P3139Transvenous lead extraction: lead age threshold to predict the success of the procedure

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
M Giannotti Santoro ◽  
L Segreti ◽  
F Fiorentini ◽  
G Bernini ◽  
V Barletta ◽  
...  

Abstract Introduction Transvenous lead extraction is a safe and effective procedure. The dwell time of the leads, with other factors, is associated with poor outcome of the procedure. However, a precise estimation of the success of the procedure is not available. Purpose The aim of this study is to identify a lead's age threshold able to predict the success of the transvenous lead extraction (TLE) procedure. Methods All patients who underwent TLE in our center from January 2009 to December 2017 were retrospectively analyzed. The primary endpoint was the clinical success of the procedure. The optimal cut-off threshold was determined by the analysis of Receiver-Operating Characteristics (ROC) curves, using the Youden index. Results We analyzed 1210 consecutive patients that required transvenous removal of 2343 leads (686 ICD leads, 1657 pacemaker leads, 322 coronary sinus leads). Clinical success was achieved in 1168 patients (96.5%). Dwelling time median of the oldest lead for a patient was 66 months (interquartile range 27.0–115.0). The oldest lead completely removed was 32 years old. ROC curve analysis showed a dwell time threshold of 107 months – 8,92 years - for clinical success (Positive Predictive Value: 99.5%; Negative Predictive Value: 7.8%) and the area under the curve (AUC) was 0.879. Comparison of ROC for dwelling time and the 0.5 curve was assessed as statistically significative (p<0.0001). Conclusions Transvenous lead extraction is an effective procedure. The best cut-off threshold to predict a very high clinical success is 107 months.

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Eric W Black-Maier ◽  
Sean D Pokorney ◽  
Robert K Lewis ◽  
Alexander Christian ◽  
Ruth A Greenfield ◽  
...  

Introduction: Percutaneous transvenous lead extraction of cardiovascular implantable electronic devices (CIEDs) is increasingly common. Although ICD leads are widely considered to be more difficult to extract than pacemaker leads, there are few direct comparisons. Methods/Results: Using a cohort of 368 consecutive patients undergoing lead extraction (dwell time >1 year) between 2005-2012, we compared baseline characteristics/outcomes in extractions involving pacing versus ICD leads. We defined major adverse events (MAE) as any events/complications that required procedural intervention, transfusion, or that resulted in death or serious harm during index hospitalization. Median age was 60.6 yrs and 29.6% were women. There were 136 (37%) pacing lead extractions and 232 (63%) ICD lead extractions. Pacing leads had a longer dwell time (6.14 yrs [IQR 1.2-10.9 ] versus 4.4 yrs [IQR 1.1-6.4], p<0.001) and higher median LVEF (55% [IQR 35-55] vs. 30% [IQR 20-40], p<0.001) compared with ICD lead patients. Indications for pacing and ICD lead extractions included sepsis/endocarditis (21.3% vs. 24.6%, p=0.48), pocket infection (40.4% vs. 34.9%, p=0.29), and lead failure (15.4% vs. 38.8%, p<0.001). There were no significant differences between pacing and ICD lead extractions in median fluoroscopy time (5.5 vs. 8.5 minutes, p=0.86) or femoral bailout rate (4.4% vs. 5.2%, p=0.73). There were similar rates of all-cause MAE during index hospitalization (5.1% vs. 5.6%), death (2.2% vs 3.2%) and clinical success (97.0% vs. 97.0%, p=0.55) in pacemaker and ICD extractions, respectively. Conclusions: ICD leads are more commonly extracted relative to pacemaker leads, and this difference is driven by larger numbers of lead failure within ICD leads. Despite much longer dwell times, major adverse events were similar in pacing lead cases compared with ICD extractions.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
L Tulecki ◽  
M Czajkowski ◽  
S Targonska ◽  
K Tomkow ◽  
D Nowosielecka ◽  
...  

Abstract Background The guidelines suggest close co-operation between TLE operating team and cardiac surgery and its key role in the management of life-threatening complications remains unquestionable. But the role of cardiac surgeon seems to be much more extended. Purpose We have analysed the role of cardiac surgery in treatment of patients undergoing TLE procedures. Methods Using standard non-powered mechanical systems we have extracted ingrown PM/ICD leads from 3207 pts (38,7% female, average age 65,7-y) during the last 14 years. Non-infectious TLE indications were in 66,4% of patients. 46% had PM DDD system, 19% PM SSI, 22% ICD, 9% CRT, 4% other systems. In 12% of patients abandoned leads were found. 8% of patients had one lead, 54% - two, 15% - three and 4% - 4–6 leads in the heart. An average dwell time of all leads was 91,5 mth. The lead entry side was left in 96% of patients, right in 3% and both – 4%. Results Procedural success 96,1%, clinical success - 97,8%, procedure-related death 0,2%. Major complications appeared in 1,9% (cardiac tamponade 1,2%, haemothorax 0,2%, tricuspid valve damage 0,3%, stroke, pulmonary embolism &lt;1%). Conclusions Rescue cardiac surgery (for severe haemorrhagic complications) is still the most frequent reason of surgical intervention (1,1%). The second area of co-operation includes supplementary cardiac surgery after (incomplete) TLE (0,8%). The third one is connected with reconstruction or replacement of tricuspid valve, which can be affected by ingrown lead or damaged during TLE procedure (0,5%). Implantation of the complete epicardial system during any surgical intervention (rescue or delayed) should be considered as a supplementation of the operation (0,65%). Some of patients after TLE need implantation of epicardial leads for permanent epicardial pacing (0,6%) and some only left ventricular lead to rebuild permanent cardiac resynchronisation (0,5%). The single experience of large TLE centre indicates the necessity of close co-operation with cardiac surgeon, whose role seems to be more comprehensive than a surgical stand-by itself. Table 1 Funding Acknowledgement Type of funding source: None


EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
T Madej ◽  
K Matschke ◽  
M Knaut

Abstract Funding Acknowledgements Type of funding sources: None. Background Extraction of cardiac implantable electronic device (CIED) leads using excimer laser is in use since &gt; 20 years, but the predictors of success, all-cause complications and mortality are not yet sufficiently statistically evaluated.  Method All consecutive laser extractions performed at our institution between September 2011 and March 2020 with lead age &gt; 12 months were included and retrospectively analysed. Results 792 leads (mean age 75 months) were extracted during 335 procedures. The indication for extraction was pocket infection in 59%, CIED endocarditis in 25%, lead dysfunction or upgrade in 14% and others in 2%. 94.6% of leads were extracted complete, 4.2% partial (&lt; 4 cm rest) and the extraction failed in 1.3% of the leads (retention of ≥ 4 cm rest). Multivariable analysis identified lead age &gt; 7.5 years (odds ratio [OR] 6.5; p = 0.0281), broken leads (OR 28.0; p = 0.0009) and implantable cardioverter-defibrillator (ICD) leads (OR 6.5; p = 0.0010) as independent predictors of failed extraction. CIED-endocarditis was independently associated with complete extraction (OR 3.3; p = 0.0218). Complete procedural success or clinical success was achieved in 330 of 335 procedures (98.6%). The lead extraction failed in five cases (1.5%). Major procedure-associated adverse events (injuries of the great vessels or heart) occurred in four cases (1.2%). Two patients died perioperatively (0.6%). Minor complications occurred in 13 cases (3.9%). Major adverse events (MAE) causally not related to the procedure occurred in 18 (5.4%) of the patients. The most frequent MAE was postoperative aggravation of the sepsis (10 patients; 3.0%).  Independent predictors of major adverse events were CIED-endocarditis (OR 6.0; p = 0.0175), preoperative C-reactive-protein (CRP) &gt; 35 mg/l (OR 3.8; p = 0.0412) and body mass index (BMI) ≥ 25 kg/m2 (OR 5.0; p = 0.0489). Ten patients (3%) died during the hospital stay.  CIED-endocarditis with preoperative CRP &gt; 35 mg/l was independently associated with hospital mortality in multivariable analysis (OR 10.7; p = 0.0020). The Kaplan-Meyer analysis of 30-day mortality showed a significantly worse survival of patients with endocarditis (Log-Rank p = 0.0102). Conclusion Leads &gt; 7.5 years, broken leads and ICD leads are independent predictors of failed extraction. CIED endocarditis, CRP &gt; 35 and BMI ≥ 25 are associated with MAE. CIED endocarditis is related to higher short-term mortality despite successful lead extraction. Abstract Figure. Predictors of major adverse events


2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Trustsavin Lohanan ◽  
Thanakorn Leesawat ◽  
Tinakon Wongpakaran ◽  
Nahathai Wongpakaran ◽  
Nuntaporn Karawekpanyawong ◽  
...  

Abstract Background The screening instrument for borderline personality disorder (SI-Bord) consists of a 5-item self-reported questionnaire on the key features of BPD from the DSM-5 using a 5-point Likert scale. This study investigated its validity and reliability in screening for BPD in university students. Methods A cross-sectional study was conducted on a sample of university students in Thailand between November and December 2019. An online assessment gathered demographic data and results from the SI-Bord, the Perceived Stress Scale-10 (PSS-10) and the Patient Health Questionnaire-9 (PHQ-9). Participants whose SI-Bord scores were ≥ 1 were randomly selected to be interviewed and assessed for a BPD diagnosis by four psychiatrists using the Structured Clinical Interview for DSM-IV Axis II Personality Disorders (SCID-II) as a reference point. An intraclass correlation coefficient (ICC) of 0.925 (95% CI, 0.805–0.979) ensured inter-rater reliability between the four psychiatrists. The diagnostic sensitivity and specificity of the SI-Bord, as compared to that of the SCID-II, were determined to indicate the cut-off score. The Receiver Operating Characteristics (ROC) was analyzed to evaluate its diagnostic accuracy. Results The study included 342 students aged 18–25 years (the mean age was 20.25 ± 1.4 years), 80.4% of whom were female. Among the 68 participants selected for an online interview, 16 were diagnosed with BPD. The cut-off score of the SI-Bord was > 9, as suggested by the Youden index, yielding a sensitivity of 56.3% and a specificity of 92.3%. It had a positive predictive value of 69.2% and negative predictive value of 87.3%. The SI-Bord had adequate discriminative power between cases and non-cases of BPD, with the area under the ROC curve being 0.83. Cronbach’s alpha for the SI-Bord was 0.76, indicating acceptable internal consistency. The SI-Bord score was positively correlated to PHQ-9 and PSS-10 scores (r = 0.67 and r = 0.69, p < 0.001, respectively) and negatively correlated to MSPSS (r = − 0.50, p < 0.001). The prevalence of BPD in the sample was 6.4%, according to the cut-off score > 9. Conclusion The SI-Bord demonstrated good reliability and validity for screening BPD in university students. However, a study in non-Thai and other population groups should be warranted.


2020 ◽  
Vol 8 (1) ◽  
pp. 32
Author(s):  
Waseem A. Shoda

Background: Evaluation of diagnostic ability of preoperative estimation of serum thyroglobulin (TG) to detect malignant thyroid nodules (TN) in comparison to the American College of Radiology, Thyroid imaging reporting and data system (ACR-TIRADS), fine needle aspiration cytology (FNAC) and intraoperative frozen section (IO-FS).Methods: 34 patients with ACR-TIRADS 2-4 TN were evaluated preoperatively for identification of malignancy and all underwent total thyroidectomy with bilateral neck block dissection if indicated. Results of preoperative investigations were statistically analyzed using the Receiver operating characteristics (ROC) curve analysis as predictors for malignancy in comparison to postoperative paraffin sections.Results: Preoperative serum TG levels had 100% sensitivity and negative predictive value, while ACR-TIRADS scoring had 100% specificity and positive predictive value with accuracy rates of 95.35% and 97.67% for TG and TIRADS, respectively. ROC curve analysis defined preoperative ACR-TIRADS class and serum TG as highly diagnostic than FNAC for defining malignancy with non-significant difference between areas under curve for TIRADS and TG. For cases had intermediate risk of malignancy on TIRADS, IO-FS had missed 3, FNAC missed 4, while serum TG levels were very high in the 13 cases and were defined by ROC curve as the only significant predictor for malignancy.Conclusions: Preoperative estimation of serum TG showed higher diagnostic validity than FNAC, high predictability of cancer and ability to verify the intermediate findings on TIRADS. Combined preoperative TIRADS and TG estimation could accurately discriminate malignant TN with high accuracy and spare the need for preoperative FNAC or IO-FS. 


EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
Z Akhtar ◽  
MM Gallagher ◽  
A Elbatran ◽  
CT Starck ◽  
L WM Leung ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. OnBehalf PROMET group Background As implantation of cardiac implantable devices (CIED) rises globally, there is a paralleled need for extraction of these devices. Indications for transvenous lead extraction (TLE) is expanding, fuelling demand. This lifesaving procedure is performed by cardiologists and cardiac surgeons (CS). Cardiologists are familiar with transvenous methods whilst cardiac surgeons possess the skillset to address the significant complications associated with this procedure. We compared non-laser TLE outcomes performed by cardiologists and cardiac surgeons from six high-volume extraction centres across Europe. Methods Data was collected retrospectively from six major European TLE centres of 2205 patients and 3849 leads (PROMET). Propensity 1:1 score matching (PSM) was performed to account for confounding variables. PSM model with variables: lead dwell time, infection indication, biventricular system and defibrillator device, was best matched. This dataset was analysed to compare outcomes of TLE performed by the cardiologists and CS. Predictors of 30-day mortality and complications were identified using a multivariate regression analysis. Results Patients treated by CS and cardiologists were similar in age (64.7 vs 66.7 years, p = NS) and equally male (70.3% vs 72.3%, p = 0.39) with a parallel infectious indication (51.7% vs 47.6%, p = 0.1). Surgeons achieved a significantly higher proportion of clinical success than cardiologists (98.9% vs 96.4%, p = 0.001) and complete lead extraction (98% vs 95.9%, p &lt; 0.01) with a higher rate of minor complications (4.1% vs 2.2%, p = 0.024); major complications were similar (0.9% vs 1.2%, respectively, p = 0.46) as was 30-day mortality (3.2% vs 2%, respectively, p = 0.28). Multivariate regression analysis revealed systemic infection (p &lt; 0.001, OR 7.2 [CI 2.3-20.1]) and defibrillator system extraction (p = 0.025, OR 3.4 [CI 1.2-10.2]) increased the odds of 30-day mortality, whilst Evolution™ sheath use reduced the odds (p = 0.025, OR 0.34 [CI 0.13-0.88]); lead dwell time (p = 0.02, OR 1.005 [1-1.009] and Evolution™ sheath use (p = 0.023, OR 2.15[1.1-4.15]) increased the odds of complications. Conclusion Cardiac surgeons and cardiologists achieved a high rate of TLE procedural success and with a similar safety profile, replicating standards seen across Europe.


2021 ◽  
pp. 030089162110149
Author(s):  
Dragan Trivanovic ◽  
Stjepko Plestina ◽  
Lorena Honovic ◽  
Renata Dobrila-Dintinjana ◽  
Jelena Vlasic Tanaskovic ◽  
...  

Background: Gastric cancer (GC) is the eighth most common cause of cancer deaths in Croatia and one of the most common causes of cancer deaths worldwide. A reliable diagnostic tool for the early detection of GC is essential. Objective: We previously suggested a pepsinogen test method to reduce the mortality from GC by allowing early detection. Here, we report an updated analysis from a prospective single-center clinical study to evaluate the sensitivity and specificity of the pepsinogen test method and to determine whether this test can be used as a part of routine laboratory assessment of high-risk patients. Methods: We present mature data of the pepsinogen test method in the Croatian population after a median follow-up of 36 months. Statistical analyses were performed using a Mann-Whitney U test, multiple logistic regression, and receiver operating characteristics (ROC) to evaluate the predictive power of the assayed biomarkers. Results: Of the 116 patients, 25 patients had GC and 91 demonstrated a nonmalignant pathology based on tissue biopsy. Cutoff values were pepsinogen I ⩽70 and pepsinogen I/II ratio ⩽3.0. Using ROC curve analysis, the accuracy, sensitivity, specificity, positive predictive value, and negative predictive value were determined to be 87.22%, 78.12%, 90.10%, 71.43%, and 92.86%, respectively, for the diagnosis of GC. The area under the curve was 0.700 (95% confidence interval 0.57–0.83). Conclusion: Pepsinogen tests are valuable for screening a population in need of further diagnosis and could help to avoid unnecessary invasive endoscopic procedures.


2020 ◽  
Author(s):  
Trustsavin Lohanan ◽  
Thanakorn Leesawat ◽  
Tinakon Wongpakaran ◽  
Nahathai Wongpakaran ◽  
Nuntaporn Karawekpanyawong ◽  
...  

Abstract Background: The screening instrument for borderline personality disorder (SI-Bord) consists of a 5-item self-reported questionnaire on the key features of BPD from the DSM-5 using a 5-point Likert scale. This study investigated its validity and reliability in screening for BPD in university students.Methods: A cross-sectional study was conducted on a sample of university students in Thailand between November and December 2019. An online assessment gathered demographic data and results from the SI-Bord, the Perceived Stress Scale-10 (PSS-10) and the Patient Health Questionnaire-9 (PHQ-9). Participants whose SI-Bord scores were ≥ 1 were randomly selected to be interviewed and assessed for a BPD diagnosis by four psychiatrists using the Structured Clinical Interview for DSM-IV Axis II Personality Disorders (SCID-II) as a reference point. An intraclass correlation coefficient (ICC) of 0.925 (95% CI, 0.805–0.979) ensured inter-rater reliability between the four psychiatrists. The diagnostic sensitivity and specificity of the SI-Bord, as compared to that of the SCID-II, were determined to indicate the cut-off score. The Receiver Operating Characteristics (ROC) was analyzed to evaluate its diagnostic accuracy.Results: The study included 342 students aged 18–25 years (the mean age was 20.25 ± 1.4 years), 80.4% of whom were female. Among the 68 participants selected for an online interview, 16 were diagnosed with BPD. The cut-off score of the SI-Bord was > 9, as suggested by the Youden index, yielding a sensitivity of 56.3% and a specificity of 92.3%. It had a positive predictive value of 69.2% and negative predictive value of 87.3%. The SI-Bord had adequate discriminative power between cases and non-cases of BPD, with the area under the ROC curve being 0.83. Cronbach’s alpha for the SI-Bord was 0.76, indicating acceptable internal consistency. The SI-Bord score was positively correlated to PHQ-9 and PSS-10 scores (r = 0.67 and r = 0.69, p < 0.001, respectively) and negatively correlated to MSPSS (r = − 0.50, p < 0.001). The prevalence of BPD in the sample was 6.4%, according to the cut-off score > 9.Conclusion: The SI-Bord demonstrated good reliability and validity for screening BPD in university students.


EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
A Polewczyk ◽  
W Jachec ◽  
L Segreti ◽  
M G Bongiorni ◽  
A Kutarski

Abstract Background Reduced left ventricle ejection fraction (LVEF) is a common risk factor of complications in patients undergoing different procedures. Aim of study The aim of the study was to assess  efficiency and safety of transvenous lead extraction (TLE) procedures in patients with reduced LVEF (&lt; 40%) compared to patients with mid-range reduced and preserved LVEF (≥40%). Study group Data from 3434 of TLE procedures (patient"s age during TLE-65,5 ± 15,5 years, female; 1168 (34,01%), performed in two high volume European Centers (PISA – Italy, Lublin-Zamość – Poland) were analysed. Results In group with reduced LVEF (A) compared to the group of patients with LVEF ≥ 40% (B) the smaller number of female was found (p &lt; 0,001). The number of devices with ICD leads was higher in group A (p &lt; 0,001). Dwelling time for oldest lead and the oldest extracted lead were longer in group B (p &lt; 0.001).  There were no differences in indications for TLE between presented groups. The procedure duration time was similar in both groups. There were no statistically significant differences in complete procedural success, clinical success, major and minor complications and procedure related death occurrence. Complete results are presented in  Table.1 Conclusion The effectiveness and safety of TLE in patients with reduced left ventricle ejection fraction does not differ from the results of the TLE procedures in patients with mid-range reduced and preserved LVEF. Abstract Table


Author(s):  
Simon Pecha ◽  
Tibor Ziegelhoeffer ◽  
Yalin Yildirim ◽  
Yeong-Hoon Choi ◽  
Stephan Willems ◽  
...  

Abstract OBJECTIVES Transvenous lead extraction using mechanical rotational- or laser sheaths is an established procedure. Lead dwell time has been recognized as a risk factor for extraction failure and procedure-related complications. We therefore investigated the safety and efficacy of transvenous extraction of leads with an implant duration of more than 10 years. METHODS Between January 2013 and March 2017, a total of 403 patients underwent lead extraction in 2 high-volume lead extraction centres. One hundred and fifty-four patients with extraction of at least 1 lead aged over 10 years were included in this analysis. Laser lead extraction was the primary extraction method, with additional use of mechanical rotational sheaths or femoral snares, if necessary. All procedural- and patient-based data were collected into a database and retrospectively analysed. RESULTS Mean patient’s age was 65.8 ± 15.8 years, 68.2% were male. Three hundred and sixty-two leads had to be extracted. The mean lead dwell time of treated leads was 14.0 ± 6.1 years. Complete procedural success was achieved in 91.6% of cases, while clinical success was achieved in 96.8%. Failure of extraction occurred in 3.2%. Leads that could not be completely removed had a significantly longer lead dwell time (18.2 vs 13.2 years; P = 0.016). Additional mechanical rotational sheaths or femoral snares were used in 26 (16.9%) patients. Overall complication rate was 4.6%, including 5 (3.3%) major and 2 (1.3%) minor complications. There was no procedure-related mortality. CONCLUSIONS Transvenous lead extraction in leads aged over 10 years is safe and effective when performed in specialized centres and with use of multiple tools and techniques. Leads that could not be completely extracted had a statistically significant longer lead dwell time.


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