Innovative Mitral Valve Repair Using a Novel Automated Suturing System: Preliminary Data.

(1) Background and Objectives: Mitral regurgitation is a common valve disease requiring surgical repair. Even with satisfactory results, repair techniques may underlie subjectivity and variability and require long learning curves. A novel approach, the "Roman Arch" technique, may ease the technical burden. This study assessed an automated suturing device's feasibility and time efficiency for a proposed simplified technique. (2) Materials and Methods: Using the MiStitch™ and MiKnot™ devices (LSI Solutions, Inc., Victor, NY, USA), the suture pattern was performed in a cadaver model. Three surgeons with different expertise levels conducted the procedures. Repair and suture placement times were recorded and analyzed. (3) Results: The modified "Roman Arch" repair was completed on all ten human heart specimens with an average total repair time of 3:01 ± 00:59 min and a trend toward reduced times as experience increased. The study confirmed the technical feasibility with 90% of the attempts rated as rather satisfactory or very satisfactory. (4) Conclusions: The MiStitch™ system effectively facilitated the modified "Roman Arch" repair in an ex vivo setting, suggesting its potential to reduce the technical complexity of mitral valve repairs. Further studies are needed to confirm its efficacy and safety in clinical practice.

In-Clinic Detection of Optic Disc Drusen Using Hand-Held Ultrasound Technology.

Neuro-ophthalmologists commonly receive referrals for possible papilloedema. One common cause of oedematous-appearing optic nerves is optic disc drusen (ODD). We describe a novel, handheld, portable ultrasound device that can be used to identify ODD in cases of suspected papilloedema. We demonstrate here that this portable ultrasound system can detect ODD in the outpatient ophthalmology and neurology settings. The portable version demonstrates several advantages. The device can be carried into the office, readily reducing visit times and office space. It is much more affordable than a traditional ultrasound machine. Images can be uploaded to a secure server and imported into the patient's chart. These cases represent one potential ophthalmological application of this novel technology that could augment the ophthalmological examination and improve patient care in the future.

[Challenges and strategies for improving efficacy in CAR-T therapy].

CAR-T cell therapy targeting CD19 and BCMA for relapsed or refractory hematopoietic tumors has been adopted in routine practice and has shown dramatic results. However, half of patients who achieve remission with CAR-T therapy eventually relapse, and thus efforts to improve the efficacy of CAR-T therapy are gaining momentum. Notably, studies have described innovative technologies that enable control of cell kinetics after infusion, which is not possible with conventional CAR-T therapies. In this article, we review the challenges of CAR-T cell therapy and the development of new technologies.

Early feasibility studies in the United States: Focus on electrophysiology.

The care of patients with heart rhythm disorders is often dependent on technologies developed to address their unique clinical needs. Although much innovation occurs in the United States, recent decades have seen a significant proportion of early clinical studies performed outside the United States, driven largely by costly and time-inefficient processes seemingly inherent to the United States research ecosystem. As a result, the goals of early patient access to novel devices to address unmet needs and efficient technology development in the United States remain incompletely realized. This review will introduce key aspects of this discussion, organized by the Medical Device Innovation Consortium, in an effort to broaden awareness and encourage engagement by stakeholders in an effort to address central issues and therefore further a growing effort to shift Early Feasibility Studies to the United States for the benefit of all involved.

Contact force and catheter stability are predictive metrics of successful pulmonary vein isolation with high-power short duration ablation in atrial fibrillation.

INTRODUCTION: Preliminary data suggest that high power short duration (HPSD) ablation for pulmonary vein isolation (PVI) are safe. Limited data are available on its effectiveness. Aim was to evaluate HPSD ablation in atrial fibrillation ablation using a novel Qdot Micro catheter. METHODS AND RESULTS: Prospective multicenter study evaluating safety and efficacy of PVI with HPSD ablation. First pass isolation (FPI) and sustained PVI was assessed. If FPI was not achieved additional ablation index (AI)-guided ablation with 45 W was performed and metrics predictive of this were determined. Sixty-five patients and 260 veins were treated. Procedural and LA dwell time was 93.9 ± 30.4 and 60.5 ± 23.1 min, respectively. FPI was achieved in 47 (72.3%) patients and 231 veins (88.8%) with an ablation duration of 4.6 ± 1.0 min. Twenty-nine veins required additional AI-guided ablation to achieve initial PVI with 24 anatomical sites ablated with the right posterior carina being the most common site (37.5%). A contact force of ≥8 g (area under the curve [AUC]: 0.81; p < 0.001) and catheter position variation of ≤1.2 mm (AUC: 0.79; p < 0.001) with HPSD were strongly predictive of not requiring additional AI-guided ablation. Out of the 260 veins, only 5 (1.9%) veins showed acute reconnection. HPSD ablation was associated with shorter procedure times (93.9 vs. 159.4 min; p < 0.001), ablation times (6.1 vs. 27.7 min; p < 0.001), and lower rates of PV reconnection (9.2% vs. 30.8%; p = 0.004) compared to moderate power cohort. CONCLUSIONS: HPSD ablation is an effective ablation modality which results in effective PVI whilst maintaining a safety profile. Its superiority needs to be evaluated in randomized controlled trials.

Catheter Ablation of Persistent AF-Where are We Now?

Persistent atrial fibrillation (AF) is a diverse condition that includes various subtypes and underlying causes of arrhythmia. Progress made in catheter ablation technology in recent years has significantly enhanced the durability of ablation. Despite these advances however, the effectiveness of ablation in treating persistent AF is still relatively modest. Studies exploring the mechanisms behind persistent AF have identified substrate-driven focal and re-entrant sources within the atrial body as crucial in sustaining AF among individuals with persistent AF. Furthermore, the widespread adoption of atrial late gadolinium enhancement cardiac magnetic resonance (CMR) imaging and the ongoing refinement of invasive voltage mapping techniques have allowed for detailed assessment of fibrotic remodelling prior to or at the time of procedure. Translation into clinical practice, however, has yielded overall disappointing results. The clinical application of AF mapping in ablation procedures has not shown any substantial advantages beyond the use of pulmonary vein isolation (PVI) alone and adjunct ablation of fibrotic areas has yielded conflicting results in recent randomized trials. The emergence of pulsed field ablation represents a welcome development in the field and several studies have demonstrated an enhanced safety profile and increased procedural efficiency with this non-thermal energy modality. Pulsed field ablation also holds promise for safe and efficient substrate ablation beyond the pulmonary veins, but further trials are needed to assess its impact on longer term success rates. Continued advancements in our comprehension of AF mechanisms, alongside ongoing developments in catheter technology aimed at safe formation of transmural lesions, are essential for achieving better clinical outcomes for patients with persistent AF.

Atrial fibrillation cryoablation is an effective day case treatment: the UK PolarX vs. Arctic Front Advance experience.

AIMS: Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation for atrial fibrillation (AF). There are limited data on the PolarX Cryoballoon. The study aimed to establish the safety, efficacy, and feasibility of same day discharge for Cryoballoon PVI. METHODS AND RESULTS: Multi-centre study across 12 centres. Procedural metrics, safety profile, and procedural efficacy of the PolarX Cryoballoon with the Arctic Front Advance (AFA) Cryoballoon were compared in a cohort large enough to provide definitive comparative data. A total of 1688 patients underwent PVI with cryoablation (50% PolarX and 50% AFA). Successful PVI was achieved with 1677 (99.3%) patients with 97.2% (n = 1641) performed as day case procedures with a complication rate of <1%. Safety, procedural metrics, and efficacy of the PolarX Cryoballoon were comparable with the AFA cohort. The PolarX Cryoballoon demonstrated a nadir temperature of -54.6 ± 7.6°C, temperature at 30 s of -38.6 ± 7.2°C, time to -40°C of 34.1 ± 13.7 s, and time to isolation of 49.8 ± 33.2 s. Independent predictors for achieving PVI included time to reach -40°C [odds ratio (OR) 1.34; P < 0.001] and nadir temperature (OR 1.24; P < 0.001) with an optimal cut-off of ≤34 s [area under the curve (AUC) 0.73; P < 0.001] and nadir temperature of ≤-54.0°C (AUC 0.71; P < 0.001), respectively. CONCLUSIONS: This large-scale UK multi-centre study has shown that Cryoballoon PVI is a safe, effective day case procedure. PVI using the PolarX Cryoballoon was similarly safe and effective as the AFA Cryoballoon. The cryoablation metrics achieved with the PolarX Cryoballoon were different to that reported with the AFA Cryoballoon. Modified cryoablation targets are required when utilizing the PolarX Cryoballoon.

Innovative nonthermal technologies for inactivation of emerging foodborne viruses.

Various foodborne viruses have been associated with human health during the last decade, causing gastroenteritis and a huge economic burden worldwide. Furthermore, the emergence of new variants of infectious viruses is growing continuously. Inactivation of foodborne viruses in the food industry is a formidable task because although viruses cannot grow in foods, they can survive in the food matrix during food processing and storage environments. Conventional inactivation methods pose various drawbacks, necessitating more effective and environmentally friendly techniques for controlling foodborne viruses during food production and processing. Various inactivation approaches for controlling foodborne viruses have been attempted in the food industry. However, some traditionally used techniques, such as disinfectant-based or heat treatment, are not always efficient. Nonthermal techniques are considered a new platform for effective and safe treatment to inactivate foodborne viruses. This review focuses on foodborne viruses commonly associated with human gastroenteritis, including newly emerged viruses, such as sapovirus and Aichi virus. It also investigates the use of chemical and nonthermal physical treatments as effective technologies to inactivate foodborne viruses.

PolarX Cryoballoon metrics predicting successful pulmonary vein isolation: targets for ablation of atrial fibrillation.

AIM: Evaluate the novel PolarX Cryoballoon in atrial fibrillation (AF) catheter ablation through a propensity-matched comparison with the Arctic Front Advance (AFA). The aim was also to identify cryoablation metrics that are predictive of successful pulmonary vein isolation (PVI) with the PolarX Cryoballoon. METHODS AND RESULTS: This prospective multi-centre study included patients that underwent cryoablation for AF. All patients underwent PVI with reconnection assessed after a 30-min waiting period and adenosine. Safety, efficacy, and cryoablation metrics were compared between PolarX and a propensity-matched AFA cohort. Seventy patients were included with 278 veins treated. In total, 359 cryoablations were performed (1.3 ± 0.6 per vein) to achieve initial PVI with 205 (73.7%) veins isolating with a single cryoablation. Independent predictors for achieving initial PVI included temperature at 30 s [odds ratio (OR) 1.26; P = 0.003] and time to reach -40°C (OR 1.88; P < 0.001) with an optimal cut-off of ≤-38.5°C at 30 s [area under the curve (AUC) 0.79; P < 0.001] and ≤-40°C at ≤32.5 s (AUC 0.77; P < 0.001), respectively. Of the 278 veins, 46 (16.5%) veins showed acute reconnection. Temperature at 30 s (≤-39.5°C, OR 1.24; P = 0.002), nadir temperature (≤-53.5°C, OR 1.35; P = 0.003), and time to isolation (≤38.0 s, OR 1.18; P = 0.009) were independent predictors of sustained PVI. Combining two of these three targets was associated with reconnection in only 2-5% of PVs. Efficacy and safety of the PolarX Cryoballoon were comparable to AFA Cryoballoon, however, cryoablation metrics were significantly different. CONCLUSIONS: The PolarX Cryoballoon has a different cryoablation profile to AFA Cryoballoon. Prospective testing of these proposed targets in large outcomes studies is required.

Innovations in Cardiac Implantable Electronic Devices.

Cardiac implantable electronic devices (CIEDs) are essential for the management of a variety of cardiac conditions, including tachyarrhythmias, bradyarrhythmias, and medically refractory heart failure (HF). Recent advancements in CIED technology have led to innovative solutions that overcome shortcomings associated with traditional devices or address unmet needs. Leadless pacemakers, subcutaneous implantable cardioverter defibrillators (ICDs), and extravascular ICDs eliminate lead-related complications common with conventional pacemakers or ICDs. Conduction system pacing (His bundle pacing and left bundle branch pacing) is a more physiologic method of pacing and avoids the deleterious consequences associated with long-term right ventricular pacing. For HF-related devices, cardiac contractility modulation is an emerging therapy that bridges a gap for many patients ineligible for cardiac resynchronization therapy and has been shown to improve HF symptoms and decrease hospitalizations and mortality in select patients. Implantable pulmonary artery pressure monitors help guide HF management and reduce hospitalizations. Lastly, new phrenic nerve stimulating devices are being utilized to treat central sleep apnea, a common comorbidity associated with HF. While further long-term studies are still underway for many of these new technologies, it is anticipated that these devices will become indispensable therapeutics in the expanding cardiovascular armamentarium.

Research progress on quality deterioration mechanism and control technology of frozen muscle foods.

Freezing can prolong the shelf life of muscle foods and is widely used in their preservation. However, inevitable quality deterioration can occur during freezing, frozen storage, and thawing. This review explores the eating quality deterioration characteristics (color, water holding capacity, tenderness, and flavor) and mechanisms (irregular ice crystals, oxidation, and hydrolysis of lipids and proteins) of frozen muscle foods. It also summarizes and classifies the novel physical-field-assisted-freezing technologies (high-pressure, ultrasound, and electromagnetic) and bioactive antifreeze (ice nucleation proteins, antifreeze proteins, natural deep eutectic solvents, carbohydrate, polyphenol, phosphate, and protein hydrolysates), regulating the dynamic process from water to ice. Moreover, some novel thermal and nonthermal thawing technologies to resolve the loss of water and nutrients caused by traditional thawing methods were also reviewed. We concluded that the physical damage caused by ice crystals was the primary reason for the deterioration in eating quality, and these novel techniques promoted the eating quality of frozen muscle foods under proper conditions, including appropriate parameters (power, time, and intermittent mode mentioned in ultrasound-assisted techniques; pressure involved in high-pressure-assisted techniques; and field strength involved in electromagnetic-assisted techniques) and the amounts of bioactive antifreeze. To obtain better quality frozen muscle foods, more efficient technologies and substances must be developed. The synergy of novel freezing/thawing technology may be more effective than individual applications. This knowledge may help improve the eating quality of frozen muscle foods.

Improvement strategies of food supply chain through novel food processing technologies during COVID-19 pandemic.

Coronavirus disease-19 (COVID-19) is a contagious disease caused by a novel corona virus (SARS-CoV-2). No medical intervention has yet succeeded, though vaccine success is expected soon. However, it may take months or years to reach the vaccine to the whole population of the world. Therefore, the technological preparedness is worth to discuss for the smooth running of food processing activities. We have explained the impact of the COVID-19 pandemic on the food supply chain (FSC) and then discussed the technological interventions to overcome these impacts. The novel and smart technologies during food processing to minimize human-to-human and human-to-food contact were compiled. The potential virus-decontamination technologies were also discussed. Finally, we concluded that these technologies would make food processing activities smarter, which would ultimately help to run the FSC smoothly during COVID-19 pandemic.

Informed consent and community engagement in open field research: lessons for gene drive science.

BACKGROUND: The development of the CRISPR/Cas9 gene editing system has generated new possibilities for the use of gene drive constructs to reduce or suppress mosquito populations to levels that do not support disease transmission. Despite this prospect, social resistance to genetically modified organisms remains high. Gene drive open field research thus raises important questions regarding what is owed to those who may not consent to such research, or those could be affected by the proposed research, but whose consent is not solicited. The precise circumstances under which informed consent must be obtained, and from whom, requires careful consideration. Furthermore, appropriate engagement processes should be central to any introduction of genetically modified mosquitos in proposed target settings. DISCUSSION: In this work, international guidance documents on informed consent and engagement are reviewed and applied to the genetically modified mosquito research context. Five analogous research endeavours that involve area-wide / open field experiments are reviewed. The approach of each in respect to the solicitation of individual informed consent and community engagement are highlighted. CONCLUSIONS: While the solicitation of individual informed consent in host settings of gene drive field trials may not be possible or feasible in some instances, local community and stakeholder engagement will be key to building trust towards the proposed conduct of such research. In this regard, the approaches taken by investigators and sponsors of political science field research and weather modification field research should be avoided. Rather, proponents of gene drive field research should look to the Eliminate Dengue field trials, cluster randomised trials, and pragmatic clinical trials for guidance regarding how the solicitation of individual informed consent of host communities ought to be managed, and how these communities ought to be engaged.

DNA methylome profiling at single-base resolution through bisulfite sequencing of 5mC-immunoprecipitated DNA.

BACKGROUND: Detection of DNA methylome at single-base resolution is a significant challenge but promises to shed considerable light on human disease etiology. Current technologies could not detect DNA methylation genome-wide at single-base resolution with small amount of sequencing data and could not avoid detecting the methylation of repetitive elements which are considered as "junk DNA". METHODS: In this study, we have developed a novel DNA methylome profiling technology named MB-seq with its ability to identify genome-wide 5mC and quantify DNA methylation levels by introduced an assistant adapter AluI-linker This linker can be ligated to sonicated DNA and then be digested after the bisulfite treatment and amplification, which has no effect of MeDIP enrichment. Because many researchers are interested in investigating the methylation of functional regions such as promoters and gene bodies, we have also developed a novel alternative method named MRB-seq, which can be used to investigate the DNA methylation of functional regions by removing the repeats with Cot-1 DNA. RESULTS: In this study, we have developed MB-seq, a novel DNA methylome profiling technology combining MeDIP-seq with bisulfite conversion, which can precisely detect the 5mC sites and determine their DNA methylation level at single-base resolution in a cost-effective way. In addition, we have developed a new alternative method, MRB-seq (MeDIP-repetitive elements removal-bisulfite sequencing), which interrogates 5mCs in functional regions by depleting nearly half of repeat fragments enriched by MeDIP. Comparing MB-seq and MRB-seq to whole-genome BS-seq using the same batch of DNA from YH peripheral blood mononuclear cells. We found that the sequencing data of MB-seq and MRB-seq almost reaches saturation after generating 7-8 Gbp data, whereas BS-seq requires about 100 Gbp data to achieve the same effect. In comparison to MeDIP-seq and BS-seq, MB-seq offers several key advantages, including single-base resolution, discriminating the methylated sites within a CpG and non-CpG pattern and overcoming the false positive of MeDIP-seq due to the non-specific binding of 5-methylcytidine antibody to genomic fragments. CONCLUSION: Our novel developed method MB-seq can accelerate the decoding process of DNA methylation mechanism in human diseases because it requires 7-8 Gbp data to measure human methylome with enough coverage and sequencing depth, affording it a direct and practical application in the study of multiple samples. In addition, we have also provided a novel alternative MRB-seq method, which removes most repetitive sequences and allows researchers to genome-wide characterize DNA methylation of functional regions.

Use of an AFX aortic cuff in the endovascular treatment of aortocaval fistula secondary to abdominal aortic pseudoaneurysm.

Aortocaval fistula (ACF) is rare and lethal and can be either primary (due to an enlarged abdominal aortic aneurysm) or secondary (iatrogenic or secondary to abdominal surgery) in origin. We describe a case of an ACF secondary to a ruptured abdominal aortic pseudoaneurysm that we successfully treated with a planned endovascular approach using an AFX aortic cuff on both the arterial and venous sides.

Clinical applications of dynamic CT angiography for intracranial lesions.

BACKGROUND: Dynamic CT angiography (dCTA) augments traditional CTA with temporal resolution and has been demonstrated to influence operative planning in skull base surgery. METHODS: Three hundred twenty-five dynamic CTA cases from a single institution were reviewed for indication of study, findings, and comparison to other modalities of imaging. RESULTS: The most frequent application of dCTA was pre-operative surgical planning (59.4%); resection of skull base tumors represented the majority of these pre-operative studies (93.3%). It was also used to evaluate new neurological symptoms (20.9%). Of these, the most common symptoms prompting a dCTA study included headache (22.1%) and visual field deficit (11.8%). The most commonly visualized vascular lesions were partial (22.9%) and complete vascular occlusions (9.0%). Dynamic CTA has also been useful in post-operative imaging for vascular malformations (9.5%) and tumors (2.5%). Finally, dCTA was employed to evaluate ambiguous abnormal findings observed on other imaging modalities (7.7%). Cerebral dCTA ruled out inconclusive abnormal vascular findings visualized on other imaging modalities (64.0%) more frequently than it confirmed them (32.0%), and was inconclusive in a singular case (4.0%). CONCLUSIONS: Cerebral dCTA is an evolving new technology with a diverse spectrum of potential applications. In addition to its role in guiding pre-operative planning for skull base surgical cases, dynamic CTA offers excellent spatial and temporal resolution for assessment of vascular lesions.

Technological Development of Brewing in Domestic Refrigerator Using Freeze-Dried Raw Materials.

Development of a novel directly marketable beer brewed at low temperature in a domestic refrigerator combined with yeast immobilization technology is presented in this study. Separately, freeze-dried wort and immobilized cells of the cryotolerant yeast strain Saccharomyces cerevisiae AXAZ-1 on tubular cellulose were used in low-temperature fermentation (2, 5 and 7 °C). The positive effect of tubular cellulose during low-temperature brewing was examined, revealing that freeze-dried immobilized yeast cells on tubular cellulose significantly reduced the fermentation rates in contrast to freeze-dried free cells, although they are recommended for home-made beer production. Immobilization also enhanced the yeast resistance at low-temperature fermentation, reducing the minimum brewing temperature value from 5 to 2 °C. In the case of high-quality beer production, the effect of temperature and initial sugar concentration on the fermentation kinetics were assessed. Sensory enrichment of the produced beer was confirmed by the analysis of the final products, revealing a low diacetyl concentration, together with improved polyphenol content, aroma profile and clarity. The proposed process for beer production in a domestic refrigerator can easily be commercialized and applied by dissolving the content of two separate packages in tap water; one package containing dried wort and the other dried immobilized cells on tubular cellulose suspended in tap water.

The connecting health and technology study: a 6-month randomized controlled trial to improve nutrition behaviours using a mobile food record and text messaging support in young adults.

BACKGROUND: Early adulthood represents the transition to independent living which is a period when changes in diet and body weight are likely to occur. This presents an ideal time for health interventions to reduce the effect of health problems and risk factors for chronic disease in later life. As young adults are high users of mobile devices, interventions that use this technology may improve engagement. The Connecting Health and Technology study aimed to evaluate the effectiveness of tailored dietary feedback and weekly text messaging to improve dietary intake of fruit, vegetables and junk food over 6 months among a population-based sample of men and women (aged 18-30 years). METHODS: A three-arm, parallel, randomized control trial was conducted. After baseline assessments, participants were randomized to one of three groups: A) dietary feedback and weekly text messages, B) dietary feedback only or C) control group. Dietary intake was assessed using a mobile food record App (mFR) where participants captured images of foods and beverages consumed over 4-days at baseline and post-intervention. The primary outcomes were changes in serves of fruits, vegetables, energy-dense nutrient-poor (EDNP) foods and sugar-sweetened beverages (SSB). The intervention effects were assessed using linear mixed effect models for change in food group serves. RESULTS: Young adults (n = 247) were randomized to group A (n = 82), group B (n = 83), or group C (n = 82). Overall, no changes in food group serves for either intervention groups were observed. An unanticipated outcome was a mean weight reduction of 1.7 kg (P = .02) among the dietary feedback only. Men who received dietary feedback only, significantly reduced their serves of EDNP foods by a mean of 1.4 serves/day (P = .02). Women who received dietary feedback only significantly reduced their intake of SSB (P = .04) by an average of 0.2 serves/day compared with controls. CONCLUSIONS: Tailored dietary feedback only resulted in a decrease in EDNP foods in men and SSB in women, together with a reduction in body weight. Using a mobile food record for dietary assessment and tailored feedback has great potential for future health promotion interventions targeting diet and weight in young adults. TRIAL REGISTRATION: Australian Clinical Trials Registry Registration number: ACTRN12612000250831 .

History and evolution of blood pressure measurement.

Hypertension is the leading cause of morbidity and mortality worldwide. Hypertension mostly accompanies no symptoms, and therefore blood pressure (BP) measurement is the only way for early recognition and timely treatment. Methods for BP measurement have a long history of development and improvement. Invasive method via arterial cannulation was first proven possible in the 1800's. Subsequent scientific progress led to the development of the auscultatory method, also known as Korotkoff' sound, and the oscillometric method, which enabled clinically available BP measurement. However, hypertension management status is still poor. Globally, less than half of adults are aware of their hypertension diagnosis, and only one-third of them being treated are under control. Novel methods are actively investigated thanks to technological advances such as sensors and machine learning in addition to the clinical needs for easier and more convenient BP measurement. Each method adopts different technologies with its own specific advantages and disadvantages. Promises of novel methods include comprehensive information on out-of-office BP capturing dynamic short-term and long-term fluctuations. However, there are still pitfalls such as the need for regular calibration since most novel methods capture relative BP changes rather than an absolute value. In addition, there is growing concern on their accuracy and precision as conventional validation protocols are inappropriate for cuffless continuous methods. In this article, we provide a comprehensive overview of the past and present of BP measurement methods. Novel and emerging technologies are also introduced with respect to their potential applications and limitations.

Characteristics of two different cryoballoon systems for treatment of paroxysmal atrial fibrillation: study protocol for a multicenter randomized controlled trial (CONTRAST-CRYO Trial).

BACKGROUND: Single-shot pulmonary vein isolation (PVI) utilizing cryothermal energy is an effective and safe treatment for atrial fibrillation (AF) patients. A novel cryoballoon system, POLARx™, has been recently introduced. The aim of this study was to compare the efficacy, safety, and biophysical parameters of PVI between the novel cryoballoon system, POLARx™, and the standard cryoballoon system, Arctic Front Advance Pro™ (AFA-Pro), in patients with paroxysmal AF. METHODS: The CONTRAST-CRYO trial is a prospective, multicenter, open-label, randomized controlled study performed at seven large cardiac centers. This study was approved by the central ethics committee or the local ethics committee of each participating hospital and has been registered at UMIN Clinical Trials Registry (UMIN000049948). The trial will assign 200 patients with paroxysmal AF undergoing PVI to POLARx™ and AFA-Pro in a 1:1 randomization. The primary endpoint is the one-shot acute success rate of the right inferior pulmonary vein. Second endpoints include freedom from documented atrial fibrillation, atrial flutter, or atrial tachycardia without antiarrhythmic drugs at 12 months after the procedure, freedom from re-do procedures, the incidence of procedure-related adverse events, freezing duration, and the biophysical parameters during applications for each PV, total procedure and fluoroscopy time, and PVI durability during re-do procedures. CONCLUSION: The CONTRAST-CRYO trial is a prospective, multicenter, randomized study designed to elucidate the difference in the efficacy, safety, and biophysical parameters between POLARx™ and AFA-Pro in paroxysmal AF patients undergoing PVI. The findings from this trial may provide a valuable indication for selecting the optimal cryoballoon system. CLINICAL TRIAL REGISTRATION:  UMIN000049948.