Impact of procedural volume on outcome optimization in transaortic transcatheter aortic valve implantation

    Impact of procedural volume on outcome optimization in transaortic transcatheter aortic valve implantation Takahide Arai, Mauro Romano, Thierry Lef`evre, Thomas Hovasse, Erik Bouvier, Marie-Claude Morice, Arnaud Farge, Philippe Garot, Bernard Chevalier PII: DOI: Reference:

S0167-5273(16)31575-3 doi: 10.1016/j.ijcard.2016.07.184 IJCA 23151

To appear in:

International Journal of Cardiology

Received date: Accepted date:

8 June 2016 27 July 2016

Please cite this article as: Arai Takahide, Romano Mauro, Lef`evre Thierry, Hovasse Thomas, Bouvier Erik, Morice Marie-Claude, Farge Arnaud, Garot Philippe, Chevalier Bernard, Impact of procedural volume on outcome optimization in transaortic transcatheter aortic valve implantation, International Journal of Cardiology (2016), doi: 10.1016/j.ijcard.2016.07.184

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Impact of procedural volume on outcome optimization in transaortic transcatheter

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aortic valve implantation

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Takahide Arai1,†, Mauro Romano2,†, Thierry Lefèvre1, Thomas Hovasse1, Erik Bouvier1, Marie-Claude Morice1, Arnaud Farge2, Philippe Garot1, Bernard Chevalier1 Department of Interventional Cardiology, Institut Cardiovasculaire Paris Sud, Massy, France

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Department of Cardiovascular Surgery and Transcatheter Heart and Vascular Therapies, Institut

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Cardiovasculaire Paris Sud, Massy, France †

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Takahide Arai and Mauro Romano contributed equally to this work.

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Corresponding author: Thierry Lefèvre Department of Interventional Cardiology, Hôpital Privé Jacques Cartier, Générale de Santé.

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6 avenue du Noyer Lambert, FR-91300 Massy, France Tel: + 33-160134602, Fax: + 33-160134603, E-mail: [email protected]

Keywords: Severe symptomatic aortic stenosis, transcatheter aortic valve implantation, transaortic approach.

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Abstract

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Background: An adequate procedural volume seems to be required to minimize the

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complication rate in TAVI. However, very few studies have investigated the relationship

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between procedural volume and outcomes in TAVI especially via the transaortic approach. The aim of this study was to evaluate the effect of procedural volume on the outcomes of

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transaortic TAVI (TAo-TAVI).

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Methods: 257 consecutive TAo-TAVI cases performed by 2 cardiac surgeons between January 2011 and June 2014 were included in the current analysis. Cumulative sum

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(CUSUM) failure analysis of combined 30-day safety endpoints was used in order to

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evaluate the learning curves. We divided the cases into two groups:early experience and late

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experience, respectively. . Procedure and outcome variables were compared. Results: The CUSUM analysis revealed a learning curve regarding the occurrence of

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adverse events at 30 days with an improvement after the initial 128 cases. We divided the cases into two groups (early group: cases 1 to 128; late group: cases 129 to 257). Although the rate of 30-day mortality was not significantly different between the 2 groups (11% and 7%, p=0.268), the incidence of adverse events such as life-threatening bleeding, stroke and AKI was significantly decreased in the late phase group (9% and 1%, p=0.002; 5% and 0%, p=0.014; 16% and 6%, p=0.002, respectively). Conclusions: The incidence of adverse events was significantly decreased in the late phase group. An appropriate number of procedures seems to be required to reduce the TAo-TAVI

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CUSUM = cumulative sum

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Abbreviations and Acronyms

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complication rate.

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TAVI = transcatheter aortic valve implantation TF = transfemoral

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TAo = transaortic

VARC = valve academic research consortium

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Introduction

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Transcatheter aortic valve implantation (TAVI) has expanded as the treatment options

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for patients with severe symptomatic aortic stenosis who are considered high risk for

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surgical aortic valve replacement [1-5]. A large volume of TAVI procedures have been performed via two major approaches: transfemoral (TF) and transapical (TA). The recently

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alternative route to the TA approach[6, 7].

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developed transaortic (TAo) approach has been reported to be feasible and safe as an

Lardizabal et al. reported that TAo-TAVI using balloon-expandable prostheses was

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associated with lower bleeding and vascular event rates compared to TA-TAVI [8].

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Furthermore, procedural adverse events related to TAo-TAVI were shown to decrease

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significantly after the first 20 cases. This suggests that an appropriate number of cases is required in order to minimize the complication rate of TAo-TAVI. The association between

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procedural volume and outcomes in TA-TAVI has been the subject of several analyses. Kempfert et al. reported that TA-TAVI outcomes were significantly improved after the first 150 cases [9, 10]. Holzhey et al. reported the TA-TAVI learning curve as assessed by the CUSUM method [11]. However, few studies have investigated the relationship between the number of cases and the outcomes in TAo-TAVI. The aim of this study was, therefore, to evaluate the effect of procedural volume on the outcomes of TAVI performed via the TAo approach.

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Materials and Methods

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Study design

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From October 2006, all consecutive high-risk patients with severe symptomatic AS

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patients treated with TAVI were prospectively included in our dedicated TAVI database. Patients with severe AS were considered candidates for TAVI if they were deemed

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ineligible or high risk for SAVR. The decision to proceed with TAVI was made by a

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dedicated heart team composed of experienced clinical and interventional cardiologists, cardiovascular surgeons and anesthesiologists. Between October 2006 and June 2014, 257

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consecutive patients undergoing TAo-TAVI performed by 2 cardiac surgeons were included

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in the current analysis. Written informed consent was obtained from all patients.

Vascular access and valve selection

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Patients were selected to undergo TAVI via the transfemoral approach (TF) or alternative approaches depending on the size, calcification and tortuosity of the ilio-femoral arterial access. The type of valve prosthesis was selected according to the diameter of the aortic annulus. The Edwards valve (Edwards Lifesciences, Irvine, CA) was used in patients with an annulus diameter of 18-28 mm, and the CoreValve (Medtronic, Santa Rosa, CA) for annular diameter of 20-29 mm. For historical reasons (the Edwards valve was first introduced in 2006), the Edwards valve was used preferentially in patients who were amenable to treatment with both valves. The CoreValve prosthesis was implanted in patients

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whose annulus size was >24.5 mm or patients with borderline ilio-femoral access

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precluding the use of 18,19,22 or 24 French Edwards sheaths. The transsubclavian (SC) or

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transaortic approach (TAo) was used as an alternative in cases of unsuitable femoral arterial

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access in recipients of the CoreValve, and the transapical (TA), transsubclavian, or transaortic route as the alternative to suboptimal femoral access with the Edwards valve.

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The same criteria for bioprosthesis sizing and selection were applied throughout the study

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period.

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Procedures

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TAo-TAVI with the Edwards Sapien XT bioprosthesis was carried out using the

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ASCENDRA 2 delivery system for 23-mm or 26-mm valves and the ASCENDRA 1 for 29 mm valves. In recipients of the Medtronic CoreValve (26, 29 and 31 mm), TAo-TAVI was

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performed with the AccuTrack delivery system. The ASCENDRA system was originally developed for the transapical approach. The Sapien XT valve, however, can be mounted in either direction and the same delivery system can be used in TAo-TAVI. The procedural techniques have been reported elsewhere [12]. In short, a straight short manubriotomy down to the second intercostal space was performed through a 5 cm skin incision. Thereafter, two purse strings were placed as in routine aortic cardiopulmonary bypass (CPB) cannulation with an additional pledgeted back-up ‘U’ suture. An 18-gauge needle was used to puncture the ascending aorta, following the insertion of a 5Fr short

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sheath over a J-shaped 0.035 inch soft guidewire. A Judkins right 4 Fr (JR4) was inserted

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over this guidewire. After exchanging the J-shaped wire for a straight guidewire to cross the

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aortic valve, the JR4 was placed in the LV. A 260 cm Amplatz super-stiff wire was inserted

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via the JR4 catheter in the LV. A graduated pig-tail catheter was placed in the right sinus of Valsalva to inject contrast medium in order to select the appropriate perpendicular view of

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the aortic annulus and position the valve. A temporary pacing catheter was placed in the

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right ventricule via the femoral vein. After introducing the delivery system over the super-stiff guidewire, balloon valvuloplasty was performed under rapid pacing (160-220/

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min). The Edwards Sapien XT bioprosthesis was introduced through the delivery system

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and then carefully positioned and deployed under rapid pacing. The CoreValve

pacing.

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bioprosthesis was deployed gradually with step-wise angiographical guidance without rapid

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Aspirin (75-160 mg) daily was recommended prior to TAVI. A bolus of heparin (100 IU kg-1) was administered at the start of the procedure to achieve an activated clotting time of 250-300 sec, and the activated clotting time was measured every 30 min thereafter.

Post-procedural care All patients were observed in the intensive care unit for at least 24 hrs after Edwards valve implantation or 72 hrs after CoreValve implantation (patients without previous pacemaker). Aspirin was continued indefinitely.

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Endpoints

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The main endpoints of this study were 30-day and 3-month mortality and a combined

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30-day safety endpoint including all cause mortality, major stroke, life-threatening bleeding, acute kidney injury-stage 3, major vascular complication and further intervention due to

Cumulative sum (CUSUM) analysis

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valve dysfunction, according to the valve academic research consortium (VARC) criteria.

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To evaluate learning curves, cumulative sum (CUSUM) failure analysis of combined

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30-day safety endpoint was used in this study as described previously [13]. In short, the

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actual minus expected failure rate was plotted against the number of cases. The curve was calculated with an expected rate of occurrence of any variables included in combined

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30-day safety endpoint of 20%. The resulting chart runs parallel to the x axis when the complication rate is as expected, turns upward when more complications than expected occur, and turns downward when a favorably low complication rate is observed.

Statistical analysis All statistical analyses were performed using SPSS version 21.0 (Chicago, IL, USA). Continuous variables are expressed as mean ± SD or with the corresponding interquartile range. Dichotomous variables are expressed as counts and percentages. Comparisons

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between the two groups were performed using Pearson’s bivariate test and the chi-square

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test for categorical covariates, and unpaired Student t test for continuous covariates. A value

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of P < 0.05 was considered significant.

Results

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Institutional learning curve

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Figure 1 shows the institution’s learning curve for TAo-TAVI. The actual outcome was poorer than expected at the beginning of the series and better than expected after the 128th

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consecutive case. This fact alone suggests that institutional experience with TAo-TAVI must

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include at least 128 cases before a reduction in the rate of complications can be observed.

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The learning curve divided by prosthesis type is shown in Supplementary figure 1.

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Baseline, procedural and post-procedural characteristics stratified by case number A total of 257 patients underwent TAo-TAVI between October 2006 and June 2014. We divided the cases into two groups (early phase group: Cases 1 to 128, late phase group: Cases 129 to 257). Baseline characteristics stratified by case number are shown in Table 1. Variations in baseline characteristics between the 2 groups resulted in significant differences in the mean age (84.5 vs 82.7, p=0.001) and the frequency of COPD (10% vs 19%, p=0.043). Although Edwards prostheses were commonly used, but the CoreValve was increasingly used in the late phase group. Procedural and post-procedural characteristics

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stratified by case number are shown in Table 2. Although the rate of 30-day mortality and

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combined 30-day safety endpoint was not significantly different between the 2 groups (11%

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and 7%, p=0.268; 19% and 12%, p=0.081, respectively), the incidence of adverse events

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such as life-threatening bleeding, stroke and AKI was significantly reduced in the late phase

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group (9% and 1%, p=0.002; 5% and 0%, p=0.014; 16% and 6%, p=0.002, respectively).

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Predictors of 30-day mortality

Predictors of 30-day mortality were evaluated by using logistic regression analysis

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(Table 3). In the univariate analysis, VARC major vascular complication and AKI were the

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mortality.

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only predictors of 30-day mortality. However, logistic EuroSCORE failed to predict 30-day

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Impact of procedural volume on 3-month survival after TAo-TAVI The median follow-up period of this cohort was 194 days (interquartile range: 28 to 347). The cumulative survival rate of all patients was calculated by the Kaplan-Meier method and compared using the log-rank test. Cumulative 3-month survival rates in each individual group were 89% and 91% in the early and late group, respectively (Figure 1). The survival rate was not significantly different between the 2 groups.

Discussion

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The present study demonstrated that an adequate number of procedures is required

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before a reduction in the complication rate of Tao-TAVI can be observed. To the best of our

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knowledge, the present study is the first to demonstrate the relationship between the

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procedural volume and outcomes after TAo-TAVI using the CUSUM method. The TAo approach was originally introduced as an alternative route when conventional

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approaches including TF, TA and SC were not suitable. However, in view of its outcomes

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and due to the simplicity of the procedure, its use has expanded as a preferred approach in non-TF patients [14]. The initial indications of the TAo approach as an alternative to the TA

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approach included patients with poor respiratory function and poor left ventricular (LV)

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function. The TA approach is performed via a left-sided thoracotomy, involving direct

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trauma to the thoracic wall, which may potentially impair the respiratory function and lead to respiratory morbidity [15]. The TAo approach can contribute to earlier recovery of lung

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function, especially in patients with pulmonary disease. With regard to ventricular function, the closure technique using purse-string sutures seems to have adverse effects on LV function. Bleizitter et al. reported that new apical wall motion abnormality was detected in more than 30% of patients treated via the TA approach [2]. Furthermore, the occurrence of pseudoaneurysm or delayed rupture after the TA approach can lead to a decrease in LV function [16] and an increase in mortality. The TAo approach seems to prevent the occurrence of the adverse events associated with the TA approach. The TAo approach appears quite feasible compared to the TA approach. The results of

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a meta-analysis including 20 studies revealed that 30-day mortality after TA-TAVI was

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11.3% (253/2242) [17]. In the study presented here, 30-day mortality was 11% in the early

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phase group and 7% in the late phase group, which seems quite comparable to the TA

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approach and in keeping with the 11% (3/27) mortality rate at 30 days reported in Tao-TAVI patients by Amrane et al [18]. Furthermore, Lardizabal et al. reported a 14% 30-day

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mortality rate in the first 44 cases of TAo-TAVI [8]. Our results seem, therefore, to be in line

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with previously reported outcomes.

Reports have been published with respect to the influence of case volume on outcomes

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after TA-TAVI. Kempfert et al. observed that the outcome after TA-TAVI was significantly

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improved after the first 150 cases [10]. Furthermore, Holzhey et al. reported the learning

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curve of TA-TAVI as assessed by the CUSUM method [11]. However, there has been only one report on the influence of case volume on outcomes after TAo-TAVI. [8]. By using the

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CUSUM method, we demonstrated that the actual outcome was better than expected after the 128 consecutive cases. Our study included a relatively larger number of patients and was the first to use CUSUM analysis to assess the effect of procedural volume on the outcomes. This study showed that there were no significant differences between the 2 groups regarding the 30-day mortality and 3-month survival rates. One of the reasons behind our findings could be that the outcomes of the study population were relatively good even in the early-phase group. The TAo approach is indeed a familiar route for cardiac surgeons given that, for example, the upper manubriotomy and ascending aorta canulation techniques

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which are implemented in TAo-TAVI are daily practice and do not require any specific

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training for cardiac surgeons. Consequently, the rate of adverse events was quite low even in

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the early-phase group.

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Another potential underlying reason is the large number of TAVI procedures via the TF and TA approach that we performed before carrying out our first TAo-TAVI cases.

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Indeed, TAVI was first performed in our center in October 2006 and when we began

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implementing TAo-TAVI, 171 TF TAVI and 89 TA TAVI had already been carried out. We also had significant experience in pre-procedural assessment including CT

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examination in addition to specific procedural and implantation techniques (e.g. two-step

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inflation), and post-procedural care. Furthermore, the interventional cardiologists

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participated in all TAo procedures in order to share their experience with the surgeons. All these factors seem to have contributed to the reduction in the complication rate and to

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the improvement in TAo-TAVI outcomes. Interestingly, this study revealed that, although the incidence of adverse events such as life-threatening bleeding, stroke and AKI decreased significantly in the late phase group, the rate of 30-day mortality was not significantly different between the 2 groups. As discussed above, we had already performed a large number of TAVI procedures via the TF and TA approaches when we carried out our first TAo-TAVI cases. Appropriate post-procedural care could be another reason accounting for the results achieved. For instance, the timely checking of biomarkers may have allowed early detection of

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hemoglobin drop or renal function deterioration and subsequent implementation of effective

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care. We were thus able to keep the adverse effects of such complications to a minimum,

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which resulted in improved outcomes.

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The classical risk-scoring methods including logistic EuroSCORE failed to predict 30-day mortality in this study. An analysis conducted in a population of patients treated by

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TA-TAVI showed that the logistic Euroscore failed to predict the outcomes. [9]. It seems

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that parameters assessing the general status of patients, such as renal function, lung function and heart function, do not adequately predict the outcomes after TAo-TAVI. One study has

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shown that the only contraindication is a complete porcelain aorta in the presence of

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calcium at the puncture site of the aorta [19]. Furthermore, the distance between the sheath

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and the aortic annulus is quite important for an appropriate procedure [12]. A new efficient evaluation tool which takes these factors into account should be developed for suitable

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assessment of the risks associated with TAo-TAVI. In summary, TAo-TAVI resulted in excellent clinical outcomes, even in patients treated in the early phase. An appropriate procedural volume seems necessary in order to reduce the rate of complications such as life-threatning bleeding, major vascular complication and AKI in TAo-TAVI. The classical risk-scoring methods, including logistic EuroSCORE, are not suitable for predicting outcomes after TAo-TAVI. Further studies are required to create a suitable model to predict outcomes after TAo-TAVI.

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Study limitations

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The present study has several limitations that should be addressed. First of all, this

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was a retrospective observational single-center study conducted in a small cohort of patients.

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Further studies with larger cohorts and multi-center analysis are required to confirm our findings. Secondly, the mean follow-up period was 194 days and long-term follow-up is

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needed to investigate the impact of valve type and case volume on long-term outcomes.

Conclusions

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The incidence of adverse events such as bleeding, major vascular complication and

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AKI was significantly lower in the late phase group. An adequate number of procedures

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prosthesis.

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seems to be required in order to reduce the complication rate in TAo-TAVI using either

Acknowledgements The authors would like to thank Mrs. Catherine Dupic for her assistance in the preparation of this manuscript.

Conflict of interest statement T.Lefevre is a proctor for transfemoral-TAVI for Edwards Lifesciences, and is a consultant for Symetis, Direct Flow Medical, Boston Scientific and Medtronic. M.Romano

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is a proctor for transapical-TAVI for Edwards Lifesciences. B.Chevalier is a proctor for

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Medtronic. The remaining authors have no conflicts of interest to disclose.

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Figure legends

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Table 1. Baseline characteristics stratified by case number

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Table 2. Procedural and post-procedural characteristics stratified by case number

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Table 3. Logistic regression analysis for the association between 30-day mortality and

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clinical findings

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Figure 1. CUSUM analysis in case of TAo-TAVI

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Figure 2. Survival curves stratified by case number

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Supplementary figure 1. (A) CUSUM analysis in Edward cases. The actual outcome tended to be better than expected after the 105th consecutive case. (B) CUSUM analysis in CoreValve cases. The actual outcome tended to be better than expected after the 21th consecutive case.

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[1] Zahn R, Gerckens U, Grube E, Linke A, Sievert H, Eggebrecht H, et al.

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[2] Moat NE, Ludman P, de Belder MA, Bridgewater B, Cunningham AD, Young CP,

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Table 1. Baseline clinical characteristics stratified by case number

(n=128) Baseline characteristics

Late

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Early

p value

(n=129)

84.5±4.2

82.7±6.4

0.001

Gender, male

62 (49%)

70 (54%)

0.383

26.1±4.3

26.9±5.1

0.231

1.73±0.20

1.77±0.24

0.165

109 (85%)

105 (83%)

0.592

12 (9%)

5 (4%)

0.080

28 (21%)

19 (15%)

0.147

5 (4%)

9 (7%)

0.273

Prior cardiac surgery, n

5 (4%)

8 (6%)

0.395

Prior stroke, n

9 (8%)

6 (5%)

0.326

Diabetes mellitus, n

24 (19%)

34 (27%)

0.183

Hypertension,n

81 (63%)

89 (72%)

0.151

Dyslipidemia, n

66 (51%)

77 (63%)

0.069

COPD, n

13 (10%)

24 (19%)

0.043

Logistic EuroSCORE, %

18.1±10.5

17.1±12.4

0.517

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Age, years

BMI (kg/m2)

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BSA (m2)

Prior MI, n Prior PCI, n

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Prior CAGB, n

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NYHA classification (III/IV)

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Creatinine clearance (ml/min)

60.2±23.6

60.4±26.9

0.939

LVEF, %

55.4±13.3

53.5±14.8

Low EF

26 (20%)

24 (20%)

0.956

AVA (cm2)

0.67±0.13

0.68±0.16

0.515

Mean gradient (mmHg)

46.5±14.1

46.2±16.0

0.884

AR grade (0-4)

0.76±0.67

0.88±0.81

0.274

44.0±11.6

45.6±12.1

0.364

107 (91%)

123 (96%)

0.138

23.8±2.1

24.0±2.1

0.497

MA

NU

SC R

IP

T

Echocardiographic data

PAP (mmHg)

TE

D

CT guided valve sizing Mean diameter of annulus by CT

0.305

CE P

Values are number (%) or mean ± SD. BMI, body mass index; BSA, body surface area; NYHA, New York Heart Association; MI, myocardial infarction; PCI percutaneous coronary intervention; CABG,

AC

coronary artery bypass grafting; COPD, chronic obstructive pulmonary disease; LVEF, left ventricle ejection fraction; AVA, aortic valve area; AR, aortic regurgitation; PAP, pulmonary artery pressure; CT, computed tomography.

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IP

T

Table 2. Procedural and post-procedural characteristics stratified by case number

(n=128)

p value

(n=129)

Edwards

106 (82%)

79 (61%)

CoreValve

22 (18%)

50 (39%)

26.7±2.3

27.4±2.2

0.042

119 (93%)

121 (96%)

0.286

14 (11%)

9 (7%)

0.268

24 (19%)

15 (12%)

0.081

6 (5%)

0 (0%)

0.014

20 (16%)

8 (6%)

0.002

Major vascular complication

6 (5%)

2 (2%)

0.105

Life-threatening bleeding

12 (9%)

1 (1%)

0.002

Annulus rupture

3 (2%)

1 (1%)

0.331

Pacemaker implantation

9 (8%)

15 (13%)

0.187

2 valve implantation

5 (4%)

5 (4%)

0.970

12 (10%)

8 (6%)

0.246

MA

NU

Type of valve

Late

SC R

Early

Size of valve

CE P

30 day mortality

TE

Procedural success

D

Post-procedural variables

30 day combined safety endpoint

AKI

AC

Major stroke

Post AR ≥grade 2

<0.001

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AC

CE P

TE

D

MA

NU

SC R

IP

T

Values are number (%) or mean ± SD. AKI, acute kidney injury; AR, aortic regurgitation.

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Table 3. Logistic regression analysis for the association between 30-day mortality and clinical

SC R

IP

T

findings

Univariate analysis

OR

95%CI

p value

1.63

0.68-3.93

0.270

1.04

0.95-1.15

0.306

1.03

0.28-3.71

0.961

0.98

0.96-1.00

0.128

Logistic EuroSCORE (per 1 increase)

1.00

0.97-1.04

0.690

AKI

4.66

1.68-12.90

0.003

Life-threatning bleeding

2.38

0.48-11.64

0.283

VARC major vascular complication

11.15

2.72-45.63

0.001

Post-procedural AR ≥grade 2

2.82

0.73-10.88

0.132

NU

Early experience

MA

Age

AC

CE P

TE

Creatinine clearance (ml/min)

D

COPD

OR, odds ratio; CI, confidence interval; other abbreviations as in Table 1.

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