Kathleen Hewitt

Outcomes Following Transcatheter Aortic Valve Replacement in the United States

IMPORTANCE Transcatheter aortic valve replacement (TAVR) was approved by the US Food and Drug Administration for the treatment of severe, symptomatic aortic stenosis and inoperable status (in 2011) and high-risk but operable status (starting in 2012). A national registry (the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy [STS/ACC TVT] Registry) was initiated to meet a condition for Medicare coverage and also facilitates outcome assessment and comparison with other trials and international registries. OBJECTIVE To report the initial US commercial experience with TAVR. DESIGN, SETTING, AND PARTICIPANTS We obtained results from all eligible US TAVR cases (n=7710) from 224 participating registry hospitals following the Edwards Sapien XT device commercialization (November 2011-May 2013). MAIN OUTCOMES AND MEASURES Primary outcomes included all-cause in-hospital mortality and stroke following TAVR. Secondary analyses included procedural complications and outcomes by clinical indication and access site. Device implantation success was defined as successful vascular access, deployment of a single device in the proper anatomic position, appropriate valve function without either moderate or severe AR, and successful retrieval of the delivery system. Thirty-day outcomes are presented for a representative 3133 cases (40.6%) at 114 centers with at least 80% complete follow-up reporting. RESULTS The 7710 patients who underwent TAVR included 1559 (20%) cases that were inoperable and 6151 (80%) cases that were high-risk but operable. The median age was 84 years (interquartile range [IQR], 78-88 years); 3783 patients (49%) were women and the median STS predicted risk of mortality was 7% (IQR, 5%-11%). At baseline, 2176 patients (75%) were either not at all satisfied (1297 patients [45%]) or mostly dissatisfied (879 patients [30%]) with their symptom status; 2198 (72%) had a 5-m walk time longer than 6 seconds (slow gait speed). The most common vascular access approach was transfemoral (4972 patients [64%]), followed by transapical (2197 patients [29%]) and other alternative approaches (536 patients [7%]); successful device implantation occurred in 7069 patients (92%; 95% CI, 91%-92%). The observed incidence of in-hospital mortality was 5.5% (95% CI, 5.0%-6.1%). Other major complications included stroke (2.0%; 95% CI, 1.7%-2.4%), dialysis-dependent renal failure (1.9%; 95% CI, 1.6%-2.2%), and major vascular injury (6.4%; 95% CI, 5.8%-6.9%). Median hospital stay was 6 days (IQR, 4-10 days), with 4613 (63%) discharged home. Among patients with available follow-up at 30 days (n=3133), the incidence of mortality was 7.6% (95% CI, 6.7%-8.6%) (noncardiovascular cause, 52%); a stroke had occurred in 2.8% (95% CI, 2.3%-3.5%), new dialysis in 2.5% (95% CI, 2.0%-3.1%), and reintervention in 0.5% (95% CI, 0.3%-0.8%). CONCLUSIONS AND RELEVANCE Among patients undergoing TAVR at US centers in the STS/ACC TVT Registry, device implantation success was achieved in 92% of cases, the overall in-hospital mortality rate was 5.5%, and the stroke rate was 2.0%. Although these postmarket US approval findings are comparable with prior published trial data and international experience, long-term follow-up is essential to assess continued efficacy and safety. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01737528.

Treatments, trends, and outcomes of acute myocardial infarction and percutaneous coronary intervention.

Coronary artery disease remains a major public health problem in the U.S. as many Americans experience an acute myocardial infarction (MI) and/or undergo percutaneous coronary intervention (PCI) each year. Given the attendant risks of mortality and morbidity, acute MI remains a principal focus of

A contemporary overview of percutaneous coronary interventions: The American College of Cardiology–National Cardiovascular Data Registry (ACC–NCDR)

The American College of Cardiology (ACC) established the National Cardiovascular Data Registry (ACC-NCDR) to provide a uniform and comprehensive database for analysis of cardiovascular procedures across the country. The initial focus has been the high-volume, high-profile procedures of diagnostic cardiac catheterization and percutaneous coronary intervention (PCI). Several large-scale multicenter efforts have evaluated diagnostic catheterization and PCI, but these have been limited by lack of standard definitions and relatively nonuniform data collection and reporting methods. Both clinical and procedural data, and adverse events occurring up to hospital discharge, were collected and reported according to uniform guidelines using a standard set of 143 data elements. Datasets were transmitted quarterly to a central facility for quality-control screening, storage and analysis. This report is based on PCI data collected from January 1, 1998, through September 30, 2000.A total of 139 hospitals submitted data on 146,907 PCI procedures. Of these, 32% (46,615 procedures) were excluded because data did not pass quality-control screening. The remaining 100,292 procedures (68%) were included in the analysis set. Average age was 64 +/- 12 years; 34% were women, 26% had diabetes mellitus, 29% had histories of prior myocardial infarction (MI), 32% had prior PCI and 19% had prior coronary bypass surgery. In 10% the indication for PCI was acute MI < or =6 h from onset, while in 52% it was class II to IV or unstable angina. Only 5% of procedures did not have a class I indication by ACC criteria, but this varied by hospital from a low of 0 to a high of 38%. A coronary stent was placed in 77% of procedures, but this varied by hospital from a low of 0 to a high of 97%. The frequencies of in-hospital Q-wave MI, coronary artery bypass graft surgery and death were 0.4%, 1.9% and 1.4%, respectively. Mortality varied by hospital from a low of 0 to a high of 4.2%. This report presents the first data collected and analyzed by the ACC-NCDR. It portrays a contemporary overview of coronary interventional practices and outcomes, using uniform data collection and reporting standards. These data reconfirm overall acceptable results that are consistent with other reported data, but also confirm large variations between individual institutions.

Impact of ethnicity and gender differences on angiographic coronary artery disease prevalence and in-hospital mortality in the American College of Cardiology-National Cardiovascular Data Registry.

Background— Although populations referred for coronary angiography are increasingly diverse, there is limited information on coronary artery disease (CAD) prevalence and in-hospital mortality other than for predominately white male patients. Methods and Results— We examined gender and ethnic differences in CAD prevalence and in-hospital mortality in a prospective cohort of patients referred for angiographic evaluation of stable angina (n=375 886) or acute coronary syndromes (ACS; unstable angina or myocardial infarction, n=450 329) at 388 US hospitals participating in the American College of Cardiology–National Cardiovascular Data Registry, an angiographic registry. Univariable and multivariable (with covariates that included risk factors, symptoms, and comorbidities) logistic regression models were used to estimate significant CAD, defined as ≥70% stenosis, and in-hospital mortality. Within stable angina and ACS cohorts, 7% of patients were black, 2% were Hispanic, 0.3% were Native American, 1% were Asian, and 90% were white, respectively. In stable angina, the risk-adjusted OR for significant CAD was 0.34 for women compared with men (P<0.0001), with black women having the lowest risk-adjusted odds (P<0.0001) compared with other females. Among ACS patients, the risk-adjusted OR of significant CAD was 0.47 for women compared with men (P<0.0001); similarly, black women had the lowest risk-adjusted odds (P<0.0001) compared with other females. Higher in-hospital mortality was reported for white women presenting with stable angina (P<0.00001). White women had a 1.34-fold (95% CI 1.21 to 1.48) higher risk-adjusted odds ratio for mortality than white men with stable angina (P<0.0001), with higher rates noted for white women who were older or had significant CAD (both P<0.0001). Lower utilization of elective coronary revascularization, aspirin, and glycoprotein IIb/IIIa inhibitors (all P<0.0001) may have contributed to higher in-hospital mortality for white women. In ACS, higher in-hospital mortality was reported for Hispanic (P=0.015) and white (P<0.0001) women; however, neither white (P=0.51) or Hispanic (P=0.13) women had higher in-hospital risk-adjusted mortality. Conclusions— The likelihood for significant CAD at coronary angiography and for in-hospital mortality varied significantly by ethnicity and gender. Future clinical practice guidelines should be tailored to gender subsets of the population, in particular for black women, to improve the efficient use of angiographic laboratories and to target at-risk populations of women and men.

Development of a risk adjustment mortality model using the American College of Cardiology–National Cardiovascular Data Registry (ACC–NCDR) experience: 1998–2000

OBJECTIVES We sought to develop and evaluate a risk adjustment model for in-hospital mortality following percutaneous coronary intervention (PCI) procedures using data from a large, multi-center registry. BACKGROUND The 1998-2000 American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR) dataset was used to overcome limitations of prior risk-adjustment analyses. METHODS Data on 100,253 PCI procedures collected at the ACC-NCDR between January 1, 1998, and September 30, 2000, were analyzed. A training set/test set approach was used. Separate models were developed for presentation with and without acute myocardial infarction (MI) within 24 h. RESULTS Factors associated with increased risk of PCI mortality (with odds ratios in parentheses) included cardiogenic shock (8.49), increasing age (2.61 to 11.25), salvage (13.38) urgent (1.78) or emergent PCI (5.75), pre-procedure intra-aortic balloon pump insertion (1.68), decreasing left ventricular ejection fraction (0.87 to 3.93), presentation with acute MI (1.31), diabetes (1.41), renal failure (3.04), chronic lung disease (1.33); treatment approaches including thrombolytic therapy (1.39) and non-stent devices (1.64); and lesion characteristics including left main (2.04), proximal left anterior descending disease (1.97) and Society for Cardiac Angiography and Interventions lesion classification (1.64 to 2.11). Overall, excellent discrimination was achieved (C-index = 0.89) and application of the model to high-risk patient groups demonstrated C-indexes exceeding 0.80. Patient factors were more predictive in the MI model, while lesion and procedural factors were more predictive in the analysis of non-MI patients. CONCLUSIONS A risk adjustment model for in-hospital mortality after PCI was successfully developed using a contemporary multi-center registry. This model is an important tool for valid comparison of in-hospital mortality after PCI.

Annual Outcomes With Transcatheter Valve Therapy: From the STS/ACC TVT Registry.

BACKGROUND The Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry has been a joint initiative of the STS and the ACC in concert with multiple stakeholders. The TVT Registry has important information regarding patient selection, delivery of care, science, education, and research in the field of structural valvular heart disease. OBJECTIVES This report provides an overview on current U.S. TVT practice and trends. The emphasis is on demographics, in-hospital procedural characteristics, and outcomes of patients having transcatheter aortic valve replacement (TAVR) performed at 348 U.S. centers. METHODS The TVT Registry captured 26,414 TAVR procedures as of December 31, 2014. Temporal trends between 2012 and 2013 versus 2014 were compared. RESULTS Comparison of the 2 time periods reveals that TAVR patients remain elderly (mean age 82 years), with multiple comorbidities, reflected by a high mean STS predicted risk of mortality (STS PROM) for surgical valve replacement (8.34%), were highly symptomatic (New York Heart Association functional class III/IV in 82.5%), frail (slow 5-m walk test in 81.6%), and have poor self-reported health status (median baseline Kansas City Cardiomyopathy Questionnaire score of 39.1). Procedure performance is changing, with an increased use of moderate sedation (from 1.6% to 5.1%) and increase in femoral access using percutaneous techniques (66.8% in 2014). Vascular complication rates are decreasing (from 5.6% to 4.2%), whereas site-reported stroke rates remain stable at 2.2%. CONCLUSIONS The TVT Registry provides important information on characteristics and outcomes of TAVR in contemporary U.S. clinical practice. It can be used to identify trends in practice and opportunities for quality improvement.

The STS-ACC transcatheter valve therapy national registry: a new partnership and infrastructure for the introduction and surveillance of medical devices and therapies.

The Society of Thoracic Surgeons (STS) and American College of Cardiology (ACC) transcatheter valve therapy (TVT) registry is a novel, national registry for all new TVT devices created through a partnership of the STS and the ACC in close collaboration with the Food and Drug Administration, the Center for Medicare and Medicaid Services, and the Duke Clinical Research Institute. The registry will serve as an objective, comprehensive, and scientifically based resource to improve the quality of patient care, to monitor the safety and effectiveness of TVT devices, to serve as an analytic resource for TVT research, and to enhance communication among key stakeholders.

Registry-Based Prospective, Active Surveillance of Medical-Device Safety.

BACKGROUND The process of assuring the safety of medical devices is constrained by reliance on voluntary reporting of adverse events. We evaluated a strategy of prospective, active surveillance of a national clinical registry to monitor the safety of an implantable vascular‐closure device that had a suspected association with increased adverse events after percutaneous coronary intervention (PCI). METHODS We used an integrated clinical‐data surveillance system to conduct a prospective, propensity‐matched analysis of the safety of the Mynx vascular‐closure device, as compared with alternative approved vascular‐closure devices, with data from the CathPCI Registry of the National Cardiovascular Data Registry. The primary outcome was any vascular complication, which was a composite of access‐site bleeding, access‐site hematoma, retroperitoneal bleeding, or any vascular complication requiring intervention. Secondary safety end points were access‐site bleeding requiring treatment and postprocedural blood transfusion. RESULTS We analyzed data from 73,124 patients who had received Mynx devices after PCI procedures with femoral access from January 1, 2011, to September 30, 2013. The Mynx device was associated with a significantly greater risk of any vascular complication than were alternative vascular‐closure devices (absolute risk, 1.2% vs. 0.8%; relative risk, 1.59; 95% confidence interval [CI], 1.42 to 1.78; P<0.001); there was also a significantly greater risk of access‐site bleeding (absolute risk, 0.4% vs. 0.3%; relative risk, 1.34; 95% CI, 1.10 to 1.62; P=0.001) and transfusion (absolute risk, 1.8% vs. 1.5%; relative risk, 1.23; 95% CI, 1.13 to 1.34; P<0.001). The initial alerts occurred within the first 12 months of monitoring. Relative risks were greater in three prespecified high‐risk subgroups: patients with diabetes, those 70 years of age or older, and women. All safety alerts were confirmed in an independent sample of 48,992 patients from April 1, 2014, to September 30, 2015. CONCLUSIONS A strategy of prospective, active surveillance of a clinical registry rapidly identified potential safety signals among recipients of an implantable vascular‐closure device, with initial alerts occurring within the first 12 months of monitoring. (Funded by the Food and Drug Administration and others.)

The American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR): a must for all hospitals with cardiovascular programs.

The desire to analyze and compare things and to make them better is one of the hallmarks of modern science and modern health care, as well as modern business practice. Although statisticians were the ones who developed the needed calculating methods and provided the formulas, hospital managers and practicing clinicians, as well as medical scientists, must apply them. Many industries use the six-sigma programs developed by the late Edward Demming and others for monitoring and improving manufacturing processes and service delivery. Accumulation of data on patients and the care (i.e., the service) they receive in hospitals is no different. In fact, the use of hospital data to improve the quality of patient care has an illustrious history. For example, Florence Nightingale in Britain, building upon her experiences serving as a nurse in the Crimean War in the 1850s, later studied conditions in British hospitals and found them lacking. She spent years meticulously analyzing and documenting findings. Her pioneering work led to improved conditions in the hospitals, such as reduction in overcrowding and improved ventilation and lighting. Hospital mortality rates fell, and a hospital was no longer a dreaded place. At about the same time, Ignaz Semmelweiss in Vienna, an obstetrician, was studying the effects of routine hand-washing with chlorine–water on the occurrence of puerperal fever in childbirth. This led to improved antisepsis in labor and delivery, with a resulting dramatic decline in infant and maternal mortality. Many other examples besides these exist. The common theme in all of them is the collection of appropriate data with a view toward improvements in patient care. This was and still is evidence-based medicine at its best.