Modelling Costs of Interventional Pulmonary Embolism Treatment: Implications of US Trends for a European Healthcare System.

BACKGROUND: Catheter-directed treatment (CDT) of acute pulmonary embolism (PE) is entering a growth phase in Europe following a steady increase in the United States (US) in the past decade, but the potential economic impact on European healthcare systems remains unknown. METHODS AND RESULTS: We built two statistical models for the monthly trend of proportion of CDT among patients with severe (intermediate- or high-risk) PE in the US. The conservative model was based on admission data from the National Inpatient Sample (NIS) 2016-2020, and the model reflecting increasing access to advanced treatment from the PERTTM national quality assurance database registry 2018-2021. By applying these models to the forecast of annual PE-related hospitalizations in Germany, we calculated the annual number of severe PE cases and the expected increase in CDT use for the period 2025-2030. The NIS-based model yielded a slow increase, reaching 3.1% (95% CI 3.0-3.2%) among all hospitalizations with PE in 2030; in the PERT-based model, increase would be steeper, reaching 8.7% (8.3-9.2%). Based on current reimbursement rates, we estimated an increase of annual costs for PE-related hospitalizations in Germany ranging from 15.3 to 49.8 million euros by 2030. This calculation does not account for potential cost savings, including those from reduced length of hospital stay. CONCLUSION: Our approach and results, which may be adapted to other European healthcare systems, provide a benchmark for healthcare costs expected to result from CDT. Data from ongoing trials on clinical benefits and cost savings are needed to determine cost-effectiveness and inform reimbursement decisions.

Contemporary Management and Outcomes of Patients With High-Risk Pulmonary Embolism.

BACKGROUND: Contemporary care patterns/outcomes in high-risk pulmonary embolism (PE) patients are unknown. OBJECTIVES: This study sought to characterize the management of high-risk PE patients and identify factors associated with poor outcomes. METHODS: A retrospective analysis of the PERT (Pulmonary Embolism Response Team) Consortium Registry was performed. Patients presenting with intermediate-risk PE, high-risk PE, and catastrophic PE (those with hemodynamic collapse) were identified. Patient characteristics were compared with chi-square testing for categorical covariates and Student's t-test for continuous covariates. Multivariable logistic regression was used to assess associations between clinical characteristics and outcomes in the high-risk population. RESULTS: Of 5,790 registry patients, 2,976 presented with intermediate-risk PE and 1,442 with high-risk PE. High-risk PE patients were more frequently treated with advanced therapies than intermediate-risk PE patients (41.9% vs 30.2%; P < 0.001). In-hospital mortality (20.6% vs 3.7%; P < 0.001) and major bleeding (10.5% vs. 3.5%; P < 0.001) were more common in high-risk PE. Multivariable regression analysis demonstrated vasopressor use (OR: 4.56; 95% CI: 3.27-6.38; P < 0.01), extracorporeal membrane oxygenation use (OR: 2.86; 95% CI: 1.12-7.30; P = 0.03), identified clot-in-transit (OR: 2.26; 95% CI: 1.13-4.52; P = 0.02), and malignancy (OR: = 1.70; 95% CI: 1.13-2.56; P = 0.01) as factors associated with in-hospital mortality. Catastrophic PE patients (n = 197 [13.7% of high-risk PE patients]) had higher in-hospital mortality (42.1% vs 17.2%; P < 0.001) than those presenting with noncatastrophic high-risk PE. Extracorporeal membrane oxygenation (13.3% vs. 4.8% P < 0.001) and systemic thrombolysis (25% vs 11.3%; P < 0.001) were used more commonly in catastrophic PE. CONCLUSIONS: In the largest analysis of high-risk PE patients to date, mortality rates were high with the worst outcomes among patients with hemodynamic collapse.

Rigid Plate Fixation for Closure of Emergent Sternotomies for Trauma.

BACKGROUND: No studies to date have evaluated the use of rigid plate fixation for emergent sternotomy in trauma patients. We evaluated our use of rigid plate fixation vs wire cerclage in patients requiring emergent sternotomy. We hypothesized there would be no difference in complications related to sternal closure between the two groups. METHODS: We performed a retrospective cohort study to include all patients who underwent emergent sternotomy from 1/1/2018 to 1/31/2021 and survived to have their sternum closed. Outcomes in patients closed with wire cerclage group (WC) were compared to patients who underwent rigid plate fixation (RPF). RESULTS: Twenty-two patients underwent emergent sternotomy. There were 11 patients in each group. There was no significant difference in admission demographics, ISS, or admission characteristics between the two groups. Complication rates related to closure (wound infection and hardware removal) were not significantly different (WC 27% vs RPF 9%, P = .58). Neither hospital length of stay (WC: 29 days vs RPF: 13 days, P = .13), ICU length of stay (WC: 6 days vs RPF: 7 days, P = .62), nor the number of ventilator days (WC: 3 days vs RPF: 1 day, P .11) were statistically different. All patients survived to discharge. DISCUSSION: This is the first study comparing RPF and WC for sternotomy closure in the setting of trauma. We found no difference in the rate of wound related complications. This study demonstrates the feasibility of rigid plate fixation for trauma sternotomy closure and lays the foundation for future prospective studies.

Physician-Modified Endograft-Facilitated Transcatheter Pulmonary Valve Replacement in Large Right Ventricular Outflow Tract.

BACKGROUND: Transcatheter pulmonary valve replacement (TPVR) in patients with a congenital or acquired abnormality resulting in enlarged right ventricular outflow tract (RVOT) is challenging and may preclude treatment with dedicated devices. We describe a technique using a physician-modified endograft to facilitate TPVR. METHODS: Six patients underwent physician-modified endograft-facilitated TPVR for severe symptomatic pulmonary insufficiency with enlarged RVOT. The fenestration was created in a commercially available endograft before implantation, which was then deployed from the dominant branch pulmonary artery into the RVOT, with the fenestration aligned with the ostium of the nondominant pulmonary artery. A covered stent was placed through the fenestration into the nondominant branch pulmonary artery, and a transcatheter heart valve was deployed within the endograft at the level of the original pulmonary valve. RESULTS: Four patients had tetralogy of Fallot, 1 had pulmonary atresia, and 1 had rheumatic valve disease. The RVOT/main pulmonary artery was severely enlarged (diameter, 44.2 [43.5-50.6] mm). All patients had reduced right ventricular (RV) function and dilated RVs (RV end-diastolic volume, 314 [235-316] mL). Successful endograft, covered stent, and transcatheter heart valve deployment were achieved in all cases without stent/valve embolization, vascular complications, or bleeding complications. At 30 days, 1 patient had mild pulmonary insufficiency, while others had none. The RV size measured by echocardiography was significantly reduced after TPVR (RV area, 34.4 [baseline] versus 29.0 [pre-discharge] versus 25.3 [30 days] cm2; P=0.03). During median follow-up of 221.5 (range, 29-652) days, there were no deaths or need for pulmonary valve reintervention. One patient developed severe tricuspid regurgitation due to entrapment of the anterior tricuspid leaflet by the endograft. The patient underwent successful tricuspid replacement and resection of the offending endograft with preservation of the pulmonary valve prosthesis. CONCLUSIONS: Simple fenestration of an off-the-shelf endograft and associated covered stent placement through the fenestration allows TPVR for patients with dysfunctional native or patch-repaired pulmonary valves and RVOT enlargement.

Interhospital Transfer of Patients With Acute Pulmonary Embolism: Challenges and Opportunities.

Acute pulmonary embolism (PE) is associated with significant morbidity and mortality. The management paradigm for acute PE has evolved in recent years with wider availability of advanced treatment modalities ranging from catheter-directed reperfusion therapies to mechanical circulatory support. This evolution has coincided with the development and implementation of institutional pulmonary embolism response teams (PERT) nationwide and internationally. Because most institutions are not equipped or staffed for advanced PE care, patients often require transfer to centers with more comprehensive resources, including PERT expertise. One of the unmet needs in current PE care is an organized approach to the process of interhospital transfer (IHT) of critically ill PE patients. In this review, we discuss medical optimization and support of patients before and during transfer, transfer checklists, defined roles of emergency medical services, and the roles and responsibilities of referring and receiving centers involved in the IHT of acute PE patients.

Timing of Recognition for Perioperative Strokes Following Cardiac Surgery.

INTRODUCTION: More than half of reported perioperative strokes following cardiac surgery are identified beyond postoperative day one. The objective of our study was to determine preoperative and intraoperative factors that are associated with stroke following cardiac surgery and to identify factors that may contribute delayed recognition of perioperative stroke. METHODS: Patients undergoing coronary artery bypass surgery or isolated valve surgery from January 2, 2015 to April 28, 2017 at an academic health system were identified from the Society of Thoracic Surgeons Registry. We determined preoperative and intraoperative factors associated with perioperative stroke. Two neurologists performed retrospective chart reviews on perioperative stroke patients to determine the last seen well time and the stroke cause. RESULTS: During the study period, 2795 patients underwent coronary artery bypass surgery or isolated valve surgery (mean age 64 ± 11 years, 71% male, 72% Caucasian, 9% history of stroke), of which 43 (1.5%) had a perioperative stroke; 31 (72%) patients had an embolic mechanism of stroke based on neuroimaging. In multivariable analysis, perioperative strokes were independently associated with increasing age (OR 1.04, 95% 1.01-1.07), history of stroke (OR 2.73, 95% CI 1.47-5.06), and history of thoracic aorta disease (OR 3.36, 95% CI 1.16-9.71). Strokes were identified after postoperative day one in 32 (74%) patients of which 26 (81%) had a preoperative last seen well time. CONCLUSION: Given the high frequency of preoperative last seen well time in perioperative stroke patients who are identified after postoperative day one, delayed stroke recognition may contribute to the bimodal distribution in timing of perioperative stroke. Frequent neurological monitoring within 24 hours after CABG or isolated valve surgery should be considered for all patients undergoing cardiac surgery, particularly elderly patients and those with a history of stroke or thoracic aorta disease, to improve early stroke recognition.

Surgical Pulmonary Embolectomy.

Surgical pulmonary embolectomy has a storied history in the domain of cardiothoracic surgery. This article provides insight on the history, current data, and future directions of surgical pulmonary embolectomy.

Heparin-Induced Thrombocytopenia in Patients Undergoing Valvular and Aortic Surgery: A Modern Assessment of Risk.

OBJECTIVE: The incidence and outcomes of patients with heparin-induced thrombocytopenia (HIT) are well defined for general cardiac surgical populations. The purpose of this study was to define the outcomes of patients with HIT in a population excluding patients who underwent coronary artery bypass grafting (CABG). METHODS: The local Society of Thoracic Surgeons cardiac surgical database was queried between January 2008 and May 2017 for patients who underwent either open valvular surgery or aortic surgery. Patients who underwent either isolated or combined CABG procedures were excluded. Cohorts were formed based on the presence or absence of postoperative HIT. Logistic regression models were built to determine the association between postoperative HIT and outcomes, adjusted for both preoperative and intraoperative variables. RESULTS: Of the total cohort (8,107 patients), 176 patients (2.2%) developed HIT after surgery. HIT patients experienced an increased incidence of morbidities postoperatively, including reoperation for bleeding, reoperation for cardiac and noncardiac etiologies, postoperative stroke, perioperative myocardial infarction, postoperative sternal infection, postoperative arrhythmia, new-onset renal failure, and dialysis (all with P < 0.01). The unadjusted 30-day mortality was 14.8% in HIT patients vs 4.9% in those without HIT (P < 0.01). After risk adjustment, reoperation for noncardiac events, renal failure, new dialysis, postoperative stroke, arrhythmia, and sternal wound infection remained significantly elevated in patients who developed postoperative HIT. CONCLUSIONS: Patients who developed HIT after non-CABG cardiac surgery experienced increased postoperative rates of morbidity and mortality. Early diagnosis and treatment remained mainstays of therapy. Early identification of patients at highest risk should prompt careful risk stratification when possible.

Diagnosis, Treatment and Follow Up of Acute Pulmonary Embolism: Consensus Practice from the PERT Consortium.

Pulmonary embolism (PE) is a life-threatening condition and a leading cause of morbidity and mortality. There have been many advances in the field of PE in the last few years, requiring a careful assessment of their impact on patient care. However, variations in recommendations by different clinical guidelines, as well as lack of robust clinical trials, make clinical decisions challenging. The Pulmonary Embolism Response Team Consortium is an international association created to advance the diagnosis, treatment, and outcomes of patients with PE. In this consensus practice document, we provide a comprehensive review of the diagnosis, treatment, and follow-up of acute PE, including both clinical data and consensus opinion to provide guidance for clinicians caring for these patients.

Outcomes of percutaneous vacuum-assisted debulking of large vegetations as an adjunct to lead extraction.

BACKGROUND: Consensus statements on lead extraction give consideration to open surgical removal in the setting of large vegetations, to mitigate the risk of massive embolism that may occur with percutaneous lead removal. Vacuum-assisted debulking (VD) of large vegetations as an adjunct to percutaneous lead extraction may provide an opportunity to mitigate these risks. METHODS: We retrospectively identified all patients undergoing lead extraction at our institution for endovascular infection from 2012 to 2018 and stratified them into two groups based on presence of adjunctive VD (n = 6) or without VD (no-VD, n = 39). VD was performed with the AngioVac system (Angio-Dynamics, Latham, NY, USA). RESULTS: Across the cohort, mean age was 62 ± 15 years, ejection fraction was 41 ± 16%, and 39% had end-stage renal disease on dialysis. Defibrillator systems were present in 71%, and 22% had cardiac resynchronization devices. Mean duration of the oldest extracted lead was 6.3 ± 4.9 years. There were no significant differences in baseline covariates between groups. Those in the VD group were significantly less likely to have Staphylococcus aureus as a causative organism (P = .04). In the VD group, vegetations targeted for debulking ranged in size from 1.8 to 6 cm (longest dimension). There were no operative deaths or clinically evident embolic events in either group. The overall nonfatal complication rate in the VD group was higher (33.3% vs 2.3%, P = .043). CONCLUSION: VD can be performed as an adjunct to percutaneous lead extraction with a reasonable safety profile. The relative safety and efficacy of this approach removal requires further study.

The Addition of Aortic Root Procedures During Elective Arch Surgery Does Not Confer Added Morbidity or Mortality.

BACKGROUND: During elective aortic arch replacement, the addition of an aortic root procedure has an unknown effect on morbidity and mortality. The purpose of this study is to determine the effect of adding an aortic root procedure to elective aortic surgery using the ARCH international database. METHODS: The ARCH Database was queried for all elective aortic arch replacements with and without aortic root replacement using moderate hypothermic circulatory arrest and antegrade cerebral perfusion from 2000 to 2015. Propensity score matching analysis was used to balance covariates, and a logistic regression model was created. RESULTS: A total of 1,169 patients were included for analysis, and 320 patients (27.4%) underwent an aortic root procedure. Patients undergoing root procedures were younger (69 versus 61 years), had less coronary artery disease (20% versus 32%), and had a higher incidence of Marfan's syndrome (4.2% versus 10.0%) (p < 0.001 for all). Concomitant coronary artery bypass grafting (26.6% versus 19.7%), total aortic arch replacement (41.6% versus 84.3%), and elephant trunk procedures (46% versus 17.2%) were performed more frequently in the nonroot cohort (p < 0.001 for all). Cardiopulmonary bypass and aortic cross-clamp times were significantly longer in the cohort of patients who underwent root procedures, whereas cerebral perfusion times were longer in the nonroot cohort (p < 0.001 for all). In both the propensity matched and nonmatched analyses, postoperative outcomes were not significantly different between patients who underwent root procedures and patients who did not (p > 0.05 for all outcomes). Multivariable logistic regression analyses showed no difference in mortality rates (odds ratio 0.62, 95% confidence interval: 0.9 to 1.34, p = 0.22) or in rates of permanent stroke (odds ratio 0.89, 95% confidence interval: 0.36 to 2.24, p = 0.81) between the root and nonroot cohorts. CONCLUSIONS: The addition of an aortic root procedure during elective aortic arch surgery lengthens cardiopulmonary bypass and aortic cross-clamp times but does not increase postoperative morbidity or mortality.

Procedural outcomes and long-term survival associated with lead extraction in patients with abandoned leads.

BACKGROUND: The decision to abandon or extract superfluous sterile leads is controversial. OBJECTIVE: The purpose of this study was to compare procedural outcomes and long-term survival of patients with and those without abandoned leads undergoing lead extraction (LE). METHODS: Retrospective review of all patients who had undergone transvenous LE at our institution from January 2007 to May 2016 was performed. Patients were stratified into 2 groups based on the presence (group 1) or absence (group 2) of abandoned leads. RESULTS: Among 774 patients who had undergone LE procedures, 38 (4.9%) had abandoned leads (group 1). Dwell time of the oldest extracted lead was longer in group 1 vs group 2 (7.6 ± 4.9 years vs 5.6 ± 4.4 years; P = .017), as was infection as an indication for LE (76% vs 33%; P <.001). A bailout femoral approach was more commonly required in group 1 than in group 2 (18.4% vs 6%; P = .007). Complete procedural success rates were similar (92.1% in group 1 vs 95.0% in group 2; P = .439), but there was a trend toward lower clinical success in group 1 (92.1% vs 97.4%; P = .088), primarily due to failure to remove all hardware in the setting of infection. Major procedural complication rates were similar (2.6% in group 1 vs 1.2% in group 2; P = .397), as was long-term survival (mean follow-up 2.3 ± 2.2 years). CONCLUSION: Abandoned leads at the time of LE were associated with increased procedural complexity, including a higher rate of bailout femoral extraction, and may be associated with lower clinical success. Among appropriately selected patients, consideration should be given to LE instead of abandonment.

Conversion From Off-Pump Coronary Artery Bypass Grafting to On-Pump Coronary Artery Bypass Grafting.

BACKGROUND: Off-pump coronary artery bypass grafting (OPCAB) has been shown to be an effective strategy for surgical revascularization. The purpose of this study was to define the incidence of intraoperative conversion from OPCAB to on-pump coronary artery bypass grafting (ONCAB) and report outcomes based on the reason for conversion. METHODS: Starting in July 2007, the Society of Thoracic Surgeons database captured patients that were planned OPCAB but then were converted to ONCAB. A total of 196,576 patients undergoing planned OPCAB within the Society of Thoracic Surgeons National Database from July 2007 to June 2014 were evaluated. Patients were grouped according to their intraoperative conversion to cardiopulmonary bypass: (1) planned conversion, (2) unplanned conversion for visualization, (3) unplanned conversion for hemodynamic instability, and (4) no conversion (OPCAB). Multiple logistic regression analysis was used to determine risk factors for conversion. RESULTS: The overall rate of conversion from OPCAB to ONCAB was 5.5%, with 49.6% of the conversions being planned. When compared with those not undergoing conversion (OPCAB, 30-day mortality observed to expected ratio [O/E], 0.8), those undergoing conversion to ONCAB experienced greater 30-day mortality regardless of etiology of conversion (planned conversion O/E, 1.4; unplanned conversion for visualization O/E, 1.6; and unplanned conversion for hemodynamic instability O/E, 2.7). Similar O/E ratios were observed for renal failure and prolonged ventilation following conversion. Logistic regression analysis showed advanced age, ejection fraction less than 35%, preoperative intraaortic balloon pump placement, increasing number of diseased coronary arteries, preoperative heart failure within 2 weeks, and urgent procedural status were all independent predictors for conversion to ONCAB (p ≤ 0.01). CONCLUSIONS: Intraoperative conversion from OPCAB to ONCAB remains a morbid event with a risk of mortality much higher than expected. Surgeons should consider elective ONCAB in those with a high risk for conversion during OPCAB.