Cardiogenic Shock Intravascular Cooling Trial (CHILL-SHOCK).

BACKGROUND: Cardiogenic shock (CS) is complicated by high mortality rates. Targeted temperature control (TTC) has been proposed as an adjunct therapy in CS. This study aims to examine the safety of TTC in patients presenting with CS. METHODS AND RESULTS: In this open-label, randomized controlled pilot trial, 20 patients with hemodynamic criteria for CS were assigned to standard of care plus TTC vs standard of care alone. The primary outcome was a composite safety outcome, including well-described complications of TTC. Secondary outcomes included mortality at 90 days, invasive hemodynamic and echocardiographic parameters, electrocardiographic measurements, and inotrope dosing. There were no significant differences in the composite analysis of prespecified safety outcomes (3 events in the TTC group vs 0 events in the control group; P = 0.24). Patients randomized to TTC demonstrated a statistically significant increase in cardiac index and cardiac power index compared to the control group at 48-96 hours after randomization (3.6 [3.1, 3.9] L/min/m2 vs 2.6 [2.5, 3.15] L/min/m2; P = 0.029 and 0.61 [0.55, 0.7] W/m2 vs 0.53 [0.435, 0.565] W/m2; P = 0.029, respectively). CONCLUSION: TTC may be a safe adjunct therapy for patients presenting with CS and may yield improvement in specific hemodynamic parameters.

Feasibility of Amulet occluder implantation after failed left atrial appendage occlusion attempt: Insights from the EMERGE LAA postapproval study.

BACKGROUND: Although expertise in left atrial appendage occlusion (LAAO) has grown, certain intricate anatomies may pose challenges, rendering them unsuitable for LAAO with the selected device. OBJECTIVE: This analysis aimed to characterize outcomes of patients with prior failed percutaneous LAAO procedures who underwent a subsequent attempt with an Amulet occluder in the EMERGE LAA postapproval study. METHODS: Patients enrolled in the National Cardiovascular Data Registry LAAO Registry who had an Amulet occluder implantation attempt between Food and Drug Administration approval (August 14, 2021) and June 30, 2023, were evaluated. A safety end point through 7 days or hospital discharge (whichever was later) and major adverse events through 45 days were reported. RESULTS: A total of 8591 patients underwent attempted Amulet occluder implantation, of whom 244 patients had prior failed LAAO. Implantation success was 88.9% and 96.2% in patients with prior failed LAAO and index LAAO, respectively (P < .001). The safety composite end point was low, occurring in 1.6% and 0.8% of patients with prior failed LAAO and index LAAO, respectively (P = .148). Any major adverse event through 45 days occurred in 7.4% and 6.3% of prior failed LAAO and index LAAO patient cohorts, respectively (P = .497); most adverse events were similar between the groups (P > .05). At 45 days, peridevice leak ≤3 mm was achieved in >90% of patients in either group. CONCLUSION: A high degree of implantation success with a low rate of adverse events can be achieved with the Amulet occluder. The findings imply that the dual occlusive mechanism Amulet occluder facilitates successful closure, even in challenging anatomic scenarios.

First Experience With Amulet in the United States: Early Insights From EMERGE LAA Postapproval Study.

BACKGROUND: The Food and Drug Administration approved the Amulet occluder (Abbott) after demonstrating safety and effectiveness in the Amulet IDE (AMPLATZER Amulet LAA Occluder) trial. OBJECTIVES: The aim of the EMERGE Left Atrial Appendage study is to evaluate early postapproval outcomes of the Amulet occluder in the United States using data from the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry. METHODS: Patients with a commercial Amulet occluder implant attempt between Food and Drug Administration approval (August 14, 2021) and December 31, 2022, were included. The safety composite endpoint included all-cause death, ischemic stroke, systemic embolism, or device/procedure-related events requiring open cardiac surgery or endovascular intervention between device implantation and 7 days or hospital discharge (whichever is later). Major adverse events through 45 days were also reported and stratified by operator experience (early [<10 cases], moderate [10-29 cases], and high [30+ cases]). RESULTS: A total of 5,499 patients underwent attempted Amulet occluder implantation. Implant success was 95.8%, and complete closure was 97.2% post-left atrial appendage occlusion and 87.1% at 45 days. A safety composite endpoint event occurred in 0.76% patients. Any major adverse event occurred in 2.9% and 5.7% of patients in-hospital and through 45 days, respectively, driven by major bleeding and pericardial effusion (PE) requiring intervention. PE requiring surgery or percutaneous intervention decreased significantly with increasing experience both in-hospital (early vs high operator experience 1.8% vs 1.1%; P = 0.006) and at 45 days (2.3% vs 1.5%; P = 0.012). CONCLUSIONS: The EMERGE Left Atrial Appendage study demonstrates favorable safety and effectiveness of the Amulet occluder in the real-world setting. More experienced operators had improved implant success and fewer PEs, suggesting a learning curve effect implanting this dual occlusive mechanism device.

Angiographic Coronary Slow Flow Is Not a Valid Surrogate for Invasively Diagnosed Coronary Microvascular Dysfunction.

BACKGROUND: Ischemia with no obstructive coronary arteries is frequently caused by coronary microvascular dysfunction (CMD). Consensus diagnostic criteria for CMD include baseline angiographic slow flow by corrected TIMI (Thrombolysis In Myocardial Infarction) frame count (cTFC), but correlations between slow flow and CMD measured by invasive coronary function testing (CFT) are uncertain. OBJECTIVES: The aim of this study was to investigate relationships between cTFC and invasive CFT for CMD. METHODS: Adults with ischemia with no obstructive coronary arteries underwent invasive CFT with thermodilution-derived baseline coronary blood flow, coronary flow reserve (CFR), and index of microcirculatory resistance (IMR). CMD was defined as abnormal CFR (<2.5) and/or abnormal IMR (≥25). cTFC was measured from baseline angiography; slow flow was defined as cTFC >25. Correlations between cTFC and baseline coronary flow and between CFR and IMR and associations between slow flow and invasive measures of CMD were evaluated, adjusted for covariates. All patients provided consent. RESULTS: Among 508 adults, 49% had coronary slow flow. Patients with slow flow were more likely to have abnormal IMR (36% vs 26%; P = 0.019) but less likely to have abnormal CFR (28% vs 42%; P = 0.001), with no difference in CMD (46% vs 51%). cTFC was weakly correlated with baseline coronary blood flow (r = -0.35; 95% CI: -0.42 to -0.27), CFR (r = 0.20; 95% CI: 0.12 to 0.28), and IMR (r = 0.16; 95% CI: 0.07-0.24). In multivariable models, slow flow was associated with lower odds of abnormal CFR (adjusted OR: 0.53; 95% CI: 0.35 to 0.80). CONCLUSIONS: Coronary slow flow was weakly associated with results of invasive CFT and should not be used as a surrogate for the invasive diagnosis of CMD.

The use of PK Papyrus covered coronary stent for carotid reconstruction: an initial institutional experience.

BACKGROUND: The use of covered stent grafts for the treatment of carotid rupture is increasingly being used given their ability to preserve the parent artery while simultaneously occluding the fistula or rupture point. METHODS: This case series describes the technical feasibility of using, and the performance of, the PK Papyrus covered coronary stent (Biotronik, Inc., Lake Oswego, Oregon, USA) in six patients with carotid rupture, including carotid cavernous fistulas, between July 2021 and October 2023 in a single-center institution in the USA. RESULTS: The median decade of life was 5 (IQR 3) with a 1:1 male-to-female ratio. The majority were black patients (n=5/6, 83.3%). The most common disease pathology was carotid cavernous fistula (n=4/6, 66.7%), followed by traumatic carotid rupture (n=2/6, 33.3%). All the stent embolization procedures were successfully treated with the PK Papyrus covered coronary stent. None of the patients had any recurrence or re-treatment. The number of stents required ranged from 1 to 3. A balloon guide catheter was used in 66.7% of cases (n=4/6). In-hospital mortality was 0.0% (n=0/6). No in-stent thrombosis was observed, but there was one case of cangrelor-associated hemorrhagic stroke conversion. Transfemoral access was used in all cases with one access site complication. Median follow-up time was 1.8 months (IQR 3.5). CONCLUSIONS: To our knowledge, this is the largest case series in the USA demonstrating the feasibility and safety of using the PK Papyrus covered coronary stent for the treatment of carotid rupture, including carotid cavernous fistulas.

Impact of extracorporeal cardiopulmonary resuscitation on neurological prognosis and survival in adult patients after cardiac arrest: an individual pooled patient data meta-analysis.

BACKGROUND: We aimed to estimate the effect of extracorporeal cardiopulmonary resuscitation (ECPR) on neurological outcome and mortality, when compared to conventional cardiopulmonary resuscitation (CCPR), using an individual patient data meta-analysis (IPDMA). METHODS: A systematic literature search was performed up to the 20th of October 2022 in the PubMed, EMBASE and CENTRAL databases. For observational studies with unmatched populations, a propensity score including age, location of arrest and initial rhythm was used to match ECPR and CCPR patients in a 1:1 ratio. The primary and secondary outcomes were unfavorable neurological outcome (Cerebral Performance Category of 3-5) and mortality, respectively, which were both collected at different time-points. RESULTS: Data from 17 studies, including 2064 matched cardiac arrest (CA) patients (1031 ECPR and 1033 CCPR cases) were included. In comparison to CCPR, ECPR was associated with a decreased odds of unfavorable neurological outcome (847, 82.2% vs. 897, 86.8% - OR 0.68 [95%CI 0.53-0.87]; p=0.002) and death (803, 77.9% vs. 860, 83.3% - OR 0.68 [95%CI 0.54-0.86]; p=0.001). These results were consistent across most of the prespecified subgroups. Moreover, the odds of both unfavorable neurological outcome and mortality were significantly influenced by initial rhythm, cause of arrest and combinations of lactate levels on admission and duration of resuscitation. CONCLUSIONS: This IPDMA showed that ECPR was associated with significantly lower rates of unfavorable neurological outcome and mortality in refractory CA. The overall effect could be influenced by CA characteristics and the severity of the initial injury.

Long-Term Outcomes of Patients With Pulmonary Embolism Managed With Endovascular Therapies Compared to Medical Therapy.

Background: Guidelines on the management of acute pulmonary embolism (PE) recommend consideration of endovascular therapies (EVT) for patients at intermediate-high risk. However, long-term data on the outcomes of patients after EVT as compared to medical therapy is lacking. This study aimed to compare outcomes of patients receiving EVT as compared to medical therapy alone at 3 to 6 months. Methods: In this single-center, retrospective cohort study, 190 patients with PE underwent evaluation for presence of right ventricular (RV) dysfunction by transthoracic echocardiogram, residual perfusion defects on ventilation-perfusion scanning, and functional capacity by 6-minute walk distance (6MWD) at 3 to 6 month follow-up. Results: Fifty-eight (31%) patients received EVT for the management of their acute PE. At follow-up (median 120 [97-170] days), 71% of patients who received EVT had normalization of RV function compared with only 34% of patients who received medical therapy alone (P < .001). Patients who received EVT had a significantly greater increase in their estimated glomerular filtration rate (P = .001), decrease in N-terminal proB-type natriuretic peptide (P = .003), and decrease in hemoglobin values (P = .018). Patients with intermediate-high to high risk PE who received EVT had significantly greater distance achieved on their 6MWD as compared to those who received medical therapy alone (P = .025). Conclusions: Patients with acute PE who received EVT plus medical therapy were more likely to achieve normalization of RV dysfunction at 3 to 6 month follow-up compared to patients who received medical therapy alone. These data suggest that EVT is an effective therapy option for acute PE in intermediate-high and high risk patients with potential durable long-term benefits.

SCAI Guidelines for the Management of Patent Foramen Ovale.

Background: Patent foramen ovale (PFO) is a vestigial congenital cardiovascular structure present in around 25% of adults. In most cases, PFO is entirely benign and requires no treatment. However, it may cause serious complications under certain circumstances. Objective: These evidence-based guidelines from the Society for Cardiovascular Angiography and Interventions (SCAI) aim to support patients, clinicians, and other stakeholders in decisions about management of PFO. Methods: SCAI convened a multidisciplinary guideline panel balanced to minimize potential bias from conflicts of interest. The Evidence Foundation, a registered 501(c)(3) nonprofit organization, provided methodological support for the guideline-development process. Following the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, the guideline panel formulated and prioritized clinical questions in population, intervention, comparison, outcome (PICO) format. A separate technical review team of clinical and methodological experts conducted systematic reviews of the evidence, synthesized data, and graded the certainty of the evidence across outcomes. The guideline panel then reconvened to formulate recommendations and supporting remarks informed by the results of the technical review and additional contextual factors described in the GRADE evidence-to-decision framework. Results: The panel agreed on 13 recommendations to address variations on 5 clinical scenarios. Conclusions: Key recommendations address patient selection for PFO closure in the prevention of recurrent PFO-associated stroke, including populations not commonly included in randomized studies, and scenarios where the PFO closure might serve a role in the prevention of other outcomes such as migraine headaches and decompression illness. The panel has also identified future research priorities to advance the field.