Transcatheter Valve Implantation Research Articles

Percutaneous closure of paravalvular leak after transcatheter valve implantation in mitral annular calcification

Percutaneous closure of paravalvular leak after transcatheter valve implantation in mitral annular calcification

Hypertension in aortic stenosis: a focused review and recommendations for clinical practice.

: In patients with aortic stenosis, the presence of hypertension negatively affects the hemodynamic severity of the stenosis, and worsens adverse left ventricular remodeling. It accelerates the progression of the stenosis and is associated with worse prognosis. Proper management of hypertension is thus crucial but there are concerns about the safety and efficacy of antihypertensive medications as well as uncertainty about optimal blood pressure (BP) targets and their impact on left ventricular mass regression and survival benefits. In the present review, we discuss these issues based on the evidence available in the current literature. Focus is first directed on the consequences of a persistently elevated BP before and after surgical aortic valve replacement or transcatheter valve implantation, and the clinical significance of an abnormal BP response during exercise in patients with significant aortic stenosis. Available data on use of antihypertensive drugs are then critically addressed, the conclusion being that calcium channel blockers may be associated with lower survival, and that diuretics may have disadvantages in patients with left ventricular hypertrophy and smaller left ventricular cavity dimensions, β-blockers may be well tolerated and a better choice for patients with concomitant coronary artery disease and arrhythmias. Renin--angiotensin system blockers improve survival given either before or after valve intervention. Emphasis is placed on the fact that evidence is not derived from randomized trials but only from observational studies. Finally, we discuss the optimal SBP level to reach in patients with aortic stenosis. Again, randomized trials are not available but observational evidence suggests that values between 130 and 139 mmHg systolic and 70-90 mmHg diastolic might represent the best option, and lower BP targets should probably be avoided.

Impact of Coronary Revascularization Strategy on Outcomes of Transcatheter Aortic Valve Implantation

Although the effect of coronary revascularization on clinical outcomes before and after transcatheter valve implantation (TAVI) is debatable, there is currently insufficient data to determine the most appropriate revascularization strategy. In this study, we present our single-center experience of percutaneous coronary intervention (PCI) and its effect on clinical outcomes and mortality in patients undergoing TAVI.We performed a retrospective analysis of 526 consecutive patients at our center, and 127 patients with obstructive coronary artery disease were included in the study. Patients were divided into two groups: the revascularization group (group 1) and the non-revascularization group (group 2). Procedural complications and long-term all-cause mortality rates were compared between the two groups.Of the 526 patients, group 1 comprised 65 patients (12.3%) who underwent PCI, and group 2 comprised 62 patients (11.7%) who did not undergo revascularization. According to Valve Academic Research Consortium 2 criteria, post-procedural complications, including pericardial effusion, stroke, major vascular complications, major bleeding, and emerging arrhythmias, were similar between the groups. A Kaplan-Meier survival curve analysis showed no significant difference between the revascularization and non-revascularization groups (Overall: 40.0±2.8 month; 95% CI 34.4-45.6 month, p=0.959). After adjustment for basal SYNTAX score, chronic kidney disease stage, previous myocardial infarction, and baseline troponin levels, the long-term survival of group 1 was significantly longer when compared with group 2 (p=0.036). In 75.4% of cases, PCI was performed within 11.0±14.7 days before or after TAVI as a staged procedure. In 13.8% of cases, PCI was performed simultaneously with TAVI. While there was no significant difference in in-hospital, 6-month, and 1-year mortality rates between the simultaneous and staged PCI groups, there was a significant difference in 30-day mortality (11.1% vs. 0%, respectively; p=0.016).Peri-procedural and long-term safety outcomes and mortality rates are not significantly different between revascularized and non-revascularized patients, and neither staged nor simultaneous PCI have adverse outcomes in patients undergoing TAVI.

Combined percutaneous approach for aortic valve implantation in poor vascular access.

Transcatheter aortic valve implantation (TAVI) is a well-established management option for symptomatic patients with severe aortic stenosis. The minimally invasive transfemoral approach is considered to be superior to non-transfemoral accesses; however, its use is often limited by concomitant peripheral artery disease (PAD). Percutaneous transluminal angioplasty with stent implantation (PTA) is a gold-standard therapy for symptomatic PAD. We present 2 cases from our cohort of patients with severe aortic stenosis and PAD previously contraindicated for TAVI because of poor peripheral vascular access. However, the patients were eventually treated either by staged PTA and TAVI through an endothelialized stent or PTA and TAVI though a newly implanted peripheral stent during one procedure. We provide recommendations based on our experience of how to select the optimal patients for such a combined minimally invasive transfemoral approach (Fig. 2, Ref. 9). Keywords: transcatheter valve implantation, peripheral arterial disease, aortic valve disease, percutaneous intervention, atherosclerosis.

P1423 Significantly higher 1-year mortality rate in patients undergoing TAVR with higher right ventricular volumes, as calculated by pre-procedural CT angiography

Abstract Background Cardiac gated computed tomography angiography (CCTA) is the mandatory pre-interventional imaging planning procedure in patients eligible for trans-catheter valve implantation (TAVR). Automated analysis of the cardiac chambers" volumes including the right ventricle (RV), can be obtained from the CCTA and thus contribute to patient selection. Objectives To assess the prognostic implications of increased RV volume using a fast automated volumetric analysis software on preprocedural CCTA data among patients undergoing TAVR. Methods CCTA of patients who underwent TAVR at two medical centers – Stanford University Medical Center (California, USA) and Tel Aviv Medical Center (Israel) – between 2013 and 2016 were analyzed by an automatic four chamber volumetric analysis (4CVA) software, and grouped according to their RV volume index, into those with the largest RV (upper 5th percentile of RV volume index (>120 ml/m2; n = 16) versus those within the 95th percentile lower volumes index (≤120 ml/m2; n = 307). Differences in baseline characteristics between the groups were adjusted for with a propensity score. The risk for one year mortality following the TAVR was compared between the two groups. Results In total 323 patients were included. There were no major differences in background and demographic characteristics between the study groups. A significantly higher 1-year mortality rate was found for patients with large RV (31.3% vs. 7.5%, p = 0.008). After adjustment for clinical characteristics, patients with RV volume index >120 ml/m2 were at almost a 5 times higher risk for 1-year mortality compared to patients with smaller RV (HR 4.9, 95% CI 1.8-13.1, p = 0.002). The addition of echocardiographic parameters to the propensity score did not eliminate the significance of RV volume index >120 ml/m2 as an independent predictor for mortality at 1-year. An analysis of RV as a continuous variable demonstrated that the risk for 1-year mortality increased by 2% for every 1 ml/m2 RV volume enlargement (p = 0.013). Conclusions Cardiac volumetric data by CCTA performed for procedural planning may help predict outcome in patients undergoing TAVR. Abstract P1423 Figure. Cox survival curves according to RVi

Access site complications following Impella-supported high-risk percutaneous coronary interventions

Mechanical circulatory support (MCS) devices are increasingly used to provide hemodynamic stability for patients with severe coronary artery disease, comorbidities, and/or impaired hemodynamics during high-risk percutaneous coronary interventions (PCI). Vascular access site complications, particularly those due to the use of large-bore sheaths, may limit outcomes in these patients. The aim of this study was to investigate the incidence and predictors of vascular complications in protected high-risk PCIs. Therefore, we included patients undergoing high-risk PCI with an Impella device from January 2016 to August 2018. Vascular complications were graded according to ‘Valve Academic Research Consortium-2’, a definition routinely used in transcatheter valve implantation procedures. In total, 61 patients (mean age 72 ± 11 years, 79% male, SYNTAX score 33 ± 7) were included, and angiographic- and fluoroscopic-guided vascular access was used for Impella implantation in all patients. Major vascular complications occurred in 5 male patients (8%). All major vascular complications were treated conservatively without the need for surgical intervention, and only one patient received a transfusion of three erythrocyte concentrates. Regression analysis revealed that patients with peripheral arterial disease of the lower extremities are at higher risk of major vascular complications. In conclusion, the utilization of Impella using a standardized protocol for angiographic- and fluoroscopic-guided vascular access was associated with a low rate of vascular complications.

Successful bailout of Sapien 3 valve balloon rupture during transcatheter valve implantation via transaortic approach.

Successful bailout of Sapien 3 valve balloon rupture during transcatheter valve implantation via transaortic approach.

Heartbeat: guidelines versus reality for patients with severe aortic stenosis

The increasing prevalence of aortic stenosis (AS) in our ageing population and clinical trials demonstrating the benefits of transcatheter valve implantation for severe symptomatic AS have focused attention on this...

Early experience with a purpose-designed temporary pacing guidewire for transcatheter valve implantation.

Early experience with a purpose-designed temporary pacing guidewire for transcatheter valve implantation.

Early Outcomes After Percutaneous Closure of Access Site in Transfemoral Transcatheter Valve Implantation Using the Novel Vascular Closure Device Collagen Plug-Based MANTA

A new collagen-based MANTA vascular closure device (VCD) was developed for closing large-bore arteriotomies after transfemoral transcatheter aortic valve implantation (TAVI). We evaluated safety and feasibility at 30-day follow-up in terms of vascular and bleeding complications and mortality of the collagen-based MANTA VCD compared with the suture-based Prostar XL VCD in a cohort of 366 patients who underwent transfemoral TAVI between January 2015 and April 2018. The MANTA VCD was used in 168 patients and the Prostar XL VCD in 198 patients, with successful closure of 98.8% and 98.5%, respectively. VARC-2 defined as major vascular and bleeding complications was similar in both groups (MANTA vs Prostar XL): 0.6% versus 1.0% (p = 0.661) and 0.6% versus 1.5% (p = 0.102). Minor vascular and bleeding complications, were significantly more frequent (10.7 vs 18.8 %, p = 0.003 and 13.7 vs 19.7%, p = 0.080, respectively) in the Prostar XL cohort. Thirty-day all-cause mortality was 2.7%, without significant difference between the groups (p = 0.278). The MANTA device is a safe and feasible option for vascular access closure in patients undergoing transfemoral TAVI.

Peri-procedural thrombocytopenia after aortic bioprosthesis implant: A systematic review and meta-analysis comparison among conventional, stentless, rapid-deployment, and transcatheter valves

BackgroundThrombocytopenia has been shown to occur soon after surgical biological aortic valve replacement (AVR), and recently reported also after transcatheter valve implantation (TAVI). The mechanism underlying this phenomenon is still unknown, and its clinical impact on the peri-operative outcome has been poorly investigated. MethodsA systematic review and a meta-analysis of all available studies reporting data about peri-procedural thrombocytopenia on isolated bio-AVR, comparing rapid-deployment (RDV), stentless (stentless-AVR), and TAVI vs. stented (stented-AVR) valves, have been performed. ResultsFifteen trials (2.163 patients) were included in the meta-analysis. Perioperative platelet reduction ranged from 35% to 55% in stented-AVR, from 60% to 77% in stentless-AVR, from 53% to 60% in RDV, and from to 21% to 72% in TAVI (apparently, balloon-expandable valves more frequently associated to thrombocytopenia). Stented-AVR required more red blood cells transfusion than stentless-AVR (P < 0.0001), whereas no difference has been found between RDV and stented-AVR. Platelet transfusion rate was very low in all surgical groups. No difference has been found in RDV and stentless-AVR vs. stented-AVR, in terms of reoperation for bleeding, and length-of-intensive care unit or hospital stay. ConclusionsThrombocytopenia-related major adverse events were mainly reported in TAVI patients, whereas clinically meaningless in surgical patients. Transient peri-procedural thrombocytopenia is common after bio-AVR, regardless of prosthesis’s type or implant modality. It should receive appropriate monitoring and focused investigations.

Radiation Exposure During Transcatheter Valve Replacement: What Cardiac Surgeons Need to Know

Transcatheter aortic valve replacement (TAVR) and transcatheter mitral valve replacement expose operators to radiation. These procedures differ primarily in whether they are performed via a transfemoral (TF) or an alternative access (AA) approach. This study compared operator radiation exposure during transcatheter valve implantation when performed via a TF vs an AA approach, when performed in a catheterization lab vs a hybrid operating room (OR), and investigated the potential benefit of disposable shielding. Dosimeters were worn during TAVR-TF (n= 50) and TAVR-AA (n= 31) procedures by operators. All TAVR-AA procedures were performed in a hybrid OR and TF procedures were performed in either catheterization labs (n= 16) or a hybrid OR (n= 34). Disposable radiation shielding pads (RADPAD; Worldwide Innovations and Technologies, Inc, Kansas City) or a placebo were added in a randomized, blinded fashion. Team radiation exposure was higher after TAVR-AA vs TAVR-TF (median 15.1 mRad [interquartile range: IQR 8.6, 32.4] vs 5.5 mRad [IQR 2.4, 9.8], P < .001). TAVR-TF procedures required the same amount of fluoroscopy time regardless of where they were performed (20.3 ± 7.4 min in hybrid OR vs 19.0 ± 6.4 min in catheterization lab, P= .55). However, radiation exposure for TAVR-TF remained higher when performed in a hybrid OR (median 9.0 mRad [IQR 4.5, 11.9] vs 2.2 mRad [IQR 1.3, 2.8], P < .001). Radiation exposure was greatest for TAVR-AA (median 15.1 mRad [IQR 8.6, 32.4]). The use of RADPAD did not decrease radiation exposure (median 9.0 mRad [IQR 4.5, 14.7] vs 9.4 mRad [IQR 2.8, 19.5], P= .82). Procedures performed in the hybrid OR were associated with higher operator radiation exposure. In comparison with the TF approach, AA cases had thehighest levels of operator radiation. This is particularly important in cases of transcatheter mitral valve replacement that can only be done via an AA approach. The use of disposable radiation shielding in this series did not attenuate operator radiation exposure. Radiation shielding within hybrid ORs should be scrutinized in an effort to remain on par with that found within catheterization labs.

Cardiac Computed Tomography - More Than Coronary Arteries? AClinical Update.

Rapid improvement of scanner and postprocessing technology as well as the introduction of minimally invasive procedures requiring preoperative imaging have led to the broad utilization of cardiac computed tomography (CT) beyond coronary CT angiography (CTA). This review article presents an overview of recent literature on cardiac CT. The goal is to summarize the current guidelines on performing cardiac CT and to list established as well as emerging techniques with a special focus on extracoronary applications. Most recent guidelines for the appropriate use of cardiac CT include the evaluation of coronary artery disease, cardiac morphology, intra- and extracardiac structures, and functional and structural assessment of the myocardium under certain conditions. Besides coronary CTA, novel applications such as the calculation of a CT-derived fractional flow reserve (CT-FFR), assessment of myocardial function and perfusion imaging, as well as pre-interventional planning in valvular heart disease or prior pulmonary vein ablation in atrial fibrillation are becoming increasingly important. Especially these extracoronary applications are of growing interest in the field of cardiac CT and are expected to be gradually implemented in the daily clinical routine. · Coronary artery imaging remains the main indication for cardiac CT. · Novel computational fluid dynamics allow the calculation of a CT-derived fractional flow reserve in patients with known or suspected coronary artery disease. · Cardiac CT delivers information on left ventricular volume as well as myocardial function and perfusion. · CT is the cardinal element for pre-interventional planning in transcatheter valve implantation and pulmonary vein isolation. · Taron J, Foldyna B, Eslami P et al. Cardiac Computed Tomography - More Than Coronary Arteries? A Clinical Update. Fortschr Röntgenstr 2019; 191: 817 - 826.

The association of diabetes mellitus treated with oral antidiabetic drugs and insulin with mortality after transcatheter valve implantation: a 3-year follow-up of the TAVIK registry

BackgroundDiabetes mellitus (DM) on insulin is a patient-related factor in the assessment of surgical risk based on the EuroSCORE II and, as such, it confers additional risk on outcomes after transcatheter aortic valve implantation (TAVI). The aim of this study was to investigate the effect of diabetes mellitus treated with insulin and oral antidiabetic drugs on clinical outcomes after TAVI.MethodsThis study is an analysis of 2000 patients who underwent TAVI between 2008 and 2015. Patients were stratified post hoc into the following categories: without diabetes (n = 1337), with diabetes treated with oral antidiabetic drugs (OAD; n = 387) and with diabetes treated using insulin (n = 276).ResultsThere was no significant difference in device success (89.5% vs 89.4% vs 88.8%, adjusted odds ratio (adjOR) 1.10 [95% confidence interval (CI) 0.64–1.91]) and VARC-2-defined major complications among the three groups of patients (without DM, OAD, and insulin, respectively). Minor but not major or disabling strokes (adjOR 2.19; 95% CI 1.11–4.3) and overall renal complications (but not stage 2/3 alone) (adjOR 1.46; 95% CI 1.18–1.81) were more common in patients with diabetes than in those without diabetes. Insulin-treated patients had a significantly lower survival rate than that of patients with orally treated diabetes and of those without diabetes at 1 year (75.7% vs. 84.5% vs 84.7%, pairwise p < 0.01) and 3 years (56.9% vs. 65.9% vs. 67.9%, adj. p < 0.05) after TAVI. However, insulin-treated diabetes was not identified as an independent risk factor for higher mortality in the first (HR 1.29; 95% CI 0.97–1.72, p = 0.084) and 3rd years (HR 1.21; 95% CI 0.98–1.49; p = 0.079) after multivariable adjustment.ConclusionsAlthough insulin-dependent DM is an established component of surgical risk assessment, it was not identified as an independent factor associated with reduced survival in TAVI. DM treated with oral antidiabetic drugs or insulin may have less role in decision making of treatment in TAVI candidates.

Imaging in patients with severe mitral annular calcification: insights from a multicentre experience using transatrial balloon-expandable valve replacement.

To investigate valve sizing and the haemodynamic relevance of the predicted left ventricular outflow tract (LVOT) in patients with mitral annular calcification (MAC) undergoing transatrial transcatheter valve implantation (THV). In total, 21 patients undergoing transatrial THV, multiplanar reconstruction (MPR), maximum intensity projection (MIP), and cubic spline interpolation (CSI) were compared for MA sizing during diastole. In addition, predicted neo-LVOT areas were measured in 18 patients and correlated with the post-procedural haemodynamic dimensions. The procedure was successful in all patients (100%). Concomitant aortic valve replacement was performed in eight patients (43%) (AVR group). Sizing using MPR and MIP yielded comparable results in terms of area, perimeter, and diameter, whereas the dimensions obtained with CSI were systematically smaller. The simulated mean systolic neo-LVOT area was 133.4 ± 64.2 mm2 with an anticipated relative LVOT area reduction (neo-LVOT area/LVOT area × 100) of 59.3 ± 14.7%. The systolic relative LVOT area reduction, but not the absolute neo-LVOT area, was found to predict the peak (r = 0.69; P = 0.002) and mean (r = 0.65; P = 0.004) post-operative aortic gradient in the overall population as well as separately in the AVR (peak: r = 0.91; P = 0.002/mean: r = 0.85; P = 0.002) and no-AVR (peak: r = 0.89; P = 0.003/mean: r = 0.72; P = 0.008) groups. In patients with severe MAC undergoing transatrial transcatheter valve implantation, MPR, and MIP yielded comparable annular dimensions, while values obtained with CSI tended to be systematically smaller. Mitral annular area and the average annular diameter appear to be reliable parameters for valve selection. Simulated relative LVOT reduction was found to predict the post-procedural aortic gradients.

Midterm outcomes of right ventricular outflow tract reconstruction using the Freestyle xenograft

Various options exist for right ventricular outflow tract (RVOT) reconstruction in congenital heart disease. The Freestyle porcine aortic root may be used but its longevity is not well defined. We performed a retrospective review of all non-Ross RVOT reconstructions using the Freestyle root in our institution. Survival and reintervention, either by surgery, transcatheter valve implantation, balloon valvuloplasty, or bare metal stent placement, were recorded. Factors associated with reintervention were assessed using Cox regression. Between January 2002 and December 2015, there were 182 patients identified. Sixteen patients were lost to follow-up and 3 patients died, unrelated to cardiac surgery. Of the remaining 163 patients, the median age was 12.2years (interquartile range 6.4-16.4), median weight was 39.0kg (interquartile range 19.9-59.3), and the median body surface area was 1.23 m2 (interquartile range 0.79-1.64). Ninety-three (57%) patients had tetralogy of Fallot. The median follow-up was 5.4years (interquartile range 2.9-8years). There were no operative or cardiac-related deaths. Thirty-eight patients (23%) required reintervention. The rate of freedom from reintervention was 93.2% (95% CI 86.7%-96.6%) at 5years and 48.4% (95% CI 34.9%-60.6%) at 10years. Age < 10years, weight < 39kg, and body surface area <1.2 m2 at the time of valve placement, as well as valve size ≤25mm were significantly associated with need for earlier reintervention. The Freestyle root in the RVOT is associated with excellent survival and low midterm need for reintervention. Its longevity is comparable to published data on homografts and other bioprosthetic valves.

Internal Banding to Reduce Paravalvular Leaks for Open Transcatheter Valve Implantation

Transcatheter valve implantation has become an alternative to open-heart conventional surgery in high-risk patients. We describe a new surgical technique that allows the implantation of a transcatheter valvular prosthesis through an open surgical approach to prevent the appearance of paravalvular leaks in patients with large native rings.

Characteristics and outcomes of patients ≤ 75 years who underwent transcatheter aortic valve implantation: insights from the SOURCE 3 Registry

Current trials and registries of transcatheter valve implantation (TAVI) mostly include patients older than 75years. Little is known about younger patients who undergo this treatment. We investigated comorbidities among patients < 75years old who underwent TAVI in the SAPIEN 3™ European post-approval SOURCE 3 Registry, and analysed outcomes at 30days and 1year. Three age groups of patients were analysed for outcomes and characteristics: < 75 (n = 235), 75-80 (n = 391) and ≥ 80years (n = 1320). Overall, the mean age was 81.6 ± 6.7years; transfemoral access was used in 87.1% of patients treated with SAPIEN 3 transcatheter heart valves. The mean logistic EuroSCORE increased according to age group (12.6%, 17.3% and 19.7%, respectively, p < 0.001). Younger patients had a higher incidence of comorbidities, particularly those not included in surgical risk score assessment tools, e.g., severe liver disease, previous radiation therapy, and porcelain aorta. Mortality rates were similar between age groups at 30days (1.7%, 2.0% and 2.3%, respectively, p = 0.79) and 1year (14.2%, 9.3% and 13.3%, respectively, p = 0.08). However, sudden cardiac death rates were higher in the < 75years age group compared with the ≥ 85years age group (20.7% vs. 4.8%, p = 0.010). In current TAVI practice, patients younger than 75years are a minority (12%). Despite younger age and lower surgical risk scores, this cohort was characterized by comorbidities not accounted for by traditional surgical risk scores. More data are needed for this age group to guide the appropriate decision between surgery and TAVI. CLINICALTRIAL. NCT02698956.

VD01 A CASE OF “VERY” SIMULTANEOUS TRANSAPICAL TRANSCATHETER AORTIC AND MITRAL VALVE IMPLANTATION

Abstract The ever widening diffusion of biological prostheses and the achievement of higher mean age have focused attention on new possible scenario: off-label use of transcatheter valve implantation (TAVI) via a valve-in-valve procedure as an alternative strategy to standard surgery redo valve replacement. We report the first simultaneous Transapical Transcatheter Aortic and Mitral Valve Implantation performed after contemporary wires positioning in aortic and mitral size. After apical puncture, soft and subsequent stiff guidewires were inserted trans-apically through the 2 prosthesis. The first wire was advanced through the aortic prosthesis and placed in femoral artery. The second one was inserted through the mitral prosthesis and placed in right superior pulmonary vein. The aortic prosthesis was introduced through a trans-apically placed sheath, positioned, and then deployed into the degenerated aortic bioprosthesis under fluoroscopic guidance. The same procedure was used for mitral prosthesis using the previous positioned wire.

TCT-686 Mixed aortic valve disease: Impact on outcome after transcatheter aortic valve implantation

The introduction of transcatheter valve implantation (TAVI) into clinical practice has provided new treatment options for patients with severe aortic valve stenosis. Mixed aortic valve disease with concomitant aortic regurgitation is common amongst these patients. We sought to investigate in