Orbital atherectomy safety and efficacy: A comparative analysis of ostial versus non-ostial calcified coronary lesions.

BACKGROUND: The safety and efficacy of coronary orbital atherectomy (OA) for treatment of ostial lesions are not yet fully established. We sought to evaluate (OA) treatment of severely calcified ostial and non-ostial lesions. METHODS: A retrospective analysis of subjects treated with OA for severely calcified ostial and non-ostial lesions, at the Mount Sinai Medical Center, Miami Beach, Florida (MSMCMB) from January 2014 to September 2020, was completed. Study baseline characteristics, lesion and vessel characteristics, procedural outcomes, and in-hospital major adverse cardiovascular events (MACE) were analyzed and compared. RESULTS: A total of 609 patients that underwent PCI with OA were identified. The majority of patients (81.9 %) had non-ostial lesions, while 16.6 % had ostial lesions (of which 2.8 % classified as aorto-ostial) and 1.5 % had unknown lesion anatomy. The mean age of the overall cohort was 74.0 ± 9.3 years, and 63.5 % were male. All patients received drug-eluting stent (DES) placement, and the overall freedom from MACE was 98.5 %, with no significant difference observed between the ostial and non-ostial groups. The freedom from cardiac death and MI was also similar between the two groups. There were low rates of bleeding complications and severe angiographic complications, and no persistent slow flow/no reflow was reported. CONCLUSIONS: This study demonstrated no significant differences in in-hospital MACE outcomes between patients with ostial versus non-ostial lesions, indicating that OA is a safe and effective treatment option for both lesion types, including those classified as aorto-ostial.

Using Artificial Intelligence in Predicting Ischemic Stroke Events After Percutaneous Coronary Intervention.

BACKGROUND: Ischemic stroke (IS) is an uncommon but severe complication in patients undergoing percutaneous coronary intervention (PCI). Despite significant morbidity and economic cost associated with post PCI IS, a validated risk prediction model is not currently available. AIMS: We aim to develop a machine learning model that predicts IS after PCI. METHODS: We analyzed data from Mayo Clinic CathPCI registry from 2003 to 2018. Baseline clinical and demographic data, electrocardiography (ECG), intra/post-procedural data, and echocardiographic variables were abstracted. A random forest (RF) machine learning model and a logistic regression (LR) model were developed. The receiver operator characteristic (ROC) analysis was used to assess model performance in predicting IS at 6-month, 1-, 2-, and 5-years post-PCI. RESULTS: A total of 17,356 patients were included in the final analysis. The mean age of this cohort was 66.9 ± 12.5 years, and 70.7% were male. Post-PCI IS was noted in 109 patients (.6%) at 6 months, 132 patients (.8%) at 1 year, 175 patients (1%) at 2 years, and 264 patients (1.5%) at 5 years. The area under the curve of the RF model was superior to the LR model in predicting ischemic stroke at 6 months, 1-, 2-, and 5-years. Periprocedural stroke was the strongest predictor of IS post discharge. CONCLUSIONS: The RF model accurately predicts short- and long-term risk of IS and outperforms logistic regression analysis in patients undergoing PCI. Patients with periprocedural stroke may benefit from aggressive management to reduce the future risk of IS.

Incidence, Predictors, and Outcomes Associated With Worsening Renal Function in Patients With Heart Failure and Secondary Mitral Regurgitation: The COAPT Trial.

Background The incidence and implications of worsening renal function (WRF) after mitral valve transcatheter edge-to-edge repair (TEER) in patients with heart failure (HF) are unknown. Therefore, the aim of this study was to determine the proportion of patients with HF and secondary mitral regurgitation who develop persistent WRF within 30 days following TEER, and whether this development portends a worse prognosis. Methods and Results In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) trial, 614 patients with HF and severe secondary mitral regurgitation were randomized to TEER with the MitraClip plus guideline-directed medical therapy (GDMT) versus GDMT alone. WRF was defined as serum creatinine increase ≥1.5× or ≥0.3 mg/dL from baseline persisting to day 30 or requiring renal replacement therapy. All-cause death and HF hospitalization rates between 30 days and 2 years were compared in patients with and without WRF. WRF at 30 days was present in 11.3% of patients (9.7% in the TEER plus GDMT group and 13.1% in the GDMT alone group; P=0.23). WRF was associated with all-cause death (hazard ratio [HR], 1.98 [95% CI, 1.3-3.03]; P=0.001) but not HF hospitalization (HR, 1.47 [ 95% CI, 0.97-2.24]; P=0.07) between 30 days and 2 years. Compared with GDMT alone, TEER reduced both death and HF hospitalization consistently in patients with and without WRF (Pinteraction=0.53 and 0.57, respectively). Conclusions Among patients with HF and severe secondary mitral regurgitation, the incidence of WRF at 30 days was not increased after TEER compared with GDMT alone. WRF was associated with greater 2-year mortality but did not attenuate the treatment benefits of TEER in reducing death and HF hospitalization compared with GDMT alone. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01626079.

Prediction of permanent pacemaker implantation after transcatheter aortic valve replacement: The role of machine learning.

BACKGROUND: Atrioventricular block requiring permanent pacemaker (PPM) implantation is an important complication of transcatheter aortic valve replacement (TAVR). Application of machine learning could potentially be used to predict pre-procedural risk for PPM. AIM: To apply machine learning to be used to predict pre-procedural risk for PPM. METHODS: A retrospective study of 1200 patients who underwent TAVR (January 2014-December 2017) was performed. 964 patients without prior PPM were included for a 30-d analysis and 657 patients without PPM requirement through 30 d were included for a 1-year analysis. After the exclusion of variables with near-zero variance or ≥ 50% missing data, 167 variables were included in the random forest gradient boosting algorithm (GBM) optimized using 5-fold cross-validations repeated 10 times. The receiver operator curve (ROC) for the GBM model and PPM risk score models were calculated to predict the risk of PPM at 30 d and 1 year. RESULTS: Of 964 patients included in the 30-d analysis without prior PPM, 19.6% required PPM post-TAVR. The mean age of patients was 80.9 ± 8.7 years. 42.1 % were female. Of 657 patients included in the 1-year analysis, the mean age of the patients was 80.7 ± 8.2. Of those, 42.6% of patients were female and 26.7% required PPM at 1-year post-TAVR. The area under ROC to predict 30-d and 1-year risk of PPM for the GBM model (0.66 and 0.72) was superior to that of the PPM risk score (0.55 and 0.54) with a P value < 0.001. CONCLUSION: The GBM model has good discrimination and calibration in identifying patients at high risk of PPM post-TAVR.

Percutaneous Coronary Intervention and Discretionary Atherectomy in Patients with Aortic Stenosis: 2016-2019 National Inpatient Sample.

BACKGROUND: Patients with aortic stenosis (AS) usually have concomitant calcified coronary artery disease (CAD) requiring atherectomy to improve lesion compliance and odds of successful percutaneous coronary intervention (PCI). However, there is a paucity of data regarding PCI with or without atherectomy in patients with AS. METHODS: The National Inpatient Sample (NIS) database was queried from 2016 through 2019 using ICD-10 codes to identify individuals with AS who underwent PCI with or without atherectomy (Orbital Atherectomy [OA], Rotational or Laser Atherectomy [non-OA]). Temporal trends, safety, outcomes, costs, and correlates of major adverse cardiovascular events (MACE) were assessed using discharge weighted data. RESULTS: Hospitalizations of 45,420 AS patients undergoing PCI with or without atherectomy were identified and of those, 88.6 %, 2.3 %, and 9.1 % were treated with PCI-only, OA, or non-OA, respectively. There was an increase in PCIs (8855 to 10,885), atherectomy [OA (165 to 300) and non-OA (795 to 1255)], and intravascular ultrasound (IVUS) use (625 to 1000). The median cost of admission was higher in the atherectomy cohorts ($34,340.77 in OA, $32,306.2 in non-OA) as compared to the PCI-only cohort ($23,683.98). Patients tend to have decreased odds of MACE with IVUS guided atherectomy and PCI. CONCLUSIONS: This large database revealed a significant increase in PCI with or without atherectomy in AS patients from 2016 to 2019. Considering the complex comorbidities of AS patients, the overall complication rates were well distributed among the different cohorts, suggesting that IVUS guided PCI with or without atherectomy in patients with AS is feasible and safe.

Coronary Steal Syndrome Secondary to Large Coronary to Pulmonary Artery Fistulas.

Coronary artery fistulas represent rare congenital or acquired defects in the coronary circulation. We describe a case of bilateral coronary to pulmonary artery fistulas resulting in coronary artery steal syndrome in a patient with a history of valve-sparing aortic repair surgery.

Coronary Orbital Atherectomy in Patients With Severe Aortic Stenosis.

OBJECTIVES: Orbital atherectomy (OA) has been shown to be safe and effective in patients with severe calcific coronary artery disease; however, there is a paucity of data on OA use in patients with concomitant severe aortic stenosis (AS). METHODS: A retrospective analysis of consecutive patients undergoing coronary OA treatment of severely calcified lesions, from January 2014 to September 2020 at the Mount Sinai Medical Center, Miami Beach, Florida (MSMCMB), was completed. Data were analyzed to assess rates of angiographic complications, successful stent placement, and in-hospital major adverse cardiovascular event (MACE; defined as the composite of cardiac death, myocardial infarction, ischemic cerebrovascular accident [CVA], and hemorrhagic CVA) in AS vs non-AS patients. RESULTS: A total of 609 patients underwent OA; of those, 32 (5.3%) had severe AS. The AS patient cohort was significantly older (80.3 years vs 73.7 years; P<.001), with a significantly higher percentage of Hispanic or Latino individuals (75% vs 56.5%; P=.04) and lower estimated glomerular filtration rate (64.6 mL/min/1.73 m² vs 76.6 mL/min/1.73 m²; P =.03) than the non-AS cohort. Angiographic complication rates were similar and both groups resulted in 100% successful stent placement. There was no difference in MACE rates between the AS and non-AS cohorts (3.1% vs 1.4%; P=.39). CONCLUSIONS: This study represents the largest real-world comparison of OA use in AS vs non-AS patients. OA appears feasible, safe, and effective prior to stent placement in patients with severe AS. Prospective randomized trials are needed to determine the ideal revascularization strategy for AS patients.

Dual Antiplatelet Therapy in Patients Aged 75 Years and Older with Coronary Artery Disease: A Meta-Analysis and Systematic Review.

Objectives: This systematic review and meta-analysis evaluates the safety and efficacy of dual antiplatelet therapy (DAPT) in elderly patients with acute coronary syndrome (ACS). Background: The safety and efficacy of DAPT in elderly patients with ACS is not well characterized. Methods: We performed a systematic literature review to identify clinical studies that reported safety and efficacy outcomes after DAPT for ACS in elderly patients. The primary outcomes of primary efficacy endpoint rates and bleeding event rates were reported as random effects risk ratio (RR) with 95% confidence interval. No prior ethical approval was required since all data are public. Results: Our search yielded 660 potential studies. We included 8 studies reporting on 29,217 patients. There was a higher risk of bleeding event rates in elderly patients treated with prasugrel or ticagrelor when compared to clopidogrel with a risk ratio of 1.17 (95% CI 1.08 to 1.27, p < 0.05). There was no difference in primary efficacy endpoint rates between elderly patients treated with prasugrel or ticagrelor when compared to clopidogrel with a risk ratio of 0.85 (95% CI 0.68 to 1.07, p=0.17). Conclusions: This systematic review and meta-analysis suggests that DAPT with prasugrel or ticagrelor compared to clopidogrel is associated with a higher risk of bleeding events in elderly patients with ACS. There was no difference in the primary efficacy endpoints between the two treatment groups.

Coronary orbital atherectomy treatment of Hispanic and Latino patients: A real-world comparative analysis.

OBJECTIVES: To assess coronary orbital atherectomy (OA) use in Hispanic or Latino (HL) patients compared to non-HL patients. BACKGROUND: HL patients are at greater risk of cardiovascular disease mortality compared with Whites with similar coronary artery calcium (CAC) scores. The safety and efficacy of coronary atherectomy in the HL patient population is unknown due to the under-representation of minorities in clinical trial research. METHODS: A retrospective analysis of consecutive patients undergoing coronary OA treatment of severely calcified lesions at the Mount Sinai Medical Center, Miami Beach, Florida (MSMCMB) was completed. From January 2014 to September 2020, a total of 609 patients from MSMCMB who underwent percutaneous coronary intervention with OA were identified in the electronic health records. RESULTS: Of those identified, 350 (57.5%) had an ethnicity classification of HL. The overall mean age was 74 years and there was a high prevalence of diabetes in the HL group compared to the non-HL group (49.7% vs. 34.7%; p = 0.0003). Severe angiographic complications were uncommon and in-hospital freedom from major adverse cardiac events (MACE), a composite of cardiac death, MI, and stroke (ischemic or hemorrhagic cerebrovascular accidents), was 98.5% overall, with no significant difference between the HL and non-HL groups, despite the higher prevalence of diabetes in the HL group. CONCLUSIONS: This study represents the largest real-world experience of OA use in HL versus non-HL patients. The main finding in this retrospective analysis is that OA can be performed safely and effectively in a high-risk population of HL patients.

Impact of baseline renal dysfunction on cardiac outcomes and end-stage renal disease in heart failure patients with mitral regurgitation: the COAPT trial.

AIMS: Baseline renal dysfunction (RD) adversely impacts outcomes among patients with heart failure (HF) and severe secondary mitral regurgitation (MR). Heart failure and MR, in turn, accelerate progression to end-stage renal disease (ESRD), worsening prognosis. We sought to determine the impact of RD in HF patients with severe MR and the impact of transcatheter mitral valve repair (TMVr) on new-onset ESRD and the need for renal replacement therapy (RRT). METHODS AND RESULTS: The COAPT trial randomized 614 patients with HF and severe MR to MitraClip plus guideline-directed medical therapy (GDMT) vs. GDMT alone. Patients were stratified into three RD subgroups based on baseline estimated glomerular filtration rate (eGFR, mL/min/1.73 m2): none (≥60), moderate (30-60), and severe (<30). End-stage renal disease was defined as eGFR <15 mL/min/1.73 m2 or RRT. The 2-year rates of all-cause death or HF hospitalization (HFH), new-onset ESRD, and RRT according to RD and treatment were assessed. Baseline RD was present in 77.0% of patients, including 23.8% severe RD, 6.0% ESRD, and 5.2% RRT. Worse RD was associated with greater 2-year risk of death or HFH (none 45.3%; moderate 53.9%; severe 69.2%; P < 0.0001). MitraClip vs. GDMT alone improved outcomes regardless of RD (Pinteraction = 0.62) and reduced new-onset ESRD [2.9 vs. 8.1%, hazard ratio (HR) 0.34, 95% confidence interval (CI) 0.15-0.76, P = 0.008] and the need for new RRT (2.5 vs. 7.4%, HR 0.33, 95% CI 0.14-0.78, P = 0.011). CONCLUSION: Baseline RD was common in the HF patients with severe MR enrolled in COAPT and strongly predicted 2-year death and HFH. MitraClip treatment reduced new-onset ESRD and the need for RRT, contributing to the improved prognosis after TMVr.

Percutaneous Coronary Intervention of Complex Calcific Coronary Lesions Utilizing Orbital Atherectomy Prior to Transcatheter Aortic Valve Replacement.

BACKGROUND: Coronary artery disease (CAD), often with severe calcification, is present in up to 75% of patients with severe aortic stenosis (AS) referred for transcatheter aortic valve replacement (TAVR). Management of CAD in such patients is challenging. Orbital atherectomy (OA) is an effective treatment of severely calcified coronary lesions prior to stent implantation. However, there is limited data on the use of OA for percutaneous coronary intervention (PCI) to treat calcific CAD patients prior to TAVR (OA PCI + TAVR). METHODS: Retrospective analysis of patients with moderate/severe calcific CAD and moderate/severe AS who underwent staged OA PCI + TAVR at one high-volume institution. Data were analyzed to assess the 1-year major adverse cardiac events after index OA PCI [MACE: death, target lesion revascularization (TLR), and myocardial infarction (MI)]. RESULTS: There were 18 patients (mean age of 82) treated with staged OA PCI + TAVR, and of those, 10 (56%) were male, 7 (39%) Caucasian, and 11 (61%) Hispanic/Latino. The average left ventricular ejection fraction was 49% and congestive heart failure was present in 12 patients (67%). There were no angiographic complications (0%), stent thrombosis (0%), or stroke events (0%). The 30-day and 1-year MACE rates were 5.6% (0% death, 0% TLR, 5.6% MI) and 17% (0% death, 11% TLR, and 17% MI [all non-Q-wave MI]), respectively. CONCLUSIONS: In this single-center observational cohort series, patients with heavily calcified coronary lesions treated with OA prior to TAVR had low rates of MACE at 30 days and 1 year. The results demonstrate the feasibility and safety of OA for the treatment of complex calcific coronary lesions prior to TAVR. An up-to-date literature review of atherectomy before, during, or after TAVR in patients with concomitant severe AS and calcific CAD is also provided. TABLE OF CONTENTS SUMMARY: There is limited data on the use of orbital atherectomy (OA) for percutaneous coronary intervention (PCI) to treat calcific coronary artery disease (CAD) patients prior to transcatheter aortic valve replacement (TAVR). Our primary aim was to evaluate the feasibility, safety, and 1-year outcome of OA PCI pre-TAVR in patients with complex CAD and severe aortic stenosis (AS). We also aimed to provide a brief up-to-date literature review of atherectomy before, during, or after TAVR in patients with concomitant severe AS and calcific CAD. This retrospective cohort study found that OA is feasible and safe for the treatment of severely calcified coronary lesions before TAVR, resulting in acceptable 30-day and 1-year outcomes.

Clinical Characteristics, Outcomes, and Epidemiological Trends of Patients Admitted With Type 2 Myocardial Infarction.

Background: Type 2 myocardial infarction (T2MI) was first established as a unique entity in 2007. However, its clinical features are not well characterized. This study aimed to determine the clinical characteristics, predictors of mortality, and hospitalization trends of patients with T2MI. Methods: The National Inpatient Sample database was queried for patients hospitalized in the United States with T2MI (January 2018 to December 2019). Data were used to assess baseline characteristics, primary diagnoses, predictors of mortality, and hospitalization and mortality trends of T2MI. Results: During the 24-month study period, 1,789,485 (76%) patients were admitted with type 1 myocardial infarction (T1MI) and 563,695 (24%) were admitted with T2MI. Patients with T2MI were more likely to be older (71 vs 68 years; P < .001) and female (47.5% vs 38.3%; P < .001), with fewer comorbidities related to coronary atherosclerosis. African Americans were the only race with a significantly higher rate of hospitalization for T2MI (15.9% vs 11.6%; P < .001). The predictors of mortality were similar in both the T2MI and T1MI cohorts. Sepsis (23.47%), hypertensive heart disease (15.35%), and atrial arrhythmias (4.49%) were the most common principal diagnoses for T2MI. T2MI hospitalizations trended consistently upward during the study period. Monthly in-hospital mortality rates were consistently higher for T2MI versus T1MI (P < .001). Conclusions: T2MI is a unique and heterogeneous clinical entity. Despite increased awareness, there is a lack of standardization of medical management and timing for revascularization, even as mortality rates remain persistently elevated compared with T1MI. Certain demographics, including African Americans, may be disproportionately affected.

In-Hospital Outcomes of Transcatheter Tricuspid Valve Repair: An Analysis From the National Inpatient Sample.

Background: Patients with severe tricuspid regurgitation carry an elevated surgical risk resulting in increasing adoption of less invasive transcatheter therapies such as transcatheter tricuspid valve repair (TTVR); however, data are limited. This study aimed to describe patient characteristics and predictors of poor outcomes among those undergoing TTVR. Methods: The National Inpatient Sample was queried (2016-2019) to identify all patients undergoing TTVR (International Classification of Diseases, Tenth Revision code 02UJ3JZ) alone or in combination with mitral transcatheter edge-to-edge repair (MTEER) (code 02UG3JZ). The primary aim was to define clinical characteristics, time trends, in-hospital outcomes, and predictors of all-cause in-hospital mortality (mortality). The secondary outcomes included predictors of increased hospitalization costs and length of stay (greater than the 75th percentile). Results: We identified 925 patients who underwent TTVR (460 [49.7%] who underwent TTVR alone and 465 [50.3%] who underwent TTVR in combination with MTEER). There was a 6.5-fold increase in TTVR adoption (P < .001). Patients were older (78 ± 10 years), female (63.2%), and White (72.7%), with frequent comorbidities. Mortality occurred in 2.2%, vascular complications occurred in 10.3%, and major bleeding occurred in 3.3%. The predictors of mortality were acute kidney injury (odds ratio [OR], 5.25; 95% CI, 5.24-5.26; P < .001), major bleeding (OR, 2.81; 95% CI, 2.80-2.83; P < .001), pericardiocentesis (OR, 2.15; 95% CI, 2.11-2.18; P < .001), and chronic liver disease (OR, 1.40; 95% CI, 1.39-1.40; P < .001). The predictors of increased length of stay or hospitalization costs included coronary artery disease, atrial arrhythmias, pulmonary hypertension, chronic liver disease, and procedural complications. Conclusions: TTVR showed increased adoption with elevated but acceptable mortality and complications considering this high-risk population. The results of randomized trials are awaited.

Direct oral anticoagulants in patients with atrial fibrillation and bioprosthetic valve replacement: A meta-analysis.

OBJECTIVES: This systematic review and meta-analysis compares direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) in patients with atrial fibrillation and bioprosthetic valve replacement or repair (BVR). BACKGROUND: The optimal anticoagulation therapy for patients with atrial fibrillation and a history of bioprosthetic valve replacement or repair (BVR) is not well understood. METHODS: We performed a systematic literature review to identify clinical studies that compared anticoagulation therapies for patients with atrial fibrillation and BVR. The primary outcomes of stroke, major bleeding, and mortality were reported as random effects risk ratio (RR) with 95% confidence interval. No prior ethical approval was required since all data is public. RESULTS: Our search yielded 101 potential studies. We included six studies reporting on 1911 patients. There was a lower risk of stroke and major bleeding in patients with atrial fibrillation after BVR treated with DOACs when compared to VKAs with risk ratios of 0.44 (95% CI 0.24-0.82, p < 0.01) and 0.53 (95% CI 0.34-0.83, p < 0.01), respectively. There was no statistically significant difference in mortality between patients with atrial fibrillation after BVR treated with DOACs compared to patients treated with VKAs with a risk ratio of 1.12 (95% CI 0.73-1.74, p = 0.60). CONCLUSION: This systematic review and meta-analysis suggests that DOACs are superior to VKAs with respect to stroke and major bleeding in patients with atrial fibrillation and BVR.

In-hospital outcomes after transcatheter edge-to-edge mitral valve repair in patients with chronic kidney disease: An analysis from the 2010-2016 National inpatient sample.

OBJECTIVES: To assess the outcomes following transcatheter edge-to-edge mitral valve repair (TMVr) in patients with chronic kidney disease (CKD). BACKGROUND: Percutaneous TMVr is beneficial in high surgical risk patients with severe mitral regurgitation (MR). However, those with CKD are not well studied. METHODS: Utilizing the International Classification of Disease (ninth and tenth revision, clinical modification codes) and the Nationwide Inpatient Sample database, we identified 9,228 patients who underwent TMVr during 2010-2016, including those with no or mild CKD (group 1, n = 6,654 [72.11%]), moderate or severe CKD (group 2, n = 2,125 [23.03%]) and end-stage renal disease (ESRD) on dialysis (group 3, n = 449 [4.86%]). In-hospital clinical outcomes, length of stay and cost were assessed. RESULTS: In-hospital mortality increased numerically as CKD severity increased, but not statistically different between groups (1.8, 3.3, and 4.5% respectively in group 1, 2, and 3, p = .07). Moderate to severe CKD (group 2) was an independent predictor of acute renal failure requiring hemodialysis (ARFD) (OR: 3.51, CI: 2.33-5.28, p < .0001), the composite outcome of death, ARFD or stroke [OR: 3.15, 95% CI: 2.10-4.76, p < .0001] and extended length of stay [OR: 1.73, 95% CI: 1.24-2.42), p = .001] while ESRD (group 3) was an independent predictor of higher hospital cost [OR: 1.66, 95% CI: 1.01-2.74), p = .04] as compared with no or mild CKD (group 1). CONCLUSIONS: High surgical risk patients with severe MR commonly have associated comorbidities including CKD. TMVr outcomes appear to worsen with worsening CKD and therefore careful clinical case selection and further studies evaluating TMVr outcomes in CKD patients is warranted.

Long-Term Clinical Outcomes of Underdosed Direct Oral Anticoagulants in Patients with Atrial Fibrillation and Atrial Flutter.

BACKGROUND: Although direct oral anticoagulants (DOACs) have been shown to be effective at reducing the risk of stroke in patients with atrial fibrillation/flutter (AF), they are sometimes underdosed off-label to mitigate their associated higher bleeding risk. We sought to evaluate frequency and clinical outcomes of inappropriate underdosing of DOACS in patients with AF. METHODS: We conducted a study of subjects with AF who had a clinical indication for stroke prophylaxis (with a congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke or transient ischemic attack, vascular disease, age 65 to 47 years, sex category [CHA2DS2-VASc] of 2 or greater) and were prescribed 1 of the 4 clinically approved DOACs (apixaban, rivaroxaban, dabigatran, or edoxaban). We compared all-cause mortality, composite of stroke and systemic embolism, composite of myocardial infarction (MI), acute coronary syndromes (ACS), and coronary revascularization, and major bleeding between patients appropriately dosed and inappropriately underdosed. RESULTS: A total of 8125 patients met inclusion criteria, with a mean follow up of 2.2 ± 2 years. Of those, 1724 patients (21.2%) were inappropriately dosed. After adjusting for baseline variables, there was no difference in all-cause mortality, risk of stroke or systemic embolism, International Society on Thrombosis and Haemostasis (ISTH) major bleeding, or composite of myocardial infarction, acute coronary syndromes, or coronary revascularization between patients appropriately dosed and inappropriately underdosed. In subgroup analysis, only apixaban demonstrated an increased incidence all-cause mortality (hazard ratio [HR] 1.24, 95% confidence interval [CI] 1.03-1.49) with inappropriate underdosing. There was no difference in the remaining clinical outcomes noted on subgroup analysis. CONCLUSION: Underdosing of DOACs did not minimize risk of bleeding, systemic embolization or all-cause mortality in patients with AF. Inappropriate underdosing with apixaban in particular was associated with increased all-cause mortality.

Artificial Intelligence Trumps TAVI2-SCORE and CoreValve Score in Predicting 1-Year Mortality Post-Transcatheter Aortic Valve Replacement.

BACKGROUND/PURPOSE: Machine learning has been used to predict procedural risk in patients undergoing various medical interventions and procedures. One-year mortality in patients after Transcatheter Aortic Valve Replacement (TAVR) has a wide range (from 8.5 to 24% in various studies). We sought to apply machine learning to determine predictors of one year mortality in patients undergoing TAVR. METHODS/MATERIALS: A retrospective study of 1055 patients who underwent TAVR (Jan 2014-June 2017) with one-year follow up was completed. Baseline demographics, clinical, electrocardiography (ECG), Computed Tomography (CT) and echocardiography data were abstracted. Variables with near zero variance or ≥50% missing data were excluded. The Gradient Boosting Machine learning (GBM) prediction model included 163 variables and was optimized using 5-fold cross-validation repeated 10-times. The receiver operator characteristic (ROC) for the GBM model was calculated to predict one-year mortality post TAVR, and then compared to the TAVI2-SCORE and CoreValve score. RESULTS: Among 1055 TAVR patients (mean age 80.9 ± 7.9 years, 42% female), 14.02% died at one year. 78% had balloon expandable valves placed. Based on GBM, the ten most predictive variables for one-year survival were cardiac power index, hemoglobin, systolic blood pressure, INR, diastolic blood pressure, body mass index, valve calcium score, serum creatinine, aortic annulus area, and albumin. The area under ROC to predict survival for the GBM model vs TAVI2-SCORE and CoreValve Score was 0.72 (95% CI 0.68-0.78) vs 0.56 (95%CI 0.51-0.62) and 0.53 (95% CI 0.47-0.59) respectively with p < 0.0001. CONCLUSION: The GBM model outperforms TAVI2-SCORE and CoreValve Score in predicting mortality one-year post TAVR.

Impact of lesion preparation strategies on outcomes of left main PCI: The EXCEL trial.

OBJECTIVES: We examined outcomes according to lesion preparation strategy (LPS) in patients with left main coronary artery (LMCA) percutaneous coronary intervention (PCI) in the EXCEL trial. BACKGROUND: The optimal LPS for LMCA PCI is unclear. METHODS: We categorized LPS hierarchically (high to low) as: (a) rotational atherectomy (RA); (b) cutting or scoring balloon (CSB); (c) balloon angioplasty (BAL); and d) direct stenting (DIR). The primary endpoint was 3-year MACE; all-cause death, stroke, or myocardial infarction. RESULTS: Among 938 patients undergoing LMCA PCI, RA was performed in 6.0%, CSB 9.5%, BAL 71.3%, and DIR 13.2%. In patients treated with DIR, BAL, CSB, and RA, respectively, there was a progressive increase in SYNTAX score, LMCA complex bifurcation, trifurcation or calcification, number of stents, and total stent length. Any procedural complication occurred in 10.4% of cases overall, with the lowest rate in the DIR (7.4%) and highest in the RA group (16.1%) (ptrend  = .22). There were no significant differences in the 3-year rates of MACE (from RA to DIR: 17.9%, 20.2%, 14.5%, 14.7%; p = .50) or ischemia-driven revascularization (from RA to DIR: 16.8%, 10.8%, 12.3%, 14.2%; p = .65). The adjusted 3-year rates of MACE did not differ according to LPS. CONCLUSIONS: The comparable 3-year outcomes suggest that appropriate lesion preparation may be able to overcome the increased risks of complex LMCA lesion morphology.

Clinical Impact of Preexisting Right Bundle Branch Block after Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis.

INTRODUCTION: Transcatheter aortic valve replacement (TAVR) is now the treatment of choice for patients with severe aortic stenosis regardless of their surgical risk. Right bundle branch block (RBBB) can be a predictor for development of significant atrioventricular (AV) block after TAVR, requiring permanent pacemaker implantation (PPI). However, data related to the risk of PPI requirement with preexisting RBBB is scarce. Hence, this systematic review and meta-analysis aims to assess clinical outcomes of patients undergoing TAVR with RBBB on preexisting electrocardiogram. METHODS: We performed a systematic literature review to identify randomized and nonrandomized clinical studies that reported any clinical impact of patients undergoing TAVR with preexisting RBBB. A total of eight databases including PubMed (Medline), Embase, Cochrane Library, ACP Journal Club, Scopus, DARE, and Ovid containing articles from January 2000 to May 2020 were analyzed. RESULTS: We identified and screened 224 potential eligible publications through the databases and found 14 relevant clinical trials for a total of 15,319 participants. There was an increased 30-day pacemaker implantation rate of 38.1% in the RBBB group compared to 11.4% in the no RBBB group with a risk ratio of 3.56 (RR 3.56 (95% CI 3.21-3.93, p < 0.01)). There was an increased 30-day all-cause mortality in the RBBB group of 9.5% compared with 6.3% in the no RBBB group with an odds ratio of 1.60 (OR 1.60 (95% CI 1.14-2.25, p < 0.01)). CONCLUSION: This study indicates that patients with preexisting RBBB have higher incidence of PPI and all-cause mortality after TAVR compared with patients without RBBB. Further trials are needed to compare the clinical outcomes based on TAVR valve types and assess the benefit of PPI in patients with new-onset RBBB after TAVR.