Five-Year Transcatheter Aortic Valve Replacement Outcomes in Chronic Hemodialysis vs. Non-Hemodialysis Patients Using Balloon-Expandable Devices.

BACKGROUND: Based on the results of a clinical trial in Japan, transcatheter aortic valve replacement (TAVR) for hemodialysis (HD) patients gained approval; however, mid-term TAVR outcomes and transcatheter aortic valve (TAV) durability in HD patients remain unexplored.Methods and Results: We analyzed background, procedural, in-hospital outcome, and follow-up data for 101 HD patients and 494 non-HD patients who underwent TAVR using balloon-expandable valves (SAPIEN XT or SAPIEN 3) retrieved from Osaka University Hospital TAVR database. Periprocedural mortality and TAVR-related complications were comparable between HD and non-HD patients. However, Kaplan-Meier analysis revealed that HD patients had significantly lower survival rates (log-rank test, P<0.001). In addition, HD patients had significantly higher rates of severe structural valve deterioration (SVD) than non-HD patients (Gray test, P=0.038). CONCLUSIONS: TAVR in HD patients had comparable periprocedural mortality but inferior mid-term survival and TAV durability than in non-HD patients. Indications for TAVR in younger HD patients should be carefully determined, considering the possibility of a TAV-in-TAV procedure when early SVD occurs.

Restrictive annuloplasty or replacement on reverse remodeling for nonischemic dilated cardiomyopathy.

BACKGROUND: For patients with nonischemic dilated cardiomyopathy (NIDCM), the indications for and results of mitral surgery remain controversial. We reviewed a strategy of mitral repair and replacement for clinically relevant secondary mitral regurgitation (MR) in patients with NIDCM. METHODS: We retrospectively reviewed 65 patients with advanced NIDCM (LVEF < 40%) who underwent mitral surgery. Of them, 47 (72%) underwent mitral annuloplasty and 18 (28%) replacement for secondary MR. The primary endpoint was postoperative reduction in indexed LV end-systolic volume (LVESVI). RESULTS: At baseline, there was no intergroup difference in LVESVI (123 ± 47 vs. 147 ± 37 ml/m2, P = 0.055), LVEF (27 ± 8% vs. 25 ± 6%, P = 0.41), incidence of severe MR (57% (27/47) vs. 72% (13/18), P = 0.40), or EuroSCORE II score (6.2% vs. 7.6%, P = 0.90). At 6 months, the annuloplasty group reduced LVESVI to a greater degree than the replacement group (P < 0.001), yielding significantly smaller postoperative LVESVI (96 ± 59 vs. 154 ± 61 ml/m2, P < 0.001) and better LVEF (P < 0.001). The rates of moderate/severe recurrent MR were 17% (8/47) and 0%, respectively. Multivariable analysis demonstrated that mitral annuloplasty (OR 6.10, 95% CI 1.14-32.8, P = 0.035) was significantly associated with postoperative LV reverse remodeling. Cumulative survival was not different between the groups (P = 0.26). CONCLUSIONS: In patients with NIDCM, mitral annuloplasty reduced LV volume to a greater degree than did mitral replacement. These findings may assist with surgical options for secondary MR associated with NIDCM.

Left ventricular assist device temporary explantation as a strategy for infection control in a pediatric patient.

We report a case of temporary Berlin Heart EXCOR® explantation in a pediatric patient with idiopathic dilated cardiomyopathy who suffered an uncontrollable inflow cannulation site infection while on bridge-to-transplantation. Despite failure to thrive and catheter-related infections, once free of the device, the patient was cured of infection using systemic antibiotics and surgical debridement. The patient underwent EXCOR® reimplantation after four months, and is awaiting heart transplantation in stable condition. A life-threatening ventricular assist device-related infection may require device explantation under conditions that may not fulfill conventional explantation criteria despite risks. Temporary explantation can be an effective strategy if isolated systolic dysfunction is managed carefully.

The usefulness of chest drain and epicardial pacing wire culture for diagnosing mediastinitis after open-heart surgery.

PURPOSE: Culture of extracted drains or epicardial pacing wires is an easy and noninvasive method for detecting mediastinitis after open-heart surgery, although studies on its sensitivity and specificity are limited. We, therefore, investigated the usefulness of this approach for diagnosing mediastinitis. METHODS: We retrospectively studied the culture results of drains and epicardial pacing wires extracted from 3308 patients. Prediction models of mediastinitis with and without culture results added to clinical risk factors identified by a logistic regression analysis were compared. RESULTS: The incidence of mediastinitis requiring surgery was 1.89% (n = 64). Staphylococcus was the causative bacterium in 64.0% of cases. The sensitivity, specificity, and positive and negative predictive values of positive culture results were 50.8%, 91.8%, 10.7%, and 99.0%, respectively. Methicillin-resistant Staphylococcus aureus had the highest positive predictive value (61.5%). A multivariate analysis identified preoperative hemodialysis (OR 5.40 [2.54-11.5], p < 0.01), long operative duration (p < 0.01), postoperative hemodialysis (OR 2.25 [1.01-4.98], p < 0.05), and positive culture result (OR 10.2 [5.88-17.7], p < 0.01) as independent risk factors. The addition of culture results to pre- and postoperative hemodialysis and a lengthy operative time improved the prediction of mediastinitis. CONCLUSIONS: A culture survey using extracted drains and epicardial pacing wires may provide useful information for diagnosing mediastinitis.

Three-step surgical management algorithm for annular rupture in transcatheter aortic valve replacement.

Objective: Whereas transcatheter aortic valve replacement is widely implemented, annular rupture is a devastating complication and could be highly mortal. However, owing to its rare incidence, the optimal treatment algorithm has not been established. Thus, we evaluated the feasibility and effectiveness of a 3-step algorithm to treat annulus rupture. Methods: From 2009 to 2022, 8 patients of 1083 transcatheter aortic valve implantation (0.8%) developed annulus rupture and were treated with the three-step algorithm. The algorithm was composed of a first step (pericardial drainage and protamine neutralization with blood pressure control), second step (manual hemostatic compression via full/partial sternotomy), and a third step (conservative treatment or radical surgical correction). Results: The median age at the procedure was 85 (78-88) years and 7 female patients were included in this study. Two (25%) patients had end-stage renal failure under hemodialysis, and median Society of Thoracic Surgeons score was 8.9% (2.1%-23.2%). The implanted transcatheter heart valves (THVs) were 7 balloon-expandable THVs and 1 self-expandable THV with balloon postdilatation. Under this strategy, 8 (100%) patients underwent pericardial drainage as first step and 5 patients achieved hemostasis. Of these, patient 1 demonstrated bleeding from left sinus of Valsalva and required a Bentall procedure. Although the etiology of this phenomenon was not investigated by contrast-enhanced computed tomography, it might be derived from pseudoaneurysm rupture or delayed annular rupture. In 2 patients, the second step treatment was needed for hemostasis. Third-step treatment was conducted in 1 patient. Postoperatively, 6 patients could be discharged without critical complications whereas 2 patients died during the hospitalization. There were no other complications during the followed-up (584 [7-1614]) days. Conclusions: In accordance with the three-step algorithm, 6 patients, including those with high-risk or inoperative status, survived.

Procedural Volume and Outcomes of Transfemoral Transcatheter Aortic Valve Replacement: From a Japanese Nationwide Registry.

The impact of procedural volume on transcatheter aortic valve replacement (TAVR) outcomes in Japan remains uncertain. Japan has carefully introduced TAVR after the establishment of techniques in Western countries and therefore may not exhibit volume-outcome relations after TAVR. Data on transfemoral TAVR was collected from the Japan Transcatheter Valve Therapy (J-TVT) registry between 2018 and 2020. Hospitals were categorized into quartiles (lowest, lower, high, and highest) based on annual TAVR volume. The primary analysis compared 30-day mortality among different TAVR volume hospitals. A multivariable adjustment analysis was performed to calculate the adjusted odds ratio (aOR) and 95% confidence intervals (CIs) of 30-day all-cause mortality with highest-volume hospital as the reference. A total of 2,741 transfemoral TAVR cases from 172 hospitals were included in the analysis. Median hospital TAVR volume was 38 (interquartile range 27 to 60) per year. Unadjusted 30-day mortality was 0.46%, 0.69%, 1.17%, and 1.18% from the lowest to the highest quartile of hospitals, respectively. There was no significant difference in 30-day mortality rates for lowest-volume hospitals (aOR 0.51, 95% CI 0.24 to 1.05, p = 0.07), low-volume hospitals (aOR 0.76, 95% CI 0.46 to 1.26, p = 0.29), or high-volume hospitals (aOR 1.11, 95% CI 0.74 to 1.67, p = 0.60). An analysis from the contemporary national registry in Japan did not find an obvious inverse relation between annual hospital volume and 30-day mortality. Our results suggest that TAVR has now reached a level of procedural maturity, with standardized outcomes observed across hospitals regardless of their annual procedural volume.

Clinical Outcomes and Factors Associated With Aortic Shrinkage After Thoracic Endovascular Aortic Repair for Aneurysmal Chronic Aortic Dissection.

PURPOSE: The effectiveness of thoracic endovascular aortic repair (TEVAR) for chronic aortic dissection (AD) with aneurysmal degeneration remains controversial. We retrospectively investigated clinical outcomes and assessed predictors of aortic shrinkage after TEVAR for chronic aneurysmal AD. MATERIALS AND METHODS: Between January 2010 and December 2021, 70 patients with double-barrel-type chronic AD were enrolled. Major intimal tears in thoracic aorta were covered by stent graft. Early and late clinical outcomes, and diameter change of downstream aorta during follow-up period were reviewed. Subsequently, factors associated with aortic shrinkage were assessed by logistic regression analysis. RESULTS: Mean age was 63 (interquartile range [IQR]: 54-68) years, 54 (80%) men, median duration from AD onset was 4 (IQR: 1-10) years, and maximum aortic diameter was 53 (IQR: 49-58) mm. Supra-aortic debranching procedure was required in 57 (81%) patients. Early aorta-related death occurred in 2 (3%) patients. Both stroke and spinal cord ischemia occurred in 1 (2%) patient. Five-year freedom rates from aorta-related death and reintervention were 96% and 51%, respectively. Sixty-four patients underwent follow-up computed tomography (84%) 1 year after TEVAR, with 33 (52%) achieving aortic shrinkage. In multivariable analysis, duration from AD onset (per year) (odds ratio [OR]: 0.82, 0.70-0.97; p=0.017) and maximum aortic-diameter ratio between aortic arch and descending aorta (per 0.1) (morphologic index; OR: 1.34, 1.04-1.74; p=0.023) were independent aortic shrinkage predictors. CONCLUSIONS: Thoracic endovascular aortic repair for chronic AD with aneurysmal degeneration achieved satisfactory survival outcomes, but with a considerable reintervention rate. Duration from AD onset and preoperative aortic morphology could affect post-TEVAR aortic shrinkage. Earlier intervention could lead to better aortic shrinkage. CLINICAL IMPACT: Thoracic endovascular aortic repair for chronic aortic dissection with aneurysmal degeneration showed low incidence of early and late aorta-related death. By contrast, aortic shrinkage rate was low with high incidence of reintervention to the residual downstream aorta. According to the assessment of preoperative variables, chronicity and aortic morphology could predict postoperative aortic shrinkage.

Risk factors for atrial arrhythmia recurrence after atrial arrhythmia surgery with pulmonary valve replacement.

Objectives: Atrial arrhythmias are a significant cause of late morbidity and mortality in patients after tetralogy of Fallot repair. However, reports on their recurrence following atrial arrhythmia surgery are limited. We aimed to identify the risk factors for atrial arrhythmia recurrence after pulmonary valve replacement (PVR) and arrhythmia surgery. Methods: We reviewed 74 patients with repaired tetralogy of Fallot who underwent PVR for pulmonary insufficiency at our hospital between 2003 and 2021. Twenty-two patients (mean age, 39 years) underwent PVR and atrial arrhythmia surgery. A modified Cox-maze III was performed in 6 patients with chronic atrial fibrillation, and a right-sided maze was performed in 12 with paroxysmal atrial fibrillation, 3 with atrial flutter, and 1 with atrial tachycardia. Atrial arrhythmia recurrence was defined as any documented sustained atrial tachyarrhythmia requiring intervention. The influence of preoperative parameters on recurrence was assessed with the Cox proportional-hazards model. Results: The median follow-up period was 9.2 years (interquartile range, 4.5-12.4). Cardiac death and redo-PVR due to prosthetic valve dysfunction were not observed. Eleven patients had atrial arrhythmia recurrence after discharge. Atrial arrhythmia recurrence-free rates were 68% at 5 years and 51% at 10 years after PVR and arrhythmia surgery. Multivariable analysis revealed that right atrial volume index (hazard ratio, 1.04; 95% confidence interval, 1.01-1.08, P = .009) was a significant risk factor for atrial arrhythmia recurrence after arrhythmia surgery and PVR. Conclusions: Preoperative right atrial volume index was associated with atrial arrhythmia recurrence, which may assist in planning the timing of atrial arrhythmia surgery and PVR.

Preoperative higher right ventricular stroke work index increases the risk of de novo aortic insufficiency after continuous-flow left ventricular assist device implantation.

During continuous-flow left ventricular assist device (CF-LVAD) support, hemodynamic shear stress causes a burden on aortic valve (AV) leaflets, leading to de novo aortic insufficiency (AI). This study investigated the influence of preoperative hemodynamic parameters on de novo AI in CF-LVAD recipients. We reviewed 125 patients who underwent CF-LVAD implantation without concomitant AV surgery between 2005 and 2018. De novo AI was defined as moderate or severe AI in those with none or trivial preoperative AI. During mean 30 ± 16 months of CF-LVAD support, de novo AI-free rate was 86% and 67% at 1 and 2 years, respectively. Multivariable analysis showed that higher right ventricular stroke work index (RVSWI) (hazard ratio, 1.12 /g/m2/beat; 95% confidence interval, 1.00-1.20; p = 0.047) and trivial grade AI (hazard ratio, 2.8; 95% confidence interval, 1.2-6.4; p = 0.020) were independent preoperative risk factors for de novo AI. The longitudinal analysis using generalized mixed effects model showed that higher RVSWI was associated with continuous AV closure after LVAD implantation (Odd ratio, 1.20/g/m2/beat; 95% confidence interval, 1.00-1.43 /g/m2/beat; p = 0.047). Right heart catheterization revealed that preoperative RVSWI was positively correlated with postoperative pump flow index in patients with continuously closed AV (r = 0.44, p = 0.04, n = 22). Preoperative higher RVSWI was a significant risk factor for de novo AI following CF-LVAD implantation. In patients with preserved right ventricular function, postoperative higher pump flow may affect AI development via hemodynamic stress on the AV.

Pseudoaneurysm after aortopulmonary window repair and bilateral lung transplantation for eisenmenger syndrome: a case report.

BACKGROUND: Aortopulmonary window (APW) is a rare congenital cardiac anomaly characterized by communication between the main pulmonary artery and ascending aorta. There are various surgical techniques, and the short- and long-term results are excellent if the surgical repair is performed early in life. To our knowledge, there have been no reports of pseudoaneurysm after APW repair. Herein, we present a case of a 30-year-old woman with an ascending aortic pseudoaneurysm found at the site of APW repair nine months after the APW repair and bilateral lung transplantation. CASE PRESENTATIONS: A 30-year-old woman presented with APW and Eisenmenger syndrome. The patient underwent APW repair and bilateral lung transplantation. We transected the communication between the aorta and pulmonary artery and closed the aortic side directly with strips of felts. Nine months after the surgery, the patient complained of chest pain. Cardiac computed tomography revealed an ascending aortic pseudoaneurysm at the anastomotic site. Emergent graft replacement of the ascending aorta was performed and the postoperative course was uneventful. CONCLUSIONS: We have presented a case of a pseudoaneurysm at the anastomotic site after APW repair and bilateral lung transplantation. The choice of surgical technique should be based on the patient's background requiring lung transplantation, and in these cases close postoperative follow-up is required.

Impact of Patent Lumbar Arteries on Aneurysm Sac Enlargement with Type II Endoleak after Endovascular Aneurysm Repair.

OBJECTIVE: This study aimed to investigate the impact of the number of patent lumbar arteries (LAs) on sac enlargement after endovascular aneurysm repair (EVAR). METHODS: This was a retrospective cohort single centre registry study. Between January 2006 and December 2019, 336 EVARs were reviewed using a commercially available device excluding type I or type III endoleaks during a follow up of ≥ 12 months. Patients were divided into four groups based on the pre-operative patency of the inferior mesenteric artery (IMA) and high (≥ 4) or low (≤ 3) number of patent LAs: Group 1, patent IMA and high number of patent LAs; Group 2, patent IMA and low number of patent LAs; Group 3, occluded IMA and a high number of patent LAs; Group 4, occluded IMA and low number of patent LAs. RESULTS: Groups 1, 2, 3, and 4 included 124, 104, 45, and 63 patients, respectively. The median follow up duration was 65.1 months. Significant differences in the incidence of overall type II endoleak (T2EL) at discharge between Group 1 and Group 2 (59.7% vs. 36.5%, p < .001) and between Group 3 and Group 4 (33.3% vs. 4.8%, p < .001) were observed. In patients with a pre-operatively patent IMA, the rate of freedom from aneurysm sac enlargement was significantly lower in Group 1 than in Group 2 (69.0% vs. 81.7% five years after EVAR, p < .001). In patients with a pre-operatively occluded IMA, the freedom rate from aneurysm sac enlargement was not significantly different between Groups 3 and Group 4 (95.0% vs. 100% five years after EVAR, p = .075). CONCLUSION: A high number of patent LAs seemed to have a significant role in sac enlargement with T2EL when the IMA was patent pre-operatively, whereas a high number of patent LAs seemed to have limited influence on sac enlargement when the IMA was occluded pre-operatively.

Midterm outcomes after surgical aortic valve replacement with the INSPIRIS RESILIA from a multicenter AVR registry.

BACKGROUND: There have been few reports on the mid- to long-term safety and efficacy validation of the INSPIRIS RESILIA aortic bioprosthesis (Edwards Lifesciences LLC, Irvine, CA, USA) in Japan. Herein, we report the mid-term results of surgical aortic valve replacement (AVR) for aortic stenosis using INSPIRIS and evaluate the hemodynamics compared to the CEP Magna series from the multicenter AVR registry (the ACTIVIST registry). METHODS: Of the 1967 patients who underwent surgical or transcatheter AVR from the ACTIVIST registry, 66 patients who underwent isolated surgical AVR with INSPIRIS by December 2020 were included in this study, and the early and mid-term results were evaluated. Hemodynamics were evaluated by comparing 272 patients undergoing isolated surgical AVR with the Magna group using propensity score matching. RESULTS: The mean age was 74.0 ±â€¯7.8 years, and 48.5 % were women. In-hospital mortality was 1.5 %, and the survival rates at 1- and 2-years were 95.2 % and 95.2 %, respectively. After propensity score matching, echocardiographic findings at discharge demonstrated that peak velocity and mean pressure gradient in the INSPIRIS group were comparable, while the effective orifice area in the INSPIRIS group was significantly larger than those in the Magna group (p = 0.048). A patient-prosthesis mismatch at discharge was significantly lower in the INSPIRIS group (11.8 %) than in the Magna group (36.4 %) (p = 0.004). CONCLUSIONS: Surgical AVR with INSPIRIS was performed safely and the mid-term results were satisfactory. The hemodynamics of INSPIRIS were comparable to those of Magna.

One-year outcome of transcatheter aortic valve replacement for bicuspid aortic valve stenosis: a report from the Japanese Nationwide registry (J-TVT registry).

The outcome of transcatheter aortic valve replacement (TAVR) for patients with bicuspid aortic valve (BAV) remains unclear, particularly among Asian patients that are known to have different valvular morphology and lower body habitus. This study investigated patient characteristics, procedural and 1-year outcome of TAVR for BAV within national TAVR registry in Japan. The patient-level data were extracted from the J-TVT (Japanese Transcatheter Valvular Therapy) registry between August 2013 and December 2018; overall, there were 423 patients (2.5%) with BAV and 16,802 patients with tricuspid aortic valve (TAV). At baseline, patients with BAV were younger and had less arteriosclerotic comorbidities. There was no statistically significant difference between BAV and TAV groups in conversion to surgery (0.5% vs. 1.1%, p = 0.34) and 30-day mortality (0.5% vs. 1.3%, p = 0.18). Cumulative all-cause survival and survival from major adverse events were analyzed. Cox proportional hazard regression model was used to estimate the hazard ratio. All-cause mortality and major adverse event rate at 1 year were comparable between the two groups. Relative hazard for all-cause mortality for BAV compared to TAV was 1.01 (0.70-1.45; p = 0.96), and for major adverse event was 0.94 (0.69-1.27; p = 0.67). From the Japanese nationwide TAVR registry, procedural and 1-year outcome of TAVR in BAV was as favorable as TAVR in TAV.

Successful surgery for secondary aortoduodenal fistula based on 18F-fluorodeoxyglucose positron emission tomography/computed tomography findings.

Secondary aortoduodenal fistula (sADF) is a critical late complication of abdominal aortic repair, requiring complete excision of the infected prosthesis. However, this is a highly invasive procedure for the elderly. We describe a case of sADF repair in a 76-year-old woman. Through 18F (fluorine-18)-fluorodeoxyglucose (FDG) positron emission tomography/computed tomography mapping, focal high FDG uptake at the sADF site, right medial limb, and ligated left lateral limb of the prosthesis was detected. The duodenal and prosthetic grafts were partially resected. The proximal and distal anastomotic segments, with no FDG uptake, were retained. The abdominal aorta was reconstructed using a bovine pericardium roll and femorofemoral bypass. Thus, FDG positron emission tomography/computed tomography mapping of the infection site could help in such cases.

Notch Signaling-Modified Mesenchymal Stem Cell Patch Improves Left Ventricular Function via Arteriogenesis Induction in a Rat Myocardial Infarction Model.

For ischemic cardiomyopathy (ICM) with limited therapeutic options, the induction of arteriogenesis has the potential to improve cardiac function through major restoration of blood flow. We hypothesized that transplantation of a Notch signaling-modified mesenchymal stem cell (SB623 cell) patch would induce angiogenesis and arteriogenesis in ischemic lesions, leading to improvement of left ventricular (LV) function in a rat ICM model. Two weeks after the induction of ischemia, SB623 cell patch transplantation into ICM rats (SB group, n = 10) or a sham operation (no-treatment group, n = 10) was performed. The LV ejection fraction was significantly improved at 6 weeks after SB623 cell patch transplantation (P < 0.001). Histological findings revealed that the number of von Willebrand factor (vWF)-positive capillary vessels (P < 0.01) and alpha smooth muscle actin (αSMA)- and vWF-positive arterioles with a diameter greater than 20 µm (P = 0.002) was significantly increased in the SB group, suggesting the induction of angiogenesis and arteriogenesis. Moreover, rat cardiomyocytes treated with SB623 cell patch transplantation showed upregulation of ephrin-B2 (P = 0.03) and EphB4 (P = 0.01) gene expression, indicating arteriogenesis induction. In conclusion, SB623 cell patch transplantation improved LV function by inducing angiogenesis and arteriogenesis in a rat ICM model.

Impact of concomitant mitral regurgitation during transcatheter aortic valve replacement on 1-year survival outcomes.

BACKGROUND: We investigated the influence of concomitant mitral regurgitation (MR) in patients undergoing transcatheter aortic valve implantation on the 1-year outcome using Japan Transcatheter Valve Therapy (J-TVT) registry data. METHODS: The patients who underwent the transcatheter aortic valve implantation for aortic stenosis performed from August 2013 to December 2019 in Japan were included. History of previous valve surgery and dialysis patients were excluded. A total of 24,979 patients were included, and 1-year follow-up data were obtained from the registry (follow-up rate 98.5 %). Propensity-score matching, using multivariable logistic regression and 1:1 matching without replacement, was performed between the patients with grade 3-4 MR (MR 3-4 group) and those with grade 0-2 MR (MR 0-2 group). All-cause death and the composite outcome of death and/or heart failure events were compared. RESULTS: After propensity score matching, 3920 cases (1960 cases each in MR 0-2 group and MR 3-4 group) were extracted. The procedure success rate was 96.4 % in MR 0-2 and 96.0 % in MR 3-4 group (p = 0.56) and the surgical conversion rate was 0.7 % in MR 0-2 group and 0.8 % in MR 3-4 group (p = 0.58). Cox regression model showed no statistical difference in 1-year survival rate between MR 0-2 group (89.4 %) and MR 3-4 group (89.6 %) (p = 0.80). However, freedom from 1-year death and/or heart failure event was lower in MR 3-4 (86.3 %) than in MR 0-2 group (88.9 %) (p = 0.01). This trend was also found in the subgroup of New York Heart Association (NYHA) class 1-2 but not in the subgroup of NYHA class 3-4. CONCLUSIONS: One-year survival rate was not different between groups but freedom from death and/or heart failure events was lower in patients with preoperative MR grade 3-4 than in patients with preoperative MR grade 0-2 after transcatheter aortic valve replacement.

Modified percutaneous coronary intervention-derived risk models (PARIS and CREDO-Kyoto integer scoring systems) applied to Japanese transcatheter aortic valve replacement patients.

OBJECTIVE: Postprocedural ischaemic and bleeding risks after transcatheter aortic valve replacement (TAVR) remain a major concern. Nevertheless, no reliable risk models incorporating both possibilities are currently available. We aimed to assess the accuracy of percutaneous coronary intervention (PCI)-derived models and the performance of a recalibrated model that included variables more applicable to TAVR. METHODS: This study included 26 869 patients who had been enrolled in a national registry. Ischaemic events were defined as myocardial infarction, stroke, transient ischaemic attack or peripheral embolism at 1 year. Bleeding events were defined as any bleeding based on the Valve Academic Research Consortium-2 consensus document at 1 year. Patterns of Non-adherence to Anti-Platelet Regimen in Stented Patients (PARIS) and Coronary Revascularisation Demonstrating Outcome Study in Kyoto (CREDO-Kyoto) integer scoring systems were tested. The models were recalibrated by applying new variables using the Fine and Gray method. RESULTS: The 1-year cumulative incidences for ischaemic and bleeding events were 2.7% and 3.1%. Patients with high PARIS and CREDO-Kyoto risk scores had higher incidences of both ischaemic (3.3% vs 2.4% vs 2.4%, p<0.001 and 2.8% vs 2.0% vs 0.8%, p<0.001) and bleeding events (3.3% vs 2.5% vs 0.8%, p<0.001 and 3.7% vs 3.0% vs 2.4%, p<0.001) when compared with intermediate and low-risk patients. The receiver operating characteristic area under the curves for these models were 0.53, 0.58, 0.56 and 0.55, respectively. After the models were recalibrated to incorporate variables more applicable to TAVR, the performance of ischaemic and bleeding models modestly improved (0.58 and 0.61, respectively). CONCLUSIONS: The PCI-derived models demonstrated modest accuracy but was inadequate for risk stratification of TAVR patients at 1-year follow-up. TRIAL REGISTRATION NUMBER: 3395.

Long-term survival after surgical or transcatheter aortic valve replacement for low or intermediate surgical risk aortic stenosis: Comparison with general population.

BACKGROUND: Long-term survival after surgery for severe aortic stenosis (AS) provides important information regarding the choice between surgical (SAVR) and transcatheter (TAVR) aortic valve replacement. This study investigated the long-term survival of AS patients with low or intermediate surgical risk who underwent SAVR or TAVR in our institution versus that of the Japanese general population. METHODS: From 2009 to 2019, 1276 consecutive patients underwent SAVR or TAVR for severe AS. Among them, we retrospectively investigated those with low (n = 383) or intermediate (n = 137) surgical risk treated with SAVR and those with low (n = 86) or intermediate (n = 333) surgical risk treated with TAVR. Their post-intervention survival was compared with that of an age- and gender-matched Japanese general population. RESULTS: The overall 5-year survival rate of SAVR for patients with low surgical risk (mean age, 72 ±â€¯9 years) was not significantly different from that of the general population (90 % vs. 89 %, respectively; p = 0.58), whereas that of patients with intermediate surgical risk (77 ±â€¯6 years) was significantly lower than that of the general population (77 % vs. 84 %, respectively; p = 0.03). After TAVR, the 5-year survival of patients with low (78 ±â€¯8 years) or intermediate (83 ±â€¯5 years) surgical risk was significantly lower than that of the general population (low risk, 64 % vs. 81 %, p < 0.01; intermediate risk, 66 % vs. 71 %, respectively, p = 0.01). CONCLUSIONS: Our study demonstrated that long-term survival after SAVR for AS patients with low surgical risk was as good as that of the age- and gender-matched general population, while the long-term survival after SAVR for intermediate-risk or TAVR for low- or intermediate-risk patients was lower than that of the general population. These findings suggest that SAVR is an appropriate option for AS patients with low surgical risk and good life expectancy, especially in Japan, where the life expectancy is the longest worldwide.