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ObjectiveLittle information exists about inter-racial differences in patients with aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI). We investigated whether differences in baseline characteristics between Asian and non-Asian population may contribute to disparities in clinical outcomes after TAVI.MethodsWe performed a registry-based, multinational cohort study of patients with severe AS who underwent TAVI at two centres in the USA and one centre in South Korea. The primary outcome was a composite of death, stroke or rehospitalisation at 1 year.ResultsOf 1412 patients, 581 patients were Asian and 831 were non-Asian (87.5% white, 1.7% black, 6.1% Hispanic or 4.7% others). There were substantial differences in baseline characteristics between two racial groups. The primary composite outcome was significantly lower in the Asian group than in the non-Asian group (26.0% vs 35.0%; HR 0.73; 95% CI 0.59 to 0.89; p=0.003). However, after adjustment of baseline covariates, the risk of primary composite outcome was not significantly different (HR 0.79; 95% CI 0.60 to 1.03; p=0.08). The all-cause mortality at 1 year was significantly lower in the Asian group than the non-Asian group (7.4% vs 12.5%; HR 0.60; 95% CI 0.41 to 0.88; p=0.009). After multivariable adjustment, the risk of all-cause mortality was also similar (HR 1.17; 95% CI 0.73 to 1.88; p=0.52).ConclusionsThere were significant differences in baseline and procedural factors among Asian and non-Asian patients who underwent TAVI. Observed inter-racial differences in clinical outcomes were largely explained by baseline differences in clinical, anatomical and procedural factors.Trial registration numberNCT03826264(https://wwwclinicaltrialsgov).

Open surgical closure and small-bore suture-based preclosure devices have limitations when used for transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or percutaneous thoracic endovascular aortic aneurysm repair. The MANTA vascular closure device is a novel collagen-based technology designed to close large bore arteriotomies created by devices with an outer diameter ranging from 12F to 25F. In this study, we determined the safety and effectiveness of the MANTA vascular closure device.A prospective, single arm, multicenter investigation in patients undergoing transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or thoracic endovascular aortic aneurysm repair at 20 sites in North America. The primary outcome was time to hemostasis. The primary safety outcomes were accessed site-related vascular injury or bleeding complications. A total of 341 patients, 78 roll-in, and 263 in the primary analysis cohort, were entered in the study between November 2016 and September 2017. For the primary analysis cohort, transcatheter aortic valve replacement was performed in 210 (79.8%), and percutaneous endovascular abdominal aortic aneurysm repair or thoracic endovascular aortic aneurysm repair was performed in 53 (20.2%). The 14F MANTA was used in 42 cases (16%), and the 18F was used in 221 cases(84%). The mean effective sheath outer diameter was 22F (7.3 mm). The mean time to hemostasis was 65±157 seconds with a median time to hemostasis of 24 seconds. Technical success was achieved in 257 (97.7%) patients, and a single device was deployed in 262 (99.6%) of cases. Valve Academic Research Consortium-2 major vascular complications occurred in 11 (4.2%) cases: 4 received a covered stent (1.5%), 3 had access site bleeding (1.1%), 2 underwent surgical repair (0.8%), and 2 underwent balloon inflation (0.8%).In a selected population, this study demonstrated that the MANTA percutaneous vascular closure device can safely and effectively close large bore arteriotomies created by current generation transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, and thoracic endovascular aortic aneurysm repair devices.URL: https://www.clinicaltrials.gov . Unique identifier: NCT02908880.

Background. QT interval prolongation is considered a risk factor for sudden cardiac death (SCD) in various non-transplant populations. Since acute allograft rejection is associated with a prolonged QT interval, we sought to investigate the effects of rejection-induced QT interval changes on SCD in heart transplant recipients. Methods. Of all patients who underwent heart transplantation between 1998 and 2007, we enrolled those with severe acute cellular rejection episodes (ISHLT grade 3A or higher, accompanied with hemodynamic compromise). In this cohort, baseline ECGs were obtained within 7 days after transplantation; follow-up ECGs were recorded at the time of the rejection episode. On all ECGs, QT interval was defined as the mean duration QT interval measurements in all leads, and corrected for heart rate with Bazett formula. A significant increase of QTc during rejection (dQTc) was defined as a relative change in QTc ≥10%. Patients were followed for SCD for 1 year after the rejection episode. Results. Of 80 patients with a severe rejection episode, 9 (11%) were excluded because of the inadequate quality of ECG recordings. Within the 1-year follow-up, 21 of 71 (30%) patients died. Of these, 14 (67%) died of SCD, and 7 (23%) died of other causes. Patients who died of SCD and survivors did not differ with regards to age (44 ± 12 years in SCD group vs. 46 ± 16 years in survivors, P = 0.61), gender (male: 83% vs. 58%, P = 0.06), incidence of infections (0.21 ± 0.43 vs. 0.20 ± 0.40, P = 0.91), malignancy (0% vs. 8%, P = 0.84), or allograft vasculopathy (29% vs. 26%, P = 0.85). No difference in Qtc prolonging drug was noted. During acute rejection, QTc interval was significantly longer in SCD group than in survivors (475 ± 57 ms vs. 437 ± 36 ms, P = 0.01), and the same was true for the incidence of dQTc > 10% (50% vs. 16%, P = 0.008). SCD-free survival as evaluated by Kaplan-Meier analysis was significantly lower in patients with dQTc > 10% (P = 0.013). On multivariate analysis, dQTc > 10% was the only independent predictor of SCD (P = 0.02). The multivariate model included left ventricular dysfunction (LVEF < 30%) and dQTc. Conclusion. Heart transplant recipients who display a significant (> 10%) prolongation of QT interval during a severe acute rejection episode may be at increased risk for SCD.

Background. Granulocyte-colony stimulating factor (G-CSF) has been shown to attenuate coronary disease in non-transplant population and decrease the incidence of acute rejections in experimental models of heart transplantation. Hypothesis. We hypothesized that G-CSF may decrease the incidence of allograft vasculopathy and rejection in heart transplant recipients. Methods. Of 247 patients who underwent heart transplantation at Stanford University Medical Center from 2000 to 2007 we enrolled 52 (21%) patients who presented with leukopenia (WBC < 2.5 x 10 9 cells/L) in the absence of active infection, rejection or malignancy. In 24 (46%) patients leukopenia was treated with G-CSF (mean dose 348 ± 78 mcg daily; G-CSF Group), and 28 (54%) patients received no G-CSF therapy (non-GCSF group). All patients were followed for 1 year after leukopenia occurence for the development of allograft vasculopathy (any new stenotic lesion on annual coronary angiography) and rejection incidence (ISHLT grade ≥3A or higher, or severe non-cellular rejection). Results. At baseline, G-CSF Group and non-G-CSF Group did not differ in age (54 ± 16 vs. 47 ± 14 years, respectively, P = 0.1), gender (male: 17% vs. 35%, P = 0.12), race (Caucasian: 79%, vs. 78%, P = 0.96), heart failure etiology (ischemic: 26% vs. 45%, P = 0.12), creatinine (1.6 ± 1.1 mg/dl vs. 1.5 ± 0.6 mg/dl, P = 0.6), LVEF (64 ± 8% vs. 64 ± 7%, P = 0.81), immunosupressive regimen (CyA/MMF/Prednisone: 42% vs. 54%, P = 0.4), or post-transplant time of leukopenia occurence (284 ± 396 days in the G-CSF Group vs. 347 ± 365 days in Controls, P = 0.57). During 1-year follow-up there were no events in the G-CSF Group, and 1 death in the non-G-CSF Group ( P = 0.34). Rejection incidence was significantly lower in the G-CSF Group (8% vs. 36% in Controls, P = 0.019), as was cardiac allograft vasculopathy (4% vs. 29%, P = 0.02). Conclusions. G-CSF therapy appears to be associated with decreased incidence of acute rejections and allograft vasculopathy in heart transplant recipients, suggesting that G-CSF may have immunomodulatory effects.