Incidence, progression, and predictors of left atrial appendage sealing after Watchman FLX device implantation with computed tomographic assessment.

BACKGROUND: Limited data exists regarding incidence, progression, and predictors of left atrial appendage (LAA) sealing after transcatheter LAA closure. We aimed to evaluate the incidence, progression, and predictive factors associated with LAA sealing after LAA closure. METHODS: This study includes patients who underwent successful LAA closure with Watchman FLX device and had both pre- and postprocedural computed tomography (CT). Postprocedural CT was performed 45 days after LAA closure and used to evaluate residual LAA patency. Patient who had residual LAA patency at 45 days underwent 1-year follow-up CT. RESULTS: A total of 105 patients (mean age: 75.2 ± 9.6 years; 53.3% female) who underwent successful LAA closure with Watchman FLX device and had pre- and postprocedural CT at 45 days were included. Residual patency was observed in 35 (33.3%) patients: 21 (20.0%) patients showed complete contrast opacification in LAA (complete LAA patency) while 14 (13.3%) patients showed contrast opacification only in the distal LAA (distal LAA patency). Among patients with residual LAA patency at 45 days, the rate of LAA sealing at 1 year was significantly higher in the distal LAA patency group than in the complete LAA patency group (75.0% vs. 16.7%; p = 0.019). Increased depth oversizing was associated with both distal LAA patency and complete LAA patency. CONCLUSION: Postprocedural CT at 45 days detected patent LAA in one-third of patients after LAA closure. LAA sealing was more frequently observed at 1 year among the distal LAA patency group than the complete LAA patency group.

Midterm follow-up after computed tomography angiography planned left atrial appendage closure.

BACKGROUND: While studies have shown the advantages of computed tomography angiography (CTA) over transesophageal echocardiography (TEE) in left atrial appendage closure (LAAC) preprocedural planning for WATCHMAN™ legacy and FLX devices, there has been no reported long-term data for this approach. OBJECTIVES: We sought to evaluate long-term outcomes using CTA-based preprocedural planning for LAAC using the WATCHMAN™ device. METHODS: A prospective analysis of 231 consecutive patients who underwent LAAC in a single, large academic hospital in the United States was conducted over a 5-year period. CTA-guided preprocedural planning was performed in all. Procedural success, adverse events, length of procedure, number of devices used, and length of stay were evaluated. Rates of death, cerebral embolism, systemic embolism, and major and minor bleeding were recorded. Adjusted predicted stroke and major bleeding rates were derived from CHA2DS2-Vasc and HAS-BLED scores, respectively. RESULTS: From January 26, 2017, to November 23, 2021, 231 patients underwent LAAC with CTA preprocedural planning by two operating physicians. The mean age of patients was 76.5 ± 8.4. 59.7% of patients were male. Mean CHA2DS2VASc and HAS-BLED scores were 4.5 ± 1.4 and 3.9 ± 0.9, respectively. All procedures were performed with intracardiac echo (100%). The procedural success rate was 99.1%. The CTA sizing strategy accurately predicted the implant size in 93.5% of patients. Mean number of devices used was 1.10 ± 0.3. Peri-procedural complication rate was 2.2%. 6 patients were lost to follow-up. Mean follow-up was 608.94 days with a total of 377.04 patient years. Median follow-up period of 368 days (interquartile range: 209-1067 days). There were 51 deaths from all causes (13.52 per 100 patient-years), 10 cases of cerebral embolism (2.65 per 100 patient-years), 2 cases of systemic embolism (0.53 per 100 patient-years), 17 cases of major bleeding (4.50 per 100 patient-years), and 31 cases of minor bleeding (8.2 per 100 patient-years). All-cause mortality at 1, 2, and 3 years was 12.7%, 20.9%, and 29.2%, respectively. CV event rates at 1, 2, and 3 years were 2.1%, 6.6%, and 10.5%, respectively. CONCLUSIONS: CTA-based preprocedural planning is accurate in predicting device size for LAAC and associated with excellent clinical outcomes at 5 years.

Efficacy of 3D-multidetector computed tomography and fluoroscopy fusion for percutaneous left atrial appendage occlusion procedures.

INTRODUCTION: We studied the impact of the use of three-dimensional multidetector computed tomography (3D-MDCT) and fluoroscopy fusion on percutaneous left atrial appendage occlusion (LAAO) procedures in relation to procedure time, contrast volume, fluoroscopy time, and total radiation. METHODS: This was a single-center, prospective, single-blinded, randomized control trial. Patients meeting criteria for LAAO were randomized to undergo LAAO with the WATCHMAN FLXTM device with and without 3D-MDCT-fluoroscopy fusion guidance using a prespecified protocol using computed tomography angiography for WATCHMAN FLXTM sizing, moderate sedation, and intracardiac echocardiography for procedural guidance. RESULTS: Overall, 59 participants were randomly assigned to the fusion (n = 33) or no fusion (n = 26) groups. The median (interquartile range) age was 79 (75-83) years, 24 (41%) were female, and 55 (93%) were Caucasian. The median CHA2 DS2 VASc and HASBLED scores were 5 (4-6) and 3 (3-4), respectively. At the time of the study, 51 (53%) patients were on a direct acting oral anticoagulant. There were no significant differences between the fusion and no fusion groups in procedure time (52.4 ± 15.4 vs. 56.8 ± 19.5 min, p = .36), mean contrast volume used (33.8 ± 12.0 vs. 29.6 ± 11.5 mls, p = .19), mean fluoroscopy time (31.3 ± 9.9 vs. 28.9 ± 8.7 min, p = .32), mean radiation dose (1177 ± 969 vs. 1091 ± 692 mGy, p = .70), and radiation dose product curve (23.9 ± 20.5 vs. 35.0 ± 49.1 Gy cm2 , p = .29). There was no periprosthetic leak in the two groups in the immediate 1-month postprocedure follow-up periods. CONCLUSIONS: There was no significant difference with and without 3D-MDCT-fluoroscopy fusion in procedure time, contrast volume use, radiation dose, and radiation dose product.

Left Atrial Appendage Closure Outcomes in Patients With Cancer at a Single Tertiary Center.

Atrial fibrillation is the most common arrhythmia in patients with underlying malignancy. Patients with cancer have a higher risk of bleeding, and at the same time, carry an elevated risk of thromboembolism related to the hypercoagulable state, type of cancer, and anticancer treatment, rendering safe anticoagulation challenging in this population. Left atrial appendage closure is an alternative treatment option in patients with atrial fibrillation and high bleeding risk; however, the data on patients with cancer are limited. Our study aimed to compare the long-term outcomes in patients with cancer receiving left atrial appendage closure using the WATCHMAN device. This is a prospective, single-center study comparing outcomes in 389 patients who underwent percutaneous left atrial appendage closure using the WATCHMAN device over 5 years in a single, large academic hospital in the United States. The postprocedural outcomes of mortality, stroke, and major bleeding were evaluated in patients with and without cancer. Our study included 57 patients with cancer and 332 without cancer. The baseline characteristics were similar between the 2 groups. Metastatic disease was present in 16.4% of patients, and 25% were receiving active treatment at the time of the procedure. The median follow-up time was 354 (interquartile range 85 to 790) days. There was no difference in mortality (hazard ratio [HR] 1.3, 95% confidence interval [CI] 0.72 to 2.35, p = 0.38), major bleeding episodes (HR 1.2, 95% CI 0.45 to 3.33, p = 0.68), and stroke (HR 0.64, 95% CI 0.19 to 2.21, p = 0.49) at 3 years after the procedure in patients with and without cancer. There was no difference in the composite outcome (postprocedural mortality, stroke, and major bleeding) between the 2 groups (HR 1.25, CI 0.75 to 2.07, p = 0.38). Percutaneous left atrial appendage closure in patients with cancer appears to be safe and has a similar long-term risk compared with patients without cancer.

Clinical impact of right ventricular pacing burden in patients with post-transcatheter aortic valve replacement permanent pacemaker implantation.

AIMS: Patients who undergo permanent pacemaker (PPM) implantation after transcatheter aortic valve replacement (TAVR) have a worse outcome. The aim of this study was to identify risk factors of worse outcomes in patients with post-TAVR PPM implantation. METHODS AND RESULTS: This is a single-centre, retrospective study of consecutive patients who underwent post-TAVR PPM implantation from 11 March 2011 to 9 November 2019. Clinical outcomes were evaluated by landmark analysis with cut-off at 1 year after the PPM implantation. Of the 1389 patients underwent TAVR during the study duration and a total of 110 patients were included in the final analysis. Right ventricular pacing burden (RVPB) ≥ 30% at 1 year was associated with a higher likelihood of heart failure (HF) readmission [adjusted hazard ratio (aHR): 6.333; 95% confidence interval [CI]: 1.417-28.311; P = 0.016] and composite endpoint of overall death and/or HF (aHR: 2.453; 95% CI: 1.040-5.786; P = 0.040). The RVPB ≥30% at 1 year was associated with higher atrial fibrillation burden (24.1 ± 40.6% vs. 1.2 ± 5.3%; P = 0.013) and a decrease in left ventricular ejection fraction (-5.0 ± 9.8% vs. + 1.1 ± 7.9%; P = 0.005). The predicting factors of the RVPB ≥30% at 1 year were the presence of RVPB ≥40% at 1 month and the valve implantation depth measured from non-coronary cusp ≥4.0 mm (aHR: 57.808; 95% CI: 12.489-267.584; P < 0.001 and aHR: 6.817; 95% CI: 1.829-25.402; P = 0.004). CONCLUSIONS: The RVPB ≥30% at 1 year was associated with worse outcomes. Clinical benefit of minimal RV pacing algorithms and biventricular pacing needs to be investigated.

Predictors of successful same-day discharge and 1-year outcomes after left atrial appendage closure.

BACKGROUND: Same-day discharge (SDD) following left atrial appendage closure (LAAC) is increasingly common but predictors of successful SDD and 1-year clinical outcomes have not been described. OBJECTIVE: The purpose of this study was to explore predictors of successful SDD and report 1-year outcomes in patients undergoing LAAC with SDD. METHODS: A prospective analysis was performed over a 20-month period of 225 consecutive patients that underwent LAAC in a large, academic hospital. All patients included in the study underwent a SDD protocol. Baseline characteristics and 1-year outcomes of patients discharged same day of the procedure versus those that required at least one overnight stay were compared. Adverse events, procedural success, and procedure times were evaluated. RESULTS: One hundred and sixty-one patients (72%) of patients were discharged the same day and 64 patients (28%) required at least an overnight stay (non-SDD: NSDD). NSDD patients were older and more often female. Procedure time was also longer in the NSDD group than in the SDD (63.4 vs. 55.1 min; p = 0.01). While overall procedural success rates were similar between the SDD and NSDD groups (99.4% vs. 98.4%; p = 0.39), NSDD patients had more complications (9.4% vs. 0%; p = 0.01) and higher number of devices per procedure (1.2 vs. 1.0; p = 0.01) as compared to SDD. At 1 year, there were no significant difference between the SDD and NSDD groups in stroke (1.1% vs. 0%; log-rank p = 0.44) and all-cause mortality (3.9% vs. 4.7%; log-rank p = 0.70). CONCLUSION: In this single-center LAAC experience, female sex, older age, and longer procedure duration were associated with higher likelihood for need of overnight stay. At 1-year follow-up, there were no significant differences in stroke events and death rates between SDD and NSDD groups.

Risk stratification of new persistent left bundle branch block after transcatheter aortic valve implantation

ABSTRACT Previous studies reported that new-onset persistent left bundle branch block (NOP-LBBB) was related to worse outcomes after transcatheter aortic valve implantation (TAVI). However, these results can be confounded by the presence of permanent pacemaker (PPM) implantation before and after TAVI. Long-term outcomes and the risk stratification of NOP-LBBB not having PPM implantation before and after TAVI have not been fully investigated. This is an international, multicenter, retrospective study of patients who underwent TAVI from July 31, 2007, to May 8, 2020. A total of 2,240 patients were included, and 17.5% of patients developed NOP-LBBB. NOP-LBBB was associated with cardiac mortality (adjusted hazard ratio [aHR] 1.419, 95% confidence interval [CI] 1.014 to 1.985, p = 0.041) and the composite outcomes of cardiac mortality and/or heart failure readmission (aHR 1.313, 95% CI 1.027 to 1.678, p = 0.030). Patients who developed NOP-LBBB with pre-TAVI left ventricular ejection fraction (LVEF) <40% were significantly associated with cardiac mortality (aHR 2.049, 95% CI 1.039 to 4.041, p = 0.038), heart failure (aHR 3.990, 95% CI 2.362 to 6.741, p <0.001), and the composite outcome (aHR 2.729, 95% CI 1.703 to 4.374, p <0.001). Although NOP-LBBB with pre-TAVI LVEF >40% had a significant decrease in LVEF 6 to 12 months after TAVI (-1.8 ± 9.7% vs +0.6 ± 8.1%, p = 0.003), NOP-LBBB with pre-TAVI LVEF <40% had a significant increase in LVEF 6 to 12 months after TAVI (+9.7 ± 13.6% vs +13.0 ± 11.7%, p = 0.157). In conclusion, patients with NOP-LBBB without pre-TAVI and post-TAVI PPM developed significantly worse long-term outcomes, especially in patients with pre-TAVI LVEF <40%. Further prospective investigation should be undertaken.

Novel computed tomography angiography-based sizing methodology for WATCHMAN FLX device in left atrial appendage closure.

BACKGROUND: While there is recent data suggesting an advantage of computed tomography angiography (CTA) over transesophageal echocardiography (TEE) for preprocedural left atrial appendage closure (LAAC) planning, there is limited published experience for sizing strategies. Device sizing for LAAC may be challenging and noninvasive algorithms that improve this selection process are warranted. OBJECTIVES: We sought to evaluate the safety and the feasibility for the implementation of a novel CTA-based sizing methodology for WATCHMAN™ FLX device in a series of patients undergoing LAAC using the TruPlan™ software package. METHODS: A prospective analysis of 136 consecutive patients who underwent LAAC over a 12-month period in a single, large academic hospital in the United States was conducted. CTA-guided preprocedural planning and intracardiac echocardiography (ICE) was performed in all. Procedural success, adverse events, length of procedure, number of devices used, and length of stay were evaluated. RESULTS: A total of 136 patients who underwent LAAC procedure with WATCHMAN™ FLX platform between October 1, 2020 until September 30, 2021 were included. The pre-specified protocol using CTA and ICE was implemented in all patients (100%). Mean CHA2 DS2 VASc score was 4.4 ± 1.3 and the mean HAS-BLED score was 3.9 ± 0.8. ICE-guided 100% transseptal puncture success rate was 100% with 98.5% of overall procedural success rate. Preprocedural CTA sizing strategy accurately predicted the implanted size in 91.1% of patients. Ten patients (7.4%) required another sized device and 2 cases were aborted. At 45-day follow-up, only 1 patient (0.7%) had significant peri-device leak (≥5 mm) on TEE. CONCLUSIONS: CTA-based preprocedural sizing methodology for WATCHMAN™ FLX in LAAC was safe, feasible and associated with excellent procedural outcomes. Further studies are warranted to confirm if the features specific to TruPlan™ may reduce the number of deployment attempts, the number of devices utilized in the procedure, and the risk of complications.

Risk Stratification of New Persistent Left Bundle Branch Block After Transcatheter Aortic Valve Implantation.

Previous studies reported that new-onset persistent left bundle branch block (NOP-LBBB) was related to worse outcomes after transcatheter aortic valve implantation (TAVI). However, these results can be confounded by the presence of permanent pacemaker (PPM) implantation before and after TAVI. Long-term outcomes and the risk stratification of NOP-LBBB not having PPM implantation before and after TAVI have not been fully investigated. This is an international, multicenter, retrospective study of patients who underwent TAVI from July 31, 2007, to May 8, 2020. A total of 2,240 patients were included, and 17.5% of patients developed NOP-LBBB. NOP-LBBB was associated with cardiac mortality (adjusted hazard ratio [aHR] 1.419, 95% confidence interval [CI] 1.014 to 1.985, p = 0.041) and the composite outcomes of cardiac mortality and/or heart failure readmission (aHR 1.313, 95% CI 1.027 to 1.678, p = 0.030). Patients who developed NOP-LBBB with pre-TAVI left ventricular ejection fraction (LVEF) <40% were significantly associated with cardiac mortality (aHR 2.049, 95% CI 1.039 to 4.041, p = 0.038), heart failure (aHR 3.990, 95% CI 2.362 to 6.741, p <0.001), and the composite outcome (aHR 2.729, 95% CI 1.703 to 4.374, p <0.001). Although NOP-LBBB with pre-TAVI LVEF >40% had a significant decrease in LVEF 6 to 12 months after TAVI (-1.8 ± 9.7% vs +0.6 ± 8.1%, p = 0.003), NOP-LBBB with pre-TAVI LVEF <40% had a significant increase in LVEF 6 to 12 months after TAVI (+9.7 ± 13.6% vs +13.0 ± 11.7%, p = 0.157). In conclusion, patients with NOP-LBBB without pre-TAVI and post-TAVI PPM developed significantly worse long-term outcomes, especially in patients with pre-TAVI LVEF <40%. Further prospective investigation should be undertaken.

Safety, Efficacy, and Cost-Effectiveness of Same-Day Discharge for Left Atrial Appendage Occlusion.

BACKGROUND: Percutaneous left atrial appendage occlusion (LAAO) with the Watchman device is FDA approved for stroke prevention in patients with nonvalvular atrial fibrillation who have an appropriate indication. During the COVID-19 pandemic, a same-day discharge protocol (SDDP) was employed to improve resource utilization, relieve hospital occupation, and reduce the possible risk of in-hospital virus transmission. OBJECTIVES: We sought to analyze the safety, feasibility, and cost effectiveness for SDDP in patients receiving LAAO. METHODS: A prospective analysis of 142 consecutive patients, 119 treated prior to SDDP and 23 who underwent SDDP following LAAO with cardiac computed tomography angiography (CTA)-guided pre-procedural planning and intracardiac echocardiogram (ICE). Procedures were performed in a single, large academic hospital in the United States. In-hospital and 45-day procedural success, adverse events, length of procedure, and length-of-stay were evaluated. RESULTS: Baseline patient characteristics including mean CHA2DS2VASc scores and mean HAS-BLED scores were similar in both groups. All procedures were successful. There was no significant difference in rates of procedural complications or in-hospital adverse events. The mean procedure time in the SDDP group was 11 minutes longer than in the conventional group (62.1 ± 5.9 vs 51.1 ± 21; P=.01). Outcomes at 45-day follow-up were similar. SDDP was associated with a reduced length of stay compared with conventional strategy and a 15% reduction in total costs. CONCLUSIONS: Same-day discharge strategy for LAAO appears safe, feasible and could become the new standard approach for LAAO. A protocol including CTA pre-procedural planning, ICE-guided deployment and conscious sedation reduces hospital occupation and lowers costs.

Left Atrial Appendage Occlusion Using Cardiac CT Angiography and Intracardiac Echocardiography: A Prospective, Single-Center Study.

OBJECTIVES: We reviewed the periprocedural events, accuracy of device selection, and outcomes of a series of patients receiving percutaneous left atrial appendage occlusion (LAAO) with cardiac computed tomography angiography (CTA)-guided preprocedural planning and intracardiac echocardiography (ICE)-guided device deployment. BACKGROUND: Percutaneous LAAO with the Watchman device (Boston Scientific) is approved by the United States Food and Drug Administration for stroke prevention in patients with non-valvular atrial fibrillation with a demonstrated contraindication to oral anticoagulation. Cardiac CTA preprocedural planning with utilization of an ICE-guided deployment may be associated with favorable outcomes. METHODS: A prospective analysis of 71 non-consecutive patients who underwent LAAO over an 18-month period with cardiac CTA-guided preprocedural planning and ICE was conducted. Procedures were performed in a single large, academic hospital in the United States. Procedural success, correlation of CTA preprocedural device sizing with final device size utilization, adverse events, length of procedure, and length of stay were evaluated. RESULTS: Preprocedural cardiac CTA-guided device sizing was consistent with the final deployed device in 69 patients (97.2%) evaluated in this case series. Procedure success rate was 100%. All implants were performed using Watchman devices, 45 (63.4%) with the original 2.5 platform and 26 (36.6%) with the Watchman FLX platform. All patients were treated with conscious sedation and the mean length of stay was 1.45 ± 0.72 days. Only 2 adverse events occurred and both resolved. CONCLUSIONS: Cardiac CTA-guided preprocedural planning resulted in accurate device sizing in this patient sample and may be used in conjunction with ICE and conscious sedation for a same-day discharge strategy in select patients.

A New WATCHMAN Sizing Algorithm Utilizing Cardiac CTA.

BACKGROUND: The WATCHMAN left atrial appendage (LAA) occlusion device has emerged as an alternative for anticoagulation in patients with non-valvular atrial fibrillation who cannot tolerate oral anticoagulation therapy. Cardiac computed tomography (CTA) is increasingly being utilized to guide WATCHMAN device sizing, however no consensus algorithm exists. We present our experience with a new cardiac CTA LAA ostium area based sizing algorithm. METHODS: This is a single center, prospective study analyzing consecutive patients who underwent cardiac CTA and WATCHMAN device implantation between March 2017 and October 2019 at University Hospitals Cleveland Medical Center. Patients baseline characteristics, procedural data, and clinical outcomes were collected and analyzed. RESULTS: 115 patients were included in our study. The mean age of our population was 76.5 years ±8.3 years. 70.4% of our patients had preserved ejection fraction. The predominant indication for device implantation was gastrointestinal bleeding in 57.4% of patients. The mean CHADSVASC score was 4.68 ± 1.4. The procedure success rate was 99.1% and the mean number of device used per case of 1.15 ± 0.4 devices. Our CTA LAA ostium area based sizing algorithm accurately predicted the final deployed WATCHMAN device size in 95.6% of cases. CONCLUSION: Our study demonstrates that cardiac CTA LAA ostium area based sizing algorithm is highly accurate at predicting WATCHMAN device size and demonstrates excellent clinical outcomes with lower device utilization per case than what is reported in literature.

Intracardiac radiofrequency ablation in living swine guided by polarization-sensitive optical coherence tomography.

SIGNIFICANCE: Pulmonary vein isolation with catheter-based radiofrequency ablation (RFA) is carried out frequently to treat atrial fibrillation. However, RFA lesion creation is only guided by indirect information (e.g., temperature, impedance, and contact force), which may result in poor lesion quality (e.g., nontransmural) and can lead to reoccurrence or complications. AIM: The feasibility of guiding intracardiac RFA with an integrated polarization-sensitive optical coherence tomography (PSOCT)-RFA catheter in the right atria (RA) of living swine is demonstrated. APPROACH: In total, 12 sparse lesions were created in the RA of three living swine using an integrated PSOCT-RFA catheter with standard ablation protocol. PSOCT images were displayed in real time to guide catheter-tissue apposition. After experiments, post-processed PSOCT images were analyzed to assess lesion quality and were compared with triphenyltetrazolium chloride (TTC) lesion quality analysis. RESULTS: Five successful lesions identified with PSOCT images were all confirmed by TTC analysis. In two ablations, PSOCT imaging detected gas bubble formation, indicating overtreatment. Unsuccessful lesions observed with PSOCT imaging were confirmed by TTC analysis. CONCLUSIONS: The results demonstrate that the PSOCT-RFA catheter provides real-time feedback to guide catheter-tissue apposition, monitor lesion quality, and possibly help avoid complications due to overtreatment, which may enable more effective and safer RFA treatment.

Risk Prediction Model for Cardiac Implantable Electronic Device Implantation After Transcatheter Aortic Valve Replacement.

OBJECTIVES: The aim of this study was to develop and validate a risk prediction model for high-grade atrioventricular block requiring cardiac implantable electronic device (CIED) implantation after transcatheter aortic valve replacement (TAVR). BACKGROUND: High-grade atrioventricular block requiring CIED remains a significant sequelae following TAVR. Although several pre-operative characteristics have been associated with the risk of post-operative CIED implantation, an accurate and validated risk prediction model is not established yet. METHODS: This was a single center, retrospective study of consecutive patients who underwent TAVR from March 10, 2011, to October 8, 2018. This cohort sample was randomly divided into a derivation cohort (group A) and a validation cohort (group B). A scoring system for risk prediction of post-TAVR CIED implantation was devised using logistic regression estimates in group A and the calibration and validation were done in group B. RESULTS: A total of 1,071 patients underwent TAVR during the study period. After excluding pre-existing CIED, a total of 888 cases were analyzed (group A: 507 and group B: 381). Independent predictive variables were as follows: self-expanding valve (1 point), hypertension (1 point), pre-existing first-degree atrioventricular block (1 point), and right bundle branch block (2 points). The resulting score was calculated from the total points. The internal validation in group B showed an ideal linear relationship in calibration plot (R2 = 0.933) and a good predictive accuracy (area under the curve: 0.693; 95% confidence interval: 0.627 to 0.759). CONCLUSIONS: This prediction model accurately predicts post-operative risk of CIED implantation with simple pre-operative parameters.

Preoperative detection of TERT promoter and BRAFV600E mutations in papillary thyroid carcinoma in high-risk thyroid nodules

ABSTRACT Objectives: This observational study analyzed telomerase reverse transcriptase (pTERT) mutations in 45 fine-needle aspiration (FNA) specimens obtained from thyroid nodules followed by postoperatively confirmation of papillary thyroid cancer (PTC) diagnosis, examining their relationship with clinicopathologic aspects and the BRAFV600E mutation. Subjects and methods: Clinical information was collected from patients who presented to Ribeirao Preto University Hospital for surgical consultation regarding a thyroid nodule and who underwent molecular testing between January 2010 to October 2012. Tests included a DNA-based somatic detection of BRAFV600E and pTERT mutations. Results: We found coexistence of pTERTC228T and BRAFV600E mutations in 8.9% (4/45) of thyroid nodules. All nodules positive for pTERT mutations were BRAFV600E positives. There was a significant association between pTERTC228T/BRAFV600E with older age and advanced stage compared with the group negative for either mutation. Conclusions: This series provides evidence that FNA is a reliable method for preoperative diagnosis of high-risk thyroid nodules. pTERTC228T/BRAFV600E mutations could be a marker of poor prognosis. Its use as a personalized molecular medicine tool to individualize treatment decisions and follow-up design needs to be further studied.

Preoperative detection of TERT promoter and BRAFV600E mutations in papillary thyroid carcinoma in high-risk thyroid nodules.

OBJECTIVES: This observational study analyzed telomerase reverse transcriptase (pTERT) mutations in 45 fine-needle aspiration (FNA) specimens obtained from thyroid nodules followed by postoperatively confirmation of papillary thyroid cancer (PTC) diagnosis, examining their relationship with clinicopathologic aspects and the BRAFV600E mutation. SUBJECTS AND METHODS: Clinical information was collected from patients who presented to Ribeirao Preto University Hospital for surgical consultation regarding a thyroid nodule and who underwent molecular testing between January 2010 to October 2012. Tests included a DNA-based somatic detection of BRAFV600E and pTERT mutations. RESULTS: We found coexistence of pTERTC228T and BRAFV600E mutations in 8.9% (4/45) of thyroid nodules. All nodules positive for pTERT mutations were BRAFV600E positives. There was a significant association between pTERTC228T/BRAFV600E with older age and advanced stage compared with the group negative for either mutation. CONCLUSIONS: This series provides evidence that FNA is a reliable method for preoperative diagnosis of high-risk thyroid nodules. pTERTC228T/BRAFV600E mutations could be a marker of poor prognosis. Its use as a personalized molecular medicine tool to individualize treatment decisions and follow-up design needs to be further studied.