Transcatheter aortic valve replacement (TAVR) is the preferred treatment option for older patients with symptomatic severe aortic stenosis. Differences in the properties of available TAVR systems can ...affect clinical outcomes. Among patients undergoing TAVR, we compared the self-expanding ACURATE neo TAVR system with the balloon-expandable SAPIEN 3 TAVR system with regard to early safety and efficacy.
In this randomised non-inferiority trial, patients (aged ≥75 years) undergoing transfemoral TAVR for treatment of symptomatic severe aortic stenosis, and who were deemed to be at increased surgical risk, were recruited at 20 tertiary heart valve centres in Germany, the Netherlands, Switzerland, and the UK. Participants were randomly assigned (1:1) to receive treatment with the ACURATE neo or the SAPIEN 3 with a computer-based randomly permuted block scheme, stratified by study centre and Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) category. The primary composite safety and efficacy endpoint comprised all-cause death, any stroke, life-threatening or disabling bleeding, major vascular complications, coronary artery obstruction requiring intervention, acute kidney injury (stage 2 or 3), rehospitalisation for valve-related symptoms or congestive heart failure, valve-related dysfunction requiring repeat procedure, moderate or severe prosthetic valve regurgitation, or prosthetic valve stenosis within 30 days of the procedure. Endpoint assessors were masked to treatment allocation. Non-inferiority of ACURATE neo compared with SAPIEN 3 was assessed in the intention-to-treat population on the basis of a risk-difference margin of 7·7% for the primary composite endpoint, with a one-sided α of 0·05. This trial is registered with ClinicalTrials.gov (number NCT03011346) and is ongoing but not recruiting.
Between Feb 8, 2017, and Feb 2, 2019, up to 5132 patients were screened and 739 (mean age 82·8 years SD 4·1; median STS-PROM score 3·5% IQR 2·6–5·0) were enrolled. 30-day follow-up was available for 367 (99%) of 372 patients allocated to the ACURATE neo group, and 364 (99%) of 367 allocated to the SAPIEN 3 group. Within 30 days, the primary endpoint occurred in 87 (24%) patients in the ACURATE neo and in 60 (16%) in the SAPIEN 3 group; thus, non-inferiority of the ACURATE neo was not met (absolute risk difference 7·1% upper 95% confidence limit 12·0%, p=0·42). Secondary analysis of the primary endpoint suggested superiority of the SAPIEN 3 device over the ACURATE neo device (95% CI for risk difference −1·3 to −12·9, p=0·0156). The ACURATE neo and SAPIEN 3 groups did not differ in incidence of all-cause death (nine patients 2% vs three 1%) and stroke (seven 2% vs 11 3%); whereas acute kidney injury (11 3% vs three 1%) and moderate or severe prosthetic aortic regurgitation (34 9% vs ten 3%) were more common in the ACURATE neo group.
TAVR with the self-expanding ACURATE neo did not meet non-inferiority compared to the balloon-expandable SAPIEN 3 device in terms of early safety and clinical efficacy outcomes. An early composite safety and efficacy endpoint was useful in discriminating the performance of different TAVR systems.
Boston Scientific (USA).
It is unclear whether laparoscopic distal gastrectomy for locally advanced gastric cancer is oncologically equivalent to open distal gastrectomy. The noninferiority of laparoscopic subtotal ...gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer compared with open surgery in terms of 3-year relapse-free survival rate was evaluated.
A phase III, open-label, randomized controlled trial was conducted for patients with histologically proven locally advanced gastric adenocarcinoma suitable for distal subtotal gastrectomy. The primary end point was the 3-year relapse-free survival rate; the upper limit of the hazard ratio (HR) for noninferiority was 1.43 between the laparoscopic and open distal gastrectomy groups.
From November 2011 to April 2015, 1,050 patients were randomly assigned to laparoscopy (n = 524) or open surgery (n = 526). After exclusions, 492 patients underwent laparoscopic surgery and 482 underwent open surgery and were included in the analysis. The laparoscopy group, compared with the open surgery group, suffered fewer early complications (15.7%
23.4%, respectively;
= .0027) and late complications (4.7%
9.5%, respectively;
= .0038), particularly intestinal obstruction (2.0%
4.4%, respectively;
= .0447). The 3-year relapse-free survival rate was 80.3% (95% CI, 76.0% to 85.0%) for the laparoscopy group and 81.3% (95% CI, 77.0% to 85.0%; log-rank
= .726) for the open group. Cox regression analysis after stratification by the surgeon revealed an HR of 1.035 (95% CI, 0.762 to 1.406; log-rank
= .827;
for noninferiority = .039). When stratified by pathologic stage, the HR was 1.020 (95% CI, 0.751 to 1.385; log-rank
= .900;
for noninferiority = .030).
Laparoscopic distal gastrectomy with D2 lymphadenectomy was comparable to open surgery in terms of relapse-free survival for patients with locally advanced gastric cancer. Laparoscopic distal gastrectomy with D2 lymphadenectomy could be a potential standard treatment option for locally advanced gastric cancer.
Background
Rates of permanent pacemaker implantation (PPI) have been low using the self‐expanding ACURATE neo device, but data regarding risk factors of PPI for this specific device are scarce.
...Methods
The study cohort consisted of patients (n = 1000) with severe aortic stenosis undergoing transfemoral transcatheter aortic valve implantation (TAVI) using the ACURATE neo prosthesis in our center between May 2012 and December 2019. For the present analysis, we excluded patients with previous permanent pacemaker (n = 110), high‐grade AV block prior to TAVI (n = 3), and patients requiring conversion to surgical valve replacement (n = 4) or the implantation of a second prosthesis as valve‐in‐valve (n = 15). Preexisting conduction abnormalities were determined, and the implantation depth of the prosthesis was measured on final angiography. Differences across quartiles based on the original consecutive cohort were analyzed with respect to implantation depth and PPI rate. Predictors of PPI were identified using logistic regression.
Results
The PPI rate was 10%. Preexisting AV block I°, right bundle branch block (RBBB), and the implantation depth were independent predictors of PPI. Across quartiles, the implantation depth differed significantly with lowest values in the last quartile, whereas differences of PPI rates across quartiles were not statistically significant, but showed a notable decrease in the last quartile.
Conclusion
Preexisting RBBB, AV block I°, and low implantation depth were independent predictors of PPI following TAVI using the ACURATE neo device. Instead of deliberately aiming at a high position, avoidance of a low implantation depth may represent a reasonable compromise to reduce the rate of PPI without increasing the risk of malpositioning.
In a trial, patients who had undergone successful TAVR were assigned to rivaroxaban or antiplatelet therapy. In this substudy in patients who underwent CT, leaflet thickening and reduced leaflet ...motion at 90 days were less common with rivaroxaban. However, in the main trial, rivaroxaban was associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding.
Valve-in-valve TAVI to treat failing surgical aortic valves (SAVs) is increasingly performed, and commissural alignment is a key technical aspect in such procedures. Surgeons optimize valve ...alignment, accounting for potential coronary eccentricity and achieving a patient-specific optimized commissural orientation, representing the ideal target for TAVI alignment. Therefore, here we present a dedicated stepwise valve-in-valve implantation technique using the ACURATE neo2. In a specific SAV postoverlap view, isolating one surgical post to the right of the screen representing the target for alignment, rotational orientation of the TAVI commissures, matching the SAV orientation, is achieved and verified before implantation. This technique has been tested in a patient-specific three-dimensionally-printed aortic root anatomy, attached to a pulsatile flow simulator, allowing for native-like simulation of coronary cannulations under fluoroscopy, and enabling detailed assessment with fluoroscopic as well as direct videographic visualization. Furthermore, the technique is exemplified by providing an educational clinical case example.
Hepatitis E virus (HEV), an emerging zoonotic pathogen, poses a significant public health concern worldwide. Recently, rat HEV (Rocahepevirus ratti genotype C1; HEV‐C1) has been reported to cause ...zoonotic infections and hepatitis in humans. Human infections with HEV‐C1 are considered to be underestimated worldwide due to limited knowledge of transmission routes, genome epidemiology, and the risk assessment of zoonosis associated with these viruses. A total of 186 wild Norway rats (Rattus norvegicus) were collected from the Republic of Korea (ROK) between 2011 and 2021. The prevalence of HEV‐C1 RNA was 8 of 180 (4.4%) by reverse‐transcription polymerase chain reaction. We first reported three nearly whole‐genome sequences of HEV‐C1 newly acquired from urban rats in the ROK. Phylogenetic analysis demonstrated that Korea‐indigenous HEV‐C1 formed an independent genetic group with those derived from R. norvegicus rats in other countries, indicating geographical and genetic diversity. Our findings provide critical insights into the molecular prevalence, genome epidemiology, and zoonotic potential of Rocahepevirus. This report raises awareness of the presence of Rocahepevirus‐related hepatitis E among physicians in the ROK.
Orthohantaviruses, causing hemorrhagic fever with renal syndrome (HFRS) and hantavirus cardiopulmonary syndrome, pose a significant public health threat worldwide. Despite the significant mortality ...and morbidity, effective antiviral therapeutics or vaccines for orthohantavirus infections are currently unavailable. This study aimed to investigate the prevalence of HFRS-associated orthohantaviruses and identify the etiological agent of orthohantavirus outbreaks in southern Republic of Korea (ROK).
We collected small mammals on Jeju Island during 2018-2020. We detected the Hantaan virus (HTNV)-specific antibodies and RNA using an indirect immunofluorescence assay test and reverse transcription-polymerase chain reaction on Apodemus agrarius chejuensis (A. chejuensis). The prevalence of anti-HTNV antibodies among rodents was 14.1%. A total of six seropositive mice harbored HTNV RNA. The amplicon-based next-generation sequencing provided nearly full-length tripartite genomic sequences of six HTNV harbored by A. chejuensis. Phylogenetic and tanglegram analyses were conducted for inferring evolutionary relationships between orthohantaviruses with their reservoir hosts. Phylogenetic analyses identified a novel distinct HTNV genotype. The detected HTNV genomic sequences were phylogenetically related to a viral sequence derived from HFRS patient in southern ROK. Tanglegram analysis demonstrated the segregation of HTNV genotypes corresponding to Apodemus spp. divergence.
Our results suggest that A. chejuensis-borne HTNV may be a potential etiological agent of HFRS in southern ROK. Ancestral HTNV may infect A. chejuensis prior to geological isolation between the Korean peninsula and Jeju Island, supporting the co-evolution of orthohantaviruses and rodents. This study arises awareness among physicians for HFRS outbreaks in southern ROK.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Coronary artery disease (CAD) is a common finding in patients suffering from aortic valve stenosis (AS), with a prevalence of over 50% in patients 70 years of age or older. Transcatheter aortic valve ...intervention (TAVI) is the standard treatment option for patients with severe AS and at least 75 years of age. Current guidelines recommend percutaneous coronary intervention (PCI) in patients planned for TAVI with stenoses of >70% in the proximal segments of non-left main coronary arteries and in >50% of left main stenoses. While the guidelines on myocardial revascularization clearly recommend functional assessment of coronary artery stenoses of less than 90% in the absence of non-invasive ischemia testing, a statement regarding invasive functional testing in AS patients with concomitant CAD is lacking in the recently published guideline on the management of valvular heart disease. This review aims to provide an overview of the hemodynamic background in AS patients, discusses and summarizes the current evidence of invasive functional testing in patients with severe AS, and gives a future perspective on the ongoing trials on that topic.
Aims
Approximately every fifth patient undergoing transcatheter aortic valve implantation (TAVI) requires a permanent pacemaker (PPM) after the procedure. The aim of this study was to analyse ...predictors of atrioventricular block III° (AVBIII) persistence with concurrent PPM dependency after TAVI.
Methods and results
Between 2010 and 2015 a total of 1198 patients underwent TAVI at the Kerckhoff Heart and Thorax Center, Germany. After exclusion of patients with prior PPM (
n
= 173) 14.7% (
n
= 176) of the patients underwent PPM implantation after the procedure. Independent predictors of PPM implantation were pre-existing right bundle branch block (RBBB,
p
< 0.001) and implantation of a CoreValve prosthesis (
p
< 0.001). A subgroup of patients with a newly implanted PPM (
n
= 102) were followed-up for a median of 73 (IQR 62–85) days. The leading indication for PPM implantation was AVBIII in 74.5% (76/102). Of these patients only 22.4% (17/76) had persistent AVBIII at follow-up. Predictors of AVBIII persistence were prior RBBB (
p
= 0.04), postdilatation (
p
= 0.006) and higher mean aortic valve gradient prior to implantation (
p
= 0.013). PPMs were implanted earlier in patients with persisting AVBIII 1 day (IQR0–2.5) vs. 4 days (IQR2–7);
p
< 0.001. Early PPM implantation after TAVI was the only independent predictor of persistent AVBIII OR 1.36 (95% 1.05–1.75);
p
= 0.02.
Conclusion
The long-term persistence of AVBIII is generally low after TAVI. Therefore, it may be wise to postpone the indication for PPM implantation for a couple of days. The only predictors of a lack of recovery of the AVB are prior RBBB, higher mean aortic valve gradients and postdilatation of the prosthesis.
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