First-in-Human Multicenter Experience of the Newest Generation Supra-Annular Self-Expanding Evolut FX TAVR System.

BACKGROUND: The latest-generation Evolut FX TAVR system (Medtronic) offers several potential design improvements over its predecessors, but early reported experience has been limited. OBJECTIVES: This study sought to report our multicenter, limited market release, first-in-human experience of transcatheter aortic valve replacement (TAVR) with the Evolut FX system and compare it with a single-center PRO+ (Medtronic) experience. METHODS: From June 27 to September 16, 2022, 226 consecutive patients from 9 US centers underwent transfemoral TAVR with the Evolut FX system for native aortic stenosis (89.4%) or prosthetic valve degeneration (10.6%). Commissural alignment was defined as 0° to 30° between native and FX commissures. Patient, anatomical, and procedural characteristics were retrospectively reviewed, and 30-day clinical and echocardiographic outcomes per Valve Academic Research Consortium-3 definitions were reported. RESULTS: Of 226 patients, 34.1% were low risk, 4% had a bicuspid valve, and 11.5% had a horizontal root (≥60°). Direct Inline sheath (Medtronic) was used in 67.6% and Lunderquist stiff wire (Cook Medical) in 35.4% of cases. Optimal hat marker orientation during deployment was achieved in 98.4%, with commissural alignment in 96.5%. At 30 days, 14.3% mild, 0.9% moderate, and no severe paravalvular leak were observed. Compared with the Evolut PRO+ experience from 1 center, FX had a more symmetrical implantation with shallower depth at the left coronary cusp (P < 0.001), fewer device recaptures (26.1% vs 39.5%; P = 0.004), and improved commissural alignment (96.5% vs 80.2%; P < 0.001). CONCLUSIONS: The Evolut FX system demonstrated favorable 30-day outcomes with a significant improvement over PRO+ in achieving commissural alignment, fewer device recaptures, and more symmetrical implantation. These features may benefit younger patients undergoing TAVR with the supra-annular, self-expanding valve, where lifetime management would be important.

Outcomes Following Shock Aortic Valve Replacement: Transcatheter Versus Surgical Approaches.

OBJECTIVES: To compare transcatheter aortic valve replacement (TAVR) with surgical aortic valve replacement (SAVR) for patients in shock. BACKGROUND: There are minimal data on the clinical and echocardiographic outcomes for patients in shock that undergo TAVR and no data comparing these outcomes to similar patients undergoing SAVR. METHODS: This is a single center, retrospective cohort study of patients having Society of Thoracic Surgeons (STS)-defined urgent or emergent AVR for aortic stenosis with clinical signs and symptoms of shock. Inclusion criteria were based on the Society of Cardiovascular Angiography & Interventions (SCAI) shock consensus statement and included: the need for inotropic or vasopressor agents, mechanical ventilation, continuous renal replacement therapy or newly initiated hemodialysis, and/or utilization of mechanical hemodynamic support. Clinical and echocardiographic outcomes for TAVR and SAVR were compared. RESULTS: Thirty-seven patients met the inclusion criteria for this study (17 TAVR, 20 SAVR). TAVR patients had a higher STS Predicted Risk of Mortality (PROM) score of 22.3% compared to 11.8% for SAVR patients (p = 0.001). No significant differences were found in baseline echocardiographic results. TAVR procedures required less procedure room time (185.9 min TAVR, 348.5 min SAVR, p < 0.001) and fewer intraoperative packed red blood cell (pRBC) transfusions (0.2 units TAVR, 3.4 units SAVR, p < 0.001). TAVR patients also had lower rates of prolonged postoperative ventilation compared to SAVR patients (38.5% TAVR, 75.0% SAVR, p = 0.047). TAVR and SAVR had similar rates of mortality at discharge (2 TAVR, 1 SAVR, p = 0.584), 30-days (2 TAVR, 1 SAVR, p = 0.584), and 1-year (8 TAVR, 5 SAVR, p = 0.149). CONCLUSIONS: Despite a higher risk TAVR group, patients in shock undergoing either TAVR or SAVR have similar 30-day mortality. At one year, SAVR patients have a numerically better, though not statistically significant, survival. These findings support the use of TAVR for patients in shock with aortic stenosis.

Cerebral Oximetry as a Real-Time Monitoring Tool to Assess Quality of In-Hospital Cardiopulmonary Resuscitation and Post Cardiac Arrest Care.

BACKGROUND: Regional cerebral oxygen saturation (rSO2) as assessed by near infrared frontal cerebral spectroscopy decreases in circulatory arrest and increases with high-quality cardiopulmonary resuscitation. We hypothesized that higher rSO2 during cardiopulmonary resuscitation and after return of spontaneous circulation (ROSC) would predict survival to discharge and neurological recovery. METHODS AND RESULTS: This prospective case series included patients experiencing in-hospital cardiac arrest. Cerebral oximetry was recorded continuously from initiation of resuscitation until ROSC and up to 48 hours post-arrest. Relationships between oximetry data during these time periods and outcomes of resuscitation survival and survival to discharge were analyzed. The cohort included 27 patients. Nineteen (70.3%) achieved ROSC, and 8 (29.6%) survived to discharge. Median arrest duration was 20.8 minutes (range=8 to 74). There was a significant difference in rSO2 between resuscitation survivors and resuscitation nonsurvivors at initiation of the resuscitative efforts (35% versus 17.5%, P=0.03) and during resuscitation (36% versus 15%, P=0.0008). No significant association was observed between rSO2 at ROSC or during the post-arrest period and survival to discharge. Among patients who survived to discharge, there was no association between cerebral performance category and rSO2 at ROSC, during resuscitation, or post-arrest. CONCLUSIONS: Higher rSO2 levels at initiation of resuscitation and during resuscitation are associated with resuscitation survival and may reflect high-quality cardiopulmonary resuscitation. However, in this small series, rSO2 was not predictive of good neurological outcome. Larger studies are needed to determine whether this monitoring modality can be used to improve clinical outcomes.

Acute myocardial infarction.

This article discusses the approach to the management of myocardial infarction (MI) in the intensive care unit setting. It includes an overview of the definition, classification, and underlying pathologic conditions of acute MI and specifically discusses the diagnosis and management of unstable angina, non-ST elevation MI, and ST-segment elevation MI. Diagnosis and treatment of the acute complications of MI are also reviewed.