Structural Heart Interventions Research Articles

Cerebral Embolic Protection: Is There a Benefit for Left Atrial and Mitral Valve Procedures?

This review aims to highlight the current evidence on the use of cerebral embolic protection devices (CEPD) in left atrial and transcatheter mitral valve procedures. It also aims to summarize the antithrombotic management of patients undergoing such procedures. Ischemic stroke is one of the most devastating complications of structural heart procedures. The manifestation of periprocedural stroke can range from asymptomatic and detectable only through brain imaging to major stroke with neurological deficits. CEP devices were initially developed to mitigate the risk of stroke associated with transcatheter aortic valve replacement (TAVR). However, the efficacy of such devices during different cardiac interventions is yet to be fully demonstrated, especially in left atrial appendage closure (LAAO), and mitral valve interventions. Few studies demonstrated that the risk of periprocedural strokes after LAAO and mitral valve interventions is not negligible and is highest during the periprocedural period and then falls. The majority of patients undergoing those procedures have cerebral ischemic injuries detected on diffusion-weighted magnetic resonance imaging (DW-MRI). Moreover, a reasonable number of those patients had debris embolization on the filters of the CEPD. Pharmacological therapy with antithrombotic agents before, during, or after structural heart interventions is crucial and should be tailored to each patient's risk of bleeding and ischemia. Close monitoring that includes a full neurological assessment and frequent follow-up visits with cardiac echocardiography are important. The risk of periprocedural stroke in left atrial and transcatheter mitral valve procedures is not negligible. Pharmacological therapy with antithrombotic agents before, during, or after structural heart interventions is important to mitigate the risk of stroke, especially the long-term risk. More prospective studies are needed to assess the efficacy of CEPD in such procedures.

Iatrogenic atrial septal defects in structural heart interventions: Opening the Pandora's box

AbstractIn the modern era of structural heart interventions, the total number of transseptal procedures is growing exponentially, thus increasing the rate and need for management of iatrogenic atrial septal defects (iASDs). To date, there are no official guidelines on the assessment and management of iASDs, due to inconclusive evidence on whether patients benefit more from the percutaneous closure of iASD than from conservative management and vigorous follow‐up. Despite the abundance of observational studies on iASDs, there is still a lack of randomized studies. Evidence so far show that percutaneous closure is no superior over conservative treatment in patients with iASDs, however, it has been demonstrated that patients with spontaneous closure of iASDs experience less heart failure (HF) hospitalizations. On the other hand, researchers have investigated the beneficial nature of interatrial shunt therapy in patients with HFpEF and, more recently, with HFrEF, due to the presumed hemodynamic benefits. Herein, we provide an updated review of relevant literature, focusing on iASD persistence rates, predicting factors for their persistence, and clinical outcomes of iASD persistence, to summarize available evidence and discuss future directions in the field.

Femoral Large Bore Sheath Management: How to Prevent Vascular Complications From Vessel Puncture to Sheath Removal.

Transfemoral access is nowadays required for an increasing number of percutaneous procedures, such as structural heart interventions, mechanical circulatory support, and interventional electrophysiology/pacing. Despite technological advancements and improved techniques, these devices necessitate large-bore (≥12 French) arterial/venous sheaths, posing a significant risk of bleeding and vascular complications, whose occurrence has been related to an increase in morbidity and mortality. Therefore, optimizing large-bore vascular access management is crucial in endovascular interventions. Technical options, including optimized preprocedural planning and proper selection and utilization of vascular closure devices, have been developed to increase safety. This review explores the comprehensive management of large-bore accesses, from optimal vascular puncture to sheath removal. It also discusses strategies for managing closure device failure, with the goal of minimizing vascular complications.

Remote proctoring during structural heart procedures: Towarda widespread diffusion of knowledge using mixed reality.

Despite its wide diffusion in surgical procedures, very few experiences are reported so far about the possible applications of remote proctoring (RP) in structural heart interventions. Our aim was to demonstrate the feasibility, safety, and efficacy of RP during transcatheter edge-to-edge repair using a mixed reality-based head-mounted display (HMD). Two users (a doctor and a proctor), wearing HMDs, were connected through a 5G network, allowing them to share audio and video signals. During the procedure, the proctor was located in a contiguous room, without any direct connection with the operator. The primary endpoint was noninferiority of HMD-mediated interaction if compared with direct in-person interaction. It was assessed using an operator-proctor interaction test based on six questions asked by the doctor to the proctor on six key procedural steps. Between September 2021 and April 2022, ninepatients were enrolled in the study (15 clips delivered). The primary endpoint was reached in 9/15 clips implanted (60%). The first threefailures were due to a chat software problem, and the others were linked with a 5G network malfunction. However, the HMD and its mixed reality tools were well tolerated by the operators, and no interference with the procedure was registered in any of the cases. In our experience, RP during structural heart interventions is feasible and efficacious. Wearing the HMD is comfortable and does not affect safety and effectiveness of interventional procedures. However, especially if consideringa wide geographic use of this tool, a stable internet connection is imperative.

Beyond Simple Visualization: A New Reality for Structural Heart Interventions?

Beyond Simple Visualization: A New Reality for Structural Heart Interventions?

Antithrombotic therapy for transcatheter structural heart intervention.

Percutaneous transcatheter structural heart interventions have considerably expanded within the last two decades, improving clinical outcomes and quality of life versus guideline-directed medical therapy for patients frequently ineligible for surgical treatment. Transcatheter structural heart interventions comprise valve implantation or repair and also occlusions of the patent foramen ovale, atrial septal defects and left atrial appendage. These procedures expose structural devices to arterial or venous blood flow with various rheological conditions leading to potential thrombotic complications and embolisation. Furthermore, these procedures may concern comorbid patients at high risk of both ischaemic and bleeding complications. This state-of-the-art review provides a description of the device-related thrombotic risk associated with these transcatheter structural heart interventions and of the current evidence-based guidelines regarding antithrombotic treatments. Gaps in evidence for each of the studied transcatheter interventions and the main ongoing trials are also summarised.

The Other Side of the Coin: Transesophageal Echocardiography Complications following Cardiac Surgery and Transcatheter Structural Heart Interventions.

Transesophageal echocardiography (TEE) is widely used in cardiac surgery and interventional cardiology and is often an indispensable tool, giving supportive anatomical understanding and smooth guidance in both settings. Despite it being considered safe, fatal complications can commonly occur after a TEE examination in cardiac surgery operating rooms and catheterization laboratories. Currently, there is a lack of awareness of the scale of the problem, as there are only small amounts of data available, mainly derived from the surgical literature. This review summarizes the main predisposing factors for TEE-associated complications (classified as patient and procedure-related) and the main preventive strategies. We aim to apply preventive strategies more broadly, especially to patients at high risk of developing TEE-related serious adverse events.

Transcatheter Structural Heart Interventions in the Acute Setting: An Emerging Indication.

Structural heart disease is increasingly prevalent in the general population, especially in patients of increased age. Recent advances in transcatheter structural heart interventions have gained a significant following and are now considered a mainstay option for managing stable valvular disease. However, the concept of transcatheter interventions has also been tested in acute settings by several investigators, especially in cases where valvular disease comes as a result of acute ischemia or in the context of acute decompensated heart failure. Tested interventions include both the mitral and aortic valve, mostly evaluating mitral transcatheter edge-to-edge repair and transcatheter aortic valve implantation, respectively. This review is going to focus on the use of acute structural heart interventions in the emergent setting, and it will delineate the available data and provide a meaningful discussion on the optimal patient phenotype and future directions of the field.

The safety of transesophageal echocardiography to guide transcatheter tricuspid valve edge‐to‐edge repair

AbstractBackgroundTransesophageal echocardiography (TEE) is primarily used to guide transcatheter structural heart interventions, such as tricuspid transcatheter edge‐to‐edge repair (TEER). Although TEE has a good safety profile, it is still an invasive imaging technique that may be associated with complications, especially when performed during long transcatheter procedures or on frail patients. The aim of this study was to assess TEE‐related complications during tricuspid TEER.MethodsThis is a prospective study enrolling 53 patients who underwent tricuspid TEER for severe tricuspid regurgitation (TR). TEE‐related complications were assessed clinically and divided into major (life‐threatening, major bleeding requiring transfusions or surgery, organ perforation, and persistent dysphagia) and minor (perioral hypesthesia, < 24 h dysphagia/odynophagia, minor intraoral bleeding and hematemesis not requiring transfusion)ResultsThe median age of the patient population was 79 years; 43.4% had severe, 39.6% massive, and 17.6% torrential TR. 62.3% of patients suffered from upper gastrointestinal disorders. Acute procedural success (APS) was achieved in 88.7% in a median device time of 36 min. A negative association was shown between APS and lead‐induced etiology (r = ‐.284, p = .040), baseline TR grade (r = ‐.410, p = .002), suboptimal TEE view (r = ‐.349, p = .012), device time (r = ‐.234, p = .043), and leaflet detachment (r = ‐.496, p < .0001). We did not observe any clinical manifest major or minor TEE‐related complications during the hospitalization.ConclusionsOur study reinforces the good safety profile and efficacy of TEE guidance during tricuspid TEER. Adequate preoperative management and intraprocedural precautions are mandatory in order to avoid serious complications. Furthermore, suboptimal intraprocedural TEE views are associated with lower TR reduction rates.Highlights Transesophageal echocardiography is a crucial and safe technique for guiding transcatheter structural heart interventions. A mix of mid/deep esophageal and trans gastric views, as well as real‐time 3D imaging is generally used to guide the procedure. Adequate preoperative management and intraprocedural precautions are mandatory in order to avoid serious problems. A shorter device time is associated with more rarely probe‐related complications. Suboptimal intraprocedural TEE views are associated with lower TR reduction rates.

Application of Transcatheter Electrosurgery in Structural Heart Interventions: A Report of Three Different Techniques

Transcatheter electrosurgery is a novel technique to traverse or cut tissue, within blood-filled spaces, using alternating current directed by guidewires and catheters. We report the first series of transcatheter electrosurgery procedures in Asia including transcaval access for transcatheter aortic valve implantation, intentional aortic leaflet laceration to mitigate the risk of coronary occlusion in transcatheter aortic valve implantation and intentional laceration of anterior mitral valve leaflet to mitigate the risk of left ventricular outflow tract obstruction. These procedures are potentially valuable in Asian patients because of their smaller body build compared to Caucasians posing a higher risk of coronary or left ventricular outflow tract obstruction during transcatheter valve implantation. There is a need to adopt transcatheter electrosurgery in Asia to treat more surgically inoperable patients, including proper simulation training, bench training and clinical proctorship.

Use of SAFARI 2™ as workhorse wire for left-sided structural heart interventions

BackgroundWith the advances in percutaneous treatment technologies, the left atrial appendage occlusion (LAAO) and the transcatheter mitral valve repair using MitraClip (TMVR) are increasingly being performed today. The SAFARI 2™ guidewire is primarily used during transcatheter aortic valve implantation (TAVI), our group has also been using it during MitraClip and LAAO procedures. Our clinical study aimed to share our data on the safety and effectiveness for the use of the SAFARI 2™ guidewire during MitraClip or LAAO procedures. MethodsThis study included a total of 1730 patients (948 patients of MitraClip and 782 of LAAO). It was designed as single arm, retrospective, and multicenter between July 2016 and August 2022. SAFARI 2™ guidewire was used exclusively during all the procedures. ResultsA total of 1730 patients (male 55.8 %) were included in the study. There was no guidewire-related complications, stroke/transient ischemic attack, bleeding (minor/major/life-threatening), need for cardiac surgery, pneumonia, and vascular dissection/rupture in patients undergoing LAAO. There were 2 device-related pericardial effusions without tamponade. No stroke/transient ischemic attack, bleeding (minor/major/life-threatening), mortality, need for cardiac surgery, pneumonia, guidewire-related complication, pericardial effusion, vascular dissection/rupture, or clip embolization was observed in patients undergoing MitraClip. ConclusionsBy taking advantage of its pre-shaped structure, the SAFARI 2™ guidewire seems to offer a reliable and safe device delivery for both MitraClip and LAAO procedures as a regular work horse wire. Our results should be confirmed by larger randomized or prospective trials.

Revolutionizing cardiovascular care: the power of histotripsy.

Histotripsy, an innovative ultrasonic technique, is poised to transform the landscape of cardiovascular disease management. This review explores the multifaceted applications of histotripsy across various domains of cardiovascular medicine. In thrombolysis, histotripsy presents a non-invasive, drug-free, and precise method for recanalizing blood vessels obstructed by clots, minimizing the risk of vessel damage and embolism. Additionally, histotripsy showcases its potential in congenital heart defect management, offering a promising alternative to invasive procedures by creating intracardiac communications noninvasively. For patients with calcified aortic stenosis, histotripsy demonstrates its effectiveness in softening calcified bioprosthetic valves, potentially revolutionizing valve interventions. In the realm of arrhythmias, histotripsy could play an important role in scar-based ventricular tachycardia ablation, eliminating channel-like isthmuses of slowly conducting myocardium. Histotripsy`s potential applications also extend to structural heart interventions, enabling the safe sectioning of basal chordae and potentially addressing mitral regurgitation. Furthermore, it showcases its versatility by safely generating ventricular septal defects, providing a non-invasive means of creating intracardiac communications in neonates with congenital heart disease. Yet, most supporting studies are in-vitro or animal studies and there are possible challenges in translating experimental data on cardiac histotripsy to the clinical level. As histotripsy continues to evolve and mature, its remarkable potential in cardiovascular disease management holds promise for improving patient outcomes and reducing the burden of invasive procedures in the field of cardiology.

Anti-MDA-LDL antibody levels indicate protection from coronary CT-derived valve calcification in the SCOT-HEART Trial

Abstract Introduction Coronary CT-derived valve calcification is becoming increasingly important in the multi-modality assessment of valvular disease, especially in aortic and mitral stenosis, where trans-catheter structural heart interventions may be indicated. Separately, natural antibodies targeted against malondialdehyde-modified LDL (MDA-LDL), an important subset of all oxidised low-density lipoproteins, are related to less coronary atherosclerosis and freedom from cardiovascular events. Purpose To investigate possible relationships between coronary CT-derived valve calcification and anti-MDA-LDL antibodies. Methods In a substudy of the multicentre randomised controlled SCOT-HEART trial (Scottish COmputed Tomography of the HEART), we investigated the association between manually assessed presence or absence of mitral and aortic valve calcification and IgM/ IgG anti-MDA-LDL antibodies. Serological biomarkers were measured using laboratory-developed enzyme-linked immunosorbent assays and assessed in tertiles versus imaging parameters, with adjustment for the ASSIGN cardiovascular risk score. Results In 830 patients (53% male, 57.6±9.8 years) with a heavy burden of cardiovascular risk factors (36% hypertension, 12% diabetes mellitus and 55% history of current or ex-smoking), the highest tertile of IgM anti-MDA-LDL related to a lower incidence of aortic valve calcification (odds ratio [95% confidence interval], 0.59 [0.36 – 0.96], p=0.04, p=0.07 for trend across tertiles) and mitral valve calcification (0.26 [0.07–0.72], p=0.02, p=0.05 for trend). There was also a trend for the highest tertile of IgG anti-MDA-LDL antibodies relating to a lower incidence of aortic valve calcification (0.36 [0.10–0.99], p=0.05, p=0.25 for trend), but not for mitral valve calcification. Conclusions Anti-MDA-LDL antibody levels were associated with a lower incidence of aortic and mitral valve calcification. Assessment of these novel biomarkers, which are known to relate to freedom from cardiovascular events, may be useful in screening patients prior to coronary CT for planning suitability for trans-catheter structural heart interventions.

Abstract 17578: Improving Access to Care With a Structural Heart Disease Program in a Metropolitan Public Healthcare System

Background: Public hospitals face challenges in providing access to structural heart interventions due to limited resources. Our aim is to describe the implementation and outcomes of a comprehensive, multi-disciplinary Structural Heart Disease Program (SHDP) in the largest public healthcare system in the United States, as a strategy to mitigate healthcare disparities and improve access to care. Methods: The SHDP at Bellevue Hospital serves as the referral center for 11 public hospitals in New York. It launched in 2022 and added a hybrid OR in March 2023. We collected clinical, demographic, and socioeconomic data for patients undergoing structural heart interventions. Results: A total of 56 patients were included from January 2022 to June 2023. The median age was 60 years (22-93 years), 59% were women, 41% were Black, 38% Hispanic, 11% White and 9% Asian. Most patients were immigrants (71%), 28.5% were uninsured, 37.5% were undocumented and 41% required an English interpreter. Only 21% of patients completed high school and 9% completed college. The most common procedure was PFO closure (30%) followed by M-TEER and BAV (Figure 1). For TAVRs and M-TEERs combined, the 30-day re-admission rate was 7.1% (n=1) and 30-day mortality was 0%, with no differences by ethnic group. Length of stay varied by procedure and there were low rates of procedural complications (Table 1). Conclusions: Our multidisciplinary SHDP program demonstrates feasibility to provide care to underserved populations in a public healthcare system with excellent outcomes. Further study of strategies aimed at improving access to structural heart interventions is warranted.

Abstract 18182: Inappropriate Shocks After Mitraclip™ Placement: Should Reassessment of Post-Procedural ICD Sensitivity Be Routine Practice?

Case Description: A 53 year old African American woman with non-ischemic cardiomyopathy (EF 10%) with intolerance to GDMT (allergies) and severe secondary MR. An ICD was placed years ago. Given LBBB and QRS 146ms, she underwent a BiV(biventricular pacing)-ICD upgrade with symptomatic improvement, but persisting exertional intolerance. TEE showed a favorable anatomic profile for transcatheter edge-to-edge MV repair and a MitraClip™ was placed. Post-procedure, the severity of MR decreased significantly (from severe to mild), however there was no sizable improvement in LV EF. Also, there were no significant EKG changes. Three months later, she experienced multiple inappropriate shocks (IAS). Device interrogation revealed T-wave oversensing (TWOS). TWOS was noted on multiple vectors with LV only pacing, but was solely associated with fusion complexes on BiV pacing. R wave sensing threshold was increased. Patient was switched to BiV only pacing and AV delay(paced and sensed) was decreased to avoid fusion beats. Patient did well and no further IAS were noted at 4 months follow-up. Discussion: ICDs (+/- CRT) are vital in preventing SCD in advanced CHF. Currently, transvenous technology is excellent at avoiding TWOS, however our case represents a challenging dilemma where repolarization may have changed post-operatively after MitraClip™ placement. T wave amplitude is dynamic and real time monitoring of sensing threshold is needed. This becomes especially important after structural heart procedures like MV TEER that can induce subclinical electroanatomic changes. While MitraClip™ can reduce ventricular arrhythmias with favorable remodeling, inappropriate sensing of devices is a small but real risk. Consequently, there are no established guidelines on routine post-procedural device interrogation. Preemptive reassessment of T wave safety margin and monitoring of sensing thresholds and lead placement may be useful following structural heart interventions.

3-dimensional intracardiac echocardiography for structural heart interventions.

New generation 3-dimensional matrix array intracardiac echocardiography catheters have become commercially available recently, increasing image plane options compared to 2-dimensional and older generation 3-dimensional intracardiac echocardiography catheters. They are beginning to play an important role in structural heart interventions, especially for transcatheter tricuspid interventions, due to advantages in some situations that increase image quality over transesophageal echocardiography.

The "Woggle" Technique for Venous Access Site Management: An Old Technique for a New Need.

Several closure devices are routinely used for percutaneous arterial access, while a relatively low number is available for the management of large bore venous accesses. The Woggle technique is a modification of the purse-string suture which was introduced several years ago in patients undergoing hemodialysis. A population of 45 patients who underwent transvenous femoral structural heart interventions was retrospectively evaluated. The Woggle technique consists of a purge string suture with a collar to maintain the tension as stable over time and a suture lock to tighten the suture. Sheaths magnitude ranged from 8 French (F) to 14 F. A rapid post-procedural hemostasis was achieved in the whole population, and in 95% of cases, definite hemostasis was obtained after the first single release; the mean time of release was 302 ± 83 min. Although no relevant bleedings were reported, a significant reduction in hemoglobin levels was found in the whole population. This decrement was statistically significant only in the group with sheaths higher than 12 F. A single mild local hematoma was recorded in the group in which smaller sheaths were used. Seventy-two percent of patients were pre-treated with a dual antiplatelet therapy. The Woggle technique has shown to be a simple, effective, and safe approach for the management of large bore venous in percutaneous structural heart interventions.

Three-Dimensional Transesophageal Echocardiography in Percutaneous Catheter-Based Cardiac Interventions.

Cardiac structural and valve interventions have remained surgical procedures for several decades. The ability to directly visualize the region of interest during surgery made imaging of these structures pre- and postsurgery a secondary tool to compliment surgical visualization. The last two decades, however, have seen rapid advances in catheter-based percutaneous structural heart interventions (SHIs). Due to the "blind" nature of these interventions, imaging plays a crucial role in the success of these procedures. Fluoroscopy is used universally in all percutaneous cardiac SHIs and helps primarily in the visualization of catheters and devices. However, success of these procedures requires visualization of intracardiac soft tissue structures. Due to its portable nature and rapid ability to show cardiac structures online, transesophageal echocardiography (TEE) has become an integral tool for guidance for all percutaneous SHI. Transcatheter aortic valve replacement-one of the earliest catheter-based procedures-while initially dependent on TEE, has largely been replaced by preprocedural cardiac CT for accurate assessment of valve sizing. Developments in echocardiography now allow live three-dimensional (3D) visualization of cardiac structures mimicking surgical anatomy during TEE. Besides showing actual 3D intracardiac structures, 3D-TEE allows visualization of the interaction of intracardiac catheters and devices with soft tissue cardiac structures, thereby becoming a "second pair of eyes" for the operator. Real-time 3D-TEE now plays an important role complementing multiplane two dimensional and biplane TEE during such interventions. In this review, we discuss the incremental role of 3D-TEE during various SHIs performed today.

Exposure and Subspecialty Training in Transcatheter Structural Heart Procedures for Cardiac Surgeons: An Evolving Necessity and Training Requirement

More than twenty years after Alain Cribier performed the first transcatheter aortic valve implantation (TAVI), the advent of transcatheter approaches for treating structural heart disease continues to grow. Cardiac surgical trainees who hope to build a lasting career must understand the clinical management of patients receiving transcatheter interventions - and if they choose to subspecialize, learn necessary skills to contribute to these evolving domains. We discuss the Canadian cardiac surgeons' role in providing transcatheter care in the context of the Heart Team, and the necessity for formalized training curricula that provide a foundation for further participation in structural heart interventions.

Use of SAFARI 2 as Workhorse Wire for Left-Sided Structural Heart Interventions

Use of SAFARI 2 as Workhorse Wire for Left-Sided Structural Heart Interventions