scholarly journals Long-Term Technical Performance of the Osypka QT-5® Ventricular Pacemaker Lead

2021 ◽  
Vol 10 (4) ◽  
pp. 639 ◽  
Author(s):  
Georg Semmler ◽  
Fabian Barbieri ◽  
Karin Thudt ◽  
Paul Vock ◽  
Deddo Mörtl ◽  
...  
Keyword(s):  
High Rate ◽  
Pacing Threshold ◽  
Technical Performance ◽  
Cardiac Implantable Electronic Devices ◽  
Kaplan Meier ◽  
Ventricular Lead ◽  
Long Term Follow Up ◽  
Technical Issues

Background: Lead-associated complications and technical issues in patients with cardiac implantable electronic devices are common but underreported in the literature. Methods: All patients undergoing implantation of the Osypka QT-5® ventricular lead at the University Clinic St. Pölten between 1 January 2006 and 31 December 2012 were retrospectively analyzed (n = 211). Clinical data including pacemaker follow-up examinations and the need for lead revisions were assessed. Kaplan–Meier analysis to estimate the rate of lead dysfunction during long-term follow-up was conducted. Results: Patients were followed for a median of 5.2 years (interquartile range (IQR) 2.0–8.7). R-wave sensing properties at implantation, compared to last follow-up, remained basically unchanged: 9.9 mV (IQR 6.8–13.4) and 9.6 mV (IQR 5.6–12.0), respectively). Ventricular pacing threshold significantly increased between implantation (0.5 V at 0.4 ms; IQR 0.5–0.8) and the first follow-up visit (1.0 V at 0.4 ms; IQR 0.8–1.3; p < 0.001) and this increase persisted throughout to the last check-up (0.9 V at 0.4 ms; IQR 0.8–1.2). Impedance significantly declined from 1142 Ω (IQR 955–1285) at implantation to 814 Ω (IQR 701–949; p < 0.001) at the first check-up, followed by a further decrease to 450 Ω (IQR 289–652; p < 0.001) at the last check-up. Overall, the Osypka QT-5® ventricular lead was replaced in 36 patients (17.1%). Conclusions: This report shows an unexpected high rate of technical issues of the Osypka QT-5® ventricular lead during long-term follow-up.

scholarly journals Endovascular Treatment of Anterior Circulation Aneurysms With the p64 Flow Modulation Device: Mid- and Long-Term Results in 617 Aneurysms From a Single Center

2021 ◽  
Author(s):  
Marta Aguilar Pérez ◽  
Elina Henkes ◽  
Victoria Hellstern ◽  
Carmen Serna Candel ◽  
Christina Wendl ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
High Rate ◽  
Long Term Results ◽  
Effective Treatment Option ◽  
Anterior Circulation ◽  
Acute Hemorrhage ◽  
Unruptured Aneurysms ◽  
Long Term Follow Up

Abstract BACKGROUND Flow diverters have become an important tool in the treatment of intracranial aneurysms, especially when dealing with difficult-to-treat or complex aneurysms. The p64 is the only fully resheathable and mechanically detachable flow diverter available for clinical use. OBJECTIVE To evaluate the safety and effectiveness of p64 for the treatment of intracranial saccular unruptured aneurysms arising from the anterior circulation over a long-term follow-up period. METHODS We retrospectively reviewed our prospectively maintained database to identify all patients who underwent treatment for an intracranial saccular (unruptured or beyond the acute hemorrhage phase) aneurysm arising from the anterior circulation with ≥1 p64 between December 2011 and December 2019. Fusiform aneurysms and dissections were excluded. Aneurysms with prior or concomitant saccular treatment (eg, coiling and clipping) were included. Aneurysms with parent vessel implants other than p64 were excluded. Anatomic features, intraprocedural complications, clinical outcome, as well as clinical and angiographic follow-ups were all recorded. RESULTS In total, 530 patients (388 females; median age 55.9 yr) with 617 intracranial aneurysms met the inclusion criteria. The average number of devices used per aneurysm was 1.1 (range 1-3). Mean aneurysm dome size was 4.8 mm (range 1-27 mm). Treatment-related morbimortality was 2.4%. Early, mid-term, and long-term angiographic follow-up showed complete or near-complete aneurysm occlusion in 76.8%, 89.7%, and 94.5%, respectively. CONCLUSION Treatment of intracranial saccular unruptured aneurysms of the anterior circulation using p64 is a safe and effective treatment option with high rate of occlusion at long-term follow-up and low morbimortality.

scholarly journals Moxetumomab pasudotox in heavily pre-treated patients with relapsed/refractory hairy cell leukemia (HCL): long-term follow-up from the pivotal trial

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Robert J. Kreitman ◽  
◽  
Claire Dearden ◽  
Pier Luigi Zinzani ◽  
Julio Delgado ◽  
...  
Keyword(s):  
Hairy Cell Leukemia ◽  
Residual Disease ◽  
Braf Inhibitor ◽  
Nucleoside Analogs ◽  
High Rate ◽  
Hairy Cell ◽  
Cell Leukemia ◽  
Long Term Follow Up

Abstract Background Moxetumomab pasudotox is a recombinant CD22-targeting immunotoxin. Here, we present the long-term follow-up analysis of the pivotal, multicenter, open-label trial (NCT01829711) of moxetumomab pasudotox in patients with relapsed/refractory (R/R) hairy cell leukemia (HCL). Methods Eligible patients had received ≥ 2 prior systemic therapies, including ≥ 2 purine nucleoside analogs (PNAs), or ≥ 1 PNA followed by rituximab or a BRAF inhibitor. Patients received 40 µg/kg moxetumomab pasudotox intravenously on Days 1, 3, and 5 of each 28-day cycle for up to six cycles. Disease response and minimal residual disease (MRD) status were determined by blinded independent central review. The primary endpoint was durable complete response (CR), defined as achieving CR with hematologic remission (HR, blood counts for CR) lasting > 180 days. Results Eighty adult patients were treated with moxetumomab pasudotox and 63% completed six cycles. Patients had received a median of three lines of prior systemic therapy; 49% were PNA-refractory, and 38% were unfit for PNA retreatment. At a median follow-up of 24.6 months, the durable CR rate (CR with HR > 180 days) was 36% (29 patients; 95% confidence interval: 26–48%); CR with HR ≥ 360 days was 33%, and overall CR was 41%. Twenty-seven complete responders (82%) were MRD-negative (34% of all patients). CR lasting ≥ 60 months was 61%, and the median progression-free survival without the loss of HR was 71.7 months. Hemolytic uremic and capillary leak syndromes were each reported in ≤ 10% of patients, and ≤ 5% had grade 3–4 events; these events were generally reversible. No treatment-related deaths were reported. Conclusions Moxetumomab pasudotox resulted in a high rate of durable responses and MRD negativity in heavily pre-treated patients with HCL, with a manageable safety profile. Thus, it represents a new and viable treatment option for patients with R/R HCL, who currently lack adequate therapy. Trial registration ClinicalTrials.gov identifier: NCT01829711; first submitted: April 9, 2013. https://clinicaltrials.gov/ct2/show/NCT01829711

Atrial fibrillation associated with increased risk of venous thromboembolism

2015 ◽  
Vol 113 (01) ◽  
pp. 185-192 ◽  
Author(s):  
Chun-Cheng Wang ◽  
Cheng-Li Lin ◽  
Guei-Jane Wang ◽  
Chiz-Tzung Chang ◽  
Fung-Chang Sung ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Venous Thromboembolism ◽  
Incidence Rates ◽  
Vein Thrombosis ◽  
Kaplan Meier ◽  
Increased Risk ◽  
Long Term Follow Up ◽  
Deep Vein

SummaryWhether atrial fibrillation (AF) is associated with an increased risk of venous thromboembolism (VTE) remains controversial. From Longitudinal Health Insurance Database 2000 (LHID2000), we identified 11,458 patients newly diagnosed with AF. The comparison group comprised 45,637 patients without AF. Both cohorts were followed up to measure the incidence of deep-vein thrombosis (DVT) and pulmonary embolism (PE). Univariable and multivariable competing-risks regression model and Kaplan-Meier analyses with the use of Aelon-Johansen estimator were used to measure the differences of cumulative incidences of DVT and PE, respectively. The overall incidence rates (per 1,000 person-years) of DVT and PE between the AF group and non-AF groups were 2.69 vs 1.12 (crude hazard ratio [HR] = 1.92; 95 % confidence interval [CI] = 1.54-2.39), 1.55 vs 0.46 (crude HR = 2.68; 95 % CI = 1.97-3.64), respectively. The baseline demographics indicated that the members of the AF group demonstrated a significantly older age and higher proportions of comorbidities than non-AF group. After adjusting for age, sex, and comorbidities, the risks of DVT and PE remained significantly elevated in the AF group compared with the non-AF group (adjusted HR = 1.74; 95 %CI = 1.36-2.24, adjusted HR = 2.18; 95 %CI = 1.51-3.15, respectively). The Kaplan-Meier curve with the use of Aelon-Johansen estimator indicated that the cumulative incidences of DVT and PE were both more significantly elevated in the AF group than in the non-AF group after a long-term follow-up period (p<0.01). In conclusion, the presence of AF is associated with increased risk of VTE after a long-term follow-up period.

Extramedullary Plasmacytoma of The Frontal Sinus: A Case Report

FACE ◽  
2021 ◽  
pp. 273250162110536
Author(s):  
Joshua Harrison ◽  
Samantha Marley ◽  
Shawhin Shahriari ◽  
Christian Bowers ◽  
Anil Shetty
Keyword(s):  
Frontal Sinus ◽  
Surgical Excision ◽  
Extramedullary Plasmacytoma ◽  
High Rate ◽  
Solitary Plasmacytoma ◽  
Case Presentation ◽  
Long Term Follow Up ◽  
History Of

We report a rare case of an extramedullary plasmacytoma (EMP) in the frontal sinus with an indolent clinical presentation. Although a history of trauma was absent, the initial diagnosis was a mucocele, based on the radiological findings. Upon surgical excision, the patient was found to have an EMP. EMP, a form of solitary plasmacytoma, has a significantly high rate of conversion to multiple myeloma. This mandates long-term follow-up, even after successful radiotherapy and/or resection. While radiation therapy is generally considered a first line treatment for EMP, surgical intervention may provide optimal treatment in complicated cases. This case presentation highlights the prognosis of patients diagnosed with EMP.

scholarly journals Reduction and Association of the Scaphoid and Lunate: A Functional and Radiographical Outcome Study

2018 ◽  
Vol 08 (01) ◽  
pp. 037-042
Author(s):  
William Aibinder ◽  
Ali Izadpanah ◽  
Bassem Elhassan
Keyword(s):  
Range Of Motion ◽  
Grip Strength ◽  
High Rate ◽  
Salvage Procedure ◽  
Level Of Evidence ◽  
Long Term Follow Up ◽  
The Mean ◽  
Ligament Disruption

Background Management of scapholunate (SL) ligament disruption is a challenging problem. The reduction and association of the scaphoid and lunate (RASL) procedure has been described with varying results. This study assessed the outcomes of the RASL procedure. Purpose The objective of this study was to assess the outcomes of patients undergoing the RASL procedure at our institution in regard to pain relief, range of motion, radiographic and functional outcomes, complications, and reoperations. Materials and Methods Twelve patients with symptomatic chronic SL instability underwent the RASL procedure. The mean age was 35 years. The mean time from injury to surgery was 40 weeks. The mean follow-up was 89 months. Outcomes included visual analog score for pain, wrist range of motion, grip strength, and Mayo Wrist Scores. Preoperative and postoperative radiographs were reviewed. Results Pain scores improved in 10 wrists. Range of motion and grip strength worsened. The average Mayo Wrist Score was 63.3. The mean SL diastasis and angle improved, but seven wrists developed progressive degenerative changes, with two requiring a salvage procedure. Symptomatic progressive screw lucency occurred in eight wrists requiring screw removal. Conclusion The RASL procedure can improve SL widening but has a high rate of early failure and reoperation. Following reoperation, long-term follow-up demonstrates reasonable long-term durability in some cases. Level of Evidence This is a Level IV, therapeutic case study.

scholarly journals Long term follow-up of patients with ventricular high rate events detected on remote monitoring of pacemakers

2019 ◽  
Vol 19 (3) ◽  
pp. 92-97
Author(s):  
Ameesh Isath ◽  
Vaibhav Vaidya ◽  
Vidhushei Yogeswaran ◽  
Abhishek Deshmukh ◽  
Samuel Asirvatham ◽  
...  
Keyword(s):  
Remote Monitoring ◽  
High Rate ◽  
Long Term Follow Up

scholarly journals LTBK-12. EORTC 26951, RANDOMIZED STUDY OF ADJUVANT PCV AFTER 59.4 GY RADIOTHERAPY: VERY LONG TERM FOLLOW-UP

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi285-vi285
Author(s):  
Martin van den Bent ◽  
Khe Hoang-Xuan ◽  
Alba Brandes ◽  
Johan Kros ◽  
M C M Kouwenhoven ◽  
...  
Keyword(s):  
Randomized Study ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Term Survival ◽  
Long Term Survival ◽  
Kaplan Meier ◽  
Tumor Group ◽  
Long Term Follow Up

Abstract BACKGROUND Between 1995 and 2002 the EORTC Brain Tumor Group conducted a prospective phase III study on adjuvant procarbazine, CCNU and vincristine (PCV) chemotherapy in anaplastic oligodendroglioma (AOD). A mature follow-up presented in 2012 showed survival benefit of the addition of PCV, in particular in 1p/19q co-deleted tumors and tumors with MGMT promoter methylation. We now present very long term follow-up. MATERIALS AND METHODS Patients were eligible if locally diagnosed with a newly diagnosed AOD. They were randomized between radiotherapy (RT, 33 x 1.8 Gy) and the same RT followed by 6 cycles PCV (RT/PCV). Primary endpoints were overall survival (OS) and progression free survival (PFS). 1p/19q status (FISH) was determined in 300 patient. Kaplan- Meier technique and Cox modeling were used for long term survival analysis. Primary analyses were adjusted for known prognostic factors. For other analyses no adjustment was performed. RESULTS With 368 patients included, a median follow-up of 18.4 years and 307 (83%) survival events, median and 20-year survival after RT/PCV versus RT alone were 42.3 mo and 16.8% vs 30.6 months and 10.1% (HR 0.78; 95% CI (0.63, 0.98), adjusted p=0.06). Eighty patients were 1p/19q codel of which 26 (33%) were still alive, in this subgroup median and 20-year survival after RT/PCV versus RT alone were 14 years and 37.1% versus 9.3 years and 13.6% (HR 0.60, 95% CI (0.35, 1.03), unadjusted p=0.06). Twenty year PFS in 1p/19q codel was 31.3% in RT/PCV treated patients and 10.8% in RT only treated patients (HR 0.49, 95% CI (0.29, 0.83), unadjusted p=0.007). In the 1p/19q codel subgroup age, WHO PS and necrosis at pathology were identified to be of independent prognostic value for OS. CONCLUSION This long term analysis confirms the earlier conclusions and provides data on long term survival in this patient group. In 1p/19q codel patients treated with RT/PCV, the 20-year PFS and OS rates are 31% and 37% respectively.

Antiprostate-specific membrane antigen (PSMA)-based radioimmunotherapy: A combined analysis of radiolabeled-J591 studies.

2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 136-136
Author(s):  
N. H. Akhtar ◽  
D. M. Nanus ◽  
J. Osborne ◽  
S. Vallabhajosula ◽  
H. Beltran ◽  
...  
Keyword(s):  
Predictive Biomarkers ◽  
Dose Fractionation ◽  
Entire Group ◽  
Two Phase ◽  
Kaplan Meier ◽  
External Domain ◽  
Long Term Follow Up ◽  
Specific Membrane

136 Background: J591 is a monoclonal antibody which selectively binds the external domain of PSMA with high affinity. Two phase I trials of radiolabeled-J591 have been published; two additional studies have been completed. 90Y is a beta-emitting particle optimal for tumor lesions 28-42 mm in size; 177Lu is best suited for lesions 1-3 mm in diameter [O'Donoghue J Nuc Med 1995]. Methods: With WCMC IRB approval, long-term follow-up of 4 clinical trials and the ongoing studies was analyzed. Prospectively collected data were supplemented with retrospective additions when necessary. Median survival (OS) was calculated by Kaplan- Meier methodology. Results: Between 10/00 and 7/10, 132 pts with metastatic CRPC received radiolabeled J591 (103 received 177Lu-J591, 29 90Y-J591) with a median follow-up of 68.5 months (mo). Median age 70.3 yrs; all progressed after multiple lines of hormonal therapy, 41.7% received prior chemo, 48.5% received post-J591 chemo. Median Halabi nomogram score for the group was 146 (range 97- 196). OS for the entire group was 16.7 mo [95% CI 13.8, 19.7]. 26 (19.7%) experienced > 30% PSA decline, with OS of 22.4 mo (vs 13.6 mo for those with any PSA increase, p=0.08; p=0.006 at phase II doses). Pts receiving 177Lu-J591 had more 30% PSA declines than 90Y-J591 (21.3% vs 6.9%, p=0.06). 37.9% had measurable disease; those who received 90Y-J591 were more likely to have measurable response than 177Lu-J591 [p=0.04]. All objective tumor responses also had significant PSA declines. Of 15 pts with baseline and follow-up CTC counts (CellSearch methodology), 12 (80%) became or remained favorable at follow-up; 3 became or remained unfavorable. Conclusions: Radiolabled J591 is tolerable and efficacious. As predicted based upon their physical properties, 177Lu-J591 appears more effective for lower volume disease, with objective responses in larger volume disease only with 90Y-J591. Current trials utilizing 177Lu-J591 focus on predictive biomarkers, dose fractionation to improve tolerance and efficacy, combination with chemotherapy, and “salvage radioimmunotherapy” to delay the onset of metastases in men with progressive biochemical (micrometastatic) disease best suitable for 177Lu-J591. [Table: see text]

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