Safety and Effectiveness of Silicone Gel-Filled Breast Implants in Primary Augmentation Patients.

BACKGROUND: Results from the MemoryGel Breast Implants Core Clinical Study suggest these devices are safe and effective at 10 years after implantation. Although clinical trials are essential for measuring the safety and effectiveness of a device, real-world evidence can supplement clinical trials by providing information on outcomes observed in diverse clinical settings for a more heterogeneous population, without fixed treatment patterns, and without continuous patient monitoring, such that follow-up is more representative of normal clinical practice. OBJECTIVES: The aim of this study was to measure real-world outcomes, including safety and effectiveness, in patients who underwent primary breast augmentation with smooth MemoryGel implants. METHODS: This was a case series looking at patients, age 22 years and older, who underwent primary breast augmentation at a single site between December 2006 and December 2016 and who had a minimum of 2 years of follow-up. Descriptive statistics were used to summarize baseline characteristics and outcomes. Kaplan-Meier models were used to estimate safety outcomes for capsular contracture (Baker grade III/IV), infection, and rupture. RESULTS: A total of 50/777 (6.4%) patients reported a complication, with an average time to complication of 3.9 years (range, 19 days-11.8 years) postprocedure. Kaplan-Meier estimates of the 10-year cumulative incidence of capsular contracture (Baker grade III/IV), infection, and rupture were 4.7%, 0.1%, and 1.6%, respectively. CONCLUSIONS: Analyses of a large population from a single site provide further support for the long-term safety and effectiveness of MemoryGel breast implants in a primary augmentation cohort.

The use of intracardiac echocardiography catheters in endocardial ablation of cardiac arrhythmia: Meta-analysis of efficiency, effectiveness, and safety outcomes.

AIMS: The optimal use of intracardiac echocardiography (ICE) may reduce fluoroscopy time and procedural complications during endocardial ablation of cardiac arrhythmias. Due to limited evidence in this area, we conducted the first systematic literature review and meta-analysis to evaluate outcomes associated with the use of ICE. METHODS AND RESULTS: Studies reporting the use of ICE during ablation procedures vs without ICE were searched using PubMed/MEDLINE. A meta-analysis was performed on the 19 studies (2186 patients) meeting inclusion criteria, collectively representing a broad range of arrhythmia mechanisms. Use of ICE was associated with significant reductions in fluoroscopy time (Hedges' g -1.06; 95% confidence interval [CI] -1.81 to -0.32; P < .01), fluoroscopy dose (Hedges' g -1.27; 95% CI -1.91 to -0.62; P < .01), and procedure time (Hedges' g -0.35; 95% CI -0.64 to -0.05; P = .02) vs ablation without ICE. A 6.95 minute reduction in fluoroscopy time and a 15.2 minute reduction in procedure time was observed between the ICE vs non-ICE groups. These efficiency gains were not associated with any decreased effectiveness or safety. Sensitivity analyses limiting studies to an atrial fibrillation (AF) only population yielded similar results to the main analysis. CONCLUSION: The use of ICE in the ablation of cardiac arrhythmias is associated with significantly lower fluoroscopy time, fluoroscopy dose, and shorter procedure time vs ablation without ICE. These efficiency improvements did not compromise the clinical effectiveness or safety of the procedure.

Comparative effectiveness of non-compounded polidocanol 1% endovenous microfoam (Varithena) ablation versus endovenous thermal ablation utilizing a systematic review and network meta-analysis.

OBJECTIVE: We compared the effectiveness and safety of polidocanol 1% endovenous microfoam ablation vs endovenous thermal ablation with radiofrequency or laser energy for treatment of venous insufficiency caused by lower extremity truncal vein incompetence via network meta-analysis of published comparative evidence. METHODS: We conducted a systematic literature review following best practices, including a prospective protocol. We screened studies published in English from 2000 to 2023 for randomized and nonrandomized studies reporting direct or indirect comparisons between polidocanol 1% endovenous microfoam and endovenous thermal ablation. Thirteen studies met our eligibility criteria for the network meta-analysis. The co-primary effectiveness outcomes were the closure rate ≥3 months after procedure and the average change in the Venous Clinical Severity Score. For the subgroup of venous ulcer patients, the ulcer healing rate was the primary effectiveness outcome. The secondary outcomes included safety and patient-reported outcomes. Network meta-analyses were conducted on outcomes having sufficient data. Categorical outcomes were summarized using odds ratios (ORs) with 95% confidence intervals (CIs). Sensitivity tests and estimates of network inconsistency were used to investigate the robustness of our meta-analysis. RESULTS: We found that polidocanol 1% endovenous microfoam was not significantly different statistically from endovenous thermal ablation for venous closure (OR, 0.65; 95% CI, 0.36-1.18; P = .16). Although not the primary aim of the study, the network meta-analysis also provided evidence to confirm our supposition that polidocanol 1% endovenous microfoam was significantly differentiated statistically from physician-compounded foam, with higher odds for vein closure (OR, 2.91; 95% CI, 1.58-5.37; P < .01). A sensitivity analysis using the longest available time point for closure in each study, with a minimum of 12 months of follow-up (median, 48 months; range, 12-72 months), showed results similar to those of the main analysis. No association was found between the risk of deep vein thrombosis and the treatment received. The available data were insufficient for a network meta-analysis of Venous Clinical Severity Score improvement and ulcer healing rates. CONCLUSIONS: Polidocanol 1% endovenous microfoam was not significantly different statistically from endovenous thermal ablation for venous closure and deep vein thrombosis risk for chronic venous insufficiency treatment, based on a network meta-analysis of published evidence. Polidocanol 1% endovenous microfoam was significantly differentiated statistically from physician-compounded foam, with higher odds of vein closure. A sensitivity analysis found venous closure findings were robust at follow-up intervals of 12 months or greater and for up to 6 years. New evidence meeting the inclusion criteria for this review will be incorporated at regular intervals into a living network meta-analysis.

Safety of CPX4 Breast Tissue Expanders in Primary Reconstruction Patients.

In the United States, 2-stage expander-to-implant-based breast reconstruction accounts for more than half of all breast reconstruction procedures. Tissue expansion technology has undergone significant advancements in the past few decades. Previous reports suggest that the most common perioperative complications associated with breast tissue expanders are infection and skin flap necrosis. However, little clinical data are available for CPX4 Breast Tissue Expanders. The aim of the study was to measure real-world outcomes related to safety and effectiveness of the tissue expansion process, in patients who underwent primary breast reconstruction following the use of CPX4 Breast Tissue Expanders. METHODS: This was a single-arm retrospective cohort design looking at patients who underwent 2-stage, expander-to-implant-based primary breast reconstruction at a single site between April 2013 and December 2016 and who had a minimum of 2 years follow-up. Descriptive statistics were used to summarize baseline characteristics and safety outcomes. RESULTS: A total of 123 patients were followed for an average of 3.73 ± 0.94 years. At least 1 complication during the time of tissue expansion, before the permanent implant, was reported in 39/123 (31.7%) patients [51/220 implants (23.2%)]. The most frequently reported complications were delayed wound healing (13.8%) and cellulitis/infection (9.7%). CONCLUSION: Analyses of real-world data from a single site provide further support for the safety and effectiveness of the CPX4 Breast Tissue Expander for women undergoing 2-stage expander-to-implant primary breast reconstruction.

Change in Estimated GFR and Risk of Allograft Failure in Patients Diagnosed With Late Active Antibody-mediated Rejection Following Kidney Transplantation.

BACKGROUND: There are challenges in designing adequate, well-controlled studies of patients with active antibody-mediated rejection (AMR) after kidney transplantation (KTx). METHODS: We assessed the functional relationship between change in estimated glomerular filtration rate (eGFR) following the diagnosis of AMR and the risk of subsequent death-censored graft failure using the joint modeling framework. We included recipients of solitary KTx between 1995 and 2013 at 4 transplant centers diagnosed with biopsy-proven active AMR at least 1 year post-KTx, who had a minimum of 3-year follow-up. RESULTS: A total of 91 patients across participating centers were included in the analysis. Of the 91 patients, n = 54 patients (59%) met the death-censored graft failure endpoint and n = 62 patients (68%) met the all-cause graft failure composite endpoint. Kaplan-Meier death-censored graft survival rates at 12, 36, and 60 months postdiagnosis of AMR pooled across centers were 88.9%, 58.9%, and 36.4%, respectively. Spaghetti plots indicated a linear trend in the change in eGFR, especially in the first 12 months postdiagnosis of active AMR. A significant change in eGFR was observed within the first 12 months postdiagnosis of active AMR, getting worse by a factor of -0.757 mL/min/1.73 m2 per month during the 12-month analysis period (a delta of -9.084 mL/min/1.73 m2 at 1 y). Notably, an extrapolated 30% improvement in the slope of eGFR in the first 12 months was associated with a 10% improvement in death-censored graft failure at 5 years. CONCLUSIONS: If prospectively validated, this study may inform the design of pivotal clinical trials for therapies for late AMR.

Predictive value of atrial fibrillation during the postradiofrequency ablation blanking period.

BACKGROUND: Recurrent arrhythmia following catheter ablation of atrial fibrillation (AF) may present early, during a standard 3-month blanking period. Early recurrence has been correlated to late recurrence, but the degree to which its absence predicts longer-term success has not been quantified. OBJECTIVE: The purpose of this study was to explore and quantify the relationship between early and late arrhythmia recurrence, specifically the negative predictive value, that is, the degree to which absence of blanking period recurrence predicts absence of late recurrence. METHODS: A systematic literature review and meta-analysis were conducted using statistical methods of a diagnostic test accuracy review. Studies of AF ablation using point-by-point radiofrequency, with repeated monitoring of arrhythmia recurrence including asymptomatic recurrence, and with separate data by AF type, were eligible. RESULTS: Nine studies met the prespecified eligibility criteria. For paroxysmal AF, 89% (confidence interval [CI] 82%-94%) of patients free from early recurrence remained free from late recurrence. The estimate for persistent AF was similar (91%; CI 75%-97%). This finding was robust in sensitivity analyses. Patients with early recurrence had a wider range of likely outcomes with longer-term follow-up. CONCLUSION: Freedom from AF recurrence during the blanking period is highly predictive of longer-term success in catheter ablation. Clinical trials in this area may be able to leverage these findings to more quickly assess the potential utility of new ablation technologies and methods, for example, by using early surrogate measures of success.

How safe and effective are flow diverters for the treatment of unruptured small/medium intracranial aneurysms of the internal carotid artery? Meta-analysis for evidence-based performance goals.

BACKGROUND: The objective of this meta-analysis was to establish safety and effectiveness benchmarks for endovascular therapy of unruptured small-to-medium internal carotid artery (ICA) aneurysms using flow diverters. METHODS: A systematic literature review and subsequent meta-analysis were performed using best research methods. Studies of any design with at least 10 patients treated with flow diverters for predominantly (≥90%) unruptured small/medium ICA aneurysms and ≥6 month follow-up were included. The primary effectiveness endpoint was complete aneurysm occlusion rate at 12 months. The primary safety endpoint was a composite measure of cumulative events that could indicate a stroke or neurologic death: any death, stroke, intracranial hemorrhage, or worsening on the modified Rankin Scale. RESULTS: 41 studies (2614 patients) met eligibility criteria for the meta-analysis. The core lab adjusted complete occlusion rate was 74.9% (95% CI 69.6% to 79.8%) at 12 months for studies using any flow diverter. With an aim of generating performance goals for a US Investigational Device Exemption (IDE) study, a pre-specified analysis was conducted using only studies with flow diverters commercially available in the USA. In this cohort, 12 month complete occlusion was 74.6% (95% CI 66.8% to 81.7%). The primary safety event rate for flow diverters commercially available in the USA was 7.8% (95% CI 4.8% to 11.4%). CONCLUSIONS: The treatment of small and medium-sized aneurysms with flow diverters is effective in achieving curative reconstruction in most cases and is associated with low rates of morbidity and mortality. This meta-analysis informs robust performance goals for evaluating new flow diverters in small/medium unruptured carotid aneurysms.

Low-fluoroscopy atrial fibrillation ablation with contact force and ultrasound technologies: a learning curve.

BACKGROUND: Fluoroscopy exposure during catheter ablation is a health hazard to patients and operators. This study presents the results of implementing a low-fluoroscopy workflow using modern contact force (CF) technologies in paroxysmal atrial fibrillation (PAF) ablation. METHODS: A fluoroscopy reduction workflow was implemented and subsequent catheter ablations for PAF were evaluated. After vascular access with ultrasound guidance, a THERMOCOOL SMARTTOUCH® Catheter (ST) was advanced into the right atrium. The decapolar catheter was placed without fluoroscopy. A double-transseptal puncture was performed under intracardiac echocardiography guidance. ST and mapping catheters were advanced into the left atrium. A left atrial map was created, and pulmonary vein (PV) isolation was confirmed via entrance and exit block before and after the administration of isoproterenol or adenosine. RESULTS: Forty-three patients underwent PAF ablation with fluoroscopy reduction workflow (mean age: 66±9 years; 70% male), performed by five operators. Acute success rate (PV isolation) was 96.5% of PVs. One case of pericardial effusion, not requiring intervention, was the only acute complication. Mean procedure time was 217±42 minutes. Mean fluoroscopy time was 2.3±3.0 minutes, with 97.7% of patients having < 10 minutes and 86.0% having < 5 minutes. A significant downward trend over time was observed, suggesting a rapid learning curve for fluoroscopy reduction. Freedom from any atrial arrhythmias without reablation was 80.0% after a mean follow-up of 12±3 months. CONCLUSION: Low fluoroscopy time is achievable with CF technologies after a short learning curve, without compromising patient safety or effectiveness.

Evaluating Prognostic Factors for Liver Transplantation Among United States Patients With Hereditary Transthyretin-Mediated (hATTR) Amyloidosis Using National Registry Data.

INTRODUCTION: Orthotopic liver transplantation has been used as a treatment for hereditary transthyretin-mediated (hATTR) amyloidosis, a rare, progressive, and multisystem disease. RESEARCH QUESTION: The objective is to evaluate survival outcomes post-liver transplantation in patients with hATTR amyloidosis in the United States and assess whether previously published prognostic factors of patient survival in hATTR amyloidosis are generalizable to the US population. DESIGN: This cohort study examined patients with hATTR amyloidosis undergoing liver transplant in the United States (N = 168) between March 2002 and March 2016 using data reported to the Organ Procurement and Transplantation Network (UNOS)/United Network for Organ Sharing (OPTN). RESULTS: A multivariable Cox hazards regression model showed among all factors tested, only modified body mass index (kg/m2 × g/L) at the time of transplant was significantly associated with survival. Higher modified BMI was associated with lower risk of death relative to a reference population (<600) with historically poor post-transplant outcomes. Patients with modified BMI 1000 to <1200 (hazard ratio [HR] = 0.27; 95% confidence interval [CI] = 0.10-0.73), 1200 to <1400 (HR = 0.20; 95% CI = 0.06-0.75), and ≥1400 (HR = 0.15; 95% CI = 0.04-0.61) exhibited improved adjusted 5-year post-transplant survival of 74%, 80%, and 85%, respectively, versus 33% in the reference population. DISCUSSION: The association between a higher modified BMI threshold at the time of transplant and improved post-transplant survival suggests that the previously published patient selection criterion for modified BMI may not be applicable to the US population.

Atrial fibrillation ablation with a spring sensor-irrigated contact force-sensing catheter compared with other ablation catheters: systematic literature review and meta-analysis.

OBJECTIVES: The objective of our review was to systematically assess available evidence on the effectiveness, safety and efficiency of a spring sensor-irrigated contact force (CF) catheter (THERMOCOOL SMARTTOUCH Catheter (ST)) for percutaneous ablation of paroxysmal or persistent atrial fibrillation (AF), compared with other ablation catheters, or with the ST with the operator blinded to CF data. DESIGN: Systematic literature review and meta-analysis. BACKGROUND: Emerging evidence suggests improved clinical outcomes of AF ablation using CF-sensing catheters; however, reviews to date have included data from multiple, distinct CF technologies. METHODS: We conducted a systematic review and meta-analysis of published studies comparing the use of ST versus other ablation catheters for the treatment of AF. A comprehensive search of electronic and manual sources was conducted. The primary endpoint was freedom from recurrent atrial tachyarrhythmia (AT) at 12 months. Procedural and safety data were also analysed. RESULTS: Thirty-four studies enrolling 5004 patients were eligible. The use of ST was associated with increased odds of freedom from AT at 12 months (71.0%vs60.8%; OR 1.454, 95% CI 1.12 to 1.88, p=0.004) over the comparator group, and the effect size was most evident in paroxysmal AF patients (75.6%vs64.7%; OR 1.560, 95% CI 1.09 to 2.24, p=0.015). Procedure and fluoroscopy times were shorter with ST (p=0.05 and p<0.01, respectively, vs comparator groups). The reduction in procedure time is estimated at 15.5 min (9.0%), and fluoroscopy time 4.8 min (18.7%). Complication rates, including cardiac tamponade, did not differ between groups. CONCLUSIONS: Compared with the use of other catheters, AF ablation using the CF-sensing ST catheter for AF is associated with improved success rates, shorter procedure and fluoroscopy times and similar safety profile.

Acute myeloid leukemia: a retrospective claims analysis of resource utilization and expenditures for newly diagnosed patients from first-line induction to remission and relapse.

OBJECTIVE: The objective of this study was to estimate resource utilization and expenditures for patients with acute myeloid leukemia (AML) in a real-world claims database. RESEARCH DESIGN AND METHODS: AML patients were identified in MarketScan claims databases between 1 January 2009 and 31 January 2015. Patients had a minimum of two AML diagnosis codes, hospitalization within 14 days after initial diagnosis, and ≥6 months of enrollment before initial diagnosis. Patients were monitored from first-line induction to a record of remission. A subset had a record of a second treatment period, defined as time from relapse to remission. Patient demographics, AML risk factors, and comorbidities were recorded. Descriptive analysis of utilization and expenditures (in 2014 $US) were reported for each cohort. RESULTS: The inclusion criteria were met in 1597 patients (mean age, 58.4 years; 51.0% male). Ninety percent of patients had ≥1 risk factor for AML. Mean (SD) healthcare expenditures for patients from first-line induction to remission (n = 681) were $208,857 ($152,090). Of the 157 who had a record of relapse, 70 had a record of a second remission. Expenditures for these patients (n = 70) from relapse to remission were $142,569 ($208,307); 60% were admitted to a hospital for a mean of 18.5 hospital days, and 20% had ≥1 emergency room visit. CONCLUSIONS: Although this claims-based analysis is limited by a lack of generalizability to noninsured populations and potential underreporting of certain events and diagnoses, we found that treating AML patients poses a significant healthcare burden, during both first-line induction and relapse. With people living longer, the number of cases of AML is expected to increase in the future.