The medical device development ecosystem: Current regulatory state and challenges for future development: A review.

BACKGROUND/PURPOSE: There has been increasing emphasis on the development of new technology to mitigate unmet clinical needs in cardiovascular disease. This emphasis results in part from recognition that many devices, although being initially developed in the United States, were studied, and then eventually approved abroad before being returned to the U.S. for clinical application. The FDA (Food and Drug Administration) guidance document on Early Feasibility Studies (EFS) and then the 21st Century Cures Act from 2013 to 2016 focused on these issues. MATERIALS/METHODS: There are multiple components of medical device translational pathways to be considered in continuing to reach the goal of providing early access to safe and effective products to the U.S. POPULATION: This review article documents the various stages from early idea innovation to device design and iteration to clinical testing and then potential approval and application in the wide clinical practice of cardiovascular health care. RESULTS: The CDRH (Centers for Devices and Radiological Health) has focused on key components including EFS, Breakthrough Devices Program, Total Product Life Cycle, the Unique Device Identification Program, the establishment of a Digital Health Center of Excellence, and leveraging Collaborative Communities. Each of these initiatives focuses on improving the Medical Device Development Ecosystem. CONCLUSIONS: Major changes in device translational research have improved the device research climate in the United States. Goals remain including increased training and education for constituencies aspiring to work in the field of device development and regulation as part of a continuous health care learning system.

New York Risk Model and Simplified Risk Score for In-Hospital/30-Day Mortality for Percutaneous Coronary Intervention.

Risk models and risk scores derived from those models require periodic updating to account for changes in procedural performance, patient mix, and new risk factors added to existing systems. No risk model or risk score exists for predicting in-hospital/30-day mortality for percutaneous coronary interventions (PCIs) using contemporary data. This study develops an updated risk model and simplified risk score for in-hospital/30-day mortality following PCI. To accomplish this, New York's Percutaneous Coronary Intervention Reporting System was used to develop a logistic regression model and a simplified risk score model for predicting in-hospital/30-day mortality and to validate both models based on New York data from the previous year. A total of 54,770 PCI patients from 2019 were used to develop the models. Twelve different risk factors and 27 risk factor categories were used in the models. Both models displayed excellent discrimination for the development and validation samples (range from 0.894 to 0.896) and acceptable calibration, but the full logistic model had superior calibration, particularly among higher-risk patients. In conclusion, both the PCI risk model and its simplified risk score model provide excellent discrimination and although the full risk model requires the use of a hand-held device for estimating individual patient risk, it provides somewhat better calibration, especially among higher-risk patients.

Ad Hoc Percutaneous Coronary Intervention in Stable Patients With Multivessel or Unprotected Left Main Disease.

BACKGROUND: There is very little information about the use of ad hoc percutaneous coronary intervention (PCI) in stable patients with multivessel (MV) disease or unprotected left main (LM) disease patients for whom a heart team approach is recommended. OBJECTIVE: To identify the extent of ad hoc PCI utilization for patients with multivessel disease or left main disease, and to explore the inter-hospital variation in ad hoc PCI utilization for those patients. METHODS: New York State's cardiac registries were used to examine the use and variation in use of ad hoc PCI for MV/LM disease as a percentage of all MV/LM PCIs and revascularizations (PCIs plus coronary artery bypass graft procedures) during 2018 to 2019 in New York. RESULTS: After exclusions, 6,425 of the 8,196 stable PCI patients with MV/LM disease (78.4%) underwent ad hoc PCI, ranging from 58.7% for patients with unprotected LM disease to 85.4% for patients with 2-vessel proximal left anterior descending (PLAD) disease. Ad hoc PCIs comprised 35.1% of all revascularizations, ranging from 11.5% for patients with unprotected LM disease to 63.9% for patients with 2-vessel PLAD disease. The risk-adjusted utilization of ad hoc PCI as a percentage of all revascularizations varied widely among hospitals (eg, from 15% in the first quartile to 46% in the last quartile for 3-vessel disease). CONCLUSIONS: Ad hoc PCIs occur frequently even among patients with MV/LM disease. This is particularly true among patients with 2-vessel PLAD disease. The frequency of ad hoc PCIs is lower but still high among patients with diabetes and low ejection fraction and higher in hospitals without surgery on-site (SOS). Given the magnitude of hospital- and physician-level variation in the use of ad hoc PCIs for such patients, consideration should be given to a systems approach to achieving heart team consultation and shared decision making that is consistent for SOS and non-SOS hospitals.

Impact of COVID-19 on percutaneous coronary intervention utilization and mortality in New York.

BACKGROUND: COVID-19 has disrupted the care of all patients, and little is known about its impact on the utilization and short-term mortality of percutaneous coronary intervention (PCI) patients, particularly nonemergency patients. METHODS: New York State's PCI registry was used to study the utilization of PCI and the presence of COVID-19 in four patient subgroups ranging in severity from ST-elevation myocardial infarction (STEMI) to elective patients before (December 01, 2018-February 29, 2020) and during the COVID-19 era (March 01, 2020-May 31, 2021), as well as to examine the impact of different COVID severity levels on the mortality of different types of PCI patients. RESULTS: Decreases in the mean quarterly PCI volume from the prepandemic period to the first quarter of the pandemic ranged from 20% for STEMI patients to 61% for elective patients, with the other two subgroups having decreases in between these values. PCI quarterly volume rebounds from the prepandemic period to the second quarter of 2021 were in excess of 90% for all patient subgroups, and 99.7% for elective patients. Existing COVID-19 was rare among PCI patients, ranging from 1.74% for STEMI patients to 3.66% for elective patients. PCI patients with COVID-19 and acute respiratory distress syndrome (ARDS) who were not intubated, and PCI patients with COVID-19 and ARDS who were either intubated or were not intubated because of Do Not Resuscitate//Do Not Intubate status had higher risk-adjusted mortality ([adjusted ORs = 10.81 [4.39, 26.63] and 24.53 [12.06, 49.88], respectively]) than patients who never had COVID-19. CONCLUSIONS: There were large decreases in the utilization of PCI during COVID-19, with the percentage of decrease being highly sensitive to patient acuity. By the second quarter of 2021, prepandemic volumes were nearly restored for all patient subgroups. Very few PCI patients had current COVID-19 throughout the pandemic period, but the number of PCI patients with a COVID-19 history increased steadily during the pandemic. PCI patients with COVID-19 accompanied by ARDS were at much higher risk of short-term mortality than patients who never had COVID-19. COVID-19 without ARDS and history of COVID-19 were not associated with higher mortality for PCI patients as of the second quarter of 2021.