Outcomes with treatment interventions for clot-in-transit in patients with pulmonary embolism: a meta-analysis.

OBJECTIVES: Clot-in-transit (CIT) in patients with pulmonary embolism (PE) has been associated with a high mortality rate and poor prognosis. The aim of this study was to evaluate the pooled efficacy of each of the 4 interventions (anticoagulation [AC] alone, systemic thrombolytic [ST] therapy, surgical thrombectomy, and catheter-based thrombectomy [CBT]) using mortality as the primary outcome. METHODS: A time limited search until March 28, 2024 was conducted using PubMed (National Institutes of Health) and EMBASE (Elsevier) databases. RESULTS: Thirteen studies (6 retrospective, 4 non-randomized prospective, and 3 pooled studies of case-reports) were included in the calculation of weighted proportion of mortality, including a total of 492 patients with CIT and PE with a mean age of 60.6 years; 50.1% were males. ST was the most frequently used treatment intervention (38.2%), followed by surgical thrombectomy (33.8%), AC alone (22.6%), and CBT (5.9%). The unweighted mortality was highest with AC alone 32.4% (36/111), followed by surgical thrombectomy 23.2% (38/164), CBT 20.7% (6/29), and ST 13.8% (26/188). The weighted mortality for AC alone was 35% (95% CI, 21% to 49%; 12 studies), surgical thrombectomy was 31% (95% CI, 16% to 47%; 12 studies), CBT was 20% (95% CI, 6% to 34%; 3 studies), and ST was 12% (95% CI, 5% to 19%; 12 studies). CONCLUSIONS: In this meta-analysis of patients with CIT and PE, the highest mortality was observed with AC alone, followed by surgical thrombectomy, CBT, and ST therapy. However, there remains a need for randomized clinical trial data to determine the best treatment.

Outcomes in High-Risk Pulmonary Embolism Patients Undergoing FlowTriever Mechanical Thrombectomy or Other Contemporary Therapies: Results From the FLAME Study.

BACKGROUND: Hemodynamically unstable high-risk, or massive, pulmonary embolism (PE) has a reported in-hospital mortality of over 25%. Systemic thrombolysis is the guideline-recommended treatment despite limited evidence. The FLAME study (FlowTriever for Acute Massive PE) was designed to generate evidence for interventional treatments in high-risk PE. METHODS: The FLAME study was a prospective, multicenter, nonrandomized, parallel group, observational study of high-risk PE. Eligible patients were treated with FlowTriever mechanical thrombectomy (FlowTriever Arm) or with other contemporary therapies (Context Arm). The primary end point was an in-hospital composite of all-cause mortality, bailout to an alternate thrombus removal strategy, clinical deterioration, and major bleeding. This was compared in the FlowTriever Arm to a prespecified performance goal derived from a contemporary systematic review and meta-analysis. RESULTS: A total of 53 patients were enrolled in the FlowTriever Arm and 61 in the Context Arm. Context Arm patients were primarily treated with systemic thrombolysis (68.9%) or anticoagulation alone (23.0%). The primary end point was reached in 9/53 (17.0%) FlowTriever Arm patients, significantly lower than the 32.0% performance goal (P<0.01). The primary end point was reached in 39/61 (63.9%) Context Arm patients. In-hospital mortality occurred in 1/53 (1.9%) patients in the FlowTriever Arm and in 18/61 (29.5%) patients in the Context Arm. CONCLUSIONS: Among patients selected for mechanical thrombectomy with the FlowTriever System, a significantly lower associated rate of in-hospital adverse clinical outcomes was observed compared with a prespecified performance goal, primarily driven by low all-cause mortality of 1.9%. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04795167.

Effect of preoperative pulmonary hypertension on outcomes in patients with severe aortic stenosis following surgical aortic valve replacement.

Pulmonary hypertension (PH) is prevalent in patients with aortic stenosis (AS); however, previous studies have demonstrated inconsistent results regarding the association of PH with adverse outcomes after aortic valve replacement (AVR). The goal of this study was to evaluate the effects of preoperative PH on outcomes after AVR. We performed a regional prospective cohort study using the Northern New England Cardiovascular Disease Study Group database to identify 1,116 consecutive patients from 2005 to 2010 who underwent AVR ± coronary artery bypass grafting for severe AS with a preoperative assessment of pulmonary pressures by right-sided cardiac catheterization. PH was defined as a mean pulmonary artery pressure of ≥25 mm Hg, with severity based on the pulmonary artery systolic pressure-mild, 35 to 44 mm Hg; moderate, 45 to 59 mm Hg; and severe, ≥60 mm Hg. We found that PH was present in 536 patients (48%). Postoperative acute kidney injury, low-output heart failure, and in-hospital mortality increased with worsening severity of PH. In multivariate logistic regression, severe PH was independently associated with postoperative acute kidney injury (adjusted odds ratio 4.1, 95% confidence interval [CI] 1.7 to 10, p = 0.002) and in-hospital mortality (adjusted odds ratio 6.9, 95% CI 2.5 to 19.1, p <0.001). There was a significant association between PH and decreased 5-year survival (adjusted log-rank p value = 0.006), with severe PH being associated with the poorest survival (adjusted hazard ratio 2.4, 95% CI 1.3 to 4.2, p = 0.003). In conclusion, severe PH in patients with severe AS is associated with increased rates of in-hospital adverse events and decreased 5-year survival after AVR.

Classification and treatment of coronary artery bifurcation lesions: putting the Medina classification to the test.

BACKGROUND: Coronary bifurcation lesions are common, difficult to treat, and associated with poorer outcomes compared to non-bifurcation lesions. The Medina classification has been widely adopted as the preferred system to classify bifurcation lesions, however there have been little efforts to characterize this metric. The objective of this study was to characterize the inter-observer variability of the Medina classification and examine its contribution to treatment selection strategy. METHODS AND MATERIALS: We invited 150 interventional cardiologists from the United States and Europe to complete an online survey evaluating 12 freeze frame coronary angiograms of bifurcation lesions. Each respondent was asked to characterize the bifurcation lesions using the Medina classification and other metrics including side branch vessel size and angle. Respondents were asked to designate either a provisional (1 stent) or dedicated (2 stent) treatment strategy. 'Complex' lesions were defined as Medina scores 1.1.1, 0.1.1, or 1.0.1. RESULTS: A total of 49 interventional cardiologists responded. In 7 of the 12 angiograms evaluated, there was >75% agreement regarding lesion classification using the Medina system. There was moderate inter-observer agreement when using Medina to classify lesions as 'Complex' vs. 'non-Complex'. 'Complex' bifurcation designation and side branch size were predictive of selection of a dedicated treatment strategy, whereas side branch angle was not. CONCLUSIONS: The Medina classification is a useful tool in characterizing coronary bifurcation lesions. For the majority of the angiograms evaluated there was good inter-observer agreement in lesion classification using the Medina system. 'Complex' bifurcation designation and side branch size were predictive of selection of a dedicated treatment strategy.

A call to action: variability in guidelines for cardiac evaluation before renal transplantation.

BACKGROUND AND OBJECTIVES: Candidates for renal transplantation are at increased risk for complications related to cardiovascular disease; however, the optimal strategy to reduce this risk is not clear. The aim of this study was to evaluate the variability among existing guidelines for preoperative cardiac evaluation of renal transplant candidates. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: A consecutive series of renal transplant candidates (n=204) were identified, and four prominent preoperative cardiac evaluation guidelines, pertaining to this population, were retrospectively applied to determine the rate at which each guideline recommended cardiac stress testing. RESULTS: The rate of pretransplant cardiac stress testing would have ranged from 20 to 100% depending on which guideline was applied. The American Heart Association/American College of Cardiology (ACC/AHA) guideline resulted in the lowest rate of testing (20%). In our population, 178 study subjects underwent stress testing: 17 were found to have ischemia and 10 underwent revascularization. The ACC/AHA approach would have decreased the number of noninvasive tests from 178 to 39; it would have identified only 4 of the 10 patients who underwent revascularization. The three other guidelines (renal transplant-specific guidelines) recommended widespread pretransplant cardiac testing and thus identified nearly all patients who had ischemia on stress testing. CONCLUSIONS: The ACC/AHA perioperative guideline may be inadequate for identifying renal transplant candidates with coronary disease; however, renal transplant-specific guidelines may provoke significant overtesting. An intermediate approach based on risk factors specific to the ESRD population may optimize detection of coronary disease and limit testing.

Non-invasive detection of pulmonary hypertension prior to renal transplantation is a predictor of increased risk for early graft dysfunction.

BACKGROUND: Early graft dysfunction is a significant complication after renal transplantation and is a marker of adverse outcomes. Although multiple predictors of graft dysfunction have been previously described, the reported prevalence of pulmonary hypertension (pulmonary HTN) in the dialysis population (40-50%), along with biologic and physiologic principles, led us to hypothesize that pulmonary HTN might be an additional risk factor for early graft dysfunction. METHODS: We performed a retrospective study that screened all adult renal transplants performed at our institution over a 3-year period and limited the evaluation to those subjects who had an estimated pulmonary artery systolic pressure on a preoperative echocardiogram report (n = 55). The primary outcome of this study was to investigate the impact of pulmonary HTN on early graft dysfunction using a combined endpoint of delayed graft function or slow graft function. RESULTS: Among patients receiving a living donor kidney, early graft dysfunction was not observed regardless of pulmonary HTN status. However, among patients receiving a deceased donor kidney, pulmonary HTN was found to be associated with a significant increased risk of early graft dysfunction (56 vs 11.7%, P = 0.01). Univariate and multivariable logistic regression supported this observation as an independent risk factor beyond potential confounding recipient, donor and graft-based risk factors for early graft dysfunction (P < 0.05). CONCLUSION: Pulmonary HTN detected on non-invasive imaging prior to renal transplantation appears to be an independent predictor of early graft dysfunction among those patients who receive a deceased donor kidney.