Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis and Small Aortic Annulus

Journal of the American College of Cardiology Vol. 58, No. 10, 2011 2011 by the American College of Cardiology Foundation ISSN 0735-1097/$36.00 Published by Elsevier Inc. doi:10.1016/j.jacc.2011.05.026 Interventional Cardiology Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis and Small Aortic Annulus Dimitri Kalavrouziotis, MD, MSC, Josep Rodés-Cabau, MD, Rodrigo Bagur, MD, Daniel Doyle, MD, Robert De Larochellière, MD, Philippe Pibarot, DVM, PHD, Eric Dumont, MD Quebec City, Quebec, Canada Objectives Background Methods Results Conclusions Valve hemodynamics and clinical outcomes among patients with a small aortic annulus who underwent transcatheter aortic valve implantation (TAVI) were examined. The presence of a small aortic annulus may complicate the surgical management of patients with severe aortic stenosis (AS). TAVI is an alternative to aortic valve replacement (AVR) in high-risk patients, but few data exist on the results of TAVI in patients with a small aortic annulus. Between 2007 and 2010, 35 patients (mean age 79.2 9.4 years) with severe AS and an aortic annulus diameter 20 mm (mean 18.5 0.9 mm) underwent TAVI with a 23-mm Edwards SAPIEN bioprosthesis (Edwards Lifesciences, Inc., Irvine, California). Echocardiographic parameters and clinical outcomes were assessed prior to discharge and at 6, 12, and 24 months. Procedural success was achieved in 34 patients (97.1%). There was 1 in-hospital death. Peak and mean transaortic gradients decreased from 76.3 33.0 mm Hg and 45.2 20.6 mm Hg at baseline to 21.8 8.4 mm Hg and 11.7 4.8 mm Hg post-procedure, respectively, both p 0.0001. Mean indexed effective orifice area (IEOA) increased from 0.35 0.10 cm 2 /m 2 at baseline to 0.90 0.18 cm 2 /m 2 post-procedure, p 0.0001. Severe prosthesis patient mismatch (IEOA 0.65 cm 2 /m 2 ) occurred in 2 patients (5.9%). At a mean follow-up of 14 11 months, gradients remained low and 30 of the 31 remaining survivors were in New York Heart Association functional class I or II. In high-risk patients with severe AS and a small aortic annulus, TAVI is associated with good post-procedural valve hemodynamics and clinical outcomes. TAVI may provide a reasonable alternative to conventional AVR in elderly patients with a small aortic annulus. (J Am Coll Cardiol 2011;58:1016 24) 2011 by the American College of Cardiology Foundation Aortic valve replacement (AVR) in patients with severe aortic stenosis (AS) and a small aortic annulus has been associated with a high incidence of prosthesis patient mismatch (PPM) (1 3). PPM has in turn been associated with diminished extent of regression of left ventricular hypertrophy, reduced coronary flow reserve, increased incidence of congestive heart failure, diminished functional capacity, and increased risk of early and late mortality (4 7). In order to allow implantation of an appropriately sized prosthetic valve and prevent PPM in a patient with a small aortic annulus, an aortic annular enlargement procedure or a complete replacement of the aortic root may be necessary at the time From the Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada. Drs. Rodés-Cabau, Doyle, and Dumont are consultants for Edwards Lifesciences Inc. Dr. Pibarot has received honoraria for presentations and research grants from Edwards Lifesciences Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Manuscript received January 25, 2011; revised manuscript received May 13, 2011, accepted May 31, 2011. of AVR. These procedures significantly enhance the complexity of the operation, and may increase morbidity and mortality, especially in elderly patients (8,9). Transcatheter aortic valve implantation (TAVI) has emerged as an alternative to AVR in high-risk patients with AS (10 12), and implanted prostheses perform well compared with currently available surgical valves with respect to relief of aortic stenosis and post-procedural valve hemodynamics (13). However, no specific data exist on the results of TAVI in patients with a small aortic annulus. In this study, we sought to examine prosthetic valve hemodynamics, as well as early and midterm outcomes of patients with a small aortic annulus who underwent TAVI at our institution. Methods Patient population. We identified all patients with severe, symptomatic, native-valve AS and an aortic annular diameter 20 mm who underwent TAVI either by a transfemoral or transapical approach at our institution. Patients that

JACC Vol. 58, No. 10, 2011 August 30, 2011:1016 24 Kalavrouziotis et al. TAVI and Small Aortic Annulus 1017 were selected for TAVI had been deemed unsuitable for conventional surgery by consultant cardiac surgeons. All patients were initially evaluated for the feasibility of a transfemoral approach; a transapical approach was ultimately selected in the setting of a prohibitively small or diseased iliofemoral arterial tree, and in the presence of mobile plaque, excessive calcification, or extreme tortuosity of the descending thoracic aorta and/or aortic arch. Further details regarding patient selection, use of a transfemoral versus transapical approach, and procedural technique have been previously published (12 14). All patients provided written informed consent, and the study was in compliance with our institutional research ethics board. Preoperative characteristics including patient demographics, cardiovascular risk factors, and comorbid medical illnesses, as well as procedural and post-operative data, were prospectively collected by dedicated personnel and entered into a registry. All patients received a 23-mm Edwards SAPIEN bioprosthesis (Edwards Lifesciences, Inc., Irvine, California). Procedural success was defined as the successful implantation of a functioning prosthesis within the aortic annulus, without procedural mortality or conversion to sternotomy. Longitudinal follow-up was obtained by outpatient clinic visit and/or telephone contact at 6 and 12 months postprocedure and yearly thereafter. Doppler echocardiography. Aortic annulus diameter was measured preoperatively using transesophageal echocardiography (TEE) in the long-axis, mid-esophageal view, from leaflet insertion to leaflet insertion in mid-systole (15). Post-procedural prosthetic transvalvular pressure gradients and effective orifice area (EOA) were measured prior to hospital discharge and at 6 and 12 months post-procedure and yearly thereafter. The left ventricular outflow tract diameter was measured immediately proximal (ventricular) to the valve prosthesis stent insertion site for calculation of the post-procedural EOA by the continuity equation (16). EOA was indexed for the patient s body surface area. Severe PPM was defined as an indexed EOA (IEOA) 0.65 cm 2 /m 2, and moderate PPM was defined as an IEOA between 0.65 and 0.85 cm 2 /m 2 (2,17). Post-procedural aortic insufficiency (AI) was classified as paravalvular, transvalvular, or mixed, depending on the origin of the regurgitant jet(s). The severity of regurgitation was graded as mild, moderate, or severe (18). Statistical analysis. Statistical analysis for the study was performed using Statistical Analysis System (SAS) software version 9.2 (SAS Institute, Inc., Cary, North Carolina). Continuous variables were expressed as mean SD and were compared using paired t tests or nonparametric equivalents where appropriate. Mixed effects modeling was used to determine the statistical significance of transaortic gradients and aortic valve areas at different time periods. An unrestricted covariance structure was used to measure the dependence among repeated measurements. The multivariate normality assumptions were verified with the Shapiro-Wilk test after a Cholesky factorization. Categorical variables were expressed as percentages. Mixed effects ordinal regression was performed to test for significant changes in AI over time. Allcause mortality at mid-term follow-up was evaluated using the Kaplan-Meier technique. All p values were 2-sided, and differences were considered statistically significant when p 0.05. Results Between April 2007 and July 2010, 164 patients with severe symptomatic AS underwent TAVI at our institution. Excluding patients with failed bioprosthetic aortic prostheses, a total of 68 patients received a 23-mm Abbreviations and Acronyms AI aortic insufficiency AS aortic stenosis AVR aortic valve replacement CI confidence interval EOA effective orifice area IEOA indexed effective orifice area NYHA New York Heart Association PPM prosthesis patient mismatch TAVI transcatheter aortic valve implantation TEE transesophageal echocardiography valve, and among these, 35 patients (51.5%) with an aortic annular diameter 20 mm (mean 18.5 0.9 mm, range 16 to 19.5 mm) were identified (Fig. 1). Eleven patients underwent a transfemoral approach (31.4%), and the remainder underwent a transapical procedure. Reasons for selecting a transapical approach were small iliofemoral arteries (n 18), extensive thrombus or mobile atherosclerotic plaque in the abdominal or thoracic aorta (n 4), horizontal ascending aorta (n 1), and extreme tortuosity of the descending thoracic aorta (n 1). The mean age of patients was 79.2 9.4 years, ranging from 55 to 96 years. Eleven patients (31.4%) had undergone previous cardiac surgery (coronary artery bypass graft surgery in 10 patients, mitral valve replacement in 1 patient). Other baseline clinical and echocardiographic characteristics of the patient cohort are shown in Table 1. Procedural success was achieved in all but 1 patient (97.1%). This patient was a 96-year-old female with a severely calcified aortic valve, severe pulmonary hypertension, and logistic EuroSCORE of 70.6. Transapical TAVI was complicated by residual post-procedural moderate paravalvular aortic regurgitation and left ventricular apical bleeding requiring surgical repair with multiple pledgeted sutures. Delayed balloon aortic valvuloplasty was performed, but the patient remained in cardiogenic shock leading to death on the third post-operative day. Autopsy revealed a large anteroapical myocardial infarction that was likely iatrogenic, related to the left ventricular apical repair, given the absence of coronary artery disease on preoperative coronary angiography. This was the only in-hospital death. This patient was excluded from subsequent analyses of post-procedural prosthetic valve hemodynamics. Major procedural and 30-day complications were severe paravalvular aortic regurgitation requiring implantation of a second 23-mm Edwards SAPIEN prosthesis within the

1018 Kalavrouziotis et al. JACC Vol. 58, No. 10, 2011 TAVI and Small Aortic Annulus August 30, 2011:1016 24 Figure 1 Aortic Annulus Diameters The distribution of aortic annular diameters, as measured on pre-operative transesophageal echocardiography, are shown (n 35). pre-existing prosthesis ( valve-in-valve ) with subsequent improvement of AI to mild grade (n 1), third-degree atrioventricular block requiring permanent pacemaker (n 2), and acute renal failure (n 3) (Table 2). Access-site complications occurred in 3 patients: 1 patient with left anterior mini-thoracotomy wound infection following transapical TAVI, another patient with a groin wound infection following transfemoral TAVI, and a third patient requiring surgical reconstruction of a torn right common femoral artery following transfemoral TAVI. There were no annular ruptures, acute aortic dissections, or coronary occlusions, no conversions to sternotomy, and in no case was cardiopulmonary bypass or extracorporeal circulation instituted for hemodynamic instability. Echocardiographic data. Peak and mean transaortic gradients decreased from 76.3 33.0 mm Hg and 45.2 20.6 mm Hg at baseline to 21.8 8.4 mm Hg and 11.7 4.8 mm Hg post-procedure, respectively, both p 0.0001. Mean EOA increased from 0.55 0.15 cm 2 at baseline to 1.41 0.25 cm 2 post-procedure, p 0.0001. Mean IEOA post-procedure was 0.90 0.18 cm 2 /m 2. Severe PPM (IEOA 0.65 cm 2 /m 2 ) occurred in 2 patients (5.9%), and moderate PPM (IEOA 0.65 to 0.85 cm 2 /m 2 ) was observed in 11 patients (32.4%) (Fig. 2). Aortic insufficiency following TAVI occurred in 25 patients (71.4%), most of which had trace insufficiency (18 of 25 patients). Mild AI was present in 6 patients (17.1%), and moderate insufficiency was seen in 1 patient who later died on post-operative day 3 in cardiogenic shock due to a large anteroapical myocardial infarction (the patient described in the previous text). The insufficiency was paravalvular in 16 of 25 patients, transvalvular in 8 patients, and mixed in 1 patient. Midterm clinical outcomes and echocardiographic data. At a mean follow-up of 14.4 11.1 months (maximum 3 years), 12 patients (35.3%) were readmitted to hospital at a mean of 10.8 9.5 months following the procedure. Causes of hospital readmission were bronchopleural pneumonia (n 3), congestive heart failure (n 3), gastrointestinal bleeding (n 3), myocardial infarction (n 2), and symptomatic atrial fibrillation (n 1). During the follow-up period, there were 3 deaths at 1, 16, and 24 months post-procedure. Using Kaplan-Meier methodology, the 1- and 2-year probabilities of survival were 94.3% (95% confidence interval [CI]: 79.5% to 99.0%) and 76.2% (95% CI: 60.2% to 89.4%), respectively (Fig. 3). Causes of death were cardiac (sudden death) in 1 patient and noncardiac in 2 patients (metastatic lung cancer and bronchopleural pneumonia, respectively). All remaining survivors were in New York Heart Association (NYHA) functional class I or II, except for 1 patient in class III due to severe pre-existing pulmonary disease requiring home oxygen. Outpatient transthoracic Doppler echocardiography at 6, 12, and 24 months revealed persistently low transprosthetic gradients and durable relief of AS among patients with aortic annular diameter 20 mm (Fig. 4A). Transprosthetic gradients and valve areas both early and late post-procedure were comparable to a contemporaneous group of 33 patients with aortic annular diameter 20 mm (range 20 to 22 mm, mean 20.5 0.7 mm) who received a 23-mm Edwards SAPIEN prosthesis for native-valve AS during the study period (Fig. 4B). The prevalence of AI was significantly lower at 6 months compared with immediately post-procedure (40.7% vs. 71.4%, respectively, p 0.013). Aortic regurgitation re-

JACC Vol. 58, No. 10, 2011 August 30, 2011:1016 24 Kalavrouziotis et al. TAVI and Small Aortic Annulus 1019 Baseline the StudyCharacteristics Population Baseline (n Characteristics of35) of Table 1 the Study Population (n 35) Age, yrs 79.2 9.4 Female 33 (94.3%) Body mass index, kg/m 2 25.4 4.3 Diabetes mellitus 11 (31.4%) Hypertension 33 (94.3%) Hyperlipidemia 28 (80%) Chronic obstructive pulmonary disease 6 (17.1%) Chronic renal failure 21 (60%) Glomerular filtration rate, ml/min* 53.3 21.7 Frailty 8 (22.9%) Porcelain aorta 12 (34.3%) NYHA functional class III or IV 33 (94.3%) Cerebrovascular disease 10 (28.6%) Atrial fibrillation 10 (28.6%) Coronary artery disease 21 (60%) Previous PCI 12 (34.3%) Previous sternotomy 11 (31.4%) Logistic EuroSCORE 18.8 14.1 Society of Thoracic Surgeons score 7.5 3.6 Echocardiographic data Left ventricular ejection fraction, % 59 13 Left ventricular ejection fraction 40% 3 (8.6%) Pulmonary artery systolic pressure 60 mm Hg 8 (22.9%) Aortic annulus diameter, mm 18.5 0.9 Aortic transvalvular pressure gradient Maximum, mm Hg 76.3 33.0 Mean, mm Hg 45.2 20.6 Aortic valve orifice area, cm 2 0.55 0.15 Aortic valve indexed effective orifice area, cm 2 /m 2 0.35 0.10 Values are mean SD or n (% of the total). *Estimated using the Modification of Diet in Renal Disease (MDRD) formula. Previous coronary artery bypass graft surgery in 10 patients, previous mitral valve replacement in 1 patient. NYHA New York Heart Association; PCI percutaneous coronary intervention. mained stable thereafter with respect to type and severity (Fig. 5). Discussion In our study of 35 high-risk patients with severe AS and a small ( 20 mm) aortic annulus, including 14 patients with annuli 19 mm in diameter, TAVI was associated with good periprocedural and mid-term outcomes, with 1 perioperative death (2.9%) and no patient requiring conversion to sternotomy or extracorporeal circulation. Post-procedural peak and mean transvalvular pressure gradients were significantly reduced, with a relatively low (5.9%) incidence of severe PPM. Trace AI was observed in 18 patients (51.4%), mild in 6 patients (17.1%), and moderate in 1 patient (2.9%). At a mean follow-up of 14 months, there was no appreciable deterioration of transprosthetic gradients and valve areas, and AI completely disappeared in 8 patients at 6-month follow-up. All but 1 patient were in NYHA functional class I or II, demonstrating a lasting salutary effect of TAVI in this patient population. Surgical management of the small aortic annulus. The presence of a small aortic annulus poses a considerable challenge in the management of patients with severe AS undergoing AVR. The optimal approach to these patients remains controversial. During AVR, an aortic annular enlargement procedure may be necessary (19,20). Recent retrospective studies (8,9,21) have shown excellent results associated with annular enlargement procedures, with little operative morbidity and mortality in selected patients, although few data are published in elderly, high-risk patients, possibly reflecting surgical reluctance to go ahead with these procedures in the nonoptimal patient. In a study by Dhareshwar et al. (8), the patients that underwent aortic annular enlargement were younger and had better left ventricular function than the patients undergoing standard AVR. Despite this, operative mortality was nearly doubled in the annular enlargement patients (5.6% vs. 2.9%, p 0.03), although there was no independent effect of annular enlargement on mortality on multivariate analysis. Other potential management options of the small aortic annulus during AVR include the implantation of smallersized mechanical valves (22,23) or stentless bioprostheses (24,25). However, bleeding risks may be 20 times higher among elderly patients with mechanical compared with biological valves (26), generally limiting the use of mechanical valves to younger patients (27,28). Furthermore, the hemodynamic superiority of stentless aortic bioprostheses continues to be debated, with available studies reporting conflicting data, both for normal (24,25,29) and smallsized aortic annuli (30 32). Our center published its Procedural In-Hospital Outcomes Variables Procedural and (nvariables 35) and Table 2 In-Hospital Outcomes (n 35) Approach Transapical 24 (68.6%) Transfemoral 11 (31.4%) Procedural success 34 (97.1%) Conversion to sternotomy 0 Use of extracorporeal circulation 0 In-hospital clinical outcomes Mortality 1 (2.9%) Stroke 0 New-onset acute renal failure 3 (8.6%) Red blood cell transfusion 19 (54.3%) Permanent pacemaker 2 (5.7%) Wound infection 2 (5.7%) Length of hospital stay, days 6 (5 10) Echocardiographic data Aortic insufficiency* 25 (71.4%) Post-procedural aortic transvalvular pressure gradient Maximum, mm Hg 21.8 8.4 Mean, mm Hg 11.7 4.8 Post-procedural aortic valve effective orifice area, cm 2 1.41 0.25 Post-procedural aortic valve indexed effective orifice area, cm 2 /m 2 0.90 0.18 Values are n (% of the total), mean SD, or median (interquartile range). *Trace or mild except in 1 patient with moderate paravalvular aortic regurgitation requiring delayed balloon aortic valvuloplasty. Gradients and valve area measured on pre-discharge transthoracic Doppler echocardiography.

1020 Kalavrouziotis et al. JACC Vol. 58, No. 10, 2011 TAVI and Small Aortic Annulus August 30, 2011:1016 24 Figure 2 Incidence of Post-Procedural Prosthesis Patient Mismatch Effective orifice area was measured on pre-discharge transthoracic Doppler echocardiography and was indexed to patient body surface area in order to define categories of prosthesis patient mismatch. The number below each bar graph corresponds to that patient s pre-procedural aortic annular diameter according to the inset table on right. IEOA indexed effective orifice area; PPM prosthesis patient mismatch. experience of over 400 implantations of the Freestyle stentless bioprosthesis (Medtronic, Inc., Minneapolis, Minnesota), among which 68 patients received a 19-mm or 21-mm prosthesis inserted with a subcoronary technique (32). The incidence of severe PPM was 58% and 17% for the 19- and 21-mm prostheses, respectively. A complete aortic root replacement technique may overcome the limitations associated with a subcoronary implantation within the otherwise unmodified aortic root. Figure 3 Survival Following Transcatheter Aortic Valve Implantation Kaplan-Meier freedom from all-cause mortality during follow-up among patients with aortic annular diameter 20 mm. However, this approach has been associated with high morbidity and mortality in elderly patients (33). Hemodynamic performance and clinical outcomes following TAVI. To the best of our knowledge, this is the first study to systematically examine the results of TAVI with the Edwards SAPIEN valve in patients with a small aortic annulus. The post-procedural mean transprosthetic gradient of 11.7 mm Hg and EOA of 1.41 cm 2 observed in our study are similar to those reported in the PARTNER (Placement of Aortic Transcatheter Valves) trial (11.4 mm Hg and 1.5 cm 2, respectively), which included 26-mm prostheses (34). Also, the incidence of moderate (32.4%) and severe (5.9%) PPM in our study is similar to that reported by Jilaihawi et al. (35) after implantation of the Medtronic CoreValve prosthesis (moderate PPM in 32%, severe PPM in 2% of patients). However, only patients with an aortic annular diameter 20 mm were evaluated in that study. Clavel et al. (13) recently published a study examining the hemodynamic performance of Cribier-Edwards and Edwards SAPIEN valves. TAVI patients were matched with respect to several variables, including body surface area, aortic annular diameter, and left ventricular ejection fraction, to a group of surgical patients that underwent AVR using stented pericardial valves (Edwards Perimount Magna) and stentless Medtronic Freestyle valves. The authors found that mean transprosthetic gradients were significantly lower among the TAVI patients (10 4 mm Hg), compared with patients receiving stented valves (13 5 mm Hg), as well as those receiving stentless bioprostheses (14 6 mm Hg). It is noteworthy that differences between mean gradients were

JACC Vol. 58, No. 10, 2011 August 30, 2011:1016 24 Kalavrouziotis et al. TAVI and Small Aortic Annulus 1021 Figure 4 Transaortic Pressure Gradients and Aortic Valve Areas at Baseline and Post-Procedure Mean transvalvular pressure gradients and aortic valve areas (mean SD) are shown over time for patients with an aortic annular diameter 20 mm (A), and those of a contemporaneous cohort of patients with annuli 20 mm who received a 23-mm Edwards SAPIEN valve during the study period (B). Post-procedural mean gradients and aortic valve areas did not differ between patients with an aortic annulus 20 mm and those with annuli 20 mm (p NS for all time periods). *p 0.0001. **p NS. more pronounced among the subgroup of patients with annular diameters 20 mm, and any hemodynamic benefit associated with TAVI was lost in those patients with larger annuli. Distention of the aortic annulus due to systematic over-sizing and the absence of a sewing ring have been suggested as some of the possible mechanisms explaining the superior hemodynamic profile associated with TAVI compared with standard surgical valves (13). In light of these data, our results suggest that the hemodynamic advantage of the Edwards SAPIEN prosthesis is maintained in small and very small ( 19 mm) annuli, and there appears to be no deleterious effect on both clinical and hemodynamic outcomes following the deployment of a fixed-sized 23-mm prosthesis within a small, calcified aortic annulus.

1022 Kalavrouziotis et al. JACC Vol. 58, No. 10, 2011 TAVI and Small Aortic Annulus August 30, 2011:1016 24 Figure 5 Incidence of Post-Procedural Aortic Insufficiency The proportion of patients without aortic regurgitation was significantly higher at 6 months compared with immediately post-procedure (59.3% vs. 28.6%, respectively, p 0.013). No other substantial change in aortic regurgitation was observed during follow-up. Post-procedural AI was observed in over two-thirds of our patients and is consistent with the rates reported in recent literature (14,34). However, the incidence of significant AI that is moderate or greater was lower in our series compared with recent studies. In our series, only 1 patient (2.9%) had moderate or greater AI post-tavi compared with 12% in the PARTNER trial (34) and 6% in the multicenter Canadian study (14). These results are concordant with those of a recent report from Détaint et al. (36), in which significant paravalvular AI that is moderate or greater was never observed in patients with an aortic annulus 22 mm, suggesting that smaller annuli may minimize prosthesis annulus incongruity and may allow for a better fit and more complete apposition of the balloonexpandable prosthesis against the aortic annulus. In high-risk patients with severe AS and a small aortic annulus, our results suggest that TAVI is associated with good clinical outcomes, with a 30-day mortality of 2.9% and 1- and 2-year survival rates of 94% and 76%, respectively. Survival in our study was better than that reported in previous TAVI studies (11,14,34), and might be partially related to the slightly lower risk profile of our study population as evaluated by the logistic EuroSCORE (mean of 19%) and the Society of Thoracic Surgeons score (mean of 7.5%). However, more than one-third of the patients included in our study had porcelain aorta as the main comorbidity determining patient inoperability, a risk factor not included in conventional surgical risk scoring systems. In addition, no cases of aortic annulus rupture were observed in this study. The potential risk of aortic annulus rupture due to excessive valve prosthesis over-dimensioning in patients with a small aortic annulus has been reported (37,38). The use of under-sized balloons for balloon valvuloplasty prior to TAVI may be important to reduce this potential life-threatening complication. Study limitations. First, this is a small, single-center series without a comparative group. However, the aim of this descriptive study was to evaluate the feasibility and safety of

JACC Vol. 58, No. 10, 2011 August 30, 2011:1016 24 Kalavrouziotis et al. TAVI and Small Aortic Annulus 1023 TAVI in an elderly cohort of patients with severe aortic stenosis and a small aortic annulus who are unsuitable for standard AVR due to prohibitive risk. Also, the relatively short duration of follow-up limits our ability to make meaningful statements about the long-term performance and durability of the Edwards SAPIEN prosthesis in the small aortic root, and further longitudinal analysis is warranted. Another limitation relates to the use of TEE to measure the aortic annular diameter. TEE may underestimate aortic annular diameter compared to multislice computed tomography (39). However, TEE-based annular measurements are extensively used in TAVI studies, including the PARTNER trial (34), and have been associated with good clinical results post-tavi (15). In the absence of a gold standard, TEE remains the imaging modality of choice for aortic annular assessment prior to TAVI in most centers. Conclusions Among high-risk patients with severe AS and a small aortic annulus, TAVI is associated with good in-hospital and mid-term outcomes, and post-procedural valve echocardiographic performance, with a relatively low incidence of severe PPM. TAVI in these patients compares favorably with currently available surgical options, and may provide a reasonable alternative to conventional AVR in elderly patients with a small aortic annulus. Acknowledgment The authors would like to thank Serge Simard, MSc, for his help with the statistical analysis. Reprint requests and correspondence: Dr. Eric Dumont, Quebec Heart and Lung Institute, Department of Cardiac Surgery, 2725 chemin Sainte-Foy, Quebec City, Quebec G1V 4G5, Canada. E-mail: eric.dumont@criucpq.ulaval.ca. REFERENCES 1. Rahimtoola SH. The problem of valve prosthesis-patient mismatch. 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