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Controversies and Complications in the Perioperative Management of Transcatheter Aortic Valve Replacement

Klein, Andrew A. MBBS, FRCA*; Skubas, Nikolas J. MD, FASE; Ender, Joerg MD, PhD

doi: 10.1213/ANE.0000000000000400
Cardiovascular Anesthesiology: Review Article
Continuing Medical Education

Transcatheter aortic valve replacement (TAVR) is performed with increasing frequency in the United States since Food and Drug Administration approval in 2011. The procedure involves the replacement of a severely stenosed native or bioprosthetic aortic valve with a specially constructed valvular prosthesis that is mounted onto a stent, without the use of cardiopulmonary bypass and the complications of a major open surgical procedure. TAVR has been performed mostly in elderly patients with multiple comorbidities or who have undergone previous cardiac surgery. The most commonly used access routes are the femoral artery (transfemoral) or the cardiac apex (transapical), but the transaortic and transubclavian approaches are also used with varying frequency. Conscious sedation may be used in patients undergoing transfemoral TAVR, but the use of general anesthesia has not been shown to carry greater risk and permits the use of transesophageal echocardiography to assist in valve positioning and diagnose complications. Cardiovascular instability during TAVR is relatively common, necessitating invasive monitoring and frequent use of vasoactive medications. Complications of the procedure are still relatively common and the most frequent is vascular injury to the access sites or the aorta. Cardiovascular collapse may be the result of major hemorrhage pericardial effusion with tamponade or coronary occlusion due to incorrect valve placement. Persistent hypotension, myocardial stunning, or injury requiring open surgical intervention may necessitate the use of cardiopulmonary bypass, the facilities for which should always be immediately available. Ongoing and planned trials comparing conventional surgery with TAVR in lower risk and younger patients should determine the place of TAVR in the medium- to long-term future.

From the *Department of Anaesthesia, Papworth Hospital, Cambridge, United Kingdom; Department of Anesthesiology, Weill Cornell Medical College, New York, New York; and Department of Anesthesiology and Intensive Care Medicine, Herzzentrum, Universität Leipzig, Leipzig, Germany.

Accepted for publication June 19, 2014

Funding: None.

The authors declare no conflicts of interest.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website.

Reprints will not be available from the authors.

Address correspondence to Andrew A. Klein, MBBS, FRCA, Department of Anaesthesia, Papworth Hospital, Papworth Everard, Cambridge, CB 23 3RE, United Kingdom. Address e-mail to Andrew.klein@nhs.net.

Since the first transcatheter aortic valve replacement (TAVR) was performed in 2001, there has been an explosion of interest in the procedure, and it has captured the attention of the medical profession and the public alike.1 After initial introduction into mainstream practice in Europe, TAVR is performed with increasing frequency in the United States since Food and Drug Administration approval was granted in 2011. The procedure involves the replacement of a severely stenosed native or bioprosthetic aortic valve (AV) with a catheter-inserted, specially constructed valvular prosthesis that is mounted onto a stent. A TAVR is performed without the use of cardiopulmonary bypass (CPB) and the complications of a major open surgical procedure. TAVR is not currently indicated for aortic regurgitation because the valve stent is not sutured as in surgical AV replacement (AVR), but anchored inside the calcified native aortic annulus or the in situ prosthetic stent (the latter is referred to as a “valve-in-valve” procedure). However, a number of centers have reported undertaking TAVR off-license for aortic regurgitation when no other treatment modalities were thought to be possible.2

The majority of published experience is with 2 valves: the balloon-expandable Edwards SAPIEN (Edwards Lifesciences, Irvine, CA) and the self-expanding Medtronic CoreValve (Medtronic CoreValve Revalving System, Minneapolis, MI). A number of other valves are currently being trialled.3

TAVR is most often performed jointly by cardiologists and cardiac surgeons, although in Europe, cardiologists may undertake it alone. The first multicenter, prospectively randomized trial (Placement of AoRTic TranNscathetER Valve [PARTNER]) showed a marked and significant improvement in terms of mortality associated with TAVR, compared with medical treatment alone, in high-risk aortic stenosis patients judged not to be suitable candidates for surgical AVR.4 A subsequent randomized controlled study showed that TAVR and conventional surgical AVR were associated with a similar mortality at 1 and 2 years in high-risk surgical candidates.5 However, important differences in morbidity were observed; surgical AVR was associated with increased bleeding and related complications, and stroke was more common after TAVR.5 Similarly, 30-day and 1-year all-cause mortality were similar among intermediate-risk surgical patients (Society of Thoracic Surgeons [STS] risk score between 3% and 8%) with symptomatic severe aortic stenosis, who were propensity score-matched between surgical and TAVR treatment.6 In a recently published trial in the United States, high-risk patients randomized to TAVR, using the CoreValve, had a significantly higher rate of survival after 1 year (absolute reduction in risk 4.9%, P < 0.001 for noninferiority and P = 0.04 for superiority compared to surgical AVR).7

However, TAVR is associated with a relatively high incidence of controversies and major complications. Indeed, these may be more frequent than those associated with conventional surgical AVR performed via sternotomy, and particular care with regards to anesthetic care and perioperative management is required.8,9

Despite a relative lack of evidence of superiority of TAVR over surgical AVR, a greater number of patients and their clinicians are keen to explore or perform the less-invasive TAVR procedure, hence the importance of understanding the particular problems and challenges associated with it.10

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Development of TAVR

The first percutaneous procedure performed on the AV was balloon aortic valvuloplasty, which was developed in the 1980s. This technique, however, did not improve valve area greatly, though modest but short-lived hemodynamic and symptomatic improvement was reported.11 Thereafter, the concept of balloon-expandable and self-expandable transcatheter valve implantation was introduced, and in 2001, Cribier et al.12 implanted the first transcatheter AV in Paris, France, in a patient with acute cardiogenic shock as a treatment of last resort. The TAVR procedure was designed to offer a less invasive alternative for patients who were deemed to be too high-risk for conventional surgical AVR. Over the last 12 years, improvements in the design of the valve and stent in which it is mounted, along with advances in valve delivery technology, have made TAVR much easier and even less invasive to perform. Recently, the delivery systems’ sizes have been greatly reduced; initially they were 22-F to 25-F (9 to 10 mm diameter), which meant the incidence of arterial injury was relatively high. Newer low-profile systems are compatible with 16-F to 19-F sheaths (outer diameter 6 or 7 mm), enabling their use in more patients.

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Overview of the Procedure

The 2 TAVR systems in mainstream clinical use differ in construction. The Edwards SAPIEN has a cobalt chromium alloy tubular frame with leaflets from bovine pericardium, whereas the CoreValve has a nitinol frame with leaflets from porcine pericardium. They also differ in method of deployment. The Edwards SAPIEN valve is balloon-expanded, whereas the CoreValve is self-expanding. Both valves are most commonly inserted in a retrograde transarterial fashion via the femoral artery (transfemoral [TF] approach). Severe peripheral arterial disease, including extreme tortuosity, marked calcification, narrowing (diameter less than 5.5 mm with current delivery sheaths), or aortic disease including aneurysm and thrombus, may prohibit the TF approach. In such cases, another suitable vessel, such as subclavian, axillary, or ascending aorta are used (the latter via a mini-sternotomy) for retrograde insertion or an antegrade transapical (TA) approach may be considered (via a left anterior intercostal mini-thoracotomy).8 In the TA-TAVR, the left ventricular (LV) cavity is punctured with a needle lateral to the apex and the ventriculotomy is then dilated serially to accommodate the valve deployment sheath. After the procedure has been completed, the LV apex is repaired with preinserted pledget sutures. A number of other access routes may also be used (Table 1) depending on operator experience.

Table 1

Table 1

Balloon aortic valvuloplasty is usually performed before valve insertion to facilitate passage of the prosthesis through the stenotic native AV. In the case of a prosthetic valve stenosis (valve-in-valve procedure), this is not required. With the balloon-expandable Edwards SAPIEN valve, rapid ventricular pacing is used to decrease arterial blood pressure and transvalvular flow, reducing the risk of movement of the valve into the aorta during deployment. The longer profile of the CoreValve, which extends from the aortic annulus to the supracoronary aorta, allows for the gradual release of the prosthesis without the need for pacing.13

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Patient Selection

The use of TAVR is geared toward patients with severe aortic stenosis, who are considered to be at substantially increased risk for conventional surgical AVR. These include patients who require reoperative sternotomy with potential damage to patent coronary arterial grafts, and those with multiple comorbidities, such as respiratory or vascular disease. These patients are deemed to be high risk based on a STS risk score >10% or logistic EuroSCORE >20%. Of note, these 2 risk stratification schemes are not equivalent, with the STS risk score considered more representative of high-risk AV surgery.14 As a result, it is not straightforward to compare the patient cohorts among the various TAVR registries. The most recent American College of Cardiology/American Heart Association Valvular Heart Disease Guidelines recommend surgical AVR if the predicted risk of mortality is below 8%, and TAVR is reserved for those elder, frail patients with significant morbidity who are considered at high risk for surgical AVR (class of recommendation I and level of evidence B for prohibitive risk, class of recommendation IIa and level of evidence B for high surgical risk).15 Multidisciplinary patient consideration is considered to be ideal,16 and the involvement of anesthesiologists early in the process of patient selection is imperative. Successful practice requires careful preoperative evaluation by a surgeon, cardiologist, and anesthesiologist to allow for the correct patient selection and delivery of tailored, patient-focused care. Concurrently, there should also be consideration as to whether sternotomy should be performed if a catastrophic event occurs; this will depend on the underlying morbidities and whether the patient has undergone previous surgery.17 Agreeing on an emergency plan in advance is very helpful in the event of a major complication, and this should ideally be documented in the medical notes.

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Planning for TAVR

Even when a percutaneous approach to the femoral artery is planned, the potential for serious complications that may result in the rapid deterioration of the patient must be respected. A surgical team, including a perfusionist and a “dry” CPB setup must be on standby. Additional available equipment includes intra-aortic balloon pump, cell salvage,16 external defibrillator pads, a warming blanket, and pumps for infusion of IV medication.

Communication among team members during the procedure is vital so that complications may be avoided or recognized promptly if they do occur. An interdisciplinary approach to TAVR by means of a heart team may facilitate alternative procedures with preplanned protocols and lead to acceptable outcomes, despite severe intraprocedural complications.18 For these reasons, a heart team approach is mandated by societal guidelines19 and, at least in the United States, is linked to reimbursement.20

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General Anesthesia Versus Sedation

There are no randomized, prospective studies comparing general anesthesia (GA) to local anesthesia with infiltration of the access site and/or monitored anesthesia care (MAC) techniques (Table 2). The choice of the particular anesthetic technique is usually influenced by the patient’s comorbidities and institutional practices. Based on recent surveys, GA appears to be the preferred technique for TAVR irrespective of cannulation access in either European or North American institutions.21 Many authors published their experience with the use of local anesthetic for infiltration of the access site in TF-TAVR22–26 or even transaxillary TAVR,27 whereas some have performed an iliohypogastric and ilioinguinal block with local anesthetic,28 supplemented by IV sedation. One center reported the use of local infiltration and IV sedation by the operator, without the presence of an anesthesiologist.24 There are case reports of thoracic epidural techniques for the TA approach29,30 (Table 3). A MAC technique may have some theoretical benefits, such as avoidance of the hemodynamic side effects of the anesthetic drugs, and therefore, decreased use of vasoactive drugs, along with the ability to monitor the central nervous system for embolic events, decreased cost, and faster patient recovery. On the other hand, the patient under GA is not at risk for airway compromise, which may require emergent intervention in the midst of an unfavorable hemodynamic environment during critical parts of the procedure. The patient remains immobile to facilitate the surgical procedural steps, and transesophageal echocardiography (TEE), which is of particular importance for the diagnosis of paraprosthetic leaks, can be performed. There is no evidence for a difference in outcome between sedation versus GA. A recent large observational study of the French Aortic National Registry in 2326 patients showed smilar device success and cumulative 30-day survival in GA compared with MAC (97.6% vs 97.0%; P = 0.41 and 91.6% vs 91.3%; P = 0.69, respectively), whereas the incidence of postprocedural aortic regurgitation ≥ mild was significantly lower in GA than in MAC (15.0% vs 19.1%; P = 0.015).32 This may be as a result of greatly increased use of TEE in patients who underwent GA compared with MAC (76.3% vs 16.9%; P < 0.001). In TF-TAVR, sedation is considered a safe option,21 but emergency conversion to GA is often required (in 1 study, the conversion rate was 17 of 100 patients), mostly due to hemorrhage after vascular complications23 or procedure-related hemodynamic alterations due to cardiac tamponade, cardiac arrest, myocardial infarction, or stroke.25 Thus, it is reasonable to carefully consider the perioperative risks associated with the TAVR procedure when planning for the anesthetic, and if sedation is used, the presence of an anesthesiologist in the operating room is vital to administer suitable drugs and monitor the patient.

Table 2

Table 2

Table 3

Table 3

In terms of anesthetic drugs for a GA technique, again high-quality evidence is lacking, and individual or institutional preferences are most frequently used (Table 3). There is no clear benefit in terms of one induction drug over another, and for inhaled or IV maintenance of anesthesia. Short-acting anesthetic drugs are preferred if tracheal extubation is planned at the end of the procedure, unless there is ongoing cardiovascular compromise or bleeding.

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Transesophageal Echocardiography

For successful TAVR, high-quality imaging modalities are needed, and fluoroscopy and TEE have complementary roles. Fluoroscopy is better to assess the location of guidewires and catheters as well as the proper position of the valve stent, but at the expense of radiation exposure to the patient and personnel. TEE is considered essential during TAVR by many operators; however, some do not use it routinely (Table 4). Use of TEE necessitates GA, but some reported their experience with mini-TEE probes on patients under MAC.31

Table 4

Table 4

TEE is considered the most accurate (and rapid) tool32 for:

  • Confirming the preoperative diagnosis (Fig. 1).
  • Excluding unfavorable anatomy that may not allow for proper seating of the prosthesis across the aortic annulus (Fig. 2).
  • Verifying the choice of prosthesis size (23, 26, or 29 mm for SAPIEN; 23, 26, 29, or 31 mm for CoreValve), by remeasuring the aortic annulus diameter (Fig. 3).
  • Establishing the baseline right and LV function and preexisting valvular disease (especially the severity of mitral regurgitation), pericardial effusion, or AV/aorta atheromas.
  • Guiding the introduction and positioning of guidewires (Figs. 4 and 5), balloon (if aortic valvuloplasty is performed), and valve stents (Fig. 6).
  • Verifying deployment of the prosthesis (Fig. 7).
  • Examining the success of the procedure (Fig. 8) and assessing the effective orifice area of the newly implanted aortic prosthesis.
  • Diagnosing complications, such as aortic regurgitation (Fig. 9), trauma to the aorta (Fig. 10) and neighboring structures,33 and pericardial effusion/tamponade.
  • Reassessing the hemodynamic environment, for example, evaluation of the ventricular function at baseline, after ventricular pacing and valve deployment.32
  • Measuring the distance from the annulus to the coronary ostia, which may be useful to predict coronary occlusion from the TAVR stent34 (Video 1, Supplemental Digital Content 1, http://links.lww.com/AA/A983).
Figure 1

Figure 1

Figure 2

Figure 2

Figure 3

Figure 3

Figure 4

Figure 4

Figure 5

Figure 5

Figure 6

Figure 6

Figure 7

Figure 7

Figure 8

Figure 8

Figure 9

Figure 9

Figure 10

Figure 10

The most recent European Association of Echocardiog raphy/American Society of Echocardiography guidelines35 recommend the use of TEE whenever there is doubt about the anatomy of the aortic root, aortic annulus size or number of AV cusps. There is considerable debate about which imaging modality is the “gold standard” for the evaluation of the aortic annulus and root at this time. Transthoracic echocardiography alone has been shown to underestimate the native annulus size by up to 15% or 1.36 mm (95% confidence interval, 1.75–4.48 mm).36 There is some evidence that 3-dimensional (3D) computed tomography (CT) as well as real-time 3D echocardiography may be more accurate.37 Three-dimensional TEE is considered more accurate in measuring the true aortic annulus diameter38 (via proper alignment of the short and long axes of the AV), and the distance of the coronary ostia from the aortic annulus (to avoid occlusion from the valve stent)34 and for the quick evaluation of the degree of (any) paraprosthetic aortic regurgitation after deployment. Adherence to sizing variables defined by cross-sectional 3D-TEE was associated with a lower incidence of paraprosthetic aortic regurgitation than conventional 2-dimensional TEE cutoffs and is advocated whenever good cross-sectional CT data are not available39 Multidetector CT measurements of the aortic annulus derive aortic annular diameter that is larger than the TEE-derived diameter by 1.5 ± 1.6 mm and may become the ideal technique for TAVR sizing.38 Aortic root assessment with cardiac magnetic resonance imaging may be a valid imaging alternative in patients unsuitable for CT.40

Transthoracic echocardiography is an alternative if sedation is chosen, but this may not allow such rapid diagnosis because of difficulties with acquiring good quality echocardiographic windows during the procedure and with the patient in the supine position. Intracardiac echocardiography31 may be an option, but experience with this technique is limited.

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Hemodynamic Monitoring and Management

Invasive monitoring should be considered standard because cardiovascular compromise may be rapid and unpredictable. This should include invasive arterial and central venous pressures. The use of pulmonary artery catheters in this setting may be considered controversial by some, but may be particularly useful in patients with moderate or severe pulmonary hypertension.41 Many of the TAVR patients have baseline pulmonary hypertension. Despite the sustained decrease of pulmonary artery systolic pressure after surgical AVR or TAVR,42 the presence of pulmonary hypertension was found to be an independent risk factor for mortality in TAVR patients, irrespective of TF or another approach.43 In a small cohort, severe pulmonary hypertension (pulmonary artery systolic pressure > 60) had an odds ratio of 7.56 and right ventricular dysfunction had an odds ratio of 3.55 for all-cause mortality at 6 months after TAVR.44 Some have used normothermic femoro-femoral CPB electively in such patients and reported favorable outcomes.45

When performing balloon aortic valvuloplasty or during deployment of a balloon-expandable valve (Edwards Sapien), rapid ventricular pacing is used to arrest cardiac ejection. The heart may take some time to recover from this insult, especially if its function was significantly impaired before TAVR, or if rapid pacing was prolonged because of adjustments to balloon or valve position before inflation. This may necessitate bolus administration of phenylephrine or meteraminol, depending on institutional preference. In an emergent situation, epinephrine (10–20 mcg) may be injected into the aortic root via the pigtail catheter normally used for contrast administration to enable the drug to work more quickly, especially if the temporarily dysfunctional heart is hardly contracting. Other drugs that may be considered in this situation include phenylephrine, norepinephrine, or meteraminol. If the heart does not recover quickly (within 30–60 seconds), external cardiac massage should be initiated, and this may have the effect of pumping the inotrope and restoring cardiac function. However, if this is not successful, urgent consideration should be given to the institution of CPB. In most instances, this can be performed quickly by placement of peripheral venous and arterial cannulas over guidewires already in situ in the femoral vessels. In some cases, sternotomy may be required; preoperative discussion of the appropriateness of such an invasive intervention in an emergency situation is therefore essential.

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Complications

The incidence of procedural complications depends on the access chosen for TAVR and on the type of implanted valve.

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Vascular Injury

Assessing the minimum diameter of the arterial access vessel is essential for proper patient selection. A relatively compliant nondiseased artery can accommodate a vascular sheath that is slightly larger (1–2 mm) than its internal diameter. By general consensus, the TF-TAVR is the most popular approach and the femoral vessels are usually percutaneously accessed. In relatively small, calcified, or tortuous vessels, the risk of injury is significant; major vascular complications include dissection, rupture, or pseudoaneurysm. In patients deemed to be at increased risk of vascular injury due to anatomical considerations, surgical exposure may be used to facilitate surgical control and repair if required. The incidence of major vascular complications in the PARTNER A randomized controlled trial comparing TAVR and surgery was 11% in the TAVR group, compared with 3.2% in the surgical group (P < 0.001),5 but without a statistically significant difference in mortality (3.4% in the TAVR group and 6.5% in the surgical group, P = 0.07).

In the first few years after the introduction of TAVR, the incidence of vascular complications was reported to be as high as 27%; vascular dissection, perforation, and hematoma at the access site were encountered in up to 15.3% of the patients and associated with significantly higher 30-day rates of complications, and 30-day and 1-year mortality.46–48 However, the size of the delivery systems has been reduced over the last 2 years to less than 5.5 mm outer diameter (depending on manufacturer and size of valve to be implanted) with a concurrently decreased incidence of access-related vascular damage to as low as 3.1% in a more recent European registry.22 Hayashida et al.50 reported a sheath:femoral artery ratio of >1.05 as predictive for major vascular complication and 30-day mortality in 102 patients undergoing TF-TAVR with either the CoreValve or the Edwards Sapien valve.49

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Pericardial Hemorrhage

Intrapericardial bleeding is possible at any point during the procedure due to injury to the heart or to the aorta, either as a result of wire perforation or annular rupture. Early detection of pericardial effusion is easier and earlier detected with echocardiography (Video 2, Supplemental Digital Content 2, http://links.lww.com/AA/A984; Video 3, Supplemental Digital Content 3, http://links.lww.com/AA/A985; Video 4, Supplemental Digital Content 4, http://links.lww.com/AA/A986). Life-threatening bleeding into the pericardium that may occur in up to 13% of patients during or immediately after TAVR is more common with a TA approach (odds risk 3.7, 95% confidence interval 1.73%–7.9%, P = 0.01) and is associated with significantly more frequent 1-year mortality (odds risk 2.54, 95% confidence interval 1.3%–4.9%, P = 0.002).50 Arterial bleeding from annular rupture will most likely require emergent sternotomy and surgical control. On the other hand, venous bleeding, which may occur as a result of injury from the pacing wire, may be managed by percutaneous pericardial drainage and close observation.

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Problems with Conduction and Arrhythmias

The conduction system passes superficially through the interventricular septum immediately below the AV. After conventional AVR, mechanical trauma, tissue edema, and local inflammation at the level of the aortic annulus and the neighboring atrioventricular node and bundle of His may induce conduction disturbances and increase the need for implantation of a pacemaker. In the PARTNER trial cohorts (Edwards SAPIEN), the reported incidence of permanent pacemaker implantation in TAVR was only slightly higher than surgical AVR (5.7% vs 5%, P = 0.68)5 and lower than medical therapy (4.5% vs 7.8%, P = 0.27).4

Conductance disturbances leading to permanent pacemaker implantation are more common for the CoreValve than for the Edwards Sapien valve. The incidence for permanent pacemaker implantation ranges from 4.9%–6% for the Edwards Sapien valve to 23.4%–39% for the CoreValve.51–53 The CoreValve stent is longer and extends inside the LV outflow tract (LVOT) where it can compress the conduction system. A higher implantation technique for the CoreValve seems to decrease the risk for conductance disturbances.51

Left bundle-branch block with left axis deviation, an interventricular septal dimension >17 mm at end-diastole, or increased baseline thickness of the native noncoronary cusp AV (>8 mm) are considered predictors for the need of a new cardiac pacemaker.52 Conduction disturbances can occur up to 72 hours after implantation; therefore, patients should be closely monitored for up to 3 days after TAVR. However, based on 1-year follow-up from a single center, the periprocedural permanent pacemaker insertion does not seem to affect clinical outcomes adversely.53

Although the incidence of ongoing ventricular fibrillation after rapid ventricular pacing is very rare, external defibrillator paddles should be attached to every patient before the procedure so that defibrillation may be performed without delay after rapid ventricular pacing if the rhythm fails to normalize.54

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Valve Malpositioning

During TAVR, there is a risk that the valve is incorrectly implanted into the aorta and the sealing cuff of the TAVR valve is not apposed to the aortic annular tissue; most commonly, the valve is placed somewhat too low (in the LVOT) or too high (in the aortic root) in the aorta. Exact positioning of the valve is important: if too low in the LVOT, it may impinge on the anterior mitral leaflet; if it is too high in the aorta, a coronary artery annulus may be blocked leading to myocardial ischemia and potential cardiovascular collapse (Video 1, Supplemental Digital Content 1, http://links.lww.com/AA/A983; Video 5, Supplemental Digital Content 5, http://links.lww.com/AA/A987; Video 6, Supplemental Digital Content 6, http://links.lww.com/AA/A988).

Coronary ostial occlusion occurred in 44 of 6668 patients (0.66%) in a recently published large registry.55 If the latter occurs, coronary stenting may be attempted and can be life-saving. Three-dimensional TEE may be the most accurate method of measuring the distance between the aortic annulus and the left main coronary ostium before implantation.56 The registry data reported that percutaneous coronary intervention was attempted in 75% of the cases and was successful in 82%; 30-day mortality was 41%. After a median follow-up of 12 (2 to 18) months, the cumulative mortality rate was 45.5%, and there were no cases of stent thrombosis or reintervention. Some may preemptively insert a stent inside the coronary ostia to avoid inadvertent obstruction from the valve prosthesis,57 or alternatively a wire can be placed before TAVR deployment to allow rapid stent placement in an emergent situation.

Incorrect positioning along with undersizing, incomplete expansion (Video 7, Supplemental Digital Content 7, http://links.lww.com/AA/A989), or asymmetric calcification (Video 8, Supplemental Digital Content 8, http://links.lww.com/AA/A990; Video 9, Supplemental Digital Content 9, http://links.lww.com/AA/A991; Video 10, Supplemental Digital Content 10, http://links.lww.com/AA/A992) may result in paraprosthetic aortic regurgitation. Intraoperative TEE echocardiography may identify calcification of the commissure between the right coronary and noncoronary cusps and the area cover index as independent predictors of significant paravalvular aortic regurgitation after TAVR.58 If significant aortic regurgitation is detected after valve implantation, either by fluoroscopy/aortography or TEE (Fig. 9, Video 11, Supplemental Digital Content 11, http://links.lww.com/AA/A993; Video 12, Supplemental Digital Content 12, http://links.lww.com/AA/A994), consideration should be given to a second balloon dilation of the prosthetic valve (only possible in the case of the Edwards Sapien valve). Such a procedure may cause further complications because it may lead to valve leaflet disruption, but if carefully performed, it may improve valve function and reduce paravalvular regurgitation.

Moderate or severe residual aortic regurgitation is much more common than after surgical AVR, occurs in 11.7% (95% confidence interval 9.6–14.1) of the patients,59 and is an independent predictor of mid- to long-term mortality (hazard ratio: 1.68 [95% confidence interval 1.21–1.44, P < 0.01] for the Edwards Sapien valve,60 or 4.89, [95% confidence interval 3.95–15.81, P < 0.001] for the CoreValve).61

Inappropriate sizing of the implanted valve is also a risk for valve malpositioning, and may, in the worst-case scenario, lead to retrograde embolization into the LV or antegrade embolization (Video 13, Supplemental Digital Content 13, http://links.lww.com/AA/A995; Video 14, Supplemental Digital Content 14, http://links.lww.com/AA/A996) into the aorta. Prosthetic valve malpositioning may occur during deployment if the heart continues to eject during rapid ventricular pacing (Video 9, Supplemental Digital Content 9, http://links.lww.com/AA/A991). Therefore, correct function of the temporary pacemaker should be ensured and the invasive pressure tracing checked to exclude continued ventricular ejection before implantation of the valve. In addition, during rapid ventricular pacing, the temporary pacemaker should be used in a fixed mode with no sensing and maximum output to minimize the risk of ventricular ejection.

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Stroke

The incidence of stroke after TAVR has declined since the inception of the procedure, from 7.8% to 2.1%–2.8%.62 When compared to conventional surgical AVR or medical treatment, TAVR is associated with a higher incidence of neurological events. Neither the approach, TF or TA, nor device are associated with the risk of neurological events, despite the different rate of high intensity transient signals recorded with transcranial Doppler.63 The etiology of stroke in TAVR patients is multifactorial: atherotic material from the ascending aorta or arch; calcific material from the native AV; thromboembolism from the catheters used in the procedure; and air embolism during LV cannulation, prolonged hypotension, or dissection of brachiocephalic vessels. In the PARTNER trial, the incidence of 30-day major stroke was not statistically different between TAVR and surgical AVR (3.8% vs 2.1%, P = 0.20), but the central nervous system-associated morbidity was higher in TAVR patients (5.5% vs 2.4%, P = 0.04).4 Similarly, Panchal et al.64 reported a higher incidence of neurological morbidity at 66 weeks among 1426 patients from randomized registries, while surgical AVR was “protective” because it was associated with a risk reduction of 0.56 (95% confidence interval 0.35–0.88, P = 0.01). The miniaturization of the newer version of prostheses may lead to a decrease in the incidence of neurologic complications and a number of debris/calcium-capturing devices, currently under investigation, may further reduce the incidence of stroke.

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Renal Function

Renal morbidity in TAVR patients is frequent and may require hemodialysis for treatment. A retrospective series (N = 213) reported an incidence of 11.7% of acute kidney injury, an independent predictor of postoperative mortality, and 1.4% need for hemodialysis. However, among patients with chronic kidney failure, acute kidney injury and need for hemodialysis were lower in TAVR than in surgical AVR.67 TAVR was not associated with more frequent renal injury in the PARTNER cohorts.4,5

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CONCLUSIONS

There is no doubt that demand for TAVR is increasing rapidly, and that the procedure poses unique demands for the cardiovascular anesthesiologist. Ideally, the anesthesiologist should be involved in patient selection as well as management during and immediately after the procedure because he/she has a unique and vital role on the heart team. For the TF approach, the decision between GA and conscious sedation is not straightforward. The intraoperative use of TEE however may be advantageous in terms of valve positioning and detection of complications, and would necessitate GA. Randomized controlled trials in progress or planned should determine whether the use of TAVR in younger patients with fewer comorbidities should be permitted, and indeed whether TAVR becomes more prevalent than surgical AVR in the medium to long-term future.

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DISCLOSURES

Name: Andrew A. Klein, MBBS, FRCA.

Contribution: This author helped prepare the manuscript.

Attestation: Andrew A. Klein approved the final manuscript.

Name: Nikolas J. Skubas, MD, FASE.

Contribution: This author helped prepare the manuscript.

Attestation: Nikolas J. Skubas approved the final manuscript.

Name: Joerg Ender, MD, PhD.

Contribution: This author helped prepare the manuscript.

Attestation: Joerg Ender approved the final manuscript.

This manuscript was handled by: Martin J. London, MD.

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REFERENCES

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