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Sex differences in procedural outcomes among patients undergoing left atrial appendage occlusion: insights from the NCDR LAAO registry. How many roll-in patients were included, and how did the outcomes of these roll-in patients compare with those of the remaining patients in the trial?. [Extracted from the article]

Randomized trials of hypertension have seldom examined heterogeneity in response to treatments over time and the implications for cardiovascular outcomes. Understanding this heterogeneity, however, is a necessary step toward personalizing antihypertensive therapy. We applied trajectory-based modeling to data on 39 763 study participants of the ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) to identify distinct patterns of systolic blood pressure (SBP) response to randomized medications during the first 6 months of the trial. Two trajectory patterns were identified: immediate responders (85.5%), on average, had a decreasing SBP, whereas nonimmediate responders (14.5%), on average, had an initially increasing SBP followed by a decrease. Compared with those randomized to chlorthalidone, participants randomized to amlodipine (odds ratio, 1.20; 95% confidence interval [CI], 1.10-1.31), lisinopril (odds ratio, 1.88; 95% CI, 1.73-2.03), and doxazosin (odds ratio, 1.65; 95% CI, 1.52-1.78) had higher adjusted odds ratios associated with being a nonimmediate responder (versus immediate responder). After multivariable adjustment, nonimmediate responders had a higher hazard ratio of stroke (hazard ratio, 1.49; 95% CI, 1.21-1.84), combined cardiovascular disease (hazard ratio, 1.21; 95% CI, 1.11-1.31), and heart failure (hazard ratio, 1.48; 95% CI, 1.24-1.78) during follow-up between 6 months and 2 years. The SBP response trajectories provided superior discrimination for predicting downstream adverse cardiovascular events than classification based on difference in SBP between the first 2 measurements, SBP at 6 months, and average SBP during the first 6 months. Our findings demonstrate heterogeneity in response to antihypertensive therapies and show that chlorthalidone is associated with more favorable initial response than the other medications. [ABSTRACT FROM AUTHOR]

The article focuses on issues related to cost-effective pricing of Alirocumab and another PCSK9 inhibitor, evolocumab, which were priced at more than 14,000 dollars annually following the U.S. Food and Drug Administration's approval in 2015. It highlights the failure of these high prices to meet conventional cost-effectiveness thresholds with enormous budgetary implications raised by the widespread PCSK9 inhibitor adoption.

Background: Percutaneous ventricular assist devices (PVADs) have been replacing intra-aortic balloon pumps for hemodynamic support during percutaneous coronary intervention (PCI), even though data supporting a benefit for hard clinical end points remain limited. We evaluated diffusion of PVADs across US markets and examined the association of market utilization of PVAD with mortality and cost. Methods: Using the 2013 to 2019 Medicare data, we identified all patients aged ≥65 years who underwent PCI with either a PVAD or intra-aortic balloon pump. We used hospital referral region to define regional health care markets and categorized them in quartiles based on the proportional use of PVADs during PCI. Multilevel models were constructed to determine the association of patient, hospital, and market factors with utilization of PVADs and the association of PVAD utilization with 30-day mortality and cost. Results: A total of 79 176 patients underwent PCI with either intra-aortic balloon pump (47 514 [60.0%]) or PVAD (31 662 [40.0%]). The proportion of PCI procedures with PVAD increased over time (17% in 2013 to 57% in 2019; P for trend, <0.001), such that PVADs overtook intra-aortic balloon pump for hemodynamic support during PCI in 2018. There was a large variation in PVAD utilization across markets (range, 0%–85%), which remained unchanged after adjustment of patient characteristics (median odds ratio, 2.05 [95% CI, 1.91–2.17]). The presence of acute myocardial infarction, cardiogenic shock, and emergent status was associated with a 45% to 50% lower odds of PVAD use suggesting that PVADs were less likely to be used in the sickest patients. Greater utilization of PVAD at the market level was not associated with lower risk mortality but was associated with higher cost. Conclusions: Although utilization of PVADs for PCI continues to increase, there is large variation in PVAD utilization across markets. Greater market utilization of PVADs was not associated with lower mortality but was associated with higher cost. [ABSTRACT FROM AUTHOR]

The article discusses a research study on gender bias in studies for cardiovascular devices that received premarket approval from the U.S. Food and Drug Administration (FDA). The researchers reviewed the demographics, comments on gender bias and analysis of results by sex for such devices between 2000 and 2007. They noted the lack of sex-specific safety and effectiveness data for high-risk cardiovascular devices before FDA approval.

Background: Postoperative pain after cardiac surgery is a significant problem, but studies often report pain value as an average of the study cohort, obscuring clinically meaningful differences in pain trajectories. We sought to characterize heterogeneity in postoperative pain experiences.Methods: We enrolled patients undergoing a cardiac surgery at a tertiary care center between January 2019 and February 2020. Participants received an electronically-delivered questionnaire every 3 days for 30 days to assess incision site pain level. We evaluated the variability in pain trajectories over 30 days by the cohort-level mean with confidence band and latent classes identified by group-based trajectory model. Group-based trajectory model estimated the probability of belonging to a specific trajectory of pain.Results: Of 92 patients enrolled, 75 provided ≥3 questionnaire responses. The cohort-level mean showed a gradual and consistent decline in the mean pain level, but the confidence bands covered most of the pain score range. The individual-level trajectories varied substantially across patients. Group-based trajectory model identified 4 pain trajectories: persistently low (n=9, 12%), moderate declining (initially mid-level, followed by decline; n=26, 35%), high declining (initially high-level, followed by decline; n=33, 44%), and persistently high pain (n=7, 9%). Persistently high pain and high declining groups did not seem to be clearly distinguishable until approximately postoperative day 10. Patients in persistently low pain trajectory class had a numerically lower median age than the other 3 classes and were below the lower confidence band of the cohort-level approach. Patients in the persistently high pain trajectory class had a longer median length of hospital stay than the other 3 classes and were often higher than the upper confidence band of the cohort-level approach.Conclusions: We identified 4 trajectories of postoperative pain that were not evident from a cohort-level mean, which has been a common way of reporting pain level. This study provides key information about the patient experience and indicates the need to understand variation among sites and surgeons and to investigate determinants of different experience and interventions to mitigate persistently high pain. [ABSTRACT FROM AUTHOR]

Background: Several defibrillator leads have been recalled due to early lead failure leading to significant patient harm. Confirming the safety of contemporary defibrillator leads is essential to optimizing treatment for patients receiving implantable cardioverter-defibrillators (ICDs). We therefore sought to assess the comparative long-term safety of the 4 most commonly implanted ICD leads within the National Cardiovascular Data Registry ICD Registry.Methods and Results: A propensity-matched survival analysis of the ICD Registry was performed evaluating 4 contemporary ICD leads in patients receiving an ICD system for the first time. All patients in the ICD Registry aged ≥18 years who underwent an implant of an ICD between April 1, 2011 and March 31, 2016 were included. Monitoring of safety began with ICD implant and continued up to 5 years. A meaningful difference in ICD failure rate was defined as twice (or more) the lead failure rate observed in the propensity-matched comparator patients. Among the 374 132 patients who received a new ICD implant, no safety alerts were triggered for the primary safety end point of lead failure for any of the high energy leads studied. Estimated rates of freedom from lead failure at 5 years ranged from 97.7% to 98.9% for the 4 high-energy leads of interest.Conclusions: Though limited by incomplete long-term outcomes ascertainment, active surveillance of the ICD Registry suggests that there were no meaningful differences in the rate of ICD high-energy lead survival for the 4 most commonly used high-energy ICD leads. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented in response to the article regarding sex, race, and ethnicity differences in implantable cardioverter-defibrillator counseling in patients with heart failure by P. L. Hess and colleagues that was published in the previous issue.

Background: The California Independent Medical Review (IMR) program was created in 2001 to provide an independent, external evaluation of insurers' denials of coverage of health services., Objective: We sought to evaluate the quality and comprehensiveness of data used to support IMR decision-making between 2015 and 2020., Results: Of the 159 cases submitted to IMR regarding denials of cardiovascular procedures, 52% of these denials were overturned by IMR, thus restoring coverage. Despite a state-wide requirement that specific references to medical and scientific evidence should be provided in IMR reviews, fewer than a quarter of reviews cited any evidence to support decision-making. Slightly more than one third of IMR review decisions were inconsistent with recommendations from professional societies and peer-reviewed evidence; the primary reason for these inconsistencies was that invasive interventions were often recommended by reviewers before utilizing guideline-directed medical or less invasive therapies., Conclusion: Our findings highlight an opportunity for improvement in the quality of IMR decision-making through a more consistent use of available scientific evidence to guide clinical reasoning., Competing Interests: S.S.D. and R.F.R. report serving on the Institute for Clinical and Economic Review (ICER) California Technology Assessment Forum. S.S.D. receives research support from the National Evaluation System for Health Technology Coordinating Center (NESTcc). J.N. receives research support from the National Institutes of Health (NIH). The remaining authors declare no conflict of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Competing Interests: Disclosures Dr Xiao receives research support from the American Association for Cancer Research. Dr Miller receives funding from Fisher and Paykel. Dr Ross receives research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing, from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology, from the Food and Drug Administration for the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation program (U01FD005938), from the Agency for Healthcare Research and Quality (R01HS022882), and from the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH; R01HS025164 and R01HL144644); in addition, Dr Ross is an expert witness at the request of relator’s attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen, Inc. Drs Ross and Dhruva report serving on the Medicare Evidence Development & Coverage Advisory Committee. Dr Dhruva receives research funding from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology and Arnold Ventures. Dr Dhruva also reports serving on the Institute for Clinical and Economic Review California Technology Assessment Forum. The other authors report no conflicts.