ABSTRACT
Peri-device leak after left atrial appendage closure (LAAC) is often treated with endovascular coils, plugs, or second occluders. This is the first study reporting the Amulet device used for peri-device leak. An 80-year-old male with paroxysmal atrial fibrillation and recurrent falls with head trauma who underwent LAAC with a 24 mm Watchman 2.5 device 3 years ago at another institution was referred to our clinic for management of the peri-device leak. Transesophageal echocardiogram showed persistent residual peri-device leak with 5 mm width along the Coumadin ridge aspect of the device. Computed tomography (CT) also showed the peri-device leak with width of 6 mm and complete opacification of left atrial appendage (LAA). Importantly, CT demonstrated that the Watchman 2.5 device was deployed at distal LAA, leaving the proximal part of LAA with length of 10 mm from ostium. Under general anesthesia, a 22 mm Amulet device was deployed successfully with complete sealing of LAA. Procedure planning is the key to minimize the risk of peri-device leak or device-related thrombosis. Careful assessment of LAA anatomy using multimodality images for peri-device leak after LAAC helped optimal treatment strategy including second LAAC with different type of devices.
Subject(s)
Atrial Appendage , Atrial Fibrillation , Male , Humans , Aged, 80 and over , Left Atrial Appendage Closure , Treatment Outcome , Cardiac Catheterization/adverse effects , Atrial Fibrillation/diagnostic imaging , Atrial Fibrillation/therapy , Warfarin , Echocardiography, Transesophageal , Atrial Appendage/diagnostic imagingABSTRACT
A large proportion of patients referred for transcatheter tricuspid valve intervention (TTVI) will have the presence of a cardiac implantable electronic device (CIED). In such patients, surgical correction of tricuspid regurgitation (TR) is associated with high rates of morbidity and mortality. Transvenous lead extraction (TLE) could potentially ameliorate CIED-induced TR; however, it carries inherent risks and frequently does not result in TR improvement. As multiple TTVI devices are in trial to gain regulatory approval, understanding which therapy is most appropriate among patients with a CIED is essential. This review centers on the nonsurgical treatment, including TLE and transcatheter tricuspid valve repair and replacement options, aimed at enhancing outcomes in patients with TR who also have concurrent CIEDs.
ABSTRACT
BACKGROUND: Limited data exists regarding incidence, progression, and predictors of left atrial appendage (LAA) sealing after transcatheter LAA closure. We aimed to evaluate the incidence, progression, and predictive factors associated with LAA sealing after LAA closure. METHODS: This study includes patients who underwent successful LAA closure with Watchman FLX device and had both pre- and postprocedural computed tomography (CT). Postprocedural CT was performed 45 days after LAA closure and used to evaluate residual LAA patency. Patient who had residual LAA patency at 45 days underwent 1-year follow-up CT. RESULTS: A total of 105 patients (mean age: 75.2 ± 9.6 years; 53.3% female) who underwent successful LAA closure with Watchman FLX device and had pre- and postprocedural CT at 45 days were included. Residual patency was observed in 35 (33.3%) patients: 21 (20.0%) patients showed complete contrast opacification in LAA (complete LAA patency) while 14 (13.3%) patients showed contrast opacification only in the distal LAA (distal LAA patency). Among patients with residual LAA patency at 45 days, the rate of LAA sealing at 1 year was significantly higher in the distal LAA patency group than in the complete LAA patency group (75.0% vs. 16.7%; p = 0.019). Increased depth oversizing was associated with both distal LAA patency and complete LAA patency. CONCLUSION: Postprocedural CT at 45 days detected patent LAA in one-third of patients after LAA closure. LAA sealing was more frequently observed at 1 year among the distal LAA patency group than the complete LAA patency group.
Subject(s)
Atrial Appendage , Atrial Fibrillation , Cardiac Catheterization , Predictive Value of Tests , Prosthesis Design , Humans , Atrial Appendage/diagnostic imaging , Atrial Appendage/physiopathology , Female , Male , Aged , Aged, 80 and over , Risk Factors , Treatment Outcome , Time Factors , Atrial Fibrillation/physiopathology , Atrial Fibrillation/diagnostic imaging , Atrial Fibrillation/therapy , Cardiac Catheterization/instrumentation , Cardiac Catheterization/adverse effects , Retrospective Studies , Incidence , Tomography, X-Ray Computed , Multidetector Computed TomographyABSTRACT
A distinctive complication with balloon-expandable (BE) THV platforms such as the Edwards Sapien (Edwards Lifescience) is the possibility of balloon rupture during THV deployment. Balloon rupture is a rare occurrence that can result in stroke due to fragment embolism, incomplete THV expansion, and/or vascular injury upon retrieval of the balloon. Careful evaluation of preoperative computed tomography is essential to identify high-risk cases. While annular and left ventricular outflow tract (LVOT) calcification are widely acknowledged as common risks for balloon injury, it's essential to note that balloon injury can manifest at various anatomical sites. In this review, we discuss the mechanism behind balloon rupture, methods to identify cases at a heightened risk of balloon injury, approaches to mitigate the risk of rupture, and percutaneous retrieval strategies.
Subject(s)
Balloon Valvuloplasty , Equipment Failure , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Humans , Aortic Valve/surgery , Aortic Valve/diagnostic imaging , Aortic Valve/physiopathology , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/physiopathology , Balloon Valvuloplasty/adverse effects , Balloon Valvuloplasty/instrumentation , Cardiac Catheters , Risk Factors , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/instrumentation , Treatment OutcomeABSTRACT
BACKGROUND: Transcatheter aortic valve replacement (TAVR) has become an established method of aortic stenosis treatment but suffers from the risk of heart block and pacemaker requirement. Risk stratification for patients who may develop heart block remains imperfect. Simultaneously, myocardial fibrosis as measured by cardiac magnetic resonance imaging (CMR) has been demonstrated as a prognostic indicator of ventricular recovery and mortality following TAVR. However, the association of CMR-based measures of myocardial fibrosis with post-TAVR conduction disturbances has not yet been explored. AIMS: We evaluated whether myocardial fibrosis, as measured by late gadolinium enhancement and extracellular volume (ECV) from CMR would be associated with new conduction abnormalities following TAVR. METHODS: One hundred seventy patients who underwent CMR within 2 months before TAVR were retrospectively reviewed. Septal late gadolinium enhancement (LGE) and ECV measurements were made as surrogates for replacement and interstitial fibrosis respectively. New conduction abnormalities were defined by the presence of transient or permanent atrioventricular block, new bundle branch blocks, and need for permanent pacemaker. Association of myocardial fibrosis and new conduction derangements were tested using receiver operator curve (ROC) and regression analysis in patients with and without pre-existing conduction issues. RESULTS: Forty-six (27.1%) patients developed post-TAVR conduction deficits. ECV was significantly higher among patients who experienced new conduction defects (26.2 ± 3.45% vs. 24.7% ± 4.15%, p value: 0.020). A greater fraction of patients that had new conduction defects had an elevated ECV of ≥26% (54.3% vs. 36.3%, p value: 0.026). ECV ≥ 26% was independently associated with the development of new conduction defects (odds ratio [OR]: 2.364, p value: 0.030). ROC analysis revealed a significant association of ECV with new conduction defects with an area under the receiver operating characteristic curve (AUC) of 0.632 (95% confidence interval: 0.555-0.705, p value: 0.005). The combination of prior right bundle branch block (RBBB) and ECV revealed a greater AUC of 0.779 (0.709-0.839, p value: <0.001) than RBBB alone (Delong p value: 0.049). No association of LGE/ECV with new conduction defects was observed among patients with pre-existing conduction disease. Among patients without baseline conduction disease, ECV was independently associated with the development of new conduction deficits (OR: 3.685, p value: 0.008). CONCLUSION: The present study explored the association of myocardial fibrosis, as measured by LGE and ECV with conduction deficits post-TAVR. Our results demonstrate an association of ECV, and thereby interstitial myocardial fibrosis, with new conduction derangement post-TAVR and introduce ECV as a potentially new risk stratification tool to identify patients at higher risk for needing post-TAVR surveillance and/or permanent pacemaker.
ABSTRACT
BACKGROUND: There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk. METHODS: We enrolled 2032 intermediate-risk patients with severe, symptomatic aortic stenosis at 57 centers. Patients were stratified according to intended transfemoral or transthoracic access (76.3% and 23.7%, respectively) and were randomly assigned to undergo either TAVR or surgical replacement. Clinical, echocardiographic, and health-status outcomes were followed for 5 years. The primary end point was death from any cause or disabling stroke. RESULTS: At 5 years, there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group and the surgery group (47.9% and 43.4%, respectively; hazard ratio, 1.09; 95% confidence interval [CI], 0.95 to 1.25; P = 0.21). Results were similar for the transfemoral-access cohort (44.5% and 42.0%, respectively; hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or disabling stroke was higher after TAVR than after surgery in the transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI, 1.02 to 1.71). At 5 years, more patients in the TAVR group than in the surgery group had at least mild paravalvular aortic regurgitation (33.3% vs. 6.3%). Repeat hospitalizations were more frequent after TAVR than after surgery (33.3% vs. 25.2%), as were aortic-valve reinterventions (3.2% vs. 0.8%). Improvement in health status at 5 years was similar for TAVR and surgery. CONCLUSIONS: Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.).
Subject(s)
Aortic Valve Stenosis/surgery , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Aged , Aged, 80 and over , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Aortic Valve Insufficiency/etiology , Aortic Valve Insufficiency/physiopathology , Aortic Valve Stenosis/complications , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/mortality , Cohort Studies , Echocardiography , Female , Health Status , Humans , Incidence , Intention to Treat Analysis , Kaplan-Meier Estimate , Male , Multivariate Analysis , Postoperative Complications/mortality , Risk Factors , Stroke/epidemiology , Stroke/etiology , Treatment OutcomeABSTRACT
INTRODUCTION: We studied the impact of the use of three-dimensional multidetector computed tomography (3D-MDCT) and fluoroscopy fusion on percutaneous left atrial appendage occlusion (LAAO) procedures in relation to procedure time, contrast volume, fluoroscopy time, and total radiation. METHODS: This was a single-center, prospective, single-blinded, randomized control trial. Patients meeting criteria for LAAO were randomized to undergo LAAO with the WATCHMAN FLXTM device with and without 3D-MDCT-fluoroscopy fusion guidance using a prespecified protocol using computed tomography angiography for WATCHMAN FLXTM sizing, moderate sedation, and intracardiac echocardiography for procedural guidance. RESULTS: Overall, 59 participants were randomly assigned to the fusion (n = 33) or no fusion (n = 26) groups. The median (interquartile range) age was 79 (75-83) years, 24 (41%) were female, and 55 (93%) were Caucasian. The median CHA2 DS2 VASc and HASBLED scores were 5 (4-6) and 3 (3-4), respectively. At the time of the study, 51 (53%) patients were on a direct acting oral anticoagulant. There were no significant differences between the fusion and no fusion groups in procedure time (52.4 ± 15.4 vs. 56.8 ± 19.5 min, p = .36), mean contrast volume used (33.8 ± 12.0 vs. 29.6 ± 11.5 mls, p = .19), mean fluoroscopy time (31.3 ± 9.9 vs. 28.9 ± 8.7 min, p = .32), mean radiation dose (1177 ± 969 vs. 1091 ± 692 mGy, p = .70), and radiation dose product curve (23.9 ± 20.5 vs. 35.0 ± 49.1 Gy cm2 , p = .29). There was no periprosthetic leak in the two groups in the immediate 1-month postprocedure follow-up periods. CONCLUSIONS: There was no significant difference with and without 3D-MDCT-fluoroscopy fusion in procedure time, contrast volume use, radiation dose, and radiation dose product.
ABSTRACT
AIMS: Patients who undergo permanent pacemaker (PPM) implantation after transcatheter aortic valve replacement (TAVR) have a worse outcome. The aim of this study was to identify risk factors of worse outcomes in patients with post-TAVR PPM implantation. METHODS AND RESULTS: This is a single-centre, retrospective study of consecutive patients who underwent post-TAVR PPM implantation from 11 March 2011 to 9 November 2019. Clinical outcomes were evaluated by landmark analysis with cut-off at 1 year after the PPM implantation. Of the 1389 patients underwent TAVR during the study duration and a total of 110 patients were included in the final analysis. Right ventricular pacing burden (RVPB) ≥ 30% at 1 year was associated with a higher likelihood of heart failure (HF) readmission [adjusted hazard ratio (aHR): 6.333; 95% confidence interval [CI]: 1.417-28.311; P = 0.016] and composite endpoint of overall death and/or HF (aHR: 2.453; 95% CI: 1.040-5.786; P = 0.040). The RVPB ≥30% at 1 year was associated with higher atrial fibrillation burden (24.1 ± 40.6% vs. 1.2 ± 5.3%; P = 0.013) and a decrease in left ventricular ejection fraction (-5.0 ± 9.8% vs. + 1.1 ± 7.9%; P = 0.005). The predicting factors of the RVPB ≥30% at 1 year were the presence of RVPB ≥40% at 1 month and the valve implantation depth measured from non-coronary cusp ≥4.0 mm (aHR: 57.808; 95% CI: 12.489-267.584; P < 0.001 and aHR: 6.817; 95% CI: 1.829-25.402; P = 0.004). CONCLUSIONS: The RVPB ≥30% at 1 year was associated with worse outcomes. Clinical benefit of minimal RV pacing algorithms and biventricular pacing needs to be investigated.
Subject(s)
Aortic Valve Stenosis , Pacemaker, Artificial , Transcatheter Aortic Valve Replacement , Humans , Transcatheter Aortic Valve Replacement/adverse effects , Cardiac Pacing, Artificial/adverse effects , Retrospective Studies , Stroke Volume , Treatment Outcome , Aortic Valve Stenosis/surgery , Ventricular Function, Left , Risk Factors , Aortic Valve/surgeryABSTRACT
BACKGROUND: While there is recent data suggesting an advantage of computed tomography angiography (CTA) over transesophageal echocardiography (TEE) for preprocedural left atrial appendage closure (LAAC) planning, there is limited published experience for sizing strategies. Device sizing for LAAC may be challenging and noninvasive algorithms that improve this selection process are warranted. OBJECTIVES: We sought to evaluate the safety and the feasibility for the implementation of a novel CTA-based sizing methodology for WATCHMAN™ FLX device in a series of patients undergoing LAAC using the TruPlan™ software package. METHODS: A prospective analysis of 136 consecutive patients who underwent LAAC over a 12-month period in a single, large academic hospital in the United States was conducted. CTA-guided preprocedural planning and intracardiac echocardiography (ICE) was performed in all. Procedural success, adverse events, length of procedure, number of devices used, and length of stay were evaluated. RESULTS: A total of 136 patients who underwent LAAC procedure with WATCHMAN™ FLX platform between October 1, 2020 until September 30, 2021 were included. The pre-specified protocol using CTA and ICE was implemented in all patients (100%). Mean CHA2 DS2 VASc score was 4.4 ± 1.3 and the mean HAS-BLED score was 3.9 ± 0.8. ICE-guided 100% transseptal puncture success rate was 100% with 98.5% of overall procedural success rate. Preprocedural CTA sizing strategy accurately predicted the implanted size in 91.1% of patients. Ten patients (7.4%) required another sized device and 2 cases were aborted. At 45-day follow-up, only 1 patient (0.7%) had significant peri-device leak (≥5 mm) on TEE. CONCLUSIONS: CTA-based preprocedural sizing methodology for WATCHMAN™ FLX in LAAC was safe, feasible and associated with excellent procedural outcomes. Further studies are warranted to confirm if the features specific to TruPlan™ may reduce the number of deployment attempts, the number of devices utilized in the procedure, and the risk of complications.
Subject(s)
Atrial Appendage , Atrial Fibrillation , Atrial Appendage/diagnostic imaging , Atrial Appendage/surgery , Atrial Fibrillation/diagnostic imaging , Atrial Fibrillation/etiology , Atrial Fibrillation/surgery , Cardiac Catheterization , Computed Tomography Angiography/methods , Echocardiography, Transesophageal/methods , Humans , Treatment OutcomeABSTRACT
BACKGROUND: Same-day discharge (SDD) following left atrial appendage closure (LAAC) is increasingly common but predictors of successful SDD and 1-year clinical outcomes have not been described. OBJECTIVE: The purpose of this study was to explore predictors of successful SDD and report 1-year outcomes in patients undergoing LAAC with SDD. METHODS: A prospective analysis was performed over a 20-month period of 225 consecutive patients that underwent LAAC in a large, academic hospital. All patients included in the study underwent a SDD protocol. Baseline characteristics and 1-year outcomes of patients discharged same day of the procedure versus those that required at least one overnight stay were compared. Adverse events, procedural success, and procedure times were evaluated. RESULTS: One hundred and sixty-one patients (72%) of patients were discharged the same day and 64 patients (28%) required at least an overnight stay (non-SDD: NSDD). NSDD patients were older and more often female. Procedure time was also longer in the NSDD group than in the SDD (63.4 vs. 55.1 min; p = 0.01). While overall procedural success rates were similar between the SDD and NSDD groups (99.4% vs. 98.4%; p = 0.39), NSDD patients had more complications (9.4% vs. 0%; p = 0.01) and higher number of devices per procedure (1.2 vs. 1.0; p = 0.01) as compared to SDD. At 1 year, there were no significant difference between the SDD and NSDD groups in stroke (1.1% vs. 0%; log-rank p = 0.44) and all-cause mortality (3.9% vs. 4.7%; log-rank p = 0.70). CONCLUSION: In this single-center LAAC experience, female sex, older age, and longer procedure duration were associated with higher likelihood for need of overnight stay. At 1-year follow-up, there were no significant differences in stroke events and death rates between SDD and NSDD groups.
Subject(s)
Atrial Appendage , Atrial Fibrillation , Stroke , Female , Humans , Atrial Appendage/diagnostic imaging , Atrial Fibrillation/diagnosis , Atrial Fibrillation/therapy , Atrial Fibrillation/complications , Patient Discharge , Stroke/etiology , Stroke/prevention & control , Treatment Outcome , MaleABSTRACT
BACKGROUND: Randomised trial data assessing the safety and efficacy of the self-expanding intra-annular Portico transcatheter aortic valve system (Abbott Structural Heart, St Paul, MN, USA) compared with any commercially available valves are needed to compare performance among designs. METHODS: In this prospective, multicentre, non-inferiority, randomised controlled trial (the Portico Re-sheathable Transcatheter Aortic Valve System US Investigational Device Exemption trial [PORTICO IDE]), high and extreme risk patients with severe symptomatic aortic stenosis were recruited from 52 medical centres experienced in performing transcatheter aortic valve replacement in the USA and Australia. Patients were eligible if they were aged 21 years or older, in New York Heart Association functional class II or higher, and had severe native aortic stenosis. Eligible patients were randomly assigned (1:1) using permuted block randomisation (block sizes of 2 and 4) and stratified by clinical investigational site, surgical risk cohort, and vascular access method, to transcatheter aortic valve replacement with the first generation Portico valve and delivery system or a commercially available valve (either an intra-annular balloon-expandable Edwards-SAPIEN, SAPIEN XT, or SAPIEN 3 valve [Edwards LifeSciences, Irvine, CA, USA]; or a supra-annular self-expanding CoreValve, Evolut-R, or Evolut-PRO valve [Medtronic, Minneapolis, MN, USA]). Investigational site staff, implanting physician, and study participant were unmasked to treatment assignment. Core laboratories and clinical event assessors were masked to treatment allocation. The primary safety endpoint was a composite of all-cause mortality, disabling stroke, life-threatening bleeding requiring transfusion, acute kidney injury requiring dialysis, or major vascular complication at 30 days. The primary efficacy endpoint was all-cause mortality or disabling stroke at 1 year. Clinical outcomes and valve performance were assessed up to 2 years after the procedure. Primary analyses were by intention to treat and the Kaplan-Meier method to estimate event rates. The non-inferiority margin was 8·5% for primary safety and 8·0% for primary efficacy endpoints. This study is registered with ClinicalTrials.gov, NCT02000115, and is ongoing. FINDINGS: Between May 30 and Sept 12, 2014, and between Aug 21, 2015, and Oct 10, 2017, with recruitment paused for 11 months by the funder, we recruited 1034 patients, of whom 750 were eligible and randomly assigned to the Portico valve group (n=381) or commercially available valve group (n=369). Mean age was 83 years (SD 7) and 395 (52·7%) patients were female. For the primary safety endpoint at 30 days, the event rate was higher in the Portico valve group than in the commercial valve group (52 [13·8%] vs 35 [9·6%]; absolute difference 4·2, 95% CI -0·4 to 8·8 [upper confidence bound {UCB} 8·1%]; pnon-inferiority=0·034, psuperiority=0·071). At 1 year, the rates of the primary efficacy endpoint were similar between the groups (55 [14·8%] in the Portico group vs 48 [13·4%] in the commercial valve group; difference 1·5%, 95% CI -3·6 to 6·5 [UCB 5·7%]; pnon-inferiority=0·0058, psuperiority=0·50). At 2 years, rates of death (80 [22·3%] vs 70 [20·2%]; p=0·40) or disabling stroke (10 [3·1%] vs 16 [5·0%]; p=0·23) were similar between groups. INTERPRETATION: The Portico valve was associated with similar rates of death or disabling stroke at 2 years compared with commercial valves, but was associated with higher rates of the primary composite safety endpoint including death at 30 days. The first-generation Portico valve and delivery system did not offer advantages over other commercially available valves. FUNDING: Abbott.
Subject(s)
Aortic Valve Stenosis/surgery , Heart Valve Prosthesis , Mortality , Postoperative Complications/epidemiology , Prosthesis Design , Stroke/epidemiology , Transcatheter Aortic Valve Replacement , Acute Kidney Injury/epidemiology , Acute Kidney Injury/therapy , Aged , Aged, 80 and over , Australia , Blood Transfusion , Cause of Death , Female , Humans , Male , Postoperative Complications/therapy , Postoperative Hemorrhage/epidemiology , Postoperative Hemorrhage/therapy , Renal Dialysis , Severity of Illness Index , Treatment Outcome , United StatesABSTRACT
Importance: There are limited data on outcomes of transcatheter aortic valve replacement (TAVR) for bicuspid aortic stenosis in patients at low surgical risk. Objective: To compare the outcomes of TAVR with a balloon-expandable valve for bicuspid vs tricuspid aortic stenosis in patients who are at low surgical risk. Design, Setting, and Participants: Registry-based cohort study of patients undergoing TAVR at 684 US centers. Participants were enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapies Registry from June 2015 to October 2020. Among 159â¯661 patients (7058 bicuspid, 152â¯603 tricuspid), 37â¯660 patients (3243 bicuspid and 34â¯417 tricuspid) who were at low surgical risk (defined as STS risk score <3%) were included in the analysis. Exposures: TAVR for bicuspid vs tricuspid aortic stenosis. Main Outcomes and Measures: Coprimary outcomes were 30-day and 1-year mortality and stroke. Secondary outcomes included procedural complications and valve hemodynamics. Results: Among 159â¯661 patients (7058 bicuspid; 152â¯603 tricuspid), 3168 propensity-matched pairs of patients with bicuspid and tricuspid aortic stenosis at low surgical risk were analyzed (mean age, 69 years; 69.8% men; mean [SD] STS-predicted risk of mortality, 1.7% [0.6%] for bicuspid and 1.7% [0.7%] for tricuspid). There was no significant difference between the bicuspid and tricuspid groups' rates of death at 30 days (0.9% vs 0.8%; hazard ratio [HR], 1.18 [95% CI, 0.68-2.03]; P = .55) and at 1 year (4.6% vs 6.6%; HR, 0.75 [95% CI, 0.55-1.02]; P = .06) or stroke at 30 days (1.4% vs 1.2%; HR, 1.14 [95% CI, 0.73-1.78]; P = .55) and at 1 year (2.0% vs 2.1%; HR 1.03 [95% CI, 0.69-1.53]; P = .89).There were no significant differences between the bicuspid and tricuspid groups in procedural complications, valve hemodynamics (aortic valve gradient: 13.2 mm Hg vs 13.5 mm Hg; absolute risk difference [RD], 0.3 mm Hg [95% CI, -0.9 to 0.3 mm Hg]), and moderate or severe paravalvular leak (3.4% vs 2.1%; absolute RD, 1.3% [95% CI, -0.6% to 3.2%]). Conclusions and Relevance: In this preliminary, registry-based study of propensity-matched patients at low surgical risk who had undergone TAVR for aortic stenosis, patients treated for bicuspid vs tricuspid aortic stenosis had no significant difference in mortality or stroke at 30 days or 1 year. Because of the potential for selection bias and absence of a control group treated surgically for bicuspid aortic stenosis, randomized trials are needed to adequately assess the efficacy and safety of transcatheter aortic valve replacement for bicuspid aortic stenosis in patients at low surgical risk.
Subject(s)
Aortic Valve Stenosis/surgery , Aortic Valve/surgery , Bicuspid Aortic Valve Disease/surgery , Stroke/etiology , Transcatheter Aortic Valve Replacement/adverse effects , Aged , Aortic Valve Stenosis/complications , Aortic Valve Stenosis/mortality , Cohort Studies , Female , Humans , Male , Propensity Score , Registries , Risk Factors , Transcatheter Aortic Valve Replacement/mortality , Treatment OutcomeABSTRACT
Aims: We sought to evaluate the outcomes of transcatheter mitral valve replacement (TMVR) for patients with degenerated bioprostheses [valve-in-valve (ViV)], failed annuloplasty rings [valve-in-ring (ViR)], and severe mitral annular calcification [valve-in-mitral annular calcification (ViMAC)]. Methods and results: From the TMVR multicentre registry, procedural and clinical outcomes of ViV, ViR, and ViMAC were compared according to Mitral Valve Academic Research Consortium (MVARC) criteria. A total of 521 patients with mean Society of Thoracic Surgeons score of 9.0 ± 7.0% underwent TMVR (322 patients with ViV, 141 with ViR, and 58 with ViMAC). Trans-septal access and the Sapien valves were used in 39.5% and 90.0%, respectively. Overall technical success was excellent at 87.1%. However, left ventricular outflow tract obstruction occurred more frequently after ViMAC compared with ViR and ViV (39.7% vs. 5.0% vs. 2.2%; P < 0.001), whereas second valve implantation was more frequent in ViR compared with ViMAC and ViV (12.1% vs. 5.2% vs. 2.5%; P < 0.001). Accordingly, technical success rate was higher after ViV compared with ViR and ViMAC (94.4% vs. 80.9% vs. 62.1%; P < 0.001). Compared with ViMAC and ViV groups, ViR group had more frequent post-procedural mitral regurgitation ≥moderate (18.4% vs. 13.8% vs. 5.6%; P < 0.001) and subsequent paravalvular leak closure (7.8% vs. 0.0% vs. 2.2%; P = 0.006). All-cause mortality was higher after ViMAC compared with ViR and ViV at 30 days (34.5% vs. 9.9% vs. 6.2%; log-rank P < 0.001) and 1 year (62.8% vs. 30.6% vs. 14.0%; log-rank P < 0.001). On multivariable analysis, patients with failed annuloplasty rings and severe MAC were at increased risk of mortality after TMVR [ViR vs. ViV, hazard ratio (HR) 1.99, 95% confidence interval (CI) 1.27-3.12; P = 0.003; ViMAC vs. ViV, HR 5.29, 95% CI 3.29-8.51; P < 0.001]. Conclusion: The TMVR provided excellent outcomes for patients with degenerated bioprostheses despite high surgical risk. However, ViR and ViMAC were associated with higher rates of adverse events and mid-term mortality compared with ViV.
Subject(s)
Bioprosthesis , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis , Mitral Valve Annuloplasty , Mitral Valve/surgery , Prosthesis Failure , Aged , Aged, 80 and over , Calcinosis/surgery , Female , Heart Valve Prosthesis Implantation/adverse effects , Humans , Male , Middle Aged , Mitral Valve/pathology , Mitral Valve Annuloplasty/adverse effects , Postoperative Complications/epidemiology , Postoperative Complications/mortality , Prosthesis Design , Stroke/etiology , Treatment OutcomeABSTRACT
AIMS: Peri-procedural transcatheter valve embolization and migration (TVEM) is a rare but potentially devastating complication of transcatheter aortic valve implantation (TAVI). We sought to assess the incidence, causes, and outcome of TVEM in a large multicentre cohort. METHODS AND RESULTS: We recorded cases of peri-procedural TVEM in patients undergoing TAVI between January 2010 and December 2017 from 26 international sites. Peri-procedural TVEM occurred in 273/29 636 (0.92%) TAVI cases (age 80.8 ± 7.3 years; 53.8% female), of which 217 were to the ascending aorta and 56 to the left ventricle. The use of self-expanding or first-generation prostheses and presence of a bicuspid aortic valve were independent predictors of TVEM. Bail-out measures included repositioning attempts using snares or miscellaneous tools (41.0%), multiple valve implantations (83.2%), and conversion to surgery (19.0%). Using 1:4-propensity matching, we identified a cohort of 235 patients with TVEM (TVEMPS) and 932 patients without TVEM (non-TVEMPS). In the matched cohort, all-cause mortality was higher in TVEMPS than in non-TVEMPS at 30 days (18.6% vs. 4.9%; P < 0.001) and after 1 year (30.5% vs. 16.6%; P < 0.001). Major stroke was more frequent in TVEMPS at 30 days (10.6% vs. 2.8%; P < 0.001), but not at 1 year (4.6% vs. 1.9%; P = 0.17). The need for emergent cardiopulmonary support, major stroke at 30 days, and acute kidney injury Stages 2 and 3 increased the risk of 1-year mortality, whereas a better renal function at baseline was protective. CONCLUSION: Transcatheter valve embolization and migration occurred in approximately 1% and was associated with increased morbidity and mortality.
Subject(s)
Embolism , Heart Valve Prosthesis/adverse effects , Postoperative Complications , Prosthesis Failure , Transcatheter Aortic Valve Replacement/adverse effects , Aged , Aged, 80 and over , Embolism/epidemiology , Embolism/etiology , Embolism/mortality , Female , Humans , Incidence , Male , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Postoperative Complications/mortality , Prosthesis Failure/adverse effects , Prosthesis Failure/etiology , Registries , Retrospective Studies , Risk Factors , Stroke/epidemiology , Treatment OutcomeABSTRACT
PURPOSE: The study aimed to characterize the geometry of the aortic root pre- and post-transcatheter aortic valve replacement (TAVR) and investigate differences in pre- and post-TAVR anatomy. BACKGROUND: A greater understanding of how aortic root geometry changes after TAVR is needed to facilitate further investigation into the hemodynamic profiles of the post-TAVR aortic root. METHODS: Anatomical measurements were conducted on de-identified, retrospective post-TAVR 4DCT scans of 109 patients with aortic stenosis obtained from the RESOLVE study. The diameter of the aortic root was measured at the level of the annulus, left ventricular outflow tract (LVOT), sinus of Valsalva, sinotubular junction (STJ) and ascending aorta. The heights of the STJ and coronary arteries were also measured. RESULTS: All aortic root dimensions were normally distributed across the cohort and changed significantly between pre- and post-TAVR conditions (P < 0.01). Post-TAVR dimensions changed significantly from peak systole to end diastole (P < 0.01). Regression models were obtained for all aortic root dimensions in terms of annulus diameter with excellent coefficient of determination (R2 > 0.95, P < 0.001). CONCLUSIONS: There are significant differences between pre- and post-TAVR as well as peak systolic and end diastolic aortic root anatomy. Appropriate anatomical dimensions should be selected for benchtop testing as the geometry varies greatly throughout the cardiac cycle.
Subject(s)
Aortic Valve Stenosis/surgery , Aortic Valve/surgery , Four-Dimensional Computed Tomography , Multidetector Computed Tomography , Transcatheter Aortic Valve Replacement , Aged , Aged, 80 and over , Aortic Valve/diagnostic imaging , Aortic Valve/physiopathology , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/physiopathology , Female , Humans , Male , Predictive Value of Tests , Retrospective Studies , Treatment Outcome , United StatesABSTRACT
BACKGROUND: Patients with severe aortic stenosis (AS) and an extra-large annulus (ELA) area (>683 mm2) can rarely be treated by transcatheter aortic valve replacement (TAVR) because of the size limitation of the transcatheter heart valves. This study aimed to evaluate the feasibility of TAVR using a 29-mm SAPIEN3 (S3) valve in patients with ELA and S3-dimensions by post-procedural computed tomography (post-CT). MethodsâandâResults: We included 261 patients undergoing TAVR using a 29-mm S3: 30 patients with ELA and 231 with non-ELA were identified. S3-dimensions were evaluated at the S3 inflow and annulus level by post-CT in 129 patients. The ELA group had a greater aortic annulus area measured by pre-procedural CT (737.3±54.7 vs. 578.4±41.9 mm2, P<0.0001), higher balloon inflation volume (36 vs. 33 mL, P<0.0001), a larger S3 area at inflow by post-CT (729.6±42.2 vs. 682.2±35.0 mm2, P<0.001), and a correlation between the inflation volume and S3 area (r=0.71, P=0.0005). No differences were observed between groups in paravalvular aortic regurgitation (PAR) ≥mild (43.3% vs. 27.6%, P=0.09), PAR ≥moderate (3.3% vs. 1.3%, P=0.39) or 1-year mortality (10.0% vs. 9.1%, P=0.87). CONCLUSIONS: TAVR using a 29-mm S3 with extra inflation of the delivery balloon can be considered as a treatment option for patients with severe AS and ELA.
Subject(s)
Aortic Valve Stenosis/surgery , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement/methods , Aged , Aged, 80 and over , Aortic Valve Insufficiency/surgery , Aortic Valve Stenosis/diagnostic imaging , Female , Humans , Male , Multidetector Computed Tomography , Prosthesis Design , Treatment OutcomeABSTRACT
Importance: Transcatheter aortic valve replacement (TAVR) indications are expanding, leading to an increasing number of patients with bicuspid aortic stenosis undergoing TAVR. Pivotal randomized trials conducted to obtain US Food and Drug Administration approval excluded bicuspid anatomy. Objective: To compare the outcomes of TAVR with a balloon-expandable valve for bicuspid vs tricuspid aortic stenosis. Design, Setting, and Participants: Registry-based prospective cohort study of patients undergoing TAVR at 552 US centers. Participants were enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapies Registry from June 2015 to November 2018. Exposures: TAVR for bicuspid vs tricuspid aortic stenosis. Main Outcomes and Measures: Primary outcomes were 30-day and 1-year mortality and stroke. Secondary outcomes included procedural complications, valve hemodynamics, and quality of life assessment. Results: Of 81â¯822 consecutive patients with aortic stenosis (2726 bicuspid; 79â¯096 tricuspid), 2691 propensity-score matched pairs of bicuspid and tricuspid aortic stenosis were analyzed (median age, 74 years [interquartile range {IQR}, 66-81 years]; 39.1%, women; mean [SD] STS-predicted risk of mortality, 4.9% [4.0%] and 5.1% [4.2%], respectively). All-cause mortality was not significantly different between patients with bicuspid and tricuspid aortic stenosis at 30 days (2.6% vs 2.5%; hazard ratio [HR], 1.04, [95% CI, 0.74-1.47]) and 1 year (10.5% vs 12.0%; HR, 0.90 [95% CI, 0.73-1.10]). The 30-day stroke rate was significantly higher for bicuspid vs tricuspid aortic stenosis (2.5% vs 1.6%; HR, 1.57 [95% CI, 1.06-2.33]). The risk of procedural complications requiring open heart surgery was significantly higher in the bicuspid vs tricuspid cohort (0.9% vs 0.4%, respectively; absolute risk difference [RD], 0.5% [95% CI, 0%-0.9%]). There were no significant differences in valve hemodynamics. There were no significant differences in moderate or severe paravalvular leak at 30 days (2.0% vs 2.4%; absolute RD, 0.3% [95% CI, -1.3% to 0.7%]) and 1 year (3.2% vs 2.5%; absolute RD, 0.7% [95% CI, -1.3% to 2.7%]). At 1 year there was no significant difference in improvement in quality of life between the groups (difference in improvement in the Kansas City Cardiomyopathy Questionnaire overall summary score, -2.4 [95% CI, -5.1 to 0.3]; P = .08). Conclusions and Relevance: In this preliminary, registry-based study of propensity-matched patients who had undergone transcatheter aortic valve replacement for aortic stenosis, patients with bicuspid vs tricuspid aortic stenosis had no significant difference in 30-day or 1-year mortality but had increased 30-day risk for stroke. Because of the potential for selection bias and the absence of a control group treated surgically for bicuspid stenosis, randomized trials are needed to adequately assess the efficacy and safety of transcatheter aortic valve replacement for bicuspid aortic stenosis.
Subject(s)
Aortic Valve Stenosis/surgery , Aortic Valve/abnormalities , Stroke/etiology , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/mortality , Aged , Aged, 80 and over , Aortic Valve/surgery , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Postoperative Complications/mortality , Propensity Score , Prospective Studies , Registries , RiskABSTRACT
BACKGROUND: Cell-type-specific genes exhibit heterogeneity in genomic contexts and may be subject to different epigenetic regulations through different gene transcriptional processes depending on the cell type involved. The gene-body regions (GBRs) of some cardiomyocyte (CM)-specific genes are long and highly hypomethylated in CMs. To explore the cell-type specificities of epigenetic patterns and functions, multiple epigenetic modifications of GBRs were compared among CMs, liver cells and embryonic stem cells (ESCs). RESULTS: We found that most genes show a moderately negative correlation between transcript levels and gene lengths. As CM-specific genes are generally longer than other cell-type-specific genes, we hypothesized that the gene-body epigenetic features of CMs may support the transcriptional regulation of CM-specific genes. We found gene-body DNA hypomethylation in a CM-specific gene subset co-localized with rare gene-body marks, including RNA polymerase II (Pol II) and p300. Interestingly, 5-hydroxymethylcytosine (5hmC) within the gene body marked cell-type-specific genes at neonatal stages and active gene-body histone mark H3K36 trimethylation declined and overlapped with cell-type-specific gene-body DNA hypomethylation and selective Pol II/p300 accumulation in adulthood. Different combinations of gene-body epigenetic modifications were also observed with genome-wide scale cell-type specificity, revealing the occurrence of dynamic epigenetic rearrangements in GBRs across different cell types. CONCLUSIONS: As 5hmC enrichment proceeded to hypomethylated GBRs, we considered that hypomethylation may not represent a static state but rather an equilibrium state of turnover due to the balance between local methylation linked to transcription and Tet oxidative modification causing demethylation. Accordingly, we conclude that demethylation in CMs can be a used to establish such cell-type-specific epigenetic domains in relation to liver cells. The establishment of cell-type-specific epigenetic control may also change genomic contexts of evolution and may contribute to the development of cell-type-specific transcriptional coordination.
Subject(s)
DNA Methylation , Demethylation , Epigenesis, Genetic , Genetic Linkage , Myocytes, Cardiac/metabolism , Transcription, Genetic , 5-Methylcytosine/analogs & derivatives , 5-Methylcytosine/metabolism , Animals , Cell Lineage/genetics , Embryonic Stem Cells , Female , Genes, Essential , Liver/metabolism , Male , Mice, Inbred C57BLABSTRACT
OBJECTIVE: The aim of this study was to perform a systematic review and meta-analyses of observational studies of transcatheter aortic valve replacement (TAVR) for bicuspid aortic valve stenosis (BcAV). BACKGROUND: TAVR for BcAV stenosis has been associated with an increased incidence of paravalvular leaks, valve malposition, pacemaker placement and all-cause mortality. The conclusions drawn have been limited by small sample sizes. The use of TAVR for BcAV stenosis remains controversial. METHODS: We searched multiple databases from the inception of the databases through September 30, 2016 for studies of TAVR for BcAV stenosis. We included all observational studies with more than one patient and at least 1 month of outcomes. RESULTS: We analyzed 13 observational studies with 758 patients. Meta analyses showed device success rate of 95% [95% confidence interval (CI) 90.2% to 98.5%] and an early safety event in 16.9% [95% CI 12.2% to 22%]. At 30 days, moderate to severe paravalvular leak was seen in 12.2% [95% CI 3.1% to 24.8%] and new pacemaker implantation in 17.9% [95% CI 14.2% to 22%]. All-cause mortality was 3.7% [95% CI 2.1% to 5.6%], which should be viewed in the context of an STS PROM of 5.0%. CONCLUSIONS: This analysis suggests that TAVR for BcAV is not associated with excess mortality. The incidence of paravalvular leaks and pacemaker implant is increased compared to tricuspid aortic valve cohorts undergoing TAVR, and operators should weigh these potential complications against the clinical benefit provided by TAVR for BcAV patients at high risk for surgical valve replacement.
Subject(s)
Aortic Valve Stenosis/surgery , Aortic Valve/abnormalities , Heart Valve Diseases/surgery , Transcatheter Aortic Valve Replacement , Aged , Aged, 80 and over , Aortic Valve/diagnostic imaging , Aortic Valve/physiopathology , Aortic Valve/surgery , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/mortality , Aortic Valve Stenosis/physiopathology , Bicuspid Aortic Valve Disease , Clinical Decision-Making , Female , Heart Valve Diseases/diagnostic imaging , Heart Valve Diseases/mortality , Heart Valve Diseases/physiopathology , Heart Valve Prosthesis , Hemodynamics , Humans , Male , Observational Studies as Topic , Postoperative Complications/etiology , Prosthesis Design , Recovery of Function , Risk Factors , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/instrumentation , Transcatheter Aortic Valve Replacement/mortality , Treatment OutcomeABSTRACT
BACKGROUND: Transcatheter aortic valve-in-valve (VIV) replacement within failed bioprosthetic surgical aortic valves is a feasible therapeutic option. However, data comparing the hemodynamic and clinical outcomes of VIV replacement with supra-annular self-expanding and balloon-expandable transcatheter heart valves (THV) are limited. MethodsâandâResults: Outcomes of 40 and 95 patients treated with supra-annular self-expanding and balloon-expandable THV, respectively, were compared after propensity score matching, which yielded 37 pairs of patients with similar baseline characteristics. Hemodynamic and clinical outcomes were analyzed. Postprocedural mean gradient was significantly lower in the self-expanding THV group than in the balloon-expandable THV group (12.1±6.1 mmHg vs. 19.0±7.3 mmHg, P<0.001). The incidence of at least mild postprocedural aortic regurgitation (AR) was comparable between the self-expanding and balloon-expandable THV groups (21.6% vs. 10.8%, P=0.39). In the self-expanding THV group, the new-generation THV showed a trend towards a lower incidence of at least mild AR compared with the early-generation THV (12.5% vs. 38.5%, P=0.07). A similar trend was observed in the balloon-expandable THV group (4.2% vs. 23.1%, P=0.08). There was no significant difference between the self-expanding and balloon-expandable THV groups in the cumulative 2-year all-cause mortality rates (22.4% vs. 43.4%, log-rank P=0.26). CONCLUSIONS: The supra-annular self-expanding THV was associated with a lower postprocedural mean gradient compared with balloon-expandable THV in patients undergoing aortic VIV replacement.