Catheter Dilation Research Articles

Simulation analysis of different types of balloon dilatation catheters for the treatment of intracranial arterial stenosis.

The application of balloon dilation catheters in the management of intracranial arterial stenosis has been gradually increasing. However, studies on the feasibility and effectiveness of different types of balloons remain relatively scarce. In this study, catheter models of three different materials were designed to simulate balloon crimping,splitting, and dilatation processes. A compliant balloon produces large deformations with poor dilatation and a stress concentration phenomenon. During dilatation, the shear stress generated in the intima and lesion area by the semi-compliant balloon was smaller than that generated by the non-compliant balloon. These results demonstrate the feasibility of using semi-compatible balloons.

Evaluation of an Outpatient Cervical Ripening Program Using Osmotic Dilators and Foley Balloon Catheters.

This study aimed to describe patient characteristics, satisfaction, and outcome measures for patients undergoing outpatient cervical ripening. A retrospective cohort study using electronic health record data from March 2020 to March 2022 from a large health system. The sample included patients with a low-risk singleton pregnancy undergoing outpatient cervical ripening with either an osmotic dilator or Foley balloon catheter. A subset of patients completed satisfaction surveys. Frequencies and means were used to describe the population and conduct comparisons by device type. Inverse probability of treatment weighted estimates were generated to address baseline differences between patients in the two device groups. Outpatient cervical ripening was completed by 120 patients (80 osmotic dilators and 40 Foley balloon catheters). The mean time from insertion to inpatient admission was 16.2 ± 4.8 hours. The mean change in simplified Bishop score (SBS) was 1.8 ± 1.4 and the mean change in dilation was 1.8 ± 1.1 cm. There were no differences in the amount of cervical change by device type. Patients returned earlier than planned 16.7% of the time, primarily for contractions or rupture of membranes. Following outpatient cervical ripening, the time from admission to delivery was 19.9 ± 10.3 hours, with no difference by device type. Vaginal delivery occurred for 74.8% of patients. Patients reported overall satisfaction with the outpatient cervical ripening experience, with the highest satisfaction among those with osmotic dilators. Patients with both device types stated they would recommend outpatient cervical ripening to others, and experienced low levels of stress and discomfort at home prior to hospital admission. Patients participating in outpatient cervical ripening with osmotic dilators or Foley balloon catheters experienced clinically meaningful changes in dilation and SBSs while at home and reported general satisfaction with the outpatient program experience. · Outpatient use of osmotic dilators or Foley balloon catheters improved Bishop scores.. · Patient and device complications were comparable to other research findings.. · Patients reported overall satisfaction with outpatient cervical ripening..

Mechanical evaluation of the dilation force of dilation devices during interventional endoscopic ultrasound.

Background and study aims To insert the metal stent delivery system (8.5F) during interventional endoscopic ultrasound (I-EUS), several dilation steps are needed, which may be related to increased bile leakage from a fistula. There have been no definitive studies of dilation force. The aim of the present study was to evaluate dilation force during I-EUS using several dilation devices. Methods In the present study, seven dilation devices were evaluated including bougie dilators such as a straight-shaped dilator (the ES dilator, Soehendra dilator, a standard ERCP catheter) a screw-shaped dilator (Tornus ES, Soehendra stent retriever), and a 4-mm balloon catheter (REN biliary balloon catheter, Hurricane RX). The diameter of each dilator and dilation force were measured. Results Of the bougie dilators, the dilation force of the ES dilator was the highest (0.908±0.035 kg). Of the balloon catheters, the dilation force of the Hurricane RX (3.261±0.024 kg) was slightly higher than that of the REN (3.159±0.072 kg). Of the bougie dilators, although the diameter of the ES dilator was not larger than that of the Tornus ES, the dilation force was stronger. Similarly, the diameter of the Soehendra stent retriever was greater than that of the ERCP catheter or Soehendra dilator and the dilation force was lower. Conclusions Compared with bougie dilators, balloon catheters have stronger dilation force according to our experimental study. The present results should be evaluated in clinical trials.

Intracoronary microcatheter indwelling for continuous pumping of low-dose thrombolytic drugs: A new approach to reperfusion in acute myocardial infarction.

Reperfusion therapy of acute myocardial infarction (AMI) refers to physical or chemical recanalization and restoration of blood flow to an occluded coronary artery, and current techniques for reperfusion therapy include intravenous thrombolysis, percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). The number of patients receiving emergency CABG in the real world is decreasing due to the disadvantages of CABG and the improvement in PCI procedures. Thrombolytic therapy has some disadvantages such as low recanalization rate, high risk of reocclusion and bleeding, and short time window. On the other hand, intracoronary interventional therapy may meet the requirements of "early, complete and persistent" patency of coronary arteries at different time points. However, in the emergency PCI, although thrombus aspiration via a catheter or balloon dilation is performed, residual thrombus with heavy or low TIMI (thrombolysis in myocardial infarction) myocardial perfusion grading is still observed in some patients, suggesting disordered microcirculation. Currently, the treatment of microcirculatory disturbance in emergency PCI mainly employed injection of tirofiban, adenosine, thrombolytic agent or other drugs into the local area via a microcatheter in a short time, all of which can significantly reduce the thrombus load and improve TIMI perfusion. Herein, we report that a microcatheter was indwelled in the coronary artery for continuous pumping of low-dose thrombolytic drugs as reperfusion therapy in 12 patients with acute and subacute MI.

The Choice Study, Cervical Ripening In-Hospital and At-Home: Qualitative Findings and Implications for Practice

Cervical ripening (CR) is recommended as the first stage of induction of labour (IOL) in most circumstances.1 The procedure involves application of an agent, either pharmaceutical such as Prostin, or mechanical, including balloon catheter or osmotic dilator, with the aim of softening and shortening the cervix in preparation for labour. Traditionally, CR has taken place in hospital. However, some UK maternity units now offer the opportunity to return home for a period after application of the cervical ripening agent, referred to as home CR.

A novel balloon dilation catheter facilitating endoscopic papillary balloon dilation in patients with Roux-en-Y gastrectomy

Video 1Selective biliary cannulation was difficult, and the catheter tended to be cannulated into the pancreatic duct. We applied a double-wire technique to achieve biliary cannulation. Finally, selective biliary cannulation was achieved. Cholangiography revealed a small stone of approximately 5mm in the common bile duct (red arrow). Subsequently, endoscopic papillary balloon dilation (EPBD) was performed using a new EPBD catheter with a diameter of 8mm. This new EPBD catheter was inserted. We inflated this EPBD catheter slightly while observing both endoscopy and fluoroscopy monitors to confirm its dilation process. EPBD was easily and effectively performed without slipping in or out of the papilla. The orifice of the papilla was dilated. Stone extraction was completely achieved.

A Simple and Minimal Invasive Method in Reduction of Depressed Nasal Bone Fracture by Using a Foley Catheter Ballooning Technique.

The nasal bone fracture is the most common type of facial bone fracture. Closed reduction with metal reduction instrument is commonly conducted for the treatment of a type II nasal bone fracture. The authors defined a new catheter dilation technique and used it in patients with type II depressed nasal bone fractures. Preoperative and postoperative nasal appearance and radiologic examination of the patients were compared. There was a statistically significant improvement in the nasal appearance of all patients. No recurrence or dorsal irregularity has been observed. This new, easily applicable catheter dilation method of closed reduction may be a simple and less invasive solution to treat type II nasal bone fractures.

Simulation and Experimental Investigation of Balloon Folding and Inserting Performance for Angioplasty: A Comparison of Two Materials, Polyamide-12 and Pebax.

A balloon dilatation catheter is a vital tool in percutaneous transluminal angioplasty. Various factors, including the material used, influence the ability of different types of balloons to navigate through lesions during delivery. Thus far, numerical simulation studies comparing the impacts of different materials on the trackability of balloon catheters has been limited. This project seeks to unveil the underlying patterns more effectively by utilizing a highly realistic balloon-folding simulation method to compare the trackability of balloons made from different materials. Two materials, nylon-12 and Pebax, were examined for their insertion forces via a bench test and a numerical simulation. The simulation built a model identical to the bench test's groove and simulated the balloon's folding process prior to insertion to better replicate the experimental conditions. In the bench test, nylon-12 demonstrated the highest insertion force, peaking at 0.866 N, significantly outstripping the 0.156 N force exhibited by the Pebax balloon. In the simulation, nylon-12 experienced a higher level of stress after folding, while Pebax had demonstrated a higher effective strain and surface energy density. In terms of insertion force, nylon-12 was higher than Pebax in specific areas. nylon-12 exerts greater pressure on the vessel wall in curved pathways when compared to Pebax. The simulated insertion forces of nylon-12 align with the experimental results. However, when using the same friction coefficient, the difference in insertion forces between the two materials is minimal. The numerical simulation method used in this study can be used for relevant research. This method can assess the performance of balloons made from diverse materials navigating curved paths and can yield more precise and detailed data feedback compared to benchtop experiments.

A Novel Balloon Catheter Dilation Apparatus for the Treatment of Depressed Nasal Bone Fracture

The nasal bone fracture is the most common type of facial bone fracture. Closed reduction with metal reduction instrument is commonly conducted for the treatment of a depressed nasal bone fracture which often leads to iatrogenic injury. In this article, a new balloon catheter dilation apparatus for nasal bone fracture is hypothesized by the authors. This device aims to repair nasal bone fracture via dilated balloons under fractured nasal bone and used as nasal internal packing system after operation. Compared with the conventional approach, it is proposed that this balloon dilation apparatus could be a potential powerful, less invasive approach to treat depressed nasal bone fractures.

CARD10: Transapical Left Ventricular Assist Device Implantation Using a Novel Accessory in Swine

Background: Conventional left ventricular assist devices (LVADs) require an anastomosis of the outflow graft to the ascending aorta. We developed and tested a LVAD accessory, which combines pump in- and transaortic outflow in a dual lumen adapter, thus, allowing LVAD implantation solely via the left ventricular apex. Methods: The LVAD accessory (Fig. A) consisted of a 3D printed titanium inflow and a 12 mm outflow stent graft. The accessory in combination with a centrifugal LVAD (HeartMate 3, HM3, Abbott, USA) was implanted in 10 adult female Landrace pigs (104 ± 13 kg). A balloon catheter (14 mm Atlas Gold PTA Dilatation Catheter, BD, USA) was introduced via the left femoral artery and placed in the left ventricle. After lower partial sternotomy, pericardiotomy and fixation ring attachment, apical coring was performed in a standard fashion on the beating heart using cardiopulmonary bypass. The balloon was exteriorized, inflated in the outflow graft and both, the accessory with the attached outflow graft, were pulled into the left ventricle and the aorta. The accessory was attached to the fixation ring. The LVAD was connected and deaired, and the balloon catheter was removed. Results: After successful LVAD implantation in all animals, echocardiography revealed no signs of aortic or mitral regurgitation. In eight animals ramp testing was performed. The HM3 flow estimate increased from 3.7 ± 1.2 L/min at 4’500 rpm to 5.4 ± 1.2 L/min at 7’200 rpm (Fig. B). Post-mortem examination (Fig. C) revealed correct placement of the LVAD accessory with the inflow in the left ventricle (blue arrow) and the outflow graft across the aortic valve (yellow arrow). There were neither signs of damage of the aortic (*) or mitral valve (+) nor signs of thrombosis. Conclusion: The novel accessory in combination with a centrifugal LVAD allowed safe and less-invasive LVAD implantation. Ramp testing revealed effective left ventricular support in the acute swine model. Further testing in a chronic heart failure model will be performed to validate these results.

Diagnostic and therapeutic strategies for vascular complications after renal transplantation: a single-center experience in 2,304 renal transplantations.

Vascular complications after renal transplantation are one of the serious surgical complications, which can affect the transplantation outcome and even endanger life if not treated properly. We performed a retrospective analysis of the 2,304 renal transplantations procedures completed between the period of Jan., 2015 and Jan., 2022, which consisted of 1,658 male patients and 646 female patients. Among the above cases, there were 54 cases of vascular complications after renal transplantation, the incidence of vascular complications in our study was 2.34% (54/2,304), the most common vascular complication was transplanted renal artery stenosis (TRAS, n = 36), followed by external iliac artery dissection (n = 5), renal artery rupture (n = 4), renal vein thrombosis (n = 3), renal artery thrombosis (n = 2), renal artery dissection (n = 1), renal artery pseudoaneurysm (n = 1), and internal iliac artery pseudoaneurysm (n = 1), and renal artery kinking (n = 1). 40 patients were treated by percutaneous transluminal angioplasty (PTA), including 3 balloon catheter dilatation and 37 endovascular stentings, and 14 underwent open surgery. Eventually, 9 patients had graft nephrectomy, resulting in an overall treatment rate of 81.5%. Most vascular complications can be treated satisfactorily with PTA. However, the overall treatment of renal artery rupture, thrombosis, renal artery kinking, and other complications is poor, and the rate of transplanted renal loss is high.

A Chemical Characterization Workflow for Nontargeted Analysis of Complex Extracts from Polymer Based Medical Device Using High Resolution LC/MS.

The chemical characterization of extractables and leachables (E&Ls) is an important aspect of biosafety and biocompatibility assessment in medical device industry. The advent of the body-contact use of medical devices in patient treatment has introduced a potential source for extractables and leachables as these medical devices are comprised of various polymeric materials. Several industry working groups, the FDA and USP, have recognized the guidance for chemical characterizations and nontargeted analysis of medical device extracts, such as ISO 10993-18:2020. The MS application of nontargeted analysis has played a critical role in understanding the E&Ls from medical device extracts. However, there have been very few reports about the MS based workflow with nontargeted analysis for medical device extracts and there is little guidance about the exact methodologies which should be used, even though there is an urgent need for a clearly defined process for the identification of medical device extracts. In this study, we demonstrated an analytical LC/MS (liquid chromatography/mass spectrometry) workflow using high resolution Exploris120 Orbitrap instrument for data acquisition and Compound Discoverer 3.3 intelligent software for data processing to profile the polymer related E&Ls from a balloon dilation catheter device extracted with 40% ethanol. An E&L ID workflow combining LC separation, data-informed MS acquisition strategy, MS information mining (including adduct ions, MS information from both electrospray ionization (ESI) (+) and ESI (-), in-source fragmentation, common fragment ions (CFIs), common neutral losses (CNLs), and in silico MS simulation was described with intelligent software processing and manual data interpretation. The workflow developed in this study was proven to be effective to provide a comprehensive profile of polymer related degradation products, polymer impurities and additives including surfactants, UV curing agent, antioxidants, and plasticizers for the device analyzed. The classification of E&L compounds using CFIs and CNLs was very effective to facilitate the identification of polymer related impurities and extract the polymer related impurities with common structures in a large data result set.

Analysis of prognostic factors of failure in perineal urethrostomy.

To identify prognostic factors of failure in patients undergoing perineal urethrostomy (PU) with Blandy technique, with inverted U-shaped perineal flap. This is a retrospective study of PU of non-oncological causes (2001-2017). Data of age, BMI, history of diabetes mellitus, etiology of urethral stricture, type of stricture, previous surgeries, dilatation and suprapubic catheter were collected. Failure was defined as the need for any instrumentation after surgery. Variables were analyzed by Cox regression and Kaplan-Meier curves were used for survival analysis. A total of 115 PU were performed. Median age was 61years (IQR 53-68) and BMI 27.9 (IQR 25-30.9). The most frequent etiologies were: lichen sclerosus (30.4%), iatrogenic (27%), and idiopathic (25.7%). 62.6% had panurethral stricture. There were no complications in 73%. Clavien I complications occurred in 25.2%, Clavien II in 0.9% and Clavien IVa in 0.9%. The overall success rate was 51.3% with a median follow-up of 71months. In the last 8years, it was 75%. In the multivariate analysis, we found that age (p = 0.01), BMI (p = 0.01), date of surgery (p = 0.01), and suprapubic catheter (p = 0.003) were predictive variables. The voiding satisfaction rate was 88.7%. PU with Blandy technique is a surgery with low morbidity. During the entire study period, it had a failure rate of 48.7% but the failure rate decreased to 25% over the last 8years. Age, BMI, date of surgery and suprapubic catheter are the most important prognostic factor of failure.

Factors Associated With Nasolacrimal Duct Probing Failure Among Children in the Intelligent Research in Sight Registry

Understanding the factors associated with nasolacrimal duct probing failure in young children may help inform practice patterns. To identify factors associated with repeated nasolacrimal duct probing in young children. This retrospective cohort study analyzed data from the Intelligent Research in Sight (IRIS) Registry for all children who underwent nasolacrimal duct probing before 4 years of age between January 1, 2013, and December 31, 2020. The Kaplan-Meier estimator was used to assess the cumulative incidence of a repeated procedure within 2 years of the initial procedure. Hazard ratios (HRs) derived from multivariable Cox proportional hazards regression models were used to evaluate the association between repeated probing and patient age, sex, race and ethnicity, geographic region, operative side, laterality of obstruction, type of initial procedure, and surgeon volume. This study included 19 357 children (9823 [50.7%] male; mean [SD] age, 1.40 [0.74] years) undergoing nasolacrimal duct probing. The cumulative incidence of repeated nasolacrimal duct probing was 7.2% (95% CI, 6.8%-7.5%) within 2 years of the initial procedure. Among 1333 repeated procedures, the second procedure involved silicone intubation in 669 (50.2%) and balloon catheter dilation in 256 (19.2%). Among 12 008 children aged 1 year or younger, office-based simple probing was associated with a slightly higher probability of reoperation compared with facility-based simple probing (9.5% [95% CI, 8.2%-10.8%] vs 7.1% [95% CI, 6.5%-7.7%]; P < .001). In the multivariable model, a greater risk of repeated probing was associated with bilateral obstruction (HR, 1.48; 95% CI, 1.32-1.65; P < .001) and office-based simple probing (HR, 1.33; 95% CI, 1.13-1.55; P < .001), and a lower risk was associated with primary balloon catheter dilation (HR, 0.69; 95% CI, 0.56-0.85; P < .001) and procedures performed by high-volume surgeons (HR, 0.84; 95% CI, 0.73-0.97; P = .02). Age, sex, race and ethnicity, geographic region, and operative side were not associated with reoperation risk in the multivariable model. In this cohort study, most children in the IRIS Registry undergoing nasolacrimal duct probing before 4 years of age did not require any additional intervention. Factors associated with lower risk of reoperation include surgeon experience, probing performed under anesthesia, and primary balloon catheter dilation.

Safety and Efficacy of the Passeo-18 Lux Drug-Coated Balloon Catheter in Atherosclerotic Femoropopliteal Lesions: The Multicenter BIOLUX P-IV China Study

The purpose of this trial was to assess the safety and effectiveness of a paclitaxel-coated balloon catheter in Chinese patients with de novo or nonstented restenotic femoropopliteal atherosclerotic lesions. BIOLUX P-IV China is a prospective, independently adjudicated, multicenter, single-arm trial conducted in China. Patients with Rutherford class 2-4 were eligible, excluded were patients in which predilation resulted in severe (≥ grade D) flow-limiting dissection or residual stenosis > 70%. Follow-up assessments were conducted at 1, 6, and 12months. The primary safety end point was 30-day major adverse event rate and the primary effectiveness end point was primary patency at 12months. We enrolled 158 patients with 158 lesions. Mean age was 67.6±9.6years, diabetes was present in 53.8% (n=85), and previous peripheral intervention/surgeries in 17.1% (n=27). Lesions were 4.1±0.9mm in diameter and 74±50mm long with a mean diameter stenosis of 91±13%; 58.2% (n=92) were occluded (core laboratory analysis). Device success was achieved in all patients. The rate of major adverse events was 0.6% (95% confidence interval: 0.0; 3.5) at 30days, consisting of 1 target lesion revascularization. At 12months, binary restenosis was present in 18.7% (n=26) and target lesion revascularization was performed in 1.4% (n=2, all clinically driven), resulting in a primary patency of 80.0% (95% confidence interval: 72.4, 85.8); no major target limb amputation occurred. Clinical improvement at 12months, defined as improvement of at least 1 Rutherford class, was 95.3% (n=130). The median walking distance per 6-minute walk test was 279m at baseline and improved by 50m at 30days and by 60m at 12months; the visual analogue scale changed from 76.6±15.6 at baseline to 80.0±15.0 at 30days and 78.6±14.6 at 12months. Our results confirmed the clinical effectiveness and safety of a paclitaxel-coated peripheral balloon dilatation catheter for the treatment of de novo and nonstented restenotic lesion of the superficial femoral and proximal popliteal artery in Chinese patients (NCT02912715).

Multi-Modality Treatment of Supraglottic Stenosis Secondary to Laryngeal Pemphigus: Sharing Experience in UiTM

Supraglottic stenosis is a rare subsite of laryngotracheal stenosis. In the literature, the common causes of supraglottic stenosis are radiation therapy or autoimmune disease. We present an experience in dealing with supraglottic stenosis secondary to laryngeal pemphigus. This is a case of a 36-year-old lady with supraglottic stenosis secondary to laryngeal pemphigus. She presented to our clinic with shortness of breath and mild stridor mainly on exertion. An office-based procedure of trans-nasal scope-guided with serial intralesional steroid injections (SILSI) using single-use Olympus Injector Force Injection Needles Max 23G, was done which halted the progression of the disease. Eventually, balloon dilatation under jet ventilation was performed to widen the size of the stenosis and reduce the symptoms. Dilatation was performed using CRE PRO Wire-guided balloon dilatation catheter from size 8mm to 12mm with respective pressure applied for about 2 minutes without interruption of spontaneous breathing, oxygenation, or ventilation. Incision of stenosis segment with micro scissor was performed in between balloon dilatation and the procedure was completed with intralesional steroid injections. Upon follow-up, we noted clinical improvement of the stenosis as well as the patient’s health perception as measured by EQ-5D-5L. Patients with supraglottic stenosis usually need tracheostomy for breathing. This multimodality treatment might be required to treat supraglottic stenosis. Endoscopic treatment can result in favourable outcomes for the patient without needing a tracheostomy. International Journal of Human and Health Sciences Supplementary Issue: 2023 Page: S25

Low-frequency neuromuscular electrical stimulation as a treatment for anejaculation caused by iatrogenic injury of the abdominal aorta: a case study

Anejaculation is the inability to ejaculate during sexual activity, either in an antegrade or retrograde fashion. Both anejaculation following an iatrogenic injury of the abdominal aorta and the efficacy of low-frequency neuromuscular electrical stimulation (NMES) in treating anejaculation have been reported rarely. In this case report, we describe a patient who experienced anejaculation following an iatrogenic injury to the abdominal aorta and eventually regained normal ejaculation ability following treatment with NMES. The patient, a 23-year-old Chinese man, underwent laparoscopic varicocele ligation on both sides, during which he sustained a ruptured wound in the abdominal aorta from a 10-mm trocar. To stop the bleeding, he underwent abdominal aortic balloon catheter dilatation combined with covered stent implantation. However, 10 days after the endovascular interventions, the patient developed hemorrhagic shock and underwent emergency exploratory laparotomy and adventitial suture of the abdominal aorta. Despite normal erectile function since a week after the last surgery, the patient complained of aejaculation for a year during intercourse or masturbation. After receiving NMES treatment for over two months, the patient reported successful intravaginal ejaculation during intercourse, and the improvement persisted for a month after treatment. Altogether, these findings suggest that NMES could be a feasible, safe, and cost-effective treatment method for improving anejaculation and provides a novel option for patients with this condition.

GBS colonization and risk of infection with foley catheter inductions

Rising rates of induction following the ARRIVE trial with increasing time spent on labor and delivery has led to consideration of outpatient induction regimens. Foley catheter inductions have lower rates of uterine tachysystole, but concern exists for risk of chorioamnionitis due to ascending infection, particularly in the setting of GBS colonization. We aimed to determine the association of GBS colonization and the risk of chorioamnionitis in those women undergoing induction with Foley catheter dilation.

Clinical Outcomes of a Non-Compliant Balloon Dilatation Catheter: MOZEC™ NC Study

The present study sought to assess the clinical outcomes of the Mozec™ Non-compliant (NC) Rx PTCA balloon dilatation catheter (BDC) (Meril Life Sciences Pvt. Ltd., Vapi, India) for dilatation of coronary lesions. This was a post-marketing, single-centre, single-arm, retrospective study. In total, 57 patients who had undergone post-dilatation with the Mozec™ NC Rx PTCA balloon dilatation catheter were evaluated. The primary endpoint was procedural success defined as (i) successful delivery of the investigational device to and across the target lesion; (ii) successful inflation, deflation, and withdrawal of the investigational device; (iii) absence of vessel perforation, flow-limiting vessel dissection, increase in thrombolysis in myocardial infarction (TIMI) flow from baseline, clinically significant arrhythmia requiring medical treatment; and (iv) achievement of final TIMI flow grade 3 after percutaneous coronary intervention of the target lesion after single or multiple attempts to cross the target lesion. Procedural success was achieved in 57 (100%) patients. There were no incidences of major adverse cardiac events (MACE)/target lesion failure (TLF). Mozec™ NC Rx PTCA balloon dilatation catheter has demonstrated favourable outcomes for the dilatation of routine and complex coronary lesions in a small cohort, as evidenced by its 100% procedural success rate and absence of MACE.

Coronary perforation incidence and temporal trends (COPIT): systematic review and meta-analysis

Abstract Background Despite advancements in Percutaneous Coronary Intervention (PCI) technology and techniques, iatrogenic coronary artery perforation (CAP) remains a dreaded potential complication within the cardiac catheterisation laboratory. Data detailing the incidence of coronary perforation during PCI has previously been obtained from relatively small datasets. A swell of large data published in recent times provides invaluable information regarding PCI related CAP. Purpose COPIT is a systematic review and meta-analysis targeted at detailing the incidence, outcomes, etiology and treatment modalities of PCI related CAP including evaluation of temporal trends since the inception of PCI to contemporary practice. Additionally, COPIT provides hypothesis generating data regarding predictors of CAP during PCI. Methods A prospective systematic review and meta-analysis using MEDLINE and EMBASE via the OVID interface (PROSPERO ID: CRD42020207881) was performed according to the PRISMA guidelines. Identified relevant studies were used in a pre-specified sensitivity analysis to detail incidence, outcomes, etiology, treatment modalities and risk factors of PCI complicated by CAP. Studies limited to PCI in high risk populations only such as CTO-PCI or rotational atherectomy only were excluded. Results 67 studies met eligibility criteria detailing 5,568,191 PCIs over a 38-year period (1982–2020). The pooled incidence of CAP was 0.39% (95% CI: 0.34–0.45%) with no change in incidence over that time. Approximately 1 in 5 perforations led to cardiac tamponade (21.1%). Ellis 3 perforations are increasing in frequency and account for 43% of all perforations. Mortality due to perforation occurs in 7.5% of all CAP (95% CI 6.7% - 8.4%) but has declined over the studied period. Meta-regression suggested that female gender, hypertension, chronic kidney disease and previous coronary bypass grafting were all associated with higher incidence of CAP. Coronary perforation was most frequently caused by distal wire exit (37%) followed by balloon dilation catheters (28%). Covered stents were used to treat 25% of perforations, with emergency cardiac surgery needed in 17%. Conclusion Coronary perforations occurs in approximately 1 in 250 all-comer PCI procedures. A tendency towards increase in coronary perforations is likely reflective of contemporary trends towards high pressure post-dilatation with 1:1 vessel sizing as well as an ageing population with increasingly complex, calcific coronary disease. However, reduction in CAP related mortality suggests earlier recognition and effective treatment with transcatheter techniques. Funding Acknowledgement Type of funding sources: None.