Evidence from ACC's NCDR registries continues to answer questions cardiovascular professionals ask every day. Insights provided by the studies conducted with these data continue to be used to inform practice and improve value. The four studies summarized here represent the latest NCDR-based research that can be used to inform practice related to TAVR, PCI and ICD implantation.

Prosthesis-Patient Mismatch After TAVR

After transcatheter aortic valve replacement (TAVR), prosthesis-patient mismatch (PPM) is common, with severe mismatch occurring in 12 percent of patients and moderate mismatch in 25 percent. And there's clinical consequence associated with this mismatch, even in the short term. These are among the findings of what the investigators say is the largest study to examine the incidence, predictors and outcomes of PPM in this setting.

Using data from the Society of Thoracic Surgeons/ACC (STS/ACC) Transcatheter Valve Therapy (TVT) Registry, Howard C. Herrmann, MD, FACC, and colleagues examined data in 62,125 patients (mean age, 81 years; 46 percent women; 94 percent white) enrolled between January 2014 and March 2017. The results were published in the Journal of the American College of Cardiology.

Based on the discharge echocardiographic effective valve area indexed (EOAI) to body surface area, PPM was classified as severe (<0.65 cm2/m2), moderate (0.65-0.85 cm2/m2) or none (>0.85 cm2/m2). No mismatch was found in 63 percent of patients. The mean EOAI was 1.0 ± 0.3 cm2/m2 (range 0.4-2.1 cm2/m2).

The investigators used multivariable regression models to examine predictors of severe PPM, along with adjusted outcomes, including mortality, heart failure (HF) rehospitalization, stroke and quality of life (QOL) at one year in 37,470 Medicare patients with claims linkage.

At 30 days of follow-up, patients with severe PPM had higher rates of HF hospitalization, stroke and death. At one year, the rates of mortality were 17.2, 15.6 and 15.9 percent in patients with severe, moderate and no PPM (p=0.02). The rates of HF rehospitalization in these groups, respectively, were 14.7, 12.8 and 11.9 percent (p<0.0001). No association was seen between severe PPM and either stroke or QOL score at one year.

In the Medicare patients (68 percent of the study population), the incidence of severe or moderate PPM was similar with the overall population, even though there were important differences compared with the non-Medicare patients, including older age, more likely female and white and more likely to have cardiac and other comorbid conditions.

Predictors of severe PPM included small (≤23 mm diameter) valve prosthesis (odds ratio [OR], 2.8); valve-in-valve procedure (OR, 2.8); and larger body surface area (OR, 1.8 per 0.2-U m2 increase), each associated with highest odds ratios along with female sex, younger age, non-White/Hispanic race, lower ejection fraction, atrial fibrillation, and severe mitral or tricuspid regurgitation.

The authors suggest that in light of the higher risk of adverse clinical outcomes in the setting of PPM, efforts should be made to identify patients at risk and avoid PPM when feasible. "A future study that compares devices and techniques to limit PPM in patients at risk for severe PPM would be of interest to guide decision making in this population," they write.

Operator Volume and Long-Term Outcomes After PCI

Operator volume makes a difference for short-term outcomes. But interestingly, risk-adjusted outcomes over one year were not different between operators performing more than 100 PCIs annually and those performing less than 50 PCIs annually (the minimum recommended by ACC/AHA/SCAI to maintain competency), according to a study of NCDR CathPCI Registry data published in Circulation.

Alexander C. Fanaroff, MD, MHS, and colleagues, linked the CathPCI Registry data with Medicare claims data to evaluate the association between PCI operator volume and outcomes at one year, including all-cause death, hospitalization for myocardial infarction (MI), or unplanned coronary revascularization. One-year unadjusted rates of death and major adverse coronary events (MACE, defined as death, readmission for MI, or unplanned coronary revascularization) were calculated using Kaplan-Meier methods. The proportional hazards assumption was not met and risk-adjusted associations between operator volume and outcomes were calculated separately from the time of PCI to hospital discharge and from hospital discharge to one-year follow-up.

Operators were stratified by average annual PCI volume (counting PCIs performed in patients of all ages): low (<50 PCIs), intermediate (50-100) and high volume (>100). Between July 1, 2009 and December 31, 2014, 723,644 PCI procedures were performed by 8,936 operators: 2,553 high-, 2,878 intermediate- and 3,505 low-volume. Compared with high- and intermediate-volume operators, low-volume operators more often performed emergency PCI and their patients had fewer cardiovascular comorbidities.

Over the one-year follow-up, a MACE event occurred in 15.9 percent of patients treated by low-volume operators, vs. 16.9 percent of patients treated by high-volume operators (p=0.004).

After multivariable adjustment, the rate of in-hospital death was significantly lower among intermediate- and high-volume operators, vs. low-volume operators (odds ratio [OR], 0.91 for intermediate vs. low; OR, 0.79 for high vs. low).

No significant differences were found in rates of MACE, death, MI or unplanned revascularization between operator cohorts from hospital discharge to one year of follow-up (adjusted hazard ratio [HR] for MACE, 0.99 for intermediate vs. low; HR 1.01 for high vs. low).

The investigators write that, "Overall, given that 44 percent of operators nationwide perform fewer than 50 PCIs annually, these findings are reassuring that the small inverse association between operator volume and short-term outcomes is not compounded by a similar association between operator volume and long-term outcomes given current case selection patterns."

Regarding the clinical implications of their research, the authors write: "Since the association between operator volumes and in-hospital mortality is small and operator volume is not associated with long-term outcomes among patients surviving the index hospitalization, clinical practice guidelines should consider volume standards in the context of overall care quality and should consider de-emphasizing operator volume as a quality measure."

HF Hospitalization May Increase ICD Complication Rates, NCDR Study Finds

Patients undergoing initial ICD placement for primary prevention who are currently hospitalized or have been recently hospitalized for heart failure (HF) are more likely to experience periprocedural complications or death, according to a study published in Circulation.

Andrew P. Ambrosy, MD, et al., used data from ACC's ICD Registry and Medicare claims to assess associations between the timing of ICD placement and outcomes during hospitalization and at 30 days and 90 days after implantation. The study cohort consisted of 81,180 patients with a diagnosis of HF with reduced ejection fraction (HFrEF) ≤35 percent who received an ICD for primary prevention. Patients were divided into three groups based on timing of ICD placement from last HF-related hospitalization: currently hospitalized (11,563; 14 percent), hospitalized within previous three months (6,252; 8 percent) and hospitalized more than three months before ICD placement or who had never been hospitalized for HF (63,365; 78 percent).

Results showed that about 20 percent of the study population were currently hospitalized or had been hospitalized within three months. The rate of periprocedural complication was highest (2.6 percent) among patients hospitalized when the ICD was implanted, followed by 1.71 percent for those hospitalized within the previous three months and 1.25 percent in patients hospitalized more than three months before or had no HF hospitalization.

In addition, patients hospitalized at the time of ICD placement or within three months had higher rates of all-cause mortality, all-cause admissions and cardiovascular admissions at both 30 days and 90 days after implantation. At 30 days after ICD placement, the complication rate was 5.24 percent for currently hospitalized patients and 3.3 percent for those hospitalized within three months, vs. 1.42 percent for patients who had a HF-related hospitalization more than three months before or had never been hospitalized for HF.

The 90-day complication rate was 7.75 percent for patients currently hospitalized, 6.25 among those hospitalized within three months and 4.61 percent among those who had been hospitalized more than three months previously or had never been hospitalized for HF.

The investigators write that the drivers of the higher aggregate periprocedural, 30-day and 90-day complication rates in the patients currently or recently hospitalized were a higher rate of stroke/TIA, MI, cardiac arrest and death. "Additional research is required to clarify the signal of increased pocket infection, endocarditis, and other systemic infections as well as to identify approaches to mitigating the overall risk of infection in patients hospitalized for HF."

"Given the highlighted safety concerns and the overall poor short-term prognosis and high competing risk of death due to progressive pump failure in patients hospitalized for HF, future prospective, real-world, pragmatic, comparative effectiveness studies should be conducted to define the optimal timing of ICD placement for primary prevention from last hospitalization for HF," they conclude.

NCDR Study Finds Cath Lab Pre-Activation Leads to Faster Reperfusion, Lower Mortality

STEMI patients may have faster reperfusion times and lower mortality rates if emergency medical service (EMS) teams notify cardiac catheterization (cath) labs before the patient arrives at the hospital, according to a study published in JACC: Cardiovascular Interventions.

Using data from ACC's Chest Pain – MI Registry, Jay S. Shavadia, MD, et al., evaluated the association between cath lab pre-activation and reperfusion timing and in-hospital mortality for 27,840 STEMI patients who were transported by EMS to 744 hospitals from January 2015 to March 2017.

Results showed that cath labs were pre-activated more than 10 minutes before arrival for 41 percent of patients (11,379), while pre-activation occurred in 10 minutes or less for 33.5 percent of patients (9,326). The cath lab was activated at hospital arrival or after for the remaining 25.6 percent of patients (7,135). The authors found that every 10-minute delay in cath lab activation was associated with increased reperfusion time.

Overall, cath lab pre-activation was associated with a 12-minute decrease in door-to-balloon time and a higher proportion of patients achieving first medical contact-to-device times of 90 minutes or less. The decrease in door-to-balloon times occurred for patients who presented during both work hours and off hours. In addition, the in-hospital mortality rate was 2.8 percent among patients who were transferred to a cath lab that had been pre-activated, compared with 3.4 percent among patients who were transferred to a lab that had not been pre-activated.

According to the authors, there is a need for a better understanding of when cath lab activation occurs in the time before a patient arrives at the hospital. They conclude their results "highlight opportunities to optimize the implementation" of cath lab pre-activation.

Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Cardiovascular Care Team, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Acute Heart Failure, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound

Keywords: ACC Publications, Cardiology Interventions, Atrial Fibrillation, Body Surface Area, Cardiac Catheterization, Chest Pain, Cohort Studies, Comorbidity, Decision Making, Echocardiography, Emergency Medical Services, Endocarditis, Follow-Up Studies, Heart Arrest, Heart Failure, Heart Valve Prosthesis, Hispanic Americans, Hospital Mortality, Hospitalization, Hospitals, Incidence, Medicare, Myocardial Infarction, Patient Readmission, Percutaneous Coronary Intervention, Primary Prevention, Prognosis, Prospective Studies, Quality of Life, Registries, Research Personnel, Myocardial Infarction, Stroke, Stroke Volume, Surgeons, Transcatheter Aortic Valve Replacement, Tricuspid Valve Insufficiency

< Back to Listings