Balloon Size Research Articles

Comparison of the effects of pre-dilatation with conventional versus larger balloon sizes on clinical outcomes in transcatheter aortic valve implantation with self-expandable valves

Abstract Background Transcatheter aortic valve implantation (TAVI) is considered an established treatment option for patients with severe aortic stenosis. When implanting self-expandable valve, pre-dilatation is often necessary to facilitate optimal transcatheter heart valve (THV) deployment. Traditionally, balloon sizes chosen for pre-dilatation are smaller than the minimum annulus diameter. Insufficient pre-dilatation can result in under-expansion of the THV, necessitating post-dilatation, and can increase the risk of complications. However, this conventional approach may not always yield the best outcomes, prompting a reassessment of balloon sizing strategies to improve procedural success and patient outcomes. Purpose The aim of this study was to investigate the impact on procedural outcomes of using larger balloons, sized less than the mean annulus diameter, for pre-dilatation compared to the traditional practice of using balloons sized less than the minimum annulus diameter during the implantation of self-expandable valves. Methods We analyzed 785 patients who underwent TAVI with self-expandable valve with pre-dilatation out of a consecutive 3880 cases at 6 centers from 2010 to 2023 (Figure 1). Among them, we divided the patients into two groups: those who underwent pre-dilation with balloons smaller than the minimum annulus diameter defined as the Conventional-size group and those who underwent pre-dilatation with balloons smaller than the mean annulus diameter defined as the Large-size group. The primary endpoint of this study was procedural success, stroke and need for permanent pacemaker implantation as designated by the VARC-3criteria. Results Of patients (69% female; mean age 84.9), there were 563 (71.7%) patients in the Conventional-size group and 222 (28.2%) patients in the Large-size group. There was no annulus rupture in either group. The incidence of post-dilatation was significantly higher in the Conventional-size group than in the Large-size group (109 of 563 [19.4%] vs. 23 of 222 [10.3%], p=0.001) (Figure 2). There was no significant difference in the incidence of primary endpoints (all p > 0.05). In post-echocardiographic outcomes, there was no significant difference in effective orifice area, mean pressure gradient, patients-prosthesis mismatch, or paravalvular leakage between the groups (P > 0.05). Conclusions This study demonstrates that a large-size strategy using a balloon smaller than the mean annulus diameter in the deployment of self-expandable valves is safe and may avoid the need for post-dilatation compared to the traditional strategy using a balloon smaller than the smallest diameter.

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.

Current application and results of the combined use of intravascular lithotripsy and rotational atherectomy for the treatment of calcified coronary lesions

Abstract Background Intravascular lithotripsy (IVL) and rotational atherectomy (RA) might be used simultaneously (Rotatripsy) to treat calcified lesions during percutaneous coronary intervention (PCI), though data on the effectiveness and sequence of their use is limited. Purpose To identify indicators for the use of Rotatripsy and to assess its safety and success rates, both acutely as at one-year follow-up. Methods Patients undergoing PCI with IVL and RA across six centers in two European countries from May 2019 to December 2023 were included. Demographic, clinical, procedural and follow-up data were collected. Angiographic and intracoronary imaging (ICI) data were analyzed centrally. Efficacy endpoints included device success (delivery of the RA-burr and IVL-balloon across the target lesion and administration of therapy without related complications), technical success (TIMI 3 flow and residual stenosis <30% by quantitative coronary analysis) and procedural success (composite of technical success with absence of in-hospital major adverse cardiovascular events (MACE: cardiac death, myocardial infarction or target vessel revascularization). Safety endpoints comprised rotatripsy-related complications and MACE at one-year follow-up. Results A total of 114 patients (75±9 years, 78% male) underwent rotatripsy for 120 lesions. Patients presented with an ACS in 58(51%) cases and chronic coronary syndrome in 56(49%). The left anterior descending artery(n=66, 55%) was the most frequently treated target vessel, with diverse lesions being addressed, including bifurcations(30%), ostial(18%), CTO(7%) and in-stent(12%) lesions. The mean burr size was 1.5±0.2mm with a maximum rotational speed of 171±15k rpm and burr/vessel ratio of 0.46±0.2. IVL involved an average of 68±25 pulses and a balloon size of 3.5±0.5mm. The predominant used sequence of rotatripsy was RA followed by IVL(n=106, 88%). Among these cases, IVL was electively combined with RA in 68(57%) lesions, and used for balloon underexpansion(n=37, 31%) and stent crossing failure after RA(n=1, 1%). Additionally, IVL served as bail-out strategy after RA and stenting in 10(8%) and preceded RA in 4(3%) lesions, particularly when balloon/stent delivery failed after IVL. After rotatripsy, stents were implanted in 116(97%) lesions and drug-eluting balloon used in 3(3%). ICI was utilized in 69(58%) target lesions. Device, technical and procedural success were 97%, 94% and 93%, respectively. Therapy-related complications occurred in 4 patients(4%), and included two(2%) coronary perforations, one(1%) dissection and one(1%) burr entrapment. At one-year follow-up (present in 77(67%)), MACE was observed in 7(6%). Conclusions Rotatripsy demonstrated efficacy across diverse clinical and anatomical settings, with the majority of procedures electively employing RA before IVL. High success rates and low complication rates were observed, with few patients experiencing MACE at one-year follow-up.

Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Disrupt PAD III Observational Study.

Intravascular lithotripsy (IVL) has shown promising safety and effectiveness in calcified peripheral artery disease (PAD) in large trials and small real-world experiences. Real-world evidence from a larger cohort is lacking, so we aimed to evaluate the real-world acute performance of IVL in the treatment of calcified PAD. The Disrupt PAD III Observational Study (OS) is a prospective, multicenter, single-arm study. Patients with claudication or critical limb-threatening ischemia (CLTI) and at least moderate calcification were eligible. Independent predictors of procedural outcomes were assessed by multivariable analysis. Between November 2017 and June 2021 across 30 global sites, 1373 patients with 1677 lesions (1531, 91.3% core lab evaluable) were enrolled. Diameter stenosis and lesion length was 80.6±17.6% and 93.5±74.3 mm, respectively. Target vessels included femoropopliteal (61%), iliac (15.8%), common femoral (10.7%), and infrapopliteal arteries (12.8%). Lesion characteristics included 31.1% chronic total occlusions (CTOs) and 19.3% long lesions (≥15 cm). At final assessment, residual stenosis was 23.8±11.3%, with 0.9% serious angiographic complications, no abrupt closures, distal embolization, no flow, or thrombotic events. Independent predictors of ≤30% residual stenosis were lesion length ≥15 cm (odds ratio [OR]=0.384), female sex (OR=1.850), age ≤75 years (OR=1.625), IVL balloon to artery ratio ≥1.0 (OR=1.538), and CTO lesions (OR=0.638). Lesion length ≥15 cm (OR=16.076) was an independent predictor of procedural complications. The Disrupt PAD III OS represents the largest assessment of IVL periprocedural outcomes in calcified PAD. It confirmed excellent procedural safety and effectiveness in complex lesions across multiple peripheral vascular beds. This final analysis of the PAD III OS represents the largest report of peripheral IVL utilization in daily clinical practice. The outcomes of this study indicate that previously reported procedural results in clinical trial settings can be translated to a broader patient population. Treatment with peripheral IVL in severely calcified stenotic lower limb lesions demonstrated consistent acute safety and stenosis reduction, even in complex patients across multiple vessel beds. In addition, the importance of proper IVL balloon sizing to achieve excellent acute stenosis reduction was confirmed by multivariate analysis.

Safety and feasibility of transcatheter closure of atrial septal defects in small children weighing less than 10 kg.

When young patients with an oval fossa defect present early with symptoms of heart failure and pulmonary hypertension, surgical treatment is recommended in small bodyweight rather than transcatheter closure. Outcomes of device closure in consecutive symptomatic children weighing under 10 kg were compared with young children aged below 4 years but weighing above 10 kg. Transthoracic echocardiography under conscious sedation guided the procedure in all without need for balloon sizing, transesophageal echocardiogram, and intubation anaesthesia. Symptoms, anthropometry, shunt ratio, pulmonary pressures, defect and device size, percentage oversizing, device/body weight ratio, complications, and post-procedural growth spurt were compared. Ninety-six patients weighing under 10 kg were compared with 160 patients weighing above 10 kg. In total, 83.3% of patients in the study group and 25% of controls were severely malnourished. The median indexed defect size was 35.2 mm/sq.m and 27.4 mm/sq.m, and the device was oversized by 8.7% and 14.2% in the study group and controls, respectively. The device/body weight ratio was 1.93 in study group and 1.4 in controls. Procedure was successful in all except one patient weighing under 10 kg who had a device embolisation. Both groups showed significant growth spurts and proportion, with severe malnutrition reduced to 42% and 11% in the two groups. Device closure was feasible and safe in patients under 10 kg. Transthoracic echocardiographic imaging on conscious sedation provided adequate guidance. Symptoms and growth significantly improved after intervention. Despite a larger defect size, smaller patients had comparable outcomes. In symptomatic children under 10 kg needing early closure, transcatheter intervention should not be deferred.

Performance of the Mammoth Balloon Catheter in Patients with Severe Aortic Valve Stenosis Undergoing Percutaneous Treatment.

Background: Balloon aortic valvuloplasty (BAV) is currently used as pre-treatment for patients undergoing trans-catheter aortic valve replacement (TAVR) as well as a stand-alone option for subjects with significant contraindications to TAVR. Mammoth is a newly available non-compliant balloon catheter (BC) included in the balloon-expandable Myval THV system (Meril Life Sciences Pvt. Ltd., India). As limited data on the performance of this BC are available, we here report the results following its use for BAV as pre-dilatation during TAVR or as a stand-alone procedure. Methods: A retrospective, single-center cohort analysis was performed on patients with severe aortic valve stenosis (AS) treated with the Mammoth BC at IRCCS Ospedale Galeazzi Sant'Ambrogio, Milan, Italy. The primary endpoint was technical success defined as successful Mammoth BC advancement across the AS followed by its full and homogeneous inflation without major complications such as aortic root/left ventricular outflow tract injury and/or stroke. Results: A total of 121 patients were treated by BAV with Mammoth BC during the study period. Among these, 105 patients underwent BAV pre-dilatation before TAVR while 16 patients underwent a stand-alone BAV procedure. Mammoth BC was delivered and successfully inflated at the target site in all of the 121 cases without BC-related complications (100% technical success). However, in the BAV "stand-alone group", three patients required two different balloon sizes while in nine patients multiple rounds (two to three) of balloon inflation were needed to significantly lower the transvalvular gradient. No cases of aortic root injury or massive aortic regurgitation due to Mammoth BC-related aortic leaflet injury were reported while one major stroke occurred late after TAVR. No intra-procedural deaths occurred nor bleeding (BARC 3-4) or major vascular complication. Conclusions: Mammoth BC use in patients with severe AS proved safe and effective, either before TAVR or as a stand-alone procedure, expanding the range of available tools for structural operators.

Fuel performance modelling of Cr-coated Zircaloy cladding under DBA/LOCA conditions

Chromium coatings are being developed for advanced technology fuel (ATF) claddings, offering negligible corrosion during normal operation, improved resistance to high-temperature steam oxidation, and superior high-temperature strength, the latter two being of utmost relevance during design basis accidents (DBAs). Demonstrating the improved response of Cr-coated Zircaloy requires the development or extension of fuel performance codes to coating simulations.In this work, material models and correlations for Cr-coated Zircaloy cladding have been derived or obtained from the literature and implemented into TRANSURANUS and the FRAPTRAN-TUmech suite. These extended tools have been used to simulate two complementary LOCA tests: QUENCH-L1 rod 4 (out-of-pile bundle test on fresh Zircaloy cladding) and IFA-650.10 (in-pile single rod test on high-burnup Zircaloy-UO2 fuel), enabling a gradual cross-verification of results between codes and a comparative performance analysis between coated and uncoated cladding.The results indicate negligible impact of coating properties other than creep on the burst time. While the superior high-temperature creep resistance of coated cladding slightly delays the burst time, additional burst data would be necessary to draw sound conclusions on the balloon size. Regarding the modelling approach, treating the coated cladding as a composite material through the definition of effective properties might result in worse performance relative to uncoated cladding, contradicting experimental observations. Therefore, the separate modelling of the coating and the cladding is recommended.

Comparison of Patent Foramen Ovale Sizing by Transesophageal Echocardiography and Balloon Sizing in Patients Undergoing Percutaneous Closure

BackgroundA patent foramen ovale (PFO) has a complex anatomy, and evaluating the size before closure may be challenging. We aimed to investigate the correlation between preprocedural transesophageal echocardiography (TEE) and balloon sizing of PFO in patients undergoing percutaneous PFO closure. MethodsA retrospective single-center study with analysis of 100 patients who, due to paradox thromboembolism in the left circulation, underwent percutaneous PFO closure. The PFO sizing was compared to measures attained by TEE and balloon sizing using linear regression analysis. ResultsPFO size measured by TEE occurred smaller than balloon sizing (2.19 mm [95% CI: 1.91 to 2.46] vs. 8.51 mm [95% CI: 8.02 to 9.00], p < 0.001). Additionally, neither the PFO channel length nor the atrial septal mobility measured by TEE correlated to the PFO size attained by balloon sizing, respectively (slope ?0.018 [95% CI: ?0.117 to 0.081], R = 0.036, p = 0.719) and (slope 0.049 [95% CI: ?0.043 to 0.141], R = 0.105, p = 0.297). Statistically significant difference in regression analysis but poor correlation was found between both TEE attained PFO and shunt size when compared to balloon sizing. Diverting patients according to the size of the PFO shunt was not statistically significant between PFO of moderate size compared, respectively, to a large and small PFO size. However, a difference was observed between a small and large PFO shunt size. ConclusionsPFO defect and shunt size measured by TEE showed a poor correlation with balloon sizing. Neither PFO channel length nor septal mobility were correlated to the PFO size measured by balloon sizing.

Determination of Inoue Balloon Size by Analysis of Mitral Valve Geometry Using Three-Dimensional Transesophageal Echocardiography in Patients with Mitral Stenosis

In percutaneous mitral balloon commissurotomy (PMBC) for patients with mitral stenosis (MS), the size of the balloon has traditionally been determined using a crude method based on the patient's height or body surface area. We aimed to evaluate the clinical value of balloon size selection by quantitatively analyzing mitral valve (MV) geometry using 3D transesophageal echocardiography (TEE). In 184 consecutive patients who underwent PMBC, the geometry of the MV annulus was analyzed during mid-diastole, including the measurement of lateral-medial diameters obtained from dedicated 3D software (LMD-3d) or from analysis using multiplanar reconstruction images (LMD-mpr). Patients were categorized into three groups: those with successful results after PMBC (SU group), those with residual mitral stenosis (MS, group), and those with significant MR (MR group). The SU, MS, and MR groups included 110, 50, and 17 patients, respectively. We compared three conventional formulas (Formula 1, 2, 3) based on the patient's height or body surface area with two new formulas derived from data in the SU group: balloon size = 0.0684 × LMD-3d + 24.309 (Formula 4) and 0.061 × LMD-mpr + 24.573 (Formula 5). Compared with the calculated balloon sizes using Formula 4, the inflated balloon sizes were significantly smaller (-0.78±1.02; p<0.001) in the MS group, while they were significantly larger (0.56±1.05; p=0.04) in the MR group. This pattern was also consistent in Formula 5. In conclusion, selecting the Inoue balloon inflation size based on the mitral annulus diameter determined by 3D TEE might be a reasonable approach.

Dialysis-associated steal syndrome as a rare complication of arteriovenous fistula angioplasty

Abstract The angioplasty of arteriovenous fistulas (AVF) has become indispensable in preserving haemodialysis access. Though well-known complications, such as pseudoaneurysm formation and rupture, can occur, the incidence of severe dialysis-associated steal syndrome (DASS) following AVF angioplasty is low. We describe a patient with limited dialysis options who developed significant DASS following angioplasty of his AVF. After excluding flow-limiting causes of DASS, the patient underwent a successful Revision Using Distal Inflow procedure, redirecting blood flow to his distal arm. Subsequently, all ischaemic symptoms resolved. While effective surgical options are available for the management of DASS, preventive measures such as proper angioplasty balloon sizing remain key.

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.

Stent Placement After Percutaneous Recanalization of Superior Vena Cava Stenosis in Maintenance Hemodialysis Patients.

This study aimed to evaluate the efficacy and safety of stent placement after percutaneous recanalization of superior vena cava (SVC) stenosis in maintenance hemodialysis patients. Adult maintenance hemodialysis patients hospitalized at a university-affiliated tertiary hospital due to SVC stenosis from January 2016 to June 2023 were prospectively included. The efficacy and safety of percutaneous blunt/sharp SVC recanalization combined with SVC stent placement were observed. The patients' demographic information and laboratory examination data, stent placement success rate, surgery-related complications, and long-term vascular access patency rate were also recorded and analyzed. The study was approved by the institutional ethics committee (2015-201) and registered at http://www.chictr.org.cn (registry number: ChiCTR-ONN-16007790). A total of 58 patients were included in the study with an average age of 54.79±13.42 years. Percutaneous SVC recanalization was successful in 53 cases, with a success rate of 91.38%, including 37 cases of traditional recanalization and 16 cases of sharp recanalization. Among 53 hemodialysis patients who underwent SVC recanalization, 14 patients successfully received covered stents and 38 patients received bare metal stents, achieving a stent placement success rate of 98.1%. One patient encountered stent displacement into the heart immediately after implantation, causing intra-operative cardiac tamponade, who was successfully rescued by thoracotomy. Fifty-two patients were followed-up for median period of 26 months (cuffed catheter: 25 patients, arteriovenous fistula [AVF]: 27 patients). The overall 2-year vascular access patency rate was 33.2% (cuffed catheter: 22.2%, AVF: 41.7%, p=0.414). There was no statistically significant difference in the 2-year vascular access patency rate between the traditional recanalization group and the sharp recanalization group (34.1% vs 31.1%, p=0.731) and between bare metal stent group and covered stent group (38.1% vs 21.4%, p=0.248). Percutaneous SVC recanalization with stent placement is an effective treatment strategy that can provide viable vascular access for maintenance hemodialysis patients with SVC stenosis. Cautions should be paid to potential life-threatening complications such as stent displacement and cardiac tamponade. Superior vena cava (SVC) stenosis is a common central venous occlusive lesion in maintenance hemodialysis patients. Whether stent should be implanted simultaneously following SVC recanalization is still lacking research. This pilot cohort study suggested that percutaneous SVC recanalization with stent placement was an effective treatment strategy which provides satisfactory vascular access for hemodialysis. We further found that SVC sharp recanalization with subsequent stent implantation was a feasible treatment, with the 2-year vascular access patency comparable to the traditional SVC recanalization group. This study also highlighted endovascular SVC recanalization should be performed with caution, and appropriate balloon sizes should be selected to avoid SVC rupture or stent displacement.

Aortic balloon valvuloplasty outcome according to calcium distribution and valve geometry – The ABCD study

BackgroundThere is little data on the outcome of balloon aortic valvuloplasty (BAV) in relation to valve dimensions and calcification patterns. The procedure is not standardized, particularly the choice of balloon size. MethodsThis retrospective multicenter study focused on BAV efficacy and safety by analyzing the relationship between balloon size, annulus geometry (i.e., diameters, perimeter, and area), and calcification patterns (total burden and calcium distribution over each individual leaflet). From March 2018 to March 2023, all consecutive patients who underwent clinically indicated BAV and ECG-gated multidetector computed tomography of the aorta were included, except those with a bicuspid valve. Calcium score was calculated on contrast-enhanced images based on a luminal attenuation threshold of +100 HU. ResultsOne hundred and fifteen patients were included. Procedural success was 82.6 %. The balloon-to-annulus ratio (BAR) relative to diameter, perimeter, and area was higher in patients with successful BAV. Patients with unsuccessful BAV had a significantly higher aortic valve calcium burden. The complication rate was 4.3 % and there was no association with valve geometry or calcium burden. A trend towards a reduced complication rate was found as calcium asymmetry increased. BAR minimum annulus diameter was the best parameter in predicting procedural success, with a cut-off at 0.85. ConclusionsBAV efficacy is correlated directly with balloon size in relation to annulus dimension and inversely with total calcium burden. The minimum diameter of the valve may be adopted as a reference for balloon sizing.

Balloon dilatation of subglottic stenoses, especially in granulomatosis with polyangiitis

Subglottic stenoses (SGS) are constrictions in the region below the vocal folds, that can pose a life-threatening problem for those affected. The aim of this research project was to identify the patient group for which the treatment of SGS by balloon dilatation can lead to long-term success. 14 patients with SGS were examined (before and up to12 months after intervention) using pulmonary function tests, laryngoscopies and two questionnaires (Clinical Chronic Obstructive Pulmonary Disease Questionnaire), (modified Medical Research Council Dyspnoea Scale) regarding the respiratory situation. Additionally, the number of necessary interventions, the degree of stenosis (according to Myer Cotton and measured in millimeters) were documented. Four patients who required only one intervention with the balloon showed better pre-interventional respiratory function and a higher subjective stress level. Lung function tests and evaluation of the questionnaires showed an improvement in the respiratory situation and state of health of all 14 patients after the initial intervention. The degree of stenosis measured in millimeters shows that patients with a stenosis diameter of less than 4 mm only required one intervention. All patients who received an intervention using a 12-mm-balloon had to be treated several times. Patients with a high degree of stenosis and a tendency towards greater subjective stress and less objective restriction of the respiratory function appear to have a higher probability of long-term successful treatment with the balloon. Furthermore, the choice of balloon size seems to be an additional decisive factor for the success of an intervention.

Predictors of Valve Failure Following Surgical Atrioventricular Valve Replacement with a Melody Valve in Infants and Children.

Options for atrioventricular (AV) valve replacement in small pediatric patients are very limited. The Melody valve has shown reasonable short-term outcomes. This study was aimed at identifying predictors of valve failure following AV valve replacement with a Melody valve at a single-center. 26 patients underwent 37 AV valve replacements with 31/37 (84%) of valves placed in the systemic AV valve position. Median age at procedure was 17months (IQR 4-33) and weight was 8.5kg (IQR 6.25-12.85). Median balloon size for valve implant was 20mm (IQR 18-22). Repeat intervention occurred in 21 cases (57%) with repeat surgery in all but one. Median freedom from re-intervention was 31months; 19% were free from re-intervention at 60months. Age < 12months weight < 10kg and BSA < 0.4 m2 were all significant risk factors for early valve failure (p = 0.003, p 0.017, p 0.025, respectively). Valve longevity was greatest with balloon inflation to diameter 1.20-1.35 times the patient's expected annular diameter (Z0), relative to both smaller or larger balloons (p = 0.038). In patients less than 12months of age, patients with single ventricle physiology had an increased risk of early valve failure (p = 0.004).

Temporary Ureter Occlusion with Simultaneous Urinary Diversion via a Single-Access Route Using a 4-French Balloon Catheter and a Pigtail Nephrostomy Drainage Catheter.

Background and Objectives: This study evaluated the efficacy and safety of temporary ureteral occlusion combined with urinary diversion using a single-access route created by inserting a balloon catheter through a pigtail nephrostomy drainage catheter. With this approach, we aimed to offer an alternative for patients with ureteral leaks who are suboptimal surgical candidates. Materials and Methods: This retrospective study included nine patients (eight of which were bilateral cases and one was unilateral, totaling seventeen cases) who underwent the surgery between September 2023 and March 2024. The method involved gaining percutaneous access to the pelvicalyceal system, inserting a 4-French Fogarty balloon catheter through a pigtail nephrostomy catheter, and inflating the balloon at the proximal or mid-ureter. Results: All 17 cases achieved technical successful with no major complications. The procedure effectively relieved symptoms associated with urinary leakage in most patients. However, the significant deflation of the balloon catheter occurred in five cases (29.4%), with three (17.6%) experiencing complete deflation. In these five cases, the final balloon size was 5.81 mm (range: 0-8.9 mm), confirming a 25.0% decrease in size from pre- to post-procedure. Ureteral occlusion was 28.3 d long on average (range: 8-57 d). All patients experienced symptom relief during temporary ureteral occlusion. Except for two patients lost to follow-up, three patients showed symptom improvement with only PCN and four patients underwent surgical closure of the fistula tract before or after balloon catheter removal. Conclusions: This study confirms that this approach is safe and effective.

Three‐dimensional transesophageal echocardiography measurements of ASD sizing parameters in comparison to balloon sizing method in percutaneous ASD closure

AbstractBackgroundBalloon sizing (BS) has been used for device size selection in percutaneous atrial septal defect (ASD) closure. Due to its limitations, alternative imaging techniques like three‐dimensional transesophageal echocardiography (3D‐TEE) are valuable for guiding ASD device size selection during ASD closure procedures. The purpose of this study was to compare ASD sizing using measurements obtained from 3D–TEE to those utilizing the standard balloon sizing method.MethodsWe identified 53 patients with single secundum type ASD without PFO who underwent percutaneous closure at the Tehran Heart Center between 2019 and 2022. Balloon sizing was performed in all patients with the stop‐flow technique, and the choice of device size was determined based on the sizing derived from BS. 3D‐TEE imaging was performed before the intervention, and the ASD shape and quality of ASD rims were assessed.ResultsAmong the 53 patients who underwent single ASD device closure, multiple 3D TEE measurements significantly correlated with balloon sizing results. This included defect area, perimeter, and diameter obtained from 3D‐TEE images multi‐planar reconstruction. ASD perimeter detected by 3D TEE had the best correlation with BS results. When divided by the shape of ASD, there was no significant difference between our 3D‐images data and BS in round or oval‐shaped ASDs.ConclusionThe 3D‐TEE study is reliable for assessing ASD configurational characteristics in percutaneous device closure candidates. 3D‐TEE has the potential to accurately determine the appropriate device size and reduce complications, costs, and procedural duration. Further research is needed to validate these findings and establish the role of 3D‐TEE measurements in guiding the best treatment decisions for ASD closure.

3D Printing of Subclavian Artery: Utility for Preprocedural Planning and Correlation With Subclavian Artery Percutaneous Vascular Interventions.

Three-dimensional (3D) printing for subclavian artery (SA) percutaneous vascular interventions (PVI) may allow superior understanding of patient specific complex anatomy and aid with preprocedural planning. Five patients with computed tomography angiography (CTA) of the neck who underwent SA PVI were queried retrospectively. 3D printing of aortic arch and great vessels was accomplished with 3D slicer software and painted with acrylic paint to highlight anatomic features. The aortic arch type and implications for preprocedural planning for SA interventions including complex chronic total occlusion (CTO) lesions were determined. Comparisons were made with SA angiograms and 3D-CTA. Of the 5 patients, type I (n = 2), type II (n = 1), and type III (n = 2) aortic arches were identified. Proximal and distal reference vessel size and total lesion length were determined using a digital millimeter caliper and correlated with intraprocedural balloons and stents. In 3D-printed models (3D-PMs) of patients with SA-CTO (n = 2), cap morphology (tapered vs blunt) and distal vessel filling were visualized, permitting optimal arterial access site selection for successful cap crossing. The vertebral arteries (VAs) were also 3D printed which further allowed the ability to delineate optimal stent deployment site (proximal or distal to VA), a common dilemma that is faced intraprocedurally. The 3D-PMs also allowed preprocedural precision in stent and balloon size and length, potentially leading to procedural efficiency and cost-effectiveness. 3D printing of aortic arch and great vessel anatomy for SA-PVI allows multiple procedure-related factors to be predicted in advance, translating to decrease in contrast volume, radiation time, procedure and fluoroscopic time, thereby improving procedure and cost efficiency.

Pseudoaneurysm formation following transarterial embolization of traumatic carotid-cavernous fistula with detachable balloon: An institutional cohort long-term study.

The goal of therapy for traumatic carotid-cavernous fistula (TCCF) is the elimination of fistula while maintaining patency of the parent artery. The treatment for TCCF has evolved from surgery to endovascular management using detachable balloons, coils, liquid embolic agents, covered stents, or flow-diverter stent through arterial or venous approaches. Despite the withdrawal of detachable balloons from the market in the United States since 2004, transarterial embolization with detachable balloons has currently remained the best initial treatment for TCCF in several countries. However, the pseudoaneurysm formation following transarterial detachable balloon embolization has rarely been observed in long-term follow-up. To determine the occurrence and long-term follow-up of pseudoaneurysm after transarterial detachable balloon for TCCF. Between January 2009 and December 2019, 79 patients diagnosed with TCCF were treated using detachable latex balloons (GOLDBAL) of four sizes. Pseudoaneurysm sizes were stratified into five grades for analysis. Initial and follow-up assessments involved computed tomography angiography at 1 month, 6 month, 1 year, and longer intervals for significant cases. Clinical follow-ups occurred semi-annually for 2 years, then annually. Factors analyzed included sex, age, fistula size and location, and balloon size. In our cohort of 79 patients treated for TCCF, pseudoaneurysms formed in 67.1%, with classifications ranging from grade 0 to grade 3; no grade 4 or giant pseudoaneurysms were observed. The majority of pseudoaneurysms did not progress in size, and some regressed spontaneously. Calcifications developed in most large pseudoaneurysms over 5-10 years. Parent artery occlusion occurred in 7.6% and recurrent fistulas in 16.5%. The primary risk factors for pseudoaneurysm formation were identified as the use of specific balloon sizes, with balloon SP and No. 6 significantly associated with its occurrence (P = 0.005 and P = 0.002, respectively), whereas sex, age, fistula size, location, and the number of balloons used were not significant predictors. Pseudoaneurysm formation following detachable balloon embolization for TCCF is common, primarily influenced by the size of the balloon used. Despite this, all patients with pseudoaneurysms remained asymptomatic during long-term follow-up.

Paravalvular regurgitation after transcatheter aortic valve replacement: incidence, quantification, and prognostic impact.

Transcatheter aortic valve replacement (TAVR) is the standard of care in aortic stenosis with results comparable to surgical aortic valve replacement. However, paravalvular regurgitation (PVR) is more common after TAVR. With the alteration of devices and implantation techniques, the incidence of moderate or more PVR has declined. Mild PVR is still common in around 30% of TAVR patients in low-risk trials. Progression of AS causes myocardial hypertrophy and varying degrees of diastolic dysfunction which may cause heart failure even in combination with small volumes of PVR. Any degree of PVR is associated with an increased risk of overall and cardiovascular mortality. Predictors of PVR are annular eccentricity, severe calcification of the aortic valve, bicuspid aortic valves, and type of prosthesis where balloon-expandable devices are associated with less PVR. PVR is diagnosed using echocardiography, aortic angiogram with or without videodensitometry, haemodynamic parameters, or cardiac magnetic resonance. PVR can be treated using post-dilation, interventional treatment using a vascular plug, or implantation of a second device. Successful post-dilation depends on balloon size which should at least be equal to or >95% of the mean annulus diameter. Implantation of a second device to reduce PVR is successful in ∼90% of cases, either through lengthening of the sealing skirt in case of inadequate position or through further expansion of the index device. Implantation of a vascular plug can successfully reduce PVR and reduce mortality.