Cardiac Damage in Degenerative Mitral Regurgitation Treated With Transcatheter Mitral Edge-to-Edge Repair.

BACKGROUND: The extent of cardiac damage and its association with clinical outcomes in patients undergoing transcatheter edge-to-edge repair (TEER) for degenerative mitral regurgitation remains unclear. This study was aimed to investigate cardiac damage in patients with degenerative mitral regurgitation treated with TEER and its association with outcomes. METHODS: We analyzed patients with degenerative mitral regurgitation treated with TEER in the Optimized Catheter Valvular Intervention-Mitral registry, which is a prospective, multicenter observational data collection in Japan. The study subjects were classified according to the extent of cardiac damage at baseline: no extravalvular cardiac damage (stage 0), mild left ventricular or left atrial damage (stage 1), moderate left ventricular or left atrial damage (stage 2), or right heart damage (stage 3). Two-year mortality after TEER was compared using Kaplan-Meier analysis. RESULTS: Out of 579 study participants, 8 (1.4%) were classified as stage 0, 76 (13.1%) as stage 1, 319 (55.1%) as stage 2, and 176 (30.4%) as stage 3. Two-year survival was 100% in stage 0, 89.5% in stage 1, 78.9% in stage 2, and 75.3% in stage 3 (P=0.013). Compared with stage 0 to 1, stage 2 (hazard ratio, 3.34 [95% CI, 1.03-10.81]; P=0.044) and stage 3 (hazard ratio, 4.51 [95% CI, 1.37-14.85]; P=0.013) were associated with increased risk of 2-year mortality after TEER. Significant reductions in heart failure rehospitalization rate and New York Heart Association functional scale were observed following TEER (both, P<0.001), irrespective of the stage of cardiac damage. CONCLUSIONS: Advanced cardiac damage is associated with an increased risk of mortality in patients undergoing TEER for degenerative mitral regurgitation. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: UMIN000023653.

Short-Term Outcomes Following Transcatheter Edge-to-Edge Repair: Insights From the OCEAN-Mitral Registry.

Background: Transcatheter edge-to-edge repair (TEER) is a less invasive treatment for patients with mitral regurgitation (MR). Limited safety and efficacy data of TEER with MitraClip, including the fourth-generation (G4) system, in a large cohort, are available. Objectives: This study aimed to summarize the initial experience of the TEER system in patients with MR from a large registry in Japan. Methods: The OCEAN (Optimized CathEter vAlvular iNtervention)-Mitral Registry is an ongoing, prospective, investigator-initiated, multicenter, observational registry for patients with primary and secondary MR undergoing transcatheter mitral valve therapies. A total of 21 centers participated in the registry. Patients undergoing TEER were enrolled, and their characteristics, procedural details, and clinical outcomes were recorded. Results: In total, 2,150 patients including 1,605 patients (75.0%) with secondary MR, were enrolled between April 2018 and June 2021. The median age was 80 years, and 43.7% were women. The median device and fluoroscopy times were 60 and 26 minutes, respectively. Those with the G4 system (618/2,150 [28.7%]) were significantly shorter than those with the second generation (G2) system (1,532/2,150 [71.3%]). Overall, 94.6% met acute procedural success without significant differences between the 2 systems (G2 94.7% vs G4 94.6%; P = 0.961). Conclusions: The OCEAN-Mitral registry has demonstrated the short-term outcomes of TEER systems, including the G4 system, in symptomatic patients with primary and secondary MR. The acute procedural success rate in the G2 system was excellent, and that in the G4 system was expected to improve with the multidisciplinary heart valve team approach. (Japanese Registry study of valvular heart diseases treatment and prognosis; UMIN000023653).

One-Year Outcomes and Their Relationship to Residual Mitral Regurgitation After Transcatheter Edge-to-Edge Repair With MitraClip Device: Insights From the OCEAN-Mitral Registry.

Background Limited data are available about clinical outcomes and residual mitral regurgitation (MR) after transcatheter edge-to-edge repair in the large Asian-Pacific cohort. Methods and Results From the Optimized Catheter Valvular Intervention (OCEAN-Mitral) registry, a total of 2150 patients (primary cause of 34.6%) undergoing transcatheter edge-to-edge repair were analyzed and classified into 3 groups according to the residual MR severity at discharge: MR 0+/1+, 2+, and 3+/4+. The mortality and heart failure hospitalization rates at 1 year were 12.3% and 15.0%, respectively. Both MR and symptomatic improvement were sustained at 1 year with MR ≤2+ in 94.1% of patients and New York Heart Association functional class I/II in 95.0% of patients. Compared with residual MR 0+/1+ (20.4%) at discharge, both residual MR 2+ (30.2%; P < 0.001) and 3+/4+ (32.4%; P = 0.007) were associated with the higher incidence of death or heart failure hospitalization (adjusted hazard ratio [HR], 1.59; P < 0.001, and adjusted HR, 1.73; P = 0.008). New York Heart Association class III/IV at 1 year was more common in the MR 3+/4+ group (20.0%) than in the MR 0+/1+ (4.6%; P < 0.001) and MR 2+ (6.4%; P < 0.001) groups, and the proportion of New York Heart Association class I is significantly higher in the MR 1+ group (57.8%) than in the MR 2+ group (48.3%; P = 0.02). Conclusions The OCEAN-Mitral registry demonstrated favorable clinical outcomes and sustained MR reduction at 1 year in patients undergoing transcatheter edge-to-edge repair. Both residual MR 2+ and 3+/4+ after transcatheter edge-to-edge repair at discharge were associated with worse clinical outcomes compared with residual MR 0+/1+. Registration Information https://upload.umin.ac.jp. Identifier: UMIN000023653.

Impact of Gender on Mortality After Transcatheter Edge-to-Edge Repair for Functional Mitral Regurgitation.

Recent studies suggested short-term mortality after transcatheter edge-to-edge repair (TEER) was comparable between men and women. However, the gender-specific prognostic difference in the long-term follow-up after TEER is still unknown. To evaluate the impact of gender on long-term mortality after TEER for functional mitral regurgitation (FMR) using multicenter registry data. We retrospectively analyzed 1,233 patients (male 60.3%) who underwent TEER for FMR at 24 centers. The impact of gender on all-cause death and hospitalization for heart failure (HF) after TEER was evaluated using multivariate regression analysis and propensity score (PS) matching methods. During the 2-year follow-up, 207 all-cause death and 263 hospitalizations for HF were observed after TEER for FMR. Men had a significantly higher incidence of all-cause death than women (18.6% vs 14.1%, log-rank p = 0.03). After adjustment by multivariate Cox regression and PS matching, the male gender was significantly associated with a higher incidence of all-cause mortality after TEER than the female gender (hazard ratio 2.11, 95% confidence interval 1.42 to 3.14 in multivariate Cox regression; hazard ratio 1.89, 95% confidence interval 1.03 to 3.48 in PS matching). The gender-specific prognostic difference was even more pronounced after 1-year of TEER. On the contrary, there was no gender-related difference in hospitalization for HF after TEER. In conclusion, women with FMR had a better prognosis after TEER than men, whereas this was not observed in hospitalization for HF. This result might indicate that women with FMR are more likely to benefit from TEER.

Incidence, Timing, and Causes of Late Bleeding After TAVR in an Asian Cohort.

Background: Data regarding the incidence, predictive factors, and clinical outcomes of post-transcatheter aortic valve replacement (TAVR) bleeding is limited in the Asian cohort. Objectives: This study sought to assess the predictors and prognostic impact of post-TAVR late bleeding. Methods: This study used the Japanese multicenter registry data to analyze 2,518 patients (mean age: 84.3 ± 5.2 years) who underwent TAVR. Late bleeding was defined as any postdischarge bleeding events after TAVR. Baseline characteristics, predictive factors, and clinical outcomes including death and rehospitalization were assessed in patients with and without late bleeding events. Results: The cumulative incidence rate of all and major late bleeding and ischemic stroke were 7.4%, 5.2%, and 3.4%, respectively, 3 years after TAVR. The independent predictive factors of late bleeding were low platelet count, high score (≥4) on the clinical frailty scale, and a New York Heart Association functional class III/IV. The cumulative mortality rates up to 3 years were significantly higher in patients with late bleeding than in those without bleeding (P < 0.001). The multivariate Cox regression analysis revealed that late bleeding, included as a time-varying covariate in the model, was associated with an increased risk of mortality following TAVR (HR: 5.63; 95% CI: 4.28-7.41; P < 0.001). Conclusions: Late bleeding after TAVR was not a rare complication, and it significantly increased long-term mortality. It should be carefully managed, especially when it is predictable in the high-risk cohort, and efforts should be taken to reduce bleeding complications even after a successful procedure.

Fascia Iliaca Block Reduces Remifentanil Requirement in Conscious Sedation for Transcatheter Aortic Valve Implantation　- A Randomized Clinical Trial.

BACKGROUND: Whether nerve block improves the quality of conscious sedation (CS) in patients undergoing transcatheter aortic valve implantation (TAVI) is unclear. This study investigated whether fascia iliaca block (FIB) reduced the remifentanil requirement and relieved pain in CS for TAVI.Methods and Results: This prospective study randomized 72 patients scheduled for elective TAVI under CS into 2 groups, with (FIB) and without (control) FIB (n=36 in each group). The sedation targeted a Bispectral Index <90 with a Richmond Agitation-Sedation Scale of -2 to -1. Dexmedetomidine (0.7 µg/kg, i.v.) combined with remifentanil (0.03 µg/kg/min, i.v.) and propofol (0.3 mg/kg/h, i.v.) was used to commence sedation. FIB using 30 mL of 0.185% ropivacaine was implemented 2 min before TAVI. Patient sedation was maintained with dexmedetomidine (0.4 µg/kg/h, i.v.) supplemented with remifentanil (0-0.02 µg/kg/min, i.v.). Remifentanil (20 µg, i.v.) was used as a rescue dose for intraprocedural pain. Compared with the control group, FIB reduced the both the total (median [interquartile range] 83.0 [65.0-98.0] vs. 34.5 [26.0/45.8)] µg; P<0.001) and continuous (25.3 [20.9/31.5] vs. 9.5 [6.8/12.5] ng/kg/min; P<0.001) doses of remifentanil administered. CONCLUSIONS: FIB reduced the remifentanil requirement and relieved pain in patients undergoing TAVI with CS. Therefore, FIB improved the quality of CS in TAVI.

The Usefulness of the Modified Essential Frailty Toolset to Predict Late Bleeding Events after Transcatheter Aortic Valve Implantation.

Frailty is strongly associated with poor short- and long-term prognoses in patients who undergo transcatheter aortic valve implantation (TAVI). However, limited data are available regarding the association between frailty and late bleeding events after TAVI. Of the 2,518 patients in the Japanese multicenter TAVI registry, 1371 patients with complete data on frailty parameters were analyzed. We developed a modified Essential Frailty Toolset (EFT) using 4 frailty parameters-gait speed, Mini-Mental State Examination (MMSE), anemia, and hypoalbuminemia-that are significant predictors of late bleeding events in this cohort. The predictive value of the modified EFT for late bleeding after TAVI was assessed in comparison with other clinical variables. Late bleeding events after TAVI occurred in 80 patients (5.8%). Gait speed, MMSE, anemia, and hypoalbuminemia were significantly associated with late bleeding. A modified EFT was developed to include these parameters, which were scored from 0 to 5 points comprising the following 4 items: gait speed (0: >1.5 m/s, 1: 1.5 to 0.75 m/s, 2: <0.75 m/s), cognition (1: MMSE <18), anemia (1: hemoglobin <13 g/100 ml in men or <12 g/100 ml in women), and malnutrition (1: albumin <3.5 g/100 ml). Multivariate Cox regression analysis revealed that the modified EFT was an independent predictor of late bleeding (adjusted hazard ratio 1.51, 95% confidence interval [CI] 1.19 to 1.92, p <0.001) In conclusion, the modified EFT was found to be a significant predictive factor for late bleeding events after TAVI. Assessment of frailty is important to predict patients with high bleeding risk after TAVI.

Impact of arm circumference on clinical outcomes in patients undergoing transcatheter aortic valve replacement.

Background: Although Arm circumference (AC) is considered to be a predictor of clinical outcomes of transcatheter aortic valve replacement (TAVR), limited data are available on the impact of this anthropometric measurement. This study aimed to investigate the clinical impact of AC on the outcomes of patients who underwent TAVR. Methods: AC was investigated in consecutive patients who underwent TAVR between March 2014 and May 2018. Patients were divided into low AC (n = 220) and high AC (n = 127) groups by a classification and regression tree (CART) survival model, and their baseline characteristics and mortality were compared. The correlations of AC with other frailty markers were also evaluated. Results: One-year clinical follow-up was completed in 100% of cases, and 89 patients (31 men, 58 women) died during the median follow-up period of 825 days. The low AC group was more fragile than the high AC group, and the AC value was significantly correlated with each frailty marker (all p < 0.05). The Cox regression analysis demonstrated the independent association of mortality with low AC (HR: 2.56, 95% confidence interval [CI]: 1.47-4.46, p < 0.001). When AC was compared to conventional prediction models of survival, the net reclassification improvement and the integrated discrimination improvement analysis showed significant improvements in predicting outcomes after including the AC with other frailty markers (all p < 0.05). Conclusions: The AC is related to frailty markers and is an important surrogate marker for predicting worse clinical outcomes after TAVR. Assessment of AC may be considered when deciding on TAVR.

Chronic kidney disease and transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) is an established treatment option for patients with severe aortic stenosis. Patients with aortic stenosis have a higher prevalence of chronic kidney disease (CKD). CKD is generally associated with an increased risk of mortality, cardiovascular events, and readmission for heart failure; this supports the concept of a cardio-renal syndrome (CRS). CRS encompasses a spectrum of disorders of the heart and kidneys, wherein dysfunction in one organ may cause dysfunction in the other. TAVI treatment is expected to break this malignant cycle of CRS and improve cardio-renal function after the procedure. However, several reports demonstrate that patients with CKD have been associated with poor outcomes after the procedure. In addition, TAVI treatments for patients with advanced CKD and those with end-stage renal disease on hemodialysis are considered more challenging. Adequate management to preserve cardio-renal function in patients undergoing TAVI may reduce the risk of cardio-renal adverse events and improve the long-term prognosis. The current comprehensive review article aims to assess the prognostic impact of CKD after TAVI and seek optimal care in patients with CKD even after successful TAVI.

Rescue Percutaneous Stenting for Cerebral Malperfusion With Acute Aortic Dissection Following TAVR.

Malperfusion syndrome is a complication of acute aortic dissection (AAD) involving a branch vessel. We report a case of bailout stenting for critical cerebral malperfusion in a patient with AAD after transcatheter aortic valve replacement. Rescue percutaneous procedure for this complication may be a treatment option in patients with high surgical risk. (Level of Difficulty: Advanced.).

The importance of side branch preservation in the treatment of chronic total occlusions with bifurcation lesions.

OBJECTIVES: The aim of this study was to identify the predictive factors for suboptimal result in side branch (SB) in chronic total occlusion (CTO) bifurcation lesions and clinical outcomes of patients with suboptimal result in SB. BACKGROUND: There is little evidence on the optimal strategy for bifurcation lesions in CTO. METHODS: We retrospectively reviewed 314 consecutive bifurcation lesions in CTO with SB ≥ 2.5 mm in 3 hospitals from March 2010 to June 2018. Patients were divided into the two groups based on the suboptimal SB treatment (SST) and optimal SB treatment (OST) groups. The baseline characteristics, procedural and clinical outcomes were compared between the two groups. This study also evaluated the predictors of suboptimal result in SB. RESULTS: Suboptimal result in SB occurred in 47 cases. Presence of stenosis in SB, bifurcations located within the occluded segment and sub-intimal tracking at SB ostium was an independent predictor of suboptimal result in SB. The cumulative incidence of target lesion revascularization (TLR) in all lesions was not significantly different between the two groups, however, TLR in right coronary artery (RCA) was significantly higher in the SST group. In the Cox regression analysis, suboptimal result in SB in RCA and sub-intimal tracking were independent predictors of TLR for MB. In patients with bifurcations located within the occluded segment, usage of two-stent technique was significantly lower in the SST group. CONCLUSIONS: Meticulous procedures are required for SB preservation to improve not only SB prognosis but also MB, especially in RCA.

Calculated plasma volume status and outcomes in patients undergoing transcatheter aortic valve replacement.

AIMS: This study investigated the prognostic value of plasma volume status (PVS) in patients who underwent transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: Plasma volume status was calculated in 2588 patients who underwent TAVR using data from the Japanese multicentre registry. All-cause mortality and heart failure hospitalization (HFH) within 2 years of TAVR were compared among the PVS quartiles (Q1, PVS < 5.5%; Q2, PVS 5.5-13.5%; Q3, PVS 13.5-21.0%; and Q4, PVS ≥ 21.0%). Subgroups were stratified by the PVS cut-off value combined with the New York Heart Association (NYHA) class as follows: low PVS with NYHA I/II (n = 959), low PVS with NYHA III/IV (n = 845), high PVS with NYHA I/II (n = 308), and high PVS with NYHA III/IV (n = 476). The cumulative all-cause mortality and HFH within 2 years of TAVR significantly increased with increasing PVS quartiles [8.5%, 16.8%, 19.2%, and 27.0% (P < 0.001) and 5.8%, 8.7%, 10.3%, and 12.9% (P < 0.001), respectively]. The high-PVS group regardless of the NYHA class had a higher all-cause mortality and HFH [9.6%, 18.2%, 24.5%, and 30.4% (P < 0.001) and 6.1%, 10.4%, 14.1%, and 11.3% (P < 0.001)]. In a Cox regression multivariate analysis, the PVS values of Q3 and Q4 had independently increased all-cause mortality [hazard ratio (HR), 1.50 and 1.64 (P = 0.017 and P = 0.008), respectively], and Q4 had independently increased HFH (HR, 1.98, P = 0.005). The low PVS with NYHA III/IV, high PVS with NYHA I/II, and high PVS with NYHA III/IV also had significantly increased all-cause mortality [HR, 1.45, 1.73, and 1.86 (P = 0.006, P = 0.002, and P < 0.001), respectively] and HFH [HR, 1.52, 2.21, and 1.70 (P = 0.049, P = 0.002, and P = 0.031), respectively]. CONCLUSIONS: Plasma volume status is useful for predicting all-cause mortality and HFH after TAVR.

Late kidney injury after transcatheter aortic valve replacement.

BACKGROUND: Information on early to late-phase kidney damage in patients who underwent transcatheter aortic valve replacement (TAVR) is scarce. We aimed to identify the predictive factors for late kidney injury (LKI) at 1-year and patient prognosis beyond 1-year after TAVR. METHODS: We retrospectively reviewed 1,705 patients' data from the Japanese TAVR multicenter registry. Acute kidney injury (AKI) and LKI, defined as an increase of at least 0.3 mg/dL in creatinine level, a relative 50% decrease in kidney function from baseline to 48 hours and 1-year, were evaluated. The patients were categorized into the 4 groups as AKI-/LKI- (n = 1.362), AKI+/LKI- (n = 95), AKI-/LKI+ (n = 199), and AKI+/LKI+ (n = 46). RESULTS: The cumulative 3-year mortality rates were significantly increased across the four groups (12.5%, 15.8%, 24.6%, 25.8%, P < .001). Multivariate analysis revealed that chronic kidney disease, coronary artery disease, periprocedural AKI, and heart failure-related re-admission within 1-year were significantly associated with LKI. The Cox regression analysis revealed that AKI-/LKI+ and AKI+/LKI+ were independent predictors of increased late mortality beyond 1-year after TAVR (P = .001 and P = .01). CONCLUSIONS: LKI was influenced by adverse cardio-renal events and was associated with increased risks of late mortality beyond 1-year after TAVR.