First Half Of Patients Research Articles

Design and Validation of a Novel Evaluation Scale to Predict Inpatient Large Vessel Occlusion Strokes: Clinical Assessment Stroke Severity for Inpatient Scale.

A large quantity of ischemic stroke events occur in patients hospitalized for non-stroke-related reason. No scale has been developed to identify the large vessel occlusion (LVO) among inpatient stroke alerts. We aimed to develop a novel evaluation scale to predict LVO from in-hospital stroke alerts. Data from consecutive in-hospital stroke alerts were analyzed at a single high volume stroke center between January 2016 and October 2020. We developed a predictive scale based on the first half of patients (training group) using multivariate logistic regression and evaluated it in the remaining half of patients (validation group) adopting receiver operating curve. Receiver operating characteristics of the scale were analyzed to evaluate its value for the detection of LVO. A total of 243 patients were enrolled for further study, among them, 94 (38.7%) had confirmed LVO. Three risk factors independently predicted the presence of LVO: recent cardiac or pulmonary procedure (1 point), neurological deficit scale (≥1: 2 points), and history of atrial fibrillation (1 point). The CAPS scale was generated based on predictive factors and demonstrated highly effective discrimination in identifying the presence of LVO in the training group (area under curve = 0.956) and the validation group (area under curve = 0.940). When the score ≥2, CAPS scale showed 97.9% sensitivity, 79.2% specificity, 74.8% positive predictive value, and 98.3% negative predictive value for discriminating LVO. CAPS scale was developed for identifying LVO among inpatient stroke alerts with high sensitivity and specificity, which may help to quickly prompt responses by appropriate stroke teams.

Interim evaluation of insertable cardiac monitor signal quality in the LUX-Dx PERFORM study

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Boston Scientific Corporation Background The LUX-Dx PERFORM Study is designed to evaluate safety and performance of the LUX-Dx Insertable Cardiac Monitor (ICM) in a general patient population. Although follow-up is ongoing, enrollment is complete, and at least half of the patients have completed 180 days of follow-up. The visibility (or absence) of P-waves in the ICM-recorded S-ECG is an important feature in the diagnosis of atrial arrhythmias. Objective Evaluate the visibility of P-waves in patients enrolled in the LUX-Dx PERFORM study. Methods P-wave visibility was evaluated from the first 356 patients enrolled in the LUX-Dx PERFORM study. The daily presenting S-ECGs (10 second rhythm) nearest to Day 7 (+/- 1) and Day 180 (+/- 7) after implant were blindly adjudicated by independent electrophysiologists to calculate the percentage of beats with clearly visible P-waves. Results Of 636 reviewed S-ECGs, 24 (3.7%) were excluded from analysis for presence of AF rhythm (11), or unavailable data (8 with insufficient adjudication and 5 with no detected R-waves from which to calculate the percentage of beats with visible P-waves). Figure 1 shows an example of a presenting S-ECG rhythm with clearly visible P-waves from the patient management system LATITUDE Clarity. The P-waves were found to be clearly visible in 89.1% of the total heart cycles (Day 7: 90.4%, Day 180: 87.8%). The average difference in percent visibility between Day 7 and Day 180 was approximately 2.2% (p=.248). At a patient level, 88% of patients had visible P-waves in at least one presenting ECG for more than 90% of beats, as shown in Figure 2. In addition, 69% of patients had visible P-waves in both presenting ECGs (Day 7 and Day 180) for at least 90% of beats. Conclusion The LUX-Dx showed consistent visibility of P-waves in the first half of patients enrolled in the LUX-Dx PERFORM study, which represents a general patient population. Adequate P-wave visibility is an important clinical feature in diagnosing atrial arrhythmias and may aid in analysis and clinic workflow efficiency.

Carotid Artery Stenting Using Five-French Distal Radial Vascular Access

Carotid artery stenting (CAS) is usually performed through a femoral vascular access using 6-9 Fr guiding catheters. We investigated whether a systematic distal radial approach using 5 Fr guiding sheaths was a safe and effective alternative to transfemoral approach for CAS. From July 2020 to October 2022, two operators at our center systematically performed CAS using a 5 Fr distal radial approach in consecutive patients. The main endpoints of the study were procedural success via distal radial and via proximal or distal radial access. The learning curve was evaluated by comparing the first half of patients versus the second half of patients enrolled. Procedural data and 30-day clinical outcomes were collected. Fifty-one patients were prospectively enrolled. CAS was effectively performed via distal radial access in 45 patients (88%). Overall radial artery success was 92%. Distal radial CAS was successfully performed in 20 out of the first 25 patients enrolled (80%), and in 25 of the last 26 patients enrolled (96%; p = 0.07). Significantly less contrast was administered in the last 26 patients compared to the first 25 enrolled (110 (70, 140) mL vs. 120 (107, 150) mL; p = 0.045). Radial artery occlusion was reported in 1 patient (2%). Only 1 minor stroke (2%) was reported in-hospital and at 30-day follow-up. In conclusion, distal radial CAS using 5 Fr catheters was a safe procedure with a high success rate. The procedure had a relatively short learning curve in operators familiar with transfemoral CAS.

Gene Therapy Hits Its Stride in the Clinic

Gene Therapy Hits Its Stride in the Clinic

Quantitative Angiographic Assessment of Aortic Regurgitation After Transcatheter Implantation of the Venus A-valve: Comparison with Other Self-Expanding Valves and Impact of a Learning Curve in a Single Chinese Center.

Objectives:We aimed to compare the quantitative angiographic aortic regurgitation (AR) into the left ventricular out flow tract (LVOT-AR) of five different types of transcatheter self-expanding valves and to investigate the impact of the learning curve on post-TAVR AR.Background:Quantitative video densitometric aortography is an objective, accurate, and reproducible tool for assessment of AR following TAVR.Methods and results:This retrospective academic core-lab analysis, analyzed 1150 consecutive cine aortograms performed immediately post-TAVR. Quantitative angiographic AR of post-procedural aortography in 181 consecutive patients, who underwent TAVR with the Venus A-valve in a single Chinese center, were compared to the results of Evolut Pro, Evolut R, CoreValve, (Medtronic, Dublin, Ireland) and Acurate Neo (Boston Scientific, Massachusetts, US) transcatheter heart valves (THVs), from a previously published pooled database. Among the 181 aortograms of patients treated with the Venus A-Valve, 113 (62.4%) were analyzable for quantitative assessment of AR. The mean LVOT-AR was 8.9% ± 10.0% with 14.2% of patients having moderate or severe AR in the Venus A-valve group. No significant difference in mean LVOT-AR was observed between Evolut Pro, Evolut R, Acurate Neo, and Venus A-valve. The incidence of LVOT-AR >17%, which correlates with echocardiographic derived ≥ moderate AR, with the Evolut Pro was lower than with the Venus A-valve (5.3% vs. 14.2%, p = 0.034), but was not different from the Evolut R (5.3% vs. 8.8%, p = 0.612), or the Acurate Neo (5.3% vs. 11.3% p = 0.16) systems. A landmark analysis after recruitment of the first half of patients treated with the Venus A valve (N = 56), showed a significantly lower mean LVOT-AR in the second half of the series (11.3% ± 11.9% vs. 6.5% ± 7.1%, p = 0.011). The incidence of LVOT-AR >17% in the latest 57 cases was also numerically lower (7.0% vs. 21.4%, p = 0.857) and compared favorably with the best in class of the self-expanding valves.ConclusionThe Venus A-valve has comparable mean LVOT-AR to other self-expanding valves but has a higher rate of moderate or severe AR than the Evolut Pro THV. However, after completion of a learning phase, results improved and compared favorably with the best in class of the commercially available self-expanding valves. These findings should be confirmed in prospective randomized comparisons of AR between different THVs.

Outcomes in patients implanted with a Watchman device in relation to choice of anticoagulation and indication for implant.

Patients with atrial fibrillation are increasingly prescribed a direct oral anticoagulant (DOAC) over warfarin and seek to avoid anticoagulation even without a history of major bleeding. This study explores the outcomes of patients implanted with a Watchman device in relation to anticoagulation choice (warfarin versus DOAC) in the post-procedure period and a history of bleeding. Patients implanted with a Watchman device at a single center were retrospectively analyzed. Characteristics including anticoagulation in the first 45 days and history of major bleed were assessed and efficacy (thromboembolism) and safety (bleeding) outcomes compared by Kaplan-Meier analysis. Two hundred nine patients were implanted (57% male, age 74.6 ± 7.8 years) and followed for 23.5 ± 7.1 months. In the first half of patients, 98% were prescribed warfarin, which dropped to 51% in the second half (p < 0.0001). A history of major bleed was present in 80.8% of the first half of patients and decreased to 60% in the second half (p = 0.001). There were 16 safety and 4 efficacy events. There was no difference in safety outcomes according to history of major bleeding or anticoagulant choice in the first 45 days. There was no difference in efficacy outcomes over the duration of follow-up according to anticoagulation choice in the first 45 days. Patients implanted with a Watchman device were increasingly over time prescribed a DOAC and implanted without a history of major bleeding. Bleeding and thromboembolic events were infrequent and related neither to choice of anticoagulant nor to prior major bleeding.

What Is the Diagnostic Accuracy of Flat-panel Cone-beam CT Arthrography for Diagnosis of Scapholunate Ligament Tears?

Cone beam CT (CBCT) is a widely available technique with possible indications in carpal ligament injuries. The accuracy of CBCT arthrography in diagnosing traumatic tears of the scapholunate ligament has not been reported. (1) What is the diagnostic accuracy of CBCT and how does it relate to the accuracy of multislice CT arthrography and conventional arthrography in diagnosing scapholunate ligament tears? (2) What is the estimated magnitude of skin radiation doses of each method? This secondary analysis of a previous prospective study included 71 men and women with suspected scapholunate ligament tears and indications for arthroscopy. Preoperative imaging was conventional arthrography and either MSCT arthrography for the first half of patients to be included (n = 36) or flat-panel CBCT arthrography for the remaining patients (n = 35). Index tests identified therapy-relevant SLL tears with dorsal or complete SLL ruptures, and these tears were compared with relevant SLL tears which were determined through arthroscopy as Geissler Stadium III and IV by probing the instable SL joint with a microhook or arthroscope. These injuries were treated by open ligament repair and Kirschner wire fixation. Accuracy values and 95% confidence intervals were calculated. Additional estimates of the radiation skin doses of each CBCT exam and two MSCT protocols were subsequently calculated using dose area products, dose length products, and CT dose indices. The diagnostic accuracy was high for all imaging methods. 95% CIs were broadly overlapping and therefore did not indicate differences between the diagnostic groups: Sensitivity of CBCT arthrography was 100% (95% CI 77 to 100), specificity was 95% (95% CI 76 to 99.9), positive predictive value was 93% (95% CI 68 to 99.8), and negative predictive value was 100% (95% CI 83 to 100). For MSCT arthrography, the sensitivity was 92% (95% CI 64 to 99.8), specificity was 96% (95% CI 78 to 99.9), positive predictive value was 92% (95% CI 64 to 99.8), and negative predictive value was 96% (95% CI 78 to 99.9). For conventional arthrography, the sensitivity was comparably high: 96% (95% CI 81 to 99.9). Specificity was (81% [95% CI 67 to 92]); the positive predictive value was 77% (95% CI 59 to 89) and negative predictive value was 97% (95% CI 86 to 99.9). Estimated mean (range) radiation skin doses were reported in a descriptive fashion and were 12.9 mSv (4.5 to 24.9) for conventional arthrography, and 3.2 mSv (2.0 to 4.8) for CBCT arthrography. Estimated radiation skin doses were 0.2 mSv and 12 mSv for MSCT arthrography, depending on the protocol. Flat-panel CBCT arthrography can be recommended as an accurate technique to diagnose scapholunate ligament injuries after wrist trauma. Estimated skin doses are low for CBCT arthrography and adapted MSCT arthrography protocols. Level III, diagnostic study.

The 2CAN Score.

Background and Purpose- A quarter of acute strokes occur in patients hospitalized for another reason. A stroke recognition instrument may be useful for non-neurologists to discern strokes from mimics such as seizures or delirium. We aimed to derive and validate a clinical score to distinguish stroke from mimics among inhospital suspected strokes. Methods- We reviewed consecutive inpatient stroke alerts in a single academic center from January 9, 2014, to December 7, 2016. Data points, including demographics, stroke risk factors, stroke alert reason, postoperative status, neurological examination, vital signs and laboratory values, and final diagnosis, were collected. Using multivariate logistic regression, we derived a weighted scoring system in the first half of patients (derivation cohort) and validated it in the remaining half of patients (validation cohort) using receiver operating characteristics testing. Results- Among 330 subjects, 116 (35.2%) had confirmed stroke, 43 (13.0%) had a neurological mimic (eg, seizure), and 171 (51.8%) had a non-neurological mimic (eg, encephalopathy). Four risk factors independently predicted stroke: clinical deficit score (clinical deficit score 1: 1 point; clinical deficit score ≥2: 3 points), recent cardiac procedure (1 point), history of atrial fibrillation (1 point), and being a new patient (<24 hours from admission: 1 point). The score showed excellent discrimination in the first 165 patients (derivation cohort, area under the curve=0.93) and remaining 165 patients (validation cohort, area under the curve=0.88). A score of ≥2 had 92.2% sensitivity, 69.6% specificity, 62.2% positive predictive value, and 94.3% negative predictive value for identifying stroke. Conclusions- The 2CAN score for recognizing inpatient stroke performs well in a single-center study. A future prospective multicenter study would help validate this score.

Identifying At-Risk Patients with Combined Pre- and Postcapillary Pulmonary Hypertension Using Interventricular Septal Angle at Cardiac MRI.

PurposeTo assess interventricular septal (IVS) angle in the identification of combined pre- and postcapillary pulmonary hypertension (Cpc-PH) in patients with pulmonary hypertension (PH) due to left-sided heart disease.Materials and MethodsIn this retrospective study, consecutive, incident patients suspected of having PH underwent same-day right-sided heart catheterization (RHC) and MRI at a PH referral center between April 2012 and April 2017. The diagnostic accuracy of the IVS angle to identify Cpc-PH in patients with pulmonary arterial wedge pressure (PAWP) greater than 15 mmHg was assessed by using receiver operator characteristic curves, sensitivity, specificity, and negative and positive predictive values. IVS angle also was assessed as a predictor of all-cause mortality by using Cox uni- and multivariable proportional hazards regression.ResultsA total of 708 patients underwent same-day MRI and RHC, and 171 patients had PAWP greater than 15 mmHg. Mean age was 70 years (range, 21–90 years) (women: mean age, 69 years; range, 21–88 years) (men: mean age, 71 years; range, 43–90 years). Systolic IVS angle correlated with diastolic pulmonary gradient (DPG) (r = 0.739, P < .001). Receiver operating characteristic curve analysis showed septal angle enabled identification of Cpc-PH (DPG ≥ 7), with an area under the receiver operating characteristic curve of 0.911 (P < .001). A 160° threshold, derived from the first half of patients with raised PAWP, enabled identification of a DPG of at least 7 mmHg with 67% sensitivity and 93% specificity (P < .001) in the second cohort of patients with raised PAWP. IVS angle was predictive of all-cause mortality (standardized univariable hazard ratio, 1.615; P < .01).ConclusionThe systolic interventricular septal angle is elevated in patients with combined pre- and postcapillary pulmonary hypertension and enables one to predict those patients who have PH due to left-sided heart disease who have an increased risk of death.Published under a CC BY 4.0 license.Online supplemental material is available for this article.

Percutaneous Femoral Implantation of an Arterial Port Catheter for Intraarterial Chemotherapy: Feasibility and Predictive Factors of Long-term Functionality

To evaluate the feasibility, functionality, and dysfunctions of an arterial port catheter implanted via the femoral artery. From November 2001 to May 2008, 93 consecutive patients (mean age 57 years old) with unresectable hepatic colorectal metastases were referred for intraarterial chemotherapy. The arterial port catheters were percutaneously implanted via the femoral artery. The catheter tips were placed as "free-floating" in the common hepatic artery (technique 1), "fixed" in the gastroduodenal artery (technique 2), or inserted in a segmental hepatic artery (technique 3). Embolization of the right gastric artery was always attempted. The technical success rate of the femoral approach was 94% (n = 88 of 93). Intraarterial chemotherapy (average 7.3 courses) was administered to 84 patients. Migration and occlusion of the catheters occurred in 12% (n = 10 of 84) and 11% (n = 9 of 84) of patients, and extrahepatic perfusion occurred in 30% (n = 25 of 84) of patients. Catheter migration occurred significantly more frequently with technique 1 (50%; n = 3 of 6) than with technique 2 (11%; n = 7 of 64; P = .03) or technique 3 (0%; n = 0 of 14; P = .02). Occurrence of gastroduodenal ulcerations was significantly lower (P = .01) when embolization of the right gastric artery was performed (8%; n = 4 of 48) than when it was not (28%; n = 11 of 36). The success rate of embolization of the right gastric artery significantly improved (P = .006) from the first half of patients treated to the second half, resulting in a significant (P = .02) decrease in the occurrence of ulcerations from 28% (n = 12 of 42) in the first half of patients treated to 7% (n = 3 of 42) in the second half. Percutaneous femoral placement of an arterial port catheter is highly feasible. Right gastric artery embolization and use of techniques 2 and 3 are good predictive factors for long-term functionality.

Small Airways Dysfunction and Neutrophilic Inflammation in Bronchial Biopsies and BAL in COPD

Background:The single-breath N2test (sbN2-test) is closely related to small airways pathology in resected lung specimens of smokers. We investigated whether uneven ventilation and airway closure are associated with specific markers of airway inflammation as obtained by bronchial biopsies, BAL, and induced sputum in patients with manifest COPD.Methods:Fifty-one patients with stable COPD not receiving corticosteroids were examined in a cross-sectional study (43 men; mean [SD] age, 63 ± 8 years; exsmokers and smokers; median pack-years, 41 [interquartile range, 31 to 51 pack-years]). Postbronchodilator spirometry (FEV1, 63 ± 8% of predicted) and sbN2-test (slope of phase III [ΔN2], closing capacity [CC]/total lung capacity [TLC] percentage of predicted) were performed. Inflammatory cell counts were assessed in bronchial biopsies, BAL (only in the first half of patients), and induced sputum. Neutrophil elastase (NE), secretory leukocyte proteinase inhibitor (SLPI), and interleukin-8 levels were determined in BAL fluid.Results:ΔN2increased with subepithelial neutrophil numbers in bronchial biopsies (rs = 0.337, p = 0.017) and with NE levels (rs = 0.443, p = 0.039), NE/neutrophil ratio (rs = 0.575, p = 0.005) and SLPI levels (rs = 0.484, p = 0.022) in BAL. CC/TLC was associated with BAL neutrophil numbers (rs = 0.448, p = 0.048). The sbN2-test was not associated with any other inflammatory cell type in BAL or biopsies, nor with inflammatory cell counts in sputum. Of importance, the correlations between ΔN2and BAL NE/neutrophil ratio, and between CC/TLC and BAL neutrophil numbers remained significant when adjusting for FEV1percentage of predicted.Conclusions:The results of the sbN2-test are associated with neutrophilic inflammation in bronchial biopsies and BAL in patients with COPD. Our findings support a role of neutrophilic inflammation in the pathogenesis of small airways dysfunction in COPD.

A trial of self-adhesive patch electrodes and hand-held paddle electrodes for external cardioversion of atrial fibrillation (MOBIPAPA)

External electrical cardioversion is the method of choice to terminate persistent atrial fibrillation. Whether the type of shock electrode affects cardioversion success is not known. We tested whether hand-held steel electrodes improve cardioversion outcome with monophasic or biphasic shocks when compared with adhesive patch electrodes. Two hundred and one consecutive patients with persistent atrial fibrillation (147 male, mean age 63+/-1 years, duration of atrial fibrillation 6.3+/-1 months) were randomly assigned to cardioversion using either a sinusoidal monophasic or a truncated exponential biphasic shock wave form. The first half of patients were cardioverted using adhesive patch electrodes, the second half using hand-held steel paddle electrodes, and all patients using an anterior-posterior electrode position. Paddle electrodes successfully cardioverted 100/104 patients (96%) and patch electrodes 85/97 patients (88%, P=0.04). This effect was comparable to that of biphasic shocks: biphasic shocks cardioverted 102/104 patients (98%) and monophasic shocks 83/97 patients (86%, P=0.001). A beneficial effect of paddle electrodes was observed for both shock wave forms. After cross-over from an ineffective monophasic to a biphasic shock, cardioversion was successful in 198/201 (98.5%) patients. Unsuccessful cardioversion after cross-over (3/201 patients) only occurred with patch electrodes (P=0.07). Hand-held paddle electrodes increase success of external cardioversion of atrial fibrillation in this trial. This increase is of similar magnitude as the increase in cardioversion success achieved with biphasic shocks. A combination of biphasic shocks, paddle electrodes, and an anterior-posterior electrode position renders outcome of external cardioversion almost always successful (104/104 patients in this trial).

Metastatic Carcinoma of the Prostate: Identifying Prognostic Groups Using Recursive Partitioning

PURPOSE While in patients with metastatic prostate cancer median survival is approximately 30 months when treated with hormonal therapy, there is substantial interpatient variation. To explain better the outcome in patients with advanced disease we developed a set of prognostic groups within a large-scale clinical trial. MATERIALS AND METHODS Southwest Oncology Group Study 8894 was a randomized prospective clinical trial that compared orchiectomy and flutamide to orchiectomy and placebo. Using the technique of recursive partitioning we analyzed 5-year survival outcomes using a substantial number of patient, treatment and disease related variables to develop a set of prognostic groups with significant differences in survival. RESULTS Of 1,286 eligible patients 1,076 had sufficient data for analysis. The patient data set was split to allow prognostic group development in the first half of patients, followed by validation in the second half of patients accrued to the study. After pruning the regression tree 4 factors had a major impact on outcome, namely appendicular versus axial disease, performance status 0 versus 1 to 3, prostate specific antigen less than 65 versus 65 ng./ml. or greater and Gleason score less than 8 versus 8 or greater. Using these criteria 3 prognostic groups were developed, including a good (hazards ratio 1), intermediate (hazards ratio 1.8) and poor (hazards ratio 2.8) group. Five-year survival estimates in the 3 groups were 42%, 21% and 9%, respectively. Using the validation test set similar 5-year survival estimates for the 3 groups of 46%, 25% and 14%, respectively.CONCLUSIONS These data from a large-scale randomized clinical trial provide a validated set of easily applied prognostic groups. We hope that our results may be validated by other investigators and we would encourage the future reporting of outcomes in patients with advanced prostate cancer using these prognostic groupings. Risk stratification is helpful for designing clinical trials and individual treatment, and it should be incorporated into future reports of outcomes of patients with metastatic disease.