This study sought to report short-term results of safety, performance, and efficacy of the Mistral device first-in-human study in patients suffering from severe functional tricuspid insufficiency.
...Patients who suffer from severe tricuspid regurgitation (TR) and who are at high surgical risk have no standard care therapy. Therefore, minimally invasive and safer methods are sought. The Mistral device is an investigational spiral-shaped device intended for percutaneous transcatheter repair. The Mistral device approximates the tricuspid leaflets by grasping together the chordae tendineae of the tricuspid valve.
Seven patients (4 women; mean age 73.14 ± 7.4 years) with severe (n = 5) and massive (n = 2) symptomatic TR and high surgical risk underwent Mistral tricuspid repair under transesophageal echocardiography guidance.
Mistral was successfully implanted in all cases with a single device deployed in 6 patients, with 2 devices deployed in 1 patient. No procedural or 30-day adverse events occurred. TR was reduced by at least 1 grade in all patients. Effective regurgitant orifice area was reduced from median 0.52 cm
(interquartile range IQR: 0.40 to 0.60 cm
) at baseline to 0.15 cm
(IQR: 0.14 to 0.21 cm
) at 30 days post-procedure (p < 0.01), vena contracta width was reduced from 0.95 cm (IQR: 0.81 to 1.16 cm) to 0.62 cm (IQR: 0.52 to 0.67 cm) (p < 0.05), and regurgitant volume decreased from 49.4 ml/beat (IQR: 45.2 to 57.7 ml/beat) to 19.7 ml/beat (IQR: 12.4 to 23.9 ml/beat) (p < 0.01). Right ventricular fractional area change improved from 27.0% (IQR: 21.3% to 33.5%) at baseline to 38.5% (IQR: 29.0% to 47.1%) at 30-day follow-up (p < 0.05). Significant improvements in New York Heart Association functional class, Kansas City Cardiomyopathy Questionnaire score, and 6-min walk test were observed at 30 days.
Tricuspid valve repair with the Mistral device appears safe and leads to 30-day reduction of tricuspid insufficiency and improvement of right ventricular function and exercise capacity.
Periprocedural systemic embolism is a well-documented complication of transcatheter aortic valve replacement (TAVR). Although the most focus was given to cerebral embolism (which remains ...unpredictable, difficult to prevent, and a source of increased morbidity and mortality after TAVR), coronary embolism remains less investigated and potentially overlooked. This study provides a case series of 3 patients diagnosed with coronary embolism after TAVR in our institution over a 2-year period (3 of 297 cases, 1%) and a systematic literature review (4 studies; 19 case reports). Overall, coronary embolism associated with TAVR is frequently characterized by proximal vessel occlusion causing ST-elevation myocardial infarction and hemodynamic instability with lower mortality in the acute phase as compared with late coronary embolism. However, it often presents with distal vessel occlusion and minor symptoms that may be overlooked in the periprocedural period. In conclusion, we suggest that TAVR-associated coronary embolism has a much higher prevalence than previously documented. Further studies are warranted to properly assess the prevalence and impact of this phenomenon.
The commonly utilized techniques for encapsulating hydrophilic molecules in NP suffer from low encapsulation efficiency because of the drug rapid partitioning to the external aqueous phase. We ...hypothesized that combining the double emulsion system with a partially water-soluble organic solvent, could result in better encapsulation yield of hydrophilic molecules in nano-sized NP, and the utilization of both biocompatible surfactants and solvents. As a model drug we used alendronate, a hydrophilic low MW bisphosphonate. The new NP preparation technique, double emulsion solvent diffusion (DES-D), resulted in improved formulation characteristics including smaller size, lower size distribution, higher encapsulation yield, and more biocompatible ingredients in comparison to classical methods. The utilization of partially water-miscible organic solvent (ethyl acetate) enabled rapid diffusion through the aqueous phase forming smaller NP. In addition, the formulated alendronate NP exhibited profound inhibition of raw 264 macrophages, depletion of rabbit's circulating monocytes, and inhibition of restenosis in the rat model. It is concluded that the new technique is advantageous in terms of smaller size, lower size distribution, higher encapsulation yield, and more biocompatible ingredients, with unaltered bioactivity.
The study sought to examine the effect of coronary artery disease (CAD) on mortality in patients undergoing transcatheter aortic valve replacement (TAVR).
CAD is common in the TAVR population. ...However, there are conflicting data on the prognostic significance of CAD and its treatment in this population.
The authors analyzed 1,270 consecutive patients with severe aortic stenosis (AS) undergoing TAVR at 3 Israeli centers. They investigated the association of CAD severity (no CAD, nonsevere CAD i.e., SYNTAX score (SS) <22, severe CAD SS >22) and revascularization completeness (“reasonable” incomplete revascularization ICR i.e., residual SS <8; ICR residual SS >8) with all-cause mortality following TAVR using a Cox proportional hazards ratio model adjusted for multiple prognostic variables.
Of the 1,270 patients, 817 (64%) had no CAD, 331 (26%) had nonsevere CAD, and 122 (10%) had severe CAD. Over a median follow-up of 1.9 years, 311 (24.5%) patients died. Mortality was higher in the severe CAD and the ICR groups, but not in the nonsevere CAD or “reasonable” ICR groups, versus no CAD. After multivariate adjustment, both severe CAD (hazard ratio: 2.091; p = 0.017) and ICR (hazard ratio: 1.720; p = 0.031) were associated with increased mortality.
Only severe CAD was associated with increased mortality post-TAVR. More complete revascularization pre-TAVR may attenuate the association of severe CAD and mortality.
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Direct oral anticoagulants (DOACs) are used as an alternative for traditional antithrombotic therapy. However, the safety profile of DOACs in patients with renal failure (RF) has not been determined.
...A systematic review was performed assessing the reported safety of DOACs compared with vitamin K antagonists (VKAs) in patients with RF and estimated creatinine clearance (eCrCL) < 50 mL/min and eCrCL 50 to 80 mL/min. MEDLINE, EMBASE, Cochrane, and the Clinical Trials Registry (ClinicalTrials.gov) were searched for randomized clinical trials up to November 2015. The data were pooled by using both traditional frequentist and Bayesian random effects models.
Nine trials met the inclusion criteria. Among 94,897 participants, 54,667 (58%) had RF. Compared with VKAs, DOACs were associated with a significantly decreased risk for major bleeding in patients with eCrCL 50 to 80 mL/min (risk ratio, 0.87 95% CI, 0.81-0.93) and a nonsignificant decrease in the risk for major bleeding in patients with eCrCL < 50 mL/min (risk ratio, 0.83 95% CI, 0.68-1.02); there was evidence of significant heterogeneity. Indirect comparisons, using Bayesian network analysis, indicated that apixaban was associated with a decreased rate of major bleeding compared with other DOACs in patients with eCrCL < 50 mL/min. DOACs were associated with a significant decrease in the risk for hemorrhagic stroke compared with VKAs in patients with eCrCL < 50 mL/min and 50 to 80 mL/min.
As a class, DOACs are associated with a reduced risk for hemorrhagic stroke compared with VKAs in patients with RF. However, DOACs may differ from each other in their relative risk for major bleeding in patients with eCrCL < 50 mL/min.
PROSPERO registry; No.: CRD42014013730; URL: http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42014013730.
Abstract The complex relationship between the inflammatory response and vascular injury and repair is of major importance to the pathogenesis of cardiovascular disease. CRP is not only a strong ...marker for cardiovascular morbidity but a modulator that suppresses local and systemic thromboregulatory pathways. In the present review we address the question of whether CRP is involved in atherogenesis, in thrombosis, or in both components of the atherothrombotic process. While CRP is present in the atherosclerotic lesion, it is probably not pro-atherogenic and correlates only minimally with atherogenesis. Alas, CRP promotes thrombus formation and vascular occlusion. Thus, CRP is most likely not affecting atheroma build-up but rather the deleterious process of plaque vulnerability and thrombus formation. Dwelling into CRP mechanism of action may lead to the design of new diagnostic modalities that will add to the predictive value of CRP in identifying those patients at high cardiovascular risk. Furthermore, defining the mechanistic domain is the foundation to the cause–effect detection of possible therapeutic interventions to counter CRP morbid effects.
BACKGROUND—Valve thrombosis has yet to be fully evaluated after transcatheter aortic valve implantation. This study aimed to report the prevalence, timing, and treatment of transcatheter heart valve ...(THV) thrombosis.
METHODS AND RESULTS—THV thrombosis was defined as follows (1) THV dysfunction secondary to thrombosis diagnosed based on response to anticoagulation therapy, imaging modality or histopathology findings, or (2) mobile mass detected on THV suspicious of thrombus, irrespective of dysfunction and in absence of infection. Between January 2008 and September 2013, 26 (0.61%) THV thromboses were reported out of 4266 patients undergoing transcatheter aortic valve implantation in 12 centers. Of the 26 cases detected, 20 were detected in the Edwards Sapien/Sapien XT cohort and 6 in the Medtronic CoreValve cohort. In patients diagnosed with THV thrombosis, the median time to THV thrombosis post–transcatheter aortic valve implantation was 181 days (interquartile range, 45–313). The most common clinical presentation was exertional dyspnea (n=17; 65%), whereas 8 (31%) patients had no worsening symptoms. Echocardiographic findings included a markedly elevated mean aortic valve pressure gradient (40.5±14.0 mm Hg), presence of thickened leaflets or thrombotic apposition of leaflets in 20 (77%) and a thrombotic mass on the leaflets in the remaining 6 (23%) patients. In 23 (88%) patients, anticoagulation resulted in a significant decrease of the aortic valve pressure gradient within 2 months.
CONCLUSIONS—THV thrombosis is a rare phenomenon that was detected within the first 2 years after transcatheter aortic valve implantation and usually presented with dyspnea and increased gradients. Anticoagulation seems to have been effective and should be considered even in patients without visible thrombus on echocardiography.
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