Effect of gadolinium contrast-enhanced T1-weighted magnetic resonance imaging for detecting extramural venous invasion in rectal cancer

Purpose

To evaluate the performance of gadolinium contrast-enhanced T1-weighted magnetic resonance imaging (CET1WI) in addition to high-resolution T2-weighted imaging (HRT2WI) for preoperative detection of extramural venous invasion (EMVI) in rectal cancer.

Methods

Fifty-nine patients with rectal cancer who underwent preoperative MRI were included in this study. The likelihood of EMVI was retrospectively scored by two readers on CET1WI, HRT2WI, and HRT2WI + CET1WI, using a subjective five-point scale ranging from 0 to 4. The pathological status of EMVI was used as a standard reference. Diagnostic parameters, including area under the receiver operating curve (AUC), sensitivity, and specificity, were calculated, and the diagnostic performances of HRT2WI and HRT2WI + CET1WI were compared. Interobserver variance was also evaluated.

Results

Eighteen (30.5%) patients showed pathological EMVI. During EMVI detection, reader A obtained an AUC of 0.768, sensitivity of 72.5%, and specificity of 73.2% from HRT2WI alone; after combination with CET1WI, these values improved to 0.864, 83.3%, and 75.6%, respectively. Differences in AUC between these techniques were not significant (p = 0.056). Reader B obtained an AUC of 0.833, sensitivity of 77.8%, and specificity of 73.2% from HRT2WI alone; after combination with CET1W1, these figures were adjusted to 0.720, 50%, and 78%; differences in AUC between techniques were significant (p = 0.027). Interobserver agreement during EMVI scoring was good for HRT2WI (κ = 0.603) and moderate for HRT2WI + CET1WI (κ = 0.413).

Conclusions

Although interobserver agreement decreased, combination of CET1WI with HRT2WI could improve EMVI detection.

     

Hochintensiver fokussierter Ultraschall (HIFU) zur Linderung tumorbedingter Schmerzen bei inoperablem Pankreaskarzinom

Background

High-intensity focused ultrasound (HIFU) in combination with palliative standard therapy is an innovative and effective treatment option for pain reduction in patients with inoperable pancreatic cancer.

Objective

Evaluation of the effects of additive ultrasound (US)-guided HIFU treatment in inoperable pancreatic cancer on the sensory and affective pain perception using validated questionnaries.

Material and methods

In this study 20 patients with locally advanced inoperable pancreatic cancer and tumor-related pain were treated by US-guided HIFU (6 stage III, 12 stage IV according to UICC and 2 with local recurrence after surgery). Ablation was performed using the JC HIFU system (HAIFU, Chongqing, China) with an ultrasonic device for real-time imaging. Clinical assessment included evaluation of pain severity using validated questionnaires with particular attention to the pain sensation scale (SES) with its affective and sensory component and the numeric rating scale (NRS).

Results

The average pain reduction after HIFU was 2.87 points on the NRS scale and 57.3?% compared to the mean baseline score (n = 15, 75?%) in 19 of 20 treated patients. Four patients did not report pain relief, however, the previous opioid medication could be stopped (n = 2) or the analgesic dosage could be reduced (n = 2). No pain reduction was achieved in one patient. Furthermore, after HIFU emotional as well as sensory pain aspects were significantly reduced (before vs. 1 week after HIFU, p < 0.05 for all pain scales).

Conclusion

US-guided HIFU can be used for effective and early pain relief and reduction of emotional and sensory pain sensation in patients with locally advanced pancreatic cancer.

     

Premorbid functional status as a predictor of 1-year mortality and functional status in intensive care patients aged 80 years or older

Purpose

We assessed the association between the premorbid functional status (PFS) and 1-year mortality and functional status of very old intensive care patients.

Methods

Using a nationwide quality registry, we retrieved data on patients treated in Finnish intensive care units (ICUs) during the period May 2012?April 2013. Of 16,389 patients, 1827 (11.1%) were very old (aged 80 years or older). We defined a person with good functional status as someone independent in activities of daily living (ADL) and able to climb stairs without assistance; a person with poor functional status was defined as needing assistance for ADL or being unable to climb stairs. We adjusted for severity of illness and calculated the impact of PFS.

Results

Overall, hospital mortality was 21.3% and 1-year mortality was 38.2%. For emergency patients (73.5% of all), hospital mortality was 28% and 1-year mortality was 48%. The functional status at 1 year was comparable to the PFS in 78% of the survivors. PFS was poor for 43.3% of the patients. A poor PFS predicted an increased risk of in-hospital death, adjusted odds ratio (OR) 1.50 (95% confidence interval, 1.07–2.10), and of 1-year mortality, OR 2.18 (1.67–2.85). PFS data significantly improved the prediction of 1-year mortality.

Conclusions

Of very old ICU patients, 62% were alive 1 year after ICU admission and 78% of the survivors had a functional status comparable to the premorbid situation. A poor PFS doubled the odds of death within a year. Knowledge of PFS improved the prediction of 1-year mortality.

     

A Systematic Review and Network Meta-Analysis to Evaluate the Comparative Efficacy of Interventions for Unfit Patients with Chronic Lymphocytic Leukemia

Introduction

Rituximab plus fludarabine and cyclophosphamide (RFC) is the standard of care for fit patients with untreated chronic lymphocytic leukemia (CLL); however, its use is limited in ‘unfit’ (co-morbid and/or full-dose F-ineligible) patients due to its toxicity profile. We conducted a systematic review and Bayesian network meta-analysis (NMA) to determine the relative efficacy of commercially available interventions for the first-line treatment of unfit CLL patients.

Methods

For inclusion in the NMA, studies had to be linked via common treatment comparators, report progression-free survival (PFS), and/or overall survival (OS), and meet at least one of the five inclusion criteria: median cumulative illness score >6, median creatinine clearance ≤70 mL/min, existing co-morbidities, median age ≥70 years, and no full-dose F in the comparator arm. A manual review, validated by external experts, of all studies that met at least one of these criteria was also performed to confirm that they evaluated first-line therapeutic options for unfit patients with CLL.

Results

In unfit patients, the main NMA (five studies for PFS and four for OS) demonstrated clear preference in terms of PFS for obinutuzumab + chlorambucil (G-Clb) versus rituximab + chlorambucil (R-Clb), ofatumumab + chlorambucil (O-Clb), fludarabine and chlorambucil (median hazard ratios [HRs] 0.43, 0.33, 0.20, and 0.19, respectively), and a trend for better efficacy versus rituximab + bendamustine (R-Benda) and RFC-Lite (median HR 0.81 and 0.88, respectively). OS results were generally consistent with PFS data, (median HR 0.48, 0.53, and 0.81, respectively) for G-Clb versus Clb, O-Clb, and R-Clb 0.35 and 0.81 versus F and R-Benda, respectively); however, the OS findings were associated with higher uncertainty. Treatment ranking reflected improved PFS and OS with G-Clb over other treatment strategies (median rank of one for both endpoints).

Conclusion

G-Clb is likely to show superior efficacy to other treatment options selected in our NMA for unfit treatment-naïve patients with CLL.

Funding

F. Hoffmann-La Roche Ltd.

     

Impact of tapered-cuff tracheal tube on microaspiration of gastric contents in intubated critically ill patients: a multicenter cluster-randomized cross-over controlled trial

Purpose

Studies on the impact of tapered-cuff tracheal tubes on rates of microaspiration and ventilator-associated pneumonia (VAP) in intubated patients have reported conflicting results. The aim of this study was to determine the influence of this shape of tracheal cuff on abundant microaspiration of gastric contents in critically ill patients.

Methods

All patients intubated in the intensive care unit (ICU) and requiring mechanical ventilation for at least 48 h were eligible for this multicenter cluster-randomized controlled cross-over open-label study. The primary outcome was abundant microaspiration of gastric contents, defined by the presence of pepsin at significant level in >30% of tracheal aspirates. Quantitative measurement of pepsin and salivary amylase was performed in all tracheal aspirates during the 48 h following enrollment.

Results

A total of 326 patients were enrolled in the ten participating ICUs (162 in the PVC tapered-cuff group and 164 in the standard-cuff group). Patient characteristics were similar in the two study groups. The proportion of patients with abundant microaspiration of gastric contents was 53.5% in the tapered-cuff and 51.0% in the standard-cuff group (odds ratio 1.14, 95% CI 0.72–1.82). While abundant microaspiration of oropharyngeal secretions was not significantly different (77.4 vs 68.6%, p = 0.095), the proportion of patients with tracheobronchial colonization was significantly lower (29.6 vs 43.3%, p = 0.01) in the tapered-cuff than in the standard-cuff group. No significant difference between the two groups was found for other secondary outcomes, including ventilator-associated events and VAP.

Conclusions

This trial showed no significant impact of tapered-cuff tracheal tubes on abundant microaspiration of gastric contents.

Trial registration

ClinicalTrials.gov, number NCT01948635.

     

Microwave ablation of liver tumors: degree of tissue contraction as compared to RF ablation

Purpose

To compare the amount of tissue contraction after microwave (MW) versus radiofrequency (RF) ablation of liver tumors.

Materials and methods

Seventy-five hepatic tumors in 65 patients who underwent percutaneous MW or RF ablations were included in this retrospective study. All patients underwent MRI within 6 months before the ablation and 24 h after the procedure. Two blinded radiologists, by consensus, performed measurements on the corresponding series of pre and post-ablation MRI. Absolute and relative contraction of liver, tumor, and control were calculated and compared.

Results

Thirty-one patients underwent MW ablations, and 44 patients underwent RF ablations. The absolute and relative contraction of the ablation zone were significantly greater with MW than RF ablation (p = 0.003 to <0.001). Thirty-two lesions were visible on both pre- and post-ablation MRI. MW ablation had significantly more tumor contraction as compared to RF ablation (p = 0.003 to 0.009). The control measurements demonstrated no significant difference in normal tissue variation between MW and RF groups.

Conclusions

MW ablation of hepatic tumors produced significantly more contraction of tumor and ablated hepatic tissue compared to RF ablation. Tissue contraction should be taken into account during pre-procedural planning and assessing treatment response by comparing pre- and post-ablation images.

     

Effect of synbiotic therapy on the incidence of ventilator associated pneumonia in critically ill patients: a randomised,double-blind,placebo-controlled trial

Objective

To investigate the effect of enteral Synbiotic 2000 FORTE^® (a mixture of lactic acid bacteria and fibre) on the incidence of ventilator associated pneumonia (VAP) in critically ill patients.

Design

Prospective, randomised, double blind, placebo controlled trial.

Setting

Tertiary referral centre, general Adult Intensive Care Unit (ICU).

Patients and participants

259 enterally fed patients requiring mechanical ventilation for 48 h or more were enrolled.

Intervention

All patients were enterally fed as per a standard protocol and randomly assigned to receive either synbiotic 2000 FORTE^® (twice a day) or a cellulose-based placebo for a maximum of 28 days.

Measurements and results

Treatment group (n = 130) was well matched with placebo group (n = 129) for age (mean 49.5 and 50 years, respectively) and APACHE II score (median 17 for both). Oropharyngeal microbial flora and colonisation rates were unaffected by synbiotics. The overall incidence of VAP was lower than anticipated (11.2%) and no statistical difference was demonstrated between groups receiving synbiotic and placebo in the incidence of VAP (9 and 13%, P = 0.42), VAP rate per 1,000 ventilator days (13 and 14.6, P = 0.91) or hospital mortality (27 and 33%, P = 0.39), respectively.

Conclusions

Enteral administration of Synbiotic 2000 FORTE^® has no statistically significant impact on the incidence of VAP in critically ill patients.

     

Relative Efficacy of Granulocyte-Macrophage Colony-Stimulating Factor,Dacarbazine, and Glycoprotein 100 in Metastatic Melanoma: An Indirect Treatment Comparison

Introduction

Advances in the treatment of metastatic melanoma have been achieved in recent years: immunotherapies and targeted therapies have demonstrated survival benefits over older agents such as granulocyte-macrophage colony-stimulating factor (GM-CSF), dacarbazine, and glycoprotein peptide vaccine (gp100) in pivotal phase 3 trials. It is important to compare therapies to guide the treatment decision-making process, and establishing the relationship between older agents can strengthen the networks of evidence for newer therapies. We report the outcome of an indirect comparison of GM-CSF, dacarbazine, and gp100 in metastatic melanoma through meta-analysis of absolute treatment effect.

Methods

A systematic literature review identified trials for inclusion in the meta-analysis. A valid network meta-analysis was not feasible: treatment-specific meta-analysis was conducted. A published algorithm was used to adjust overall survival estimates from trials of GM-CSF, dacarbazine, and gp100 for heterogeneity in baseline prognostic factors. Survival estimates were compared in three patient groups: stage IIIB–IV M1c, stage IIIB–IV M1a, and stage IV M1b/c.

Results

One trial of GM-CSF, four of dacarbazine, and one of gp100 were included in the analysis. After adjusting for differences in baseline prognostic factors, median overall survival (OS) in all patient groups was longer for those receiving GM-CSF than for those receiving dacarbazine or gp100. The observed survival over time for GM-CSF was similar to the adjusted survival for dacarbazine and greater than for gp100 in all patient groups.

Conclusion

The relative treatment effect of GM-CSF, dacarbazine, and gp100 has been reliably estimated by adjusting for differences in baseline prognostic factors. Results suggest that OS with GM-CSF is at least as good as with dacarbazine and greater than with gp100. Given the role of these agents as controls in phase 3 trials of new immunotherapies and targeted agents, these results can be used to contextualize the efficacy of newer therapies.

Funding

Amgen Inc.

     

Intraoperative Molecular Imaging of Lung Adenocarcinoma Can Identify Residual Tumor Cells at the Surgical Margins

Purpose

During lung surgery, identification of surgical margins is challenging. We hypothesized that molecular imaging with a fluorescent probe to pulmonary adenocarcinomas could enhance residual tumor during resection.

Procedures

Mice with flank tumors received a contrast agent targeting folate receptor alpha. Optimal dose and time of injection was established. Margin detection was compared using traditional methods versus molecular imaging. A pilot study was then performed in three humans with lung adenocarcinoma.

Results

The peak tumor-to-background ratio (TBR) of murine tumors was 3.9. Fluorescence peaked at 2 h and was not improved beyond 0.1 mg/kg. Traditional inspection identified 30 % of mice with positive margins. Molecular imaging identified an additional 50 % of residual tumor deposits (p?<?0.05). The fluorescent probe visually enhanced all human tumors with a mean TBR of 3.5.

Conclusions

Molecular imaging is an important adjunct to traditional inspection to identify surgical margins after tumor resection.

     

The Effectiveness of Trimetazidine Treatment in Patients with Stable Angina Pectoris of Various Durations: Results from the CHOICE-2 Study

Introduction

Trimetazidine (TMZ) has been shown to reduce angina symptoms and to increase exercise capacity in randomized clinical trials, but more extensive data would be useful to assess its effects in real-world clinical practice and in patients with different durations of disease.

Methods

CHOICE-2 was a Russian, multicenter, 6-month, open-label, prospective observational study that assessed the effect of adding TMZ modified release 35 mg bid to antianginal treatment in a real-world setting. The present analysis of CHOICE-2 results explored the effects of adding TMZ to background antianginal therapies with regard to the duration of stable angina.

Results

A total of 741 patients with known durations of disease were divided into four groups according to stable angina pectoris (AP) duration, ranging from less than 1 year to more than 9 years. Addition of TMZ led to a significant decrease in the frequency of angina attacks and in the use of short-acting nitrates in all groups. In patients with recently diagnosed angina (AP duration < 1 year), the average number of angina attacks per week decreased significantly from 3.75 ± 4.63 to 0.67 ± 1.51 and in those with advanced disease (AP duration > 9 years) from 5.63 ± 5.24 to 1.32 ± 2.07. Angina-free walking distance also improved significantly. Addition of TMZ also improved patient well-being. Results were achieved rapidly (within 2 weeks), were maintained over 6 months, and were obtained in all patient groups regardless of angina duration.

Conclusion

TMZ added to other antianginal therapies proved to be effective for reducing angina attacks and short-acting nitrate use, increasing angina-free walking distance, and improving patient well-being in a real-life setting, irrespective of angina duration, including patients with recently diagnosed angina. This provides an opportunity for intensification of treatment early on in the disease process, with the aim of decreasing angina burden and improving patient quality of life.

Funding

Servier.

Trial Registration

ISRCTN identifier ISRCTN65209863.

Plain Language Summary

Plain language summary available for this article.

     

Intrapartum transperineal ultrasound for evaluating uterine contraction intensity in the second stage of labor

Purpose

To clarify whether intrapartum transperineal ultrasound (ITU) can be used to evaluate uterine contraction intensity, and whether the intensity is associated with the duration of the second stage.

Methods

A prospective observational study was performed involving 86 women with a normal singleton term fetus and more than three contractions every 10 min. ITU was performed for contractile and non-contractile periods of labor at the beginning of the second stage, and one representative “angle of progression (AoP)” image was selected for each period. The Mann–Whitney U test was used to compare ?AoP, the difference between the two angles, depending on the duration of the second stage. Receiver operating characteristic curves were used to evaluate the probability of duration of the second stage ≤50 min in nulliparous women.

Results

Among nulliparous women, ΔAoP differed significantly according to the duration of the second stage (52.5° ± 5.0° for ≤50 min vs. 30.9° ± 2.1° for >50 min; P < 0.001). Receiver operating characteristic curve analysis showed that approximately 85% of nulliparous women with ΔAoP greater than 40° delivered within 50 min.

Conclusion

These findings could be utilized in the evaluation of uterine contraction intensity, and ?AoP measurement could be used to predict the duration of the second stage of labor in nulliparous women.

     

Automatic adjustment of pressure support by a computer-driven knowledge-based system during noninvasive ventilation: a feasibility study

Objective

To evaluate the feasibility of using a knowledge-based system designed to automatically titrate pressure support (PS) to maintain the patient in a “respiratory comfort zone” during noninvasive ventilation (NIV) in patients with acute respiratory failure.

Design and setting

Prospective crossover interventional study in an intensive care unit of a university hospital.

Patients

Twenty patients.

Interventions

After initial NIV setting and startup in conventional PS by the chest physiotherapist NIV was continued for 45?min with the automated PS activated.

Measurements and results

During automated PS minute-volume was maintained constant while respiratory rate decreased significantly from its pre-NIV value (20?±?3 vs. 25?±?3?bpm). There was a trend towards a progressive lowering of dyspnea. In hypercapnic patients PaCO₂ decreased significantly from 61?±?9 to 51?±?2?mmHg, and pH increased significantly from 7.31?±?0.05 to 7.35?±?0.03. Automated PS was well tolerated. Two system malfunctions occurred prompting physiotherapist intervention.

Conclusions

The results of this feasibility study suggest that the system can be used during NIV in patients with acute respiratory failure. Further studies should now determine whether it can improve patient-ventilator interaction and reduce caregiver workload.

     

Estimating Long-Term Survival of Adults with Philadelphia Chromosome-Negative Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia Treated with Blinatumomab Using Historical Data

Introduction

Blinatumomab is a bispecific T cell-engaging antibody construct indicated for adult patients with relapsed/refractory (R/R) Ph(?) B-precursor acute lymphoblastic leukemia (ALL), an aggressive disease with poor prognosis. A phase 2 single-arm clinical study showed that 43% of patients achieved CR/CRh within two cycles and approximately 20% of patients receiving blinatumomab were still alive after 2 years.

Methods

The objective of the current analysis was to estimate long-term survival of patients receiving blinatumomab beyond the observed time period in the clinical study using a large historical observational dataset. Conditional survival probabilities of blinatumomab-treated patients beyond month 60 were assumed to be the same as the US general population.

Results

At month 60, the estimated proportion of blinatumomab-treated patients alive was more than double that of historical patients (12.6% vs 5.4%). The mean overall survival was 76.1 months for blinatumomab patients and 39.8 months for historical patients. Sensitivity analyses including additional follow-up data from the clinical study showed consistent results.

Conclusions

These findings suggest that blinatumomab provides substantial overall survival benefit to patients with (R/R) Ph(?) B-precursor ALL compared with salvage chemotherapy.

Funding

Amgen.

Trial Registration

ClinicalTrials.gov identifier NCT01466179 and NCT02003612.

     

Semi-Automated Volumetric and Morphological Assessment of Glioblastoma Resection with Fluorescence-Guided Surgery

Purpose

Glioblastoma (GBM) neurosurgical resection relies on contrast-enhanced MRI-based neuronavigation. However, it is well-known that infiltrating tumor extends beyond contrast enhancement. Fluorescence-guided surgery (FGS) using 5-aminolevulinic acid (5-ALA) was evaluated to improve extent of resection (EOR) of GBMs. Preoperative morphological tumor metrics were also assessed.

Procedures

Thirty patients from a phase II trial evaluating 5-ALA FGS in newly diagnosed GBM were assessed. Tumors were segmented preoperatively to assess morphological features as well as postoperatively to evaluate EOR and residual tumor volume (RTV).

Results

Median EOR and RTV were 94.3 % and 0.821 cm³, respectively. Preoperative surface area to volume ratio and RTV were significantly associated with overall survival, even when controlling for the known survival confounders.

Conclusions

This study supports claims that 5-ALA FGS is helpful at decreasing tumor burden and prolonging survival in GBM. Moreover, morphological indices are shown to impact both resection and patient survival.

     

Prediction of 5-year survival in advanced-stage ovarian cancer patients based on computed tomography peritoneal carcinomatosis index

Objective

To evaluate whether the quantification of peritoneal metastases in advanced-stage ovarian cancer patients using the peritoneal carcinomatosis index, detected by CT (CT-PCI), correlates with the serum levels of tumor marker CA-125 and 5-year survival.

Methods

The CT-PCI was determined in 82 patients with stage III or stage IV ovarian cancer using the Sugarbaker classification prior to cytoreductive surgery. Linear regression analysis was used to correlate CT-PCI and CA-125 levels. Correlation of presurgical CT-PCI, optimal surgical cytoreduction, and 5-year survival was established using binary logistic regression analysis. A score for prediction of 5-year survival probability was established using multivariate backwards binary logistic regression.

Results

Presurgical CT-PCI correlates significantly with presurgical CA-125 serum levels (r = 0.487, P < 0.001). Multivariate binary logistic regression suggested significantly improved 5-year survival with lower CT-PCI and lower ECOG performance scores.

Conclusion

CT-PCI allows quantification of peritoneal disease in advanced-stage ovarian cancer patients, similar to CA-125. CT-PCI in combination with ECOG performance has the potential to help evaluate the 5-year survival probability.

     

Comparison of FLT-PET/CT and CECT in gastric cancer diagnosis

Aim

To date, no data are available on the use of 18-fluorothymidine positron emission tomography/computed tomography (FLT-PET/CT) for preoperative gastric cancer staging. Herein, we attempt to assess the value of FLT-PET/CT for preoperative gastric cancer staging in comparison with contrast-enhanced computed tomography (CECT).

Materials and methods

In a group of 96 gastric cancer patients, 96 FLT-PET/CT, 56 abdominal cavity CECT, and 51 resective operations were done. All three (FLT-PET/CT, CECT, and resective operation) were done in 29 patients. The results of FLT-PET/CT, CECT, and histopathological examinations were used to assess the ability of FLT-PET/CT and CECT to identify primary tumors, regional nodal metastases, and distant abdominal metastases. Assessment of regional lymph nodes was based on SUVmax in FLT-PET/CT and SAD (short-axis diameter) in CECT.

Results

In the group of 56 patients examined with FLT-PET/CT and CECT, identification of the primary tumor was possible in 56 cases (100%) and in 53 cases (94.6%), respectively, (p = 0.013). Using ROC curve, the sensitivity and specificity of FLT-PET/CT in metastatic regional lymph node assessment were higher than those of CECT (p = 0.0033). FLT-PE/CT enabled identification of a greater number of extraregional abdominal metastases than CECT (n = 56; 19 vs. 15, respectively), but the difference was not statistically significant (p > 0.41).

Conclusions

The ability of FLT-PET/CT to identify primary tumors is greater than that of CECT, and thus FLT-PET/CT was better in evaluating regional nodal metastases. FLT-PET/CT enabled identification of a greater number of abdominal metastases than CECT, but the difference was not statistically significant.

     

Short cervix detection in pregnant women by transabdominal sonography with post-void technique

Purpose

This study aimed to evaluate the diagnostic properties of transabdominal sonography with the post-void technique for cervical length measurement.

Methods

This study was a prospective cohort study. The inclusion criteria were pregnant women aged 18–40 years with gestational age of 18–23 completed weeks. Transabdominal sonography with vertical bladder depth of less than 5 cm and transvaginal cervical length measurements were carried out by a single experienced sonographer.

Results

There were 307 eligible pregnant women. The mean age of all subjects was 29.0 years. The mean cervical length obtained through transabdominal and transvaginal measurement was 3.33 and 3.47 cm, respectively. Ten patients (3.3 %) were identified as having a short cervix using transvaginal sonography, and 12 patients (3.9 %) were identified using transabdominal sonography.

Conclusion

Transabdominal sonography with vertical bladder depth of less than 5 cm performed better compared with transvaginal sonography. It may not be necessary to perform transvaginal sonography if transabdominal sonography reveals the cervical length to be more than 2.5 cm.

     

Pooled Aquablation Results for American Men with Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia in Large Prostates (60–150 cc)

Introduction

To present short-term safety and efficacy data of men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) treated with Aquablation.

Methods

Men with LUTs secondary to BPH (60–150 cc) underwent Aquablation treatment from February 2016 to December 2017 across 17 investigational sites in the USA from two contemporary investigational device exemption (IDE) studies called WATER (NCT02505919) and WATER II (NCT03123250).

Results

One hundred seven males with mean age of 67.3?±?6.5 years were treated with Aquablation; mean prostate volume was 99.4?±?24.1 cc. The pooled results show that large prostates have an average procedure time of less than 36 min and discharge on average 1.6?±?1 days. The IPSS decreased by 16.7?±?8.1 points at 3 months and Q_max increased by 11.2?±?12.4 ml/s. The Clavien-Dindo (CD) grade 2 or higher event rate at 3 months was 29%. A non-hierarchical breakdown for CD events yielded 18% grade 2 and 19% grade 3 or higher.

Conclusion

Men with LUTS secondary to BPH (60–150 cc) in a pooled analysis were treated safely and effectively with Aquablation up to 3 months postoperatively.

Trial Registration

ClinicalTrials.gov identifiers, NCT02505919 and NCT03123250.

Funding

PROCEPT BioRobotics.

     

700-nm Zwitterionic Near-Infrared Fluorophores for Dual-Channel Image-Guided Surgery

Purpose

The purpose of this study was to develop a family of 700-nm zwitterionic pentamethine indocyanine near-infrared fluorophores that would permit dual-channel image-guided surgery.

Procedures

Three complementary synthetic schemes were used to produce novel zwitterionic chemical structures. Physicochemical, optical, biodistribution, and clearance properties were compared to Cy5.5, a conventional pentamethine indocyanine now used for biomedical imaging.

Results

ZW700-1a, ZW700-1b, and ZW700-1c were synthesized, purified, and analyzed extensively in vitro and in vivo. All molecules had extinction coefficients ≥199,000 M^?1 cm^?1, emission ≥660 nm, and stability ≥99 % after 24 h in warm serum. In mice, rats, and pigs, ≥80 % of the injected dose was completely eliminated from the body via renal clearance within 4 h. Either alone or conjugated to a tumor targeting ligand, ZW700-1a permitted dual-channel, high SBR, and simultaneous imaging with 800-nm NIR fluorophores using the FLARE® imaging system.

Conclusions

Novel 700-nm zwitterionic NIR fluorophores enable dual-NIR image-guided surgery.