Impact of left ventricular ejection fraction and aortic valve gradient on mortality following transcatheter aortic valve intervention.

BACKGROUND: Data regarding the impact of reduced left ventricular ejection fraction (LVEF) and/or reduced mean aortic valve gradient (AVG) on outcomes following transcatheter aortic valve intervention (TAVI) have been conflicting. We sought to assess the relationship between LVEF, AVG, and 1-year mortality in patients undergoing TAVI. METHODS: We prospectively evaluated 298 consecutive adults undergoing TAVI from 2015 to 2018 at an academic tertiary medical center. Patients were categorized according to LVEF and mean AVG. The primary outcome of interest was all-cause mortality at 1 year. RESULTS: Of 298 adults undergoing TAVI, 66 (22.1%) had baseline LVEF ≤45% while 232 (77.9%) had baseline LVEF >45%; 173 (58.1%) had baseline AVG < 40mmHg while 125 (41.9%) had baseline AVG ≥ 40mmHg. Rates of 1-year all-cause mortality were significantly higher in patients with LVEF ≤45% (28.8% vs 12.1%, p = 0.001) and those with AVG < 40mmHg (19.7% vs 10.4%, p = 0.031) compared to those with LVEF >45% and AVG ≥ 40mmHg respectively. In multivariable analysis, higher AVG (per mmHg) (OR 0.97, 95% CI 0.94-0.99, p = 0.026) was noted to be independently associated with lower rates of 1-year mortality, while LVEF was not (OR 0.98, 95% CI 0.96-1.01). CONCLUSIONS: In this prospective, contemporary registry of adults undergoing TAVI, while 1-year unadjusted mortality rates are significantly higher in patients with reduced LVEF and reduced AVG, risk-adjusted mortality at 1 year is only higher in those with reduced AVG - not in those with reduced LVEF.

Transcatheter aortic valve replacement in heart failure.

Patients with severe aortic stenosis (AS) may develop heart failure (HF), the presence of which has traditionally been deemed as a final stage in AS progression with poor outcomes. The use of transcatheter aortic valve replacement (TAVR) has become the preferred therapy for most patients with AS and concomitant HF. With its instant afterload reduction, TAVR offers patients with HF significant haemodynamic benefits, with corresponding changes in left ventricular structure and improved mortality and quality of life. The prognostic covariates and optimal timing of TAVR in patients with less than severe AS remain unclear. The purpose of this review is to describe the association between TAVR and outcomes in patients with HF, particularly in the setting of left ventricular systolic dysfunction, acute HF, and right ventricular systolic dysfunction, and to highlight areas for future research.

Standardized Definitions for Cardiogenic Shock Research and Mechanical Circulatory Support Devices: Scientific Expert Panel From the Shock Academic Research Consortium (SHARC).

The Shock Academic Research Consortium is a multi-stakeholder group, including representatives from the US Food and Drug Administration and other government agencies, industry, and payers, convened to develop pragmatic consensus definitions useful for the evaluation of clinical trials enrolling patients with cardiogenic shock, including trials evaluating mechanical circulatory support devices. Several in-person and virtual meetings were convened between 2020 and 2022 to discuss the need for developing the standardized definitions required for evaluation of mechanical circulatory support devices in clinical trials for cardiogenic shock patients. The expert panel identified key concepts and topics by performing literature reviews, including previous clinical trials, while recognizing current challenges and the need to advance evidence-based practice and statistical analysis to support future clinical trials. For each category, a lead (primary) author was assigned to perform a literature search and draft a proposed definition, which was presented to the subgroup. These definitions were further modified after feedback from the expert panel meetings until a consensus was reached. This manuscript summarizes the expert panel recommendations focused on outcome definitions, including efficacy and safety.

Position Statement on Vascular Access Safety for Percutaneous Devices in AMI Complicated by Cardiogenic Shock.

In the United States, the frequency of using percutaneous mechanical circulatory support devices for acute myocardial infarction complicated by cardiogenic shock is increasing. These devices require large-bore vascular access to provide left, right, or biventricular cardiac support, frequently under urgent/emergent circumstances. Significant technical and logistical variability exists in device insertion, care, and removal in the cardiac catheterization laboratory and in the cardiac intensive care unit. This variability in practice may contribute to adverse outcomes observed in centers that receive patients with cardiogenic shock, who are at higher risk for circulatory insufficiency, venous stasis, bleeding, and arterial hypoperfusion. In this position statement, we aim to: 1) describe the public health impact of bleeding and vascular complications in cardiogenic shock; 2) highlight knowledge gaps for vascular safety and provide a roadmap for a regulatory perspective necessary for advancing the field; 3) propose a minimum core set of process elements, or "vascular safety bundle"; and 4) develop a possible study design for a pragmatic trial platform to evaluate which structured approach to vascular access drives most benefit and prevents vascular and bleeding complications in practice.

A Stepwise Approach Utilizing a Double-Helix Wire Technique, Snare Capture and a Switch From a Transfemoral to Transradial Approach to Remove an Entrapped Balloon.

During an attempted PCI utilizing a femoral approach, a balloon became entrapped in the Left Circumflex Artery. Initial retrieval efforts including pulling the balloon and inflating a second balloon over the entrapment failed, the balloon fractured, and the distal end of the balloon apparatus migrated out of the guide catheter. We utilized a stepwise approach with a double helix wiring technique, snares and a change from a transfemoral to transradial approach to successfully retrieve the foreign bodies. This case highlights the importance of utilizing multiple techniques in series and understanding anatomical influences on equipment retrieval when single techniques and approaches fail.

Mechanical Aspiration Thrombectomy Using the Penumbra CAT RX System for Patients Presenting With Acute Coronary Syndrome.

Patient undergoing PCI can have distal embolization and microvascular obstruction despite normalization of epicardial blood flow. Aspiration thrombectomy has been studied previously to reduce infarct size, but prior methods of aspiration thrombectomy were associated with increased risk of stroke and is currently recommended as a bailout strategy. Penumbra CAT RX has been recently approved for aspiration thrombectomy, we evaluated the catheter's use in an academic cardiac catheterization lab. Patients undergoing cardiac catherization at an academic medical center who had deployment of the Penumbra CAT RX from 2017 through 2020 were included in the case series. TIMI flow pre and post procedure were determined by individual operator. Endpoints included 30-day cardiovascular death and post-procedural stroke. The Penumbra CAT RX catheter was used in a total of 34 patients, with 71% STEMI, 23% NSTEMI, 3% UA, and 3% new onset heart failure. TIMI 3 flow was achieved in 88% of cases. There were no cases of 30-day cardiovascular death or post procedural stroke. Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization laboratories with use in select cases. The Penumbra CAT RX appears to be safe and highly effective at thrombus removal in the acute setting without increased stroke risk as seen with manual aspiration thrombectomy.

Percutaneous Coronary Intervention Following Diagnostic Angiography by Noninterventional Versus Interventional Cardiologists: Insights From the CathPCI Registry.

BACKGROUND: There are limited contemporary, national data describing diagnostic cardiac catheterization with subsequent percutaneous coronary intervention (ad hoc percutaneous coronary intervention [PCI]) performed by an invasive-diagnostic and interventional (Dx/IC) operator team versus solo interventional operator (solo-IC). Using the CathPCI Registry, this study aimed at analyzing trends and outcomes in ad hoc PCI among Dx/IC versus solo-IC operators. METHODS: Quarterly rates (January 2012 to March 2018) of ad hoc PCI cases by Dx/IC and solo-IC operators were obtained. Odds of inhospital major adverse cardiovascular events, net adverse cardiovascular events (ie, composite major adverse cardiovascular event+bleeding), and rarely appropriate PCI were estimated using multivariable regression. RESULTS: From 1077 sites, 1 262 948 patients were included. The number of invasive-diagnostic operators and cases performed by Dx/IC teams decreased from nearly 9% to 5% during the study period. Patients treated by Dx/IC teams were more often White and had fewer comorbidities compared with patients treated by solo-IC operators. Considerable variation existed across sites, and over two-fifths of sites had 0% ad hoc PCI performed by Dx/IC. In adjusted analyses, ad hoc performed by Dx/IC had similar risks of major adverse cardiovascular event (OR, 1.04 [95% CI, 0.97-1.11]) and net adverse cardiovascular events (OR, 0.98 [95% CI, 0.94-1.03]) compared with solo-IC. Rarely appropriate PCI, although low overall (2.1% versus 1.9%) occurred more often by Dx/IC compared with solo-IC (OR, 1.20 [95% CI, 1.13-1.26]). CONCLUSIONS: Contemporary, nationwide data from the CathPCI Registry demonstrates the number of Dx/IC operator teams and cases has decreased but that case volume is stable among operators. Outcomes were independent of operator type, which supports current practice patterns. The finding of a higher risk of rarely appropriate PCI in Dx/IC teams should be further studied.

Push Is Better Than Shove: Radial Snare-Guided Repositioning of an Extracardiac Impella Device.

BACKGROUND: Bedside manipulation of an Impella CP is often necessary as subtle changes in device position after initial placement can dramatically affect proper function. CASE PRESENTATION: A 59 year old man in cardiogenic shock on V-A ECMO support underwent Impella CP placement to function as an LV vent. Bedside manipulation led to the Impella dislodging into the ascending aorta and kinking in half. Percutaneous rescue was performed in the cardiac catheterization laboratory by snaring the device, and guiding it back into the LV in a controlled fashion restoring normal function. CONCLUSIONS: Bedside manipulation of an Impella is often necessary, but may cause device dislodgement. Re-entry into the LV is challenging and replacement of the device carries significant cost and clinical implications. Radial approach, snare guided repositioning offers an alternative solution to an increasingly encountered challenge.

Efficacy and Safety of Vorapaxar by Intensity of Background Lipid-Lowering Therapy in Patients With Peripheral Artery Disease: Insights From the TRA2P-TIMI 50 Trial.

Background Patients with peripheral artery disease are at increased risk of both major adverse cardiovascular events (MACEs) and limb events. The pathobiology of limb events is likely multifactorial. Observational studies suggest a benefit of statin therapy for reducing the risk of limb ischemic events while randomized trials demonstrate a benefit with more potent antithrombotic therapies, particularly those targeting thrombin. Whether the effects of these therapeutic pathways are independent and complementary is not known. Methods and Results The TRA 2°P-TIMI 50 (Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events-Thrombolysis in Myocardial Infarction 50) trial demonstrated that vorapaxar significantly reduced MACEs and limb events. The purpose of the current analysis was to evaluate the association of statin use and intensity and the occurrence of MACEs and limb events in 5845 patients with symptomatic peripheral artery disease randomized in TRA 2°P-TIMI 50 and then to understand whether statin use modified the benefits of vorapaxar for MACEs or limb ischemic events. We found that statin therapy was associated with significantly lower risk of MACEs (hazard ratio [HR], 0.77; 95% CI, 0.66-0.89; P<0.001) and limb ischemic events (HR, 0.73; 95% CI, 0.60-0.89; P=0.002). The benefit of vorapaxar for reducing MACEs and limb events was consistent regardless of background statin (P-interaction=0.715 and 0.073, respectively). Event rates were lowest in patients receiving the combination of statin therapy and vorapaxar. Conclusions In conclusion, statin use and intensity is associated with significantly lower rates of MACEs and limb ischemic events. Thrombin inhibition with vorapaxar is effective regardless of background statin therapy. These results suggest that targeting both lipid and thrombotic risk in peripheral artery disease is necessary in order to optimize outcomes.

A "fully upper extremity" bailout of direct transaxillary large bore arterial access: A refinement within arm's reach?

Contemporary direct ("fully percutaneous") transaxillary (TAx) large-bore arterial access technique advocates for a 0.018" wire to be passed from femoral arterial access to axillary artery to serve percutaneous bailout options. However, in certain patients, avoiding femoral arterial access entirely may be desired. We describe the merits of a "fully upper extremity" (FUE) bailout approach, as a refinement to previously described direct TAx technique.

Transradial Access for High-Risk Percutaneous Coronary Intervention: Implications of the Risk-Treatment Paradox.

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