Transcatheter heart valve (THV) thrombosis has been increasingly reported. In these studies, thrombus quantification has been based on a 2-dimensional assessment of a 3-dimensional phenomenon.
...Postprocedural, 4-dimensional, volume-rendered CT data of patients with CoreValve, Evolut R, and SAPIEN 3 transcatheter aortic valve replacement enrolled in the RESOLVE study (Assessment of Transcatheter and Surgical Aortic Bioprosthetic Valve Dysfunction With Multimodality Imaging and Its Treatment with Anticoagulation) were included in this analysis. Patients on anticoagulation were excluded. SAPIEN 3 and CoreValve/Evolut R patients with and without hypoattenuated leaflet thickening were included to study differences between groups. Patients were classified as having THV thrombosis if there was any evidence of hypoattenuated leaflet thickening. Anatomic and THV deployment geometries were analyzed, and thrombus volumes were computed through manual 3-dimensional reconstruction. We aimed to identify and evaluate risk factors that contribute to THV thrombosis through the combination of retrospective clinical data analysis and in vitro imaging in the space between the native and THV leaflets (neosinus).
SAPIEN 3 valves with leaflet thrombosis were on average 10% further expanded (by diameter) than those without (95.5±5.2% versus 85.4±3.9%;
<0.001). However, this relationship was not evident with the CoreValve/Evolut R. In CoreValve/Evolut Rs with thrombosis, the thrombus volume increased linearly with implant depth (
=0.7,
<0.001). This finding was not seen in the SAPIEN 3. The in vitro analysis showed that a supraannular THV deployment resulted in a nearly 7-fold decrease in stagnation zone size (velocities <0.1 m/s) when compared with an intraannular deployment. In addition, the in vitro model indicated that the size of the stagnation zone increased as cardiac output decreased.
Although transcatheter aortic valve replacement thrombosis is a multifactorial process involving foreign materials, patient-specific blood chemistry, and complex flow patterns, our study indicates that deployed THV geometry may have implications on the occurrence of thrombosis. In addition, a supraannular neosinus may reduce thrombosis risk because of reduced flow stasis. Although additional prospective studies are needed to further develop strategies for minimizing thrombus burden, these results may help identify patients at higher thrombosis risk and aid in the development of next-generation devices with reduced thrombosis risk.
Transcatheter aortic valve replacement (TAVR) is increasingly being performed in cardiac catheterization laboratories using transthoracic echocardiography (TTE) to guide valve deployment. The risk of ...paravalvular regurgitation (PVR) remains a concern.
We retrospectively reviewed 454 consecutive patients (mean age, 82 ± 8; 58% male) who underwent transfemoral TAVR at Emory Healthcare from 2007 to 2014. Two hundred thirty-four patients underwent TAVR in the cardiac catheterization laboratory with TTE guidance (TTE-TAVR; mean Society of Thoracic Surgeons score, 10%), while 220 patients underwent the procedure in the hybrid operating room with transesophageal echocardiography (TEE) guidance (TEE-TAVR; mean Society of Thoracic Surgeons score, 11%). All patients received an Edwards valve (SAPIEN 55%, SAPIEN-XT 45%). Clinical and procedural characteristics, echocardiographic parameters, and incidence of PVR were compared.
The incidence of at least mild PVR at discharge was comparable between TTE-TAVR and TEE-TAVR (33% vs 38%, respectively; P = .326) and did not differ when stratified by valve type. However, in the TTE-TAVR group, there was a higher incidence of second valve implantation (7% vs 2%; P = .026) and postdilation (38% vs 17%; P < .001) during the procedure. Although not independently associated with PVR at discharge (odds ratio = 1.12; 95% CI, 0.69-1.79), TTE-TAVR was associated with PVR-related events: the combined outcome of mild PVR at discharge, intraprocedural postdilation, and second valve insertion (odds ratio = 1.58; 95% CI, 1.01-2.46). There were no significant differences in PVR at 30 days, 6 months, and 1 year between the two groups.
TTE-TAVR in a high-risk group of patients was associated with increased incidence of intraprocedure PVR-related events, although it was not associated with higher rates of PVR at follow-up. Multicenter randomized trials are required to confirm the cost-effectiveness and safety of TTE-TAVR.
Abstract Background Neutrophil-lymphocyte (NLR) and platelet-lymphocyte ratios (PLR) mark systemic inflammation. Patients with high NLR and PLR have worse cardiovascular disease and outcomes. We ...assessed the role of these ratios in predicting outcomes after transcatheter aortic valve replacement (TAVR). Methods The association between NLR and PLR with baseline characteristics, 30-day outcomes, and 1-year readmission/survival was determined in patients that underwent TAVR between 2007 and 2014 and had baseline complete blood count with differential. A subgroup analysis determined the association between change in NLR and PLR (discharge-baseline) and 1-year outcomes. Results In 520 patients that underwent TAVR, a higher NLR (p = 0.01) and PLR (p = 0.02) were associated with a higher STS-PROM score, and with increased occurrence of the 30-day early-safety outcome (by VARC-2), even after adjusting for STS-PROM score, valve generation (Sapien vs. Sapien XT), and access (transfemoral vs. non-transfemoral) (NLR: OR 1.29, 95% CI 1.04–1.61; PLR: OR 1.27, 95% CI 1.01–1.60) but not with 1-year readmission or survival. In our subgroup analysis (N = 294), change in PLR was not associated with the 1-year outcomes but a high change in NLR was associated with worse 1-year survival/readmission and 1-year survival, even after adjusting for STS-PROM score, valve generation and access (HR 1.22, 95% CI 1.04–1.44 and HR 1.26, 95% CI 0.99–1.6, respectively). Conclusions NLR and PLR correlate with surgical risk. An elevated NLR and PLR were associated with the occurrence of 30-day adverse outcomes, similar to the STS-PROM score. A high variation of NLR from baseline to discharge may help stratify patients that underwent TAVR in addition to traditional risk factors.
The effect of frailty on outcomes after transcatheter aortic valve replacement (TAVR) remains incompletely understood. The objective of this study was to evaluate the performance of four commonly ...used frailty markers as predictors of early and late outcomes among patients undergoing TAVR.
A review was performed of 361 high- and extreme-risk patients undergoing TAVR from 2011 to 2015. Four frailty variables were assessed: serum albumin (g/dL), 5-m walk (seconds), grip strength (kg), and Katz index of independence in activities of daily living. Logistic regression was used to examine the association between the frailty indicators and 30-day composite of mortality, stroke, new heart block requiring permanent pacemaker, major or life-threatening bleeding, acute renal failure, major vascular complication, and 30-day readmission rate. Minimum distance to the perfect point (0, 1) was performed to delineate a cutoff point for each frailty indicator, and risk models were compared using receiver-operating characteristics curves.
The composite of outcomes occurred in 28% of patients. Serum albumin, activities of daily living, and 5-m walk were independent predictors for 30-day composite outcomes, but only albumin was predictive of 30-day mortality. A new frailty model (four frailty indicators, age, and sex) to predict 30-day mortality was created and compared with The Society of Thoracic Surgeons predicted risk of mortality. Better discrimination was found with the new frailty model (area under the curve 0.74 versus 0.58). New individual frailty variable cutoff values were found to predict our composite of events.
Among high- and extreme-risk patients undergoing TAVR, our new frailty model was more discriminative of 30-day mortality than The Society of Thoracic Surgeons predicted risk of mortality. New cutoff values for frailty indicators were identified and will require further validation.
Abstract Background A minimalist approach for transcatheter aortic valve replacement (MA-TAVR) utilizing transfemoral access under conscious sedation and transthoracic echocardiography is increasing ...in popularity. This relatively novel technique may necessitate a learning period to achieve proficiency in performing a successful and safe procedure. This report evaluates our MA-TAVR cohort with specific characterization between our early, midterm, and recent experience. Methods We retrospectively reviewed 151 consecutive patients who underwent MA-TAVR with surgeons and interventionists equally as primary operator at Emory University between May 2012 and July 2014. Our institution had performed 300 TAVR procedures before implementation of MA-TAVR. Patient characteristics and early outcomes were compared using Valve Academic Research Consortium 2 definitions among 3 groups: group 1 included the first 50 patients, group 2 included patients 51 to 100, and group 3 included patients 101 to 151. Results Median age for all patients was 84 years and similar among groups. The majority of patients were men (56%) and the median ejection fraction for all patients was 55% (interquartile range, 38.0%-60.0%). The majority of patients were high-risk surgical candidates with a median Society of Thoracic Surgeons Predicted Risk of Mortality of 10.0% and similar among groups. The overall major stroke rate was 3.3%, major vascular complications occurred in 3% of patients, and greater-than-mild paravalvular leak rate was 7%. In-hospital mortality and morbidity were similar among all 3 groups. Conclusions In a high-volume TAVR center, transition to MA-TAVR is feasible with acceptable outcomes and a diminutive procedural learning curve. We advocate for TAVR centers to actively pursue the minimalist technique with equal representation by cardiologists and surgeons.
The aim of this study was to test the hypothesis that transcatheter electrosurgery might allow intentional detachment of previously placed MitraClip(s) from the anterior leaflet to recreate a single ...mitral orifice for transcatheter mitral valve implantation (TMVI), leaving the retained MitraClip(s) securely fastened to the posterior leaflet and without interfering with the mitral bioprosthesis.
Patients with severe mitral regurgitation or stenosis despite edge-to-edge mitral repair with the MitraClip typically have few therapeutic options because the resultant double orifice precludes TMVI. Transcatheter electrosurgery may allow detachment of failed MitraClip(s) from the anterior leaflet to recreate a single orifice for TMVI.
This was a single-center, 5-patient, consecutive, retrospective observational cohort. Patients underwent transcatheter electrosurgical laceration and stabilization of failed MitraClip(s) to recreate a single orifice, leaving the MitraClip(s) securely fastened to the posterior leaflet. Subsequently, patients underwent TMVI with an investigational device, the Tendyne mitral bioprosthesis, on a compassionate basis. Patients were followed up to 30 days.
MitraClip detachment from the anterior leaflet and Tendyne implantation were successful in all patients. All patients survived to discharge. All patients were discharged with grade 0 central mitral regurgitation. Two patients had moderate perivalvular mitral regurgitation that did not require reintervention. During the follow-up period of 30 days, there were no deaths, cases of valve dysfunction, or reintervention. There was no evidence of erosion or bioprosthetic valve dysfunction attributable to the retained MitraClip(s) still attached to the posterior leaflet.
Transcatheter electrosurgical detachment of failed MitraClips from the anterior leaflet followed by TMVI is technically feasible and safe at 30 days. Longer term study is needed to determine the clinical benefit of this approach and new algorithms for TMVI sizing following electrosurgical laceration and stabilization of a failed MitraClip to avoid perivalvular leak.
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This study sought to evaluate the clinical results of a percutaneous approach to mitral valve repair for mitral regurgitation (MR).
A surgical technique approximating the middle scallops of the ...mitral leaflets to create a double orifice with improved leaflet coaptation was introduced in the early 1990s. Recently, a percutaneous method to create the same type of repair was developed. A trans-septal approach was used to deliver a clip device that grasps the mitral leaflet edges to create the double orifice.
General anesthesia, fluoroscopy, and echocardiographic guidance are used. A 24-F guide is positioned in the left atrium. The clip is centered over the mitral orifice, passed into the left ventricle, and pulled back to grasp the mitral leaflets. After verification that MR is reduced, the clip is released.
Twenty-seven patients had six-month follow-up. Clips were implanted in 24 patients. There were no procedural complications and four 30-day major adverse events: partial clip detachment in three patients, who underwent elective valve surgery, and one patient with post-procedure stroke that resolved at one month. Three additional patients had surgery for unresolved MR, leaving 18 patients free from surgery. In 13 of 14 patients with reduction of MR to < or =2+ after one month, the reduction was maintained at six months.
Percutaneous edge-to-edge mitral valve repair can be performed safely and a reduction in MR can be achieved in a significant proportion of patients to six months. Patients who required subsequent surgery had elective mitral valve repair or intended replacement.
A single healthcare experience with Impella RP Shekiladze, Nikoloz; Condado, Jose F.; Sandesara, Pratik B. ...
Catheterization and cardiovascular interventions,
January 1, 2021, Letnik:
97, Številka:
1
Journal Article
Recenzirano
Objectives
To understand the predictors of survival and indications for Impella RP in a single healthcare experience.
Background
The Impella RP can be used to temporarily support patients with right ...ventricular (RV) dysfunction after left ventricular assist device (LVAD) placement or myocardial infarction (MI). However, recent postmarket approval data have raised concerns of higher than expected mortality with this device.
Methods
A retrospective chart review and analysis of all patients that underwent Impella RP placement in the Emory Healthcare system between January 2016 and December 2018 were performed. Patients were classified according to the indication.
Results
A total of 39 patients underwent Impella RP placement. Six patients were post‐LVAD, 9 were implanted for massive pulmonary embolism with persistent shock, 8 for postcardiac surgery RV failure (non‐LVAD), 11 for RV failure post‐MI, and 5 for new or worsening nonischemic cardiomyopathy. The worst survival was noted in MI‐related cardiogenic shock group and in patients who presented with cardiac arrest (3/12). All observed deaths were due to persistent refractory shock. There was no device related death. Survival improved during the last year of experience compared to the first 2 years.
Conclusion
This study supports the selective use of the Impella RP, with a higher than national reported survival rate (49% vs. 28.6%). Indication appears to be an important factor determining survival.
An incompetent aortic valve (AV) results in aortic regurgitation (AR), where retrograde flow of blood into the left ventricle (LV) is observed. In this work, we parametrically characterized the ...detailed changes in intra-ventricular flow during diastole as a result of AR in a physiological
in vitro
left-heart simulator (LHS). The loss of energy within the LV as the level of AR increased was also assessed. The validated LHS consisted of an optically-clear, flexible wall LV and a modular AV holder. Two-component, planar, digital particle image velocimetry was used to visualize and quantify intra-ventricular flow. A large coherent vortical structure which engulfed the whole LV was observed under control conditions. In the cases with AR, the regurgitant jet was observed to generate a “kinematic obstruction” between the mitral valve and the LV apex, preventing the trans-mitral jet from generating a coherent vortical structure. The regurgitant jet was also observed to impinge on the inferolateral wall of the LV. Energy dissipation rate (EDR) for no, trace, mild, and moderate AR were found to be 1.15, 2.26, 3.56, and 5.99 W/m
3
, respectively. This study has, for the first time, performed an
in vitro
characterization of intra-ventricular flow in the presence of AR. Mechanistically, the formation of a “kinematic obstruction” appears to be the cause of the increased EDR (a metric quantifiable
in vivo
) during AR. EDR increases non-linearly with AR fraction and could potentially be used as a metric to grade severity of AR and develop clinical interventional timing strategies for patients.
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