Conventional Group Research Articles

Smartphone application for improving self-awareness of adherence to edoxaban treatment: a randomised controlled trial (ADHERE-APP)

Abstract Background Adherence to oral anticoagulants is essential for stroke prevention in patients with atrial fibrillation (AF). This study aims to test the feasibility and effectiveness of the smartphone app-based intervention to improve drug adherence in patients with AF. Methods This prospective, randomised, open-label, multicentre trial (ADHERE-APP) enrolled a total of 502 patients at 9 university hospitals in South Korea from November 2021 to January 2023. Patients with AF aged ≥19 years requiring oral anticoagulation,and were treated with edoxaban were enrolled. Patients were randomized in a 1:1 ratio to the conventional treatment group and the app conditional feedback group. Patients in the app conditional feedback group used a smartphone application that pushed alarms for taking medication and measuring blood pressure (BP) and heart rate (HR) at specific times of the day. In addition to medication alarms, the habit of measuring one’s BP and HR could improve drug adherence by increasing self-awareness of the disease. The automatic BP machine was connected to the smartphone via Bluetooth and the measured BP and HR were automatically updated on the smartphone app. The primary endpoint was adherence to edoxaban as measured by pill count at 12 and 24 weeks. In addition, we evaluated the differential effect of the smartphone application by age on the primary endpoint. Results Among the 502 patients, the mean age was 66.0±10.0 years and 67.7% were male. Of the 372 patients who completed 12-weeks trial, edoxaban adherence at 12 weeks was high in both arms, with no difference in the primary outcome (96.5% [92.5%-100.0%] vs. 98.0% [93.2%-99.5%], P = 0.488). or in secondary outcomes, including the proportion of patients achieving adherence ≥ 80% or 95%. In patients aged >65 years, adherence to edoxaban was higher in the app conditional feedback group than in the conventional treatment group (95.8% [93.0%-99.5%] vs. 98.0% [95.8%-99.5%], P = 0.049). Conclusions Overall adherence to edoxaban was much higher than expected in patients with AF. There was no difference in edoxaban adherence between the app conditional feedback group and the conventional treatment group, however, in older patients, app feedback increased medication adherence.

Impact of the thin-walled sheath on the distal radial artery occlusion: a randomized trial

Abstract Background Distal transradial access (dTRA) has been increasingly accepted as an alternative to the transradial access (TRA) for coronary angiography (CAG) and/or percutaneous coronary intervention (PCI). Although the dTRA has been significantly associated with better patient comfort, shorter haemostasis time, and fewer vascular access-related complications, such as haematoma and proximal radial artery occlusion (pRAO), it has also been associated with an increased risk of distal radial artery occlusion (dRAO). Purpose The aim of the present study was to investigate whether the 6-Fr thin-walled sheath was superior to the conventional radial sheath with respect to the incidence of distal radial artery occlusion (dRAO) at 24 h after CAG and/or PCI via dTRA. Methods A prospective, single-centre trial of patients who were randomized to undergo CAG and/or PCI with either a 6-Fr thin-walled sheath or a 6-Fr conventional sheath. The primary endpoint was the incidence of dRAO at 24 h postoperatively, as evaluated by Doppler ultrasound. The second endpoints included the puncture success rate, puncture time, the incidence of pRAO, pain during the sheath placement, and other vascular-associated complications. Results A total of 620 patients were included in the study. The mean age of the patients was 66.6± 9.7 years (median age 69.0 years [interquartile range 60.0- 74.0 years]), and 66.3% were men. The baseline patient and procedural characteristics were similar between the two groups. For the primary endpoint, the incidence of dRAO at 24 h after the procedure was 1.0% (3/314) in the thin-walled sheath group and 3.6% (11/306) in the conventional sheath group (RR= 0.266, 95%CI= 0.075-0.943, P= 0.027) according to the intention-to-treat (ITT) analysis. For secondary endpoints, the incidence of pRAO was 0.3% (1/314) in the thin-walled sheath group and 2.3% (7/306) in the conventional sheath group (P= 0.029). No significant difference was observed between the thin-walled sheath and the conventional sheath groups regarding the puncture success rate (92.4% vs. 92.5%, P= 0.952). The severity of pain experienced during the sheath placement was similar between the two groups (VAS 2 vs. 2 P=0.426). Other secondary endpoints, including procedural outcomes and other puncture-related outcomes and access-related complications, were not significantly different between the two groups. Conclusion A thin-walled sheath can reduce the incidence of early-term dRAO in patients who underwent CAG and/or PCI via the dTRA.The primary endpoint of the trial

The clinical outcome reflects the heart rhythm profile after defibrillation for shockable rhythm in refractory out-of-hospital cardiac arrest

Abstract Background The prognosis of refractory out-of-hospital cardiac arrest (OHCA) is generally poor. A recent Prague OHCA study has demonstrated that an invasive approach (including extracorporeal cardiopulmonary resuscitation, ECPR) is a feasible treatment strategy in refractory OHCA. Post-hoc analysis of Prague OHCA showed that patients with initial ventricular fibrillation (VF) had manifested better clinical outcomes than those with non-shockable rhythms irrespective of cardiopulmonary resuscitation (CPR) strategy. However, initial shockable rhythm could deteriorate to a non-shockable rhythm during CPR, mainly after defibrillation. The study aimed to stratify the prognosis of patients according to rhythm profile after initial VF in refractory OHCA during pre-hospital and early hospital periods. Methods The analysis enrolled patients with a witnessed OHCA of presumed cardiac cause, with initial VF, and without early recovery of spontaneous circulation. The primary outcome was a composite of survival with Cerebral Performance in Category (CPC) 1 or 2 at 180 days. Results 155 (median age 56y, 10 % females) patients with initial VF were enrolled. The median (IQR) duration of resuscitation was 54 (33-69) minutes. Overall survival with CPC 1 or 2 was 40.4 %. 71 patients were randomized to invasive CPR arm and 84 subjects were treated with conventional CPR. Out of all invasively treated patients, ECPR (veno-arterial extracorporeal membrane oxygenation, VA ECMO) was used in 56 cases without stable recovery of spontaneous circulation and 8 patients primary allocated in conventional group. A proportion of survival with CPC 1 or 2 varied by rhythm course: ongoing VF (9 / 28; 32 %), recovery of organized rhythm (43 / 63; 68 %), documentation of pulseless electrical activity (7 / 30; 23%), and progression to asystole (4 / 34; 12 %); P < 0.05. Tables 1 and 2 show differences in primary endpoint according to rhythm profile between invasive and conventional study arms. Conclusion Deterioration of initial shockable rhythm to asystole bears a poor prognosis in refractory OHCA even when ECPR is readily available. An invasive approach (including VA ECMO) seems to be beneficial in patients with ongoing VF and with regular electrical activity regardless of effective pulsation.

To analyse the correlation between UAER and eGFR and the risk factors for reducing eGFR in patients with type 2 diabetes

ObjectiveTo analyse the correlation between urinary albumin excretion rate (UAER) and estimated glomerular filtration rate (eGFR) and the risk factors for reducing eGFR in patients with type 2 diabetes mellitus (T2DM).MethodsA total of 431 T2DM patients admitted between January 2019 and March 2020 were selected and divided into two groups according to eGFR level. Comparing the differences between baseline data and clinical indicators, multivariate logistic regression was used to analyse the risk factors of eGFR reduction and to analyse the association between UAER and eGFR.ResultsIn total, 167 patients were included in the study group and 264 patients were included in the conventional group. The study group participants were older, had longer diabetes duration, and had higher fatty liver, peripheral vascular disease (PVD), hypertension prevalence, and mean body mass index (P < 0.05). The levels of various indicators were lower than those of the conventional group (P < 0. 05). Additionally, PVD, nocturnal systolic blood pressure, fatty liver, and beta-2-microglobulin (β 2-MG) were independent risk factors for eGFR decline, with high density lipoprotein (HDL) and fasting C-peptide (CP) as protective factors. There was no obvious correlation between UAER and eGFR.ConclusionPeripheral vascular disease, systolic blood pressure, fatty liver, and beta-2-microglobulin are risk factors for decreased eGFR levels in patients with T2DM, which should be applied for control DKD. HDL and fasting CP have important effects on maintaining eGFR, and blood pressure and fasting CP can be used as new targets for subsequent diabetic kidney disease treatment.

Improved clinical outcome by means of three-dimensional electroanatomically- guided slow pathway elimination with irrigated, contact- force sensing catheter

Abstract Background Slow pathway (SP) ablation, in the context of atrioventricular node reentrant tachycardia (AVNRT) treatment could result in either complete elimination or only modification of the SP with ambiguity regarding associated benefits. Purpose Three-dimensional electroanatomical mapping (3D-EAM) with irrigated, contact-force sensing may be used adjunctively aiming to complete SP elimination. Our purpose was to compare a 3D-EAM based strategy targeting SP elimination to the conventional fluoroscopic approach with respect to clinical outcome. Methods Eighty-four consecutive AVNRT patients (33 males, mean age 50.1±11.7 years) underwent a conventional fluoroscopic ablation approach (N=42) or a 3D-EAM-guided ablation irrigated, contact-force sensing catheter (ThermoCool SmartTouch ST, Biosense Webster, Inc.) focusing on complete SP elimination (N=42). Results Several procedural parameters improved with 3D-EAM use, including fluoroscopy time (2.0±4.3min vs 11±4.0min) and slow pathway elimination frequency (100% vs 50%, all p&amp;lt;0.001). Altogether, over a mean follow-up of approximately 2.0 years, recurrence occurred in 6 of 42 (14.3%) in the conventional group as compared to 1 of 42 (2.4%) in the EAM-based group (P =0.04). Conclusions The present study showed that an EAM-based SP elimination strategy is not only feasible and safe but it is also accompanied by improved clinical outcome in the setting of AVNRT ablation.

Application of Endovenous Laser Treatment Combined with Foam Sclerotherapy for the Minimally Invasive Treatment of Great Saphenous Vein Varicosity

Objective: To evaluate the efficacy of endovenous laser treatment (EVLT) combined with foam sclerotherapy (FS) in the treatment of great saphenous vein varicosity (GSVV). Methods: A total of 50 patients with GSVV, treated between March 2021 and March 2024, were selected and randomly divided into two groups using a random number table. The combination group (25 cases) underwent EVLT combined with FS, while the conventional group (25 cases) underwent EVLT alone. The total effective rate, complication rate, disease severity score, and serological indicators were compared between the two groups. Results: The total effective rate in the combination group was higher, and the complication rate was lower compared to the conventional group (P &lt; 0.05). One week after surgery, the disease severity score in the combination group was lower, coagulation function indicators were better, and inflammatory factor levels were lower compared to the conventional group (P &lt; 0.05). Conclusion: EVLT combined with FS can improve the clinical efficacy in GSVV patients, prevent postoperative complications, reduce disease severity, protect patients’ coagulation function, and alleviate postoperative inflammatory responses, showing significant advantages in combined surgery.

Randomized trial assessing worsening renal function with dapagliflozin addition in acute decompensated heart failure: ROAD-ADHF trial

Abstract Background Dapagliflozin (DAPA), a sodium-glucose co-transporter 2 inhibitor, has shown to reduce cardiovascular mortality in patients with chronic heart failure.1) In addition, DAPA can enhance diuresis in patients with acute decompensated heart failure (ADHF).2) However, there is little known how early initiation of DAPA might impact the worsening renal function (WRF) when combined with standard decongestive therapy for ADHF. Purpose We aimed to evaluate the impact of initiating DAPA within 24 hours after ADHF admission on WRF, compared to standard decongestive therapy with loop diuretics alone. Methods We enrolled consecutive ADHF patients with a left ventricular ejection fraction (LVEF) less than 50%. The patients were prospectively randomized to either the DAPA group who received DAPA at a dose of 10 mg once daily within 24 hours of admission or the conventional therapy group (CON group) who received loop diuretics alone. Furosemide, loop diuretic, dosage was adjusted by increase or decrease of 10 mg to maintain urine output between a 1-2 mL/kg/hour.3) The primary endpoint was the incidence of WRF, which was defined as an increase in the serum creatinine of ≥ 0.3 mg/dL from baseline within 7 days of admission.4) Additionally, right heart catheterization (RHC) was performed before discharge if the consent was obtained. Results From May 2021 to May 2023, we analyzed a total of 114 patients (56 in the DAPA group and 58 in the CON group). The mean age was 73 years, 35% were female, and the mean LVEF was 32.5%. There was no significant difference in the incidence of WRF between two groups (16.1% in the DAPA group vs. 12.1% in the CON group, P=0.54, Figure 1). The cumulative loop diuretics dose over 7 days was lower in the DAPA group than CON group (184 ± 9.64 mg vs. 214 ± 9.81 mg, P=0.03, Figure 2). RHC before discharge was performed in 54 patients (96.4%) in the DAPA group and in 54 (93.1%) in the CON group. There were no significant differences in the pulmonary artery wedge pressure, pulmonary artery pressure, right atrial pressure, and cardiac index by the thermodilution method or the Fick method between two groups. Conclusion This randomized prospective trial revealed the early initiation of DAPA within 24 hours of admission for ADHF reduced loop diuretic demand without inducing WRF compared to standard decongestive therapy.Figure 1Figure 2

Intensive blood pressure lowering after endovascular thrombectomy in acute ischaemic stroke: an updated systematic review and meta-analysis of randomized controlled trials

Abstract Background Endovascular thrombectomy is an effective treatment in those with acute ischemic stroke. However, following successful reperfusion there are still many uncertainties as to the factors which influence patient outcome. Effective blood pressure management in this cohort has been elicited as one of these factors, with worse outcomes seen at both the high and low extremes. Purpose Pinpointing an optimal systolic blood pressure target after this procedure is still uncertain. We aimed to perform an updated meta-analysis of randomised controlled trials (RCTs) to evaluate the safety and efficacy of intensive blood pressure management as compared to conventional blood pressure management in this patient population. Methods We searched various electronic databases, including Embase, MEDLINE (via PubMed), and CENTRAL, to retrieve relevant RCTs evaluating a strategy of intensive blood pressure management after endovascular thrombectomy compared to conventional management. We pooled risk ratio (RR) with 95% confidence intervals (CI) for dichotomous outcomes and mean difference (MD) with 95% CI for continuous outcomes, using RevMan 5.4. Results The meta-analysis included 4 RCTs with a total of 1560 patients. According to the analysis, intensive blood pressure management was associated with a statistically significant decrease in the number of patients showing functional independence (modified Rankin scale mRS score=0-2) at 90 days (RR 0.81; CI = 0.72-0.91; I2 = 12%). Regarding 90-day mortality, the pooled results from three RCTs showed no statistically significant difference between the intensive blood pressure management group and the conventional blood pressure management group (RR 1.17; CI = 0.90-1.52; I2 = 0%). There was no statistically significant difference between the two groups regarding the incidence of intracerebral haemorrhage (ICH) (RR 1.05; CI = 0.90-1.23; I2 = 0%) and the incidence of symptomatic intracerebral haemorrhage (sICH) (RR 1.10; CI = 0.76-1.60; I2 = 0%). Conclusion The meta-analysis showed no benefit of intensive lowering of blood pressure in terms of functional independence at 90 days, mortality rates, and incidence of ICH. Future large-scale trials should focus on other interventions to improve prognosis in these patients.Figure 1Figure 2

Tele-education in point-of-care ultrasound training

BackgroundTraditionally, ultrasound skills have been taught through a one-on-one approach, where instructors physically guide learners’ hands at the bedside or in the workshop. However, this method is frequently challenged by scheduling and cost limitations. Our objective was to create a tele-education model for point-of-care ultrasound training and evaluate its effectiveness and its impact on learners’ perceived workload compared to conventional education and self-directed learning methods.MethodsWe conducted a 3-arm randomized trial, comparing tele-education (TE), conventional education (CE) and self-directed learning (SL) methods. All subjects underwent online didactic lectures prior to a hands-on ultrasound workshop. The TE group utilized an ultrasound machine equipped with a speakerphone, a webcam for direct visualization of learner’s hand maneuvers, and an analog-to-video converter for the real-time streaming of ultrasound images. This configuration enabled remote instructors to provide immediate verbal feedback to learners. In contrast, the CE group received in-person coaching, while the SL group had no instructors present. Following the coaching session, subjects completed a scenario-based skill test and a survey on the National Aeronautics and Space Administration task load index (NASA-TLX) to measure their ultrasound competency and perceived workload, respectively.ResultsTwenty-seven ultrasound novices were randomly allocated into 3 groups. The median skill test score of TE, CE, and SL was 22 [interquartile range (IQR): 18–28], 24 [IQR: 21–31], and 16 [IQR: 15–18], respectively (p < 0.01). Pairwise comparisons of median test scores of 3 groups demonstrated a statistical significance in comparisons of TE vs. SL (22 vs. 16, p = 0.01) and CE vs. SL (24 vs. 16, p < 0.01), but not in TE vs. CE (22 vs. 24, p = 0.56). There was no statistical significance observed in the median NASA-TLX scores among the 3 groups; 54 [IQR:47–61] in TE, 57 [IQR:22–64] in CE, and 66 [IQR: 66–72] in SL (p = 0.05).ConclusionsOur tele-education model was more effective than self-directed learning. There was no statistically significant difference in effectiveness between the tele-education and the conventional education groups. Importantly, tele-education did not impose a significantly higher workload on learners compared to conventional education or self-directed learning. Tele-education has a substantial potential as an alternative to conventional ultrasound training.

Differential effects of heat-not-burn, electronic cigarettes and conventional cigarettes on endothelial glycocalyx

Abstract Background Heat-not-burn cigarette (HNBC) and electronic cigarette (Ecig) constitute non-combustible smoke products. Their effect on endothelial glycocalyx has not been investigated so far. Patients and Methods: Out of 100 subjects attending smoking cessation clinic: α) 50 smokers were randomized to usage of HNBC (n=25) or Ecig (n=25) and β) 50 smokers were used as control group. Participants randomized to the newer tobacco products had similar clinical and demographic characteristics to the control group. Smoking status was verified by measuring the concentration of exhaled carbon monoxide [(e CO) (ppm), Bedfont Scientific, Maidstone, Kent UK]. Perfused Boundary Region (PBR), which is inversely related to endothelial glycocalyx thickness in sublingual arterioles (range 5–25 μm) and blood levels of cotinine, a stable metabolite of nicotine, was assessed in all participants. Exhaled CO, endothelial glycocalyx, and blood cotinine were assessed at baseline and after 1 month. Results Conventional cigarette smokers were aged: 48 ± 5 years, 53% female and used 27 ± 9 cigarettes/day, 29 ± 9 pack-years. HNBC users were aged: 46 ± 14 years, 55% female and used 26 ± 8 cigarettes/day, 30 ± 8 pack-years. Ecig users were aged: 45 ± 8 years, 51% female and used 27 ± 10 cigarettes/day, 28 ± 10 pack-years. Compared to baseline, switching to HNBC for 1 month improved only PBR20-25 (2.55±0.49 vs 2.34±0.34 μm, p=0.002). Ecig use did not alter endothelial glycocalyx in any range of microvessels throughout the study (p&amp;gt;0.05). In contrast, Tcig smoking for one month further worsened endothelial glycocalyx in all microvessels ranges compared to baseline (p&amp;lt;0.05). Blood cotinine levels were similar at baseline and after 1 month using HNBC (p=0.432), Ecig (p=0.535) or conventional cigarette (p=0.489). Compared to baseline, exhaled CO decreased in HNBC or Ecig users (mean percent change: -55% and -58% respectively p&amp;lt;0.001), while remained unchanged in Tcig smokers (p=0.312) at 1 month. Thus, Tcig smokers had higher CO than those who switched to HNBC or E-cig after one month (p&amp;lt;0.01). Conclusion Conventional cigarette users further worsened endothelial glycocalyx after continuing to smoke for one month. In contrast, smokers who switched to Ecig maintained glycocalyx integrity, while those who switched to HNBC showed modest improvement in glycocalyx integrity in microvessels ranging from 20 to 25 μm. Cotinine levels, which reflect nicotine exposure, were similar between the Tcig, HNBC and Ecig groups. Thus, endothelial glycocalyx impairment in the conventional cigarette group was independent of nicotine consumption and possibly related to greater exposure to toxic emissions, such as CO, after Tcig use than after switching to HNBC or Ecig.

Modern heart failure treatment is superior to conventional treatment across the left ventricular ejection spectrum: Real-life data from the Swedish Heart Failure Registry 2013-2020

Abstract Background Heart failure (HF) is a clinical syndrome characterized by high mortality and morbidity. In 2016, Sacubitril/valsartan, an angiotensin receptor-neprilysin inhibitor (ARNI), was recommended as a new treatment option for HF in patients with HFrEF. In the 2021 European Society of Cardiology guidelines for treatment of HFrEF patients Sodium-glucose cotransporter 2 inhibitors (SGLT2i) were introduced because they demonstrated significantly reduced HF events or cardiovascular (CV) mortality. Since ARNI and SGLT2i were introduced to treat HF, its therapeutic regimen has modernized from previous treatment with beta-blocker (BB) and angiotensin-converting enzyme inhibitor (ACEi)/angiotensin II receptor blocker (ARB) with mineralocorticoid receptor antagonist (MRA) as added-on in HF with reduced ejection fraction (HFrEF). Purpose This study is aimed to compare effectiveness of modern therapy including ARNI and SGLT2i with conventional heart failure treatment. Conventional HF treatment includes (BB, ACEi/ARB, with or without MRA) and modern heart failure treatment (BB, ACEi/ARB, MRA, SGLT2i or BB, ARNI, MRA with/without SGLT2i) in real-world. Methods This observational study (2013-2020), using the Swedish HF Registry, involved 20,849 HF patients. Patients received either conventional (BB, ACEi/ARB, with/without MRA, n=20,140) or modern (BB, ACEi/ARB, MRA, SGLT2i or BB, ARNI, MRA with/without SGLT2i, n=709) treatment at the index visit. The endpoints were all-cause and cardiovascular (CV) mortality. Results Modern HF therapy was associated with a significant 28% reduction in all-cause mortality compared to conventional HF treatment (adjusted HR [aHR]: 0.72 (95% CI 0.54 - 0.96), p=0.024), and had 33% reduced all-cause mortality (aHR: 0.67 (95% CI 0.48 - 0.94), p=0.019) within 2 years of index registration. Similarly, modern HF therapy was associated with a significant 62% reduction in CV mortality compared to conventional HF treatment (aHR: 0.38 (95% CI 0.21 - 0.68), p=0.0013). In addition, we found a 58% reduced CV mortality (aHR 0.42 (95% CI 0.22 - 0.79), p=0.0067) within 2 years of index registration. In the propensity score 1:1 matched cohort in which ARNI was included in the matching procedure, i.e., no ARNI was used in any of the two treatment groups and the effect of SGLT2i was the target assessment. The results were associated with a statistically significant risk reduction of 42% in all-cause mortality in the modern HF treatment group compared to the conventional treatment group (aHR: 0.58 (95% CI 0.36 - 0.94), p=0.028), and a 49% (aHR: 0.51 (95% CI 0.29 - 0.89), p=0.018) risk reduction within 2 years of index registration. Conclusion This study demonstrates that modern HF therapy in a real-world Swedish HF population is associated with a statistically significant risk reduction in all-cause and CV mortality, regardless of EF, sex, age, eGFR, and etiology of HF compared to conventional HF therapy.Central Illustration

Collision mapping enables accurate localization of the slow pathway in atrioventricular nodal reentrant tachycardia

Abstract Introduction Atrioventricular Node Reentry Tachycardia (AVNRT) is commonly treated with catheter ablation, with high success and low complication rates. However a small risk of complete AV block still remains. Recent studies could show that using collision map is a feasible approach in mapping the slow pathway. The aim of the current study is to show a reduction of the total ablation points needed to modify/ablate the slow pathway using the collision mapping compared to conventional 3D mapping guided slow pathway modulation/ablation and therefore minimize the risk of a complete heart block. Methods Patients diagnosed with AVNRT (n = 24) underwent collision mapping for slow pathway identification, compared to a historical cohort (n=76) using conventional mapping. For collision mapping a dynamic visualization of atrial propagation during sinus rhythm was condcted. Two propagation fronts were observed to collide at the triangle of Koch, one propagation through the slow and one through the fast pathway. The designated collision zone was considered ideal for catheter ablation (Figure 1). The endpoint after ablation in both groups was non-inducibility of AVNRTs. Results After propensity score matching the collision mapping group needed significantly fewer ablation impulses (2 (IQR 1 - 5) vs. 6 (IQR 2,5 - 11,5) p = 0.002) and shorter ablation time (p &amp;lt; 0.001) compared to the conventional group (Table 1). No significant differences were observed in procedure time (p = 0.209), fluoroscopy time (p = 0.296), or dose area product (p = 0.391). Conclusion Collision Mapping in AVNRT ablation showed a notable reduction in ablation points, suggesting enhanced procedural efficiency and safety.Figure 1Table1

Three-dimensional-printed guide plate for direct percutaneous pedicle screw implantation in minimally invasive transforaminal lumbar interbody fusion surgery: a retrospective study of 162 patients

BackgroundThis study aimed to investigate the impact of three-dimensional (3D)-printed guide plate-assisted percutaneous pedicle screw implantation on minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) surgery.MethodsOverall, 162 patients who underwent MIS-TLIF at Tai’an City Central Hospital were retrospectively reviewed. The studied variables included operative time, volume of intraoperative blood loss, fluoroscopy time, postoperative drainage volume, visual analogue scale (VAS) score, Oswestry disability Index (ODI) score (preoperatively and at 2 weeks, 3 months, 6 months, and 12 months after surgery), and intervertebral fusion rate at 6 months after surgery.ResultsThe conventional group included 99 patients who underwent a conventional procedure, while the 3D printing group included 63 patients who underwent 3D-printed guide plate-assisted percutaneous pedicle screw implantation. The conventional group required more times of positioning needle punctures than the 3D printing group (22.2 ± 5.9 vs. 16.1 ± 4.9). The operation and fluoroscopy time were also longer in the former group (183.5 ± 51.1 min vs. 148.8 ± 40.3 min and 30.2 ± 5.9 s vs. 24.1 ± 4.9 s, respectively). In 3D printing group, lower back pain VAS scores and ODI scores at 2 weeks and 3 months after surgery were observed. There were no significant differences in terms of the volumes of intraoperative blood loss; postoperative lower limb pain VAS scores; and interbody fusion rate (P > 0.05).ConclusionThe novel 3D-printed guide plate-assisted percutaneous pedicle screw implantation can achieve better amelioration of back pain and recovery of function. It also reduced the times of positioning needle puncture and fluoroscopy time during percutaneous screw placement surgery and reduced the duration of surgery.

Comparison of surgical performance using articulated (ArtiSential®) and conventional instruments for colorectal laparoscopic surgery: A single-centre, open, before-and-after, prospective study.

Rigid surgical instruments limit movement whereas articulated instruments offer better control in small spaces and allow for intuitive and ergonomic movements. However, the effectiveness of the use of articulated instruments in improving colorectal laparoscopic outcomes remains unclear. The aim of this work was to determine whether colorectal laparoscopic surgical proficiency improved when multijoint instruments were used instead of conventional ones. We enrolled 70 consecutive patients (n = 20 for conventional instruments) aged 19-80 years who underwent elective laparoscopic surgery for colorectal diseases. Unedited surgery videos were validated using the modified Global Operative Assessment of Laparoscopic Skills (mGOALS) scale. Learning curves were analysed using a cumulative sum control chart for mGOALS grades. The surgery type, length of hospital stay and 30-day postoperative complication rates were comparable between the groups, and the surgeon's mGOALS grades were similar (p = 0.190). However, in the articulated group, the scores were significantly higher for depth perception (p = 0.012) and tissue-handling domains (p = 0.046), while surgical duration was significantly shorter and intraoperative blood loss was significantly lower (p = 0.022), compared with those in the conventional (p = 0.002) group. Learning curve findings indicated that the first 10 and subsequent 40 surgeries in the articulated group were within the inexperienced and experienced phases, respectively. The mGOALS score in the experienced phase improved in the articulated group compared with that in the conventional group (p = 0.036). The use of articulated instruments in laparoscopic colorectal surgery showed potential benefits. Further studies are needed to confirm these findings.

Effect of groove splint fixation on early swelling and blood flow velocity of the injury limb in elderly patients with distal radius fractures

To observe the effects of groove splint fixation on early hand swelling, blood flow velocity, and clinical function in elderly patients with distal radius fractures. Between March 2021 and February 2022, 64 patients of unilateral closed distal radius fractures were treated with manual reduction and external fixation with splints. There were 10 males and 54 females, the age ranged from 60 to 78 years old, with an average age of (67.7±4.7) years old. According to the order of admission, the patients were divided into the groove splint group and the conventional splint group, with 32 cases in each group. In the groove splint group, there were 4 males and 28 females, with an average age of (68.6±4.8) years old. There were 13 patients with left-sided fractures, and 19 patients with right-sided fractures, with 22 cases classified as AO type A and 10 cases as AO type C. The mean time from injury to treatment was 3.0 (2.0, 4.0) h. In the conventional splint group, there were 6 males and 26 females, with an average age of (66.9 ± 4.4) years old. There were 17 patients with left-sided fractures and 15 patients with right-sided fractures, with 20 cases classified as AO type A and 12 cases as AO type C. The mean time from injury to treatment was 3.0 (2.0, 5.0) h. After manual reduction, patients were treated with groove splint or conventional splint. Swelling, assessed by the difference in limb circumference between the injured and healthy limbs, was measured at 1, 3, 7, and 14 days post-treatment. Blood flow velocities in the superficial palmar arch and dorsal metacarpal veins were measured at 1, 3, and 7 days post-treatment. Radiographic evaluations of radial styloid height, palmar tilt, and ulnar variance were performed preoperatively and 3 months post-treatment. Functional outcomes were assessed using the DASH (Disabilities of the Arm, Shoulder, and Hand) score 3 and 12 months post-treatment. Statistical analyses were conducted to compare the outcomes between the two groups. All 64 patients were followed up for the least 12 months. The swelling value of the palm in the groove splint group [(1.897±0.071) cm, (1.200±0.169) cm, (0.994±0.085) cm] was significantly improved compared to the conventional splint group[(2.283±0.268) cm, (1.893±0.269) cm, (1.183±0.126) cm] on days 3, 7, and 14 days posttreatment, with a statistically significant difference (P<0.001). On the first and third day after splint fixation, the difference in blood flow velocity of the superficial palmar arch in the groove splint group(0.017±0.009), (0.018±0.011) L·min-1 were lower than that in the conventional splint group(0.023±0.011), (0.025±0.013) L·min-1, with statistical significance (P<0.05). On the 3rd and 7th days, the difference was not statistically significant (P>0.05). Comparison of blood flow velocity differences between the dorsal metacarpal vein and the two groups showed no statistically significant difference on the first day after splint fixation (P>0.05). On the 3rd and 7th days, the blood flow velocity difference between the groove splint group[(0.037±0.019), (0.021±0.013) L·min-1] decreased compared to the conventional splint group[(0.062±0.033), (0.037±0.022) L·min-1], and the difference was statistically significant (P<0.05). There was no statistically significant difference in the palm angle, ulnar deviation angle, and radius height of the distal radius before and after reduction (P>0.05). The DASH score showed a statistically significant difference at follow-up 3-month[(6.1±2.8) scores vs (8.2±3.7) scores] , P<0.05, but no statistically significant difference at follow-up 12-month (P>0.05). Fixing distal radius fractures with groove splints in the early stage can reduce the impact on the blood flow velocity of the superficial palmar arch and dorsal palmar vein, reduce venous reflux obstruction and swelling of injury limb, alleviate wrist and finger joint stiffness, and improve early clinical efficacy of the affected limb. However, it has no significant impact on clinical function one year after injury.

Impact of CT attenuation correction on viable myocardium detection in combined SPECT and PET/CT: A retrospective cohort study.

The influence of computed tomography attenuation correction (CTAC) on the accuracy of diagnosing viable myocardium using Tc-99m-MIBI dedicated cardiac cadmium-zinc-telluride (CZT) single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) combined with F-18-FDG Positron Emission Tomography/Computed Tomography (PET/CT) metabolic imaging, compared with conventional SPECT MPI, remains to be fully elucidated. To evaluate the impact of CTAC on the accuracy of diagnosing viable myocardium using Tc-99m-MIBI dedicated cardiac CZT SPECT MPI combined with F-18-FDG PET/CT, compared to conventional SPECT MPI. 193 patients underwent CZT SPECT and F-18-FDG PET/CT imaging, while 39 patients underwent conventional SPECT and F-18-FDG PET/CT imaging, with both groups utilizing CT for attenuation correction. The injured myocardium (hibernating and scarring) was quantified using the Q.PET software. After CTAC, both groups showed significant improvements in perfusion of the injured myocardial areas, particularly in the inferior wall (INF). The reduction in perfusion was more notable in the CZT SPECT group than that in the conventional group, particularly in the inferior and lateral walls. Among patients with large cardiac chambers, those undergoing MPI with CZT, with normal weights, or males, hibernating myocardium (HM) and scar post-CTAC reductions were particularly significant in the INF. If HM ≥ 10% is considered an indicator for recommended revascularization, among the 87 patients without prior cardiac bypass, 25 (28.7%) might not require revascularization treatment. Dedicated cardiac CZT SPECT and conventional SPECT MPI combined with F-18-FDG PET/CT significantly influenced the assessment of viable myocardium. The impact of CTAC was more profound in dedicated cardiac CZT SPECT, particularly in the INF region. CTAC significantly enhances the accuracy of viable myocardial assessment and may influence clinical decisions regarding revascularization therapy. Therefore, CTAC should be routinely used in dedicated cardiac CZT SPECT MPI combined with F-18-FDG PET/CT for myocardial viability diagnosis.

Effectiveness of 2 Lip Taping Techniques in Infants With Bilateral Cleft Lip and Palate: A Randomized Clinical Trial.

This trial was designed to test the efficacy of 2 lip taping methods in modifying the maxillary arch dimensions (MADs) of infants with bilateral cleft lip and palate (BCLP) before lip repair surgery. Parallel-group randomized clinical trial. The trial was conducted at 3 centers in Baghdad city. Thirty-six nonsyndromic infants with BCLP. The eligible infants were randomly assigned to either the first experimental group that received a conventional horizontal tape (3 M Steri strip-1/4 inch) or the second experimental group that received a custom-made tape made of Steri strips and orthodontic extra oral elastics. All of the included infants in both groups had rubber base impressions taken for them at the start of treatment (T1) and right before surgical lip repair (T2). A desktop scanner was used to scan each of the generated models, creating digital models that could be used for outcome evaluation. Virtual MAD measurements were performed by a blinded assessor on the generated digital models both before (T1) and after (T2) treatment. At T2, both groups showed statistically significant changes in all measured MADs, with a mean difference ranging from 1.36 to 2.95 mm for the conventional taping group and from 1.46 to 7.96 mm for the custom-made one. The comparison of the 2 groups revealed both statistically and clinically significant differences with a P value <.05. The custom-made taping demonstrated more constriction in maxillary arch in terms of changes, which could provide easier surgical manipulation for the cleft parts. Lip taping appears to be an efficient technique for modifying the MADs in infants with BCLP.

Postoperative early initiation of sequential exercise program in preventing persistent spinal pain syndrome type-2 after modified transforaminal lumbar interbody fusion: a prospective randomized controlled trial.

This prospective randomized controlled trial aimed to investigate the impact of early postoperative sequential motor control (starting first day post-operatively) and core stabilization training (starting fifth week post-operatively) compared to conventional exercise (starting fifth weeks post-operatively) on the risk of developing persistent spinal pain syndrome type-2 (PSPS-T2). 395 patients with lumbar degenerative diseases (LDDs) undergoing modified transforaminal lumbar interbody fusion and a 12-week postoperative exercise program (sequential vs. conventional exercise: 214 vs. 181) were evaluated for low back pain (LBP) intensity, Oswestry Disability Index (ODI), pressure pain threshold (PPT), temporal summation (TS), fatty infiltration of paraspinal muscles, transversus abdominis (TrA) activation capacity and Fear-Avoidance Beliefs Questionnaire (FABQ) pre-operatively, 3 months post-operatively, and 1 year post-operatively. At 3-month postoperative assessment, LBP in sequential exercise group were lower than those in conventional exercise group (P < 0.05), and sequential-exercise patients had greater local-area PPTs, lower TS, lower TrA activation capacities and less fatty infiltration of erector spinae than did the conventional-exercise patients (P < 0.05). At 1-year postoperative assessment, fewer sequential-exercise patients had PSPS-T2 compared with conventional-exercise patients (11/214 vs. 20/181; P < 0.05). LBP at rest and FABQ were lower in sequential-exercise patients than conventional-exercise patients (P < 0.05). Furthermore, both PPT and TS at 1-year postoperative assessment were associated with these measurements at 3-month postoperative assessment in patients with PSPS-T2 (P < 0.05). Postoperative sequential exercise has more positive effects to avoid PSPS-T2 than conventional exercise in patients with LDDs possibly because of its advantages in improving central and peripheral sensitization.

The effect of blended tube feeding compared to conventional formula on clinical outcomes in adults: A systematic review.

To explore the effect of blended tube feeding compared to conventional formulas on nutritional status, quality of life, anthropometry, diarrhoea and tube blockages in adults receiving tube feeding. The protocol was registered (PROSPERO CRD42022372443). Five databases (MEDLINE, EMBASE, CINAHL, Scopus, CENTRAL) were searched from commencement of database to 14th June 2023 to identify studies comparing blended tube feeding to conventional formulas in adults receiving tube feeding. Certainty assessment was conducted using the Cochrane Risk of Bias Tools and the Grading of Recommendations, Assessment, Development and Evaluations framework, and a narrative synthesis of results is provided. From 4227 studies screened, eight were included (total n = 763 patients, 9-215 patients). Three studies were hospital-based and five were home-based with duration from 8 days-8 months. Blended tube feeding and conventional formulas were nutritionally equivalent in only three studies; energy and protein concentration of formulas ranged from 1.7-7.1 kJ/mL and 21-68.5 g/L for the blended tube feeding groups, and 4.2-6.7 kJ/mL and 39-100 g/L for the conventional groups. No studies assessed nutrition status or quality of life using validated measures. Blended tube feeding was associated with a clinically relevant reduction in diarrhoea with a low level of certainty. For remaining outcomes, there were inconclusive findings and an overall very low certainty of evidence for each. The effect of blended tube feeding compared to conventional formulas on all outcomes remains uncertain. Blended tube feeding may reduce the incidence of diarrhoea. Future research using nutritionally equivalent comparisons and validated outcome measures is required.

Conventional vaginal approach vs. transvaginal natural orifice transluminal endoscopic surgery for treating apical prolapse, a randomized controlled study

ObjectiveVaginal hysterectomy combined with uterosacral suspension (USLS) is a technique for treating pelvic organ prolapse. Vaginal natural orifice transluminal endoscopic surgery (vNOTES) has been described as an alternative minimal invasive approachfor treating various gynecological and non-gynecological pathologies. The aim was to compare the surgical time between conventional vaginal hysterectomy combined with USLS and vNOTES hysterectomy combined with USLS. Study designMulti-center randomized controlled trial performed 2019–2021 at Rambam Health Care Campus (Israel) and Imelda Hospital (Belgium). Thirty women underwent vNOTES procedures and 30 women underwent conventional vaginal procedures. The primary outcome was total surgical time. Secondary outcomes included hysterectomy time, USLS time, intraoperative bleeding, length of hospitalization, pain during the first 24 h postoperative, the need of analgesia, intraoperative and postoperative adverse events, and patient-reported outcomes questionnaires. Parametric statistical methods were used to analyze the data. ResultsCompared to conventional vaginal procedures, vNOTES procedures were shorter in total surgical time (77 vs. 93 min, p = 0.004), hysterectomy time (26 vs 33 min, p < 0.001), and USLS time (20 vs 26 min. p = 0.02). Blood loss was higher in conventional vaginal compared to vNOTES surgery, as reflected by the mean blood loss estimate (143 vs 60 ml. p < 0.001) and the delta-hemoglobin (pre-operation minus the post-operation hemoglobin level (1.8 vs 1.2 ml/dL, p = 0.01). There was no difference between the groups regarding analgesics used, postoperative pain, surgical objective outcomes, and scores on patient-reported outcomes questionnaires. Adverse events were significantly more frequent in the conventional vaginal group than in the vNOTES group (p < 0.001 for intraoperative events and p = 0.05 for events that occurred in the follow-up time interval). ConclusionvNOTES hysterectomy with USLS has lower surgical times than conventional vaginal hysterectomy with USLS, lower blood loss and less adverse events. Other surgical objective and subjective outcomes were similar between the approaches.