Long-Term Outcomes of Chronic Total Occlusion Percutaneous Coronary Intervention Among Medicare Beneficiaries.

Background: Chronic total occlusion (CTO) percutaneous coronary interventions (PCIs) represent 4% of all PCIs for stable angina in the United States and have been associated with lower success and higher in-hospital event rates compared with non-CTO PCIs. We aimed to examine long-term outcomes of CTO PCI compared with non-CTO PCI, including prespecified subgroups of high-risk non-CTO PCI (atherectomy/saphenous vein graft/unprotected left main).

Methods: Among 551,722 patients in the National Cardiovascular Data Registry CathPCI Registry linked to Medicare (July 2009-December 2016), we evaluated in-hospital events and long-term major adverse cardiovascular events of CTO PCIs (N = 29,407) compared with non-CTO PCIs (N = 522,315).

Relation of the Number of Cardiovascular Conditions and Short-term Symptom Improvement After Percutaneous Coronary Intervention for Stable Angina Pectoris.

With aging of the population, cardiovascular conditions (CC) are increasingly common in individuals undergoing PCI for stable angina pectoris (AP). It is unknown if the overall burden of CCs associates with diminished symptom improvement after PCI for stable AP. We prospectively administered validated surveys assessing AP, dyspnea, and depression to patients undergoing PCI for stable AP at our institution, 2016-2018.

Rationale and Design of the SAFE-PAD Study.

Background: Recent evidence from randomized controlled trials has raised concerns about the long-term safety of paclitaxel-coated peripheral devices used for femoropopliteal artery revascularization. In response to a call for more real-world data on the safety of these devices, the SAFE-PAD study (Safety Assessment of Femoropopliteal Endovascular treatment with Paclitaxel-coated Devices) was designed with input from the Food and Drug Administration to provide a long-term, comprehensive evaluation of the mortality risk associated with paclitaxel-coated devices among Medicare beneficiaries.

Methods And Results: SAFE-PAD is an observational cohort study of fee-for-service Medicare beneficiaries that underwent femoropopliteal artery revascularization with either a drug-coated device or nondrug-coated device from 2015 through 2018.

Long-term outcomes of percutaneous coronary intervention for in-stent restenosis among Medicare beneficiaries.

Background: In-stent restenosis (ISR) is highly prevalent and leads to repeat revascularisation. Long-term implications of ISR are poorly understood.

Aims: This study aimed to evaluate the long-term outcomes of patients undergoing percutaneous coronary intervention (PCI) for ISR.

Use of Administrative Claims to Assess Outcomes and Treatment Effect in Randomized Clinical Trials for Transcatheter Aortic Valve Replacement: Findings From the EXTEND Study.

Background: Whether passively collected data can substitute for adjudicated outcomes to reproduce the magnitude and direction of treatment effect observed in cardiovascular clinical trials is not well known.

Methods: We linked adults ≥65 years of age in the HiR (US CoreValve Pivotal High Risk) and SURTAVI trials (Surgical or Transcatheter Aortic Valve Replacement in Intermediate-Risk Patients) to 100% Medicare inpatient claims, January 1, 2011, to December 31, 2016. Primary (eg, death and stroke) and secondary trial end points were compared across treatment arms (eg, transcatheter aortic valve replacement [TAVR] versus surgical aortic valve replacement [SAVR]) using trial-adjudicated outcomes versus outcomes derived from claims at 1 year (HiR) or 2 years (SURTAVI).

Relation of Frailty to Outcomes After Catheter Ablation of Atrial Fibrillation.

Catheter ablation for atrial fibrillation (AF) improves outcomes compared with medical treatment alone. Risk stratification for outcomes following AF ablation remains an important area of uncertainty. This analysis evaluated the association between frailty and outcomes following AF ablation.

Association between procedure appropriateness and patient-reported outcomes after percutaneous coronary intervention.

Objective: The Appropriate Use Criteria (AUC) has been used to identify individuals who are likely to benefit from percutaneous coronary intervention (PCI) for stable ischaemic heart disease. However, whether physicians reliably grade PCI appropriateness and whether AUC categories stratify symptomatic improvement in real-world practice are unclear.

Methods: Patient-reported outcomes measures (PROMs) for angina (Seattle Angina Questionnaire (SAQ-7)), dyspnoea (Rose Dyspnea Scale (RDS)) and depression (Patient Health Questionnaire-2 (PHQ-2)) were collected on patients undergoing elective coronary angiography at an academic medical centre.

Comparison of Clinical Trials and Administrative Claims to Identify Stroke Among Patients Undergoing Aortic Valve Replacement: Findings From the EXTEND Study.

Background: Cerebrovascular events (CVEs) are devastating complications after aortic valve replacement. We assessed whether billing claims accurately identify CVEs in place of clinical event adjudication in structural heart disease trials.

Methods: Adult participants in the US CoreValve High Risk and SURTAVI trials (Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients) were linked to Medicare inpatient claims from January 1, 2006 to December 31, 2016.

Association of Frailty With 30-Day Outcomes for Acute Myocardial Infarction, Heart Failure, and Pneumonia Among Elderly Adults.

Importance: The addition of a claims-based frailty metric to traditional comorbidity-based risk-adjustment models for acute myocardial infarction (AMI), heart failure (HF), and pneumonia improves the prediction of 30-day mortality and readmission. This may have important implications for hospitals that tend to care for frail populations and participate in Centers for Medicare & Medicaid Services value-based payment programs, which use these risk-adjusted metrics to determine reimbursement.

Objective: To determine whether the addition of frailty measures to traditional comorbidity-based risk-adjustment models improved prediction of outcomes for patients with AMI, HF, and pneumonia.

Trends in isolated aortic valve replacement in the United States in the early phase of expansion of TAVR.

This study aimed to evaluate changes in volume, risk profile, and outcomes among elderly individuals undergoing isolated aortic valve replacement (AVR) after TAVR approval in the United States. Retrospective cohort study of patients ≥65 years old with at least one procedural code for isolated SAVR or TAVR among the Medicare beneficiaries between January 1, 2009 and December 31, 2014. A total of 137,563 hospitalizations for isolated AVR between 2009 and 2014 were included (SAVR: 102,968 [74.

Frailty and related outcomes in patients undergoing transcatheter valve therapies in a nationwide cohort.

Aims: We sought to identify the prevalence and related outcomes of frail individuals undergoing transcatheter mitral valve repair and transcatheter aortic valve replacement (TAVR).

Methods And Results: Patients aged 65 and older were included in the study if they had at least one procedural code for transcatheter mitral valve repair or TAVR between 1 January 2016 and 31 December 2016 in the Centers for Medicare and Medicaid Services Medicare Provider and Review database. The Hospital Frailty Risk Score, an International Classification of Diseases, Tenth Revision (ICD-10) claims-based score, was used to identify frailty and the primary outcome was all-cause 1-year mortality.

Validating the use of registries and claims data to support randomized trials: Rationale and design of the Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study.

Background: Randomized controlled trials are the "gold standard" for comparing the safety and efficacy of therapies but may be limited due to high costs, lack of feasibility, and difficulty enrolling "real-world" patient populations. The Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study seeks to evaluate whether data collected within procedural registries and claims databases can reproduce trial results by substituting surrogate non-trial-based variables for exposures and outcomes.

Methods And Results: Patient-level data from 2 clinical trial programs-the Dual Antiplatelet Therapy Study and the United States CoreValve Studies-will be linked to a combination of national registry, administrative claims, and health system data.

Depression and Angina Among Patients Undergoing Chronic Total Occlusion Percutaneous Coronary Intervention: The OPEN-CTO Registry.

Objectives: This study sought to examine depression prevalence among chronic total occlusion (CTO) patients and compared symptom improvement among depressed and nondepressed patients after percutaneous coronary intervention (PCI).

Background: Depression in cardiovascular patients is common, but its prevalence among CTO patients and its association with PCI response is understudied.

Methods: Among 811 patients from the OPEN-CTO (Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion Hybrid Procedures) registry, we evaluated change in health status between baseline and 1-year post-PCI, as measured by the Seattle Angina Questionnaire (SAQ) and the Rose Dyspnea Score.

Cost-effectiveness analysis of short-duration dual antiplatelet therapy with newer drug-eluting stent platforms versus longer-duration dual antiplatelet therapy with a second-generation drug-eluting stent in elective percutaneous coronary intervention.

Background: The cost-effectiveness of newer drug-eluting stents (DES) such as biodegradable-polymer or polymer-free stents with shorter dual antiplatelet therapy (DAPT) duration is unknown. We evaluated the cost-effectiveness of treatment with newer DES that may allow for shorter DAPT duration.

Patients And Methods: We performed a cost-effectiveness analysis of treatment with newer DES platforms followed by 1 or 3 months of DAPT compared with standard second-generation DES followed by 6 or 12 months of DAPT in patients with stable coronary disease.

Parachute use to prevent death and major trauma when jumping from aircraft: randomized controlled trial.

Objective: To determine if using a parachute prevents death or major traumatic injury when jumping from an aircraft.

Design: Randomized controlled trial.

Setting: Private or commercial aircraft between September 2017 and August 2018.

The Value of Claims-Based Nontraditional Risk Factors in Predicting Long-term Mortality After MitraClip Procedure.

Background: We sought to identify nontraditional risk factors coded in administrative claims data and evaluate their ability to improve prediction of long-term mortality in patients undergoing percutaneous mitral valve repair.

Methods: Patients undergoing transcatheter mitral valve repair using MitraClip implantation between September 28, 2010, and September 30, 2015 were identified among Medicare fee-for-service beneficiaries. We used nested Cox regression models to identify claims codes predictive of long-term mortality.

Association of Hospital Surgical Aortic Valve Replacement Quality With 30-Day and 1-Year Mortality After Transcatheter Aortic Valve Replacement.

Importance: Hospital outcomes for transcatheter aortic valve replacement (TAVR) may be dependent on the quality of evaluation, personnel, and procedural and postprocedural care common to patients undergoing cardiac surgery.

Objectives: We sought to assess whether those hospitals with better patient outcomes for surgical aortic valve replacement (SAVR) subsequently achieved better TAVR outcomes after launching TAVR programs.

Design, Setting, And Participants: This national cohort included US patients 65 years and older.

Impact of a Claims-Based Frailty Indicator on the Prediction of Long-Term Mortality After Transcatheter Aortic Valve Replacement in Medicare Beneficiaries.

Background Prospectively collected frailty markers are associated with an incremental 1-year mortality risk after transcatheter aortic valve replacement (TAVR) compared with comorbidities alone. Whether information on frailty markers captured retrospectively in administrative billing data is similarly predictive of long-term mortality after TAVR is unknown. We sought to characterize the prognostic importance of frailty factors as identified in healthcare billing records in comparison to validated measures of frailty for the prediction of long-term mortality after TAVR.

Trends in Isolated Surgical Aortic Valve Replacement According to Hospital-Based Transcatheter Aortic Valve Replacement Volumes.

Objectives: This study sought to evaluate the trends in isolated surgical aortic valve replacement (SAVR) procedures across hospitals with different transcatheter aortic valve replacement (TAVR) volumes among Medicare beneficiaries.

Background: The volume of TAVR has increased in the United States since its approval, now exceeding that of isolated SAVR.

Methods: Hospitalizations of adults (≥18 years of age) with International Classification of Diseases-9th Revision-Clinical Modification procedure codes for SAVR (35.

Meta-Analysis of Bleeding Risk Prediction Scores in Patients After Percutaneous Coronary Intervention on Dual Antiplatelet Therapy.

The duration and type of dual antiplatelet therapy (DAPT) prescribed to patients after percutaneous coronary intervention (PCI) involves carefully balancing reduced ischemia and increased bleeding risk for individual patients. Whereas multiple bleeding risk scores exist, the performance of these models to predict long-term bleeding in the setting of DAPT across different settings and populations is unclear. Therefore, we performed a systematic review and meta-analysis to compare the performance of current bleeding risk prediction scores for predicting major long-term bleeding events in patients on DAPT post-PCI.

A Survey of Interventional Cardiologists' Attitudes and Beliefs About Public Reporting of Percutaneous Coronary Intervention.

Importance: Public reporting of procedural outcomes has been associated with lower rates of percutaneous coronary intervention (PCI) and worse outcomes after myocardial infarction. Contemporary data are limited on the influence of public reporting on interventional cardiologists' clinical decision making.

Objective: To survey a contemporary cohort of interventional cardiologists in Massachusetts and New York about how public reporting of PCI outcomes influences clinical decision making.

Applicability of Publicly Reported Hospital Readmission Measures to Unreported Conditions and Other Patient Populations: A Cross-sectional All-Payer Study.

Background: Readmission rates after hospitalizations for heart failure (HF), acute myocardial infarction (AMI), and pneumonia among Medicare beneficiaries are used to assess quality and determine reimbursement. Whether these measures reflect readmission rates for other conditions or insurance groups is unknown.

Objective: To investigate whether hospital-level 30-day readmission measures for publicly reported conditions (HF, AMI, and pneumonia) among Medicare patients reflect those for Medicare patients hospitalized for unreported conditions or non-Medicare patients hospitalized with HF, AMI, or pneumonia.