Abstract: Objectives. To assess the safety and efficacy of a new simplified procedure for transfemoral (TF) transcatheter aortic valve replacement (TAVR): the FAST protocol. Background. A minimalist approach for TF-TAVR has been reported. The goal of this simplified strategy is to reduce the rate of specific complications associated with general anesthesia, second vascular access, and use of temporary pacemaker, and to reduce the length of stay. Methods. We retrospectively reviewed all TF-TAVR cases performed at our center between January 2015 and December 2017. The FAST strategy consisted of local anesthesia with conscious sedation, echocardiographically guided TF puncture for main vascular access, radial approach for secondary arterial access, and left ventricular guidewire rapid pacing. Patients were sorted according to the initial strategy (FAST vs standard). The primary outcome was an early safety composite outcome including all-cause mortality, all stroke, life-threatening bleeding, acute kidney injury, coronary artery obstruction, major vascular complication, and valve-related dysfunction. Results. A total of 285 consecutive patients were included in the present analysis (76 FAST patients and 209 standard patients). There were no baseline differences between groups. Complete FAST procedure was feasible in 83.0% of cases and all FAST procedures were successful. The primary outcome was significantly lower in the FAST group (1.3% vs 14.3%; P<.001). The use of FAST protocol resulted in a reduction of major bleeding (1.3% vs 10.1%; P=.01), blood transfusion (2.6% vs 14.3%; P<.01), and vascular complications related to the secondary access (0.0% vs 5.3%; P=.04). The length of stay was also significantly lower in the FAST group (4.9 days vs 6.4 days; P<.01). Conclusions. FAST can be safely performed and is associated with lower rates of iatrogenic complications and a shorter length of stay.
J INVASIVE CARDIOL 2019;31(10):300-306.
Key words: minimalist approach, minimally invasive, radial approach, transcatheter aortic valve replacement, TAVR
Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of severe symptomatic aortic valve stenosis in elderly patients and has recently been shown to be non-inferior to conventional surgery in intermediate-risk patients.1 Increasing operator experience, refinement of transcatheter heart valves, introducers and delivery systems, and progress in cardiovascular imaging have contributed to the decrease in complication rates associated with TAVR.2 Nevertheless, vascular complications have been reported as a major cause of morbidity and mortality after TAVR.3-5 In addition, right ventricular (RV) temporary pacing during TAVR is time-consuming and can be associated with vascular and pericardial complications. Therefore, with the objective of reducing the complexity and enhancing the safety of our transfemoral (TF) TAVR procedures, we adopted a new, minimally invasive protocol using local anesthesia and conscious sedation, echocardiographically guided TF puncture for main vascular access, radial approach for secondary arterial access, and left ventricular guidewire rapid pacing (the FAST protocol). We sought to evaluate the safety and efficacy of the FAST protocol in routine practice, in comparison with a standard approach.
Study design and population. We retrospectively reviewed all consecutive cases of TF-TAVR performed at our center from January 2015 to December 2017. Edwards Sapien 3 valve (Edwards Lifesciences) and CoreValve/EvolutR CoreValve (Medtronic) were used. All TAVR procedures were performed in a standard cardiac catheterization laboratory with fully percutaneous access-site entry and closure. The study was conducted according to the Declaration of Helsinki. As this was a retrospective analysis conducted per institutional guidelines for data security and privacy, a waiver of consent was granted. Data were anonymized by authors prior to analysis.
Procedural details. The choice of valve type and FAST or standard protocol was left to the discretion of the operators and decided preoperatively. The specificities of FAST protocol using local anesthesia with conscious sedation are described below:
• Radial access (RA): the left or right RA was obtained using an arterial puncture kit and a 5 Fr, 10 cm Radifocus radial introducer sheath (Terumo Interventional Systems). A 5 Fr, 125 cm-long pigtail catheter was advanced to the aortic sinus over a standard 0.35 J-wire to perform aortography in order to guide valve deployment. The percutaneous closure success of the main femoral access (FA) was evaluated with a final iliofemoral angiogram, using the radial 125 cm pigtail catheter.
• Ultrasound-guided femoral puncture: main FA was obtained by ultrasound guidance to ensure a puncture above the femoral bifurcation and to avoid front wall calcifications.
• No systematic use of RV lead: procedures with the Medtronic CoreValve/EvolutR valves underwent a femoral venous access using a 6 Fr, 25 cm-long Radifocus introducer sheath, making the temporary pacing lead placement in the RV more accessible in case of high-degree conduction disturbances.
• Guidewire pacing: temporary pacemaker was connected to a Safari2 wire (Boston Scientific) (negative clip) and to the patient’s skin (positive clip) using alligator clips, allowing the deployment of the Edwards valves under rapid ventricular pacing.
All procedures not performed with this specific protocol were included in the standard approach group. Patients in the standard group have also benefited from an ultrasound-guided femoral puncture for the main access because we started using this technique at our center in 2014. All TF-TAVRs in the two groups underwent the same preclosure technique with two Perclose Proglide devices (Abbott Vascular) and an iliofemoral angiogram at the end of each procedure. In the FAST group, the second RA site was closed with a TR Band (Terumo Interventional Systems) or local compression, according to the discretion of the operator. In the standard group, the second FA site was closed by manual compression, Perclose Proglides, or AngioSeal (Terumo Interventional Systems), according to the discretion of the operator.
As per institutional protocol, patients were treated with 3 months of dual-antiplatelet therapy or with 3 months of anticoagulant therapy in addition to clopidogrel if the patient had a relevant indication for anticoagulant therapy
Data collection and follow-up. Baseline demographics, medical history, cardiac catheterization data, and cardiac outcomes were abstracted from medical charts. Additional follow-up and outcome data was collected via systematic telephone calls or clinical visits.
Clinical endpoints and definitions. Patients were dichotomized according to the choice of the initial strategy (FAST vs standard). The primary endpoint was an early (30-day) safety composite outcome according to the Valve Academic Research Consortium (VARC)-2 criteria,6 including all-cause mortality, all stroke, life-threatening bleeding, acute kidney injury, coronary artery obstruction, major vascular complication, and valve-related dysfunction. Secondary outcomes included length of stay, all bleedings according to Bleeding Academic Research Consortium (BARC) classification, red blood cell transfusions, per-procedural tamponades, and all vascular complications.7 Vascular complications were also classified as related to the primary or secondary access. Hospital length of stay was calculated from the procedure date to the discharge date.
Statistical analysis. Continuous variables are presented as mean ± standard deviation for variables following normal distribution, whereas nominal variables are presented as absolute values and percentages. Group comparisons were tested for differences with the Student’s t-test for continuous variables, and the Chi-square test or Fisher’s exact test was used for categorical variables. No imputation of data was made for missing variables. Statistical analyses were performed using GraphPad Prism, version 7 (GraphPad Software) and R software, version 3.5.0.
Population and procedural baseline characteristics. Between January 2015 and December 2017, a total of 285 consecutive patients undergoing TF-TAVR were included in the present analysis (76 patients in the FAST group and 209 patients in the standard group). Baseline characteristics of the study population are presented in Table 1. Mean age was 84.5 years, and 44.5% were men. Mean EuroScore II was 4.93% and mean left ventricular (LV) ejection fraction was 57%. There were no significant differences in baseline characteristics between the two groups. Procedural characteristics and complications are summarized in Table 2. The valve type distribution between Edwards Sapien 3 and Medtronic CoreValve/EvolutR CoreValve was the same in the two groups and remained stable during the 2 years of the study (Figure 1). The standard group included CoreValve implantation in 42 procedures (40.4%) and EvolutR implantation in 62 procedures (59.6%). In the FAST group, only 1 procedure used a CoreValve device, while all other procedures utilized the EvolutR valve. Patients in the FAST group generally received a higher dose of heparin and protamine compared with patients in the standard group.
Feasibility and procedural outcomes. The FAST procedure was completely feasible in 63 patients (83.0%). Failure to obtain RA occurred in 3 patients, leading to use of the FA as secondary access in 2 patients and brachial access in 1 patient, with no vascular complications. The use of temporary RV lead was necessary in 10 patients (13.0%), for postdilation with complete removal at the end of the procedure in 4 patients and for symptomatic atrioventricular block post implantation in 6 patients. Fluoroscopy time was significantly lower in the FAST group (13.2 ± 8.4 min vs 15.9 ± 8.5 min; P=.02).
Endpoints. The primary outcome was significantly lower in the FAST group (1.3% vs 14.8%; P<.001) (Table 3). There were no deaths or strokes/transient ischemic attacks (TIAs) in the FAST group vs 10 deaths and 4 strokes/transient ischemic attacks (TIAs) in the standard group (0.0% vs 4.8% [P=.07] and 0.0% vs 1.9% [P=.58], respectively). There was also a downward trend to life-threatening bleedings and major vascular complications in the FAST group vs the standard group, without statistically significant differences between the two groups (1.3% vs 5.3%, respectively [P=.19] and 1.3% vs 7.2%, respectively [P=.08]). Patients in the FAST group had significantly lower rate of major bleedings (1.3% vs 10.1%; P=.01), vascular complications related to secondary access (0.0% vs 5.3%; P=.04), and red blood cell transfusions (2.6% vs 14.3%; P<.01). The rate of preimplantation balloon valvuloplasty (BAV) was lower in the FAST group vs the standard group (2.6% vs 19.6%, respectively; P<.001), as was the rate of new pacemaker implantation (7.9% vs 17.7%, respectively; P=.04). Rates of all-cause mortality (0.0% vs 4.8%; P=.07) and tamponade (0.0% vs 3.8%; P=.11) were not significantly different in the two groups (Figure 2). Length of stay from procedure to discharge was significantly reduced in the FAST group compared with the standard group (4.9 ± 2.3 days vs 6.4 ± 4.8 days, respectively; P<.01) (Figure 1). The occurrence of events and the primary composite outcome were well balanced over the study period.
The present study comparing the minimally invasive FAST protocol with the standard approach in TF-TAVR procedures demonstrated a significant reduction of the early safety composite outcome. FAST protocol was also associated with improved periprocedural outcomes, such as a reduction in fluoroscopy time, use of temporary RV lead, and length of stay.
To our knowledge, this is the first study evaluating the feasibility and safety of this minimally invasive protocol in comparison with a standard approach. Minimally invasive procedures have been reported before,8 but no data existed on its safety and efficacy in routine use.
Although general anesthesia decreased in recent years in French practices (from 70.3% to 47.2% from 2010 to 2015, with >80% via TF approach in 2015),9 it remains a widespread practice, especially in the United States, where >80% procedures are still performed under general anesthesia (from 97.6% to 82.6% from 2012 to 2015).10 Nevertheless, to reduce postprocedural hospital stay and procedure costs,11,12 the use of local anesthesia with conscious sedation in TF-TAVR seems to be safe, with fewer postprocedural complications and lower early mortality rate, suggesting its broad application.12 TF-TAVR procedures performed under general anesthesia represent <3% of all cases in our study and correspond to critical respiratory or unstable hemodynamic status.
Tamponade. Rates of cardiac tamponade significantly increased in recent years.9 RV temporary pacing during TAVR is time-consuming and can be associated with vascular and pericardial complications. More than one-half of reported tamponade cases in TAVR could be attributed to RV perforation by temporary pacemaker, including use of passive RV leads with a balloon, which we did not adopt in our routine practice.13 In our study, even if there was a trend in favor of the FAST group concerning the rate of tamponade, the difference between the standard group was not statistically significant. Using LV guidewire for rapid pacing is a simple and reproducible technique that can be used effectively and safely during TAVR procedures.14 Nevertheless, in order to make the temporary pacing lead placement in the RV more accessible in case of high-degree conduction disturbances, a venous access can be performed before valve implantation, as we did for CoreValve/EvolutR procedures.
Femoral main access. In percutaneous TF-TAVR, the routine use of two-dimensional ultrasonographically guided FA, compared with traditional anatomic landmark palpation with angiography-guided access, was associated with substantial reductions in access-related vascular and bleeding complications.15 Echocardiographically guided puncture has been routinely used for the femoral main access for several years at our institution, and was used in all procedures in the current study. In our opinion, ultrasound-guided puncture should be part of any TF-TAVR simplification protocol; thus, we described it in the FAST protocol even though it was used in all TF-TAVR procedures.
Radial approach. In TAVR, about 25% of vascular access-site complications have been reported to be related to the secondary access. The rate of major vascular complications related to the secondary access could reach 39% in patients with the FA as secondary access.16 The use of RA as a secondary access seems safe and effective,17 and has been associated with a major reduction in vascular complications.16,18 Our results are consistent with the literature data, with a significant reduction in vascular complications related to secondary access and major bleedings in the FAST group, despite the increased use of heparin inherent with the use of RA. Nevertheless, in case of RA as secondary access, specific devices such as compatible long-shaft 6 Fr balloons or stents must be present in the catheterization laboratory. In our study, all vascular complications in the FAST group were resolved by using the RA (4 cases with prolonged balloon inflation, and 1 case with auto-expandable stent), without the necessity of a second FA. However, the use of right RA as secondary access could have some drawbacks, including the necessity of embolic protection such as the Sentinel Cerebral Protection System (Boston Scientific). Nevertheless, left RA is the preferred secondary access site, as it shortens the length to the femoral vessel in cases with vascular complications.
Preimplantation BAV. TAVR procedures with or without preimplantation BAV are associated with similar outcomes as stroke/TIA and permanent pacemaker implantation.19 Furthermore, performing TAVR without preimplantation BAV is associated with a reduction in contrast volume and total procedural time.20 In addition, standard BAV may be poorly tolerated hemodynamically, especially in patients with low LV ejection fraction. In our study, preimplantation BAV concerns <3% of cases in the FAST group, which goes in the direction of a maximally simplified, safe procedure. In addition, even if the relationship between preimplantation BAV and pacemaker rate remains controversial, it could be one hypothesis to explain the lower rate of pacemaker implantation in the FAST group.19,21-24
Length of stay. The postprocedural length of stay was significantly shorter in the FAST group, with a variation of 1.5 days. Factors associated with delayed discharge are usually blood transfusion and pacemaker implantation.25 The occurrence of these two events was significantly less common in the FAST group. The reduction in length of stay presents several positive aspects, especially in frail or elderly patients in whom prolonged hospitalization can be prejudicial, and also offers potential cost-saving benefits.
Study limitations. Despite very promising results, our study has the inherent limitations of any retrospective study from a single center. However, it is currently the largest population ever to compare the simplified FAST protocol using both commercially available valve types. As this study was not randomized, a selection bias could be present. Nevertheless, both strategies were performed regardless of patient characteristics and all consecutive patients were included in the present analysis. Despite this, we cannot exclude that there was a selection bias when the operator decided to perform the FAST protocol. Indeed, there were no pre-established selection criteria to choose either protocol; the decision to practice the procedure according to FAST or standard protocol was made by the main operator’s discretion.
Antithrombotic therapies and bleeding risk factors were not included in the baseline characteristics. Even so, per our institutional protocol, patients were treated with the same antithrombotic therapies in both groups, ie, 3 months of dual-antiplatelet therapy or 3 months of anticoagulant therapy in addition to clopidogrel if the patient had a relevant indication for anticoagulant therapy. EvolutR was the main valve used in the FAST protocol, whereas both CoreValve and EvolutR valves were used in the standard group, which could induce potential bias.
Furthermore, considering that most of the FAST procedures were performed in the last year of the study (96% of FAST procedures completed in 2017), a learning-curve effect could have influenced our results. Nevertheless, the TF-TAVR experience began in 2009 at our institution. Considering that the 285 TAVR procedures studied were all performed by one of the three experienced operators at our center, with >300 procedures accomplished before the time of the study, the effect of a learning curve on the results is unlikely.9 On the other hand, patients who did not benefit from the FAST protocol were included in the standard group, which had no predefined protocol contrary to the FAST group. This lack of standardization can lead to a comparison bias between the two groups.
Last, although this is the largest report on this minimally invasive approach, our cohort is still relatively small to detect significant differences in the clinically important outcomes of all-cause mortality and stroke. Indeed, the significance of the primary endpoint was essentially driven by major bleeding and transfusion. Nevertheless, the reduction of major bleeding and transfusion is of importance in such procedures to reduce morbidity and hospital length of stay. Whether such a strategy could reduce stroke and/or mortality can only be speculative and should be investigated in a dedicated, randomized, sample-size powered, controlled trial.
Technological advances in devices and delivery systems are evolving, with the aim to simplify the procedure while enhancing safety. FAST can be performed safely by experienced operators and is associated with lower rates of iatrogenic complications. Given that TAVR indications are likely to expand to younger patients with lower surgical risk, the incidence of life-threatening complications remains an issue and could be an argument to extend FAST indications.
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From 1the Hôpital privé de Parly 2 Le Chesnay, Department of Cardiology, Le Chesnay, France; and 2Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Cochin, Department of Cardiology, and Université Paris-Descartes, Paris, France.
Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Jégou reports consultant fees from Edwards Lifesciences. Dr Dambrin reports consultant fees from Medtronic. The remaining authors report no conflicts of interest regarding the content herein.
Manuscript submitted March 8, 2019, provisional acceptance given April 24, 2019, final version accepted July 2, 2019.
Address for correspondence: Arnaud Jégou, MD, Hôpital privé de Parly 2 Le Chesnay, Department of Cardiology, 21 rue Moxouris, 78150 Le Chesnay, France. Email: email@example.com