Effect of oral tolvaptan for 1 year in patients with functional mitral regurgitation.

The effect of the oral selective vasopressin V2-receptor antagonist tolvaptan for chronic phase therapy on patients with FMR remains unclear. We aimed to determine the efficacy of oral tolvaptan in patients with significant functional mitral regurgitation (FMR) to reduce the mortality and rehospitalization due to worsening heart failure (HF). We enrolled 219 patients (mean age 76 ± 9 years, 59.4% men) who were admitted at our hospital due to congestive HF during different two 1-year periods. The patients were divided into 2 groups: those who had significant FMR (MR ≥ grade 2 [n = 76]) and those who did not (MR < grade 2 [n = 143]) at discharge. The patients were further divided into a study group that received tolvaptan during follow-up and a control group that did not receive tolvaptan. We used an inverse probability of treatment weighting method with the primary end point defined as overall all-cause mortality and rehospitalization due to worsening HF within 1 year. Of the 76 patients with significant FMR at discharge, 2 of 20 (10%) who were administered tolvaptan died and 8 (40%) were readmitted to a hospital. Of the 56 patients who did not receive tolvaptan, 2 (3.5%) died and 18 (27.5%) required rehospitalization. After multiple adjustments, there were no significant differences for overall survival and rehospitalization between the groups (log-rank p = 0.700 and 0.510, respectively). Our results suggest that oral tolvaptan administration in addition to conventional diuretics had less impact on outcomes in patients with significant FMR.

Comparison of long-term mortality in patients who underwent transcatheter aortic valve replacement with or without anti-atherosclerotic therapy.

Atherosclerosis is a risk factor for both aortic stenosis (AS) and coronary artery disease. This study aimed to investigate whether anti-atherosclerotic therapy (AT), defined as the simultaneous use of antiplatelet agents, statins, and renin aldosterone system inhibitors, had long-term clinical benefits for patients who underwent transcatheter aortic valve replacement (TAVR). Between October 2013 and May 2017, 2518 patients (31% men; median age, 85 years) who underwent TAVR in 14 Japanese centers were divided into two groups: patients who were prescribed anti-atherosclerotic therapy (AT, n = 567) and patients who were not (no AT, n = 1951). The median follow-up period for this cohort was 693 days (interquartile range, 389-870 days). Compared to no AT group, AT group was associated with significantly lower 2-year all-cause mortality (11.7% vs. 16.5%; log-rank p = 0.002) and 2-year cardiovascular mortality rates (3.5% vs. 6.0%; log-rank p = 0.017). In a propensity-matched cohort (n = 495 each; median follow-up, 710 days [IQR, 394 - 896 days]), patients in AT group had a lower prevalence of 2-year cardiovascular mortality (3.8% vs. 6.2%, log-rank p = 0.024) than that in the no AT group. In the multivariate stepwise regression analysis, AT was a significant predictor of cardiovascular mortality (hazard ratio 0.45; 95% confidence interval 0.25-0.80; p = 0.007). AT may improve survival in post-TAVR patients. Future studies are necessary to identify an optimal treatment regimen to improve long-term outcomes after TAVR.

Clinical safety and efficacy of tolvaptan for acute phase therapy in patients with low-flow and normal-flow severe aortic stenosis.

Conventional diuretic therapy for low-flow (LF) severe aortic stenosis (SAS) often has an inadequate effect or causes hemodynamic instability. Tolvaptan is used for acute heart failure in addition to conventional diuretics, and it does not cause intravascular dehydration. This study aimed to retrospectively investigate the safety and efficacy of tolvaptan in the acute phase in 56 consecutive patients with SAS and compared LF-SAS with normal-flow (NF) SAS. The primary endpoints were adverse clinical events (death, worsening heart failure, worsening renal failure, fatal arrhythmia, cardiogenic or hypovolemic shock, and use of inotropic agents) and the volume of urine within 48 h of tolvaptan administration. Among 56 patients, 16 had LF-SAS (29%), and 40 had NF-SAS (71%). Severe adverse clinical events were not observed 48 h after tolvaptan administration. In both groups, the urine volume significantly increased after tolvaptan administration in comparison to 24 h before tolvaptan administration (both, p < 0.01). There were no changes in the urine volume during the initial 24 and 48 h. In the LF-SAS group, tolvaptan resulted in a significant decrease in fluid balance during the initial 24 and 48 h compared to 24 h before tolvaptan administration (p < 0.05). Adding tolvaptan to conventional treatment is safe and effective without renal dysfunction and hypotension in patients with SAS, including those with LF.

Association between valvuloarterial impedance after transcatheter aortic valve implantation and 2-year mortality in elderly patients with severe symptomatic aortic stenosis: the OCEAN-TAVI registry.

Pre-procedural valvuloarterial impedance (Zva) is considered as a useful predictor of mortality in patients diagnosed as having severe aortic stenosis (AS) who undergo transcatheter aortic valve implantation (TAVI). However, the prognostic significance of post-procedural Zva remains unclear. We aimed to evaluate the prognostic significance of Zva after TAVI. We retrospectively analyzed the clinical and echocardiographic data of 1004 consecutive elderly patients (median 84 years old, 27.5% men) who underwent TAVI for severe symptomatic AS. Zva was calculated after TAVI, and patients were divided into three groups based on tertile values: the high [> 3.33 (n = 335)], intermediate [2.49-3.33 (n = 334)], and low Zva groups [< 2.49 (n = 335)]. The estimated 2-year all-cause and cardiovascular mortalities using Kaplan-Meier analysis were 16.2% [95% confidence interval (CI) 11.8-20.4] and 5.9% (95% CI 3.2-8.6), respectively. There were no significant intergroup differences in each endpoint (long-rank p = 0.518 for all-cause mortality, p = 0.757 for cardiovascular mortality). Multivariable Cox regression analyzes with adjustments of patient characteristics and medications showed that the post-procedural Zva was not associated with the 2-year all-cause mortality [intermediate Zva group versus (vs.) low Zva group: adjusted hazard ratio (aHR) = 1.34, 95% CI 0.75-2.40, p = 0.316; high Zva group vs. low Zva group: aHR = 1.17, 95% CI 0.64-2.16, p = 0.613] and cardiovascular mortality (intermediate Zva group vs. low Zva group: aHR = 1.50, 95% CI 0.56-4.06, p = 0.421; high Zva group vs. low Zva group: aHR = 1.25, 95% CI 0.43-3.65, p = 0.682). Our results suggest that post-procedural Zva was not associated with 2-year all-cause or cardiovascular mortalities in patients with severe symptomatic AS who underwent TAVI.

The MAGGIC risk score predicts mortality in patients undergoing transcatheter aortic valve replacement: sub-analysis of the OCEAN-TAVI registry.

This study is aimed to evaluate the performance of MAGGIC risk score for predicting mortality by external validation using multicenter transcatheter aortic valve replacement (TAVR) registry. We assessed 1383 patients who underwent TAVR from October 2013 to April 2016. Patients were divided into 2 groups according to the median of MAGGIC score and we compared the incidence of all-cause death between high and low MAGGIC score. To assess whether the MAGGIC risk score add prognostic value on STS risk score, we also compared the incidence of all-cause death between the 2 groups according to low, intermediate, and high STS score. The median of MAGGIC score was 29 (interquartile range: 13-46). Within 2 years, 147 cases of all-cause death were observed. The high MAGGIC (30-46) risk score was significantly associated with an increased risk of all-cause death as compared to low MAGGIC (11-29) risk score and this relationship was also observed in patients with high STS risk score. However, this relationship was not observed in patients with low and intermediate STS score. Multivariate analysis showed that the MAGGIC risk score was an independent predictor of all-cause death (hazard ratio, 1.07; 95% confidence interval, 1.03-1.11). Our results demonstrated that the MAGGIC score predicts all-cause death in TAVR population and provides better risk stratification, particularly in patients with high STS risk.

Clinical Characteristics and Long-Term Outcomes of Rotational Atherectomy　- J2T Multicenter Registry.

BACKGROUND: Rotational atherectomy (RA) is an adjunct tool for the management of heavily calcified coronary lesions during percutaneous coronary intervention (PCI), but the long-term clinical outcomes of RA use remain unclear in this drug-eluting stent era.Methods and Results:This multi-center registry assessed the characteristics and outcomes of patients treated by RA for calcified coronary lesions between 2004 and 2015. Among 1,090 registered patients, mean age was 70±10 years and 815 (75%) were male. Sixty percent of patients had diabetes mellitus and 27.7% were receiving hemodialysis. The procedure was successful in 96.2%. In-hospital death occurred in 33 patients (3.0%), and 14 patients (1.3%) developed definite/probable stent thrombosis. During the median follow-up period of 3.8 years, the incidence of major adverse cardiac events (MACE), defined as all-cause death, acute coronary syndrome, stent thrombosis, target vessel revascularization and stroke, was 46.7%. On multivariable Cox hazard analysis, hemodialysis (HR, 2.08; 95% CI: 1.53-2.86; P<0.0001) and age (HR, 1.03; 95% CI: 1.01-1.04; P<0.0001) were strong independent predictors of MACE. Conversely, statin treatment was associated with lower incidence of MACE (P=0.035). CONCLUSIONS: This study has provided the largest Japanese dataset for long-term follow-up of RA. Although RA in calcified lesions appears feasible with a high rate of procedural success, a high incidence of MACE was observed.

Comparison of midterm outcomes of transcatheter aortic valve implantation in patients with and without previous coronary artery bypass grafting.

The midterm safety and feasibility of transcatheter aortic valve implantation (TAVI) for patients with a history of coronary artery bypass graft (CABG) and high operative risk are unclear. This study compared the midterm outcomes of patients undergoing TAVI with or without previous CABG surgery. Between October 2013 and July 2016, 1,613 patients underwent TAVI according to the Optimized CathEter vAlvular iNtervention (OCEAN)-TAVI registry (previous CABG: n = 120; no previous CABG: n = 1493). The propensity score comprised the variables of the Society of Thoracic Surgeons Score, previous myocardial infarction, peripheral artery disease, chronic kidney disease > stage 2 (estimated glomerular filtration rate < 60 mL/min/1.73 m2), and the TAVI approach method. After propensity matching, 118 patients were classified into the CABG and non-CABG groups. Kaplan-Meier analysis revealed that the incidence of overall cardiovascular death in the CABG group was significantly higher than in the non-CABG group (log-rank; p = 0.004). Overall mortality due to heart failure was higher in the CABG than in the non-CABG group (8.5 vs. 1.7%, p = 0.038). The present study demonstrated that patients with a history of CABG who underwent TAVI had a higher frequency of cardiovascular death, mainly due to heart failure. Heart failure detection and rigorous heart failure management are required after TAVI.

Incidence, Predictors, and Midterm Clinical Outcomes of Myocardial Injury After Transcatheter Aortic-Valve Implantation.

Our aim was to assess the clinical effects of myocardial injury after transcatheter aortic-valve implantation (TAVI). Between October 2013 and July 2016, 157 patients underwent TAVI with Sapien XT, Sapien 3, or CoreValve prostheses at our institute. Of these, 130 patients for whom the transapical approach was not used were included in this study. Myocardial injury was defined as a peak troponin I level of ≥1.5 ng/mL within 48 hours after TAVI. We evaluated the predictors of myocardial injury and compared the clinical outcomes of 82 patients classified as the myocardial injury group and 44 patients classified as the non-myocardial injury group. The patients were aged 85 ± 6 years. Myocardial injury occurred in 82 patients (65.1%). Age (per 1 increase) (odds ratio [OR]: 1.11, 95% confidence interval [CI]: 1.01-1.22, P = 0.041), female sex (OR: 3.88, 95% CI: 1.23-12.22, P = 0.021), valve type (Sapien XT; OR: 4.22, 95% CI: 1.15-15.47, P = 0.03, Core valve; OR: 18.12, 95% CI: 2.86-114.59, P = 0.002), balloon aortic valvuloplasty as a bridge therapy (OR: 0.10, 95% CI: 0.02-0.42, P = 0.002), and left ventricular end-diastolic volume (LVEDV) (per 1 increase) (OR: 0.97, 95% CI: 0.95-0.99, P = 0.003) were associated with myocardial injury in a multivariate model. The myocardial injury group did not have a higher rate of midterm (365-day) mortality (log-rank test P = 0.57) than the non-myocardial injury group on Kaplan-Meier analysis. Myocardial injury after TAVI was not associated with midterm mortality.

Body Surface Radiation Exposure in Interventional Echocardiographers During Structural Heart Disease Procedures.

Background: The distribution of radiation exposure on the body surface of interventional echocardiographers during structural heart disease (SHD) procedures is unclear. Objectives: This study estimated and visualized radiation exposure on the body surface of interventional echocardiographers performing transesophageal echocardiography by computer simulations and real-life measurements of radiation exposure during SHD procedures. Methods: A Monte Carlo simulation was performed to clarify the absorbed dose distribution of radiation on the body surface of interventional echocardiographers. The real-life radiation exposure was measured during 79 consecutive procedures (44 transcatheter edge-to-edge repairs of the mitral valve and 35 transcatheter aortic valve replacements [TAVRs]). Results: The simulation demonstrated high-dose exposure areas (>20 µGy/h) in the right half of the body, especially the waist and lower body, in all fluoroscopic directions caused by scattered radiation from the bottom edge of the patient bed. High-dose exposure occurred when obtaining posterior-anterior and cusp-overlap views. The real-life exposure measurements were consistent with the simulation estimates: interventional echocardiographers were more exposed to radiation at their waist in transcatheter edge-to-edge repair than in TAVR procedures (median 0.334 µSv/mGy vs 0.053 µSv/mGy; P < 0.001) and in TAVR with self-expanding valves than in those with balloon-expandable valves (median 0.067 µSv/mGy vs 0.039 µSv/mGy; P < 0.01) when the posterior-anterior or the right anterior oblique angle fluoroscopic directions were used. Conclusions: During SHD procedures, the right waist and lower body of interventional echocardiographers were exposed to high radiation doses. Exposure dose varied between different C-arm projections. Interventional echocardiographers, especially young women, should be educated regarding radiation exposure during these procedures. (The development of radiation protection shield for catheter-based treatment of structural heart disease [for echocardiologists and anesthesiologists]; UMIN000046478).

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.

Association between periodontal bacteria and degenerative aortic stenosis: a pilot study.

PURPOSE: Although several reports have described the relationship between periodontal disease and cardiovascular disease, information about the association between periodontal disease and the progression of degenerative aortic stenosis (AS) is lacking. Therefore, we performed a retrospective, single-center, pilot study to provide insight into this potential association. METHODS: Data from 45 consecutive patients (19 men; median age, 83 years) with mild or moderate degenerative aortic stenosis were analyzed for a mean observation period of 3.3±1.9 years. The total amount of Aggregatibacter actinomycetemcomitans and Porphyromonas gingivalis and titers of serum immunoglobulin G (IgG) against periodontal bacteria and high-sensitivity C-reactive protein (hs-CRP) were evaluated. Aortic valve area (AVA), maximal velocity (Vmax), mean pressure gradient (mean PG), and the Doppler velocity index (DVI) were evaluated. The change in each parameter per year ([ParameterLATEST-ParameterBASELINE]/Follow-up Years) was calculated from the retrospective follow-up echocardiographic data (baseline vs. the most recently collected data [latest]). RESULTS: No correlation was found between the concentration of periodontopathic bacteria in the saliva and AS status/progression. The anti-P. gingivalis antibody titer in the serum showed a significant positive correlation with AVA and DVI. Additionally, there was a negative correlation between the anti-P. gingivalis IgG antibody titer and mean PG. The hs-CRP concentration showed positive correlations with Vmax and mean PG. Meanwhile, a negative correlation was observed between the anti-P. gingivalis IgG antibody titer and ΔAVA/year and Δmean PG/year. The hs-CRP concentration showed positive correlations with Vmax and mean PG, and it was significantly higher in patients with rapid aortic stenosis progression (ΔAVA/year <-0.1) than in their counterparts. CONCLUSIONS: Our results suggest that periodontopathic bacteria such as A. actinomycetemcomitans and P. gingivalis are not directly related to the status/progression of degenerative AS. However, inflammation and a lower immune response may be associated with disease progression.

Sex differences in clinical outcomes after rotational atherectomy of calcified coronary stenoses: from multicenter registry.

BACKGROUND: Recent improvements in devices and medications may diminish the risk of adverse events following percutaneous coronary intervention (PCI) in women. However, complex calcified coronary lesions are increasingly being encountered in clinical practice, which remain challenging for contemporary PCI. Rotational atherectomy (RA) of severely calcified lesions is an option that facilitates the technical success of PCI. We aimed to examine sex differences in long-term clinical prognoses after PCI with RA in the drug-eluting stent (DES) era. METHODS AND RESULTS: We evaluated J2T ROTA registry data from 1,090 patients with severely calcified de novo coronary artery stenoses who underwent PCI using RA at 3 hospitals between 2004 and 2015. After excluding patients who received regular hemodialysis, 788 patients, including 570 men and 218 women, were ultimately analyzed. The primary endpoint was major adverse cardiovascular and cerebrovascular events (MACCE), which included death, acute coronary syndrome (ACS), and stroke. The women were significantly older, and presented more frequently with chronic kidney disease, ACS, atrial fibrillation, lower body mass indexes, and worse lipid profiles than the men. During the observation period, MACCE occurred in 197 patients (25%) (118 deaths, 29 strokes, and 50 ACS). In the unmatched population, women had a higher MACCE rate than men (hazard ratio: 1.48, [95% confidence interval: 1.07-2.06]). However, sex was not associated with MACCE in the propensity score-matched population. CONCLUSION: In the DES era, differences between sexes were not observed in relation to long-term MACCE in patients undergoing PCI with RA for severely calcified coronary artery stenoses.

Prognostic Impact of Scoring Balloon Angioplasty After Rotational Atherectomy in Heavily Calcified Lesions Using Second-Generation Drug-Eluting Stents: A Multicenter Registry-Based Study.

BACKGROUND: We aimed to assess the impact of scoring balloon angioplasty (SBA) after rotational atherectomy (RA) on long-term clinical outcomes in patients who underwent percutaneous coronary intervention (PCI) using second-generation drug-eluting stents (DES). The long-term outcomes associated with SBA after RA in severely calcified lesions is unknown. METHODS: Using the J2T ROTA registry data, we evaluated the clinical events of patients who underwent PCI using RA for heavily calcified lesions from January 2004 to December 2015. A total of 307 patients who underwent PCI with second-generation DES were analyzed and divided into the SBA (n = 96) and conventional balloon angioplasty (CBA) groups (n = 211). Eighty-two and 189 patients comprised the "SBA after small burr (SBA-SB)" and "CBA after small burr (CBA-SB)" subgroups, respectively, for the subgroup analysis. Study endpoints were incidence of 3-year major adverse cardiac events (MACE), target vessel revascularization (TVR), and target lesion revascularization (TLR). RESULTS: Kaplan-Meier analysis revealed that the incidence of 3-year cumulative MACE, TVR, and TLR were comparable between groups, and that the incidences of 3-year cumulative MACE, TVR, and TLR were significantly lower in the SBA-SB subgroup than in the CBA-SB subgroup (log-rank p = 0.008; log-rank p = 0.047; log-rank p = 0.045; respectively). Multivariate Cox regression model indicated that SBA after RA was an independent predictor of MACE (hazard ratio: 0.337; 95% confidence interval: 0.139 to 0.817; p = 0.016). CONCLUSIONS: Additional SBA following RA was associated with lower MACE incidence in patients undergoing RA with a small-sized burr.

Direct Oral Anticoagulants Versus Vitamin K Antagonists in Patients With Atrial Fibrillation After TAVR.

OBJECTIVES: The aim of this study was to compare long-term all-cause mortality between direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs) in patients with atrial fibrillation (AF) after transcatheter aortic valve replacement (TAVR). BACKGROUND: The optimal anticoagulant agent for patients with AF after TAVR has not been clarified. METHODS: OCEAN (Optimized Transcatheter Valvular Intervention) is a prospective, multicenter, observational cohort registry comprising 2,588 patients who underwent TAVR between October 2013 and May 2017. Of these, 403 patients (15.6%) with AF on anticoagulant therapy were identified, of whom 227 (56.3%) were prescribed DOACs and 176 (43.7%) were prescribed VKAs. Patients who successfully discharged after TAVR were stratified into DOAC and VKA groups on the basis of the prescription of anticoagulant agents, and the analyses started from discharge. RESULTS: In total, 33.3% of patients were men. The mean age was 84.4 ± 4.7 years, and the average CHA2DS2-VASc score was 5.1 ± 1.1. The median follow-up duration was 568 days. A multivariate Cox regression model and inverse probability of treatment weighting based on the propensity score demonstrated that the DOAC group was significantly associated with a lower incidence of all-cause mortality compared with the VKA group (10.3% vs. 23.3%; Cox-adjusted hazard ratio: 0.391; 95% confidence interval: 0.204 to 0.749; p = 0.005; and 10.2% vs. 20.6%; inverse probability of treatment weighting-adjusted hazard ratio: 0.531; 95% confidence interval: 0.294 to 0.961; p = 0.036, respectively). CONCLUSIONS: Compared with VKAs, DOACs might be associated with lower long-term all-cause mortality in patients with concomitant AF who are successfully discharged after TAVR. This finding warrants investigation in ongoing prospective randomized trials.

Long-term cardiovascular prognosis after rotational atherectomy in hemodialysis patients: Data from the J2T multicenter registry.

BACKGROUND: Hemodialysis (HD) patients have heavy calcium deposits in their stenotic coronary arteries and worse post-percutaneous coronary intervention (PCI) prognoses than those who do not undergo HD. Rotational atherectomy (RA) facilitates PCI success in severely calcified lesions. We aimed to identify clinical and procedural characteristics that predict HD patients' long-term prognoses after PCI that included RA in the drug-eluting stent (DES) era. METHODS: This study included 302 patients who underwent regular HD from J2T Multicenter Registry database of 1090 consecutive patients who underwent RA to treat de novo calcified lesions at three university hospitals between 2004 and 2015. The primary endpoint was cardiovascular (CV) death. RESULTS: During the 5-year observation period, 59 CV deaths (19.5%) occurred. The CV death group and non-CV death group had comparable profiles except significantly lower left ventricular ejection fraction, higher brain natriuretic peptide (BNP), lower rate of RA burr upsizing, and lower rate of final thrombolysis in myocardial infarction (TIMI) 3 flow achievement in the CV death group. Cox regression analysis revealed that increasing ablation burr size (hazard ratio [HR]: 0.33; 95% confidence interval [CI]: 0.13-0.81), final TIMI 3 flow (HR: 0.07; 95% CI: 0.02-0.28), lower BNP level, and optimal medication were independently associated with better CV mortality in HD patients. CONCLUSION: In the DES era, oral medications at the time of PCI and stepwise calcium ablation were associated with improved long-term CV mortality in HD patients who are scheduled to undergo RA to treat severely calcified coronary artery stenoses, as therapeutic strategies.

Efficacy and safety of transcatheter aortic valve implantation with Edwards SAPIEN 3 and XT in smaller Asian anatomy.

We aimed to compare the efficacy and safety of transcatheter aortic valve implantation (TAVI) using Edwards SAPIEN 3 (S3) valve and SAPIEN XT) in smaller anatomy. The new generation S3 TAVI device has been used worldwide; however, its efficacy and safety in smaller Asian anatomy remain unknown. Between February 2014 and March 2017, 166 consecutive patients (S3, 54; XT, 112) were treated with balloon-expandable TAVI in a single center and their outcomes were analyzed. Median patient age was 85 (range: 81-88) years and mean body surface area was 1.41 ± 0.15 m2. A 23-mm size valve was used in S3 and XT groups (70 vs. 62%, p = 0.224). The transfemoral approach was more frequently used in the S3 than in the XT group (96 vs. 72%, p < 0.001). Although, the minimal luminal diameter of the femoral artery was smaller in the S3 group (5.9 vs. 6.4 mm, p = 0.001), the rates of major (2 vs. 11%, p = 0.226) and minor (11 vs. 5%, p = 0.107) vascular complications did not increase. The frequency of paravalvular leaks (PVL) ≥ 2 was significantly reduced in the S3 group (11 vs. 61%, p < 0.001); however, pre- (24 vs. 91%, p < 0.001) and post- (4 vs. 19%, p < 0.001) dilatations were less frequently performed. Pacemaker implantation incidence did not increase (4 vs. 5%, p = 1.0) and peak velocity of the transcatheter heart valve was significantly higher in the S3 group (2.3 vs. 2.2 m/s, p = 0.046). Device success was high (89 vs. 93%, p = 0.387) while the 30-day all-cause mortality was low (2 vs. 1%, p = 0.583) in both groups. TAVI with the S3 device was safe and effective, with low incidence of vascular complications and reduced PVL, in smaller body-sized Asians.

Prognostic Impact of Low-Flow Severe Aortic Stenosis in Small-Body Patients Undergoing TAVR: The OCEAN-TAVI Registry.

OBJECTIVES: This study aimed to analyze the prognostic impact of low-flow (LF) severe aortic stenosis in small-body patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: Western literature demonstrates a poor prognosis with paradoxical LF and low-flow low-gradient (LF-LG) severe aortic stenosis (AS), as defined by stroke volume index (SVi) <35 ml/m2 and mean pressure gradient <40 mm Hg with preserved left ventricular ejection fraction (LVEF). However, this poor prognosis is contested in Japan owing to the smaller body size of Japanese patients relative to that of Western patients. Additionally, there are no reports of the prognostic implication of paradoxical LF or LF-LG severe AS in small-body patients undergoing TAVR. METHODS: This was a retrospective analysis of 723 consecutive Japanese patients (median age 85 years; 32.6% male; median body surface area 1.4 m2) who underwent TAVR for severe AS at 9 sites in Japan. The primary and secondary endpoints were cumulative all-cause and cardiovascular mortality after TAVR, respectively. RESULTS: Ninety-seven (13.4%) patients had paradoxical LF severe AS whereas 38 (5.3%) had paradoxical LF-LG with severe AS. PLF was associated with a significant increase in all-cause (hazard ratio [HR]: 3.00; 95% confidence interval [CI]: 1.34 to 6.72; p < 0.001) and cardiovascular mortality (HR: 5.58; 95% CI: 1.19 to 26.2; p < 0.01), as compared with patients' normal flow and preserved LVEF. PLF-LG was associated with a significant increase in all-cause mortality (HR: 3.76; 95% CI: 1.09 to 13.73; p < 0.01), as compared with normal flow high gradient with preserved LVEF. SVi was an independent predictor of cardiovascular mortality on multivariate analysis after adjustments for age, sex, clinically relevant variables, and other echocardiographic parameters (HR: 1.96; 95% CI: 1.19 to 3.23; p < 0.01). CONCLUSIONS: Among Japanese small-body patients with severe AS, both paradoxical LF and LF-LG severe AS were associated with poor outcomes following TAVR. SVi was an independent predictor of cardiovascular mortality after TAVR. (Optimised Transcatheter Valvular Intervention registry [OCEAN-TAVI]; UMIN000020423).

A case of congestive heart failure caused by secondary hypocortisolism.

Congestive heart failure caused by secondary hypocortisolism is rare but clinically significant, because its appropriate treatment is effective. Severe hyponatremia with indefinite complaint resembling depression or persisting fever despite antibiotics may be important for establishing this diagnosis.

Timing of Susceptibility to Mortality and Heart Failure in Patients With Preexisting Atrial Fibrillation After Transcatheter Aortic Valve Implantation.

The relationship between cardiac rhythm and adverse events after transcatheter aortic valve implantation (TAVI) remains unclear. To compare the prognostic impact of preexisting atrial fibrillation (AF) and new-onset AF (NOAF) after TAVI, we assessed 1,124 patients (846 with sinus rhythm [SR], 49 with NOAF, and 229 with preexisting AF) who underwent TAVI with a balloon-expandable valve from October 2013 to April 2016. The incidences of all-cause death and rehospitalization for heart failure (HF) were retrospectively evaluated. The median follow-up period was 370 days (range 188 to 613). In the Kaplan-Meier analysis, the incidences of all-cause death and rehospitalization for HF were significantly higher in patients with preexisting AF than those in patients with NOAF and SR. The multivariable analysis showed that preexisting AF was significantly associated with increased all-cause death (hazard ratio [HR] 1.54; 95% confidence interval [CI] 1.02 to 2.34) and rehospitalization for HF (HR 2.94; 95% CI 1.75 to 4.93). The landmark analysis demonstrated that patients with preexisting AF had a significantly higher incidence of rehospitalization for HF within the first 6 months after TAVI (HR 4.04; 95% CI 2.23 to 7.32), and a higher incidence of all-cause death from 6 months to 2 years after TAVI (HR 2.12; 95% CI 1.15 to 3.90). Our study demonstrated that preexisting AF increased the risk of all-cause death and rehospitalization for HF after TAVI in comparison with NOAF or SR. Moreover, there was a specific timing of susceptibility to all-cause death and rehospitalization for HF after TAVI.

Incidence, Predictors, and Mid-Term Outcomes of Percutaneous Closure Failure After Transfemoral Aortic Valve Implantation Using an Expandable Sheath (from the Optimized Transcatheter Valvular Intervention [OCEAN-TAVI] Registry).

The aim of this study was to evaluate the incidence, predictors, and outcomes of percutaneous closure device (PCD) failure during transfemoral transcatheter aortic valve implantation (TAVI) with an Edwards Sapien-XT prosthesis using an expandable sheath (eSheath). From October 2013 to April 2016, 1,215 patients who underwent TAVI were prospectively enrolled in the Optimized Transcatheter Valvular Intervention (OCEAN-TAVI) registry. Of these, 478 patients underwent transfemoral TAVI with Sapien-XT prosthesis using an eSheath and percutaneous closure with a Perclose ProGlide system. We evaluated the predictors of PCD failure and whether it affected the clinical outcomes. Patients were aged 85 years (interquartile range 82 to 88 years). PCD failure occurred in 36 patients (8%). Sheath-to-femoral artery ratio (SFAR) (per 1 increase) (odds ratio 5.40, 95% confidence interval 1.28 to 22.92, p = 0.022) predicted PCD failure in a multivariate model. The sensitivity-specificity curves identified an SFAR threshold of 1.03; the area under the curve for SFAR as a predictor of PCD failure was 0.629. The PCD failure group did not have a higher rate of 30-day mortality (0% vs 1%, p = 0.52) or mid-term (365-day) mortality (log-rank test p = 0.85) compared with the PCD success group in the Kaplan-Meier analysis. In conclusion, PCD failures occurred in 8% of the patients and were not associated with 30-day or mid-term mortality rates after percutaneous transfemoral TAVI. The SFAR threshold of 1.03 was useful for predicting PCD failures.