REVIEW ARTICLE Transcatheter aortic valve insertion: anaesthetic implications of emerging new technology

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1 British Journal of Anaesthesia 103 (6): (2009) doi: /bja/aep311 REVIEW ARTICLE Transcatheter aortic valve insertion: anaesthetic implications of emerging new technology A. A. Klein 1 *, S. T. Webb 1, S. Tsui 2, C. Sudarshan 2, L. Shapiro 3 and C. Densem 3 1 Department of Anaesthesia and Intensive Care, 2 Department of Cardiothoracic Surgery and 3 Department of Cardiology, Papworth Hospital, Papworth Everard, Cambridge CB23 3RE, UK *Corresponding author. andrew.klein@papworth.nhs.uk. Transcatheter aortic valve insertion is a new development that potentially offers a number of advantages to patients and healthcare providers. These include the avoidance of sternotomy and cardiopulmonary bypass, and much faster discharge from hospital and return to functional status. The procedure itself however is quite complex, and presents significant demands in planning and implementation to the multidisciplinary team. Anaesthetic input is essential, and patient care in the perioperative period can be challenging. Early results have shown a significant mortality and morbidity rate, but the majority of procedures to date have been carried out in elderly patients with multiple comorbidities, making comparison with surgical aortic valve replacement inappropriate. Long-term outcomes are not yet known, but randomized controlled trials should allow this procedure and its application to be properly assessed. Br J Anaesth 2009; 103: Keywords: anaesthesia, general; complications, aortic valve disease; heart, catheterization; surgery, cardiovascular The development of new technology in valve and stent manufacture has recently led to the introduction of a novel treatment for severe aortic valve stenosis, without the need for sternotomy and cardiopulmonary bypass (CPB). 24 Transcatheter aortic valve insertion (TAVI) may potentially offer advantages to patients and healthcare providers, but the procedure is still in its infancy and long-term outcomes are not yet known. In addition, the conditions and environment in which TAVI is carried out are substantially different from surgical aortic valve replacement (AVR). Therefore, a team approach is essential to provide a safe and successful service. The role of the anaesthetist in such a team is very important, as patients are often elderly with multiple comorbidities and organ dysfunction. The haemodynamic consequences of vascular and cardiac access and valve deployment in the beating heart may lead to morbidity and mortality if not adequately managed, and the postoperative course may be complicated. Careful anaesthetic management along with meticulous perioperative care should facilitate improvements in outcome. A summary of the procedure itself and suggestions for patient management will be provided, along with a discussion of the possible complications and the available literature to date. Aortic stenosis and aortic valve replacement Aortic stenosis is a common condition, becoming more prevalent with the ageing population. AVR is indicated after the development of symptoms (angina, syncope, or cardiac failure) or worsening left ventricular function. Severe aortic stenosis is defined as valve area 1.0 cm 2 or mean gradient.40 mm Hg, and occurs in approximately 2% of the population over 80 yr of age. Untreated, this is associated with an incidence of sudden death of 10 15% per year and an average survival of 2 3 yr. 3 Surgical AVR is a very successful procedure. When performed as a sole procedure in patients who have not undergone previous cardiac surgery, mortality and morbidity is low (under 4% in the UK in 2003; documents/pdf/5thbluebook2003.pdf). Even in octogenarians, mortality ranges from 5% to 10%. 14 However, operative mortality is increased in patients with severe left ventricular dysfunction, advanced comorbidity (notably renal and respiratory disease), and previous sternotomy (especially if patent coronary grafts are present). 23 Despite these good results, neurological dysfunction after surgery with CPB is still relatively common, and bleeding with associated blood transfusion # The Author [2009]. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please journals.permissions@oxfordjournal.org

2 Anaesthesia for transcatheter aortic valve and wound infection remain a concern. In addition, patients with multiple comorbidities (as measured by logistic EuroSCORE) may require more prolonged intensive care and hospital stay, thus increasing consumption of resources. 7 is complex and demanding, 25 placing the anaesthetist at the forefront of the multidisciplinary team required to implement the technology. Transcatheter aortic valve insertion Minimally invasive or transcatheter surgery offers a number of potential advantages (Table 1). Modern design and manufacturing techniques have led to the development of a number of valve prostheses which can be compressed or crimped, reducing their size, and allowing delivery to the heart on a catheter through a vascular sheath. 8 The diseased native aortic valve is initially dilated with a balloon catheter. The pre-crimped tissue valve prosthesis is then re-expanded within the dilated native aortic valve. Two manufacturers have recently brought such devices to market. The Edwards-Sapien valve (Edwards Lifesciences Inc., IR, USA) and the CoreValve Revalving System (Medtronic, MN, USA) have both received CE mark approval, and are currently undergoing considerable investigation (Figs 1 and 2). Aggressive marketing and unmet clinical needs have led to rapid uptake of the technology. Transcatheter valve implantation demands considerable technical skill, and there is a learning curve reflecting this. 922 In addition, there are a number of complications that are unique to this method of valve replacement. These can lead to considerable morbidity and mortality, potentially in excess of conventional AVR (Table 2). Patients currently undergoing TAVI are often deemed to be at high risk for conventional surgery. Poor ventricular function is associated with more marked haemodynamic instability during and after the procedure, and may be a relative contraindication. Therefore, management during the procedure Table 1 Potential advantages of transcatheter aortic valve insertion. AVR, aortic valve replacement; CPB, cardiopulmonary bypass; ICU, intensive care unit No need for sternotomy No need for CPB Reduced use of resources Faster recovery, reduced tissue damage Less postoperative pain, increased patient satisfaction Reduced ICU stay or avoidance of ICU admission Reduced hospital stay Reduced wound infection, sternal dehiscence, and mediastinitis Avoidance of re-sternotomy and damage to adherent structures owing to adhesions, including patent coronary grafts Reduced neurological complications? No activation of coagulation cascade, reduced bleeding and blood transfusion Reduced release of vasoactive substances, therefore less vasodilatation and immunomodulation Reduced myocardial dysfunction after cross clamp/ cardioplegia Shorter ICU and hospital stay cost offset at present by increased prosthetic valve cost Fig 1 Transcatheter aortic valve (Edwards-Sapien valve, Edwards Lifesciences Inc., IR, USA) valve is mounted in stent, ready to be crimped before delivery. Valve is pictured next to a one pence coin. Nitenol stent in diamond cell configuration Porcine pericardium sutured to frame Scalloped skirt Fig 2 Transcatheter aortic valve (CoreValve Revalving System, Medtronic, MN, USA). Table 2 Complications of transcatheter aortic valve insertion. AVR, aortic valve replacement; CPB, cardiopulmonary bypass Poor recovery of cardiac function after rapid ventricular pacing, especially if poor ventricular function pre-procedure; may require temporary CPB support if extreme Haemodynamic instability; may require inotropic support Incorrect stent placement; too high may impair coronary flow, leading to myocardial ischaemia and infarction (may require emergent coronary stent placement); too low may lead to device embolization Embolization of aortic (atherosclerotic or calcific) material or air, leading to neurological dysfunction or overt stroke Aortic regurgitation, especially paravalvular; may need further device dilatation to improve moulding of device to aorta Complete heart block, may be delayed up to 7 days after procedure, may require permanent pacemaker Transfemoral approach Vascular access damage (femoral/iliac artery or aorta), including dissection, rupture, and haemorrhage Transapical approach Difficulty closing ventricular apex, leading to haemorrhage Post-thoracotomy pain 793

3 Klein et al. Approaches to the aortic valve Transfemoral approach This requires the placement of a sheath up to 24 French in size (8 mm diameter) in the common femoral artery. Preoperative computed tomography (CT) and formal angiography is required to confirm adequate vascular dimensions and lack of tortuosity or intravascular thrombus (Fig. 3). 30 Severe vascular calcification and aortic disease ( particularly aneurysmal dilatation) are also relative contraindications to this approach. 19 Percutaneous puncture of the femoral artery is commonly attempted. However, vascular complications may be reduced by adopting a surgical (open) approach. After exposure of the femoral artery by the surgical team (either side may be chosen, depending on preprocedure imaging), the artery is punctured and a guidewire is advanced retrogradely into the ascending aorta. The guidewire is then manipulated across the aortic valve under fluoroscopic control (this may not be straightforward). The femoro-iliac artery is then serially dilated until it can accommodate the access sheath required for the TAVI catheter (Fig. 4). After completion of the procedure, the sheath is removed and the femoral artery closed under direct vision or with a closure device (such as the Femostop, RADI medical systems, Uppsala, Sweden) if a percutaneous approach was used. Both devices currently available in the market can be deployed by this route, however the CoreValve device may be preferred because of the relatively smaller size of the sheath required during deployment. Fig 3 Angiogram showing tortuous femoral and iliac arteries; this patient would not be suitable for transfemoral transcatheter aortic valve insertion. Transapical approach This is an alternative method if the transfemoral approach is not possible After localization of the cardiac apex using transthoracic echocardiography (TTE), a submammary mini-thoracotomy is performed, usually about 5 7 cm in length. The pleura and pericardium are opened, and the apex of the heart exposed. Pledgeted sutures are placed at the left ventricular apex, and then a guidewire is inserted into the left ventricle. The guidewire is directed anterogradely through the left ventricular outflow tract across the native aortic valve into the ascending aorta. The apex is dilated until it can permit insertion of the access sheath for the valve insertion catheter. 26 After completion of the procedure, the sheath is removed and the pledgeted sutures are tied to close the left ventriculotomy. A chest drain is placed into the left pleura, and the thoracotomy incision is closed. Currently, only the Edwards-Sapien valve is suitable for the transapical approach because of the nature of its deployment (Fig. 5). Other approaches If the femoral artery is significantly diseased but the transapical approach is deemed to be relatively contraindicated (for example if the patient has severe chronic lung disease and respiratory impairment), a number of other transarterial approaches have also been described. These are not in routine use owing to their relative complexity. They include the subclavian and iliac arteries. The CoreValve device may be currently more suitable for these approaches because of its smaller size when sheathed. If the size to which the valves can be reduced to during deployment continues to decrease as the technology is refined, then other approaches may be used more frequently, such as transbrachial or even radial. Patient selection Recent National Institute for Health and Clinical Excellence (NICE) guidelines 17 and licensing regulations have restricted the use of TAVI to selected patients, who are either deemed to be at greatly increased risk of death or severe complications from conventional open surgery, or who are not suitable for surgical AVR (Table 3). 6 Patients previously turned down for surgery may be suitable for TAVI. Previous (or multiple) sternotomy is not a contraindication for either transfemoral or transapical approach, and indeed is regarded by most centres as a key indication, especially in the presence of patent coronary grafts. Redo-sternotomy in patients with a patent mammary artery graft is considered to be particularly risky because of the incidence of graft damage during surgical dissection of adhesions or sudden malignant arrhythmias owing to the transmission of diathermy current

4 Anaesthesia for transcatheter aortic valve TOE probe Balloon inflated with contrast Transcatheter valve within stent Valve delivery sheath Transvernous right ventricular pacing wire Wire in left ventricle Fig 4 Fluorogram taken during procedure, demonstrating balloon being blown up to expand stent and valve during actual valve deployment by the transfemoral (retrograde) approach. The patient has had a previous sternotomy (the sternal wires can be seen). The valve being deployed is the Edwards-Sapien valve. Pigtail catheter in sinus of Valsalva Fully deployed transcatheter valve TOE probe Surgical retractor Fig 5 Fluorogram taken after transapical deployment of transcatheter aortic valve. Contrast has been injected into the ascending aorta (aortogram), and there is no regurgitation into the left ventricle, demonstrating valvular competency. The valve being deployed is the Edwards-Sapien valve. There are also a number of patients not referred for surgery or turned down after surgical assessment because of medical conditions, especially chronic respiratory disease. These patients may be suitable for TAVI, with the transfemoral approach being particularly favourable because of the avoidance of postoperative hypoventilation owing to pain. Careful anaesthetic assessment of potential candidates in conjunction with further investigation may lead to successful management of patients who previously had no alternative to medical therapy. There are a number of relative contraindications to TAVI, which may change as the technology develops. These include bicuspid aortic valve (because the altered anatomy makes secure placement of the transcatheter valve potentially unstable), previous mechanical AVR, endocarditis, recent myocardial infarction or cerebrovascular accident, moderate to severe mitral or tricuspid valve regurgitation, left ventricular or atrial thrombus, aortic annular dimensions outside the manufacturers range (device-specific), ascending aorta.45 mm. 795

5 Klein et al. Table 3 Patients currently suitable for transcatheter aortic valve insertion. AVR, aortic valve replacement Criteria Logistic EuroScore.20 Severe respiratory disease Refused surgery by two surgeons Previous sternotomy and patent coronary artery bypass grafts Rationale After referral for TAVI, detailed TTE is required to confirm the diagnosis, assess disease severity, and establish the annular and ascending aortic dimensions. If views are inadequate or the aortic valve annulus cannot be accurately assessed, transoesophageal study may be required. Coronary angiography is performed, and angioplasty may be indicated if proximal flow-limiting lesions are present to minimize the extent of non-revascularized myocardium. CT, angiography, or both are also required to allow detailed assessment of potential vascular access. In addition, comorbid conditions should be carefully assessed and optimized if necessary. A team approach to patient assessment and investigation is essential. 12 Comprehensive anaesthetic input is necessary; this should include preoperative assessment by the anaesthetist involved in the programme. Multidisciplinary meetings to plan the procedure should take place, and the anaesthetist should attend these as a matter of course. Hybrid catheter laboratory The ideal location for the TAVI is a hybrid location combining features of the catheter laboratory and operating theatre. 27 High-quality fluoroscopic imaging equipment is required to facilitate precise device placement. The room used must conform to operating theatre standards, including piped anaesthetic gases, vacuum and gas scavenging. In addition, a CPB machine should be in the room, ready for use with a dry circuit fitted. Other equipments required for the procedure includes cell salvage and proper surgical lighting (headlamps may be sufficient). Anaesthetic management High-risk of mortality with conventional AVR Risk of prolonged postoperative mechanical ventilation Consensus of opinion regarding unsuitability for surgical AVR Risk of cardiac or coronary artery bypass graft damage during re-do sternotomy Preoperative care Baseline haematological and biochemical testing should be performed and 2 U of blood should be cross-matched. Aspirin 300 mg is given before operation. Consideration should be given to i.v. preoperative hydration, especially in patients with chronic renal dysfunction. This may reduce renal injury secondary to contrast administration during the procedure. Intraoperative care If general anaesthesia is chosen, a cardiac type anaesthetic, aiming for haemodynamic stability, is appropriate. This should include large-bore i.v. and arterial access, usually placed under local anaesthesia before induction. Nitrous oxide should be avoided because of cardiac depression and potential expansion of intrathoracic air. Tracheal intubation and mechanical ventilation are necessary to facilitate passage of the transoesophageal echocardiography (TOE) probe. Central venous access and urinary catheterization are performed. Standard antibiotic prophylaxis for valve surgery should be administered according to local protocol. Continuous patient warming is used, including fluid warming, throughout the procedure, and the patients temperature continuously monitored. In some instances, transarterial AVR may be carried out under local anaesthesia and deep sedation. This may avoid complications potentially associated with general anaesthesia in patients with severe chronic disease, but may not provide ideal operating conditions. Patient movement may jeopardize the procedure leading to complications. Airway obstruction may occur and may be difficult to diagnose because of restricted access and environmental distractions. If open surgical transarterial access is required, local anaesthesia and sedation may be insufficient. In addition, TOE is not possible, which may make intraoperative echocardiographic assessment during the procedure more difficult or impossible. TOE is superior to TTE because it allows continuous visualization of the aortic valve during the procedure, assisting the operator in correct placement of the device. 1 It can also be used to accurately measure the aortic annulus, essential for valve sizing (as opposed to open sizing in conventional AVR). In addition, it allows rapid diagnosis of complications and guides management of severe haemodynamic compromise. Newer threedimensional technology may further improve the understanding of the dynamic anatomy, and is currently being evaluated for this procedure. Cell salvage should be used; in the majority of cases blood loss will be minimal, but on occasion will be significant during vascular or left ventricular closure. Therefore shed blood should be collected in a heparinized custom reservoir, and processed for autotransfusion when an adequate volume is present. Valve implantation procedure After the stenotic valve has been crossed with a guidewire, balloon aortic valvuloplasty is carried out to dilate the native valve before deployment of the device. Rapid ventricular pacing is instituted via a temporary transvenous or epicardial ventricular pacing wire to reduce left ventricular ejection and cardiac motion, therefore stabilizing both the 796

6 Anaesthesia for transcatheter aortic valve valvuloplasty balloon during inflation and the valve during deployment. TOE and arterial waveform observation are used to verify the lack of ventricular contraction and peripheral arterial pulse waves during testing of rapid ventricular pacing. 2 After each episode, there may be considerable delay before optimum cardiac function resumes, accompanied by systemic hypotension. This period of haemodynamic instability is likely to be prolonged in patients with significant pre-existing left ventricular dysfunction. In such instances, the administration of vasopressors may be required, and very occasionally CPB will be necessary to allow resting of the heart. Catecholamine inotropic drugs such as epinephrine may worsen hypotension when administered to patients with left ventricular hypertrophy 4 and should be used with caution. Echocardiographic assessment should be used to provide guidance for vasoactive drug use during the procedure. Multiple imaging modalities are used to ensure optimal positioning of the device across the aortic valve including fluoroscopy, aortography, and TOE. After valve implantation, TOE is performed to assess the degree of paravalvular regurgitation, the patency of the coronary arteries, and to rule out haemopericardium and aortic dissection. Valve area and transvalvular gradient may be measured at this stage. Paravalvular regurgitation is often present immediately after valve deployment. This improves after hours, as the valve morphology alters at body temperature. Postoperative care Tracheal extubation can usually be performed at the end of the procedure. Close postoperative monitoring is necessary, and admission to an intensive care or highdependency unit is required, depending on institutional preference. Early critical care discharge is likely if the procedure was uncomplicated, and hospital discharge may be possible significantly earlier than after conventional AVR. After wound infiltration with local anaesthesia, analgesia requirements after transfemoral AVR are minimal, and regular oral paracetamol is usually sufficient. However, the transapical approach is associated with more severe pain after operation. Intercostal local anaesthesia nerve block may be very effective, in combination with i.v. patientcontrolled opioid analgesia and regular oral paracetamol. Regular aspirin and clopidogrel, starting soon after the end of the procedure, are recommended by the manufacturers unless contraindicated. These are normally continued for 3 6 months. Patients who re-present after TAVI for non-cardiac surgery can be managed similarly to patients after conventional ( pericardial) AVR. There is no evidence that discontinuing anti-platelet drugs increases the risk of valve thrombosis perioperatively, and full heparinization is not required. Review of published data After early experience in animal models, the first human percutaneous transcatheter aortic valve implantation was performed in Since then, equipment and techniques have evolved rapidly, and more than 1000 TAVI procedures have now been carried out. 22 The paucity of published outcome data has, in part, been compromised by commercial sensitivities and protracted copyright legal cases. Transvenous approach Initially, transcatheter intervention procedures were carried out using a transvenous trans-septal approach to the aortic valve via the femoral vein. 15 This route avoids the potential complications associated with arterial access, namely small vessel calibre, vessel tortuosity, and atherosclerotic occlusive disease. However, crossing the interatrial septum and mitral valve with a large device is technically challenging, risks damage to intracardiac structures, and may be associated with haemodynamic instability. The technique has been shown to be feasible but difficult to reproduce and its complexity has limited its widespread use. Initial studies (I-REVIVE and RECAST trials) reported the successful use of transcatheter aortic valve implantation in 27 out of 36 high-risk patients deemed inoperable for conventional AVR However, moderate or severe paravalvular leak occurred in 17 patients (63%). In addition, major adverse cardiac and cerebrovascular events occurred in seven patients (26%) at 30 days and in an additional 10 patients (37%) at 6 months. Major events within 30 days of the procedure included six deaths and one stroke. Deaths were caused by cardiac tamponade (two patients), sepsis (one patient), heart block (one patient), ventricular arrhythmia (one patient), and unknown aetiology (one patient). Transarterial approach The retrograde transarterial method of aortic valve implantation was developed as an alternative to the transvenous approach. 29 This is now the method of choice for transcatheter AVR. Single-centre experience with a transarterial balloon-expandable aortic stent valve (Cribier-Edwards Valve) has been reported in 50 high-risk patients. 30 Valve implantation was successful in 86% of patients, intraprocedural mortality was 2% (one patient), and 30-day mortality was 12% (six patients). The intraprocedural death was caused by aortic injury. The additional five post-procedural deaths occurring within 30 days were owing to ventricular arrhythmia, left main stem coronary artery occlusion, iliac injury, stroke and multiorgan failure (one patient each). Although the logistic EuroSCORE is not validated for transcatheter valve implantation, the estimated 30-day predicted mortality for this patient group for conventional surgery was 28%. After 1 yr, there were significant benefits in terms of valve area, left ventricular ejection fraction, mitral 797

7 Klein et al. regurgitation, and functional status. There was no evidence of structural device failure during follow-up. Multicentre experience with the device via the transfemoral route has been reported in 86 high-risk patients. 13 Valve implantation was accomplished in 88% of patients and periprocedural mortality was 6% (five patients). Thirty-day mortality was 12% (10 patients) which compares well with the estimated logistic EuroSCORE of 22%. Serious morbidity was reported as occurring in 32% of patients. Multicentre experience of the transapical approach has also been published with similar results. Thirty-day mortality was 8% (four out of 50 patients), with serious in-hospital morbidity of 24%. 28 The results of ongoing studies in Europe and Canada (REVIVE trial) and the US (REVIVAL II) are awaited. In particular, evidence about the long-term function of the valves is required. Additionally, there is anecdotal evidence that a relatively high number of patients are left with a degree of residual ( paravalvular) aortic regurgitation. The significance of this is also not yet known. The high rate of morbidity associated with both approaches to transcatheter AVR is obviously of some concern. The incidence of similar morbidity in comparable high-risk surgical patients is not clear. Randomized controlled multicentre trials of surgical and transcatheter AVR in high-risk patients are currently taking place. 5 The PARTNER trial started recruiting patients in April 2007, randomizing them between surgical AVR and TAVI or medical management and TAVI if surgery is contraindicated (full details at However, final results will not be available until Conclusion TAVI offers the attractive possibility of valve surgery without sternotomy and CPB. However, the procedure is still in its infancy. 20 A steep learning curve and further refinements are inevitable. As the technology continues to evolve, the devices are likely to become smaller and easier to deliver atraumatically. Experienced anaesthetic involvement is required, from inception and throughout the procedure itself. The results of ongoing trials are awaited, including randomized controlled trials. 5 Morbidity and mortality is currently relatively high in the patient group receiving this treatment, and long-term outcomes are not yet known, therefore caution is required when discussing the implications of surgery with each individual patient. Acknowledgement The authors wish to acknowledge the assistance of the Wythenshawe (Manchester) TAVI team in providing Figure 2 and some data for this article. Funding Funding was restricted to institutional and departmental resources. References 1 Berry C, Oukerraj L, Asgar A, et al. Role of transoesophageal echocardiography in percutaneous aortic valve replacement with the corevalve revalving system. 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