Outcomes With Hybrid Catheter-Directed Therapy Compared With Aspiration Thrombectomy for Patients With Intermediate-High Risk Pulmonary Embolism.

PURPOSE: Intermediate-high-risk pulmonary embolism (IHR PE) is a challenging form of embolism obstruction that causes right ventricular (RV) dysfunction. The optimal management of IHR PE has not been established. This single-center prospective, observational study aimed to evaluate the efficacy and safety of complex catheter-directed therapy (CDT) - catheter-directed mechanical aspiration thrombectomy (CDMT) supplemented with catheter-directed thrombolysis (hybrid CDT) in comparison to CDMT alone for IHR PE. METHODS: A propensity score based on the pulmonary embolism severity index class and Miller obstruction index (MOI) was calculated, and 21 hybrid CDT cases (mean age 54.8 (14.7) years, 9/21 women) were matched with 21 CDMT cases (mean age 58.8 (14.9) years, 13/21 women). The baseline demographics, clinical, and treatment characteristics were analyzed. RESULTS: No significant differences were detected regarding baseline demographics and PE severity parameters. Hybrid CDT demonstrated a higher reduction in mean pulmonary artery pressure (mPAP) (hybrid CDT: median mPAP reduction 8 mmHg (IQR: 6-10 mmHg) vs CDMT: median mPAP reduction 6 mmHg (IQR: 4-7 mmHg); P = 0.019), MOI score (hybrid CDT: median change - 5 points (IQR: 5-6 points) vs CDMT median change - 3 points (IQR: 3-5 points); P = 0.019), and median RV: left ventricular ratio (hybrid CDT: median change 0.4 (IQR: 0.3-0.45) vs CDMT median change 0.26 (IQR: 0.2-0.4); P = 0.007). No major bleeding was observed. Both the hybrid CDT and CDMT alone treatments are safe and effective in managing IHR PE. CONCLUSIONS: Hybrid CDT is a promising technique for the management of IHR PE with insufficient thrombus load reduction by CDMT. TRIAL REGISTRATION: NCT0447356-registration date 16 July 2020.

Catheter-directed mechanical aspiration thrombectomy in a real-world pulmonary embolism population: a multicenter registry.

AIMS: High- (HR) and intermediate-high risk (IHR) pulmonary embolisms (PEs) are related to high early mortality and long-term sequelae. We aimed to describe clinical outcomes and adverse events in IHR and HR pulmonary embolism (PE) treated with catheter-directed mechanical thrombectomy (CDMT) in a real-world population. METHODS AND RESULTS: This study is a multicenter, prospective registry enrolling 110 PE patients treated with CDMT between 2019 and 2022. The CDMT was performed using the 8F Indigo (Penumbra, Alameda, CA, USA) system bilaterally in pulmonary arteries (PAs). The primary safety endpoints included device or PE-related death during the 48-h after CDMT, procedure-related major bleeding, or other major adverse events. Secondary safety outcomes were all-cause mortality during hospitalization or the follow-up. The primary efficacy outcomes were the reduction of PA pressures and change in the right-to-left ventricular (RV/L) ratio assessed in the imaging 24-48 h after the CDMT.71.8% of patients had IHR PE and 28.2% HR PE. 11.8% of patients had a failure and 34.5% had contraindications to thrombolysis, and 2.7% had polytrauma. There was 0.9% intraprocedural death related to RV failure and 5.5% deaths within the first 48 h. CDMT was complicated by major bleeding in 1.8%, pulmonary artery injury in 1.8%, and ischaemic stroke in 0.9%. Immediate haemodynamic improvements included a 10.4 ± 7.8 mmHg (19.7%) drop in systolic PAP (P < 0.0001), a 6.1 ± 4.2 mmHg (18.8%) drop in mean PAP, and 0.48 ± 0.4 (36%) drop in RV/LV ratio (P < 0.0001). CONCLUSION: These observational findings suggest that CDMT may improve hemodynamics with an acceptable safety profile in patients with IHR and HR PE.

Role of catheter-directed therapies in the treatment of acute pulmonary embolism. Expert opinion of the Polish PERT Initiative, Working Group on Pulmonary Circulation, Association of Cardiovascular Interventions, and Association of Intensive Cardiac Care of the Polish Cardiac Society.

Thanks to advances in interventional cardiology technologies, catheter-directed treatment has become recently a viable therapeutic option in the treatment of patients with acute pulmonary embolism at high risk of early mortality. Current transcatheter techniques allow for local fibrinolysis or embolectomy with minimal risk of complications. Therefore, these procedures can be considered in high-risk patients as an alternative to surgical pulmonary embolectomy when systemic thrombolysis is contraindicated or ineffective. They are also considered in patients with intermediate-high-risk pulmonary embolism who do not improve or deteriorate clinically despite anticoagulation. The purpose of this article is to present the role of transcatheter techniques in the treatment of patients with acute pulmonary embolism. We describe current knowledge and expert opinions in this field. Interventional treatment is described in the broader context of patient care organization and therapeutic modalities. We present the organization and responsibilities of pulmonary embolism response team, role of pre-procedural imaging, periprocedural anticoagulation, patient selection, timing of intervention, and intensive care support. Currently available catheter-directed therapies are discussed in detail including standardized protocols and definitions of procedural success and failure. This expert opinion has been developed in collaboration with experts from various Polish scientific societies, which highlights the role of teamwork in caring for patients with acute pulmonary embolism.

Prognostic Value of Pulmonary Artery Pulsatility Index in Right Ventricle Failure-Related Mortality in Inoperable Chronic Thromboembolic Pulmonary Hypertension.

Chronic thromboembolic pulmonary hypertension (CTEPH) is an ominous disease leading to progressive right ventricular failure (RVF) and death. There is no reliable risk stratification strategy for patients with CTEPH. The pulmonary artery pulsatility index (PAPI) is a novel hemodynamic index that predicts the occurrence RVF. We aimed to investigate prognostic value of PAPI in inoperable CTEPH. Consecutive patients with inoperable CTEPH were enrolled. PAPI was calculated from baseline right heart catheterization data. A prognostic cut-off value was determined, and characteristics of low- and high-PAPI groups were compared. The association between risk assessment and survival was also evaluated. We included 50 patients (mean age 64 ± 12.2 years, 60% female). The number of deaths was 12 (24%), and the mean follow-up time was 52 ± 19.3 months. The established prognostic cut-off value for PAPI was 3.9. The low-PAPI group had significantly higher mean values of mean atrial pressure (14.9 vs. 7.8, p = 0.0001), end-diastolic right ventricular pressure (16.5 vs. 11.2, p = 0.004), and diastolic pulmonary artery pressure (35.8 vs. 27.7, p = 0.0012). The low-PAPI group had lower survival as compared to high-PAPI (log-rank p < 0.0001). PAPI was independently associated with survival and may be applicable for risk stratification in inoperable CTEPH.

Association of Electrocardiographic Signs of Right Ventricular Hypertrophy and Clot Localization in Chronic Thromboembolic Pulmonary Hypertension.

The role of electrocardiography (ECG) in chronic thromboembolic pulmonary hypertension (CTEPH) diagnosis and prognosticating has not been yet established. We aimed to assess the relationships of the recommended ECG criteria of right ventricular hypertrophy (RVH) with clot localization in CTEPH patients. ECG patterns of RVH according to the American College of Cardiology Foundation were assessed in patients with newly diagnosed CTEPH. We enrolled 58 (45.3%) patients with proximal and 70 (54.7%) with distal CTEPH. Receiver-operating characteristics curves analysis indicated that the following ECG abnormalities predicted proximal CTEPH localization: RV1 > 6 mm-AUC 0.75 (CI: 0.66-0.84, p < 0.00001); SV6 > 3 mm-AUC 0.70 (CI: 0.60-0.79, p < 0.00001); SI > RI wave-AUC 0.67 (CI: 0.58-0.77, p = 0.0004); RV1:SV1 > 1.0-AUC 0.66 (CI: 0.56-0.76, p = 0.0009); RV1 peak > 0.035 s (QRS < 120 ms)-AUC 0.66 (CI: 0.56-0.75, p = 0.0016); RV1:SV1 > RV3(V4):SV3(V4)-AUC-0.65 (CI: 0.54-0.75, p = 0.0081); RaVR > 4 mm-AUC 0.62 (CI: 0.52-0.71, p = 0.002) and PII > 2.5 mm-AUC 0.62 (CI: 0.52-0.72, p = 0.00162). Pulmonary vascular resistance significantly correlated with amplitudes of RV1 (r = 0.34, p = 0.008), SV6 (r = 0.53, p = 0.000027) and PII (r = 0.44, p = 0.00007). In patients with CTEPH, only 8 out of 23 ECG RVH criteria were useful for differentiating between proximal and distal CTEPH localization and we found that RV1 and SV6 may contribute as potential discriminators.

Balloon pulmonary angioplasty in chronic thromboembolic pulmonary hypertension: a multicentre registry.

BACKGROUND: Balloon pulmonary angioplasty (BPA) is a promising therapy for patients with chronic thromboembolic pulmonary hypertension (CTEPH) who are ineligible for pulmonary endarterectomy. AIMS: The present study aimed to evaluate the safety and efficacy of BPA for CTEPH using the first multicentre registry of a single European country. METHODS: Data were obtained from the Database of Pulmonary Hypertension in the Polish Population (NCT03959748), a prospective, multicentre registry of adult and paediatric pulmonary arterial hypertension (PAH) and CTEPH, for a total of 236 patients with confirmed CTEPH (124 women; mean age 67 years) who underwent 1,056 BPA procedures at eight institutions in Poland. RESULTS: In 156 patients who underwent follow-up assessments after a median of 5.9 (IQR: 3.0-8.0) months after final BPA, the mean pulmonary arterial pressure decreased from 45.1±10.7 to 30.2±10.2 mmHg (p<0.001) and pulmonary vascular resistance from 642±341 to 324±183 dynes (p<0.001), and the six-minute walking test (6MWT) improved from 341±129 to 423±136 m (p<0.001). Pulmonary injury related to the BPA procedure occurred in 6.4% of all sessions. Eighteen patients (7.6%) died during follow-up, including 4 (1.7%) who died within 30 days after BPA. Overall survival was 92.4% (95% confidence interval [CI]: 87.6%-94.9%) three years after the initial BPA procedure. CONCLUSIONS: This multicentre registry confirmed significant improvement of haemodynamic, functional, and biochemical parameters after BPA. Complication rates were low and overall survival comparable to the results of another registry. Therefore, BPA may be an important therapeutic option in patients with CTEPH in Poland.

Pulmonary embolism response team: A multidisciplinary approach to pulmonary embolism treatment. Polish PERT Initiative Report.

BACKGROUND: A pulmonary embolism response team (PERT) is a multidisciplinary team established to improve clinical care for patients with pulmonary embolism (PE). However, data regarding detailed institutional experience and clinical outcomes from such teams are sparse. AIMS: We aim to assess the frequency of activations, patients' characteristics, PE severity, applied treatments, and outcomes of PE patients treated by Polish PERTs. METHODS: The survey registry was conducted between June 2018 and July 2020. All consecutive PERT activations of four institutionalized PERTs in Poland were analyzed. Patients' characteristics, therapies applied, and in-hospital outcomes were evaluated. RESULTS: There were 680 unique PERT activations. Most activations originated from Emergency Departments (44.9%), and the remaining originated from internal medicine/cardiology units (31.1%), surgery/orthopedics (9.1 %), oncology (6.3%), intensive care units (6.0%), and others (2.5%). The origin of activation varied significantly among institutions (P <0.01). Most PERT cases were patients with intermediate-high risk PE (42.9%), whereas high-risk PE occurred in 10% of patients. Anticoagulation alone was delivered to 80.3% of patients, and 23.3% of patients received at least one advanced therapy: catheter-directed therapies (11.3%), systemic thrombolysis (5.3%), surgical embolectomy (2.4%), vena cava filter placement (3.7%), and extracorporeal membrane oxygenation (0.6%). In-hospital mortality in the whole study group was 5.1%, with significant differences between institutions (P = 0.01). CONCLUSIONS: The frequency of PE severity, type of delivered catheter-directed treatment, and in-hospital mortality vary between institutions without significant discrepancies in PERT activations. This variation between expert centers highlights the local differences in PERTs' organizational and operational forms.

Balloon Pulmonary Angioplasty in Technically Operable and Technically Inoperable Chronic Thromboembolic Pulmonary Hypertension.

BACKGROUND: In this study, we aimed to assess the efficacy and safety of balloon pulmonary angioplasty (BPA) in patients with technically inoperable distal-type chronic thromboembolic pulmonary hypertension (d-CTEPH) and technically operable proximal-type disease (p-CTEPH) by analyzing the results of BPA treatment in two collaborating CTEPH referral centers. METHODS AND RESULTS: We assessed hemodynamic results, functional efficacy, complication and survival rate after BPA treatment in 70 CTEPH patients (median age 64 years; (interquartile range (IQR): 52-73 years)), of whom 16 (median age 73 years; (QR 62-82 years)) were in the p-CTEPH subgroup. Altogether, 377 BPA procedures were performed, resulting in significant (p < 0.001) improvement in mean pulmonary artery pressure (mPAP 48.6 ± 10 vs. 31.3 ± 8.6 mmHg), pulmonary vascular resistance (694 ± 296 vs. 333 ± 162 dynes*s*cm-5), six-minute walk test (365 ± 142 vs. 433 ± 120 metres) and N-terminal pro B-type natriuretic peptide (1307 (510-3294) vs. 206 (83-531) pg/mL). The rate of improvement did not differ between the sub-groups. Lung injury episodes and severe hemoptysis were similarly infrequent in d-CTEPH and p-CTEPH (6.4% vs. 5%; p = 0.55 and 1.0% vs. 2.5; p = 0.24, respectively). There was no significant difference between the sub-groups regarding survival (p = 0.53 by log-rank test). CONCLUSION: BPA may be beneficial in patients with p-CTEPH who cannot undergo pulmonary endarterectomy (PEA). Larger long-term studies are needed to better define the efficacy, safety, and optimal BPA procedural standards in this population.

Continuous Aspiration Thrombectomy in High- and Intermediate-High-Risk Pulmonary Embolism in Real-World Clinical Practice.

OBJECTIVES: We sought to assess the technical and clinical feasibility of continuous aspiration catheter-directed mechanical thrombectomy (CDT) in patients with high- or intermediate-high-risk pulmonary embolism (PE). METHODS AND RESULTS: Fourteen patients (eight women and six men; age range: 29-71 years) with high- or intermediate-high-risk PE and contraindications to or ineffective systemic thrombolysis were prospectively enrolled between October 2018 and February 2020. The Indigo Mechanical Thrombectomy System (Penumbra, Inc., Alameda, California) was used as CDT device. Low-dose local thrombolysis (alteplase, 3-12 mg) was additionally applied in three patients. Technical and procedural success was achieved in 14 patients (100%). Complete or nearly complete clearance of pulmonary arteries was achieved in nine patients (64.3%), whereas partial clearance was achieved in five (35.7%). A significant improvement in the pre- and postprocedural patients' clinical status was observed in the following fields (median; interquartile range): heart rate (110; 100-120/min vs. 85; 80-90/min; p < 0.0001), systolic blood pressure (106; 90-127 mmHg vs. 123; 110-133 mmHg; p = 0.049), arterial oxygen saturation (88.5; 84.2-93% vs. 95.0; 93.8-95%, p = 0.0051), pulmonary artery systolic pressure (55; 44-66 mmHg vs. 42; 34-53 mmHg; p = 0.0015), Miller index score (21.5; 20-23 vs. 9.5; 8-13; p < 0.0001) and right ventricular/left ventricular ratio (1.3; 1.3-1.5 vs. 1.0; 0.9-1.0; p < 0.0001). No major periprocedural bleeding was detected. CONCLUSIONS: CDT is a feasible and promising technique for management of high- or intermediate-high-risk PE to decrease thrombus burden, reduce right heart strain, and improve hemodynamic and clinical status. Some patients may benefit from simultaneous local low-dose thrombolytic therapy. Nevertheless, its criteria and role in CTD-managed patients require further elucidation.

Implementation of a regional multidisciplinary pulmonary embolism response team: PERT-POZ initial 1-year experience.

BACKGROUND: Pulmonary embolism (PE) is the third most common potentially life­threatening cardiovascular disease. A new approach of pulmonary embolism response teams (PERTs) has been introduced to provide rapid multidisciplinary assessment and treatment of patients with PE. However, detailed data on institutional experience and clinical outcomes from such teams are missing. AIMS: The aim of this study was to report our experience with the management of PE guided by the PERT-POZ within the first year of operation. METHODS: We performed a prospective study of PERT-POZ activations at a university care center between October 2018 and October 2019. Patient characteristics, therapies, and clinical outcomes were evaluated. RESULTS: There were 86 unique PERT-POZ activations, and PE was confirmed in 80 patients including: 9 patients (11.25%) classified as low­risk PE, 19 (23.75%) as intermediate­low risk, 38 (47.5%) as intermediate­high, and 14 (17.5%) as high­risk. Sixty patients (75%) received anticoagulation only, 28 (35%) direct oral anticoagulant, 7 (8.75%) vitamin K antagonist, 23 (28.75%) low-molecular-weight heparin, and 2 (2.50%) unfractionated heparin. Ten patients (12.5%) were treated with catheter­directed thrombectomy, 6 (7.5%) received systemic thrombolysis, 2 (2.5%) underwent surgical embolectomy, 2 (2.5%) were on extracorporeal membrane oxygenation support, and 2 (2.5%) underwent pharmacomechanical venous thrombectomy. There were 7 (8.75%) in­hospital deaths, and 2 (2.5%) deaths during a 3­month follow­up. Bleeding complications were rare: only 3 patients (3.75%) had major bleeding events, but none after administration of systemic thrombolysis. CONCLUSIONS: Our study demonstrated that after the creation of PERT-POZ with a precise activation protocol, patients with intermediate and high­risk PE received most optimal treatment strategies.

The Polish adaptation of the CAMbridge Pulmonary Hypertension Outcome Review (CAMPHOR).

BACKGROUND: Pulmonary hypertension (PH) results in severely impaired quality of life (QoL) in people with this condition. The CAMbridge Pulmonary Hypertension Outcome Review (CAMPHOR) is the only questionnaire providing a disease-specific measurement of symptoms, functioning and QoL in PH patients. It has already been adapted for use in several countries. The aim of this study was to adapt and validate CAMPHOR for the Polish-speaking population. METHODS: Two panels (bilingual and lay) were conducted to translate CAMPHOR into Polish. This new version was then tested by cognitive debriefing interviews with 15 patients. Finally, a postal validation survey was conducted with 56 patients on two occasions 2 weeks apart to assess its psychometric properties. RESULTS: No problems were experienced in producing a Polish translation of CAMPHOR. Interviewees responded well to the Polish CAMPHOR, finding it relevant, comprehensible and easy to complete. For all three CAMPHOR scales (Symptoms, Activity, QoL), The Cronbach alpha coefficients were above 0.8 at both time points, indicating high internal consistency. Test-retest reliability for the three scales achieved a value above 0.80. Predicted correlations with the Nottingham Health Profile provided evidence of the construct validity of CAMPHOR scales. The Polish CAMPHOR could distinguish between patients who differed according to their perceived general health and perceived disease severity. No significant differences in scores were found between participants grouped by gender or age. CONCLUSIONS: The Polish version of CAMPHOR demonstrated good psychometric properties and is recommended for use in clinical practice.