 2 . They improved at 10.2 ± 3.5 mmHg (p < 0.0001), 19.3 ± 6.6 mmHg (p < 0.0001) and 1.73 ± 0.47cm 2 (p < 0.0001) at discharge. The mean transvalvular PG at 3-6 months (n = 24), 1 year (n = 25) and 2 years (n = 15) was 11.2 ± 3.8 mmHg (p < 0.0001), 11.1 ± 3.2 mmHg (p < 0.0001) and 11.2 ± 3.3 mmHg (p < 0.0001), respectively. Left ventricular mass index decreased from 123.0 ± 35.0 g/m 2 before surgery to 113.4 ± 35.0 g/m 2 (p = 0.0133) at discharge. It has dropped to 88.0 ± 25.0 g/m 2 (p = 0.0007) at 2 years. Constrictive pericarditis caused heart failure in one patient. INSPIRIS RESILIA bioprosthesis showed improved hemodynamic performance in the early postoperative phase. There were fewer valve-related events observed., (© 2022. The Japanese Society for Artificial Organs.)

Background: This study aimed to elucidate the short-term surgical outcomes and hemodynamics of the Intuity valve compared to the standard bioprosthesis in Japanese patients., Methods and results: Among the 307 consecutive patients who underwent aortic valve replacement (AVR) between February 2019 and March 2021, the Intuity valve was implanted in 95 patients (Intuity group) and a conventional stented bioprosthesis was implanted in 193 patients (conventional group). After propensity score matching, there was no significant difference in in-hospital mortality between the Intuity (n=2, 3%) and conventional groups (n=0, P=0.490). Operation, cardiopulmonary bypass, and aortic cross-clamping times were significantly shorter in the Intuity group. Although the effective orifice area index, trans-prosthetic mean pressure gradient, and peak velocity were similar between the 2 groups at 1 week postoperatively, the Intuity group showed a better mean pressure gradient and peak velocity at 1 year postoperatively. Complete atrioventricular block requiring permanent pacemaker implantation developed in 2 patients (3%) in the Intuity group and none in the conventional group (P=0.476). Mild or greater paravalvular leakage was present in 8 patients (13%) in the Intuity group and 2 patients (3%) in the conventional group (P=0.095)., Conclusions: AVR using the Intuity valve in Japanese patients is satisfactory, with a better valve performance and a low incidence of complete atrioventricular block at 1 year postoperatively.

Background: This study retrospectively evaluated the long-term patient outcomes and durability of the Mosaic mitral porcine bioprosthesis in the Japan Mosaic valve long-term multicenter study., Methods and results: The medical records of 390 patients who underwent mitral valve replacement with the Mosaic bioprosthesis at 10 centers in Japan (1999-2014) were reviewed. Patient data were collected using the Research Electronic Data Capture software. Patient survival was determined using the Kaplan-Meier method. Freedom from structural valve deterioration (SVD) and valve-related reoperation and death were determined using actuarial methods. The median (interquartile range [IQR]) age of the cohort was 73 (69-77) years. The median (IQR) follow-up period was 4.83 (1.84-8.26) years. The longest follow-up period was 15.8 years. The 30-day mortality rate was 5.4%. The 12-year actuarial survival rate was 54.1±4.5%, and the freedom from valve-related death was 85.3±3.4%. The freedom from reoperation at 12 years was 74.3±5.7%. The freedom from SVD at 12 years was 81.4±6.6% for patients aged ≥65 years and 71.6±11.1% for those aged <65 years. The median (IQR) mean pressure gradient was 4.1 (3.0-6.0) and 5.6 (4.0-6.7) mmHg at 1 and 10 years, respectively. The median (IQR) effective orifice area was 1.7 (1.4-2.0) and 1.4 (1.2-1.6) cm 2 at 1 and 10 years, respectively., Conclusions: The Mosaic porcine bioprosthesis offered satisfactory long-term outcomes for up to 12 years.

To assess the early hemodynamics after mitral valve replacement (MVR) using the St Jude Medical (SJM) Epic bioprosthesis. MVR was performed using the SJM Epic bioprosthesis in 35 patients from June 2018 to April 2020; three patients were excluded because the postoperative transthoracic echocardiography (TTE) data were unavailable. Data from postoperative TTE at 1 week and 3 months after the procedure were reviewed. The mean mitral pressure gradient (mMPG) was calculated using a continuous wave Doppler method. Left ventricular outflow tract (LVOT) was calculated using a pulse wave Doppler method. The effective orifice area (EOA) was measured from pressure half time. There were 12 men (37.5%) and 20 women (62.5%) with a mean age of 75.9 years (61-88 years). The mean body surface area was 1.51 ± 0.22 cm 2 . The 25 mm and 27 mm valves were used in more than 50% of cases. The mMPG was 4.9 ± 1.7 mmHg and 5.4 ± 1.6 mmHg at 1 week and 3 months after surgery, respectively. EOA was 2.18 ± 0.50 cm 2 and 2.31 ± 0.59 cm 2 at 1 week and 3 months after surgery, respectively. The peak velocity of the LVOT (n = 22) was 103.3 ± 21.3 cm/s and 106.8 ± 27.4 cm/s at 1 week and 3 months after surgery, respectively. No findings suggested paravalvular regurgitation and LVOT obstruction. Using the SJM Epic bioprosthesis in MVR resulted in satisfactory hemodynamics in the early postoperative period, even with small valve sizes. Further accumulation of cases and evidence, including mid- to long-term results, is required in the future., (© 2021. The Japanese Society for Artificial Organs.)

Objectives: To reveal the mid-term outcomes of Contegra implantation for the reconstruction of the right ventricular outflow tract to proximal branch pulmonary arteries in a multicentre study., Methods: Between April 2013 and December 2019, 178 Contegra conduits were implanted at 5 Japanese institutes. The median age and body weight at operation were 16 months (25th-75th percentile: 8-32) and 8.3 kg (6.4-10.6). Sixteen patients were neonates (9.0%). Selected conduit sizes were 12 mm in 28 patients (15.7%), 14 mm in 67 patients (37.6%), 16 mm in 66 patients (37.1%), 18 mm in 5 patients (2.8%) and <12 mm in 12 patients (6.7%). Fifty-six grafts (31.4%) were ring supported. Proximal branch pulmonary arteries were concomitantly augmented in 85 patients (47.5%). Follow-up was completed in all patients and the median follow-up period was 3.1 years (1.3-5.1)., Results: The overall, conduit explantation-free and conduit infection-free survival rates at 5 years were 91.3%, 71.0% and 83.7%, respectively. Infection (P = 0.009) and common arterial trunk (P = 0.024) were risk factors for explantation. Conduit durability was shorter in smaller one (P < 0.001). Catheter interventions (for conduit to proximal branch pulmonary artery)-free survival rates at 5 years was 52.9%; however, need for catheter interventions was not a risk factor for conduit explantation., Conclusions: Mid-term outcomes of reconstruction of the right ventricular outflow tract to the proximal branch pulmonary arteries with Contegra were acceptable. The need for explantation over time was higher in smaller conduits. Conduit infection was a strong risk factor for conduit explantation. Frequently and repeated catheter interventions effectively extended the conduit durability., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Objectives: A new stented bovine pericardial valve (Avalus™) has been proven safe and effective with good hemodynamic performance in Western populations. However, its use in Japanese patients is poorly understood. We retrospectively compared the feasibility, safety, and valve haemodynamics between the Avalus™ and Magna™ valves in patients who underwent surgical aortic valve replacement (SAVR)., Methods: This study included 87 patients receiving an Avalus™ valve and 387 receiving a Magna™ valve. We evaluated adverse events, outcomes, and valve haemodynamics within 1 year postoperatively. There were no significant differences in any surgical risk scores., Results: No in-hospital mortality occurred in the Avalus™ group, but two mortality events occurred in the Magna™ group. No pacemaker implantation for complete atrioventricular block was required in the Avalus™ group. There was no significant difference in in-hospital or clinical outcomes between the two groups until 1 year postoperatively. Left ventricular mass index reduction appeared to predominate in the Avalus™ over Magna™ group. There was no significant difference in the mean pressure gradient or effective orifice area of each valve size at 1 week or 1 year between the two groups, apart from the mean pressure gradient of the 23-mm valve at 1 week. Three patients (3.4%) in the Avalus™ group and 39 (10.8%) in the Magna™ group (p = 0.12) had severe patient-prosthesis mismatch at 1 week postoperatively., Conclusions: The new Avalus™ stented aortic valve bioprosthesis was associated with good in-hospital outcomes and good valve functionality post-SAVR in Japanese patients.

Purpose: To date, clinical data on real-world treatment practices in Japanese patients with atrial fibrillation (AF) after bioprosthetic valve (BPV) replacement are needed. We conducted a large-scale, prospective, multicenter study to understand the actual usage of antithrombotic therapy and the incidence of thromboembolic and bleeding events in these patients, and to eliminate the clinical data gap between Japan and Western countries., Methods: This was an observational study, in patients who had undergone BPV replacement and had a confirmed diagnosis of AF, with no mandated interventions. We report the baseline demographic and clinical data for the 899 evaluable patients at the end of the enrollment period., Results: Overall, 45.7% of patients were male; the mean age was 80.3 years; AF was paroxysmal, persistent, or permanent in 36.9%, 34.6%, and 28.5% of patients, respectively. Mean risk scores for stroke and bleeding were 2.5 (CHADS 2 ), 4.1 (CHA 2 DS 2 -VASc), and 2.5 (HAS-BLED). Many patients (76.2%) had comorbid hypertension and 54.8% had heart failure. Most BPVs (65.5%) were positioned in the aortic valve. Warfarin-based therapy, direct oral anticoagulant (DOAC)-based therapy, and antiplatelet therapy (without warfarin and DOAC) were administered to 55.0%, 29.3%, and 9.7% of patients, respectively., Conclusion: Patients enrolled into this study are typical of the wider Japanese AF/BPV population in terms of age and clinical history. Future data accruing from the observational period will contribute to future treatment recommendations and guide therapeutic decisions in patients with BPV and AF., Trial Registration: ClinicalTrials.gov Identifier: UMIN000034485.

Background: This study retrospectively evaluated the long-term patient outcomes and durability of the Mosaic aortic porcine bioprosthesis in the Japan Mosaic valve long-term multicenter study., Methods and results: We reviewed the records of 1,202 patients who underwent aortic valve replacement with the Mosaic bioprosthesis at 10 centers in Japan (1999-2014). Patient data were collected using Research Electronic Data Capture. Patient survival was determined by Kaplan-Meier methodology. Freedom from structural valve deterioration (SVD) and valve-related reoperation and death were determined by actuarial methods. The median (interquartile range [IQR]) age of the cohort was 76 (70-80) years. The median (IQR) follow-up period was 3.52 (1.71-5.35) years. The longest follow-up was 15.8 years. The 30-day mortality rate was 2.3%. The 12-year actuarial survival rate was 59.9±7.5%, and the freedom from valve-related death was 81.1±7.9%. The freedom from reoperation was 86.4±2.6% at 12 years. The freedom from SVD at 12 years was 93.5±2.9% for patients aged ≥65 years and 98.2±1.8% for those aged <65 years. The median (IQR) systolic pressure gradient was 17 (12-23) and 19 (12-25) mmHg at 1 and 10 years, respectively. The median (IQR) effective orifice area was 1.2 (1.1-1.5) and 1.1 (1-1.5) cm 2 at 1 and 10 years, respectively., Conclusions: The Mosaic porcine bioprosthesis showed satisfactory long-term outcomes over 12 years.

Objectives: This study aimed to compare the clinical impact of mild postprocedural aortic regurgitation (post-AR) to that of none-trivial post-AR after transcatheter aortic valve implantation (TAVI) and to identify the vulnerability factors to mild post-AR., Background: Moderate-severe post-AR, associated with increased mortality, is an important issue. However, the clinical impact of mild post-AR remains controversial., Methods and Results: We analyzed data from 1,572 consecutive patients (1,026 of none-trivial post-AR and 546 of mild post-AR) obtained from the Optimized transCathEter vAlvular Intervention (OCEAN-TAVI) Japanese multicenter registry. We evaluated the 1-year cumulative cardiovascular death and re-hospitalization rates for heart failure (HF) after TAVI according to the degree of post-AR. Kaplan-Meier curves showed no significant difference between "none-trivial post-AR" and "mild post-AR" in terms of cardiovascular death, but a significant difference was noted in the cumulative incidence of re-hospitalization for HF between the two groups (hazard ratio 1.57, 95% confidence interval 1.02-2.41, p = .04). In the stratified analysis, only in patients with not more than 50% of left ventricular ejection fraction (LVEF), concentric left ventricular hypertrophy (LVH), and none-trivial pre-procedural aortic regurgitation (pre-AR), mild post-AR resulted in a higher incidence of re-hospitalization for HF., Conclusions: In this study, the clinical impact of mild post-AR compared to none-trivial post-AR tended to be augmented in the presence of reduced LVEF, concentric LVH, and none-trivial pre-AR. Pre-procedure echocardiographic findings including LVEF, left ventricular geometry, and pre-AR may help to judge the necessity of postdilatation in case of mild post-AR just after the bioprosthesis deployment., (© 2019 Wiley Periodicals, Inc.)

Objective: The valve-in-valve procedure, in which a transcatheter heart valve (THV) is implanted into a degenerated bioprosthetic valve, is standardized for high-risk patients. However, this procedure is challenging in Japanese patients who have a small aortic annulus. We investigated the feasibility, safety, and therapeutic efficacy of the valve-in-valve procedure involving a degenerated stented bioprosthesis, stentless bioprosthesis, or THV., Methods: We performed a single-center, non-comparative study of the aortic valve-in-valve procedure (AORTIC VIV study). Beginning in October 2016, the aortic valve-in-valve procedure was performed in seven patients with a stented bioprosthesis, in three patients with a stentless bioprosthesis, and in one patient with a THV., Results: No 30-day post-procedure mortality or severe morbidities occurred. The mean echocardiographic gradient in the aortic position improved from 41 (38-48) to 17 (11-22) mmHg at 30 days (p = 0.01). No paravalvular or mild and more transvalvular leaks were detected. The New York Heart Association functional class improved from 2 (2-2.5) to 1 (1-1) at 30 days postoperatively (p = 0.01). Although the procedure failed in two patients with an implanted stentless bioprosthesis, the third patient with a stentless bioprosthesis and the one patient with a degenerated THV successfully underwent the valve-in-valve procedure., Conclusions: Feasibility, safety, and potential efficacy of the aortic valve-in-valve procedure were confirmed in selected Japanese patients with a degenerated aortic bioprosthesis. The valve-in-valve procedure for stentless bioprostheses was technically challenging.

Transcatheter aortic valve implantation (TAVI) is a viable treatment option for high-risk patients with severe aortic stenosis. In Japan, TAVI can be performed using first-generation self-expandable Medtronic CoreValve or balloon-expandable Edwards SAPIEN-XT from 2012. Since the durability and hemodynamic outcomes after transcatheter heart valve (THV) implantation in Japanese patients have not been clearly elucidated, we assessed serial changes in post-TAVI THV performances over a-3-year period by transthoracic echocardiography (TTE). From January 2012 to September 2014, among 83 patients with severe aortic stenosis, 26 underwent TAVI with CoreValve and 57 underwent TAVI with SAPIEN-XT. We assessed the serial changes in first post-implant (FPI) and 3-year post procedure THV hemodynamics by TTE. Valve performance was evaluated by serial assessment of aortic valve mean pressure gradient (PG) and aortic valve area (AVA) assessments. Three-year clinical outcomes were compared between the patients with CoreValve and those with SAPIEN-XT. Seventeen patients with CoreValve and 34 patients with SAPIEN-XT had FPI and 3-year TTEs. The AVA decreased significantly from FPI to 3-year follow-up among patients with SAPIEN-XT, but not among patients with CoreValve. The mean aortic PG decreased significantly from FPI to the 3-year follow-up point among patients with CoreValve; however, it was not significantly different from those with SAPIEN-XT. The absolute change in mean PG from FPI to the 3-year follow-up point decreased significantly among those with CoreValve compared to those with SAPIEN-XT. Clinical outcomes after TAVI were similar for both devices at 3-years after TAVI. In this study, long-term clinical outcomes for CoreValve and SAPIEN XT were similar. The 3-year THV performance of both devices was maintained after TAVI. Serial change in mean aortic PGs for CoreValve decreases significantly from FPI to the 3-year follow-up point compared to that for SAPIEN-XT.

Purpose: In 2014, the American Heart Association (AHA)/American College of Cardiology (ACC) guidelines were largely revised with regard to the selection of prosthetic valves. (1) A mechanical prosthesis is reasonable for aortic valve replacement (AVR) or mitral valve replacement (MVR) in patients less than 60 years of age, (2) A bioprosthesis is reasonable in patients more than 70 years of age, and (3) Either a bioprosthetic or mechanical valve is reasonable in patients between 60 and 70 years of age.Japan faces the unprecedented population aging, and moreover, the average life expectancy is longer among the Japanese than the Westerners. In Japan, whether this choice is appropriate seems questionable., Methods: This time, with the revision of the AHA/ACC guidelines, it might be necessary to take into consideration the average life expectancy of Japanese people and revise the Japanese guidelines accordingly., Results: We should consider whether 60-70 years should be set as a gray zone regarding the age criteria for choosing biological valves, or if the age should be set higher relative to that specified in the western guidelines, given the longer Japanese life expectancy., Conclusion: We believe that the development of unique, Japanese guidelines for the selection of prosthetic valves will allow us to provide appropriate selection and treatment for each patient.

Purpose: Pulmonary valve replacement long after repair of tetralogy of Fallot can improve cardiac function, functional status, and arrhythmia propensity. This has not been reported in Japan. We aim to evaluate the effects of pulmonary valve replacement in repaired tetralogy of Fallot., Methods: Nineteen patients underwent pulmonary valve replacement after repair of tetralogy of Fallot, excluding Rastelli type operation, between August 1981 and August 2011. The results of the pulmonary valve replacement were assessed by analyzing preoperative and postoperative cardiothoracic ratio, cardiac function, functional status, QRS duration and durability of the prosthetic valves., Results: There were neither operative nor late deaths. The Cardiothoracic ratio significantly improved from 61.0 ± 5.2 % preoperatively to 56.2 ± 4.8 % postoperatively (P < 0.001). The New York Heart association functional class significantly improved from 2.4 ± 0.8 preoperatively to 1.2 ± 0.4 postoperatively as well. Left ventricular ejection fraction showed significant improvement. QRS duration showed significant reduction. The freedom redo pulmonary valve replacement at 20 years was 100 %., Conclusion: Pulmonary valve replacement long after repair of previous tetralogy of Fallot had clinical benefits with low mortality. We recommend bioprosthesis for pulmonary valve replacement when adult-sized valve can be accommodated.

This study was performed to evaluate surgical outcomes in octogenarian patients undergoing valve surgery. Sixty patients (mean age 82.3 ± 1.9 years) who underwent valve surgery were reviewed. Aortic valve disease was found in 65% of the patients. Preoperatively, 20% of the patients were in NYHA class IV. An urgent operation and concomitant coronary artery bypass grafting were performed in ten patients each. A bioprosthetic valve was exclusively used for valve replacement except in two patients. Mitral valve repair was done in seven patients. Operative mortality was 13.3% for the period. No risk factors for operative mortality were detected by multivariate analysis; however, urgent operation, preoperative NYHA class IV, preoperative renal dysfunction, perioperative use of an intra-aortic balloon pumping, and prolonged cardiopulmonary bypass time had significant effects on operative mortality. The actuarial survival rate at 1 and 3 years after surgery was 82.6 and 71.5%, respectively, and 97.6% of late survivors reported that their activity level was equal to or better than the preoperative level. Valve surgery can be performed in octogenarian patients with acceptable mortality, good long-term results, and good quality of life. Early referral to surgery should be important to obtain a better postoperative outcome.

Background and Aim of the Study: Although the trend of bioprosthesis use has been evaluated extensively, the durability of currently available bioprostheses has not been determined in middle-aged patients. The study aim was to determine the long-term fate of bioprostheses implanted in patients aged < 60 years., Methods: Valve implantation data were collected from 43 centers in Japan. The data included patient age at implantation, type of valve, implant position, follow up period, and cause of reoperation including structural valve deterioration (SVD) and non-SVD. Between 1975 and 2005, a total of 697 bioprostheses was implanted in the mitral position, and 247 in the aortic position. The mean follow up period was 9.2 years. Rates of freedom from SVD and reoperation were determined using an actuarial method., Results: The mean age at implantation was 45 +/- 10.9 years. The 15-year freedom from SVD was 39% for those with valves implanted in the aortic position, and 27% in the mitral position (p = 0.004). For the same period, the actuarial freedom from reoperation was 31% for valves in the aortic position, and 24% in the mitral position (p = 0.178). The difference in actuarial freedom from SVD was not significant between age groups in the mitral position. However, there were differences in actuarial freedom from SVD in the aortic position for patients aged < 10 years when compared to the other age groups (p < 0.001). New-generation valves showed better long-term durability than older valves (p = 0.05)., Conclusion: The long-term freedom from SVD in middle-aged patients was unfavorable for bioprostheses implanted in the aortic and mitral positions. Middle-aged patients must be made aware that reoperation will be necessary; consequently, the choice of bioprosthesis should be dictated by patient-surgeon preference.

There is some controversy regarding the choice of prosthetic valves in patients with heart disease and concomitant end-stage renal disease requiring chronic dialysis. Dialysis patients tend to have a short life expectancy. In Japan, the 1-year survival of the dialysis patients was 80% in the 1980s, but exceeds 85% in the 2000s. The 5-year survival has been 54%-60% for the past 20 years. In addition, the 10-year and 15-year survivals have been 35%-42% and 23%-31%, respectively. However, in the United States, the 5-year survival had only improved to 35% among patients who started dialysis between 1996 and 2000, and the life expectancies of chronic dialysis patients in their sixth, seventh and eighth decades is 5.3-6.2 years, 3.8-4.5 years, and 2.7-3.2 years, respectively. The life expectancy of dialysis patients in Japan is thus better than that of patients in the United States. Some surgeons prefer to use bioprosthetic valves because of a high rate of hemorrhagic complications in dialysis patients. They are hesitant to use anticoagulation therapy in dialysis patients with mechanical valves. Others prefer mechanical valves because of the potential for early structural dysfunction of bioprosthetic valves implanted in the dialysis patients with abnormal calcium metabolism, which can cause calcium deposition on the bioprosthetic valves during the early postoperative period. The life expectancy of dialysis patients in Japan is relatively high. The potential risk of early calcification of bioprosthetic valves should be taken into account when choosing prosthetic heart valves for these patients in Japan.

We have many choices when selecting artificial valves for valve replacement surgery. It is necessary to know the characteristics of the various prosthetic valves to make an appropriate decision for each valvular heart disease patient. In this review paper, we describe the features and benefits of the artificial valves available in Japan. Standard and new generation bioprostheses and mechanical prostheses are reviewed. The new technology of the catheter-delivery heart valve is also mentioned in this paper.

Background: Refractory arrhythmias caused by right ventricular (RV) volume overload resulting from pulmonary regurgitation are the main concern in adult patients after repair of tetralogy of Fallot (TOF). Early pulmonary valve replacement (PVR) may prevent irreversible RV dysfunction and refractory arrhythmias, so the present study evaluated the PVR outcomes in adult patients with a severely dilated RV (d-RV) and refractory arrhythmias after TOF repair., Methods and Results: Three TOF patients with a d-RV and tachyarrhythmias underwent PVR between the ages of 28 and 38 years. All had a d-RV (RV end-diastolic volume index (RVEDVI) >200 ml/m(2)) with a polymorphic nonsustained ventricular tachycardia (NSVT). Atrial tachycardia (AT) was identified in 2 patients and they underwent radiofrequency catheter ablation. The arrhythmias in all 3 were refractory to antiarrhythmic drugs. One year after PVR, the RVEDVI, left ventricular ejection fraction, right atrial pressure, cardiac index, cardiothoracic ratio, brain natriuretic peptide levels, and peak VO(2) improved in all, but without normalization. During the 2.6-3.8 year follow-up, all experienced tachyarrhythmias (NSVT or AT), which were controlled with medication., Conclusions: PVR may be beneficial for refractory arrhythmias, even in TOF patients with a d-RV, but it is difficult to completely normalize the hemodynamics and resolve the arrhythmogenicity.

A 42-year-old man suffering from massive aortic valve regurgitation with mild stenosis because of a bicuspid valve underwent surgery in May 2007. The surgical procedure was performed through a right anterolateral thoracotomy using the peripheral cannulation method. Cardiac arrest was achieved by direct aortic cross-clamping and selective cardioplegia delivery. The aortic valve was replaced with a bioprosthesis. The operation and aortic cross-clamping periods were 265 and 117 min, respectively. The patient's recovery was uneventful, and he was discharged from hospital 8 days after surgery.

Transvenous endocardial pacemaker implantation is contraindicated in patients after prosthetic tricuspid valve replacement. A 65-year-old woman underwent both replacement of the mitral and tricuspid valves and pacemaker implantation with epicardial lead for bradycardia with chronic atrial fibrillation. At 2 years after this operation, the pacemaker's battery became low, and she was admitted for a battery exchange. To avoid frequent battery exchanges because of high stimulation thresholds, a left ventricular pacing lead was implanted via a coronary vein. There were no complications and the stimulation thresholds were stable. Coronary vein leads enable a minimally invasive approach, improve safety, and give effective stimulation for patients with a prosthetic tricuspid valve. This is the first case report in Japan of left ventricular pacing in such a patient.

There are advantages to using aortic homografts as aortic valve replacements (AVR), particularly in patients with complex infective endocarditis. To determine the importance of a domestic homograft valve bank, our 23 surgical cases of homograft-AVR were reviewed. Since 2000, the Tissue Bank of the National Cardiovascular Center has supplied 23 aortic homograft valves for the treatment of complex aortic valve endocarditis. Fourteen of 23 patients had prosthetic valve endocarditis and 20 patients had an aortic annular abscess. The early mortality rate was 17% (4 patients), in all of whom prosthetic valve replacement had been performed previously. No recurrent endocarditis and no recurrent aortic regurgitation were noted at medium-term follow-up. An aortic homograft valve is the conduit of choice in cases of infective endocarditis and the importance of a domestic homograft valve bank should be recognized.

The concept of patient-prosthesis mismatch (PPM) was defined as existing "when the effective prosthetic valve area, after insertion into the patient, is less than that of a normal valve". However, based on the correlation between the mean transvalvular pressure gradient and the corrected effective orifice area (EOA), PPM is currently defined as an EOA corrected by a body surface area (BSA) of 65 years old, while supra-annular implantation of a bioprosthesis was done in patients >or=65 years old with a small aortic annulus. We discuss our present strategy after the introduction of a new high performance prosthesis, since the EOAs are dramatically increased.

Objective: Recently, there has been an increase in case of repeated open-heart valve surgery and the clinical results of the second surgery are only slightly worse than those of the first surgery. However, clinical results of the third open-heart valve surgery at the same position are rarely reported. Clinical features of third open-heart valve surgery at the same position are discussed in this study., Methods: Between 1995 and 2004, 16 patients underwent third open-heart valve surgery at the same valve position under cardiopulmonary bypass. The average age of the 16 patients, 12 females and 4 males, was 56 +/- 15 years. Clinical features of the 16 cases were retrospectively analyzed., Results: Mechanical valve nonstructural dysfunction was the most common valve malady, followed by bioprosthetic valve dysfunction. The duration of surgery from skin incision to establishment of the cardiopulmonary bypass was 94 +/- 42 minutes. Myocardial ischemia time was 137 +/- 38 minutes and extracorporeal circulation time was 212 +/- 82 minutes. Early mortality was seen in 1 patient (6.25%) and late mortality was seen in 1 patient., Conclusion: Mechanical valve nonstructural valve dysfunction leads to repeated valve surgery. The clinical results of the third open-heart valve surgery at the same valve position are acceptable, and the mid-term survival is excellent.

Forty-nine artificial cardiac valves implanted in 44 patients less than 15 years old were reviewed. Out of 49 valves, 16 were mechanical and 33 were xenografts. Average follow-up was 2 years 5 months. Marked valvular stenosis developed in 11 out of the 33 xenografts, an incidence of 15% per patient-year. In patients with a xenograft valve, the incidence of sepsis was found to be 4% per patient-year and brain accidents, 4% per patient-year. In patients with mechanical valves, the incidence of stenosis was only 2% per patient-year and brain accidents, 2% per patient-year. There was no sepsis. From these follow-up results, mechanical valves seem to be superior to xenografts when used in patients less than 15 years old.