FOCUS ISSUE: VALVULAR HEART DISEASE: STATE-OF-THE-ART PAPER
Outcomes and Safety of Percutaneous Aortic Valve Replacement
Alan Zajarias, MD*,* and
Alain G. Cribier, MD
* Cardiovascular Division, Washington University School of Medicine, St. Louis, Missouri
Hôpital Charles Nicolle, Department of Cardiology, University of Rouen, Rouen, France
Manuscript received May 7, 2008;
revised manuscript received November 7, 2008,
accepted November 13, 2008.
* Reprint requests and correspondence: Dr. Alain G. Cribier, Service de Cardiologie, Hôpital Charles Nicolle, 1 Rue de Germont, 76000 Rouen, France (Email: Alain.Cribier{at}chu-rouen.fr).
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Abstract
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The concept of transcatheter aortic valve replacement was developed with the goal of offering a therapeutic solution to patients with severe symptomatic aortic stenosis who are not considered good candidates for surgical valve replacement. Initial attempts were complicated by vascular access problems and lack of appropriate tools. With time and experience, early problems were solved and the concepts of valve sizing, valve positioning, and patient selection were defined. Technological improvements allowed the use of smaller arterial sheaths to decrease vascular trauma, special catheters to facilitate valve delivery, and treatments on the valve prostheses that would ensure longer durability. After 5 years, the number of transcatheter aortic valve replacements has grown significantly, and will likely continue as this technology becomes increasingly available. Currently, 2 valve models, the Edwards SAPIEN valve (Edwards Lifescience, Irvine, California) and the CoreValve ReValving system (CoreValve Inc., Irvine, California), have been used in over 4,000 cases worldwide for the treatment of symptomatic aortic stenosis. Midterm follow-up shows no evidence of restenosis or prosthetic valve dysfunction. Transfemoral and transapical delivery routes can be selected depending on the quality of vascular access and the type of prosthesis used. Randomized trials that are currently underway will confirm procedural safety and guide the applicability of this technology.
Key Words: aortic stenosis • valvuloplasty • catheter • stent • survival
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Abbreviations and Acronyms
| | AI = aortic insufficiency | | AS = aortic stenosis | | AVR = aortic valve replacement | | BAV = balloon aortic valvuloplasty | | EOA = effective orifice area | | LVEF = left ventricular ejection fraction | | MACCE = major adverse cardiovascular and cerebrovascular events |
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As noted earlier by Ross and Braunwald (1), the natural history of symptomatic aortic stenosis (AS) carries a poor prognosis. Medically treated patients with symptomatic AS have a 1- and 5-year survival of 60% and 32%, respectively (2). Aortic valve replacement (AVR) is the only effective treatment for symptomatic AS that alleviates symptoms and improves survival. In the ideal candidate, surgical AVR has an estimated operative mortality of 4% (3). However, the mortality rate associated with AVR increases substantially with increasing age, the presence of left ventricular dysfunction, or other comorbidities. These factors are considered one of the main reason for which one-third of patients with valve disease are not referred for surgery (4). Transcatheter AVR opened the possibility of treating patients who until now had been left untreated because it was believed that their operative mortality outweighed the benefits offered by traditional AVR.
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Risk Stratification
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The ability to identify high-risk patients is crucial in assisting those who would benefit the most from innovative treatment. Expected operative mortality is calculated with specific tools that combine clinical, demographic, and surgical variables that have been shown to influence outcomes. These algorithms were developed to compare individual hospital outcomes with population means; however, they are also used to provide an estimated risk for patients to facilitate an educated decision when considering cardiac surgery. These tools can only estimate the probability of death of a group of patients with similar risk profiles, not the outcome of individual patients (5). Patients are considered to have a high operative risk when their scores are in the upper decile for mortality or have a 30-day mortality >15%.
The most commonly used risk calculators are the Society of Thoracic Surgery Predicted Risk of Mortality (STS-PROM) and the European System for Cardiac Operative Risk Evaluation (EuroSCORE). The EuroSCORE collects patient variables to generate an estimated operative mortality rate. Although initially applied to European patients undergoing coronary artery bypass surgery, it has been validated in other heterogeneous populations, and has been applied to valvular surgery as well (6). Because the prevalence of high-risk patients was low in the initial population that generated this tool, the logistic EuroSCORE was then developed to more accurately predict their mortality (7). However, this algorithm has been shown to persistently overestimate the mortality rate (5,8). The STS-PROM score is derived from the STS database, a voluntary registry of practice outcomes, and estimates the risk of mortality, morbidity, renal failure, and length of stay after valvular and nonvalvular cardiac surgery (9). This score has been shown to underestimate the true mortality rate after cardiac surgery, but it more closely reflects the operative and 30-day mortality for the highest-risk patients having AVR (10).
The STS-PROM and the EuroSCORE provide an objective way to quantify risk. Although thorough, these risk scores do not include certain characteristics that would complicate surgery and increase the operative mortality, such as: previous mediastinal irradiation, the presence of a severe calcification in the thoracic aorta (porcelain aorta), anatomical abnormality of the chest wall, history of mediastinitis, cirrhosis, or patient's frailty. In addition, the algorithms were calculated from patients who underwent surgery, thus limiting their applicability to patients who were not considered surgical candidates. Clinical judgment and the patient's level of independent function are subjective parameters that influence outcomes after cardiac surgery but are difficult to measure. In clinical trials, risk calculators can objectively standardize patients; however, these tools should be used in conjunction with clinical judgment to appropriately select patients who will benefit the most from therapeutic interventions.
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Percutaneous Aortic Valve Prostheses
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Transcatheter AVR has evolved significantly since its creation. Six years after the report of the first successful valvular implantation (11), multiple valve prototypes have been reported and are currently in different stages of development. The Edwards SAPIEN valve (Edwards Lifescience, Irvine, California) and the CoreValve ReValving system (CoreValve Inc., Irvine, California) contribute the largest patient experience and are the focus of the remainder of this paper.
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Edwards SAPIEN Valve
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The Edwards SAPIEN valve is a bovine pericardium prosthesis mounted on a balloon-expandable stent that is placed in the subcoronary position. It can be placed by an antegrade, retrograde, or transapical approaches (Fig. 1).
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Figure 1 Profile of the Edwards SAPIEN Transcatheter Heart Valve
The Edwards SAPIEN transcatheter aortic prosthesis is mounted on a balloon-expandable stainless steel stent that is placed in the subcoronary position. The trileaflet bovine pericardial prosthesis is attached to the stent and treated with an anticalcification treatment. The stent has a polyethylene terephthalate fabric skirt that decreases perivalvular leaks.
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Antegrade Approach
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The initial report of a successful percutaneous implantation of an aortic bioprosthesis in a patient with severe symptomatic AS who presented in cardiogenic shock in April 2002 was greeted with enthusiasm (11). From 2003 to 2004, single-center registries to document the feasibility of the procedure, on a compassionate basis, were started under the names of I-REVIVE (Initial Registry of Endovascular Implantation of Valves in Europe) and RECAST (Registry of Endovascular Critical Aortic Stenosis Treatment) (12). These registries used a 23-mm bioprosthesis made of equine pericardium mounted on a stainless steel balloon-expandable stent. Valve placement was primarily done via the antegrade (transseptal) approach. Procedural success was achieved in 75%. Aortic valve area increased consistently from 0.6 to 1.6 cm2 and was accompanied by a decrease in mean transvalvular gradient (37 to 9 mm Hg) and an increase in left ventricular ejection fraction (LVEF) (45% to 53%). The 30-day mortality rate was 23% and the 30-day major adverse cardiovascular and cerebrovascular events (MACCE) rate was 26% (13). Patient survival was 63% by 6 months, and was limited by the severity of patient comorbidities.
Moderate to severe perivalvular aortic insufficiency (AI), seen in 63%, and valve embolization were procedural limitations caused by the availability of a single valve size (23 mm in diameter). Because of venous distensibility, sheath insertion was not limited by vessel size, tortuosity, or the presence of peripheral vascular disease. Valve placement was simple because the device crossed the smooth aspect of the aortic valve. However, the technique was challenging because of the need for a transseptal puncture, the navigation of the catheter/valve ensemble across the mitral and aortic valve, and the guidewire interaction with the mitral valve and subvalvular apparatus, contributing to poorly tolerated acute mitral insufficiency. The summation of all of these problems limited the diffusion of this approach, prompted technical improvements in the delivery system, and promoted the resurgence of the retrograde approach.
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Retrograde Approach
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Significant technical and prosthetic modifications followed to solve the previously encountered limitations. To reduce the degree of perivalvular regurgitation, valves were oversized in relation to the aortic annulus, and a second prosthesis size, 26 mm, became available. The transverse diameter of the aortic annulus at the level of aortic leaflet insertion was identified for appropriate valve sizing. In addition, the necessary landmarks for valve positioning were recognized, decreasing the risk of valve embolization. A catheter with a manually activated deflectable tip (Retroflex catheter, Edwards Lifescience), which aids in the atraumatic passage across the aortic arch and in centering the guidewire through the aortic commissures, facilitated the valve delivery through the retrograde approach. Modifications in the delivery sheath also reduced vascular complications. Sheath length was increased to deliver the catheter/valve ensemble directly in the descending aorta, decreasing the risk of vascular injury (14). Minimal arterial diameter, vessel tortuosity, and vessel calcification were still the major limiting factors.
Multicenter registries from the U.S. (REVIVAL II [tRanscatheter EndoVascular Implantation of VALves II] trial), European Union (REVIVE II [Registry of EndoVascular Implantation of Valves in Europe II]), and Canada (Canadian Special Access) included patients with a valve area <0.8 cm2 and a high predicted operative mortality (logistic EuroSCORE >20%) to continue to evaluate procedural safety and efficacy. New valve modifications were added to improve long-term function, which included: use of bovine pericardium, elongation of the skirt to decrease perivalvular insufficiency, and the addition of an anticalcification treatment, culminating in the prosthesis that is currently used. The series of retrograde implantation published by Webb et al. (14) showed initial procedural success of 78%, which increased to 96% after the first 25 cases, reflecting an important learning curve (15). The observed 30-day mortality was 12%, whereas the expected 30-day mortality was 28%. At median follow-up, there was no evidence of valve deterioration, migration, or valvular insufficiency. Moderate perivalvular leaks were seen in 3 cases at 1 month. Perivalvular AI was mild, clinically inconsequential, and stable during follow-up in the majority of the patients (Table 1).
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Table 1 Symptoms, Outcomes, and Adverse Events After Retrograde Transcatheter Aortic Valve Replacement Using the Edwards SAPIEN Valve
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Reported data of patients with severe AS who underwent transcatheter AVR in the European Union (Edwards Sapien Aortic Bioprothesis European Outcome Registry [n = 598], T. Lefevre, personal communication, October 2008) show a 95% implant success (16). The improvement in effective orifice area (EOA), LVEF, and mean aortic gradient echoed the previously reported results. In addition, 65% had AI  1/4, and 26% had grade 2/4 at 6 months. Of the 79.2% of patients with New York Heart Association functional class III to IV symptoms, only 10% persisted with this degree of limitation at 30 days after implantation. The 30-day survival was 93.6%. Transcatheter AVR was aborted in 2.3% primarily because of failed arterial access and inability to cross the valve. Intraprocedural death was 0.3%, 30-day mortality was 6.4%, cerebrovascular events occurred in 3.4%, and vascular complications occurred in 7.4%, as detailed in Table 1. The presence of vascular complications increase mortality considerably, suggesting careful patient selection.
In September 2007, the Edwards SAPIEN valve, as it is now known, achieved the CE mark in the European community, prompting diffusion of the technology and use of out of research protocol for high-risk individuals. Preliminary results from an ongoing registry note maintenance of the safety profile with the diffusion of the technology to centers outside those involved in clinical trials. A multicenter randomized trial, PARTNER US (Placement of AoRTic traNscathetER), whose primary end point is 1-year mortality, is currently enrolling patients in the U.S. and Canada. The trial includes patients with severe symptomatic AS who are poor surgical candidates, and has 2 treatment arms. An arm powered for superiority analysis compares optimal medical treatment and balloon aortic valvuloplasty (BAV) to transcatheter AVR in patients who are deemed inoperable, whereas a noninferiority analysis will be applied to the arm that compares traditional AVR with transcatheter AVR in patients with elevated surgical risk (STS score >10%). Results for this trial will determine the diffusion of transcatheter AVR, and will help establish conditions for future use.
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Transapical Approach
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The transapical approach is the most recently developed form of transcatheter AVR. Initial experience in an animal model has been able to be extrapolated to early human experience with promising results (17–19). The procedure involves a small left lateral thoracotomy and should be performed in a hybrid operative suite. It requires a direct puncture and sheath insertion into the left ventricle. A guidewire is used to cross the aortic valve, and the rest of the procedure follows the same steps involved in valve preparation and deployment as described for the retrograde approach. The introduction of the valve catheter requires the Ascendra Transapical Delivery System (Edwards Lifescience).
The first published data from Lichtenstein et al. (18) consisted of 7 high-risk patients with AS. Valve implantation was successful in all of them, and there were no procedural deaths. Transvalvular gradient and aortic valve area improvement was seen in all patients, and the results were consistent with those found after retrograde implantation. Observed 30-day mortality was lower than the expected mortality (14% vs. 35%) (17,18). Published multicenter experience using this innovative approach is limited. Walther et al. (20) reported on 93.2% successful implantations with a conversion rate to traditional AVR of 6.8%. These high-risk patients had a median intensive care unit stay of 20 h. Trace to mild AI was seen in 23 patients. The 30-day mortality was 13.6%, whereas the predicted operative mortality was 26.8%. Use of extracorporeal circulatory support was frequent (47%) during the initial procedures; however, after familiarization of the technique, the use decreased. Currently, prophylactic insertion of venous guidewires is done in all cases, but use of extracorporeal circulation is rare. A recently published U.S.-based feasibility study noted successful valve placement in 90% of the cases accompanied by persistent improvement in symptoms, valve area, mean gradient, AI, and quality of life (21). Forty-seven percent of the patients were considered inoperable, and their mean STS score was 13.4%. Patient survival was 81.8% at 1 month, 71.7% at 3 months, and 58.7% at 6 months. In 65%, MACCE were seen and included a 5% incidence of stroke, 2.5% need for emergent cardiac surgery, and 17.5% myocardial infarction rate.
Interim analysis of data from a large series (n = 168) of high-risk patients treated with the transapical AVR included in the TRAVERCE (Trans-Apical surgical Delivery of the Cribier-Edwards Aortic Bioprothesis Clinical Feasibility) study are shown in Table 2
(22). Correct placement was seen in 92.8% of the cases, and only 7.1% had to be converted to open AVR. Improvement in LVEF and aortic valve area was seen, whereas appropriate valve function was maintained during follow-up. The overall 6-month survival was 70% for this technique. Cerebrovascular events, arrhythmias, and partial coronary occlusion were seen in 2.9%, 2.4%, and 1.8%, respectively. Ventricular bleeding at the puncture site was seen in 4.8%. Aortic insufficiency, valve malposition, and valve migration were the most common causes contributing to an unsuccessful procedure followed by perivalvular AI. Placement of a second valve (valve-in-valve) was required in 3% to decrease the AI or correct valve malposition.
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Table 2 Symptoms, Outcomes, and Adverse Events After Transapical Transcatheter Aortic Valve Replacement Using the Edwards SAPIEN Valve
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The differences in outcomes of the previously reported series reflect the complexity of the technique and the importance of appropriate patient selection. Patients who require the transapical approach have a higher incidence of peripheral vascular disease, which is a marker of worse long-term outcome. Although smaller, the U.S. feasibility series consisted of a sicker patient population with a higher estimated mortality. The U.S. transapical programs were temporarily interrupted, causing the need to re-learn the procedure, which may have contributed to the morbidity. Although in its early stage, transapical AVR has the potential of becoming a new option for the treatment of high-risk patients requiring AVR. Patients who require AVR but have a "porcelain aorta" or have peripheral vascular disease that limits their candidacy for retrograde transcatheter AVR should be considered for the transapical approach.
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CoreValve ReValving System
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The CoreValve ReValving system is a percutaneously placed porcine pericardial bioprosthesis designed for the aortic position. It is mounted in a self-expanding nitinol frame that extends from the left ventricular outflow tract into the aortic root. The frame has 3 dedicated functional areas that allow proper orientation, anchoring, and valve placement. The valve rests in a constrained supra-annular position avoiding interference with the coronary ostia and is used to treat AS. The prosthesis is sized according to the left ventricular outflow tract diameter. The CoreValve ReValving system has the advantage being self-centering and partially repositionable, allowing for more liberty during deployment (Fig. 2).
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Figure 2 Profile of the CoreValve ReValving System
The CoreValve transcatheter aortic heart valve is a self-expanding nitinol frame porcine pericardium prosthesis developed for the treatment of aortic stenosis, regurgitation, and failing surgical bioprosthesis. The frame has 3 distinct functional levels with different radial and hoop strengths. The valve is placed across the left ventricular outflow tract and extends into the aortic root.
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Patients included in the published registries were characterized by having: 1) severe AS; 2) aortic annular dimensions between 20 and 27 mm and an ascending aortic diameter of <45 mm; and 3) age >80 years with a EuroSCORE >20%, age >75 years and EuroSCORE >15%, or age >65 years and 1 of the following: cirrhosis, respiratory failure, pulmonary hypertension, previous cardiac surgery, right ventricular failure, chest radiation, or a burned chest that would complicate AVR.
Initial designs used a 24-F system that required full anesthesia, extracorporeal circulation, and a surgical cut-down for device placement. New-generation devices quickly followed that decreased the delivery sheath size to 21- and 18-F subsequently, converting the procedure to a completely percutaneous one. Published data from the original cohort that used the 24- and 21-F systems described 25 patients with high risk for AVR. Patients were predominantly women (80%) with a mean age of 80 years and had multiple comorbidities. The acute device success, defined as a successfully placed valve, was 88%. Procedural success, defined as device success and absence of MACCE at 48 h, was 68%. The mean aortic valve gradient decreased from 44.24 ± 10.79 mm Hg to 12.38 ± 3.03 mm Hg acutely and was unchanged at 30 days (23). Post-procedure AI decreased or was unchanged in 78%. Severe AI was not seen in patients with a successfully deployed valve. Two patients had immediate conversion to open AVR because of valve malposition, and BAV was the only treatment given to another when the prosthesis was unable to cross the native vasculature. In-hospital MACCE events were seen in 32% and included a 20% mortality rate and major bleeding in 24%. Thrombocytopenia was seen in all patients with circulatory support.
The use of extracorporeal circulatory support quickly declined as smaller-diameter catheters became available, and consequentially so did the presence of thrombocytopenia and bleeding. With completion of the learning curve, the MACCE rate decreased as well. A comprehensive series (n = 86) using the 21- and 18-F devices included high-risk patients with similar clinical characteristics. The acute device success rate was 88%, and the procedural success at 48 h was 74% (24). Two patients required a second prosthesis to reduce the degree of AI. The aortic valve area increased acutely, post-procedural AI improved or remained unchanged in 66%, and severe AI was not seen after successful device deployment (24,25). With the use of the 18-F delivery system, procedural duration diminished, circulatory support was no longer used, and the procedure became truly percutaneous without the need of a surgical cut-down (Table 3). The CoreValve ReValving system achieved the CE mark in 2007, and since then a multicenter registry using the 18-F prosthesis has been created. Recently published results show a procedural success rate of 97% with 1.5% procedural mortality (26,27). Hemodynamic improvement continues with a significant decrease in the mean aortic gradient and an increase in the aortic valve area. Severe perivalvular AI, procedural stroke, and tamponade have become negligible. Permanent pacemaker implantation was required in 9.3% and seems to be a function of prosthesis position (Table 3) (26).
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Table 3 Symptoms, Outcomes, and Adverse Events After Retrograde Transcatheter Aortic Valve Replacement Using the CoreValve ReValving System
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Other Aortic Prosthesis
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Second-generation transcatheter aortic valve prototypes, such as the Lotus (28) (Sadra Medical, Saratoga, California), AorTx (Hansen Medical, Mountain View, California), Direct Flow (Direct Flow Medical, Inc., Santa Rosa, California) (29), and Paniagua PHV (Endoluminal Technology Research, Miami, Florida) among others, are undergoing first-in-man implantations. Design innovations that allow the use of smaller arteriotomies and the freedom to reposition the prosthesis and decrease the rate of perivalvular insufficiency create attractive options for the future. Their availability will depend on the result of initial feasibility registries and how they perform against the older-generation devices.
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Patient Selection
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Patient selection is crucial for transcatheter AVR success. Candidates considered for transcatheter AVR must have severe symptomatic AS in addition to a formal contraindication to surgery or other characteristics that would limit their surgical candidacy because of excessive mortality or morbidity risk. The procedure should be offered to patients who have a potential for functional improvement after valve replacement. Anatomical criteria must be met to facilitate valve delivery and placement. Tortuosity, calcification, and minimal luminal diameter of the aorta, iliac, and femoral arteries influence patient selection and the implantation route. Patients with heavily calcified, small, tortuous arteries should undergo placement through a transapical approach to prevent vascular complications. The transfemoral approach should be utilized in patients with iliofemoral arteries that meet the necessary characteristics. The minimal vessel diameter required for sheath insertion in the transfemoral approach is 7 and 8 mm for the 22- and 24-F catheters, respectively, for the Edwards SAPIEN valve. Smaller arterial diameters (6 mm) are accepted with the CoreValve ReValving system because its delivery catheter is 18-F. The presence of basal left ventricular septal hypertrophy may interfere with valve delivery and predispose to valve migration.
The transcatheter heart valve must be slightly larger than the aortic annulus to decrease the amount of perivalvular AI and achieve appropriate valve anchoring. Currently, only patients with an aortic annulus diameter of 18 to 24 mm can be considered for placement of an Edwards SAPIEN prosthesis; a 23-mm valve is used when the annulus diameter is between 18 and 21 mm, whereas a 26-mm prosthesis is sized for an annulus of 21 to 24 mm. The CoreValve ReValving system uses a 26-mm valve for an annulus diameter of 20 to 23 mm and a 29-mm valve for a 23- to 27-mm annulus. A larger aortic annulus may provide inappropriate support for the stent frame and may be associated with valve embolization. Marked oversizing of the prosthesis may cause aortic annular rupture in patients with a calcified aortic root.
Patients with bicuspid aortic valves are not optimal candidates for transcatheter heart valve implantation because the valvular orifice is elliptical and may predispose to perivalvular AI (30). Future valve prostheses may overcome this limitation. The presence of concomitant AI is not a contraindication to transcatheter valve replacement as long as the predominant lesion is AS, the mechanism of AI is not annular dilation, and the required annular dimensions for valve seating exist. Patients with low-gradient AS and poor ventricular function can be considered for transcatheter heart valve implantation; however, it is unclear whether this therapy may alter their prognosis. The completion of the PARTNER US trial may elucidate the role of transcatheter AVR in these patient subsets. The experience of transcatheter aortic prosthesis in noncalcific degenerative AS (rheumatic) is limited and currently cannot be recommended.
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BAV
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The use of BAV for the treatment of degenerative, calcific AS was introduced in 1986 (31). It acutely increases aortic valve area and decreases patients' symptoms; however, it is accompanied by a >80% restenosis rate at 1 year (32). After its introduction, the use of BAV declined because of the elevated mortality and complication rate (33). The use of balloons that require a smaller arteriotomy size, pre-shaped guidewires, and rapid ventricular pacing has been associated with a lower mortality (4%) and complication rate (6%) (34). Current American College of Cardiology/American Heart Association Guidelines only recommend the use of BAV as a bridge to surgery in hemodynamically unstable patients with severe AS who are at high risk for AVR, or as a reasonable treatment for symptom palliation in patients with severe AS who cannot undergo AVR because of serious comorbid conditions (35). Familiarity with the BAV technique is necessary for transcatheter AVR because it is part of the implantation procedure. A BAV may be used for symptom palliation in patients awaiting transcatheter AVR, for accurate prosthesis sizing, and to predict possible coronary occlusion in patients with nodular calcifications in the aortic valve leaflets.
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Conclusions
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Transcatheter AVR holds the potential of offering lifesaving treatment to patients with severe AS who are currently undertreated. The ongoing PARTNER US trial will attempt to identify the role of transcatheter AVR in patients with severe symptomatic AS who have a high surgical mortality risk. Physicians must evaluate patients' needs and expectations knowing that in certain situations, comfort, symptom relief, and avoidance of morbidity are more important than increased longevity. Today, transcatheter AVR should remain limited to high-risk patients, and uncontrolled diffusion should be avoided. In the future, if the results continue to be favorable, increased indications for this technology may become available.
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Footnotes
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Dr. Cribier is a consultant for Edwards Lifescience (Irvine, California).
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References
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Abstract
Risk Stratification