Percutaneous Heart Valve Implantation Research Articles

Treatment of Severe Aortic Stenosis

Of 73 patients with severe AS who did not undergo AVR, 15 (14%) died at 15-month follow-up [12]. Of these 73 patients, symptoms were thought to be unrelated to the AS in 31 patients. Exercise stress tests for symptoms were performed in only 4% of the 42 asymptomatic patients. Asymptomatic patients with low-gradient severe AS and normal LVEF with reduced stroke volume index had at 46-month follow-up aortic valve events similar to those with normal stroke volume index [13]. Of 248 patients with severe AS and a normal LVEF, 94 had a lowgradient ( 40 mm Hg mean gradient) (group 3) [14]. Symptoms were present in 49% of group 1 patients, in 55% of group 2 patients, and in 60% of group 3 patients (p not significant). At 45-60-month follow-up, the incidence of AVR or death was 71% for group 1, 77% for group 2, and 76% for group 3 (p value not significant). Kaplan-Meier survival curves for time to death in all 3 groups were significantly better for patients with AVR versus no AVR [14]. E/E 1 lateral was an independent predictor of time to death in patients who did not receive AVR [15]. Percutaneous heart valve implantation may be performed in nonsurgical patients with end-stage calcific AS. In the Placement of Aortic Transcatheter Valves (PARTNER) trial, 699 high-risk patients with severe AS, mean age 84 years, were randomized to AVR or (transcatheter aortic valve replacement) TAVR [16]. All-cause mortality was 3.4% for the TAVR group versus 6.5% for the AVR group at 30 days (p value not significant) and 24.2% for the TAVR group versus 26.8% for the AVR group at 1 year (p value not significant). Major stroke was 3.8% for the TAVR group versus 2.1% for the AVR group at 30 days (p value not significant) and 5.1% for the TAVR group versus 2.4% for the AVR group at 1 year (p value not significant). Major vascular complications at 30 days were 11.0% for the TAVR group versus 3.2% for the AVR group (p<0.001). At 1-year, there were similar improvements in cardiac symptoms for both groups. In the PARTNER trial, among inoperable patients with severe AS, compared with standard care, TAVR caused significant improvements in health-related quality of life maintained for at least 1 year [17]. On the basis of the available data, AVR should be performed in operable patients with severe AS. However, TAVR should be performed in non-operable patients with symptomatic severe AS to improve survival and quality of life compared with medical management.

Transcatheter aortic valve‐in‐valve implantation of a corevalve in a degenerated stenotic sapien heart valve prosthesis

Treatment options for re-stenotic aortic valve prosthesis implanted by transcatheter technique have not been evaluated systematically. We describe the case of a 75-year-old dialysis patient who was treated by transcatheter aortic valve implantation 3.5 years ago and now presented with severe stenosis of the percutaneous heart valve. The patient was initially treated with a trans-apical implantation of an Edwards Sapien 26 mm balloon expandable valve. The patient remained asymptomatic for 3 years when he presented with increasing shortness of breath and significant calcification of the valve prosthesis on transesophageal echocardiography. Valve-in-valve percutaneous heart valve implantation using a 26-mm CoreValve prosthesis was performed under local anesthesia. The prosthesis was implanted without prior valvuloplasty. Pacing with a frequency of 140/min was applied during placement of the valve prosthesis. Positioning was done with great care using only fluoroscopic guidance with the aim to have the ventricular strut end of the CoreValve prosthesis 5 mm higher than the ventricular strut end of the Edwards Sapien prosthesis. After placement of the CoreValve prosthesis within the Edwards Sapien valve additional valvuloplasty with rapid pacing was performed in order to further expand the CoreValve prosthesis. The final result was associated with a remaining mean gradient of 5 mm Hg and no aortic regurgitation. In conclusion, implantation of a CoreValve prosthesis for treatment of a restenotic Edwards Sapien prosthesis is feasible and is associated with a good functional result.

New actors, new theater

Since the first catheterization of a human ves­ sel by Werner Forssmann in 1929 [1], the actors playing in the field of vessel catheterization have continued to change over time, passing from the radiologist to the radiologist with angio­ logy expertise to the cardiologist with radiologi­ cal expertise, and with the advent of coronary angio plasty by Gruentzing [2], to the cardiolo­ gist with surgical skills, that is, the interven­ tional cardiolo gist. Similarly, the old, dirty and dark radiological suites, which resembled a photo graphy dark room rather than an operat­ ing room, have becoming larger, brighter and contain plenty of new and exciting equipment including the brilliance intensificator, the recent flat panel, intravascular ultrasound, intracardiac echocardiogram, functional flow and pressure wire consoles, optical coherence tomography, angioplasty catheters and a number of differ­ ent small and large stents and occluder devices. This technological escalation changed the role of the invasive professional from a simple observer and recorder of physiological and pathological pheno mena to a real endovascular intervention­ alist, the expert in translating body images into therapeutic actions. Now, with the advent of hybrid procedures such as congenital heart and structural heart disease interventions, in particular percutaneous heart valve implantation, the interventionalist’s next leap is to gain real surgical skills, becoming a new figure – a true endocardiovascular sur­ geon. In the 1940s’ poor Italy, which lacked a true working public health system, the family physician was not only the physician, but also the surgeon and medicine doctor. They were able to not only make a diagnosis, but also to carry out surgical procedures such as cesarean partum, skin incision and abscess drainage. Now, we have to simply go back and re­educate ourselves about a little bit of surgery. By changing the actor, the theater cannot remain the same; it is necessary that health sys­ tem governers throughout the world are aware of the dramatic changes and must be prepared to provide hybrid rooms that incorporate all the necessities of this new age: space, sterility and powerful image equipment including flat panel and computed tomography, together with all the usual instrumentation of the interventional cardiologist. The cost would probably be high to begin with, but this new combination of actor and theater will probably be the only cardiovascular surgery required for the next 30 years.

A Novel Stent for Percutaneous Heart Valve Implantation: First In Vitro Results

Percutaneous aortic valve implantation has become an alternative technique to surgical valve replacement in patients with high risk for surgery. This technique is at its beginning and stents used for valve prostheses remain standard vascular stents. These stents are, however, not designed to undergo heart valve stress. They do not match the aortic environment geometry, and induce exaggerated tissue traumatism. Reduced implant lifetime may therefore be expected. The purpose of the present work is to evaluate in vitro the technical feasibility of noninvasive aortic valve replacement with a novel more specific stent. This stent is especially adapted to its implantation environment with a design that matches the shape of the aortic root while respecting the valve functions. We present a design, a manufacturing process and in vitro performances for the stent under static pressure loading and pulsatile flow. The stent shows good dynamic behavior in keeping position imposed at implantation time and in matching the aortic root dimensions changes. Prosthesis static and dynamic regurgitation are evaluated and show values close to those obtained with other commercially available prostheses.

Calcific aortic stenosis and statin therapy: A new insight

Considering the molecular similarities between calcific aortic stenosis and atherosclerosis, we would like to highlight the potential benefit of statin therapy after balloon aortic valvuloplasty to delay restenosis in patients awaiting a percutaneous heart valve implantation.

Six-month outcome of transapical transcatheter aortic valve implantation in the initial seven patients

The current treatment of choice for symptomatic aortic stenosis is aortic valve replacement (AVR) with cardiopulmonary bypass (CPB), but AVR is associated with significant operative morbidity and mortality in elderly patients with multiple co-morbid conditions. We recently reported the first successful aortic valve implantation procedure (AVI) via a mini-thoracotomy and left ventricular apical puncture without cardiopulmonary bypass. We now report 6-month follow-up in our initial seven patients. Seven patients (77+/-10 years old) with symptomatic aortic stenosis were deemed to be non-surgical candidates for AVR and not suitable for a transfemoral percutaneous heart valve implantation due to aorto-iliac disease. The predicted 30-day operative mortality was 31+/-23% according to logistic Euroscore. Patients underwent minimally invasive transapical AVI. With the guidance of fluoroscopy and transesophageal echocardiography, balloon predilation was followed by deployment of a 26mm Cribier-Edwardstrade mark valve (Edwards Lifesciences Inc., Irvine, CA) during rapid ventricular pacing to reduce forward flow and cardiac motion. Valve implantation was successful in all seven patients. There were no intra-procedural mortalities or complications. Thirty-day operative mortality was 14%. One patient died at day 12 due to pneumonia. Two patients died from non-cardiac diseases at day 51 and 85. The remaining four patients completed 6-month follow-up. The aortic valve area increased from 0.7+/-0.3 to 1.8+/-0.7 and 1.5+/-0.5cm(2) at 1 and 6 months, respectively. The mean transaortic gradient was reduced from 32+/-8 to 10+/-5 and 11+/-8mmHg at 1 and 6 months, respectively. Following AVI, none or trivial, mild, and moderate aortic regurgitation was observed in 4, 2, and 1 patients, respectively. There were no valve-related complications during the follow-up. Aortic valve implantation can successfully be performed via a minimally invasive apical approach without the need for cardiopulmonary bypass. The early results in this initial series are encouraging. This initial experience suggests that the minimally invasive transapical approach is a viable alternative for patients in whom open-heart surgery is not feasible or poses unacceptable risks.

Treatment of Calcific Aortic Stenosis With the Percutaneous Heart Valve: Mid-Term Follow-Up From the Initial Feasibility Studies: The French Experience

The aim of this work was to study the feasibility, safety, efficacy, and durability of percutaneous heart valve (PHV) implantation in the aortic position. We developed a PHV (equine pericardium valve in a balloon-expandable, stainless-steel stent) to treat patients with inoperable aortic stenosis (AS). Thirty-six patients (aortic valve area < or =0.7 cm2, New York Heart Association [NYHA] functional class IV, and severe comorbidities), formally declined for surgery, were recruited on a compassionate basis. The PHV was implanted by retrograde or antegrade trans-septal approach. Clinical and echocardiographic outcomes were assessed serially. Twenty-seven patients were implanted successfully (23 antegrade, 4 retrograde) in the subcoronary position with improvement in valve area (0.60 +/- 0.11 cm2 to 1.70 +/- 0.10 cm2, p < 0.0001) and transvalvular gradient (37 +/- 13 mm Hg to 9 +/- 2 mm Hg, p < 0.0001). Paravalvular aortic regurgitation was grade 0 to 1 (n = 10), grade 2 (n = 12), and grade 3 (n = 5). One week post-procedure, improvement in left ventricular function (45 +/- 18% to 53 +/- 14%, p = 0.02) was most pronounced in patients with ejection fraction <50% (35 +/- 10% to 50 +/- 16%, p < 0.0001). Thirty-day major adverse events after successful implantation were 26% (pericardial tamponade, stroke, arrhythmia, urosepsis, and one death unexplained at autopsy). Eleven patients are currently alive with follow-up of 9 months (n = 2), 10 months (n = 3), 11 months (n = 1), 12 months (n = 2), 23 months (n = 1), and 26 months (n = 2). All patients experienced amelioration of symptoms (>90% NYHA functional class I to II). Percutaneous heart valve function remained unchanged during follow-up, and no deaths were device-related. Percutaneous heart valve implantation is feasible in inoperable patients with end-stage AS leading to hemodynamic and clinical improvement. Continued advances and improved patient selection should decrease adverse events in the near future.

Retrograde percutaneous aortic valve implantation for critical aortic stenosis

Recently, a prosthetic aortic valve has been implanted percutaneously in several patients using an antegrade transseptal approach. This has been shown to be feasible and associated with dramatic hemodynamic improvement. We report a retrograde implantation of a percutaneous heart valve (PHV) in an 84-year-old man with critical aortic stenosis and refractory congestive heart failure after difficulties encountered with an initial antegrade approach. While attempting antegrade transseptal implantation of a PHV, the anterior leaflet of the mitral valve was tethered by the guidewire resulting in severe mitral regurgitation and pulseless electrical activity. Cardiac resuscitation was successful. Utilizing a retrograde approach, the PHV was successfully implanted in a stable position below the coronary ostia and well above the mitral valve leaflets. The aortic valve area increased from 0.55 to 1.7 cm2 with only mild paravalvular aortic regurgitation. Despite marked improvement in aortic valve function, the patient died secondary to guidewire-induced mitral valve anterior leaflet laceration, severe mitral regurgitation, and cardiogenic shock. Retrograde implantation of a PHV can be successfully performed with substantial increase in aortic valve area and an acceptable degree of aortic regurgitation. Although the retrograde approach may be associated with greater risk of vascular access site complications, it may be considerably safer by avoiding potential guidewire injury to the mitral valve. Further refinements in technique may establish the retrograde approach as the preferred means of PHV implantation in nonsurgical patients with critical aortic stenosis.

Issue Highlights

HomeCirculationVol. 110, No. 11Issue Highlights Free AccessIn BriefPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessIn BriefPDF/EPUBIssue Highlights Originally published14 Sep 2004https://doi.org/10.1161/circ.110.11.1337Circulation. 2004;110:1337IN VIVO MAGNETIC RESONANCE IMAGING OF CORONARY THROMBOSIS USING A FIBRIN-BINDING MOLECULAR MAGNETIC RESONANCE CONTRAST AGENT, by Botnar et al.Most acute coronary syndromes are caused by thrombosis at the site of a rupture plaque. New methods are being developed to allow for direct noninvasive imaging of coronary thrombus. Botnar and colleagues demonstrate the feasibility of using fibrin-binding molecular magnetic resonance (MR) contrast agents with coronary MR imaging. They show that, in an animal model, in-stent thrombosis can be observed with this technique of MR imaging. These recent advances in MR technology coupled with the use of novel clot-binding compounds could have promise in visualizing the formation of thrombus in patients with unstable coronary syndromes. See p 1463.ACUTE IMPROVEMENT IN GLOBAL AND REGIONAL LEFT VENTRICULAR SYSTOLIC FUNCTION AFTER PERCUTANEOUS HEART VALVE IMPLANTATION IN PATIENTS WITH SYMPTOMATIC AORTIC STENOSIS, by Bauer et al.Patients with severe aortic stenosis and normal ejection fractions may have subtle systolic dysfunction as measured by tissue Doppler imaging. These changes often are underestimated and yet may contribute importantly to symptoms. It has been thought that progressive interstitial fibrosis contributes largely to this dysfunction. In 8 patients who had percutaneous aortic valve implantation after having surgery declined as a result of hemodynamic instability and/or severe comorbidity, reduction in aortic gradient, as measured at 24 hours compared with baseline, was accompanied by an improvement in ejection fraction and in regional systolic function as measured by tissue Doppler imaging. This immediate improvement occurred even in patients with low ejection fractions. These findings suggest that the major influence on the immediate improvement in regional systolic function is the reduction of afterload. Further immediate improvement is limited by other factors, such as myocardial fibrosis. Future larger studies with evaluations at different time points may clarify the relationship of these important findings to patient outcomes and aid determination as to the appropriate timing of aortic valve surgery. See p 1473.IMPROVED VASCULAR GENE TRANSFER WITH A HELPER-DEPENDENT ADENOVIRAL VECTOR, by Wen et al.Vascular gene transfer traditionally has been accomplished with first-generation adenoviral vectors; however, this methodology is limited by brief transgene expression and a significant host inflammatory response in the vessel wall. To overcome these limitations, modified second-generation and third-generation, or “helper-dependent,” adenoviral vectors have been constructed. These vectors offer stable and prolonged transgene expression with minimal associated inflammation. In this study, Wen et al utilize helper-dependent adenoviral vectors to demonstrate stable vascular gene transfer of urokinase plasminogen activator for at least 56 days with a minimal inflammatory response in a rabbit carotid artery model. This study highlights how recent advances in vector technology enhance transgene expression in the vessel wall and will facilitate more durable manipulation of gene expression in future studies of vascular disease. See p 1484.Visit www.circ.ahajournals.org:Cardiology Patient PageMeasurement of Cholesterol: A Patient Perspective. See p e296.Images in Cardiovascular MedicineVentricular Tachycardia Late After Cardiac Transplantation. See p e298.Multislice Computed Tomography in Complex Pulmonary Atresia After Stent Implantation. See p e299.Download figureDownload PowerPointBook ReviewMetabolic Cardiomyopathy, 2nd ed. See p e301. Previous Back to top Next FiguresReferencesRelatedDetails September 14, 2004Vol 110, Issue 11 Advertisement Article InformationMetrics https://doi.org/10.1161/circ.110.11.1337 Originally publishedSeptember 14, 2004 PDF download Advertisement

Acute Improvement in Global and Regional Left Ventricular Systolic Function After Percutaneous Heart Valve Implantation in Patients With Symptomatic Aortic Stenosis

The newly developed percutaneous heart valve (PHV) implantation technique decreases transaortic pressure gradient in patients with aortic stenosis. PHV replacement effects on left ventricular (LV) global and regional systolic function are currently unknown. Eight patients with severe aortic stenosis had 2D echocardiography at baseline and 24 hours after PHV implantation to evaluate changes in LV volume and LV ejection fraction. Regional function, ie, both peak systolic anterior and posterior wall tissue velocity, as well as strain and strain rate imaging, were measured by tissue Doppler imaging from a short-axis view. At 24 hours, a significant reduction in transaortic mean pressure gradient (from 46+/-15 to 8+/-3 mm Hg; P<0.0001) was accompanied by an increase in aortic valve area (from 0.59+/-0.11 to 1.69+/-0.11 cm2; P<0.0001). LV end-diastolic volume remained unchanged (102+/-36 to 101+/-12 mL; P=NS), whereas LV ejection fraction increased (48+/-18% to 57+/-12%; P<0.01). Improvement in posterior wall displacement (posterior wall tissue velocity increased from 2.2+/-0.5 to 4.4+/-1.0 cm/s(-1); P=0.0003) and deformation (strain rate imaging increased from 1.0+/-0.3 to 1.9+/-0.7 s(-1), P=0.009, and strain increased from 11+/-5% to 17+/-9%; P=0.02) were observed. Immediately after PHV replacement, improvement of LV global and regional systolic function was evidenced by tissue Doppler imaging.