The rationale and design of the SMART CRT trial.

AIMS: The SMART CRT study will assess the efficacy of an atrioventricular optimization algorithm to improve reverse remodeling among patients undergoing cardiac resynchronization therapy (CRT) in the presence of interventricular electrical delay. METHODS AND RESULTS: The SMART CRT study is a global, multicenter, prospective, randomized study of patients undergoing CRT implantation. The primary endpoint of this trial is response rate to CRT, defined as decrease in left ventricular end-systolic volume (LVESV) ≥15% at 6 months compared to preimplant baseline. Additional prespecified analyses are: (1) clinical composite endpoint combining all-cause mortality, heart failure events, New York Heart Association class, and Quality of Life (using a patient global assessment instrument); (2) the individual components of the clinical composite endpoint; (3) 6-minute walk distance; (4) Kansas City Cardiomyopathy Questionnaire; (5) LVESV as a continuous variable; and (6) absolute left-ventricular ejection fraction. Subjects with intraventricular delay ≥ 70 ms measured between the right ventricular and left ventricular pacing leads will be randomized in a 1:1 ratio to have either an AV Delay and pacing chamber determined by SmartDelay™ or a Fixed AV Delay of 120 ms with biventricular pacing. Enrollment of an estimated 726 of subjects from up to 100 centers worldwide is planned to achieve 436 randomized subjects and 370 complete data sets required to power the primary endpoint. CONCLUSIONS: This trial will provide important data regarding the importance of AV Delay programming in patients with prolonged interventricular delay at the pacing sites.

Effects of Atrioventricular Optimization on Left Ventricular Reverse Remodeling With Cardiac Resynchronization Therapy: Results of the SMART-CRT Trial.

BACKGROUND: The role of atrioventricular optimization (AVO) to improve cardiac resynchronization therapy outcomes remains controversial. Previous post hoc analyses of a multicenter trial showed that measures of electrical dyssynchrony (right ventricular-left ventricular [LV] or LV electrical delay durations) are associated with patients who benefit from AVO. METHODS: This was a global, multicenter, prospective, randomized trial of de novo cardiac resynchronization therapy implant patients with an right ventricular-LV duration ≥70 ms to determine whether AVO results in greater reverse remodeling. Patients were randomized 1:1 for either an AVO algorithm (SmartDelay) that determines atrioventricular delay and pacing chamber, biventricular or LV only, or a fixed atrioventricular delay of 120 ms with biventricular pacing. Paired echocardiograms performed at baseline and 6 months were evaluated. The primary end point was echocardiographic cardiac resynchronization therapy response, defined dichotomously as a >15% reduction in LV end-systolic volume. RESULTS: A total of 310 patients (n=120 women) were randomized and had completed 6 months of follow-up. The echocardiographic cardiac resynchronization therapy response rate did not statistically differ between the groups (SmartDelay, 74.8%; fixed, 67.7%; P=0.17). Analyses of prespecified secondary end points demonstrated significant improvements in the absolute (median: SmartDelay, -41.0 mL; fixed, -33.0 mL; P=0.01) and relative change in LV end-systolic volume (SmartDelay, -38.3%; fixed, -27.8%; P=0.03) for patients with SmartDelay optimization. Similar results were observed for the relative improvement in LV ejection fraction (SmartDelay, 46.7%; fixed, 32.1%; P=0.050); absolute improvement in LV ejection fraction trended to be higher with SmartDelay (P=0.06). CONCLUSIONS: Analysis of reverse remodeling parameters demonstrated that AVO via SmartDelay, relative to the nonoptimized fixed atrioventricular delay comparator group, improved absolute and relative changes in LV function in patients with longer right ventricular-LV duration. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03089281.

Acute performance of a right ventricular automatic pacing threshold algorithm for implantable defibrillators.

INTRODUCTION: Automatic pacing threshold (AT) testing with threshold trending and output adjustment may simplify follow-up and improve cardiac rhythm device longevity. The objective of this study was to evaluate the performance of a new right ventricular (RV) AT algorithm for implantable cardioverter defibrillators (ICDs) using RVcoil to Can evoked response sensing. METHOD: Patients undergoing ICD, with or without cardiac resynchronization therapy device, implant, replacement, or upgrade were enrolled. A pulse generator emulator (Can) was temporarily placed in the device pocket. An external pacing system (Boston Scientific, St. Paul, MN, USA) with customized software was used for performing threshold tests and data acquisition. RV manual threshold and up to four AT tests using various pacing parameters were conducted. The threshold measurement and the capture detection performance of the RV AT tests were evaluated through comparison with visual examination of surface electrocardiogram. RESULTS: Data from 43 patients were analyzed. A total of 158 AT tests were performed, in which 144 AT tests (91.1%) measured correct threshold values. No consecutive asystolic noncaptured beats were observed in any AT tests, and none of the AT tests resulted in incorrectly low threshold measurements. The difference between manual and AT measurements was -0.05 ± 0.43 V. The accuracy for detecting capture and noncaptured beats were 95% and 99%, respectively. CONCLUSION: The RVcoil to Can evoked response sensing based RV AT algorithm can reliably measure pacing threshold for ICDs, including CRT-Ds.

States' Rights, Gun Violence Litigation, and Tort Immunity.

The devastating toll of gun violence has given rise to hundreds of lawsuits seeking justice on behalf of victims and their families. A significant number of challenges against gun companies, however, are blocked by courts' broad reading of the Protection of Lawful Commerce in Arms Act (PLCAA) - a federal statute often interpreted to shield the gun industry from civil liability. This article reexamines PLCAA in light of the Supreme Court's recent federalism caselaw, which counsels courts to narrowly construe federal laws that could otherwise upset the balance of power between states and the federal government. Since PLCAA infringes on traditional areas of state authority, the Supreme Court's federalism jurisprudence requires lower courts to interpret PLCAA narrowly, to not bar states from imposing negligence, nuisance, product liability, or other common law liability on gun companies. Reading PLCAA in line with federalism principles would preserve states' traditional authority over their civil justice laws, and enable gun violence victims, and their families, to hold gun companies responsible for wrongdoing.