Determination of Treatment Efficacy after Revascularization of Intermittent Claudication Patients by Physical Function Assessment.

PURPOSE: There have been few reports examining changes in physical activity (PA) after revascularization of lower extremities from the perspective of physical function at discharge. The purpose of this study was to clarify the effects of physical function before discharge on the amount of PA after discharge in patients who underwent revascularization. METHODS: The subjects were 34 Fontaine class II patients admitted for elective surgical revascularization or endovascular treatment at two hospitals from September 2017 to October 2019. Triaxial accelerometers were used to measure changes in sedentary behavior (SB) before admission and 1 month after discharge. Multiple regression analysis was performed on the 6-min walking distance (6MWD) at the time of discharge and the change in SB 1 month after discharge; the cutoff value was calculated from the receiver operating characteristic (ROC) curve. RESULTS: SB 1 month after discharge significantly decreased in the decreased SB group compared to the increased SB group (575.5 [400-745.2] vs. 649.5 [453.8-809.2], p <0.01). ROC curve was plotted with SB increase/decrease as the dependent variable and 6MWD at discharge as the independent variable; the cutoff value was 357.5 m. CONCLUSION: 6MWD measurement at discharge may help predict changes in SB after discharge.

Iliac vein variation in the sacral promontory on three-dimensional computed tomography angiography: a prospective observational study before laparoscopic sacrocolpopexy.

INTRODUCTION AND HYPOTHESIS: Venous injury may occur during exposure of the anterior longitudinal ligament at the anterior sacral promontory (SP). We aimed to quantitatively measure the extent of the vascular window (VW) in front of the SP in patients with internal iliac vein (IIV) variations using preoperative three-dimensional computed tomography angiography (3DCTA). We hypothesized that patients with IIV variations would have a narrow VW. METHODS: This prospective observational study included patients scheduled for laparoscopic sacrocolpopexy (LSC) between July 2022 and April 2023 who underwent preoperative 3DCTA. The primary endpoint was the VW measurement in the standard and variant IIV groups using 3DCTA before LSC. The secondary endpoint was the difference between the two IIV groups adjusted for age, body mass index, hypertension, and diabetes using an analysis of covariance (ANCOVA) model. Multiple regression analysis was performed to analyze the effect of factors on the distance from the SP to great vascular bifurcations. RESULTS: There were 20 cases of IIV variation (20.2%). VW was 28.8 ± 12.4 mm in the variant group and 39.6 ± 12.6 mm in the standard group (p = 0.001). In the ANCOVA model, IIV variations affected VW (coefficient, -11.8; 95% confidence interval [CI], -18.4 to -5.08, p < 0.001). Multivariate analysis revealed that the aorta-SP distance decreased with age (coefficient, -0.44; 95% CI, -0.77 to -0.11, p = 0.009). CONCLUSIONS: One in five women has a vascular variant at the SP that restricts the "safe" zone of fixation to < 3 cm.

Mirabegron versus vibegron in previously untreated female patients with overactive bladder: A randomized, single-clinic, open-label trial.

OBJECTIVES: This study aimed to assess the efficacy and safety of mirabegron compared with vibegron (both 50 mg once daily) in Japanese female patients with symptoms of overactive bladder (OAB). METHODS: This prospective, 12-week, two-arm, parallel-group, open-label randomized trial (UMIN000038288) was conducted at a single clinic from December 2019 to September 2022. The primary efficacy outcome measure was the change in mean total overactive bladder symptom scores (OABSSs) from baseline to end of treatment (EOT) (Week 12). The secondary efficacy outcome measures were changes in mean International Prostate Symptom Score from baseline to EOT, the ratio of patients who achieved a minimal clinically important change (MCIC) of total OABSS, and individual domains of the King's Health Questionnaire. Safety assessments, such as adverse events (AEs), postvoid residual volume, and patient-reported incidences, were recorded at every visit. RESULTS: There was no statistically significant adjusted mean difference between mirabegron and vibegron in terms of the primary outcome of the mean change from baseline to EOT in the total OABSS. The difference in the percentage of patients in the mirabegron and vibegron groups achieving an MCIC on the total OABSS was not statistically significant but appeared to be clinically important. The incidence of treatment-related AEs was significantly higher for the vibegron group (38.5%) than the mirabegron group (19.1%) (p = .047). CONCLUSIONS: These results showed that both drugs were effective in female OAB patients, with no significant differences in terms of efficacy. However, the safety of vibegron requires further investigation.

Comparison of outcomes of laparoscopic sacrocolpopexy with concomitant supracervical hysterectomy or uterine preservation.

INTRODUCTION AND HYPOTHESIS: Sacrocolpopexy was traditionally performed for post-hysterectomy prolapse or during concurrent hysterectomy. Sacrocolpopexy outcome with uterine preservation is poorly investigated. This study compared outcomes of laparoscopic sacrocolpopexy with concurrent supracervical hysterectomy or uterine preservation. METHODS: This retrospective study compared data of patients with pelvic organ prolapse who underwent laparoscopic sacrocolpopexy with uterine preservation with the data of controls who underwent laparoscopic sacrocolpopexy with supracervical hysterectomy. We analyzed composite failure in uterine preservation versus concurrent supracervical hysterectomy (primary objective) and evaluated factors associated with the primary outcome of composite failure after laparoscopic sacrocolpopexy with preservation or supracervical hysterectomy (secondary objective). Composite failure was defined as subjective bulge symptoms, reoperation, or anatomical prolapse. Cox models indicated time to composite failure as an endpoint. RESULTS: Of 274 patients, 232 underwent laparoscopic sacrocolpopexy with supracervical hysterectomy and 42 underwent laparoscopic uterine preservation. After propensity score matching (ratio: 2, for the laparoscopic sacrocolpopexy with supracervical hysterectomy group), 56 patients (24.1%) were in the supracervical hysterectomy group and 28 (66.7%) in the uterine preservation group. All patients underwent 24 months of follow-up. The composite failure rates were 10.7% for supracervical hysterectomy and 3.6% for preservation (p=0.87). The mean estimated blood loss was 10 ml (preservation, 10.0 ml [5.0-10.0] versus supracervical hysterectomy, 10.0 ml [10.0-15.0]; p=0.007). In the Cox proportional hazards model, higher preoperative body mass index and the point Ba increased composite failure risk. CONCLUSIONS: Although not statistically significant, composite failure in the two techniques is likely clinically meaningful.

Medium-Term Risk of Recurrent Pelvic Organ Prolapse within 2-Year Follow-Up after Laparoscopic Sacrocolpopexy.

Objective: The present study was performed to determine the risk of recurrent pelvic organ prolapse (POP) within 2 years after laparoscopic sacrocolpopexy (LSC) in patients with uterovaginal prolapse. Materials and Methods: A retrospective comparative study was performed in a population of 204 patients over a 2-year follow-up period following LSC with concomitant supracervical hysterectomy or uterine preservation at a single urological clinic between 2015 and 2019. The primary outcome was surgical failure following LSC in cases of POP, focusing on failures occurring before the 2ndyear of follow-up. Logistic regression analysis was used to determine the odds ratios (ORs) for surgical failure. Results: The primary outcome, surgical failure in cases of POP, occurred 2 years after the initial surgery in 19 of the 204 patients (9.3%) (95% confidence interval [CI], 5.7% - 14.2%). Surgical failure was most common in the anterior compartment (n = 10, 4.9%), and further surgery was performed in seven of the patients with surgical failure (3.4%). The poor primary outcome was predicted by lysis of adhesions (OR, 7.5, 95% CI, 1.6-33.8, P = 0.008) and preoperative POP stage IV (OR, 3.5; 95% CI, 1.1-10.8, P = 0.03) on multivariable logistic regression analysis. Conclusion: The overall rate of surgical failure following LSC in our cohort was 9.3% over the 2-year follow-up period after surgery, and preoperative prolapse stage IV was associated with a higher risk of recurrence.

Association between hospital-acquired functional decline and 2-year readmission or mortality after cardiac surgery in older patients: a multicenter, prospective cohort study.

BACKGROUND: Hospital-acquired functional decline (HAFD) is a new predictor of poor prognosis in hospitalized older patients. AIMS: We aimed to assess the impact of HAFD on the prognosis of older cardiac surgical patients 2 years after discharge. METHODS: This multicenter prospective cohort study assessed 293 patients with cardiac disease aged ≥ 65 years who underwent cardiac surgery at 7 Japanese hospitals between June 2017 and June 2018. The primary endpoint was the composite outcome of cardiovascular-related readmission and all-cause mortality 2 years after discharge. HAFD was assessed using the total Short Physical Performance Battery at hospital discharge. RESULTS: The primary outcome was observed in 17.3% of the 254 included patients, and HAFD was significantly associated with the primary outcome. Female sex (hazard ratio [HR], 2.451; 95% confidence interval [CI] 1.232-4.878; P = 0.011), hemoglobin level (HR, 0.839; 95% CI 0.705-0.997; P = 0.046), preoperative frailty (HR, 2.391; 95% CI 1.029-5.556; P = 0.043), and HAFD (HR, 2.589; 95% CI 1.122-5.976; P = 0.026) were independently associated with the primary outcome. The incidence rate of HAFD was 22%, with female sex (odds ratio [OR], 1.912; 95% CI 1.049-3.485; P = 0.034), chronic obstructive pulmonary disease (OR, 3.958; 95% CI 1.413-11.086; P = 0.009), and the time interval (days) between surgery and the start of ambulation (OR, 1.260, 95% CI 1.057-1.502; P = 0.010) identified as significant factors. DISCUSSION: HAFD was found to be an independent prognostic determinant of the primary outcome 2 years after discharge. CONCLUSION: HAFD prevention should be prioritized in the hospital care of older cardiac surgery patients.

Medium-term outcomes 2 years after laparoscopic sacrocolpopexy: a retrospective cohort study in Japan.

This study was performed to investigate medium-term outcomes and reoperation rates after laparoscopic sacrocolpopexy (LSC). We examined 119 patients undergoing LSC for symptomatic pelvic organ prolapse (POP). The primary outcomes were subjective failure and anatomical failure at 2 years; a score ≥ 2 on question 3 of the PFDI-20 was considered to indicate subjective failure. POP-Q stage 2 or higher in any compartment was considered to indicate anatomical failure. Secondary outcomes were reoperations for POP recurrence, mesh-related complications, and stress urinary incontinence (SUI). The rates of subjective failure and anatomical failure were 4.2% (n = 5) and 9.2% (n = 11), respectively. Reoperations were needed in 13.4% (n = 16) of patients, including SUI with tape procedure in 7.5% (n = 9), POP recurrence in 4.2% (n = 5), and mesh-related complications in 1.6% (n = 2). The subjective failure rate at 2 years after LSC was acceptably low.Impact StatementWhat is already known on this subject? Laparoscopic sacrocolpopexy (LSC) has clinical efficacy equivalent to open sacrocolpopexy, and there is evidence that LSC involves less blood loss and shorter length of hospital stay. However, there is still insufficient evidence to assess medium-term outcomes after LSC in Japan.What the results of this study revealed? The findings of this study showed excellent medium-term rates of subjective failure (4.2%) and anatomical failure (8.4%) after LSC. We demonstrated that patients with persistent postoperative vaginal bulge (subjective failure) also had no improvement in postoperative urinary and colorectal symptoms. Our cohort had low rates of reoperation (13.4%) after LSC. The most common reoperations were for stress urinary incontinence (SUI) (7.5%), followed by pelvic organ prolapse (POP) recurrence (4.2%) and mesh-related complications (1.6%).What are the implications of these findings in clinical practice and/or further research? This study showed that LSC is a safe and effective treatment for POP. Comparative evaluation of anatomical outcomes and the patient's condition is required to understand the extent to which LSC positively impacts a woman's pelvic floor-related quality of life.

Hospital-Acquired Functional Decline and Clinical Outcomes in Older Cardiac Surgical Patients: A Multicenter Prospective Cohort Study.

This study aimed to determine the effect of hospital-acquired functional decline (HAFD) on prognosis, 1-year post-hospital discharge, of older patients who had undergone cardiac surgery in seven Japanese hospitals between June 2017 and June 2018. This multicenter prospective cohort study involved 247 patients with cardiac disease aged ≥65 years. HAFD was defined as a decrease in the short physical performance battery at hospital discharge compared with before surgery. Primary outcomes included a composite outcome of frailty severity, total mortality, and cardiovascular readmission 1-year post-hospital discharge. Secondary outcomes were changes in the total score and sub-item scores in the Ki-hon Checklist (KCL), assessed pre- and 1-year postoperatively. Poor prognostic outcomes were observed in 33% of patients, and multivariate analysis identified HAFD (odds ratio [OR] 3.43, 95% confidence interval [CI] 1.75-6.72, p < 0.001) and low preoperative gait speed (OR 2.47, 95% CI 1.18-5.17, p = 0.016) as independent predictors of poor prognosis. Patients with HAFD had significantly worse total KCL scores and subscale scores for instrumental activities of daily living, mobility, oral function, and depression at 1-year post-hospital discharge. HAFD is a powerful predictor of prognosis in older patients who have undergone cardiac surgery.

Effect of Home-based Exercise Therapy for Peripheral Arterial Disease Patients Underwent Endovascular Treatment: A Clinical Controlled Design.

OBJECTIVE: This study aimed to clarify the effect of home-based exercise therapy on physical activity in peripheral arterial disease (PAD) patients after EVT. METHODS: Study design was controlled clinical design. The subjects were 30 patients (76.6% men) who underwent EVT in the Sakakibara Heart Institute of Okayama. Patients with EVT meeting the inclusion criteria were divided into two groups, intervention group (Home-based exercise) and control group. Patients' basic characteristics, the number of steps walked and QOL questionnaire (WIQ, SEPA, Vascu QOL) were assessed before surgery and, at the 3 month after discharge. A two-way analysis of variance (ANOVA) was performed to compare number of steps walked and QOL questionnaire. RESULTS: Interaction effect were observed in the number of steps walked (F (1,28) =13.89, p<0.01). A multiple comparison test confirmed a significant increase between results of before surgery and at three months after surgery in the intervention group (p<0.01). An interaction between the presence and absence of intervention was found for the WIQ pain score (F(1,28) = 5.86, p=0.01), speed score (F(1,28) = 3.80, p=0.04) and SEPA (F(1,28) = 4.99, p=0.03). In a multiple comparison study, there was a significant increase in WIQ pain and speed scores in both groups before and 3 months after discharge from the hospital. CONCLUSION: Home-based exercise therapy using physical activity indices has the potential to improve number of steps and quality of life in patients with PAD after EVT.

Perioperative changes in physical performance affect short-term outcome in elderly cardiac surgery patients.

AIM: The effect of changes in physical performance during the perioperative period on the prognosis of older patients undergoing cardiac surgery has not been studied in detail. This study aimed to investigate the effect of perioperative changes in physical performance on the prognosis of older patients undergoing cardiac surgery. METHODS: A total of 223 patients were graded as either frail or non-frail according to a cutoff score of 9 based on preoperative Short Physical Performance Battery scores. The non-frail patients were further grouped into high, recovery, or decreased score groups, depending on their score at the time of discharge compared with preoperative scores. Basic characteristics, preoperative and postoperative clinical data, 6-month post-discharge mortality, readmission rates, and vital function (Kihon Checklist scores) were compared. RESULTS: In total, 16.1% of patients were in the frail group, while 18.4%, 35.4%, and 30.1% were in the decreased, recovery, and high score groups, respectively. The Short Physical Performance Battery scores in the decreased group were significantly lower at discharge, and the rate of readmission was significantly higher (17.7%, P < 0.05). In addition, the Kihon Checklist scores were significantly lower than the preoperative scores (5.7 ± 4.0 vs 8.6 ± 5.5, P < 0.05). CONCLUSIONS: Both preoperative and postoperative physical performance must be considered when predicting the prognosis of older patients undergoing cardiac surgery. Geriatr Gerontol Int 2021; 21: 676-682.

Rehabilitation progress after lower-extremity bypass surgery in patients with peripheral arterial disease with different occlusive lesions.

[Purpose] To examine the differences in rehabilitation progress after lower-extremity bypass surgery for peripheral arterial disease (PAD) depending on the occlusive lesions. [Participants and Methods] This was a retrospective study. We included 50 patients (61 limbs; 38 males and 12 females; mean age, 73 years) who underwent lower-extremity bypass surgery for Fontaine stage 2-3 PAD. The patients were assigned to the aortoiliac (A-I) group (n=23), femoropopliteal (F-P) group (n=18), and below-knee group (n=9). We evaluated the postoperative rehabilitation progress and length of hospital stay of these groups. [Results] The postoperative ankle-brachial pressure index (ABI) of the A-I group was significantly lower than that of the F-P group, although there were no differences before surgery. The progress of rehabilitation and the length of hospitalization showed no significant differences among the three groups. The postoperative date of independent walking was significantly later in the presence of complications than in the absence of complications. [Conclusion] The progress of rehabilitation after lower-extremity bypass surgery did not differ depending on the occlusive lesions, and patients may acquire independent walking ability in approximately 5 days in the absence of postoperative complications.

Factors related to physical functioning decline after cardiac surgery in older patients: A multicenter retrospective study.

BACKGROUND: As few studies have examined physical functioning changes after cardiac surgery, the factors related to the decline in physical functioning remain unclear. This study aimed to investigate the factors related to physical functioning decline after cardiac surgery in older patients. METHODS: The final study sample consisted of 523 older (≥65 years) patients (age 74.2±6.1 years, 66% male) who underwent cardiac surgery at 8 Japanese institutions. We excluded patients who were unable to walk independently or had a slow gait speed (<0.8m/s) before surgery, and those who were unable to regain independent walking after surgery. We divided the patients into two groups, a decline-in-gait-speed group and a non-decline-in-gait-speed group, according to whether their gait speed was less than 0.8m/s at discharge. We analyzed patients' clinical characteristics to identify the factors that predicted the postoperative decline in gait speed. RESULTS: Eighty-nine patients (17.0%) showed a postoperative decline in gait speed. Multivariate logistic regression analysis showed that the following factors predicted a postoperative decline in gait speed: age [odds ratio (OR) 1.06, 95% confidence interval (CI) 1.02-1.11]; estimated glomerular filtration rate (OR 0.98, CI 0.96-0.99); preoperative gait speed (OR 0.01, CI 0.00-0.08); and the postoperative day on which the patient could walk independently (OR 1.08, CI 1.02-1.14). CONCLUSIONS: Physical functioning declined in 17% of patients after surgery. The decline could be predicted by several clinical factors, including some that are modifiable. These results suggest that further interventional research on rehabilitation before and after cardiac surgery for older patients might help overcome the decline in physical functioning.

Clinical importance of change in physical activity after endovascular treatment combined with exercise training in patients with peripheral arterial disease.

We aimed to investigate the characteristics of changes in amount of physical activity of patients with peripheral arterial disease (PAD) before/after endovascular treatment (EVT) combined with exercise training. Twenty-two patients with peripheral arterial disease at stage-II of the Fontaine classification who received EVT combined with exercise training were included in this study. A tri-axial accelerometer was used to record physical activity every day from the day before surgery to 3 months after discharge from hospital. The mean number of walking steps before surgery was 2664 steps (611 steps-5404 steps), whereas those after surgery was 3393 (567 steps-7578 steps). Ankle Brachial Index (from 0.69 to 1.03; p < 0.001), maximum walking distance (from 728.2 to 1271.8 m; p < 0.05) and Vascu-QOL (from 98.9 to 137.9; p < 0.01) showed improvement between before and after surgery. Physical activity of patients with PAD was still low at 3 months after surgery even though walking ability, QOL, and self-efficacy were improved after EVT combined with exercise training. Among the 22 patients, the number of walking steps increased in 17 of them and decreased in 5 of them. Compared with the patients in the increased-steps group, those in the decreased-steps group were significantly older (p < 0.05), and had a significantly higher cardiovascular event rate within the first 3 months after surgery (p < 0.05). These results suggested that, not only the improvement of walking ability, but increase in physical activity after EVT combined with exercise training is also important for short-term prognosis.

Selective detection of sub-atto-molar Streptavidin in 10(13)-fold impure sample using photonic crystal nanolaser sensors.

Biosensors selectively detecting a very small amount of biomarker protein in human blood are desired for early and reliable diagnoses of severe diseases. This paper reports the detection of protein (streptavidin: SA) in ultra-low concentration, with an ultra-high selectivity against contaminants, using photonic crystal nanolasers. For biotin-modified nanolasers in pure water with SA, an extremely-low detection limit of 16 zM is evaluated. Even in a mixture with 1 µM bovine serum albumin as the contaminant, 100 zM SA is detected, meaning a selectivity of 10(13). These are remarkable capabilities that are promising for practical biosensing in the medical applications mentioned above.

Super-sensitivity in label-free protein sensing using a nanoslot nanolaser.

Microphotonic sensors have been actively studied with increasing demands for label-free biosensing in medical diagnoses and life sciences. For high-throughput and low-cost sensing, a high sensitivity is crucial for eliminating the pre-concentration process, while a simple setup of sensors is also desirable. This paper demonstrates a super-sensitivity for protein, which satisfies these requirements. The key device is a photonic crystal nanolaser, in particular with a nanoslot. Even using a simple setup, the nanolaser achieves an extraordinary-low detection limit for BSA protein, i.e. 255 fM on an average, which cannot be explained by its bulk index sensitivity. The specific adsorption of the protein is observed only around the nanoslot with strong laser intensity. This suggests that the super-sensitivity arises from the effective trapping of protein in the nanoslot.