Size of Self-Expandable Transcatheter Heart Valve and Mid-Term Adverse Events After Transcatheter Aortic Valve Replacement.

The hemodynamic performance of self-expandable valves (SEVs) is a preferable choice for small aortic annuli in transcatheter aortic valve replacement (TAVR). However, no data are, so far, available regarding the relation between the size of SEVs and clinical outcomes. This study aimed to evaluate the impact of prosthesis size on adverse events after TAVR using SEVs. We retrospectively analyzed 1,400 patients (23-mm SEV: 13.6%) who underwent TAVR using SEVs at 12 centers. The impact of SEV size on all-cause death and heart failure (HF) after TAVR was evaluated by multivariate Cox regression and propensity score (PS) matching analysis. During the follow-up period (median 511 days), 201 all-cause deaths and 87 HF rehospitalizations were observed. The incidence of all-cause death was comparable between small- (23-mm SEV) and larger-sized (26- or 29-mm SEV) (16.8% vs 13.9%, log-rank p = 0.29). The size of SEV was not associated with a higher incidence of all-cause death (hazard ratio [HR] 1.21, 95% confidence interval [CI] 0.79 to 1.86 in Cox regression; HR 1.31, 95% CI 0.77 to 2.23 in PS matching) and HF after TAVR (subdistribution HR 0.79, 95% CI 0.37 to 1.72 in Cox regression; subdistribution HR 1.00, 95% CI 0.44 to 2.30 in PS matching). The multivariate model including postprocedural prosthesis-patient mismatch showed consistent results. In conclusion, small SEVs had comparable midterm clinical outcomes to larger-sized SEVs, even if the prosthesis-patient mismatch was observed after TAVR.

Performance and outcomes of the SAPIEN 3 Ultra RESILIA transcatheter heart valve in the OCEAN-TAVI registry.

BACKGROUND: Data on the performance of the latest-generation SAPIEN 3 Ultra RESILIA (S3UR) valve in patients who undergo transcatheter aortic valve replacement (TAVR) are scarce. AIMS: We aimed to assess the clinical outcomes, including valve performance, of the S3UR. METHODS: Registry data of 618 consecutive patients with S3UR and of a historical pooled cohort of 8,750 patients who had a SAPIEN 3 (S3) valve and underwent TAVR were collected. The clinical outcomes and haemodynamics, including patient-prosthesis mismatch (PPM), were compared between the 2 groups and in a propensity-matched cohort. RESULTS: The incidence of in-hospital death, vascular complications, and new pacemaker implantation was similar between the S3UR and the S3 groups (allp>0.05). However, both groups showed significant differences in the degrees of paravalvular leakage (PVL) (none-trivial: 87.0% vs 78.5%, mild: 12.5% vs 20.5%, ≥moderate: 0.5% vs 1.1%; p<0.001) and the incidence of PPM (none: 94.3% vs 85.1%, moderate: 5.2% vs 12.8%, severe: 0.5% vs 2.0%; p<0.001). The prevalence of a mean pressure gradient ≥20 mmHg was significantly lower in the S3UR group (1.6% vs 6.2%; p<0.001). Better haemodynamics were observed with the smaller 20 mm and 23 mm S3UR valves. The results were consistent in a matched cohort of patients with S3UR and with S3 (n=618 patients/group). CONCLUSIONS: The S3UR has equivalent procedural complications to the S3 but with lower rates of PVL and significantly better valve performance. The better valve performance of the S3UR, particularly in smaller valve sizes, overcomes the remaining issue of balloon-expandable valves after TAVR.

Long-term prognostic value of the H2FPEF score in patients undergoing transcatheter aortic valve implantation.

AIMS: A considerable proportion of candidates for transcatheter aortic valve implantation (TAVI) have underlying heart failure (HF) with preserved ejection fraction (HFpEF), which can be challenging for diagnosis because significant valvular heart disease should be excluded before diagnosing HFpEF. This study investigated the long-term prognostic value of the pre-procedural H2FPEF score in patients with preserved ejection fraction (EF) undergoing TAVI. METHODS AND RESULTS: Patients who underwent TAVI between October 2013 and May 2017 were enrolled from the Optimized CathEter vAlvular iNtervention-Transcatheter Aortic Valve Implantation Japanese multicentre registry. After excluding 914 patients, 1674 patients with preserved EF ≥ 50% (median age: 85 years, 72% female) were selected for calculation of the H2FPEF score and were dichotomized into two groups: the low H2FPEF score [0-5 points; n = 1399 (83.6%)] group and the high H2FPEF score [6-9 points; n = 275 (16.4%)] group. Patients with high H2FPEF scores were associated with a higher prevalence of New York Heart Association Functional Class III/IV (59.3% vs. 43.7%, P < 0.001), diabetes (24.4% vs. 18.5%, P = 0.03), and paradoxical low-flow, low-gradient aortic stenosis (15.9% vs. 6.2%, P < 0.001). These patients showed worse prognoses than those with low H2FPEF scores regarding the cumulative 2 year all-cause mortality (26.3% vs. 15.5%, log-rank P < 0.001), cardiovascular mortality (10.5% vs. 5.4%, log-rank P < 0.001), HF hospitalization (16.2% vs. 6.7%, log-rank P < 0.001), and the composite endpoint of cardiovascular mortality and HF hospitalization (23.8% vs. 10.8%, log-rank P < 0.001). After adjustment for several confounders, the high H2FPEF scores were independently associated with increased risk for all-cause mortality [adjusted hazard ratio (HR), 1.48; 95% confidence interval (CI), 1.09-2.00; P = 0.011] and for the composite endpoint of cardiovascular mortality and HF hospitalization (adjusted HR, 1.95; 95% CI, 1.38-2.74; P < 0.001). Subgroup analysis confirmed the excess risk of high H2FPEF scores relative to low H2FPEF scores for the composite endpoint of cardiovascular mortality and HF hospitalization increased with a lower Society of Thoracic Surgeons (STS) score (STS score <8%: adjusted HR, 2.40; 95% CI, 1.50-3.85; P < 0.001; STS score ≥8%: adjusted HR, 1.34; 95% CI, 0.79-2.28; P = 0.28; Pinteraction = 0.030). CONCLUSIONS: The H2FPEF score is useful for predicting long-term adverse outcomes after TAVI, including all-cause mortality, cardiovascular mortality, and HF hospitalization for patients with preserved EF. More aggressive interventions targeting HFpEF in addition to the TAVI procedure might be relevant in patients with high H2FPEF scores, particularly in those with a lower surgical risk.

Pre-Existing Left Bundle Branch Block and Clinical Outcomes After Transcatheter Aortic Valve Replacement.

Background: Few reports on pre-existing left bundle branch block (LBBB) in patients undergoing transcatheter aortic valve replacement (TAVR) are currently available. Further, no present studies compare patients with new onset LBBB with those with pre-existing LBBB. Objectives: This study aimed to investigate the association between pre-existing or new onset LBBB and clinical outcomes after TAVR. Methods: Using data from the Japanese multicenter registry, 5,996 patients who underwent TAVR between October 2013 and December 2019 were included. Patients were classified into 3 groups: no LBBB, pre-existing LBBB, and new onset LBBB. The 2-year clinical outcomes were compared between 3 groups using Cox proportional hazards models and propensity score analysis to adjust the differences in baseline characteristics. Results: Of 5,996 patients who underwent TAVR, 280 (4.6%) had pre-existing LBBB, while 1,658 (27.6%) experienced new onset LBBB. Compared with the no LBBB group, multivariable Cox regression analysis showed that pre-existing LBBB was associated not only with a higher 2-year all-cause (adjusted HR: 1.39; 95% CI: 1.06-1.82; P = 0.015) and cardiovascular (adjusted HR: 1.60; 95% CI: 1.04-2.48; P = 0.031) mortality, but also with higher all-cause (adjusted HR: 1.43, 95% CI: 1.07-1.91; P = 0.016) and cardiovascular (adjusted HR: 1.81, 95% CI:1.12-2.93; P = 0.014) mortality than the new onset LBBB group. Heart failure was the most common cause of cardiovascular death, with more heart failure deaths in the pre-existing LBBB group. Conclusions: Pre-existing LBBB was independently associated with poor clinical outcomes, reflecting an increased risk of cardiovascular mortality after TAVR. Patients with pre-existing LBBB should be carefully monitored.

Midterm outcomes of transcatheter aortic valve replacement in patients with active cancer.

OBJECTIVES: The clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with aortic stenosis (AS) and concomitant active cancer remain insufficiently explored. This study aimed to assess the midterm outcomes of TAVR in patients diagnosed with AS and active cancer. METHODS: Data from the OCEAN-TAVI, a prospective Japanese registry of TAVR procedures, was analysed to compare prognoses and clinical outcomes in patients with and without active cancer at the time of TAVR. RESULTS: Of the 2336 patients who underwent TAVR from October 2013 to July 2017, 89 patients (3.8%) had active cancer, whereas 2247 did not. Among patients with active cancer, 49 had limited-stage cancer (stage 1 or 2). The prevalent cancers identified before TAVR were colon (21%), prostate (18%), lung (15%), liver (11%) and breast (9%). Although the periprocedural complications and 30-day mortality rates were comparable between the groups, the 3-year survival rate after TAVR was notably lower in patients with active cancer (64.7%) than in those without active cancer (74.7%; p=0.016). Nevertheless, the 3-year survival rate of patients with limited-stage cancer (stage 1 or 2) did not significantly differ from those without cancer (70.6% vs 74.7%, p=0.50). CONCLUSIONS: The patients with active cancer exhibited significantly reduced midterm survival rates. However, no distinct disparity existed in those with limited-stage cancer (stage 1 or 2). Although TAVR is a viable treatment in patients with AS with active cancer, the type and stage of cancer and prognosis should be carefully weighed in the decision-making process.

Clinical Implication of Supra-Normal Left Ventricular Ejection Fraction in Patients Undergoing Transcatheter Aortic Valve Replacement.

BACKGROUND: Individuals with heart failure displaying supra-normal left ventricular ejection fraction (snLVEF) may exhibit less favorable clinical outcomes in contrast to their counterparts with normal left ventricular ejection fraction (nLVEF). The distinctive characteristics and mid-term prognosis of individuals with severe aortic stenosis and snLVEF following transcatheter aortic valve replacement (TAVR) remain enigmatic. METHODS: Among 7393 patients diagnosed with severe aortic stenosis who underwent TAVR between 2013 and 2019 and were enlisted in the optimized transcatheter valvular intervention (OCEAN-TAVI) multicenter registry (UMIN000020423), we selected patients with left ventricular ejection fraction (LVEF) ≥ 50%. snLVEF was defined as LVEF exceeding 65%. We compared the baseline characteristics and assessed three-year post-TAVR mortality and heart failure readmission rates between the snLVEF (LVEF > 65%) and nLVEF cohorts (LVER 50-65%). RESULTS: Our study cohort comprised 5989 patients (mean age 84.4 ± 5.1 years and 1783 males). Among these, 2819 patients were categorized within the snLVEF cohort, while the remaining 3170 were allocated to the nLVEF group. Individuals within the snLVEF cohort were more likely to be female and displayed lower levels of natriuretic peptides, as well as smaller left ventricular dimensions in comparison to their nLVEF counterparts (p < 0.05 for all). The presence of snLVEF emerged as an independent predictor of the three-year composite endpoint relative to nLVEF, with an adjusted hazard ratio of 1.16 (95% confidence interval 1.02-1.31, p = 0.023) after accounting for several potential confounding factors. CONCLUSIONS: snLVEF was relatively common among candidates for TAVR with preserved ejection fraction. Patients harboring snLVEF appear to manifest a distinctive clinical profile and encounter less favorable clinical outcomes following TAVR in contrast to those characterized by nLVEF.

Rationale and design of Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation (NAPT) Trial.

BACKGROUND: Despite the wide implementation of transcatheter aortic valve implantation (TAVI), the optimal antithrombotic therapy after TAVI has not been established yet. Owing to the accumulating evidence supporting the efficacy and safety of single antiplatelet therapy (SAPT) over dual antiplatelet therapy, the latest guideline recommends life-long SAPT. However, there is scarce evidence supporting SAPT compared with non-antithrombotic therapy. Given the vulnerability of patients undergoing TAVI in terms of high bleeding risk, the benefit of SAPT may be canceled out by its potential increased bleeding risk. STUDY DESIGN AND OBJECTIVES: Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation (NAPT) Trial is a prospective, randomized controlled, open-label blinded endpoint multicenter trial conducted in Japan, testing the non-inferiority of non-antithrombotic therapy compared with aspirin monotherapy in patients who underwent TAVI and had no indications for long-term oral anticoagulation therapy (OAC). Patients who successfully underwent trans-femoral TAVI for severe aortic stenosis with either balloon-expandable or self-expandable valves are eligible for inclusion. Key exclusion criteria are (i) occurrence of perioperative complications (ii) indications of taking antithrombotic drugs for other reasons; (iii) eGFR <30 ml/min/1.73 m2 or hemodialysis or peritoneal dialysis. A total of 360 patients will be randomized (1:1) to aspirin monotherapy vs. non-antithrombotic therapy. The primary outcome is a composite of all-cause mortality, myocardial infarction, stroke, and bleeding. All bleeding events based on the Valve Academic Research Consortium 3 are included as a component of the primary outcome. CONCLUSION: The NAPT trial will determine the non-inferiority of a non-antithrombotic therapy compared with aspirin monotherapy after TAVI.

Prognostic Value of Electrocardiographic Left Ventricular Hypertrophy After Transcatheter Aortic Valve Implantation: Insights from the OCEAN-TAVI Registry.

Electrocardiogram (ECG) left ventricular hypertrophy (LVH) is associated with the prognosis of patients with aortic stenosis. However, the impact of the presence or absence of ECG-LVH on the clinical outcomes after transcatheter aortic valve implantation (TAVI) is limited. This study aimed to assess the prognostic value of ECG-LVH among patients with aortic stenosis treated by TAVI. A total of 1,667 patients who underwent TAVI were prospectively enrolled into the OCEAN-TAVI (Optimized CathEter vAlvular iNtervention-Transcatheter Aortic Valve Implantation) registry. A total of 1,446 patients (mean age 84 years; 29.9% men) were analyzed. The Sokolow-Lyon index was used to determine the presence of ECG-LVH. LVH was also assessed using transthoracic echocardiography (TTE). We investigated the association between ECG-LVH and all-cause and cardiovascular mortality. This study identified ECG-LVH and TTE-LVH in 743 (51.5%) and 1,242 patients (86.0%), respectively. The Kaplan-Meier analysis revealed that all-cause mortality was significantly higher among patients without ECG-LVH than among those with ECG-LVH (log-rank p <0.001). In the multivariable analysis, the absence of ECG-LVH was independently associated with all-cause mortality (hazard ratio 1.98, 95% confidence interval 1.39 to 2.82, p <0.001), regardless of the presence or absence of TTE-LVH. Furthermore, the presence of TTE-LVH with the absence of ECG-LVH was observed in 575 patients (40%), which was associated with cardiovascular mortality (hazard ratio 2.84, 95% confidence interval 1.56 to 5.17, p <0.001). In conclusion, the absence of ECG-LVH was independently associated with an increased risk of all-cause mortality after TAVI. Risk stratification using both ECG-LVH and TTE-LVH is a useful predictor of adverse clinical outcomes after TAVI.

No Antithrombotic Therapy After Transcatheter Aortic Valve Replacement: Insight From the OCEAN-TAVI Registry.

BACKGROUND: Several trials demonstrated that aspirin monotherapy compared with aspirin plus clopidogrel is associated with a lower incidence of bleeding without an increased risk of ischemic events in patients after transcatheter aortic valve replacement (TAVR); however, there remains a paucity of data to prove the necessity of even aspirin monotherapy. OBJECTIVES: This study aimed to compare clinical outcomes and valve performance of the 3 different antithrombotic strategies post-TAVR from the OCEAN-TAVI (Optimized transCathEter vAlvular iNtervention) registry. METHODS: Patients who received anticoagulation or had procedural complications were excluded. The remaining patients were classified into 3 groups according to the antithrombotic regimen at discharge: 1) nonantithrombotic therapy (None); 2) single-antiplatelet therapy (SAPT); and 3) dual-antiplatelet therapy (DAPT). The primary outcome was the incidence of net adverse clinical events (NACEs) (ie, cardiovascular death, stroke, myocardial infarction, and life-threatening or major bleeding). RESULTS: Overall, 3,575 TAVR patients were included (None, 293; SAPT, 1,354; DAPT, 1,928). The median follow-up period was 841 days (IQR: 597-1,340 days). The incidence of NACEs did not differ between the groups (None vs SAPT: adjusted HR [aHR]: 1.18; P = 0.45; None vs DAPT: aHR: 1.09; P = 0.67). There was a lower incidence of all bleeding in patients with no antithrombotics (None vs SAPT: aHR: 0.63; P = 0.12; None vs DAPT: aHR: 0.51; P = 0.04). The valve performance was similar among the groups. Leaflet thrombosis was detected in 8.5% of the nonantithrombotic group. CONCLUSIONS: Compared with SAPT/DAPT, the nonantithrombotic strategy was not associated with an increased risk of NACEs and potentially reduced the risk of bleeding events. The nonantithrombotic strategy may be an acceptable alternative to SAPT/DAPT in selected patients with TAVR.

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.

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.

Late expansion of mechanically expanding transcatheter aortic valves.

Several studies have demonstrated better hemodynamic stability of mechanically expanding valves following transcatheter aortic valve replacement (TAVR). This study aims to assess the expansion or recoil of transcatheter aortic valves using multidetector computed tomography (MDCT). This was a retrospective study. Among 873 patients who underwent TAVR with balloon-expandable (SAPIEN 3) or mechanically expanding valves (LOTUS) at Keio University Hospital between 2013 and 2020, those who underwent serial MDCT and echocardiographic assessment (pre-procedure, discharge, 6 months, 1 year, and 2 years post-TAVR) as our hospital protocol were included in this analysis (N = 30; LOTUS = 12; SAPIEN 3 = 18). The pre- and post-procedural echocardiographic data and the valve expansion rate evaluated by MDCT were compared between the groups. In LOTUS valves, late-phase expansion was observed on computed tomography (mean expansion rate, 83.8% at discharge and 86.8%, 2 years postoperative, p < 0.001), and a gradual increase in the aortic valve area was observed on echocardiography (aortic valve area: 1.45 cm2 at discharge and 1.51 cm2, 2 years postoperative, p = 0.01). Conversely, in SAPIEN 3, valve expansion was not seen in the late phase (mean expansion rate, 84.5% at discharge and 83.8%, 2 years postoperative) with a decrease in the aortic valve area (1.41 cm2 at discharge and 1.37 cm2, 2 years postoperative, p = 0.04). The expansion of the middle portion of the LOTUS valves was attributed to the increase in the aortic valve area. In conclusion, this study demonstrated the greater late-phase expansion and better valve performance of mechanically expanding valves.

Balloon Post-Dilatation Improves Long-Term Valve Performance After Balloon-Expandable Valve Implantation.

BACKGROUND: The impact of balloon post-dilatation (BPD) on short- and long-term valve performance after Sapien 3 (S3) implantation is unknown. This study aimed to evaluate the impact of balloon post-dilatation (BPD) on short- and long-term valve performance after the implantation of S3. METHODS: A total of 846 patients implanted with S3 from the OCEAN-TAVI registry were included in this study. The patients were divided into BPD and non-BPD groups. The clinical outcomes and valve functions were compared. RESULTS: The BPD group included 173 (20.4%) patients and the non-BPD group comprised 673 (79.6%) patients. The prosthesis-patient mismatch (PPM) rates were significantly lower in the BPD group than in the non-BPD group before and after propensity score matching at in-hospital follow-up (before matching: 12 [7.1%] vs. 108 [16.3%], p = 0.002; after matching: 8 [6.3%] vs. 19 [14.8%], p = 0.027) and at 1-year follow-up (before matching: 14 [12.5%] vs. 112 [23.6%], p = 0.010; after matching: 9 [10.5%] vs. 19 [22.1%], p = 0.039). The rates of acute kidney injury, cardiac tamponade, and in-hospital cardiovascular death were significantly higher in the BPD group than in the non-BPD group (acute kidney injury: 22 [12.7%] vs. 33 [4.9%], p < 0.001; cardiac tamponade: 3 [1.7%] vs. 2 [0.3%], p = 0.028; in-hospital cardiovascular death: 4 [2.3%] vs. 3 [0.4%], p = 0.016). After matching, these clinical outcomes were similar between the BPD and non-BPD groups. CONCLUSIONS: The BPD group demonstrated better short- and long-term valve performance. Caution is needed to avoid procedure-related complications in patients undergoing BPD.

Clinical outcomes of transcatheter aortic valve implantation in failed bioprosthetic surgical valves vs. native aortic stenosis: insights from a meta-analysis.

There is no meta-analysis comparing clinical outcomes between valve-in-valve transcatheter aortic valve implantation for failed surgical bioprosthetic valves (ViV-TAVI) and native valve TAVI for aortic stenosis (NV-TAVI). We aimed to investigate clinical outcomes between ViV-TAVI and NV-TAVI using a meta-analysis. EMBASE and MEDLINE were searched through April 2020 to investigate the comparative outcomes between ViV-TAVI and NV-TAVI. The main outcomes were short-term (30-day/in-hospital) mortality, pacemaker implantation (PMI), life threatening and/or major bleeding, stroke, and coronary obstruction, and long-term (1-year) mortality and stroke. Our search identified 5 observational studies enrolling a total of 8428 patients (1442 patients with ViV-TAVI and 6986 with NV-TAVI). ViV-TAVI was associated with significantly lower rates of short-term mortality, PMI, and life threatening and/or major bleeding, compared with NV-TAVI (relative risk [RR] [95% CI] 0.54 [0.34-0.84], P = 0.007; 0.25 [0.19-0.35], P < 0.0001; 0.64 [0.46-0.89], P = 0.008, respectively). There were no significant differences in rates of short-term stroke and coronary obstruction between ViV-TAVI and NV-TAVI (RR [95% CI] 0.59 [0.35-1.01], P = 0.06; 1.86 [0.78-4.41], P = 0.16, respectively). ViV-TAVI was also associated with a significantly lower rate of 1-year mortality compared with NV-TAVI (RR [95% CI] 0.64 [0.51-0.81], P = 0.0002), whereas there was no significant difference in long-term stroke (RR [95% CI] 0.71 [0.45-1.12], P = 0.51). ViV-TAVI was associated with significantly lower rates of short-term mortality, PMI, and life threatening and/or major bleeding, and long-term mortality, without increased risks of stroke and coronary obstruction, compared with NV-TAVI.

Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement.

BACKGROUND: It is controversial that cerebral embolic protection devices (CEPDs) reduce clinical stroke during transcatheter aortic valve replacement (TAVR). Herein, we investigated the impact of CEPDs on in-hospital clinical stroke using a nationally representative sample. METHODS AND RESULTS: Using the National Inpatient Sample (NIS) database, 109,240 patients who underwent TAVR between 2017 and 2018 were included. They were categorized into 2 groups according to usage of CEPDs; the CEPD and non-CEPD groups. After propensity score matching, 3805 pairs were acquired. Our main outcome was in-hospital clinical stroke. Other outcomes were in-hospital mortality, acute kidney injury (AKI), AKI leading to hemodialysis, bleeding requiring transfusion, overall bleeding complications, infectious complications, length of stay, and total cost. In-hospital clinical stroke did not significantly differ between the 2 groups (0.7% versus 1.1%, p = 0.449). The CEPD group was associated with a significantly lower in-hospital mortality (0.5% versus 1.4%, p = 0.029) and reduced total cost ($49,047 ± 19,666 versus $50,051 ± 23,190, p < 0.001), compared with the non-CEPD group, whereas there were no significant differences in the other outcomes. CONCLUSIONS: By using the NIS database with a large number of cases, TAVR with CEPDs was not associated with a lower incidence of in-hospital clinical stroke compared with no use of CEPDs after matching.

Impact of New York Heart Association Functional Class on Outcomes After Transcatheter Aortic Valve Implantation.

BACKGROUND: In the current guidelines, indications for transcatheter aortic valve implantation (TAVI) are expanded to include several subgroups of asymptomatic patients with severe aortic stenosis (AS), and there is a paucity of data on the prognostic impact of New York Heart Association (NYHA) functional class in patients with severe AS undergoing TAVI. METHODS: Among 2588 patients enrolled in the OCEAN-TAVI registry, patients were divided into 4 groups according to baseline NYHA class (class I in 95 patients, class II in 1172 patients, class III in 1126 patients, and class IV in 195 patients). RESULTS: Median follow-up was 729 days. The cumulative 2-year incidence of all-cause death was significantly higher in patients with NYHA class IV and III than in those with NYHA class II and I. (30.0%, 21.3%, 13.4%, and 11.2%, respectively, P < 0.001). After adjusting confounders, NYHA class IV and III, but not NYHA class II were independently associated with higher mortality compared with NYHA class I (reference) (adjusted HR: 3.43, 95%CI: 1.83-7.15, P < 0.001; adjusted HR: 2.07, 95%CI: 1.15-4.19, P = 0.013; and adjusted HR: 1.50, 95%CI: 0.83-3.04, P = 0.19, respectively). With increasing NYHA class, there was an incremental increase of heart failure hospitalization in the effect size relative to the reference (NYHA class I). CONCLUSIONS: The long-term outcomes of patients with NYHA class I were better than those with NYHA class IV or III in some selected patients undergoing TAVI.