Percutaneous Devices for the Treatment of Complex Native Valve Mitral Leaflet and Aortomitral Continuity Defects: Review and Case Series.

Percutaneous closure of paravalvar leaks (PVLs) was once only performed in extreme or non-surgical risk cases not suitable for redo-surgery with tissue or mechanical valves. This technique is now the treatment of choice with long term outcomes that are better than redo operations.123 As interventionalists become more familiar with using PVL devices, more off label device use has been reported in non-surgical cases involving complex native mitral valve regurgitation (NVMR). In this review, we appraise the literature regarding percutaneous treatment of paravalvar leaks and more recently esoteric off label use. We also describe two recent challenging cases where percutaneous devices were used to treat severe leaks that developed as a sequela of previous infective endocarditis. We also provide specific recommendations regarding periprocedural strategy and focus on the importance of device choice to provide an optimal outcome.

Development of a pro-arrhythmic ex vivo intact human and porcine model: cardiac electrophysiological changes associated with cellular uncoupling.

We describe a human and large animal Langendorff experimental apparatus for live electrophysiological studies and measure the electrophysiological changes due to gap junction uncoupling in human and porcine hearts. The resultant ex vivo intact human and porcine model can bridge the translational gap between smaller simple laboratory models and clinical research. In particular, electrophysiological models would benefit from the greater myocardial mass of a large heart due to its effects on far-field signal, electrode contact issues and motion artefacts, consequently more closely mimicking the clinical setting. Porcine (n = 9) and human (n = 4) donor hearts were perfused on a custom-designed Langendorff apparatus. Epicardial electrograms were collected at 16 sites across the left atrium and left ventricle. A total of 1 mM of carbenoxolone was administered at 5 ml/min to induce cellular uncoupling, and then recordings were repeated at the same sites. Changes in electrogram characteristics were analysed. We demonstrate the viability of a controlled ex vivo model of intact porcine and human hearts for electrophysiology with pharmacological modulation. Carbenoxolone reduces cellular coupling and changes contact electrogram features. The time from stimulus artefact to (-dV/dt)max increased between baseline and carbenoxolone (47.9 ± 4.1-67.2 ± 2.7 ms) indicating conduction slowing. The features with the largest percentage change between baseline and carbenoxolone were fractionation + 185.3%, endpoint amplitude - 106.9%, S-endpoint gradient + 54.9%, S point - 39.4%, RS ratio + 38.6% and (-dV/dt)max - 20.9%. The physiological relevance of this methodological tool is that it provides a model to further investigate pharmacologically induced pro-arrhythmic substrates.

Incidence, Technical Safety, and Feasibility of Coronary Angiography and Intervention Following Self-expanding Transcatheter Aortic Valve Replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a well-established treatment option for severe aortic stenosis (AS). AS and coronary artery disease frequently coincide, and therefore some patients may require coronary angiography (CAG) and/or intervention (PCI) post-TAVR. Due to valve stent design, most self-expanding prostheses always cover the coronary ostium, and therefore may hinder future access. The objective of this research was to evaluate the incidence, safety and feasibility of CAG/PCI in patients with prior self-expanding TAVR valves. METHODS: Among 2170 patients (age 82 ±â€¯6 years, 43% male) who underwent TAVR with Corevalve or Evolut prostheses, as part of the Italian CoreValve ClinicalService® framework (data from 13 Italian centers), the occurrence of CAG/PCI following TAVR and periprocedural characteristics were examined. RESULTS: During median follow-up of 379 days, 41 patients (1.9%) required CAG and/or PCI (total 46; 16 CAG, 14 PCI, 16 both PCI/CAG). 56.5% of the procedures were performed under emergency/urgency settings. Left system coronary angiography was successfully performed in most cases (28/32, 87.5%), while right coronary angiography was successful only in 50.0% (16/32). PCI procedures (20 for left system, 3 for right system, 4 for graft) were successfully performed in 93.3% (28/30) of the procedures. No CAG/PCI procedure-related complications including prosthesis dislodgment or coronary ostium dissection occurred. CONCLUSIONS: CAG and PCI procedures following CoreValve TAVR is safe and mostly feasible, although the success rate of selective right coronary angiography was relatively low when compared to the left system. Further investigations are required to explore this issue.

Bioresorbable vascular scaffold implantation for severely calcified lesions after excimer laser lesion preparation.

Bioresorbable vascular scaffolds (Absorb BVS, Abbott Vascular, Santa Clara, CA) temporarily elute antiproliferative drugs and provide vessel support, which then subsequently resorb to allow restoration of normal vessel function and architecture. To attain the best possible results with BVS, a dedicated implantation technique (PSP: adequate lesion preparation, proper sizing, postdilatation) is considered mandatory, and calcified lesions are one of the most challenging lesion subsets for BVS implantation. In five cases with severe calcifications refractory to balloon predilatation, we performed excimer laser catheter ablation (ELCA: Turbo Elite catheter; Spectranetics Corporation, Colorado Springs, CO, USA), which facilitated adequate lesion expansion with high-pressure noncompliant balloon inflation and BVS implantation. During the follow-up period (481 days [interquartile range: 445-579]), all patients continued dual antiplatelet therapy (DAPT) and there were no cases of cardiac death, myocardial infarction, or scaffold thrombosis. For treatment of severely calcified lesions with bioresorbable scaffolds, ELCA could be considered an effective potential strategy. After the procedure, prolonged DAPT was prescribed.

Impact of Mitral Annular Calcium on Outcomes after Transcatheter Aortic Valve Implantation.

A high prevalence of mitral annular calcium (MAC) is expected in patients undergoing transcatheter aortic valve implantation (TAVI); however, data regarding the prevalence of MAC and impact on risk of cardiovascular events are lacking. To determine the prevalence of MAC and its association with clinical outcomes in patients undergoing TAVI, we retrospectively analyzed 424 patients who underwent transfemoral TAVI from 2007 to 2015 and whose preoperative computed tomography images were available for assessment of MAC. Severe circumferential MAC (SC-MAC) was defined as calcification involving at least the whole posterior annulus alone or with the attachment of the anterior leaflet. Clinical outcomes were examined according to Valve Academic Research Consortium-2 criteria up to 2 years. SC-MAC was found in 17.7% of patients. Patients with SC-MAC were more likely to be female, with a higher prevalence of atrial fibrillation and peripheral artery disease. There were no differences between the groups regarding age, functional class, prevalence of diabetes, kidney disease, and operative risk. Female gender and peripheral artery disease were independent predictors of SC-MAC. SC-MAC did not appear to be associated with periprocedural and 30-day outcomes. At 2 years' follow-up, patients with SC-MAC had significantly higher cardiovascular and all-cause mortality rates. SC-MAC was an independent predictor of cardiovascular mortality during follow-up. In conclusion, SC-MAC is a frequent finding in the TAVI population and appears to be an independent predictor of cardiovascular mortality at 2 years' follow-up.

Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Encapsulating Bioactive Hydrogels Improve Rat Heart Function Post Myocardial Infarction.

Tissue engineering offers an exciting possibility for cardiac repair post myocardial infarction. We assessed the effects of combined polyethylene glycol hydrogel (PEG), human induced pluripotent stem cell-derived cardiomyocyte (iPSC-CM), and erythropoietin (EPO) therapy in a rat model of myocardial infarction. PEG with/out iPSC-CMs and EPO; iPSC-CMs in saline; or saline alone was injected into infarcted hearts shortly after infarction. Injection of almost any combination of the therapeutics limited acute elevations in chamber volumes. After 10 weeks, attenuation of ventricular remodeling was identified in all groups that received PEG injections, while ejection fractions were significantly increased in the gel-EPO, cell, and gel-cell-EPO groups. In all treatment groups, infarct thickness was increased and regions of muscle were identified within the scar. However, no grafted cells were detected. Hence, iPSC-CM-encapsulating bioactive hydrogel therapy can improve cardiac function post myocardial infarction and increase infarct thickness and muscle content despite a lack of sustained donor-cell engraftment.

Mechanism and Implications of the Tricuspid Regurgitation: From the Pathophysiology to the Current and Future Therapeutic Options.

The tricuspid valve was virtually ignored for a long time in the past. However, significant tricuspid regurgitation (TR) often accompanies left-side heart valve pathology and does not always reverse with its correction. If left untreated, TR can progress and result in progressive right ventricular failure. Current guideline recommendations still hold minor differences. Nevertheless, there is a consensus to operate on patients with severe TR undergoing left-sided valve surgery (class I) or those with mild to moderate TR with a dilated annulus (≥40 or ≥21 mm2, Class IIa). However, in case of the primary TR, surgical options is limited by a relatively high risk of mortality and morbidity. For these patients, new percutaneous approaches are becoming available but no long-term data are still available. In this review, we provide a comprehensive overview of the epidemiological and pathophysiological aspects of TR, and the current and future directions of therapy.

Advances in percutaneous interventional therapies: the tricuspid valve.

Tricuspid regurgitation (TR) is a prevalent valve condition, with an estimated 1.6 million people in the USA living with moderate or greater severity. Functional TR, which predominantly develops due to left-sided heart disease, is the predominant condition affecting the tricuspid valve in the Western world and severe TR is associated with substantial morbidity and mortality. In part, due to a prolonged latency period with insidious symptoms, patients are often referred for surgery at advanced stages, with associated increased or prohibitive surgical risk. In addition, surgical treatment can result in high rates of recurrence. Therefore, there is an unmet need for percutaneous therapies that may provide a relatively low-risk treatment option. There are several devices with early human feasibility data available that will be reviewed in this article.

Stepwise use of circulatory support devices in a patient refractory to cardiopulmonary resuscitation.

This case describes the management of a patient admitted to an emergency department with general malaise, who deteriorated into cardiac arrest and refractory to advanced life support measures. After extracorporeal cardiopulmonary resuscitation (eCPR) with veno-arterial extracorporeal membrane oxygenation in association with an Impella 2.5 device, the patient underwent cardiac surgery (tissue aortic valve replacement, coronary artery bypass grafting and implantation of short-term paracorporeal left ventricular assist device). Subsequently a long-term LVAD was implanted and the patient was successfully discharged shortly afterwards. This report illustrates the challenges of 'clinical decision making' in a complex patient utilising a wide range of left ventricular support mechanical devices with varying degrees of invasiveness, whilst also reflecting on the current financial and economic considerations in utilizing this type of care pathway.

Saphenous Vein Graft Aneurysm 10 Years After Paclitaxel-Eluting Stent Implantation.

A patient underwent paclitaxel-eluting implantation for a saphenous vein graft stenosis. A follow-up angiogram at 8 months demonstrated no restenosis, with multifocal peristent contrast staining. After 10 years, a saphenous vein graft aneurysm was revealed within the stented segment. This late complication should be kept in mind when evaluating patients who have received prior drug-eluting stents.

Use of a parallel stiff wire to facilitate percutaneous Impella RP ventricular assist device positioning.

Despite optimal medical management, some patients with severe right ventricular failure fail to respond and may benefit from additional support with the implantation of a RV assist device. Experience to date with Impella RP is limited. We report a case of percutaneous Impella RP implantation, using a parallel stiff wire to reduce anatomical tortuosity by acting as a buddy-wire to facilitate device implantation and reduce the risk of tricuspid ring damage in a patient recently treated with tricuspid ring annuloplasty.

Impact of post-procedural hyperglycemia on acute kidney injury after transcatheter aortic valve implantation.

BACKGROUND: Post-operative hyperglycemia, in individuals with and without diabetes, has been identified as a predictor of acute kidney injury (AKI) in patients following cardiac surgery. Whether or not this is also true for patients undergoing transcatheter aortic valve implantation (TAVI) is unknown. OBJECTIVES: To evaluate whether post-procedural glucose levels are associated with AKI after TAVI. METHODS AND RESULTS: A total of 422 consecutive patients undergoing transfemoral TAVI were included in the analysis. For each patient, plasma glucose levels were assessed at hospital admission, 4h after the procedure and daily during hospitalization. Post-procedural hyperglycemia was defined as 2 consecutive blood glucose readings ≥150mg/dL in the 72-hour period following TAVI. AKI was defined according to the VARC consensus report regarding standardized endpoint definitions. Overall, 137 (32.5%) patients developed post-procedural hyperglycemia and 138 (33%) patients developed AKI. Hyperglycemia was associated with a 2-fold higher incidence of AKI than in patients without hyperglycemia (48% vs. 25%, p<0.001). In-hospital mortality was higher in patients with hyperglycemia than in those without hyperglycemia (9.6% vs. 1.8%, p<0.001). In-hospital mortality rate was also higher in patients who developed AKI (12.7% vs. 2.7%, p<0.001). Patients with acute hyperglycemia that developed AKI had the highest in-hospital and long-term mortality rate (15% and 38%). Post-procedural hyperglycemia was an independent predictor of AKI. CONCLUSIONS: Post-procedural hyperglycemia is associated with a higher incidence of AKI and mortality after TAVI. Randomized controlled trials are needed to determine whether meticulous post-procedural glycemic control following TAVI impacts upon clinical outcomes.

Clinical and economic consequences of non-cardiac incidental findings detected on cardiovascular computed tomography performed prior to transcatheter aortic valve implantation (TAVI).

Transcatheter aortic valve implantation (TAVI) is an effective treatment option for patients with severe degenerative aortic valve stenosis who are high risk for conventional surgery. Computed tomography (CT) performed prior to TAVI can detect pathologies that could influence outcomes following the procedure, however the incidence, cost, and clinical impact of incidental findings has not previously been investigated. 279 patients underwent CT; 188 subsequently had TAVI and 91 were declined. Incidental findings were classified as clinically significant (requiring treatment), indeterminate (requiring further assessment), or clinically insignificant. The primary outcome measure was all-cause mortality up to 3 years. Costs incurred by additional investigations resultant to incidental findings were estimated using the UK Department of Health Payment Tariff. Incidental findings were common in both the TAVI and medical therapy cohorts (54.8 vs. 70.3%; P = 0.014). Subsequently, 45 extra investigations were recommended for the TAVI cohort, at an overall average cost of £32.69 per TAVI patient. In a univariate model, survival was significantly associated with the presence of a clinically significant or indeterminate finding (HR 1.61; P = 0.021). However, on multivariate analysis outcomes after TAVI were not influenced by any category of incidental finding. Incidental findings are common on CT scans performed prior to TAVI. However, the total cost involved in investigating these findings is low, and incidental findings do not independently identify patients with poorer outcomes after TAVI. The discovery of an incidental finding on CT should not necessarily influence or delay the decision to perform TAVI.

Aortic balloon valvuloplasty--review and case series.

Aortic balloon valvuloplasty (BAV) was initially devised in the 1980s as an alternative procedure to the surgical treatment of aortic stenosis, with the theory behind it being both minimally invasive as well as having a lower complication rate [Hara H, et al. Percutaneous balloon aortic valvuloplasty revisited: time for a renaissance? Circulation 2007 March;115(12):e334-8]. In practice however, the procedure was found to have a higher complication rate with only a modest haemodynamic improvement compared to the surgical approach. Most important of all it had an unacceptably high restenosis rate as a substitute for surgery [Otto CM, et al. 3-year outcome after balloon aortic balloon valvuloplasty: insights into prognosis of valvular aortic stenosis. Circulation 1994;89:642-50]. As a result, the procedure has fallen out of favour and has been abandoned at many health care facilities [Hara H, et al. Percutaneous balloon aortic valvuloplasty revisited: time for a renaissance? Circulation 2007 March;115(12):e334-8]. This article will review the management of patients with severe aortic stenosis that are unsuitable to undergo surgery.