SGLT-2 inhibitors in heart failure and chronic kidney disease: A review for internists.

Despite current therapies, heart failure and chronic kidney disease continue to be major causes of morbidity and mortality. Sodium-glucose cotransporter 2 (SGLT-2) inhibitors have recently become standard-of-care therapy for these conditions. This review summarizes important randomized controlled trials of SGLT-2 inhibitors and guidelines for using these agents in patients with heart failure and chronic kidney disease in both clinic and hospital settings.

Outcomes With Intravascular Ultrasound and Optical Coherence Tomography Guidance in Percutaneous Coronary Intervention.

Intracoronary imaging has become an important tool in the treatment of complex lesions with percutaneous coronary intervention (PCI). This retrospective cohort study identified 1,118,475 patients with PCI from the Nationwide Readmissions Database from 2017 to 2019. Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) were identified with appropriate International Classification of Diseases, Tenth Revision codes. The primary outcome was major adverse cardiac events. The secondary outcomes include net adverse clinical events (NACEs), all-cause mortality, myocardial infarction (MI) readmission, admission for stroke, and emergency revascularization. The multivariate Cox proportional hazard regression was used to adjust for demographic and co-morbid confounders. Of 1,118,475 PCIs, 86,140 (7.7%) used IVUS guidance and 5,617 (0.5%) used OCT guidance. The median follow-up time was 184 days. The primary outcome of major adverse cardiac events was significantly lower for the IVUS (6.5% vs 7.6%; hazard ratio [HR] 0.89, 95% confidence interval [CI] 0.86 to 0.91, p <0.001) and OCT (4.4% vs 7.6%; HR 0.69, 95% CI 0.61 to 0.79, p <0.001) groups. IVUS was associated with significantly lower rates of NACEs (8.4% vs 9.4%; HR 0.92, 95% CI 0.89 to 0.94, p <0.001), all-cause mortality (3.5% vs 4.3%; HR 0.85, 95% CI 0.82 to 0.88, p <0.001), readmission for MI (2.7% vs 3.0%; HR 0.95, 95% CI 0.91 to 0.99, p = 0.012), and admission for stroke (0.5% vs 0.6%; HR 0.86, 95% CI 0.78 to 0.95, p = 0.002). OCT was associated with significantly lower rates of NACEs (6.6% vs 9.4%; HR 0.81, 95% CI 0.73 to 0.89, p <0.001) and all-cause mortality (1.8% vs 4.3%; HR 0.51, 95% CI 0.42 to 0.63, p <0.001). Emergency revascularization was not significantly different with IVUS guidance. Readmission for MI, stroke, and emergency revascularization were not significantly different with OCT guidance. A subgroup analysis of patients with ST-elevation MI and non-ST-elevation MI showed similar results. In conclusion, the use of IVUS and OCT guidance with PCI were associated with significantly lower rates of morbidity and mortality in real-world practice.

One-year outcomes of catheter ablation for atrial fibrillation in young patients.

BACKGROUND: Atrial fibrillation (AF) is relatively less frequent in younger patients (age < 50). Recently, studies have suggested that early restoration of sinus rhythm may lead to improved outcomes compared with rate control, however the efficacy of catheter ablation for AF in young is scarce. METHODS: We included all hospitalized patients between 18 and 50 years with a diagnosis of AF from the Nationwide Readmission Database 2016-2017 from the Healthcare Cost and Utilization Project. Demographic and comorbidity data were collected and analyzed. Outcomes assessed included one-year AF readmission rates, all-cause readmission, ischemic stroke, and all-cause mortality. Subgroup analyses were performed for all demographic and comorbidity variables. RESULTS: Overall, 52,598 patients (medium age 44, interquartile range 38-48, female 25.7%) were included in the study, including 2,146 (4.0%) who underwent catheter ablation for AF. Patients who underwent catheter ablation had a significantly lower rate of readmission for AF or any cause at one year (adjusted hazard ratios (HR) of 0.52 [95% confidence interval (CI): 0.43-0.63] and HR of 0.81 [95% CI: 0.72-0.89], respectively). There was no difference in 1-year readmission for stroke or all-cause mortality between the two groups. Subgroup analyses showed a consistent reduction in the risk of AF readmission among major demographic and comorbidity subgroups. CONCLUSION: Catheter ablation in young patients with AF was associated with a reduction in 1-year AF related and all-cause readmissions. These data merit further prospective investigation for validation, through dedicated registries and multicenter collaborations to include young AF from diverse population.

Underutilization of Drug-Eluting Stents in Infrapopliteal Intervention for Chronic Limb-Threatening Ischemia.

PURPOSE: Multiple randomized clinical trials have shown superiority of drug-eluting stents (DES) over bare-metal stents (BMS) for infrapopliteal disease. However, real-world data on DES utilization and outcomes in infrapopliteal chronic limb-threatening ischemia (CLTI) patients are unknown. MATERIALS AND METHODS: We utilized the Nationwide Readmission Database (NRD) from 2016 to 2017 to extract patients undergoing infrapopliteal intervention with stents (BMS and DES) for CLTI using appropriate ICD-10 codes. Multilevel logistic regression with hospital ID as random effect was used to assess DES utilization. Primary outcome was the composite of target limb major amputation (TLmajA) and target limb revascularization (TLR). Multivariate Cox-proportional hazard regression was used to adjust for confounders. RESULTS: Our study included a total of 1817 patients. Of these patients, 1056 patients (58.1%) received DES; DES utilization was stable (relative change: +2.5%, p-trend: 0.867) between 2016 and 2017 and was higher in teaching hospitals (adjusted odds ratio [aOR] = 1.28, 95% CI = 1.03-1.61, p=0.029] and medium (aOR = 3.13, 95% CI = 2.17-4.55, p≤0.001) and large (aOR = 1.56, 95% CI = 1.14-2.17, p=0.005) bed-sized hospitals. Inter-class correlation was 0.44 suggesting ~44% variation in DES utilization between any 2 random hospitals; DES was associated with lower rate of the primary composite outcome (aHR = 0.75, 95% CI = 0.62-0.92, p=0.004) compared with BMS. CONCLUSION: In patients undergoing infrapopliteal intervention for CLTI, DES demonstrated significant underutilization despite supportive evidence of their superiority compared with BMS; DES was associated with improvement in the primary composite outcome compared with BMS.

Timing of Repair in Postinfarction Ventricular Septal Defect.

The optimal timing of postinfarction ventricular septal defect (PI-VSD) repair is subject to debate. Patients with ventricular septal defect (VSD) and ST-elevation myocardial infarction (STEMI) were queried using appropriate International Classification of Diseases, Ninth and Tenth Revision Clinical Modification codes from the National Inpatient Sample (2003 to 2018). VSD repair was identified using appropriate International Classification of Diseases, Ninth and Tenth Revision Procedure Coding System codes. Data were stepwise stratified by cardiogenic shock (CS) and time of repair from admission to create 6 clinically relevant groups: shock 1 (CS; 0 to 7 days), shock 2 (CS; 8 to 14 days), and shock 3 (CS; >14 days). Nonshock groups were classified similarly. The primary outcome was in-hospital mortality. Multilevel hierarchical logistic regression was used to adjust for confounders for each group. We identified 10,902 patients with PI-VSD. In shock 1 (n = 5,794), VSD repair was associated with lower mortality (OR 0.76; 95% CI 0.68 to 0.86, p <0.001) compared to no VSD repair. In shock 2 (n=1,009) mortality was numerically lower in those who received VSD repair, but not statistically different. In shock 3 (n=483), mortality was numerically higher in those who received VSD repair, but not statistically different. In nonshock 1 (n=5,108), VSD repair was associated with higher mortality (odds ratio [OR] 1.59; 95% confidence interval [CI] 1.33 to 1.90; p <0.001). In nonshock 2 (n = 1,265), mortality was numerically higher in patients with VSD repair, although not statistically different. In nonshock 3 (n = 472), mortality was numerically lower in patients with VSD repair, although not statistically different. Mechanical circulatory support use increased over the 16 years (relative change + 18%, p <0.001), with no significant change in mortality among patients with PI-VSD. In conclusion, in patients with CS, early PI-VSD repair was associated with lower mortality. However, in patients without CS, early PI-VSD repair was associated with higher mortality.

Transcatheter aortic valve replacement in patients with aortic stenosis and cardiac amyloidosis.

Background: Though the co-prevalence of aortic stenosis (AS) and cardiac amyloidosis (CA) is increasingly recognized, the role of transcatheter aortic valve replacement (TAVR) in patients with CA remains unclear. Methods: The National Readmission Dataset (2016-18) and ICD-10 codes were used to identify those with CA and AS, in conjunction with TAVR status. The primary outcome was a composite of heart failure (HF) readmissions and all-cause mortality. All outcomes were followed up to 1-year with a median follow up time 172-days. Kaplan-Meier curves and multivariate cox-proportional hazard regression were used for time-to-event analysis. Results: Of 1,127 CA patients, 92 (8.2%) had undergone TAVR. Patients with CA who received TAVR were younger and more commonly had coronary artery disease (67.3% vs 44.2%). Teaching (93.6% vs 81.1%) and large hospitals (77.7% vs 59.3%) performed more TAVRs. In multivariate analysis, TAVR was associated with an improved primary outcome (8.9% vs 24.4%, HR:0.32; 95% CI 0.14-0.71, p = 0.007) and with reduced HF readmissions (3.8% vs 19.4%, HR:0.22; 95% CI 0.07-0.68, p = 0.008). All-cause mortality was numerically lower in TAVR patients with CA but did not reach statistical significance. Conclusions: CA patients who receive TAVR are younger, and the procedure is more commonly performed at large, teaching hospitals. TAVR was associated with a lower primary composite outcome of HF readmissions and all-cause mortality.

Impact of catheter ablation in patients with atrial flutter and concurrent heart failure.

BACKGROUND: No studies assessed impact of atrial flutter (AFL) ablation on outcomes in patients with AFL and concurrent heart failure (HF). OBJECTIVES: To assess the effect of AFL ablation on mortality and HF readmissions in patients with AFL and HF. METHODS: This retrospective cohort study identified 15,952 patients with AFL and HF from the 2016-17 Nationwide Readmissions Database. The primary outcome was a composite of all-cause mortality and/or HF readmission at 1 year. Secondary outcomes included HF readmission, all-cause mortality, and atrial fibrillation (AF) readmission at 1 year. Propensity score match (1:2) algorithm was used to adjust for confounders. Cox proportional hazard regression was used to generate hazard ratios. RESULTS: Of the 15,952 patients, 9889 had heart failure with reduced ejection fraction (HFrEF) and 6063 had heart failure with preserved ejection fraction (HFpEF). In the matched HFrEF cohort (n = 5421), the primary outcome was significantly lower in patients undergoing ablation (HR 0.72, 95% CI 0.61-0.85, P < .001). HF readmission (HR 0.73, 95% CI 0.61-0.89, P = .001), all-cause mortality (HR 0.62, 95% CI 0.46-0.85, P = .003), and AF readmission (HR 0.63, 95% CI 0.48-0.82, P = .001) were also significantly reduced. In the matched HFpEF cohort (n = 2439), the primary outcome was lower in the group receiving ablation but was not statistically significant (HR 0.80, 95% CI 0.63-1.01, P = .065). CONCLUSION: In patients with AFL and HFrEF, AFL ablation was associated with lower mortality and HF readmissions at 1 year. Patients with AFL and HFpEF did not show a similar significant reduction in the primary outcome.

Invasive Approaches in the Management of Cocaine-Associated Non-ST-Segment Elevation Myocardial Infarction.

OBJECTIVES: The aim of this study was to determine the impact of invasive approaches and revascularization in patients with cocaine-associated non-ST-segment elevation myocardial infarction (NSTEMI). BACKGROUND: The role of invasive approaches in cocaine-associated NSTEMI is uncertain. METHODS: This retrospective cohort study identified 3,735 patients with NSTEMI and history of cocaine use from the Nationwide Readmissions Database from 2016 to 2017. Invasive approaches were defined as coronary angiography, percutaneous coronary intervention (PCI), and coronary artery bypass grafting (CABG). Revascularization was defined as PCI and CABG. The primary efficacy outcome was major adverse cardiac events (MACE), and the primary safety outcome was emergent revascularization. Nonadherence was identified using appropriate International Classification of Diseases-Tenth Revision codes. Two propensity-matched cohorts were generated (noninvasive vs. invasive and noninvasive vs. revascularization) through multivariate logistic regression. RESULTS: In the propensity score-matched cohorts, an invasive approach (hazard ratio [HR]: 0.72; 95% confidence interval [CI]: 0.56 to 0.92; p = 0.008) and revascularization (HR: 0.54; 95% CI: 0.40 to 0.73; p < 0.001) (compared with a noninvasive approach) were associated with a lower rate of MACE, without an increase in emergent revascularization. On stratification, PCI and CABG individually were associated with a lower rate of MACE. Emergent revascularization was increased with PCI (HR: 1.78; 95% CI: 1.12 to 2.81; p = 0.014) but not with CABG. Nonadherent patients after PCI and CABG did not have significant difference in rate of MACE. PCI in nonadherent patients was associated with an increase in emergent revascularization (HR: 4.45; 95% CI: 2.07 to 9.57; p < 0.001). CONCLUSIONS: Invasive approaches and revascularization for cocaine-associated NSTEMI are associated with lower morbidity. A history of medical nonadherence was not associated with a difference in morbidity but was associated with an increased risk for emergent revascularization with PCI.

A New WATCHMAN Sizing Algorithm Utilizing Cardiac CTA.

BACKGROUND: The WATCHMAN left atrial appendage (LAA) occlusion device has emerged as an alternative for anticoagulation in patients with non-valvular atrial fibrillation who cannot tolerate oral anticoagulation therapy. Cardiac computed tomography (CTA) is increasingly being utilized to guide WATCHMAN device sizing, however no consensus algorithm exists. We present our experience with a new cardiac CTA LAA ostium area based sizing algorithm. METHODS: This is a single center, prospective study analyzing consecutive patients who underwent cardiac CTA and WATCHMAN device implantation between March 2017 and October 2019 at University Hospitals Cleveland Medical Center. Patients baseline characteristics, procedural data, and clinical outcomes were collected and analyzed. RESULTS: 115 patients were included in our study. The mean age of our population was 76.5 years ±8.3 years. 70.4% of our patients had preserved ejection fraction. The predominant indication for device implantation was gastrointestinal bleeding in 57.4% of patients. The mean CHADSVASC score was 4.68 ± 1.4. The procedure success rate was 99.1% and the mean number of device used per case of 1.15 ± 0.4 devices. Our CTA LAA ostium area based sizing algorithm accurately predicted the final deployed WATCHMAN device size in 95.6% of cases. CONCLUSION: Our study demonstrates that cardiac CTA LAA ostium area based sizing algorithm is highly accurate at predicting WATCHMAN device size and demonstrates excellent clinical outcomes with lower device utilization per case than what is reported in literature.

Transcatheter aortic valve replacement in aortic regurgitation: The U.S. experience.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) can be an effective option for high-risk Aortic Regurgitation (AR) patients. Although international experiences of TAVR for AR are published, U.S. data are limited. This study sought to report the short-term outcomes of TAVR in AR in the U.S. METHODS: Study cohorts were derived from the Nationwide Inpatient Sample (NIS) and Nationwide Readmissions Database (NRD) 2016-17. TAVR and AR were identified using ICD-10-CM-codes. The key outcomes were all-cause mortality, disabling stroke, valvular complications, complete heart block (CHB)/permanent pacemaker placement (PPM), open-heart surgery, acute kidney injury (AKI) requiring dialysis, and vascular complications. Multivariate logistic regression was used to adjust for confounders. RESULTS: 915 patients from the NIS (male-71%, age ≥65-84.2%) and 822 patients from the NRD (male-69.3%, age ≥65-80.5%) underwent TAVR for AR. The median length of stay (LOS) was 4 days for both cohorts. In-hospital mortality was 2.7%, and 30-day mortality was 3.3%. Disabling strokes were noted in 0.6% peri-procedurally and 1.8% at 30-days. Valve-related complications were 18-19% with paravalvular leak (4-7%) being the most common. Approximately 11% of patients developed CHB and/or needed PPM in both cohorts. In NRD, 2.2% of patients required dialysis for AKI, 1.5% developed vascular complications, and 0.6% required open-heart surgery within 30-days post-procedure. Anemia was predictive of increased overall complications and valvular complications, whereas peripheral vascular disease was a predictor of increased valvular complications and CHB/PPM. CONCLUSION: TAVR is a promising option in AR. Further studies are necessary for the expansion of TAVR as the standard treatment in AR.

A Systematic Review of the Cardiovascular Manifestations and Outcomes in the Setting of Coronavirus-19 Disease.

The impact of coronavirus disease, 2019 (COVID-19), has been profound. Though COVID-19 primarily affects the respiratory system, it has also been associated with a wide range of cardiovascular (CV) manifestations portending extremely poor prognosis. The principal hypothesis for CV involvement is through direct myocardial infection and systemic inflammation. We conducted a systematic review of the current literature to provide a foundation for understanding the CV manifestations and outcomes of COVID-19. PubMed and EMBASE databases were electronically searched from the inception of the databases through 27 April 2020. A second literature review was conducted to include major trials and guidelines that were published after the initial search but before submission. The inclusion criteria for studies to be eligible were case reports, case series, and observation studies reporting CV outcomes among patients with COVID-19 infection. This review of the current COVID-19 disease and CV outcomes literature revealed a myriad of CV manifestations with potential avenues for treatment and prevention. Future studies are required to understand on a more mechanistic level the effect of COVID-19 on the myocardium and thus provide avenues to improve mortality and morbidity.

Catheter Ablation for Atrial Fibrillation in Patients With Concurrent Heart Failure.

Due to limited real-world data, the aim of this study was to explore the impact of catheter ablation (CA) for atrial fibrillation (AF) in heart failure (HF). This retrospective cohort study identified 119,694 patients with AF and HF from the Nationwide Readmissions Database (NRD) from 2016 to 2017. Propensity-matching was generated using demographics, comorbidities, hospital and other characteristics through multivariate logistic regression. Greedy's propensity score match (1:15) algorithm was used to create matched data. The primary end point was a composite of HF readmission and mortality at 1 year. Secondary outcomes include HF readmission, mortality, AF readmission, and any-cause readmission at 1 year. Of the 119,694 patients, 63,299 had HF with reduced ejection fraction (HFrEF), and 56,395 had HF with preserved ejection fraction (HFpEF). In the overall HFrEF cohort, the primary outcome was similar (HR, 95% confidence interval, p-value) (1.01, 0.91 to 1.13, 0.811). AF readmission (0.41, 0.33 to 0.49, <0.001) and any readmission (0.87, 0.82 to 0.93, <0.001) were reduced with CA. In the propensity-matched HFrEF cohort, results were unchanged (primary outcome: 1.10, 0.95 to 1.27, 0.189; AF readmission: 0.46, 0.36 to 0.59, <0.001; any readmission: 0.89, 0.82 to 0.98, 0.015). In the overall HFpEF cohort, the primary outcome was similar (0.90, 0.78 to 1.04, 0.154). AF readmission was reduced with CA (0.54, 0.44 to 0.65, <0.001). In the propensity-matched HFpEF cohort, results were unchanged (primary outcome 1.10, 0.92 to 1.31, 0.289; AF readmission 0.44, 0.33 to 0.57, <0.001). CA did not reduce mortality and HF readmission at one year irrespective of the type of HF, but significantly reduce readmission due to AF.

In-hospital outcomes after switching from a bivalirudin-first strategy to an unfractionated heparin-first strategy for percutaneous coronary interventions.

BACKGROUND: The optimal anticoagulation strategy for percutaneous coronary interventions (PCIs) remains debated. We report outcomes after switching from a bivalirudin-first to an unfractionated heparin (UFH)-first strategy for PCIs in a large academic center. METHODS: Patients undergoing PCI from June 1st 2013-May 31st, 2015 were identified through the National Cardiovascular Data Registry (NCDR), and divided into the "bivalirudin era" (June 2013-July 2014) and the "UFH era" (October 2014-May 2015). Bleeding outcomes were compared using multivariable logistic regression adjusted for potential confounders. RESULTS: A total of 1,145 patients were identified (bivalirudin era =752, UFH era =393). Radial access for PCI increased over time, and was lower in the bivalirudin era (26% vs. 34%, P<0.05). There were 32 major bleeds (4.3%) in the bivalirudin era and 29 major bleeds (7.4%) in the UFH era (P=0.03), with the majority being hemoglobin drops (≥3 g/dL) without overt clinical bleeding (85.7% of bleeds in the bivalirudin era and 86.2% of bleeds in the UFH era). After adjustments for other common major causes of bleeding, bivalirudin was associated with 78% lower odds of bleeding (OR =0.22; 95% CI: 0.05-0.91). CONCLUSIONS: An increase in major bleeding events occurred after switching to an UFH-first strategy, primarily associated with hemoglobin drop (≥3 g/dL) without overt clinical bleeding. Major overt bleeding was rare (0.3%) and similar in both groups. These results suggest a UFH-first strategy for PCI may have a role in patients with low bleeding risk.