Statin utilization and cardiovascular outcomes in a real-world primary prevention cohort of older adults.

Background: Statins are a cost-effective therapy for prevention of atherosclerotic cardiovascular disease (ASCVD). Guidelines on statins for primary prevention are unclear for older adults (>75 years). Objective: Investigate statin utility in older adults without ASCVD events, by risk stratifying in a large healthcare network. Methods: We included 8,114 older adults, without CAD, PVD or ischemic stroke. Statin utilization based on ACC/AHA 10-year ASCVD risk calculation, was evaluated in intermediate (7.5%-19.9%) and high-risk patients (≥ 20%); and categorized using low and 'moderate or high' intensity statins with a follow up period of ∼7 years. Cox regression models were used to calculate hazard ratios for incident ASCVD and mortality across risk categories stratified by statin utilization. Data was adjusted for competing risk using Elixhauser Comorbidity Index. Results: Compared with those on moderate or high intensity statins, high-risk older patients not on any statin had a significantly increased risk of MI [HR 1.51 (1.17-1.95); p<0.01], stroke [HR 1.47 (1.14-1.90); p<0.01] and all-cause mortality [HR 1.37 (1.19-1.58); p<0.001] in models adjusted for Elixhauser Comorbidity Index. When comparing the no statin group versus the moderate or high intensity statin group in the intermediate risk cohort, although a trend for increased risk was seen, it did not meet statistical significance thresholds for MI, stroke or all-cause mortality. Conclusion: Lack of statin use was associated with increased cardiovascular events and mortality in high-risk older adults. Given the benefits appreciated, statin use may need to be strongly considered for primary ASCVD prevention among high-risk older adults. Future studies will assess the risk-benefit ratio of statin intervention in older adults.

Outcomes of Valve-in-Valve Transcatheter Aortic Valve Replacement.

Structural valve degeneration is increasingly seen given the higher rates of bioprosthetic heart valve use for surgical and transcatheter aortic valve replacement (TAVR). Valve-in-valve TAVR (VIV-TAVR) is an attractive alternate for patients who are otherwise at high risk for reoperative surgery. We compared patients who underwent VIV-TAVR and native valve TAVR through a retrospective analysis of our institutional transcatheter valve therapy (TVT) database from 2013 to 2022. Patients who underwent either a native valve TAVR or VIV-TAVR were included. VIV-TAVR was defined as TAVR in patients who underwent a previous surgical aortic valve replacement. Kaplan-Meier survival analysis was used to obtain survival estimates. A Cox proportional hazards regression model was used for the multivariable analysis of mortality. A total of 3,532 patients underwent TAVR, of whom 198 (5.6%) underwent VIV-TAVR. Patients in the VIV-TAVR cohort were younger than patients who underwent native valve TAVR (79.5 vs 84 years, p <0.001), with comparable number of women and a higher Society of Thoracic Surgeons risk score (6.28 vs 4.46, p <0.001). The VIV-TAVR cohort had a higher incidence of major vascular complications (2.5% vs 0.8%, p = 0.008) but lower incidence of permanent pacemaker placement (2.5% vs 8.1%, p = 0.004). The incidence of stroke was comparable between the groups (VIV-TAVR 2.5% vs native TAVR 2.4%, p = 0.911). The 30-day readmission rates (VIV-TAVR 7.1% vs native TAVR 9%, p = 0.348), as well as in-hospital (VIV-TAVR 2% vs native TAVR 1.4%, p = 0.46), and overall (VIV-TAVR 26.3% vs native TAVR 30.8%, p = 0.18) mortality at a follow-up of 1.8 years (0.83 to 3.5) were comparable between the groups. The survival estimates were also comparable between the groups (log-rank p = 0.27). On multivariable Cox regression analysis, VIV-TAVR was associated with decreased hazards of death (hazard ratio 0.68 [0.5 to 0.9], p = 0.02). In conclusion, VIV-TAVR is a feasible and safe strategy for high-risk patients with bioprosthetic valve failure. There may be potentially higher short-term morbidity with VIV-TAVR, with no overt impact on survival.

Long-Term Outcomes of Valve-in-Valve Transcatheter Aortic Valve Implantation Versus Redo Surgical Aortic Valve Replacement: Meta-Analysis of Kaplan-Meier-Derived Data.

Valve-in-valve (ViV) transcatheter aortic valve implantation (ViV-TAVI) in patients with failed bioprostheses arose as an alternative to redo surgical aortic valve replacement (SAVR). To evaluate all-cause mortality in ViV-TAVI versus redo-SAVR, we performed a study-level meta-analysis of reconstructed time-to-event data from Kaplan-Meier curves of nonrandomized studies published by August 2023. A total of 16 studies met our eligibility criteria, with a total of 4,373 patients (2,204 patients underwent ViV-TAVI and 2,169 patients underwent redo-SAVR). Pooling all the studies, ViV-TAVI showed a lower risk of all-cause mortality in the first 6 months (hazard ratio [HR] 0.58, 95% confidence interval [CI] 0.46 to 0.73, p <0.001), with an HR reversal after this time point favoring redo-SAVR (HR 1.92, 95% CI 1.58 to 2.33, p <0.001). Pooling only the matched populations (which represented 64.6% of the overall population), ViV-TAVI showed a lower risk of all-cause mortality in the first 6 months (HR 0.56, 95% CI 0.43 to 0.73, p <0.001], with a reversal after 6 months favoring redo-SAVR (HR 1.55, 95% CI 1.25 to 1.93, p <0.001). The meta-regression analyses revealed a modulating effect of the following covariates: age, coronary artery disease, history of coronary artery bypass graft surgery, and implanted valves <25 mm. In conclusion, ViV-TAVI is associated with better survival immediately after the procedure than redo-SAVR; however, this primary advantage reverses over time, and redo-SAVR seems to offer better survival at a later stage. Because these results are pooled data from observational studies, they should be interpreted with caution, and randomized controlled trials are warranted.

Impact of Guideline-Directed Statin Intervention for Primary Prevention in Patients With Diabetes.

OBJECTIVE: We examined guideline-directed statin intensity (GDSI) use and atherosclerotic cardiovascular disease (ASCVD) outcomes in patients with diabetes across a contemporary health care system. RESEARCH DESIGN AND METHODS: Patients without preexisting ASCVD were categorized by diabetes status and 10-year ASCVD risk (borderline [5-7.4%], intermediate [7.5-19.9%], high [≥20%]). Mean ±SD time to start of or change to GDSI was calculated. Incident ASCVD and all-cause mortality association, stratified by ASCVD risk, was calculated using Cox regression. RESULTS: Among 282,298 patients, 28,807 (10.2%) had diabetes and 253,491 (89.8%) did not. Only two-thirds of intermediate- and high-risk patients with diabetes were receiving GDSI therapy at 5-year follow-up. In fully adjusted models, patients with diabetes not taking a statin (vs. GDSI) had a significantly higher risk of stroke and mortality in the intermediate- and high-risk groups (hazard ratio for mortality 1.81 [95% CI 1.58-2.07] vs. 1.41 [1.26-1.57]; P for interaction < 0.01). CONCLUSIONS: Significant gaps remain in GDSI use for high-risk patients with diabetes, conferring an increased risk of ASCVD outcomes and all-cause mortality.

Self-Expanding Transcatheter Aortic Valves Optimize Transvalvular Hemodynamics Independent of Intra- Versus Supra-Annular Design.

This study sought to characterize transvalvular hemodynamics during the first 30 days after transcatheter aortic valve implantation (TAVI) across various transcatheter heart valves (THVs), while adjusting for annular dimensions. This was an observational study of TAVIs from September 2021 to October 2022. The primary outcome was mean transvalvular pressure gradient (TVPG), measured using transthoracic echocardiography at day 0, day 1, and day 30 post-TAVI, and were compared across 3 THV, including the self-expandable intra-annular Portico (Abbott Vascular, Santa Clara, California) valve, the balloon-expandable SAPIEN 3 Ultra (Edwards Lifesciences, Irvine, California), and the self-expandable supra-annular Evolut Pro+ (Medtronic, Minneapolis, Minnesota). A total of 560 patients who underwent TAVI were identified, of which 106 (18.9%) received a Portico THV, 176 (31.4%) received a SAPIEN THV, and 278 (49.6%) received an Evolut THV. For Portico THV, the TVPG on day 0 increased from 6.0 (4.7 to 9.0) to 7.0 (6.0 to 10.0) by day 30 (p = 0.009). For SAPIEN THV, the TVPG on day 0 increased from 6.5 (5.0 to 8.0) to 12.0 (9.0 to 15.0) by day 30 (p <0.001). For Evolut THV, the TVPG on day 0 increased from 6.0 (5.0 to 9.0) to 7.2 (5.0 to 10.0) by day 30 (p = 0.001). Adjusting for time and annular diameter in a multivariable mixed effects model, the SAPIEN group had a significantly greater increase in TVPG over time than the Evolut reference group (p <0.001), while there was no difference in the change of TVPG over time for the Portico group vs. the Evolut group (p = 0.874). In conclusion, compared with balloon-expandable valves, self-expanding THV may optimize transvalvular hemodynamics across all annular diameters, independent of their supra-annular and intra-annular design.

Valve-in-valve transcatheter aortic valve replacement versus isolated redo surgical aortic valve replacement.

OBJECTIVE: To compare outcomes of patients undergoing valve-in-valve transcatheter aortic valve replacement (ViV TAVR) versus redo surgical aortic valve replacement (SAVR). METHODS: This was a retrospective study using institutional databases of transcatheter (2013-2022) and surgical (2011-2022) aortic valve replacements. Patients who underwent ViV TAVR were compared with patients who underwent redo isolated SAVR. Clinical and echocardiographic outcomes were analyzed. Kaplan-Meier survival estimation and Cox regression were performed. Cumulative incidence functions were generated for heart failure readmissions. RESULTS: A total of 4200 TAVRs and 2306 isolated SAVRs were performed. Of these, there were 198 patients who underwent ViV TAVR and 147 patients who underwent redo SAVR. Operative mortality was 2% in each group, but observed to expected operative mortality in the redo SAVR group was higher than in the ViV TAVR group (1.2 vs 0.32). Those who underwent redo SAVR were more likely to require transfusions and reoperation for bleeding, to have new-onset renal failure requiring dialysis, and to require a permanent pacemaker postoperatively than those in the ViV group. Mean gradient was significantly lower in the redo SAVR group than in the ViV group at 30 days and 1 year. Kaplan-Meier survival estimates at 1 year were comparable, and on multivariable Cox regression, ViV TAVR was not significantly associated with an increased hazard of death compared with redo SAVR (hazard ratio, 1.39; 95% CI, 0.65-2.99; P = .40). Competing-risk cumulative incidence estimates for heart-failure readmissions were higher in the ViV cohort. CONCLUSIONS: ViV TAVR and redo SAVR were associated with comparable mortality. Patients who underwent redo SAVR had lower postoperative mean gradients and greater freedom from heart failure readmissions, but they also had more postoperative complications than the VIV group, despite their lower baseline risk profiles.

Acute Coronary Syndrome After Transcatheter Aortic Valve Implantation (Results from Over 40,000 Patients).

Acute coronary syndrome (ACS) encompasses a broad category of presentations from unstable angina to ST-elevation myocardial infarctions. Most patients undergo coronary angiography upon presentation for diagnosis and treatment. However, the ACS management strategy after transcatheter aortic valve implantation (TAVI) may be complicated because of challenging coronary access. The National Readmission Database was reviewed to identify all patients who were readmitted with ACS within 90 days after TAVI between 2012 and 2018. Their outcomes were described between patients who were readmitted with ACS (ACS group) and without (non-ACS group). A total of 44,653 patients were readmitted within 90 days after TAVI. Among them, 1,416 patients (3.2%) were readmitted with ACS. The ACS group had a higher prevalence of men, diabetes, hypertension, congestive heart failure, peripheral vascular disease, and a history of percutaneous coronary intervention (PCI). In the ACS group, 101 patients (7.1%) developed cardiogenic shock, whereas 120 patients (8.5%) developed ventricular arrhythmias. Overall, 141 patients (9.9%) in the ACS group died during readmissions (vs 3.0% in the non-ACS group, p <0.001). Among the ACS group, PCI was performed in 33 (5.9%), whereas coronary bypass grafting was performed in 12 (0.82%). The factors associated with ACS readmission included a history of diabetes, congestive heart failure, chronic kidney disease, and PCI, and nonelective TAVI. Coronary artery bypass grafting was an independent factor related to in-hospital mortality during ACS readmission (odds ratio 11.9, 95% confidence interval 2.18 to 65.4, p = 0.004), whereas PCI was not (odds ratio 0.19, 95% confidence interval 0.03 to 1.44, p = 0.11). In conclusion, patients readmitted with ACS have significantly higher mortality compared with those readmitted without ACS. History of PCI is an independent factor associated with ACS after TAVI.

A Readmission Risk Score for Transcatheter Aortic Valve Replacement: An Analysis of 200,000 Patients.

OBJECTIVE: The objective of this study was to leverage a national database of TAVR procedures to create a risk model for 30-day readmissions. METHODS: The National Readmissions Database was reviewed for all TAVR procedures from 2011 to 2018. Previous ICD coding paradigms created comorbidity and complication variables from the index admission. Univariate analysis included any variables with a P-value of ≤0.2. A bootstrapped mixed-effects logistic regression was run using the hospital ID as a random effect variable. By bootstrapping, a more robust estimate of the variables' effect can be generated, reducing the risk of model overfitting. The odds ratio of variables with a P-value <0.1 was turned into a risk score following the Johnson scoring method. A mixed-effect logistic regression was run using the total risk score, and a calibration plot of the observed to expected readmission was generated. RESULTS: A total of 237,507 TAVRs were identified, with an in-hospital mortality of 2.2 %. A total of 17.4 % % of TAVR patients were readmitted within 30 days. The median age was 82 with 46 % of the population being women. The risk score values ranged from -3 to 37 corresponding to a predicted readmission risk between 4.6 % and 80.4 %, respectively. Discharge to a short-term facility and being a resident of the hospital state were the most significant predictors of readmission. The calibration plot shows good agreement between the observed and expected readmission rates with an underestimation at higher probabilities. CONCLUSION: The readmission risk model agrees with the observed readmissions throughout the study period. The most significant risk factors were being a resident of the hospital state and discharge to a short-term facility. This suggests that using this risk score in conjunction with enhanced post-operative care in these patients could reduce readmissions and associated hospital costs, improving outcomes.

Outcomes of Transcatheter Aortic Valve Replacement in Patients With Concomitant Aortic Regurgitation.

BACKGROUND: This study sought to evaluate outcomes of transcatheter aortic valve replacement (TAVR) in patients with moderate or greater aortic regurgitation (AR). METHODS: This was an observational study using an institutional database of TAVRs from November 2012 to April 2022. The study compared outcomes of TAVR in patients with isolated aortic stenosis (AS) vs patients with AS and concomitant AR (moderate or greater). Those patients with trace or mild AR were excluded. Clinical and echocardiographic outcomes were compared, with end points established by the Valve Academic Research Consortium 3. Kaplan-Meier survival estimation and Cox regression for mortality were performed. Competing-risk cumulative incidence estimates for heart failure readmissions were also compared. RESULTS: Of 3295 patients, 605 (53.4%) had severe AS with no AR and 529 (46.6%) had severe AS with moderate or severe AR. There were no significant differences in in-hospital mortality, length of stay, stroke, myocardial infarction, permanent pacemaker requirement, transfusion requirement, minor or major vascular complications, or 30-day readmissions between the 2 groups (P > .05). There were also no significant differences in annular dissection or rupture, coronary obstruction, or device embolization. Mean gradient and paravalvular leak rates at 30 days and 1 year were similar between the groups. Survival estimates were comparable, and, on multivariable Cox regression, mixed aortic valvular disease was not associated with an increased hazard of death as compared with isolated AS (hazard ratio, 1.01; 95% CI, 0.81-1.25; P = .962). Cumulative incidence estimates for heart failure readmissions were comparable between groups. CONCLUSIONS: TAVR can be safely performed in patients with mixed valvular disease, with outcomes comparable to those in isolated AS.

Safety and Efficacy of Direct Oral Anticoagulants Versus Warfarin in Patients With Chronic Kidney Disease and Atrial Fibrillation.

Patients with atrial fibrillation (AF) commonly have impaired renal function. The safety and efficacy of direct oral anticoagulants (DOACs) in patients with chronic kidney disease (CKD) and end-stage renal disease has not been fully elucidated. This study evaluated and compared the safety outcomes of DOACs versus warfarin in patients with nonvalvular AF and concomitant CKD. Patients in our health system with AF prescribed oral anticoagulants during 2010 to 2017 were identified. All-cause mortality, bleeding and hemorrhagic, and ischemic stroke were evaluated based on degree of renal impairment and method of anticoagulation. There were 21,733 patients with a CHA2DS2-VASc score of ≥2 included in this analysis. Compared with warfarin, DOAC use in patients with impaired renal function was associated with lower risk of mortality with a hazard ratio (HR): 0.76 (95% confidence interval [CI] 0.70 to 0.84, p value <0.001) in patients with eGFR >60, HR 0.74 (95% CI 0.68 to 0.81, p value <0.001) in patients with eGFR >30 to 60, and HR 0.76 (95% CI 0.63 to 0.92, p value <0.001) in patients with eGFR ≤30 or on dialysis. Bleeding requiring hospitalization was also less in the DOAC group with a HR 0.93 (95% CI 0.82 to 1.04, p value 0.209) in patients with eGFR >60, HR 0.83 (95% CI 0.74 to 0.94, p value 0.003) in patients with eGFR >30 to 60, and HR 0.69 (95% CI 0.50 to 0.93, p value 0.017) in patients with eGFR ≤30 or on dialysis. In conclusion, in comparison to warfarin, DOACs appear to be safe and effective with a lower risk of all-cause mortality and lower bleeding across all levels of CKD.

Impact of residual coronary atherosclerosis on transfemoral transcatheter aortic valve replacement.

OBJECTIVES: This study reports on the clinical effects of complete vs incompletely revascularized coronary artery disease on transcatheter aortic valve replacement (TAVR). BACKGROUND: There is a high prevalence of active coronary artery disease (CAD) in patients undergoing TAVR but preemptive revascularization remains controversial. METHODS: Patients were categorized into three cohorts: complete revascularization (CR), incomplete revascularization of a major epicardial artery (IR Major), and incomplete revascularization of a minor epicardial artery only (IR Minor). When feasible, SYNTAX scoring was performed for exploratory analysis. Analyses were performed using Cox proportional hazard models and Kaplan-Meier method. RESULTS: A total of 323 patients with active CAD were included. Adjusted outcomes showed that patients with IR Major had increased incidence of acute myocardial infarction (AMI) or revascularization compared with those in the CR cohort (HR 3.72, P = 0.048). No difference was noted in all-cause mortality or all-cause readmission rates. Exploratory secondary analysis with residual SYNTAX scores showed a significant interaction between disease burden and AMI/revascularization, as well as all-cause readmission. All-cause mortality remained unaffected based on residual SYNTAX scores. CONCLUSIONS: This is a retrospective single-center study reporting on pre-TAVR revascularization outcomes in patients with active CAD. In this analysis, we found that patients undergoing TAVR benefited from achieving complete revascularization to abate future incidence of AMI/revascularization. Despite this finding, all-cause mortality remained unaffected. Future efforts should focus on the role of functional assessment of the coronaries, as well as the long-term effects of complete revascularization in a larger patient cohort.