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Transcatheter aortic valve implantation - Top 30 Publications

Pre- and postoperative tricuspid regurgitation in patients with severe symptomatic aortic stenosis: importance of pre-operative tricuspid annulus diameter.

Secondary tricuspid regurgitation (STR) is commonly found in patients with aortic stenosis and is associated with increased morbidity. The study sought to evaluate the prevalence of pre-operative STR and its progression after surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI). Also, it sought to analyse the predictors of post-operative changes in STR.

First experience with transfemoral transcatheter aortic valve implantation without prior balloon pre-dilatation using a latest generation repositionable and retrievable transcatheter heart valve†.

: The aim of this study was to prove technical feasibility and document haemodynamic and clinical outcomes of transcatheter aortic valve implantation (TAVI) with the latest generation repositionable and retrievable Lotus™ transcatheter heart valve (THV) without prior balloon-aortic valvuloplasty (BAV). It has been demonstrated for self-expandable and balloon-expandable THV that implantation without prior BAV is not only feasible and safe but also results in lower fluoroscopy times and amounts of contrast agent while yielding non-inferior haemodynamic and clinical outcome. To date no reports exist for TAVI without BAV for the Lotus™ THV.

Clinical trends in surgical, minimally invasive and transcatheter aortic valve replacement†.

Transcatheter aortic valve replacement (TAVR) and minimally invasive aortic valve replacement (MIAVR) have emerged as alternatives to surgical aortic valve replacement (SAVR) via traditional sternotomy. However, their effect on clinical practice remains unclear. The study's objective is to describe clinical trends between TAVR, MIAVR and SAVR in patients with severe aortic stenosis (AS).

Concomitant therapy: off-pump coronary revascularization and transcatheter aortic valve implantation.

Significant coronary artery disease (CAD) is common among patients evaluated for transcatheter aortic valve implantation (TAVI). Only little data exist on outcome of patients undergoing concomitant off-pump coronary revascularization and TAVI. The goal of this study was to analyse the impact of concomitant off-pump revascularization on early clinical outcome and 2-year follow-up of patients undergoing TAVI.

Apical closure device for full-percutaneous transapical valve implantation: stress-test in an animal model†.

Transapical valve implantation is traditionally performed through a left antero-lateral mini-thoracotomy. A self-expandable apical closure device has recently been developed for full-percutaneous transapical valve implantation. We performed haemodynamics stress-tests on an animal model to evaluate the sealing properties.

Concomitant Valve-in-Valve Transcatheter Aortic Valve Replacement and Left Ventricular Assist Device Implantation.

Redo aortic valve replacement (AVR) performed simultaneously with left ventricular assist device (LVAD) implantation carries potential for increased mortality rates. Although transcatheter AVR has been used for patients with previous LVAD placement, no literature reports concomitant valve-in-valve transcatheter AVR and LVAD implantation. Our patient had severe aortic prosthetic valve deterioration and advanced heart failure. Given the risks associated with reoperative aortic valve surgery, we chose transcatheter AVR at the time of LVAD implantation. Transthoracic echocardiography results showed severe aortic prosthetic valve deterioration with moderate aortic regurgitation as well as severe left ventricular dysfunction (ejection fraction, 11%). After redosternotomy, we performed transcatheter AVR via the ascending aorta and subsequent LVAD implantation. The postoperative course was uneventful. Generally, patients with structural deterioration of a bioprosthetic valve who report for LVAD therapy present considerable challenges to the surgeon. Concomitant transcatheter AVR offers a less-invasive alternative to surgical AVR that minimizes ischemic injury to myocardium.

Utilization and outcomes of transcatheter aortic valve replacement in the United States shortly after device approval.

The objective of this study was to assess the national uptake of TAVR, associated in-hospital outcomes, and the effect of procedural experience on outcomes in the first two years following device approval.

Transcatheter Aortic Valve Implantation in Patients With Advanced Chronic Kidney Disease.

Advanced chronic kidney disease (CKD) is associated with poor outcomes in patients who underwent surgical aortic valve replacement, whereas its prognostic role in transcatheter aortic valve implantation (TAVI) remains unclear. This study aimed to investigate outcomes in patients with advanced CKD who underwent TAVI. A total of 1,904 consecutive patients who underwent balloon-expandable TAVI in 33 centers between 2007 and 2012 were enrolled in the Italian Transcatheter Balloon-Expandable Valve Implantation Registry. Advanced CKD was defined according to the estimated glomerular filtration rate: 15 to 29 ml/min/1.73 m(2) stage 4 (S4), <15 ml/min/1.73 m(2) stage 5 (S5). Edwards Sapien or Sapien-XT prosthesis were used. The primary end point was all-cause mortality during follow-up. Secondary end points were major adverse cardiac events at 30 days and at follow-up, defined with Valve Academic Research Consortium 2 criteria. A total of 421 patients were staged S5 (n = 74) or S4 (n = 347). S5 patients were younger and had more frequently porcelain aorta and a lower incidence of previous stroke. Periprocedural and 30-day outcomes were similar in S5 and S4 patients. During 670 (±466) days of follow-up, S5 patients had higher mortality rates (69% vs 39%, p <0.01) and cardiac death (19% vs 9%, p = 0.02) compared with S4 patients. Male gender (hazard ratio [HR] 1.6, 95% confidence interval [CI] 1.2 to 2.2), left ventricular ejection fraction <30% (HR 2.3, 95% CI 1.3 to 4), atrial fibrillation (HR 1.4, 95% CI 1.0 to 1.9), and S5 CKD (HR 1.5, 95% CI 1.0 to 2.1) were independent predictors of death. In conclusion, TAVI in predialytic or dialytic patients (i.e., S5) is independently associated with poor outcomes with more than double risk of death compared with patients with S4 renal function. Conversely, in severe CKD (i.e., S4) a rigorous risk stratification is required to avoid the risk of futility risk.

Post-dilation in transcatheter aortic valve replacement: A systematic review and meta-analysis.

The aim of this study was to perform a meta-analysis to compare the outcomes of patients undergoing TAVR with and without balloon post-dilation (PD).

A longer total duration of rapid ventricular pacing does not increase the risk of postprocedural myocardial injury in patients who undergo transcatheter aortic valve implantation.

Rapid ventricular pacing (RVP) is used during transcatheter aortic valve implantation (TAVI). RVP disturbs myocardial oxygen balance, and when prolonged, it may cause procedure-related myocardial injury (PMI). This study investigated whether a longer duration of RVP increased the occurrence of PMI or worsened long-term mortality after TAVI. We retrospectively analyzed data from 188 patients who underwent TAVI in our institute from January 2013 to July 2015. Myocardial injury was represented by the peak value of creatine kinase-myocardial band (CK-MB) within 72 h after the procedure; an increase greater than 5 times the upper reference limit was regarded as PMI. There was no difference in RVP time (RVPT) between patients with and without PMI (median [range]: 57 [9-189] s vs. 54 [0-159] s, p = 0.9). A higher peak CK-MB was significantly correlated with the apical approach for the procedure (p < 0.001) but not with total RVPT (p = 0.22). A subanalysis of 133 patients whose troponin I was tested within 72 h postprocedurally showed no correlation between the peak value and RVPT (p = 0.40). Shortening RVPT did not result in myocardial protection; thus, RVPT during TAVI should be sufficient to optimize valve placement.

Left Ventricular Outflow Tract Migration of a Balloon-Expandable Prosthesis During Transcatheter Aortic Valve Implantation.

Valve migration into the left ventricular outflow tract (LVOT) during transcatheter aortic valve implantation (TAVI) is a life-threatening complication. An 89-year-old female patient was admitted for TAVI due to severe symptomatic aortic stenosis. After deployment of a balloon-expandable prosthesis, the prosthesis had migrated into the LVOT. The prosthesis was reimpacted to the aortic annulus by a balloon-assisted recapture procedure. Immediately after recapturing the prosthesis with an oversized balloon, the patient's vital signs deteriorated due to acute aortic regurgitation (AR), and a prompt valve-in-valve (V-in-V) procedure allowed us to stabilize the patient's condition. This is the first reported case of a V-in-V procedure using an oversized balloon and a larger prosthesis to treat migration of the initial prosthesis into the LVOT. Balloon recapture and V-in-V procedure using an oversized balloon and larger prosthesis for a migrated balloonexpandable prosthesis into the LVOT is feasible, but hemodynamic support should be prepared before recapture and Vin-V because overdilatation of the first prosthesis might cause hemodynamic collapse due to severe AR.

Midterm Outcomes With a Self-Expandable Transcatheter Heart Valve in Japanese Patients With Symptomatic Severe Aortic Stenosis.

Transcatheter aortic valve implantation (TAVI) is a viable alternative to surgical aortic valve replacement in high-risk or inoperable patients with aortic stenosis (AS). Here we report the midterm outcomes of high-risk Japanese patients with severe AS who underwent TAVI with a self-expandable TAV.Methods and Results:The CoreValve Japan Trial was a prospective, multicenter trial of the CoreValve System. A group of 55 patients (mean age 82.5±5.5 years, 30.9% male, 100% NYHA class III/IV, STS 8.0±4.2%) were enrolled in the 26-mm/29-mm CoreValve study, and 20 patients (mean age 81.0±6.6 years, 5.0% male, 100% NYHA class III/IV, STS 7.0±3.3%) were enrolled in the 23-mm CoreValve study, which started 1 year later. For the 26-mm/29-mm cohort, the 3-year all-cause mortality rate was 32.6%; major stroke was 15.4%. Mean pressure gradient (MPG), effective orifice area (EOA), and NYHA class showed sustained improvement. Paravalvular regurgitation (PVR) at 3 years was 28.6% (none), 25.7% (trace), 40.0% (mild), 5.7% (moderate), and 0.0% (severe). For the 23-mm cohort, the 2-year all-cause mortality rate was 5.0%; major stroke was 5.0%. MPG, EOA, and NYHA class showed sustained improvement. PVR at 2 years was 16.7% (none), 33.3% (trace), 44.4% (mild), 5.6% (moderate), and 0.0% (severe).

Five-Year Outcomes of the First Pivotal Clinical Trial of Balloon-Expandable Transcatheter Aortic Valve Replacement in Japan (PREVAIL JAPAN).

Transcatheter aortic valve replacement (TAVR) has been an alternative less invasive therapy for high-surgical risk/inoperable patients with aortic valve stenosis (AS) in Japan. We report 5-year outcomes of the first pivotal clinical trial of TAVR in Japan (PREVAIL JAPAN).Methods and Results:A total of 64 patients with AS who were considered unsuitable candidates for surgery were enrolled at 3 centers in Japan (mean age: 84.3±6.1 years, female: 65.6%, STS score: 9.0±4.5%). Transfemoral approach (TF) and transapical approach (TA) was performed in 37 patients and 27 patients, respectively. At 5 years, freedom from all-cause death was 52.7% (TF: 51.3%, TA: 56.3%). Risk of all stroke at 5-year was 15.8% (TF: 8.9%, TA: 25.5%) and risk of major adverse cardiac and cerebrovascular events at 5 years was 58.0% (TF: 51.3%, TA: 69.2%). Mild or greater aortic regurgitation (AR) at 1 week was not associated with increased all-cause death at 5 years (69.1%) compared with none or trace AR (48.3%) (P=0.184). Patients with high STS score (>8) had higher mortality rate than those with low STS scores (≤8).

Balloon aortic valvuloplasty in the transcatheter aortic valve implantation era: A single-center registry.

Percutaneous balloon aortic valvuloplasty (BAV) has been limited by the risk of complications and restenosis. However, growing use of transcatheter aortic valve implantation (TAVI) has revived interest in this technique. We analyzed the current indications for BAV and outcomes in a single center.

Balloon aortic valvuloplasty in the transcatheter aortic valve replacement era: A challenge to organization of the heart team.

Endovascular aneurysm repair (EVAR)- and transcatheter aortic valve replacement (TAVR)-associated acute kidney injury.

Acute kidney injury (AKI) after surgery or intervention is an important complication that may impact mortality, morbidity, and health care costs. Endovascular procedures are now performed routinely for a variety of pathologies that were traditionally treated with open surgery because randomized trials comparing endovascular and open surgery have shown at least equally good results and reduced complication and hospitalization rates with endovascular techniques. However, endovascular procedures have been associated with an increased risk for postoperative AKI, predominantly owing to contrast nephrotoxicity. Over the years, endovascular techniques have progressively been applied for the treatment of complex cardiovascular pathologies, and in recent years, nephrologists have increasingly encountered patients who developed AKI after endovascular aneurysm repair or transcatheter aortic valve replacement. These 2 procedures typically involve high-risk patients who have several established AKI risk factors prior to intervention. Several studies have investigated the incidence, risk factors, and natural course of AKI after endovascular aneurysm repair and transcatheter aortic valve replacement. This review summarizes current data on incidence, risk factors, pathophysiology, prognostic implications, and treatment of AKI associated with endovascular aneurysm replacement and transcatheter aortic valve replacement.

Transcatheter aortic valve implantation with the self-expandable venus A-Valve and CoreValve devices: Preliminary Experiences in China.

Transcatheter aortic valve implantation (TAVI) has been demonstrated to be an effective alternative to surgical aortic valve replacement (SAVR) in patients with aortic stenosis who are deemed high risk or inoperable. Currently, TAVI procedures in China mostly make use of the domestic Venus A-Valve and the CoreValve; however, there is no data on their comparative performance.

The "hidden experiment": percutaneous vs. surgical cut-down for transfemoral transcatheter aortic valve implantation.

Mortality, Length of Stay, and Cost Implications of Procedural Bleeding After Percutaneous Interventions Using Large-Bore Catheters.

Bleeding complications after percutaneous transcatheter interventions that used large-bore catheters are frequent and associated with high mortality and morbidity.

Structural Heart Disease Intervention: The Canadian Landscape.

Cardiovascular disease encompasses coronary artery disease and valvular heart disease, and the prevalence of both increases with age. Over the past decade, the landscape of interventional cardiology has evolved to encompass a new set of percutaneous procedures outside the coronary tree, including transcatheter aortic valve implantation, transcatheter mitral valve repair, and left atrial appendage occlusion. These interventions have sparked a new discipline within interventional cardiology referred to as structural heart disease (SHD) intervention. The access to and numbers of such procedures performed in Canada is currently unknown. This "first of its kind" survey of structural interventions provides insight into the landscape of SHD intervention in Canada and the challenges faced by cardiologists to deliver this important care.

Can we perform rotational atherectomy in patients with severe aortic stenosis? Substudy from the OCEAN TAVI Registry.

The aim of this study was to report the safety of coronary rotational atherectomy (RA) in patients with severe aortic stenosis (AS). RA in the clinical setting seems challenging because coronary slow flow leads to hemodynamic instability.

Diastolic Function and Transcatheter Aortic Valve Replacement.

Little is known about baseline diastolic dysfunction and changes in diastolic dysfunction grade after transcatheter aortic valve replacement (TAVR) for aortic stenosis (AS) and its impact on overall outcomes. The aim of this study was to describe baseline diastolic dysfunction and changes in diastolic dysfunction grade that occur with TAVR and their relationship to mortality and rehospitalization.

Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients.

Background Although transcatheter aortic-valve replacement (TAVR) is an accepted alternative to surgery in patients with severe aortic stenosis who are at high surgical risk, less is known about comparative outcomes among patients with aortic stenosis who are at intermediate surgical risk. Methods We evaluated the clinical outcomes in intermediate-risk patients with severe, symptomatic aortic stenosis in a randomized trial comparing TAVR (performed with the use of a self-expanding prosthesis) with surgical aortic-valve replacement. The primary end point was a composite of death from any cause or disabling stroke at 24 months in patients undergoing attempted aortic-valve replacement. We used Bayesian analytical methods (with a margin of 0.07) to evaluate the noninferiority of TAVR as compared with surgical valve replacement. Results A total of 1746 patients underwent randomization at 87 centers. Of these patients, 1660 underwent an attempted TAVR or surgical procedure. The mean (±SD) age of the patients was 79.8±6.2 years, and all were at intermediate risk for surgery (Society of Thoracic Surgeons Predicted Risk of Mortality, 4.5±1.6%). At 24 months, the estimated incidence of the primary end point was 12.6% in the TAVR group and 14.0% in the surgery group (95% credible interval [Bayesian analysis] for difference, -5.2 to 2.3%; posterior probability of noninferiority, >0.999). Surgery was associated with higher rates of acute kidney injury, atrial fibrillation, and transfusion requirements, whereas TAVR had higher rates of residual aortic regurgitation and need for pacemaker implantation. TAVR resulted in lower mean gradients and larger aortic-valve areas than surgery. Structural valve deterioration at 24 months did not occur in either group. Conclusions TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk, with a different pattern of adverse events associated with each procedure. (Funded by Medtronic; SURTAVI ClinicalTrials.gov number, NCT01586910 .).

Aortic valvuloplasty via the radial artery: Case reports and review of the literature.

The use of balloon aortic valvuloplasty (BAV) has increased with the development of transcatheter aortic valve implantation (TAVI) to medically optimize patients prior to procedure. It has been traditionally done by a retrograde approach via the femoral artery or an antegrade approach via the femoral vein. Large sheaths have been required with traditional balloons which require large vessel access. Use of a low profile compliant valvuloplasty balloon has been demonstrated to have adequate BAV results with smaller sheath sizes. We review the literature and report two cases where low profile compliant valvuloplasty balloons were used to perform BAV via the radial artery in patients without adequate femoral arterial access. © 2017 Wiley Periodicals, Inc.

Impact of the Clinical Frailty Scale on Outcomes After Transcatheter Aortic Valve Replacement.

Background -The semi-quantitative clinical frailty scale (CFS) is a simple tool to assess patient`s frailty and has been shown to correlate with mortality in elderly patients even when evaluated by non-geriatricians. The aim of the current study was to determine the prognostic value of CFS in patients who underwent transcatheter aortic valve replacement (TAVR). Methods -We utilized the Optimized CathEter vAlvular iNtervention (OCEAN) Japanese multicenter registry to review data of 1215 patients who underwent TAVR. Patients were categorized into 5 groups based on the CFS stages: CFS1-3, CFS4, CFS5, CFS6, and CFS≥7. We subsequently evaluated the relationship between CFS grading and other indicators of frailty including body mass index (BMI), serum albumin, gait speed, and mean hand grip. We also assessed differences in baseline characteristics, procedural outcomes, and early and mid-term mortality among the 5 groups. Results -Patient distribution into the 5 CFS groups was as follows: 38.0% (CFS1-3), 32.9% (CFS4), 15.1% (CFS5), 10.0% (CFS6), and 4.0% (CFS≥7). The CFS grade showed significant correlation with BMI (Spearman's ρ=-0.077, p=0.007), albumin (ρ=-0.22, p<0.001), gait speed (ρ=-0.28, p<0.001), and grip strength (ρ=-0.26, p<0.001). Cumulative 1-year mortality increased with increasing CFS stage (7.2%, 8.6%. 15.7%, 16.9%, 44.1%, p<0.001). In a Cox regression multivariate analysis, the CFS (per 1 category increase) was an independent predictive factor of increased late cumulative mortality risk (hazard ratio: 1.28; 95% confidence interval: 1.10-1.49; p<0.001). Conclusions -In addition to reflecting the degree of frailty, the CFS was a useful marker for predicting late mortality in an elderly TAVR cohort.

The Clinical Frailty Scale: Upgrade Your Eyeball Test.

With the emergence of transcatheter aortic valve replacement (TAVR) as a therapeutic option to treat high-risk older adults suffering from aortic stenosis, the geriatric concept of frailty has assumed mainstream relevance for cardiovascular practitioners. We have eagerly adopted tools to objectify the definition of frailty and accordingly discern good and bad candidates among a pool of complex octogenarians with multiple chronic conditions - a daunting yet mission-critical task. Initial studies published during the first half of this decade revealed that frailty status was one of the top predictors of mid-term mortality and incident disability after TAVR1, leading to its integration in clinical care pathways and predictive risk models. The encouraging findings from small single-center studies are now being validated in larger multi-center registries and trials, affirming the strengths and uncovering the limitations of various frailty assessment tools.

3D transoesophageal echocardiography in the TAVI sizing arena: should we do it and how do we do it?

Transcatheter aortic valve implantation (TAVI) was initially proven as an alternative to valve replacement therapy in those beyond established risk thresholds for conventional surgery. With time the technique has been methodically refined and offered to a progressively lower risk cohort, and with this evolution has come that of the significant imaging requirements of valve implantation. This review discusses the role of transoesophageal echocardiography (TOE) in the current TAVI arena, aligning it with that of cardiac computed tomography, and outlining how TOE can be used most effectively both prior to and during TAVI in order to optimise outcomes.

Spectral detector CT for cardiovascular applications.

Spectral detector computed tomography (SDCT) is a novel technology that uses two layers of detectors to simultaneously collect low and high energy data. Spectral data is used to generate conventional polyenergetic images as well as dedicated spectral images including virtual monoenergetic and material composition (iodine-only, virtual unenhanced, effective atomic number) images. This paper provides an overview of SDCT technology and a description of some spectral image types. The potential utility of SDCT for cardiovascular imaging and the impact of this new technology on radiation and contrast dose are discussed through presentation of initial patient studies performed on a SDCT scanner. The value of SDCT for salvaging suboptimal studies including those with poor contrast-enhancement or beam hardening artifacts through retrospective reconstruction of spectral data is discussed. Additionally, examples of specific benefits for the evaluation of aortic disease, imaging before transcatheter aortic valve implantation, evaluation of pulmonary veins pre- and post-pulmonary radiofrequency ablation, evaluation of coronary artery lumen, assessment of myocardial perfusion, detection of pulmonary embolism, and characterization of incidental findings are presented.

2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.

Direct percutaneous transaxillary implantation of a novel self-expandable transcatheter heart valve for aortic stenosis.

The aim of this study was to evaluate safety, feasibility, and efficacy of transaxillary TAVI using a novel self-expandable transcatheter heart valve (THV) via a direct percutaneous technique.