Transcatheter Valve Procedures Research Articles

E-42 | Prevalence of Cardiorenal Syndrome among Admission Cases undergoing Transcatheter Valve Procedures and its Association with Hospital Outcomes

E-42 | Prevalence of Cardiorenal Syndrome among Admission Cases undergoing Transcatheter Valve Procedures and its Association with Hospital Outcomes

Patients with transcatheter valve procedures admitted to contemporary cardiac intensive care units: insights from the CCCTN registry

Abstract Funding Acknowledgements Type of funding sources: None. Background Transcatheter cardiac valve procedures, including transcatheter aortic valve replacement (TAVR) and transcatheter edge-to-edge repair (TEER), have increased in the recent years. Peri-procedural management strategies, including whether there is a need for routine admission to cardiac intensive care units (CICUs), are not well defined. Purpose We aimed to describe the epidemiology of patients with transcatheter cardiac valve procedures admitted to contemporary CICUs. Methods We identified patients who underwent transcatheter cardiac valve procedures (TAVR or TEER) from CICUs in North America from 2017 to 2021 using data from the CCCTN (Critical Care Cardiology Trials Network) Registry. We assessed patient characteristics and the reason for triage to a CICU among those admitted for TAVR or TEER. Among patients admitted for TAVR or TEER, we further compared resource utilization and outcomes between patients (1) with an admission or CICU indication of post-procedural monitoring alone versus (2) admissions following TAVR or TEER for other reasons. Results Of 17,852 CICU admissions, 641 (3.6%) had a TAVR/TEER leading to or during their CICU stay. Compared with patients without a TAVR/TEER during CICU stay, patients with the procedure were older (median [IQR]: 80 [74-85] vs. 66 (55-75) years) and a history of coronary artery disease (54% vs. 36%, P<0.01). Monitoring alone, without another CICU indication at the time of admission, was the most frequent admission indication in patients with TAVR/TEER (n= 474, 74%). Patients admitted with TAVR or TEER for monitoring alone had low rates of any shock (2%) and mechanical ventilation (3%) and low SOFA scores (2 [1-4]); Figure). In contrast, patients with TAVR/TEER admitted for other indications had higher rates of shock (26%) and mechanical ventilation (25%) and higher SOFA scores (4 [3-7]). There were 0 cases of mechanical circulatory support (MCS) use in patients admitted for monitoring only. CICU (0.2% vs. 4.2%) and in-hospital (1.5% vs. 9.0%) mortality was multifold lower in patients with TAVR or TEER admitted for monitoring alone compared to patients with TAVR or TEER with an admission indication beyond monitoring. Conclusions In contemporary North American CICUs, nearly 3 of 4 admissions of patients with TAVR or TEER are for procedural monitoring alone. Need for advanced CICU therapies and mortality rates were low among patients admitted to the CICU for monitoring alone following TAVR or TEER. Given expected growth of these procedures over time, these observations highlight potential opportunities to redirect triage of the majority of patients following TAVR or TEER to less costly hospital units.

Appropriateness criteria for the use of cardiac computed tomography, SIC-SIRM part 2: acute chest pain evaluation; stent and coronary artery bypass graft patency evaluation; planning of coronary revascularization and transcatheter valve procedures; cardiomyopathies, electrophysiological applications, cardiac masses, cardio-oncology and pericardial diseases evaluation.

In the past 20 years, cardiac computed tomography (CCT) has become a pivotal technique for the noninvasive diagnostic workup of coronary and cardiac diseases. Continuous technical and methodological improvements, combined with fast growing scientific evidence, have progressively expanded the clinical role of CCT. Randomized clinical trials documented the value of CCT in increasing the cost-effectiveness of the management of patients with acute chest pain presenting in the emergency department, also during the pandemic. Beyond the evaluation of stents and surgical graft patency, the anatomical and functional coronary imaging have the potential to guide treatment decision-making and planning for complex left main and three-vessel coronary disease. Furthermore, there has been an increasing demand to use CCT for preinterventional planning in minimally invasive procedures, such as transcatheter valve implantation and mitral valve repair. Yet, the use of CCT as a roadmap for tailored electrophysiological procedures has gained increasing importance to assure maximum success. In the meantime, innovations and advanced postprocessing tools have generated new potential applications of CCT from the simple coronary anatomy to the complete assessment of structural, functional and pathophysiological biomarkers of cardiac disease. In this complex and revolutionary scenario, it is urgently needed to provide an updated guide for the appropriate use of CCT in different clinical settings. This manuscript, endorsed by the Italian Society of Cardiology (SIC) and the Italian Society of Medical and Interventional Radiology (SIRM), represents the second of two consensus documents collecting the expert opinion of cardiologists and radiologists about current appropriate use of CCT.

When Aortic Stenosis Is Not Alone: Epidemiology, Pathophysiology, Diagnosis and Management in Mixed and Combined Valvular Disease.

Aortic stenosis (AS) may present frequently combined with other valvular diseases or mixed with aortic regurgitation, with peculiar physio-pathological and clinical implications. The hemodynamic interactions between AS in mixed or combined valve disease depend on the specific combination of valve lesions and may result in diagnostic pitfalls at echocardiography; other imaging modalities may be helpful. Indeed, diagnosis is challenging because several echocardiographic methods commonly used to assess stenosis or regurgitation have been validated only in patients with the single-valve disease. Moreover, in the developed world, patients with multiple valve diseases tend to be older and more fragile over time; also, when more than one valvular lesion needs to address the surgical risk rises together with the long-term risk of morbidity and mortality associated with multiple valve prostheses, and the likelihood and risk of reoperation. Therefore, when AS presents mixed or combined valve disease, the heart valve team must integrate various parameters into the diagnosis and management strategy, including suitability for single or multiple transcatheter valve procedures. This review aims to summarize the most critical pathophysiological mechanisms underlying AS when associated with mitral regurgitation, mitral stenosis, aortic regurgitation, and tricuspid regurgitation. We will focus on echocardiography, clinical implications, and the most important treatment strategies.

Optimal antiplatelet and anticoagulation strategies in acute coronary syndromes.

Antithrombotic therapy has become increasingly challenging due to the thrombotic and bleeding risk of patients presenting with acute coronary syndrome (ACS) today. Contributing factors include increasing age, underlying comorbidities (e.g., renal failure, atrial fibrillation [AF]), or concomitant interventions including transcatheter valve procedures requiring individualized antithrombotic strategies. Thanks to the development of novel stent platforms with biocompatible polymers and thin strut design allowing for amore rapid endothelialization, shortening or de-escalation of antiplatelet therapies is an attractive option for reducing bleeding events. In fact, several trials have been recently published or are currently underway that address the issue of early monotherapy after short-term dual antiplatelet therapy in ACS patients. Patients with AF and ACS are at aparticularly high risk for thromboembolic and bleeding events. An individualized combination approach of antiplatelet therapy plus non-vitaminK oral anticoagulants should be favored in these patients to reduce bleeding risk according to recent randomized trials and guidelines. In contrast to de-escalation strategies in ACS patients at high bleeding risk, in patients with myocardial infarction in whom the long-term risk for ischemic events prevails, prolongation of an intensified antithrombotic therapy on top of acetylsalicylic acid is recommended. This review summarizes the recent evidence and offers practical recommendations to determine patients' bleeding versus thrombo-ischemic risk in order to tailor early and late antithrombotic therapy after ACS.

Imaging and Patient Selection for Transcatheter Tricuspid Valve Interventions.

With the emergence of transcatheter solutions for the treatment of tricuspid regurgitation (TR) increased attention has been directed to the once neglected tricuspid valve (TV) complex. Recent studies have highlighted new aspects of valve anatomy and TR etiology. The assessment of valve morphology along with quantification of regurgitation severity and RV function pose several challenges to cardiac imagers guiding transcatheter valve procedures. This review article aims to give an overview over the role of modern imaging modalities during assessment and treatment of the TV.

Aortic Stenosis with Other Concomitant Valvular Disease: Aortic Regurgitation, Mitral Regurgitation, Mitral Stenosis, or Tricuspid Regurgitation.

Aortic stenosis presenting as part of a multiple valve disease scenario or as mixed valve disease is frequent. These scenarios induce hemodynamic interactions that may result in diagnostic pitfalls. Echocardiography is the cornerstone technique for diagnosis of valve disorders, but other modalities may be useful. In addition to assessment of each individual lesion, the heart valve team must integrate numerous parameters into the management strategy, including global assessment of clinical and hemodynamic effects, operative risk, life expectancy, natural history of untreated valve disease, valve reparability, and/or suitability for single or multiple transcatheter valve procedures.

Rapid ventricular pacing during transcatheter valve procedures using an internal device and programmer: A demonstration of feasibility.

To develop a protocol for using a pre-existing, permanent pacemaker or defibrillator device for rapid ventricular pacing during transcatheter valve procedures and demonstrate feasibility. Placement of a passive fixation, temporary pacemaker wire is considered routine during most transcatheter valve procedures to facilitate controlled or rapid ventricular pacing at the time of balloon expansion or valve deployment. Many patients presenting for such procedures have a pre-existing, permanent pacemaker or defibrillator device which could be used for the same function, obviating the need for temporary pacemaker wire placement. We developed a strategy for rapid pacing from the pre-existing device using a programmer during transcatheter valve procedures in consecutive patients over a 3-month period. Complications and clinical outcomes were recorded. There were 135 transcatheter valve procedures performed during the study. Of these, 28 (20.7%) had pre-existing devices (17 transcatheter aortic valve replacement, 3 aortic valve-in-valve, 2 mitral valve-in-valve, and 6 balloon aortic valvuloplasty). All patients underwent rapid ventricular pacing using a commercially available device programmer. There were no adverse events related to device pacing and no patients required placement of a temporary pacemaker wire during the procedure. At 30-days follow-up, there were no deaths, one major vascular complication related to arterial access, and one patient with renal failure requiring dialysis. Pacing from a commercially available device programmer is safe, feasible, and may reduce both procedural cost and complications such as cardiac tamponade by avoiding placement of a temporary pacemaker lead during transcatheter valve procedures.

Planning minimally invasive mitral valve surgery

Minimally invasive mitral valve surgery (MIMVS) has still not been widely adopted as standard approach for surgical treatment of mitral valve disease due to a lack of consistent supporting evidence. Several studies have demonstrated MIMVS to be associated with shorter hospitalization stay, less bleeding and less wound infections, in spite of increased risk of stroke and longer operating times. In our philosophy, these complications can be reduced by use of precise patient selection and extensive preoperative planning. The current review aims to present an overview of current literature on this topic together with our institutions experience in this field. Advanced application of echocardiography and computed tomography (CT) with three-dimensional anatomical reconstruction could lead to an exclusion of high-risk patients for MIMVS, resulting in a reduction of complications and leading to potential superiority of this procedure compared to conventional surgery. With emergence of trans-catheter and surgical off-pump mitral valve procedures, echocardiography will play an increasingly important role, as these operations require echo-guidance. Due to technological advancements in the field of CT, we foresee this imaging modality to become more widely accepted and available, facilitating a more precise assessment of cardiac function and valvular pathology.

RAPID VENTRICULAR PACING DURING TRANSCATHETER VALVE PROCEDURES USING AN INTERNAL DEVICE AND PROGRAMMER: A DEMONSTRATION OF FEASIBILITY

Placement of a passive fixation, temporary pacemaker wire is considered routine during most transcatheter valve procedures to facilitate rapid ventricular pacing and reduce cardiac contractility at the time of balloon expansion or valve deployment. Many patients presenting to such procedures have a

Transcatheter Valve Procedures and the Anesthesiologist.

Department of Anesthesiology, Perioperative Care, and Pain Medicine, NYU Langone Health, New York, New York The authors declare that they have nothing to disclose. Address Correspondence to: Jennie Ngai, MD, Department of Anesthesiology, Perioperative Care, and Pain Medicine, NYU Langone Health, 550 First Avenue, TH 530, New York, NY 10016. E-mail: [email protected]

MitraClip removal: surgical techniques to preserve native mitral valve leaflets.

Transcatheter valve procedures are wide-spreading techniques for the treatment of heart valves pathologies. In case of implantation failure, the transcatheter device often needs to be removed. This procedure, which can alter the biological structure integrity, can limit the option available for the subsequent traditional surgery. One of the most popular devices for transcatheter mitral valve repair is the MitraClip system. In this work, we describe 2 different techniques for the surgical removal of MitraClip. These techniques aim to preserve the valve leaflets integrity, to allow for subsequent mitral valve surgical repair.

Radiation Exposure by Three-Dimensional Rotational Angiography (3DRA) During Trans-catheter Melody Pulmonary Valve Procedures (TMPV) in a Pediatric Cardiac Catheterization Laboratory.

This retrospective study aims to evaluate radiation exposure by three-dimensional rotational angiography (3DRA) during trans-catheter Melody pulmonary valve (TMPV) procedures. 3DRA has been reported to have added value in the management of complex congenital heart disease aiding in the performance of interventional procedures albeit with concerns of higher radiation exposure. We test the hypothesis that 3DRA does not cause additional radiation exposure during TMPV procedures. We analyzed all 81 TMPV procedures performed at St. Louis Children's Hospital, MO, USA, from January 1, 2011 to December 31, 2014. Dose-area product (DAP), DAP indexed to body weight (DAP/BW), fluoroscopy time (FT), and weight-fluoroscopy time product of each procedure were recorded. We reviewed each procedure's images to determine whether additional interventions were performed (e.g., pulmonary artery angioplasty or treatment of conduit pseudo-aneurysm). 3DRA was used in 36% of the procedures. 3DRA group had a higher number of additional procedures performed. The 3DRA group did not differ from the non-3DRA group in DAP, DAP/BW, and weight-fluoroscopy time product. 3DRA does not cause greater radiation exposure during TMPV procedures.

Computed tomography, electronic health record, and private medical cloud—impact of information technology on clinical decision making

Integration of CT imaging data into the electronic health record (EHR) resulting in shared ‘private medical clouds’ accessible throughout larger health care systems has become reality. These data clouds have potential impact on clinical decision making as exemplified in the context of acute aortic syndromes (AAS) and transcatheter valve procedures. Modern systems allow additional semi-automated data analysis for computerized decision support.

Apical closure device for transapical valve procedures.

Transapical transcatheter valve procedures are performed through a left minithoracotomy and require apical sutures to seal the apical access site. The use of large-calibre devices compromises any attempt to fully perform the procedure with a thoracoscopic approach or percutaneously. We report our preliminary experience in animals with a new sutureless self-expandable apical occluder, engineered to perform transapical access site closure in a minimally invasive setting with large-size introducer sheaths. The apical occluder with extendable waist was implanted in six young pigs during an acute animal study. Under general anaesthesia, animals (mean weight: 62 ± 8 kg) received full heparinization (heparin: 100 UI/kg; activated clotting time above 250 s). Through a median sternotomy, a 21-Fr Certitude™ introducer sheath (outer diameter: 25 Fr) was placed over the wire into the cardiac apex. The delivery catheter carrying the constrained apical plug was inserted into the sheath and deployed under fluoroscopic control, whereas the Certitude™ was retrieved. After protamine infusion, we observed and recorded the 1-h bleeding with standard haemodynamic parameters. Animals were sacrificed, and hearts analysed. Six apical closure devices were successfully introduced and deployed in six pig hearts through large-size apical sheaths at first attempt. In all animals, the plugs guaranteed immediate apical sealing and traces of blood were collected in the pericardium during the 1-h observational period (mean of 16 ± 3.4 ml of blood loss per animal). Haemodynamic parameters remained stable during the entire study period and no plug dislodgement was detected with normal systemic blood pressure (mean arterial mean blood pressure: 65 ± 7 mmHg). Post-mortem analysis confirmed the full deployment and good fixation of all plugs, without macroscopic damages to the surrounding myocardium. This sutureless self-expandable apical occluder is a simple device capable of sealing large-size apical access sites (20-35 Fr) in an acute animal study. This approach is a step further towards less invasive transapical valve procedures in the clinical setting, and further animal tests will be performed to confirm the long-term efficacy and safety of this device.

Cerebral Protection during Transcatheter and Surgical Heart Valve Procedures Using a Novel Endovascular Filter Device

Cerebral Protection during Transcatheter and Surgical Heart Valve Procedures Using a Novel Endovascular Filter Device

Welche Herzklappe für welchen Patienten – Selektion der Klappen interventionell und konventionell

Prosthesis choice for aortic or mitral valve replacement should be individualized and discussed by an interdisciplinary heart team and the informed patient. Taking into account the age, comorbidities, compliance and lifestyle of the patient, the heart team should evaluate if a patient can undergo mechanical or biological conventional heart valve replacement, or if a catheter based procedure should be offered. A mechanical valve is indicated if the patient already has a mechanical valve, or if there is an increased risk for degeneration of a biological prosthesis, and if there are no contraindications for lifelong anticoagulation. A biological valve is indicated if good quality anticoaguloation is unlikely, bleeding risk is increased, or previous mechanical valve thrombosis has occurred. A bioprosthesis should also be considered in young women contemplating pregnancy. Transcatheter valve procedures (TAVI) are an alternative to the conventional procedure in patients with high surgical risk. The experience of the heart team is of utmost importance for the assessment and decision making. The results of ongoing large randomized trials will further specify the indications for TAVI.

Pushing the limits—further evolutions of transcatheter valve procedures in the mitral position, including valve-in-valve, valve-in-ring, and valve-in-native-ring

Transcatheter heart valve (THV) procedures are constantly evolving. We report our experience with valve-in-valve, valve-in-ring, and direct-view valve-in-native-ring implantation in the mitral position. Fourteen patients undergoing THV implantation in the mitral position were included. Clinical and postoperative data, including echocardiography and further follow-up, were analyzed. Ten valve-in-valve and 2 valve-in-ring procedures were successfully performed using the transapical access route. For the third valve-in-ring procedure we used an antegrade left-atrial access via right anterolateral minithoracotomy. In 1 patient surgical mitral valve replacement was planned. Intraoperatively, the annulus appeared severely calcified and regular implantation of a bioprosthesis was not possible. As a last resort, a 29-mm Sapien XT valve (Edwards Lifesciences Inc, Irvine, Calif) was implanted under direct view. The initial result was satisfactory, but on the first postoperative day relevant paravalvular regurgitation occurred. Subsequently, the valve was fixed to an atrial cuff by 1 running suture. In this series 27-, 29-, and 31-mm bioprostheses and 28- and 30-mm annuloplasty rings were treated with 26- or 29-mm Sapien XT valves. Postoperative echocardiography on day 10 and after 6 weeks revealed good prosthesis function in all cases. In 2 valve-in-valve patients who solely received anticoagulation therapy with acetylsalicylic acid, signs of beginning valve thrombosis occurred after 8 weeks and 3 months, respectively. During further course, valve function was normalized using warfarin therapy. Our results demonstrate feasibility of valve-in-valve and valve-in-ring THV procedures in the mitral position. Permanent anticoagulation therapy with warfarin seems to be necessary to prevent valve dysfunction. THV implantation in a calcified native mitral ring for bailout seems not to be reproducible and thus cannot be recommended.

Role of computed tomography imaging for transcatheter valvular repair/insertion

During the last decade, the development of transcatheter based therapies has provided feasible therapeutic options for patients with symptomatic severe valvular heart disease who are deemed inoperable. The promising results of many nonrandomized series and recent landmark trials have increased the number of percutaneous transcatheter valve procedures in high operative risk patients. Pre-procedural imaging of the anatomy of the aortic or mitral valve and their spatial relationships is crucial to select the most appropriate device or prosthesis and to plan the percutaneous procedure. Multidetector row computed tomography provides 3-dimensional volumetric data sets allowing unlimited plane reconstructions and plays an important role in pre-procedural screening and procedural planning. This review will describe the evolving role of multidetector row computed tomography in patient selection and strategy planning of transcatheter aortic and mitral valve procedures.

Transcatheter valve repair/implantation

Real time 3-dimensional transesophageal echo is a relatively new technology that enables online imaging that is highly accurate and precise for evaluating cardiac structures. Moreover, this methodology allows for accurate online guidance of interventional cardiac procedures for structural heart disease. In this report, we describe the use of real time, 3D transesophageal (TEE) for aortic valve replacement with percutaneous, bioprosthetic valves as well as for transcatheter mitral repair with the MitraClip device. For each procedure, we describe 3D evaluation of valvular structures prior to the procedure, and how 3D imaging is used to guide the procedure as well as to assess the results of the procedure. Use of 3D TEE has proven to be a substantial advance for evaluating patients prior to percutaneous heart valve procedures and especially for guiding and monitoring percutaneous, transcatheter heart valve procedures.