High Crossover Rate Research Articles

Long-term health-related quality of life and rhythm outcomes of catheter ablation versus antiarrhythmic drugs in patients with atrial fibrillation

BackgroundData on long-term effects of catheter ablation vs antiarrhythmic drugs (AADs) on health-related quality of life (HRQoL) and atrial fibrillation (AF) burden are limited. ObjectiveThe study aimed to assess long-term HRQoL and rhythm data in patients with symptomatic AF. MethodsThe 75 patients who underwent ablation and 74 receiving AAD in the Catheter Ablation compared with Pharmacological Therapy for Atrial Fibrillation trial were followed for 48 months. The General Health subscale of the 36-Item Short-Form Health Survey, time to first AF episode ≥1 hour, and AF burden, recorded by implantable cardiac monitors, were compared. ResultsOne hundred forty-seven patients completed follow-up, with 7 crossovers in the ablation group and 34 crossovers in the AAD group. General Health improved by ablation from a median of 62 points at baseline to 79.2 points at follow-up (P < .001) and by AAD from a median of 67 to 77 points (P < .001), without treatment differences (P = .77). Time to first AF episode ≥1 hour was longer (median 257 days in the ablation group vs 180 days in the AAD group; P = .025). The cumulative AF burden during follow-up was lower in the ablation group (median 0.3%; interquartile range [IQR] 0%–1.4%) than in the AAD group (1.6%; IQR 0.1%–11.0%) (P = .01). The cumulative reduction in AF burden compared with baseline was greater in the ablation group (median −89.5%; IQR −98.4% to −51.3%) than in the AAD group (−52.7%; IQR −92.6% to 263.6%); P < .001). ConclusionHRQoL improvement at long-term did not differ between ablation and AAD groups despite a larger reduction in AF burden after ablation. The results should be interpreted in the light of a high crossover rate in the AAD group.

Mendelian segregation and high recombination rates facilitate genetic analyses in Cryptosporidium parvum.

Very little is known about the process of meiosis in the apicomplexan parasite Cryptosporidium despite the essentiality of sex in its life cycle. Most cell lines only support asexual growth of Cryptosporidium parvum (C. parvum), but stem cell derived intestinal epithelial cells grown under air-liquid interface (ALI) conditions support the sexual cycle. To examine chromosomal dynamics during meiosis in C. parvum, we generated two transgenic lines of parasites that were fluorescently tagged with mCherry or GFP on chromosomes 1 or 5, respectively. Infection of ALI cultures or Ifngr1-/- mice with mCherry and GFP parasites resulted in cross-fertilization and the formation of "yellow" oocysts, which contain 4 haploid sporozoites that are the product of meiosis. Recombinant oocysts from the F1 generation were purified and used to infect HCT-8 cultures, and phenotypes of the progeny were observed by microscopy. All possible phenotypes predicted by independent segregation were represented equally (~25%) in the population, indicating that C. parvum chromosomes exhibit a Mendelian inheritance pattern. The most common pattern observed from the outgrowth of single oocysts included all possible parental and recombinant phenotypes derived from a single meiotic event, suggesting a high rate of crossover. To estimate the frequency of crossover, additional loci on chromosomes 1 and 5 were tagged and used to monitor intrachromosomal crosses in Ifngr1-/- mice. Both chromosomes showed a high frequency of crossover compared to other apicomplexans with map distances (i.e., 1% recombination) of 3-12 kb. Overall, a high recombination rate may explain many unique characteristics observed in Cryptosporidium spp. such as high rates of speciation, wide variation in host range, and rapid evolution of host-specific virulence factors.

The use of venoarterial extracorporeal membrane oxygenation in cardiogenic shock: a narrative review.

Cardiogenic shock (CS) develops in up to 10% of patients with acute myocardial infarction (AMI) and carries a 50% risk of mortality. Despite the paucity of evidence regarding its benefits, venoarterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly used in clinical practice in patients with AMI in CS (AMI-CS). This review aims to provide an in-depth description of the four available randomized controlled trials to date designed to evaluate the benefit of VA-ECMO in patients with AMI-CS. The literature search was conducted on PubMed, Google Scholar, and clinicaltrials.gov to identify the four relevant randomized control trials from years of inception to October 2023. Despite differences in patient selection, nuances in trial conduction, and variability in trial endpoints, all four trials (ECLS-SHOCK I, ECMO-CS, EUROSHOCK, and ECLS-SHOCK) failed to demonstrate a mortality benefit with the use of VA-ECMO in AMI-CS, with high rates of device-related complications. However, the outcome of these trials is nuanced by the limitations of each study that include small sample sizes, challenging patient selection, and high cross-over rates to the intervention group, and lack of use of left ventricular unloading strategies. The presented literature of VA-ECMO in CS does not support its routine use in clinical practice. We have yet to identify which subset of patients would benefit most from this intervention. This review emphasizes the need for designing adequately powered trials to properly assess the role of VA-ECMO in AMI-CS, in order to build evidence for best practices.

Iron-Based Thermally Regenerative Flow Battery Recharged by Distillation of Acetone

Thermo-electrochemical conversion systems can convert abundant low-grade heat into electricity. In particular, thermally regenerative flow batteries (TRFBs) have gained significant attention owing to their high power density compared to other thermo-electrochemical conversion systems. However, the variety of redox species is limited in previous studies. To provide an alternative option for the redox species, we newly propose using Fe, and investigate the performance of an Fe-based TRFB called the solvation difference flow battery (SDFB). In this study, the SDFB uses [Fe(CN)6]4−/3− as the redox species and can be recharged by the distillation of acetone. The maximum power density was 40 W m−2 and the thermal efficiency was estimated to be 0.20% at an average power density of 16 W m−2. In addition, we discuss the challenges for future improvements. The cell voltage should be enhanced by optimizing the electrolyte components, such as solvents and counterions. For the cell design, the cell resistance is reduced by improving the flow fields of the electrolytes to enhance the mass-transfer properties. Moreover, a membrane that satisfies both a high ion conductivity and low crossover rate of the solvents is required. This study provides new options for the redox species in TRFBs.

The Narrow Footprint of Ancient Balancing Selection Revealed by Heterokaryon Incompatibility Genes in Aspergillus fumigatus.

In fungi, fusion between individuals leads to localized cell death, a phenomenon termed heterokaryon incompatibility. Generally, the genes responsible for this incompatibility are observed to be under balancing selection resulting from negative frequency-dependent selection. Here, we assess this phenomenon in Aspergillus fumigatus, a human pathogenic fungus with a very low level of linkage disequilibrium as well as an extremely high crossover rate. Using complementation of auxotrophic mutations as an assay for hyphal compatibility, we screened sexual progeny for compatibility to identify genes involved in this process, called het genes. In total, 5/148 (3.4%) offspring were compatible with a parent and 166/2,142 (7.7%) sibling pairs were compatible, consistent with several segregating incompatibility loci. Genetic mapping identified five loci, four of which could be fine mapped to individual genes, of which we tested three through heterologous expression, confirming their causal relationship. Consistent with long-term balancing selection, trans-species polymorphisms were apparent across several sister species, as well as equal allele frequencies within A. fumigatus. Surprisingly, a sliding window genome-wide population-level analysis of an independent dataset did not show increased Tajima's D near these loci, in contrast to what is often found surrounding loci under balancing selection. Using available de novo assemblies, we show that these balanced polymorphisms are restricted to several hundred base pairs flanking the coding sequence. In addition to identifying the first het genes in an Aspergillus species, this work highlights the interaction of long-term balancing selection with rapid linkage disequilibrium decay.

Opioid-Free Analgesia is Safe and Effective in Anterior Cervical Spine Surgery: A Randomized Controlled Trial.

Randomized controlled trial (RCT). Compare the efficacy of a multimodal, opioid-free (OF) pain management pathway with a traditional opioid-containing (OC) pathway in patients undergoing anterior cervical procedures. Previous studies have compared opioid-based pain regimens to opioid-sparing regimens following cervical spine surgery, but have been limited by high rates of crossover, retrospective designs, reliance on indwelling pain catheters, opioid utilization for early postoperative analgesia, and/or a lack of patient-reported outcome measures. This is a RCT in which patients were allocated to either an OF or OC perioperative pain management protocol. Eligible study participants included adult (age up to 18y) patients who underwent primary, 1-level or 2-level anterior cervical surgery [anterior cervical discectomy and fusion (ACDF), anterior cervical disc arthroplasty (ACDA), or hybrid (ACDF and ACDA at different levels)] for degenerative pathology. The primary outcome variable was subjective pain level at 24 hours postoperative. The final study cohort consisted of 50 patients (22 OF, 28 OC). Patients in the OF group reported lower median postoperative pain levels at 6 hours (4 for OF vs. 7 for OC; P =0.041) and 24 hours (3 for OF vs. 5 for OC; P =0.032). At 2-week and 6-week follow-up, pain levels were similar between groups. Patients in the OF group reported greater comfort at 12 hours (9 for OF vs. 5 for OC; P =0.003) and 24 hours (9 for OF vs. 5 for OC; P =0.011) postoperatively. Notably, there were no significant differences in patients' reported pain satisfaction, overall surgical satisfaction, or overall sense of physical and mental well-being. In addition, there were no significant differences in falls, delirium, or constipation postoperatively. A multimodal OF pain management pathway following anterior cervical surgery for degenerative disease results in statistically noninferior pain control and equivalent patient-reported outcome measures compared with a traditional OC pathway.

Ivosidenib: A Review in Advanced Cholangiocarcinoma.

Ivosidenib (Tibsovo®), a first-in-class, oral small molecule, potent and selective inhibitor of mutant isocitrate dehydrogenase 1 (mIDH1), is approved in the EU and USA for the treatment of adults with pretreated, advanced, mIDH1 cholangiocarcinoma (CCA). It is presumed to exert its cytostatic effects in this setting by suppressing 2-hydroxyglutarate, an oncometabolite produced by mIDH1 that impairs cellular differentiation and promotes tumorigenesis. In the multinational phase 3 ClarIDHy study in patients with pretreated, advanced mIDH1 CCA, monotherapy with ivosidenib once daily significantly prolonged progression-free survival (PFS) and almost doubled the disease control rate compared with placebo. Moreover, it had a favourable effect on overall survival (OS), which was also significantly prolonged after correcting for a high rate of crossover from the placebo group (permitted by the trial protocol). Ivosidenib treatment preserved health-related quality of life (HRQOL) relating to physical function, pain and appetite loss/eating and was generally well tolerated, with the most common treatment-emergent adverse events being low-grade diarrhoea, nausea and fatigue. Thus, ivosidenib represents a novel and valuable targeted therapy for the subset of patients with pretreated, advanced CCA tumors harbouring mIDH1.

Bilateral versus single internal thoracic coronary artery bypass grafting: the ART RCT

Background There is debate whether the use of more arterial grafts during coronary artery bypass graft surgery provides advantages to the standard operation using the left internal thoracic artery plus vein grafts. We review data from the Arterial Revascularisation Trial to determine whether there is support for the multiple arterial graft hypothesis. Methods Patients undergoing coronary artery bypass graft for clinical reasons and who provided written informed consent were randomised to standard coronary artery bypass graft using the single internal thoracic artery or use of bilateral internal thoracic arteries. Additional vein grafts could be used. The primary outcome was all-cause mortality at 10 years and exploratory analyses were carried out to test the multiple arterial graft hypothesis. Results A total of 3102 patients were enrolled (1548 bilateral internal thoracic artery and 1554 single internal thoracic artery). Follow-up to 10 years for vital status was 98% complete. In the bilateral group, 14% of patients received a single internal thoracic artery only and use of radial artery grafts occurred in about 20% of patients in both groups. Aspirin was used in 81% of the patients, beta-blockers in 74%, statins in 90% and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers in 73%. At 10 years, death rates were 20.3% and 21.2% in the bilateral internal thoracic artery and single internal thoracic artery groups, respectively (hazard ratio 0.96, 95% confidence intervals 0.82 to 1.12; p = 0.62) and composite of all-cause mortality, myocardial infarction or stroke 24.9% and 27.3%, respectively (hazard ratio 0.90, 95% confidence interval 0.79 to 1.03; p = 0.12). Exploratory analyses using the ‘as-treated’ approach indicate that outcomes were better in patients who received multiple arterial grafts (adding the right internal thoracic and/or radial arteries) compared with a single arterial graft. This effect appeared to be greater in patients with diabetes and those aged 70 years or less. Use of total arterial grafting without vein grafts may provide the best outcomes. Limitations The elevated cross-over rate between bilateral internal thoracic artery and single internal thoracic artery and the non-randomised use of radial artery grafts may have contributed to a loss of power to detect a difference in mortality between the two groups. Moreover, secondary analyses are prone to bias as they compare non-randomised groups. Conclusions The Arterial Revascularisation Trial is one of the largest long-term studies in cardiac surgery. The primary analysis did not show a mortality benefit for bilateral internal thoracic artery at 10 years, perhaps due to high crossover rates in the bilateral internal thoracic artery group and concomitant use of the radial artery. Secondary analyses suggest a mortality benefit for patients receiving multiple arterial grafts compared with single arterial graft with possible greater effects in patients with diabetes and separately in patients aged 70 years or above. The trial will follow patients to 15 years and the continuing Randomized Comparison of the Clinical Outcome of Single versus Multiple Arterial Grafts trial will further test the multiple arterial graft hypothesis. Trial registration This trial is registered as ISRCTN46552265. Funding This project was funded by the British Heart Foundation, the UK. Medical Research Council and the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation programme and will be published in full in Efficacy and Mechanism Evaluation; Vol. 10, No. 7. See the NIHR Journals Library website for further project information.

Cardiovascular Outcomes of Transulnar Versus Transradial Percutaneous Coronary Angiography and Intervention: A Regression Matched Meta-Analysis

Transradial access (TRA) and transulnar access (TUA) are in close vicinity, but TRA is the preferred intervention route. The cardiovascular outcomes and access site complications of TUA and TRA are understudied. Databases, including MEDLINE and Cochrane Central registry, were queried to find studies comparing safety outcomes of both procedures. The outcome of interest was in-hospital mortality and access site bleeding. Secondary outcomes were all-cause major adverse cardiovascular events, crossover rate, artery spasm, access site large hematoma, and access site complications between TUA and TRA. A random-effect model was used with regression to report unadjusted odds ratios (ORs) by limiting confounders and effect modifiers, using software STATA V.17. A total of 4,796 patients in 8 studies were included in our analysis (TUA=2,420 [50.4%] and TRA=2,376 [49.6%]). The average age was 61.3 and 60.1years and the patients predominantly male (69.2% vs 68.4%) for TUA and TRA, respectively. TUA had lower rates of local access site bleeding (OR 0.58, 95% confidence interval 0.34 to 0.97, I2=1.89%, p=0.04) but higher crossover rate (OR 1.80, 95% confidence interval 1.04 to 3.11, I2=75.37%, p=0.04) than did TRA. There was no difference in in-hospital mortality, all-cause major adverse cardiovascular events, arterial spasm, and large hematoma between both cohorts. Furthermore, there was no difference in procedural time, fluoroscopy time, and contrast volume used between TUA and TRA. TUA is a safer approach, associated with lower access site bleeding but higher crossover rates, than TRA. Further prospective studies are needed to evaluate the safety and long-term outcomes of both procedures.

Long Term Results of a Randomised Trial of Stenting of the Superficial Femoral Artery for Intermittent Claudication

Primary stenting of the superficial femoral artery (SFA) in intermittent claudication (IC) has been shown to increase health related quality of life (HRQoL) after 12 and 24 months. An extended follow up of HRQoL 36 and 60 months after randomisation is presented. A multicentre randomised controlled trial was conducted at seven vascular clinics in Sweden between 2010 and 2020. One hundred patients randomised to either primary stenting and best medical treatment (BMT; n = 48) or BMT alone (n = 52) were followed for 60 months. HRQoL, assessed by the Short Form 36 Health Survey (SF-36) and EuroQoL 5 dimensions (EQ5D) 36 and 60 months after randomisation, was the primary outcome. Walking Impairment Questionnaire (WIQ) score, re-interventions, progression to chronic limb threatening ischaemia (CLTI), amputation, and death were secondary outcomes. At the 36 month follow up, the stent group (n = 32) had statistically significantly better scores in the SF-36 domain “Role Physical” (p = .023) and the Physical Component Summary (p = .032) compared with the control group (n = 30); however, there was no statistically significant difference in EQ5D scores (p = .52). WIQ was statistically significantly better in the stent group compared with the control group (p = .029) at 36 months. At the 60 month follow up, no statistically significant difference in HRQoL was seen between patients in the stent (n = 31) and control groups (n = 32). Crossover from the control group to the stent group was 25% at 60 months. There were no differences in progression to CLTI, amputation (2.1% vs. 1.9%), or mortality (14.6% vs. 15.4%) between groups. In patients with IC caused by isolated SFA lesions, primary stenting conferred benefits to HRQoL until 36 months from treatment vs. BMT alone, but these benefits were no longer detectable at 60 months, where a high crossover rate affected the power of the final analysis.

PARP inhibitors and overall survival in ovarian cancer, reevaluation advised in all settings.

PARP inhibitors in ovarian cancer have been a breakthrough therapy of the past decade, driven by positive trial results, and supported by an original pharmacological rationale. However, with mature data, detrimental survival results led to the withdrawals, in 2022, of all approved PARP inhibitors in the most advanced settings' indication (as monotherapy in third or subsequent lines) by the US Food and Drug Administration (FDA). Two other indications, as maintenance after relapse, were also restricted. In this work, based on pooled meta-analysis in each setting, we question a unique situation in oncology: a survivalbenefit is seen in front-line settings, with, at the same time, a survivaldecrement in later lines. Either this original feature is explained by the unique biological action of PARP inhibitors-through synthetic lethality-in patients with ovarian cancer and homologous repair deficiency. Another explanation may be trial design: decrement in later lines could partly explain why beneficial results were seen in early settings, simply by avoiding late exposure to PARP inhibitors in the experimental arm in those trials. High crossover rates seen in some trials further support this alternate hypothesis. We contend our analysis and recent survival results of PARP inhibitors warrant a whole reassessment of the place of these compounds in the landscape of ovarian cancer treatments.

Efficacy and Safety of Coronary Intervention Via Distal Trans-Radial Access (DTRA) in Patients with Low Body Mass Index

Background: The distal transradial approach (dTRA) is anticipated to improve the benefits of transradial availability, hemorrhagic incidents and the occurrence of radial artery occlusion (RAO) with the dTRA is uncertain. The aim of this study to investigate the puncture time rate, homeostasis and radial artery occlusion related to low BMI in distal artery access (dTRA) vs conventional radial artery access (cTRA). Study design: This cross-sectional study was carried out at NICVD, Nawabshah, for the duration of six months from July 2022 to December 2022. Materials and Methods: The total participants were 160 who diagnosed coronary artery disorder and include 75 participants in dTRA and 85 participants in cTRA. The age group were included &gt;21 years. The demographic data, surgical methods, catheterization, procedure-related data, procedures of puncture, ultrasound follow up and BMI were recorded. All data was analyzed by SPSS 22 version. Results: The mean age of participants in dTRA group was 72.0±10.1 years and cTRA group was 73.0±18.0 years. In gender, age and BMI were non-significant in both groups. The crossover rate, puncture time, one needle puncture rate and radial artery occlusion were shown significantly change in dTRA and cTRA group, p=0.005. Conclusion: Distal radial access is a new facility for cardiovascular interventions that provides several benefits over prior links. The key benefits would be less arterial blockage and faster hemostasis. When compared to traditional radial artery access, the dTRA may be a viable and reliable connectivity site for both diagnostic and interventional coronary methods, with a decreased prevalence of RAO, high crossover rate and time needed for hemostasis. Keywords: Distal transradial artery (dTRA); conventional transradial artery (cTRA); Radial artery occlusion (RAO)

Long Term Results of a Randomised Trial of Stenting of the Superficial Femoral Artery for Intermittent Claudication

Primary stenting of the superficial femoral artery (SFA) in intermittent claudication (IC) has been shown to increase health related quality of life (HRQoL) after 12 and 24 months. An extended follow up of HRQoL 36 and 60 months after randomisation is presented. A multicentre randomised controlled trial was conducted at seven vascular clinics in Sweden between 2010 and 2020. One hundred patients randomised to either primary stenting and best medical treatment (BMT; n= 48) or BMT alone (n= 52) were followed for 60 months. HRQoL, assessed by the Short Form 36 Health Survey (SF-36) and EuroQoL 5 dimensions (EQ5D) 36 and 60 months after randomisation, was the primary outcome. Walking Impairment Questionnaire (WIQ) score, re-interventions, progression to chronic limb threatening ischaemia (CLTI), amputation, and death were secondary outcomes. At the 36 month follow up, the stent group (n= 32) had statistically significantly better scores in the SF-36 domain "Role Physical" (p= .023) and the Physical Component Summary (p= .032) compared with the control group (n= 30); however, there was no statistically significant difference in EQ5D scores (p= .52). WIQ was statistically significantly better in the stent group compared with the control group (p= .029) at 36 months. At the 60 month follow up, no statistically significant difference in HRQoL was seen between patients in the stent (n= 31) and control groups (n= 32). Crossover from the control group to the stent group was 25% at 60 months. There were no differences in progression to CLTI, amputation (2.1% vs. 1.9%), or mortality (14.6% vs. 15.4%) between groups. In patients with IC caused by isolated SFA lesions, primary stenting conferred benefits to HRQoL until 36 months from treatment vs. BMT alone, but these benefits were no longer detectable at 60 months, where a high crossover rate affected the power of the final analysis.

Distal Trans-radial Access Compared to Conventional Trans-radial Access in Coronary Interventions: A Meta-analysis.

Distal trans-radial access (dTRA) is a novel technique of arterial cannulation in coronary interventions. The comparative efficacy of dTRA and conventional trans-radial access (TRA) in attenuating peri-procedural complications is unknown. Embase and PubMed/MEDLINE were searched from their inception until June 25, 2022, for randomized clinical trials. Outcomes included were radial artery occlusion (RAO), radial artery spasm, hemostasis time, access time, unsuccessful cannulation, crossover rate, and early discharge after trans-radial stenting of coronary arteries (EASY) type I-III hematomas. Statistical analysis was conducted using the random effects model to derive risk ratios (RRs) and mean differences (MDs) with their corresponding 95% confidence intervals (CIs). A total of 6 randomized clinical trials comprising 3240 patients were included. Subjects were predominantly male (73%) and had a mean age of 66 years. The dTRA group had a lower risk of RAO [RR 0.43 (95% CI, 0.26-0.69); P = 0.0005; I 2 = 0%] and had a shorter hemostasis time [MD -22.85 min (95% CI, -39.06 to -6.65); P = 0.006; I 2 = 99%]. The dTRA group had a higher crossover rate [RR 3.04 (95% CI, 1.88-4.91); P = 0.00001; I 2 = 56%] and a longer access time [MD 0.68 min (95% CI, 0.17-1.18); P = 0.009; I 2 = 99%]. The TRA group had a lower rate of unsuccessful cannulation [RR 0.81 (95% CI, 0.70-0.95); P = 0.01; I 2 = 92%]. There was no significant difference between the groups for radial artery spasm and EASY type I-III hematomas. dTRA is a safe alternative to conventional TRA for coronary interventions with a lower risk of RAO. Future trials are required to further compare both approaches.

Could radiation exposure be the Achilles’ heel of distal transradial artery access?

Distal transradial access for vascular interventions has gained ground recently. While the novel approach is associated with reduced radial artery occlusion and faster hemostasis, it could be related with prolonged procedural time, higher crossover rate and increased radiation, comparing to conventional transradial approach. Whether the radiation is increased in the procedures performed by the novel approach remains unambiguous. In the specific article, we aim to review the current literature and to propose possible explanations for this phenomenon. Could radiation be the Achilles’ heel of distal transradial artery access?

Distal Versus Conventional Radial Access for Coronary Angiography and Intervention: The DISCO RADIAL Trial.

Currently, transradial access (TRA) is the recommended access for coronary procedures because of increased safety, with radial artery occlusion (RAO) being its most frequent complication, which will increasingly affect patients undergoing multiple procedures during their lifetimes. Recently, distal radial access (DRA) has emerged as a promising alternative access to minimize RAO risk. A large-scale, international, randomized trial comparing RAO with TRA and DRA is lacking. The aim of this study was to assess the superiority of DRA compared with conventional TRA with respect to forearm RAO. DISCO RADIAL (Distal vs Conventional Radial Access) was an international, multicenter, randomized controlled trial in which patients with indications for percutaneous coronary procedure using a 6-F Slender sheath were randomized to DRA or TRA with systematic implementation of best practices to reduce RAO. The primary endpoint was the incidence of forearm RAO assessed by vascular ultrasound at discharge. Secondary endpoints include crossover, hemostasis time, and access site-related complications. Overall, 657 patients underwent TRA, and 650 patients underwent DRA. Forearm RAO did not differ between groups (0.91% vs 0.31%; P=0.29). Patent hemostasis was achieved in 94.4% of TRA patients. Crossover rates were higher with DRA (3.5% vs 7.4%; P=0.002), and median hemostasis time was shorter (180 vs 153minutes; P< 0.001). Radial artery spasm occurred more with DRA (2.7% vs 5.4%; P=0.015). Overall bleeding events and vascular complications did not differ between groups. With the implementation of a rigorous hemostasis protocol, DRA and TRA have equally low RAO rates. DRA is associated with a higher crossover rate but a shorter hemostasis time.

The Possibility of Intermediate–Temperature (120 °C)–Operated Polymer Electrolyte Fuel Cells using Perfluorosulfonic Acid Polymer Membranes

The technical possibility and possible issues of an intermediate–temperature–operated polymer electrolyte fuel cell (@120 °C) is investigated with an eye toward the launching of new fuel cell heavy–duty vehicles on the world market. Commercial perfluorosulfonic acid membrane and a commercial Pt catalyst supported on carbon are selected to clarify the possible issues in the fuel cells. The cell resistivity at high humidity is less than 0.1 Ω cm–2. The mass activity (@ 0.85 V, Pt loading amount: 0.33 mgPt cm−2) approaches 850 A gPt –1. The high gas crossover rate through the membrane leads to decreased open circuit voltage, which necessitates the use of higher Pt loadings (>0.30 mgPt cm–2) at the cathode to mitigate the effect of the mixed potential. Pt degradation during 120 °C operation at low humidity is found to be much lower than that during 80 °C operation at high humidity based on the results of load–cycle durability testing.

Primary results from the Japanese Heart Failure and Sudden Cardiac Death Prevention Trial (HINODE).

AimsThe HINODE study aimed to analyse rates of mortality, appropriately treated ventricular arrhythmias (VA), and heart failure in Japanese patients and compared with those in Western patients.Methods and resultsAfter treatment decisions following contemporary practice in Japan, patients were prospectively enrolled into four cohorts: (i) internal cardioverter‐defibrillator (ICD), (ii) cardiac resynchronization therapy (CRT) defibrillator (CRT‐D), (iii) standard medical therapy (‘non‐device’: ND), or (iv) pacing (indicated for CRT; received pacemaker or CRT pacing). Cohorts 1–3 required a left ventricular ejection fraction ≤35%, a history of heart failure, and a need for primary prevention of sudden cardiac death based on two to five previously identified risk factors. Endpoint outcomes were adjudicated by the independent committees. ICD and CRT‐D cohorts, considered as high‐voltage (HV) cohorts, were pooled for Kaplan–Meier analysis and propensity‐matched to Multicenter Automatic Defibrillator Implantation Trial‐Reduce Inappropriate Therapy (MADIT‐RIT) arm B and C patients. The study enrolled 354 patients followed for 19.6 ± 6.5 months, with a minimum of 12 months. Propensity‐matched HV cohorts showed comparable VA (P = 0.61) and mortality rates (P = 0.29) for HINODE and MADIT‐RIT. The ND cohort presented a high crossover rate to ICD therapy (6.1%, n = 7/115), and the CRT‐D cohort showed elevated mortality rates. The pacing cohort revealed that patients implanted with pacemakers had higher mortality (26.0%) than those with CRT‐Pacing (8.4%, P = 0.05).ConclusionsThe mortality and VA event rates of landmark trials are applicable to patients with primary prevention in Japan. Patients who did not receive guideline‐indicated CRT devices had poor outcomes.

Distal or Traditional Transradial Access Site for Coronary Procedures: A Single-Center, Randomized Study.

This study aimed to compare the efficacy and safety of the distal transradial approach (dTRA) versus the conventional transradial approach (TRA) for coronary angiography and percutaneous coronary interventions. The recommended approach for coronary procedures is TRA. However, it is associated with radial artery occlusion (RAO). The dTRA could potentially decrease the incidence of RAO. One thousand forty-two consecutive patients were randomized (1:1) to right dTRA or TRA. The primary endpoint was the rate of RAO, which was evaluated by Doppler ultrasound at 60days after randomization. Five hundred eighteen and 524 patients were randomized to dTRA and TRA, respectively. Follow-up Doppler evaluation of the radial artery was accomplished in 404 (78.0%) patients in the dTRA group and 392 (74.8%) in the TRA group. The rate of RAO was significantly reduced in the dTRA group compared with TRA group (3.7% vs 7.9%, respectively; P=0.014). The rate of successful sheath insertion was lower in the dTRA group compared with the TRA group (78.7% vs 94.8%, respectively; P< 0.001). More punctures (median=2 [IQR: 1-3] vs median=1 [IQR: 1-2]; P< 0.001) and a longer time (120 vs 75 seconds; P< 0.001) were required for sheath insertion in the dTRA group compared with the TRA group. The hemostasis time was shorter in the dTRA group compared with the TRA group (60 vs 120minutes; P< 0.001). The dose area product was higher in the dTRA group (median=32,729 in the dTRA vs 28,909 cGy/cm2 in the TRA group; P=0.02). No significant differences were observed in the secondary safety endpoints (bleeding [Bleeding Academic Research Consortium≥2] and severe radial artery spasm). According to our study, dTRA was associated with a lower rate of forearm RAO, a shorter time of hemostasis, a higher crossover rate and dose area product, and a longer procedural time compared with TRA.

O18 LONG-TERM CROSSOVER RATE FROM WATCHFUL WAITING TO SURGERY OF INITIALLY MIDLY SYMPTOMATIC OR ASYMPTOMATIC INGUINAL HERNIAS IN MEN AGES 50 YEARS AND OLDER

Abstract Aim Inguinal hernia (IH) belongs to the most common surgical pathology worldwide. Approximately, one third of patients are asymptomatic. Watchful waiting (WW) has been regarded as a justifiable treatment option, but doubts still exist since high crossover (CO) rates to surgery may occur. The aim of this study is to assess the CO rates after 13-year follow-up of our randomized controlled trial (RCT). Material and Methods In our original study, 496 men with an asymptomatic or mildly symptomatic IH were randomly assigned to elective repair or WW. A retrospective review was conducted of patients initially assigned to WW. Primary outcome was CO rate to surgery. Secondary outcomes included reason for crossing over and time between initial randomisation and the CO to surgery. Results In the original RCT, 95 of 262 WW patients electively crossed over to surgery (35.4%) after 32.9 months. Currently, 212 of the 262 (81.0%) WW patients were reviewed, and 133/212 (62.7%) crossed over to surgery. Median follow-up was 13 years (range, 8-15 years). Mean time to CO was 35.2 months SD (40.8). Motivations for crossing over to surgery were predominantly due to progression of symptoms (83.5%), and in 8 (3.8%) cases due to an emergency event. Conclusions In the presented population, WW on the long-term remains a safe strategy, saving one third of patients an operation, although CO to surgery will likely occur. Insights into the natural course of untreated inguinal hernia that are valuable during patient counseling can be offered in the form of long-term CO rate due to progression of symptoms.