Intravascular lithotripsy (IVL) enabled the percutaneous closure of a severely calcified paravalvular leak regurgitation following implantation of a self-expandable transcatheter aortic valve: a case report
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SUBMITTER: Evola S
PROVIDER: S-EPMC10914981 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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Project description:IntroductionThe combination of intravascular lithotripsy (IVL) and drug-coated balloon (DCB) angioplasty for calcified peripheral lesions is associated with promising short-term results. However, data regarding the 12 months performance of this treatment option is missing. This study reports on the outcomes of IVL and DCB angioplasty for calcified femoropopliteal disease.MethodsPatients treated with IVL and DCB for calcified femoropopliteal lesions between February 2017 and September 2020 were included into this study. The primary outcome measure of this analysis was primary patency. Secondary patency, freedom from target lesion revascularization (TLR) and overall mortality were additionally analyzed.ResultsFifty-five (n = 55) patients and 71 lesions were analyzed. Most patients presented with long-term limb-threatening ischemia (n = 31, 56%), 47% (n = 26) were diabetics, and 66% (n = 36) had long-term kidney disease. The median lesion length was 77 mm (interquartile range: 45-136), and 20% (n = 14) of the lesions were chronic total occlusions (CTOs). Eccentric calcification was found in 23% of the vessels (n = 16), and circumferential calcium (peripheral arterial calcium scoring system [PACSS] Class 3 and 4) was present in 78% (n = 55) of the treated lesions.The technical success after IVL amounted to 87% (n = 62) and the procedural success to 97% (n = 69). A flow-limiting dissection was observed in 2 cases (3%). Both the rates of target lesion perforation and distal embolization were 1% (n = 1). A bail-out scaffold was deployed in 5 lesions (7%). At 12 months the Kaplan-Meier estimate of primary patency was 81%, the freedom from TLR was 92% and the secondary patency 98%. The overall survival amounted to 89%, while the freedom from major amputation to 98%. The presence of eccentric disease, CTOs, or PACSS Class 4 did not increase the risk for loss of patency or TLR.ConclusionsIn this challenging cohort of patients, the use of IVL and DCB for calcified femoropopliteal lesions was associated with promising 12 months outcomes and an excellent safety profile.
| S-EPMC9896408 | biostudies-literature
Project description: Not available
| S-EPMC8878926 | biostudies-literature
Project description:Left main coronary artery disease subtends a large area of potentially jeopardized myocardium. Percutaneous coronary intervention for severe left main coronary artery disease is a reasonable treatment option for select patients. Severe coronary artery calcium of the left main artery increases the complexity of percutaneous coronary intervention and is associated with increased risk of periprocedural complications and worse long-term clinical outcomes. Intravascular lithotripsy (IVL) utilizes sonic pressure waves to modify severe coronary artery calcium and has emerged as a safe and effective alternative to coronary atherectomy. However, left main lesions were excluded from regulatory approval clinical trials of IVL. Herein, we review all available data regarding the use of IVL treatment for severe left main coronary artery disease.
| S-EPMC11308112 | biostudies-literature
Project description:BackgroundCoronary calcification impairs stent delivery and optimal expansion, a significant predictor of subsequent stent thrombosis and restenosis. Current calcium ablative technologies may be limited by guidewire bias and periprocedural complications. Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify calcium, enhance vessel compliance, and optimize stent deployment. The Disrupt CAD III study demonstrated high (92.4%) procedural success and low (7.8%) 30-day major adverse cardiac event (MACE) rates following IVL, but longer term follow-up is required to determine the durability of clinical benefit and the late impact of optimized stent implantation associated with IVL. This analysis evaluates 1-year outcomes from the Disrupt CAD III study.MethodsDisrupt CAD III (NCT03595176) was a prospective, single-arm approval study designed to assess the safety and effectiveness of IVL as an adjunct to coronary stenting in de novo, severely calcified coronary lesions (n = 384). MACE was defined as the composite of cardiac death, myocardial infarction (MI), or ischemia-driven target vessel revascularization; target lesion failure was defined as cardiac death, MI, or ischemia-driven target lesion revascularization (ID-TLR).ResultsAt 1 year, MACE occurred in 13.8% of patients (cardiac death: 1.1%, MI: 10.5%, ischemia-driven target vessel revascularization: 6.0%) and target lesion failure occurred in 11.9% (ID-TLR: 4.3%), both driven by non-Q-wave MI (9.2%). Stent thrombosis (definite or probable) occurred in 1.1% of patients (including 1 event [0.3%] beyond 30 days).ConclusionsDisrupt CAD III represents the largest long-term (1-year) analysis of coronary IVL to date. IVL treatment prior to coronary stent implantation in severely calcified lesions was associated with low 1-year rates of MACE, ID-TLR, and stent thrombosis.
| S-EPMC11308114 | biostudies-literature
Project description:Calcified coronary lesions are notorious for posing technical difficulty during angioplasty. Fortunately, more devices are available to tackle coronary calcifications. However, there remain difficult cases whereby a single modality is insufficient. Here we report the feasibility and success of a case, using Novo combination of Shockwave Lithotripsy after Orbital Atherectomy. (Level of Difficulty: Intermediate.).
| S-EPMC8305089 | biostudies-literature
Project description:Background: Whereas the efficacy and safety of intravascular lithotripsy (IVL) have been confirmed in de novo calcified coronary lesions, little is known about its utility in treating stent underexpansion. This study aimed to investigate the impact of IVL in treating stent underexpansion. Methods and Results: Consecutive patients with stent underexpansion treated with IVL entered the multicenter IVL-Dragon Registry. The procedural success (primary efficacy endpoint) was defined as a relative stent expansion >80%. Thirty days device-oriented composite endpoint (DOCE) (defined as a composite of cardiac death, target lesion revascularization, or target vessel myocardial infarction) was the secondary endpoint. A total of 62 patients were enrolled. The primary efficacy endpoint was achieved in 72.6% of patients. Both stent underexpansion 58.5% (47.5−69.7) vs. 11.4% (5.8−20.7), p < 0.001, and the stenotic area 82.6% (72.4−90.8) vs. 21.5% (11.1−37.2), p < 0.001, measured by quantitative coronary angiography improved significantly after IVL. Intravascular imaging confirmed increased stent expansion following IVL from 37.5% (16.0−66.0) to 86.0% (69.2−90.7), p < 0.001, by optical coherence tomography and from 57.0% (31.5−77.2) to 89.0% (85.0−92.0), p = 0.002, by intravascular ultrasound. Secondary endpoint occurred in one (1.6%) patient caused by cardiac death. There was no target lesion revascularization or target vessel myocardial infarction during the 30-day follow-up. Conclusions: In this real-life, largest-to-date analysis of IVL use to manage underexpanded stent, IVL proved to be an effective and safe method for facilitating stent expansion and increasing luminal gain.
| S-EPMC9000023 | biostudies-literature
Project description:IntroductionParavalvular leak (PVL) is a severe complication of transcatheter aortic valve replacement (TAVR) that can lead to poor outcomes. TAVR-in-TAVR is a promising treatment for PVL; however, reports on its safety or efficacy are limited. In this study, we aimed to investigate the clinical outcomes of TAVR-in-TAVR using balloon-expandable prostheses for PVLs after TAVR.MethodsWe retrospectively analyzed data from patients who underwent TAVR-in-TAVR using balloon-expandable Sapien prostheses for PVL after an initial TAVR at our institution. The procedural success, in-hospital complications, all-cause mortality, and echocardiographic data for up to 2 years post-surgery were evaluated.ResultsIn total, 31 patients with a mean age of 81.1 ± 7.9 years and mean Society of Thoracic Surgeons score of 8.8 ± 5.4% were identified. The procedural success rate of TAVR-in-TAVR was 96.8% (30/31). No in-hospital deaths, cardiac tamponade, or conversion to sternotomy occurred. Re-intervention was performed in only one patient (3.2%) during hospitalization. The all-cause mortality rates at 30 days and 2 years were 0% and 16.1%, respectively. A significant reduction in the PVL rate was observed at 30 days compared with that at baseline (p < 0.01).DiscussionOur findings suggest that TAVR-in-TAVR using balloon-expandable prostheses is safe and effective for PVL after TAVR with low complication rates and acceptable long-term outcomes. Further studies with larger sample sizes are needed to confirm our findings.
| S-EPMC10985156 | biostudies-literature
Project description:ObjectivesThe purpose of this study was to review the experiences with transcatheter closure of mitral PVL after surgical valve replacement.BackgroundTranscatheter closure of paravalvular leak (PVL) is an intricate alternative to surgical closure. But it represents one of the most intricate procedures in the field of structural heart interventions, especially for patients with mitral PVL.MethodsFrom January 2015 through January 2019, 35 patients with mitral PVL after valve replacement underwent transcatheter closure. We reviewed the catheter techniques, perioperative characteristics, and prognosis. The median follow-up was 26 (3-48) months.ResultsAcute procedural success was achieved in 33/35 (94.3%) patients. Twenty-five patients had single mitral prosthetic valve replacements; 10 had combined aortic and mitral prosthetic valve replacements previously; 28 had mechanical valves; and 7 had bioprosthetic valves. All percutaneous procedures were performed with local anesthesia except for seven transapical cases with general anesthesia. Multiple approaches were used: transfemoral, transapical, and transseptal via an arteriovenous loop. Multiple devices were deployed. There were no hospital deaths. The procedural time was 67-300 (124 ± 62) minutes. Fluoroscopic time was 17-50 (23.6 ± 12.1) minutes. The hospital stay was 5-17 (8.3 ± 3.2) days. Complications included recurrent hemolysis, residual regurgitation, acute renal insufficiency, and anemia. Twenty-seven (77.1%) patients improved by ≥1 New York Heart Association functional class at the 1-year follow-up.ConclusionsTranscatheter mitral PVL closure requires complex catheter techniques. However, this minimally invasive treatment could provide reliable outcomes and shorter hospital stays in selected patients. This trial is registered with NCT02917980.
| S-EPMC7943287 | biostudies-literature
Project description: Not available
| S-EPMC8084382 | biostudies-literature
Project description:Intravascular lithotripsy can be used as an effective therapy for lesion preparation in severely calcified lesions. The mechanism, as shown by optical coherence tomography, is calcium fractures. The aforementioned modification is performed with minimal risk of perforation, no-reflow and a low incidence of flow-limiting dissection and myocardial infarctions. Other techniques, such as cutting or scoring balloons and rotational atherectomy have also been shown to increase luminal diameter, but other complications, such as distal embolization, induced by these treatment modalities, are a source of concern. This review describes a single-center study of all-comer patients, including those with complex characteristics. This therapy is very effective, with a very low risk of complications. In this article, we characterize the mechanism of action of the intravascular lithotripsy catheter, its optical coherence tomography validation, clinical applications, and comparison with other calcium-modifying technologies, as well as future directions, which can be used to improve the technology.
| S-EPMC10167520 | biostudies-literature