Impact of osteoporotic risk in men undergoing transcatheter aortic valve replacement: a report from the LAPLACE-TAVI registry.

Low body weight and advanced age are among the best predictors of osteoporosis. Osteoporosis Self-Assessment Tool (OST) values are calculated by a simple formula [(body weight in kilograms - age in years) × 0.2] to identify patients at increased risk of osteoporosis. In our recent single-center study, we demonstrated an association between OST and poor outcomes in postmenopausal women after transcatheter aortic valve replacement (TAVR). We aimed to investigate the impact of osteoporotic risk in men with aortic stenosis who underwent TAVR in a large cohort. In this multi-center study, 1,339 men who underwent TAVR between April 2010 and July 2023 were retrospectively analyzed. Women were excluded from the present study. All patients were deemed appropriate for TAVR after a review by a multidisciplinary team. Baseline characteristics of patients were compared by dividing patients into three tertiles, based on the OST value: ≤ - 6.16, - 6.16 to - 4.14, and - 4.14 < for tertiles 1, 2, and 3, respectively. Primary endpoint was all-cause mortality after TAVR. Tertile 1 (patients with the lowest OST values) included older patients with smaller body mass index, lower hemoglobin and albumin levels. In addition, they had greater clinical frailty scale, slower 5-meter walk test, weaker hand grip strength, and more cognitive impairment, indicating increased frailty. They were more severely symptomatic, with lower ejection fractions, smaller aortic valve areas, and more tricuspid regurgitation than were patients in the other two groups. Multivariate analysis revealed that OST tertiles 3 was associated with decreased risk of all-cause mortality (hazard ratio, 0.66; 95% confidence interval, 0.48-0.90), compared with OST tertile 1 as a reference. For OST tertiles 1, 2, and 3, the estimated 1-year survival rates of all-cause mortality post-TAVR were 83.6% ± 1.9%, 91.1% ± 1.4%, and 93.1% ± 1.3%, respectively, (log-rank, p < 0.001).　In conclusions, in men as same as women, osteoporotic risk assessed by OST values was overlapped with increased frailty. The simple OST formula was useful for predicting all-cause mortality in patients undergoing TAVR in large registry datasets.

Applications and Limitations of Equilibrium Density Gradient Analytical Ultracentrifugation for the Quantitative Characterization of Adeno-Associated Virus Vectors.

Adeno-associated virus (AAV) vectors are produced as a mixture of the desired particle (full particle, FP), which is filled with the designed DNA, product-related impurities such as particle without DNA (empty particle, EP), and aggregates. Cesium chloride or iodixanol equilibrium density gradient ultracentrifugation (DGE-UC) has been used for the purification of AAV vectors. DGE-UC can separate FP from impurities based on the difference in their buoyant densities. Here, we report the applications and limitations of equilibrium density gradient analytical ultracentrifugation (DGE-AUC) using a modern AUC instrument that employs DGE-UC principles for the characterization and quantitation of AAV vectors. We evaluated the quantitative ability of DGE-AUC in comparison with sedimentation velocity AUC (SV-AUC) or band sedimentation AUC (BS-AUC) using AAVs with different DNA lengths and different serotypes. DGE-AUC enabled the accurate quantification of the ratio of FP to EP when the AAV vector primarily contains these particles. Furthermore, we developed a new workflow to identify the components of separated peaks in addition to FP and EP. Ultraviolet absorption spectra obtained by multiwavelength detection can also support peak assignment following component identification. DGE-AUC experiments for AAV vectors have limitations with regard to minor components with low absorption at the detected wavelength or those with a density similar to that of major components of AAV vectors. DGE-AUC is the only analytical method that can evaluate particle density heterogeneity; therefore, SV-AUC or BS-AUC and DGE-AUC are complementary methods for reliable assessment of the purity of AAV vectors.

Ipsilateral snare technique for the safe delivery of the Evolut PRO transcatheter aortic valve system: a case report.

Background: Transcatheter aortic valve implantation (TAVI) requires several bail-out techniques for safe valve delivery and deployment. Particularly in cases of challenging aortic anatomy, the snare technique from the contralateral side of the surgical site can facilitate delivery of the transcatheter heart valve (THV) system. However, there are no previous reports of the snare technique from the ipsilateral side of the surgical site in TAVI cases. Case summary: A 77-year-old woman presented with severe aortic stenosis and congestive heart failure. As computed tomography showed a heavily calcified aortic arch, we performed TAVI using the ipsilateral snare technique to control the direction of the Evolut THV system. There was no haematoma or excessive bleeding at the surgical site during the procedure, and the patient was discharged without complications. Discussion: In cases with challenging anatomy of the aorta, the ipsilateral snare technique may be useful for the safe delivery of the Evolut system.

Enhancement of recombinant adeno-associated virus activity by improved stoichiometry and homogeneity of capsid protein assembly.

Studies of recombinant adeno-associated virus (rAAV) revealed the mixture of full particles with different densities in rAAV. There are no conclusive results because of the lack of quantitative stoichiometric viral proteins, encapsidated DNA, and particle level analyses. We report the first comprehensive characterization of low- and high-density rAAV serotype 2 particles. Capillary gel electrophoresis showed high-density particles possessing a designed DNA encapsidated in the capsid composed of (VP1 + VP2)/VP3 = 0.27, whereas low-density particles have the same DNA but with a different capsid composition of (VP1 + VP2)/VP3 = 0.31, supported by sedimentation velocity-analytical ultracentrifugation and charge detection-mass spectrometry. In vitro analysis demonstrated that the low-density particles had 8.9% higher transduction efficacy than that of the particles before fractionation. Further, based on our recent findings of VP3 clip, we created rAAV2 single amino acid variants of the transcription start methionine of VP3 (M203V) and VP3 clip (M211V). The rAAV2-M203V variant had homogeneous particles with higher (VP1+VP2)/VP3 values (0.35) and demonstrated 24.7% higher transduction efficacy compared with the wild type. This study successfully provided highly functional rAAV by the extensive fractionation from the mixture of rAAV2 full particles or by the single amino acid replacement.

Procedural Volume and Outcomes of Transfemoral Transcatheter Aortic Valve Replacement: From a Japanese Nationwide Registry.

The impact of procedural volume on transcatheter aortic valve replacement (TAVR) outcomes in Japan remains uncertain. Japan has carefully introduced TAVR after the establishment of techniques in Western countries and therefore may not exhibit volume-outcome relations after TAVR. Data on transfemoral TAVR was collected from the Japan Transcatheter Valve Therapy (J-TVT) registry between 2018 and 2020. Hospitals were categorized into quartiles (lowest, lower, high, and highest) based on annual TAVR volume. The primary analysis compared 30-day mortality among different TAVR volume hospitals. A multivariable adjustment analysis was performed to calculate the adjusted odds ratio (aOR) and 95% confidence intervals (CIs) of 30-day all-cause mortality with highest-volume hospital as the reference. A total of 2,741 transfemoral TAVR cases from 172 hospitals were included in the analysis. Median hospital TAVR volume was 38 (interquartile range 27 to 60) per year. Unadjusted 30-day mortality was 0.46%, 0.69%, 1.17%, and 1.18% from the lowest to the highest quartile of hospitals, respectively. There was no significant difference in 30-day mortality rates for lowest-volume hospitals (aOR 0.51, 95% CI 0.24 to 1.05, p = 0.07), low-volume hospitals (aOR 0.76, 95% CI 0.46 to 1.26, p = 0.29), or high-volume hospitals (aOR 1.11, 95% CI 0.74 to 1.67, p = 0.60). An analysis from the contemporary national registry in Japan did not find an obvious inverse relation between annual hospital volume and 30-day mortality. Our results suggest that TAVR has now reached a level of procedural maturity, with standardized outcomes observed across hospitals regardless of their annual procedural volume.

Predictors for all-cause mortality in men after transcatheter aortic valve replacement: A report from the LAPLACE-TAVI registry.

Background: Information regarding the outcomes of transcatheter aortic valve replacement (TAVR) in men is limited. This study aimed to investigate short- to mid-term outcomes and prognostic predictors in this population. Method and Results: The data of 519 men were analyzed from 1,693 consecutive patients with symptomatic severe aortic stenosis who underwent TAVR at six hospitals between April 2010 and July 2020. The primary endpoint was all-cause mortality at 30 days after TAVR. The mean age and Society of Thoracic Surgeons (STS) score were 83.7 ± 5.9 years and 6.3 ± 4.7%, respectively. Overall, 23.5% of patients consumed alcohol with a frequency of > 1 drinks/week, and 12.1% consumed alcohol with a frequency of > 8 drinks/week, while 66.1% were former smokers and 4.2% were current smokers. Mortality at 30 days was 0.8%. During the median follow-up period of 448 days, the estimated survival rates at 1 year post-TAVR was 90.7 ± 1.4%. In multivariate analysis, the serum albumin level [hazard ratio (HR): 2.20, 95% confidence interval (CI):1.36-3.62, p = 0.001], atrial fibrillation (HR: 1.79, 95% CI: 1.13-2.82, p = 0.012), and STS score (HR: 1.33, 95% CI: 1.06-1.67, p = 0.015) were independently associated with all-cause mortality following TAVR. Adjusted hazard ratios of current smoking, heavy drinking, and presence of cancer were 1.05 (95% CI: 0.36-2.98),1.37 (95% CI: 0.75-2.48), and 1.13 (95% CI: 0.75-2.48), respectively. Conclusion: Our study demonstrated that serum albumin levels, atrial fibrillation, and STS score were independently associated with all-cause mortality following TAVR in men.

Access Site-Stratified Analysis of the Incidence, Predictors, and Outcomes of Impella-Supported Patients With Cardiogenic Shock.

This study aimed to evaluate the incidence, predictors, and outcomes of Impella-assisted patients with cardiogenic shock, stratified by the access site-transaxillary (TX) or trans-subclavian (TS) versus the conventional transfemoral (TF) approach. For this study, we analyzed the cases entered into the Japanese Percutaneous Ventricular Assist Device registry between February 2020 and December 2021. A multivariable logistic regression analysis was conducted to calculate the adjusted odds ratio (aOR) and 95% confidence intervals (CIs) to identify the predictors of the TX/TS approach, with reference to those who received the conventional TF approach. A log-rank test was performed to compare the 30-day mortality between the 2 approaches. A total of 2,564 cases of Impella were included in the study, of which 167 (6.5%) were accessed by way of the TX/TS approach. TX/TS approach cases were younger and had a higher percentage of concomitant use of extracorporeal membrane oxygenation or an intra-aortic balloon pump. The predictors of the TX/TS approach included a presentation with the acute coronary syndrome (aOR 0.32, 95% CI 0.16 to 0.63, p <0.001), cardiac arrest (aOR 0.10, 95% CI 0.02 to 0.36, p = 0.003), cardiogenic shock (aOR 0.51, 95% CI 0.33 to 0.79, p = 0.002), and inotropic use (aOR 1.88, 95% CI 1.08 to 3.49, p = 0.033). The 30-day mortality was comparable between TX/TS and TF approaches (29.3% vs 29.6%, respectively; log-rank, p = 0.64). Our analysis revealed that approximately 6% of the Impella-assisted patients with cardiogenic shock received the TX/TS approach as their first access site. These results suggest that the TX/TS approach may be a viable alternative to the TF approach in certain patients requiring Impella support.

Annuloplasty effect of transcatheter edge-to-edge repair with MitraClip system on multiple degenerative mitral regurgitations.

Background: Previous reports have shown a mitral annuloplasty-like effect after MitraClip, i.e. a shortening of the anterior-posterior diameter of mitral valve annulus. However, the clinical benefit of this phenomenon is unclear. Case summary: An 87-year-old woman with multiple degenerative mitral regurgitation (MR) jets, including a central-medial jet and a lateral jet, underwent MitraClip procedure. After a single clip implantation, anterior-posterior diameter of mitral annulus was shortened and both MR jets were significantly reduced. Discussion: Even in the case of multiple MR jets, a single clip deployment with the MitraClip system may provide an acceptable MR reduction if the clip shows the mitral annuloplasty effect.

Discrepancy between invasive and echocardiographic transvalvular gradient after TAVI: Insights from the LAPLACE-TAVI registry.

BACKGROUND: Echocardiography-based transvalvular mean pressure gradient (ECHO-mPG) used to assess the forward valve function and structural valve deterioration could overestimate the true pressure gradient. This study evaluated the discrepancy between invasive and ECHO-mPG after transcatheter aortic valve implantation (TAVI) with respective valve type and size, its impact on a device success criterion, and predictors of a pressure discrepancy. METHODS: We analyzed 645 patients registered in a multicenter TAVI registry (balloon-expandable valve [BEV]: 500; self-expandable valve [SEV]: 145). The invasive transvalvular mPG was measured after valve implantation using two Pigtail catheters (CATH-mPG), while the ECHO-mPG was measured within 48 h after TAVI. Pressure recovery (PR) was calculated using the following formula: ECHO-mPG × effective orifice area (EOA)/ascending aortic area (AoA) × (1 - EOA/AoA). RESULTS: ECHO-mPG was weakly correlated with (r = 0.29, p < 0.0001), and consistently overestimated CATH-mPG in both BEV and SEV, and respective valve sizes. The magnitude of the discrepancy was larger for BEV than SEV (p < 0.001) and smaller valves (p < 0.001). After the correction of PR using the above formula, the pressure discrepancy remained for BEV (p < 0.001) but not SEV (p = 0.10). The proportion of patients with an ECHO-mPG > 20 mmHg decreased from 7.0% to 1.6% after correction (p < 0.0001). Among the baseline and procedural variables, post-procedural ejection fraction, BEV versus SEV, and smaller valves were associated with a larger discrepancy in mPG. CONCLUSIONS: ECHO-mPG could be overestimated after TAVI, especially in patients with a smaller BEV. A higher ejection fraction, BEV, and smaller valves were predictors of a pressure discrepancy between CATH- and ECHO-mPG.

Volume-outcome relationship in complication-related mortality after percutaneous coronary interventions: an analysis on the failure-to-rescue rate in the Japanese Nationwide Registry.

In-hospital mortality following percutaneous coronary intervention (PCI) varies across institutions with different annual PCI volumes. The failure to rescue (FTR) rate, defined as the mortality rate following PCI-related complications, may account for the volume-outcome relationship. The Japanese Nationwide PCI Registry, a consecutive, nationally mandated registry between 2019 and 2020, was queried. The FTR rate is defined as 'the number of patients who died following PCI-related complications' divided by 'the number of patients who experienced at least one PCI-related complication.' Multivariate analysis was used to calculate the risk-adjusted odds ratio (aOR) of the FTR rates among hospitals stratified into tertiles as low (≤ 236/year), medium (237-405/year), and high (≥ 406/year). A total of 465,716 PCIs and 1007 institutions were included. A volume-outcome relationship was observed for in-hospital mortality, and the medium-volume (aOR 0.90, 95% confidence interval [CI] 0.85-0.96), as well as high-volume (aOR 0.84, 95% CI 0.79-0.89) hospitals, had significantly lower in-hospital mortality than low-volume hospitals. Complication rates were lower at high-volume centers (1.9%, 2.2%, and 2.6% for high-, medium-, and low-volume centers, respectively; p < 0.001). The overall FTR rate was 19.0%. The FTR rates for the low-, medium-, and high-volume hospitals were 19.3%, 17.7%, and 20.6%, respectively. The medium-volume hospitals had a lower FTR rate (aOR 0.82, 95% [CI] 0.68-0.99), whereas the FTR rate was similar at the high-volume hospitals compared with that of the low-volume hospitals (aOR 1.02, 95% CI 0.83-1.26). In-hospital mortality was low after PCI in high-volume hospitals. However, the FTR rate in high-volume hospitals was not necessarily lower than that in low-volume hospitals. The FTR rate did not account for the volume-outcome relationship in PCI.

Impact of periprocedural bleeding on mid-term outcome in nonagenarians who underwent transcatheter aortic valve implantation: insights from LAPLACE registry.

Data from several recent studies have demonstrated the safety and efficacy of transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS) even in nonagenarians. However, the impact of periprocedural bleeding following TAVI on their outcome remains unclear. In the aLliAnce for exPloring cLinical prospects of AortiC valvE disease (LAPLACE) registry, we compared outcomes between the bleeding and no-bleeding groups among 1953 patients < 90 years old (mean age, 83.0 ± 4.6 years old) and 316 nonagenarians (mean age, 91.7 ± 1.9 years old) who underwent TAVI with a median follow-up period of 628 days. The group with any periprocedural bleeding showed a higher 30-day mortality than the no-bleeding group in patients < 90 years old (3.3% vs. 0.5%, p = 0.001) and nonagenarians (7.9% vs. 0.7%, p = 0.001). In patients < 90 years old, severe periprocedural bleeding (n = 85) was associated with a higher mid-term all-cause mortality rate than no severe bleeding (n = 1,868), even after adjusting for covariates (hazard ratio [HR], 1.994; 95% confidence interval [CI] 1.287-2.937; p = 0.002). On the other hand, in nonagenarians, any periprocedural bleeding (n = 38) was associated with a higher mid-term cardiovascular (CV) mortality rate (21.1% vs. 4.3%, log-rank p = 0.014) than no bleeding (n = 278), even after adjusting for covariates (HR, 3.104; 95% CI 1.140-8.449; p = 0.027). In conclusion, any periprocedural bleeding after TAVI was associated with mid-term CV mortality in nonagenarians, whereas severe bleeding was associated with mid-term all-cause mortality in patients < 90 years old.

Midterm Outcomes of Underweight Patients Undergoing Transcatheter Aortic Valve Implantation: Insight From the LAPLACE-TAVR Registry.

Background: Obesity is a major risk factor for cardiovascular disease; however, a paradoxical effect of obesity has been reported in patients with heart failure or myocardial infarction. Although several studies have suggested the same obesity paradox in patients undergoing transcatheter aortic valve replacement (TAVR), they included a limited number of underweight patients. Objectives: This study aimed to clarify the effect of being underweight on TAVR outcomes. Methods: We retrospectively analyzed 1,693 consecutive patients undergoing TAVR between 2010 and 2020. The patients were categorized according to body mass index: underweight (<18.5 kg/m2; n = 242), normal weight (18.5 to 25 kg/m2; n = 1,055), and overweight (>25 kg/m2; n = 396). We compared midterm outcomes after TAVR among the 3 groups; all clinical events were in accordance with the Valve Academic Research Consortium-2 criteria. Results: Underweight patients were more likely to be women and have severe heart failure symptoms, peripheral artery disease, anemia, hypoalbuminemia, and pulmonary dysfunction. They also had lower ejection fractions, smaller aortic valve areas, and higher surgical risk scores. Device failure, life-threatening bleeding, major vascular complications, and 30-day mortality occurred more frequently in underweight patients. The midterm survival rate of the underweight group was inferior to those of the other 2 groups (P < 0.0001; average follow-up, 717 days). In the multivariate analysis, underweight was associated with noncardiovascular mortality (HR: 1.78; 95% CI: 1.16-2.75) but not cardiovascular mortality (HR: 1.28; 95% CI: 0.58-1.88) after TAVR. Conclusions: Underweight patients had a worse midterm prognosis, demonstrating the obesity paradox in this TAVR population. (Outcomes of transcatheter aortic valve implantation in Japanese patients with aortic stenosis: multi-center registry; UMIN000031133).

Effectiveness of high implantation of SAPIEN 3 in preventing pacemaker implantation: A propensity score analysis.

BACKGROUND: In transcatheter aortic valve implantation, high implantation on the aortic annulus may prevent conduction pathway injury, leading to a decrease in the rate of permanent pacemaker implantation. AIM: To assess the impact of high implantation of SAPIEN 3 on the prevention of permanent pacemaker implantation. METHODS: Since August 2020, we have performed high implantation by fluoroscopically positioning the lower part of the lucent line at the virtual basal ring line on a coplanar view before valve implantation. Patients treated before the adoption of this method were defined as the conventional group. We compared the high implantation group with the conventional group using propensity score analysis. RESULTS: Overall, the high implantation group (n=95) showed a significantly shorter ventricular strut length than the conventional group (n=85): median 1.3 (interquartile range 0.2-2.4) mm vs 2.8 (1.8-4.1) mm (P<0.001). The permanent pacemaker implantation rate was significantly lower in the high implantation group than in the conventional group (2.1% vs 11.8%; P=0.009). According to 100 propensity score analyses based on multiple imputation and the selection of appropriate covariates, the median P value for the comparison of permanent pacemaker implantation rates after transcatheter aortic valve implantation between the high implantation group and the conventional group ranged between 0.001 and 0.017, indicating a more significant reduction in the permanent pacemaker implantation rate in the high implantation group than in the conventional group. Neither valve dislodgement nor the need for a second valve was observed in either group. CONCLUSIONS: The high implantation of SAPIEN 3 successfully decreases ventricular strut length, reducing the permanent pacemaker implantation rate after transcatheter aortic valve implantation.

A novel "proximal first" Inoue balloon catheter for retrograde aortic valvuloplasty: Initial case report.

The Inoue balloon, invented for percutaneous transseptal mitral commissurotomy for mitral stenosis, is initially dilated in the distal portion and then the proximal portion, forming an hourglass shape that stabilizes the balloon at the mitral valve orifice with a pulling action. The device has been successfully applied to antegrade aortic valvuloplasty; the hourglass shape stabilizes the balloon across the aortic valve without rapid ventricular pacing. Subsequently, an Inoue balloon was developed for retrograde aortic valvuloplasty using the same design as the antegrade balloon. The hourglass-shaped balloon, however, has difficulty maintaining stability across the aortic valve because the distal portion of the balloon, which inflates first, directly receives systolic pressure from the left ventricle. A novel Inoue balloon was invented to overcome this issue by altering the manner of inflation: the proximal portion inflates first, followed by the distal portion. Theoretically, the proximal portion, which initially inflates just above the aortic valve, remains secure across the valve by applying a pressing force that counteracts the systolic forward pressure. Furthermore, a radiopaque marker is placed at the center of the balloon to enable rapid and precise balloon adjustment. We present a case involving a 65-year-old female hemodialysis patient with severe symptomatic aortic stenosis who we successfully treated with balloon aortic valvuloplasty using the novel Inoue balloon followed by transcatheter aortic valve implantation. The present case demonstrates the feasibility and effectiveness of the novel "proximal first" Inoue balloon for retrograde balloon aortic valvuloplasty for severe aortic stenosis.

Catheter-based biopsy leading to early surgical intervention of the pulmonary artery intimal sarcoma.

Pulmonary artery intimal sarcoma (PAIS) is an extremely rare disease that portends a dismal prognosis. To reach a diagnosis, several diagnostic measures are performed but pathological confirmation is required for an ultimate diagnosis. We report a case where a catheter-based, less invasive approach led to the diagnosis and curative intervention for PAIS. .

Zero-fluoroscopy ablation for cardiac arrhythmias: A single-center experience in Japan.

BACKGROUND: Exposure to radiation during catheter ablation procedures poses a risk to the heath of both the patient and electrophysiology laboratory staff. Recently, the feasibility and effectiveness of zero-fluoroscopy ablation have been reported. However, studies on the outcomes of zero-fluoroscopy ablation in Japan remain limited. This study investigated the outcomes of zero-fluoroscopy ablation for cardiac arrhythmias at a Japanese institute. METHODS AND RESULTS: We present a retrospective analysis of the safety, efficacy, and feasibility data from 221 consecutive patients who underwent zero-fluoroscopy ablation. Of these patients, 181 had atrial fibrillation, 17 had paroxysmal supraventricular tachycardia, 13 had atrial tachycardia, 6 had ventricular tachycardia, and 4 had ventricular premature contractions. We performed zero-fluoroscopy ablation using three-dimensional electro-anatomical mapping systems and intracardiac echocardiography imaging. Ultrasound-guided sheath insertion was performed on all cases. Our experience includes exclusively endocardial cardiac ablations. The mean follow-up was 24 months. The recurrence rates were 25.4% for atrial fibrillation, 5.9% for paroxysmal supraventricular tachycardia, 15.4% for atrial tachycardia, 33.3% for ventricular tachycardia, and 25% for ventricular premature contraction. Complications occurred in two patients (0.9%), and there was no occurrence of death. A fluoroscopic guide was used in three cases for the confirmation of vascular access (one case) and for complications (two cases). CONCLUSIONS: Zero-fluoroscopy ablation was routinely performed without compromising on safety and efficacy. This approach may eliminate the exposure to radiation for all individuals involved in this procedure.

Transcatheter Versus Surgical Aortic Valve Replacement in the United States (From the Nationwide Readmission Database).

Clinical outcomes of transcatheter aortic valve implantation (TAVI) have significantly improved with the accumulation of operator and institution experience as well as the wide use of newer generation devices. There is limited data on TAVI outcomes compared with surgical aortic valve replacement (SAVR) in contemporary practice in the United States. We queried the 2018 Nationwide Readmission Database of the United States. International Classification Diagnosis code 10 was used to extract TAVI and SAVR admissions. A propensity-matched cohort was created to compare TAVI and SAVR outcomes. A weighted 48,349 TAVI and 24,896 SAVR for aortic stenosis were included and 4.9% of TAVI were performed with an embolic protection device. In propensity-matched cohort (12,708 TAVI and 12,708 SAVR), TAVI conferred lower in-hospital mortality (1.7% vs 3.8%), acute kidney injury (11.3% vs 22.9%), and transfusion rate (5.9% vs. 20.6%) whereas new pacemaker rate was higher in TAVI compared with SAVR (10.5% vs. 7.0%) (all p values < 0.001). Stroke rate was similar between TAVI and SAVR (1.5% vs. 1.5%) (p value = 0.79). The routine discharge was more frequent (66.9% vs 25.8%) and length of stay was shorter (4.8 vs. 9.8 days) in TAVI than SAVR. Hospitalization cost was higher in SAVR than TAVI (51,962 vs 57,754 U.S. dollars) (all p values < 0.001). In-hospital mortality was also lower in TAVI compared with isolated SAVR. TAVI was performed more frequently than SAVR in 2018 in the United States with lower in-hospital mortality of TAVI compared with both SAVR and isolated SAVR.

Clinical Significance and Prognosis of Right Heart Thrombi Associated With Acute Pulmonary Thromboembolism　- Results of a Multicenter Registry of Thrombolysis in Japan.

BACKGROUND: Thrombolytic therapy is standard treatment in acute pulmonary thromboembolism (PTE) with hemodynamic instability. Although right heart thrombi (RHT) appear to increase mortality in acute PTE, large-scale studies of acute PTE with RHT are scarce.Methods and Results:Patient data (from August 2005 to May 2014) obtained from post-marketing surveillance of thrombolytic therapy using a tissue-type plasminogen activator were analyzed retrospectively. Of the 2,698 confirmed cases of acute PTE who underwent echocardiographic assessment, 166 (6.2%) were diagnosed with RHT. PTE patients with RHT, compared with those without RHT, had higher rates of mortality (20.2% vs. 10.4%, P<0.001), hemodynamic instability (53.0% vs. 37.7%, P<0.001), and PTE recurrence (6.6% vs. 2.3%, P=0.003). When considering PTE-related hemodynamic severity (cardiopulmonary arrest/collapse, massive, submassive, and non-massive), mortality was significantly higher in patients with RHT in the massive (19.8% vs. 7.7%, P=0.002) and submassive (8.0% vs. 2.8%, P=0.018) groups, whereas no significant differences was found between those with and without RHT in the cardiopulmonary arrest/collapse (51.7% vs. 52.1%, P=0.960) and non-massive (1.6% vs. 0%, P=0.596) groups. CONCLUSIONS: PTE patients with RHT had higher mortality, severity, and PTE recurrence rates. RHT was particularly associated with worse outcomes in patients with massive or submassive PTE.