Background:The details and consequences of a small aortic annulus among transcatheter aortic valve replacement (TAVR) patients remain uncertain. This study investigated the short-term outcomes in patients with small annular size and compared the 30-day outcome between intra- and supra-annular devices, with similar outer casing diameter in this subgroup.
Methods and Results:Cases registered in the Japanese national TAVR registry between August 2013 and December 2017 were analyzed. Among a total of 5,870 registered patients, 647 (11.0%) had small annulus (area ≤314 mm2) measured by multi-detector computed tomography. Patients with a small annulus had a significantly smaller indexed effective orifice area (iEOA, 1.10 cm2/m2[0.92–1.35] vs. 1.16 cm2/m2[0.96–1.39], P<0.001) and higher mean pressure gradient (mPG, 10.0 mmHg [6.9–14.2] vs. 8.5 mmHg [6.0–11.5], P<0.001) compared with a normal-sized annulus. Among patients with a small annulus, those receiving a 20 mm intra-annular device had a smaller iEOA (0.94 cm2/m2[0.78–1.06] vs. 1.07 cm2/m2[0.8–1.24], P=0.001) and higher mPG (14.0 mmHg [10.0–18.5] vs. 11.0 [7.0–14.0], P<0.001) compared with those receiving a 23-mm supra-annular device, although the incidence of paravalvular leakage (≥moderate) was similar (14.4% vs. 16.5%, P=0.69).
Conclusions:Patients with a small annulus were associated with less hemodynamic improvement. A supra-annular device is associated with better echocardiographic improvement in patients with a small annulus, without increasing paravalvular leakage.
Background:The effect of sex on mortality is controversial; furthermore, sex differences in left ventricular (LV) remodeling after transcatheter aortic valve implantation (TAVI) remain unknown.
Methods and Results:This study included 2,588 patients (1,793 [69.3%] female) enrolled in the Optimized CathEter vAlvular iNtervention (OCEAN)-TAVI Japanese multicenter registry between October 2013 and May 2017. We retrospectively analyzed the effect of sex on mortality, and evaluated changes in the LV mass index (LVMI) after TAVI. Female sex was significantly associated with lower all-cause and cardiovascular mortality (log-rank P<0.001 for both). Multivariate analysis showed that female sex was independently associated with lower cumulative long-term mortality (hazard ratio 0.615; 95% confidence interval 0.512–0.738; P<0.001). Regression in the LVMI was observed in both sexes, and there was no significant difference in the percentage LVMI regression from baseline to 1 year after TAVI between women and men. Women had a survival advantage compared with men among patients with LVMI regression at 1 year, but not among patients with no LVMI regression.
Conclusions:We found that female sex is associated with better survival outcomes after TAVI in a large Japanese registry. Although LVMI regression was observed in women and men after TAVI, post-procedural LV mass regression may be related to the sex differences in mortality.
Background:The REPRISE Japan study, a prospective multicenter single-arm trial, was undertaken to confirm the safety and effectiveness of transcatheter aortic valve replacement (TAVR) with the LOTUS valve in Japanese subjects with severe symptomatic calcific aortic stenosis at extreme or high surgical risk.
Methods and Results:REPRISE Japan enrolled 40 subjects in the transfemoral (TF) cohort (mean age 84 years; mean [±SD] Society of Thoracic Surgeons [STS] score 6.4±2.9%); 10 additional subjects were treated with a transaortic (TAo) approach (mean age 84 years; mean STS score 6.3±3.3%). A subanalysis was also performed on subjects treated with the 21-mm LOTUS valve (n=15; mean age 84 years; mean STS score 5.3±2.1%). The primary safety endpoint (a composite of all-cause mortality, stroke, life-threatening or major bleeding events, acute kidney injury [Stage 2/3], and major vascular complications at 30 days) occurred in 15% of TF subjects. The primary effectiveness endpoint (a composite of all-cause mortality, disabling stroke, and moderate or greater paravalvular leak [PVL; core laboratory assessed] at 6 months) occurred in 5.3% of TF subjects. Across the TF, TAo, and 21-mm LOTUS valve cohorts, no subjects exhibited moderate or greater PVL at 6 months. The 30-day rate of pacemaker implantation was 22.5% in the TF cohort (TAo: 20%; 21 mm: 13.3%).
Conclusions:Data from REPRISE Japan confirm the safety and efficacy of the LOTUS Valve when used in Japanese clinical practice.
Background:The aim of this study was to clarify the clinical outcomes of patients with atrial functional mitral regurgitation (FMR) who underwent the MitraClip procedure compared with those with conventional FMR and sinus rhythm (SR).
Methods and Results:Of 303 patients with FMR who underwent the MitraClip procedure, 40 with “atrial-FMR” defined as FMR with permanent atrial fibrillation and normal left ventricular (LV) function/size and 115 with “sinus-FMR” defined as FMR with SR and LV dysfunction were reviewed. Transthoracic and 3D transesophageal echocardiography, and the cardiac complication rate (composite of all-cause death, heart failure admission, mitral valve (MV) surgery, and redo MitraClip procedure) during the 12-month follow-up were compared between the groups. After the MitraClip procedure, reductions in the mitral annular area and its anteroposterior dimension and in the leaflet closure area were observed in both groups. MV orifice area was smaller with greater transmitral pressure gradient (P<0.05) after the procedure in atrial-FMR patients than in those with sinus-FMR. The prevalence of residual MR was similar, but significant tricuspid regurgitation (TR) was more prevalent in the atrial-FMR group at follow-up. Cardiac complication rate was comparable between groups (20% vs. 25%, P=0.63).
Conclusions:Reduction of MR occurred in atrial-FMR probably because of the increase in leaflet coaptation area. Significant TR was more common after the MitraClip procedure in patients with atrial-FMR than with sinus-FMR. However, mid-term outcomes were comparable between patients with atrial-FMR and sinus-FMR.
Background:This study aimed to evaluate the early outcomes of Perceval sutureless valves in the Korean population and to introduce a modified technique of guiding suture placement during valve deployment.
Methods and Results:From December 2014 to April 2019, 121 patients (mean age: 74.7±6.2 years; 53.7% female) received a Perceval sutureless aortic valve replacement. To prevent conduction system injury, the depth of guiding suture placement (1 mm below the nadir of the annulus) was modified. All patients underwent echocardiographic evaluation at discharge and 6–12 months postoperatively, with a mean follow up of 13.7±11.2 months. Concomitant surgeries, such as coronary artery bypass grafting, and other valvular surgeries, were performed in 45.5% of cases. The mean aortic cross-clamp times for isolated and minimal procedures were 32.8±7.9, and 41.2±8.0 min, respectively. The overall transvalvular mean gradients were 13.1±3.8 mmHg at discharge and 11.5±4.7 mmHg at the last follow up. After modifying the guiding suture placement, permanent pacemaker implantation risk decreased from 9.9% to 2.5%. Cardiac-related mortality was 0.8%, with no patient developing valvular or paravalvular aortic regurgitation, valve thrombosis, or endocarditis.
Conclusions:Perceval valve implantation provided a significant cardiac-related survival benefit with excellent early hemodynamic and clinical outcomes. Further research is needed to determine whether adjusting the implantation depth, such as modification of the guiding suture technique, can reduce the risk of permanent pacemaker implantation.
Background:This study aimed to investigate the trajectory of functional recovery of activities of daily living (ADL) from the time of admission up to hospital discharge, and explored which preoperative and postoperative variables were independently associated with functional decline in ADL at discharge of patients after cardiovascular surgery.
Methods and Results:In this observational study, we evaluated ADL preoperatively and at discharge using the Functional Independence Measure (FIM) in patients after cardiovascular surgery. Functional decline in ADL was defined as scoring 1–5 on any one of the FIM items at discharge. Multiple logistic regression was performed to predict the functional decline in ADL at discharge. We found that 18.8% of elective cardiovascular surgery patients suffered from decreased ADL at discharge. The Mini-Mental State Examination (odds ratio (OR): 0.573, 95% confidence interval (CI): 0.420–0.783), gait speed (OR: 0.032, 95% CI: 0.003–0.304) and initiation of walking around the bed (OR: 1.277, 95% CI: 1.103–1.480) were independently associated with decreased ADL at discharge.
Conclusions:A functional decline in ADL at discharge can be predicted using preoperative measures of cognitive function, preoperative gait speed and postoperative day of initiation of walking. These results show that preoperative cognitive screening and gait speed assessments can be used to identify patients who might require careful postoperative planning, and for whom early postoperative rehabilitation is needed to prevent serious functional ADL deficits.
Background:Patients are prone to permanent pacemaker implantation (PPM) after valve surgery, yet current data on the effects of postoperative PPM are scarce and large-scale studies are lacking. The aim of this study was to determine rates and long-term outcomes of PPM after cardiac valve surgery.
Methods and Results:A total of 24,014 patients who received valve surgery from 2000 to 2013 were identified from the Taiwan National Health Insurance Research Database. The number of valve surgeries and the proportion of PPM implantations after valve surgery increased (P<0.001). After 1 : 5 propensity score matching, 602 and 3,010 patients were categorized to the PPM and non-PPM groups, respectively. Late outcomes included all-cause mortality, cardiovascular death, sepsis, and readmission due to any cause. The mean follow up was 4.3 years. PPM was associated with a higher all-cause mortality rate (33.6% vs. 29.8%; hazard ratio [HR], 1.14; 95% confidence interval [CI], 0.98–1.32), though not significant at the threshold of P<0.05. PPM was also associated with higher all-cause mortality rates in subgroups that received mitral valve (MV) replacement surgery, combined aortic valve replacement (AVR) with MV surgeries, and combined AVR with tricuspid valve surgeries.
Conclusions:The PPM rate after valve surgery is increasing, and is associated with short-term adverse effects. Patients with PPM may have a higher long-term mortality rate.
Background:The PERIcardial SurGical AOrtic Valve ReplacemeNt (PERIGON) Japan Trial was developed to assess the safety and effectiveness of the 17-mm Avalus bioprosthesis (Medtronic, Minneapolis, MN, USA) in patients undergoing surgical aortic valve replacement.
Methods and Results:The primary endpoint in the trial was the percentage of patients achieving the composite of at least 1 class improvement in New York Heart Association (NYHA) functional class at 1 year compared with baseline and effective orifice area index (EOAI) of 0.6 cm2/m2or greater at 1-year after implantation, compared with a performance goal of 60%. The present study reports outcomes through 2 years. Eleven patients were implanted (10 [91%] female, median age 78.3 years). From baseline to 1 year, 10 subjects (91%) showed an improvement in NYHA classification. At 1 year, mean (±SD) EOAI was 0.82±0.17 cm2/m2, with 10 patients (91%) having an EOAI ≥0.6 cm2/m2. As such, 9 of 11 patients (82%) successfully met the primary endpoint. One death occurred between the 1- and 2-year follow-up visits, unrelated to the valve. There were no valve reinterventions, explants, or device deficiencies through 2 years.
Conclusions:The PERIGON Japan Trial met its primary endpoint. Surgical implantation of the 17-mm Avalus aortic bioprosthesis can be performed with an acceptable incidence of device-related adverse events, and the valve performs effectively based on echocardiographic findings.
Background:This study evaluated the long-term outcomes for up to 20 years after On-X mechanical valve implantation in the left side of the heart.
Methods and Results:Between 1999 and 2015, 861 patients (mean age=51.6±10.9 years) who underwent prosthetic valve replacement using the On-X valve in the aortic or mitral position were enrolled (aortic=344, mitral=325, double=192). The mean clinical follow-up duration was 10.5±5.3 (median 10.9) years. Operative mortality occurred in 26 patients (3.0%), and linearized late cardiac mortality was 0.9%/patient-year without an intergroup difference. Linearized thromboembolism, bleeding, prosthetic valve endocarditis, non-structural valve deterioration (NSVD), and reoperation rates were 0.8%/patient-year, 0.6%/patient-year, 0.2%/patient-year, 0.5%/patient-year, and 0.5%/patient-year, respectively. Prosthetic valve endocarditis was more frequent after double valve replacement than after aortic or mitral valve replacement (P=0.008 and 0.005, respectively). NSVD and reoperation rates were significantly lower aortic valve replacement than after mitral or double valve replacement (P=0.001 and 0.002, P=0.001 and <0.001, respectively). Valve replacement in the mitral position was the only risk factor for NSVD (hazard ratio [95% confidence interval]=5.247 [1.608–17.116], P=0.006).
Conclusions:On-X valve implantation in the left side heart had favorable clinical outcomes with acceptable early and late mortality and a low incidence of prosthetic valve-related complications. Particularly in the aortic position, the On-X valve had better long-term non-structural durability.
Background:The aortic valve area index (AVAI) in aortic stenosis (AS) is measured by echocardiography with a continuity equation using the stroke volume index by Doppler (SVIDoppler) or biplane Simpson (SVIBiplane) method. AVAIDopplerand AVAIBiplaneoften show discrepancy due to differences between SVIDopplerand SVIBiplane. The degree of discrepancy and utility of combined AVAIs have not been investigated in a large population of AS patients, and the characteristics of subjects with larger discrepancies are unknown.
Methods and Results:We studied 820 patients with significant AS (AVADoppler<1.5 cm2) enrolled in the Asian Valve Registry, a prospective multicenter registry at 12 Asian centers. All-cause death and aortic valve replacement were defined as events. SVIDopplerwas significantly larger than SVIBiplane(49±11 vs. 39±11 mL/m2, P<0.01) and AVAIDopplerwas larger than AVAIBiplane(0.51±0.15 vs. 0.41±0.14 cm2/m2, P<0.01). An increase in (AVAIDoppler− AVAIBiplane) correlated with shorter height, lower weight, older age, smaller left ventricular (LV) diameter and increased velocity of ejection flow at the LV outflow tract. Severe AS by AVAIDoppleror AVAIBiplaneenabled prediction of events, and combining these AVAIs improved the predictive value of each.
Conclusions:Discrepancy in AVAI by Doppler vs. biplane method was significantly more pronounced with increased LV outflow tract flow velocity, shorter height, lower weight, older age and smaller LV cavity dimensions. Combining the AVAIs enabled mutual and incremental value in predicting events.
Background:A thorough understanding of the anatomy of the aortic valve is necessary for aortic valve-sparing surgery. Normal valvar dimensions and their relationships in the living heart, however, have yet to be fully investigated in a 3-dimensional fashion.
Methods and Results:In total, 123 consecutive patients (66±12 years, Men 63%) who underwent coronary computed tomographic angiography were enrolled. Mid-diastolic morphology of the aortic roots, including height of the interleaflet triangles, geometric height, free margin length of each leaflet, effective height, and coaptation length were measured using multiplanar reconstruction images. Average height of the interleaflet triangle, geometric height, free margin length, effective height, and the coaptation length were 17.3±1.8, 14.7±1.3, 32.6±3.6, 8.6±1.4, and 3.2±0.8 mm, respectively. The right coronary aortic leaflet displayed the longest free margin length and shortest geometric height. Geometric height, free margin length, and effective height showed positive correlations with aortic root dimensions. Coaptation length, however, remained constant regardless of aortic root dimensions.
Conclusions:Diversities, as well as characteristic relationships among each value involving the aortic root, were identified using living-heart datasets. The aortic leaflets demonstrated compensatory elongation along with aortic root dilatation to maintain constant coaptation length. These measurements will serve as the standard value for revealing the underlying mechanism of aortic regurgitation to plan optimal aortic valve-sparing surgery.
Background:Although diastolic flow reversal (DFR) in the descending aorta, assessed via transesophageal echocardiography (TEE), is a simple and easy indicator for evaluating aortic regurgitation, the association between DFR pattern and clinical outcomes following transcatheter aortic valve implantation (TAVI) is unclear. The purpose of this study was to evaluate the effect of DFR patterns on clinical outcomes following TAVI.
Methods and Results:Two-hundred and eleven patients (mean age, 83.6±5.7 years; 69% female) who underwent TAVI were retrospectively assessed via intraprocedural TEE. DFR was evaluated using pulsed-wave Doppler in the descending aorta before and after TAVI. The primary endpoint was major adverse cardio-cerebrovascular events (MACCEs). Although only 7 patients (3.3%) had moderate or severe paravalvular leak, as assessed by color Doppler echocardiography, holo-DFR (HDFR) was observed in 33 patients (16.0%) after TAVI. MACCEs occurred in 40 patients during the median follow up of 282 days (interquartile range: 160–478 days). The estimated cumulative MACCE-free survival at 1 year was significantly lower in patients with HDFR than in those without HDFR. A Cox proportional hazards analysis revealed that HDFR after TAVI was independently associated with MACCEs.
Conclusions:HDFR was associated with an increased risk of MACCEs after TAVI. DFR evaluated by intraprocedural echocardiography could serve as a simple and easy method for predicting clinical outcomes.
Background:Risk factors for atherosclerotic disease including dyslipidemia have been shown to be associated with aortic valve calcification (AVC). Nuclear magnetic resonance (NMR)-measured lipoprotein particles, low-density and high-density lipoprotein particles (LDL-p, HDL-p) in particular, have emerged as novel markers of atherosclerotic disease; however, whether NMR-measured particles are associated with AVC remains to be determined. This study aimed to examine the association between NMR-based lipoprotein particle measurements and standard lipids with AVC. The primary variables of interest were LDL-p (nmol/L), HDL-p (μmol/L), LDL-cholesterol, and HDL-cholesterol (both in mg/dL).
Methods and Results:A community-based random sample of Japanese men aged 40–79 years examined in 2006–2008, in Shiga, Japan was studied. Presence of AVC was defined as an Agatston score >0. Lipoprotein particles were measured using NMR spectroscopy. In the main analysis, multivariable-adjusted odds ratios (ORs) and 95% confidence intervals (95% CIs) for the prevalence of AVC across the higher quartiles of lipids in reference to the lowest ones were obtained. Of 874 participants analyzed, 153 men had AVC. Multivariable-adjusted ORs of prevalent AVC for the highest vs. the lowest quartile were significantly elevated for LDL-p (OR, 2.20; 95% CI: 1.23–3.93) and LDL-cholesterol (OR, 2.16; 95% CI: 1.23–3.78). In contrast, neither HDL-p nor HDL-cholesterol was associated with AVC.
Conclusions:The association of prevalent AVC with NMR-based LDL-p was comparable to that with LDL-cholesterol.
Background:Although diabetes mellitus (DM) is a common comorbidity of aortic stenosis (AS), clinical evidence about the long-term effect of DM on patients with AS is insufficient.
Methods and Results:Data were acquired from CURRENT AS, a large Japanese multicenter registry that enrolled 3,815 patients with severe AS. Patients without initial valve replacement were defined as the conservative group; among them, 621 (23.4%) had DM, whereas 1997 did not. The DM group was further divided into 2 groups according to insulin treatment (insulin-treated DM, n=130; non-insulin treated DM, n=491). The primary outcome was a composite of aortic valve (AV)-related death and heart failure (HF) hospitalization. Secondary outcomes were AV-related death, HF hospitalization, all-cause death, cardiovascular death, sudden death, and surgical or transcatheter AV replacement during follow up. As a result, DM was associated with higher risk for the primary outcome (52.8% vs. 42.9%, P<0.001), with a statistically significant adjusted hazard ratio (HR 1.33, 95% confidence interval: 1.14–1.56, P<0.001). All secondary outcomes were not significantly different between DM and non-DM patients after adjusting for confounding factors, except for HF hospitalization. Insulin use was not associated with higher incidence of primary or secondary outcome.
Conclusions:In initially conservatively managed patients with AS, DM was independently associated with higher risk for a composite of AV-related death or HF hospitalization; however, insulin use was not associated with poor outcomes.
Background:The changes in electrocardiographic left ventricular hypertrophy (ECG-LVH) after transcatheter aortic valve implantation (TAVI) are not fully elucidated.
Methods and Results:The study group included 64 patients who underwent TAVI for aortic stenosis. Their 12-lead ECGs before and at 2 days and 1, 6 and 12 months after TAVI were analyzed, and ECG-LVH was evaluated using various definitions. Values and prevalence of each ECG-LVH parameter significantly decreased between 1 and 6 months after TAVI. Values of ECG-LVH parameters decreased especially in patients with ECG-LVH at baseline.
Conclusions:Regression of ECG-LVH was observed between 1 and 6 months after TAVI.