Transcatheter Treatment Research Articles

Volume-Outcome Relationship in Surgical and Cardiac Transcatheter Interventions with a Focus on Transcatheter Aortic Valve Implantation.

“Practice makes perfect” is an old saying that can be true for complex interventions. There is a strong and persistent relationship between high volume and better outcomes with more than 300 studies being reported on the subject. The more complex the procedure, the greater the volume-outcome relationship is. Failure to rescue was shown to be one of the factors explaining higher mortality rates post complex surgery. High-volume centers provide a better safety net, thanks to the structure and better protocols, and low-volume operators have better results at high-volume centers than at low-volume centers. Finally, effort should be made to regroup complex procedures in high-volume centers, but without compromising patient access to the procedures. Adaptation to local and geographic constraints is important.

Non-Inferiority of Sutureless Aortic Valve Replacement in the TAVR Era: David versus Goliath.

Background: The rapid development of transcatheter treatment methods has made transcatheter aortic valve replacement (TAVR) a feasible alternative to conventional surgical aortic valve replacement (SAVR). Recently, indications for TAVR have been expanded to intermediate- and low-risk patients, although there still remains a portion of ineligible patients. We sought to evaluate and compare our experience with sutureless SAVR and transapical TAVR in the “grey-area” of patients unsuitable for transfemoral access. Methods: Between April 2018 and June 2021, 248 consecutive patients underwent a sutureless SAVR (SU-SAVR) or TA-TAVR at our institution. We performed a pair-matched analysis and identified 56 patient pairs based on the EuroSCORE II. All transcatheter procedures were performed using SAPIEN XT/3™ prostheses, while all surgical procedures deployed the Perceval (LivaNova) aortic valve. Results: All patients presented with multiple comorbidities as reflected by the median EuroSCORE-II of 3.1% (IQR 1.9–5.3). Thirty-four patients from the surgical group (60.7%) underwent a concomitant myocardial revascularization. There was no significant difference in major adverse events, pacemaker implantation or postoperative mortality during follow-up. Both interventions demonstrated technical success with similar mean postoperative pressure gradients at follow-up and no cases of paravalvular leakage. Conclusions: Sutureless aortic valve replacement constitutes a feasible treatment alternative for patients with aortic valve disease who are ineligible for transfemoral access route and/or require concomitant coronary revascularization. With its excellent hemodynamic performance, similar survival compared to TA-TAVR, and high cost-efficiency without compromising the postoperative outcomes and in-hospital length of stay SU-AVR might be considered for patients in the “grey-area” between TAVR and SAVR.

Outcome Predictors in Catheter Interventions for Severe Right Ventricular Outflow Tract Obstructions.

Introduction & aim of workTranscatheter treatment for critical pulmonary stenosis and membranous pulmonary atresia has become the gold standard of care in many centers. We aimed at evaluating the predictors of outcome in interventions for treatment of duct-dependent right ventricular outflow tract obstruction with intact interventricular septum.Subjects & methods68 cases with pulmonary atresia with intact interventricular septum (PA/IVS) and 50 cases with critical pulmonary stenosis (CPS), all younger than 3 months of age, were operated during the period of 10 years; excluding patients with tricuspid valve annulus Z-score smaller than −4, evidence of right ventricular-dependent coronary circulation or additional malformations.ResultsAge, weight, body surface area as well as tricuspid & pulmonary valve Z-scores were significantly less in PA/IVS; right ventricular pressure was similar in both groups however procedural success and survival to hospital discharge was higher in the CPS group. Lower age, weight and body surface area were associated with procedural failure. Weight was the only predictor of procedural success; while weight and lower post-procedural right ventricular pressure were independent predictors for survival to hospital discharge. Post-procedural right ventricular pressure and length of stay were less in the CPS group. tricuspid and pulmonary valve annulus Z-scores were the only independent predictors of the post-procedural milrinone duration in PA/IVS.ConclusionWe advocate for the use of larger balloon/pulmonary annulus ratio, to achieve a lower right ventricular pressure not fearing excessive pulmonary regurgitation that might be beneficial for right ventricular growth; and for the combination with ductal stenting in borderline or bipartite right ventricles.

Pulmonary vein stenosis: Anatomic considerations, surgical management, and outcomes.

The study objective was to evaluate outcomes of pulmonary vein stenosis repair in a large single-center cohort. Clinical data from a pulmonary vein stenosis registry were retrospectively reviewed identifying patients who underwent pulmonary vein stenosis repair. The primary/index operation was defined as the patient's first pulmonary vein stenosis operation during the study period. Between January 2007 and August 2019, 174 patients underwent pulmonary vein stenosis repair. Bilateral pulmonary vein stenosis occurred in 111 patients (64%); 71 patients (41%) had 4-vessel disease. Fifty-nine patients (34%) had primary pulmonary vein stenosis. Median age was 9months (interquartile range, 5-27) and weight was 6.5kg (4.7-10.2). Surgical techniques evolved and included ostial resection, unroofing, reimplantation, sutureless, modified sutureless, and a newer anatomically focused approach of pulmonary vein stenosis resection with lateralization or patch enlargement of the pulmonary vein-left atrium connection. Twenty-three patients (13%) required reoperation. Cumulative 2-year incidence of postoperative transcatheter intervention (balloon dilation±stenting) was 64%. One-, 2-, and 5-year survivals were 71.2%, 66.8%, and 60.6%, respectively. There was no association between surgery type and reoperation rate (hazard ratio, 2.38, P=.25) or transcatheter intervention (hazard ratio, 0.97, P=.95). The anatomically focused repair was associated with decreased mortality on univariate (hazard ratio, 0.38, P=.042) and multivariable analyses (hazard ratio, 0.19, P=.014). Antiproliferative chemotherapy was also associated with decreased mortality (hazard ratio, 0.47, P=.026). This large single-center surgical pulmonary vein stenosis experience demonstrates encouraging midterm results. A new anatomically focused repair strategy aims to alleviate pulmonary vein angulation to minimize turbulence and shows promising early outcomes. Continued follow-up is required to understand longer-term outcomes for this surgical approach.

Paravalvular Leak Echo Imaging before and during the Percutaneous Procedure

Percutaneous device closure has become a valuable alternative to surgery in the management of paravalvular leaks. Consequently, imaging in these patients is currently not only meant to verify the hemodynamic significance of the lesion but also to assess the feasibility of transcatheter treatment. We present a methodology of comprehensive echocardiography assessment that allows for the selection of patients and plans the intervention. Next, procedure-oriented steps of echocardiography imaging, which are essential for eventual success, are reviewed.

Multi-Modality Imaging of the Tricuspid Valve: From Tricuspid Valve Disease to Catheter-Based Interventions.

Tricuspid valve disease represents a major health problem that affects a wide proportion of heart failure patients with a significant prognostic impact. In recent years an increasing number of minimally invasive and transcatheter treatments have been developed. The choice of the optimal transcatheter device therapy needs a careful patient selection and a dedicated anatomic assessment, mainly based on echocardiographic and computed tomography evaluation. Moreover, cardiac magnetic resonance has an established role in the functional assessment of right heart chambers with relevant prognostic implications. In this review we describe the role of multimodality imaging in the tricuspid valve disease assessment with an intervention-oriented perspective, from the pre-operative planning for different devices to the intraprocedural guide during transcatheter edge-to-edge repair.

Clinical outcomes and predictors in patients with previous cardiac surgery undergoing mitral valve transcatheter edge-to-edge repair.

Mitral-valve transcatheter edge-to-edge repair (MV-TEER) is recommended in patients with severe functional mitral regurgitation (FMR) and in those with degenerative mitral regurgitation (DMR) not eligible to traditional surgery. Patients with a history of previous cardiac surgery are considered at high risk for surgical reintervention, but data are lacking regarding procedural and clinical outcomes. aim of this study was to assess the efficacy and clinical results of MV-TEER in patients with previous cardiac surgery enrolled in the "multicentre Italian Society of Interventional Cardiology registry of transcatheter treatment of mitral valve regurgitation" (GIOTTO). Patients with previous coronary artery bypass grafting (CABG), surgical aortic valve replacement (AVR), or mitral valve repair (MVR) were included. Those with multiple or combined previous cardiac surgeries were excluded. Clinical follow-up was performed at 30 days, 1 year, and 2 years. The primary endpoint was a composite of death or rehospitalization at 1- and 2-year follow-ups. A total of 330 patients enrolled in the GIOTTO registry were considered (CABG 77.9%, AVR 14.2%, andMVR 7.9%). Most patients showed FMR (66.9%), moderate reduction of left ventricular (LV) ejection fraction, and signs of LV dilation. Procedural and device successes were 94.8% and 97%. At 1 and 2 years, the composite endpoint occurred are 29.1% and 52.4%, respectively. The composite outcome rates were similar across the three subgroups of previous cardiac surgery (p = 0.928) and between the FMR and DMR subgroups (p = 0.850) at 2 years. In a multivariate analysis, residual mitral regurgitation (rMR) ≥2+ was the main predictor of adverse events at 1 year (hazard ratio:1.54 [95% confidence interval,CI: 1.00-2.38]; p = 0.050). This association was confirmed at 2years of Kaplan-Meier analysis (p = 0.001). MV-TEER is effective in these patients, regardless of the subtype of previous cardiac surgery and the MR etiology. An rMR ≥2+ is independently associated with adverse outcomes at 1-year follow-up.

Ligation of patent ductus arteriosus through left anterior mini-thoracotomy in preterm infants.

Patent ductus arteriosus is an important cause of morbidity and mortality, especially in very low birth weight infants. The aim of the study is to report our single-centre short-term results of preterm patients who underwent ligation through left anterior mini-thoracotomy. Data of 27 preterm infants operated by the same surgeon who underwent Patent ductus arteriosus (PDA) closure with left anterior mini-thoracotomy technique between November 2020 and January 2022 at a single institution were reviewed. The patients were divided into two groups according to their weight at the time of surgery. Data on early postoperative outcomes and survival rates after discharge were collected. Twenty-seven patients with a mean (±SD) gestational age of 25.8 (±2.0) weeks and a mean birth weight of 1027 (±423) g were operated using left anterior mini-thoracotomy technique. The lowest body weight was 480 g. Complications such as bleeding, abnormal healing of incision, or pneumothorax were not seen. There were 8 mortalities after the operation (29,6 %). The causes of the deaths were sepsis, necrotising enterocolitis, hydrops fetalis, hepatoblastoma, and intracranial bleeding. There was no statistically significant difference in the rates of complication between the groups. Left anterior mini-thoracotomy technique can be performed as the first choice when transcatheter intervention cannot be applied in preterm infants. It provides easy access to the PDA, a good exposure, minimal contact with the lungs, good cosmetic results in early and mid-term and shortens the operation time, especially in very low birth weight preterm babies. However, early ligation may be helpful to minimise the complications related to PDA.

Transcatheter Treatment of Mitral Regurgitation.

Mitral valve disease, and in particular mitral regurgitation, is a common clinical entity. Until recently, surgical repair and replacement were the only therapeutic options available, leaving many patients untreated mostly due to excessive surgical risk. Over the last number of years, huge strides have been made regarding percutaneous, catheter-based solutions for mitral valve disease. Transcatheter repair procedures have most commonly been used, and in recent years there has been exponential growth in the number of devices available for transcatheter mitral valve replacement. Furthermore, the evolution of these devices has resulted in both smaller delivery systems and a shift towards transeptal access, negating the need for surgical incisions. In line with these advancements, and clinical trials demonstrating promising outcomes in carefully selected cases, recent guidelines have strengthened their recommendations for these devices. It is appropriate, therefore, to now review the current transcatheter repair and replacement devices available and the evidence for their use.

Transcatheter Treatment of Ascending Aortic Pathology: Are we there Yet?

Transcatheter Treatment of Ascending Aortic Pathology: Are we there Yet?

An Up-to-Date Narrative Review on Congenital Heart Disease Percutaneous Treatment in Children Using Contemporary Devices.

Background: Congenital heart pathology has a significant burden regarding morbidity and mortality in the pediatric population. Several transcatheter interventions and devices have been designed as an alternative to surgical repair. Percutaneous interventions have been proven to yield good results in most cases but with less stress and trauma than that attributed to surgical treatment, especially in frail pediatric patients. We aimed to review the literature and to investigate the feasibility and efficacy of transcatheter interventions and implantable devices for congenital heart disease management in children. Methods: We performed a search in Scopus and MEDLINE databases using prespecified keywords to retrieve clinical studies published between 2000 and 2021. Results: This article provides an up-to-date review regarding the applicability of interventional techniques in simple inter-atrial or inter-ventricular defects, and in challenging congenital defects, such as hypoplastic left heart syndrome, tetralogy of Fallot, or coronary artery fistula. Furthermore, we reviewed recent indications for defibrillator and cardiac resynchronization therapy, and new and promising devices currently being tested. Conclusion: Transcatheter treatment represents a feasible and efficient alternative to surgical repair of congenital heart defects. Novel devices could extend the indications and possibilities of percutaneous interventions in pediatric patients with congenital heart diseases.

Transcatheter Tricuspid Valve Replacement: A Feasible Solution to a Real-world Problem.

As one of the most prevalent valvular pathologies affecting millions globally, moderate-to-severe tricuspid regurgitation (TR) predisposes to increased mortality. Despite the well-established risk of adverse outcomes, an overwhelming majority of TR patients are managed conservatively due to challenges associated with timely diagnosis, clinical course of the disease, competing comorbities that carry prohibitive surgical risk, and poor surgical outcomes. These challenges highlight the importance of transcatheter tricuspid valve replacement (TTVR) which has restructured TR management in promising and innovative ways. We start with an overview of the pathophysiology of TR considering its implications in management. We then elaborate on the current state of TR management, including its limitations, thereby highlighting the unique role of TTVR. This is followed by a review of perioperative considerations such as careful patient selection, role of multimodality imaging, the various imaging techniques that are available and their contribution towards successful TTVR. We then review the valves that are currently available and under investigation, including the latest data available on device efficacy and safety, and highlight the ongoing clinical trials. TTVR is evolving at an exponential pace and has made its mark in the treatment of severe symptomatic tricuspid regurgitation. The promising results sustained by currently available devices and ongoing investigation of valves under development continue to pave the path for further innovation in transcatheter interventions. However, it is important to acknowledge and appreciate the novelty of this approach, the lack of long-term data on safety, efficacy, morbidity, and mortality, and use the lessons learned from real-world experiences to provide a definitive and reproducible solution for patients with symptomatic TR.

Comparison of non-invasive assessment for pulmonary vascular indices by two-dimensional echocardiography and cardiac computed tomography angiography with conventional catheter angiocardiography in unrepaired Tetralogy of Fallot physiology patients weighing more than 10 kg: a retrospective analysis.

Assessment of pulmonary vascular dimensions (PVDs) in Tetralogy of Fallot (TOF) is an integral part of planning transcatheter and surgical interventions. We sought to examine the reliability and correlation of echocardiography (ECHO) and computed tomography angiography (CTA) measurements with those obtained by cardiac catheterization and angiography (CCA). Tetralogy of Fallot physiology patients undergoing ECHO, CTA, and CCA within a month prior to surgical correction during 2018-2020 were retrospectively enrolled. Indexed diameter of pulmonary annulus (iPAnn), indexed right pulmonary artery (iRPA), indexed left pulmonary artery (iLPA) and indexed descending aorta (iDA) were measured using ECHO and CTA followed by derivation of Nakata index (NI), McGoon's ratio (MGR), ratio of predicted peak right ventricular (RV) and left ventricular (LV) pressures (pRV/pLV) and Z-scores. Comparison with CCA-derived measurements was made and correlational equations were subsequently deduced. Pulmonary vascular dimensions for 54 patients with mean age of 15.5 ± 9.3 years (range: 3-34 years) were analysed. Computed tomography angiography and CCA measurements for iPAnn, iRPA, NI, MGR, pRV/pLV, and Z-score were comparable with each other while ECHO parameters were significantly lower than CCA. However, iLPA diameter was significantly underestimated by ECHO and overestimated by CTA. Correlational analysis showed stronger correlation between CTA- and CCA-derived PVD as against ECHO measurements except for iDA, pRV/pLV, and Z-score. For unrepaired TOF physiology patients weighing more than 10 kg, CTA-acquired PVD are reliable and comparable with CCA except for DA for which ECHO is non-inferior. Non-invasive modalities though are inferior to CCA for LPA sizing. Utilizing derived equations, precise estimation of PVD can be carried out using non-invasive tools.

The role of mechanical valves in the aortic position in the era of bioprostheses and TAVR: Evidence-based appraisal and focus on the On-X valve

Patients who need a prosthetic aortic heart valve may decide, working with their cardiologist and cardiac surgeon, among a variety of options: surgical or transcatheter approach, bioprosthetic or mechanical valve, or a Ross procedure if suitable to their age and anatomy. This review article examines the evidence for survival benefit with mechanical aortic valves, discusses bioprosthetic structural valve degeneration and its consequences, and considers the risks of redo aortic valve surgery or subsequent valve-in-valve (ViV) transcatheter intervention. It highlights the unique characteristics of the On-X aortic valve, including the US Food and Drug Administration approved and American College of Cardiology/American Heart Association guideline supported reduced anticoagulation target INR of 1.5 to 2.0, and discusses the PROACT Xa trial comparing apixaban vs warfarin anticoagulation. The choice of prosthetic valve should be individualized, carefully considering each patient's unique circumstances. In that context, the On-X aortic valve offers a potential lifetime solution without need for a repeat operation, while minimizing the risks of long-term anticoagulation. In an era of enthusiasm for bioprosthetic and transcatheter-based approaches, the option of a second-generation bileaflet mechanical valve with optimized hemodynamics—the On-X aortic valve—may well align with patient expectations.

Novel devices for managing heart failure.

Despite advances in heart failure (HF) therapies, the associated morbidity, mortality, hospitalization rates, and healthcare expenditures remain high. A significant proportion of patients with HF remain symptomatic despite receiving optimal medical therapy. Consequently, there exists a large unmet clinical need for novel therapies for treating acute and chronic HF. With the exponential growth of transcatheter interventions in structural heart disease, novel applications of minimally invasive, device-based therapies have been sought in an effort to bridge this treatment gap. The rationale, development, and current data underscoring these therapies will be summarized in this review. Recent studies have demonstrated the safety and efficacy of devices that alter left ventricular geometry (i.e., ventriculoplasty), create anatomic shunts to decompress the left atrium, and modulate vena caval and renal blood flow. However pivotal large trials evaluating clinical outcomes are ongoing. Innovative device-based therapies may expand our armamentarium against the growing heterogeneous and morbid HF syndrome.

O-4 | Transcatheter Interventions for Elastinopathy-Associated Peripheral Pulmonary Stenosis

O-4 | Transcatheter Interventions for Elastinopathy-Associated Peripheral Pulmonary Stenosis

B-40 | Percutaneous Axillary Artery Access in Children with Congenital Heart Disease

Percutaneous axillary artery access has been underutilized in children. In this study, we aimed to describe the efficacy and safety of percutaneous axillary access in complex pediatric transcatheter interventions.

Sex-Related Differences in Transcatheter Mitral Valve Repair: A Systematic Review and Meta-Analysis

Objective: Inequalities in postoperative outcomes between males and females are well described with females often experiencing inferior outcomes after heart valve surgery. The recent literature has demonstrated equivalent or improved outcomes for females after transcatheter aortic valve replacement. Transcatheter mitral valve repair (TMVr) and replacement (TMVR) is a relatively newer field with significantly less literature comparing sex differences. This systematic review and meta-analysis looks to provide a comprehensive summary of the published literature comparing outcomes between males and females undergoing transcatheter MV interventions. Methods: PubMed, MEDLINE, and Scopus were systematically searched for all studies comparing outcomes between males and females undergoing TMVr and TMVR. A total of 2,178 English manuscript titles and abstracts were reviewed. Articles were excluded if data were not provided regarding sex differences, transcatheter MV intervention, full-length text was not accessible, or if insufficient data was provided. A total of 2,170 articles were excluded, and 8 articles were included in this study. Results: Pooled estimates of outcomes demonstrated rates of acute kidney injury (OR 1.28 [95% CI, 1.14–1.44; p < 0.0001]) favored females, while rates of major bleeding favored males (OR 0.85 [95% CI 0.76–0.96; p = 0.01]). Rates of mortality, postoperative MI, and stroke did not differ significantly. Conclusion: A trend has emerged in heart valve interventions with males tending to have improved outcomes after surgical intervention and females experiencing equivalent or improved outcomes after transcatheter interventions. This meta-analysis identified increased rates of acute kidney injury for males, increased rates of major bleeding for females, and otherwise comparable morbidity and mortality in males and females undergoing TMVr.

Clinical Outcomes of Mitral Valve Disease With Mitral Annular Calcification

The prevalence of mitral valve disease with mitral annular calcification (MAC) and its clinical outcomes remain uncertain. This study sought to evaluate the prevalence of significant mitral disease due to MAC, and the impact of intervention on the clinical outcomes in these patients. All patients who underwent transthoracic echocardiography (TTE) between January 2014 and December 2015 in our health care system were reviewed and identified for having MAC with significant mitral valve disease (i.e., either≥moderate mitral regurgitation (MR) or mitral stenosis (MS)). The primary endpoints of the study were all-cause mortality and a composite outcome of mortality or heart failure hospitalization at 3-year follow-up. Of 41,136 patients who underwent TTE, MAC was identified in 2,855 (6.9%) patients, including 434 (1.1% of total) patients who had significant MR and/or MS (median age [IQR], 80 [73 to 87] years; 63% women). MAC predominately involved the posterior annulus (95%), with the majority having calcification of both trigones (55%), the leaflets (71%), and circumferential involvement (67%). During 3-year follow-up, 59 (14%) patients underwent surgical or transcatheter MV intervention. Patients who did not undergo mitral intervention had higher all-cause mortality (HR 2.80, 95% CI 1.60 to 4.92; p <0.001) and a greater risk of the composite outcome (HR 1.43, 1.00 to 2.04; p=0.05) than those treated. Survival at 3-year follow-up was markedly greater in those with mitral intervention (78% vs 50%; p <0.001). This survival benefit remained after multivariable adjustment. In conclusion, MAC affects approximately % of patients who undergo echocardiography. Those with significant mitral valve disease due to any degree of MAC have poor survival, which may be ameliorated with transcatheter or surgical intervention.

New ESC/EACTS guideline recommendations for the treatment of secondary mitral regurgitation: reflections on the evidence

New <scp>ESC</scp>/<scp>EACTS</scp> guideline recommendations for the treatment of secondary mitral regurgitation: reflections on the evidence