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“The advances led by this technology have significantly revolutionised our procedures,” states José Andres Guirola Ortiz (Hospital Clinico Universitario Lozano Blesa, Zaragoza, Spain), discussing how the “invaluable” Lightning (Penumbra) CAVT system fits within his practice. Speaking to Interventional News, he shares how the unique mechanism of the device has benefits for both the operator and patient and he provides his thoughts on upcoming trial data for its safety and efficacy in the treatment of pulmonary embolism (PE).
In 2019, the European Society of Cardiology (ESC) guidelines1 updated recommendations to encompass percutaneous interventional technologies in patients with intermediate- or high-risk PE where haemodynamic deterioration has occurred as an alternative to rescue thrombolysis. For Guirola Ortiz, most patients he sees fall within this risk category, “irrespective of their suitability for fibrinolysis”.
“A decade ago, the majority were high- or massive-risk PE patients,” he reflects, but states that, retrospectively, this fact was influenced by a 2001 publication by Miguel Angel de Gregorio (University of Zaragoza, Zaragoza, Spain) on pulmonary fragmentation and fibrinolysis2.
“My mentor, [de Gregorio], collaborated with intensive care to be one of the first to formulate a protocol for addressing high-risk pulmonary embolism in unstable patients. At the time they required pulmonary angiography for diagnosis, primarily because computed tomography angiography was not available. Consequently, their thought process was: “If diagnosis is needed, why not treat simultaneously?”
With this simultaneous diagnosis and treatment de Gregorio later released scientific article which considered deviation from the eighth American College of Chest Physicians (ACCP) guideline in regard to PE catheter-directed therapies (CDT), a minimally invasive alternative to open surgery3 and was one of the first to make this suggestion.
Fast forward 20 years, and technological innovations are occurring quickly, Penumbra’s Lightning CAVT system an example of these advancements, which Guirola Ortiz stated has “revolutionised” his procedural workflow “notably reducing blood loss”. The Lightning system is designed with intermittent aspiration to facilitate quick thrombus removal in vessels of various sizes and minimize the potential for blood loss, speeding up procedures and reducing the need for thrombolytics. Powered by the Penumbra ENGINE, Lightning can detect pressure differentials within the catheter and provide audio-visual cues which are “invaluable” Guirola Ortiz highlights, “when determining whether the catheter has free-flow or is obstructed by a thrombus”.
With Lightning’s CAVT system, interventionalists have access to a robust safety profile that promotes an endovascular-first approach for treatment of PE patients. Guirola Ortiz expands on the clinical outcomes he looks for when treating these patients: “Primarily, we review the patient’s stability concerning arterial pressure and normalisation, and a reduction in cardiac frequency coupled with standard oxygen saturation levels”. Then, he continues, “we consistently measure the pulmonary artery pressure (PAP) before, during, and after thrombectomy—a decline of 10mmHg or more in systolic PAP significantly correlates with better patient outcomes” he opines.
Furthermore, Guirola Ortiz and his team then assess the patient’s cardiac conditions using echo tricuspid annular plane systolic excursion (TAPSE), and the right and left ventricular (RV/LV) ratio, pre- and post- 48 hours of treatment. Research such as that of Felix Götzinger (Universität des Saarlandes, Saarbrücken, Germany) et al4, has begun to suggest that interventional treatment options may lead to a rapid improvement in RV/LV function and pulmonary haemodynamics. For Guirola Ortiz, this data will “be instrumental in identifying patients who will benefit most” from CAVT for the treatment of PE, referencing the ongoing STRIKE-PE trial which aims to evaluate the long-term functional outcome, safety and performance of the Lightning system.
STRIKE-PE—a prospective, multicentre study of adult patients with clinical symptoms consistent with acute PE and a RV/LV ratio of 0.9 or greater—released interim data analysis at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023 annual meeting (9–13 September, Copenhagen, Denmark). Presented by John Moriarty (University of California, Los Angeles Medical Center, Los Angeles, USA) their interim analysis included 87 patients at 90 day follow-up with a mean age of 59.4 years, 59.8% of patients were male and 94.3% had intermediate-risk PE. All patients received frontline endovascular treatment with the Lightning 12 aspiration system.
Moriarty reported that the observed change in the RV/LV ratio was statistically significant, showing a 27.5% decrease. Investigators also saw a decrease in intraprocedural systolic pulmonary artery pressure (sPAP) of 9.4mmHg or 18%. Patients that required an intensive care unit (ICU) stay, the median length of stay was one day—36.8% of patients did not require an ICU stay. The researchers did note a 2.3% major bleeding event rate which occurred within 48-hours of treatment.
A unique aspect of STRIKE-PE was the emphasis on QoL (quality of life) outcomes. Moriarty noted the Borg dyspnea scale (range, 0 [none] to 10 [maximal]) at rest decreased from four to zero at 90-day follow-up. The distance covered during the six-minute walk test (6MWT) increased in this patient cohort from 179 metres at baseline, to 299 metres at 90-day follow-up. Additionally, the investigators reported a 17.7% Pulmonary Embolism Quality of Life (PEmb-QoL) survey average at 90-days (range, 0% [extent of daily life affected] to 100%) which was previously recorded as 36.7 on discharge.
“By assessing both short-term (RV/LV ratio) and long-term outcomes via quality-of-life surveys such as the PEmb-QoL survey and the functional outcome of the 6MWT, we will have a clearer picture of patient outcomes. Data from the STRIKE-PE trial will pave the way for guideline revisions in favour of minimally invasive endovascular thrombectomy,” Guirola Ortiz asserts.
So far, he continues, conclusions from the STRIKE-PE trial have shown “significant reductions” in RV/LV ratio and sPAP, as well as a quick thrombectomy time when deploying the Lightning 12 in the treatment of PE patients in a real-world population. A result which, makes him “optimistic for the future of minimally invasive pulmonary procedures”.
In light of ongoing research and the technological advancements embodied by the Lightning system for the treatment of PE, Guirola Ortiz considers whether there will be a paradigm shift in how these patients are considered for treatment in the future. For him, a “decline in the usage of fibrinolytics” is ahead, as well as a “[reduction] in the likelihood of significant bleeding complications with CDTs”.
This shift, he believes, will “largely depend on new randomised controlled trials (RCTs) presenting favourable outcomes”. Guirola Ortiz tells Interventional News how “most contemporary guidelines” are based on a 1988 RCT by Marc Verstraete (Katholieke Universiteit Leuven, Leuven, Belgium)5 which appraised intravenous and intrapulmonary recombinant tissue-type plasminogen activator in the treatment of acute high-risk PE, which he says “bears little resemblance to today’s treatment methods”. “Yet,” Guirola Ortiz continues, “since 1988, there have been no RCTs conducted comparing CDT with peripheral thrombolysis, leading to the present evidence deficit”.
However, while awaiting more robust contemporary data, Guirola Ortiz emphasises that safety and efficacy studies are important but “not every intervention requires an RCT for validation to be included in guidelines—as humorously illustrated by Gordon CS Smith’s paper6 on the use of parachutes”. Today, Guirola Ortiz underlines that, for his practice, the Lightning CAVT system “advances” the standard of care they can provide across a broad range of indications, such as deep vein thrombosis (DVT) and acute portal thrombosis for liver transplant patients, subsequently improving procedural efficacy, and overall patient care.
- Konstantinides et al 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS): The Task Force for the diagnosis and management of acute pulmonary embolism of the European Society of Cardiology (ESC). European Heart Journal, Volume 41, Issue 4, 21 January 2020, Pages 543–603.
- de Gregorio MA et al. Mechanical fragmentation and intrapulmonary fibrinolysis in the treatment of massive pulmonary embolism haemodynamic repercussions. Arch Bronconeumol. 2001; 37; 58–4.
- de Gregorio MA et al. Endovascular treatment of a haemodynamically unstable massive pulmonary embolism using fibrinalysis and fragmentation. Experience with 111 patients in a single centre. Why don’t we follow ACCP recommendations? Arch Bronconeumol. 2011 Jan; 4711; 17–24.
- Götzinger F et al. lnterventional therapies for pulmonary embolism. Nature Reviews Cardiology, Volume 20, October 2023, 670–684.
- Verstraete M et al. Intravenous and intrapulmonary recombinant tissue-type plasminogen activator in the treatment of acute massive pulmonary embolism. Circulation 77, No. 2, 353–360, 1988.
- Gordon CS Smith, Jill P Pell. Parachute use to prevent death and major trauma related to gravitational challenge: Systematic review of randomised controlled trials. BMJ Volume 327 20-27 December 2003 bmj.com.
Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. The results may not be predictive of all patients. Individual results may vary depending on a variety of patient-specific attributes.