Transcatheter Aortic Valve Replacement (TAVR) Complications in the ED

Authors: Samuel Rouleau, MD (EM Resident Physician, UC Davis Medical Center) and Brit Long, MD (EM Attending Physician, San Antonio, TX) // Reviewed by: Alex Koyfman, MD (@EMHighAK)

Case

An 82-year-old man presents with worsening fatigue. He has a history of hypertension, aortic stenosis status post transcatheter aortic valve replacement (TAVR) one month ago, heart failure with persevered ejection fraction. His vital signs include blood pressure 135/90, heart rate 75, pulse oximetry > 94% on room air, and afebrile. He is currently on dual anti-platelet therapy with aspirin and clopidogrel. He also takes lisinopril and metoprolol. On exam, lung auscultation is clear with no rales, no pitting edema in the lower extremities, new systolic murmur. Initial labs demonstrate a hemoglobin of 7.4 (previously normal) and indirect hyperbilirubinemia. Chest x-ray reveals cardiomegaly with trans aortic valve implant, best seen on lateral view.


Introduction

Aortic stenosis occurs with narrowing of the aortic value and can be due to calcific disease, congenital abnormality, or rheumatic valve disease. This is the second most common valvular pathology in the United States.1 In North America and Europe, calcific disease is the most common etiology of aortic stenosis, and, as a result, the prevalence of aortic stenosis increases with age.1, 2 One study compared aortic stenosis in hospitalized patients during the years 1989-1991 to 2007-2009 and found that the age at diagnosis increased by a mean of 4 years, but the incidence rate remained relatively stable.3 Importantly, the relative risk of 1- and 3-year mortality between the two time periods was improved at 0.58 (95% CI 0.53 – 0.63) and 0.60 (95% CI 0.56 – 0.65), suggesting an improvement in the treatment of patients hospitalized with aortic stenosis, which is definitively treated by surgery or Transcatheter Aortic Valve Replacement (TAVR).3 Furthermore, another systematic search estimated that the prevalence of severe aortic stenosis in individuals 75 years of age and older is 3.4%, and there are approximately 9,000 new TAVR candidates each year.4

Since its approval in 2011, the TAVR procedure has become a popular and effective method of treating aortic stenosis, especially in those at risk for the traditional surgical approach.5 TAVR procedures are generally recommended for those over the age of 75 given the uncertainty of the long-term durability of the valve.5 In the United States between 2011 and 2019, 276,000 patients underwent TAVR procedure, and volumes have increased every year.6 In 2019, TAVR outpaced traditional Surgical Aortic Valve Replacement (SAVR) by approximately 15,000 (72,991 TAVR procedures versus 57,626 SAVR).6 While this new approach to aortic valve stenosis has showed much promise and a rapid adaptation, there remain questions around safety, specifically regarding the variability of patient outcomes associated with procedure volume per center, and long term durability.7, 8 The quick proliferation and adoption of the TAVR procedure make it imperative for emergency physicians to be aware of TAVR-associated complications and effective management.


Peri-Procedural TAVR Complications

Typically, TAVR (or Transcatheter aortic valve implantation – TAVI) is a relatively safe procedure with low periprocedural mortality rates that are estimated to be between 1.1-4.2 %.9, 10 However, there are several important peri-procedural complications. The following complications typically occur during or immediately following the procedure, when the patient is under the supervision of the proceduralist or a post-anesthesia provider. These complications include: short-term vascular access bleeding – estimated 6-8%,11 device embolization – typically < 1%,11 coronary occlusion  <1% when intervening on native valve,11 aortic dissection/perforation – estimated less than 0.2 %,12 ventricular perforation causing cardiac tamponade – one early cohort found tamponade occurred up to 4% of the time though rates have declined,13 aortic annular rupture – estimates 0.2% or less,14 and end organ damage – such as acute kidney injury (AKI) in up to 10% of patients, but underlying kidney function has a significant role in risk for AKI.15 While emergency physicians should be aware of peri-procedural complications of TAVR procedures, they must have a more comprehensive understanding of complications with delayed complications, which are significantly more likely to be occurring in those who present to the emergency department (ED) with a history of TAVR.


TAVR Complications beyond the Peri-Procedural Window

To create an applicable schema for emergency physicians, we have categorized possible TAVR complications into vascular access/bleeding, mechanical cardiac issues, electrical conduction complications, and end organ damage.

 

Vascular Access Site Complications and Bleeding

Although percutaneous coronary procedures were historically done by accessing the femoral vessels, it is also possible to access the subclavian artery through the deltopectoral groove and other less common aortic approaches.16, 17 Accessing the right radial artery is becoming increasingly popular. In fact, a multicenter study of approximately 5,000 patients who underwent TAVR found significantly less vascular complications in the radial access group (total n = 939, 0.9%) compared to the femoral access group (total n = 4016, 4.1%).17 As such, emergency physicians cannot assume that a patient with a history of TAVR underwent iliofemoral access and must examine the wrists and subclavian areas.

Bleeding can manifest as a medical emergency. Access site bleeding is relatively common, and one single center study found that approximately 15% of its 926-patient cohort experienced access site bleeding.18 Importantly, all access site bleeds presented within 30 days.18 The presentation of access site bleeding will typically be straightforward with a chief complaint of bleeding in the month following TAVR. The initial management for access site bleeding parallels emergency medical management of bleeding in general with achieving hemostasis, attaining good IV access for potential transfusion, and monitoring for hypovolemic shock. However, unlike a typical bleed, access site bleeding may be indicative of arterial perforation.19 Accordingly, any patient that presents with access site bleeding post-TAVR warrants vascular surgery and/or interventional cardiology consult, as definitive repair may require an additional procedure, such as balloon angioplasty or placement of stent graft or other endoprosthesis.19

Hematomas and pseudoaneurysms are also possible access site related complications that typically present days to week after TAVR procedure.19 In the PARTNER Trial, a RCT where 419 patients underwent TAVR, 64 patients (15%) had major vascular complications.20 Of these 64 patients, 15 had access site hematomas.20 Of note, hematoma and pseudoaneurysm are classically associated with iliofemoral access and seem to occur less frequently after radial artery access.17, 21 The RIVAL trial (n = 7,021) found that 42 of 35,07 individuals in the radial access group had hematoma compared with 106 of 3,514 in the femoral access group (HR 0.40, 95% CI 0.28-0.57).21 For pseudoaneurysms that required intervention, the findings were 7 cases in the radial group compared to 23 in the femoral group (HR 0.30 95% CI 0.13-0.71).21 Hematomas and pseudoaneurysms will present with a painful mass over vascular-access site. The two can be differentiated on physical exam.19 A pseudoaneurysm will be pulsatile, as it is essentially a hematoma that communicates with an artery.19 Furthermore, POCUS can be used to differentiate a hematoma from a pseudoaneurysm.22CT angiography can be used, as well.23 Distinguishing between a hematoma and pseudoaneurysm is necessary to determine treatment. Hematomas will typically resolve in days to weeks with close monitoring, though surgical evacuation may be necessary for large hematomas.22 Conversely, pseudoaneurysms are managed with ultrasound-guided compression or by directly injecting thrombin; if these therapies fail, surgical repair may be needed.22

This is an example of a pseudoaneurysm. Note the turbulent flow on color doppler. Case courtesy of Dr Charlie Chia-Tsong Hsu. Radiopaedia.org. From the case rID: 19203.

Lastly, post-TAVR patients are at higher risk for bleeding in general. After TAVR placement, patients are placed on dual anti-platelet therapy for 3-6 months.24 TAVR patients with another indication for anti-coagulation will be on aspirin in addition to their anti-coagulation regimen, but specific anti-platelet and anti-coagulation recommendations post-TAVR remain somewhat controversial, with variation in therapy to be expected.24 Nevertheless, emergency physicians should be vigilant for any sign of bleeding in a patient with a TAVR and clarify their anti-platelet/anti-coagulation therapy in order to guide diagnostic testing and ascertain the need for reversal if bleeding is significant and/or causing hemodynamic instability.

 

Prosthetic Valve Complications

Emergency physicians should be aware of possible valvular complications of prosthetic aortic valves. Valve thrombosis and valvular leak, or paravalvular regurgitation, are two specific complications seen.

Valve thrombosis is rare, estimated to occur in <1% of patients who have undergone TAVR.25 It typically presents within 2 years of the procedure.25 Valve thrombosis is when a thrombi forms within a leaflet (generally on the aortic side) of the transcatheter heart valve.26 Presentation of valve thrombosis can widely vary, as some valve thromboses can be small and remain asymptomatic. Symptomatic valve thromboses will present with signs and symptoms of worsening cardiac function.27 Definitive diagnosis of valve thrombosis will rarely be made in the ED, as it may require dedicated imaging, such as CT angiography of the chest or transesophageal echocardiography (TEE).25 CT angiography will show thrombotic mass or low-density thrombi typically without calcification, typically on the aortic side of prosthetic leaflets.25TEE may demonstrate thickened leaflets or presence of thrombus.25 Treatment is typically anti-coagulation to promote resolution of the thrombus.25 In a cohort of 4,266 patients where 26 had developed valve thrombosis, 23 were treated with warfarin, and 21 of the 23 patients were bridged with IV heparin.25 Anti-coagulation led to resolution of thrombosis and improvement of prosthetic valve function.25 It is beyond the scope of emergency physicians to determine the anticoagulation regimen if valve thrombosis is diagnosed in the ED. In patients with a history of TAVR, decreased cardiac function and signs or symptoms of new or worsening heart failure warrant cardiology consultation and admission.

Paravalvular regurgitation, or valvular leak, occurs when the prosthetic valve is not completely flush with the aortic annulus, which can be caused by calcium deposits, improper valve sizing, or a prosthesis that is too small.28 The rate of valvular leak varies widely and has been decreasing with newer generations of prosthetic valves.28 Differences in the timing and methodology of assessment for valvular leak complicate an accurate epidemiologic understanding of incidence and prevalence. Estimates for mild valvular leak vary widely from 7-70 %, and moderate to severe is estimated to occur around 0-24 % of the time.29, 30 Nevertheless, paravalvular regurgitation can progress over time and may lead to increasing volume in the left ventricle, resulting in heart failure.28 Significant hemolysis may occur as well.28, 31 The main mechanism of hemolysis is turbulent flow through the prosthetic valve or leakage around the prosthetic valve, and both the magnitude of flow and an irregular angle of flow tend to result in hemolysis.31 Emergency physicians should suspect hemolysis due to paravalvular leak in post-TAVR patients who are newly anemic without other signs and symptoms of bleeding. On laboratory work-up, mechanical hemolysis will manifest as fragmented erythrocytes on peripheral smear, reticulocytosis, low haptoglobin, elevated LDH, indirect hyperbilirubinemia, and hemosiderin in urine.31 An emergency physician adept at POCUS echocardiography may see regurgitation across the aortic valve, though further imaging with TEE is generally performed in these patients.31 The treatment of hemolysis related to paravalvular leak varies with severity.31 Case reports suggest that beta-blockers may be effective by reducing shearing forces acting on red blood cells.31 However, if paravalvular leak is severe and is complicated by hemolysis requiring blood transfusion or related to endocarditis, then typically surgical intervention is required.31 Patients who have undergone TAVR and have new cardiopulmonary symptoms warrant cardiology consult and potential admission.

Obstruction of the coronary arteries typically occurs intra-procedurally but can also be delayed. One data collection of over 17,000 TAVR patients found the incidence of delayed coronary obstruction (DCO) to be 0.22%.32 It is more likely to occur after “valve-in-valve” procedures, when TAVR is being done to place a new valve into a previously placed bioprosthetic or mechanical valve that has become stenotic. Most cases occurred within 7 days, with the latest presentation being under 2 months.32 The presentation of this complication is severe with cardiac arrest occurring in 12 of the 38 cases (31.6%) and ST-segment elevation occurring in 9 (23.7%).32 In this cohort, the left coronary artery was obstructed in 35 of the 38 (92.1%) DCO cases.32 The death rate is high in these patients, and 19 (50%) of DCO cases ultimately died during hospitalization.32 From the perspective of an emergency physician, a patient presenting after TAVR with cardiac arrest or STEMI should undergo standard resuscitation. However, it is imperative to communicate the history of TAVR to cardiology.

Both prosthetic valve endocarditis and valvular stenosis (obstruction) occur in post-TAVR patients, though these complications are not unique to the TAVR procedure. Emergency physicians should be aware that prosthetic heart valves increase the risk for endocarditis.33 Specifically, one multicenter registry of 7,944 TAVR patients found that 53 patients had infective endocarditis and mean time of presentation was 6 months (IQR 1 – 14 months).33  Symptoms consistent with valve stenosis and endocarditis should prompt consultation and/or admission.

 

Cardiac Arrythmias

High-degree heart block and new-onset atrial fibrillation are possible complications of TAVR placement. In general, the development of new AV conduction abnormalities is dependent on many factors that are patient and procedural related.34Those with a right bundle branch block prior to the procedure are more likely to develop AV block that requires permanent pacemaker.35 One large review estimates that complete heart block after TAVR occurs in 19-22% of individuals.34 The onset of cardiac arrythmias often occurs prior to prosthesis insertion during balloon valvuloplasty, prosthesis position, and wire traversing the aortic valve.34 The risk of AV block also depends on the design of the prosthesis, and some valves are associated with higher incidence of arrhythmia.34 The rate of patients requiring pacemaker implantation in a UK Registry of patients who received the CoreValve was 24.4%.34 Pacemaker implantation occurs the vast majority of the time before hospital discharge.34 However, a 2011 cohort of 358 patients saw no difference in mortality among post-TAVI patients who required pacemaker implantation compared to those who did not undergo pacemaker implantation.36 While AV blocks tend to occur during the procedure, emergency physicians should be aware that patients who have undergone a TAVR may have underlying AV dysfunction and could have a permanent pacemaker in place while undergoing initial assessment and management. During resuscitation, an emergency physician must ascertain whether or not the pacemaker is functioning adequately, and the presence of the pacemaker should not preclude emergency physicians from resuscitating with accordance of ACLS guidelines.

New-onset atrial fibrillation occurs less frequently in TAVR when compared to the traditional surgical approach.37 The incidence has been reported from 6-11 %.37, 38 New onset atrial fibrillation was associated with a higher rate of stroke or embolism after 30 days, 13.6% in atrial fibrillation group versus 3.2 %, in a prospective registry of 2,700 patients.39 The pathophysiology is not clear, and ED management of new onset atrial fibrillation is similar to a patient without a TAVR.

 

Stroke

Stroke is an associated adverse event with TAVR procedure.40 It is a more frequent occurrence after TAVR than the open-surgical approach.40 The majority of strokes occur intra-operatively as cerebral microemboli are generated.40 However, strokes can be a delayed adverse event as well. In a study of 1,061 patient, 54 patients (approximately 5%) experienced cerebrovascular event within 30 days.41 Risk factors included new-onset atrial fibrillation (OR 2.76), peripheral vascular disease (HR 2.02), and prior cerebrovascular disease (2.04).41 Therefore, patients who have recently undergone TAVR with new onset atrial fibrillation who present with neurological symptoms should undergo prompt stroke evaluation in the ED. Importantly, the TAVR procedure is not an absolute contraindication to thrombolytic therapy. Recent arterial puncture at a noncompressible site is a relative contraindication and would only apply to TAVR patients who were accessed through the subclavian artery.42

 

Acute Kidney Injury (AKI)

AKI is also seen in patients who have undergone TAVR procedure. This complication is most commonly identified in the peri-procedural timeframe and hospitalization. Pre-existing chronic kidney disease (CKD) is the main risk factor.43 A cohort of approximately 100 patients with CKD who underwent TAVR found that 11% developed AKI, defined by reduction in eGFR >25%, and 1.4% had a new hemodialysis requirement.43 The main predictive factors were hypertension (OR 4.66, 95% CI 1.04-20.87), COPD (OR 2.64, 95% CI 1.10-6.36), and peri-operative blood transfusion (OR 3.47, 95% CI 1.30-9.29).43


Summary

  • TAVR is an increasingly common procedure; in 2019, TAVR was used more frequently than SAVR.
  • While there are serious peri-procedural complications associated with TAVR, emergency physicians must be prepared to diagnose and manage complications beyond the peri-procedural window.
  • Our proposed schema for these complications is: vascular access/bleeding, mechanical cardiac issues, electrical conduction complications, and end-organ damage.
  • Hematomas and pseudoaneurysms are more common after femoral access than radial access; they must be differentiated using imaging as pseudoaneurysms may require procedural intervention.
  • Valve thrombosis is a rare complication, typically presenting with worsening cardiac function. Definitive imaging with CT angiography or TEE is needed. Anti-coagulation is the mainstay of treatment, though there are no formal guidelines.
  • The severity of paravalvular leak corresponds with the severity of the symptoms. Severe leak/regurgitation may require surgical management. Mechanical hemolysis can present with severe anemia.
  • Delayed Coronary Obstruction is rare and more commonly occurs with “valve-in-valve” procedures. Typical presentation is with cardiac arrest or STEMI. Mortality is high.
  • New cardiac arrythmias typically present shortly after valve replacement, though new-onset atrial fibrillation can occur within 30 days. A small percentage may develop complete heart block, requiring pacemaker implantation.
  • Stroke is more common after TAVR procedure, and emergency physicians should consider this in patients presenting with neurological symptoms after TAVR placement.

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