Catheter-Directed Interventions (CDIs) for Acute Pulmonary ... · The intensity and invasiveness of...

110 Hellenic Journal of Vascular and Endovascular Surgery | Volume 2 - Issue 3 - 2020

INTRODUCTION

Pulmonary embolism (PE) is the third most common vascular disease in the United States after myocardial infarction and stroke1. Patients with acute PE present on a spectrum ranging from incidentally found clots without hemodynamic insult or cardiopulmonary dysfunction to sudden hypotension and pos-sible death at another extreme2.

Author for correspondence:Efthymios D. Avgerinos, MD, FACS, FEBVSAssociate Professor of Surgery, University of Pittsburgh Medical Center, Presbyterian University Hospital, Heart and Vascular Institute - Suite 351.1, 200 Lothrop Street, Pittsburgh PA 15213, USATel: +1 412 9510413E-mail: [email protected] 1106-7237/ 2019 Hellenic Society of Vascular and Endovascular Surgery Published by Rotonda Publications All rights reserved. https://www.heljves.com

The intensity and invasiveness of treatment modalities for acute PE should be commensurate with the level of hemod-ynamic, cardiac, and respiratory compromise. Conservative management with anticoagulation alone is the gold standard treatment modality for all PE patients 3,4. Patients, however, who present with signs of right ventricular dysfunction with or without hypotension require prompt debulking and reperfu-sion therapy to prevent high-anticipated morbidity and mor-tality (3-15% for intermediate, >15% for high-risk PE)5.

Benefits of systemic thrombolysis accrue from the rapid recanalization of pulmonary arteries, leading to improve-ments in pulmonary artery pressures, right ventricle (RV) function, ventilation/perfusion mismatches, and overall he-modynamics6. However, frequent contraindications for lytics in this patient cohort as well as high rates of intracranial and other major hemorrhages have limited its use, even in cases of high-risk PE7.

The local delivery of thrombolytic agents—catheter-di-rected thrombolysis (CDT)—has been an area of increasing interest. Navigating a catheter through an obstructed throm-

Catheter-Directed Interventions (CDIs) for Acute Pulmonary Embolism: a 10-year single-center experience

Sina Asaadi, MD, Patrick Cherfan, MD, Adham N. Abou Ali, MD, Rabih A. Chaer, MD, Efthymios D. Avgerinos, MD

Division of Vascular Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pa, USA

Abstract:Objectives: Catheter-directed interventions (CDIs) are increasingly used for patients with acute PE, primarily to prevent mortality. The purpose of this study was to evaluate the outcomes, the safety, and the comparative effectiveness of the various CDIs as they have evolved over the past 10 years. Methods: Patients who underwent a CDI for acute intermediate-risk and high-risk PE between the years 2009 and 2019 were identified and grouped based on PE severity (high vs. intermediate risk) and type of interventions (catheter throm-bolysis (CDT) vs. suction thrombectomy (ST)). In principle, ST was preferred for patients with a contraindication for lytics. Perioperative outcomes, including major bleeding and mortality, were assessed and compared between techniques. Clinical success was defined as survival without any adverse event. Statistical significance was set at P≤.05Results: During the study period, 365 patients (59.36±19.4 years old, 50.7% males, 91.2% intermediate-risk PE) received a CDI (CDT=330 and ST=35). Clinical success was 94% for the intermediate risk and 56.3% for the high-risk cohort. In-cidence of major bleeding was 4.2% [0.6% (n=2) strokes] in the intermediate-risk group vs 21.8% [9.3% (n=3) strokes] in the high-risk group, mainly driven by the need for transfusion. The mortality rate was 0.6% in the intermediate-risk group vs. 15.6% in the high-risk group. There were no statistically significant differences in mortality and major bleeding between CDT and ST in both the intermediate and high-risk groups. Length of hospital and ICU stay were significantly lower in patients who underwent CDT when compared to ST in the intermediate-risk group (5.87 ± 4.6 vs. 8.04 ± 4.4, P=0.003 and 2.23 ± 2.1 vs. 3.48 ± 2.5, P<0.001 respectively), likely mirroring the underlying condition related to the contraindication for lytics.Conclusion: Catheter interventions for intermediate and high risk PE are safe life-saving procedures when performed in a high volume center with appropriate expertise. CDT and ST demonstrate similar efficacy. Further prospective studies are needed to determine their comparative cost-effectiveness.Keywords: Pulmonary embolism, Catheter-directed interventions (CDIs), Catheter-directed thrombolysis (CDT), Ultra-sound-assisted thrombolysis (USAT), Suction Thrombectomy (ST).

Catheter-Directed Interventions (CDIs) for Acute Pulmonary Embolism: a 10-year single-center experience 111

bus in the pulmonary arteries creates a channel for drug de-livery and increases the surface area of the thrombus exposed to thrombolytic agents8,9. More commonly performed those days in patients with absolute contraindications to thrombol-ysis is suction thrombectomy, which is presumed to provide similar therapeutic benefits to CDT without using thrombolyt-ic agents. With a variety of options at hand, choice of treat-ment remains case-specific while taking into account physi-cian preference.

Several observational series have been published regard-ing the ability of catheter-directed interventions (CDIs) to de-crease PE clot burden and improve patient outcomes with less associated complications when compared to systemic throm-bolysis. However, few have compared those techniques to each other. The purpose of this study is to review our experi-ence on catheter interventions for PE and assess comparative effectiveness between different treatment modalities.

METHODS

Patient SelectionIn this single-center retrospective study, patients who un-derwent CDT (Standard or Ultrasound-assisted) and suction thrombectomy (ST) for the treatment of acute PE from 2009 to 2019 were identified from our institution’s electronic med-ical records.

Patients were grouped per PE type/severity as high or in-termediate risk. Per standard definition, patients who devel-oped hypotension requiring vasopressors or inotropic support were classified as having a high-risk (massive) PE. Others who were hemodynamically stable but with signs of right ventricu-lar dysfunction on imaging (echocardiography or CT angiogra-phy), or through positive biomarkers (troponin or brain natriu-retic peptide), were considered as having an intermediate-risk (sub-massive) PE10.

Patients who did not meet the above-mentioned criteria for intermediate-risk or high-risk PE, in addition to those who underwent a CDI at an outside institution before being trans-ferred, were excluded from the study.

Clinical success was defined as survival to discharge with no major bleeding, perioperative stroke, decompensation, persistent shock, or any other procedure-related adverse event (i.e., heart or valve injury) for both groups.

Global Utilization of Streptokinase and Tissue Plasmino-gen Activator for Occluded Coronary Arteries (GUSTO) criteria were used to define major bleeding. Major bleeding events in-cluded GUSTO moderate (need for transfusion with no hemo-dynamic instability) and GUSTO severe (intracranial bleeding or leading to hemodynamic instability) cases11.

This study was approved and exempted from informed consent by the institutional quality improvement review com-mittee.

Treatment ProtocolTreatment options consisted of either CDT (Standard or Ul-trasound-assisted) or ST and were initially chosen based on

physician preference and availability of resources. During the reported time frame, experience and devices have evolved. A multidisciplinary response team (PERT) has been fully active since 2014. In todays practice, a standard treatment algorithm has been implemented12. All interventions were performed in a standard angiography suite or hybrid operating room with fixed-imaging fluoroscopic capacities.

The majority of patients were maintained on therapeutic heparin protocol (unfractionated or low molecular weight) throughout the interventional treatment. Early on, we used to discontinue systematic heparin during thrombolysis (similar to DVT or arterial lysis protocols) and maintained just a sheath drip (500 units per hour). This practice was later abandoned. All patients were eventually transitioned to systemic, oral, and long-term anticoagulation therapy (warfarin, enoxaparin, or factor Xa inhibitors) before discharge.

Either femoral or internal jugular vein access (based on physician preference) was obtained under ultrasound guid-ance in all patients. When CDT was planned for bilateral PEs, a dual lumen sheath (10 or 12Fr) was used.

Few patients (mainly high-risk PE) with a low cardiopulmo-nary reserve and/or with residual iliofemoral venous throm-bus identified on duplex, had a retrievable inferior vena cava (IVC) filter placed before pulmonary artery catheterization.

Standard CDT was performed using Cragg-McNamara (Boston Scientific) or Uni-Fuse (AngioDynamics) multisidehole catheters, and Ultrasound-assisted CDT was performed using the EkoSonic system (EKOS Boston Scientific Corp)(Figure 1). Infusion of a loading dose of 2 to 4 mg of tissue plasmino-gen activator was started at the interventionist’s discretion, followed by a maintenance dose at a rate of 1 mg per hour per catheter. Patients were monitored in the intensive care unit (ICU) throughout infusion therapy. Fibrinogen levels and activated partial thromboplastin times were assessed and re-corded at set intervals.

Suction thrombectomy was performed using Inari FlowTriever (Inari Medical, Irvine CA), Indigo CAT-8 (Penum-bra, Alameda, CA), or AngioVac (AngioDynamics, Latham, NY) systems. (Figures 2 and 3)

Early on (2009-2011), lytics infusion time and dose were tailored according to clinical improvement, noted by more than 50% clot resolution on repeated angiography. Thrombo-lytics were discontinued if no improvement was noted after 48 hours. After 2011, termination was generally based on improved clinical (tachycardia and hypotension, dyspnea, or supplemental oxygen) and/or echocardiographic parameters (RV strain on repeat echocardiogram). Those were assessed 12 to 24 hours after the initiation of thrombolysis, and cathe-ters were pulled out at the patient’s bedside. For the past few years, following the OPTALYSE results, thrombolytic infusion did not typically exceed 8 hours13 (Figure 4).


Figure 1. Ultrasound assisted thrombolysis. (a) Pulmonary arteriogram indicating bilateral thrombus; (b) EKOS catheters in the right and left main pulmonary arteries, notice the radiopaque ultrasound probes along the infusion length of the catheters.

(a) (b)

Figure 2. Novel aspiration thrombectomy devices. (a) The FlowTriever (Inari Medical Inc., Irvine, Calif) consists of a flexible large-bore aspira-tion 0.035 guide catheter 20 or 24Fr (T20 and T24), and a catheter system of self-expanding nitinol discs (6-10, 11-14, and 15-18 mm), which can be advanced through the aspiration sheath to mechanically engage thrombi. The side port tubing of the sheath connects to a 60cc locking syringe that can generate up to 29mmHg negative pressure. Given the large bore access, the T20 sheath can remove up to 104mL/sec, the T24 up to 143mL/sec. A smaller T16 sheath/catheter is available but not recommended for routine use given its weak suctioning power. It is used complimentary to the larger sheaths to reach more distal targets. (b) The Indigo continuous aspiration mechanical thrombectomy (CAT) system (Penumbra, Inc, Alameda, Calif) has three components: a catheter, a separator, and a vacuum pump. It is an 8Fr catheter (CAT-8). The separator wire allows thrombus fragmentation and mobilization as well as cleaning of the catheter when it is obstructed by thrombus. The vacuum pump provides continuous suction and can aspirate up to 8mL/ sec by applying and maintaining negative pressure of almost -29 mm Hg. A CAT-12 system is anticipated to enter the market by the end of 2020.


Figure 3. Aspiration thrombectomy using the Indigo CAT8 device. Notice the complete left main pulmonary artery obstruction and subsequent thrombectomy that led to complete thrombus removal. The pulmonary artery pressure had a significant drop from 53 to 49mmHg.

Figure 4. Thrombus reduction as seen in CT pulmonary arteriogram 48 hours after catheter directed thrombolysis.


Figure 5. Catheter interventions are not complication free procedures. (a) coronary sinus was accidentally cannulated and likely injured as 4 hours after initiation of thrombolysis patient developed cardiac tamponade that required emergent surgical evacuation; (b) 1st generation Angiovac (Angiodynamics, NY) thrombectomy, led to tricuspid valve rupture that required open repair. The device is not currently promoted for use in PE.

High-risk (n=32) P-value Intermediate-risk (n=333) P-valueCDT

(n=22)Suction Thrombectomy

(n=10)CDT


(n=25)Age (years) 59.36 ± 19.4 64.60 ± 12.5 0.58 58.55 ± 15.1 60.30 ± 16.8 0.40Male (%) 9 (40.9) 4 (40) 1.00 154 (50) 13 (52) 0.47Highest Troponin(ng/mL) 1.26 ± 1.9 1.70 ± 1.9 1.00 0.58 ± 0.9 0.66 ± 0.7 0.14Highest BNP(pg/mL) 402.0 ± 315.0 396.20±468.5 0.67 428.72 ± 432.1 495.34 ± 816.3 0.78ASA1 0 0 0.76 5 (1.5) 0 0.942 0 0 29 (8.8) 2 (5.7)3 10(50%) 3(37.5%) 161 (51.8) 16 (45.7)4 7(35%) 4(50%) 95 (30.9) 13 (37.1)5 3(15%) 1(12.5%) 4 (1.2) 1 (2.9)CHF 0 0 14 (4.5) 1 (4) 0.70History of CAD 2(9.1%) 5(50%) 0.01* 41 (13.3) 2 (8) 0.37DVT 1(4.5%) 0 0.68 64 (20.8) 5 (20) 0.58Pulmonary HTN 0 0 10 (3.2) 0 0.45Recent OCP use or hormone ther-apy

2 (9.1%) 1 (10%) 0.69 15 (4.9) 1 (4) 0.67

History of PE 4 (18.2%) 1 (10%) 0.49 41 (13.3) 5 (20) 0.22History of malignancy 5 (22.7%) 2 (20%) 0.62 47 (15.3) 7 (28) 0.08Recent trauma (1month) 1 (4.5%) 2 (20%) 0.22 16 (5.2) 2 (8) 0.36Recent surgery (1month) 6 (27.3%) 3 (30%) 0.59 45 (14.6) 8 (32) 0.02*Hypercoagulable state 2 (9.1%) 0 0.46 21 (6.8) 3 (12) 0.24Lytic Contraindications 0.02 <0.001Minor 7 (31.8%) 2 (20%) 65 (21.1%) 4 (16%)Major 1 (4.5%) 4 (40%) 4 (1.2%) 12 (48%)Bilateral PE 19 (83.6%) 9 (90%) 0.63 285 (92.5%) 20(80%) 0.07RV/LV ratio(n=203)

1.21±0.2(n=11)

1.09±0.1(n=7)

0.68 1.11±0.3(n=168)

1.02±0.1(n=17)

0.52

Pulmonary artery pressure (mmHg)(n=234)

44.99±13.6(n=18)

52.16±26.6(n=6)

0.92 47.61±17.0(n=199)

49.34±14.1(n=11)

0.55

*P-value less than 0.05 considered as statically significant.BNP; Brain Natriuretic Peptide, ASA: American Society of Anesthesiology, CHF Congestive Heart Failure, CAD: Coronary Artery Disease, DVT: Deep Vein Throm-bosis, HTN: Hypertension, RV: Right Ventricle, LV: Left Ventricle, OCP: Oral Contraceptive Pills, PE: Pulmonary EmbolismTable 1. Patient demographics, risk factors and PE Characteristics across groups.


Data analysisData collected included demographic information, risk factors, and laboratory markers such as troponin and brain natriuretic peptide plasma levels. Major and minor lytic contraindications were defined based on current guidelines from the American Heart Association and European Society for Cardiology con-sensus guidelines2.

Outcomes included periprocedural complications such as ischemic cerebrovascular or cardiac events, need for addition-al surgical intervention, length of ICU, and hospital stay, and supplemental oxygen use at discharge.

Comparisons were made using the Chi-square, Fisher ex-act, or Mann-Whitney U tests depending on the nature of the data. Kaplan-Meier (KM) analysis with log-rank test were used to compare long-term survival between PE groups. Binary logistic regression was performed to identify factors associat-ed with clinical success.

Statistical analysis was performed using Statistical Package for the Social Sciences, version 25 (IBM Corp, Armonk, NY). A P-value of 0.05 was considered as cutoff for significance.

RESULTSOver 10 years, 365 patients with acute PE underwent CDIs at our institution. Among these, 333 were in the intermedi-ate-risk group, and 32 were in the high-risk group. Patients demographics, risk factors and PE characteristics are summa-rized in Table 1.

Overall clinical success was 90.7%. Clinical failure was mainly predicted by the severity of PE, troponin levels and female gender (Table 2). Perioperative details are described separately in each PE subgroup.

Kaplan-Meier analysis revealed a significant difference in 5-year survival between the intermediate-risk and high-risk PE groups (54% vs 40%, P < 0.001).

Intermediate-risk groupIn this group, 92.4% (n= 308) received CDT and 7.6% (n= 25) received a ST. Mean age was 58.6 ±15.2 years and 50.1% (n= 167) were males. Major bleeding occurred in 4.2% (n= 14) of cases, and the rate of clinical success was 94% (n=313).

Patients who underwent CDT had significantly lower rate of contraindications to lytics when compared to the ST group (23.3% (n=69) vs. 16 64% (n=16), P< 0.01). There were no sig-nificant differences in other baseline characteristics (Table 1). In-hospital death was very low in both groups (0.6% (n= 2) vs. 0, P=1.00) . In the CDT group, major bleeding occurred in 3.9% (n=12), including 2 groin hematomas that required aspiration, 2 hemorrhagic strokes, 1 coronary sinus perforation and 8 transfusions ≥ 2 units. In the ST group, there were two major bleeding events (8%), including 1 hemorrhagic stroke, 1 tricus-pid valve rupture and 2 transfusions ≥ 2 units. Overall, hospital stay and ICU stay were longer in the ST group when compared to the CDT group (8.04+4.4 vs 5.87+4.6 days, P= 0.003, and 3.48+2.5 vs 2.23+2.1 days, P= 0.001 respectively). (Table 2).

Univariate logistic model Multivariate logistic model

Variable OR 95% C.I P value OR 95% C.I P value

Age (years) 1.02 0.99-1.05 0.06 1.01 0.99-1.04 0.17

Gender (female) 3.64 1.64-8.28 0.002 3.38 1.36-8.39 0.009

Type of PE (massive) 12.17 5.297-27.96 <0.001 10.45 3.95-27.63 <0.001

Troponin(ng/mL) 1.50 1.18-1.90 0.001 1.42 1.09-1.85 0.010

Table 2. Multivariate analysis for clinical failure.

High-risk (n=32) P-value Intermediate-risk (n=333) P-valueCDT


(n=10)CDT


(n=25)LOS 9.77±6.1 12.80±12.5 0.95 5.87+4.6 8.04±4.4 0.003*ICU stay 6.18±5.9 9.89±13.5 0.68 2.23+2.1 3.48±2.5 0.001*Clinical Success 13(59.1%) 5(50) 0.65 291(94.5) 22(88) 0.21Perioperative stroke 2(9.1%) 0 0.46 3(1.0%) 0 0.79IVC filter 12(54.5) 5(50) 1.00 43(13.9) 6(24) 0.23^Discharge O2 4(18.2%) 1(10) 0.63 37(12%) 2(8) 0.80Perioperative MI 0 0 1(0.3%) 0 0.92In hospital death(mortality) 2(9.1%) 3(30%) 0.16 2(0.6%) 0 0.85Surgical conversion 2(9.1%) 0 0.46 2(0.6%) 0 0.85Major Bleeding 6 (27%) 1 (10%) 0.63 12 (3.9%) 2 (8%) 0.25

*P-value less than 0.05 considered as statistically significant.LOS: Length of hospital stay, ICU: Intensive Care Unit, MI: Myocardial Infarction^ Discharge on home oxygen Table 3. CDI outcomes.


HIGH-RISK GROUP In this group, 68.7% (n= 22) received a CDT vs. 31.3% (n= 10) who received a ST. The mean age was 61 ±17.5 years. The overall rate of clinical success (survival without any compli-cation) was 56.3% (n=18). Major bleeding occurred in 21.8% (n= 7) of cases.

Sub-analysis based on treatment modality (CDT vs ST groups) did not show significant differences in baseline char-acteristics except for a history of coronary disease (9.1% (n=2) for CDT vs. 50% (n=5) for ST, P= 0.01) and fewer lytic contrain-dications in the CDT group (36.3% (n=8) vs. 60% (n=6), P= 0.02) (Table 1).

In-hospital mortality was 15.6% for this cohort and did not differ between treatment groups (9.1% (n=2) for CDT vs 30% (n= 3) for ST, P= 0.13). Major bleeding occurred in 27% (n=6) of CDT patients (including 4 transfusions ≥ 2 units, 1 neck hemat-oma which required embolization and 1 hemorrhagic stroke). Of those, 2 patients wth groin hematomas and 2 others with no identifiable source of bleeding were managed conserva-tively. On the other hand, major bleeding occurred in 10% (n=1) patient from the ST group (Hemoglobin drop <7 g/dl re-quiring multiple transfusions). Two patients in the CDT group but none in the ST group required open surgical conversion. Overall, hospital and length of ICU stay were similar (Table 2).

DISCUSSIONThis study aimed to review our institution’s experience with acute PE patients who underwent endovascular revasculariza-tion and to compare the results of different interventions, in-cluding CDT (Standard and Ultrasound-assisted thrombolysis) and ST in both high-risk and intermediate-risk PE. Our results indicated high clinical success rates for the intermediate risk PE population and reasonable rates for the otherwise highly morbid high-risk PE population. No major differences were identified between the treatment alternatives of CDT versus ST.

Various clinical trials and consequent meta-analyses have demonstrated lower mortality with systemic thrombolysis in comparison with anticoagulants alone, but a high incidence of stroke and bleeding rates along with multiple contraindications have resulted in a higher desire for catheter interventions 14,15. Since the publication of the ULTIMA trial indicating the superi-ority of ultrasound assisted thrombolysis (USAT) over systemic anticoagulation in improving hemodynamic parameters with-out any significant increase in the bleeding complication rates, we’ve seen a tremendous increase of these interventions.15 Both standard and ultrasound assisted CDT techniques have demonstrated promising results in preventing mortality 16,16. An on-going trial (SUNSET sPE trial) aims at assessing whether ultrasound-assisted thrombolysis results in superior thrombus clearance compared with standard CDI in patients with inter-mediate-risk PE17. While ultrasound assisted thrombolysis has been leading the field of interventions more recently non lytic techniques are entering the market targeting to provide an even safer alternative by eliminating the systemic bleeding ef-fect that even locally administered tPA can have. Mechanical

thrombus aspiration provides rapid clot removal while avoid-ing the use of thrombolytics. These devices are however bulk-ier and may introduce other risks, while the distal pulmonary arterial branches cannot be reached.

The novel suction thrombectomy systems that have been recently introduced to the US market and received FDA ap-proval are the Indigo CAT 8 (Penumbra, Inc, Alameda, Calif) and Flowtriever (Inari Medical Inc., Irvine, Calif). Despite hav-ing some differences, both work with similar technical princi-ples18,19. Due to their relatively recent emergence, real word studies evaluating their safety and effectiveness and their comparison against CDT are limited.20-24 Ciampi-Dopazo et al. showed a technical success of 94.4% and a clinical success of 83.3% in 8 high-risk and 10 intermediate-risk cases of PE who underwent aspiration thrombectomy with CAT 820. Wible et al., in a single-center retrospective study, used suction thrombectomy using FlowTriever in acute PE in 8 high-risk and 38 intermediate-risk cases. Their results demonstrated tech-nical success and significant improvement in mean pulmo-nary artery pressure, with a 100% survival rate and no proce-dure-related delayed complications21. A previously published study by our institution showed no significant differences in clinical outcomes such as major bleeding, length of ICU stay, hospital stay, and clinical success between CDT and ST. How-ever, due to the smaller number of patients when the study was conducted, no sub-analysis could be done after further stratification based on PE type22.

In current study, we attempted to compare the outcomes of CDT to ST in both high-risk and intermediate-risk PEs. With the exception of length of stay being shorter for CDT in the intermediate-risk PE population, there were no significant dif-ferences in treatment outcomes. The increased ICU and hospi-tal stay likely relates to the higher incidence of recent surgery and trauma in this sub-population (P= 0.019). Irrespective of technique used mortality rates remained close to 0 for the intermediate-risk PE population and 15% for the high-risk PE ones. The traditional quoted rates for anticoagulation treat-ment for these subgroups are 3-15% and >15% respectively.1 It is worth mentioning that this experience incorporates our learning curve which included poor patient selection and var-ious complications25. In 2019, we had no major bleeding and 97% clinical success for a total of 33 cases (intermediate and high risk).26

Another important factor to be considered is cost-effec-tiveness. Device costs are roughly estimated as follows: stand-ard multisidehole catheter approximately $120 (x2 for bilat-eral infusion), EKOS catheter approximately $2600 (x2 for bi-lateral infusion), Flowtriever approximately $5040 and Indigo CAT8 approximately $5580. Hospital resources usage will ulti-mately drive the final bill. In our comparative study the pop-ulations compared weren’t identical in terms of baseline dis-ease as ST was used for those who had contraindications for lytics (recent surgery or trauma) thus reasons to stay longer in hospital. Although a randomized trial is unlikely to happen, comparing series from high-volume centers should be helpful in choosing the appropriate personalized treatment modality.


Our experience with CDIs highlights the importance of appropriate patient selection and bleeding risk assessment. Multiple techniques have been used throughout the years and a learning curve does exist, particularly as new devices are introduced in the field. While CDT is safe and effective for a subset of patients ST can be used for all PEs requiring an intervention and it remains the only option for patients with contraindications to lysis. The bulkiness and trackability of the ST devices along with a typically higher price account for their limitations against CDT. It is thus fair to say that the two tech-niques are complimentary. Systemic thrombolytics or surgical thrombectomy are otherwise a valid alternative for some pa-tient subgroups or when appropriate interventional expertise is not available. These facts come in line with the interven-tional algorithm guided by the PERT Consortium consensus12.

Our study is limited by its retrospective nature. Despite be-ing among the largest series on CDIs for acute PE, the sample sizes in the high-risk PE group as well as in the ST group remain small, limiting the ability to draw inferences. Alongside, data on patient functional status and quality of life at follow up was not collected, limiting our ability to determine the effect of these interventions in longer term functional outcomes, main-ly late PE sequelae and pulmonary hypertension.

CONCLUSIONCDT (Standard and Ultrasound-assisted) and ST for acute high-risk or intermediate-risk PE demonstrate similar safety and ef-ficacy profiles when performed in high volume centers with appropriate expertise. Further prospective studies are needed to fully determine their comparative cost-effectiveness.

AUTHOR CONTRIBUTIONSConception and design: SA, PC, AAA, RC, EAData collection: SA, PC, AAAStatistical analysis: SA, PC, AAACritical revision of the article: RC, EAFinal approval of the article: RC, EAObtained funding: Not applicable Overall responsibility: EA

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