Comparative Data of Procedural and Midterm Outcomes in Patients Who Underwent Percutaneous Left Atrial Appendage Closure Between the WATCHMAN FLX and WATCHMAN 2.5 Devices　- Insight From the OCEAN-LAAC Registry.

BACKGROUND: Limited data are available regarding clinical outcomes after percutaneous left atrial appendage closure using WATCHMAN FLX (WM-FLX) and WATCHMAN-2.5 (WM2.5) devices in Asian patients.Methods and Results: Data of 1,464 consecutive patients (WM-FLX, n=909; WM2.5, n=555) were extracted from a Japanese multicenter registry, and clinical data were compared between the 2 groups. No in-hospital deaths, periprocedural stroke, or device embolization occurred. Procedural success was significantly higher in the WM-FLX than WM2.5 group (95.8% vs. 91.9%; P=0.002) owing to the lower incidence of periprocedural pericardial effusion (0.55% vs. 1.8%; P=0.021). No significant differences in all-cause death, postprocedural stroke, and device-related thrombus were observed between the 2 groups. However, the cumulative bleeding rate at 1 year was substantially lower in the WM-FLX group (7.8% vs. 16.4%; P<0.001). Landmark analysis of bleeding events highlighted lower bleeding rates in the WM-FLX than WM2.5 group within the first 6 months (6.4% vs. 14.8%; P<0.001), with comparable bleeding rates over the 6- to 12-month period (1.5% vs. 3.2%, respectively; P=0.065). CONCLUSIONS: This study demonstrated higher early safety and lower 1-year bleeding rates in the WM-FLX than WM2.5 group. The lower bleeding events with WM-FLX are likely due to multiple factors other than purely difference in devices, such as postprocedural drug regimen.

Micro-CT evaluation of high pressure-decellularized cardiovascular tissues transplanted in rat subcutaneous accelerated-calcification model.

We have succeeded in reducing the calcification of acellular aortas or valves in porcine allogeneic system by removing the DNA and phospholipids, but its further reduction is desirable. Here, the calcification of the acellular tissue was evaluated in rat subcutaneous transplantation model which is known as calcification model. Acellular samples prepared by high-hydrostatic pressure (HHP) protocols with different washing media were implanted and the calcification was monitored under micro-computed tomography for 1 and 3 months. The amount of the calcium deposition was quantitatively evaluated by atomic absorption spectroscopy. A cell culture medium showed very good cell removal ability but led to severe calcification at 1 month, and surprisingly the calcium deposition increased as the washing period increased. This calcification was suppressed by removing the DNA fraction with high DNase concentration. On the other hand, the calcification was greatly reduced when washed with saline even at low DNase concentration after 2 weeks washing. These results suggest that the ion species in the washing medium and the residual DNase cooperatively affect the tendency of in vivo calcification, which led us to the possibility of reduced calcification of acellular cardiac tissues.

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.).

Predictors and Prognostic Impact of Nutritional Changes After Transcatheter Aortic Valve Replacement.

BACKGROUND: Little is known about changes in nutritional status as an index of frailty on clinical outcomes after transcatheter aortic valve replacement (TAVR). This study aimed to assess the clinical impact of serum albumin changes after TAVR. METHODS: Changes in serum albumin levels from baseline to 1 year after TAVR were evaluated in 1524 patients who were classified as having hypoalbuminemia (<3.5 g/dl) and normoalbuminemia (≥3.5 g/dl) at each timepoint. The patients were categorized into 4 groups: NN (baseline normoalbuminemia, 1-year normoalbuminemia: n = 1119), HN (baseline hypoalbuminemia, 1-year normoalbuminemia: n = 202), NH (baseline normoalbuminemia, 1-year hypoalbuminemia: n = 121), and HH (baseline hypoalbuminemia, 1-year hypoalbuminemia: n = 82). We also defined late hypoalbuminemia as hypoalbuminemia identified at the 1-year assessment. Clinical outcomes were compared among 4 groups. Multivariable analysis was driven to assess the variables associated with late hypoalbuminemia and long-term mortality. RESULTS: The cumulative 3-year mortality was significantly different among the 4 groups (NN: 11.4%, HN: 10.7%, NH: 25.4%, HH: 44.4%, p < 0.001). Multivariable Cox regression analysis revealed that the NH group had a higher mortality risk (hazard ratio [HR]; 2.80 and 3.53, 95% confidence interval [CI]; 1.71-4.57 and 2.06-6.06, p < 0.001 and p < 0.001, respectively), whereas the HN group had a similar risk (HR; 1.16, 95% CI; 0.66-2.06, p = 0.61) compared with the NN group. Baseline hypoalbuminemia, low body mass index, liver disease, peripheral artery disease, and hospital readmission within 1 year were predictors of late hypoalbuminemia (all p < 0.05). CONCLUSION: Serial albumin assessment may identify poor prognostic subsets in patients with persistent and late acquired malnutrition after TAVR.

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.

Safety and efficacy of minimalist approach in transfemoral transcatheter aortic valve replacement: insights from the Optimized transCathEter vAlvular interventioN-Transcatheter Aortic Valve Implantation (OCEAN-TAVI) registry.

OBJECTIVES: Favourable results have been reported for monitored anaesthesia care that includes local anaesthesia and conscious sedation [minimalist approach (MA)] for transfemoral transcatheter aortic valve replacement (TAVR). However, the efficacy of MA is still controversial in Japan. We describe our experience from a Japanese multicentre registry. METHODS: Between October 2013 and April 2016, 1215 consecutive Japanese patients with symptomatic, severe aortic stenosis undergoing TAVR with self-expandable or balloon-expandable valves were prospectively included in the Optimized transCathEter vAlvular intervention-Transcatheter Aortic Valve Implantation (OCEAN-TAVI) registry. Of these patients, we retrospectively reviewed 921 consecutive patients who underwent elective transfemoral-TAVR. We evaluated the perioperative results of MA-TAVR and non-minimalist approach (NMA) TAVR using propensity score matching analysis. RESULTS: A total of 118 patients underwent MA-TAVR, and 802 patients underwent NMA-TAVR [median age 84 vs 85 years, P = 0.25; Society of Thoracic Surgeons (STS) score 7.6 vs 6.4, P = 0.01]. One hundred eighteen matched pairs were compared after propensity score matching. In-hospital mortality and stroke/transient ischaemic attack were not significantly different between the MA-TAVR and the NMA-TAVR groups (2.5% vs 0.8%, P = 0.3; 1.7% vs 0.8%, P = 0.6, respectively). Major or life-threatening bleeding and the transfusion rate were significantly lower in the MA-TAVR group (3.4% vs 17%, P = 0.003; 6.8% vs 29%, P = 0.0002, respectively). The total intensive care unit days and length of hospital stay were significantly lower in the MA-TAVR group (P ≤ 0.0002). CONCLUSIONS: MA-TAVR has similar results to NMA-TAVR in terms of mortality and stroke in this Japanese multicentre registry. Shorter procedure time and hospital stays were seen in the MA-TAVR group. MA-TAVR is as safe and effective as NMA-TAVR.

Patients Refusing Transcatheter Aortic Valve Replacement Even Once Have Poorer Clinical Outcomes.

Background Although transcatheter aortic valve replacement ( TAVR ) is the least invasive treatment for patients with symptomatic aortic stenosis, some patients hesitate to undergo the procedure. We investigated the clinical impact of treatment delay after patient refusal of TAVR . Methods and Results We used the Japanese OCEAN (Optimized Catheter valvular intervention) regsitry data of 1542 patients who underwent TAVR . Refusal was defined as at least 1 refusal of TAVR at the time of informed consent. Patients were separated into 2 groups: refusal (28/1542, 1.8%) and non-refusal (1514/1542, 98.2%). We compared the baseline characteristics, procedural outcomes, and mortality rates between the groups. Additionally, data on reasons for refusal and those leading to eventually undergoing TAVR were collected. Age, surgical risk scores, and frailty were higher in the refusal group than in the non-refusal group ( P<0.05 for all). Periprocedural complications did not differ between groups, whereas 30-day and cumulative 1-year mortality were significantly higher in the refusal group than in the non-refusal group (7.1% versus 1.3%, P=0.008 and 28.8% versus 10.3%, P=0.010, respectively). Multivariate Cox regression analysis revealed that TAVR refusal was an independent predictor of increased midterm mortality (hazard ratio: 3.37; 95% confidence interval: 1.52-7.48; P=0.003). The most common reason for refusal was fear (13/28, 46.4%), and the most common reason for changing their mind was worsening heart failure (21/28, 75.0%). All patients in the refusal group decided to undergo TAVR within 20 months (median: 5.5 months). Conclusions Refusing TAVR even once led to poorer prognosis; therefore, this fact should be clearly discussed when obtaining informed consent.

Prognostic Value of Hypoalbuminemia After Transcatheter Aortic Valve Implantation (from the Japanese Multicenter OCEAN-TAVI Registry).

Hypoalbuminemia, a frailty criterion, belongs to a group of co-morbidities not captured as a traditional risk factor. We assessed its prognostic value in patients who underwent transcatheter aortic valve implantation (TAVI). The study included 1,215 consecutive patients from the Optimized Catheter Valvular Intervention -TAVI Japanese multicenter registry. Hypoalbuminemia was defined as serum albumin level <3.5 g/dl. Baseline characteristics, procedural outcomes, and all-cause, cardiovascular and noncardiovascular mortality rates after TAVI were compared between patients with albumin level <3.5 g/dl (hypo[h]-ALB group, n = 284) and those with albumin level >3.5 g/dl (nonhypo[nh]-ALB group, n = 931). Several baseline characteristics differed significantly between both groups, including age (85.1 ± 5.1 vs 84.2 ± 4.9 years, p = 0.012), ejection fraction (58.5 ± 14.3% vs 62.9 ± 12.4%, p <0.001), baseline kidney function, or liver disease. The 30-day mortality rate in all patients showed significant differences between the 2 groups (3.9% vs 1.3%, p = 0.005). During a mean follow-up of 330 days, cumulative all-cause, cardiovascular, and noncardiovascular mortality rates were significantly higher in the hALB group than in the nhALB group (log-rank test, p <0.001, p = 0.0021, and p <0.001, respectively). The groups were also analyzed using a propensity matching model for adjusting the baseline differences. The analysis revealed that the poorer prognosis of the hALB group in terms of cumulative all-cause and noncardiovascular mortality was retained (p = 0.038, and p = 0.0068, respectively); however, differences in cardiovascular mortality rates in the 2 groups were attenuated (p = 0.93). In conclusion, hypoalbuminemia was associated with poor prognosis, highlighted by the increase in noncardiovascular mortality. Baseline albumin level could be a useful marker for risk stratification before TAVI.