Balloon Diameter Research Articles

Feasibility and efficacy assessment of a novel size-adjustable cryoballoon for ablation of atrial fibrillation in a multicenter clinical setting

Abstract Background The POLARx-FIT cryoballoon (CB) system introduces a unique feature, allowing the selection of two distinct balloon sizes within a single catheter. This innovation holds promise for treating larger pulmonary veins (PV), providing increased flexibility to achieve optimal occlusions. However, there is a scarcity of clinical data supporting its application in this context. Purpose To compare the benefits and safety of the new POLARx-FIT system to those of the existing POLARx system currently in use for PV isolation (PVI) in patients with atrial fibrillation (AF). Methods The first 140 consecutive patients who underwent CB-based PVI with the POLARx-FIT system were retrospectively compared with 300 consecutive patients treated with the POLARx system. Protocol-directed cryoablation was delivered for 180 sec or 240 sec according to operator’s preference for isolation achieved in ≤60 sec, or 240 sec if isolation occurred >60 sec or when time to isolation was not available. The ablation endpoint was PVI as assessed by entrance and exit block. In the POLARx-FIT group the choice of balloon size (28 or 31 mm) was determined during the procedure while attempting to occlude each vein. Results Two-thousand one-hundred fifty-five cryo-applications (CBA) from 440 patients were analysed (300, 68.2% POLARx; 140, 31.8% POLARx-FIT). PVI was achieved with cryoablation only in all patients. The mean number of freeze applications per patient was similar between groups (5.0±1.4 in the POLARx-FIT vs 5.3±1.8 in the POLARx group, p=0.207) whereas the number of PVs treated in a single-shot fashion was higher in the POLARx-FIT group (444, 80.7% with one shot; 75, 13.7% with 2 shots; 31, 5.6% with more than 2 shots) than in the POLARx one (1168, 70.2% with one shot, p=0.0002; 294, 17.7% with two shots and 143, 8.6% with more than two shots). Among the POLARx-FIT cases, in 54.2% (n=298) of applications, the 31-mm diameter was employed as a first choice, while in the remaining 45.8% (n=252) of applications, the 28-mm diameter was adopted. A switch to a different balloon diameter was applied in 11.6% of cases. The first pass isolation (i.e. a single shot CBA to achieve PVI) was slightly higher when using a 31 mm diameter (n=250, 83.9%) than a 28 mm diameter (n=194, 77.0%, p=0.05). Three (0.7%) transient phrenic nerve palsy were observed (all in the POLARx group, 0.9%, p=0.554), with full recovery in the 48-h post procedure; no major procedure-related adverse events were reported at 30 days post-procedure. Conclusion In this first multicentric experience in a clinical practice setting, this novel cryo-balloon system proved to be safe and effective and resulted in a high proportion of successful single-freeze isolation. The intraprocedural flexibility of balloon size contributed to its versatility, leading to a variation in balloon diameter in about 12% of freeze applications.

Mid- and long-term outcomes of percutaneous balloon mitral valvuloplasty guided solely by echocardiography

Objective: To evaluate the mid-and long-term clinical outcomes of percutaneous balloon mitral valvuloplasty (PBMV) guided solely by echocardiography. Methods: A total of 71 patients with moderate to severe mitral stenosis who underwent PBMV guided solely by echocardiography at Fuwai Hospital, Chinese Academy of Medical Sciences, from January 2016 to December 2022 were retrospectively included. The clinical data and follow-up information were collected and analyzed. Results: Finally, 71 patients (11 males and 60 females) aged (48.6±12.4) years, including 3 pregnant women were included. One patient required surgical intervention due to moderate to severe mitral regurgitation, resulting in a procedure success rate of 98.6% (70/71). The procedural duration was (84.1±40.2) minutes, with the balloon diameter of (26.5±1.1) mm and number of dilatations of 2.9±0.7. The mean mitral transvalvular pressure gradient decreased from (12.6±6.1) mmHg (1 mmHg=0.133 kPa) preoperatively to (5.4±2.4) mmHg postoperatively, while the mitral valve orifice area increased from (0.9±0.2) cm² to (1.7±0.3) cm² (both P<0.001). Before discharge, 16 patients developed new mild mitral regurgitation, five developed new moderate mitral regurgitation, and one patient had a small amount of pericardial effusion absorbed by herself. No severe complications such as death, pericardial tamponade, or thromboembolism occurred during the perioperative period. The average follow-up duration was 12-84 (49.7±21.4) months. At two years postoperatively, the mean mitral transvalvular pressure gradient was (6.2±2.5) mmHg, and the mitral valve orifice area was (1.6±0.3) cm². Eight patients underwent surgical mitral valve replacement at an median of [M(Q1, Q3)] 18 (5, 53) months postoperatively, and one patient died during the follow-up period due to non-cardiac reasons. Conclusion: The mid-and long-term outcomes of PBMV guided solely by echocardiography are favorable.

Compensating for Angiographic Underestimation With Oversized Balloon Angioplasty in Patients With Chronic Limb-Threatening Ischemia and Occluded Below-the-Knee Vessels.

Our study aims to determine optimal sizing of below-the-knee (BTK) artery angioplasty without intravascular ultrasound (IVUS), compensating for conventional angiography underestimation by selecting a balloon size one size larger than the 1-to-1 angiographic sizing. Our study is a retrospective, single-center study. Patients were separated into 2 groups as over and angiographic reference group which the over group is larger balloon diameter selection (0.5-mm larger balloon diameter selection), and angiographic reference group is 1-to-1 balloon diameter selection by angiographic images. Primary end point was the target vessel reocclusion, whereas major and minor amputation was the secondary end point. Eighty-four patients with occluded BTK lesions treated with balloon angioplasty (Opt=43, Over=41). Primary patency was 62.8% at 12 months in angiographic reference group and 82.9% in over group (p=0.039). Amputation rate at 1-year follow-up was 9.8% in angiographic reference group and 16.3% in over group (p=0.382). TLR rate is 4.9% in over group versus 20.9% in angiographic reference group (20.9%) at 1-year follow-up (p=0.029). Our study demonstrates that oversizing the balloon diameter by one size larger in BTK artery angioplasty, guided by conventional angiography, results in a higher patency rate and a lower target lesion revascularization (TLR) rate, while amputation rate remains statistically similar between the 2 groups. Our study highlights the importance of compensating for conventional angiography's underestimation in BTK artery angioplasty by using a balloon size one size larger than the 1-to-1 angiographic sizing. Our findings demonstrate that oversizing the balloon leads to significantly higher patency rates and lower TLR rates, with no increase in amputation risk. This approach provides a practical, cost-effective solution for clinicians performing angioplasty without IVUS, allowing for better vessel treatment and outcomes in patients with chronic limb-threatening ischemia. Clinicians can implement this strategy to optimize long-term results in BTK interventions.

Radial artery access with a sheathless 0.087” inner diameter balloon guide catheter (Walrus) for neurointerventional procedures: Technique and clinical outcomes

Radial artery access with a sheathless 0.087” inner diameter balloon guide catheter (Walrus) for neurointerventional procedures: Technique and clinical outcomes

Association of gastric myotomy length in peroral endoscopic myotomy (POEM) with gastro-esophageal junction distensibility measured by Endoluminal Functional Lumen Imaging Probe (EndoFLIP).

Endoluminal Functional Lumen Imaging Probe (EndoFLIP) is a device that measures gastro-esophageal junction (GEJ) distensibility. However, it is not demonstrated that GEJ distensibility increases proportionally with varying gastric myotomy length in peroral endoscopic myotomy (POEM). This study aimed to investigate the association between gastric myotomy length in POEM and intraoperative EndoFLIP findings. This single-center, retrospective cohort study included patients who underwent POEM with intraoperative EndoFLIP from December 2019 to January 2023. Using EndoFLIP, minimal balloon diameter and its distensibility index (DI) were measured pre- and post-myotomy. Primary and secondary outcomes were the post-myotomy EndoFLIP findings at 30ml and 40ml volume fills. The study included 44 patients (mean age 53.1years, 50% female). Chicago classification included achalasia type I (39%), II (41%), III (9%), hypercontractile esophagus (2%), and EGJOO (9%). The mean esophageal myotomy length was 7.5 ± 2.2cm and gastric myotomy was 2.1 ± 0.6cm. Simple linear regression analyses indicated that for each 1cm increase in gastric myotomy length, the DI at 30ml volume fill was estimated to increase by 2.0mm2/mmHg (p < 0.05, R2 = 0.41), the minimal diameter at 30ml volume fill was estimated to increase by 2.4mm (p < 0.05, R2 = 0.48), and the minimal diameter at 40ml volume fill was estimated to increase by 1.3mm (p < 0.05, R2 = 0.09). This study demonstrates a significant linear relationship between gastric myotomy length and GEJ distensibility measured by EndoFLIP during POEM. These findings may be useful in clinical practice by enabling EndoFLIP to help calibrate a desired gastric myotomy length to achieve optimal DI and minimal diameter.

Outcomes of balloon-assisted maturation with large-diameter balloons.

Balloon-assisted maturation (BAM) is a well-established technique for maturation of inadequate arteriovenous fistulas (AVF). The objective of this study was to evaluate outcomes of initial BAM using large-diameter angioplasty balloons. Charts of patients who underwent BAM between 2018 and 2021 at a single academic institution were reviewed. AVF maturation rate was the primary outcome. Secondary outcomes included procedural complications, re-intervention rates, post-procedure vein diameter, and time to catheter-free hemodialysis (HD). Outcomes of patients that underwent initial BAM with ⩾7 mm diameter balloons (Group I) were compared to those of patients that had initial BAM with <7 mm balloons (Group II). Group I (n = 149) was a significantly younger cohort and had more men compared to Group II (n = 90). There were no significant differences associated with procedural details and complication rates. Median vein diameter was larger (5.9 mm, IQR: 5-6.4) in Group I compared to Group II (5.1 mm, IQR: 4.2-5.9; p = 0.03) on post-procedure Duplex ultrasound. There was also a higher incidence of vein stenosis in Group II. The overall maturation rate was higher in Group I (97% vs 88%, p = 0.003), and a larger proportion of patients in Group II required more than one BAM to achieve maturation (33% vs 16%, p = 0.002). The median time to catheter-free HD after first BAM was 29 days (IQR: 19-47) in Group I and 42 days (IQR: 24-75) in Group II (p = 0.002). At 60 days after first BAM, the incidence of catheter-free HD was 83% in Group I versus 67% in Group II (p = 0.001). Our study demonstrates that the ability to utilize large angioplasty balloons during initial BAM is associated with higher rates of AVF maturation with fewer re-interventions and shorter time to catheter-free dialysis. AVFs that can tolerate this procedure often have more favorable baseline characteristics.

Intravascular ultrasound-guided drug-coated balloon angioplasty for femoropopliteal artery disease: a clinical trial.

Drug-coated balloons (DCBs) have demonstrated favourable outcomes following endovascular therapy for femoropopliteal artery (FPA) disease. However, uncertainty remains whether the use of intravascular ultrasound (IVUS) can improve the outcomes of DCBs. This prospective, multicentre, randomized trial, conducted at seven centres in South Korea, compared the outcomes of IVUS-guided vs. angiography-guided angioplasty for treating FPA disease with DCBs. Patients were assigned to receive IVUS-guided (n = 119) or angiography-guided (n = 118) angioplasty using DCBs. The primary endpoint was 12-month primary patency. Between May 2016 and August 2022, 237 patients were enrolled and 204 (86.0%) completed the trial (median follow-up; 363 days). The IVUS guidance group showed significantly higher primary patency [83.8% vs. 70.1%; cumulative difference 19.6% (95% confidence interval 6.8 to 32.3); P = .01] and increased freedom from clinically driven target lesion revascularization [92.4% vs. 83.0%; difference 11.6% (95% confidence interval 3.1 to 20.1); P = .02], sustained clinical improvement (89.1% vs. 76.3%, P = .01), and haemodynamic improvement (82.4% vs. 66.9%, P = .01) at 12 months compared with the angiography guidance group. The IVUS group utilized larger balloon diameters and pressures for pre-dilation, more frequent post-dilation, and higher pressures for post-dilation, resulting in a greater post-procedural minimum lumen diameter (3.90 ± 0.59 vs. 3.71 ± 0.73 mm, P = .03). Intravascular ultrasound guidance significantly improved the outcomes of DCBs for FPA disease in terms of primary patency, freedom from clinically driven target lesion revascularization, and sustained clinical and haemodynamic improvement at 12 months. These benefits may be attributed to IVUS-guided optimization of the lesion before and after DCB treatment.

Feasibility of intentional bioprosthetic valve fracture in the tricuspid position.

Transcatheter tricuspid valve-in-valve (ViV) replacement has yielded good hemodynamic outcomes in the treatment of dysfunctional bioprosthetic valves (BPVs). Intentional fracture of certain rigid BPV frames, if feasible, allows a larger implanted valve when compared with implant into an unfractured BPV. There remains limited data on the feasibility of tricuspid valve frame fracture. Evaluate the feasibility of transcatheter tricuspid ViV replatement with fracture of the underlying BPV ring. An international multicenter registry of tricuspid ViV replacement with intentional tricuspid valve frame fracture was created. Demographic data along with procedural characteristics, outcomes, and follow-up data were collected. Comparison was made to the pre- and post-ViV replacement with fracture of the tricuspid valve frame conditions. Ten patients from six centers were included with a median age and weight of 29 years and 67.3 kg respectively. Tricuspid valve frame fracture was performed using a median balloon diameter 3 mm (IQR 3-5) larger than the true inner diameter (ID). The final ID was a mean of 1.5 mm (95% CI: 0.35, 2.64: p < 0.05), and median 1.1 mm (0.5, 2.1) larger than the reported true ID of the surgical BPV after ViV replacement. The mean tricuspid inflow gradient by echocardiogram decreased by 6.65 mmHg (95% CI: 4.14, 9.15: p < 0.001). All procedures were without complication, specifically there was no heart block, pericardial effusion, or right coronary disruption. Intentional tricuspid valve frame fracture with tricuspid ViV replacement is feasible and can increase the valve orifice potentially reducing the risk of ViV patient prosthesis mismatch and is not associated with significant complications.

Risk and protective factors for secondary procedures after endoscopic dilatation of primary obstructive megaureters.

High-pressure balloon dilatation (HPBD) of the ureterovesical junction with double-J stenting is a minimally invasive alternative to ureteral reimplantation or cutaneous ureterostomy for first-line surgical treatment of primary obstructive megaureter (POM). The aim of our study was to identify the risk factors associated with the need for secondary procedures due to HPBD failure. Prospective data were collected from patients who underwent HPBD for POM between 2007 and 2021 at a single institution. The collected data included patient demographics, diagnostic modalities, surgical details, results, and follow-up. Multivariate logistic regression analysis was performed. Fifty-five ureters underwent HPBD for POM in 50 children, with a median age of 6.4months (IQR: 4.5-13.8). Nineteen patients (37.25%) underwent secondary ureteric reimplantation, with a median of 9.8months after primary HBPD (95% CI 6.2-9.9). The median follow-up was 29.4months (IQR: 17.4-71). Independent risk factors for redo-surgery in a multivariate logistic regression model were: progressive ureterohydronephrosis (OR = 7.8; 95% CI 0.77-78.6) and early removal of the double-J stent. A risk reduction of 7% (95% CI 2.2%-11.4%) was observed per extra-day of catheter maintenance. The optimal cut-off point is 55days, ROC curve area: 0.77 (95% CI 0.62-0.92). Gender, distal ureteral diameter, pelvis diameter, dilatation balloon diameter and preoperative differential renal function did not affect the need for reimplantation. The use of a double-J stent for at least 55days seems to avoid the need for a secondary procedure. Therefore, we recommend removing the double-J catheter at least 2months after the HBPD.

Long-Term Results of Percutaneous Balloon Aortic Valvuloplasty in Children With Aortic Stenosis: A Single-Center Experience.

Congenital aortic stenosis is a common pathology in the childhood age group and its clinical spectrum varies between asymptomatic and severe heart failure. In our study, we planned to evaluate the long-term results of patients who underwent balloon aortic valvuloplasty (BAV) due to critical aortic valve stenosis in our clinic. Patients aged 0-18 years who underwent aortic balloon valvuloplasty due to aortic stenosis in our clinic between January 2002 and January 2022 were retrospectively evaluated. Among the 48 patients who underwent balloon valvuloplasty due to aortic stenosis, 13 (27%) were female, and 35 (73%) were male. The median age at the time of the procedure was 27.5 months (IQR: 4-96), the median weight was 9.9 kg (IQR: 5.40-29.50), and the median height was 79 cm (IQR: 54-133). The median follow-up duration was 93.5 months (IQR: 38-132). Angiographic assessments in all patients revealed a median left ventricular pressure of 160 mmHg (IQR: 140-200) and a median pressure gradient between the left ventricle and the aorta of 60 mmHg (IQR: 42-80). The median balloon diameter used was 10 mm (IQR: 8-12). Post-procedural measurements showed a median mean gradient of 30 mmHg (IQR: 20-35) between the left ventricle and the aorta. The procedure was successful in 45 (93.5%) patients. During follow-up, 11 patients required surgical intervention. Ross procedure was performed in five patients, homograft in five patients, and mechanical valve implantation in one patient. Risk factors for the need for surgical intervention were evaluated in detail. During the follow-up, the risk factor for intervention was determined to be aortic insufficiency. Aortic valve balloon valvuloplasty is a safe and successful treatment method for critical aortic stenosis. It should be the first choice of treatment option in suitable patients.

Injury to the sinus nodal artery during radiofrequency ablation of atrial fibrillation and atrial tachycardia: its prevalence and treatment with percutaneous coronary intervention

Abstract Background/Introduction Injury to the sinus node artery (SNA) leading to SN dysfunction during radiofrequency catheter ablation (RFCA) of atrial Fibrillation (AF) and atrial tachycardia (AT) has been reported. Purpose The purpose of this study was to elucidate the prevalence and clinical course of SNA injuries during RFCA of AF/AT and examine the efficacy of the percutaneous coronary intervention (PCI) to restore SN function. Methods We retrospectively analyzed data from 6,906 consecutive patients (pts) who underwent RFCA of AF/AT (6,379 pts with AF ablation and 527 pts with AT ablation) in two institutions between January 2013 and December 2022. Results Among 6,906 pts, 9 (0.13%) pts developed SN dysfunction due to SNA injury during RFCA (8 with AF, 1 with AT). Acute SNA injury (total occlusion or severe narrowing of the SNA) was confirmed by coronary angiography (CAG) during the RFCA session in 8/9 pts. In the remaining patient, SNA injury was suspected based on the CT angiography. The culprit sites of the SNA injury were located at the septal site of the superior vena cava-right atrium junction in 4 pts (44%), on the left atrial appendage ridge in 3 (33%), on the roof of the left atrium adjacent to the right superior pulmonary vein in 1 (11%), and in the persistent left superior vena cava in 1 (11%). PCI to the occluded SNA was performed in 8 of the 9 pts: 1) coronary blood flow of the SNA was restored by a 0.014" guidewire advancement into the occluded artery using a micro-catheter followed by direct nitroprusside injection in 4 pts; 2) the direct balloon angioplasty using 0.75-1.5 mm diameter balloons was required to maintain the blood flow of SNA in 3 pts; and 3) CAG revealed spontaneous recovery of the blood flow of SNA in one pt. The remaining patient did not receive the CAG/PCI. All 8 pts who underwent the PCI resulted in restoration of normal sinus rhythm. During a median of 44 months follow-up, all 8 pts who received the PCI maintained normal sinus rhythm, while one patient without PCI demonstrated persistent SN dysfunction. Conclusions SNA injury during RFCA is a rare but critical complication. Prompt recognition by CAG and subsequent PCI effectively restores SN function in pts with unexpected SN dysfunction during RFCA procedures.

Jailed high-pressure balloon technique is superior to jailed wire technique in protecting side branch of coronary bifurcation lesions

Objectives. This study investigated the influence of higher pressure protection with a small diameter balloon of side branch (SB) on bifurcation lesions. Background. Of the different coronary stent implantation techniques, the modified jailed balloon technique has become a viable option for bifurcation lesions. However, there was no detailed study on the relationship between the balloon inflation pressure of the main vessel (MV) and SB. Methods. In this study, we collected information of patients who underwent percutaneous coronary intervention (PCI) for bifurcated lesions between March 2019 and December 2022. They were divided into two groups according to the operation way: active jailed balloon technique (A-JBT) group and jailed wire technique (JWT) group. Results. A total of 216 patients were enrolled. The A-JBT group had a larger SB stenosis diameter (1.53 ± 0.69 vs. 0.95 ± 0.52, p < .001), the lower degree of stenosis (44.34 ± 18.30 vs. 63.69 ± 17.34, p < .001) compared to the JWT group. However, the JWT group had a higher incidence of SB occlusion (18.0% vs. 1.9%, p < .001) compared to the A-JBT group. Nevertheless, the success rate for both groups was 100%. Conclusions. This novel high inflation pressure and small diameter balloon approach we propose has significant advantages. There is a lower rate of SB occlusion and SB dissection, which is more cost-effective and provides better clinical outcomes for the patient. This method should be considered in the future for treating bifurcation lesions.

Balloon neck-plasty to create a wide-necked aneurysm in the elastase-induced rabbit model.

The elastase-induced aneurysm (EIA) model in rabbits has been proposed for translational research; however, the adjustment of aneurysm neck size remains challenging. In this study, the technical feasibility and safety of balloon neck-plasty to create a wide-necked aneurysm in rabbit EIA model were investigated. Male New Zealand White rabbits (N = 15) were randomly assigned to three groups: group A, EIA creation without neck-plasty; group B, neck-plasty immediately after EIA creation; group C, neck-plasty 4 weeks after EIA creation. The diameter of balloon used for neck-plasty was determined 1 mm larger than origin carotid artery diameter. All rabbits were euthanized 4 weeks after their final surgery. Aneurysm neck, height, dome-to-neck (D/N) ratio, and histologic parameters were compared among the groups. Aneurysm creation was technically successful in 14 out of 15 rabbits (93.3%), with one rabbit experiencing mortality due to an adverse anesthetic event during the surgery. Saccular and wide-necked aneurysms were successfully created in all rabbits. Aneurysm neck was significantly greater in groups B and C compared to group A (all P < .05). D/N ratio was significantly lower in groups B and C compared to group A (all P < .05). Additionally, tunica media thickness, vessel area, and luminal area were significantly greater in groups B and C compared to group A (all P < .05). These variables were found to be significantly greater in group B compared to group C (all P < .05). The creation of a wide-necked aneurysm using balloon neck-plasty after elastase induction in rabbits has been determined to be technically feasible and safe.

Retrospective analysis on diameters of drug-coated balloons and predilatation balloons in infra-inguinal endovascular treatment (RABBIT study).

This multicenter retrospective study assessed the clinical outcomes of endovascular therapy (EVT) using a drug-coated balloon (DCB) that was larger than the predilatation balloons for femoropopliteal artery lesions. We analyzed 1140 cases with symptomatic peripheral artery disease that underwent EVT with DCB for femoropopliteal lesions between 2017 and 2021. The primary endpoint was procedural failure, defined as a composite of deteriorated dissection and bailout stenting. The secondary endpoints included deteriorated dissection, bailout stenting, restenosis, and target lesion revascularization. We performed propensity score matching to compare the clinical outcomes between EVT with a DCB which was larger than the predilatation balloon (larger DCB) and EVT with a DCB which was not (nonlarger DCB). We assigned 276 cases to the larger DCB group and 864 cases to the nonlarger DCB group. Procedural failure was observed in 75 cases, whereas restenosis occurred in 282 cases during a mean follow-up period of 12.7 ± 9.7months. Propensity score matching extracted 273 pairs with no intergroup difference in baseline characteristics, except the predilatation balloon size. Procedural failure (9.2% versus 6.1%, P = 0.11), deteriorated dissection and bailout stenting proportion (both P > 0.05), and 1-year rates of freedom from restenosis (82.4% versus 84.1%, P = 0.59) and target lesion revascularization (89.7% versus 90.4%, P = 0.83) showed no significant difference between the larger and nonlarger DCB groups. Irrespective of whether the DCB size was larger than the predilatation balloon, no difference was observed in either procedural or clinical outcomes.

Optimising Percutaneous Coronary Interventions: The Impact of Stent Type and Diameter on Long-Term Clinical Outcomes in Large Coronary Arteries.

Background and Objectives: Our study aimed to reveal the effect of using 4 mm bare-metal stents (BMS), 4 mm drug-eluting stents (DES), or 3 mm DES with 4 mm diameter balloon post-dilation strategies on long-term clinical outcomes and endpoints for large-diameter coronary artery percutaneous coronary intervention (PCI). Materials and Methods: In our study, patients who had undergone PCI were retrospectively screened between January 2014 and July 2020. The study included 350 patients and was divided into three groups; Group I (n = 134) included patients with direct 4.0 mm BMS implantation, Group II (n = 109) included patients with direct 4.0 DES implantation, and Group III (n = 107) included patients with 4mm NC post-dilatation after 3 mm DES implantation. Primary endpoints were determined as target lesion revascularisation, cardiac mortality, and myocardial infarction associated with the target vessel. Our secondary endpoint was all-cause mortality. Results: No differences were observed between the groups in terms of the baseline variables. Stent length was the highest in Group II and the shortest in Group III. There were no significant differences between the groups regarding major adverse cardiovascular events (MACE). Conclusions: Our study suggests that in percutaneous coronary interventions for non-complex lesions, there is no significant difference in MACE outcomes when directly implanting a 4 mm diameter DES, a 4 mm diameter BMS, or a 3 mm diameter DES, followed by post-dilation with an appropriately sized NC balloon when the target vessel diameter is in the range of 4 to 4.4 mm.

The Impact of Balloon Pre-dilatation Techniques on Drug-Coated Balloon Therapy for Femoropopliteal Artery Disease: Six-Month Results From the CIVILIAN Registry.

The purpose of this study is to compare the initial outcomes of using the Chocolate balloon pre-dilatation (CLP) and sequential enlarging angioplasty pre-dilatation (sequential balloon pre-dilation [SP]) techniques versus the conventional balloon pre-dilatation (CP) method prior to drug-coated balloon (DCB) treatment for femoropopliteal (FP) lesions. This was a retrospective analysis of prospectively collected data from the CIVILIAN (Clinical InVestigation of different lesIon preparation modaLIty followed by DCB in femoropopliteal Artery occlusioN disease) registry. Between March 2021 and November 2022, 3 pre-dilation techniques used prior to the DCB angioplasty were included. The study endpoint included intraoperative finial severe dissection after provisional stent placement, bailout stenting rate, the diameter of the largest pre-dilation balloon and DCB, as well as major adverse events (MAEs), including death, major limb amputation, or target vessel revascularization at 6 months. During the study period, 435 limbs (429 patients) were pre-dilated before DCB treatment in FP lesions, 166 limbs were pre-dilated with Chocolate balloons, 93 limbs with sequential enlarging balloon pre-dilation technique, and 176 limbs with CP. The largest pre-dilation balloon was significantly larger in CLP and SP groups than that in the CP group (CLP 4.74±0.52 mm vs CP 4.36±0.64 mm, p<0.001; SP 4.82±0.69 mm vs CP 4.36±0.63 mm, p<0.001). A consistent result was shown in DCB diameter (CLP 4.86±0.44 mm vs CP 4.71±0.51 mm, p=0.003; SP 4.90±0.58 mm vs CP 4.71±0.51 mm, p=0.006). The bailout stenting rate was significantly lower in the CLP group than that in the CP group (18.1% vs 30.1%, p=0.011). The rates of MAEs at 6 months in the CLP and SP groups were comparable to those in the CP group (7.2% and 8.6% vs 6.3%, p>0.05). The risk for intraoperative bailout stenting rate was related to TASC D classification (3.59, 95% CI: 1.83-7.05, p<0.001), chronic total occlusion (CTO) lesion (1.82, 95% CI: 1.07-3.10, p=0.028), as well as pre-dilated with the conventional balloon (1.64, 95% CI: 1.00-2.69, p=0.048). By utilizing chocolate balloon and sequential enlarging angioplasty, it becomes possible to use larger pre-dilation balloons and DCBs. In addition, the use of the chocolate balloon can significantly reduce the need for bailout stenting when compared with conventional balloons. The utilization of a chocolate balloon and sequential enlarging angioplasty has emerged as a promising technique for angioplasty procedures. This approach allows for the use of larger pre-dilation balloons and drug-coated balloons. The use of the chocolate balloon can significantly reduce the need for bail-out stenting when compared to conventional balloons. Further research is required to determine the impact of vessel preparation techniques on the primary patency.

P320 Impact of Enterography on the Outcomes of Endoscopic Balloon Dilation for Ileocolonic Anastomotic Strictures in Crohn's Disease

Abstract Background Ileocolonic anastomotic stricture (ICAS) is a common complication following surgery for complicated Crohn's Disease (CD). Endoscopic balloon dilation (EBD) has emerged as a non-invasive therapeutic modality for symptom relief and delaying surgical interventions. However, the impact of enterography, utilizing magnetic resonance imaging (MRI) or computed tomography (CT), in characterizing ICAS and its influence on short- and long-term EBD outcomes remain unclear. Methods This retrospective study included patients who underwent EBD for ICAS. Demographic and clinical data were collected, encompassing short-term outcomes (procedure complications and symptom improvement) and long-term outcomes (need for surgery, hospitalization, or repeat dilation). Results A total of 15 patients with ICAS were included in the study, with 46.7% being females, and a mean age of 41.2±15.6 years at the time of EBD. Six patients (40%) had undergone enterography six months prior to EBD. The median balloon diameter used for dilation was 15mm (range: 10mm to 17mm) and during the procedure, significant mucosal inflammation of the anastomosis (Rutgeerts Score ≥2) was observed in seven patients (46.7%). EBD was successful in 12 patients (80%) without any immediate complications. In the 12-month post-procedure period, one patient experienced hospital admission due to intestinal occlusion, one patient required abdominal surgery, and another patient underwent two additional EBD procedures. We did not observe a trend for an increased occurrence of complications in patients submitted to EBD without prior recent enterography, in the 12 months following the procedure or thereafter. Conclusion In this small but homogeneous cohort, our findings suggest that recent enterography does not significantly improve ICAS EBD outcomes. Therefore, our data suggest that performing enterography should not delay EBD in symptomatic CD patients with ICAS.

Optimal dilation duration of 10 mm diameter balloons after limited endoscopic sphincterotomy for common bile duct stones: a randomized controlled trial

Limited endoscopic sphincterotomy (EST) combined with endoscopic papillary balloon dilation (EPBD) is widely used. However, the optimal duration of small balloon dilation in choledocholithiasis remains controversial. We aimed to determine the optimal duration for 10 mm diameter balloon dilation after limited EST in choledocholithiasis. In this randomized controlled clinical trial, 320 patients were randomly assigned to receive small balloon dilation (10 mm in diameter) for 1 min (n = 160) or 3 min (n = 160) after deep bile duct cannulation. No significant difference in success rate of stone extraction between the two groups was observed. The incidence of post-ERCP pancreatitis (PEP) was higher in the 1 min group (10.6%) than in the 3 min group (4.4%) (P = 0.034). The logistic regression analysis showed that guidewire into the pancreatic duct, cannulation time > 5 min and 1 min balloon dilation were independent risk factors for PEP. There were no significant differences in other post-ERCP adverse events such as acute cholangitis, bleeding, perforation, etc. between the two groups. In conclusion, 3 min in duration was determined to be the optimal dilation condition for the removal of common bile duct stones.

Comparison between intermittent claudication versus chronic limb-threatening ischemia in peripheral arterial disease: a retrospective multicenter cohort study.

The anatomical distribution, characteristics of lesions, and treatment modalities for peripheral artery disease (PAD) are diverse. Endovascular intervention is popular for symptomatic PAD, for both intermittent claudication (IC) and chronic limb-threatening ischemia (CLTI). We aimed to investigate the endovascular devices used by comparing patients with PAD referred for endovascular revascularization with IC and CLTI. We identified 736 patients with PAD enrolled in the multicenter PAD registry in South Korea from 2019 to 2022. Of these patients, 636 received endovascular treatment at the time of this study. After excluding missing data, we analyzed 506 patients with IC or CLTI. Patients' characteristics, target lesions, and endovascular device data such as type, length, balloon diameter, and stent, were examined. Procedure outcomes of the aortoiliac, femoropopliteal, and below-the-knee lesions were analyzed. Patients with CLTI were more likely to have diabetes mellitus, below-the-knee interventions, and multilevel PAD than the IC group. Patients with IC had more aortoiliac artery lesions and underwent atherectomies than the CLTI group (63.3% and 61.1% vs. 39.7% and 40.6%, respectively; P < 0.001). In patients with femoropopliteal lesions, those with CLTI were more revascularized with stents than the patients with IC, without significant differences (35.3% vs. 29.1%, P = 0.161). Compared to the IC group, the CLTI patients showed significantly worse rates of primary patency, amputation, and mortality (P = 0.029, P < 0.001, and P < 0.001, respectively). Among Korean patients with PAD, there is a significant difference in baseline and lesion characteristics, endovascular strategies, and short-term follow-up outcomes among those with IC and CLTI.

A multi-center study of the MicroNET-covered stent in consecutive patients with acute carotid-related stroke: SAFEGUARD-STROKE.

Acute carotid-related stroke (CRS), with its large thrombo-embolic load and large volume of affected brain tissue, poses significant management challenges. First generation (single-layer) carotid stents fail to insulate the athero-thrombotic material; thus they are often non-optimized (increasing thrombosis risk), yet their use is associated with a significant (20-30%) risk of new cerebral embolism. To evaluate, in a multi-center multi-specialty investigator-initiated study, outcomes of the MicroNET-covered (cell area ≈ 0.02-0.03 mm2) carotid stent (CGuard, InspireMD) in consecutive CRS patients eligible for emergency recanalization. Treatment, other than study device use, was according to center/operator routine. Seventy-five patients (age 40-89 years, 26.7% women) were enrolled in 7 interventional stroke centers. The median Alberta Stroke Program Early CT Score (ASPECTS) was 9 (6-10). Study stent use was 100% (no other stent types implanted); retrograde strategy predominated (69.2%) in tandem lesions. Technical success was 100%. Post-dilatation balloon diameter was 4.0 to 8.0 mm. 89% of patients achieved final modified Thrombolysis in Cerebral Infarction (mTICI) 2b-c/3. Glycoprotein IIb/IIIa inhibitor use as intraarterial (IA) bolus + intravenous (IV) infusion was an independent predictor of symptomatic intracranial hemorrhage (OR = 13.9, 95% CI: 5.1-84.5, p < 0.001). The mortality rate was 9.4% in-hospital and 12.2% at 90 days. Ninety-day mRS0-2 was 74.3%, mRS3-5 13.5%; stent patency was 93.2%. Heparin-limited-to-flush predicted patency loss on univariate (OR = 14.3, 95% CI: 1.5-53.1, p < 0.007) but not on multivariate analysis. Small-diameter balloon/absent post-dilatation was an independent predictor of stent patency loss (OR = 15.2, 95% CI: 5.7-73.2, p < 0.001). This largest to-date study of the MicroNET-covered stent in consecutive CRS patients demonstrated a high acute angiographic success rate, high 90-day patency and favorable clinical outcomes despite variability in procedural strategies and pharmacotherapy (SAFEGUARD-STROKE NCT05195658).