Standardized Methodology for Transfemoral Transcatheter Aortic Valve Replacement With the Edwards Sapien XT Valve Under Fluoroscopy Guidance

Abstract: Objectives. To provide a simplified, standardized methodology for a successful transfemoral transcatheter aortic valve replacement (TAVR) procedure with the Sapien XT valve in patients with severe aortic stenosis (AS). Background. TAVR is currently reserved for patients with severe, symptomatic AS who are inoperable or at high operative risk. In many institutions, TAVR is performed under general anesthesia with intubation or with conscious sedation. In addition, many institutions still use transesophageal echo (TEE) during the procedure for aortic root angulations and positioning of the valve prior to implantation. Methods. We enrolled 100 consecutive patients (mean age, 80 ± 7 years; range, 50-94 years; female n=59) with severe symptomatic AS. Annulus measurements were based on computed tomography angiograms. All patients underwent fluoroscopy-guided transfemoral TAVR with little to no sedation and without simultaneous TEE. Results. TAVR was predominantly performed with the use of local and central analgesics; only 36% of our cohort received conscious sedation. Procedural success of TAVR was 99%. Transthoracic echocardiography before discharge excluded aortic regurgitation (AR) >2 in all patients (AR >1; n=6). In-hospital stroke rate was 6%. The vessel closure system was successfully employed in 96%. Major vascular complication rate was 1%. The 30-day mortality was 2%. Conclusions. Fluoroscopy-guided TAVR with the use of just analgesics with or without conscious sedation is safe and effective, and this potentially enables a more time-effective and cost-effective procedure. This paper provides simplified, stepwise guidance on how to perform transfemoral TAVR with the Sapien XT valve.

J INVASIVE CARDIOL 2014;26(9):451-461

Key words: aortic valve stenosis, transfemoral TAVR, procedure methodology

_______________________________________

Aortic valve replacement (AVR) is the therapy of choice for severe aortic stenosis (AS). Operative mortality of isolated surgical AVR is as low as 1%-3% in patients younger than 70 years and 4%-8% in selected older adults.^1-3 Transcatheter AVR (TAVR) is increasingly utilized for the treatment of severe AS in select high-risk or inoperable patients.^4-7 Despite TAVR being a less invasive procedure, the 2-year follow-up data from the Partner trial showed that, in high-risk patients, the rates of death from any cause were similar in the TAVR and surgery groups.⁸ Optimizing the TAVR procedure may help set it apart as the procedure of choice for severe AS when compared with conventional surgical AVR.

Although TAVR is being performed more frequently, a standard for the preparation and implementation of the procedure has not yet been established. For example, some centers use transesophageal echocardiography (TEE) for the assessment of annulus size, while others use computed tomography angiography (CTA). Currently, many centers perform TAVR under general anesthesia with fluoroscopy and intraprocedural TEE guidance. Candidates suitable for TAVR are high-risk patients by definition; therefore, it is essential to keep the procedure as least invasive and simple as possible. Often, catecholamines are required during induction and course of general anesthesia to avoid systemic hypotension. However, the use of catecholamines can be detrimental in patients with severe AS. Furthermore, in some patient groups (eg, severe chronic obstructive pulmonary disease), general anesthesia with mechanical ventilation is challenging.⁹ 

A case series reported by a group in Rouen, France showed the feasibility and safety of performing fluoroscopy-guided transfemoral TAVR with the use of conscious sedation and local anesthesia.¹⁰ Greif et al further demonstrated that TAVR can be performed with the use of only analgesics and no sedation.¹¹ Although several studies and case reports have shown how the TAVR procedure has evolved over the years, no one has provided a standardized, stepwise approach to performing TAVR. The main purpose of this paper is to provide a refined, step-by-step procedural approach for transfemoral implantation of the Sapien XT valve under fluoroscopic guidance and with minimal to no sedation. 

Methods

Patient selection and preparation. From October 2011 until June 2013, we prospectively evaluated and treated 100 consecutive patients with severe symptomatic AS using our stepwise technique for transfemoral TAVR with the Sapien XT valve (Edwards Lifesciences). Our TAVR procedural team consisted of interventional cardiologists, cardiac surgeons, and a dedicated anesthesiologist for all cases. 

Diagnostic work-up for all patients before TAVR included electrocardiogram-gated 64-slice multidetector CTA of the heart and thoracic/abdominal aorta, transthoracic echocardiography (TTE), TEE, coronary angiography, aortic root angiography, and selective iliofemoral angiography. 

MSCT protocol. All patients underwent CT angiography using 64-slice CT (Somatom Sensation 64 Cardiac; Siemens). Studies were performed with contrast medium enhancement with 90-110 mL of iodinated contrast agent (Imeron 350; Bracco Imaging) infused at 5 mL/s. Thoracic studies were acquired with simultaneous recording of the patients’ ECGs in order to allow for retrospective registration of image reconstruction to the desired cardiac phase. Image reconstruction intervals relative to RR (%RR) with the least cardiac motion were determined based on a preview series. Reconstruction parameters of the heart comprised a 0.75 mm section thickness with 0.3 mm increment. No additional beta blockade was administered to achieve slower heart rates. Abdominal series were acquired in a second scan within the same session without ECG gating. In the case of severe arrhythmia, the entire scan was performed without ECG gating.

Image reconstruction. All CT datasets were transferred to a dedicated workstation (Syngo InSpace; Siemens). The transverse, coronal, and sagittal planes were automatically generated by the software. Subsequently, the aortic annulus was manually determined by the first section below the valve sinus in all 3 planes. The valve size was decided based on the mean diameter measurement (long diameter + shortest diameter)/2).¹²

Valve size selection. Selection of the appropriate valve size (23 mm, 26 mm, and 29 mm) was based on CT measurement of the aortic annulus. A 23 mm prosthesis was implanted for mean annulus size ≥19 and <22 mm, a 26 mm prosthesis for mean annulus size ≥23 and <25 mm, and a 29 mm prosthesis for mean annulus size ≥26 and <28 mm. For patients with annulus size ≥22 and <23 mm and ≥25 and <26 mm, a 23 mm or 25 mm Edwards balloon was utilized for sizing, respectively. All other patients received balloon valvuloplasty with a 20 mm Edwards balloon (23 mm prosthesis), a 23 mm Edwards balloon (26 mm prosthesis), or a 25 mm Edwards balloon (29 mm prosthesis), respectively. In case of borderline annulus sizes and planned balloon sizing, the larger sheath size — if possible — was chosen (the 18 Fr eSheath for prosthesis sizes between 23 and 26 mm, and the 20 Fr eSheath for prosthesis sizes between 26 and 29 mm).¹² 

Anesthesia and hemodynamic monitoring. The majority of our patients (61%) underwent the TAVR procedure with local and central analgesics only. Prior to the procedure, patients were prepared with central venous access via the right jugular vein. Alternatively, a long dual-lumen central venous line was placed through a transfemoral access. All cases were performed without Swan-Ganz catheter. Monitoring devices utilized during the procedure included 3-channel ECG, continuous oxygen saturation, and hemodynamic assessment via radial artery catheter. In the absence of any contraindications, a face mask was used to deliver oxygen to the patient at 6 L/min. Analgesia was maintained using intravenous remifentanil administered at 0.025-0.100 µg/kg/min. Local analgesia was obtained with 2% lidocaine (20 mL on each femoral site). Conscious sedation was achieved with midazolam (1-2 mg predominantly) in 32 patients and with propofol only in 4 cases. 

Stepwise Instruction for Transfemoral TAVR Procedure

1. Contralateral access: place a long sheath (21 cm, 6 Fr) in femoral artery and vein.
2. Place a temporary pacemaker lead in the apex of the right ventricle. Place an angled pigtail catheter in the right coronary cusp. 
3. Definition of the perpendicular implantation view (Figure 1, Right Cusp Rule¹³). The injection volume for a root shot is 10 mL, with a flow of 10 mL/s.
4. Access vessel puncture technique and the Proglide parallel suture vessel closure technique: assess and select the access site based on CT imaging. The puncture site must be above the femoral bifurcation and below the inguinal ligament. Select a segment of the vessel without calcification on the anterior wall to safely place the interior sutures with the Proglide system (Figure 2).
5. Predilation and placement of the sheath over the Amplatz Extra-Stiff wire (Cook Medical): in cases of severely kinked pelvic vessels, place the sheath over a Lunderquist wire (Cook Medical) or Back-up Meier wire (Boston Scientific).
6. Cross the native valve using an Amplatz left 1 (AL 1) catheter and a straight wire (standard wire or glide wire). Alternatively, an Amplatz left 2 (AL 2), a Judkins right 4 (JR 4), or a Multipurpose catheter can be used to cross the native valve.
7. Placement of the Amplatz Extra-Stiff guidewire: once you cross the native valve, advance the AL 1 catheter into the left ventricle (LV). Exchange the AL 1 catheter for a straight pigtail catheter over a long exchange wire. In a right anterior oblique (RAO) 30° view, place the curved Amplatz Extra-Stiff wire through the pigtail catheter and into the LV apex. This wire placement into the LV should be done carefully and under fluoroscopy. Avoid positioning the wire in the mitral apparatus. The left anterior oblique (LAO) view can help to clarify the wire route and position. Figure 3 shows the bend of the wire and its optimal placement in the LV apex.
8. Choice and bend of the guidewire: the recommended guidewire for the Edwards Sapien system is the Cook Amplatz Extra-Stiff wire. The alternatively used Amplatz Super-Stiff guidewire (Cook Medical) will straighten the flex mechanism of the Novaflex deployment catheter and will push the deployment catheter toward the outer curve of the aortic arch and to the side of the non-coronary cusp.
9. Place the valvuloplasty balloon in the middle of the annulus and inflate under rapid pacing (180-200 beats/min when the systolic pressure drops below 50 mm Hg (pulse pressure <10 mm Hg). If balloon sizing of the annulus is required, obtain a perpendicular view and then inject contrast (10 mL with a flow of 10 mL/s) through the pigtail placed in the aortic sinus during full balloon inflation.
10. Valve alignment in the descending aorta: cross the aortic arch with the flexed system. Place the valve prosthesis coaxial to the annulus (Figure 4). The position of the prosthesis can be manipulated by placing tension on the wire, by rotating or deflecting the flexed catheter system.
11. Final positioning of the prosthesis under rapid pacing: Figure 5 shows the landing zone of the different Sapien XT valve sizes along with the intended implantation height that is determined based on the distance to the coronary ostia. 
12. The two-step deployment: store a reference picture with the optimal root shot (Figure 6A). Under rapid pacing (180-200 beats/min), when the systolic pressure is less than 50 mm Hg (pulse pressure <10 mm Hg), inject 10 mL of contrast agent at 10 mL/s. Pull the pigtail catheter back above the valve. The position of the valve prosthesis, the aortic root anatomy, the left coronary ostium, and the annulus line will be visible for a few seconds (Figure 6B). Carefully adjust the valve prosthesis as needed. When an optimal position of the prosthesis is achieved (Figure 6C), deploy the prosthesis half way (Figure 6D). If the position of the valve did not change, then deploy the valve completely (Figure 6E). The balloon should be fully inflated for 3 seconds. If the position of the valve moved — mostly in an upward direction — then it should be carefully adjusted while the valve is being slowly deployed.
13. After implantation, the position of the valve should be confirmed angiographically in the perpendicular plane with 10 mL of contrast agent at 10 mL/s (Figure 6F). In this perpendicular view, the distance to the coronaries is well visualized (sometimes a LAO cranial view is necessary for correct visualization of the ostium of the left main stem). In addition, the deployment of the valve frame can now be assessed. If the valve frame is under deployed at certain segments — perhaps due to heavy calcification of the native valve — postdilation of the prosthesis can now be considered. If the valve is positioned too high or too low, then placement of a second valve can be discussed. 
14. If deployment of a second valve is required, be cautious when going across the initial valve that was inadequately deployed, as it may not be fixed and can get pushed into the LV. Ensure good position and then slowly deploy the second valve to avoid placement of this new valve in the same position as the first valve. 
15. Once the prosthesis is deployed and is noted to be in a good position, pull back the guidewire. Obtain a final angiography in an RAO view to ensure a good functional result. Inject 30 mL of contrast agent at a flow rate of 15 mL/s to visualize valvular or paravalvular aortic regurgitation (Figure 7). In our institution, we assess the severity of AR angiographically in an RAO 30° view (Figure 7A). If AR is noted in the RAO 30° view, the severity of the AR is confirmed in a second plane (LAO 60°) that is 90° to the first plane (Figure 7B). Paravalvular regurgitation showing a large-volume jet under fluoroscopy in two separate planes generally implies significant AR. 
16. Postdilation of an underdeployed valve (Figure 8): if significant paravalvular regurgitation (degree >1) is noted due to underdeployment of the valve, then postdilation of the valve with a balloon should be considered. The postdilation can be done with the Novaflex system balloon with additional volume or with a commercially available balloon (Table 4).
17. For the postdilation, place a larger part (2/3) of the balloon toward the ventricle to ensure that mainly the lower part of the prosthesis valve frame is enlarged when the balloon is inflated (Figure 8D). Dilation of the upper prosthesis frame should be avoided to prevent destruction of the valve geometry. 
18. Remove the access sheath and close the puncture site using the previously placed Proglide sutures. Keep the guidewire in the vessel until successful closure. If a suture fails, place a new Proglide suture. Finally, remove the contralateral arterial and venous sheath.

Procedural Endpoints and Definitions

The primary endpoints included: device success; any in-hospital AR, stroke, transient ischemic attack (TIA), periprocedure myocardial infarction (MI), acute kidney injury (AKI), permanent pacemaker implant (PPM), vascular complications, and mortality; and also 30-day mortality.

Device success was assessed according to the VARC-2 definition (defined as absence of procedural mortality, and correct positioning of a single prosthetic heart valve into the proper anatomical location, and intended performance of the prosthetic heart valve with no prosthesis-patient mismatch, mean aortic valve gradient <20 mm Hg or peak velocity <3 m/s, no moderate or severe prosthetic valve regurgitation).¹⁴ All complications, such as stroke, TIA, MI, AKI, and vascular complications, were defined based on the VARC-2 criteria.¹⁴ For assessment of AKI, we used the creatinine value obtained the day before the TAVR procedure and the highest value obtained in the period following the TAVR procedure until discharge. AR was assessed by a modified angiographic classification described first by Sandler et al.¹⁵ Hemodynamic data were taken into consideration in cases where the angiographic results were unclear.¹⁶ In addition, all patients underwent postprocedural TTE evaluation performed by an independent specialist in cardiac imaging. In-hospital mortality was defined as death from any cause during the initial hospitalization, and 30-day mortality was defined as death from any cause within 30 days of the procedure.

Procedural medications. All patients were preloaded with 500 mg of intravenous aspirin. Before vessel closure, heparin was completely antagonized with protamine. Patients on warfarin received only 50% of the heparin dose. After the procedure, patients were placed on life-long aspirin with an oral dose of 100 mg per day. Patients on warfarin received 100 mg aspirin for 4 weeks. Dual-antiplatelet therapy was not given except for patients with additional percutaneous intervention during TAVR (n=8). 

Statistical analysis. Categorical data are presented as frequencies and percentages. Normally distributed continuous data are presented as mean ± standard deviation.

Results

Baseline characteristics. The clinical characteristics of the study population are shown in Table 1. CT image quality for aortic annulus assessment was adequate for all patients. 

Procedural outcomes and endpoints. Procedural success was achieved in 99% of our patients with a reduction of mean aortic gradient from 42.3 ± 18 mm Hg to 11.5 ± 4.5 mm Hg and reduction of the maximal aortic gradient from 70.2 ± 26.4 mm Hg to 19.9 ± 8.4 mm Hg. Length of treatment (“puncture to closure time”) was 59.4 ± 17.4 min. The mean contrast volume used was 163.2 ± 63.6 mL. 

TAVR was performed with only local and central analgesics in 61% of our patients; 36% received conscious sedation along with analgesics. Transition to general anesthesia was required in 3 patients (2 due to acute coronary occlusion with subsequent PCI, 1 due to temporary output failure after rapid pacing). 

After valve implantation, 89% of our patients had no significant angiographic evidence of AR. Only 11% of our patients were noted to have moderate AR grade >1, but none had AR grade >2. Postdilation was performed in 15 patients with AR >1 or visually underdeployed valves. The functional result improved in all patients after postdilation. Transthoracic echocardiography was used to exclude significant AR in all patients before discharge (AR >1, n=6; AR >2, n=0). 

TIA rate was 1% and stroke rate was 6%. Three patients had a minor stroke, 1 patient developed an embolic occlusion of the middle cerebral artery that was treated immediately with successful thrombus retrieval,¹⁷ 1 patient had a cerebellar stroke, and 1 patient had a diffuse embolic shower. All TIA and strokes occurred during the periprocedure period. No patients developed TIA or stroke related to postdilatation (Table 3).

Two patients had a periprocedural MI: 1 patient had an acute coronary occlusion from valve material embolization into the left coronary artery, and the other patient had an MI from coronary obstruction from the native aortic leaflet. We also had 1 pericardial tamponade that was successfully treated with pericardiocentesis.

Acute kidney injury was noted in 15 patients. None of our patients required intermittent or continuous renal replacement therapy after the TAVR procedure. The mean creatinine was 1.4 ± 0.8 mg/dL before and 1.5 ± 1.0 mg/dL after TAVR. According to VARC-2 definition, stage 3 AKI was 1% (Table 3).

A permanent pacemaker (PPM) was implanted in 16 patients, of whom 4 patients had undergone postdilation of the implanted valve. The indications for PPM implant are listed in Table 3. 

In-hospital mortality was 4% and the 30-day mortality was only 2%. One patient died during the procedure from left main artery occlusion, and another patient died on day 7 from multi-organ failure. We had 2 additional deaths; 1 patient died on day 35 after developing a malignant arrhythmia, and 1 patient died on day 40 from heart failure. All discharged patients were alive after 30 days (Table 3). 

We used the Proglide vessel closure system in all patients. In 77% of the cases, the initial two sutures were sufficient for vessel closure (Table 2). The vascular access-site complication rate was 9%; 6 patients had an inguinal hematoma, of which 4 were surgically repaired at a later time than the TAVR, 1 patient had acute vessel occlusion that was treated with surgical thrombectomy, and 2 patients developed a pseudoaneurysm that was treated with thrombin injection. Based on VARC-2 definition, our major vascular complication rate was 1% and the minor vascular complication rate was 8% (Table 3).

Discussion

The Sapien XT valve and its delivery system, the NovaFlex, can be implanted through smaller sheath sizes (16 Fr to 20 Fr depending on valve size), thereby increasing the rate of transfemoral access for TAVR in more patients.¹⁸ In addition to the improvements in the prosthesis device and equipment, the manner in which TAVR is performed has evolved over the years. During the early stages of TAVR, this procedure was being performed under general anesthesia with endotracheal intubation.¹⁹ In addition, several different imaging modalities were being utilized for valve sizing and for aortic root imaging to determine a safe and precise position for valve prosthesis deployment.^12,20 Our study demonstrated that transfemoral TAVR with the Sapien XT valve can be performed reliably and safely under fluoroscopy guidance and with minimal to no sedation in patients unsuitable for surgical aortic valve replacement. With our simplified stepwise method, we were able to achieve procedural success in 99% of our patients. 

Analgesics versus conscious sedation. The study performed by Durand et al used lidocaine 2% for local anesthesia, and they administered midazolam and nalbuphine for conscious sedation in all patients.¹⁰ Greif et al took this a step further and showed that TAVI can be successfully performed with the use of only local anesthesia and mild analgesic medication.¹¹ Patients generally get restless and start to move as the conscious sedation fades. This can often hinder the procedure and increase the risk of complications. Our study substantiated the findings of Durand et al;¹⁰ in addition, we further demonstrated that TAVR with the Sapien XT valve can be performed safely and effectively with only analgesic use and no sedation, thereby substantiating the findings of Greif et al. ¹¹ Sixty-one percent of our patients underwent successful transfemoral TAVR with the use of just remifentanyl administered through a central line and local lidocaine 2% for pain management. The risk of respiratory and cardiovascular (CV) complications with moderate and deep sedation is greater in medically compromised patients,²¹ such as the patients who are undergoing TAVR. There are several advantages to performing transfemoral TAVR with only central and local analgesics. First, the hemodynamics are more stable. Second, it dismisses the respiratory and CV risk associated with sedation. Third, as sedation fades, the patients tend to become restless and move during the procedure, thereby increasing the risk of complications. By using only analgesics, the patients are awake and can follow commands. Fourth, the level of patient alertness with analgesic use allows for prompt assessment and management of neurologic sequelae related to TAVR procedure. In addition, new bundle branch block during the procedure can mask the ECG signs of an acute coronary occlusion; however, when the patient is alert, they can further communicate with the physician if they experience any symptoms of angina. Finally, previous studies¹⁹ have shown that TAVR durations under monitored conscious sedation were significantly shorter when compared to TAVR performed under general anesthesia with intubation. There was a trend for shorter intensive care unit (ICU) and hospital stays with conscious sedation. The study by Ben-Dor et al¹⁹ showed that 11.4% of their patients were converted from monitored anesthesia to general anesthesia with intubation during TAVR; this is significantly high when compared to the low rate (3%) of conversion as noted in our study and as noted in the study performed by Greif et al (<1%).¹¹

Fluoroscopy guidance for valve implantation. Fluoroscopy-guided aortic root alignment for valve prosthesis deployment can be quickly and accurately achieved by following the right cusp rule.¹³ The Sapien XT valves implanted by Durand et al and Greif et al were under fluoroscopy guidance as well.^10,11 When we compared the procedural outcomes of our transfemoral TAVR using Sapien XT with those of Durand et al and Greif et al,^{10, 11} we noted the following differences. We had lower 30-day mortality (2% vs 5.5% and 3.1%, respectively), lower AR grade ≥3 (0% vs 1.4% and 0.6%, respectively), lower VARC major vascular complications (1% vs 8.2% and 2.5%, respectively), less contrast dye use (163.2 ± 63.6 mL vs 243.5 ± 107.1 mL and 163.81 ± 53.58 mL, respectively), and reduced procedure time (59.4 ± 17.4 min vs 105.9 ± 40.3 min and 135.37 ± 37.85 min, respectively). The noted differences could be attributed to disparities in patient selection, assessment of valve annulus size and vascular access site, operator experience, and techniques. We speculate that our simplified technique for aortic root alignment with the “follow the right cusp rule” contributed to our reduced contrast volume and procedural time. In most centers, TAVR is performed with intraprocedural TEE. There are a few disadvantages to using intraprocedural TEE. First, there are no available techniques to align the aortic annulus perpendicularly using TEE. Second, the acoustic shadowing from calcium and valve prosthesis impedes adequate visualization with the use of TEE. Our study, in agreement with the previous mentioned studies,^10,11 also demonstrated that transfemoral TAVR can be successfully performed under fluoroscopy guidance only.

Aortic regurgitation. The 2-year PARTNER data²² showed stable valve hemodynamics over the observation period. However, a significant rise of cardiac mortality was noted in patients with significant AR in the German Heart Registry.²³ Furthermore, even mild AR may have a negative long-term outcome.

The evaluation of AR is challenging even with the use of TEE. To date, there is no standardized imaging method for assessment of AR after TAVR. For the evaluation of AR, we used a modified angiographic grading as described by Sadler et al.¹⁵ In case of significant regurgitation in the standard RAO 30° view, a second angiography was performed perpendicular to the first plane. Figure 7 illustrates the modified angiographic grading system we used for assessing AR. 

Meticulous patient preparation, including precise annulus sizing, is of paramount importance to lower the risk of postprocedural AR. As shown by Binder et al,²⁰ CTA is superior to an echo-based aortic annulus sizing. In future, it can be speculated that preprocedure TEE will only be utilized in case of equivocal valve area or annulus measurements. The degree of valve calcification is an important predictor for the occurrence of AR after valve deployment;²⁴ it also determines the success of immediate balloon postdilation as the treatment of choice of AR.²⁵ Recommended balloon volumes for postdilation are shown in Table 4. 

Stroke and TIA. Stroke is a serious complication of TAVR. Not all strokes are clinically apparent. Silent foci on cerebral magnetic resonance imaging can be detected in up to 84% of patients undergoing TAVR.²⁶ In our cohort, clinically apparent cerebral strokes occurred in 6 patients; 1 patient had a TIA. Mortality in patients suffering from major strokes is more than 3.5-fold higher than in non-stroke patients.²⁷ Accordingly, 2 out of 6 patients with stroke in our cohort died. Thirty-day stroke rates using Edwards Sapien prostheses are reported to be 4.2%.²⁷ Partner data reveal a 30-day stroke rate of 6.7% in Partner A²⁸ or 5.5% in Partner B,²⁹ respectively. It is known that approximately 50% of patients with major strokes have persistent neurological symptoms.²⁷ One of our patients with major stroke received successful thrombus aspiration immediately after the procedure with subsequent full recovery.¹⁷ This emphasizes the importance of performing TAVR under conscious sedation and/or with analgesics, as it allows for prompt assessment and treatment of any neurological sequelae resulting from the procedure. Contrary to other observations, we did not find higher rates of stroke after postdilation.²⁵

Permanent pacemaker. In a meta-analysis, a total of 189 of 2887 patients (6.5%) had a PPM implanted after TAVR with an Edwards Sapien valve.³⁰ Another meta-analysis reported a 5.4% mean incidence of PPM implantation following the TAVR procedure.³¹ The need of PPM implantation after surgical AVR is also a well-known finding with an incidence as high as 7%.³² The CHOICE randomized clinical trial compared the balloon-expandable valve (Edwards Sapien XT) with the self-expandable valve (Medtronic CoreValve) in patients undergoing TAVR.³³ In the CHOICE trial, although the placement of a postprocedure PPM was less frequent in the Sapien XT group compared with the CoreValve group (17.3% vs 37.6%; P=.001), it was still a high PPM implantation rate.³³ At first glance, the PPM implantation rate in our population (16%) seems high. One possible explanation for this observation is that we expanded the indication for PPM to include new-onset left bundle branch block that was persistent for more than 24 hours. Persistent left bundle branch block after AVR is a predictor of syncope, atrioventricular block (AVB), and sudden cardiac death.³⁴ Currently, no guidelines based on randomized clinical trials, are available for the indication of PPM implantation after TAVR. However, the 2013 European Society of Cardiology (ESC) guidelines³⁵ issued a class IC indication for PPM implantation after cardiac surgery and TAVR for patients with high degree or complete AVB after a 7-day clinical observation. The observation period was shorter for patients with complete AVB with a low rate of escape rhythm. We were a bit liberal with our indications for a PPM, as we also implant CoreValve prostheses at our institution. One-third of patients undergoing a CoreValve TAVR required a PPM within 30 days.³⁶ Based on the 2013 ESC guidelines, only 5% of our patients had a compelling indication for a PPM. 

Vascular access and complications. The rate for successful puncture-site closure using a double-parallel Proglide technique was 96%; this reflects the safety and effectiveness of this procedure. Four patients with failed access-site closure were successfully treated with vascular surgery. Griese et al³⁷ used 2 Proglide sutures deployed in a pre-close technique for access-site closure in 162 patients who received TAVR. The VARC major vascular complications noted in the Griese et al study was 4.3%. The Partner studies report remarkably that vascular complications are accompanied by adverse patient outcomes.⁸ Our low rate of major access-site related complications is promising and can be attributed to careful patient preparation. 

Mortality. The SOURCE registry³⁸ reports a 30-day mortality of 6.3%, whereas the Partner Investigators describe a 30-day mortality of 5.0% in Partner A²⁸ and 3.4% in Partner B,²⁹ respectively. We do acknowledge that these earlier studies used the first-generation Sapien transcatheter heart valves (Edwards Sapien), thereby increasing the risk of morbidity and mortality. The 30-day mortality of the Sapien XT cohort in the study performed by Durand et al was 5.5%.¹⁰ Our in-hospital mortality rate of only 4% with 1 procedure-related fatality is low. The 30-day mortality was even lower at 2%. Possible explanations for the lower rate of mortality can be attributed to careful patient selection, comprehensive patient preparation, operator experience, and to the feasibility of conducting the procedure with minimal to no sedation; however, this cause-effect relationship cannot be determined. 

Study limitations. This is a prospective study reflecting a single-center experience, and therefore, selection bias may have influenced our findings. In addition, the number of patients examined was limited. The success of the TAVR procedure was determined based on the consensus of the TAVR team that comprised interventional cardiologists, non-invasive cardiologists, cardiothoracic surgeons, and ancillary support staff. The patients who underwent TAVR at our institution had a EuroScore-2 of 11.5% and an STS score of 8.4% — indicating an intermediate- to high-risk collective — with a good chance of success and a life expectancy of more than 1 year. Conservative therapy or valvuloplasty was recommended to patients unsuitable for TAVR. 

Conclusions

The results of this study demonstrate that transfemoral TAVR with the Sapien XT valve can be safely and effectively performed under fluoroscopy guidance with analgesics for pain control, and with little to no sedation. Careful patient selection, extensive patient preparation, and experience of the TAVR implantation team are of paramount importance for success. Our simplified stepwise method provides a standardize way to perform transfemoral TAVR with excellent procedural results. Our stepwise method can also be used for implantation of the newer Edwards Sapien 3 transcatheter heart valve (Edwards Lifesciences).

Acknowledgments. We would like to express our gratitude to the staff of the intensive care unit/cardiac catheterization laboratory, and to our cardiac surgery and anesthesia colleagues.

References

1. Vahanian A, Alfieri O, Andreotti F, et al; ESC Committee for Practice Guidelines (CPG); Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS). Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2012;42(4):S1-44.
2. Iung B, Baron G, Butchart EG, et al. A prospective survey of patients with valvular heart disease in Europe: the Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003;24(13):1231-1243.
3. Choong CK, Sergeant P, Nashef SA, Smith JA, Bridgewater B. The Euroscore risk stratification system in the current era: how accurate is it and what should be done if it is inaccurate? Eur J Cardiothorac Surg. 2009;35(1):59-61.
4. Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002;106(24):3006-3008.
5. Thomas M, Schymik G, Walther T, et al. One-year outcomes of cohort 1 in the Edwards Sapien Aortic Bioprosthesis European Outcome (SOURCE) registry: the European registry of transcatheter aortic valve implantation using the Edwards Sapien valve. Circulation. 2011;124(4):425-433.
6. Webb JG, Pasupati S, Humphries K, et al. Percutaneous transarterial aortic valve replacement in selected high-risk patients with aortic stenosis. Circulation. 2007;116(7):755-763.
7. Zahn R, Gerckens U, Grube E, et al; German Transcatheter Aortic Valve Interventions-Registry I. Transcatheter aortic valve implantation: first results from a multi-centre real-world registry. Eur Heart J. 2011;32(2):198-204.
8. Kodali SK, Williams MR, Smith CR, et al; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012;366(18):1686-1695.
9. Licker M, Schweizer A, Ellenberger C, Tschopp JM, Diaper J, Clergue F. Perioperative medical management of patients with copd. Int J Chron Obstruct Pulmon Dis. 2007;2(4):493-515.
10. Durand E, Borz B, Godin M, et al. Transfemoral aortic valve replacement with the Edwards Sapien and Edwards Sapien XT prosthesis using exclusively local anesthesia and fluoroscopic guidance: feasibility and 30-day outcomes. JACC Cardiovasc Interv. 2012;5(5):461-467.
11. Greif M, Lange P, Nabauer M, et al. Transcutaneous aortic valve replacement with the Edwards Sapien XT and Medtronic CoreValve prosthesis under fluoroscopic guidance and local anaesthesia only. Heart. 2014;100(9):691-695 (Epub 2014 Jan 23).
12. Kasel AM, Cassese S, Bleiziffer S, et al. Standardized imaging for aortic annular sizing: implications for transcatheter valve selection. JACC Cardiovasc Imaging. 2013;6(2):249-262.
13. Kasel AM, Cassese S, Leber AW, von Scheidt W, Kastrati A. Fluoroscopy-guided aortic root imaging for TAVR: “follow the right cusp” rule. JACC  Cardiovasc Imaging. 2013;6(2):274-275.
14. Kappetein AP, Head SJ, Généreux P, et al; Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document (VARC-2). Eur J Cardiothorac Surg.  2012;42(5):S45-S60.
15. Sandler H, Dodge HT, Hay RE, Rackley CE. Quantitation of valvular insufficiency in man by angiocardiography. Am Heart J. 1963;65:501-513.
16. Sinning JM, Hammerstingl C, Vasa-Nicotera M, et al. Aortic regurgitation index defines severity of peri-prosthetic regurgitation and predicts outcome in patients after transcatheter aortic valve implantation. J Am Coll Cardiol. 2012;59(13):1134-1141.
17. Thilo C, Maurer CJ, Berlis A, von Scheidt W, Kasel AM. Successful management of cerebral embolism during TAVR. Clin Res Cardiol. 2014;103(4):329-331 (Epub 2014 Jan 8).
18. Cribier A. Development of transcatheter aortic valve implantation (TAVI): a  20-year odyssey. Arch Cardiovasc Dis. 2012;105(3):146-152.
19. Ben-Dor I, Looser PM, Maluenda G, et al. Transcatheter aortic valve replacement under monitored anesthesia care versus general anesthesia with intubation. Cardiovasc Revasc Med. 2012;13(4):207-210.
20. Binder RK, Webb JG, Willson AB, et al. The impact of integration of a multidetector computed tomography annulus area sizing algorithm on outcomes of transcatheter aortic valve replacement: a prospective, multicenter, controlled trial. J Am Coll Cardiol. 2013;62(5):431-438.
21. Becker DE, Haas DA. Management of complications during moderate and deep sedation: respiratory and cardiovascular considerations. Anesth Prog. 2007;54(2):59-68; quiz 69.
22. Makkar RR, Fontana GP, Jilaihawi H, et al; the PARTNER Trial Investigators. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med. 2012;366(18):1696-1704.
23. Abdel-Wahab M, Zahn R, Horack M, et al, German Transcatheter Aortic Valve Interventions Registry. Aortic regurgitation after transcatheter aortic valve implantation: Incidence and early outcome. Results from the german transcatheter aortic valve interventions registry. Heart. 2011;97(11):899-906.
24. Schultz C, Rossi A, van Mieghem N, et al. Aortic annulus dimensions and leaflet calcification from contrast MSCT predict the need for balloon post-dilatation after tavi with the medtronic corevalve prosthesis. EuroIntervention. 2011;7(5):564-572.
25. Nombela-Franco L, Rodes-Cabau J, DeLarochelliere R, et al. Predictive factors, efficacy, and safety of balloon post-dilation after transcatheter aortic valve implantation with a balloon-expandable valve. JACC Cardiovasc Interv. 2012;5(5):499-512.
26. Kahlert P, Knipp SC, Schlamann M, et al. Silent and apparent cerebral ischemia after percutaneous transfemoral aortic valve implantation: a diffusion-weighted magnetic resonance imaging study. Circulation. 2010;121(7):870-878.
27. Eggebrecht H, Schmermund A, Voigtlander T, Kahlert P, Erbel R, Mehta RH. Risk of stroke after transcatheter aortic valve implantation (TAVI): a meta-analysis of 10,037 published patients. EuroIntervention. 2012;8(1):129-138.
28. Leon MB, Smith CR, Mack M, et al; The PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363(17):1597-1607.
29. Smith CR, Leon MB, Mack MJ, et al; The PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364(23):2187-2198.
30. Erkapic D, De Rosa S, Kelava A, Lehmann R, Fichtlscherer S, Hohnloser SH. Risk for permanent pacemaker after transcatheter aortic valve implantation: a comprehensive analysis of the literature. J Cardiovasc Electrophysiol. 2012;23(4):391-397.
31. Bates MG, Matthews IG, Fazal IA, Turley AJ. Postoperative permanent pacemaker implantation in patients undergoing transcatheter aortic valve implantation: what is the incidence and are there any predicting factors? Interact Cardiovasc Thorac Surg. 2011;12(2):243-253.
32. Huynh H, Dalloul G, Ghanbari H, et al. Permanent pacemaker implantation following aortic valve replacement: current prevalence and clinical predictors. Pacing Clin Electrophysiol. 2009;32(12):1520-1525.
33. Abdel-Wahab M, Mehilli J, Frerker C, et al. Comparison of balloon-expandable vs self-expandable valves in patients undergoing transcatheter aortic valve replacement: the choice randomized clinical trial. JAMA. 2014;311(15):1503-1514.
34. El-Khally Z, Thibault B, Staniloae C, et al. Prognostic significance of newly acquired bundle branch block after aortic valve replacement. Am J Cardiol. 2004;94(8):1008-1011.
35. Brignole M, Auricchio A, Baron-Esquivias G, et al. 2013 ESC guidelines on cardiac pacing and cardiac resynchronization therapy: the task force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Eur Heart J. 2013;34(29):2281-2329 (Epub 2013 Jun 24).
36. Khawaja MZ, Rajani R, Cook A, et al. Permanent pacemaker insertion after CoreValve transcatheter aortic valve implantation: incidence and contributing factors (the UK CoreValve Collaborative). Circulation. 2011;123(9):951-960.
37. Griese DP, Reents W, Diegeler A, Kerber S, Babin-Ebell J. Simple, effective and safe vascular access site closure with the double-Proglide preclose technique in 162 patients receiving transfemoral transcatheter aortic valve implantation. Catheter Cardiovasc Interv. 2013;82(5):E734-E741.
38. Thomas M, Schymik G, Walther T, et al. Thirty-day results of the Sapien Aortic Bioprosthesis European Outcome (SOURCE) registry: a European registry of transcatheter aortic valve implantation using the Edwards Sapien valve. Circulation. 2010;122(1):62-69.

_______________________________________

From the Departments of ¹Cardiology and ²Cardiothoracic Surgery, Klinikum Augsburg, Herzzentrum Augsburg-Schwaben, Augsburg, Germany; and ³Deutsches Herzzentrum, Technische Universität, Munich, Germany.

Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Kasel is a medical consultant for and receives research support from Edwards LifeSciences. Dr Krapf is a medical consultant for Edwards LifeSciences. The other authors report no conflicts of interest regarding the content herein.

Manuscript submitted April 4, 2014, provisional acceptance given April 14, 2014, final version accepted May 5 2014.

Address for correspondence: Markus Kasel, MD, Department of Cardiovascular Disease, Deutsches Herzzentrum München, Lazarettstraße 36, 80636 Munich, Germany. Email: amkasel1@gmail.com