Non-compliant Balloon Research Articles

Coronary Intravascular Lithotripsy Effectiveness and Safety in a Real-World Cohort.

Background: Coronary artery calcification is a predictor of adverse outcomes after percutaneous coronary intervention (PCI). Intravascular lithotripsy (IVL) is a promising tool for the treatment of calcified lesions. The aim of this study was to assess the effectiveness and safety of IVL. Methods: A single-center observational study of PCI procedure, with assessment of the outcomes of patients undergoing PCI using IVL, was performed. Angiographic procedural success was used as the primary effectiveness endpoint. The primary safety endpoint was defined as a composite of cardiac death, myocardial infarction and target vessel revascularization within 30 days. Results: A total of 111 patients were included. Indications for PCI spanned the spectrum of chronic (53.2%) and acute coronary syndromes (43%). Lesion preparation before IVL was performed with non-compliant (42%), cutting or OPN (14.4%) balloons and with atherectomy techniques in 11% of procedures. Intravascular imaging was used in 21.6% of procedures. The primary effectiveness endpoint was achieved in 100% and the primary safety endpoint in 3.6% of procedures. Peri-procedural complications were minimal and successfully resolved. Conclusions: IVL was an effective and safe technique for the treatment of calcified coronary lesions. These findings contribute to the growing body of evidence supporting the use of IVL in the management of these challenging scenarios.

Evaluation of post-dilatation on longitudinal stent deformation and postprocedural stent malapposition in the left main artery by optical coherence tomography (OCT): an in vitro study

BackgroundThe diameter of the ostial and proximal left main coronary artery can be greater than 5.0 mm. However, the diameters of the mostly available coronary drug-eluting stents (DESs) are ≤ 4.0 mm. Whether high-pressure dilatation can increase the diameter of stents from 4.0 to 5.0 mm and whether post-dilatation leads to longitudinal stent deformation (LSD) of 4.0-mm-diameter stents have rarely been studied. Therefore, this study aims to evaluate LSD and stent malapposition of six types of commercially available 4.0-mm-diameter stents in China in a 5.0-mm-diameter artificial blood vessel model by optical coherence tomography (OCT) in vitro.MethodsThe left main coronary artery was simulated by a truncated cone-shaped silicone tube. The internal diameters were 4.0 mm at one end of the silicone tube and 5.0 mm at the other end. Six different types of coronary stents widely used in China were selected for this study. Each stent was respectively implanted into the simulated blood vessel and dilated to a diameter of 4.2 mm according to the stent-balloon pressure compliance table. The stents were subjected to post-dilatation with a 5.0 × 15-mm noncompliant balloon. The LSD ratio of the longitudinal axis of each stent and stent malapposition were measured through OCT, and any fractures of the stents were determined.ResultsNone of the six types of stents fractured following post-dilatation. The longitudinal axes of the BuMA and Excrossal stents were slightly shortened, while the other stents were elongated after high-pressure post-dilatation. All stents expanded to a diameter of 5.0 mm without incomplete stent apposition, except for the Nano Plus stent, which remained malapposed after high-pressure post-dilatation.ConclusionAll 4.0-mm-diameter stents can be expanded to a diameter of 5.0 mm by noncompliant balloon post-dilatation without stent strut fracture. Most stents were found to be well apposed after high-pressure post-dilatation. However, LSD was observed after post-balloon dilatation. Stent malapposition might be positively correlated with the percentage change in stent length.

Contemporary approach to heavily calcified lesions: tools of the trade, challenges, and pitfalls

Coronary artery calcifications (CAC) affect more than 90% of men and more than 67% of women older than 70; the spread is mainly due to the high occurrence of major cardiovascular risk factors. The presence of CAC can be detected by several noninvasive and invasive methods like computed tomography (CT), coronary angiography (CA), Intravascular Ultrasound (IVUS), and Optical Coherence Tomography (OCT), with each system providing different information that can be used in the treatment strategy of CAC. Several devices can modify calcium during PCI: high-pressure non-compliant balloons, cutting/scoring balloons, atheroablative technologies, and intravascular Lithotripsy (IVL). Each technique has advantages and disadvantages that every interventional cardiologist should know to perform an optimal PCI and to achieve the best result and clinical outcome. This is a narrative review that aims to illustrate the contemporary management of CAC, focusing on the available techniques to assess calcifications and their novel advancements and explaining the existing tools to treat CAC with a focus on their significant challenges and pitfalls.

Treatment of Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage using the Neurospeed Semi-compliant Balloon.

Cerebral vasospasm (CV) following aneurysmal subarachnoid hemorrhage (aSAH) may lead to morbidity and mortality. Endovascular mechanical angioplasty may be performed if symptomatic CV is refractory to noninvasive medical management. Off-label compliant remodelling balloons tend to conform to the course of the vessel, contrary to noncompliant or semi-compliant balloons. Our objective is to describe our initial experience with the semi-compliant Neurospeed balloon (approved for intracranial stenosis) in cerebral vasospasm treatment following aSAH. All patients included in the prospective observational SAVEBRAIN PWI (NCT05276934 on clinicaltrial.gov) study who underwent cerebral angioplasty using the Neurospeed balloon for the treatment of medically refractory and symptomatic CV after aSAH were identified. Patient demographic information, procedural details and outcomes were obtained from electronic medical records. Between February 2022 and June 2023, 8consecutive patients underwent CV treatment with the Neurospeed balloon. Angioplasty of 48arterial segments (supraclinoid internal carotid artery, A1and A2segments of the anterior cerebral artery, M1and M2segments of the middle cerebral artery) was attempted and 44/48 (92%) were performed. The vessel diameter significantly improved following angioplasty (+81%), while brain hypoperfusion decreased (-81% of the mean TMax). There was no long-term clinical complication, 4% periprocedural complications occurred. The semi-compliant Neurospeed balloon is effective in the treatment of cerebral vasospasm following aSAH, bringing anew device into the armamentarium of the neurointerventionalist to perform intracranial angioplasty.

An unusual complication after transcatheter aortic valve implantation: a case report

Abstract Background Ventricular septal defect (VSD) is an unusual complication of transcatheter aortic valve implantation (TAVI). The risk factors are not well understood but may include oversizing, calcification amount and location, left-ventricular chamber morphology, and valve-in-valve (ViV) procedures. Percutaneous treatment is challenging but is usually the preferred option. Case summary An 80-year-old woman with two previous surgical aortic valve replacements was admitted to our Cardiology Department for decompensated heart failure. New bioprosthesis degeneration (19 mm Mitroflow™, Sorin Group, Canada) was observed with severe intraprosthetic aortic regurgitation. After evaluation, the heart team chose to perform ViV TAVI. Because of the high risk of coronary obstruction, chimney stenting of both coronary arteries was performed. A 23 mm self-expandable Navitor™ valve (Abbott, IL, USA) was implanted, but the Mitroflow™ valve had to be cracked to minimize the persistent high gradient. During valve fracture, the non-compliant balloon broke and a small iatrogenic VSD appeared. However, the patient remained stable, so conservative management was selected. During follow-up, she developed severe haemolytic anaemia and heart failure; therefore, percutaneous closure of the iatrogenic VSD was performed twice, which was a difficult challenge. Discussion A viable alternative to redo surgery is ViV TAVI. Risks include higher rates of prosthesis–patient mismatch and coronary obstruction. Occasionally, bioprosthetic valve fracture is required, particularly in small bioprostheses, to achieve low gradients. Anecdotally, fracture has led to annular rupture and VSD. Most VSDs are small and without clinical or haemodynamic repercussions; however, in symptomatic cases, percutaneous closure is a viable alternative to surgery.

Assessment of Bridging Stents in In Situ Laser Fenestrations of Aortic Endografts With Intravascular Ultrasound

ObjectiveTreatment of complex aortic aneurysms with the in situ laser fenestration (ISLF) technique involves implantation of a balloon expandable stent graft (bSG) in the created fenestration. Adequate expansion of this bSG is of importance both to achieve seal and to ensure target vessel stability. This experimental study assessed the expansion rate of different bSGs in the ISLF setting using intravascular ultrasound (IVUS). MethodsA commercially available aortic endograft was used to test the laser fenestration technique (Zenith Alpha, Cook Medical LLC, Bloomington, IN, USA). The ISLF was stented with the following bSGs: two Gore Viabahn VBX balloon expandable endoprostheses (WL Gore & Associates, Bloomington, IL, USA), three BeGraft Peripheral and three BeGraft Plus (Bentley InnoMed GmbH; Hechingen, Germany), and three Advanta V12 (Atrium, Hudson, NH, USA). The bSGs were expanded in three steps: (1) nominal, (2) rated burst pressure, and (3) dilatation with a non-compliant balloon at 15 atmospheres. After each step, an IVUS assessment of the bSG minimal diameter and the area at the fenestration (FA) and in a fully expanded segment distal to the fenestration (SA) was performed. A mean of the three IVUS measurements was used as the value for comparison. An insufficient bSG expansion was defined as a mean of FA/SA of < 0.8 (i.e., < 80% expansion). ResultsThe VBX was the only bSG that could be expanded to its intended diameter (i.e., at least 80%) at nominal pressure. The BeGraft Peripheral and BeGraft Plus showed the lowest expansion degrees after nominal and rated burst pressure. All bSGs that were tested reached a sufficient expansion degree after the use of a higher pressure balloon. ConclusionIn this ex vivo experiment, a dilatation up to nominal pressure showed satisfactory expansion only for the VBX. The consistency of the results when applied to the different types of stent grafts that were analysed reflects structural stent graft specific issues to consider when choosing the right device in cases of ISLF.

Development of a Rabbit Iliac Arterial Stenosis Model Using a Controlled Cholesterol Diet and Pullover Balloon Injury.

This study aimed to develop a rabbit iliac stenosis model and evaluate the effects of different mechanical injury techniques on the degree of arterial stenosis. Eighteen rabbits were divided into three groups: cholesterol-fed with pullover balloon injury (group A; n = 6), cholesterol-fed with localized balloon dilatation (group B; n = 6), and chow-diet with pullover balloon injury (group C; n = 6). After baseline angiography, the left iliac arteries of all rabbits were injured with a 3 × 10 mm noncompliant balloon using either a wide pullover technique (groups A and C) or a localized balloon dilatation technique (group B). A nine-week follow-up angiography was performed, and the angiographic late lumen loss and percentage of stenosis were compared. Group A exhibited the most severe late lumen loss (A vs. B, 0.67 ± 0.13 vs. 0.04 ± 0.13 mm, p < 0.0001; A vs. C, 0.67 ± 0.13 vs. 0.26 ± 0.29 mm, p < 0.05; stenosis percentage 32.02% ± 6.54%). In contrast, group B showed a minimal percentage of stenosis (1.75% ± 6.55%). Pullover-balloon injury can lead to significant iliac artery stenosis in rabbits with controlled hypercholesterolemia. This model may be useful for elucidating the pathogenesis of atherosclerosis and for evaluating the efficacy of novel therapeutic interventions.

Mechanism of balloon burst during transcatheter aortic valve replacement pre-dilatation: Image observation and validation by finite element analysis

BackgroundBalloon burst during transcatheter aortic valve replacement (TAVR) is serious complication. This study pioneers a novel approach by combining image observation and computer simulation validation to unravel the mechanism of balloon burst in a patient with bicuspid aortic valve (BAV) stenosis. MethodA new computational model for balloon pre-dilatation was developed by incorporating the element failure criteria according to the Law of Laplace. The effects of calcification and aortic tissue material parameters, friction coefficients, balloon types and aortic anatomy classification were performed to validate and compare the expansion behavior and rupture mode of actual balloon. ResultsBalloon burst was dissected into three distinct stages based on observable morphological changes. The mechanism leading to the complete transverse burst of the non-compliant balloon initiated at the folding edges, where contacted with heavily calcified masses at the right coronary sinus, resulting in high maximum principal stress. Local sharp spiked calcifications facilitated rapid crack propagation. The elastic moduli of calcification significantly influenced balloon expansion behavior and crack morphology. The simulation case of the calcific elastic modulus was set at 12.6 MPa could closely mirror clinical appearance of expansion behavior and crack pattern. Furthermore, the case of semi-compliant balloons introduced an alternative rupture mechanism as pinhole rupture, driven by local sharp spiked calcifications. ConclusionsThe computational model of virtual balloons could effectively simulate balloon dilation behavior and burst mode during TAVR pre-dilation. Further research with a larger cohort is needed to investigate the balloon morphology during pre-dilation by using this method to guide prosthesis sizing for potential favorable outcomes.

Abstract 14961: Revitalizing Graft Patency: Intravascular Lithotripsy in Calcified Saphenous Vein Graft to Left Anterior Descending Artery Stenosis

A 73-year-old man with coronary artery disease (CAD), coronary artery bypass graft, heart failure [EF 25%] &amp; hypertension presented with Non-ST Segment Myocardial Infarction. Angiography revealed multivessel CAD with chronic total occlusion (CTO) of mid-left anterior descending (LAD) after a large first diagonal branch, CTO of mid-left circumflex &amp; distal right coronary artery. Saphenous vein graft (SVG) to obtuse marginal was patent. SVG-diagonal &amp; SVG-ramus intermedius were occluded. Mid SVG-LAD showed severe calcified stenosis (Fig. 1A). Native LAD beyond the SVG provided left to right collaterals to right posterior descending artery. Complex high-risk coronary intervention was performed on the SVG-LAD with mechanical circulatory support (MCS; Impella CP). SVG-LAD had a balloon undilatable lesion despite high pressure inflation with 4.0 mm cutting balloon (Fig. 1B). Intravascular ultrasound (IVUS) revealed severe stenosis with extensive circumferential calcification (Fig. 1C). Subsequently, intravascular lithotripsy (IVL) with 4.0 mm Shockwave balloon followed by high pressure balloon angioplasty with 4.5 mm noncompliant (NC) balloon was performed with significant luminal gain and fractures in calcium (Fig. 1D). The lesion was treated with 5.0 mm drug eluting stents that were post dilated with 5.0 mm NC balloon with excellent angiographic and IVUS result (Figs. 1E &amp; F). MCS was successfully removed at the end of the case.SVG grafts are associated with poor long-term patency compared to arterial grafts. PCI to SVG has a high failure rate and PCI of native vessel is often preferable. High risk SVG interventions with atherectomy have been recently reported, though data is limited. IVL has been safely used in heavily calcified native coronary arteries, however, its use in SVG disease is rare. We report the first off-label use IVL of SVG-LAD with MCS for treatment of a last-remaining conduit. Additional studies to assess IVL efficacy in vein grafts are warranted.

Abstract 12561: Intravascular Lithotripsy Use for Percutaneous Fontan Pathway Rehabilitation in an Adult With Fontan Pathway Obstruction

Introduction: Fontan pathway obstruction is a serious complication characterized by an anatomical or functional narrowing anywhere in the cavo-pulmonary pathways. Here we report the first case where an innovative Fontan conduit rehabilitation procedure with intravascular lithotripsy was used achieving a significant increase in the pathway size. Case: A 28-year-old male with tricuspid atresia status-post Fontan palliation (age 23 months) with bare metal stent implant to treat obstruction at age 15, presented with syncope, ascites and varicose veins. Imaging studies revealed a cirrhotic liver morphology and Fontan pathway obstruction with minimal diameter of 12 mm. Cardiac catheterization confirmed severe Fontan conduit obstruction in addition to LPA stenosis. Serial covered Cheatham-Platinum stents were implanted for conduit coverage followed by Palmaz stents. Non-compliant Atlas balloon dilation to 20 atm was performed without expansion of the Fontan pathway beyond 12 mm due to severe calcification. A 7.0 x 60 mm shock-wave lithotripsy balloon was added alongside the Atlas balloon to modulate the heavily calcified wall with subsequent expansion of the conduit to 21 mm after inflating the Atlas balloon to 14 atm. Discussion: Several studies demonstrated that transcatheter stenting of stenotic Fontan conduits can be safely performed. Intravascular lithotripsy has emerged as a novel therapy for the treatment of coronary vascular calcification. We report the first case of an innovative percutaneous Fontan conduit rehabilitation procedure using a lithotripsy shock wave balloon in an adult with severely calcified Fontan pathway obstruction and prior stents, achieving a 75% increase in the pathway size without significant complications. Further studies are needed to evaluate the long-term safety and efficacy of this novel approach, but this case presents an exciting option for future directions in the percutaneous treatment of Fontan pathway obstruction.

Modified balloons to prepare severely calcified coronary lesions before stent implantation: a systematic review and meta-analysis of randomized trials

BackgroundThe performance of modified balloons (namely cutting or scoring balloons) to prepare severely calcified lesions in patients undergoing percutaneous coronary intervention (PCI) remains controversial. We investigated the clinical and imaging outcomes of patients undergoing PCI assigned to modified balloon therapy to prepare severely calcified coronary lesions before stent implantation.MethodsIn this meta-analysis, we aggregated the study-level data from trials enrolling invasively treated patients who were randomly assigned to modified balloon or control therapy to prepare severely calcified lesions before stenting. The primary outcome was major adverse cardiac events (MACE), including death, myocardial infarction (MI), and repeat revascularization. The secondary outcomes included the individual components of the primary outcome, coronary perforation and final minimal stent area (MSA) as measured by intracoronary imaging.ResultsA total of 648 participants in six trials were allocated to modified balloon therapy (n = 335) or control therapy (semi-compliant, non-compliant, or super high-pressure balloon, n = 313). The median follow-up was 11 months. Overall, MACE occurred in 8.96% of patients assigned to a modified balloon and 12.78% of patients assigned to control therapy [risk ratio = 0.70, 95% confidence interval (CI) 0.35–1.39; P = 0.24]. There was a significant treatment effect-by-modified balloon type interaction for the outcome MACE in patients assigned to cutting balloon compared with control therapy [RR = 0.40 (0.28–0.56), P for interaction (Pint) < 0.001]. Patients treated with a modified balloon compared with control therapy showed neither a significant difference for the other clinical outcomes nor for final MSA [standardized mean difference = 0.67 (− 0.71, 2.06); P = 0.26].ConclusionsIn patients treated with PCI for severely calcific coronary artery disease a strategy of lesion preparation with a modified balloon before stenting does not improve clinical or imaging outcomes compared with control therapy. The different performance of cutting and scoring balloons warrants further investigation.Graphical

Redo-TAVI with SAPIEN 3 in SAPIEN XT or SAPIEN 3 - impact of pre- and post-dilatation on final THV expansion.

When a balloon-expandable transcatheter heart valve (THV) is chosen to treat a failed balloon-expandable THV, there is a risk of underexpansion with a potential impact on performance. We aimed to assess the impact of pre- and post-dilatation on the expansion of balloon-expandable THVs after redo-transcatheter aortic valve implantation (TAVI). Redo-TAVI was performed on the bench with a 23 mm SAPIEN 3 (S3) implanted within a 23 mm SAPIEN XT (SXT) or a 23 mm S3, both of which served as the "failed" THVs. Pre- and/or post-dilatation was performed using a 23 mm non-compliant TRUE balloon. Expansion of the index and redo-THVs were assessed before and after pre-/post-dilatation using microcomputed tomography (micro-CT), and THV hydrodynamic testing was conducted. Without pre- or post-dilatation, the S3 was underexpanded, for all combinations, particularly in the mid-portion of the THV (18.6 mm and 19.7 mm representing 81% and 86% of the nominal diameter inside the SXT and S3, respectively). Pre- and post-dilatation had an additive effect on diameter expansion of the redo-THV, which remained constrained in most combinations. The only combination to achieve nominal expansion was the S3 in S3 when both pre- and post-dilatation were performed. The S3 remained underexpanded inside the SXT despite pre- and post-dilatation (93% in the mid-portion). Improved redo-THV expansion was accompanied by 2.7 mm (12%) overexpansion of the index THV. While all samples had acceptable hydrodynamic performance, the underexpanded samples had worse leaflet pinwheeling. When performing redo-TAVI with a 23 mm S3 inside a 23 mm SXT or S3, only the S3 in S3 with the use of pre- and post-dilatation reached full expansion. This underlines the importance of CT assessment of THV expansion and the role of pre-/post-dilatation.

Safety and efficacy of a novel calcified plaque modification technique - Shockwave Intravascular Lithotripsy - in patients with coronary artery disease: Mid-term outcomes.

Coronary interventions in calcified lesions are associated with a higher rate of adverse clinical events. Initial aggressive plaque modification along with post-implantation optimization is pivotal for achieving a favorable outcome of percutaneous coronary intervention (PCI). Recently, the Shockwave C2 Intravascular Lithotripsy (S-IVL) System, a novel acoustic wave-based device designed to modify calcified plaque, has been introduced into clinical practice. We evaluated the mid-term safety and efficiency of S-IVL in a cohort of 131 consecutive patients with severely calcified coronary lesions. We retrospectively analyzed a total of 131 consecutive S-IVL PCI procedures. The study had two main inclusion criteria - the presence of a calcified resistant lesion (defined by inadequate non-compliant balloon catheter inflation) or a significantly underexpanded stent (more than 20% of reference diameter). The study had two primary endpoints - successful clinical outcome and safety concerns. Clinical success was defined as effective stent deployment or optimization of a previously underexpanded stent (with less than <20% in-stent residual stenosis). Safety outcomes were defined as periprocedural complications, such as device failure and major adverse cardiac and cerebrovascular events (MACCE). Clinical follow-up was performed at the end of hospitalization and 6 months after the index procedure. In-hospital MACCE was 4.6% with 1.5% target lesion revascularization (TLR) and one case of subacute fatal stent thrombosis. At 6-month follow-up, the MACCE rate was 7.9% with a concomitant TLR rate of 3.8%. Our mid-term data confirm acceptable safety and efficacy of intravascular lithotripsy as a valuable strategy for lesion preparation and stent optimization in a cohort of 131 consecutive patients with severely calcified coronary lesions.

Evaluation of long-term outcomes of percutaneous coronary intervention in patients with moderate to severe calcified coronary artery lesions.

Coronary artery calcification reduces elasticity and can cause hemodynamic disturbances, increasing the risk of cardiovascular complications. Furthermore, coronary calcifications make cardiovascular interventions difficult. The present study aimed to study the cardiovascular outcomes of the coronary intervention of calcified lesions in the Iranian population. The present cross-sectional study evaluated patients with moderate to severe calcified coronary artery lesions on angiography who were candidates for percutaneous coronary intervention (PCI). Demographic, echocardiographic, and angiographic data of the patients were recorded. In addition, clinical outcomes, including mortality, myocardial infarction, stroke, and stent thrombosis, were also measured 1 year after the procedure. A total of 125 participants (65% male and 35% female) with a median age of 69 (13.0) years old were enrolled. The most common calcification degree was 270° (43.5%), followed by 360° (35.5%) and 180° (21.0%). Most patients had thrombolysis in myocardial infarction (TIMI) score of 3 (47.6%). A more than 10% residual coronary minimum lumen diameter was seen in 25.8% of patients. Puncture site hemorrhage and contrast-induced nephropathy were observed in 2 (1.6%) and 1 (0.8%) patients, respectively. Following 1 year after PCI, no cases of mortality, cerebrovascular accident, myocardial infarction, and stent thrombosis were reported. Furthermore, we observed one case of heart failure (0.8%) and target lesion revascularization (0.8%). In addition, we revealed a significant relationship between calcification degree and TIMI (p < 0.001) and body mass index (p = 0.049). Percutaneous management of calcified lesions with noncompliant balloon and one or two guidewires was associated with a good success rate and few complications.

Design of percutaneous transluminal coronary angioplasty balloon catheters

BackgroundEight commercially available percutaneous transluminal coronary angioplasty (PTCA), including semi-compliant and non-compliant balloons, have been assessed in detail on their tip, balloon, shaft, RX-Port, and hypotube design. Important performance characteristics such as tip deformation, balloon elongation, and deflation rate have been quantified.MethodsFive catheters of each model were evaluated during various tests. The robustness of the tips was evaluated through compression, measuring any occurrence of damage. The longitudinal growth of the balloons was recorded during inflation up to Rated Burst Pressure (RBP). The forces required to move the catheter forward and retract it into the guide catheter were measured in a simulated use test setup. The deflation behavior was studied by measuring extracted contrast media over time. Furthermore, balloon compliance and catheter dimensions were investigated.ResultsThe outer dimensions of the catheter were found to be smallest at the hypotube (0.59–0.69 mm) and highest at the balloon, respectively, the crossing profile (0.9–1.2 mm). The tip diameter increased after compression by 1.7–22%. Cross-sections of the folded balloons revealed a tri- and two-fold, respectively. The measured balloon elongation ranged from 0.6 to 2.0 mm. After the inflation of the balloon, an increase in friction between the guide wire and the catheter was observed on four catheters. A maximum increase of 0.12 N to 1.07 N was found. Cross-sections of the RX-Port revealed a semicircular-shaped inflation lumen and a circular guide wire lumen. The measured deflation rate ranged from 0.004 to 0.013 µL/s, resulting in an estimated balloon deflation time of 10.2–28.1 s.ConclusionThis study provides valuable insights into the design characteristics of RX PTCA balloon catheters, which can contribute to facilitating the development of improved catheter designs and enhancing clinical outcomes. Distinctions between SC and NC catheters, such as balloon performance and dimensions, are evident. It is important to note that no single catheter excels in all aspects, as each possesses unique strengths. Therefore, it is essential to consider individual intervention requirements when selecting a catheter.The research also identifies specific catheter weaknesses, such as reduced wall thickness, fringes at the tip, and reduced performance characteristics.

A Systematic Review and Meta-Analysis Including 354 Patients from 13 Studies of Intravascular Lithotripsy for the Treatment of Underexpanded Coronary Stents

Calcified coronary plaque (CCP) represents a challenging scenario for interventional cardiologists. Stent underexpansion (SU), often associated with CCP, can predispose to stent thrombosis and in-stent restenosis. To date, SU with heavily CCP can be addressed using very high-/high-pressure noncompliant balloons, off-label rotational atherectomy/orbital atherectomy, excimer laser atherectomy, and intravascular lithotripsy (IVL). In this meta-analysis, we investigated the success rate of IVL for the treatment of SU because of CCP. Studies and case-based experiences reporting on the use of IVL strategy for treatment of SU were included. The primary end point was IVL strategy success, defined as the adequate expansion of the underexpanded stent. A metanalysis was performed for the main focuses to calculate the proportions of procedural success rates with corresponding 95% confidence intervals (CIs). Random-effects models weighted by inverse variance were used because of clinical heterogeneity. This meta-analysis included 13 studies with 354 patients. The mean age was 71.3years (95% CI 64.9 to 73.1), and 77% (95% CI 71.2% to 82.4%) were male. The mean follow-up time was 2.6months (95% CI 1 to 15.3). Strategy success was seen in 88.7% (95% CI 82.3 to 95.1) of patients. The mean minimal stent area was reported in 6 studies, the pre-IVL value was 3.4mm2 (95% CI 3 to 3.8), and the post-IVL value was 6.9mm2 (95% CI 6.5 to 7.4). The mean diameter stenosis (percentage) was reported in 7 studies, the pre-IVL value was 69.4% (95% CI 60.7 to 78.2), and the post-IVL value was 14.6% (95% CI 11.1 to 18). The rate of intraprocedural complications was 1.6% (95% CI 0.3 to 2.9). In conclusion, the "stent-through" IVL plaque modification technique is a safe tool to treat SU caused by CCP, with a high success rate and a very low incidence of complications.

Mid-Term Outcomes of Novel Covered Stent with Biodegradable Membrane in Porcine Coronary Artery Perforation.

Currently, commercially covered stents are the main treatment for coronary artery perforation (CAP), but without satisfied late-term outcomes when compared to drug-eluting stents (DES). This study seeks to report a new covered stent to treat porcine CAP, which is manufactured with DES and a biodegradable membrane fabricated by poly-L-lactic acid (PLLA) polymer. Experimental swines experienced CAP in proximal-middle of right coronary artery (RCA) by non-compliant balloon burst, and covered stent was deployed in breach segment. Meanwhile, coronary angiography (CAG), optical coherence tomography (OCT), histological light microscopy and scan electron microscopy were performed to characterize the performance of covered stent. Seven swines were used for this study. Two swines were euthanasia at 14 days and 28 days after procedure, respectively. The remaining 5 kept alive until sacrifice at six months. CAG at six months showed total occlusion at the stented segment of RCA in all swines. The interventional revascularization of occlusion lesion was instituted in two swines. After recanalizing occlusion lesion, OCT examination visualized diffuse heterogeneous fibrous plaques, as well as organized thrombosis, lipid deposits and several neoatherosclerosis in the occluded segment. Serial histopathologic and electron microscopies at 14 days, 28 days and six months revealed gradual occlusive vessel lumen with diffuse heterogeneous fibroplasia, smooth muscle proliferation, inflammation response and local neoatherosclerosis, moreover with identification of PLLA polymer membrane degradability. The new covered stent with biodegradable membrane could seal urgent coronary breach and prevent experimental swines death, but with all stent occlusion in mid-term (six months) follow-up, which might be attributed to diffuse heterogeneous fibroplasia, smooth muscle proliferation, inflammation response and local neoatherosclerosis with the degradation of PLLA membrane.

Bioprosthetic Valve Remodeling in Nonfracturable Surgical Valves: Impact on THV Expansion and Hydrodynamic Performance

BackgroundThere are limited data on the effect of bioprosthetic valve remodeling (BVR) on transcatheter heart valve (THV) expansion and function following valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) in a nonfracturable surgical heart valve (SHV). ObjectivesThis study sought to assess the impact of BVR of nonfracturable SHVs on THVs after VIV implantation. MethodsVIV TAVR was performed using 23-mm SAPIEN3 (S3, Edwards Lifesciences) or 23/26-mm Evolut Pro (Medtronic) THVs implanted in 21/23-mm Trifecta (Abbott Structural Heart) and 21/23-mm Hancock (Medtronic) SHVs with BVR performed with a noncompliant TRUE balloon (Bard Peripheral Vascular Inc). Hydrodynamic assessment was performed, and multimodality imaging including micro–computed tomography was performed before and after BVR to assess THV and SHV expansion. ResultsBVR resulted in limited improvement of THV expansion. The largest gain in expansion was observed for the S3 in the 21-mm Trifecta with up to a 12.7% increase in expansion at the outflow of the valve. Minimal change was observed at the level of the sewing ring. The Hancock was less amenable to BVR with lower final expansion dimensions than the Trifecta. BVR also resulted in notable surgical post flaring of up to 17.6°, which was generally more marked with the S3 than with the Evolut Pro. Finally, BVR resulted in very limited improvement in hydrodynamic function. Severe pinwheeling was observed with the S3, which improved slightly but persisted despite BVR. ConclusionsWhen performing VIV TAVR inside a Trifecta and Hancock SHV, BVR had a limited impact on THV expansion and resulted in SHV post flaring with unknown consequences on coronary obstruction risk and long-term THV function.

Management of Cerebral 4-Vessel Disease With Anterior Circulation Symptoms by Stenting Both Vertebral Arteries at the Same Session.

Stroke is among the leading causes of mortality and morbidity worldwide. The coexistence of bilateral carotid and vertebral artery (VA) occlusion and/or stenosis is in the very rare entity group in the literature. Here, we present a case with bilateral carotid artery occlusion and bilateral VA stenosis, who presented with an atypical clinical presentation and underwent bilateral vertebral percutaneous transluminal angioplasty (PTA) and stenting in the same session. A 67 year old male patient was brought to the emergency department with complaints of inability to speak and weakness in both legs for 1 day. There were bilateral infarct areas in the anterior cerebral artery region and an additional infarct area in the left middle cerebral artery region. First, the right VA stenosis level was crossed using a 0.14 guidewire. After PTA, balloon-expandable stenting was performed with a 3.0×12 mm NC (non-compliant) balloon, and nearly complete recanalization was observed. Therefore, it was decided to perform an intervention on the left VA in the same session. As in this example case, in cases where cerebral perfusion is severely impaired, medical treatment after recanalization may be one of the best treatment options. The carotid arteries are the main arteries supplying the anterior circulation, and the vertebral arteries supply blood to the posterior circulation. However, in cases where both carotid arteries are occluded/dysfunctional, all cerebral perfusion remains over the vertebrobasilar system. However, in cases such as this, where both carotid arteries are occluded/dysfunctional, all cerebral perfusion remains over the vertebrobasilar system and may be responsible for anterior circulation strokes. The situation becomes more severe if both vertebral artery critical stenosis is added. Synchronous carotid and vertebral artery revascularization is not recommended in the guidelines for patients with combined carotid and vertebral artery disease. In patients with four-vessel occlusion/stenosis, as in this particular case, the intervention method and priorities are unclear. We achieved a favorable clinical outcome with simultaneous bilateral vertebral artery angioplasty and stenting, a hazardous method that can be a guide as an approach option in similar cases.

Outcomes after Percutaneous Coronary Intervention in Patients with Extremely Calcified Left Main Lesions.

Background and Objectives: Available data with regard to the outcomes of patients with severely calcified left main (LM) lesions after revascularization by percutaneous coronary intervention (PCI) when compared to non-calcified LM lesions is unclear. Materials and Methods: The present study sought to retrospectively investigate in hospital and 1 year post-intervention outcomes of patients with extremely calcified LM lesions after PCI facilitated by calcium-dedicated devices (CdD). Seventy consecutive patients with LM PCI were included. CdD requirement was based on suboptimal results after balloon angioplasty. Results: Twenty-two patients (31.4%) required at least one CdD, while nine patients (12.8%) required at least two. Intravascular lithotripsy and rotational atherectomy were the predominantly used methods(59.1% and 40.9% respectively, for in-group ratios), while ultra-high pressure and scoring balloons contributed the least to lesion preparation (9%). In 20 patients (28.5%), severe or moderate calcifications were angiographically identified, but non-compliant balloon predilation was adequate and CdD were not necessary. Total procedural time was significantly higher in CdD group (p-value 0.02). Procedural and clinical success were obtained in 100% of cases. There were no major adverse cardiac and cerebrovascular events (MACCE) recorded during hospitalization. MACCE at 1 year post-procedure were recorded in three patients (4.2% overall). All three events were documented in the control group (6.2%), and no events were recorded in CdD group (p-value 0.23). There was one cardiac death at 10 months and two target lesion revascularizations for side-branch restenosis. Conclusions: Patients with extremely calcified LM lesions treated by PCI present a favorable prognosis if angioplasty is facilitated by more aggressive lesion debulking using calcium-dedicated devices.