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]

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.

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.

scholarly journals Prospective Long-Term Follow-up after First-Line Subcutaneous Cladribine Treatment in Patients with Hairy Cell Leukemia. a Study of the SAKK (Swiss Group for Clinical Cancer Research)

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 2875-2875
Author(s):  
Rudolf A. Benz ◽  
Kornelius Arn ◽  
Martin Andres ◽  
Thomas Pabst ◽  
Urban Novak ◽  
...  
Keyword(s):  
Overall Survival ◽  
Secondary Malignancies ◽  
Hairy Cell ◽  
First Line ◽  
Purine Analogues ◽  
Minor Response ◽  
Kaplan Meier ◽  
Long Term Follow Up

Abstract Introduction : Hairy cell leukemia (HCL) is a chronic mature B-cell neoplasm with a very indolent clinical course and patients may survive for many decades. First-line treatment with purine analogues such as cladribine (Cld) is considered standard of care since it is very efficient and induces profound remissions. However, patients with HCL often relapse after purine analogues and repeated treatment may increase morbidity and mortality. Despite good clinical evidence of long term control of the disease by several mainly single center studies of patients treated with purine analogues, there is only one study analyzing mainly subcutaneous (sc) treated patients based on registry data. We therefore performed a pooled long-term follow-up analysis of our prospective multicenter studies treating patients with sc Cld focusing on survival, secondary malignancy and retreatment. Materials and Methods : The SAKK included patients treated for HCL in 4 studies between 1993 and 2005. Three studies focused on first-line regimens with sc Cld, whereas the fourth protocol focused on the effect of Rituximab monotherapy in patients pretreated with Cld. Classical morphologic, immunohistochemistry and flow cytometry criteria were used as inclusion criteria and response was assessed by established criteria. Treatment algorithms in the 4 studies were as follows: 1) 5 days of Cld 0.14mg/kg sc followed by max 2 cycles of 7 days of Cld 0.1mg/kg sc in case of minor response or no response (SAKK 32/93); 2) Single shot of Cld 0.25mg/kg sc followed by a maximum of 2 cycles of 0.14mg/kg sc for 5 day in case of minor response, no response or relapse (SAKK 32/95); 3) 5 consecutive days of Cld 0.14mg/kg sc versus the same dose in 5 weekly applications (SAKK 32/98); 4) Rituximab 375 mg/m2iv weekly for 4 weeks in relapsed patients (SAKK 31/98). SAKK 32/93 included 63, SAKK 32/95 74 and SAKK 32/98 100 patients. Of the 26 patients registered in 31/98 20 were already in SAKK 32/93, 32/95 and 32/98. Therefore, we also included the treatment information and follow-up data of these 20 patients. All patients were subject to life-long follow-up within the clinical trials. Further information including secondary malignancies and retreatments were obtained by sending out questionnaires to the treating physicians of the study patients. Of the 237 patients 4 patients were in two of the studies and 10 patients have been excluded because of non-classical HCL phenotype. Therefore, a total of 223 patients were included in the analysis. Overall survival and follow-up time were assessed by Kaplan-Meier and reverse Kaplan-Meier method, respectively. Results : The median age of patients at the time of diagnosis was 55 (range 21 to 96) years, 50 patients were female (22.4%) and 173 (77.6%) male. At the time of data analysis, the median follow-up time was 12.1 (95%-CI 10.0 to 14.0) years. A total of 129 (57.8%) patients had the last follow-up information more than two years prior to the data cut-off in May 2016, however, the available information of all patients was used for the sub-analyses including secondary malignancies or retreatment. By the cut-off date, 49 patients have died, 14 (28.6%) due to secondary malignancies and 7 (14.3%) due to HCL progression. Median overall survival from diagnosis was 31.6 (95%-CI 31.6 to 37.8) years. Retreatment was necessary in 53 (23.7%) patients after a mean of 6 (0.2 to 20.4) years and first retreatment was mainly Cld (64%), rituximab (19%) or Cld and rituximab (13%). 21 patients (9.4%) required more than one retreatment with a mean number of 1.57 (range 1 to 5) treatments. A total of 42 (18.8%) patients developed secondary malignancies with an average time to occurrence of 7.1 (range: 0.1 to 17.7) years. The majority of the secondary malignancies were of non-hematological origin (85.9%), most frequently skin cancer (31.0%), followed by prostate cancer (19.0%) and colorectal cancer (16.7%). Six patients (14.4%) developed hematological secondary malignancies with a predominance of B-lymphoid neoplasms. Conclusion : Long-term overall survival in HCL patients treated with sc Cld was excellent and comparable to studies using iv Cld. Despite the long follow-up, sc Cld had a curative potential and relapses requiring re-treatment were observed only in a minority of patients. Secondary malignancies were predominantly non-hematological. These data indicate that patients need to be followed carefully with a special focus on secondary malignancies. Disclosures Chalandon: Roche: Membership on an entity's Board of Directors or advisory committees, Other: Travel costs.

Long-term outcomes following deep brain stimulation for Parkinson’s disease

2020 ◽  
Vol 132 (1) ◽  
pp. 205-210 ◽  
Author(s):  
Frederick L. Hitti ◽  
Ashwin G. Ramayya ◽  
Brendan J. McShane ◽  
Andrew I. Yang ◽  
Kerry A. Vaughan ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Deep Brain Stimulation ◽  
Multivariate Regression ◽  
Long Term Outcomes ◽  
Telephone Surveys ◽  
Kaplan Meier ◽  
Long Term Follow Up ◽  
Deep Brain

OBJECTIVEDeep brain stimulation (DBS) is an effective treatment for several movement disorders, including Parkinson’s disease (PD). While this treatment has been available for decades, studies on long-term patient outcomes have been limited. Here, the authors examined survival and long-term outcomes of PD patients treated with DBS.METHODSThe authors conducted a retrospective analysis using medical records of their patients to identify the first 400 consecutive patients who underwent DBS implantation at their institution from 1999 to 2007. The medical record was used to obtain baseline demographics and neurological status. The authors performed survival analyses using Kaplan-Meier estimation and multivariate regression using Cox proportional hazards modeling. Telephone surveys were used to determine long-term outcomes.RESULTSDemographics for the cohort of patients with PD (n = 320) were as follows: mean age of 61 years, 70% male, 27% of patients had at least 1 medical comorbidity (coronary artery disease, congestive heart failure, diabetes mellitus, atrial fibrillation, or deep vein thrombosis). Kaplan-Meier survival analysis on a subset of patients with at least 10 years of follow-up (n = 200) revealed a survival probability of 51% (mean age at death 73 years). Using multivariate regression, the authors found that age at implantation (HR 1.02, p = 0.01) and male sex (HR 1.42, p = 0.02) were predictive of reduced survival. Number of medical comorbidities was not significantly associated with survival (p > 0.5). Telephone surveys were completed by 40 surviving patients (mean age 55.1 ± 6.4 years, 72.5% male, 95% subthalamic nucleus DBS, mean follow-up 13.0 ± 1.7 years). Tremor responded best to DBS (72.5% of patients improved), while other motor symptoms remained stable. Ability to conduct activities of daily living (ADLs) remained stable (dressing, 78% of patients; running errands, 52.5% of patients) or worsened (preparing meals, 50% of patients). Patient satisfaction, however, remained high (92.5% happy with DBS, 95% would recommend DBS, and 75% felt it provided symptom control).CONCLUSIONSDBS for PD is associated with a 10-year survival rate of 51%. Survey data suggest that while DBS does not halt disease progression in PD, it provides durable symptomatic relief and allows many individuals to maintain ADLs over long-term follow-up greater than 10 years. Furthermore, patient satisfaction with DBS remains high at long-term follow-up.

Pulmonary pure ground-glass opacity lesions: Use of computed tomography attenuation for predicting tumor progression.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 7548-7548
Author(s):  
Takashi Eguchi ◽  
Ryoichi Kondo ◽  
Satoshi Kawakami ◽  
Mina Matsushita ◽  
Tetsu Takeda ◽  
...  
Keyword(s):  
Computed Tomography ◽  
Ground Glass Opacity ◽  
Attenuation Value ◽  
Kaplan Meier ◽  
Ct Attenuation ◽  
Long Term Follow Up ◽  
The Difference ◽  
Ct Attenuation Value

7548 Background: Cases with pure ground-glass opacity (GGO) are increasing with the use of computed tomography (CT). In some cases, pure GGO on follow-up CT may represent tumor enlargement or the presence of solid components. We evaluated the natural progression of pure GGO lesions during a long-term follow-up period of more than 2 years. Methods: We retrospectively investigated 95 patients with pure GGO lesions detected between February 2003 and December 2010, in whom these lesions were monitored using CT for more than 2 years. Results: The median follow-up period was 64.7 months (range, 24–114 months). During the follow-up period, areas showing GGO increased in size or appeared to have solid components in 49 patients (group 1) and showed no change in 46 patients (group 2). We compared patient characteristics and tumor properties between the 2 groups. Mean CT attenuation values of the tumors differed significantly between groups 1 (-639.9 ± 88.9 HU) and 2 (-709.2 ± 60.9 HU). In contrast, no significant differences were noted with regard to age, gender, smoking history, lung cancer history, tumor size, and total numbers of GGO lesions between the 2 groups. The difference in the time to tumor growth according to the initial mean CT attenuation value was estimated using the Kaplan–Meier method. The growth incidence at 114 months for lesions with a mean CT attenuation value of -650 HU or more (n = 35) and less than -650 HU (n = 60) were estimated to be 96% and 48%, respectively. The difference between the 2 Kaplan–Meier curves was statistically significant (p < 0.0001). The usefulness of the mean CT attenuation value in predicting the growth of GGO lesions was evaluated using receiver operating characteristic analysis. The sensitivity and specificity was 63% and 87%, respectively, for a mean CT attenuation cutoff value of -650 HU. The area under the curve was 0.76. Conclusions: Many pure GGO lesions have potential for growth as seen during long-term follow-up. CT attenuation is useful in predicting the growth of GGO lesions.

Long Term Follow-Up and Retreatment of Patients with Low-Grade Lymphoproliferative Disorders (LPD) after 1 Year of Phamacokinetic (PK) Based Maintenance Therapy with Rituximab.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 4479-4479
Author(s):  
Jennifer R. Duff ◽  
James W. Lynch
Keyword(s):  
Maintenance Therapy ◽  
Progression Free Survival ◽  
Complete Response ◽  
Subsequent Treatment ◽  
Entire Group ◽  
Published Data ◽  
Low Grade ◽  
Long Term Follow Up

Abstract Background: We previously published data from a PK based maintenance trial in patients with CD 20 positive LPD. The PK based schedule derived from that trial was 1 dose every 3 months and is currently being evaluated in a large randomized trial (ECOG 4402). There has been appropriate concern that offering maintenance therapy may select for tumor cells resistant to rituximab thereby compromising the chance of response if patients are retreated once relapsing after such therapy. We now present long term follow-up on patients with low grade LPD treated on that trial. We furthermore report the results of retreating 5 patients who initially responded but relapsed after one year of maintenance rituximab. Methods: Patients with CD20 positive LPD (except SLL/CLL) were treated with four weekly infusions of rituximab 375mg/m2. All patients without PD were then monitored for 1 year and received a single infusion of 375mg/m2 when the level fell below <25mcg/ml. Among 22 patients with low grade LPD 10 (45%) achieved a complete response and 5 (23%) a partial response for an overall response rate with 68%. With a minimal follow-up of 69 months, all but 2 patients have sufficient data available to evaluate their subsequent treatment and response. Results: Of the 22 patients, there were 18 with follicular lymphoma, 2 with lymphoplasmacytoid lymphoma and 1 each with MALT and NOS. The median progression free survival (PFS) for the entire group was 23 months, but for responders the PFS was 50 months. 6/22 (27%) remain in continuous complete remission with no further therapy with a median follow-up of 72.5 mo. (range 69–76). Nine patients who initially responded have subsequently relapsed and were treated at the discretion of the treating physician as follows: 2 received no treatment one of whom experienced a spontaneous CR lasting 59 months, one patient with an isolated CNS relapse received intrathecal and local radiotherapy and is currently in CR with no further therapy at 71mo, 1 patient died in PR of a presumed MI and 5 received retreatment with rituximab accompanied by 2 years of maintenance therapy given as 1 dose every 3 months. Of the 5 patients who were retreated with rituximab the outcomes are listed in table I. Conclusions: Individualized PK dosing for rituximab for 1 year yielded 27% prolonged DFS in patients with LG LPD. Although the numbers of patients treated are very small, 80% of those who responded to rituximab and subsequently relapsed retained sensitivity to rituximab and have had durable benefits, comparable to their first course. Future trials which evaluate the efficacy of limited duration maintenance strategies should continue follow-up of patients after progression to determine whether subsequent treatment with rituximab offers clinical benefit. Table I Patient # 1st PFS 2nd Response 2nd PFS 1 18mo CR 44mo+ 2 23mo NR NA 3 27mo CR 33mo 4 29mo CR 33mo+ 5 50mo PR 29mo+

P1835Application of SYNTAX score I, II and residual SYNTAX as predictors of long-term clinical outcomes after coronary artery bypass grafting

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
E B Martins ◽  
W Hueb ◽  
E G Lima ◽  
P C Rezende ◽  
C L Garzillo ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Artery Bypass ◽  
Prognostic Significance ◽  
Syntax Score ◽  
Kaplan Meier ◽  
Syntax Score Ii ◽  
Long Term Follow Up ◽  
Residual Syntax Score

Abstract Background The evaluation of coronary disease by SYNTAX score I (SSI) is used to grade coronary complexity. Following SSI, two other scores were developed: SYNTAX score II (SSII) and residual SYNTAX score (rSS). Nevertheless, there is still a lack of evidence about the prognostic significance of these scores among patients undergoing CABG. Purpose Our aim was to evaluate the relation of the SSI, SSII and rSS score with outcomes in a long-term follow-up after elective CABG. Methods This is a single center, registry-based study. Baseline SSI was calculated from patients undergoing CABG by interventional cardiologists. SSI results were considered as usual: <23, 23–32 and >32. SSII and rSRR were then calculated and categorized in tertiles: <21.4, 21.4–29.4 and >29.4 for SSII and 0, 1–5 and >5 for rSS. Primary outcome was a composite of overall death, myocardial infarction, additional revascularization, or stroke (MACCE). Results Data were obtained from 559 patients. Median follow-up was 6 years (IQR: 4.9–9.8) and 170 events were documented. The Kaplan-Meier curves (figure 1) showed significant differences of MACCE in higher SSI, SSII and rSS (p=0.039, 0.033, <0.001 respectively). After multivariate adjustment, rSS, ejection fraction (EF) and age were found to be independent predictors of MACCE (p<0.001, 0.034 and 0.006, respectively). Figure 1 Conclusion In this sample SSI, II and residual were associated with the occurrence of events. However, just the rSS remained an independent predictor of MACCE together with age and EF.

Percutaneous retrogasserian glycerol injection in the management of trigeminal neuralgia: long-term follow-up results

1990 ◽  
Vol 73 (2) ◽  
pp. 212-216 ◽  
Author(s):  
Takamitsu Fujimaki ◽  
Takanori Fukushima ◽  
Shinichiro Miyazaki
Keyword(s):  
Trigeminal Neuralgia ◽  
Content Type ◽  
Kaplan Meier ◽  
Glycerol Injection ◽  
Sensory Disturbances ◽  
Long Term Follow Up ◽  
The Face ◽  
Median Pain

✓ The results in 122 patients with trigeminal neuralgia who underwent percutaneous retrogasserian glycerol injection are presented. Eighty patients were followed from 38 to 54 months. The recurrence rate at 54 months was 72% (Kaplan-Meier analysis), and the median pain-free interval was 32 months. Complications associated with the procedure were significantly high: 63% of the patients had definite hypesthesia of the face and 29% had unpleasant dysesthesias, including two cases of anesthesia dolorosa. Sensory disturbances were most frequent in patients who had received a previous alcohol block procedure. Among the patients without previous peripheral procedures, 50% developed sensory disturbances. Because of the high rates of recurrence and sensory disturbances, the authors prefer microvascular decompression for the management of trigeminal neuralgia.

scholarly journals Occurrence and outcomes of type 3 endoleaks in endovascular aortic repair within the Vascular Quality Initiative database

2020 ◽  
Vol 2 (1) ◽  
pp. e000054
Author(s):  
Juliet Blakeslee-Carter ◽  
Adam Beck ◽  
Emily Spangler
Keyword(s):  
Endovascular Aneurysm Repair ◽  
Index Hospitalization ◽  
Procedural Information ◽  
Kaplan Meier ◽  
Long Term Follow Up ◽  
Clinical Consequences ◽  
Aneurysm Repair ◽  
Type 3

ObjectivesType 3 endoleaks (T3ELs) represent a lack of aneurysm protection from systemic pressure. Previous studies have found a ~2% incidence of T3EL after standard infrarenal endovascular aneurysm repair (EVAR); however, no prior studies with new-generation devices have been able to determine an association between T3EL and clinical outcomes. Here we examine T3EL within the Society for Vascular Surgery Vascular Quality Initiative (VQI) to define rates of occurrence, rates and modes of reintervention, and clinical consequences of these endoleaks.Design and settingParticipants receiving infrarenal EVAR in the VQI from January 2003 to September 2018 were analyzed in a retrospective cohort study.ParticipantsOf 42 246 entries in the EVAR procedural registry, 41 604 had complete procedural information and were included in analysis. Of these, 36 082 had long-term follow-up, and 26 422 had follow-up (9–21 months per VQI reporting standards) with complete endoleak data recorded.InterventionsAll patients included in this study underwent an infrarenal EVAR.ResultsWithin the VQI database, the rate of T3EL in infrarenal EVAR during index hospitalization was 0.37% (n=157/41 604), of which 85% were due to midgraft separation and 15% were due to fabric disruptions. Out of the 157 index hospitalization T3ELs, 4.5% (n=7) received procedural reintervention during that hospitalization, which accounted for 1% of all index hospitalization reinterventions. During the 21-month follow-up, the rate of incident T3EL was 0.7% (n=205/26 422), which accounted for 5% of all endoleaks seen during follow-up. Reinterventions for incident T3EL at follow-up were done in 30 patients (rate 0.1%), which accounted for 9% of endoleak reinterventions and 3.3% of all reinterventions. The presence of incident T3EL found during follow-up was associated with a significant decrease in 5-year survival (74% vs 80%, respectively; p=0.041) in Kaplan-Meier analysis.ConclusionT3ELs rates at placement and follow-up remain low; however, the majority reported in long-term follow-up are incident and these incident endoleaks are associated with decreased survival in EVAR.

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.

Sign in / Sign up

Export Citation Format

Share Document