ABSTRACT
A 76-year-old female with a complicated medical history presented for Watchman (Boston Scientific) placement 2 months after mitral valve transcatheter edge-to-edge repair (TEER). Preoperative workup before Watchman placement confirmed the presence of a thrombus in the left superior pulmonary vein. Post-procedure mitral valve TEER transesophageal echocardiogram showed no thrombus in the left atrium appendage or pulmonary veins. We believe the thrombus in the left superior pulmonary vein occurred secondarily due to epithelium damage during the mitral valve TEER.
Subject(s)
Cardiac Catheterization , Echocardiography, Transesophageal , Heart Valve Prosthesis Implantation , Mitral Valve Insufficiency , Mitral Valve , Pulmonary Veins , Venous Thrombosis , Humans , Female , Aged , Pulmonary Veins/diagnostic imaging , Pulmonary Veins/surgery , Mitral Valve Insufficiency/surgery , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/etiology , Mitral Valve Insufficiency/physiopathology , Cardiac Catheterization/adverse effects , Cardiac Catheterization/instrumentation , Treatment Outcome , Venous Thrombosis/diagnostic imaging , Venous Thrombosis/etiology , Venous Thrombosis/surgery , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/instrumentation , Mitral Valve/surgery , Mitral Valve/diagnostic imagingABSTRACT
Left atrial appendage occlusion (LAAO) is rapidly growing as valid stroke prevention therapy in atrial fibrillation. Cardiac imaging plays an instrumental role in preprocedural planning, procedural execution, and postprocedural follow-up. Recently, cardiac computed tomography (CCT) has made significant advancements, resulting in increasing use both preprocedurally and in outpatient follow-up. It provides a noninvasive, high-resolution alternative to the current standard, transesophageal echocardiography, and may display advantages in both the detection and characterization of device-specific complications, such as peridevice leak and device-related thrombosis. The implementation of CCT in the follow-up after LAAO has identified new findings such as hypoattenuated thickening on the atrial device surface and left atrial appendage contrast patency, which are not readily assessable on transesophageal echocardiography. Currently, there is a lack of standardization for acquisition and interpretation of images and consensus on definitions of essential findings on CCT in the postprocedural phase. This paper intends to provide a practical and standardized approach to both acquisition and interpretation of CCT after LAAO based on a comprehensive review of the literature and expert consensus among European and North American interventional and imaging specialists.
Subject(s)
Atrial Appendage , Atrial Fibrillation , Cardiac Catheterization , Consensus , Predictive Value of Tests , Stroke , Tomography, X-Ray Computed , Humans , Atrial Appendage/diagnostic imaging , Atrial Appendage/physiopathology , Atrial Fibrillation/diagnostic imaging , Atrial Fibrillation/therapy , Atrial Fibrillation/physiopathology , Treatment Outcome , Cardiac Catheterization/adverse effects , Cardiac Catheterization/instrumentation , Cardiac Catheterization/standards , Stroke/prevention & control , Stroke/etiology , Risk Factors , Echocardiography, TransesophagealSubject(s)
Anticoagulants , Atrial Appendage , Atrial Fibrillation , Cardiac Catheterization , Contraindications, Drug , Treatment Failure , Humans , Atrial Appendage/physiopathology , Atrial Appendage/diagnostic imaging , Atrial Fibrillation/drug therapy , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Anticoagulants/adverse effects , Anticoagulants/administration & dosage , Risk Factors , Cardiac Catheterization/adverse effects , Cardiac Catheterization/instrumentation , Stroke/prevention & control , Stroke/etiology , Risk Assessment , Hemorrhage/chemically induced , Clinical Decision-Making , Female , Aged , Male , Patient SelectionSubject(s)
Anticoagulants , Atrial Appendage , Atrial Fibrillation , Contraindications, Drug , Humans , Atrial Appendage/physiopathology , Atrial Appendage/diagnostic imaging , Anticoagulants/adverse effects , Anticoagulants/administration & dosage , Atrial Fibrillation/drug therapy , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Risk Factors , Treatment Failure , Stroke/prevention & control , Stroke/etiology , Risk Assessment , Cardiac Catheterization/adverse effects , Cardiac Catheterization/instrumentation , Clinical Decision-Making , Patient Selection , Hemorrhage/chemically inducedABSTRACT
Left ventricular outflow tract obstruction is a rare complication following transcatheter mitral valve implantation. Diagnosing the underlying cause is mandatory to select from different treatment options. We report a case of stent-graft implantation into the left ventricular outflow tract for dynamic left ventricular outflow tract obstruction caused by systolic anterior motion of the anterior mitral valve leaflet (SAM).
Subject(s)
Heart Valve Prosthesis Implantation , Mitral Valve , Stents , Ventricular Outflow Obstruction , Humans , Ventricular Outflow Obstruction/surgery , Ventricular Outflow Obstruction/etiology , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/methods , Stents/adverse effects , Mitral Valve/surgery , Cardiac Catheterization/methods , Cardiac Catheterization/adverse effects , Mitral Valve Insufficiency/surgery , Male , Female , Aged , Ventricular Outflow Obstruction, LeftSubject(s)
Atrial Appendage , Cardiac Catheterization , Mitral Valve Insufficiency , Mitral Valve , Humans , Atrial Appendage/surgery , Atrial Appendage/physiopathology , Atrial Appendage/diagnostic imaging , Cardiac Catheterization/methods , Cardiac Catheterization/instrumentation , Cardiac Catheterization/adverse effects , Mitral Valve Insufficiency/surgery , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/physiopathology , Mitral Valve/surgery , Mitral Valve/diagnostic imaging , Mitral Valve/physiopathology , Treatment Outcome , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/instrumentation , Atrial Fibrillation/surgery , Atrial Fibrillation/complications , Atrial Fibrillation/therapyABSTRACT
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.
Subject(s)
Cardiac Catheterization , Fibrinolytic Agents , Humans , Fibrinolytic Agents/therapeutic use , Fibrinolytic Agents/adverse effects , Cardiac Catheterization/methods , Cardiac Catheterization/instrumentation , Cardiac Catheterization/adverse effects , Thrombosis/prevention & control , Thrombosis/etiology , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis Implantation/adverse effects , Treatment OutcomeABSTRACT
BACKGROUND: Limited data are available on transcatheter patent foramen ovale (PFO) closure outcomes in the elderly. AIMS: Through this study, we aimed to determine the incidence and predictors of adverse events (recurrent cerebrovascular events [CVE] and atrial fibrillation [AF]) post-PFO closure in older patients with cryptogenic events. METHODS: This multicentre international study included patients over 60 years undergoing PFO closure for cryptogenic thromboembolic events. A dedicated database compiled baseline, procedural, and follow-up data. Competing risk and adjusted outcome predictor analyses were conducted. RESULTS: A total of 689 patients were included (median age 65 years, 41.2% female, mean Risk of Paradoxical Embolism [RoPE] score 4.5). The procedural success rate was 99.4%. After a median follow-up of 2 (interquartile range 1-5) years, 66 patients (9.6%) had died. CVE and stroke rates were 1.21 and 0.55 per 100 patient-years, respectively. Diabetes (hazard ratio [HR] 3.89, 95% confidence interval [CI]: 1.67-9.07; p=0.002) and atrial septal aneurysm (ASA; HR 5.25, 95% CI: 1.56-17.62; p=0.007) increased the CVE risk. New-onset AF occurred at a rate of 3.30 per 100 patient-years, with 51.3% within one month post-procedure. Older age (HR 1.05 per year, 95% CI: 1.00-1.09; p=0.023) and the absence of hypertension (HR 2.04, 95% CI: 1.19-3.57; p=0.010) were associated with an increased risk of AF. CONCLUSIONS: Older patients undergoing PFO closure had a relatively low rate of CVE and new-onset AF after a median follow-up of 2 years. The presence of diabetes, ASA, and a more advanced age determined an increased risk of adverse clinical events. These factors may be considered in the clinical decision-making process regarding PFO closure in this challenging population.
Subject(s)
Atrial Fibrillation , Cardiac Catheterization , Foramen Ovale, Patent , Humans , Foramen Ovale, Patent/complications , Foramen Ovale, Patent/surgery , Female , Male , Aged , Middle Aged , Risk Factors , Cardiac Catheterization/adverse effects , Cardiac Catheterization/methods , Treatment Outcome , Atrial Fibrillation/complications , Atrial Fibrillation/epidemiology , Stroke/etiology , Stroke/epidemiology , Stroke/prevention & control , Embolism, Paradoxical/etiology , Embolism, Paradoxical/epidemiology , Embolism, Paradoxical/prevention & control , Septal Occluder Device/adverse effects , Aged, 80 and over , Age Factors , IncidenceSubject(s)
Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Humans , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis/adverse effects , Mitral Valve/surgery , Mitral Valve/diagnostic imaging , Mitral Valve/physiopathology , Mitral Valve Insufficiency/surgery , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/physiopathology , Treatment Outcome , Prosthesis Failure , Female , Male , Cardiac Catheterization/instrumentation , Cardiac Catheterization/methods , Cardiac Catheterization/adverse effects , Aged , Echocardiography, TransesophagealABSTRACT
BACKGROUND: The objective of this study is to investigate the incidence, potential risk factors, and clinical outcomes of incomplete device endothelialization (IDE) in atrial fibrillation (AF) patients undergoing Watchman left atrial appendage closure (LAAC). METHODS: In this study, 68 AF patients who underwent successful implantation of the Watchman device without peri-device leak (PDL) during follow-up were included. The endothelialization status was assessed using Transesophageal echocardiography (TEE) and LAA computed tomography angiography (CTA) at 6 weeks and 6 months post-implantation. Adverse cerebro-cardiac events were documented at one-year follow-up. Baseline characteristics, including age, device sizes, and clinical indicators, were analyzed as potential predictors for IDE. RESULTS: IDE was observed in 70.6% and 67.6% of patients at 6 weeks and 6 months after implantation, respectively. Higher levels of high-density lipoprotein cholesterol (HDL-C) [odds ratio (OR): 15.109, 95% confidence interval (CI): 1.637-139.478, p = 0.017 and OR: 11.015, 95% CI: 1.365-88.896, p = 0.024] and lower aspartate aminotransferase (AST) (OR 0.924, 95% CI: 0.865-0.986, p = 0.017 and OR: 0.930, 95% CI: 0.874-0.990, p = 0.023) at baseline were found to be significantly associated with IDE at 6 weeks and 6 months, respectively, although no significant difference in adverse cerebro-cardiac events was noted between incomplete and complete DE groups during 1-year follow-up CONCLUSIONS: IDE is found to be a prevalent occurrence in humans following LAAC. Elevated HDL-C and reduced AST levels are shown to be linked to an increased risk of IDE after LAAC.
Subject(s)
Atrial Appendage , Atrial Fibrillation , Cardiac Catheterization , Echocardiography, Transesophageal , Humans , Atrial Fibrillation/diagnosis , Atrial Fibrillation/epidemiology , Atrial Fibrillation/physiopathology , Atrial Fibrillation/surgery , Atrial Appendage/diagnostic imaging , Atrial Appendage/physiopathology , Male , Female , Aged , Risk Factors , Incidence , Middle Aged , Treatment Outcome , Time Factors , Cardiac Catheterization/adverse effects , Cardiac Catheterization/instrumentation , Computed Tomography Angiography , Risk Assessment , Aged, 80 and over , Left Atrial Appendage ClosureABSTRACT
BACKGROUND: Transcatheter mitral valve replacement (TMVR) is a therapeutic option for patients with severe mitral regurgitation (MR) who are ineligible for conventional surgery. There are limited data on the outcomes of large patient cohorts treated with TMVR. AIMS: This study aimed to investigate the outcomes and predictors of mortality for patients treated with transapical TMVR. METHODS: This analysis represents the clinical experience of all patients enrolled in the Tendyne Expanded Clinical Study. Patients with symptomatic MR underwent transapical TMVR with the Tendyne system between November 2014 and June 2020. Outcomes and adverse events up to 2 years, as well as predictors of short-term mortality, were assessed. RESULTS: A total of 191 patients were treated (74.1±8.0 years, 62.8% male, Society of Thoracic Surgeons Predicted Risk of Mortality 7.7±6.6%). Technical success was achieved in 96.9% (185/191), and there were no intraprocedural deaths. At 30-day, 1- and 2-year follow-up, the rates of all-cause mortality were 7.9%, 30.8% and 40.5%, respectively. Complete MR elimination (MR <1+) was observed in 99.3%, 99.1% and 96.3% of patients, respectively. TMVR treatment resulted in consistent improvement of New York Heart Association Functional Class and quality of life up to 2 years (both p<0.001). Independent predictors of early mortality were age (odds ratio [OR] 1.11; p=0.003), pulmonary hypertension (OR 3.83; p=0.007), and institutional experience (OR 0.40; p=0.047). CONCLUSIONS: This study investigated clinical outcomes in the full cohort of patients included in the Tendyne Expanded Clinical Study. The Tendyne TMVR system successfully eliminated MR with no intraprocedural deaths, resulting in an improvement in symptoms and quality of life. Continued refinement of clinical and echocardiographic risks will be important to optimise longitudinal outcomes.
Subject(s)
Cardiac Catheterization , Heart Valve Prosthesis Implantation , Mitral Valve Insufficiency , Mitral Valve , Humans , Mitral Valve Insufficiency/surgery , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/physiopathology , Mitral Valve Insufficiency/mortality , Male , Female , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/instrumentation , Aged , Mitral Valve/surgery , Mitral Valve/diagnostic imaging , Mitral Valve/physiopathology , Treatment Outcome , Aged, 80 and over , Cardiac Catheterization/methods , Cardiac Catheterization/adverse effects , Cardiac Catheterization/instrumentation , Heart Valve Prosthesis , Risk Factors , Middle AgedABSTRACT
BACKGROUND: Patients treated with left atrial appendage occlusion (LAAO) are at high bleeding risk. Intensive antithrombotic treatment is recommended after the procedure to prevent device-related thrombosis. OBJECTIVES: This study sought to evaluate the incidence, consequences, and predictors of early nonprocedural bleeding after LAAO. METHODS: This was a multicenter study including 1,649 patients undergoing LAAO in 9 centers. Early nonprocedural bleeding was defined as bleeding unrelated to the procedure occurring within 3 months after device implantation. The severity of bleeding was defined by the Valve Academic Research Consortium-2 classification. A sensitivity analysis was performed at 45 days. RESULTS: A total of 121 (7.3%) patients experienced early nonprocedural bleeding events, and 69 (57.0%) were classified as major bleeding (4.2% of patients). Independent predictors of early nonprocedural bleeding were dual antiplatelet therapy (DAPT) at discharge (adjusted HR [aHR]: 1.61; 95% CI: 1.12-2.33; P = 0.01), prior gastrointestinal bleeding (aHR: 2.15; 95% CI: 1.38-3.35; P < 0.001), and multiple locations of prior bleeding (aHR: 2.33; 95% CI: 1.34-4.05; P < 0.001). DAPT at discharge was predictive of both all and major nonprocedural bleeding at 3 months and 45 days. After a median follow-up of 2.3 years (Q1-Q3: 1.1-4.1 years), early nonprocedural bleeding was independently associated with an increased risk of all-cause death (aHR: 1.53; 95% CI: 1.15-2.06; P < 0.001). This heightened mortality risk was similar at 45 days. CONCLUSIONS: Early nonprocedural bleeding after LAAO occurred in â¼7% of patients within 3 months, with more than one-half being classified as major bleeding. Regardless of severity, early nonprocedural bleeding was associated with increased mortality. DAPT at discharge determined an increased risk of early nonprocedural bleeding after LAAO. These results emphasize the importance of bleeding risk for determining antithrombotic strategies after LAAO.
Subject(s)
Atrial Appendage , Atrial Fibrillation , Cardiac Catheterization , Hemorrhage , Platelet Aggregation Inhibitors , Humans , Atrial Appendage/physiopathology , Atrial Appendage/diagnostic imaging , Male , Female , Aged , Risk Factors , Time Factors , Atrial Fibrillation/mortality , Atrial Fibrillation/diagnosis , Atrial Fibrillation/complications , Treatment Outcome , Risk Assessment , Platelet Aggregation Inhibitors/adverse effects , Platelet Aggregation Inhibitors/therapeutic use , Hemorrhage/etiology , Incidence , Aged, 80 and over , Cardiac Catheterization/adverse effects , Cardiac Catheterization/instrumentation , Cardiac Catheterization/mortality , Dual Anti-Platelet Therapy/adverse effects , United States/epidemiology , Middle Aged , Fibrinolytic Agents/adverse effects , Fibrinolytic Agents/administration & dosage , Retrospective Studies , Europe , Anticoagulants/adverse effects , Anticoagulants/therapeutic use , Anticoagulants/administration & dosageSubject(s)
Atrial Appendage , Atrial Fibrillation , Cardiac Catheterization , Humans , Atrial Appendage/physiopathology , Atrial Appendage/diagnostic imaging , Treatment Outcome , Atrial Fibrillation/physiopathology , Atrial Fibrillation/therapy , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Cardiac Catheterization/instrumentation , Cardiac Catheterization/adverse effects , Risk Factors , Stroke/prevention & control , Stroke/etiology , Time Factors , Left Atrial Appendage ClosureABSTRACT
The evolution of percutaneous procedures that use transseptal puncture to treat left-sided structural heart disease has led to the emergence of iatrogenic atrial septal defects as a potential complication. These defects can result in hemodynamic decompensation and worsening clinical outcomes. Some iatrogenic atrial septal defects require immediate closure, others do not. This case report presents 2 patients who underwent transcatheter edge-to-edge mitral valve repair with transseptal puncture and required iatrogenic atrial septal defect closure (1 immediate and 1 delayed). The goal of this report is to highlight iatrogenic atrial septal defect assessment and the possible need for closure after transseptal puncture.
Subject(s)
Cardiac Catheterization , Echocardiography, Transesophageal , Heart Septal Defects, Atrial , Iatrogenic Disease , Mitral Valve Insufficiency , Mitral Valve , Humans , Cardiac Catheterization/methods , Cardiac Catheterization/adverse effects , Cardiac Catheterization/instrumentation , Heart Septal Defects, Atrial/surgery , Heart Septal Defects, Atrial/diagnosis , Mitral Valve Insufficiency/surgery , Mitral Valve Insufficiency/diagnosis , Mitral Valve/surgery , Mitral Valve/diagnostic imaging , Male , Aged , Female , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis Implantation/instrumentation , Heart Injuries/etiology , Heart Injuries/diagnosis , Heart Injuries/surgery , Treatment Outcome , Aged, 80 and over , PuncturesABSTRACT
BACKGROUND: The Alterra adaptive prestent is a novel self-expanding device designed to provide a landing zone for the 29 mm SAPIEN 3 valve to treat pulmonary regurgitation in patients with a right ventricular outflow tract that is too large for a balloon expandable valve alone. The mechanism of fixation for the Alterra prestent is radial force from the self-expanding stent frame, combined with a unique set of flared "tines" that protrude from both ends of the stent. AIMS, METHODS, AND RESULTS: In this report, we describe 6 patients who underwent uncomplicated transcatheter pulmonary valve replacement with an Alterra adaptive prestent and SAPIEN 3 valve and had surveillance chest computed tomography (CT) scans performed 1 day to 21 months after implant. In each patient, the CT scan demonstrated extravascular extension of a portion of the Alterra prestent, without clinical sequelae, but with extension into the ascending aorta in 1 patient and contact with the ascending aorta, left pulmonary vein, or left atrial appendage in 3 others. CONCLUSIONS: Surveillance CT imaging shows that the Alterra prestent can perforate the pulmonary artery and/or right ventricle. Although no sequelae were seen in these patients, prestent perforation has the potential to be clinically important. Implanters should be aware of this finding and its potential implications. As experience with the Alterra prestent grows, it will be important to further define the risk factors, incidence, and implications of this phenomenon.
Subject(s)
Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Predictive Value of Tests , Prosthesis Design , Humans , Male , Female , Treatment Outcome , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis Implantation/adverse effects , Time Factors , Adult , Cardiac Catheterization/instrumentation , Cardiac Catheterization/adverse effects , Pulmonary Valve/diagnostic imaging , Pulmonary Valve/surgery , Pulmonary Valve/physiopathology , Pulmonary Valve Insufficiency/diagnostic imaging , Pulmonary Valve Insufficiency/physiopathology , Pulmonary Valve Insufficiency/surgery , Pulmonary Valve Insufficiency/etiology , Young Adult , Computed Tomography Angiography , Adolescent , Pulmonary Artery/diagnostic imaging , Pulmonary Artery/physiopathology , Tomography, X-Ray ComputedABSTRACT
A patient presenting with acute ischemic stroke associated with patent foramen ovale (PFO) had concurrent deep vein thrombosis, pulmonary embolism, and new-onset atrial fibrillation. Upon initiation of anticoagulation therapy, the patient developed hemorrhagic transformation of the stroke. The patient's multiple potential sources of embolic stroke were treated with concomitant left atrial appendage occlusion and PFO closure through the PFO, made possible by using the Steerable Amulet Sheath under 3D-intracardiac echocardiography guidance.
Subject(s)
Atrial Appendage , Cardiac Catheterization , Echocardiography, Three-Dimensional , Foramen Ovale, Patent , Humans , Foramen Ovale, Patent/diagnostic imaging , Foramen Ovale, Patent/therapy , Foramen Ovale, Patent/complications , Atrial Appendage/diagnostic imaging , Atrial Appendage/physiopathology , Cardiac Catheterization/instrumentation , Cardiac Catheterization/adverse effects , Treatment Outcome , Ischemic Stroke/etiology , Ischemic Stroke/diagnostic imaging , Ultrasonography, Interventional , Male , Septal Occluder Device , Atrial Fibrillation/diagnostic imaging , Atrial Fibrillation/therapy , Atrial Fibrillation/physiopathology , Atrial Fibrillation/complications , Aged , Embolic Stroke/etiology , Embolic Stroke/prevention & control , Embolic Stroke/diagnostic imaging , Female , Echocardiography, Transesophageal , Middle AgedSubject(s)
Bioprosthesis , Cardiac Catheterization , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Mitral Valve , Prosthesis Failure , Humans , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis Implantation/adverse effects , Mitral Valve/surgery , Mitral Valve/diagnostic imaging , Mitral Valve/physiopathology , Cardiac Catheterization/instrumentation , Cardiac Catheterization/adverse effects , Mitral Valve Insufficiency/surgery , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/physiopathology , Treatment Outcome , Prosthesis Design , Male , Female , AgedABSTRACT
BACKGROUND: Transcatheter mitral valve-in-valve replacement offers a less-invasive alternative for high-risk patients with bioprosthetic valve failure. Limited experience exists in intermediate-risk patients. We aim to evaluate 1-year outcomes of the PARTNER 3 mitral valve-in-valve study. METHODS: This prospective, single-arm, multicenter study enrolled symptomatic patients with a failing mitral bioprosthesis demonstrating greater than or equal to moderate stenosis and regurgitation and Society of Thoracic Surgeons score ≥3% and <8%. A balloon-expandable transcatheter heart valve (SAPIEN 3, Edwards Lifesciences) was used via a transeptal approach. The primary end point was the composite of all-cause mortality and stroke at 1 year. RESULTS: A total of 50 patients from 12 sites underwent mitral valve-in-valve from 2018 to 2021. The mean age was 70.1±9.7 years, mean Society of Thoracic Surgeons score was 4.1%±1.6%, and 54% were female. There were no primary end point events (mortality or stroke) through 1 year, and no left-ventricular outflow tract obstruction, endocarditis, or mitral valve reintervention was reported. Six patients (12%) required rehospitalization, including heart failure (n=2), minor procedural side effects (n=2), and valve thrombosis (n=2; both resolved with anticoagulation). An additional valve thrombosis was associated with no significant clinical sequelae. From baseline to 1 year, all subjects with available data had none/trace or mild (grade 1+) mitral regurgitation and the New York Heart Association class improved in 87.2% (41/47) of patients. CONCLUSIONS: Mitral valve-in-valve with a balloon-expandable valve via transseptal approach in intermediate-risk patients was associated with improved symptoms and quality of life, adequate transcatheter valve performance, and no mortality or stroke at 1-year follow-up. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03193801.