STS INTERMACS Database: The Key to Conduct Single-Arm Trials in Advanced Heart Failure Patients.

BACKGROUND: Safe introduction of novel mechanical circulatory support (MCS) devices into clinical practice is a challenging process. Single-arm trials using a control arm from existing database is an effective alternative that could be applied for regulatory approval. This study analyzes the capability of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database to establish objective performance criteria and select patient population that could be used for future single-arm MCS trials. METHODS: Patients with INTERMACS profiles IM1-2 and IM3-5, who underwent implantation of isolated left ventricular assist devices between 2014 and 2017, were included. Both cohorts were further stratified into shock and nonshock groups using surrogate markers of shock (extracorporeal membrane oxygenation, temporary ventricular assist device, vasopressor infusions). Survival, transplantation rates, adverse events, 6-minute walk test, and quality-of-life measures were obtained for all 4 groups at 6 and 12 months. RESULTS: Total of 7907 patients were divided into IM1-2 (n = 3909), IM3-5 (n = 3998), shock (n = 3469), and nonshock (n = 3040) groups. Recategorization occurred in 11% of patients from the IM3-5 group into the shock group. Overall, patients in the shock group had similar outcomes to the IM1-2 group (1-year survival: 86% vs 85%; P = .74). Patients in the nonshock group also had similar outcomes to the IM3-5 (1-year survival: 90% vs 90%; P = .43). CONCLUSIONS: The INTERMACS database can successfully establish objective performance criteria and concurrent control group for single-arm trials that could be used to support regulatory approval of new, less invasive MCS. INTERMACS data allow reliable comparisons of outcomes and adverse events.

The Role of Minimally Invasive and Endoscopic Technologies in Morbid Obesity Treatment: Review and Critical Appraisal of the Current Clinical Practice.

Bariatric surgery is the most effective treatment for morbid obesity. Availability of different procedures with low complication rates, performed through a minimally invasive approach, have caused profound positive effect on patient's quality of life and has led to their worldwide, rapid expansion of the field. The laparoscopic revolution has introduced the concept of lowering more and more the treatments' invasiveness, leading to a change in the researchers' mentality. They are now constantly looking for reducing patients' discomfort through new methodologies and devices: aim of this review is to provide an in-depth analysis of the most promising, innovative procedures offering an alternative approach to "classic" laparoscopic procedures. They are described from their original development phases to the most recent experimental and clinical evidence. This review will discuss as well their future perspectives, and includes endoluminal techniques and/or procedures based on alternative concepts, all representing an appealing alternative to surgical approach. We conducted a MEDLINE for articles, clinical trials, and a patent search relating to the minimally invasive management of obesity, excluding intragastric balloons, SILS, and NOTES, and we selected 77 articles. Results are reported for each procedure/device, and discussed both in these paragraphs and in the final, general discussion. The concept of minimally invasive procedures continues to change and evolve over time with novel technologies emerging every year.