A risk model of mortality rate in dialysis patients following transcatheter aortic valve replacement.

BACKGROUND: Dialysis patients undergoing transcatheter aortic valve replacement (TAVR) generally have poor prognosis compared with non-dialysis patients. Furthermore, there are few reliable risk models in this clinical setting. Therefore, we aimed to establish a risk model in dialysis patients undergoing TAVR that would be informative for their prognosis and the decision-making process of TAVR. METHODS: A total 118 dialysis patients (full cohort) with severe aortic stenosis underwent TAVR in our institute between 2012 and 2022. The patients of the full cohort were randomly assigned to two groups in a 2:1 ratio to form derivation and validation cohorts. Risk factors contributing to deaths were analyzed from the preoperative variables and a risk model was established from Cox proportional hazard model. RESULTS: There were 69 deaths following TAVR derived from infectious disease (43.5 %), cardiovascular-related disease (11.6 %), cerebral stroke or hemorrhage (2.9 %), cancer (1.4 %), unknown origin (18.8 %), and others (21.7 %) during the observational period (811 ±â€¯719 days). The cumulative overall survival rates using the Kaplan-Meier method at 1 year, 3 years, and 5 years in the full cohort were 82.8 %, 41.9 %, and 24.2 %, respectively. An optimal risk model composed of five contributors: peripheral vascular disease, serum albumin, left ventricular ejection fraction < 40 %, operative age, and hemoglobin level, was established. The estimated C index for the developed models were 0.748 (95 % CI: 0.672-0.824) in derivation cohort and 0.705 (95 % CI: 0.578-0.832) in validation cohort. The prediction model showed good calibration [intraclass correlation coefficient = 0.937 (95%CI: 0.806-0.981)] between actual and predicted survival. CONCLUSIONS: The risk model was a good indicator to estimate the prognosis in dialysis patients undergoing TAVR.

Impact of 12-Month Angioscopic Thrombi and Yellow Plaque After Drug-Eluting Stent Implantation.

BACKGROUND: Coronary angioscopy (CAS) has 2 unique abilities: direct visualization of thrombi and plaque color. However, in the recent drug-eluting stent (DES) era, serial CAS findings after DES implantation have not been fully elucidated. We investigated the impact of CAS findings after implantation of a polymer-free biolimus A9-coated stent (PF-BCS) or durable polymer everolimus-eluting stent (DP-EES).Methods and Results: We investigated serial CAS and optical coherence tomography (OCT) findings at 1 and 12 months in 99 patients who underwent PF-BCS or DP-EES implantation. We evaluated factors correlated with angioscopic thrombi and yellow plaque, and the clinical impact of both thrombi and yellow plaque at 12 months (BTY). The BTY group included 17 (22%) patients. The incidence and grade of thrombi and yellow plaque decreased from 1 to 12 months. Although no patients had newly appearing thrombi at 12 months, 2 DP-EES patients had newly appearing yellow plaque at 12 months. Multivariable analysis revealed HbA1c, minimum stent area, and adequate strut coverage were significant factors correlated with 12-month angioscopic thrombi, and DP-EESs were significantly correlated with 12-month yellow plaque. However, BTY was not correlated with clinical events. CONCLUSIONS: The management of diabetes, stent area, and adequate stent coverage are important for intrastent thrombogenicity and polymer-free stents are useful for stabilizing plaque vulnerability.

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.

Impact of baseline yellow plaque assessed by coronary angioscopy on vascular response after stent implantation.

BACKGROUND: The relationship between baseline yellow plaque (YP) and vascular response after stent implantation has not been fully investigated. METHODS: This was a sub-analysis of the Collaboration-1 study (multicenter, retrospective, observational study). A total of 88 lesions from 80 patients with chronic coronary syndrome who underwent percutaneous coronary intervention were analyzed. Optical coherence tomography (OCT) and coronary angioscopy (CAS) were serially performed immediately and 11 months after stent implantation. YP was defined as the stented segment with yellow or intensive yellow color assessed by CAS. Neoatherosclerosis was defined as a lipid or calcified neointima assessed by OCT. OCT and CAS findings at 11 months were compared between lesions with baseline YP (YP group) and lesions without baseline YP (Non-YP group). RESULTS: Baseline YP was detected in 37 lesions (42 %). OCT findings at 11 months showed that the incidence of neoatherosclerosis was significantly higher in the YP group (11 % versus 0 %, p = 0.028) and mean neointimal thickness tended to be lower (104 ±â€¯43 µm versus 120 ±â€¯48 µm, p = 0.098). CAS findings at 11 months demonstrated that the dominant and minimum neointimal coverage grades were significantly lower (p = 0.049 and P = 0.026) and maximum yellow color grade was significantly higher (p < 0.001) in the YP group. CONCLUSIONS: Baseline YP affected the incidence of neoatherosclerosis as well as poor neointimal coverage at 11 months after stent implantation.

First Report of Electromagnetic Interference Between Percutaneous Ventricular Assist Device and Implantable Cardioverter-Defibrillator.

Electromagnetic interference (EMI) between implantable left ventricular assist devices and cardiac implantable electronic devices has been observed. We demonstrated the first case of EMI between a percutaneous ventricular assist device and an implantable cardioverter-defibrillator, validated by an extra vivo simulation test. EMI might depend on the distance between devices. (Level of Difficulty: Advanced.).

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.

Impact of calcified nodule on target lesion failure after stent implantation in hemodialysis patients.

BACKGROUND: Little is known about intravascular imaging predictors of cardiac events after drug-eluting stent (DES) implantation in hemodialysis (HD) patients. We aimed to reveal the association between calcified nodules (CN) and target lesion failure (TLF) in HD patients after DES implantation. METHODS: We enrolled 114 HD patients who underwent DES implantation between October 2016 and October 2020. The patients were divided into a CN group (39%, 44 patients) and a non-CN group (61%, 70 patients). The primary endpoint was the incidence of TLF, including cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization. RESULTS: HD duration was longer, and the calcium burden was higher in the CN group than in the non-CN group. Over a median follow-up of 607 days [interquartile range: 349-965 days], the cumulative incidence curve showed that the CN group had a significantly higher incidence of TLF than the non-CN group (31.8% vs. 11.4% within 3 years, p = 0.008).　On Fine-Gray sub-distribution hazard model analysis, the CN group was associated with an increased rate of TLF (hazard ratio [HR]: 2.86; 95% confidence interval [CI]: 1.21-6.75, p = 0.016). An in-stent CN was observed in 73% of the lesions with target lesion revascularization in the CN group, whereas no in-stent CN was observed in the non-CN group (p = 0.026). CONCLUSIONS: CN was an independent predictor of TLF in patients undergoing HD. In-stent CN was an important cause of TLF after DES implantation in CN lesions in HD patients; therefore, a different strategy should be considered for treating the lesions.

A Risk Model for 1-Year Mortality After Transcatheter Aortic Valve Replacement From the J-TVT Registry.

Background: Although transcatheter aortic valve replacement (TAVR) has demonstrated favorable outcomes in randomized studies, there remains a sizable group of patients in whom TAVR may be futile. Characterizing the survival rate in a wide array of patients undergoing TAVR can help develop effective strategies for improving the allocation of medial resources. Objectives: The aim of this study was to develop a risk model to estimate 1-year mortality after TAVR from a representative nationwide registry in Japan. Methods: The J-TVT (Japan Transcatheter Valve Therapies) registry contains complete data, including 1-year outcomes, on patients undergoing TAVR in Japan. A total of 17,655 patients underwent TAVR between 2013 and 2018. They were randomly divided into 2 groups in a 7:3 ratio to form a derivation cohort of 12,316 patients and a validation cohort of 5,339 patients. A risk model was constructed for 1-year mortality in the derivation cohort, and its discrimination and calibration were assessed in the validation cohort. Results: The mean age of all registered patients was 84.4 years, and 68.8% were women. The mean body size area was 1.43 m2, and the mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 7.3%. The estimated 1-year survival was 91.8%; 202 and 1,316 deaths were observed at 30 days and 1 year, respectively; The estimated C index for the developed model was 0.733 (95% CI: 0.709-0.757) in the validation cohort, with good calibration. Conclusions: A prediction model for 1-year survival following TAVR derived from a national clinical database performed well and should aid physicians managing TAVR patients.

Efficacy of a Protective Sheet for Reducing Ocular Radiation Exposure During Transcatheter Aortic Valve Implantation.

BACKGROUND: The use of hybrid operating rooms (HOR) for transcatheter aortic valve implantation (TAVI) has increased, so radiation exposure during procedures that use X-ray fluoroscopy is a fundamental problem not only for patients but also for surgeons and interventional cardiologists, increasing the risk of cataracts among operators. We investigated the efficacy of leaded glasses and protective sheets for ocular radiation protection.Methods and Results: Between January 2020 and February 2021 we enrolled 54 TAVI procedures using the transfemoral approach. The subjects were divided into a curtain protection group (Group C, n=20), glass protection group (Group G, n=17), and sheet protection group (Group S, n=17). The cumulative dose (CD) of the operators showed a decreasing trend in Group S compared with the other two groups. The CD normalized by dose area product (CD/DAP) of the operators was significantly reduced in Group S compared with Group C. However, Group G showed no significant difference compared with Group C. Regarding the distribution of CD/DAP, Group S had a significantly lower distribution than that in groups C and G. CONCLUSIONS: Protective sheets provide more stable radiation protection than conventional curtains or leaded glasses.

Preoperative hypomagnesemia as a possible predictive factor for postoperative increase of transvalvular pressure gradient in hemodialysis patients treated with transcatheter aortic valve implantation.

BACKGROUND: Patients undergoing maintenance hemodialysis (HD) with severe aortic stenosis are at a high risk for bioprosthetic valve dysfunction after transcatheter aortic valve implantation (TAVI). Currently, preoperative factors that predict the occurrence of valve dysfunction after TAVI on HD patients remain to be elucidated. The aim of this study is to analyze the association between preoperative clinical factors and valve stenosis after TAVI on HD patients. METHODS: Twenty-four of HD patients who underwent TAVI at our institution between April 2012 and January 2016 were analyzed. The mean aortic transvalvular pressure gradient (MPG) and effective orifice area index (EOAi) were assessed by serial echocardiography. Associations between preoperative clinical factors and time-series changes in MPG were examined using mixed-effects linear regression model for repeated measures. RESULTS: Three patients developed severe structural valve deterioration with calcific valve stenosis requiring reoperation. A multivariate linear mixed-effects model showed that lower serum magnesium (sMg) levels were associated with the increase of MPG after TAVI (beta-coefficient = 0.019, p = 0.03). No correlation was observed with serum calcium, phosphorus, or intact parathyroid hormone. Time-series changes of MPG and EOAi had significant difference between lower and higher sMg group. All 3 of the patients who underwent reoperation showed lower preoperative sMgs. CONCLUSION: Among bone-mineral metabolism markers, preoperative hypomagnesemia was associated with the increase of MPG after TAVI, suggesting that hypomagnesemia could predict post-TAVI valve dysfunction in HD patients. Further studies with larger sample sizes are warranted.

Comparison of 1-Month and 12-Month Vessel Responses Between the Polymer-Free Biolimus A9-Coated Stent and the Durable Polymer Everolimus-Eluting Stent.

BACKGROUND: A polymer-free biolimus A9-coated stent (PF-BCS) may achieve better arterial healing than a durable polymer drug-eluting stent owing to its polymer-free feature.Methods and Results: This multicenter, prospective, observational study enrolled 105 patients (132 lesions) who underwent PF-BCS (51 patients, 71 lesions) or durable polymer everolimus-eluting stent (DP-EES, 54 patients, 61 lesions) implantation. Serial coronary angioscopy (CAS) and optical coherence tomography (OCT) examinations were performed at 1 and 12 months, and the serial vessel responses were compared between PF-BCS and DP-EES. The primary outcome measure was the incidence of subclinical intrastent thrombus on CAS. The secondary outcome measures were: adequate strut coverage (≥40 µm) on OCT and maximum yellow color grade on CAS. The incidence of thrombus was high at 1 month (100% vs. 93%, P=0.091), but decreased at 12 months (18% vs. 25%, P=0.56), without a significant difference between PF-BCS and DP-EES. The adequate strut coverage rate was significantly higher (84±14% vs. 69±22%, P<0.001) and yellow color was significantly less intense (P=0.012) at 12 months in PF-BCS than in DP-EES; however, they were not significantly different at 1 month (adequate strut coverage: 47±21% vs. 50±17%, P=0.40; yellow color: P=0.99). CONCLUSIONS: Although the thrombogenicity of PF-BCS was similar to that of DP-EES, the adequate coverage and plaque stabilization rates of PF-BCS were superior to those of DP-EES at 12 months.

Pathophysiological evaluations of initial plaque development after heart transplantation via serial multimodality imaging and cytokine assessments.

BACKGROUND: Detailed morphological characteristics of de novo and donor-transmitted plaques and the association of serum T-lymphocyte cytokine levels with plaque progression of coronary allograft vasculopathy within 1 year after heart transplantation are unknown. METHODS: In this retrospective analysis of data in a prospectively maintained database, 40 heart transplant recipients were included. We performed serial 3 vessel optical coherence tomography and intravascular ultrasound analyses, at the 8 week (baseline) and 12 month post-transplantation follow-ups, and serum cytokine measurements (n = 23). The correlation between serum cytokines and Δplaque burden (between baseline and follow-up) was evaluated depending on plaque morphology. RESULTS: Thirteen de novo plaques (maximum intimal thickness ≥0.5 mm at the 12 month follow-up without plaques at baseline) were identified in 8 recipients, and 31 donor-transmitted plaques (maximum intimal thickness ≥0.5 mm at baseline) were detected in 17 recipients. Compared with donor-transmitted plaques, the Δplaque burden in the de novo plaques, with mainly fibrous morphology, was high (38.8% [29.6%-41.2%] vs 8.7% [1.33%-13.6%], p < 0.001). Stratification of the morphology of donor-transmitted plaques revealed that the Δplaque burden in fibrous plaques (10.6% [7.0%-18.0%]) was similar to that in fibroatheroma (10.3% [8.7%-23.8%]). Serum interleukin-31 levels at baseline correlated with fibrous plaque proliferation (r = 0.73, p = 0.007) even under immunosuppressive conditions, whereas other cytokines (interleukin-1ß, interleukin-17, and interferon-gamma) were mostly undetectable. CONCLUSIONS: Intimal fibrous proliferation contributed to the progression of donor-transmitted and de novo plaques. Serum interleukin-31 levels at baseline may contribute to intimal fibrous proliferation within 1 year after heart transplantation.

Iatrogenic Atrial Septal Defect Requiring Transcatheter Closure Following Transcatheter Mitral Valve Repair.

BACKGROUND: Transcatheter mitral valve repair with the MitraClip system has been established in selected high-risk patients. The MitraClip procedure results in a relatively large iatrogenic atrial septal defect (iASD). This study aimed to investigate the prevalence and clinical course of iASD requiring transcatheter closure following the MitraClip procedure.Methods and Results: This study was conducted at all 59 institutions that perform transcatheter mitral valve repair with the MitraClip system in Japan. The data of patients on whom transcatheter iASD closure was performed were collected. Of the 2,722 patients who underwent the MitraClip procedure, 30 (1%) required transcatheter iASD closure. The maximum iASD size was 9±4 mm (range, 3-18 mm). The common clinical course of transcatheter iASD closure was hypoxemia with right-to-left shunt or right-sided heart failure with left-to-right shunt. Of the 30 patients, 22 (73%) required transcatheter closure within 24 h following the MitraClip procedure, including 12 with hypoxemia and 5 with right-sided heart failure complicated with cardiogenic shock. Of the 5 patients, 2 required mechanical circulatory support devices. Twenty-one patients immediately underwent transcatheter iASD closure, and hemodynamic deteriorations were resolved; however, 1 patient died without having undergone transcatheter closure. CONCLUSIONS: Transcatheter iASD closure was required in 1% of patients who underwent the MitraClip procedure. Many of these patients immediately underwent transcatheter iASD closure because of hypoxemia with right-to-left shunt or right-sided heart failure with left-to-right shunt.

Coronary access after repeat transcatheter aortic valve replacement in patients of small body size: A simulation study.

BACKGROUND: Coronary artery access after repeat transcatheter aortic valve replacement (TAV-in-TAV) is reportedly more difficult because leaflet displacement of the first transcatheter heart valve (THV) impairs coronary cannulation; however, its effects in small patients are unknown. This study aimed to simulate coronary accessibility after TAV-in-TAV in patients of small body size. METHODS: We retrospectively analyzed computed tomography scans after initial THV implantation and classified patients by THV and coronary artery location, valve-to-aorta distance, and valve-to-coronary distance. Risks were compared between the SAPIEN and CoreValve/Evolut series, among THV generations, and between bicuspid and tricuspid aortic valves in the CoreValve/Evolut series. RESULTS: A total of 254 patients (SAPIEN series, n = 164; CoreValve/Evolut series, n = 90) were enrolled. The average body surface area of the patients was 1.44 m2. Patients were classified as "feasible" (26%), "theoretically feasible with low risk" (19.7%), "theoretically feasible with high risk" (8.7%), or "unfeasible" (45.8%). The "unfeasible" rate was significantly higher in the CoreValve/Evolut series than in the SAPIEN series (78.9% vs 26.2%; P < .001). A significantly higher "unfeasible" rate was identified in the current model of SAPIEN (SAPIEN, 8.3%; SAPIENXT, 1.8%; SAPIEN3, 48.2%; P < .001), but not in the CoreValve/Evolut series (CoreValve, 83.3%; Evolut R, 80.0%; Evolut PRO, 71.4%; P = .587). Patients with a bicuspid aortic valve had a lower "unfeasible" rate compared to those with a tricuspid aortic valve (60.0% vs 86.2%; P = .014). CONCLUSIONS: Patients of small body size may have a high probability of "unfeasible" coronary access after TAV-in-TAV, especially when treated with current high-frame devices, suggesting the need for careful strategic planning for initial THV implantation.

A hybrid approach for a case with a high risk of not only surgical but transcatheter aortic valve replacement.

An 86-year-old woman with severe aortic stenosis was thought to be at a high risk for surgical aortic valve replacement and inoperability due to old age and porcelain aorta. Furthermore, transcatheter aortic valve replacement (TAVR) was considered difficult due to high risk of coronary obstruction secondary to the aortic root anatomy and poor vascular access associated with marked atherosclerotic lesions on the distal aortic arch with peripheral artery disease. We successfully treated her with TAVR via the brachiocephalic artery in combination with prophylactic off-pump coronary artery bypass grafting.