Procedural Success Research Articles

A Framework for Multimodal Medical Image Interaction.

Medical doctors rely on images of the human anatomy, such as magnetic resonance imaging (MRI), to localize regions of interest in the patient during diagnosis and treatment. Despite advances in medical imaging technology, the information conveyance remains unimodal. This visual representation fails to capture the complexity of the real, multisensory interaction with human tissue. However, perceiving multimodal information about the patient's anatomy and disease in real-time is critical for the success of medical procedures and patient outcome. We introduce a Multimodal Medical Image Interaction (MMII) framework to allow medical experts a dynamic, audiovisual interaction with human tissue in three-dimensional space. In a virtual reality environment, the user receives physically informed audiovisual feedback to improve the spatial perception of anatomical structures. MMII uses a model-based sonification approach to generate sounds derived from the geometry and physical properties of tissue, thereby eliminating the need for hand-crafted sound design. Two user studies involving 34 general and nine clinical experts were conducted to evaluate the proposed interaction framework's learnability, usability, and accuracy. Our results showed excellent learnability of audiovisual correspondence as the rate of correct associations significantly improved (p < 0.001) over the course of the study. MMII resulted in superior brain tumor localization accuracy (p < 0.05) compared to conventional medical image interaction. Our findings substantiate the potential of this novel framework to enhance interaction with medical images, for example, during surgical procedures where immediate and precise feedback is needed.

Anesthésie locale comparée à l'anesthésie locorégionale dans les procédures TAVI par voie transfémorale

IntroductionTranscatheter aortic valve implantation (TAVI) has become the treatment of choice for the most fragile patients with severe aortic stenosis. The transfemoral route is preferred as the simplest and safest. The aim of our study was to compare the efficacy, tolerance and safety of local vs. locoregional anesthesia in trans-femoral TAVI procedures. Material and methodThis was a single-center retrospective study. Patients treated with femoral TAVI between February 25 and November 15, 2022 at the University Hospital of Reims were included, and two groups (local and locoregional anesthesia) were compared. ResultsTAVI success rate (92.9%), death rate (3.0%) and procedure duration (90.5 ± 13.5 minutes) did not differ between groups (p = 0.18, 0.15 and 0.55 respectively). For intra- and post-procedural treatments, the use of sedation, analgesics and benzodiazepines did not differ between groups. The cumulative dose of Remifentanil used per-procedure was lower in the local anesthesia group than in the locoregional anesthesia group (148.6 ± 71.9 mcg vs. 208.9 ± 110.0 mcg; p = 0.025). ConclusionsIn this non-randomized retrospective study, local and locoregional anesthesia had comparable safety and efficacy in transfemoral TAVI procedures. In a constrained context and with a view to simplification, these results encourage transfemoral TAVIs to be performed under local anaesthesia, and to consider a “PCI-like” approach, without the presence of an anaesthetist, for selected patients without respiratory, musculoskeletal or agitation disorders, or vascular approach difficulties.

Effectiveness of pharmacological procedural sedation in children with autism spectrum disorder: A systematic review and meta-analysis.

Management of primary healthcare and routine minor procedures for children with autism spectrum disorder (ASD) can be challenging; therefore, when behavioural strategies fail, sedative medications are often employed. We evaluated the effectiveness of the current pharmacological strategies for managing children with ASD. We performed a systematic review and meta-analysis of the current approaches for procedural sedation in children with ASD. Twenty studies met inclusion criteria. Dexmedetomidine, midazolam, propofol and chloral hydrate were the most efficient agents for successful procedures, while propofol had the highest number of adverse events. The most frequently used agents were dexmedetomidine and midazolam or a combination of the two, and the effectiveness of dexmedetomidine plus midazolam was superior to dexmedetomidine alone. Multiple effective drug regimens exist for procedural sedation in children with ASD. These results could support the development of specific guidelines for procedural sedation in children with ASD.

Management of pediatric thyroglossal duct cyst: A case report

Introduction: Thyroglossal duct cysts are common congenital neck anomalies in children, diagnosed through clinical assessment and ultrasound, and treated with the Sistrunk procedure to prevent complications like infection and malignancy. Case Description: We present a case of a 4-year-old male patient with a progressively enlarging neck mass for three months. The mass was asymptomatic, did not cause any eating difficulties, and moved upwards during swallowing and tongue protrusion. Upon physical examination, a soft, mobile, cystic mass approximately 3 cm in diameter was identified beneath the hyoid bone. Supporting examinations, including ultrasound and fine-needle aspiration cytology, led to the diagnosis of a thyroglossal duct cyst. The patient underwent a successful Sistrunk procedure, which involved the excision of the cyst along with a portion of the hyoid bone. Postoperative management included administration of intravenous antibiotics and paracetamol, culminating in a full recovery without any signs of infection. The patient exhibited complete wound healing within two weeks. There was no evidence of cyst recurrence during a follow-up examination six months later. Conclusion: Despite being common, thyroglossal duct cysts require thorough evaluation to avoid misdiagnosis, and are typically identified by a slowly growing midline neck mass that moves with swallowing and tongue protrusion, often near the hyoid bone.

Feasibility and early outcomes of atrial septal defect prostheses use for percutaneous closure of widely open patent foramen ovale

Abstract Background The efficient closure of patent foramen ovale (PFO) with short canal length and large width, usually associated with atrial septal aneurysm (ASA), remains challenging. These cases frequently require the use of larger PFO devices to avoid the risk of device embolism at the cost of a higher rate of residual shunting, mostly due to interdisk spacing. The use of atrial septal defect (ASD) prosthesis could be useful in these patients. Purpose To describe feasibility and early outcomes of the use of ASD device for percutaneous closure of widely open PFO representing an "ASD-like anatomy". Methods Since January 2022 in a high volume French university center, we started to use ASD device for percutaneous closure of selected cases of PFO with complex anatomy as mainly defined by a sheathed width of PFO ≥ 5 mm and sheathed canal length ≤ 10 mm (Figure 1) facing major per-operative residual shunt with PFO prostheses in some patients. In addition to the descriptive results, we compared this ASD device subgroup with a cohort of patients with similar anatomy but previously treated in our center with PFO device. All available transesophageal echocardiography (TEE) examinations were reviewed. The main objective was to describe the feasibility of the procedure (success and safety), the secondary endpoint was immediate post-procedural moderate to severe residual right-to-left shunt (RLS), defined as ≥ 10 bubbles in the left atrium within 3 cardiac cycles after transfemoral agitated saline injection. Results A total of 65 patients was treated with ASD devices, procedural success was achieved in all patients with a low rate (4,2%) of intrahospital complications (two supraventricular arrythmia, one anaphylactic shock and one minor laryngeal injury) and without device embolism. As compared with a cohort of 127 patients of similar anatomy treated with PFO device, patients in the ASD device group had more complex characteristics especially higher mean sheathed PFO width and shorter mean sheathed PFO canal length. Immediate post-procedural residual moderate to severe RLS did not differ significatively between groups (Table 1). No or minimal shunting was observed in 91% and 92% of cases (p=NS) but the three patients with severe RLS were all in the PFO device group. Conclusion Percutaneous closure of "ASD-like" PFO with ASD prostheses is feasible and safe. Larger studies and longer follow-ups are now required to confirm the expected improved sealing effect with this strategy.

Multimodal machine learning-based technical success prediction in patients undergoing transcatheter aortic valve implantation

Abstract Background Procedural success is fundamental to achieving optimal clinical outcome, and prediction of procedural success and failure is of key importance in the selection of the appropriate treatment strategy in patients with severe aortic stenosis requiring aortic valve replacement. Purpose We aimed to develop a prediction model for procedural success in patients undergoing transcatheter aortic valve implantation (TAVI) using multimodal information and employing machine learning algorithms. Method In a prospective TAVI registry, patient baseline demographics, clinical history, medication, laboratory, procedural characteristics, electrocardiogram, angiography, transthoracic and transesophagel echocardiography, and computed tomography information were collected prospectively and extracted as numeric data. Data preprocessing included the imputation of missing values and the elimination of features with high collinearity. We incorporated several feature selection (FS) and classification algorithms for model development. Datasets for each target were randomly split into train/validation sets (70/10%) and hold-out test sets (20%). All machine learning processes, including preprocessing, feature selection, parameter, and hyperparameter optimization, were carried out on training and validation sets in 10-fold cross-validation. Different metrics, including area under the curve (AUC) in receiver operating characteristic curve analyses, sensitivity, and specificity, were calculated for model evaluation on the holdout test set. Procedural success was defined as technical success in the Valve Academic Research Consortium-3 (VARC-3). Technical failure differentiated between vascular and cardiac complications. Results In a total of 2,576 patients undergoing TAVI with a contemporary device between March 2012 and June 2023, 242 (9.4%) had technical failure: 70 (2.7%) had cardiac and 178 (6.9%) had vascular technical failure. The sensitivity and specificity for overall technical failure were 0.71 and 0.77, respectively, with AUC of 0.76 (95% CI: 0.69-0.84) achieved by the recursive feature elimination and AdaBoost algorithm. For cardiac technical failure, the ANOVA FS and Random Forest (RF) model yielded sensitivity and specificity of 0.71 and 0.77, with an AUC of 0.76 (95% CI: 0.65 to 0.87). Vascular technical failure showed AUC of 0.76 (95% CI: 0.69 to 0.84), with sensitivity and specificity of 0.72 and 0.73, respectively, with achieved using the ANOVA FS and RF model. Conclusion The initial results of the novel prediction model for technical success are promising. Further improvements and external validation are warranted to support the use of the proposed model in clinical practice.Central Illustration

Cardiac amyloidosis and left atrial appendage closure: a multicenter retrospective study

Abstract Background Thromboembolic stroke risk remains a clinical challenge in cardiac amyloidosis (CA) patients with atrial fibrillation because of the increased prevalence of left atrial appendage thrombi irrespective of CHA2DS2-VASc score and a higher prevalence of factors that increase the risk of bleeding with anticoagulation. Left atrial appendage closure (LAAC) is an effective option in patients with atrial fibrillation and high bleeding risk; however, data describing a LAAC strategy for stroke prevention in patients with CA is limited. Among non-CA patients, procedural success and serious complication rates are around 98% and 3% respectively. Purpose In this multicenter retrospective study, we aimed to investigate whether left atrial appendage closure (LAAC) could reduce the risk of bleeding complications and ischemic cerebrovascular events in patients with CA. Methods In an international multi-center retrospective study, patients with CA that underwent LAAC were included. The diagnosis of CA was established on the basis of histologic confirmation or advanced multimodality cardiac imaging as per current consensus statements. Results A total of 28 patients (93% male; 87% ATTR-CA; 13% AL-CA; mean age 80 years) met inclusion criteria. At baseline, mean CHA2DS2-VASc and HAS-BLED scores were 4 and 3 respectively, mean left ventricular ejection fraction was 50%, and mean indexed left atrial volume was 58 mL/m2. 21% of patients had a prior history of ischemic stroke, 14% prior history of hemorrhagic stroke, 7% prior transient ischemic attack, and 54% had a prior history of major or minor bleeding. Procedural success was achieved in 26 patients (93%) with procedural complications occurring in 2 patients (vascular access site bleeding and cardiac tamponade). Regarding in-hospital and follow-up complications, 0% ischemic stroke, 0% hemorrhagic stroke, and major or minor bleeding in 4% of patients. During follow up, device thrombosis occurred in only 1 patient. Conclusion LAAC is a feasible and effective alternative to anticoagulation in patients with CA and excessive bleeding risk, with procedural success and complication rates similar to reported studies of non-CA patients.

Prognostic outcome of ACS in HTX patients after PCI

Abstract Background Cardiovascular disease (CVD) is the leading cause of mortality and morbidity worldwide, particularly in countries with limited access to healthcare [1,2]. Acute coronary syndrome is a collective term for several clinical conditions resulting from narrowing or occlusion of the coronary arteries [3,4]. Another group of patients affected by cardiovascular disease are those who have undergone heart transplantation. Long-term survival after transplantation is limited by cardiac allograft vasculopathy, a condition that affects the coronary arteries of the donor heart and causes diffuse narrowing [5,6]. Our retrospective analysis aims to compare the prognostic outcomes of HTX patients with ACS who underwent PCI with patients without a history of HTX. Results A total of 3194 patients with ACS were enrolled, of whom 1.16% (37) had a previous heart transplant. Patients with prior transplantation were on average younger (52.54 ± 15.13 vs. 69.76 ± 12.16, p &amp;lt; 0.001), had less dyspnea (p &amp;lt; 0.001) and a different distribution of ACS types (p &amp;lt; 0.001), as shown in Figure 1. There were no differences in sex (p = 0.287), BMI (p = 0.123), hypertension (p = 0.557), diabetes mellitus (p = 0.188) and previous myocardial infarction (p = 0.681). The majority of HTX patients were diagnosed with ISHLT CAV III (58.54%) and the average time to PCI was 12 years after transplantation. Multi-vessel disease was more common in HTX patients (p &amp;lt; 0.001). In addition, calcification was less frequent in the HTX group than in the control group (p &amp;lt; 0.001), and the lesion morphology was more diffuse in the HTX group (p &amp;lt; 0.001). On the other hand, there was no difference in the distribution of target vessels (p = 0.424), with the left anterior descending being the most frequently treated coronary artery, followed by the left circumflex and right coronary arteries. HTX patients received more stents (p &amp;lt; 0.001). There was also a difference in post-procedural TIMI flow achieved (p = 0.047), with less TIMI 3 flow achieved after PCI in the HTX group (80% vs. 93.59%). Technical success was less likely to be achieved in the HTX group (62.50% vs. 96.29%, p &amp;lt; 0.001), as was procedural success (47.06% vs. 89.68%, p &amp;lt; 0.001). There was no difference in the incidence of complications, which include perforation and bleeding (p = 0.284). All-cause mortality at three years (39.02% vs. 17.50%, p &amp;lt; 0.001), stroke (7.32% vs. 1.59%, p = 0.035) and myocardial infarction (p = 0.026) were higher in the HTX group. Over a period of three years, MACCE was more likely to occur in the HTX sub-group, which is shown graphically in Figure 2. Conclusion Interventional treatment of ACS in HTX patients is an option with a complication rate comparable to non-HTX patients and with a lower technical and procedural success - partly due to the diffuse nature of CAV and the involvement of distal and microvascular vessels. Overall MACCE and survival are inferior to the control population.Figure 1Figure 2

Coronary sinus reducer device for the treatment of refractory angina: a single center experience

Abstract Introduction The coronary sinus Reducer emerged as a complementary therapy in patients with angina refractory to optimal medical therapy and not amenable to revascularization. Aim The aim of this study was to assess the safety and efficacy of the Reducer in a real-world cohort of patients presenting with refractory angina. Methods and population Twenty-six patients with refractory angina, objective evidence of myocardial ischemia attributable to the left coronary artery and deemed unsuitable for revascularization were treated with Reducer at a single center between April 2018 and January 2023. Safety endpoints were procedural success and complications. Efficacy endpoints, assessed at 6-month, were a reduction in Canadian Cardiovascular Society angina (CCS) class and a reduction in pharmacological antianginal therapy. Results Twenty-one (81%) patients had end-stage coronary artery disease without targets for further revascularization (13 had previous CABG ± PCI and 8 had only PCI) and 5 patients had microvascular disease without epicardial stenosis. All procedures were performed via right jugular vein. The mean procedure and fluoroscopy duration were 66±29 and 19±8 minutes. Procedural success was achieved in all patients, with no device related complications. There was one cardiac tamponade, promptly treated with pericardiocentesis. Regarding the efficacy endpoint, 21 patients (81%) had at least 1 grade reduction in CCS class, 13 patients (50%) had at least 2 class reductions, and 7 patients (28 %) became asymptomatic, with a mean reduction of CCS class of 1.4±0.9, from 2.6±0.5 to 1.2±0.9 (p=0.001) at 6-month follow-up. During this time frame, twelve patients (46%) withdrew or reduced the dose of at least one anti-anginal drug. The mean reduction of anti-anginal drugs was 0.54 ±0.86, from 3.5±1.02 to 2.9±1.07 (p=0.04). Conclusion In this real-world, single-center experience, implantation of Reducer was safe and associated with improvement of angina and reduction of anti-anginal drugs intake in patients with refractory angina unsuitable for revascularization.

TAVI for treating severe aortic valve disease in cardiogenic shock: a single centre experience

Abstract Introduction Recent evidence shows the safety and efficacy of TAVI in patients with aortic valve disease (AVD) presenting in cardiogenic shock (CS). However, there is limited data regarding CS management in the cardiac intensive care unit (CICU) and its outcomes. We aimed to describe the CS features, pre-TAVI management and short-term clinical outcomes of a cohort of CS patients (pts) submitted to TAVI. Methods Single-centre retrospective registry of consecutive pts with AVD undergoing TAVI in CS, from January 2020 to October 2023. CS was defined as pre-procedural hypotension/hypoperfusion requiring vasoactive drugs or mechanical circulatory support (MCS) devices. The severity of CS was defined according to the SCAI classification. Procedural related outcomes according to the VARC-3 criteria and 30-day mortality were assessed. Results A total of 16 pts (1% of our global TAVI cohort, 62% male, mean age 79±5 years) meet the inclusion criteria. The majority (n=13) presented severe aortic stenosis, two had degenerated aortic bioprosthesis with severe regurgitation and one had native valve severe regurgitation. 6 pts (38%) had isolated left ventricle (LV) dysfunction and 10 (62%) had biventricular dysfunction. The admission LVEF was 33±8% and the mean transaortic gradient for those with aortic stenosis was 46±13mmHg. The EuroSCORE II estimated for a single non-CABG emergency procedure was 37±15%. All patients were refused for surgical treatment upon Heart Team discussion. At admission, 12 (75%) patients presented in CS SCAI-C, 1 (6%) in SCAI-D and 3 (19%) in SCAI-E. These last 3 patients presented in cardiac arrest upon admission to the CICU (time to ROSC from 2 to 15 minutes). The peak lactate level at 48 hours was 3.4 mmol/L [2.1-5.1] and the highest Vasoactive-Inotropic Score (VIS) during admission was 21 [11-45]. None of the patients needed MCS pre-TAVI. 5 (31%) patients required invasive mechanical ventilation and 5 (31%) renal replacement therapy. Median time between CICU admission and transfemoral TAVI was 2.5 days [IQR 1-7]. Procedural success was 100%, with 57% receiving a balloon-expandable and 43% a self-expandable valve. Post-TAVI CICU length of stay was 6 days [IQR 5-9]. Most common procedural complication were the need for permanent pacemaker implantation (n=2, 12%) and access-related bleeding (n=2, 12%). Hospital length-of-stay was 20±15 days. Thirty-day mortality was 12% (n=2). Conclusion In this cohort of CS patients selected for TAVI treatment, procedural success was achieved in all cases. While complications were similar to the general TAVI population, in-hospital mortality remained high but very acceptable. These results suggest that, if correctly selected, aortic valve disease patients in CS represent a niche for whom brief stabilization and urgent percutaneous valve treatment might impact their dismal prognosis.

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 &amp;lt;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.

LBBAP versus conventional CRT reimplantation after transvenous lead extraction: report from a monocentric experience

Abstract Background Cardiac resynchronization therapy – defibrillator (CRT-D) reimplantation after transvenous lead extraction (TLE) can be challenging due to fibrotic remnants and absence of target veins. Left bundle branch area pacing (LBBAP) is emerging as an alternative to conventional CRT, but data is lacking about its feasibility after TLE. Purpose To explore the feasibility and safety of LBBAP as alternative to conventional CRT though epicardial pacing (EP) in patients undergoing CRT-D TLE. Methods We prospectively enrolled all patients admitted for complete CRT-D extraction and replacement from July 2022 to September 2023. At the moment of reimplantation, the choice between EP and LBBAP was made on the basis of posterolateral CS branches viability at post-extraction CS venography. Procedural success was defined as effective stimulation and absence of major complications while the primary endpoints were procedural time, QRS complex duration and electrical lead parameters. Patients undergoing LBBAP and EP reimplantation were compared. Results Twenty-six patients were enrolled (mean age 68.3 ± 7.2 years, p = 0.538; 12% females, p = 0.859). The most frequent cause of device extraction was pocket infection (58%, p = 0.773). Seventeen (65%, p = 0.783) patients had estimated high risk of procedural severe complications measured by EROS score. Overall, 80 leads were extracted. Mechanical extractors and snares were deemed necessary in 35 cases (43%, p = 0.917) and in 2 cases, respectively. Almost all patients (n=25, 96%) underwent right-sided reimplantation. Procedural success was achieved in 24 cases (92%). Compared to standard CRT through EP, LBBAP reimplantation accounted for a faster procedure (109.5 ± 34.2 vs. 126.5 ± 46.8 min; p = &amp;lt;0.001), less radiologic exposure (877.0 ± 234.6 vs. 1332.0 ± 515.1 sec, p &amp;lt;0.001) and better ventricular pacing thresholds (0.7± 0.1 vs. 1.8± 0.6 V, p &amp;lt;0.001). Despite a similar pre-extraction paced QRS duration (127.4 ± 13.8 vs. 133.0 ± 14.4 msec; p = 0.610), LBBAP reported significant improvement in final QRS duration (105.0 ± 13.1 vs. 127.1 ± 10.4 msec, p &amp;lt; 0.001) with major reduction in QRS duration (- 10.9 ± 7.5 vs - 6.8 ± 10.1, p &amp;lt; 0.001). Conclusion After a CRT TLE procedure, LBBAP reimplantation accounted for lower procedure duration, lower radiologic exposure, narrower QRS and lower ventricular pacing thresholds, demonstrating to be a valuable alternative to EP.

Safety and feasibility of drug eluting and perfusion therapy for left main disease: JDEPTH-LM pilot study

Abstract Background Reducing cardiovascular events arising from ostial lesions of the left circumflex artery (LCx) remains an issue following percutaneous coronary intervention (PCI) for left main disease (LMD). Despite expert consensus recommendation for the drug coated balloon (DCB) use to address it, there are concerns in using DCB following the standard practice of crossover-stenting from the left main trunk (LMT) to left anterior descending artery (LAD). Specifically, utilizing a DCB in isolation for the ostial LCx after stenting may result in additional carina shift. The combination of a conventional balloon for LMT-LAD and a DCB for LMT-LCx in KBT could potentially cause hemodynamical instability due to prolonged occlusion time for the entire left coronary artery system. Accordingly, we hypothesized the combined usage of DCB and perfusion balloon (PB) could provide a safe and effective approach for drug-eluting therapy in ostial LCx lesion. This approach aims to facilitate prolonged inflation while maintaining coronary blood flow during KBT for LMD. Purpose The aim of this study was to assess the safety and feasibility of prolonged KBT with DCB and PB for LMD. Methods In this single-center prospective observational study, we enrolled patients of de-novo LMD with ostial LCx lesion, requiring crossover stenting for the LMT-LAD followed by conventional KBT (C-KBT). IVUS-guided procedure was mandated as per the study protocol. Following confirming the achievement of optimal left main PCI by IVUS, a double-effect KBT (W-KBT) was employed. This technique involved the use of a PB for the LMT-LAD and a DCB for the LMT-LCx, sized in a 1:1 ratio to the balloons used in C-KBT. Patients in cardiogenic shock, those requiring a two-stent technique for LMD, and individuals without achievement of TIMI3 flow in the LCx after C-KBT were excluded. The primary endpoint was procedural success, defined as device delivery and balloon inflation time ≥30 sec. Secondary endpoints included the total balloon inflation time (W-KBT time), the incidence of ST-change cases, time to ST-change (ST-change time), changes in blood pressure and heart rate (delta BP and delta HR, respectively), and the frequency of inotrope usage following W-KBT. Results Between January 2023 and December 2023, 12 patients were included among 73 patients with LMD who underwent PCI during this study period. Mean age was 73.8±7.2 years (91.7% men) and median SYNTAX score was 29 (IQR: 26.3 to 34.5). The incidence of ACS was 8.3%. Procedural success was achieved in 100% of cases. The results of secondary endpoints were as follows: median W-KBT time: 60 sec (IQR: 60 to 60); the incidence of ST-change: 50% (no cases with ST-elevation); mean ST-change time: 41.2±7.1 sec; mean delta BP: -13.7±11.4 mmHg; mean delta HR: -3.4±5.9 bpm; and the use of inotrope: 0%. Conclusion Within the limited sample size of this pilot study, the safety and feasibility of the "first-in-man" technique of W-KBT were confirmed.Procedure of W-KBTStrength of W-KBT

Transcatheter closure of atrial septal defect (ASD) in adult and paediatric population without transoesophageal echocardiography/general anaesthesia

Abstract Background Transcatheter device closure is the preferred therapeutic option for ostium secundum atrial septal defect(OS-ASD). Standard practice is to perform it under transoesophageal echocardiography(TEE) guidance. However, TEE is performed under general anaesthesia (GA) and leads to increases in cost, procedural duration, ICU stay, total hospital stays, risk of oesophageal injury and complications of GA. Transthoracic echocardiography(TTE) is an excellent alternative and prior studies have shown it to be a safe alternative in paediatric population. In current study we analysed safety and efficacy of TTE-guided device closure of OS-ASD in all comer population irrespective of age, weight, defect size. Methods The study enrolled all patients who underwent device closure of OS-ASD between March 2017 and December 2023. All procedures were performed under LA for adults and conscious sedation for children. The device was placed under fluoroscopy guidance and position were confirmed on TTE. Procedural success, device, defect size ratio, procedural time, fluoroscopy time, complications, intensive care unit/hospital stay duration were analysed and compared with our own experience of 125 patients with TEE-guided closures before switching to complete TTE-guided procedure(before 2017). Results 340 patients underwent TTE-guided device closure of ASD. Procedure success was 97.4% with acceptable risk of major complications. Three(0.8%) had embolization into pulmonary artery, successfully operated surgically. Two had tamponade requiring drainage. In 9 patients, device could not be deployed despite multiple attempts and approaches. All of these had defect size of &amp;gt; 34mm and deficient IVC rim along with shorter (other than aortic) rim. Findings were compared with our own previous experience of TOE guided closure (practised before 2017). Compared to TOE group, TTE group had significantly lower total procedural duration (75±4 vs. 28 ±1 min; p &amp;lt; 0.01), intensive care unit stay (24±10 vs. 10.5±1 h; p &amp;lt; 0.01), and hospital (48±12 vs. 25.5±4h; p &amp;lt; 0.01) stay duration. Fluoroscopic time was similar in both. There was no mortality in either group. Major complications were comparable, TTE-guided group had less post-procedure complications of vomiting and headache. Additional findings of less pre-procedure fasting duration and early commencement of post procedure oral intake were noted in TTE group. Conclusion TTE-guided device closure of OS-ASD is a safe and feasible in all-comer population in experienced hands. It can definitely negate the use of TEE except in very poor echo window. The added advantages include utilization of physiological variations in PV/LV pressure during cough, Valsalva manoeuvres in awake patients. It definitely reduces the procedural duration, cost of procedure and dependence on GA and trained transoesophageal echocardiographer.

Clinical experience of transapical off-pump mitral valve repair with NeoChord implantation

Abstract Introduction Transapical off-pump mitral valve repair with NeoChord implantation is a novel minimally invasive surgical procedure to treat degenerative mitral valve regurgitation (MR). has gained widespread application for patients presenting with severe mitral regurgitation caused by leaflet prolapse or flail. However, there is a scarcity of data concerning the clinical experience with this device. Purpose This prospective study aims to assess 1-year clinical results of the Neochord Procedure in a consecutive cohort of patients. Methods Between March 2018 and December 2023, 38 patients with severe symptomatic degenerative MR were enrolled in the study. All patients presented with severe MR due to flail of 1 or both leaflets and they all completed postoperative echocardiographic assessment up to 1 year. We identified the primary endpoint as composed of procedural success , freedom from mortality, reintervention, recurrence of severe MR , and decrease of at least 1 New York Heart Association (NYHA) functional class at 1-year follow- up. Results Median age was 59 years (21% female). Acute procedure success (defined as successful placement of at least 3 neochords with reduction of residual MR to less than 2+) was achieved in all patients. The intraoperative and in-hospital mortality rate was 0%. At 1-year overall survival was 97% with the one reported death attributed to other causes. Following the procedure, almost all patients (94%) reported a decrease in NYHA functional class at 1-year follow-up along with a reduction in diuretic usage (18% of patients presented with NYHA Class I, while 76% of them presented with NYHA Class II). Moreover, 18% of patients exhibited mild MR, while 63% presented with moderate MR, and 10% had no detectable mitral leakage. Conclusion Transapical off-pump mitral valve repair with NeoChord implantation seem to be a safe procedure for patients. However, further investigations with a larger sample size and longer follow-up periods are warranted.

Intravascular lithotripsy in the management of underexpanded stents

Abstract Introduction Stent underexpansion significantly heightens the risk of major adverse cardiac events (MACE), and available treatment options for this condition remain limited. Intravascular Lithotripsy (IVL) technology disrupts superficial and deep calcium by using localized pulsative sonic pressure waves, emerges as a promising tool for underexpanded stents. Methods Following PRISMA guidelines, we systematically explored PubMed, SCOPUS, and Cochrane databases up to September 3, 2023, for studies evaluating IVL's safety and efficacy in treating underexpanded stents. We gathered angiographic (QCA) and intracoronary imaging (OCT or IVUS) data, examining the stent's minimal diameter stenosis (MDS), minimal lumen diameter (MLD), minimal stent area (MSA), and minimal lumen area (MLA) pre- and post-IVL application. Procedural success constituted the efficacy endpoint, while peri-procedural complications, in-hospital-30-days and long-term mortality, and MACE were safety endpoints Results This meta-analysis comprised 21 studies including 669 patients and 673 treated lesions in underexpanded stent. The mean age was 73.2 ± 2.1 years, with an overall IVL procedural success rate of 93% [(95% Confidence Interval (CI): 88%-96%, I2=29%), while the in-hospital-30-days and long-term mortality incidence were 1% (95% CI: 1%-3%, I2=0%) and 3% (95% CI: 2%-6%, I2=0), respectively. The 30-days target lesion revascularization (TLR) was approximately 6% (95% CI: 3%-12%, I2=50%). There was a significant increase in the MDS [Standardized Mean Difference (SMD): +50.52%, 95% CI: 39.4-61.6, I2=94%)] and in MSA (SMD: +3.52, 95% CI: 2.47 to -4.58, I2=83%) immediately after IVL application. It was observed a significant increase in MLD (SMD: +1.54, 95% CI: 1.09 to 1.98, I2=95%) and in the MLA (SMD: +3.64, 95% CI: 2.62-4.66, I2=5%). Major procedural and device related complications were 3% (95% CI: 1%-6%, I2=0%) and 1% (95% CI: 0%-2%, I2=85%) respectively. Notably low rates were observed for stent thrombosis (0%, 95% CI: 0%-2%, I2=0%), dissections (1%, 95% CI: 1%-4%, I2=0%), perforations (1%, 95% CI: 1%-3%, I2=0%) and no-reflow (0%, 95% CI: 0%-1%, I2=0%). Conclusions IVL demonstrates promise as a safe and effective strategy for underexpanded stent treatment, characterized by low rates of periprocedural complications. Future prospective studies are now warranted to compare IVL to other lesion preparation strategies.30day All-Cause Mortality after IVL use.Minimum Stent Diameter after IVL use.

Radial versus femoral access for rotational atherectomy angioplasty

Abstract Introduction The transfemoral approach (TFA) is a potentially advantageous acess site for complicated and prolonged percutaneous coronary angioplasty like rotational atherectomy (RA). Despite this, there is mounting data that suggests the transradial approach (TRA), an alternative to the TFA acess, is linked to reduced rates of mortality and access site complications. Aim This study was conducted with the aim of providing a quantitative appraisal of clinical outcomes of TRA for patients undergoing RA procedure. Methods In this retrospective study, we analyzed all RA procedures performed from March 2013 to June 2019 at our single center institution. Primary endpoints were procedural success, in-hospital mortality, and major adverse cardiovascular events (MACE) during hospitalization. Results Of the 98 patients undergoing RA, the TRA approach was chosen for 79% patients, and the TFA approach for 21% patients. No significant difference in procedural success rates was observed (94% vs. 91%, p=0.19). The use of RA via TRA correlated with a lower contrast volume (p=0.027) and a decreased post-procedure hospital stay (p=0.005). After multivariate adjustment, TRA demonstrated a noteworthy reduction in in-hospital mortality odds (OR: 0.62; 95% CI: 0.44 to 0.87; p = 0.003), major bleeding (OR: 0.48; 95% CI: 0.33 to 0.70; p &amp;lt; 0.001), MACE (OR: 0.68; 95% CI: 0.51 to 0.89; p = 0.015), and 30-day mortality (OR: 0.68; 95% CI: 0.51 to 0.89; p = 0.015). Conclusions Even though RA is a complex procedure, employing radial access (TRA) might be associated with favorable outcomes. These include a lower contrast volume, shorter hospital stay, and reduced odds of in-hospital mortality, major bleeding, MACE, and 30-day mortality compared to femoral access (TFA).

OSDOKINA crush technique for the management of side branch ostial lesion ISTANBOL study

Abstract Background Isolated ostial bifurcation lesions (Medina type 0.0.1) represent &amp;lt;20% of coronary bifurcation lesions. Percutaneous coronary intervention (PCI) of this subset of lesions is challenging for the interventional cardiologist because of the technical difficulty and potential risk of serious complications. Purposes Recently, we devised a new technique, called the OSDOKINA crush technique, for the treatment of Medina type 0.0.1 coronary bifurcation lesions. The aim of this study was to evaluate the technical feasibility, safety and short-term and midterm procedural and clinical results achieved with OSDOKINA crush technique for Medina type 0.0.1 coronary bifurcation lesions. Materials and Methods Between September 2020 and January 2024, we included 49 patients who had Medina type 0,0,1 coronary bifurcation lesions. The vessel size had to be ≥2.5 mm by visual estimation on coronary angiography. Demographic, clinical and lesion characteristics of the cases were recorded. Quantitative coronary angiography analyses were performed using dedicated bifurcation angiographic software. Procedural success was defined as successful implantation of the stent into the target lesion, causing a final residual stenosis ≤30%. Major adverse cardiac events(MACE) were defined as cardiac death, myocard infarction and target lesion revascularisation. All patients were followed up to twelve months after the intervention. Results The lesion localisations were the ostium of diagonal branch in 19 (38.7%), ostium of the obtuse marginalis branch in 17 (34.6%), ostium of right posterior descending or right posterolateral branch in 13 (26.7%). SB RVD, SB lesion length and SB diameter stenosis by QCA were 2.65±0.35 mm, 9.4±3.9 mm, and 79.8±12.6, respectively. SB predilatation was applied in all cases. In 1 patient (2.1%), a stent had to be placed in the main branch using the double-kissing mini crush technique due to flow-limiting dissection that developed after the second kissing balloon inflation. Considering all cases, the angiographic success rate was 97.9% (n: 48). All patients had 12-month follow-up results. Acute myocardial infarction occurred in 1 patient (2.1%) due to side branch stent thrombosis. No patient had main branch revascularization. Cardiac or non-cardiac death was not observed. Cumulative MACE was 2.1%(n:1). Conclusion The OSDOKINA crush technique has excellent acute results and midterm clinical outcomes in the management of Medina type 0.0.1 coronary bifurcation lesions. Multicenter studies with large patient groups are needed.

Outcomes by race and ethnicity in patients undergoing percutaneous coronary intervention of chronic total occlusion

Abstract Background Percutaneous coronary intervention (PCI) of chronic total occlusion (CTO) carries increased risk for worse outcome. There is limited data on whether race and/or ethnicity affect outcomes. Materials and methods We included patients who underwent CTO intervention from 2012 to 2017 at The Mount Sinai Hospital (New York). Data were collected prospectively but examined retrospectively. The patients were stratified by race/ethnicity in Caucasians, African Americans, Asians and Hispanics. The primary end point was major adverse cardiac events (MACE) defined as the composite of death, myocardial infarction (MI), and target vessel revascularization (TVR) at 1 year follow-up. Secondary outcomes included individual components of the MACE (death, MI or TVR), and bleeding. Results A total 1,684 patients were included of which (49.8%) were Caucasians, 168 (10%) were African Americans, 396 (23.5%) were Asians and 281 (16.7%) were Hispanics. African Americans had the highest proportion of female patients (39%) and more often had a history of smoking (26.2%) and insulin-dependent diabetes mellitus (46.6%) compared to the other groups. They had the highest prevalence of in-stent restenosis as the target lesion (Table 1). Caucasians were older (65.9±11.1 years) with more calcified lesions and longest lesion length compared to the other groups. Asians had highest prevalence of multi-vessel coronary disease. Caucasians and Asians had higher Syntax score and more stents implanted. Procedural success was similar between the groups (Table 1). Adjusted analyses did not show any differences in clinical outcomes between groups (Table 2). Conclusion In spite of many differences between racial/ethnical groups in baseline and procedural characteristics, procedural success of CTO intervention and 1-year MACE rates were similar between groups.Procedural characteristicsAdjusted 1-year outcomes

Safety and efficacy of leadless pacemaker extraction using a novel retrieval tool: a multicenter analysis

Abstract Background Leadless pacemakers (LP) have emerged as a safe and effective alternative for cardiac pacing, increasingly adopted by the medical community. While rare, complications such as pacemaker syndrome or device dislodgment can occur. In such instances, the extraction of the leadless pacemaker and its replacement with a new device should be considered. Purpose This multicenter study aimed to describe the use of the Aveir retrieval sheath during Micra extraction procedure and to assess the success rates and potential complications associated with the procedure. Methods In this observational study, we analyzed prospectively collected data from 14 patients that underwent leadless pacemaker using Abbott retrieval catheter at three high volume centers for pacemaker extraction and leadless implant in United States. Thought femoral vein the Aveir steerable retrieval catheter is advanced to the right atrium and then across the tricuspid valve. Under TEE and fluoroscopy guidance the snare is advanced over the Micra, and the button is secured. A protective sleeve is advanced over the LP. With application of traction to snare and countertraction with the sleeve against the endocardium, the LP is free from the myocardium and removed via the sheath. (Fig. 1) The procedural duration should be intended as the combined total of the time taken for the extraction of the existing pacemaker and the implantation time of the new device. Extractions performed during the first year were described as early and thereafter as late. Procedural success was described as complete extraction of LP without procedural complication. Results The reason for early explant was LP dislodgment and for late explant was pacemaker syndrome. Median time to extraction was 4±2 months in early explant and 35±9 months in late explant. Procedural time in early and late groups was 68.7 and 72.3 min respectively (P=0.32). Fluoroscopy time in early and late groups was 12.2 and 16.4 respectively (P= 0.18). LP was then replaced with a transvenous pacemaker. Success was 100% in both groups. No complication occurred in both groups. Conclusion Micra pacemaker using Aveir retrieval catheter is an effective tool irrespective of dwell time.