Impact of untreated chronic obstructive coronary artery disease on outcomes after transcatheter aortic valve replacement.

BACKGROUND AND AIMS: In transcatheter aortic valve replacement (TAVR) recipients, the optimal management of concomitant chronic obstructive coronary artery disease (CAD) remains unknown. Some advocate for pre-TAVR percutaneous coronary intervention, while others manage it expectantly. The aim of this study was to assess the impact of varying degrees and extent of untreated chronic obstructive CAD on TAVR and longer-term outcomes. METHODS: The authors conducted a retrospective cohort study of TAVR recipients from January 2015 to November 2021, separating patients into stable non-obstructive or varying degrees of obstructive CAD. The major outcomes of interest were procedural all-cause mortality and complications, major adverse cardiovascular events, and post-TAVR unplanned coronary revascularization. RESULTS: Of the 1911 patients meeting inclusion, 75%, 6%, 10%, and 9% had non-obstructive, intermediate-risk, high-risk, and extreme-risk CAD, respectively. Procedural complication rates overall were low (death 0.4%, shock 0.1%, extracorporeal membrane oxygenation 0.1%), with no difference across groups. At a median follow-up of 21 months, rates of acute coronary syndrome and unplanned coronary revascularization were 0.7% and 0.5%, respectively, in the non-obstructive population, rising in incidence with increasing severity of CAD (P < .001 for acute coronary syndrome/unplanned coronary revascularization). Multivariable analysis did not yield a significantly greater risk of all-cause mortality or major adverse cardiovascular events across groups. One-year acute coronary syndrome and unplanned coronary revascularization rates in time-to-event analyses were significantly greater in the non-obstructive (98%) vs. obstructive (94%) subsets (Plog-rank< .001). CONCLUSIONS: Transcatheter aortic valve replacement can be performed safely in patients with untreated chronic obstructive CAD, without portending higher procedural complication rates and with relatively low rates of unplanned coronary revascularization and acute coronary syndrome at 1 year.

Acute post-procedural inducibility is a poor predictor of clinical outcomes in high-risk patients (PAINESD > 17) undergoing scar-related ventricular tachycardia ablation.

AIMS: Ventricular tachycardia (VT) non-inducibility in response to programmed ventricular stimulation (PVS) is a widely used procedural endpoint for VT ablation despite inconclusive evidence with respect to clinical outcomes in high-risk patients. The aim is to determine the utility of acute post-ablation VT inducibility as a predictor of VT recurrence, mortality, or mortality equivalent in high-risk patients. METHODS AND RESULTS: We conducted a retrospective analysis of high-risk patients (defined as PAINESD > 17) who underwent scar-related VT ablation at our institution between July 2010 and July 2022. Patients' response to PVS (post-procedure) was categorized into three groups: Group A, no clinical VT or VT with cycle length > 240 ms inducible; Group B, only non-clinical VT with cycle length > 240 ms induced; and Group C, all other outcomes (including cases where no PVS was performed). The combined primary endpoint included death, durable left ventricular assist device placement, and cardiac transplant (Cox analysis). Ventricular tachycardia recurrence was considered a secondary endpoint (competing risk analysis). Of the 1677 VT ablation cases, 123 cases met the inclusion criteria for analysis. During a 19-month median follow-up time (interquartile range 4-43 months), 82 (66.7%) patients experienced the composite primary endpoint. There was no difference between Groups A and C with respect to the primary [hazard ratio (HR) = 1.21 (0.94-1.57), P = 0.145] or secondary [HR = 1.18 (0.91-1.54), P = 0.210] outcomes. These findings persisted after multivariate adjustments. The size of Group B (n = 13) did not permit meaningful statistical analysis. CONCLUSION: The results of post-ablation PVS do not significantly correlate with long-term outcomes in high-risk (PAINESD > 17) VT ablation patients.

Hyperlipidemia and Cardiovascular Disease in People with Type 1 Diabetes: Review of Current Guidelines and Evidence.

PURPOSE OF REVIEW: In this review, we discuss the prevalence of cardiovascular disease in people with type 1 diabetes. We outline key risk factors associated with increased cardiovascular event rates and discuss the prevalence and mechanisms underlying hyperlipidemia in people with type 1 diabetes. Finally, we summarize the evidence to support early and more aggressive lipid-lowering therapy in people with type 1 diabetes and review current guideline recommendations. RECENT FINDINGS: Comprehensive treatment of hyperglycemia, hypertension, and hyperlipidemia reduces adverse cardiovascular outcomes in people with type 2 diabetes. In contrast, evidence to support a comparable benefit of intensive cardiovascular risk factor management in people with type 1 diabetes is lacking from prospective, randomized trials and has only been shown in registries. Therefore, current treatment guidelines extrapolate prospective clinical trial evidence obtained in people with type 2 diabetes to provide similar treatment recommendations for people with type 1 and type 2 diabetes. Evidence supports the more aggressive treatment of cardiovascular risk factors in people with type 1 diabetes, who would likely benefit from early risk stratification and comprehensive risk factor management, including aggressive lipid-lowering therapy.

Pharmacokinetic Profile of Spectrum Reduced Nicotine Cigarettes.

INTRODUCTION: Spectrum research cigarettes have been developed with varying nicotine content for use in studies evaluating the effects of a regulatory policy reducing the permissible nicotine content in cigarettes. This study aimed to characterize the nicotine pharmacokinetic profile of Spectrum cigarettes. METHODS: Twelve daily smokers attended four sessions and had blood nicotine, exhaled carbon monoxide, and subjective effects measured before and after smoking either a single cigarette of their preferred brand or high (10.9 mg/cigarette), medium (3.2 mg/cigarette), or low (0.2 mg/cigarette) nicotine content Spectrum research cigarettes, in a double-blind design with order counterbalanced. RESULTS: The boost in blood nicotine concentration was dose-dependent, with a boost of 0.3, 3.9, and 17.3 ng/mL for low-, medium-, and high-nicotine content Spectrum cigarettes. The high dose Spectrum had a similar nicotine boost to the "preferred brand" cigarettes (19 ng/mL). Subjects took longer puffs on the low nicotine cigarettes, but smoked these cigarettes faster than other cigarette types. High nicotine Spectrum cigarettes reduced the urge to smoke more than other cigarette types. CONCLUSIONS: This study shows that Spectrum research cigarettes produce blood nicotine absorption in a dose-dependent manner, and therefore, are appropriate for use in studies of nicotine reduction in cigarettes. IMPLICATIONS: This is the first study to determine the pharmacokinetic profile of Spectrum reduced nicotine content research cigarettes following an overnight abstinence. These data could provide evidence to regulatory agencies about the effects of reduced nicotine cigarettes when considering regulations on tobacco reduction.

The Effect of Price on the Consumption of Reduced Nicotine Cigarettes.

BACKGROUND: Price affects the demand for cigarettes, indicating that smokers, perhaps especially lower income smokers, may choose low nicotine cigarettes (LNC) if they were commercially available and cost less than fully nicotinized conventional cigarettes. The present study tests the hypothesis that smokers will prefer purchasing LNCs at a lower price point than conventional cigarettes given a fixed budget. METHOD: A laboratory-based, within-subject, 3 (nicotine level) × 3 (price) factorial design provided smokers opportunities to purchase standard (0.7 per mg tobacco), moderately reduced (0.3 mg), and very low-nicotine (0.03 mg). Spectrum research cigarettes according to an escalating price structure (low-nicotine costing the least, high-nicotine costing the most) given a fixed, laboratory-provided "income." Participants were 20 overnight-abstinent smokers who previously smoked and rated each of the three cigarettes. RESULTS: Overall, smokers rated LNCs as less satisfying compared with standard nicotine cigarettes (SNC), t(18) = -5.40, p < .001. In the free-choice session, subjects were more likely to choose LNC that cost less compared with SNC that cost more, even after an 8-hour abstinence period, F(2, 19) = 4.32, p = .03. Those selecting LNC or moderate nicotine cigarettes after abstinence smoked more cigarettes per day, t(17) = 2.40, p = .03 and had higher dependence scores on the HONC, t(18) = 2.21, p = .04 that those selecting SNC. CONCLUSION: The results indicate that smokers' response to price points when purchasing cigarettes may extend to LNC if these were commercially available. Differential cigarette prices based on nicotine content may result in voluntary selection of less addicting products. IMPLICATIONS: The Food and Drug Administration has proposed a rule that would reduce nicotine content in commercially available cigarettes. However, it is not known how smokers may respond in an environment where products of differing nicotine content and of differing prices are available. This study demonstrates that price may be an important factor that could lead smokers to select reduced nicotine products voluntarily, even if those products are rated as inferior or less satisfying.

Outcomes of Atrial Fibrillation Ablation in Heart Failure Subtypes.

BACKGROUND: Catheter ablation (CA) improves clinical outcomes in patients with atrial fibrillation (AF) and heart failure (HF) with reduced ejection fraction (HFrEF). We aimed to evaluate the impact of CA on clinical and quality-of-life outcomes across HF subtypes. METHODS: All patients undergoing AF ablation at a tertiary center were enrolled in a prospective registry and included in this study (2013-2021). The primary end point was AF recurrence. Secondary end points included AF-related hospitalizations and quality-of-life outcomes. Patients were categorized according to their HF status: no HF, HFrEF, HF with mildly reduced ejection fraction (HFmrEF), and HF with preserved ejection fraction (HFpEF). RESULTS: A total of 7020 patients were included (80% no HF, 8% HFrEF, 7% HFmrEF, and 5% HFpEF). Over 3 years, the cumulative incidence of AF recurrence after ablation was as follows: HFpEF (53%), HFmrEF (41%), HFrEF (41%), and no HF (34%); P<0.01. Multivariable Cox analyses confirmed these findings using no HF group as reference (HFpEF: hazard ratio, 1.47 [95% CI, 1.21-1.78]; HFmrEF: hazard ratio, 1.23 [95% CI, 1.04-1.45]; and HFrEF: hazard ratio, 1.17 [95% CI, 1.01-1.37]; P<0.05 for all). In all groups, CA resulted in a significant reduction of AF-related hospitalization (mean rate per 1 patient-years [before and after CA]; HFpEF [1.8 versus 0.3], HFmrEF [1.1 versus 0.2], HFrEF [1.1 versus 0.2], and no HF [1 versus 0.1]; P<0.01 for each comparison) and significant improvement in quality of life as measured by both the AF symptom severity score and the AF burden score (P<0.01 for the comparison between baseline and follow-up for each score when tested separately). CONCLUSIONS: AF recurrence rates after CA were higher in patients with HF compared with those without HF, with patients with HFpEF being at the highest risk of recurrence. Nonetheless, CA was associated with a significant reduction in AF symptoms, AF-related hospitalization, and HF symptoms in most patients irrespective of HF subtypes.

Effectiveness of Pre-TAVR CTA as a Screening Tool for Significant CAD Before TAVR.

BACKGROUND: Computed tomography angiography (CTA) and invasive coronary angiography (ICA) are routinely performed before transcatheter aortic valve replacement (TAVR) to assess aortic root anatomy and screen for coronary artery disease (CAD), respectively. OBJECTIVES: This study explored the efficacy of CTA as a screening tool for significant proximal CAD before TAVR. METHODS: With proper ethical oversight, patients undergoing TAVR at Cleveland Clinic with a preprocedural CTA and invasive coronary angiography (ICA), and no prior percutaneous intervention, were identified from 2015 to 2021. Blinded to ICA results, the authors reviewed the left main, proximal left anterior descending coronary artery, proximal left circumflex coronary artery, and proximal right coronary artery by CTA coronary reconstruction to assess for nonsignificant stenosis (0% to 49%), moderate stenosis (50% to 69%), and severe stenosis (≥70%). Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and Cohen Kappa statistic were analyzed. RESULTS: 2,217 patients (53.4% male, age 79.2 ± 8.5 years) met inclusion criteria. CTA evaluation revealed a sensitivity of 90%, specificity of 92%, PPV of 74%, and NPV of 97% for detecting ≥50% stenosis. Using a ≥70% stenosis cutoff, evaluation revealed a sensitivity of 91%, specificity of 97%, PPV of 83%, and NPV of 99%. Assessment of bypass graft patency revealed a sensitivity of 86%, specificity of 97%, PPV of 84%, and NPV of 98%. Cohen Kappa analysis indicated substantial to near perfect agreement between pre-TAVR CTA and ICA. CONCLUSIONS: Pre-TAVR CTA has a high NPV for high-grade proximal stenosis of each coronary artery. As a result, CTA can be used as a screening tool to rule out significant proximal CAD in patients undergoing TAVR.

Modifying Post-operative Opioid Stewardship Through a System of Educational Feedback.

Background: The opioid overdose epidemic remains one of the leading focuses of the United States' public health agenda. Current literature has suggested that many surgical procedures are associated with an increased risk of chronic opioid use in the post-operative period of opioid-naïve patients. We aimed to assess whether providing feedback on the average morphine milligram equivalents (MMED) and opioid utilization by selected post-operative patients would impact the provider opioid prescribing patterns.Methods: An opioid stewardship educational intervention provided didactic and email feedback to general surgeons about their prescribing patterns and summary feedback on opioid usage among post-operative patients from the pre-intervention period. We used descriptive statistics, Chi Square, Fisher's Exact test, Wilcoxon Rank Sum, two sample t test, and Spearman's rho to analyze the data gathered.Results: A total of 5142 patients with an average age of 43.9 years were included in the study period. Women accounted for 3096 (60.2%) and 2046 (39.8%) were men. The surgeries during the study period included 1928 (37.5%) appendectomies and 3214 (62.5%) cholecystectomies. The predominant surgical approach was laparoscopic 5028 (97.8%). In both groups, the total MMED and total number of pills prescribed decreased significantly after the intervention was implemented. There were no refill prescriptions nor 30-day readmissions among those discharged with an opioid prescription in either study phase.Discussion: An intervention that provided general surgeons with feedback about their post-operative prescription patterns and data on post-operative opioid utilization by patients decreased prescribed MMED.

Effect of insurance type on perioperative outcomes after robotic-assisted pulmonary lobectomy for lung cancer.

BACKGROUND: Insurance type has been reported to be an independent predictor of overall survival in lung cancer patients. We studied the effect of insurance type on patient outcomes after minimally invasive pulmonary lobectomy for lung cancer. METHODS: We retrospectively analyzed 433 consecutive patients who underwent robotic-assisted pulmonary lobectomy by one surgeon during an 80-month period. Perioperative outcomes and intraoperative and postoperative complications were noted. Disposition at discharge after surgery (favorable, eg, transfer to home with self-care or with home health nursing and/or physical therapy, versus unfavorable, eg, long-term acute care or rehabilitation facility, hospice, or death) and 5-year overall survival (5-years OS) were also recorded. We used Pearson χ2, analysis of variance (ANOVA), and Kruskal-Wallis test to compare variables and Cox regression for survival analysis. RESULTS: There were 107 patients (mean age 57.5 years) with private insurance, 118 (mean age 70.3 years) with public insurance (Medicare or Medicaid), 196 (mean age 71.8 year; P < .001) with combination insurance plans (Medicare plus a privately supplied supplemental), and 12 patients with no insurance (excluded owing to low sample size). There were more current smokers in the public insurance group, more former smokers in the combination insurance group, and more nonsmokers in the private insurance group (P = .03). There were more comorbidities in the public and combination insurance groups versus the private insurance group, including gastroesophageal reflux disease (P = .003), hypertension (P = .01), and hyperlipidemia (P < .001). The groups had no differences in tumor size or pathologic stage. There were higher numbers of intraoperative conversions to open lobectomy in the private and public insurance groups versus the combination insurance group (P = .001). Also, the private and combination insurance groups had more cases of favorable disposition at discharge after surgery compared with the public insurance group (P < .001). Multivariable regression analyses identified private insurance type as an independent predictor of favorable disposition at discharge (public versus private plan; odds ratio, 0.43; 95% confidence interval [CI], 0.22-0.85, P = .02) and 5-year OS (combination versus private plan; hazard ratio, 2.68; 95% CI, 1.26-5.67, P = .01; public versus private plan; HR, 2.84; 95% CI, 1.37-5.89; P = .01). CONCLUSION: Although public or combination insurance type was associated with greater risk of all-cause mortality, and public insurance type was associated with less favorable disposition at discharge after surgery and overall conversion to open lobectomy, insurance type was not associated with increased intraoperative complications, hospital duration of stay, or in-hospital mortality after minimally invasive robotic-assisted pulmonary lobectomy.