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Ann Thorac Surg 2009;87:1757-1763. doi:10.1016/j.athoracsur.2009.03.047
© 2009 The Society of Thoracic Surgeons
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Original Articles: Adult Cardiac

Transcatheter Aortic Valve Implantation: Selection Strategy Is Crucial for Outcome

Nawwar Al-Attar, FRCS, PhDa, Dominique Himbert, MDb, Fleur Descoutures, MDb, Bernard Iung, MDb, Richard Raffoul, MDa, David Messika-Zeitoun, MDb, Eric Brochet, MDb, Fady Francis, MDc, Hassan Ibrahim, MDd, Alec Vahanian, FRCP, MDb, Patrick Nataf, MDa,*

a Assistance Publique-Hôpitaux de Paris, Department of Cardiovascular Surgery, Bichat-Claude Bernard Hospital, Paris, France
b Assistance Publique-Hôpitaux de Paris, Department of Cardiology, Bichat-Claude Bernard Hospital, Paris, France
c Assistance Publique-Hôpitaux de Paris, Department of Thoracic and Vascular Surgery, Bichat-Claude Bernard Hospital, Paris, France
d Assistance Publique-Hôpitaux de Paris, Department of Anaesthesiology, Bichat-Claude Bernard Hospital, Paris, France

Accepted for publication March 17, 2009.

* Address correspondence to Dr Nataf, Department of Cardiac Surgery, Bichat Hospital, 46 rue Henri Huchard, Paris, 75018, France (Email: patrick.nataf{at}bch.aphp.fr).

Presented at the Forty-fifth Annual Meeting of The Society of Thoracic Surgeons, San Francisco, CA, Jan 26–28, 2009.


Drs Himbert, Iung, and Vahanian disclose that they have financial relationships with Edwards Lifesciences; Dr Nataf with Edwards Lifesciences and Medtronic.

 

   Abstract
Top
 Abstract
Introduction
 Patients and Methods
 Results
 Comment
 Discussion
 Acknowledgments
 References
 
Background: We describe the results of transcatheter aortic valve implantation (TAVI) in high-risk patients with aortic stenosis. Transfemoral access was the first option, and if contraindicated, the transapical approach was used.

Methods: Fifty patients were consecutively treated with TAVI because of high surgical risk or contraindications to operation. Mean age was 83 ± 6 years, and most were in New York Heart Association classes III and IV. The predicted surgical mortality was 28% ± 14% using the European System for Cardiac Operative Risk Evaluation and 16% ± 7% using the Society of Thoracic Surgeons Predicted Risk of Mortality. The Edwards-SAPIEN (Edwards Lifesciences Inc, Irvine, CA) valve was implanted using a transfemoral approach in 35 patients and the transapical approach in 15. The transapical patients had more comorbidity (diabetes, previous myocardial infarction, previous coronary artery bypass grafting, peripheral artery disease, renal failure, porcelain aorta, and previous stroke).

Results: Successful implantation was 85.7% and 100% in the transfemoral and transapical group, respectively. Gradients were satisfactory. In-hospital mortality was 8% in the transfemoral and 27% in the transapical group. Stroke was only observed in the transfemoral group. Overall 1-year survival was 74% ± 11% in the transfemoral group and 60% ± 13% in the transapical.

Conclusions: The results attributed to each approach (transfemoral or transapical) are strongly influenced by the selection strategy. Patients in the transapical group had more comorbidity and consequently a more critical early postoperative period. The respective places of transfemoral and transapical approaches need to be clarified for each approach by a randomized study.


This article has been selected for the open discussion forum on the CTSNet Web Site: http://www.ctsnet.org/sections/newsandviews/discussions/index.html

 

Aortic valve replacement (AVR) is the reference treatment for symptomatic aortic stenosis [1]. AVR is performed with cardiopulmonary bypass and aortic cross-clamping. Increased operative mortality and higher risk for valve-related events has been observed in elderly patients. Furthermore, several factors have been identified to increase operative risk and mortality associated with AVR [2]. In addition to comorbidities, patients may present with technical difficulties that make AVR challenging to perform. This is particularly true in patients undergoing redo operations with patent coronary artery bypass grafts (CABG) or in the presence of a heavily calcified, atheromatous, or porcelain ascending aorta or sequelae of chest radiotherapy.

Transcatheter aortic valve implantation (TAVI) techniques have been developed to provide alternative approaches to patients for whom conventional AVR is fraught with a considerable risk. These techniques have been performed with two distinct approaches, namely the transfemoral and transapical routes, with established feasibility [3–15]. In this study, we describe the outcomes of patients undergoing TAVI according to an inclusion strategy that favors the transfemoral approach as a first option, leaving the transapical approach for patients refused both AVR and transfemoral TAVI.


   Patients and Methods
Top
 Abstract
 Introduction
 Patients and Methods
Results
 Comment
 Discussion
 Acknowledgments
 References
 
Patients
From September 2006 to May 2008, 50 patients treated for severe symptomatic aortic stenosis for whom a conventional operation was considered high risk or contraindicated by a multidisciplinary team were referred for TAVI and included in a prospective registry. The transfemoral approach was used to treat 35 patients and the transapical approach in 15. Patient characteristics are described in Table 1. All patients gave informed consent. The first 7 patients were included in the PARTNER EU (Placement of AoRTic traNscathetER valves—European Union) study, and the protocol was approved by the local ethics committee.


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  		Table 1 Demographics and Characteristics of the Study Population
 
All patients underwent complete clinical examination, transthoracic, transesophageal echocardiography (TEE), coronary angiography, aortic and femoroiliac angiography, and multislice computed tomography. The selection strategy initially adopted by our team consisted of considering the transfemoral approach as the first option, and the transapical approach only if the transfemoral route was contraindicated.

All patients received the Edwards-SAPIEN Transcatheter Heart Valve (Edwards Lifesciences Inc, Irvine, CA). All TAVI procedures were performed under general anesthesia, with fluoroscopic and TEE guidance. Heparin was administered intravenously at 110 IU/kg.

The transfemoral approach consisted of the insertion of a 22F or 24F sheath into the common femoral artery under direct vision. This was followed by retrograde crossing and predilatation of the native valve. The prosthesis was pushed by a flexible catheter (RetroFlex, Edwards Lifesciences Inc), positioned within the aortic annulus, and then delivered by balloon inflation under rapid ventricular pacing. The procedure has been described in detail previously [3–6].

Transapical TAVI was performed through a left anterolateral minithoracotomy. The site of the incision was determined by localization of the apex by transthoracic echocardiography before the patient was prepared for the operation. The pericardium was opened and suspended to the thoracic wall. The left ventricular apex was then punctured through 2 purse-string sutures. A sheath (initially 33F, then 26F) was introduced in the left ventricle and the prosthesis implanted using the antegrade route with the Ascendra system (Edwards Lifesciences Inc) under rapid ventricular pacing [10–12]. At the end of the procedure, intravenous protamine was administered at an equivalent dose.

During the hospital stay, clinical and echocardiographic data were obtained and all adverse events were prospectively recorded. After discharge, clinical and echocardiographic follow-up was obtained in all survivors at 1 to 3 months, 6 months, and 1 year, and then annually. Outcomes were described according to the guidelines for reporting mortality and morbidity after cardiac interventions [16]. Procedural success is defined as valve implantation in the correct position, with good immediate hemodynamic result and no major complications.

Statistical Analysis
Data are expressed as mean ± standard deviation. The nonparametric Wilcoxon test was used to compare continuous variables in the transfemoral and transapical groups, and categoric variables were compared by the Fisher exact test. Comparison of echocardiographic variables according to the time from procedure was done by the Mann-Whitney test. Analysis of the predictive factors of late survival was performed using a multivariate Cox model including the transfemoral or transapical approach and patient risk score according to the European System for Cardiac Operative Risk Evaluation (EuroSCORE) or the Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) score. All tests were two-sided. A value of p < 0.05 was considered to indicate a statistically significant difference. Statistical analysis was performed using Statistica 5.0 software (Statsoft Inc, Tulsa, OK).


   Results
Top
 Abstract
 Introduction
 Patients and Methods
 Results
Comment
 Discussion
 Acknowledgments
 References
 
Procedural success for TAVI was 85.7% for the transfemoral group and 100% for the transapical group (p = 0.12). The procedure failed in 5 patients in the transfemoral group due to inability to cross the iliac artery in 3 patients, to cross the aortic valve in 1 patient, and hemopericardium in 1 patient because of perforation of the left ventricle by the guide wire and subsequent death. One patient died after a vascular intervention and the remaining 3 survivors were treated medically and are alive on follow-up. No intraoperative deaths occurred in the transapical group.

In all successful implantations of the valve, the aortic valve area and mean transprosthetic gradient were good. There were no prosthesis malpositioning or conversion to on-pump surgical AVR. Paravalvular leaks were frequent immediately after implantation, but were mild or moderate in 40 of 45 patients (88%). In 2 patients (1 transfemoral and 1 transapical), severe aortic regurgitation immediately after implantation was managed by implantation of a second prosthesis into the first one ("valve after valve"), with satisfactory results. Grade III paravalvular aortic regurgitation was detected in a further 3 patients, with no hemodynamic consequences (Table 2).


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  		Table 2 Immediate Postimplantation Results
 
Vascular complications after the procedure occurred in 6 patients (12%). In the transfemoral group, these consisted of 4 iliac dissections. Three were treated by surgical grafting, with uneventful outcomes in 2 patients, 1 patient died on day 4, and 1 was treated by iliac stenting, complicated by acute leg ischemia due to stent occlusion on day 1, requiring an emergency operation with a favorable outcome. In the transapical group, delayed rupture (after 1 week) of the femoral arterial access site occurred in 1 patient, and thrombosis of the common iliac artery developed in 1 patient with severe peripheral artery disease in the context of septic shock that led to leg ischemia and contributed to her eventual death.

Stroke occurred in the transfemoral TAVI in 2 patients, with full recovery within 2 months in both. No strokes occurred in the transapical group, probably related to the antegrade positioning and manipulation of the delivery system and valve. In 2 patients, a pacemaker was implanted to treat atrioventricular blocks. Three tamponades occurred: one during a transfemoral procedure, which led to intraprocedural death; one 4 hours after a transapical procedure, with satisfactory recovery after surgical drainage; and one 2 days after a transapical procedure due to the rupture of the left ventricular apex, requiring emergency reintervention. This was followed by multiorgan failure and death at day 39. All-cause in-hospital mortality was 14% (Table 3).


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  		Table 3 Complications
 
Mean follow-up was 8.6 ± 5.6 months (range, 4 to 22 months). Six patients died after discharge (Table 4). One-year survival rates were 67% ± 11% for the whole TAVI cohort, and 74% ± 11% and 60% ± 13% for the transfemoral and transapical subsets, respectively (p = 0.04, Fig 1). Late complications included pericardial effusion 1 month after a transapical TAVI treated with surgical drainage. A false aneurysm of the apex of the left ventricle occurred 2 months after a transapical TAVI and was treated by surgical closure with uneventful recovery. There was no reintervention, hemolysis, or permanent valve-related impairment.


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  		Table 4 Intrahospital and Postdischarge Mortality Presented With the Cause
 

Figure 1
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  		Fig 1. Kaplan-Meier analysis of survival overall (thick line) in the 50 consecutive patients treated with transcatheter aortic valve implantation (AVI), and in those treated with transfemoral (TF, dotted line) or transapical (TA, thin line) approaches.

 

   Comment
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
Discussion
 Acknowledgments
 References
 
Age-related degenerative calcific aortic stenosis is currently the most frequent indication for aortic valve replacement [17]. In selected elderly patients, the operative mortality of AVR is 7% to 10% [18, 19]. Scores predicting operative risk have been used to provide an objective assessment of potential mortality and morbidity for patients, with variable accuracy [20]. Nevertheless, the patient profile has changed during a 25-year study period (1978 to 2003), with patients presenting with several comorbidities, particularly coronary artery disease, concomitant CABG, and a greater incidence of left-sided heart failure [21]. TAVI techniques have thus provided an alternative therapeutic approach to patients previously denied operations because of high operative risk [14].

The population of the present study was at high surgical risk or presented technical challenges to surgical AVR. In our strategy for selecting patients for this technique, the transfemoral approach was the first option, leaving the transapical approach for patients refused both conventional operations and the transfemoral approach. High risk was demonstrated by the predicted mortality rate of 28% by the EuroSCORE and 16% by the STS PROM for the study population.

The overall observed hospital mortality of 14% compares favorably with these predicted mortality rates. In-depth analysis of the mortality patterns reveals that per-procedure death occurred only in the transfemoral group. The transapical approach is a more direct approach that allows surgical control of the site of puncture and the introduction of the necessary instruments, which may explain procedural safety. Conversely, postprocedural in-hospital death was greater in the transapical group. This correlates with higher risk in these patients because they had more severe peripheral artery disease, more frequent coronary artery disease, previous CABG and myocardial infarction, renal failure, and extracardiac comorbidities, all known to negatively affect survival [2, 21, 22].

Although the EuroSCORE was numerically higher in the transapical group compared with the transfemoral group (30% ± 12% vs 26% ± 14%), as was the STS PROM (19% ± 9% vs 15% ± 6%), this difference was not statistically significant in either score (p = 0.17 and p = 0.29, respectively), which may be explained by the small sample size and that these scores do not capture all relevant variables. Dewey and colleagues [20] showed that the different scores collect a large number of preoperative data that are not all incorporated in the calculation of predicted mortality. Thus, of more than 50 variables collected by the STS PROM, only 24 are actually used in its mortality algorithm for patients undergoing valve operations. [20] These scores have obvious limitations in the prediction of operative mortality of these patients, and their suitability for assessing risk reduction of TAVI has been questioned [23].

The selection strategy in this series led to the transapical approach being used in patients contraindicated for the transfemoral approach, which is a reasonable explanation for the greater postprocedural mortality rate. In general, the hospital deaths were mostly due to cardiac causes; whereas once the patient passed the critical postoperative period, death was due to noncardiac causes in half of the patients. This finding is consistent with the literature and reflects the challenges of the immediate and early postoperative period [5, 6, 24].

The most important complications of TAVI were access complications related to femoral puncture. The major vascular complications in the transfemoral group concerned the introduction of significantly wide sheaths (22F and 24F) requiring postprocedural surgical vascular repair. Death in 1 patient emphasizes the severity and risk of this complication. This rate is expected to decrease by the reduction of the diameters of the introduction systems [8]. Nevertheless, femoral puncture performed in the transapical group to allow periprocedural angiography was also associated with significant complications and contributed to death in 1 patient.

The stroke rate was 4% despite a high-risk study population. Strokes occurred only in the transfemoral group, but were transient. No stroke occurred after transapical TAVI, which seems a consistent advantage of this approach [11, 24]. Again, the more direct approach and less manipulation with the aorta is a logical explanation for a lower risk of stroke in the transapical group.

Complete atrioventricular blocks requiring pacemaker implantation concerned 4% of patients and have been described in similar ranges with the SAPIEN prosthesis [4–7, 12]. There was no myocardial infarction, coronary obstruction, or induced mitral valve dysfunction, which confirmed the anatomic adequacy of the prosthesis to the left ventricular outflow tract and the environing structures. Adequate preprocedural annulus sizing and continuous TEE monitoring during TAVI may have contributed to this result.

Patient survival in the present series with the transfemoral approach is consistent with those previously reported [4, 6, 8, 25, 26]. Midterm survival was lower in patients who could not be treated by transfemoral access and underwent the transapical procedure. This finding is in accordance with the 72% survival at 3 months and the 60% survival at 6 months observed in a feasibility study [27]. However, the results are less favorable than those reported in the series from pioneering centers of the transapical technique, which do not apply the same selection strategy and have a large experience [11, 24].

A limitation of this study is that it is a description of our early experience with TAVI. The patient population was small and not randomized to be treated by one approach or another. The learning curve has a crucial and direct influence on clinical outcomes and the true benefit/risk ratio of the technique may be underestimated. The incremental improvements acquired with experience may have affected patient selection, procedural performance, and postprocedural management.

In conclusion, transcatheter aortic valve implantation expands the scope of the treatment of aortic stenosis in high-risk patients. Although two different approaches have been advocated for valve implantation, their results are influenced by the selection strategy. Because of our selection strategy, patients in the transapical group had more comorbidities and consequently a more critical early postoperative period and lower overall survival. In-depth analysis of the mortality patterns showed that per-procedure death occurred only in the transfemoral group. The respective places of transfemoral and transapical approaches need to be clarified in a randomized study.


   Discussion
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Discussion
Acknowledgments
 References
 
DR TODD M. DEWEY (Dallas, TX): President Chitwood, Dr Wood, members and guests. My disclosure is that I am a consultant for Edwards Lifesciences. I would like to congratulate Dr Al-Attar and his colleagues at Bichat for a very interesting and timely study. Since the first reported clinical implantation of a transcatheter aortic valve by Dr Alain Cribier in 2002, the rate of introduction into the clinical arena of this technology has been exceedingly rapid; and, in fact, commercialization of both balloon-expandable and self-expanding aortic valve platforms in Europe as an alternative to conventional surgery in high-risk patients has led to the implantation of over 2000 valves over the last several years. Increasing transcatheter experience has allowed a number of centers to standardize the procedure in terms of technique and surmount the learning curve that is inherent with any new technology, especially one as difficult as this and working on patients as sick as these are. Despite this, procedure mortality still remains relatively high and places a premium on patient selection.

Dr Al-Attar and his colleagues report a selection strategy using access as their first order to decide whether to proceed with transfemoral or transapical implantation; and, to their credit, they report no conversions to open AVR [aortic valve replacement] and no valve embolizations due to malplacement. But survival was clearly worse in the transapical group compared with the transfemoral group, despite being able to successfully deploy the valve in 100% of the patients. Often this happens due to clustering of higher-risk patients into the transapical arm.

I would like to ask Dr Al-Attar and his colleagues that since they clearly demonstrate that the transapical and the transfemoral populations are intrinsically different, with significant disparities in the rates of coronary disease, previous myocardial infarction, previous bypass grafting and renal failure, did they also look to see if there was a difference between the two patient populations in regards to preoperative mitral regurgitation, and, if so, did this have an effect on their outcomes, particularly postoperatively? Additionally, did they test to see if any variables were independent predictors of mortality based on their preoperative demographics, including operative approach? Given the time frame of their patient accrual, were these patients enrolled and how many of them in the PARTNER EU trial, and hence, did trial protocol influence your decision to use transfemoral as your default approach?

And finally, you report 100% success rate with the TA [transapical approach] vs only 85% with the transfemoral but a transapical mortality of 27%, which is nearly one and a half times that predicted by the STS [Society of Thoracic Surgeons] predicted risk of mortality. Clearly, some centers use a selection strategy opposite of theirs in that TA is their primary approach and it allows them to treat all-comers despite femoral access, and some centers actually report equivalent mortalities to some of the best centers in transfemoral. Besides access, what other variables do you feel are important in determining which patients are to be treated either transfemorally or transapically? Do you think your selection strategy as presented is biased against the TA cohort by preferentially putting the higher-risk patients in this group, and if so, why compare the outcomes between the two groups because they are inherently not comparable populations? I would like to thank the Society for the privilege of discussing this paper. Thank you.

DR AL-ATTAR: Thank you, Dr Dewey, for your questions. This study represents our early experience. Its size was small and it was not randomized. It was not designed to answer specifically your first question. The learning curve influenced some outcomes, the way we selected our patients and the perioperative management.

So specifically regarding mitral regurgitation, we did not look into it. However, other variables did show up, and in this series, previous myocardial infarction was a significant factor of mortality. Coronary artery disease and revascularization procedures also contributed, without achieving statistical significance. But we have continued to follow-up our patients and our cohort has now shown that the NYHA [New York Heart Association] class and left ventricular ejection fraction are important contributors to survival.

Regarding the influence of the feasibility trial or the PARTNER EU trial; indeed, we started the transapical procedure with the beginning of the PARTNER EU study since it was at that time that we had access to the transapical approach and the trial protocol did influence selection strategy. The cardiologists had already gone through their learning curve with the transfemoral approach.

Regarding your last question, I think you might say that these populations are not entirely comparable, but the transapical approach has had bad press so far, and I believe this paper contributes to understanding why this is so. If you include patients that have been denied every therapeutic possibility—conventional surgery, transfemoral approach—then they are the most ill, the most risky, and they can be expected to have the worst outcomes. But if you look at our data, patients in the transfemoral group had more major adverse cardiac and cerebrovascular events, vascular access complications were the major complications of TAVI [transcatheter aortic valve implantation], and strokes only happened in the transfemoral group. So given its limitations, our study shows that patients in the transapical group and despite being at higher risk, did fare better at least in regards to some of the complications. I thank you for your kind attention.


   Acknowledgments
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Discussion
 Acknowledgments
References
 
The first 7 patients were included in the PARTNER EU study, and the valves were provided by Edwards Lifesciences Inc, Irvine, California, as part of the study protocol. All the other patients were treated with the financial support of the Assistance Publique-Hôpitaux de Paris.


   References
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Discussion
 Acknowledgments
 References
 

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Right arrow Valve disease

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